DMHT includes products designed to offer information, monitoring, guidance, diagnosis or treatment for individuals through a mobile phone app or other digital channel.  It is a broad term, encompassing everything from basic mindfulness apps to more sophisticated AI-driven therapy solutions.

Focus groups and interviews (involving current and potential users of DMHT) fed into a report, published in April, titled: Digital Mental Health Technology: User and Public Perspectives. The report forms part of a 3-year joint programme between the MHRA and NICE aimed at improving outcomes for people with mental health conditions with access to safe and effective DMHTs. The programme aims to leverage the insights and experiences of both current and potential users of DMHTs to shape the development of future regulatory and evaluation frameworks.

The report identifies several key findings:

• Most participants agree that, overall, there has been a notable improvement in attitudes towards mental health in recent years. Stigma nevertheless remains, particularly in certain settings, including the workplace.
• Capacity cannot keep up with the growing demand for mental health services.
• The consensus is that DMHT could make a valuable contribution within mental health care and support.However, it should form part of a wider integrated package of care, as opposed to being a substitute for formal diagnosis and professional help.
• Around half the participants had used DMHT to support their mental health – most of these were basic products such as mood trackers and meditation apps.A high proportion of users had since stopped - cost (many apps charge a monthly or annual subscription) and effectiveness being barriers to longer term use.
• The individual experiences captured in the report present an interesting picture – people are increasingly open-minded to the benefits which technology can offer. In today's climate, where long waiting lists restrict access to care, DMHTs can provide immediate, anonymous, and convenient options for many, and help bridge the widening gap between demand and capacity.

Nevertheless, many participants are reluctant to rely entirely on technology. For formal diagnosis and treatment, being seen by a healthcare professional is still considered the 'safer' route, and the benefits of face-to-face interaction cannot be replicated by an app.   

One key area of focus in the report is around the regulation, and quality control, of DMHT. The report highlights the potential complexities, and challenges, in ensuring a consistent approach, especially since the level of potential risk will vary considerably between different types of app.

The report provides an interesting insight into both the opportunities, and limitations of DMHT – when used in the right way, technology can play a vital role in supporting our already over-burdened mental health services.  But the consensus, for now at least, is just that – it is a supporting role.  The medical profession remains critical – as one participant put it: "Empathy is really important – you don't get this from an app".

 The report's findings will help focus further research, and the design of future regulatory and evaluation frameworks, for DMHT.  It seems likely that the MHRA and NICE will seek input from DMHT developers as part of their wider programme of research.  Developers, and their insurers, will want to keep abreast of this and seize every opportunity, where possible, to proactively engage in the research programme; the outcomes of which could significantly impact the future regulation of their products.

In February 2023, five EU countries submitted a proposal to ban more than 10,000 PFAs. PFAs most commonly known as 'forever chemicals' comprise a group of thousands of synthetic chemicals which are degradation, heat and oil resistant. These properties make PFAs useful in the medical industry, in both products and production processes.  They are used in an extensive list of medical devices and supplies including implants, ventilators, surgical meshes and protective gowns. Moreover, they can be used to extend the shelf life of many pharmaceuticals and are used in special paints which allow hospitals to use strong cleaning chemicals to sterilise rooms. Many PFAs have limited or no alternatives and as such they are arguably a critical, albeit microscopic, part of how our medical industry functions. 

However, the fact PFAs do not break down over time means that they accumulate in the environment, animals and humans for decades. The Norwegian Environment Agency (involved in the draft EU proposal) stated:

"You can find PFAs in penguins in the Antarctic, in polar bears in the Arctic, even in the rain water in Tibet". 

According to the European Environment Agency these 'forever chemicals' can lead to problems such as:

"liver damage, thyroid disease, obesity, fertility issues and cancer"

As people become increasingly aware of possible associations between PFAs and health issues, there has been an increase in litigation. For example, in the US a class action brought against Thinx, a manufacturer of period underwear, resulted in a huge settlement at the beginning of the 2023. A further class action is being pursued against a similar producer of menstrual underwear, Knix Wear, which advertised its products as free of 'forever chemicals'. 

Discussions by regulators around the banning of PFAs are gaining traction globally. In September 2022, California banned the sale of many consumer items containing intentionally added PFAs. More recently, the EU's proposed ban aims to reduce the presence and continued accumulation of PFAs in the environment. Last April, the UK Health and Safety Executive (HSE) followed suit and published an assessment of the use of PFAs in the UK, which includes recommendations to ban hundreds of PFAs.  

Global steps towards a ban on PFAs may present a difficult challenge for manufacturers in the medical industry in considering whether there are alternatives that can be used. The five  EU countries behind the EU proposal stated that: 

"In many cases, no such alternatives [to PFAs] currently exist, and in some they possibly never will."

Major manufacturers in the healthcare industry are looking to change their product strategy, for example, by investing in sustainable coatings for medical devices, and phasing out the use of PFAs where alternatives are available. However, for other medical devices, where there are no available alternatives to PFAs, further research and investment will be required. 

Finding the way to regulate the use of PFAs, particularly in the healthcare industry will be crucial. Differentiating the essential nature of its use in that industry, which saves lives, from other industries where suitable alternatives may be readily available is key.  

The Johner Institute, a consultancy which supports medical device manufacturers with research around product development and regulatory compliance, believes a solution is to develop a risk-based regulation in which the amount of PFAs any product contains, along with the type of exposure, and the inherent risks of the substance used, are determined. The Johner Institute considers that "risk acceptance must again depend on benefits". 

So, does the risk posed by PFAs depend on the benefits of its use? In the medical industry, perhaps the answer is that it does. An outright ban of PFAs before suitable alternatives are identified could have a significant impact on the lives of vulnerable people who depend on those products. Careful consideration must therefore be given to any regulation developed to ensure the rights of patients are protected.  

PAs and AAs are unregulated healthcare professionals who work under the supervision of GMC registered doctors and surgeons to provide medical care as part of a multidisciplinary team. PAs and AAs currently have direct contact with patients and are expected to undertake key tasks, which include performing diagnostic and therapeutic procedures, analysing test results and developing management plans.

PAs and AAs usually undergo a three-year undergraduate degree followed by two years post-graduate training (to include 1,600 hours of on-the-job clinical hours) and are not required to specialise in any specific field of medicine.  The PA and AA qualification route is significantly less onerous compared with the five years of medical school training and two years of NHS placements undertaken by registered doctors.

At present there are circa 1,500 PAs working in hospitals and 1,700 in primary care settings in the UK. However, the Government's NHS Long Term Workforce Plan (published in June 2023), includes a proposed expansion of up to 10,000 roles by 2036/37 for PAs and AAs to help fill record NHS vacancies.

In addition, the Government has set in motion its plan to regulate PAs as if they were doctors – under the auspices of the GMC.

In strong support of the strategy, Victoria Atkins, the current Health and Social Care Secretary, has said that "PAs and AAs are already making a great contribution to the NHS, supporting doctors to provide faster high-quality care for patients. This new legislation paves the way for these professionals to be held to the same strict standards as doctors, boosting patient safety".

The backlash to the Government's long-term plan has however been significant with the Doctors Association (DAUK) calling it "hazardous". DAUK say that although PAs and AAs hold an important support role within the make-up of the NHS, they do not undergo the "extensive rigorous training" of a doctor or develop the "depth of experience that defines a doctor's professional capacity".

In response to the Government's plans, the BMA circulated an anonymous UK wide survey (said to be the first of its kind) asking for their members' (primarily registered doctors) and the public's views on the role of PAs and AAs in healthcare.

87% of doctors participating in the poll reported that the way PAs currently work in the NHS is either "always" or "sometimes" a safety risk to patients. A further 86% of participants felt patients were not aware of the difference between PAs/AAs and those of registered doctors. Worryingly, such confusion was said to stem from an increase in PAs and AAs holding themselves out as doctors on social media or during patient consultations.

Doctors participating in the survey were also asked to describe their experience of working with PAs. One concerned GP stated their workload was "doubled" when supervising PAs, since "they do not possess the requisite knowledge to manage any complication" or "recognise when they are out of depth".  Another GP described their clinic PA as "the most worrying person I have ever had to supervise in over 30 years as a GP. Their basic knowledge is poor, they are unable to present a coherent history and examination, unable to formulate a differential diagnosis".

Responding to the survey results, Philip Banfield, BMA Chair, stated "here at last are numbers that show the shocking scale of concern from medics".

The BMA has called for the regulation of PAs and AAs to be by the Health and Care Professions Council (HCPC), the regulator for non-doctor healthcare practitioners (such as physiotherapists, dieticians and paramedics) to avoid blurring the lines between the roles of doctors and other healthcare professionals. Encouraged by the BMA, over 10,000 UK doctors have written to their MPs, urging them to oppose the proposed changes to expand PA and AA numbers and to regulate them under the GMC.

The BMA is also calling for 'Physician Associates' to be renamed 'Physician Assistants', as well as an immediate moratorium on the employment on PAs (and other medical associates) until there is clarity about their role and scope of practice.

What's Next?

Currently there is no suggestion that the Government is slowing down its plans. In November 2023 a draft Order providing regulatory powers to the GMC (the draft "Anaesthesia Associates and Physician Associates Order 2024") was laid down before Parliament for consultation. PA and AA recruitment drives have also been set in motion.

The concerns highlighted by the BMA poll serve as an important reminder to all healthcare organisations which employ PAs and AAs to ensure that they are appropriately supervised and demonstrate the correct skills, without straying beyond their remit or role. Of paramount importance is to ensure that patients being attended to by PAs and AAs understand who is treating them and the standard of care they are going to receive.

Insurers can play a key role in risk management by checking that their healthcare insureds have protocols in place to support and monitor medical associates, and that there are pathways to facilitate the escalation of a patient's care to a qualified doctor when appropriate.

A failure to take these precautions may result in an increase in patient safety incidents, bringing with it an increased risk of claims. It follows that healthcare organisations need to ensure that appropriate indemnity provision is in place for any PAs and AAs and that their healthcare insureds' risk management systems and policies are fully up to date and sufficiently robust.

Covid then shifted practices to reduce in person contact to protect staff and patients from the risk of infection. Although pandemic pressures have now eased, remote GP consultations remain a commonly used  means of delivering care. Experts from Nuffield Trust and Oxford University examined 95 UK safety incidents within GP practices and Out of Hours settings between 2020 and 2023, such as settled compensation claims, reports and complaints. 

Errors made over the phone included missed diagnoses and an underestimation of the severity of serious conditions including sepsis, cancer and congenital heart disease. It was concluded that such errors would not have been made if patients had been examined face-to-face. Further, the study identified an increased risk of patients coming to harm if they had urgent symptoms such as new abdominal or chest pain.

To address these risks, the study recommends that general practice staff carefully consider arranging face-to-face appointments for patients who have undergone initial remote consultations but are not showing signs of improvement. This approach can help ensure a more thorough examination and evaluation, reducing the likelihood of oversight or misinterpretation of symptoms. In addition, patients with pre-existing complex illnesses may benefit from face-to-face consultations, as these cases often require a comprehensive understanding of the patient's medical history and a detailed physical examination. Furthermore, it is suggested that clinicians may wish to consider refresher training on telephone and online consultations covering history taking, rapport building and safety netting.

There is potential for the types of risks identified in the study to translate into an increase in claims. This will be of considerable concern for Practices, practitioners and their insurers, particularly given the potential exposure to substantial damages given the nature of the conditions referred to in the study.

Insurers will want to satisfy themselves that Practices have robust protocols for remote consultations in place to identify, assess and manage risks, including those of misdiagnosis. For Practices and practitioners, implementing the recommendations made in the study will assist in mitigating the risks. In addition, clear and effective communication channels should be in place to facilitate the escalation of a patient's care as necessary to ensure that any concerns or the need for further intervention are promptly addressed and actioned. 

Sales for these injections and other semaglutide products have increased 300% in the last three years. Novo Nordisk, the largest manufacturer of weight loss injections, reported a 77% increase in Ozempic global sales in 2022 alone.

The surge in sales is propelled by Medi-spas (hybrids between traditional day spas and medical clinics), and online pharmacies, which sell the injections for off-label weight loss use.  Clinically, the injections are recommended only for patients with a BMI over 30; however, undercover investigations have found clinics offering the products without verifying BMI or even when customers have overtly revealed that their BMI falls below the suitability requirements.

The off-label use of the injections is raising numerous health concerns. Doctors in the US have reported Ozempic-users coming into A&E with severe complications from malnutrition as a result of their suppressed appetites. In early October 2023, the FDA required an update to Ozempic's labelling, in response to user reports that it could cause blocked intestines.

Some of these novel health concerns are sprouting into litigation. Novo Nordisk has been sued in the US, alongside its competitor, Eli Lilly. The plaintiff alleges that the injection caused gastroparesis- a condition which stops the intestine absorbing any nutrients. The lawsuit recognises that weight loss is an off-label use for the injection, but states that this is widely popularised in the media. It claims that manufacturers are aware of the popularity of this use and mimic this trend in their advertising. The claim references Novo Nordisk's 2018 ad-campaign, which stated that "adults lost on average up to 12 pounds", with the 1970s pop-classic "Magic" playing in the background. The lawsuit therefore alleges that, in the circumstances, the manufacturers have failed to adequately warn prescribers and patients of known risks associated with the injections.

Plaintiff law firms in the US are scouting the market for a new class action. Some firms have been offering consultations to consumers of the injections who have experienced adverse side effects. The firm representing the plaintiff against Novo Nordisk and Eli Lilly has reported that 400 people have come forward with potential claims – but they anticipate the numbers will grow into the thousands.

Whilst these movements have been contained in the US, what happens across the pond tends to be mirrored in the UK – also a large consumer of these products. In the UK, semaglutide products are only available on prescription; however, prescribers operate in a variety of settings, including online pharmacies and Medi-spas' which might escape robust oversight.

Manufacturers must have clear guidelines for the intended purposes of their products, and show caution in warning about side effects from known off-label uses. Where insuring prescribers, whether at Medi-spas or pharmacies, insurers should consider the risk exposure, where prescribers may not be following the manufacturer's guidelines – such as failing to undertake proper medical checks into a user's suitability for these 'weight loss' products.

Mass litigation around these trending weight loss injections is bubbling under the surface and insurers should be alive to the emerging risks.

The use of AI in medical devices brings about new risks. For example, AI relies on the data fed into it. This means medical devices may be trained on data sets which underrepresent certain population groups. As a result, these devices can have reduced efficacy or safety when used on patients from those underrepresented populations.

To mitigate these new risks, the UK is working towards developing new regulatory frameworks. The MHRA is due to roll out changes to existing regulations over medical devices in 2024.  As an interim measure, in 2021, the MHRA, together with the FDA and Health Canada published 'Ten Principles of Good Machine Learning Practice'. The principles give guidance to developers of AI technologies on how to mitigate these new risks and best prepare themselves for compliance with future regulation.

Building on the existing 'Ten Principles' the MHRA, FDA and Health Canada have now also published 'Five Guiding Principles for Machine Learning-Enabled Medical Devices'. These new five principles offer a way for manufacturers of medical devices to avoid heavy regulatory burdens when updating and upgrading the AI systems in their medical devices.

Currently, when a medical device undergoes a sufficient degree of change, the manufacturer must inform its conformity assessment body. These bodies may require that the device is reassessed for approval. Since AI in healthcare needs to continuously adapt and respond to new input data, this creates a catch-22 for developers. They will want to ensure their devices are performing to the highest standards and adapting to new data generated by increased usage of the device. However, in doing so, they may be changing their device which in turn necessitates re-approval.

The five guiding principles aim to address this issue by offering manufacturers an alternative regulatory route where they have a 'Predetermined change control plan' (PCCP). This is a plan where the manufacturer specifies:

• Planned modifications to a device;
• A protocol for implementing and controlling those modifications;
• An assessment of the impact of those modifications.

This is good news for manufacturers. A robust PCCP can reduce regulatory burden by avoiding the need for reassessment. A PCCP does this by demonstrating that changes are safe, effective and will not negatively impact the performance of the device. Manufacturers will benefit from these principles when trying to navigate an uncertain and transitory regulatory environment around the use of AI in healthcare.

JS was considered a risk to herself resulting in treatment at a specialist child and adolescent psychiatric unit. Unfortunately, in the days after discharge JS was twice detained under s.136 MHA following acts of self-harm and attempted suicide. JS was then detained under s.2 MHA to an adult medical ward in order to treat the physical consequences of an overdose.

JS remained on the adult ward for several weeks, even after her detention under s.2 MHA expired. During this time, she made further self-harm attempts, leading to prescriptions for anti-psychotic and anti-depressant medications and the introduction of a 'Care Plan of Restrictions.' The Hospital Trust made an application to the Court of Protection for an order under s.16 MCA; seeking declarations that JS should remain in hospital and subject to the strict restrictions of the care plan.

Manchester University Hospitals NHS Foundation Trust v JS and others – the judgment

After considering the legal mechanisms by which JS had been detained, HHJ Burrows found that JS had been unlawfully deprived of her liberty after the s.2 MHA authority had expired. This was notwithstanding his finding that JS had a clear lack of mental capacity, and that the existing care provision in hospital (while "sub-optimal") was the most suitable option for JS at the time.

In his judgment, HHJ Burrows explored the relationship between the MCA and MHA. He summarised the MCA as applying "to anyone over 16 lacking the capacity to make any decision…It is relevant to those receiving care or treatment outside Hospital, but also to those receiving care and treatment in a hospital for conditions that are not mental health conditions." The MHA, on the other hand, (as its name would suggest) specifically deals with mental health issues and "is mainly concerned with patients detained in Hospital". HHJ Burrows found that JS was within the scope of the MHA and should have been treated under this Act. JS was ineligible for detention under the MCA and so she had been unlawfully deprived of her liberty.

An appeal against HHJ Burrow's decision was heard and dismissed by Theis J in August this year. Theis J went on to endorse the practical advice suggested by the Secretary of State for Health and Social Care, in situations where MCA and MHA decisions are unclear (set out in paragraph 118 of her Judgment).

Manchester University Hospitals NHS Foundation Trust v JS and others – the impact

JS is now entitled to bring a claim for damages for the unlawful deprivation of her liberty. This will be particularly galling for the Trust as JS had previously been lawfully detained under the MHA and this detention could have continued. The potential claim has arisen solely because of a misunderstanding of how the MHA and MCA should be used.

It is paramount that, when making decisions as to detention, medical practitioners ensure they properly understand the legal framework using the guidance set out by the Court:

1. Treatment under the MHA is preferable to the MCA when:

• the patient has to be detained for treatment for their mental disorder; and
• there is no alternative outside the hospital setting; and
• no other treatment plans are available.

2. The key benefits of detention under the MHA (when available) are:

• The MHA provides a framework of regulation for patients with complex mental health needs who require treatment in hospital, and the MCA cannot offer these same safeguards.
• The MHA puts power in the hands of medical professionals to deal with patient care, rather than the court.

Insurers may wish to consider drawing this guidance to the attention of any Insured who is required to make decisions on detention to prevent avoidable claims.

So, let's remind ourselves as to how we got here. A time that appears a long distant memory for doctors and insurers alike, when in line with Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, doctors had a limited duty to disclose anything to their patients about treatment options, as long as they were supported by a responsible body of medical professionals, i.e, the “professional practice test”.

Montgomery v Lanarkshire Health Board [2015] was a landmark case on the issue of informed consent.  The ruling established that a patient should be informed about anything they want to know in terms of alternative treatments – not just what a doctor deems necessary to reveal.  The case introduced a patient-based standard of care, whereby a doctor should discuss with their 

patient the material risks of treatment, and any reasonable alternative or variant treatment options (including no treatment).  This represented a significant move away from the professional practice test and towards a more patient-centred approach.

Whereas consent was once considered a supporting act to many clinical negligence claims, all of a sudden, consent became the star of the show!

McCulloch – what happened?

Mr McCulloch died of cardiac arrest following numerous hospital admissions for nausea, vomiting and chest pain. The day before his death, a consultant cardiologist discharged Mr McCulloch on the basis that his condition was not life-threatening.  A claim was brought by Mr McCulloch's widow and relatives, who made wide-ranging allegations of negligence against the doctor.  The key allegation was whether the doctor's decision not to administer non-steroidal anti-inflammatory drugs (“NSAIDs”), or to discuss that option with the Claimant, was negligent.  Medical evidence was heard by three cardiologists, and at first instance it was held that the cardiologist’s decision not to offer NSAIDs to Mr McCulloch was supported by a responsible body of professional opinion.  The Claimant's claim therefore failed.

On appeal, the Supreme Court held that the professional practice test (Bolam) applies to a doctor’s assessment of whether a treatment is reasonable.  It was found that the doctor's decision not to prescribe NSAIDs was reasonable because, in her professional judgment, she did not regard it as appropriate to offer them.  When supported by reasonable and logical expert evidence, the doctor had effectively discharged the duty to discuss all risks and alternative treatments, as established in Montgomery.

Impact on Defendants and Insurers

In McCulloch it was unanimously held that a “reasonable alternative” treatment (as described in Montgomery) should be considered using the professional practice test, rather than a purely patient-led approach.   It was held that a doctor should identify a range of reasonable treatments and explain these to the patient – however they are under no obligation to inform the patient about options they do not consider reasonable (even when they have knowledge of an alternative body of opinion which may deem the treatment 'reasonable'.)  

So, what does this mean? For one, McCulloch has essentially removed the uncertainty for doctors about feeling obliged to advise of all possible treatments. This has to be a good thing. Patients are reliant on the expertise of doctors to guide them on their treatment options. Claimant lawyers may disagree, but being inundated with options which could be unreasonable in the circumstances arguably puts too much onus on the patient.

This ruling has come as a welcome relief to medical professionals and their indemnity providers, with the Court emphasising the importance of professional skill and judgment when considering reasonable treatment options.  This approach was supported by the General Medical Council and British Medical Association, who both intervened in the appeal.  The judgment confirmed it is for the doctor to decide what constitutes a reasonable treatment option, not the court.

Whilst this decision is unlikely to take us back to the pre-Montgomery era, when it comes to clinical negligence claims, the Supreme Court has levelled the playing field for doctors facing allegations of inadequate consent. 

The facts of Blair v Jaber (where two passengers sought compensation from a taxi driver following a sudden brake), are not relevant to the clinical negligence sphere. However, the outcome of the decision undoubtedly is. The Claimants successfully argued that the general damages awarded should be increased due to "the unexpected and massive increase in inflation"; resulting in a hefty 12% uplift.

Recorder Jack accepted the Claimants' argument that he was entitled to consider whether a change in circumstances between the publication of the Judicial College Guidelines for the Assessment of General Damages in Personal Injury Cases ("the Guidelines") and the date of the compensation award meant the valuation should be departed from. He also accepted that "the very substantial drop in the value of money which has taken place since [the publication of the Guidelines]" was such a circumstance. In this case the increase was not significant (£8,000 increased to £8,960 for the First Claimant and £3,000 to £3,200 for the Second Claimant). In clinical negligence claims however, such an uplift could result in an increase of tens of thousands of pounds in other cases.

Defendants should now expect other claimants to follow suit and push for higher settlement figures. The practical impact of this should therefore be considered and steps taken.

Firstly, Insurers or their advisors should review any significant general damages reserves they are holding, and consider whether adjustments are necessary.

Secondly, existing settlement offers from Claimants which do not reflect the uplift but which remain open for acceptance should be revisited. Subject to the value of the offer and the likely uplift, a previously unattractive offer might now appear more reasonable.

Finally, all defendants and their insurers should be alive to the current fluctuations in the interest rate; a sudden decrease may give grounds for a successful defence to the uplift.

In early May 2023, concerns arose regarding the validity of test results at a centre in Ibadan, Nigeria. An investigation identified possible fraudulent or incorrect entries to the NMC register.  

To ensure professionals from abroad have the correct skills to provide care in the UK, they must complete a two-stage test of competence before joining the NMC register – a computer-based test in their home country and a practical test in the UK. Pearson VUE, which runs the computer-based test of competence programme on behalf of the NMC, alerted the regulator of ‘anomalous’ data at the Nigerian test centre. The results of more than 500 nurses and midwives working in the UK are now under scrutiny and testing at the centre is currently suspended.

No determinations have yet been made on the fitness to practise of the nurses in question, however, the NMC will write to the relevant individuals to advise them about the ongoing investigation. Andrea Sutcliffe, Chief Executive of the NMC, reported that "Data from one test site in Nigeria is unusual and concerning. We have regulatory processes which we will now follow and, if necessary, we can refuse registration or remove people from our register to protect the public and people who use health and care services".

Whilst an unusual set of circumstances, these events nevertheless serve as an important reminder to all healthcare organisations to ensure that staff demonstrate the correct skills and knowledge. There have been several instances in recent years of unqualified individuals posing as nurses, which has highlighted the need for organisations to  implement robust screening processes and regular monitoring. To fail to do so may cause problems in terms of insurance cover.

In addition, GPs must be aware of their duty to check the registration of the nurses they employ in accordance with the Royal College of General Practitioners guidelines. If found to be employing unregistered nurses, GPs face legal action and, again, insurance cover may be impacted.  GPs and other healthcare organisations can access the NMC's free employer confirmation service to check a nurse's current registration status and conditions of practice.

Ambulance services, out of hours services, walk-in centres and (to a lesser extent) GPs should be prepared for an increase in requests for mental health related assistance. Organisations should take steps now to ensure staff are appropriately trained to deal with any incidents and aware of: (1) what assistance they can provide; and (2) when (and where) to refer patients. Policies should also be put in place to assist with determining when an incident represents a threat to life and the police should therefore be contacted. Thorough training and robust policies will ensure staff are better equipped to deal with the likely influx, and able to make informed and defensible decisions. This will assist with defending any claims arising out of such assistance or, in a worst-case scenario, explaining actions at an inquest.

Insurers of the above services will probably want to consider whether the current policy provision is sufficient to cover the likely surge in mental health related interactions and attendances by their insureds. The Met estimates that almost a million hours are spent by officers waiting in hospitals for mental health patients to be assessed. This is just one element of assistance the Met currently provides, so the actual total is likely to be in the several millions. From 31 August 2023 onwards, these millions of hours will need to be provided elsewhere and the burden will, most likely, fall on ambulance, out of hours and walk-in services. Insurers of such services will therefore want to consider whether an increased insurance capacity is required.

The impact will not, however, be limited to out of hours services, walk-in centres and GPs as a variety of organisations rely on police assistance. For instance, it is common practice for mental health providers to ask the police to undertake a welfare check if a patient misses a mental health appointment. Such entities therefore need to consider how this service will be provided once Met involvement ceases. Unfortunately, it will likely be the organisation that faces possible criticism (and/or is subject to litigation) if a welfare check has not been completed and an injury or death occurs.

Each healthcare organisation should therefore consider undertaking a review of what assistance the Met currently provides and ensure that appropriate replacement provisions are in place from 31 August 2023 onwards. Failure to do so may result in a comparable surge in litigation and difficult questions at inquests.

Where we were

Introduced in 2013, QOCS is a form of costs protection in personal injury and clinical negligence cases. The purpose of the scheme was to "ensure that a party is not denied access to justice because of the prospect of incurring liability for adverse costs beyond its means". However, the Civil Procedure Rules Committee (CPRC) has made it very clear that that was the intended extent of the protection. It did not anticipate that some claimants might incur costs arguing unmeritorious points without any risk to themselves, and at a significant cost to defendants. The decisions of Cartwright and Ho, allowed this to happen, extending QOCS's intended limited effect to protect claimants from adverse costs orders and negating the need for costly After the Event ('ATE') insurance premiums.

So, what exactly went awry? In short:

• The Court of Appeal's decision in Cartwright precluded defendants from enforcing cost orders in their favour against damages payable to a claimant pursuant to a Part 36 offer or Tomlin Order. In practice, this called into question the utility of offers for defendants.
  
  
• In Ho, the Supreme Court (citing Cartwright) went a step further and ruled that defendants were not able to recover costs awarded in their favour by off-setting them against costs awarded to the claimant.

Both judgments left it open to the CPRC to revisit the Rules, with the Supreme Court recognising that its ruling in Ho "may lead to results that at first blush look counterintuitive and unfair".

Where are we now?

Well, the CPRC listened, and the amendments to CPR 44.14 have now been implemented, effectively reversing the decisions in Ho and Cartwright, and restoring some balance to the regime. The CPRC confirmed its intention "to ensure that adverse behaviours in litigation are discouraged and the claimant bears adequate financial risk". The effect of the changes will allow a defendant to enforce a costs order in their favour against:

• A cost order in a claimant's favour (in addition to those for damages); and
• Damages and costs payable to a claimant pursuant to a Part 36 offer or Tomlin Order.

These changes will likely give renewed bite to Part 36 offers made by defendants and their insurers, encouraging competitive offers at an early stage and putting claimants at risk on their damages and costs if a reasonable offer is rejected. Where claims are settled by way of a Part 36 offer or Tomlin Order, defendants can now recover costs in certain circumstances, and if necessary, by set off against the deemed order for damages, interest, and any claimant costs.

The rule amendments only apply to claims issued on or after 6 April 2023. Given the increased pressure they present for claimants and their legal representatives (with enhanced exposure to defendant costs orders), we anticipate that there has been a flurry of cases issued protectively, ahead of the deadline. This may result in claimants circumventing their obligations under the Pre-Action Protocol for the Resolution of Clinical Disputes, which (ironically) could incur cost penalties. 

The potential for satellite litigation arising out of the rule changes cannot be ruled out as a result of claimants attempting to avoid their effect. With the intention behind the changes having been made very clear by the CPRC, it is hard to see that any such attempt will result in us finding ourselves back where we were.

Whilst these changes will be very much welcomed by defendants and their insurers, it is important to be mindful that QOCS protection has not been completely eroded. It remains the case that if a defendant wins at trial, or the claim is discontinued, it will be unable to recover any costs (as there will be no order for damages and costs to enforce against). Pending a fixed costs regime affecting all personal injury and medmal cases, defendants still need to have a careful eye on the cost benefit of defending even unmeritorious claims, but at least for now defendants and their insurers can be assured that they are back on a more level playing field.

Yes, that is correct, two separate teams, in two separate countries, working together on the same operations. Described by Dr Jeelani as "man-on-mars stuff", these teams were provided with Metaverse virtual reality headsets, where the teams spent months practising to perfect the procedures using VR projections of the twins made up from their CT and MRI scans. This allowed the teams to successfully complete one of the most complex separation processes in history.

But what is the Metaverse and what does it mean for the future of healthcare?

In July 2021, Meta (previously Facebook) founder Mark Zuckerberg announced that the company would be transitioning from a social media platform to that of "the metaverse". As part of its evolution, Meta developed the highly advanced VR technology headset that was used for the twins' surgery.

In simple terms, the Metaverse is the amalgamation of physical and virtual realities. Take the CT and MRI scans of the twin boys as an example – these physical images were projected into a separate reality, where virtual surgery could be tried and tested before performed in real life. This has the obvious benefit of trialling risky surgeries without putting the patient at risk. As Accenture's 2022 'Digital Health Technology Vision Report' reported, the Metaverse is "the next horizon in healthcare", where surgical teams can practice and learn from procedures before performing the real thing.

A stark contrast to the traditional teaching of surgery (we all know the old adage "see one, do one, teach one"), this new technology allows medical professionals the opportunity for trial and error, prior to performing real surgery. This has many benefits for the future of medicine. Recent medical students at the University of Connecticut were taught and performed real life surgeries using Meta's VR technology. Metaverse surgery allowed mistakes to be made in virtual reality and feedback to be shared and actioned before the students carried out the procedures on real-life patients. Owing to this, it was stated that students were able to learn 570% faster with a 7x increase in performance.

VR technology has benefits for seasoned professionals during live surgery too, such as to help navigate surgical instruments to the correct place, and to alert surgeons when they should consider removing additional, suspect tissue.

Ultimately, this means that medical professionals will be confident performing highly intricate and ever-changing surgeries, and that confidence will surely benefit the patient experience leading to fewer claims and a more efficient and streamlined process.

For medmal insurers, the challenge will be keeping up with this everchanging technological landscape. Underwriters will want to examine policy wording rigorously to ensure that risks are properly identified, and careful consideration is given to where cover should fall. The age-old question of distinguishing operator error from product performance is likely to arise, territorial limits may need to be reviewed and surgical roles and responsibilities carefully defined.  What we can be sure of is that 'space-age medicine' has well and truly arrived.

The Principles, published last week by the US Food and Drug Administration (FDA), Health Canada and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), are intended to serve as the bedrock for developing GMLP and facilitate growth.

We have looked at the Principles to highlight litigation and regulatory risks that healthcare companies and their insurers should guard against.

• Risk: Products developed without input from clinicians on possible risks to patients

  
  A product could be placed on the market before "real world" considerations are assessed, based on doctors' experiences. The product may function perfectly, but only in the mind of a software engineer who does not have clinical experience. The Principles encourage obtaining multi-disciplinary clinical expertise throughout a product's lifecycle to ensure a product is as safe as possible.

• Risk: Data collected and used for machine learning is not representative of the intended patient population

  
  If a data set is taken from too narrow a patient group, the result could be sub-optimal treatment of medical conditions where AI is used to assist diagnosis. The Principles encourage ensuring that data adequately reflect the intended patients' age, gender, sex, race and ethnicity.

• Risk: Products placed on the market before the risks of injury and side-effects are adequately investigated

  
  Recent history is littered with examples of products whose risks were not fully understood until many months or years after they had been prescribed to large numbers of patients. The Principles advocate using machine learning models that support the mitigation of risks at the outset, based on an understanding of the clinical risks and benefits.

• Risk: Human factors not taken into account

  
  Humans interact with technology but are fallible; they may misinterpret the results of AI analysis or be too dependent on AI where common sense would show that a different decision should be made. The Principles recommend that manufacturers address how people interpret data when developing AI models.

• Risk: The laboratory used as a substitute for real-life

  
  Conditions in the testing phase of a product must be relevant to real-life conditions, or else the product will under-perform (or perform differently) when it is placed on the market. The Principles support making laboratory conditions as relevant as possible by predicting what the intended patient population and the clinical environment will be.

• Risk: The manuals and instructions accompanying a product are sub-standard

Where a product is alleged to have caused an injury, the courts will assess the information and instructions that accompanied it. Clear warnings by a manufacturer, about a product's intended use and limitations, can make the difference between a product being deemed "safe", as opposed to "defective." The Principles remind manufacturers to ensure that users are provided with clear information that is appropriate for the intended audience, whether providers or patients.  

The Supreme Court has handed down its judgment in Ho v Adelekun [2021] UKSC 43, removing the ability of defendants to recover costs awarded in their favour by off-setting them against costs awarded to the claimant in certain situations. This overturns the earlier Court of Appeal decision, along with the decision in Howe v MIB (No.2) [2017] EWCA Civ 932.

The issues in Ho

The underlying claim in Ho was a personal injury dispute which settled for £30,000 by way of acceptance of a Part 36 offer, with the Defendant liable to pay the Claimant's costs. The Defendant then contended that the Claimant was entitled to no more than 'Fixed Recoverable Costs' rather than assessed costs on the standard basis. The point was argued to the Court of Appeal, where the Claimant lost and was held to be entitled to fixed costs of around only £16,700. The Defendant was awarded the costs of the appeal, which amounted to £48,600.

The Claimant argued that she was protected by Qualified One-Way Costs Shifting (QOCS) from paying any of the Defendant's costs. The decision in Cartwright v Venduct Engineering Limited [2018] had already made clear that neither a Tomlin Order or a Part 36 settlement could be considered to be a court order for 'damages and interest' (see Part 44 CPR) such as would trigger a successful defendant's right to enforce an order for costs against damages paid. The Defendant argued, however, that it was possible to set off the costs ordered in favour of one party against the costs ordered for the other, which would wipe out the £16,700 costs payable to the Claimant.

The Court of Appeal held itself bound by the earlier decision of Howe and accepted the Defendant’s interpretation of the rules. The Claimant appealed on this issue to the Supreme Court.

A reluctant ruling by the Supreme Court?

The Supreme Court unanimously, albeit apparently somewhat reluctantly, allowed the Claimant's appeal. It held that off-setting costs constitutes "enforcement" for the purposes of the QOCS provisions in Part 44 CPR. Accordingly, it is not possible to off-set a defendant's costs against the claimant's costs. Defendants can therefore no longer expect that they will recover costs awarded in their favour (e.g. at an interlocutory application) by way of offset against costs awarded to the claimant upon settlement of the case.

The Supreme Court justices appeared reluctant to rule on such a procedural question at all, recognising that this ruling "…may lead to results that at first blush look counterintuitive and unfair. Why should a defendant which has a substantial costs order in his favour have to pay out costs to a claimant under an order made against him when the two costs orders would net off against each other, leaving both sides to meet their own solicitor’s costs themselves?" Nevertheless, on a correct interpretation, this was the effect of the Rules.

The judgment left it open to the Civil Procedure Rules Committee to amend the Rules if the Supreme Court’s interpretation of them did not reflect how the QOCS regime is supposed to operate.

What this means for defendants and insurers

This ruling further erodes the fairness of the QOCS regime for defendants, particularly in the context of medical malpractice cases where most cases (even those with little merit) settle before trial. It also partially undermines the defendant's most powerful weapon in the CPR armoury to put the claimant at risk of paying the defendant's costs: a Part 36 offer. It is no longer a given that a defendant can enforce its costs against a claimant’s costs if the claimant fails to beat the offer at trial. By way of example: if a defendant makes a Part 36 offer of £10,000, and the claimant fails to beat the offer at trial, the defendant's costs recovery will be limited to the level of damages awarded. The defendant's costs could be much higher, but it can no longer seek the balance of its costs by offsetting against the claimant's costs.

Ever since the introduction of QOCS in 2013, defendant practitioners have seen an increase in unmeritorious claims being pursued way beyond the pre-action stage, only to be abandoned late in the litigation when considerable defence costs have been incurred. We may now see reasonable defendant Part 36 offers being increasingly ignored or rejected. This decision therefore arguably goes beyond what the QOCS rules were designed to achieve, which was essentially to stem the recovery of large ATE premiums and success fees, by protecting the claimant from paying the defendant's costs as a 'trade-off'.

This decision gives no extra protection to claimants; the chief beneficiaries are claimant lawyers whose costs are now further insulated, which again was not the intention of QOCS. Surely, this decision must lead the Civil Procedure Rules Committee to review the QOCS provisions to redress the imbalance. Only time will tell.

For now, the decision in Ho means that claimants and their solicitors can sleep very comfortably at night, knowing that their costs are further protected from the scary prospect of offset by the QOCS 'Ghostbusters'.

1. Bloods that are required to facilitate a 'two week wait' referral (potential cancer cases);
2. Bloods that are extremely overdue and/or essential for safe prescribing of medication or monitoring of conditions;
3. Bloods that could avoid a hospital admission or prevent an onward referral; and
4. Those with suspected sepsis or conditions with a risk of death or disability.

Allegations of a delay in diagnosis of a serious condition are among the most common negligence claims faced by GPs. As a patient's primary care provider, a GP is the first medical practitioner to review a patient who has concerns. There may be occasions when a serious condition is not immediately recognised, perhaps due to the presenting symptoms being consistent with a different, less concerning, medical issue, or the symptoms requiring monitoring for potential improvement before further investigations take place. This can result in delays in the patient receiving treatment, and the GP's (alleged) failure can become the subject of litigation.

Such a claim will be founded on the basis that earlier diagnosis would have avoided a period of pain and suffering and/or that the patient's outcome may have been better, or (in very serious cases) that the delay led to death. GPs prudently seeking to avoid such claims might well institute precautionary investigations, including blood tests.

The current shortage of test tubes means that GPs will have to decide (with relatively little guidance) which blood tests are urgent and which can wait. It is certainly foreseeable that a GP could be criticised for deciding a blood test was not "clinically urgent" if later investigations reveal a sinister diagnosis for which prompt treatment was key.

In order to protect themselves, GPs should ensure they keep comprehensive notes setting out why they have concluded a blood test is "clinically urgent" or not. Where they conclude the latter, a detailed summary including references to the patient's symptoms, possible causes of the symptoms and the reason why a blood test can be delayed should be included, in order to assist with explaining the decision in the event it later becomes the subject of an allegation of avoidable delay.

GPs should also ensure that they have robust follow up procedures in place. If a decision is made to delay a blood test, the patient needs to be explicitly told that a blood test would usually be desirable but that it is being delayed due to NHS England guidance;  the GP should explain why it is considered that the delay is unlikely to have adverse consequences. The GP should record this conversation in the patient's notes. A plan should be agreed with the patient as to when the blood test will take place and how this will be arranged, and the patient's contact details should be confirmed to avoid any additional delay in arranging a necessary blood test.

The Report is set against a backdrop of events that the RHC says pose particular questions for the life sciences industry to grapple with, including:

• Brexit and the fact the EU has adopted new medical device regulations, whereas UK regulations are two decades old;
• The Independent Medicines and Medical Devices Safety Review, published last year by Baroness Cumberlege that contained significant criticism of the existing regulatory regime; and
• The power at the government’s disposal to introduce secondary legislation under the Medicines and Medical Devices Act 2021. 

The RHC is an independent body and its recommendations are not UK government policy. However, the Secretary of State for Business, Energy and Industrial Strategy (BEIS), Kwasi Kwarteng, has warmly welcomed the Report, calling it “highly relevant and timely.” The Report will influence the government's plans for reform of medical device regulations.  Anyone whose work in medical devices encompasses risk management or insurance is encouraged to study the Report.

Based on our experience in advising companies on regulatory risks and defending product liability claims, these are three recommendations that caught our eye:

Recommendation: Centre the regulation of medical devices on the needs of patients

Implications

The RHC is pushing for patient representation on expert groups before devices are placed on the market. It also recommends that existing patient consultation initiatives should be expanded. Manufacturers would need to review how they explain to patients the balance of risks and benefits when seeking regulatory approval. They would also need to obtain better patient feedback from clinical trials.

Whilst these steps may increase costs, it could make products more immune to product liability litigation where patients suffer side-effects. The difficult question of how much risk is acceptable will have had patient input before a product is put into circulation. That will inform the court when it considers allegations that a product is defective. In addition, patient groups might demand better explanations of risks, or additional safety measures – which in turn may make products safer and less likely to attract litigation. 

Recommendation: Build international partnerships through mutual recognition of other jurisdictions’ regulations

Implications

The one aspect of medical devices regulation that is most likely to become a political hot potato is this: what was Brexit for? In the run up to concluding the “Brexit Deal” (the Trade and Cooperation Agreement of December 2020), the Prime Minister emphasised that Brexit was about sovereignty and the UK taking back control of its laws.

The life sciences industry has generally been sceptical that there can be much of a 'sovereignty dividend' from Brexit because UK manufacturers will need to comply with EU requirements to sell products there. Equally, European manufacturers will be keener on investing in the UK if the UK adopts broadly similar standards to their own. The RHC recognises this and refers to the need for “international efforts to increase regulatory cooperation, and reduce potential barriers to trade.” By acknowledging this issue, the Report chimes with points made by industry and regulators that are adding up to a clear warning to the government not to diverge too far from international standards.

Patient safety comes into this too. Baroness Cumberlege, in her report, suggested that the government should consider adopting the patient safety measures in the EU's new Medical Device Regulation 2017/745.

The Report supports our view that we expect that future UK regulations, for all but the most innovative products, will be broadly similar to EU standards.

Recommendation: Develop a UK patient safety database 

Implications

The RHC notes data programmes that are currently maintained by the Medicines and Healthcare products Regulatory Agency (MHRA) and the NHS. It calls for a combined reporting system for adverse incidents that should be held on a MHRA database. If this comes to fruition then it could mitigate the problem, identified by Baroness Cumberlege, that it has taken too long for regulators and manufacturers to spot trends when a product is underperforming.

Manufacturers and their insurers will welcome this initiative. Better data could lead to better systems, allowing manufacturers to issue more timely guidance to clinicians or even recall products from the market at an earlier stage.

What next?

Two recommendations the government has rejected

 The government has rejected two of the key recommendations that had caught the eye of insurers and manufacturers with experience of defending product liability litigation:

1. A compensation agency

The Report proposed establishing a "redress agency": a non-adversarial process, intended to supplement existing rights, to compensate patients injured by medicines and medical devices. However, the government has rejected this proposal, concluding that a new agency would not, in itself, make products safer or drive the right incentives for industry.

2. A payment scheme

The Report also recommend a "cost of care" scheme to provide payments for the costs incurred by patients where products have failed. The government does not think that this is necessary and has instead highlighted that patients can obtain compensation by suing healthcare providers for clinical negligence, or manufacturers for product liability.

Four recommendations the government has accepted

 Whilst a redress agency and payment scheme will not make it onto the statute book, the government intends to take up other recommendations made by Baroness Cumberlege. Amongst the recommendations the government has accepted are four that could have a significant impact on the litigation risk associated with life sciences products:

1. A Patient Safety Commissioner

The government has already legislated for a Patient Safety Commissioner through the Medicines and Medical Devices Act 2021. The government hopes that the Commissioner will "act as a champion for patients in relation to medicines and medical devices." The first Commissioner is expected to be appointed next year. Industry will be interested to see whether the Commissioner will work with manufacturers to improve safety standards - or become a high-profile advocate for patients seeking compensation from companies. A public consultation on the role of the Commissioner is open until 5 August 2021.

2. A change of focus for the Medicines and Healthcare products Regulatory Agency (the MHRA)

Baroness Cumberlege criticised how the MHRA responds to adverse event reporting and its approach towards regulating medical devices. The government has accepted this criticism and put its weight behind the MHRA's initiative to better equip itself to make timely and robust interventions to promote patient safety. This change of focus, aimed at spotting problems with products and removing them from the market sooner rather than later, could work for both manufacturers and the public in improving vigilance.

3. Guidance on consent

The Report found that there needed to be improvement over patients giving informed consent and that more should be done to ensure that information given to patients is clear and meaningful. The government has accepted this recommendation and supports the General Medical Council's (the GMC) revised guidance on consent, which came into effect last year. All other professional regulators will now consider this issue when they next review their guidance. A more uniform approach towards consent could drive up standards and limit the scope for arguments over whether hospitals and manufacturers have a defence based on consent.

4. Information for patients

Baroness Cumberlege recommended that a single patient aid (i.e. set of information) should be produced for every surgical procedure or medical intervention. The materials should be co-designed by patients and clinicians. The government has accepted this and has tasked the National Institute for Health and Care Excellence (NICE) with taking a lead in designing "Patient Decision Aids". As with the above initiative led by the GMC, industry will hope that these changes will speed up the resolution of disputes by providing more certainty over the information given to patients. The quality of instructions and warnings that accompany products can make or break a defence to a product liability claim.

Managing litigation risk in the post Cumberlege era

 The Review was commissioned in response to failings concerning healthcare products that go back decades. The government's response to the review ushers in reforms that are likely to have an impact on the litigation landscape for years to come. There is a lot more in the government's response than its rejection of the proposals to limit the role of the courts in compensating patients. Steps to give patients greater representation in the system, a change of focus for the MHRA, and a more uniform approach towards how patients provide consent and receive information may all have an impact on the litigation risk associated with life sciences products. The life sciences industry will want to make sure its perspective is taken into account. Manufacturers should engage with the government, MHRA, professional regulators and NICE as these changes take effect.

For decades, UK industry and government had become accustomed to life sciences regulations originating from Europe. Businesses needed to comply with only one set of rules in order to sell products across the EU and EEA, including the UK. 

If the life sciences industry had asked for Christmas presents from the UK government, then near the top of the list would have been a plea for clarity over whether the UK would use Brexit to introduce a low-regulation regime to rival the highly regulated EU market.

If the UK used Brexit to diverge from EU regulations, manufacturers would need to grapple with different rules to sell products in the UK compared to the EU. In the years following the referendum in 2016, there were whisperings from government of plans to introduce a low regulation regime in the UK. Angela Merkel, the German chancellor, warned of the risk, to the EU, of the UK morphing into a "Singapore-on-Thames". As the EU and UK took it to the wire to negotiate a trade agreement, the life sciences industry wondered what Boris Johnson meant by "taking back control" and "sovereignty" being at the heart of Brexit. 

Christmas present for medicines manufacturers 

The TCA agreed on 24 December 2020 acknowledges that Brexit has created barriers to trade but contains provisions to streamline how trade between the EU and UK is conducted in certain products. Medicines, along with other products such as wine and chemicals, are catered for by specific Annexes to the TCA. 

The Annex relating to medicines makes statements of intent but is light on detail. There are provisions that relate to mutual recognition of Good Manufacturing Practice (GMP) and concern record keeping, documents and inspections. Businesses have welcomed this as it should avoid the cost of duplicating the need to evidence GMP compliance.

What is of more interest is what the UK has agreed to in terms of the future direction of travel for medicines regulation. 

Under Annex TBT-2, the parties have agreed to "facilitate the availability of medicines" between the EU and UK, including by "promoting regulatory approaches in line with the relevant international standards". Standards should be in line with practices and guidelines developed by international bodies, notably the World Health Organisation (WHO) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). In addition, the parties have agreed to consult each other on proposals to introduce significant changes to technical regulations and to cooperate over developing and implementing internationally agreed standards. The TCA has created a Working Group to be made up of EU and UK representatives with the purpose of facilitating future cooperation. 

The effect of the UK signing up to these provisions in the TCA and Annex TBT-2 is that the UK does not intend to diverge from common standards with the EU that concern medicines. Both parties intend to cooperate so that future regulations will be aligned and drafted with international approaches in mind. 

This is not too much of a surprise. Even before Brexit, there was a trend towards countries' regulatory regimes converging. It makes sense for companies as well as patients. Business benefits where similar regulations are in force around the world. Development costs are reduced and more markets are available. For the public, medicines cost less, and post-production vigilance is made easier, where more patients are taking the same drug placed on the market in compliance with similar regulations.  

Cold turkey for medical devices 

The life sciences industry had grown used to a diet of EU legislation relating to anything from sticking plasters to knee implants but that has now come to an end. Whilst the TCA deals with medicines, it does nothing specific for trade in medical devices. Manufacturers must look elsewhere for clues about the likely future regulation of medical devices by the UK. This uncertainty is compounded by the fact that the UK and EU are shortly to be out of step when it comes to regulating medical devices.

Until now, the principal EU legislation concerning medical devices dated from the 1990s. Following high profile litigation concerning products such as breast implants and prosthetic hips, the EU created a new regime via the Medical Device Regulation 2017 (the MDR). The MDR is intended to learn lessons from the past and bring legislation into line with technical advances and changes in science over the last quarter century. The full application of the MDR was delayed due to the Covid-19 pandemic. There was an unforeseen consequence of this delay: because the MDR did not take full effect during the Brexit transition period, it is not part of the body of retained EU law that is automatically written into the UK statute book. But for accidents of timing, the UK would have adopted the latest EU law on medical devices. 

Will the UK remain out of step with the EU? Manufacturers can look to two sources for answers: the UK government's response to the report of the Independent Medicines and Medical Devices Safety Review (the Review) and statements by the UK regulator, the Medicines and Healthcare products Agency (MHRA).

The Review was set up to examine the healthcare system following concerns over pelvic mesh, sodium valproate and hormone pregnancy tests. Chaired by Baroness Cumberlege, it reported in July 2020 and concluded that all elements of the healthcare system share blame for failures. The Review highlighted the importance of stronger regulations to protect patients. It recommended that the UK develop standards that are "at least as stringent" as those set out in the MDR. 

On 11 February 2021, the Medicines and Medical Devices Act 2021 (the Act) came into law. The Act provides additional powers to the UK government to amend the law relating to medical devices. The UK government has referenced the Review and the MDR in explaining that the Act will be used to ensure that regulations applicable to medical devices can be updated. 

The MHRA has made statements that indicate it is likely the Act will be used to strengthen medical device regulations in keeping with the MDR. The MHRA sees this as part of its role in advocating for the UK's regulatory system to take into consideration international standards and global harmonisation of regulations designed to promote safety. 

Christmas bonus for the UK

The UK government's aim to attract investment in the life sciences sector was given a boost by the nation's contribution towards developing the AstraZeneca Covid-19 vaccine and by the MHRA being the first regulator to approve both the Pfizer and AstraZeneca vaccines in December 2020. Off the back of these developments, the UK government announced that pharmaceutical companies will be offered similarly fast-track approvals for innovative medicines, as the UK builds on the MHRA's role during the pandemic. It appears that such initiatives will complement, not detract, from the UK's commitments under the TCA to cooperate with the EU over international standards. In what would be a twist to the Brexit saga, industry will wait to see if an outcome of Covid-19 is that the MHRA positions itself with first-mover advantage, thereby playing an enhanced role in developing standards that the EU will adopt.

Christmases past and future

We all fervently hope that advances in Covid-19 vaccines and therapies will mean that Christmas Eve 2021 will be celebrated in very different circumstances to last year. Amidst the long hoped-for gatherings of family and friends, the anniversary of the EU and UK agreeing the TCA may be looked back on as a pivotal moment in the Brexit saga. It was the moment the UK government committed to a future where the UK remains in step with the EU over medicines regulation – whilst signalling that it will do the same for medical devices. Agreement was reached with the EU just as the UK was setting the agenda over Covid-19 vaccines. After years of uncertainty for the life sciences sector following the Brexit referendum, these developments will be worth raising a glass to. 

Political involvement in life sciences products reached a new level over Christmas and the New Year with the approval in the UK of the Pfizer/BioNtech (Pfizer) and the Oxford/AstraZeneca (AstraZeneca) vaccines.

A shot in the arm for innovation

In pre-pandemic days, the industry accepted (sometimes with frustration) the time required to run clinical trials, and the necessary caution shown by regulators in approving innovative products.

The process for developing and approving the Pfizer and AstraZeneca vaccines relied upon expedited clinical trials and a swifter regulatory approval process, as well as a regulation which allows for a "medicinal product" to be authorised "on a temporary basis" in response to the spread of an agent, including a pathogen, "which may cause harm to human beings". This is Regulation 174 of the Human Medicine Regulations 2012 (Regulation 174)

The Medicines and Healthcare products Regulatory Agency (MHRA) authorised the vaccines under Regulation 174 in response to the pandemic.  The MHRA is independent but its decision to use Regulation 174 is just the break-through that politicians were desperate for.

The use of Regulation 174, and the MHRA's approach which involved reviewing clinical trials data on a rolling basis, have been in the context of a global emergency. However, any individual suffering from a disease must cope with their own emergency – that, in many cases, will involve higher stakes for them personally than the pandemic. Charities, and other groups that advocate for innovative drugs to be brought to the market more quickly and efficiently, have taken an interest in the speed with which these new medicines have been approved.

The UK BioIndustry Association has argued that the experience of the pandemic ought to shorten the time it ordinally takes for a new medicine to go from an innovative idea to a treatment for patients.

Needling Pfizer and the BMA

The licence granted to Pfizer by the MHRA requires that the vaccine doses should be administered three to four weeks apart. However, to vaccinate as many people as possible, the government has extended the interval between the first and second jabs to up to 12 weeks. The government argues that this will provide broader protection to society as a whole.

In response, Pfizer has warned that there is "no data" to support plans to delay the second dose of its vaccine. The British Medical Association (BMA) has said the government's preferred timetable is unreasonable and unfair. The BMA has questioned the science behind the government's initiative.

By issuing new guidelines, the government has made the vaccine roll out an enormous exercise in administering medicines 'off licence' and has effectively pitted itself against the manufacturers and the Regulators. The approach is a stark example of expediency winning over the time-consuming process of varying a licence.

The US Food and Drug Administration has stated that the timeframes involved in the Pfizer vaccination programme should not be changed without another clinical trial, which also suggests that, in the UK, political factors, as much as scientific ones, are involved in decisions on how best to roll out the vaccine. 

Brexit booster

Gavin Williamson, the UK's Education Secretary, has been pilloried for boasting that the UK was the first to approve a Covid-19 vaccine "because we're a much better country than every single one of them". However, the UK has made a significant contribution in developing the AstraZeneca vaccine, being the first country to approve both the Pfizer and AstraZeneca vaccines and in leading the way in sequencing the genome of the virus's mutations.

According to Pfizer, other countries' regulators took their cue from the MHRA to see if they could also speed up their regulatory processes to approve its vaccine. The MHRA has also supported the World Health Organisation in working with other countries to approve the vaccines. 

Following Brexit, the MHRA has a chance to enhance its own reputation independently of the EU system. The UK government has announced that pharmaceutical companies will be offered fast-track approvals for innovative medicines, as the UK builds on the MHRA's role during the pandemic. This is part of a broader government initiative to attract life sciences companies to invest in the UK. Companies will be offered the same rolling review of data that speeded up approval of the Pfizer vaccine.

Who will call the shots?

The use of Regulation 174, decisions to administer the vaccines 'off label' and the novel approach taken towards clinical trials have all, to a greater or lesser degree, come about through political pressure exerted during an emergency. This is a change from the pre-pandemic position where progress was controlled by regulators and scientists.

A legacy of the pandemic will be greater interest in, and knowledge about, how life sciences products are brought to the market. Will scientists and regulators retain the upper hand, or will that role now fall to politicians?

In future, there will be more informed debate about how quickly innovative products can get from the laboratory to hospitals, whether temporary authorisation of medicines should occur more often and whether the regulatory system should be changed to boost industry in the UK following Brexit. Handled well, the legal and regulatory changes brought about by the pandemic could prove to be of lasting benefit for industry.

The Nocebo Effect is a phenomenon whereby a patient who is warned of possible adverse side effects from a drug, or is made aware of negative reports of a medical device, is more likely to suffer an adverse reaction from that drug or device than a patient who didn't know.  It is the sister of the Placebo Effect which occurs where a patient believes a treatment (even if it's a "sugar pill") will be effective and so benefits from it.

Whilst the Nocebo Effect has psychological origins, it induces genuine physical reactions in the body. The most commonly studied symptom is pain.

The Imperial College study*

A recent study into statins, carried out by Imperial College researchers, is a timely reminder of the phenomenon.

It notes from previous research that statins are a potentially-life saving drug, reducing the risk of heart attack and stroke by 25-35%, but about 20% of patients stop taking statins because of reported adverse side effects such as muscle aches, fatigue or joint pain.

The study, of 60 people over the course of a year, was a blinded trial using statins, a placebo and no medication.  Researchers concluded that up to 90% of reported side effects were experienced largely because of a "negative association" with the therapy, and not because of a pharmacological effect of the drug – the Nocebo Effect.

It is thought that the Nocebo Effect, as far as statins are concerned, is caused by GPs, cardiologists and the media emphasising the side-effects of the drugs to the detriment of balanced reporting.

We can infer that patients would have suffered fewer side-effects, and may have benefitted from the therapy, if reporting of the side-effects had been less alarming.

An increasing problem in the internet age

The Nocebo Effect could be on the rise due to a tendency for some products to be targeted on social media platforms, causing the internet to become flooded with criticism of the product.  Concerned patients, who may in fact be "worried well", access the internet, read the criticisms, and find that they experience the physical symptoms described in what they read.

The Nocebo Effect and litigation

Where patients experience side-effects, and the media pick up on it, litigation may follow: particularly where innovative products are concerned.

Manufacturers can face litigation in which claimants allege that a particular product is "defective" because it has caused an adverse reaction and therefore fails to meet the required safety standard. Where the adverse reaction is subjective and not clinically measurable, it is worth checking whether there are wider causes.  

The implications of the Nocebo Effect in these circumstances have been considered by the Court. In the metal-on-metal hip litigation, in which we acted for one of the manufacturers, claimants argued that the poor performance of some hip products, compared to other devices, meant that the products failed to meet the safety standard required in law. Often a claimant's first symptom was pain, which was understood to be an indicator of an unacceptable level of metal ions in the blood, but we noted cases in which first reports of pain followed alarmist media reporting of, for example "killer hips".

Relying on expert evidence from a behavioural scientist, we argued that wide-spread negative media reports had caused a worsening of some patients' conditions, whether resulting from a negative association or from a worsening perception of their symptoms. This was a factor in the relatively high numbers of patients undergoing revision surgery to explant metal-on-metal products.

This evidence was adduced in related litigation. On 21 May 2018, Andrews J handed down her judgment in favour of the defendant manufacturer in Gee & Others v DePuy International Limited [2018]. Andrews J concluded that the Nocebo Effect had affected performance data as it could:

"… lead to a subjective perception of increased pain and/or a loss of function; a misattribution of pain; and/or an increased willingness on the part of some patients to seek help, or to consent to revision surgery…"

Evidence of the Nocebo Effect was therefore an important factor in the Court deciding that the statistics relating to the safety performance of metal-on-metal hip products were unreliable.

Of wider public concern

The impact of media reporting, and the Nocebo Effect, goes beyond High Court litigation.

The media play a crucial role in informing the public about exciting, innovative medical products, and in investigating problems, reporting debate and disseminating information that is valuable and urgent to patients. However, the Imperial College study is just the latest example of the serious implications of unbalanced reporting. Individuals can be caused unnecessary anxiety and either stop taking vital medicines or demand revision surgery when it is not necessary.

The Imperial College researchers recommend that "doctors should inform patients of the nocebo effect when prescribing statins and manage their expectations of taking them, to help encourage people to stay on or take the medication". This latest study is an important reminder, at a critical time, that clinicians, regulators and the media share in responsibility for ensuring that reporting of side-effects is measured and focused on the available evidence. Otherwise, the Nocebo Effect risks making unbalanced reporting of side-effects a self-fulling prophecy.

* Details of the study can be found via the New England Journal of Medicine: https://www.nejm.org/doi/full/10.1056/NEJMc2031173

We highlight six key points made in the Guide and consider them from the perspective of producers and their insurers.

1. CE marking is no more than a minimum threshold for certifying a product is safe

AI products designed to support clinical decision-making, or monitor physiological processes, are likely to be deemed a medical device and regulated accordingly. Regulators and legislators have responded to high-profile medical products litigation in recent years by ushering in an era of tighter regulation, such as the Medical Devices Regulation 2017/245 (EU) (which will be reflected in post Brexit arrangements). This makes healthcare AI products amongst the most tightly regulated products in the world. That said, the Guide reinforces the legal position that regulatory compliance will not always provide a complete defence against allegations that a product is unsafe. Where possible, manufacturers should go beyond compliance in demonstrating that their products meet safety standards. This can be done best by generating good performance data during clinical trials and monitoring the performance of a product once it is in use.

2. Claims about the performance of a product should be scrutinised

We generally advise manufacturers to ensure that marketing departments do not have the upper hand in making claims about a product's potential benefits. Claims about performance need to be supported by clinical evidence gathered in the R&D phase of a product's lifecycle. Such data can be useful too if a product is subject to a regulatory investigation. Being able to provide potential claimants and regulators with robust performance evidence mitigates the risk of long-term litigation.

3. Consider whether the product will actually work in practice

Litigation can arise where the user of the medical device lacks the training or infrastructure for the product to work as it is designed to. This is a particular risk for AI products. Producers should ensure that the guidance accompanying a product covers the systems needed to integrate the new technology, how data should be gathered and what complementary software may be needed. The more guidance is provided and followed, the less likely it is that there will be an error.

4. Be prepared to spend time encouraging clinicians to use the AI, including considering using a persuasive story

Producers should be wary of the implications of this point in the Guide. NHSX is concerned that it can be difficult to persuade clinicians to adapt their practices to use AI. We recommend that manufacturers resist any pressure to puff up the promise of their products. Instead, companies can help procurement teams 'sell' a product by offering training so that users understand its potential. In the event of litigation, manufacturers may be able to rely upon the 'learned intermediary' doctrine to show that the product is safe and effective in the hands of a trained clinician.

5. Be clear on who has responsibility if anything goes wrong

We expect that NHSX will advocate for contracts to include more robust indemnities in favour of hospitals, to apply in the event of allegations that AI caused, or contributed to, injury or death in patients. Manufacturers are advised to invest time in negotiating such clauses, particularly to ensure that manufacturers are not left to pick up the pieces where an injury is the result of user error on the part of a clinician, 'off-label' use or the failure of hospital protocols.

6. Ask about a producer's post-market surveillance plans to monitor the safety of a device once it is on the market

Hospitals and manufacturers should be aligned on this issue. Monitoring the performance of a product, once it is on the market, is good practice and is required under existing legislation. Also, monitoring performance means that manufacturers can respond swiftly in the event of concerns, whether by issuing guidance to users or recalling a product if needed.

The Guide has been published during the midst of the Covid-19 crisis. NHSX emphasises that the pandemic has been a catalyst for the exploration and uptake of AI solutions.  We will look back on 2020 as the year that AI became essential to healthcare and increasingly offered cause for optimism across a range of clinical challenges. The Guide provides timely pointers for those investing in the sector on how best to work with other parties in the supply chain to bring about innovative products whilst reducing the risk of litigation.

 A link to the Guide can be found here: https://www.nhsx.nhs.uk/ai-lab/explore-all-resources/adopt-ai/a-buyers-guide-to-ai-in-health-and-care/  

However, the reality seems to be a little different. A simple online search will quickly reveal the number of disappointed patients (or parents of patients), struggling to get an NHS prescription. In fact, to date, only a handful of NHS prescriptions for cannabis-based medicine have been written by doctors.

But why?

Prescribing Problems

Well, first we need to differentiate between the public and the private health sectors. Whilst NHS prescriptions for cannabis-based medicine seem hard to come by, private prescribing seems to be thriving. Grow Biotech, for example, which handles about three quarters of all medical cannabis imported into the United Kingdom said that, as at July, it had received more than 100 requests for private prescriptions.

The NHS, on the other hand, tells a very different story; the reason for this seems to be the guidance produced by the National Institute for Health and Care Excellence ("NICE") for the NHS. NICE's role is to consider the benefits derived from a treatment and balance that against the cost to the public purse. Its guidelines states that there is not enough evidence to recommend cannabis-based medicines for severe, treatment-resistant epilepsy. Whilst the guidelines do not prohibit prescribing the drug, the lack of a 'positive' recommendation means that many NHS doctors do not feel confident to do so – for fear of criticism, complaints, and perhaps even legal claims. It is understood that some NHS trusts (which undoubtedly have the cost question in mind) have effectively blocked clinicians' attempts to prescribe the drugs.

Judicial Review

And this was the exact situation in which the parents of Charlie Hughes (aged 3) found themselves.

As reported in the media, Charlie suffers from a rare form of treatment resistant epilepsy, called West syndrome. Under the care of the NHS, he was given six different anti-epileptic drugs but saw no improvement in his condition. His father, Matt Hughes, felt that they were 'all out of options' after trying traditional medication, and so turned to medical cannabis. After obtaining a prescription privately (clinicians at two NHS Trusts refused to prescribe), the family reported that Charlie's seizures reduced (from 120 a day, to 20) and his development started to improve. Brain scans also showed a significant reduction in 'chaotic brain activity' associated with seizures, his father said. However, the treatment has come at a significant cost to the Hughes family, who have been paying between £1,000 and £3,000 a month for oil made from the whole cannabis plant (including both CBD and THC).

Given this, the family made an application for a judicial review of the NICE guidelines. On 30 July 2020, Mr Justice Holman granted permission for a judicial review on the basis of:

1. 'Alleged inadequate consultation'; and

2. 'Alleged failure to take into account relevant considerations'.

 NICE contends that evidence for the effectiveness of cannabis-based medicines is so far relatively weak and the evidence regarding its safety is limited.

The family, on the other hand will argue that current evidence (despite much of it being anecdotal and low quality) should be enough at least to support modest recommendations for doctors to consider cannabis oil for severe cases of treatment resistant epilepsy. As cannabis is not a single molecule medicine, it is more difficult to assess in randomised control trials – accordingly, a more flexible and pragmatic approach to assessment of its efficacy may need to be deployed.

The lawyer acting for the family in the judicial review proceedings said that although NICE left the option open to clinicians, its guidance was 'so cautious that the effect is children aren’t getting medical cannabis'.

Where are we heading?

The likely outcome of the Judicial Review remains very finely balanced. Whilst the hearing offers a glimmer of hope for those patients seeking NHS prescriptions of cannabis-based medicines, even if the Judicial Review is successful, it is unclear what any redrafted guidelines might look like – and they will only ever be guidelines. In the event they do become more 'supportive', we would expect to see a change in the landscape, with perhaps: 

• Doctors and clinicians feeling more comfortable in recommending these types of medicines;

• Thereby increasing NHS prescriptions of cannabis-based drugs;

• Creating more data, to assist in understanding efficacy and benefit;

• And perhaps generating a new, more flexible, approach to medicine and 'non-traditional' drugs.

   

  Harry Sumnall, Professor of Substance Use at Liverpool John Moores University said: "NICE has argued that the guidance is clear and that there is nothing stopping the NHS from currently prescribing cannabis-based products. Perhaps a successful outcome for the claimant will lead to clarity over this or generate momentum for prescribing in the claimant’s particular case".

   

However, with thousands of COVID-19-related illnesses and deaths arising from the virus, it is likely that the pandemic will lead to an increase in medical malpractice claims, both in the NHS and private sector. For obvious and very sad reasons, fatal claims will inevitably increase. For non-fatal claims, it is currently unclear what long-term effects viral pneumonia and/or acute respiratory distress syndrome will have on the lungs. Psychiatric injury related to COVID-19 exposure is also possible.

Clinical negligence 'directly' related to COVID-19 may arise from a hospital's system's lack of preparedness for a pandemic, a clinician's failure to diagnose the disease, inappropriate treatment for a patient once diagnosed, inadequately trained clinicians performing procedures outside of their usual expertise, and patients who are inadvertently exposed to the disease. There could also be claims 'indirectly' related to COVID-19. These could include: cancer patients experiencing delays to their chemotherapy treatment resulting in death or a reduction in life expectancy, delays in routine operations (e.g. orthopaedic surgery) resulting in prolonged pain, misdiagnosis of a variety of illnesses due to an increase in telephone consultations, and an increase in dental claims as a result of the cessation of routine dental care.

The Bolam test for breach of duty 

Given the extremely rare set of circumstances, this begs the question – will we see an evolution of the Bolam test? As a reminder, the Bolam test for breach of duty is as follows: A doctor is not guilty of negligence if they have acted in accordance with a practice accepted as proper by a responsible body of doctors skilled in that particular art. The case of Bolitho added the requirement for that body of opinion to be reasonable, responsible and for their position to withstand a logical analysis of risks and benefits.

Picture this future claim scenario – a patient with COVID-19 receives treatment from a doctor or nurse who is acting outside of their usual speciality; let's say, a general surgeon. That treatment, for whatever reason, causes the patient an injury. Applying the Bolam principles, what is the 'responsible body' in this scenario? Would it be general surgery or a respiratory physician? What practice is accepted as 'proper' in a pandemic? What expert evidence would need to be obtained to opine on breach of duty? Perhaps we will see 'COVID-19 experts' as a new expert witness specialism. These are questions that the Courts will have to assess. But on the face of it, the Bolam test may no longer be an appropriate test for COVID-19-related claims in these circumstances.

Even if a patient is being treated by a clinician in their 'usual speciality' – the obvious example would be a respiratory physician – Bolam may still be an inappropriate legal test to establish whether that physician's treatment has fallen below a reasonable standard. How can an expert witness opine as to what is 'reasonable and responsible' in these highly unusual circumstances, where the demands and pressures on any practitioner are beyond the scope of any training? Although Government advice at the time of the alleged breach will have to be considered, there simply is no precedent in recent history for what counts as acceptable in a pandemic on this scale. 

'A square peg and round hole' springs to mind. It seems entirely possible that a new legal test would have to be formulated in a COVID-19 claim. We have already seen this happen with consent cases; the Montgomery test has effectively made the Bolam test redundant when assessing whether a patient has been appropriately advised of the material risks before consenting to treatment. COVID-19 may result in a further move away from Bolam.

Causation

In COVID-19 cases, it may be difficult to assess causation. To use fatal claims as an example, reported cases indicate that many deaths will involve patients with underlying health conditions. It will therefore need to be established whether death was caused by COVID-19, the unrelated health condition, or a combination of both; and would the patient have died when they did 'but for' the negligent treatment?

In non-fatal claims, the scientific evidence to assess the existence of any long-term lung damage may not be available for several years. Respiratory experts may not be able to accurately assess this 'on the balance of probabilities' until such studies have concluded.

Any associated psychiatric injury may be multifactorial in cause; a future claimant may have lost their job or even family members as a result of the virus, which may have caused or contributed to the injury; it is suggested that the circumstances of the pandemic (including the effects of lockdown) will in themselves cause a deterioration in the mental health of many.

In cases where the cause of infection needs to be assessed, it seems likely that a claimant will not have to prove the precise cause, as this would be near impossible, but that the breach(es) of duty increased the risk of infection by more than 50%. To do so, statistical evidence of hospital acquired COVID-19 infections may play a big part, as we have seen in MRSA claims. Microbiology expert evidence will also be critical.

In both cases, the Supreme Court overturned the decisions of the Court of Appeal and found that Barclays Bank and Morrisons were not vicariously liable for the acts of: an independent contractor (in the case of the bank), and a disgruntled employee (in the case of the supermarket). 

We explore some of the key details, and consider the impact that the decisions will have, particularly in the healthcare arena.

Barclays Bank plc v Various Claimants

The Claimants had alleged that Barclays Bank was vicariously liable for the actions of the late Dr Gordon Bates – an independent contractor – who was alleged to have committed sexual assaults against prospective employees of Barclays whilst carrying out pre-employment medical examinations on behalf of the bank. 

The original High Court judgment (of 2017) concluded that the bank was vicariously liable for Dr Bates' actions (as did the subsequent Court of Appeal decision), but the five Supreme Court Justices disagreed, permitting the Bank's appeal, and concluding that, in fact, it was not vicariously liable for the independent contractor. 

Some of the key features of the Supreme Court's reasoning were as follows:

• Dr Bates was a "classic independent contractor"– he carried out work for the NHS, conducted medical examinations for a range of clients, and wrote a weekly newspaper article;
• He was "working for his own business or enterprise" as opposed to for the bank: he was in business "on his own account as a medical practitioner, with a portfolio of patients and clients. The work for the bank was a very small proportion of his work";
• It was also noted that "he no doubt carried his own medical liability insurance";
• Dr Bates had autonomy – he could "refuse to do a requested examination if he chose".

VM Morrisons Supermarkets pls v Various Claimants

 The facts of the Morrisons case are very different. Here, Andrew Skelton, a senior internal auditor – and a (disgruntled) employee (as opposed to an independent contractor) – was asked to transmit payroll data to KPMG. Instead, he released personal data (pertaining to around 100,000 Morrisons employees) online and sent it anonymously to UK newspapers. 

He received an eight-year jail sentence, and 5,000 Morrisons employees subsequently brought a group action for compensation. Again, the High Court and Court of Appeal concluded that Morrisons was vicariously liable, but the Supreme Court disagreed, finding that the online disclosure of the data was not part of Mr Skelton's "field of activities", as it was not an act he was authorised to do. Furthermore, it stated:

"although there was a close temporal link and an unbroken chain of causation linking the provision of the data to Skelton for the purpose of transmitting it to KPMG and his disclosing it on the internet, a temporal or causal connection does not in itself satisfy the close connection test".

Taking a similar approach to that of the Barclays case above, the president of the Supreme Court, Lord Reed said: Skelton was not engaged in furthering Morrisons' business when he committed the wrongdoing in question' – which appears to be, therefore, a key consideration.

Comments and Conclusions

Of course, whilst every case will be determined on its individual facts, the two Supreme Court decisions are helpful in illustrating the general view of the Court in this complicated arena. 

By refusing to extend the principles of vicarious liability to both independent contractors, or employees acting far outside of the scope of their employment, the Supreme Court has given a firm steer on this area of law and restored some boundaries. This will be of great reassurance to businesses and their insurers. 

In the healthcare arena, it is encouraging to see the Court give a strong endorsement of the principle that private healthcare providers are not vicariously liable for the activity of independent contractors, such as those with practising privileges. However, care needs to be taken by clinics and healthcare providers as to how they contract with and regulate such individuals – for example, limiting the level of 'control' that is exerted over the contractor, and considering for whose benefit the business is being conducted. 

The unfounded claims seen so far range from the frankly bizarre – that blow drying your face can kill off the virus - to the potentially fatal. 

In Iran, around 300 people have reportedly died after ingesting toxic methanol because of baseless rumours that it can help cure Coronavirus. In the US, a man has died and his wife is critically ill after taking chloroquine phosphate, an additive used to clean fish tanks. Chloroquine phosphate is also found in an anti-malaria medication, which Donald Trump has plugged as a treatment for Covid-19.

To try to filter the fact from the fiction amongst the daily bombardment of online updates, advice, tips and reports, the UK Government has established a rapid response unit within the Cabinet Office. Its purpose: to wage war against inaccurate information circulating online.  

Among other issues, the unit is tasked with cracking down on the spread of false medical information by fake "experts", and it is working with social media firms to identify and remove unfounded, and potentially harmful, content.  

The Government is also working with authorised health bodies to promote official medical advice, and the public is being asked to scrutinise the source of any online medical information. 

Next week, the Government will re-launch its "Don't Feed the Beast" campaign to encourage us all to question what we are reading, and sharing, online. It has put together the SHARE checklist which sets out five steps for identifying inaccurate information. 

One MP has gone a step further and called for a new offence of 'knowingly sharing misinformation about Covid-19' because of the inherent danger of "information contagion" around the virus.

At a time when many people across the globe are stuck inside their homes, already in a heightened state of panic, and becoming increasingly addicted to checking the latest Covid-19 updates, the potential for the spread of false information is huge. Throw into the mix unfounded health claims and irresponsible media reporting and there may well be legal / regulatory fallout (the impact of which is illustrated in one of our previous blogs).  

Just as we all have our part to play in staying home and bringing the virus under control, we also have a responsibility to be cautious with what information we share with friends and family. Whilst mainstream media work hard to keep us updated, we need to work together to try to stem the spread of inaccurate and dangerous material.

Even in less critical times, regulators must walk a difficult tightrope by encouraging innovation whilst also protecting patients from harm. However, the clamour for products that will defeat the virus is such that usual regulatory constraints are being loosened. Nobody could criticise regulators or industry for wanting to work at speed to deliver a solution. However, the safety of vulnerable patients means that the risks of placing new products on the market under these circumstances must be assessed with particular care.

Medical devices

Companies that produce personal protective equipment (PPE), including coveralls, masks and gloves, are under pressure to scale up supply of their products. The European Commission published Recommendation (EU) 2020/403 earlier this month setting out circumstances under which PPE can be placed on the market – even if it does not yet bear the CE mark that demonstrates conformity with regulations. Whilst they will welcome the EU's intervention, manufacturers and insurers should ensure that the limitations of new PPE are understood, and explained to users, before they are made available. Equally, care should be taken over the manuals and training that accompanies PPE so that they are used safely.

The shortage of ventilators has been a headline problem in the UK. Until we have a pharmaceutical answer to Coronavirus, ventilators are the most critical weapon in a hospital's armoury. The UK Government has asked manufacturers of other products to step forward to produce new ventilators. These are products that are classified as medical devices and regulated as such.

Whilst there is a cost to producing ventilators according to a pre-existing design, devices that are already on the market have been tested and assessed by Notified Bodies – without the pressure of the current crisis. They also benefit from having been used for years in hospitals by experienced clinical staff.  Manufacture in accordance with existing specifications should therefore result in safe devices.  Nevertheless, the Medicines and Healthcare products Agency (MHRA) has given the industry additional protection by issuing Specification RMVS001 for the Rapidly Manufactured Ventilator System. The Specification dilutes the regulatory burden on manufacturers and recognises that full compliance with usual testing standards is not possible in "the current emergency".

Pharmaceuticals

It is hoped that by next year, a vaccine will be available. Work to produce a vaccine that would normally take around a decade is being compressed into months. There are reports that several drugs are already entering human trials, including in the UK. 

In the UK, the MHRA has stated that it is prioritising the support and authorisation for the development of a vaccine; it is ready to ensure that applications for approval of clinical trials for a vaccine are dealt with as expeditiously as possible. At EU level, the European Medicines Agency (EMA) has also committed to support and fast-track development of vaccines and treatments for Coronavirus.

Clinical trials are needed to test whether new medicines are safe and effective. Sponsors and CROs involved in clinical trials for a Coronavirus vaccine will need to ensure that the risks of participation in clinical trials are made clear to trial subjects, particularly regarding unknown side effects, and that all patients involved receive a high standard of care. Regardless of advice and care given, however, industry guidelines provide for compensation for patients in the event of injury sustained as a consequence of participation in clinical trials; it is therefore vital that sponsors and CROs have adequate insurance cover in place.

Ultimately, regulators may be more comfortable with repurposing existing drugs. For example, Remdesivir is an anti-viral drug that was developed in response to the Ebola outbreak in 2014. Chloroquine and hydroxychloroquine – anti-malarial drugs – are also being mentioned.  All have been mooted as potential solutions to the Coronavirus outbreak. The advantage of repurposing existing drugs is that that they have been through clinical trials and their toxicity has already been assessed.

A battle on many fronts

Day to day battles against the pandemic are being waged by healthcare staff in trying circumstances. Governments and regulators hope the Life Sciences industry will increase production of much needed equipment for clinicians, as well as ultimately providing the pharmaceutical solution to win the war against Coronavirus. Whilst the loosening of regulatory constraints is welcome, everyone will benefit from manufacturers ensuring that the speed of industry's response is matched by a proportionate analysis of the risks.

To keep up to date with all of our COVID-19 updates please click here to visit our dedicated information hub.

Rebecca's decision to openly display her contraceptive patch has received a lot of online commentary. Unfortunately (albeit expectedly) much of this has had a misogynistic tinge, shaming her for her choice. However, a positive conversation has followed, with many commentators praising the contestant for de-stigmatising the use of the contraceptive patch.

The contraceptive patch contains the same hormones as the combined pill – oestrogen and progestogen – and works in the same way by preventing the release of an egg each month. When used correctly, the patch is more than 99% effective at preventing pregnancy (but will not protect against sexually transmitted infections – Love Island has confirmed to Huffington Post that the villa is supplied with condoms).

Each patch lasts for one week, and is changed every week for three weeks, before a week's break. It is therefore a useful alternative option for women who might find it difficult to ensure they take the pill every day at the same time (which can impact the effectiveness of progestin-only pills). In addition, because the hormones from the patch aren't absorbed by the stomach, it is still effective if the woman suffers vomiting or diarrhoea (unlike the pill). The patch may therefore be a good contraceptive option for many women.

But, the commentary that has followed Rebecca's reality TV show debut has indicated that many women have never been offered this option and were unaware it even existed.

NICE guidelines state that women asking for contraception should be given information about, and offered a choice of, all methods, and go on to list fourteen different options (including the contraceptive patch). A 2018 survey revealed that the majority of women (59.1%) are supplied contraception by their GP. It is therefore imperative that GPs are aware of all the available options and discuss them fully with patients, to ensure they are acting in accordance with NICE guidelines.

Nevertheless, a 2016 survey by the Family Planning Association found that just 2% of GPs offered the full range of contraceptive methods (13% did not offer the contraceptive patch). The GPs surveyed highlighted that there is not enough time to discuss contraceptive options with patients during a standard appointment and suggested that a lack of training qualifications and funding prevented their practice from offering Long-Acting Reversible Contraceptives (such as the implant).

In the early days of campaigning, this General Election was billed as the "Brexit Election": the pivotal moment to "Get Brexit Done"; or a chance to Revoke Article 50; or … just another staging post in the attempt to muddle through and find that elusive compromise. However, after six weeks of campaigning, a host of other issues have also been debated. They include policies affecting hospitals, pharmaceuticals and medical devices. 

We invited clients to debate the manifestos at a roundtable meeting. The outcome of the meeting does not reflect industry's views in any scientific way but, perhaps, suggests the issues that may inspire hope - or dread - on Friday morning when the results come in. 

What to look out for from Friday

The Conservative Party

 The biggest impact of a Conservative victory will be the drive to conclude Brexit and secure a deal with the EU by the end of 2020. Under a Conservative government, the UK may not remain aligned with EU regulations for much longer. 

Otherwise, the most eye-catching Conservative initiatives are for the "fastest ever" increase in the science budget, an NHS visa to fast-track filling some roles with workers from overseas and more investment in innovative treatments. During our roundtable, support for the Conservatives remained steady, although there was significant concern at the lack of clarity on whether the UK will diverge materially from the EU regulatory regime governing drugs and medical devices. 

The Labour Party

 Labour has tried to define this election by highlighting issues other than Brexit. Alongside a pledge to increase NHS budgets by 3.9% per year in real terms, the Labour party has set out radical policies to transform healthcare.

Labour wants to invest more in artificial intelligence, ensure NHS data is not exploited and progress the prescription of medicinal cannabis. However, one policy attracted significant scrutiny: the proposal to use the Patents Act to force pharmaceutical companies to accept 'fair' prices for their products, or else lose their exclusive rights over drug patents. Some at the roundtable expressed concern that this policy would stifle innovation, with companies withdrawing investment for R&D. By the end of the debate, support for the Labour party had dipped.

The Liberal Democrats 

The Liberal Democrats are leveraging their opposition to Brexit as a means of preventing US companies from gaining access to the NHS or the UK drug market. In addition, they would increase spending on R&D, support the tech sector through tax credits and seek to simplify the regulatory landscape. A Liberal Democrat government would remain in the EU, providing certainty over regulatory obligations.

At the roundtable, the Liberal Democrats initially polled in line with national opinion polls, but by the end had emerged as the party with the largest increase in support. 

The Others

Could we end up with a coalition, made up of Green, Brexit, SNP, Plaid Cymru or DUP members of parliament? Stranger things have happened. If one or more of the Green Party or nationalist parties end up in Government, then look out for policies on tackling addiction, preventative healthcare, innovation and digital health. The roundtable concurred that the Brexit Party has very little to say regarding healthcare and life sciences. 

What next? 

Our roundtable suggests that the most important issue after the election will be whether the next Government legislates for the UK to diverge from EU regulations. The Conservative party is leading in the opinion polls but despite six weeks of campaigning there is not much clarity over the direction a Conservative Government would take. It will take a lot of work to fill in the gaps on the way to getting Brexit done. 

What is endometriosis?

Endometriosis is a condition where the endometrium, the innermost lining of the uterus, grows in other areas of the reproductive system and thickens, breaks down and bleeds with each menstrual cycle. The tissue is unable to leave the body and becomes trapped, resulting in scar tissue and adhesions.

For patients, endometriosis can lead to infertility, chronic fatigue, and bowel and bladder problems. Nationally, this condition costs the UK economy £8.2 billion per year due to the cost of treatment, healthcare and the time that sufferers take off work. 

The long delay in diagnosis often sparks debate. Critics have been quick to attribute the delay to the "gender pain gap", arguing that historical disparities in the medical treatment of women have led to misdiagnosis of female hormonal issues. A recent study by Birmingham University concluded that endometriosis is "a neglected area of research and funding". However, the delay in diagnosis and treatment of this illness arguably goes much further than gender disparities. 

Reasons for delayed diagnosis

It is widely accepted that both patients and physicians contribute to the delay in diagnosis. Female sufferers often ignore their symptoms, believing them to be the onset of menstrual cramps ("dysmenorrhea"). Those who do seek help from doctors are regularly treated with oestrogen-progesterone contraceptive pills or anti-inflammatory drugs (NSAIDs). These reduce pelvic pain, but may subsequently prevent diagnosis until the disease progresses some years after its initial presentation.

To avoid a delay in diagnosis, it is important for healthcare providers to identify women who are at high risk of having the condition; they need to be looking out for patients with a family history and those whose symptoms do not respond to non-steroidal anti-inflammatory drugs ('NSAIDs') or hormone treatment. The overlap of symptoms with a variety of problems, including ovarian cysts, irritable bowel syndrome and depression, continues to make accurate diagnosis problematic. 

Impact on health care providers & their Insurers 

The Minister for Women's Health, Caroline Dinenage, has urged clinicians to break down the stigma around endometriosis, by ensuring they follow NICE guidelines.
If health care providers continue to misdiagnose endometriosis despite the increasing public awareness of this issue, there could be a spike in related claims; for example, if a patient has a prolonged period of pain and suffering as a result of a delay in diagnosis, or if there is an impact on fertility.

Whilst limited UK case law exists at present, the recent case of X v Dartford and Gravesham NHS Trust (2018) considered damages owed to a claimant with pelvic inflammatory disease which remained undiagnosed and untreated for six months. As a result, she suffered from regular bouts of abdominal pain and became infertile. The breakdown of Special Damages included £12,000 for two cycles of IVF treatment and total damages amounted to £72,500. Such a case may be a useful indicator of the potential endometriosis claims awaiting health care providers and medical malpractice insurers. 

Insurers should seek confirmation that their Insureds (particularly those in primary care) are up to date on the literature surrounding endometriosis diagnoses to avoid falling foul of what is likely to be a developing area of delayed diagnosis claims. 

In Bailey & Ors v GlaxoSmithKline (GSK) the Claimants allege that Seroxat (an anti-depressant manufactured by GSK), is defective under the Consumer Protection Act 1987 (the CPA) on the basis that adverse effects following discontinuance of the drug are worse than with other comparable anti-depressants.  

Following the Claimants' opening submissions in April 2019, the trial judge (Lambert J) ruled that the Claimants' case was limited to the risks of Seroxat relative to comparator drugs in respect of withdrawal symptoms (i.e. the "worst in class" case) and could not be extended to the relative risks and benefits more generally as between Seroxat and its comparators (i.e. the "risk/benefit" case). The Claimants appealed that ruling.

The risk/benefit approach lies at the heart of two leading product liability cases in recent years, both concerning medical products: Wilkes v DePuy [2016] and Gee v DePuy [2018].

A further judgment for the modern era of complex products

The judgment is good news for GSK, but has important implications for manufacturers in general. Although the judgment means that it will not feature in the Seroxat litigation, the Court of Appeal has endorsed the risk/benefit analysis used in Wilkes (and adopted in Gee) to determine if products are defective under the CPA. 

For years, judicial guidance on the factors the Court should take into account when determining if a complex product is defective was limited to A v National Blood Authority [2001]. In that case, Burton J ruled that a number of factors were not relevant to the Court's assessment. These factors included using a risk/benefit analysis; for example: considering the benefits of a drug alongside its side effects, or weighing up the risks associated with an implant against the fact it has a vital medical purpose.

However, in Wilkes Hickinbottom J (now LJ) handed down a judgment fit for the era of complex and highly regulated medical products. He ruled that the Court must take a "flexible approach", meaning that an assessment of the benefits of a product, compared to its risks, can be appropriate. Two years later in Gee, Andrews J favoured the analysis of Hickinbottom J, stating that there were "substantial difficulties" with Burton J's "fundamentally flawed" approach.

None of National Blood Products, Wilkes or Gee has been appealed, meaning they have equal precedent value. Manufacturers wishing to deploy a risk/benefit defence may therefore have been concerned that the Court could, in future, prefer the approach of Burton J.  This would deny them the argument that a product is not defective because the benefits provided by the product outweigh the risks.

The Court of Appeal's ruling concerns procedural matters and is not a judgment on the allegation that Seroxat is defective.  GSK has succeeded in limiting the litigation to the Claimants' pleaded case, and so the Claimants' arguments over how a risk/benefit analysis should be used by the Court will not feature. However, we expect that other defendant manufacturers, wishing to deploy a risk/benefit analysis in future litigation, will refer claimants and the Court to passages in the Court of Appeal's judgment which endorse the approach adopted by Hickinbottom J in Wilkes.

Procedural points for defendants

The Court of Appeal judgment also provides important tactical guidance that can be used by defendants in group litigation. The Court of Appeal emphasised:

• Claimants must identify the issues to be determined at trial at the outset – this will form the basis of the management of the case (including in relation to disclosure and expert evidence). The Court of Appeal ruled that allowing parties at trial to expand the issues is to "undermine such good case management".

   

• If a party wishes to challenge the list of identified issues, this must be done in good time.

   

• For claims under the CPA, there must be absolute clarity in relation to the alleged defect. This drives the scope of expert evidence and, ultimately, the focus of the trial. In this case, GSK has shut down the Claimants' attempt to introduce fresh issues (the risk/benefit analysis), at a late stage of the litigation, which would have had serious costs (and possible liability) consequences.

It remains to be seen how the Claimants in the Seroxat litigation will proceed following this judgment. In the meantime, manufacturers of complex products, and their insurers, will take note of a judgment that follows hot on the heels of Wilkes and Gee and endorses using a risk/benefit analysis in determining if a product is defective.

A copy of the judgment can be found here

In November 2018, the law governing medicinal cannabis underwent an overhaul; for the first time in the UK's history it was legalised (albeit in very specific circumstances).

Whilst this change in the law was celebrated by many, in the year that has since passed, only a handful of patients have actually benefitted. Our February blog considered some of the reasons behind this, including: prescribing issues; cost; and availability.

Where are we now?

Just this month, two cannabis based medicines, Epidyolex (for epilepsy), and Sativex (for multiple sclerosis), have been approved for use by the NHS in England, following new guidelines from NICE. Doctors will now be authorised to prescribe these drugs to patients - albeit, again, in certain situations and for specific conditions.

Epidyolex

For children with Lennox Gastaut syndrome and Dravet syndrome (two types of severe epilepsy), a prescription for Epidyolex may now be accessible.  

Clinical trials have shown that the oral solution, which contains CBD (cannabidiol), could reduce the number of seizures in some children by up to 40%.  Given the number of people said to be suffering with these syndromes (5,000 and 3,000 respectively), this drug may offer much needed relief to a significant number of children.

Epidyolex has been approved for use in Europe since September but, in its draft guidance, NICE concluded that it did not offer 'value for money' (it costs between £5,000 and £10,000 per patient, per year). Now, however, the manufacturer, GW Pharmaceuticals, has agreed a discounted price with the NHS.

Sativex

Unlike Epidyolex (which contains only CBD), Sativex combines CBD and THC (Tetrahydrocannabinol – the main psychoactive component in cannabis), and has been approved for treating muscle stiffness and spasms in adults in multiple sclerosis. Doctors will not be able to prescribe it to treat pain.

Sativex was the first cannabis based medicine to be licensed in the UK after clinical trials, and has been available on the NHS in Wales for over five years. At that time, regulators in England said that it was not cost effective; that decision has now been reversed.  

Public Response

Many are delighted with this announcement. Professor Helen Cross, a consultant in paediatric neurology at Great Ormond Street Hospital, who led UK trials of Epidyolex said it was "great news". She explained that the syndromes are "both complex difficult epilepsies with limited effective treatment options and this gives patients another option… that could make a difference to care."

There have been some responses, however, expressing concerns. Many parents are paying substantial sums for medicines containing both CBD and THC, which are being imported from Europe and Canada, and are disappointed that NICE not has not approved any cannabis based medicines for childhood epilepsy that contain both components. Mille Hinton, spokesperson for campaign group End Our Pain has said: "This restrictive guidance is condemning many patients to having to pay for life-transforming medicine privately, to go without or to consider accessing illegal and unregulated sources."

What Next?

Legal developments a year ago promised change. It is clear that advancements in this (controversial) area are slow and incremental in nature; whilst the legalisation of medicinal cannabis is undoubtedly a positive step for UK medicine and law, it is likely to be some time until the benefits are felt by the majority of patients.

And what next? It is hoped that with ongoing clinical trials, increased data, and perhaps, further public pressure, opportunities to use UK cannabis based medicine will make further strides forward. How long that might take is an entirely different question.

In November 2018, the law governing medicinal cannabis underwent an overhaul; for the first time in the UK's history it was legalised (albeit in very specific circumstances).

Whilst this change in the law was celebrated by many, in the year that has since passed, only a handful of patients have actually benefitted. Our February blog considered some of the reasons behind this, including: prescribing issues; cost; and availability.

For those new to the jargon, Innovate UK's 2018 report "The immersive economy in the UK"  provides some helpful definitions to help separate the "virtual" from the "augmented". The report also highlights the potential for huge growth in the immersive technology sector, citing a forecast by Citi which indicates that the market could be worth a staggering $569bn by 2025.

Virtual reality programmes are already used in the training of medical professionals. In terms of patient treatment, research into the use of virtual reality therapy for acrophobia (fear of heights) has already been carried out in the UK and was published in The Lancet Psychiatry in 2018 (see link).

In May of this year, it was announced that the US Food and Drug Administration (FDA) had approved an augmented reality platform, "Surgical AR", which uses augmented reality and artificial intelligence to allow surgeons to visualise details which they would otherwise be unable to see during surgical procedures.

In July, a new clinical trial, "gameChange", was launched in England. The trial, which will involve over 400 NHS patients across the country (from Bristol, Manchester, Newcastle, Nottingham and Oxford), will test a virtual reality therapy for patients with severe mental health difficulties, such as schizophrenia. The therapy aims to treat the social withdrawal of patients with severe mental health issues through a step by step programme in which a virtual coach guides them through anxiety-provoking situations. It is reported to be the largest clinical trial yet of a virtual reality therapy for a mental health disorder.

More recently, it has been reported this month, that a hospital in Cardiff is conducting a trial directed at the use of virtual reality headsets for pain management during childbirth.

Whilst there appear to be significant potential benefits to the use of immersive technologies in a medical setting (particularly in the treatment of mental health issues), their introduction may raise new legal challenges.

In the video gaming sector, reports of the visuals in some games triggering epileptic seizures led to litigation in the US in the 1990s. Other potential effects that could be linked to the use of virtual/augmented reality include:

• experience of nausea or motion sickness;

• physical injury as a result of a user being unable to properly navigate their own physical environment whilst immersed in the virtual/augmented world; or

• possible interference with other medical devices.

Manufacturers of these new therapies will therefore need to take great care in:

• the design of the product visuals and any accessories (e.g. headsets and controls);

• provision of detailed terms of use and user guides, including any necessary restrictions on use, training, and education of users;

• warnings, contraindications, and disclaimers.

The amalgamation of healthcare and artificial intelligence is a relatively new, but rapidly growing idea. The market is predicted to surpass $8 billion (£6.39 billion) by 2026. The consumer-oriented section of this market brings with it numerous benefits; for example, it allows users to monitor their calorie intake, track stress levels, and assess health symptoms. .

The announcement that Alexa will be providing NHS advice is a huge step forward in this market. When a user reports their symptoms to Alexa, the device will search the NHS website and provide information on the possible causes of the symptoms, actions that could be taken at home, and whether it is necessary to seek expert help. This development could help to ease the burden on GPs, especially in light of falling GP numbers.

While the advantages are numerous, there are also a number of potential risks. Two of the most significant questions are: (i) who is liable in case of medical negligence?; and (ii) what protection is there for user privacy?

In terms of liability, the potential risks may be relatively small in circumstances where a consumer simply relays Alexa's findings to a doctor. However, the risks associated with the use of such devices substantially increase if a worried user decides to self-medicate. Previous case law concerning the NHS's 111 service suggests that liability could lie with the NHS. However, in circumstances where an NHS operator is effectively replaced by a device, liability could arguably fall on the product manufacturer, which could open the floodgates for product liability claims.

• There is a threat to the pregnant woman's physical or mental health;

• The pregnancy is the product of rape or incest; or

• There is severe foetal impairment

The "Creasy amendment" (in reference to Labour MP Stella Creasy who proposed it), means that the Government must give effect to these recommendations by 21 October 2019 i.e. it must bring forward regulations to decriminalise abortion in Northern Ireland (at least in these circumstances). 

The vote is therefore an important step towards the decriminalisation of abortion. However, a number of obstacles remain. First, if a Northern Ireland Executive is formed before 21 October 2019, then the obligation will fall away. Given the strength of opposition to abortion which still exists in Northern Ireland, it is possible that some will see this as a necessary step to avoid decriminalisation.

Secondly, the statutory instrument must be laid before both Houses of Parliament, meaning that there is still opportunity for it to be amended, weakened or even halted. Although the report provides detailed recommendations, it is inevitable that there will be much debate regarding the exact wording of any future regulation.

The immediate practical impact is, therefore, likely to be limited. Should it lead to abortion being decriminalised in Northern Ireland, however, the future impact will be significant. It will enable women in Northern Ireland to access abortion services at home, removing the financial and emotional burden of having to travel abroad for abortion procedures. In addition, since abortion providers often also offer other gynaecological and contraceptive services, their introduction into Northern Ireland will enable women to take greater control over their reproductive function.

Any change will also have a direct impact on existing abortion providers. In 2018 the number of Northern Irish women seeking abortions in England and Wales increased by 22%. Indeed, many abortion providers give specific guidance for women travelling from Northern Ireland. If Northern Irish women are able to access abortion care at home, then this will reduce the burden on providers in England and Wales.

Last Wednesday's vote is the first step in what is likely to be a long (and hotly-debated) road towards the decriminalisation of abortion in Northern Ireland. However, the significant numbers of MPs who voted in favour demonstrates that legal access to abortion care is now more widely accepted as a woman's right and there is cross-party commitment to ensuring that women across the UK have access to this medical procedure.

Phil Brown, representing the Association of British HealthTech Industries (ABHI), made a point about the EU Medical Devices Regulation (Regulation (EU) 2017/745). Mr Brown said that the Regulation is about more than just manufacturing standards. The ABHI's view is that compliance makes for good business practice generally. We agree. When it comes to risk management, businesses in general should take note of the issues covered by the Regulation.

When it takes effect in 2020 the Regulation will apply to medical devices but it provides useful guidance for manufacturers of any product that carries the risk of causing injury to the public. Here are three key approaches required by the Regulation that should be considered by any manufacturer keen to guard against product liability risks:

1. Take a lifecycle approach to safety

Under the Regulation, manufacturers will be required to obtain more data regarding the safe performance of their products, before they are put on the market. Once products are on the market, companies will have greater obligations to carry out vigilance and track how devices perform. This provides a number of benefits to business: products will have been put through more rigorous testing, making their products safer; products that do not perform well and present a risk to consumers will be recalled more quickly; and in the event of threatened litigation, companies will be better placed to refer in their defence to data that demonstrates the safety of the product.

2. Ensure there is financial cover in case of liability

The Regulation requires manufacturers to have sufficient financial cover to cater for their potential liability in the event that a product is defective. This could take the form of insurance or alternatively sufficient funds so that a company, in effect, insures itself against litigation. This makes good business sense. No company intends to attract lawsuits but unforeseen circumstances can lead to claims. The recent history of medical devices litigation includes examples of companies whose products were not defective but nevertheless became embroiled in disputes that were expensive to resolve. It is vital to have insurance (or a reserve fund) in place to avoid potential insolvency caused by protracted litigation. Businesses should examine their catalogues to assess where their litigation risk lies and what the financial impact of claims might be.

3. Engage with the distribution chain

Medical devices distribution chains are ever more complex as the number of available life sciences products increases and the healthcare market becomes more globalised. Manufacturers take on a disproportionate risk if distributors fail to do their part in making the tracking and recalling of products as efficient as possible. Under the Regulation, distributors and importers are required to cooperate with manufacturers to ensure the traceability of devices. This makes good business sense as all parties in a distribution chain will have responsibility to make sure that they can trace any product that has the potential to cause harm.

Neural tube defects (such as spina bifida or anencephaly) affect about 1,000 pregnancies per year in the UK. Over 40% of cases are fatal and most babies who survive will need continuing care.

Adding folic acid to flour is not a new idea; it was first recommended by the Government's Scientific Advisory Committee on Nutrition ("SACN") in 2006 who noted that, in addition to increasing the folate intake of pregnant women, it would be of 'net benefit to the UK population'. Although over a decade has passed without any action, adding supplements to flour is not a particularly drastic step; currently UK milled wheat flour already has thiamine, niacin, iron and calcium added to it during production.

Over sixty countries around the world add folic acid to flour, and campaigners for the introduction have highlighted the success the policy has had in these countries. Following its introduction in Canada in the late 1990s neural tube defects halved; in Australia they fell by 14%.

Concerns have been raised, however, about the impact the introduction could have on the general population. It has been suggested that a consistently high intake of folic acid could cover up the symptoms of Vitamin B12 deficiency (which can be a particular concern for the elderly). Equally, folic acid supplements can interact with some medicine and so certain individuals may be advised to monitor their intake. The Government has confirmed that 'due consideration' will be given to these concerns as part of the consultation and any implementation.

The consultation runs for twelve weeks and should be of interest to any organisations or healthcare professionals involved in the care of pregnant women, children, and adults with neural tube defects. Insurers may wish to draw the consultation to the attention of their Insureds, so they can ensure that any concerns or queries they have are raised during the consultation period.

If the outcome of the consultation is in favour of mandatory fortification, Insureds will need to be aware of the introduction date and the potential impact on the care they provide. Advice given to women during (and before) pregnancy about folic acid will need to be updated, as will advice to patients taking medicine that interacts with folic acid. Finally, medical practitioners should be ready to discuss the introduction with any patients who may be concerned about it.

For those not familiar with the case that has prompted this call, Mr Ian Paterson is a former breast surgeon who was convicted in 2017 of intentionally wounding patients by carrying out unnecessary operations. He was sentenced to 20 years in prison.

As well as a criminal trial, the case generated large scale civil litigation; over 800 individuals brought claims against the NHS, Mr Paterson and the private hospital where he held practising privileges (for which we acted).

Following Mr Paterson’s conviction, the Government launched an independent inquiry (which is currently ongoing) to "review the circumstances surrounding [his] malpractice that have affected so many patients, as a case study, and consider other past and current practices". The Government's aim is to make recommendations to improve the safety and quality of care provided nationally to all patients, in both the independent sector and the NHS.

RCS Position Paper

The RCS is calling for the "entire healthcare sector" to "do everything it can to prevent someone like Ian Paterson from ever causing harm again”.

The position paper sets out a number of recommendations, including:

• Equivalent reporting requirements for both the NHS and the private sector (which could be a condition for registration with the CQC);

   

• Registration of all new surgical procedures and devices used in either sector, with related data collected in the appropriate national audits, before they are routinely offered to patients;

   

• Streamlining robust clinical governance procedures across the independent sector to enable effective monitoring of consultants’ practising privileges, supported by a clearer remit for Medical Advisory Committees;

   

• A review of the Appraisal process to encourage sharing of information regarding a Doctor’s performance between the public and private sector;

   

• A review of multi-disciplinary team (MDT) working in the independent sector to ensure it includes arrangements for information sharing between the two sectors;

   

• A national framework to ensure consistent standards of training. 

The Future

The recommendations are ambitious and potentially onerous, and Government and providers will need to consider each of them in detail to decide whether they can be implemented.  It will then, inevitably, take time for any such overarching recommendations to be implemented.  Whilst this suggests a great deal of uncertainty at the moment for private healthcare providers, one thing is clear: change is afoot. Over the coming months and years, we can expect to see more audits, more regulations and more obligations – all of which will impact on private healthcare providers, as well as their insurers. 

Against this backdrop, the following points set out by NICE regarding the evidence of the risks and benefits associated with mesh products may be particularly relevant for parties defending claims, whether manufacturers, hospitals or their insurers:

• There is evidence of benefits associated with mesh procedures, but limited evidence on the long-term adverse effects  

• The true prevalence of long-term complications is unknown  

• Discussion with patients should refer to the uncertainty surrounding the long-term adverse effects for all procedures, including those involving mesh materials  

• There is limited evidence regarding the benefits of partial or complete removal of mesh products, compared with choosing not to remove such products  

• Equally, there is limited evidence of the long-term effectiveness and complications for some alternatives to surgical procedures 

• NICE supports the use of a national registry to provide more reliable evidence than is available currently on the use of mesh procedures in England and Wales, and their long-term effects 

 It is well known that large numbers of women in the UK are reported to have experienced serious side effects as a result of surgery involving mesh products. There have been many reports of the impact these complications have had on the lives of the patients involved. Patients and their families, as well as hospitals and manufacturers, will study the Cumberlege report in detail when it is published later this year. In the meantime, the NICE guidelines published last week do not add anything of significance to what was already known, but they do at least offer a starting point for the debate about the evidence regarding mesh products and the extent to which the benefits outweigh the associated risks.

Vertex have defended the price of the drug as they argue that NICE's "cost-effectiveness threshold" does not take into account the frequency of the disease and, therefore, the number of patients who use and pay for the drug. Whilst this may be true, the main reason Vertex can suggest such a hefty price is because they have patented Orkambi and therefore have a monopoly. The NHS simply has nowhere else to buy Orkambi. It is this monopoly that has led campaigners to call for the Government to invoke "Crown" use and bring the deadlock to an end.

So, what is "Crown" use and will the Government be able to rely on it?

Crown use is found within the Patents Act 1977. Section 55(1) 'Use of patented inventions for services of the Crown,' allows a government department to sell, or offer to sell, a patented product, without the consent of the proprietor of the patent. Crucially, this will not be considered an infringement of the patent concerned, although the Government would have to pay compensation to the proprietor of that patent.

Crown use has been invoked before, such as in Pfizer v Ministry of Health, where it was held that the Minister of Health was able to authorise a company to import drugs from Italy for NHS patients. However, the Pharmacy Minister, Steve Brine, is less certain that it can be used in this situation. In an adjournment debate on 4 February, he argued that 'Crown use has only really been intended to deal with emergencies.' Although the impact on patients is significant, it is not clear that the deadlock would be considered an "emergency". The Government would simply be authorising Crown use as a means of bypassing the commercial deadlock between Vertex and the NHS.

If Crown use was used, the cost would, according to section 57A of the Act, include a sum for the loss of profits that the proprietor of the patent has incurred through not securing a contract providing the drug. This cost is likely to be expensive and would be decided by the Court, meaning the NHS may end up paying what Vertex has asked for in any event.

In addition, the impact on future pharmaceutical companies of invoking Crown use should not be underestimated. The loss of profits, if not compensated properly by the Court, may hinder Vertex from developing new treatments, which would be detrimental to patients. Such a step may also lead to pharmaceutical companies viewing the UK as a volatile and unpredictable market, leading them to focus their attention elsewhere. Amidst the current Brexit uncertainty, this is to be avoided if possible.

Finally, whilst invoking Crown use might be a short term fix, it is likely that it will result in litigation between Vertex and the Government meaning a delay in the drug being manufactured and released via the NHS, thereby defeating the ultimate aim.

Earlier this week, that proposal became a reality, after the new law passed its third reading in Parliament (the final stage before receiving Royal Assent).

Max and Keira's Law

The Organ Donation (Deemed Consent) Act, which will be called Max and Keira's Law, is named after Max Johnson, who underwent a heart transplant aged 9, and Keira Ball, who, at the same age, tragically passed away following a car accident. Keira's organs saved 4 lives, including Max's.

What will change?

Currently, in England, the organs of a person who has died can be used only if that person consented when they were alive, usually by registering as a donor.

The new system, which is expected to come into effect in Spring 2020, will

mean that consent is presumed, unless someone has chosen to opt out (or they fall within an exempt group). It will be a "soft opt-out" system however, and families will still have the final say on donation; this means they could potentially overrule their relative’s wishes to donate or to opt out.

The Potential Impact

The British Heart Foundation (the "BHF") reports that there are currently more than 6,000 people on the NHS waiting list for transplants and that every day, 3 people die whilst waiting for an organ.

It is hoped that the change in the law will lead to many more organs being donated and lives being saved every year. 

Other countries, including Wales, Spain, Croatia and Portugal are already operating opt-out systems, with Spain having the world's highest rates of organ donation. Wales, where a presumed consent system has operated since December 2015, has the UK's highest with a 75% donor consent rate (compared to 58% in 2015). Scotland is currently considering its own opt-out system after a Government consultation found that 82% of the public was in favour.

What Next?

Whilst acknowledging the passing of Max and Keira's Law as a "historic moment", the BHF identifies that it needs to be supported by investment in training, education and resources.

In our blog last year, we touched on how difficult it can be for grieving families to accept a loved one's decision to donate. The role of specialist nurses who facilitate formal family discussions around organ donation is vitally important, to ensure that professional support is available at such challenging times.

It is also really important for family members to have open and transparent discussions with one other about their own wishes. Government statistics show that under the current system, families are significantly more likely to support the donation of a relative's organs or tissue if they know what that relative's views were.

Whilst it was hoped that the legalisation of cannabis would mean that more patients could benefit, quickly and openly, from its therapeutic properties, it seems that the reality is an entirely different story.

Legalisation

Prior to legalisation, almost all cannabis based medicinal products were classed as Schedule 1 drugs under the Misuse of Drugs Regulations 2001, meaning they were considered to have no therapeutic value, and could not (legally) be prescribed. Since 1 November 2018, however, cannabis has moved to Schedule 2 – falling into the category of drugs which are controlled, have a recognised medical use, but can be prescribed only in certain circumstances (and only by specialist hospital doctors).

NHS Guidance for Doctors in England, released in late 2018, suggested that prescription of cannabis required clear published evidence of its benefit, and that other treatment options had been exhausted.      

The Reality

Whilst legalised nearly four months ago, so far virtually no-one in the UK has actually been able to obtain a prescription for medicinal cannabis. But why?

As feared by many, the new Regulations have proved extremely difficult to navigate and somewhat prohibitive. The Schedule 2 requirements and the preconditions in the NHS Guidance have set the bar too high.

Prescribing Issues

It seems the actual 'prescribing' of the drug has also caused a lot of concern, with one doctor reporting on the 'challenge' of just getting hold of the right prescription pad. Another, Dr David McDowell (a pain specialist) described the current prescribing process as "torturous" – with doctors having to get prescriptions approved by the Medicines and Healthcare products Regulatory Agency (MHRA). The prescription is then valid for 28 days, and, at present, doctors cannot prescribe more than one month's worth of medication at any time.

Cost

But doctors and patients are not only facing administrative or prescribing hurdles – there's also the cost. All of the four patients who are set to receive medicinal cannabis this month are doing so privately. One patient has confirmed that he is paying £695 for one month's supply, adding that he did not think that it would be a sustainable option for him.

It has been reported that, where necessary, the patient's NHS Trust could meet the costs, but the current position is that "no cannabis-based products for medicinal use are routinely commissioned".

Availability

And what about the availability of the drug?

Well, just after a month after its reclassification, in December 2018, Carly Barton was given a prescription for cannabis – however, she was unable to receive the medication as none had been imported. She told the BBC last year that she had been buying cannabis on the "black market" instead of taking very strong opiates, including fentanyl, which she had been prescribed for pain.

What's Next?

It is hoped that as cannabis based drugs become more accepted, processes become more familiar, and availability improves, these difficulties will diminish. As things stand, it appears that the one step forward has been followed by several steps back – and the fears of the MS Society are being realised.

There is an awfully long way to go before patients will really benefit from the therapeutic values that the Government deemed cannabis to have.

The Topol Review, commissioned by former Health Secretary Jeremy Hunt and published last week, explores the impact of technological innovation on the NHS workforce and identifies the need for specialist training for clinicians and the development of new skills. Although the report focuses specifically on the NHS workforce, the issues it addresses are relevant to all clinicians, and the report will make interesting reading for all healthcare providers (including those in the private sector), medical technology producers and insurers.    

We are, in the words of Dr Eric Topol, at a "unique juncture in the history of medicine", with new technologies enabling more individualised care and empowering patients to take a more active role in decisions about treatment.

Genomics, digital medicine and AI-based technologies all have the potential to transform healthcare: genomics can provide for more accurate diagnoses of genetic-based diseases; digital medicine is already giving patients greater control over their own healthcare needs; and AI could lead to faster (and potentially more accurate) diagnoses, easing the burden on clinicians and allowing more time for one-to-one patient care.

However, the potential advantages of technological innovation will only be realised if organisations are sufficiently prepared, and have the required skills, to adopt new technology in a safe and effective way.

Topol predicts that within 20 years, 90% of all jobs in the NHS will require some element of digital skills. Healthcare providers will not only need to invest in the technology itself, but also in training people with the right professional skills to support this changing environment. Without appropriately trained staff, and reliable and effective systems to guarantee the safety of healthcare technologies, we will face new safety risks which could result in harm to patients. Clinicians need to understand both the opportunities digital technology can offer, and its limitations, including the potential consequences of relying on and trusting innovative developments (such as machine learning) too blindly or too quickly.

There needs to be close collaboration between manufacturers, industry regulators and clinicians to share knowledge and review the regulatory requirements of new technologies, alongside cyber security and data privacy issues. The increasing complexity of regulating digital technologies calls for additional training for staff at the MHRA and other regulators, to ensure that they "continue to be able to provide meaningful regulatory oversight”.

This approach will be critical to establishing a framework for the safe development of new technologies and how they are regulated to protect patients and reduce the risk of harm.  

Health Education England chief executive Ian Cumming has said that recommendations in the Topol Review would be “made a reality” through the development of the workforce implementation plan (to support the NHS Long Term Plan).

If, as predicted by Health Secretary Matt Hancock, the UK is to deliver the most advanced health and care service in the world, there needs to be a fundamental shift in the balance of skills within the workforce, and, as Topol concludes, "there is no time to waste".

The issue of the public wanting innovation in healthcare, but with as little risk as possible, is not a new one. Regulators and the courts have had to grapple with this for decades, trying to determine how much risk should be tolerated when allowing new products onto the market.

Here are three particularly critical issues covered in the AoMRC's report that create dilemmas for industry and clinicians to deal with. We include our suggestions for mitigating the risks:

Issue 1. AI depends on human programming

The dilemma

The report recognises the power of AI. Algorithms can standardise treatment according to up-to-date guidelines, raise minimum standards quickly and reduce unwarranted variations in treatment. However, decision making tools may be programmed based on incorrect assumptions and incomplete information about patients, or whole populations. If that happens, significant numbers of patients across an entire healthcare system could be harmed over a short timeframe.

Mitigating the risks

Producers can work with hospitals and regulators to establish a framework for the safe development of AI in healthcare. This might include how clinicians should be trained, how new devices or techniques should be put through clinical trials, and the best methods for capturing patient information and conducting follow-up reviews of patient populations.

Issue 2. Many different professions are involved in creating AI

The dilemma

The report emphasises that people other than doctors will become integral to the provision of healthcare, particularly computer programmers and technology companies. This is generally a good thing as wider expertise is brought to bear on treating disease. However, few clinicians understand how AI works, few computer programmers will have medical qualifications and computer coding may be hidden as intellectual property. In the event AI is defective, it may be difficult to collate the evidence needed to determine responsibility for avoidable injuries.

Mitigating the risks

It will be mutually beneficial for manufacturers and hospitals to work out, in advance, where liability should lie in the event of injuries caused by AI. The allocation of liability should be set out clearly in contracts. All parties should take responsibility for identifying how and where injuries could arise and how they can collectively limit the risks. For example, manufacturers could provide training in new equipment; and hospitals could ensure that only clinicians who had received the necessary training were permitted to use the AI.

Issue 3. AI is already in the hands of the public

The dilemma

The report refers to the plethora of apps offering advice to patients directly, without the involvement of a doctor. It notes that apps could, potentially, prescribe treatments. On the one hand, greater numbers of people could access healthcare in a far quicker and cost-effective way than they do now. People who struggle to make an appointment to see an overstretched GP may benefit from AI solutions. However, this approach may prove dangerous if patients misunderstand the data generated by their smartphones, or if users are young, elderly or otherwise vulnerable.

Mitigating the risks

Manufacturers should set out the limits of the AI, emphasising the need for users to exercise their own judgement and common sense. Disclaimers should warn against unreasonable reliance on AI. Manufacturers could also consider limiting access to some of their products, perhaps based on prescription by doctors.

The AoMRC report provides an up-to-date assessment of the opportunities and risks presented by AI. Clinicians, manufacturers and hospitals will need to work together to ensure that patients benefit from new products, moving as quickly as is safe for patients and breaking nothing but technological boundaries.

Link to the AoMRC can be found here.

Even easier to miss (nestled in one paragraph on page 114 of the 136 page document), is the Plan's recommendation that the procurement requirements under the Health and Social Care Act 2012 are repealed. This is a significant development which could potentially have a huge impact on private healthcare providers which contract with the NHS.

The 2012 Act currently requires NHS Clinical Commissioning Groups to put out to tender any contract worth £615,278 or more. These types of contract represent a hefty part of the NHS purse; the Department of Health's published accounts reported that £13.1 billion of the NHS's budget in 2017/2018 was spent on non-NHS organisations (including the voluntary sector, local authorities and private providers).

This requirement means that non-NHS entities have the opportunity to tender for a significant number, and wide variety, of NHS contracts; and has led to many NHS contracts being awarded to private companies (Richard Branson's Virgin Care alone holds over 400 individual contracts).

However, the Plan concludes that the current set-up leads to wasted procurement costs and fragmented provision (particularly in the GP / urgent care sectors), and identifies this as an area ripe for streamlining and cost-saving. The BMA has voiced its support, with Chair Dr Chaand Nagpaul describing the procurement requirement as a 'wasteful use of resource'.

The intention is for the provisions in the Act to be replaced by 'statutory guidance'. This means that NHS Commissioners will be able to decide when and where procurement should be used, subject to what is described as 'a 'best value' test to secure the best outcomes' (with no further explanation given). Without further guidance, it is unclear when NHS Commissioners will choose to tender contracts and whether or not there will be a uniform approach across the UK.

Private providers should note that the contracts they currently hold could, in future, be kept within the NHS, without there being an opportunity to re-tender. Likewise, providers hoping to expand their businesses by tendering for future contracts may not get the chance. For those providers whose work currently involves a large number of NHS contracts, consideration needs to be given to the potential impact that losing those contracts may have on their business.

Ms Doyle-Price, who was already a junior minister in the Department of Health, has said that, through this role, she has met people who have been bereaved by suicide whose 'stories of pain and loss will stay with [her] for a long time'. The Minister is to set up a task-force which will work with experts in suicide and self-harm prevention, charities, clinicians and those personally affected by suicide. Her aim is to ensure that every local area has an effective suicide prevention plan in place.

The appointment was not without controversy (as a recording of Ms Doyle-Price joking that she would rather commit suicide than join UKIP emerged), and it has been suggested that this does not go far enough to tackle mental health issues. However, her appointment, alongside a £1.8million pledge from Theresa May to ensure that the Samaritans' helpline remains free, indicates that the Government has recognised the impact of suicide and is committed to tackling mental health issues.

Suicide can be a difficult topic to talk about, but its impact cannot be underestimated. There are more than 4,500 self-inflicted deaths every year in England, and suicide remains the leading cause of death in men under 45. One in five adults has considered taking their own life at some point. Ms Doyle-Price's appointment should, therefore, be welcomed by all.

What does it mean for Insurers?

Insurers will be aware that a suicide will invariably require an inquest to be opened. Healthcare providers, including individual practitioners (such as GPs), will often be called to give evidence, leading to a claim on the policy for representation. If there is any potential criticism, the suicide can be used to found a legal action (for failing to prevent the suicide), brought by family members of the deceased. These claims allege that the care provided to the deceased was inadequate. However, claims can also be brought against employers of those who commit suicide for failing to spot the signs of mental ill-health or for exposing the employee to distressing situations (for example in prisons or the ambulance service). For Insurers of such entities, it is important to be aware of the risk of such claims, and take steps to mitigate them.

It is, therefore, extremely positive that pro-active steps are being undertaken by the Government in this area. The appointment of Ms Doyle-Price, and the work her task force will undertake, is intended to:

1. De-stigmatise mental health issues, particularly with regard to suicidal thoughts, leading to more open discussion and a greater willingness to seek assistance;

2. Ensure local areas implement a suicide-prevention plan to set up triggers to identify those at risk of suicide and enable them to seek (and receive) help at an earlier stage; and

3. Encourage the various entities involved with individuals at risk of suicide to work together and cross-refer, in order to prevent suicidal individuals falling through the cracks.

The work that the suicide prevention minister will carry out is ultimately intended to reduce the numbers of individuals who take their life. As well as the obvious benefits for the individual concerned, and society as a whole, any reduction in the suicide rate should lead to a comparable reduction in claims, and so also benefit Insurers.

Insureds with expertise in the healthcare arena should be encouraged to work with the taskforce to ensure that their experience is fed into the wider strategy, and that they are able to effectively implement any suicide-prevention plan. It will also be important for Insureds to keep abreast of any recommendations that arise out of the Minister's work and for Insurers to ensure that any prospective Insureds are compliant with them.

Hopefully, Ms Doyle-Price and her taskforce will be able to bring about a positive change in this traumatic area. We will provide further updates on any recommendations.

Further information on help for suicidal thoughts and coping with the loss of a loved one to suicide can be found here and here.    

Despite its title, Hawking's book poses more questions than it provides answers. Even for the author of "A Brief History of Time", Hawking readily acknowledges that attempting to predict the future is a hard task. He sets out to solve it by examining the present in order to see whether we are equipped to tackle the future.

Some of the most vital questions posed by the book foretell the complex legal issues that lie ahead for the life sciences sector.

Will Artificial Intelligence overtake human intelligence?

Hawking comments that we are facing an explosion of artificial intelligence. We may end up with machines whose intelligence exceeds ours by more than ours exceeds that of snails. We are warned that failing to recognise this fact could be humankind's worst mistake.

The life sciences industry will need to grapple with the challenges of artificial intelligence far sooner than other sectors. The book suggests that it will become increasingly difficult for regulators to oversee clinical choices where human decision making is delegated to machines. Computer experts, not clinicians, may become key decision makers. If computers become more intelligent than us, then society may lose its confidence in human regulators. If matters go to court, some may question how a judge, even when supported by human experts, can determine if there has been negligence, or whether any party is at fault, where an outcome is the result of a decision by a higher form of intelligence.

What could wipe out the human race first: overcrowding, nuclear war or disease?

Despite the prospect of artificial intelligence improving healthcare, Hawking worries about the threat posed by epidemic diseases, ranking it alongside nuclear war as a threat to human existence. He notes that the growth in the global population has been exponential, jumping from 1 billion to 7.6 billion in 200 years. The rise of a new disease could have devastating consequences in overcrowded conditions.

If we take this warning seriously, then governments and healthcare providers should not rest on their laurels, looking back at past achievements such as eradicating smallpox or taking the fight to Ebola. Rather, the sector should redouble its efforts to be prepared to confront the next outbreak of a disease that may have been hitherto little understood. Companies that manufacture vaccinations will need to mitigate the risks associated with clinical trials of relatively obscure new treatments, as well as prepare for risks created by public pressure to release drugs into the market at speed. 

Will anyone truly be expert in anything?

Such is the rate of scientific research and publication, that Hawking laments that, in the near future, no one person will be able to keep up with the rate of scientific progress in their chosen field. This could have consequences for regulators and the courts. 

Regulators will increasingly need to take action by committee, across multiple jurisdictions. This could hasten an era of better cooperation and a convergence of standards across countries.

The traditional adversarial approach to litigation, where it is alleged that a drug or device has failed to meet the relevant standard of safety, may have to be rethought if it is no longer possible to trust in one or two experts. In future legal disputes, expert witnesses may become little more than mouthpieces for committees - or the spokespeople for artificial intelligence.

What will happen to our DNA, are we going to be replaced by synthetic biology?

There has been relatively little change in human DNA in the last 10,000 years. But we are at the threshold of being able to redesign it completely. Hawking predicts that regulators will be unable to prevent someone from redesigning humans using genetic engineering. From both a biological and an engineering perspective, the human race will become increasingly complex. 

The opportunities and risks associated with redesigning humans are mind-boggling (although perhaps, in time, we will come to comprehend it all, as Hawking predicts the wide-spread use of computers implanted in the brain). Those who work in the sector will manufacture products that cannot be imagined today. Regulators and law-makers may struggle to keep up, forcing judges to fill in the gaps when issues come before them.

The Pinnacle hip was approved for use in the United States and the EU and was subject to the world's most stringent regulatory standards. Despite this, a scan of mainstream media reports on metal-on-metal hips over the last ten years reveals scores of headlines using emotive words and expressions such as "fear", "crippled for life", "misery", "alarm", "scare", "poisoning", "agony", "toxic", "link to cancer" and "must be banned". After a trial that ran for over three months, the Court ruled that the products were not defective, so giving the lie to the hyperbole.

The media can play a vital role in investigating and holding to account governments, regulators and healthcare institutions. In this blog alone, we have reported on the Dr Bawa-Garba case,   the debate over medicinal cannabis, the contaminated blood enquiry and the opioid epidemic – all examples from the last few months where investigations by the media have contributed to regulatory intervention, government action and judicial decisions for the benefit of society as a whole. The media also has an essential role in disseminating urgent healthcare information issued by governments and regulators.

But Gee v Depuy showed that sections of the press sometimes overstep the mark where reporting of healthcare concerns falls into the seductive trap of spicing up headlines with emotional language designed to worry the public. Lawyers should be wary of bringing claims inspired by such stories.  Whilst media outlets benefit from increased sales, the implications can be serious:

1. For individuals

Patients can be caused unnecessary anxiety, and demand revision surgery (which carries its own risks) when it is not necessary, or at best premature.

Gee v Depuy demonstrated that adverse, and unfair, media reporting has an effect on clinicians too. The risk is that medical professionals will react to a media storm by taking an overly cautious approach in particular cases, whether revising an implant too early or shying away from prescribing the best treatment for a particular condition.

2. For society as a whole

In the wider context, manufacturers may decide that innovation is not worth the risks. Any medical product that interacts with people's physiology, or introduces artificial components into the body, will have some form of side-effect. Laboratory and clinical trials can only go so far in predicting what the side-effects will be in order to help regulators determine if the risks associated with a product are outweighed by the benefits. It is only once a product is in use in the population at large that a manufacturer knows how a product will perform over the longer term. Manufacturers ought to be free to innovate, within the constraints of regulation, and be held to account based on scientific knowledge once it is available. If the media does not give them the space to do so, then manufacturers will be wary of bringing new products to the market.

Emotive headlines can also have an impact on decisions taken by large numbers of people, with consequences for society in general. A case in point is the decline in MMR vaccination rates following media reports based on Andrew Wakefield's erroneous allegation of a link between the vaccine and autism, with a resulting rise in the incidence of childhood illnesses that the vaccine is designed to prevent.

Over the last couple of years, society has become increasingly concerned about the effect of fake news. It can skew elections and ruin reputations. For the healthcare sector, Gee v Depuy shows that misleading reporting of complicated medical issues can lead to hysteria, unwarranted attacks on manufacturers and the public being denied the most appropriate medicines and medical devices. It is important that media outlets stress-test the evidence and investigate the bigger picture to avoid stories amounting to fake news.

A detailed analysis of the sad facts of this case can be found in our previous article. In short, in 2011 Dr Hadiza Bawa-Garba was the junior doctor in charge of the Emergency Department and Children's Assessment Unit at Leeds Royal Infirmary on the day a six-year old boy, Jack Adcock, attended with vomiting and diarrhoea. Jack's subsequent death, of cardiac arrest caused by undiagnosed sepsis, led to Dr Bawa-Garba being convicted of gross negligence manslaughter in November 2015. Dr Bawa-Garba was given a 24 month suspended sentence (upheld by the Court of Appeal).

The General Medical Council (GMC) recommended that Dr Bawa-Garba was struck off the medical register. However, the Medical Practitioners Tribunal Service (MPTS) considered this disproportionate and instead imposed a 12-month suspension. The GMC then took the unusual step of appealing this decision to the High Court, which concluded that the MPTS had not respected the verdict of the jury in the criminal case and Dr Bawa-Garba was struck off the medical register.

Controversy

The case attracted significant attention within the medical community and many doctors have accused the GMC of acting heavy-handedly. More than £350,000 was raised to fund Dr Bawa-Garba's appeal, and more than 1,500 doctors signed a letter expressing 'deep-seated concerns' at her treatment, which they considered threatened the 'culture of openness' that is encouraged within the medical community.

Implications for the medical community

On Monday the Court of Appeal restored the MPTS's original decision not to strike Dr Bawa-Garba off the register and instead suspend her registration.

Whilst it is important to remember that this case involves the tragic death of a young boy the case has implications for the medical community as a whole:

1. The threshold is high for the Court to intervene in decisions of specialist adjudicative bodies

The Court found that it should only interfere with the decision of a specialist adjudicative body (such as the MPTS) if:

i. There was an error of principle in carrying out the evaluation; or

ii. The decision was irrational (meaning it fell outside of what could properly and reasonably be decided).

This is important as it makes clear that the Court will only intervene in extreme cases. With such a high threshold there seems little to be gained in appealing a tribunal decision, save in unusual cases like Dr Bawa-Garba's, whether you are the individual practitioner - or a third party like the GMC. In most cases the tribunal's decision (for good or bad) will be final.

2. The MPTS and the Criminal Court have different functions

The decision emphasises that the Criminal Court and a tribunal such as the MPTS have different functions. The Criminal Court was tasked with looking at Dr Bawa-Garba's past conduct and determining whether it constituted gross negligence manslaughter. The MPTS's function, on the other hand, was to look to the future and consider what sanction was most appropriate to ensure the protection of the public in all the circumstances.

The MPTS was therefore entitled to consider that, prior to Jack Adcock's treatment, no questions had ever been raised about Dr Bawa-Garba's clinical competence, and her hospital had continued to employ her (without issue) for the four years following the incident, but prior to her being charged by the police. When taking these matters into account, the MPTS were entitled to conclude Dr Bawa-Garba was not a risk to the public, even in light of her gross negligence manslaughter conviction. The MPTS had also noted the context of wider systemic failings including staff shortages and IT system failures that had delayed test results.

3. A criminal offence does not mean automatic erasure from the register 

The judgment makes clear that, even in cases where the individual practitioner has been convicted of a criminal offence, there is no 'presumption of erasure' from the register. The MPTS (or an equivalent tribunal) should consider whether a lesser sanction would be consistent with the maintenance of public confidence in the profession, and its professional standards. In Dr Bawa-Garba's case, as she was a competent and useful doctor (who presented no material continuing danger to the public, and could provide considerable useful future service to society) it was entitled to conclude a 12-month suspension was the appropriate course of action.

However, that could all be set to change as the General Pharmaceutical Council (GPhC), which regulates the sector, plans to strengthen the rules governing online prescribing.

Proposed changes

Just over a month ago, the GPhC published a discussion paper (Making sure patients and the public obtain medicines and other pharmacy services safely online). Open to comment until 21 August 2018, the proposed changes will mean that online pharmacies would be obliged to put in place new safeguards to protect people who want to obtain certain medicines online, including:

• Antibiotics: these should usually only be prescribed and supplied if physical examination or diagnostic testing shows that they are clinically appropriate and thought has been given to stewardship guidelines (i.e. to slow the emergence of resistance);

   

• Opiates (such as codeine and tramadol): should only be prescribed and supplied if the patient has given consent for the prescriber to contact the patient's GP and the GP has confirmed to the prescriber that the prescription is appropriate for the patient (and appropriate monitoring is in place);

   

• Non-surgical cosmetic medicinal products (such as Botox): should only be prescribed and supplied after the prescriber has carried out a physical examination of the patient.

Why?

It seems that both public and expert opinion have some part to play in the proposed changes.

Sarah Wollaston MP (doctor and chairwoman of the Commons Health Select Committee) has recently been quoted as saying that prescribing medicines such as opioids through online pharmacies was "appalling… that is the way to end up with people having addiction. It shouldn’t be allowed".

America's opioid crisis is well documented, referred to as the "worst drug crisis in American History" and there's concern that the UK is following suit. In 2017, nearly 24 million opioids were prescribed in the UK– equivalent to around 2,700 packs per hour, and latest figures show the number of people dying from opioid-related drug misuse has reached a record high in England and Wales.

The inappropriate prescription of antibiotics has dominated the headlines for a while now ("Antibiotic madness: A fifth of prescriptions given out by GPs are to patients who do not need them": Mail Online), with the concern being that it results in the development of resistant strains of bacteria – the 'superbugs'. Concerns over Botox have caught the attention of both the GMC and the NMC in the past few years, so perhaps it's no surprise that the GPhC has felt the need to tackle these issues too.

What will be the impact?

Well, any changes to the rules will take a while to implement – at the moment, the GPhC is still in consultation on its proposals-  but, if, and when, the rules do change, patients can expect to see a more stringent approach taken to their prescribing.

Online prescribers will need to be extremely careful in their approach, documenting all their decisions accurately and appropriately, and ensuring that the correct checks and processes are in place – and Insurers will want to make sure that this is the case.

A jury in the US state of Missouri awarded the claimants US$550m in compensation and US$4.14bn in punitive damages. Johnson & Johnson has said that it will appeal the decision. This follows its success in overturning earlier jury awards on appeal.

There are many high-profile examples of litigation concerning healthcare products having success in the US before becoming a concern in the UK: metal-on-metal hips, pelvic mesh and Seroxat being some. Those disputes involved highly complex medical devices and pharmaceuticals. By contrast, talc products, such as baby powder, seem commonplace and uncomplicated. Should UK insurers be concerned about a new wave of litigation concerning established and seemingly low risk healthcare products hitting these shores? The answer is probably not. Various factors mean that litigation concerning such products is less likely to be successful here.

The first instance verdicts making the headlines in the US are jury decisions. In England and Wales, civil claims are decided by a judge sitting without a jury. Plaintiff lawyers in the US are experienced in maximising the emotional impact that a claimant's evidence can have on a jury.

It is notable that in number of cases concerning Johnson & Johnson, jury decisions have been overturned by an appeal tribunal consisting of judges. An English judge would not be unsympathetic towards claimants' personal stories, but could be expected to weigh up the evidence more dispassionately, so removing the emotion found in US cases that can have a profound impact on the outcome of a personal injury claim. Claimants here may find it significantly more difficult to persuade a court of a causal link between use of talc products and cancer.

Evidence

The Missouri litigation examined contradictory expert evidence over whether or not the products could cause cancer. In England & Wales, insurers and their manufacturers have the benefit of recent case law that sets out how a court here would scrutinise scientific evidence that allegedly supports a claim that a product is unsafe.

The decision in Gee v DePuy & Ors [2018] handed down in May this year concerned claimants implanted with metal-on-metal hips. The Court held that the evidence cited by the claimants could not be relied upon because there were too many potentially confounding factors skewing the findings, much of the primary data was unreliable and the underlying studies referred to in reports were inadequate. Defendants in future will refer to Gee as an example of scientific studies about healthcare products failing to stand up to judicial scrutiny.

The weight of scientific opinion in the public domain does not appear strong enough for claimants to bring a case here. The NHS states on its website that "further research in the form of good-quality prospective studies would be required" to prove a link between talc and ovarian cancer. Ovacome is a charity that provides advice and support to women with ovarian cancer. Its fact sheet examines evidence published to date and states "this weak link between talc and ovarian cancer is just speculation at the moment. With no convincing results from research studies, it is hard to imagine that talc is a significant cause of ovarian cancer."

Claims brought here would be under the strict liability regime set out by the Consumer Protection Act 1987 (the Act) or in tort for negligence. Claims under the Act would need to demonstrate that talc products were defective in failing to meet the level of safety consumers generally are entitled to expect, and that any such defect caused injury.

In the absence of evidence proving a causal link between talc products and cancer, it is difficult to see how claims under the Act could succeed. Claims alleging negligence would need to prove that manufacturers breached their duty of care towards users. Johnson & Johnson have stated on the record that it carried out testing into the risks. In light of these statements, claimants would struggle to prove that manufacturers were negligent in supplying talc products.

Lessons for the UK

Although it is unlikely that litigation over household staples such as talcum powder could succeed in England & Wales, the US litigation does offer some lessons for the UK. The talc litigation is just the latest example of a growing trend in product liability litigation, both here and in the US, where claims are brought on behalf of multiple claimants citing scientific studies based on data concerning large populations. Increasing amounts of health data are being generated as patients are monitored with more scrutiny, governments support the establishment of registries and record keeping is digitised.

The result of this is that claimant law firms have access to more and more information, both primary data sources and epidemiological studies. It is important that manufacturers invest in tracking and analysing data generated about their products, both to ensure that their products' safe performance is monitored but also to be prepared to discuss and explain the evidence with concerned patients, or the media, before concerns snowball into litigation.

The litigation in the US has raised questions over the adequacy of warnings provided with talc products. The litigation is a reminder that manufacturers should keep under review the warnings that accompany their products. If latest scientific studies reveal new concerns over a product then manufacturers should consider whether the warnings and guidance accompanying their products need to be updated.

The litigation in the US was not inspired by steps taken by the regulator. In response to questions over the safety of talc products, the US Food and Drug Administration (the FDA) stated that "before we can take action …. we need sound scientific data to show that it is harmful under its intended use."

The FDA's finding after commissioning a survey was that it "found no asbestos fibers or structures in any of the samples". Despite the FDA's findings, litigation continued in the US. The lesson for manufacturers is that it is not enough to assume that claimant law firms will drop litigation where the regulator has investigated and decided not to act.

A similar story was seen here in the metal-on-metal hip litigation where most products remained licensed for use by the Medicines and Healthcare products Regulatory Agency. The fact that a product is approved by the regulator will lend considerable weight to an argument that it is safe, but may not in itself be enough to persuade claimants to drop their claims.

Manufacturers and their insurers in the UK need not be too concerned about the astronomically large jury awards against Johnson & Johnson in the US being replicated in this jurisdiction. The nature of our legal system means that claimants would be less likely to succeed in bringing claims; nevertheless, product liability in the healthcare sector is a developing area and the talc litigation raises points of interest for manufacturers and insurers to consider. 

This article was first published in Insurance Day.

Now, following a fierce public response, that decision has, temporarily at least, been overturned.

Last month, Home Secretary Sajid Javid gave special dispensation for Alfie to use the drug to prevent life threatening seizures. This followed the Government's decision to grant a 20-day licence to 12-year old Billy Caldwell, who hit the headlines after cannabis oil from Canada, used to treat his severe epilepsy, was confiscated from his mother at Heathrow airport.

These decisions accompanied a Government announcement that it would be establishing an expert panel of clinicians to advise ministers on individual applications to prescribe cannabis-based medicines. The applications process will be quick, with ministers issuing final decisions within 2 to 4 weeks.

The panel is intended as an interim measure whilst the Government undertakes a two-part review into the classification of cannabis for medicinal purposes. Cannabis based products are currently listed in Schedule 1 of the Misuse of Drugs Regulations 2001 (Schedule 1 drugs by definition have little or no therapeutic benefits). If the review identifies significant medical and therapeutic benefits, the intention is for cannabis to be re-classified for medical use.

The first part of the review is now complete and England's Chief Medical Officer, Dame Sally Davies, has reported that there is "clear evidence from highly respected and trusted research institutions that some cannabis based medicinal products have therapeutic benefits for some medical conditions".

In light of these findings, Dame Sally Davies questions, in her report the rationale for keeping cannabis based medicinal products within Schedule 1. Moving these drugs out of Schedule 1 would mean that registered practitioners could, under controlled conditions, prescribe them for medical benefit. It would also allow further research to be undertaken, including by means of clinical trials, to improve the evidence base for the therapeutic benefits associated with using cannabis-based drugs.

The Government review is a significant step towards changing the current laws around medical cannabis, and investors have been quick to catch on to the opportunities this might bring – Imperial Brands, better known for its position in the tobacco industry, has reportedly invested in Oxford Cannabinoid Technologies (OCT), a UK-based biopharmaceutical company researching cannabinoid-based medicine. Chief Development Officer of Imperial Ventures, Matthew Phillips, has stated that the investment "enables Imperial to support OCT’s important research while building a deeper understanding of the medical cannabis market".

Public response to the Government's review has been largely positive. A number of medical experts have welcomed Dame Sally Davies' findings and the potential opportunities that reclassification may bring in terms of improved patient treatment. Dr Adrian James, a registrar at the Royal College of Psychiatrists has acknowledged the "significant health benefits" that properly reviewed and approved cannabis products for medicinal use can have.

The legalisation of cannabis for recreational purposes remains a far more divisive issue both for the public and the medical profession; Dr James said: "as mental health doctors we can say with absolute certainty that its use carries severe risks for some, including psychosis, depression and anxiety”. The Government has made it clear that the current review will not consider reclassification of cannabis as a Class B drug and will not consider the legalisation of cannabis for recreational use.

But what do we know about Hancock and his likely impact on the healthcare sector? Hancock, an Oxford graduate, was first elected as an MP for West Suffolk in 2010 and has previously worked as an economist at the Bank of England, and as George Osborne's Chief of Staff. The reshuffle represents a significant promotion for Hancock, who had been a Junior Minister up until January of this year (when he was appointed Culture Secretary).

In terms of his healthcare credentials, Hancock has no discernible background and no known connections to the NHS or any private providers. He has not mentioned GPs or Doctors once since he started in Parliament 8 years ago and there is no evidence healthcare has been a particular area of interest for him. Aside from his wife (who is an osteopath), it seems Hancock's connections to the sector are limited. It is therefore hard to predict whether his appointment will be a help or hindrance to those working within healthcare, and whether it will lead to any deviations from the current status quo.

We can, however, look at Hancock's voting record to give us a clue to what the future holds. Hancock has consistently voted for reforming the NHS (including giving more power to GPs to commission services, and the Government's 2011 NHS reorganisation). In 2011 he  voted against attempts to change the Government's NHS reform plans (including dropping the proposed market-based approach). It therefore appears Hancock has some appetite for introducing reform within the healthcare sector.

Hancock is a keen supporter of technology;  he even created his own app so his constituents can track what he is working on. He may therefore be a positive influence as the NHS seeks to modernise and increase its efficiency.

Hancock's appointment also marks the end of Jeremy Hunt's tenure. Hunt, who was the longest-serving Health Secretary, has recently been applauded for leading calls for a new funding package for the NHS to mark its 70th anniversary (which has resulted in an extra 3% a year for the NHS). However, Hunt has faced much criticism whilst in the role. This was particularly potent with regards to the controversial junior doctor's contract (which sparked the biggest walk-out of doctors in the NHS's history). Many, therefore, have been celebrating Hancock's appointment not for what he will bring to the role, but because it marks the end of Hunt's influence in the healthcare sector.

Ultimately, Hancock is a relative unknown in relation to healthcare and we will have to wait and see to determine what, if any, significant impact he will have on the sector.

In the United Kingdom, a medicine's terms of use are defined by the marketing authorisation or product licence granted by the Medicines and Healthcare products Regulatory Agency (MHRA). This contains a summary of product characteristics which outlines the conditions it is intended to treat, recommended doses, warnings and side effects. It gives the comfort that the risks of the medicine have been assessed by the regulator and considered to be offset by the benefits.

However, "off-label" medicine is not as concerning as it may sound. It can include drugs used for one disease but found to be beneficial for sufferers of another, drugs given in a different way – if the drug is approved in capsule form but given in an oral solution, or drugs given at a different dose to the approved amount.

Off-label use of medicines can be beneficial. Take propranolol as an example – this drug has been approved for treatment of hypertension and the prevention of angina pectoris. However, a study in 1991 found that taking propranolol prior to an exam improved the performance of students prone to cognitive dysfunction from test anxiety. Propranolol has also been shown to assist with sports, public speaking and musical performances. Even household aspirin has off-label beneficial properties.

In 2006, a study found that in a sample of common medicines, 21% of prescriptions were for off-label use. Such practice is more common within certain subgroups of patients; in paediatrics especially there are difficulties in developing age-appropriate formulations – 78% of children discharged were taking an off-label medicine. There are clinical situations where it may be in the best interests of the patient to use a medicine off-label. It can even become the predominant treatment for an illness. For example in the US, the FDA has not approved the use of tricyclic antidepressants to treat neuropathic pain, yet that is considered to be standard treatment.

A greater responsibility is placed on healthcare professionals when they prescribe off-label medicine. They must be satisfied that this approach would best serve the needs of the patient, and pay close attention in particular to the risks associated with the off-label use of that medicine such as adverse reactions. To this end, healthcare professionals would be wise to ensure that they use consent forms which highlight that the medicine is being prescribed off-label, even if such use is commonplace.

The vote means that the wording of the eighth amendment to the Irish constitution, which currently asserts the 'equal right to life' for a pregnant woman and an unborn foetus (at any gestation), will be amended to read 'provision may be made by law for the regulation of termination of pregnancies'. For the first time, abortion will become legal in the Republic of Ireland; the first step towards provision of abortion care has been taken.

Abortion in the Irish Republic is illegal unless it occurs as the result of a medical intervention performed to save the life of the woman. This exception (contained in The Protection of Life During Pregnancy Act 2013) is so narrow that it resulted in only 25 abortions in 2016 (figures for 2017 have yet to be released). The penalty for performing or undergoing abortion outside this exception is 14 years in prison. By comparison, the average prison sentence for a rape conviction in the Republic of Ireland is 5 to 7 years.

The Irish Republic has not historically prevented women from seeking abortion elsewhere; it is estimated that 10 women a day travel to England to seek terminations. These women need to pay for the termination procedure and the cost of travel and accommodation.

So what are the practical implications for Ireland? In the immediate future there should be a reduction in the stigma surrounding abortion, given the increased dialogue, and the strength of the result. The referendum allows the Irish Government to enact laws to regulate abortion, so legislation will have to be drafted and implemented. It appears that abortion will be available 'on demand' up to 12 weeks gestation (in line with many other European countries), but there will be thorny issues to decide such as provision for conscientious objection and what (if any) reasons are required for an abortion after 12 weeks.

The Irish health care system will need to take steps to provide adequate abortion services; medical practitioners will need to be trained, and policies, guides and codes of good practice put in place. Medical training in universities will need to be updated to ensure abortion provision is part of the core curriculum for students of Obstetrics and Gynaecology.

In the long term, the result of this vote is hugely significant. It will enable women in the Irish Republic to access abortion services at home, and removes the financial, and emotional, burden of having to travel for abortion procedures abroad. The result is a step towards giving Irish women greater control over their bodies.

The vote is also likely to have an impact on the UK. Given the changes required to Ireland's health care system, UK abortion providers are likely to be asked for input, and as abortion services improve in Ireland, we can expect the numbers of women travelling to the UK for abortions to reduce, which should go some way to reducing the burden on UK abortion providers.

Most importantly, the referendum result throws into stark contrast the position of Northern Ireland, where abortion at any gestation remains a criminal offence. There have already been strident calls for this anomalous situation to be resolved. Will the momentum of the Republic's referendum drive a change in Northern Ireland, or will political considerations demand the status quo?

However you view the outcome, Friday's landmark result will have a vast impact on the provision of health care to women in Ireland, and the UK.

Thousands of patients, all over the world, have been implanted with MoM hip prostheses, many of whom commenced litigation. In England and Wales the claims were primarily brought against manufacturers of orthopaedic devices (but also involved private healthcare providers, NHS Trusts and individual surgeons) and concerned an alleged adverse reaction to the MoM implants.

Ten different manufacturers faced claims from hundreds of individuals, and various Group Litigation Orders were put in place to manage the claims. In late 2015 it was ordered that a trial of preliminary issues should take place in the Group Litigation against manufacturers DePuy and Corin (to be heard together). All other claims were stayed pending the outcome. The trial of the claims against Corin was subsequently vacated and only the DePuy Pinnacle litigation proceeded.

The Claimants' case was that the MoM hip implants were defective under the Consumer Protection Act 1987 ("CPA") - i.e. their safety was 'not such as persons generally are entitled to expect' – because they had suffered an adverse reaction to the metal debris ("ARMD") that is generated from the articulating surfaces of the metal "ball and socket" joints. The threshold for a claim under the CPA is much lower than in negligence as there is strict liability so long as there is a defect in the product and this defect caused injury or damage. It is therefore a powerful tool for Claimants.

In the DePuy Pinnacle litigation the Claimants' primary case on defect was the alleged propensity to produce metal debris. There was also a secondary allegation that the Pinnacle implants required earlier revision than other comparable products.

There had previously been two key decisions in relation to the CPA: A v National Blood Authority in 2001 and Wilkes v DePuy in 2016. National Blood Authority found for the Claimants; and Wilkes found for the Defendant. In reaching their different conclusions (albeit on two very different sets of facts) the judges used widely contrasting methods of analysis. As both decisions were first instance the law on bringing a claim under the CPA remained unclear and somewhat contradictory. Andrews J's judgment given this morning goes some way to clarifying the position (although, as another first instance decision, it does not overturn the previous two).

The decision to find in favour of DePuy should reassure manufacturers (and their insurers). It bolsters an argument (along with Wilkes) that National Blood Authority should be distinguished (or approached with caution), meaning a claim under the CPA should be easier to defend. It also provides much needed guidance on what should be considered a defect under the CPA, what relevant circumstances the Court should take into account when considering a claim under the CPA, and on what basis comparisons to other products should be made. We will be considering these points, and providing guidance on the practical impact of the decision, in our upcoming blog series. However, for now, manufacturers (and insurers) can be content that this landmark decision has gone in their favour.

RPC represented Corin in the Corin Metal-on-Metal hip litigation

The approach over the water

In some countries, the health benefits of water are recognised to an even greater extent, with qualified health professionals not only advocating, but also prescribing, courses of water-based treatments for a range of conditions, including muscular complaints and circulatory disorders.

'Medical spas' are big business abroad, especially in those towns and villages which benefit from the presence of natural thermal springs.

Troubled waters in the United Kingdom

There was a time when the health benefits of mineral-rich thermal waters were more highly valued in this country. Think about the natural thermal springs in Bath, first discovered around 863BC by Prince Bladud, who claimed to have been cured of his leprosy after bathing in the warm waters. And Buxton, a place of medieval pilgrimage, which, by the end of the 19^th century, was a significant centre for hydrotherapy and other water-related treatments on account of its thermal springs.

From the early 17th century until around 1948, a vast number of spas sprung up in England, and 'taking the waters' became a common trend for treating ailments including scurvy, epilepsy and various skin complaints.

But nowadays, in the UK at least, we tend to see a 'spa day' as a thing of relaxation and luxury, an indulgent treat, different to the 'medical spa' concept which you might find abroad.

A number of factors have contributed to this. The advent of the NHS in England in 1948 led to a declining association between spas and their medicinal benefits. The nature of therapeutic treatments offered to patients and the way that they were perceived by those delivering them changed; spa medicine fell out of favour as patients gained greater access to cutting edge treatments, and the promise of new drug-based solutions prevailed. Spa treatments had been funded by the State, via NHS contracts, but the funding was removed over time and, as a result, many spa towns in the UK fell into decay or were demolished.

Time to take the plunge?

This contrasts with the position in a number of other countries, where there remains an understanding of (and state support for) the health and therapeutic benefits that thermal water-based treatments can offer, for both preventative and rehabilitation purposes. In central Europe for example, a weekly trip to the local spa is, for many, a routine part of a healthy lifestyle.

As financial pressure on the NHS reaches crisis point and concerns around the long-term impact of prescription drugs begin to surface, there are increasingly strong reasons to turn to more holistic therapies here in the UK.

"Baby is born in China four years after parents died in car crash"

"Chinese baby born four years after parents' death"

There's no doubt that the story of baby Tiantian has evoked a huge response across the globe. Some saw it as a wonderful tale of love and life; others viewed it with a worried suspicion. But what are the real implications for IVF providers (and their insurers) here in the UK, and what might we expect to see by way of progress in the coming years?

To set the scene, having been married for a couple of years, Shen Jie and Liu Xi had been trying to conceive through IVF. In March 2013, five days before their fertilised egg was due to be implanted in Liu, they both died in a car crash.

After the tragic accident, and for the next three years, the parents of Shen and Liu fought a lengthy and complicated legal battle in the Chinese Courts – arguing that they should have the rights to the four frozen embryos that their children had left behind. They eventually won, and baby Tiantian ("sweet") was born in December 2017 to a surrogate in Laos (surrogacy being illegal in China).  He is now living with his grandparents.

Although the case has been reported as unprecedented, it should not come as such a shock in the UK, where our own laws allow the birth of a child through IVF after a biological parent has died (subject to express consent). And, in fact, a very similar case appeared in the UK not so long ago - Mr and Mrs M. v HFEA (Human Fertilisation and Embryology Authority).

In that relatively unreported case, which was concluded just last year, Mr and Mrs M's daughter had died five years previously (aged 28) from bowel cancer. They requested that the HFEA give them the rights to their daughter's frozen eggs – this was denied. The key contention centred on documentation. In the UK, the HFEA requires that the woman (or, if the eggs have been fertilised, both partners) decide what should happen to eggs in the event of death or mental incapacity. Unfortunately, Mr and Mrs M's daughter's forms had not been fully completed, and whilst the daughter had said that her eggs should be stored should she die, she did not specify what should subsequently happen to them. Whilst the family claimed that the woman wanted her parents to raise any potential offspring, there are no automatic inheritance rights in respect of eggs or embryos under UK law.

After two years of legal wrangling, the Courts overturned the HFEA's decision; Mr and Mrs M took their daughter's unfertilised eggs to the US for fertilisation by a sperm donor – they remain anonymous and there have been no further reports on the outcome of this. 

But what does all of this mean for IVF providers (and their Insurers) in the UK?

Well, there is a clear demand for IVF – over a quarter of a million UK babies have been born as a result – and there are many wonderful success stories – opportunities for business are vast. But there are definite risks – the potential for multiple pregnancies, ectopic pregnancy, OHSS to name just a few, and that's not taking into account the issues that arise if someone subsequently dies.

The facts of Springer v University Hospitals of Leicester NHS Trust [2018] EWCA Civ 436 concern a claimant who entered into a CFA in 2010 but did not give notice to the defendant NHS Trust at the time. Instead, the Claimant delayed until September 2012 before sending a letter of claim, and notice of a later CFA, to the Trust. Proceedings were served in February 2013 and settled in July 2014. The Claimant sought to rely upon the 2010 CFA when recovering his costs.

In the judgment handed down last month, the Court of Appeal dismissed the Claimant's appeal against an order refusing an application for relief from sanction for failing to serve the required notice of funding at the right time. This meant that the Claimant could not recover the success fee from 2010.

The judgment is welcome news for defendant hospitals and other healthcare providers, as well as manufacturers of medical products dealing with personal injury claims, for three reasons in particular:

1. Not all defendants share Hickinbottom LJ's sense of history  

Hickinbottom LJ (who gave the leading judgment) commented that the pre-April 2013 rules on success fees are "to a large extent now of only historical interest". As a result of the Jackson costs reforms, for CFAs entered into on or after 1 April 2013, success fees are no longer recoverable from the other side (save for certain exceptions, such as claims relating to diffuse mesothelioma). This case, by contrast, concerned a CFA entered into before April 2013 where, in principle, the success fee is recoverable against the defendant.

Healthcare providers, manufacturers and their insurers might disagree with Hickinbottom J's view that this is now history. Many such defendants will have long running personal injury claims on their books where CFAs were entered into some years ago but proceedings have not concluded. That may be because limitation "standstill" arrangements have been agreed to allow for investigations and settlement discussions or because claims have been brought on behalf of children (for whom the usual limitation periods do not apply). For that reason, this judgment will be relevant to some cases that are still running.  

Practical tip: In claims where a claimant attempts to recover a success fee based on a pre-April 2013 CFA, defendants should require the claimant to demonstrate that they served the required notice of funding when it was entered into (which now will have been some years ago). If notice was not served on time then this judgment can be relied upon to argue that the defendant should not be liable for the success fee after the claim is resolved (which may be a significant saving, especially in particularly complex cases).

2.  Court of Appeal recognises a defendant's "loss of opportunity"

The Court of Appeal considered whether the claimant should be afforded relief from sanction, and permitted to recover the success fee, under "Denton"   principles. In refusing relief, Hickinbottom J held "the key finding … was that the NHS Trust had suffered significant prejudice as a result of the breach." By not being served with notice of the claim and success fee until two and a half years had passed, the Trust had lost the opportunity to take pro-active steps in investigating and resolving the claim. The Claimant's error was sufficiently serious to mean that good reason had to be shown for the mistake. The Claimant failed to show good reason and so the appeal failed.

Practical tip: When responding to an application for relief from sanction, gather evidence which demonstrates that a claimant's error had a significant impact on the management of the case and so relief should be denied. The facts of this case provide a useful precedent.

3. A lesson in proportionality

In our view, the judgment has wider application than under the "Denton" test alone. Parties to litigation should take account of the principle of proportionality. Defendants can refer to this judgment to argue that a claimant should accept a reduced costs award if his or her conduct means that the defendant has lost an opportunity to resolve litigation at an earlier stage. Many defendants will recognise the exasperation expressed by Hickinbottom J when he noted that the costs claimed from the defendant were double the amount for which the claim was eventually settled.

Practical tip: When it comes to detailed assessment, consider whether costs have escalated due to the claimant's conduct, in order to argue for a reduction in the sums payable by the defendant. At an early stage, defendants can remind claimants to take a proportionate approach to incurring costs. In later negotiations or disputes over costs, defendants can refer to this judgment to argue that the claimant should be held to account (for example over disclosure or the instruction of experts).

For the first time, the Royal College of GPs has produced new recommendations dubbed "three before GP". The recommendations encourage patients to take three steps before visiting their GP, in an attempt to ease the pressure on surgeries. The three steps require patients to ask themselves whether they can: 1) self-care 2) use NHS Choices or another reputable website or resource or 3) seek advice or treatment via a pharmacist. The recommendations follow recent statistics showing that up to one quarter of all GP appointments could, in reality, be avoided, with reports from some GPs of patients attending for issues like indigestion over the Christmas period.

The recommendations have, however, faced criticism for encouraging patients to turn to "Doctor Google", and because of the other risks that this approach to healthcare could have, including a potential delay in diagnosis of serious conditions, and an over reliance on pharmacists who may not be appropriately qualified to respond.

Media reports of the struggles faced by the NHS do prompt the question, what does the future look like? Recent reports suggest that Brexit will place greater pressure on the NHS, with more than 100 elected officials warning that leaving the EU is the "biggest threat of all" to the health service, because of a loss of staff, increased difficulty in importing materials, withdrawal from key EU health agencies and a delay in receiving new medicines and treatments from the European Medicines Agency. Statistics from the Nursing and Midwifery Council already reveal an 89% fall since the Brexit vote in applications from nurses in EU countries to work in the UK.

So, what is the alternative, if the future really is as bleak as we are being led to believe? The NHS has historically been compared to the healthcare system in the US, where the average cost of hospital stays for cancer patients in 2015 was $31,390, around half of the average household income. The prohibitive costs of healthcare in the US have led to an increase in a new form of funding: online donation sites, for example YouCaring, have seen a real expansion, with patients turning to strangers to help foot the bill for their ever increasing medical costs. 

But even in the US there are concerns about this kind of funding, with critics saying that it is undignified to be forced to rely on the financial support of strangers, and that reliance on donations can perpetuate existing inequalities.

The other possibility is, of course, an increase in private healthcare, with a greater focus on private medical insurance and private providers. This isn't necessarily a solution though. Patients will still need to pay for their treatment (through medical insurance or their own pockets) and this could lead to more issues for the NHS, with funding pumped in to the private sector, rather than to support the NHS.

However, Professor Mike Hannay (Managing Director, East Midlands Academic Health Science Network and Chair, AHSN Network) explained at the Westminster Health Forum on 1 March 2018 that the UK as a whole is not making the most of innovation in healthcare. The relatively slow rate at which innovative medical products are adopted means lost opportunities – bad news for patients and hospitals alike.

This trend can be reversed if better use is made of data.  In response to comment from the floor at the Forum, Professor Hannay emphasised that it is critical for manufacturers to ensure that they have maximised the potential of published data on a product's performance, before the device is released to the market. Doing so means that users have confidence in an innovative product and so are more likely to adopt it quickly.

But data on clinical performance are not just important to bringing products to the market – data can be essential to keeping them there. Performance data can also be deployed to defend speculative litigation against manufacturers that arises once products are being used.

Faced with the prospect of litigation data, collected via clinical trials, and once the product is in the field, can be deployed for a number of reasons:

• Reassuring the "worried well".  The media and public are fascinated with healthcare products. The distinction between "patients" and "consumers" is increasingly blurred and the media find that stories on innovative medical products sell newspapers. But what sells even more? Articles about new medicines or devices that have not performed as well as some people had hoped. If a product is targeted in this way, manufacturers are well advised to get on the front foot as soon as possible and defend their product, by talking to the media, and providing information to patients. If they do not, then manufacturers run the risk that patients - who would otherwise have no complaints about a product - become concerned and contact lawyers. This task will be much easier for manufacturers if they have ready access to credible and well-presented data measuring safety and performance.

• Engaging with regulators. If regulators, such as the MHRA in the UK, receive negative reports regarding the performance of a product then manufacturers may have limited time in which to respond to the regulators' enquiries. Positive and early engagement with regulators makes it more likely that public statements or actions about a product are proportionate. This in turn means that the public is provided with better, higher quality, data and mitigates the risk that lawyers or the media fill an information vacuum.

• Adding to scientific debate. Sometimes, the seeds of litigation are sown in the rarefied soil of academic journals. Enterprising journalists may stumble across research that raises concerns over a medicine or device and use the findings for their own article in the mainstream media. In the event of litigation, largely forgotten papers that had been gathering dust are debated between experts in court rooms. To pre-empt these risks, manufacturers should ensure that data are collected and discussed in peer-reviewed publications. Manufacturers will then have academic papers at their disposal to respond to scientific concerns with like-for-like publications.

• Mounting a robust defence.  The medical device community bears the scars of high-profile litigation in recent years. In some instances, some products that did in fact meet acceptable levels of safety and performance, were unfairly dragged into litigation (metal-on-metal hips and pharmaceuticals provide examples). One of the best ways to avoid being swept up in such litigation is to ensure that performance data are collected and to hand.

In November 2015, Dr Hadiza Bawa-Garba was convicted of the manslaughter of six-year old Jack Adcock, on the grounds of gross negligence.  Dr Bawa-Garba was a junior doctor who had recently returned from maternity leave. She was solely in charge of the Emergency Department and Children’s Assessment Unit at Leeds Royal Infirmary on the day that Jack, who had Down’s Syndrome, was brought in. Over the course of the day a series of errors (administrative, personal and systems-related) culminated in the boy’s tragic death.

Dr Bawa-Garba was convicted of manslaughter and given a 24-month suspended sentence which the Court of Appeal upheld in December 2016.

What followed was a tussle between the General Medical Council (GMC) and the Medical Practitioners Tribunal Service (MPTS) over the appropriate severity of Dr Bawa-Garba’s sanction. The GMC initially recommended that she be struck off the medical register, however the MPTS found in December 2017 that erasure was "disproportionate", and instead imposed only a 12-month suspension.

In January of this year, the GMC successfully appealed the MPTS decision and Dr Bawa-Garba was struck off the register. Ouseley LJ said that the Tribunal had not respected the verdict of the jury as it should have, instead reaching its own, less severe, view of Dr Bawa-Garba’s culpability. 

Following the successful appeal, Jeremy Hunt tweeted that he was “deeply concerned about possibly unintended implications here for learning & reflective practice”. He suggested that the decision will mean doctors are more hesitant to admit mistakes through fear of severe repercussions and said: “If we are going to keep patients safe then we have to make sure that doctors are able to learn from mistakes.”

The decision has sparked intense debate in the medical community; with many focussing on the role NHS under-resourcing has to play in the increasing frequency of medical malpractice cases. An open letter to the GMC written by medics in December 2017 read: “We now see [doctors] being held criminally responsible for mistakes made whilst working under these pressures, which, with chronic staff shortages, prolonged underfunding and low morale, now occur with worrying frequency.”

The Williams Review

The rapid policy Williams Review, announced on 6 February 2018, will be chaired by Professor Sir Norman Williams and will investigate the following issues: 

• how we ensure healthcare professionals are adequately informed about gross negligence manslaughter (GNM), and the prosecution process

• how we ensure that reflective learning and transparency are protected where a mistake has been made

• lessons the GMC needs to learn in relation to dealing with professionals following the criminal process for GNM 

The Review is expected to announce its findings by the end of April. 

Medical errors 

In the same month as the Review announcement, the Health Secretary spoke again on medical malpractice, this time highlighting on 26 February the 237 million drug errors which healthcare professionals make each year. Research has suggested these could be causing 700 deaths a year, and are a contributing factor in thousands more. 

The NHS continues to face resourcing challenges, and attributing blame in medical malpractice cases is becoming an increasingly fraught topic of debate. The Medical Protection Society this week have criticised the law on medical manslaughter as setting too low a bar for conviction. MPS medical director Dr Rob Hendry said: "The public and medical profession would expect that extreme cases where there is intent to cause harm or a high degree of recklessness result in prosecution – and we support that. Most medical manslaughter cases are however more complex, involve systems failures, and are devastating for all concerned." The MPS recommend legal reform so that 'careless' actions alone do not result in conviction.

Medical professionals and their insurance providers will be hoping that Mr Hunt’s focus on malpractice will not only bring clarity and reassurance for those who make mistakes, but also that steps are taken to address the root issues that lead to errors being made.

Look out for our comment on the Review's findings, once published.

Alfie's case

Alfie, aged six, suffers with a rare form of epilepsy (only nine other children in the world suffer with the same condition), and can have between 20 and 30 violent seizures a day. In September last year, Alfie's mother, Hannah, took him to the Netherlands to take a cannabis based medication (prescribed by a paediatric neurologist there), which saw his seizures reduce in number, duration and severity; he went 24 days without an attack.

It was on that basis that Alfie's family requested a licence from the UK Government, which would allow him legally to take cannabis oil to treat his epilepsy, and it was this request that has sparked furious debate.

Parliamentary Debate

During the debate over Alfie's requested licence, a spokesperson for the Home Office stated that cannabis 'is not recognised in the UK as having any medicinal benefit' and emphasised the importance of thoroughly testing medicines to 'ensure that they meet rigorous standards before being placed on the market, so that doctors and patients are assured of their efficacy, quality and safety'.

Lord Dear (independent crossbencher and former Chief Constable of the West Midlands) told the House of Lords that the current legal classification of the drug as having no therapeutic value had been 'roundly rebuffed' by other countries.  Calling on the Government to look urgently at the licensing of the drug for medicinal use, Lord Dear contrasted the UK's approach with numerous EU countries, US states, Canada and Israel, who all allow 'under medical supervision licensed use of cannabis'.  Policing Minister, Nick Hurd, has also commented that 'we are aware that the position is shifting in other countries - we monitor that closely'. 

The World Health Organisation is presently reviewing cannabis use, and Baroness Williams assured peers that the Government was keeping 'a very close eye on the outcome of that review' to take 'a view on it in due course'.

Government Response

Despite the above, Alfie's request for a licence was denied on the basis of current legislation, which states that Cannabis (as a Schedule 1 drug) cannot be practically prescribed, administered or supplied to the public, and can only be used for research under a licence.  The Government is now considering whether a clinical trial – which would be led by Alfie's medical team, based on 'sufficient and rigorous evidence' – could provide another option. In the meantime, Alfie has unfortunately been readmitted to hospital.

But what does this show about the Government's stance on medicinal cannabis? Society's and individual attitudes towards the decriminalisation of drugs seem to be shifting, but policy also has a part to play; there are arguments that the UK's attitude is lagging behind other European and American countries (adding to concerns that, following Brexit, patients in the UK will access the latest treatments some years later than those in the EU).

Clinical and Legal issues when bringing a drug to market

If Alfie were placed on a clinical trial which yielded successful results, this would likely pave the way for further advancements in the use of cannabis oil as medicine. But there would be many issues to consider in the meantime:

• Legally: new regulations would have to be considered and implemented;

• Practically: manufacturers would need to boost output, and would need to review published information such as patient information leaflets;

• Medically: patients would need to be monitored and side effects noted and reported;

• Statistically: data would need to be collected and analysed.

• Ethically: the risks of such treatment will be relatively unknown (very little UK data would be available) and this would cause concern for healthcare professionals, providers (and their insurers). Patient consent would need to be managed extremely carefully (with all possible adverse reactions covered).

However, for those potential patients who are suffering, it would probably be a risk they would happily take.

The research study involved 861 participants with Lynch Syndrome, a rare hereditary disorder. Lynch Syndrome is caused by a mutation in genes involved in DNA repair and is diagnosed through genetic testing (consisting of a blood test).  It is associated with a high risk of colon cancer, such that patients with the syndrome are estimated to have an 80% chance of developing colon cancer over their lifetime. Those diagnosed with Lynch Syndrome are also at an increased risk for developing other types of cancer (including endometrial, ovarian, stomach, and small intestine).

The comprehensive study was carried out by over 30 researchers from hospitals and universities in 13 different countries. For the purpose of the study, the 861 participants were randomly assigned to one of two groups. Over a period of two years one group was given 300mg of aspirin twice a day; the other received a placebo. The participants were then followed up for 5 – 10 years.

Analysis of the data collected revealed that, within two years, 20 participants (10 from the aspirin group, and 10 from the placebo group) had developed colon cancer. By 10 or more years, 28 more participants had developed colon cancer; however, only 8 were from the aspirin group, compared to 20 from the placebo group. This equated to a 44% lower rate of colon cancer in the aspirin group, when compared with the placebo group. Even at the end of the study neither the participants nor the investigators were told which participants had received the placebo, and which had received aspirin. This helped to ensure an unbiased analysis of the long term follow up data.

For sufferers of Lynch Syndrome this is clearly significant. The researchers concluded that: 'the case for prescription of aspirin to this high-risk group is clear', and it seems likely that this advice will be heeded. However, further research will be required to establish a recommended dosage, and duration of aspirin treatment.

For the wider medical community, this research demonstrates how pharmaceuticals that have already been through rigorous testing and approval for one application can be used across a variety of alternative treatment pathways. Aspirin was first developed by pharmaceutical company, Bayer, in the second half of the nineteenth century (aspirin was initially Bayer's brand name) and has been in widespread use for 150 years. There have been multiple clinical trials relating to aspirin: into its efficacy as an anti-clotting agent, in the 1960s and 1980s; and into its ability to prevent heart attacks, in the 1970s and 1980s. Its risk profile for these uses, including possible side effects (e.g. ulcers), is therefore well known.

Where it can be proven, the benefit of using an established pharmaceutical product in a novel treatment situation should mean that the product can be more swiftly adopted as a possible treatment, without requiring the extensive research into long term side effects necessary with a product that is new to the market. It remains to be seen what other benefits "everyday" medicines, such as aspirin, could have.

The working group has been asked to consider the value and operation of the cap and to publish recommendations on the development of a 'bespoke process for clinical negligence claims', which are expected to be revealed in the autumn of this year. The group will include representatives of the legal profession and of the NHS.

In 2016-17, legal costs accounted for 37% of the £1.7 billion the NHS paid out on clinical negligence claims. The Department for Health and Social Care estimates in its consultation response that the proposed cap on costs will save the government £40 million. Jeremy Hunt emphasised the need for a system which is 'not only just for those who have suffered but also just to other patients, both in terms of making sure we learn from mistakes and also pay legal costs in a proportionate and reasonable way.' He called 'excessive' legal fees a 'terrible use of money that could be spent on patient care'.

Last week's announcement responds to a consultation paper published by the Department of Health in January 2017 which invited comments on designing and implementing a scheme of fixed recoverable costs for clinical negligence claims between £1,000 and £25,000. The paper received 167 responses, mainly from law firms, of which 90% represented either claimants or both claimants and defendants. 85% of lawyers and law firms representing the claimant side strongly opposed the suggestion of a cap on recoverable costs. Defendants' solicitors are unlikely to be affected as dramatically by a costs cap because in many cases they are unable to recover costs at all from claimants, even if the claim is defeated, due to 'qualified one-way costs shifting' (QOCS). They might well have supported a cap, however, to promote their clients' interests.

Critics of the proposal for fixed recoverable costs are concerned that it will result in a lower standard of legal representation. Law Society president, Joe Egan, warned: 'Fixing costs could end up limiting the time specialist solicitors can spend understanding the details of an incident in care. Patients must not be denied the legal help they need to get the full compensation they are entitled to in law.' Peter Walsh, chief executive of Action Against Medical Accidents, said that high legal costs could be better avoided by better investigation of incidents in the NHS and early admissions of liability.

Better monitoring of care and investigation of incidents are current topics of reflection in both the NHS and the independent healthcare sector, with a non-statutory inquiry this year looking into lessons that can be learnt from the conviction of consultant breast surgeon, Ian Paterson.

A fixed recoverable costs scheme will benefit healthcare organisations and their insurers in the independent sector as well as in the NHS. We may, however, see some tactical claim demands, and less flexibility on settlements if claimant law firms risk losing costs.

Chronic traumatic encephalopathy (CTE) is an Alzheimer’s-like disease that has been most commonly associated with former professional American football players. Previous studies have shown that repetitive hits to the head — even without concussion — can result in CTE, but scientists say the Boston study is the most definitive, so far, to have found this connection.

In American football, and other contact sports, numerous claims have been brought by former athletes against sports governing bodies, universities, helmet manufacturers and others. This study could therefore be a 'game changer' for defendants and insurers dealing with a CTE claim.

As a former semi-professional rugby player, I personally find this study, somewhat troubling. Thankfully, I have experienced concussion only once or twice in my career (that I am aware of at least), but the number of hits to the head is immeasurable. At the time of my retirement in 2010, there were no 'concussion protocols', or any sort of criteria that a player had to meet before returning to the field of play. The only test I can recall was one simple question by the physiotherapist or team doctor: "How many fingers am I holding up? Correct: you are fine".

Things are now very different. To continue with rugby union as an example, any suspected head injury requires a player to leave the field for a head injury assessment (HIA). Pass the HIA, and the player may return to action. Fail it, and it is game over. Any player who fails a HIA must then go through a rigorous 'return to play protocol', before being cleared by the medical team. Whilst the HIA is certainly an improvement, its effectiveness has been questioned by a number of medical figures in recent months, and these new findings are only going to raise more questions.

Figures published by the Rugby Football Union indicate that the majority (80-90%) of concussions resolve in a short (7-10 days) period. During this time, however, the brain is more vulnerable to further injury. If a player returns too early, before full recovery, this could result in:

• Prolonged concussion symptoms

• Possible long term health consequences such as psychological and/or brain degenerative disorders

• A further concussive event being FATAL, due to severe brain swelling – known as second impact syndrome. 

Clearly, any failure by a doctor to conduct the HIA correctly, or an incorrect decision such as allowing a player to return to action too early, can have a significant, or even fatal, impact on the athlete. The pathway for a claim in this instance is pretty clear. But what about a former athlete who is diagnosed with CTE many years after retirement? Should a doctor's duty of care now extend to not only conducting a HIA, but also keeping a close eye on every player on the field, and the number of hits to the head? Should records be kept by the sports organisation of the number of hits to the head each player gets per game? And how many is too many? The questions are endless…

Arguably, there is an acceptance by every athlete taking the field in a contact sport that they are going to take hits to the head. That is a given. But clinicians practising in the field of sports medicine should sit up and take note of this study. It is not enough to look out for full blown concussion injuries; they must also be more aware of players taking repeated hits to the head over the course of a game, or even a full season. Failure to do so could, in theory, pave the way for CTE claims against sports clubs or the practitioners themselves.

The UK's next moves on the Brexit chessboard could affect the Life Sciences industry in different ways:

Safe moves

Philip Hammond, the Chancellor of the Exchequer, is the personification of those who regret Brexit. Many in the Life Sciences industry share his view. Membership of the EU meant regulatory certainty, unfettered access to European markets, and prestige for the UK through the influence of the MHRA (the UK's regulator) and presence of the European Medicines Agency in London. Unless a second referendum reverses Brexit, the Chancellor and his supporters argue for as close a regulatory alignment with the EU as possible. UK manufacturers in the single market, or a version of the current customs union, would be subject to the existing regulatory framework concerning pharmaceuticals and medical devices. There would be no need for manufacturers to grapple with a competing set of UK regulations. This delivers certainty for industry and limits risk, as manufacturers operate within established rules. Over time, however, the regulatory regimes in the UK and EU could diverge on a piecemeal basis, perhaps in response to public concerns over the manner in which medical products are manufactured or sold, causing headaches for the industry.

Bold moves

Someone who is enjoying Brexit much more than Phillip Hammond is Michael Gove, Secretary of State for the Department for Environment, Food and Rural Affairs (Defra). Since his return to the Government last year, Mr Gove has used the department as a platform to argue that Brexit provides an opportunity for the UK to forge its own regulatory framework for industry, including Life Sciences. His stance was backed by Boris Johnson, the Foreign Secretary, in a speech yesterday. The UK could become more competitive as manufacturers take advantage of cuts in "red tape" to drive down costs and increase sales. For industry, a bonfire of the regulations might appear attractive but it would be pointless as British products would still need to be compliant with regulations where they are placed on the market. That said, at EU level, new regulations (such as the Medical Devices Regulation 2017) can take years to make their way through the various committees of the European Commission and European Parliament. By contrast, the UK could respond more nimbly to public concerns over medical products or new technologies. The UK could become the pace-setter at adopting better regulations and setting higher standards. UK manufacturers could go beyond compliance standards set by the EU, whilst also enjoying a competitive edge by selling products that are proven to be safer than competitor devices from Europe.

Backwards moves

There is a wing of the Conservative Party that takes a long term view, seeing the UK's membership of the EU as a mere historical blip. They are led by the back-bencher Jacob Rees-Mogg, dubbed "the honourable member for the 19th Century." At first glance, it appears that there would be very little to be gained if the clock were turned right back to an era before patient pressure groups, open access to information, data gathering, independent auditing and stringent standards. However, in previous eras medical practitioners and companies were able to innovate more quickly. Advances in medicine have tended to be characterised by one step back for every two steps forwards. It is in experimenting that advances are made, but some patients have suffered in the past and governments have rightly legislated to tighten the rules concerning clinical trials to make medical products safer. If the Government can find a way to boost innovation, whilst ensuring that products remain as safe as possible, then industry might welcome a dose of Victorian medicine.

Just make a move!

The Government has now announced that the statutory public inquiry will be led by Mr Justice Langstaff.

Following his retirement from the High Court, Langstaff J will chair the inquiry full time from 1 May 2018. Langstaff J will be consulting on the terms of reference for the inquiry with those affected, their families and other stakeholders, before final terms are confirmed to the House of Commons.

Following his appointment, Langstaff J has said that "nothing less than a thorough examination of the evidence will suffice: and the process needs to lead to a full report within the shortest timescales that such thoroughness can accommodate."

In separate but connected news, a private individual has launched a claim against the Secretary of State concerning the discretionary support provided to NHS patients infected by contaminated blood. The claim has been brought under the Equality Act 2010 and the Human Rights Act 1998, on the basis that the discretionary support arrangements discriminate against patients with Hepatitis C. 

Using somatic cell nuclear transfer ("SCNT") (by which a viable embryo is created from a body cell and an egg cell), the scientists inserted nuclei from an aborted foetal monkey into egg cells. 21 eggs were then implanted into surrogate mother monkeys, resulting in 6 pregnancies; 2 of which produced Zhong Zhong and Hua Hua.

Since Dolly's dramatic entrance onto the world stage, SCNT has been used to create about 20 different animals, including frogs, mice, rabbits, pigs, cows and even dogs (an Afghan Hound named Snuppy). However, this is the first time the technique has successfully been used to produce primates. Zhong Zhong and Hua Hua are not the first primate clones however; Tetra, a rhesus monkey born in 1999 as a result of embryo splitting (a process similar to the natural development of twins) bears that title. Embryo splitting is considered a less beneficial technique, however, as it can generate no more than four offspring at a time; with SCNT the possibilities are (theoretically) endless.

The scientists' announcement has created widespread publicity, and divided reactions – whereas some see it as a positive advancement of science, others fiercely condemn the cloning of monkeys and question where this will lead us.

The advantage of cloning primates lies in the opportunity it presents for animal testing-based research. Non-human primates have long been considered valuable for research purposes, because of their high degree of genetic, anatomical and physiological similarities to humans. Macaques in particular are used extensively in animal testing (79% of all non-human primate testing in the UK uses macaques).

Using cloned macaques in testing, i.e. genetically identical test subjects, makes it easier to pinpoint the cause of different test results. Various treatments can be tested on the macaques without the need to consider any other factors (if the monkeys are genetically identical then different outcomes can only result from the treatment method). The scientists have also highlighted that SCNT can produce macaques with 'the same genetic background except the gene manipulated'. Research can therefore assist in studying diseases with a genetic basis (the team have specifically indicated the potential research opportunities into Alzheimer's and Parkinson's).

Inevitably, many question the morality of using animals in this way, and query their welfare during the testing process. Previous attempts, with similar processes, have led to macaques dying from impaired body development and respiratory failure, and criticisms have been compounded by questions over the efficiency of this process (79 embryos were implanted into 21 surrogate mothers with 6 resulting pregnancies, only 2 of which survived). Furthermore, censure of animal testing is often heightened when the animal in question is a primate, in which many of us recognise human features.

The potential impact for humans of Zhong Zhong and Hua Hua's cloning has also led to fierce public debate. Whilst the scientists involved stressed that 'there's no intention for us to apply this method to humans', many commentators drew a link between the two. Work on human reproductive cloning is already banned in many countries (including the UK) and so it is unlikely that we will see developments in this area any time soon. However, the successful cloning of macaques does mean that such a process is feasible (if not necessarily desirable). Is it just a matter of time?

But what obligations arise following treatment? In December 2017, the High Court handed down judgment in the case of Gallardo-v-Imperial College Healthcare Trust which considered just that.

The Facts

Mr Gallardo underwent major abdominal surgery at Charing Cross Hospital in January 2001. During the operation a malignant gastrointestinal stromal tumour ("GIST") was removed. Following the operation, Mr Gallardo spent some time in intensive care before being moved to the private wing of the hospital and discharged in April 2001. He was seen privately by his treating surgeon as an out-patient on more than one occasion in 2001/2. His treating surgeon died in 2014 and played no part in the proceedings.

Mr Gallardo sued the Trust which runs Charing Cross Hospital; he argued that he was not told that the tumour was malignant, that there was a risk that the cancer could recur, or that he would need regular CT scans and monitoring. The cancer did recur, and in 2011 Mr Gallardo underwent further major surgery.

The defendant Trust argued that Mr Gallardo was properly informed of the malignancy and risk of recurrence following his operation; however, the question of liability was somewhat complicated by the fact that post-operatively Mr Gallardo moved from being treated as an NHS patient to being treated as a private patient. The Trust contended it had no continuing responsibility for Mr Gallardo after he became a private patient. Any breach of duty occurred when Mr Gallardo was a private patient, and so was not the responsibility of the Trust. Further, it was argued (unattractively) that Mr Gallardo failed to make appropriate arrangements for his own follow-up and monitoring.

The Decision

The Court found that Mr Gallardo's treatment and prognosis, the significant risk of recurrence, and the need for regular CT scans and monitoring were not properly explained to him in 2001.

In considering when Mr Gallardo should have been told about his condition, and the need for follow-up monitoring, the Court applied the principles set out in the Supreme Court decision in Montgomery that a patient has the right to be informed of the treatment outcome, prognosis, and the follow-up care and treatment options. Whilst a number of factors may affect the timing of such a discussion (e.g. the patient's condition and ability to participate), these must be balanced against the patient's right to be informed.

The Court held that such a discussion should not be unduly delayed and should take place as soon as the patient is well enough to participate fully and to understand what he/she needs to be told. In this case, the discussion with Mr Gallardo should have taken place following his discharge from the intensive care unit, before his move to the private wing.

The Trust's argument that it had no continuing responsibility for Mr Gallardo after he became a private patient was rejected. The Court found that the Trust owed Mr Gallardo a duty to advise him of the outcome of his surgery, his prognosis, and the need for follow-up. It was a continuing duty, and one which the Trust failed to discharge.

As to causation, it was found that if CT scans been done annually after the first 2 years, the recurrence of the tumour is likely to have been diagnosed 4 years earlier. As such, the surgery would not have been as extensive or difficult as it proved to be in 2011.

The decision is a cautionary tale for those in the medical field, re-emphasising the importance of the role of the patient as an active participant in their treatment.

Currently, in England, the organs of a person who has died can be used only if that person consented when they were alive, usually by registering as a donor. If the deceased had not made their wishes known, a family member can also agree to the donation. Although there is no legal requirement to do so, when appropriate consent has been given by the deceased person, their family will still be consulted in practice, and some families can find it difficult to accept a loved one's decision to register as a donor. Around 100 families a year do not support a deceased relative's decision to consent and in these cases, the donation does not proceed.  

Government statistics indicate that 3 people die each day because of a lack of suitable organs and that, under the current system, although 8 out of 10 people say that they would want to donate their organs and tissue after death, most people never register to be donors.  

The Government is now proposing a new 'opt-out' system, whereby everyone (subject to certain exempt groups of people) is presumed to give consent, unless they choose to opt out. The hope is that the numbers of organs donated, and lives saved, will be greatly increased.  

Wales introduced the 'presumed consent' model in 2015 and, in June last year, Scotland confirmed that it will follow suit, after a Government consultation found that 82% of the public was in favour.   

The subject of organ donation can be difficult for many reasons, not least because of the inevitable challenge of thinking and making decisions about one's own death. For some, religious beliefs or background can be a significant factor in their decision.  

One part of the consultation considers what role the family should play in these decisions - should they be able to make the final call and potentially overrule their relative's decision to be an organ donor? If a new 'opt-out' system is implemented, it seems likely that England may follow Wales and Scotland, and adopt a 'soft opt-out'. This means that a person's deemed consent can be rebutted if the family can show that the person was in fact opposed to donation (but had failed to opt-out when they were alive).    

Statistics published by the Government show that, under the current system, families are significantly more likely to support the donation of a relative's organs or tissue, if they know what that relative's views were. Sally Johnson, of NHS Blood and Transplant, which co-ordinates the organ donor scheme, said she hoped the consultation would "drive a national conversation about organ donation". Whatever your opinion may be, an open discussion with family and loved ones may help to ease difficult discussions and decision-making at the most challenging of times.    

The consultation closes on 6 March 2018; we will publish an update in due course.

And this is where Black Box VR comes in. Combining gaming with fitness, the Idaho based firm has created a virtual reality experience which could see individuals lose weight through participating in a 'gamified' workout – particularly useful in combatting the childhood/ adolescent obesity crisis.  

Entering  a 'black box' containing a bespoke resistance training machine, and wearing a "HTC Vive" headset (heralded as one of the most 'immersive' available), the individual then competes against an avatar (aptly named 'Razer') and, eventually, one another (no physical contact of course – this is virtual combat).

This new innovation was showcased at the CES Technology Show in Las Vegas, held just this month, and promises further developments. Black Box's plan is to open specialised gyms across America, which each hold a number of 'black boxes'. These black boxes are then reserved by individuals for their workout, which is tracked over time.  It is hoped that an 'at home' version of the system could be developed in the future.

But what really makes this form of exercise any different from an exercise class at your local gym? Addiction. Black Box is targeted at the gamers, who, addicted to playing their usual 'sedentary' game, can now burn calories whilst immersing themselves in virtual reality.  Job Stauffer (a former games developer) attributes his 37kg weight loss to playing these fitness games; 'playing games is a sedentary experience but VR changes all of that – room-scale experiences are engaging your body in full'.

Sounds good. But what about the downside? Of course, this remains very much at an early stage – there is no real data to evidence prolonged and sustained weight loss – it could be a gimmick. The risk here, of course, is that unhappy black-boxers complain, potentially exposing gyms to claims that they have made unsubstantiated fitness statements (similar to the Fitbit litigation).

And perhaps most importantly, safety. One industry source queried whether any consideration had been given to the impact on the body of using the headset during strenuous exercise.  As well as the potential for physical harm, what about potential psychological harm? There has been much debate over the impact of video games on (young) people – so who knows what a combination of strenuous activity (with all of the endorphins that releases) plus gaming might do to the participant. And who might be to blame should there be any negative outcome? Consideration also has to be given to third parties; after an adrenaline fuelled session swinging a virtual weapon at virtual targets, the gym-goer is then released from the black box into the streets… and should anything happen, would third parties argue that manufacturers owe a duty of care not just to the user, but to a wider section of society?

However you feel about this new technology, it is clear that this idea of gaming/ gyming is a growing market and one to keep an eye on – and, before you know it, it might be you in the black box fighting Razer.

The CQC's current rating system resembles Ofsted inspection reports: independent hospitals, GP surgeries and social care services are currently given a rating of Outstanding, Good, Requires Improvement or Inadequate, based on five key questions. Healthcare organisations such as abortion clinics, online GP providers, cosmetic surgery providers and substance misuse clinics will now also be subject to rating by the CQC, although the CQC is likely to launch a public consultation in 2018 to establish whether these organisations will be rated using the existing system or by different measures.

Jeremy Hunt, Health Secretary, said: "These changes are a world first for patient safety, modernising our tough Ofsted-style inspection scheme so we keep pace with the changing landscape of healthcare, as well as helping tech savvy patients to make informed decisions about their care."

The ratings system should afford better transparency to patients and allow healthcare providers who have not previously been rated by the CQC to identify areas for improvement.

Whether it can deliver those anticipated benefits will depend upon the measures used and the practical application of them. Healthcare providers will want to be considering their performance now, in order to avoid adverse reputational consequences.

For the insurers of healthcare providers the ratings system will give an initial broad brush impression of the insured's performance. It will not be a substitute for detailed investigation of risk.

Some media reporting of this issue has focussed on the role that pharmaceutical companies are alleged to have played in perpetuating addiction and contributing to the "crisis" through aggressive marketing and the resultant over-prescription of opioid painkillers such as Vicodin, Percocet and OxyContin. In August, the Office of the Deputy Attorney General of New Hampshire announced that it had commenced proceedings against Purdue Pharma, a manufacturer of OxyContin, following a 2 year investigation into Purdue's conduct in the context of the state's Consumer Protection Act (see link). The complaint docket can be seen here. It is not yet clear whether this action, or any other such litigation brought against pharmaceutical companies in the US will be successful and, whilst acknowledging that there is a different regulatory regime in the US, there are still lessons that manufacturers of pharmaceuticals in the UK can learn, particularly in the context of the emerging litigation:

Lesson 1:  Consider the need for controlled marketing

Purdue is alleged (amongst other things) to have engaged in deceptive marketing techniques starting in the 1990s in which it held out that the benefits of long term opioid use (reduced pain and improved function) were proven, and that the risks were exaggerated.

Manufacturers and suppliers should ensure that statements made in product marketing are accurate, sustainable and supported by sound scientific evidence. They should not allow their marketing and sales departments to make unsustainable promises.

Lesson 2: Consider education for users

It is alleged that Purdue marketed OxyContin to primary healthcare providers who were most likely to see patients with chronic pain conditions, but least likely to have the appropriate training and experience to appraise the marketing and patients' pain conditions. Manufacturers and suppliers should consider means of comprehensive dissemination of information to those who will use (i.e. prescribe) their product (including training and education) to ensure that it is used as intended.

Lesson 3: Be clear about what the product does and provide explicit warnings and disclaimers

Perhaps the most significant allegations against Purdue are that it misinformed healthcare providers and patients about the risks of addiction, and overstated therapeutic efficacy.

The literature that accompanies any pharmaceutical product should set out its limits as well as specific and explicit warnings on any adverse effects or contraindications. Manufacturers should also consider the need to include disclaimers warning against predictable, but unreasonable, uses of the product. Warnings, contraindications and disclaimers should be subject to regular review and updated as necessary in light of relevant findings during the post-market surveillance process.

The claimant (Mr W) received the hepatitis B vaccine in December 1998, January 1999, and July 1999. In November 2000, Mr W was diagnosed with multiple sclerosis ("MS"). Mr W died in 2011.

In 2006, Mr W (and members of his family) brought proceedings against Sanofi Pasteur alleging that its hepatitis B vaccine was defective. The claimants referred to the lack of any family history of MS, and the short period of time between the vaccination and the diagnosis of MS. They argued that this factual evidence gave rise to a presumption of defect and a causal link between the injection and Mr W's MS.

The claimants won but the decision was subsequently appealed and overturned. The case was subject to further appeals, including to the Court of Appeal in Paris where it was noted that there was no scientific consensus as to a causal relationship between the vaccine and MS. 

A fresh appeal was brought before the Court of Cassation who referred three questions to the CJEU. The questions focussed on whether proof of defect and of the causal link between defect and damage can be established by factual evidence where there is no scientific consensus as to a causal link between a vaccine and a disease.

Key points from the CJEU ruling include:

• The Product Liability Directive does not address how proof of defect is to be established by any given claimant. It is the responsibility of member states to determine, what evidence is admissible, methods by which such evidence can be obtained, and the level of proof required in line with the framework set out by the Product Liability Directive;
• Methods of proof other than those based on medical research should not be excluded by national courts. To do so could place excessive burden on claimants in cases where there is said to be no medical consensus as to whether there is a causal link between the vaccine and the damage;
• National legislature/national courts cannot introduce a method of proof which means that certain pre-determined factual evidence related to causation triggers an automatic presumption of a causal link between the vaccine and the damage; and
• Factual evidence (such as that relied upon in the main proceedings of this case) can lead a national court to conclude that a claimant has discharged his/her burden of proof. However, the evidence must be sufficiently serious, specific, and consistent for such a conclusion to be drawn. Importantly, the courts must have regard to arguments and evidence presented by a producer in challenging the explanation put forward by the claimant. 

This preliminary ruling is not binding on courts in the UK, and does not reverse or change the burden of proof on claimants to establish defect, damage, and the causal relationship between the two, as set out in the Product Liability Directive. However, it does provide a useful insight into the kinds of factual evidence that the courts may be prepared to hear in product liability cases involving a vaccination, and the conclusions that may be drawn in the absence of solid scientific evidence from either side.

In September this year the Medicines and Healthcare products Regulatory Agency ("MHRA") published its "Human Factors and Usability Engineering" guidance for manufacturers of medical devices (including drug-device combination products), and notified bodies.

The guidance looks at the importance of considering "human factors". By "human factors" in the development of medical devices it means how a person interacts with systems surrounding them, including the technology they use. The guidance applies to the future design of products as well as changes in how users interface with existing products, and aims to clarify regulatory expectations in relation to medical devices that are to be made available on the UK market. The guidance is intended to be in line with international standards and with guidance on the same topic from the FDA (the US Food and Drug Administration).

A central theme in the guidance is that producers of medical devices should be considering human factors as integral to their design, development, and evaluation process, particularly given that more and more medical devices are being used in increasingly diverse settings, including in patients' own homes. The guidance sets out ways in which producers can apply human factors and usability engineering to medical devices to optimise safety and performance. Key points include:

• The Medical Devices Directive (93/42/EC) sets out (in Annex I) a number of requirements, including the need to reduce the risk of error due to the ergonomic features of the device, design of measurement, monitoring, and display scales in line with ergonomic principles, and providing information needed to use the device safely, taking into account the training and knowledge of the potential user.

• Human factors studies can be used to address regulatory requirements, but where they involve clinical use of the device on humans, MHRA ethics committee approval may be required.

• Device users should not have to read, understand and remember complex instructions for use. A well designed device should be easy to use correctly.

• Application of human factors to product design results in devices which are more pleasing to use and therefore likely to be used correctly, in accordance with their intended purpose.

• Manufacturers should engage in pro-active post-market surveillance, reviewing all feedback and acting on that feedback where appropriate to improve current and future designs.

• Manufacturers should seek out feedback from users and should review complaints data for potential user error in relation to their own device, and for similar devices where available. Where adverse event reports and product recall data for such devices are available for public review, those reports should also form part of manufacturers' active post market surveillance strategy. The new regulations will require manufacturers of certain classes of device to submit a periodic product safety report, setting out a summary of the results and conclusions of analyses of post-market surveillance data

Whilst the guidance was produced with the current EU regulations on medical devices in mind, and is a not a mandatory compliance requirement, it is intended that the guidance will be of assistance to producers seeking to demonstrate compliance with the new EU regulations which will fully apply from 26 May 2020.

The inquiry will be led by the Bishop of Norwich, the Right Reverend Graham James, who confirmed that the concerns of former patients of Ian Paterson and their families and representatives will inform the inquiry. Current thinking is that the inquiry will consider:

• responsibility for the quality of care in the independent sector;
• appraisal and ensuring validation of staff in the independent sector;
• the safety of multi-disciplinary working;
• information sharing, reporting of activity and raising concerns between the independent sector and the NHS;
• the role of insurers of independent healthcare providers;
• arrangements for medical indemnity cover for clinicians in the independent sector.

The Department of Health's decision to make the inquiry "non-statutory" means that there will be no fixed process, no legislative powers to compel participants to give witness or documentary evidence, and it is unclear to what extent the inquiry's information gathering process or conclusions will be made public. What we do know is that the inquiry will convene in January 2018 and is expected to report in summer 2019, with more details regarding scope and procedure expected at a future date.

The Government unveiled its Industrial Strategy on 27 November 2017. It adopts many of the recommendations set out in the life sciences industry's own report to the Government, published in August. Taken together, the Government's document and the industry report present a vision of an optimistic future. Manufacturers and their insurers tempted to explore the opportunities on offer should do so with an appreciation of the risks involved.

Key themes emerging from the Industrial Strategy and the industry's report include: embracing challenges presented by an ageing population, harnessing technology to develop new clinical platforms, and collaboration between industry and the NHS.

An ageing population

Society is changing. These days, royal brides become princesses in their late 30s; consumers snap up lifestyle devices that provide clinical data; and people expect to remain active well beyond the lifespan of previous generations. The Government sees these challenges as opportunities. Industry should too, whilst considering the risks. The general trend in recent years has been for consumers and patients to demand ever more of medical devices. Whereas a hip replacement was once designed for little more than a walk to the local shops, now bespoke implants are intended for marathon runners and ballet dancers. The flip side of this demand is raised consumer expectations. When bringing new devices to market, manufacturers should ensure that surgeons explain the risks, benefits, and limitations of new products to their patients.

New technology

Whilst social media coalesced around the #royalwedding, the Government was promoting the UK's potential as a hub for bringing new technology into the clinical sphere. Robotic operating theatres, algorithms, and artificial intelligence have all been identified as having the potential to improve patient outcomes. Producers of new technology should not lose sight of the fact that there will remain the potential for human error, and robots cannot be sued. It will be important for manufacturers to work with clinicians to identify where human decision making is required and who is ultimately responsible for decisions assisted by new technology.

Collaboration

A much loved British institution, which commands respect beyond these shores, was basking in attention on Monday. The NHS is unique amongst healthcare providers in its scope and potential for harnessing data taken from a wide and diverse population. The Government wants companies to see the potential in using the NHS as a means to test products, so that they are developed and put through clinical trials here and then sold overseas. In taking this opportunity, manufacturers should scrutinise the detail of their contracts with the NHS. If companies do not have control over key aspects of clinical trials, for example patient selection, then the liability wording in the clinical trial agreement should reflect this.

Some in the industry may have viewed the Government's initiative and industry report with a degree of cynicism. After all, there is a reason why the industry report noted that UK funds "… do not normally invest in … life sciences in the UK, due to relatively high levels of risk … and poor return on investments in the 1990s." That sums up the past. However, the future looks bright for life sciences. The 1990s saw many an annus horribilis as some high-profile litigation rocked the industry. In recent years, though, the sector has bounced back. Carefully managed, there can be a happy ever after for any royal couple - or manufacturer of life sciences products. 

In 2011, Mr John Bulloch died following the failure to diagnose an infection (negligence was admitted by the relevant NHS Trusts). At the time of his death, Mr Bulloch had been in a relationship with Ms Jacqueline Smith for 16 years, and cohabiting for 11.

In 2016, Ms Smith brought a claim against the first and second defendant NHS Trusts under the FAA for dependency damages (but not bereavement damages); this claim was compromised and did not progress. Ms Smith then joined the Secretary of State for Justice as a third defendant in order to pursue a claim for bereavement damages. Ms Smith claimed that the FAA was incompatible with the ECHR and sought either:

• A reading of the FAA which was compliant with the ECHR; or  
• A declaration that the FAA was incompatible with the ECHR; and  
• Damages equivalent to the statutory amount of bereavement damages (which were £11,800 at the time of Mr Bulloch's death).  

Ms Smith relied on Article 8 of the ECHR (the right to respect for one's private and family life) and Article 14 (prohibition of discrimination).

In particular, she argued that "private life" (Article 8), includes the right to establish and develop personal relationships. Ms Smith's grief at the loss of her relationship with Mr Bulloch was therefore within the remit of the article. By failing to acknowledge her grief and denying her right to recover bereavement damages, Ms Smith argued that the FAA was incompatible with Article 8. Ms Smith also contended that the FAA was incompatible with Article 14 because it discriminated against those individuals who had chosen not to enter into a marriage or civil partnership.

At first instance, Mr Justice Edis found that the case did not engage, or fall within the ambit of, Article 8 (as the absence of a right to compensation for Ms Smith's grief was only 'tenuously linked' to respect for Ms Smith's family life). The case was therefore dismissed and Ms Smith appealed.

The Court of Appeal found that the scheme for bereavement damages under the FAA did have a link to the "core value" of respect for family life and therefore fell within the ambit of Article 8. However, the Court of Appeal could not read the FAA in a way that extended the award of bereavement damages to cohabitees of more than 2 years; although it did find that there was no justification for the limitation on the availability of bereavement damages under the FAA. On that basis, and because Article 8 was engaged, the court made a declaration of incompatibility.

This case will make it more difficult to rely on the limitations imposed by the FAA, and we can expect to see other claimants seeking similar latitude. We expect the Government to pay close attention, and anticipate that steps will be taken to amend the FAA in the New Year. Insurers should therefore consider increasing existing reserves now to reflect an entitlement to bereavement damages; and should certainly take this into account when looking at new matters involving a death.

'Natural Cycles' uses an algorithm to establish a woman's fertility. Users are asked to input their temperature each morning and the app designates the day as either 'red', meaning the user is fertile, or 'green'. It then advises the user to abstain or take other precautions on the 'red' days to avoid falling pregnant.

'Natural Cycles' is classified by the Medicines and Healthcare products Regulatory Agency (MHRA) as a 'medical device', meaning that it will have had to evidence full compliance with EU regulation and meet stringent testing requirements to obtain approval. 'Natural Cycles' co-founder, Raoul Scherwitzl, said that the app was granted certification in the EU having demonstrated, during clinical studies, that it improves the effectiveness of traditional contraception. The app does have a reduced failure rate in comparison to other contraceptive methods, but the technology is not 100% fool proof. Out of 4054 women who took part in the clinical study, there were 143 identified unplanned pregnancies. Of these, 10 were due to the app wrongly assuring women that they were not fertile on a particular day.

The growing prevalence of mHealth is not limited to contraception. In November 2017, the NHS announced that it was rolling out a pilot scheme called 'GP at Hand' to 3.5 million Londoners. 'GP at Hand' enables patients to check their symptoms through an app, and if necessary, connect to a GP via video within 2 hours. 

'GP at Hand' is not classified as a 'medical device' by the MHRA because it falls short of making medical diagnoses; instead it analyses symptoms and provides a recommended timeframe in which to seek a doctor's opinion. This means that, unlike 'Natural Cycles', the app does not need certification by a notified body before it can be promoted to patients. 

A relatively small proportion of the many mHealth apps on the market are classified as 'medical devices' by the MHRA, but, as apps become ever more advanced to meet users' demands, developers will need to be aware of the MHRA requirements and, if necessary, ensure their apps are fully compliant.

For those apps which are not regulated by medical device legislation, developers should nevertheless always bear in mind that patient safety is at stake and take all necessary steps to mitigate risks. Even with an app like 'GP at Hand', it's not difficult to imagine a scenario in which a patient with a serious illness is falsely told there's no urgent need to see a doctor, with potentially life-threatening consequences.

Practical steps for developers:

• Undertake extensive testing to assess the level of risk.
• Be aware of any regulatory requirements, particularly as apps become more advanced and diagnostic in nature.
• Ensure that clinicians are involved in the development process throughout so that medical risks can be identified accurately.
• Give users comprehensive instructions for use and guidance to help eliminate user error.
• Include product warnings to alert users to the risks of over-reliance on the app in place of appropriate clinician review.

The discount rate is applied to future losses on lump sum payments for personal injury cases, usually where there are catastrophic injuries and very high awards. The amount of money awarded in compensation is discounted to reflect the amount of interest that capital should gain when it is (in theory) invested by the claimant.

Needless to say, the reduction of the rate in February dramatically changed the amount of compensation that a claimant would receive. To give an example, a 35-year old female claimant with loss of earnings of £12k a year would have previously received £196,800 under the old rate, but would now receive approximately £289,320 using the new rate.

With payments set to increase significantly, it's unsurprising that insurers labelled the reduction 'crazy' and marched down to Downing Street to meet with Philip Hammond within 24 hours of the announcement. Continued lobbying from the market, and other organisations and bodies adversely affected. In an extreme case of the right hand not knowing what the left hand was doing, the Justice Department appear to have been unaware of the massive impact on the NHS – which joined in the lobbying. All this resulted in a promise of a Government Consultation to consider how the rate would be set in the future.

The consultation has now been completed and a report is anticipated imminently. Rumours have been flying around that the new rate will be set at between 0-1%.

'But when will that be?' many of you may be pondering… The short answer is: no one is entirely sure.

Justice Minister Lord Keen announced in early November that the new discount rate can be expected to take effect in early 2018, only for the Ministry of Justice to backtrack on this statement almost immediately, calling it "too ambitious" although changes would come as soon as possible, within the constraints of parliamentary procedure...

Parliamentary procedure is notoriously time-consuming, especially where controversial issues arise, and therefore it seems that the original forecasts are correct in predicting that the new rate will not be introduced until late 2018. This would be logical as wider personal injury reforms are also expected to come into effect at that time. More pessimistic reports suggest that the new rate may not be introduced until early 2019.

Ultimately, the new rate should be more positive for the insurance market, whenever it is eventually implemented. The new discount rate is intended to better reflect "the actual investment habits of claimants" according to the Ministry of Justice: investment methods will be treated as 'low risk' rather than 'very low risk', and therefore compensation payments will be reduced.

It has now been confirmed that the Cabinet Office will oversee the inquiry, after campaigners raised concerns regarding the independence of the Department of Health.

Many of those infected in the 1970s and 80s were men suffering from haemophilia, who were given "factor concentrates" taken from blood plasma. Much of the contaminated stock was imported from the US, where drug companies allegedly paid prisoners and drug-addicts to donate their blood.

Following a public outcry, in 1988, the UK government set up a compensation scheme for those affected. All those who received compensation signed to waive their right to pursue any future legal action against the government. Many expected to survive only a few years and therefore pursuing legal action was not high on their list of priorities. Litigation was pursued by a number of claimants against the National Blood Authority, in what proved to be a leading case on the meaning of defect under the Consumer Protection Act 1987.

At the end of 2015, the Department of Health was presented with a detailed report requesting an increase in the annual support available to the remaining victims. In September this year, the High Court granted a group litigation order allowing surviving victims and relatives of those who have died to bring proceedings against the NHS.

It is believed that around 2,400 people died as a result of receiving contaminated blood and many feel that a full investigation is long overdue. When announcing the inquiry in July, Theresa May acknowledged that those affected "deserve answers as to how this could possibly have happened". Investigations will, of course, take time, and we expect that it will be a number of years before a full report is published (a £1.24m investigation in Canada took five years to complete).

The investigation is likely to scrutinise the role played by the NHS – what was known, when, and by whom. Labour MP Diana Johnson has stressed that the statutory inquiry must "use its full powers" and not be "inhibited in its functions by the possibility of criminal liability being inferred”. In April, Andy Burnham, Mayor of Greater Manchester, referred to there being evidence of "a criminal cover-up on an industrial scale".

Companies involved in the making and/or distribution of blood products at the time will likely also face questions; in February 2015, following Canada's investigation, a trial began in Toronto against a pharmaceutical company and the Canadian Red Cross, alleging criminal negligence causing bodily harm and endangering the public. If litigation does proceed in the UK civil Courts, Defendants may seek to rely on the development risks defence in terms of what was known / knowable at the time. It will be interesting to see whether any decision follows the National Blood Authority case.

In summary, the appellant (Armes) was in the care of the respondent (Nottinghamshire County Council), who placed her into the care of foster parents on two separate occasions. During her first placement the appellant was physically and emotionally abused, and during her second placement she was sexually abused. For the purpose of this appeal, the Local Authority were not alleged to have been negligent in selecting and supervising the foster parents, however the appellant alleged vicarious liability for the abuse committed (which the High Court and Court of Appeal had previously dismissed).  

In its findings, the Supreme Court considered the inability of foster parents to compensate the children appropriately for the abuse committed, and commented that exposing local authorities to this risk of liability may improve supervision and vetting of foster parents. Some commentary has criticised the judgment for its potential to discourage Local Authorities from placing children in foster care.  

The wider concern is that this is a significant move away from the typical employer/employee relationship, which historically has been an essential component for a finding of vicarious liability. In recent years the courts have extended the scope of the principle to relationships said to be "akin" to employment, but this is a step further. Notably, this case (and previous cases extending vicarious liability) has arisen in circumstances where the perpetrator of the wrong, and therefore the appropriate defendant, would not have sufficient funds to compensate the injured party.  

A Supreme Court judgment will be difficult to dislodge in future "test" cases, and it remains to be seen whether vicarious liability will be extended to other sectors/relationships. In the meantime, organisations should consider the extent of their insurance and whether it covers the risk of being held vicariously liable for non-employees' actions. Insurers should also take account of this developing risk when considering the requirements of their insureds, and in the policy terms that they offer.  

For practical next steps, some organisations have already moved to a structure whereby former non-employees are employed, with cross indemnity provisions in their employment contracts, which can provide some level of protection and certainty. 

Any issue with the safety of a medical product should be reported to the MHRA. Guidance from the MHRA suggests that reportable circumstances include (but are not limited to) when a medicine causes side effects, when someone is injured by a medical device (either because its labelling or instructions aren't clear or because it has been broken or misused) or when someone receives the wrong diagnosis because of a medical device. A report can be made by anyone, including patients. Depending on the severity of the report, it will be investigated either by the MHRA directly, or by the manufacturer or a nominated medical specialist.

The Human Medicines Regulations 2012 require manufacturers to have systems in place to record and review any complaints received about a product, as well as an effective system for recalling medicinal products at any time. Any complaint relating to the product should be investigated by the manufacturer. If a defect is identified that could result in a recall or abnormal restriction on supply, the manufacturer should inform the MHRA, and an investigation will be carried out.

If the investigation determines that a recall of the faulty medicine or device is required, it will be the responsibility of the licence holder (usually the manufacturer) to ensure that the recall is carried out effectively, working closely with the MHRA and the Defective Medicines Report Centre (DMRC). The following issues can lead to a recall if they are not addressed:

• Problems with labelling or packaging
• Potential contamination of the product
• Health risks associated with the product. 

The MHRA may issue a safety alert to inform healthcare professionals and wholesalers of the identified problem.

For manufacturers, a side effect of any product recall is that there can be increased regulatory scrutiny and, in some circumstances, litigation. In order to comply with the Human Medicines Regulations, manufacturers should:

• Ensure that systems are in place to monitor and record complaints, and to ensure that appropriate investigations are carried out in a timely manner.
• When the need for a potential recall is identified, seek to understand the cause of the problem and remedy it quickly, to reduce the potential class of affected individuals.
• Before announcing the recall, ensure that there is a consistent approach to internal and external communications of the issue; any inconsistencies in information could lead to difficult questions if litigation is pursued. 

China's offering for clinical trial sponsors looking to explore farther afield includes the following:  

• An ageing population, reflective of the advances in healthcare and nutrition, and the now historical one child policy 
• A densely populated pool of patients, meaning lower costs 
• Government support, following a decade long focus by the Chinese government on the development of new drugs  
• An upgraded regulatory infrastructure, with the introduction of new anti-corruption disciplinary rules and recent regulations to promote good clinical practices  

The updated infrastructure has the potential to improve the quality of clinical trials undertaken in China. Indeed, Astra Zeneca has reportedly "expressed confidence" in its Phase III trial programme in China, specifically for prospective immuno-oncology treatments, and will "expand its activities in pursuit of a strong regulatory submission there".  

However, reports in late 2016 questioned whether the new regulations have been enforced effectively. China's regulator, the CFDA (Chinese Food & Drug Administration), undertook an investigation into 1,622 clinical trials for new pharmaceutical drugs that were awaiting approval, finding that more than 80% of the data failed to meet the analysis requirements (some including potentially fraudulent activity).  

We can expect to see further regulatory enforcement in the coming years as part of China's ambition to achieve a gold standard clinical trial practice, as well as efforts to improve the infamously slow approval process (already seen in recently announced policy changes to allow drugs to get into the clinic faster). International sponsors should be both cautious and encouraged.  

Sponsors thinking of running clinical trials in China should consider:  

• Planning for a lengthy application process at the outset 
• Recruiting nationals or Chinese speakers to assist on the ground 
• Investing in specialists to guide them through the regulations 
• Liaising closely with the CFDA  

Until now, cases like this would have required Court approval as well as the agreement of the patient's family and medical professionals. A distinction has traditionally been drawn between the withdrawal of life-saving treatments, for example dialysis, which did not require Court approval, and the withdrawal of food and water, which did. The distinction appears to have been based on the almost emotional significance assigned to the idea of withdrawing sustenance from an individual.

In his judgment, Jackson J commented that the decision about what was in M's best interests is one that "could lawfully have been taken by her treating doctors, having fully consulted her family and having acted in accordance with the Mental Capacity Act and with recognised medical standards". A key factor in the decision appeared to be a desire to avoid the delay and cost incurred in seeking Court approval; Jackson J commented that even in cases such as M's, where the patient's family and her doctors were in agreement, the legal costs of bringing the case to Court had reached almost £30,000.

The decision has received praise from some, who describe it as a "helpful step towards a clearer, more person-centred view of end-of-life care" (Sarah Wootton, chief executive of Compassion in Dying). Indeed, it is hard to imagine circumstances where a Court might have reached a different view from the patient's family and treating clinicians, arguably those best placed to determine what is in the patient's best interests. Jackson J did make clear that in certain circumstances a Court application would be appropriate, stating that: "The Court is always available where there is disagreement, or where it is felt for some other reason that an application should be made"; but he anticipated that such applications will be rare.

The claimant's cervical tumour developed to stage IIB invasive cancer of the cervix as a result of a delay in diagnosis. Prior to undergoing chemo-radiotherapy treatment, the claimant had 12 of her eggs frozen; the treatment left her completely infertile.

The defendant NHS Trust admitted liability for the delayed diagnosis, but the issue of damages proceeded to trial. The claimant's claim for damages included the cost of four surrogate pregnancies using either her own frozen eggs or, if necessary, donor eggs.

The claimant's preference was for any surrogacy arrangement to be made in California, where commercial surrogacy arrangements are lawful and binding.  She and her partner could then secure parental legal status for any child born to the surrogate mother, without the risks associated with surrogacy arrangements in the UK.

Giving judgment, Sir Robert Nelson rejected the claim for the costs of surrogacy in California (for UK public policy reasons) as well as a claim for the cost of donor eggs, but did allow for the cost of two surrogacies in the UK.

In his judgment, Sir Robert Nelson highlighted some of the difficulties encountered in UK surrogacy arrangements, including:  

• whilst non-commercial surrogacy is permitted, commercial surrogacy arrangements are illegal;
• surrogacy arrangements are legally unenforceable;
• the surrogate mother retains parental legal status. This may result in a refusal to give the child to the intended parents;
• the intended parents may apply to the court for a parental order, but only after the child has been born, and only with the consent of the surrogate mother.   

The NHS Trust argued that the costs awarded for the surrogacies should be reduced (or dismissed) because the claimant had access to substantial damages awarded for her other injuries. Sir Robert Nelson rejected this argument on the basis that the claim for the costs of surrogacy were a valid and separate head of claim, and the claimant's other damages should not be treated as a substitute.

This case establishes, for the first time, that it is possible to seek damages to fund surrogacy as a separate head of claim. Limitations remain however in relation to the use of donor eggs and overseas surrogacy arrangements.  

In handing down judgment, Sir Robert Nelson acknowledged that attitudes to surrogacy have changed, and continue to change, but made it clear that "such change must be brought about by the Law Commission and Parliament, or perhaps the Supreme Court." A suggestion perhaps that reform is needed, and a possible indication of changes to come.

A number of high-profile cases in recent years have been brought on the basis that manufacturers had produced medical products that failed to meet acceptable levels of safety. It appeared that the current regulatory framework dating from the 1990s had failed. But in many cases, manufacturers found that they produced devices that performed well but the regulations themselves provided only limited protection against speculative claims that their products were defective.

In response to these issues, the European Union has scrapped the 1990s legislative framework and replaced it with a new regime.

On 25 May 2017, the new EU Regulation came into force and will take effect in 2020 after a transitional period. When Brexit occurs we do not expect the Government or Parliament to amend it in any material way. It ushers in change designed to bring the legal framework regulating medical devices into the 21st Century. For insurers worried about the litigation risk associated with medical products, some key points are:

• Data. Manufacturers will now be required to obtain more data regarding the safe performance of their devices before they are put on the market. Once on the market, manufacturers will have greater obligations to carry out vigilance and track how their products perform. This means that manufacturers will be better equipped to deal with concerns over the safety of their products: either the products will be recalled more quickly than they are now; or manufacturers will be able to refer to more data to demonstrate that their products are safe.

• Notified bodies.  Notified Bodies are entities with delegated authority from national regulators, tasked with auditing a manufacturer's quality system and technical documentation before a device can be CE marked and distributed. Notified Bodies will now shift from being industry partners and become more like policemen. This means manufacturers' products and processes will be subject to greater scrutiny before they get to the market. For insurers, this will provide greater assurance that products are safe.

• Knowledge sharing.  Patients implanted with a device will be given an implant card. The European databank on medical devices (Eudamed) is being overhauled by the new regulations to allow wider access. Patients will be able to use their implant card to access information regarding the safety and performance of their implant. For manufacturers and insurers, it is good news that patients will have more information. The 'worried well' will be reassured; for those with genuine cause for concern, better information exchange can be used to resolve litigation at an earlier stage than it is now.

Unless there is a successful appeal to the Supreme Court, this decision is likely to spell the end of the increasingly common argument that there should be an award of damages for a failure to obtain informed consent, in addition to, and independent of, any award of damages for pain, suffering and loss of amenity.

The Facts

The claim was brought by the daughter of Mr Ewan (Deceased) on behalf of his Estate. Mr Ewan was diagnosed with aortic valve stenosis in September 2006, and was advised to undergo a transcatheter aortic valve implantation procedure (TAVI). Sadly, Mr Ewan died during the procedure due to the complication of bleeding from the aorta. It was alleged that the Defendants had failed to advise the Deceased of the alternatives of open heart surgery or conservative treatment.

First Instance

The Claimant succeeded at first instance on the basis that, had the Deceased been warned of the risks of TAVI, he would not have undergone the procedure and therefore he would not have died when he did. The Claimant recovered £15,000.00 in damages for pain, suffering and loss of amenity, funeral costs and expenses. The Claimant also argued that the failure to obtain informed consent should result in a separate, additional award for damages. That argument was dismissed.

Appeal

In granting permission to appeal, the Court of Appeal stated that the failure to obtain informed consent was an important and developing area of law and medical ethics.

At the appeal hearing, it was argued that the Claimant should have been awarded a separate, additional sum for the Deceased's “loss of personal autonomy” based on an inadequate consent process and the decisions in Chester v Afshar [2005] and Montgomery v Lanarkshire Health Board [2015].

The Court of Appeal unanimously upheld the decision of the lower Court and, in summary, confirmed that there is no independent cause of action against a doctor for failing to obtain informed consent. The Judges found that allowing the award would "open the floodgates" to patients who had received excellent care despite omissions taking place during the consent process. In his leading judgment, Lord Justice Davis agreed that the risk of a proliferation of such claims would have “very real, even if unquantifiable, financial, practical and other implications.”

Summary