Cumberlege comments that the Review
has been about people who have suffered avoidable harm. Our report is entitled “First Do No Harm”. Having spent two years listening to heart wrenching stories of acute suffering, families fractured, children harmed and much else, I and my team thought it an appropriate title. It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not. ... We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago. The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. This is why one of our principal recommendations is the appointment of an independent Patient Safety Commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. The Commissioner would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act. This person would be the golden thread, tying the disjointed system together in the interests of those who matter most. Secretary of State, we are entering a new world, in which innovation and technology will bring exciting change. There is potential to do so much good, but we must ensure the risks of increasingly complex healthcare are understood and where the system is not sure of the risks it must say so. Had it done so in the case of our three interventions, I have no doubt that much anguish, suffering and many ruined lives could have been avoided.The Report states
1.1 This Review was announced in the House of Commons on 21st February 2018 by Jeremy Hunt, the then Secretary of State for Health and Social Care. Its purpose is to examine how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future.
1.2 Under my chairmanship the Review was asked to investigate what had happened in respect of two medications and one medical device:
- hormone pregnancy tests (HPTs) – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages;
- sodium valproate – an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy; and
- pelvic mesh implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. Its use has been linked to crippling, life- changing, complications; and to make recommendations for the future.
1.3 The Review was prompted by patient-led campaigns that have run for years and, in the cases of valproate and Primodos over decades, drawing active support from their respective All-Party Parliamentary Groups and the media. As the Secretary of State commented: ‘We must acknowledge that the response to these issues from those in positions of authority has not always been good enough. Sometimes the reaction has felt too focussed on defending the status quo, rather than addressing the needs of patients and, as a result, patients and their families have spent too long feeling that they were not being listened to...’
1.5 The Review was asked to consider how to strengthen the patient voice in order to help build a ‘system that listens, hears and acts – with speed, compassion and proportionality.’
1.6 On the face of it we were being asked to investigate three disparate interventions governed by two different product regulatory frameworks in the one Review. It soon became apparent, however, that far more binds these interventions than separates them:
- they all are taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy;
- patients affected by each tell similar and compelling stories of their battles to be listened to when things go wrong;
- patients turning to each other for help and mutual support;
- patients campaigning for years, if not decades, to achieve acknowledgement, resorting to the media and politicians to take up their cause because the healthcare system did not.
1.7 The Review looks not just at what happened in the three individual cases but how the healthcare system reacted as a whole, and how that response can be made more robust, speedy and appropriate. It is in this sense a system-wide review.
1.8 Finally, as complex and wide-ranging as our Review proved to be, we know that there are many who contacted us during the course of our work and who were disappointed that we could not also consider their concerns about other medications and devices on the market. The list is long – Essure (a contraceptive device), Roaccutane (a treatment for severe acne that can cause birth defects if used in pregnancy), Poly Implant Prostheses (PIP) breast implants, cervical cancer vaccination, in utero exposure to hormones, valproate use in children. We are aware of the similarities between pelvic mesh and mesh used for hernia procedures and we have heard from a number of people adversely affected following hernia mesh procedures. With regards to mesh, the scope of this Review relates only to pelvic mesh, which following insertion resides in the pelvis to support pelvic organs. So, neither hernia mesh nor the other medications and devices listed above were within our remit. Concerns about these taken together, however, point to a healthcare system that cannot be relied upon to identify and respond promptly to safety concerns. We believe that what we have to say and recommend for the future will have an important read-across to these and other interventions and the manner in which they are approved, delivered, regulated and monitored.
1.9 What follows is a summary of what we heard, and then a summary of our observations and recommendations and the reasoning behind them. These recommendations cover England only, though we know the devolved administrations are following our work closely. We hope those governments will consider the recommendations we have made for England.
What we heard
1.10 Patients were at the heart of our Review. Although our focus was on England, we travelled to the four corners of the UK to listen and learn. We met with hundreds of affected patients and their families and heard by email, phone and letter from many more. It became all too clear that those who have been affected have been dismissed, overlooked, and ignored for far too long. The issue here is not one of a single or a few rogue medical practitioners, or differences in regional practice. It is system-wide.
1.11 We took evidence from a wide range of stakeholders, from clinicians and the Royal Colleges, from the pharmaceutical industry and manufacturers of devices, from the full range of NHS and private sector providers and arms-length bodies including the regulators, professional and disciplinary bodies and finally from the Department of Health and Social Care. Collectively we refer to this group of stakeholders as the healthcare system.
1.12 The patients’ stories were harrowing. Our two-year journey took its toll on all of us but that paled into insignificance in the face of so much adversity borne with such resilience and bravery by those we met and heard from. They told their stories with dignity and eloquence, but also with sadness and anger, to highlight common and compelling themes:
- the lack of information to make informed choices;
- lack of awareness of who to complain to and how to report adverse events;
- the struggle to be heard;
- not being believed;
- dismissive and unhelpful attitudes on the part of some clinicians;
- a sense of abandonment;
- life-changing consequences, not only for those directly affected, but for their families and friends too;
- breakdown of family life;
- loss of jobs, financial support and sometimes housing;
- loss of identity and self-worth;
- a persistent feeling of guilt;
- children becoming their mothers’ and siblings’ carers;
- clinicians untutored in the skills they need to make a proper diagnosis;
- clinicians not knowing how to learn from patients;
- inaccurate or altered patient records;
- a lack of interest in, and an inability to deliver, the monitoring of adverse outcomes and long-term follow-up across the healthcare system.
1.13 These testimonies provided the background to our own diligent inquiry into the roles played by those whose job it is to ‘listen, hear and act with compassion, speed and proportionality’.
What we learnt
1.14 What follows will not make comfortable reading for many who have dedicated their lives with the best of intentions to delivering high-quality and compassionate treatment and care. We recognise that most people do excellent work most of the time in the health service. They work hard, they work long hours and they came into the healthcare professions to help sick people get better, never more so than during the Covid-19 pandemic. We recognise too that the constituent parts of the healthcare system do for the most part what each is asked to do. But what they have been asked to do is not the solution to the problem as we see it.
1.15 Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous. Crucial opportunities are lost to learn about what works well, what does not, what needs special measures put around its use, and what should be withdrawn because the risks over time outweigh the benefits. Without such information it is not possible for doctors and patients to understand the risks, and patients cannot make informed choices. This applies both to medications and to medical devices.
1.16 The lack of such vigilant, long-term monitoring has been a predominant thread throughout our work. Its absence means that the system does not know the scale of the problems we were asked to investigate:
i. The system does not know, so neither do we, just how many women have been treated for stress urinary incontinence and the repair of pelvic organ prolapse using polypropylene mesh. The system does not know, so neither do we, how many women have been cured of their incontinence, or been successfully treated for their prolapse – only then to experience a long list of life-changing conditions that include loss of sex life, chronic pain, infection, difficulty voiding, recurrent urinary incontinence, permanent nerve damage or damage to surrounding organs, haemorrhage, autoimmune disease and psychiatric injury. We met so many women with limited mobility having to rely on a wheelchair or crutches to move around, unable to sit for periods at a time, unable to play with their children or carry their grandchildren. Living daily with the consequences of the operations and procedures they thought would cure them. The effects of these procedures have caused fractured relationships for some and placed some women and their families in dire financial straits. In short, the system does not know the true long-term complication rate for pelvic mesh procedures. In the absence of such information, it is impossible to know how many women would have chosen a different form of treatment – a different care pathway – if only they had been given the information they needed to make a fully-informed choice;
ii. The system does not know, so neither do we, just how many women over four decades took sodium valproate, a highly effective treatment for managing epilepsy but a known teratogenic medication, who then went on to become pregnant because they had not been properly informed as to the risk they were taking and the options open to them. The system does not know, so neither do we, how many of those children were subsequently born with either significant malformations, developmental delay or autism (now termed Foetal Valproate Spectrum Disorder or FVSD). The research tells us that 10% of unborn children exposed to the medication are likely to suffer physical birth defects such as spina bifida, hare lip and cleft palate, heart problems and limb defects, and 40% will have a developmental delay or autism. The system still does not know where all these valproate-affected children, now adults in many cases, are, or how to contact them to secure the proper diagnosis and assessment of their care needs. The system does not know how to ensure every woman of childbearing age on sodium valproate is continuously monitored, advised of the risks and aware of the Pregnancy Prevention Programme. How then can the system minimise the risk of future babies being damaged by valproate taken in pregnancy?
iii. The system does not know, so neither do we, just how many women took a Hormone Pregnancy Test, such as Primodos, between the 1950s and 1978 when it was withdrawn. The system does not know, so neither do we, how many miscarriages may have occurred after taking this medication, how many of the children born to mothers who took Primodos may have suffered physical malformations or died before reaching adulthood, or how many of those children, now adults, may still be alive and in need of extensive care and support.
1.17 The healthcare system collects a huge amount of information. But it cannot answer these fundamental questions. How then can it spot trends and complications and act swiftly and coherently to protect patients and prevent harm? How then can it design and provide the services that those affected need to lead as full a life as possible? How then can the healthcare system be considered a system for all?
1.18 We heard about the failure of the system to acknowledge when things go wrong for fear of blame and litigation. There is an institutional and professional resistance to changing practice even in the face of mounting safety concerns. There can be a culture of dismissive and arrogant attitudes that only serve to intimidate and confuse. For women there is an added dimension – the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.
1.19 We heard about a system that does not work in a joined-up fashion, and that lacks the leadership to deliver coherent and fully integrated patient safety policy directives and standards. Mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of overall effective accountability. This culture has to change, starting at ground level while being encouraged and supported from the top. Witness Professor Ted Baker, the Care Quality Commission’s (CQC) Chief Inspector of Hospitals, speaking at a recent Patient Safety Learning Conference at The King’s Fund, referring to an ‘insidious culture of defensiveness and blame.’
1.20 We heard about a system that cannot be relied upon to identify promptly significant adverse outcomes arising from a medication or device because it lacks the means to do so. For decades there has been something known as the ‘Yellow Card’ system through which clinicians, and indeed patients, can report suspected adverse reactions to treatment. But it is clear that there is gross under-reporting, and our complaints systems are both too complex and too diffuse to allow early signal detection.
1.21 We heard much said about manufacturers being motivated by sales, speed to market and returns to shareholders; manufacturers who contest their liability to contribute towards help for these patient groups. Those suffering from mesh complications around the world have had to resort to litigation to have the wrongs done to them acknowledged. Valproate-affected families have also failed in their group litigation attempt in the UK. In France it is a government-backed scheme that will pay compensation to those who have suffered one or more complications attributable to Fetal Valproate Spectrum Disorder. HPT-affected families in the UK have one failed litigation behind them although we understand that solicitors are now preparing to file a second group action in the UK in relation to HPTs.
1.22 We heard about the gaps in knowledge and evidence gathering that have already been identified by the National Institute for Health and Care Excellence (NICE), and by others who set the standards for best clinical practice. Crucial research evidence that should help shine a light on what are safe and effective interventions is neither prioritised nor funded. And we heard about research that is funded by manufacturers that never sees the light of day because it is negative or inconclusive for the product in question, or is less than transparent in its declaration of conflicts of interest when positive findings are reported.
1.23 All that we have heard leads us to conclude the system is not safe enough for those taking medications in pregnancy or being treated using new devices and techniques. Patients are being exposed to a risk of harm when they do not need to be. And, while we have looked in detail at only three interventions, we have heard nothing that would lead us to believe that things are different for other surgical procedures and devices or other medications.
1.24 It has taken this Review to shine a light on systemic failings. That the healthcare system itself failed to do so suggests that it has either lost sight of the interests of all those it was set up to serve or does not know how best to do this. The NHS is funded by the taxpayer for the benefit of all of society – current and future. Patients have been affected adversely by poor or indifferent care, have suffered at the hands of clinicians who do not, or who chose not to listen, and have been abandoned by a system that fails to recognise and then correct its mistakes at the earliest opportunity. At times patients have been denied their fundamental right to have the information they need to make fully informed choices. These patients should not have to campaign for years or even decades for their voices to be heard. Patients should not have to find the evidence to say whether the treatments they are being offered are safe and will leave them better off than before. They should not have to join the dots of patient safety. But when they do just that, they deserve to be listened to with respect.
1.25 Medicine has made great strides in what it has been able to do to prolong life and treat the previously untreatable. But along that journey of scientific progress it has also become complex and potentially too dangerous to be left solely in the hands of clinicians. The influence of patients within the NHS and the overall delivery of healthcare needs to be increased to balance the authority both directly and indirectly of those we call stakeholders in the healthcare system – the professionals certainly, but others too, including big pharma. Patients are unable to make decisions that concern what happens to them because of a widespread lack of truly informed consent and a reluctance or inability by those charged with patient care and treatment to listen and, having listened, to act and where necessary remedy mistakes or misjudgements made. We have much more to say about this throughout our report.
1.26 In the following chapters we catalogue a list of missed opportunities. These are moments when something could or should have been done to minimise continuing patient harm in respect of each of the three interventions. We also set out our recommendations below and the justification for them.
1.27 Many will have benefited from pelvic mesh implants. Likewise, sodium valproate will have been an effective treatment for many. But this cannot justify the damage done to those who have suffered without prior knowledge of the dangers they faced – which could take years to present. While the title of our report may not be original, it was chosen with care. ‘FIRST DO NO HARM’ is a fundamental maxim of medical practice – and that has not been the case here. After ‘first do no harm’ comes, of course, ‘NEXT DO SOME GOOD’. We do not want to stifle the medical progress which has enabled many of us to live longer and in better health over the last fifty years. The task for the healthcare system is to get the balance right. It can and must do both.
Our Recommendations
1.28 Our Terms of Reference required us to investigate whether the response of the healthcare system was sufficiently robust, speedy and appropriate. In the following chapters we will show that it was not, resulting in avoidable harm. The passage of time between the concerns being raised and the effectiveness of actions taken to address those concerns and then to investigate and learn the lessons – decades in the case of sodium valproate and Primodos – demonstrably added to the suffering and pain of those affected. The system, and those that oversee it, need to acknowledge what has gone so badly wrong.
Recommendation 1:
The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
1.29 The patient voice and influence within the NHS and the overall delivery of health care needs to be strengthened. The failure of the healthcare system to respond to patient concerns is a recurrent theme, most recently raised by the Paterson Inquiry. Patients often know when something has gone wrong with their treatment. All too often they are the first to know. Their experience must no longer be considered anecdotal and weighted least in the hierarchy of evidence-based medicine.
1.30 We do not need another re-organisation of the NHS to get this right; we do not need another regulatory body in an already crowded field. But we do need a new voice, with statutory powers, to talk and act from the perspective of the patient, to encourage the system to do what needs to be done and hold it to account. We need a person of standing who sits outside the healthcare system and who is accountable to Parliament through the Health and Social Care Select Committee. This new voice, which we are calling the Patient Safety Commissioner, would continue the work this Review has started, in pressing the system to take timely action where action is called for to minimise harm.
1.31 This new Commissioner would champion the patient voice and from this unique perspective would support and encourage the efforts of the healthcare system to improve patient safety around the use of medicines and medical devices. The Commissioner would lead, with full patient group engagement and involvement, on developing a set of principles of Better Patient Safety that would govern the way the Commissioner fulfilled her or his remit.
1.32 Where there are areas of concern related to the use of medicines and devices, the healthcare system will need to satisfy the Patient Safety Commissioner on the outcomes required for change, who is responsible for delivery and who will take the lead on co-ordination. The Patient Safety Commissioner will wish to monitor the effectiveness of the outcomes.
Recommendation 2:
The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.
1.33 Litigation has, so far, not served our patient groups well. We would not wish to remove the option to litigate, but for the future we propose a Redress Agency. This agency would supplement the current systems for resolution of disputes between patients and the healthcare system. This Redress Agency is not about addressing the needs of those already affected by the three interventions considered by this Review - these are addressed by Recommendation 4. It is about creating a new way of delivering redress in the future. There are precedents for this both in the UK and abroad, see Appendix 3.
1.34 The Redress Agency will provide a standing structure which is easy for patients to access and use. Rather than blaming individuals, decisions will be based on avoidable harm looking at systemic failings. This will encourage reporting by clinicians and so provide faster resolution for claimants. The Redress Agency will administer decisions using a non-adversarial process. The support or redress offered could be both financial and non-monetary.
1.35 To enable flexibility to adapt and respond to situations as they arise, different injury types would have separate schemes. Each scheme would have its own eligibility criteria and its own funding. A levy for pharmaceuticals could be paid into a pharmaceuticals scheme and separately a levy for medical devices could be paid into a medical devices scheme. Placing such products on the UK market should be made conditional upon contributing to a scheme. The Redress Agency would administer these schemes.
1.36 The costs of running the Redress Agency could be met by contributions from manufacturers and the state, but it must be situated outside the current organisations and the exercise of its functions must be entirely independent.
1.37 Those responsible for the Redress Agency will have an important role to play in harm prevention as adverse event reports would be centralised, so enabling data to be provided that will help regulators detect signals earlier.
Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.
1.38 In our view all three of the interventions have caused avoidable psychological harm in some patients. It is clear that mesh has caused significant physical harm and valproate has caused physical and neurodevelopmental harm. We believe that the state and manufacturers have an ethical responsibility to provide ex gratia payments to those who have experienced avoidable damage from the interventions we have reviewed. We recommend these schemes provide discretionary payments. Each of the three interventions should have its own scheme with tailored eligibility criteria. These payments are not intended to cover the costs of services which are available free of charge, such as health care and social security payments, but rather for other needs that could, for example, include travel to medical appointments, respite breaks or emergency payments where a parent has had to stop working to cover care. Patients have waited far too long for redress. Any scheme must be set up promptly. However, each should be structured so that it can be incorporated into the wider Redress Agency for the future as set out in Recommendation 3.
1.39 Individuals who obtain compensation from litigation or from out of court settlements (like J&J’s Scottish pelvic mesh settlement) will not need recourse to these schemes.
Recommendation 4:
Separate schemes should be set up for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
1.40 We believe that those harmed are due not only an apology but better care and support through specialist centres: specialist centres for mesh, and separately specialist centres for those affected by medications taken during pregnancy. As well as meeting clinical needs, these centres should act as a one stop shop, able to signpost and refer patients to other services including educational, social and welfare. NHS England as the commissioner should collaborate with other government bodies which provide these services. As centres of excellence, such centres should have the responsibility to research better treatments and to audit outcomes. We have been in discussions with NHS England about commissioning these centres. At the time of writing, the commissioning process for specialist mesh centres is ongoing and we have been actively engaged in this process, see Chapter 5, paragraphs 5.12 – 5.13.
Recommendation 5:
Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.
1.41 Post Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) will have to change, as indeed it recognises. This provides an opportunity to bring much needed cultural and legislative reform and to become more public-facing. The MHRA does not have the public profile of some other international regulators, such as the US Food and Drugs Administration (FDA). If they have concerns patients need to know what the MHRA does and how to contact it. The MHRA must work both for patients and with them. Reform, underpinned by legislation, is needed so that the views of patients are systematically listened to and their experiences of medications and devices are used to inform licensing and regulatory decisions. These strategic themes are further explored in Chapter 2 Theme 11.
1.42 For both medicines and medical devices there is a need for more robust, publicly accessible post-marketing surveillance. This should include mandatory requirements on healthcare organisations to report adverse events within a designated time period. The MHRA should provide assessments of the risks of individual medicines or devices and of classes of medicines or device where one or more members of the class carries an elevated risk.
1.43 The spontaneous reporting platform for medicines and devices, the Yellow Card system, needs reform. It needs to provide a user-friendly, accessible, transparent repository of adverse event reports. We recognise that the MHRA has previously tried to persuade other EU member states to be more open over adverse device reports. In our view openness and transparency should be a statutory requirement for adverse event reporting in the UK. The MHRA should be required to invite representatives of those who report adverse events (both patients and healthcare professionals) to be involved in evaluating and making decisions on specific safety concerns.
1.44 Medicines have to pass tests of quality, safety and efficacy before reaching the market. Medical devices are less rigorously examined before they are first marketed. This is because devices continually evolve, so by the time a clinical trial was complete the device may be onto a new iteration. Unlike medicines many implantable medical devices are intended to be permanent.
1.45 At present the MHRA has no involvement in the pre-market phase of medical device development. It should develop a proactive regulatory role for devices that is more akin to the licensing of medicines; this must be clinically focussed and at least as stringent as the new EU Medical Devices Regulations (MDR). The MHRA should keep a register of all devices approved for the UK market. Manufacturers should be required to apply to the MHRA before marketing their device. The MHRA should assess the application in a way that is proportionate to the risks posed taking into account relevant factors such as, the evidence base supplied, approvals in other jurisdictions, and the post-marketing surveillance plans. If approved a device will be added to the register. Marketing approval for devices should be a staged process, progressing to wider use and dissemination of the device as more information becomes available. In the event of an issue with a device the MHRA must have the power to remove a device from the register. Given there are an estimated 600,000 or more devices on the market we recognise that initially this will almost certainly involve some ‘grandfathering’ of currently marketed devices.
Recommendation 6:
The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
1.46 Post-market surveillance for devices and medicines needs to be high-quality and comprehensive, and it can be greatly facilitated by digital technology and big data. It became apparent to us that there were problems with obtaining comprehensive data and creating registries. We know that mature registries can deliver good- quality long-term outcome data using measures that matter to patients. They are, however, few and far between and all too often prompted by catastrophe.
1.47 We propose a two-stage process for data gathering. Firstly, the setting up of a mesh database with comprehensive coverage. In November 2019 the Secretary of State accepted what we had to say and mandated the requisite data collection by NHS Digital. The second stage will consist of establishing a mesh registry or registries to investigate specific issues in depth. Contact information can be extracted from a database into the registry to enable this research to take place.
1.48 Ultimately the goal must be to establish a database for all implantable medical devices, which can feed into registries as required.
1.49 While this recommendation focuses on medical devices, consideration should be given to the creation of comparable databases for specific medications, for example the use of medications during pregnancy.
Recommendation 7:
A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.
1.50 We have been concerned by conflicts of interest, both potential and real, in the provision of care or treatment, particularly where doctors have financial and other links with the pharmaceutical and medical device companies. Currently there is no central register of clinicians’ financial and non-financial interests.
1.51 Other regulators should consider similar requirements as necessary, and the Professional Standards Authority should evaluate whether conflicts of interests have been adequately declared.
1.52 There is also no easily accessible means of identifying the accredited competencies of individual clinicians. The General Medical Council (GMC) has introduced registration for GPs and for specialists who want to practise as consultants. We recommend that this should be expanded to include all doctors’ particular clinical interests (and any supporting accreditation).
1.53 We believe that responsibility for transparency of interests should not lie only with the medical profession. Medicines and medical device manufacturers should also ensure that they publish details of payments and payments in kind that they make to teaching hospitals, research institutions and individuals. This should be a statutory requirement similar to the Physician Payments Sunshine Act 2010 in the US. Consideration should be given as to where these disclosures should be published, including potentially expanding Disclosure UK and making it mandatory.
Recommendation 8:
Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
1.54 Our recommendations are designed to reduce the risk of similar cases of avoidable harm in future and to pave the way for a healthcare system that looks and feels very different from the past. It should not take years of campaigning by patients and yet another series of reviews or inquiries to achieve this.
1.55 We hope this Government, and all those bodies that comprise the healthcare system, will take heed of what we have to say, and that our recommendations, if accepted in full as we believe they should be, will be implemented with real determination and a sense of urgency. Our final recommendation shifts the focus to implementation.
Recommendation 9:
The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation.
