13 Jul 2020

The Independent Medicines and Medical Devices Safety Review published its report last week in a truly scathing assessment on the failure of the UK healthcare system to protect women against undue harm. The report, instructively titled “First Do No Harm”, makes far-reaching and radical recommendations to urgently improve patient safety.

The Independent Review was commissioned in 2018 by the then Secretary of State for Health, Jeremy Hunt MP, to assess three medical interventions; Primodos, Sodium Valproate and pelvic mesh, following several patient-led campaigns that warned of untold harm caused to women.

During the two year process of collecting patient testimonials and evidence gathering, the Review’s Chair, Baroness Julia Cumberlege, identified several key themes that cross-cut these three treatments and highlight wide-spread learnings for the whole health system, including the NHS, private providers, regulators, professional bodies and industry.

For those of us who work with industry, clinicians and patient groups to improve access to medicines, and have witnessed first-hand the enormous lengths taken by many to put patients, and their safety first, to report adverse events and to maintain transparency, the Review is an agonising reminder of the pain caused when things go wrong.

No-one is listening

As the Review clearly states, the interventions under discussion were all taken or used by women who have told compelling stories of their battle to be heard. Damming evidence is detailed of the widespread dismissal of many symptoms expressed by women as ‘normal’ and attributable to ‘women’s problems’, such evidence leads the report to conclude that, well beyond the three interventions it was designed to assess, the NHS is not safe enough for those taking medications in pregnancy, or being treated with devices.

This conclusion will be difficult to stomach for many women, and will bring a wave of recognition for those of us who have battled to have our voice heard in our healthcare decisions, spent years waiting for a diagnosis of conditions such as endometriosis or been told to treat heavy menstrual bleeding with a hot water bottle.

The Review advocates that woman should be listened to and treated with respect. I don’t think I will be alone in being dumbfounded about that basic approach still being missing in our healthcare system, and that somehow, parts of the healthcare system remain so entrenched in sexism that this could be seen as a radical new approach. The Review argues that the patient voice must be louder, to balance out the voices of authority and of those with most influence, including professionals and big pharma.

It is recommended a Patient Safety Commissioner is brought into the NHS, to do just this. The role would act as an independent champion for patients, with a statutory responsibility to listen to them and to advocate for improvements to patient safety.

A Patient Safety Commissioner would be a powerful sign of change for patients who told Baroness Cumberlege that no-one has been listening. It would create a clear point of entry to patients who face so many barriers when raising their concerns and ensure the patient voice is at the centre of decision making within both the NHS and industry. It is hard to see how a reasonable Government can resist such calls. However, there remains a much broader issue to be tackled in how women’s health is prioritised from research to the clinical teaching curriculum.

If implemented, the person who undertakes the Patient Safety Commissioner position would gather powerful expertise that would be useful not just in the NHS but for the pharmaceutical and medical devices industries to listen to too.

A culture of blame

The Review also repeats a recommendation that has appeared in reports for the last 20 years that the NHS must make a shift away from a culture of blame to one where honesty about failings enables learnings and improvement. Currently, the NHS has an “institutional and professional resistance to changing practice,” whereby “mistakes are perpetuated through a culture of denial, a resistance to no-blame learning” worsened by persuasive “dismissive and arrogant attitudes that only serve to intimidate and confuse.”

To steer away from the blame game culture, the Review calls for the introduction of an independent Redress Agency. Rather than blaming individuals, the Agency will look to assess patient’s concerns in terms of avoidable harm and systemic failings. Such a system would be non-adversarial and could offer patients redress both financially and in non-monetary support. To implement this system, the Review recommends the introduction of a levy to be paid by pharmaceutical and medical device companies in return for access to the UK market.

The implementation of this is altogether more complex than the Patient Safety Commissioner. The idea of a levy for all medicines and devices companies to support the Redress Agency may not be widely welcomed, particularly for the majority of companies for whom patient safety is already a crucial aspect of their work, with billions invested in clinical trials for safety, monitoring of products in market and adverse event reporting. However, supporting such a scheme makes a signal to patients that the life sciences industry is a responsible partner, who truly cares about ensuring patients undergo no harm and is willing to support patients, even when things go wrong.

Upholding transparency

If the life sciences industry is to prove its patient-centric credentials, it will need to overcome the criticisms raised in the report which argue that manufacturers are often primarily motivated by sales, speed to market and returns to shareholders, instead of helping the patients their technologies are made for. As such, concerns around conflicts of interest arise, particularly in terms of doctors who have links, financial and otherwise, to pharmaceutical and medical device companies.

Pharmaceutical companies are already heavily regulated in their dealings with clinicians and have to declare all their funding and non-financial support that they provide. However, anyone involved in healthcare lobbying in the UK will know that demonstrating this transparency is paramount. The Review is a fresh reminder that the job is never done.

It calls for an improvement in transparency around the payments made to clinicians, which should, it argues, be captured by a General Medical Council (GMC) register. Furthermore, the Review calls for mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians, similar to the Physician Payments Sunshine Act 2010 in the US. This recommendation is part of a wider trend which is pushing governments and corporations toward being more open.

The voluntary rules for the devices industry are not as strict as those for medicines. I am sure that the health tech industry will be watching closely to see if there is now a growing appetite to place a statutory responsibility on medical product manufacturers to declare any payments or other transfers of value.

Measuring what matters to patients

For all the talk of a data revolution, it is a fact that the NHS often fails to utilise the huge amounts of information it collects to improve patient care. As a result of not bringing existing data together, and failing to fill knowledge gaps, crucial opportunities are lost to learn which treatments work well, and which do not. To avoid this situation in the future, post-market surveillance for devices and medicines needs to be high-quality and comprehensive, to ensure the NHS can adapt care accordingly.

The pharmaceutical industry invests a huge amount in pharmacovigilance data collection and would be a willing partner to work with the NHS to ensure the health service can more effectively collect and analyse patient safety data.

Witnesses for the report also highlighted the need to collect data on improvements in health outcomes as perceived by the patient, with the report recommending the establishment of patient-identifiable registries for new devices and medicines that can be interrogated over time to assure long-term efficiency and detect harm. It suggests that for these registries to benefit patients, as well as improving disease knowledge for industry, they must be funded in part by the health system and in part by industry.

Despite the benefits of such registries being clear to both the NHS and industry, private sector involvement in health data is a topic that policy makers have been wrestling with for a long time. It has to be hoped this report will help push this debate along.

The B word

In 2020, it would be astounding for a healthcare review to be undertaken without mentioning Brexit, and the Medicines and Medical Devices Safety Review is no different. The Review positions the UK’s exit from the EU as a key opportunity for reform, in particular, with regard to the role of the Medicines and Healthcare products Regulatory Agency (MHRA). The report urges the MHRA to reform the ‘Yellow Card’ system, whereby people report adverse reactions to treatments. It challenges this system as promoting under-reporting, being too complex and too ridged to allow early detection of issues. Instead, the MHRA must introduce a “user-friendly, accessible, transparent repository of adverse event reports.”

In addition, the report recognises that whilst medicines pass tests of quality, safety and efficacy before reaching the market, medical devices are less rigorously examined before they are first marketed. It recognises that historically, devices undergo less examination due to their evolving nature but argues that this is the very reason why devices must be better regulated moving forward, tasking a post-Brexit MHRA to take on this challenge.

The report hints that the Government should utilise secondary legislation, arising from the expected passing of the Medicines and Medical Devices Bill 19/21, to reform the MHRA enabling it to overhaul adverse event reporting and tighten up device regulation requirements in the UK. Industry and regulatory experts will need to monitor the Bill closely to ensure they can support the Government to shape future medicines and device regulations in a timely way.

What next?

The Government has stated it needs to take its time to absorb and respond to the report, “as the very least it deserves”. However, with charges from the Opposition that the report “reeked of misogyny, ageism and ableism,” requiring urgent and thorough action, there will be a vocal campaign to ensure the Government returns their considerations to the House sooner rather than later.

For now, the campaigners who have worked tirelessly for decades to raise their concerns can feel relieved that their stories have been heard and an apology has been given. The success of their campaigning may act to spur on other patients who feel their voices have been silenced. A positive outcome of the Review will be better appreciation and respect for the voice of patients in every aspect of healthcare.

Looking ahead, if the recommendations within the Review are taken up, in part or in full, they will have far-reaching consequences for the NHS, patients and industry. Now, more than ever, is an important time to be engaging with the Government, to ensure the healthcare system in the UK works for everyone.