MPs told: current pharma self-regulation system is not working

The Group heard from Dr Alan Black, a former pharmaceutical physician with 30 years experience, about concerns relating to the UK regulatory body, the Prescription Medicines Code of Practice Authority (PMCPA), its industry board to which it reports, the Association of the British Pharmaceutical Industry (ABPI) and the high number of cases brought to the PMCPA against Moderna, Pfizer and AstraZeneca for violations of the regulatory code in relation to their Covid-19 vaccines.

Dr Black's presentation is reproduced below, in full.

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As a pharmaceutical physician, a big part of my career has been spent working on the development, licencing and marketing of medicines, including many anti-infectives. In 2020, it struck me that several things did not feel right about the rollout of the covid vaccines. My initial red flag was the widespread use of the term “safe and effective”. When working in the pharmaceutical industry I had become accustomed to the principle that the term “safe” should never be used to describe any medicine. Such use is actually prohibited by both the industry’s code of conduct and the MHRA’s own guidance on the promotion of medicines. Yet the media, politicians, even the MHRA itself, were seemingly everywhere describing these vaccines as “safe”. My attempts to raise this matter with the MHRA however fell on stoney ground. Therefore I took to social media to share my concerns and report on any actions I had taken or formal complaints I had made and was then contacted by others who shared my concerns.

I will briefly summarise how the promotional and communications activities of pharmaceutical companies are regulated in the UK:

The pharmaceutical industry in the UK interacts with the British people in many ways. Whether it be advertising its products to healthcare professionals, distributing press releases, briefing politicians or recruiting for clinical trials, all of these activities, and more, are regulated to some extent by the same body, the Prescription Medicines Code of Practice Authority (the PMCPA). These are all important and potentially very influential interactions and so this places a great deal of responsibility on the body regulating them to ensure that they are conducted correctly.

The MHRA is an agency of the Department of Health and Social Care and holds ultimate responsibility for regulating medicines advertising, for which it is accountable to the Secretary of State. However, for the activities of pharmaceutical companies regarding advertising of their own prescription medicines, the MHRA has entirely delegated this responsibility to the pharmaceutical industry trade body the Association of the British Pharmaceutical Industry (the ABPI) which has established the PMCPA to compile and enforce the ABPI Code of Practice (the Code). The UK government has thus given the pharmaceutical industry the valuable privilege of self-regulation and the MHRA no longer appears to take any interest in this important aspect of pharmaceutical regulation.

However, I believe this model of pharmaceutical regulation is broken and that the reason for this is almost entirely due to the PMCPA’s close links to the ABPI, including:

a) All the current funding of the PMCPA comes entirely from the pharmaceutical industry. The bulk of this is delivered either via the ABPI from a levy imposed on member companies as a condition of membership, or directly from individual companies as a result of administrative charges imposed by the PMCPA for violations of its Code. The PMCPA are keen to make it known that these administrative charges are not fines as such, they are described as a contribution towards the costs of dealing with complaints. These charges are therefore not, it would appear by design, large enough to be in any way deterrent*. I do not disagree with the PMCPA continuing to be entirely funded by the pharmaceutical industry, rather than by the taxpayer. However, I do think there is a problem with the way those funds are collected, administered and used.

b) The ABPI appoints (and therefore presumably can dismiss) the Chair of the PMCPA Appeal Board (operationally probably the most important and influential person in the PMCPA).

c) The ABPI appoints the CEO of the PMCPA (the other big operational voice in the PMCPA). The CEO then reports to the Board of the ABPI who can also presumably dismiss him/her.

d) The ABPI appoints the other members of the Appeal Board (including a number of places reserved specifically for employees of pharmaceutical companies)

e) The ABPI have final sign-off on the constitution of the PMCPA, including any proposed changes.

The PMCPA’s claim that it is independent of the ABPI must therefore be taken with a large pinch of salt. When it comes to this self-regulatory system it would appear that pharmaceutical industry interests are very much in the driving seat.

I worked in the pharmaceutical industry for 30 years but the covid era brought into focus for me just how inadequate this self-regulatory system has now become. Between 2020 and 2025, five companies responsible for the development, manufacture and distribution of covid vaccines have so far been found guilty in at least 19 separate cases of a total of around 67 individual breaches of the ABPI Code of Practice. Some of these are very serious breaches indeed including:

· advertising unlicenced covid vaccines (6 counts)

· advertising prescription only medicines (covid vaccines) to the public (2 counts)

· misleading the public about the efficacy of their covid vaccines (10 counts)

· misleading the public about the safety of their covid vaccines (3 counts)

· using the prohibited term “safe” to describe their covid vaccines (2 counts)

· providing unbalanced information about their covid vaccines to the public

· failure to comply with an undertaking given to the PMCPA

· failing to maintain high standards (17 counts)

· bringing discredit on, and reducing confidence in, the pharmaceutical industry (9 counts)

· and worse, about which I’ll say more in a minute…..

Only the existence of self-regulation has possibly prevented some of these companies being subjected to criminal charges. And these 19 are just the cases relating to covid vaccines, and then only the covid vaccine cases of which I am personally aware. Many more complaints, many more cases, and many more breaches involving many more companies and many more medicinal products were found over this same five-year period. Often multiple and repeated breaches for the same companies. It’s also worth remembering that none of these covid vaccine cases have arisen as a result of investigations, surveillance or monitoring by the PMCPA. All have arisen as a result of complaints submitted to them by a small number of eagle-eyed and concerned members of the public – either as individuals or groups.

Moderna is one of the covid vaccine manufacturers who feature most prominently on the list of PMCPA cases over the past couple of years, both in terms of the number and seriousness of its breaches. Despite only being a member of the ABPI since 2023 they have so far racked up 6 cases involving 29 separate breaches of the Code on their own. In addition to a significant contribution to many of the breaches already discussed, including the ubiquitous failure to maintain high standards (7 counts) and bringing discredit on its industry (4 counts), they have also been found guilty of some of the worst breaches of their industry’s code. They have been found guilty of:

· permitting the inappropriate targeting of advertising at children,

· permitting the offer of inappropriate financial inducements to children and their parents,

· “provision of a pecuniary advantage or benefit to a healthcare professional in connection with the promotion of medicines or as an inducement to prescribe, supply, administer and/or recommend a medicine” (I am no lawyer but that sounds a lot like bribery to me),

· misleading its own regulatory body by failing to provide a full and frank disclosure of all the facts to the PMCPA in its response to a previous case.

And yet Moderna is still the UK government’s chosen principle partner, for the development and manufacture of medicines using the novel (and many would argue as yet unproven) mRNA technology, via a 10 year, multi-billion pound partnership based at a newly built facility in Oxford. This partnership was initiated by the previous government and has been enthusiastically progressed by the current one. One is tempted to ask, based on Moderna’s documented record of misinformation and questionable ethical practices over the past two years, the findings of its repeated failure to maintain high standards and bringing discredit on its industry, whether the case for the continuation of this “strategic” partnership needs to be subjected to further scrutiny. This appalling record by Moderna has even resulted in the PMCPA recently issuing them a rare public reprimand and ordering an audit of Moderna’s systems of governance and compliance. The results of this audit are currently awaited.

For me, the clearest indication that the interests of the British public are taking second place to those of the pharmaceutical industry in this failing system is evidenced by the fact that the PMCPA is now taking on average over a year to deal with any complaint it receives and a large proportion of complaints are now coming from outside the pharmaceutical industry. There is an even longer delay for cases that go to appeal. This trend has been increasing year on year for about a decade and has been easily identifiable from successive PMCPA annual reports over that period (in 2015 the average time taken to deal with a case was only 9.8 weeks). Meanwhile the ABPI has looked on and done nothing*. Why not ? Well, one only has to ask who benefits from these delays? When complaints about breaches of the rules by pharmaceutical companies (sometimes very serious breaches) are now mostly coming from the public, (healthcare professionals, campaign groups and the like) who has most to gain from them being kicked down the road for months, or now apparently even years? While cases are being considered by the PMCPA, expensive and effective but inappropriate promotional or communications activities and campaigns can continue unchecked. And perhaps even more importantly, potential damage to public relations or image can be diluted by the passage of time. Therefore, even when found guilty, offences can then just be dismissed as historical, one-offs, caused by rogue elements or errant individuals who have now moved on or been retrained.

How Do We Fix It ?

I have no general objections to many aspects of the PMCPA model of regulation. The ABPI Code of Practice is mostly a pretty solid and useful document which sets out standards of behaviour which, if followed, would serve the public interest well. It is with the actual enforcement of these required standards that I actually take issue. Although the PMCPA itself appears to be staffed by competent and well-intentioned individuals with a genuine desire to do the right thing, it is my assertion that this system as currently operated, runs largely for the benefit of the pharmaceutical industry and that it is failing the British public on a number of counts. I have 5 suggestions for how we can improve and maintain a truly independent and efficient PMCPA system which can help regain public trust in the pharmaceutical industry and ensure that it adheres to the rules set out in its Code of Practice, as well as all the official laws and regulations governing its activities.

· The PMCPA must become truly independent of the ABPI

· The PMCPA must be given adequate resources to enable it to do its job properly

· Penalties and sanctions imposed by the PMCPA must be truly deterrent

· The PMCPA must be given proper investigative powers and encouraged to be more proactive in uncovering wrong-doing

· MHRA itself must take a more active role in the oversight of the PMCPA

Although not directly comparable I think there are perhaps lessons to be learned from the independent regulation of companies providing financial services.

With the current political drive to encourage more pharmaceutical investment in the UK I think it’s unlikely anything is going to change soon. However, I think one of the lessons we need to learn from the covid era, but probably won’t, is that the current pharma self-regulatory system is not working as it should be.

The last time Parliament held any kind of investigation into the UK pharmaceutical industry was a Health Committee investigation in 2005. I would like to finish with a quote from the report of that investigation which I think has turned out to be prescient:

“Our overarching conclusion is that the U.K. pharmaceutical industry is in many ways outstanding: it conducts excellent research, produces products which make a vital contribution to the health of the nation and is of great economic importance; however for want of critical scrutiny by, and lack of deference and accountability to, the public and public bodies, the industry lacks the discipline and quality control that it needs but cannot itself provide.”

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Footnote

* In 2024 the ABPI increased slightly the PMCPA levy and admin charges payable by its members. Between 2015 and 2023 the administrative charge payable was £3,500 per Code clause breach and £12,000 per breach if it was unsuccessfully appealed. In January 2024 these charges were increased to £5,000 and £13,000 respectively, possibly in an attempt to provide more resources to enable the PMCPA to reduce the time taken to deal with complaints. At the time of writing there is no evidence that this has been successful and the delays continue to increase.