Raising concerns about the MHRA (part three)

Steve Brine MP
Health and Social Care Committee,
House of Commons,
London, SW1A 0AA

Letter by email

SENT: 23 February 2024

Dear Steve,

Following our letters of 24 October 2023 and 11 December 2023 we wondered if you, the Health and Social Care Select Committee Members and Expert Advisory Panel have had a chance to consider all the very important points raised?

Just to remind you, the then Health Select Committee published a report, the Influence of the Pharmaceutical Industry, as long ago as 2004/5. It said worryingly of the MHRA “The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate”, of the Yellow Card scheme “This system is widely considered to be failing” and of conflicts of interest: “The MHRA is unusual in being one of few European agencies where the operation of the medicines regulatory system is funded entirely by fees derived from services to industry”. Drug regulatory agencies in other countries are more often only partly funded by licence fees.

Licensing was also criticised: “The organisation, process and techniques of the MHRA now focusses much more on bringing drugs to market fast” with less and less consideration being given to “relative merit or value, or therapeutic need”. In both its written and oral evidence the report found “the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except a need for more transparency”. The committee recommended there be an independent review of the MHRA.

Subsequently, the IMMDS Review, "Sling the Mesh" and groups campaigning for the acknowledgement of damage caused by anti-epileptic medicine, found similar failings. "Sling the Mesh" went as far, in written evidence to the IMMDS Review, to state that the “MHRA has been too close to the industry…underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff…[we] have little faith in the ability of medical institutions that are responsible for patient safety to be open and transparent over patient safety failings.” Review Recommendation 6 stated “the MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation [...]”.

There were and are multiple concerns about the licensing process, including the evaluation of clinical trials; the control of marketing; staffing levels, particularly in relation to post-marketing evaluation; the withdrawal of drugs; the Yellow Card system; and licensing related to generics. Surprisingly, against this backdrop, CEO June Raine has stated her aim to take the MHRA from watchdog to "enabler," to speed up clinical trials and "transform" the regulatory process. This alone warrants a full and proper investigation.

Turning to the Covid vaccines, it was within this context that we raised our concerns, in particular about the lack of scrutiny of the licensing data, post-marketing surveillance and Yellow Card follow up by the MHRA of these vaccines. Freedom of Information Act requests, seemingly often reluctantly addressed by the MHRA, revealed an Agency still failing in all these respects as well as transparency, with many requests for data refused using deflective exemptions.

Already in June 2021 an Imperial College study showed “concerns about side effects and whether vaccines have been through enough testing are holding people back from getting vaccinated against COVID-19”. As more of the public were fully vaccinated and receiving boosters, credible reports were occurring of significant side-effects, including serious heart conditions and in some cases death. By November 2021 it became clear the MHRA had no process for following up or investigating serious or fatal adverse effects. In July 2022 it still did not know how many it had investigated, as the Minister’s answer to this written question from the Rt Hon Esther McVey MP also confirmed. This problem was longstanding and well known. The MHRA must have been aware of it when the Covid-19 vaccines were declared safe.

In effect, the MHRA licences medical products as safe knowing it lacks the processes to properly monitor adverse events. In the case of Covid-19 vaccines, given the comparatively novel technology and record manufacturing speed, could the MHRA have even properly scrutinised the licensing data or known the short term safety? These concerns have never been satisfactorily or systematically investigated and evaluated and in the UK now we are seeing falling vaccination levels to other diseases, contributing to the recent surge in measles cases, which “deeply concerns” you. Historically trust and confidence in vaccines and vaccine safety has been high in the UK but it seems that the experience of the Covid-19 vaccines has undermined this and by association trust in the regulator and the pharmaceutical industry.

Few of the recommendations made in the 2004/5 report, the IMMDS Review or your Committee’s own follow up seem to have been adequately implemented. Now more than ever a wide-reaching and in-depth review is needed. Indeed your Committee was particularly keen to ensure substantial revision to the MHRA was “urgently implemented” yet now seems reluctant to grasp the nettle. Surely both public interest and commercial advantage to the UK pharmaceutical industry converge here if it means trust in the regulator, vaccines and the industry are restored?

We would therefore be keen to know yours, the Health and Social Care Select Committee’s Members’ and Expert Advisory Panel’s response to all our points and most importantly, what your next steps will be?


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