In spring 2022, Dame June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), described the agency as having transformed itself “from watchdog to enabler”. In the same speech, she boasted that she “tore up the rule book and we allowed companies to immediately start juxtaposing, not sequential phases of clinical trials, but overlapping, beginning the next one before the previous had been finished”. Those changes would, no doubt, be welcome to a pharmaceutical industry now contributing 86% of the MHRA’s funding.
In 2005, the House of Commons Health Committee expressed concerns that pharmaceutical funding would lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies”. The Committee also criticised the MHRA saying that it “failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate” and that “greater transparency is also fundamental to the medicines regulatory system. There has to be better public access to materials considered by the MHRA prior to licensing”.
The public have a right of access to recorded information held by public authorities under the Freedom of Information Act 2000 (FOIA), one of the pillars upon which open government operates. The main principle behind the Act is that people have a right to know about the activities of public authorities unless there is a good reason – a presumption or assumption in favour of disclosure. In addition to requiring publication of certain information, the Act facilitates public use of Freedom of Information Requests (FOIR).
The MHRA’s website states: “The agency’s guiding principle is full transparency unless non-disclosure is justified on the basis of established freedom of information exemptions.”
In common with other public authorities, the MHRA published a series of quarterly ‘disclosure logs‘ of FOIRs “answered in full or in part”, starting in 2005. The disclosure logs were limited to a simple summary of requests and did not include the response. For example, there is a FOIR ref 20/521 with the intriguing title “Request for data – Covid” and the MHRA categorised its response as “Disclosed in Full”. There is no way of finding out what information was provided without submitting a further FOIR.
The publication of disclosure logs ceased at the end of 2020 and the following note was published on the MHRA’s website: “Redacted responses to all FOI requests received by the MHRA from January 1st 2021 are now published on this page. The last disclosure log we will publish is October 1st-December 31st 2020.”
The set of individual FOIRs, published from January 1st 2021, is incomplete with missing responses for the weeks commencing January 11th and 18th 2021, and for the week commencing August 9th 2021. From the end of June 2021, there was a publication hiatus until mid-August 2021. Subsequent publication was haphazard, with delays of up to several months, suggesting internal review issues. The posting of individual FOIRs stopped completely at the end of April 2022 and the MHRA no longer publishes individual FOIRs or disclosure logs.
This suppression of information by the MHRA comes at a time when public confidence in regulation is already fragile. By contrast, the Ministry of Defence, a public authority with good reason to be cautious about transparency, publishes timely, weekly sets of suitably redacted FOI responses. It appears the MoD has a considerably greater commitment to transparency than the MHRA.
The only option remaining for individuals is to make their own FOIR, ideally through a publicly accessible platform such as WhatDoTheyKnow.com (WDTK). It is perhaps unsurprising that there was an increase from 59 FOI requests to the MHRA through WDTK in 2020, to 118 in 2021, and 122 in 2022. Notably, the MHRA refused 24% of the WDTK FOIR submitted in 2022 while no requests had been refused in 2020 and 2021.
Analysis of the 44 FOIA requests submitted to MHRA through WDTK year to date 2023 shows that 16 are currently being processed and two have been reported as “data not held”. Of the remaining 26, ten are significantly late, two have been referred back for Internal Review, and one has been referred up to the Information Commissioner; taken together, this represents a major failure to respond to the satisfaction of the requester.
In an attempt to place the missing disclosure logs (since January 1st 2021) and the unpublished FOIR (since May 1st 2022) in the public domain, I submitted two requests to the MHRA through WDTK on January 5th and 18th 2023, respectively.
Two months having passed, I have yet to receive the disclosure logs. On March 5th, my request for the unpublished individual FOIRs was refused under section 22 of the Act with the following message:
No decision has been taken to stop the publishing of FOI responses. We remain committed to publishing responses, but we accept that there has been a long delay and a backlog of responses to publish has now developed. We intend to resume publishing towards the end of March with the aim to have caught up the backlog over the next two to three months, and then establishing a more regular publication cycle.
Whilst we recognise there is a clear public interest in providing copies of our FOI replies, doing so ahead of our proposed publication timeframe would involve taking resource from our front line customer team to focus on this activity, leading to a delay in responses to customers making contact with the team. Given that we have a plan to begin publishing shortly we do not believe the public interest is best served by bringing this activity forward.
It seems we have to wait until April 2023 to be given access to FOIA responses from a year ago!
Meanwhile, I have examined earlier requests escalated, as complaints, to the Information Commissioner (ICO). These show an average delay of just under a year between the initial request to the MHRA and the ICO’s decision. In 2017 there were just two complaints to the ICO about MHRA responses, and only one in each of the years 2018 to 2020. However, in 2021 30 complaints were taken to the ICO with 26 of the refusals being upheld, 12 citing section 14 of the Act (‘vexatious’ requests), the MHRA’s exemption of choice.
The ICO advises public authorities that for a request to be ‘vexatious’ it should be “likely to cause a disproportionate or unjustified level of disruption, irritation or distress”. Requests the MHRA apparently finds particularly vexatious are those seeking what the 2005 House of Commons Health Committee described as “materials considered by the MHRA prior to licensing”, as well as materials evidencing routine and additional pharmacovigilance activities.
In common with ICAN, HART and others, I have been seeking access to materials supporting the MHRA’s decision to license the AstraZeneca COVID-19 novel vaccine, Vaxzevria. Though quietly withdrawn from use in much of Europe, including the U.K., Vaxzevria remains licensed and has been administered to children. It has been disproportionately associated with adverse reactions and those damaged by it are being largely ignored by the authorities. Important information is being withheld from the public which has a right to see all the data provided by AstraZeneca to the MHRA.
In December 2020, Vaxzevria was granted temporary authorisation under Regulation 174 of the Human Medicine Regulations 2012. On June 24th 2021, it was authorised with a Conditional Marketing Authorisation (CMA), a label used to describe “medicinal products that address an unmet medical need, such as a lack of alternative therapy for a serious and life-threatening disease”. The MHRA Public Assessment Report on Vaxzevria goes on to state that: “CMAs may be granted where comprehensive clinical data are not yet complete.” The supporting Risk Management Plan for Vaxzevria identifies “missing information” and specifies a set of pharmacovigilance activities with milestone deliverables and due dates.
In late August 2022, I submitted a FOIA request for a number of these deliverables which, according to the Public Assessment Report, the MHRA should have received. The MHRA replied to say that the information I requested was “not held”, either because the surveillance activities had been “removed” or because delivery dates had slipped by up to a year, conveniently to December 2022. My requests for internal review have been “delayed” with the final message from the MHRA, dated January 20th 2023, stating “We apologise you have not yet received a response and we hope to respond to you as soon as we can.” At the time of writing, two subsequent FOIRs, submitted on February 4th 2023 and requesting specific deliverables identified in the current “Conditions of Authorisation for Vaxzevria” have yet to be satisfied.
The MHRA is in breach of the Act due to numerous delayed responses (from the second quarter of 2021) and withdrawal from its website of the ‘Publication Scheme’ in December 2014. It has also breached the Government’s principles of transparency and open government by removing its Publication Scheme in December 2014, ceasing publication of the Disclosure logs (from January 2021), ceasing publication of FOI responses (from May 2022), and arguably making excessive use of exemptions, particularly section 14 or ‘vexatious requests’ (from fourth quarter 2021 onwards).
The public have a right of access to the recorded information held by public authorities through an Act which is sometimes described as ‘purpose and applicant blind’. Instead, the MHRA has pulled up an information drawbridge, giving the impression that it is acting as ‘enabler’ for its paymaster, the pharmaceutical industry while being vexed, distressed or irritated by the public asking for important information.
It is time Parliament revisited observations it made in 2005 and asked whether it remains the case that the MHRA has “failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate” and whether it continues to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies”. On behalf of those injured by the COVID-19 novel vaccines, enabled by the MHRA, Parliament should urgently be finding out what the agency has to hide.
Prior to his recent retirement, Charles served as a military pilot followed by senior roles in the City and in school leadership.
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