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.