14 November 2022: Raine - A

Dame June Raine is Head of the Medicines and Healthcare products Regulatory Agency (MHRA). She is a qualified doctor but has worked in the world of medicine regulation since the mid-1980s. The brief history of the bodies with responsibilities for regulating medicines was reviewed. In 1985 the witness started working to review medicines on “safety, efficacy, and quality”. This included how the licences for drugs are granted. Her career continued in a similar vein until 2019 when she became Interim Chief Executive, then Chief Executive in 2021 of MHRA.

Pharmacovigilance seeks to understand the risks of medicines and acting to manage or minimise those risks. Haemovigilance has a similar focus but for blood and blood products.

The MHRA works to ensure the safety, quality, and efficacy of medicines, medical equipment, and blood components. It has inherited and developed many of the roles of the previous bodies. The target audience is healthcare professionals who use or prescribe medicines as well as the public on whom they are used as part of their healthcare. The licencing process involves early work to obtain a build-up of knowledge, including making approvals for clinical trials and even laboratory assessments. In the latter stages there will be a group of people including doctors, scientists, toxicologists, medical journalists, and others to consider al, the available information before granting approval. Part of the process includes looking at the research, and if gaps are identified, requiring more work to be carried out. There is also the published/printed material that goes with the medicine which lists uses, limitations, side-effects, etc. These have to use accessible language so that the public can understand what is written. After licensing, the MHRA require regular safety updates according to a set schedule or as new information comes to light.

MHRA is an executive agency of the Department of Health and Social Care (DH). There are quarterly meetings with the sponsoring NHS team where MHRA gives reports on its work. Ministers in the DH have accountability roles, as does the Health Committee. There are clear processes and boundaries for avoiding conflicts of interest. The Cumberlege Review has caused the MHRA to examine its policies and processes related to many areas of work and context including conflicts of interest.

In relation to responding to emerging risks, the first responsibility falls on the manufacturers. There has never been a need to prosecute manufacturers for not disclosing issues, and this is seen as a sign that the system overall is effectively robust. The “Yellow Card Scheme” is a notification mechanism for anyone to inform the MHRA if there is a problem with a medicine or piece of equipment. Since Covid, the biggest users of the Scheme have been the public. Patient reporting overall has grown since early days in 2005. This system is not comprehensive or perfect, but it is an important and useful aspect of public health safety.

Counsel asked about use of the Yellow Card Scheme. The main focus for improving the use of the Scheme is in hospitals. Initially, each report could be checked on a case-by-case basis. Later it used statistically-based algorithms. On the case of a report related to a known risk, in the early days it relied on a person taking the time to make a report to the Scheme. Counsel recalled the situation of blood products for people with bleeding disorders where HCV was known about. The witness agreed that even with the current opportunity to use online systems it still relies on people making reports. The MHRA makes specific efforts to get more health professionals to use the Scheme. The online reporting has helped, but it is not yet embedded into the working practice of all clinicians.

Publications, including international studies are regularly reviewed to monitor the information held by the MHRA on all medicines and equipment. This type of surveying of intelligence helps to inform assessments of benefits and risks. The process has more recently had a focus on looking at alternative treatments, for example, as might have been highlighted with Cryoprecipitate over factor concentrates.

The issues surrounding public and patient involvement and transparency on decision-making was raised. The witness was asked about what is available for people to see; barring commercial confidentiality. The witness explained what was available publicly, and what was not. The role of patient and patient organisations in licencing decisions has advanced greatly in recent times. A variety of forums and settings were described where patients are involved in the work or MHRA, including on matters of product use and safety. Patients are involved through processes such as “user testing” and supporting the readability drafting of leaflets. There is a Patient Involvement Strategy. Some of the work involved was greater than anticipated and so there has been some slippage of the timetable.

The National Patient Safety Alert system is reserved for more serious matters. There is the possibility of initiating a public information campaign, and that might involve linking to specific charities who can effectively communicate with their members or those in the public with contact details for people. Opportunities for the public to engage with the MHRA are available through the organisation’s website. There is not a single publication, portal, or channel for information on all medicines for the public comparable to the British National Formulary. The witness said this was a gap in provision.

In relation to unlicenced, off-use medicines, or named-patient prescriptions, it is also an area requiring greater attention. There is the overarching principle of clinical freedom which will require more work to better link to the work carried out by the MHRA.

The Cumberlege Review was referenced to highlight certain issues. It listed areas where there was no counting or reporting, despite the large amount of data collected in healthcare settings otherwise. This meant some areas of information which might have been expected to be collected isn’t collected. The MHRA received the Cumberlege Review in great seriousness, and it is helpful in moving forward to fill the gaps identified within the Review The Yellow Card adverse events issue was mentioned as needing attention, and the MHRA is concentrating on this need. There are gaps in the knowledge and evidence identified by NICE (National Institute for Health and Care Excellence) related to best practice and conflicts of interests. This is also an area being worked on by MHRA. Brexit too has had an impact on the work of MHRA. It was agreed that there is still work to be done to involve patients more effectively in the work of MHRA. It was acknowledged to be a slow process.

Cumberlege also highlighted issues around regulatory systems as an issue in the public mind and experience. The witness mentioned the SafetyConnect System, risk management tools, “nudge” behavioural change, etc. which have been taken forward as a result of Covid. The witness mentioned how colleagues in Australia had highlighted the usefulness of certain Covid response tools originating in the UK. The question was raised of imposing binding timescales, for example on risk management being published. There appear to be technological issues holding this up. Clearly, the Cumberlege Review has highlighted a range of issues, many of which fall at the feet of the MHRA to resolve. On a number of these, when Counsel asked for a progress update, the witness said she would have to come back to the Inquiry.

The opportunities available through having a Patient Safety Initiative were discussed. It was noted how the role had recently been filled for the UK, but is still to happen in Northern Ireland, Scotland, and Wales.