MHRA launches new conflicts of interest code of practice for independent advisors

The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a new, single code of practice for all its scientific advisory committees, to ensure that experts providing it with advice are independent and impartial, and that processes in place to manage conflicts of interest are robust, consistent and clear to all.

The launch of the new code of practice follows a six-week public consultation, launched in response to a key recommendation of the Independent Medicines and Medical Devices Safety Review for the MHRA to review the way it identifies and manages potential conflicts of interest from members of expert advisory committees. These include the Commission on Human Medicines (CHM) and its expert advisory groups.

The new proposals will help to ensure that the MHRA is a transparent and inclusive independent regulator. They will also support the Agency’s commitment to ensuring that the perspectives of those with lived and personal experiences have greater inclusion in regulatory decisions.

Other steps include:

• Prohibiting members of advisory committees from holding personal interests in industries relevant to the work of that committee, such as the pharmaceutical, medical device and/or biotechnology industry
• Clarifying the way we manage any conflicts of interest that arise as a result of patient involvement in discussions with the advisory committees and working groups.

Dr Glenn Wells. MHRA Chief Partnerships Officer said:

The independent committees that advise the MHRA provide an additional layer of expertise and input to our regulatory decision-making so that we can be sure we are delivering the right outcomes for patients and the public.

In recognition of this important role, we are strengthening the code of practice for all independent advisory committees so the public can feel confident that those called upon to give their expert opinions do so in an impartial way.

Part of this means ensuring that those with relevant experience of the topics being discussed as a patient, family member or carer, are invited to committee meetings to inform the discussions that are taking place.

The new proposals will be introduced from 8 September 2022.

1. The new code of practice can be found on the MHRA website alongside the government’s response to the public consultation
2. The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK, by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
3. The MHRA is an executive agency of the Department of Health and Social Care.
4. The MHRA utilises expert and impartial advice from a number of advisory committees, including:

• The Commission on Human Medicines (CHM), which advises MHRA on the safety, efficacy and quality of medicinal products,
• The Devices Expert Advisory Committee (DEAC) and its successors, which provides MHRA with advice on a wide range of aspects relating to the introduction and safe use of medical devices,
• The British Pharmacopoeia Commission (BPC), which provides official standards for pharmaceutical substances and medicinal products,
• Herbal Medicines Advisory Committee (HMAC), which advises MHRA on the safety and quality of herbal medicinal products for human use,
• Advisory Board for Registration of Homeopathic Products (ABRHP), which advises MHRA on safety and quality in relation to any homeopathic medicinal product for human use,
• UK Stem Cell Bank Steering Committee (UKSCBSC), which oversees the activities of the UK Stem Cell Bank and UK research involving established human embryonic stem cell lines, whether obtained from the bank or from elsewhere.
• The Review Panel, which carries out statutory and non-statutory reviews of proposals, decisions and provisional decisions taken by MHRA.