The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors
Stakeholders and the UK public are invited to have their say on how the Medicines and Healthcare products Regulatory Agency (MHRA) manages the conflicts of interest for independent experts and how patients can be more involved in expert committee meetings to ensure consistency and transparency.
The six-week consultation, which launched today, outlines a number of key proposals that strengthen the current code of practice, to ensure that experts providing the MHRA with advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust and clear to all. It also enables greater inclusion of patient experts in committee discussions so that individuals with lived and personal experiences can contribute to discussions more easily.
The UK regulator is committed to responding to the recommendations set out in the Independent Medicines and Medical Devices Review and is taking steps to be a more transparent and inclusive independent regulator.
The proposals include:
- A register of interests accessible to all (through GOV.UK), which will be updated to reflect any changes from members
- The provision of more guidance on interests, to ensure that members can provide relevant information if or when their circumstances change
- Encouraging greater inclusion of patient experts in expert groups and committee discussions, so that individuals with lived and personal experience can contribute to discussions more easily.
- A new panel process to advise on complex or novel conflicts to ensure standards are upheld consistently and to deal with breaches of the conflict-of-interest policy as necessary and any disciplinary action that may be warranted
The changes proposed will impact all expert groups, including the Commission on Human Medicines, bringing together requirements across all groups for the first time, ensuring consistency and high standards for all.
Dr June Raine, Chief Executive of MHRA said:
“We know that trust is an important factor in our role as regulator. We want to attract and retain the right expertise in those who give the regulator independent advice; but the public should also feel confident those called upon to give their expert opinions do so in an impartial way.
“This consultation, which I encourage all to respond to, demonstrates how seriously we take independent and impartial advice on our regulatory decisions.”
The public consultation will run for six weeks from 12 April 2022. Have your say by visiting our consultation page.
Notes to editors
- 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.
- The MHRA is an executive agency of the Department of Health and Social Care.
- 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), 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.