Consultation outcome

Consultation on a new Code of Practice for the Expert Advisory Committees

• From: Medicines and Healthcare products Regulatory Agency and Commission on Human Medicines
• Published: 12 April 2022
• Last updated: 8 September 2022 — See all updates

This consultation has concluded

Read the full outcome

Summary of responses to consultation - new Code of Practice for the Expert Advisory Committees

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Code of practice

PDF, 389 KB, 28 pages

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Detail of outcome

A consultation document which summarises the proposals to improve and strengthen the Code of Practice for experts who provide advice on which decisions about the regulation of medicines and medical devices are based, to ensure that experts providing the advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust and clear to all, was posted on the GOV.UK website on 8 September 2022. The deadline for comments was 24 May 2022.

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Original consultation

Summary

We are consulting on a set of proposals to improve and strengthen the Code of Practice for experts who provide advice on which decisions about the regulation of medicines and medical devices are based, to ensure that experts providing the advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust and clear to all.

This consultation ran from
11am on 12 April 2022 to 11:45pm on 24 May 2022

Consultation description

Through the proposals outlined in this consultation we aim to:

• Actively manage conflicts of interest and associated issues of gifts, hospitality, other payments and influence
• Proactively support individuals to ensure that they know what is and is not acceptable – to prevent wrongdoing from occurring
• Provide the public with accessible information so that they can see what is happening and, where appropriate, ask questions
• Take firm and decisive action when individual wrongdoing is discovered – including where appropriate, disciplinary action

The proposed changes also seek to encourage greater inclusion of patient and their representatives in advisory committee discussions, so that individuals with lived and personal experience can contribute to discussions more easily.

We look forward to receiving views on these proposals from all interested parties – patients, manufacturers and suppliers, researchers, developers, clinicians, other healthcare professionals and the wider public - to allow us to review them further and refine them so that they reflect best practice.

We invite you to respond to our questions here.

This consultation will run for six weeks, from 12 April until 24 May 2022.

Documents

Consultation document

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Consultation document

PDF, 384 KB, 25 pages

Annex 1: List of recommendations

HTML

Annex 1: List of recommendations

PDF, 177 KB, 4 pages

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Annex 2: The function and purpose of MHRA advisory committees

HTML

Annex 2: The function and purpose of MHRA advisory committees

PDF, 174 KB, 3 pages

Annex 3: Other relevant interests

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Annex 3: Other relevant interests

PDF, 84.1 KB, 1 page

Code of Practice

HTML

Code of Practice

PDF, 362 KB, 27 pages

Image of a mature woman using a laptop

JPEG, 129 KB

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Published 12 April 2022
Last updated 8 September 2022 + show all updates

1. 8 September 2022

   The MHRA's response to the public consultation on a new Code of Practice, has been added.

2. 12 April 2022

   First published.