Consultation outcome

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

Updated 8 September 2022

Introduction

This is the government’s response to the public consultation on a new Code of Practice which will apply to chairs, members, co-opted members and invited and patient experts participating in or providing advice to the following Commissions and Expert Advisory Committees (referred to as advisory committees), and their respective expert advisory groups (EAGs) /expert working groups (EWGs) and other supporting groups:

• Commission on Human Medicines (CHM)
  • CHM Expert Advisory Groups (EAGs)
  • CHM Expert Working Groups (EWGs)
  • Herbal Medicines Advisory Committee (HMAC)
  • Advisory Board for Registration of Homeopathic Products (ABRHP)
• British Pharmacopoeia Commission (BPC)
  • BPC Expert Advisory Groups (EAGs)
  • BPC Expert Panels (EPs)
  • BPC Working Parties (WPs)
• Committee on Medical Devices (CMD)^{[footnote 1]}
  • CMD Expert Advisory Groups (EAGs)
• United Kingdom Stem Cell Bank Steering Committee (UKSCBSC)
• The Review Panel.

Note: The principles in the Code also apply to observers and invited experts who are asked to contribute written advice and do not attend committee meetings.

The response document sets out the following:

• An outline of why the consultation took place;
• Statistical reporting of the responses and summaries of the key themes; and
• An explanation of how consultation responses will feed into the new Code of Practice and next steps in implementation.

Background

From 14 April 2022 to 24 May 2022 the Medicines and Healthcare products Regulatory Agency (MHRA) led a consultation exercise on a set of proposals to improve and strengthen the Code of Practice on conflicts of interest for experts who provide advice on which decisions about the regulation of medicines and medical devices are based or provide advice on standards used in the British Pharmacopeia.

These proposals intended to ensure that experts providing advice are independent and impartial, and that the processes in place to identify and manage conflicts of interest are robust and transparent to allow public scrutiny.

The proposals also sought to enable greater inclusion of patients and their representatives in advisory committee discussions, so that individuals with lived and personal experiences can contribute to discussions more easily. This is an ongoing commitment for MHRA, of which this Code of Practice forms just one part.

We asked for views on our proposals. The consultation was open to the public, but particularly encouraged responses from patients and their representatives, manufacturers and suppliers of medicinal products and medical devices, researchers, clinicians and other healthcare professionals.

Our key objective was to utilise the feedback to further develop and mould the Code of Practice so that it reflects best practice and encourages public confidence.

We will continue to engage with the public and stakeholders through a number of other forums to ensure that our proposals are delivering on our key objectives of enabling independent and impartial advice to Ministers and the MHRA, with robust and transparent policies in place to allow public scrutiny of any conflicts of interest identified.

Executive Summary

The government launched the “Consultation on a new Code of Practice for Expert Advisory Committees” on 14 April 2022. The consultation closed on 24 May 2022. The consultation was hosted online, accessible via GOV.UK. The consultation launch was supported by a press release and direct invitations to interested parties to respond including healthcare professional associations and membership bodies, patient and public representative groups, and members of advisory committees and working groups.

In total, 217 responses were submitted electronically. Of these 160 were full responses where the respondents answered all the consultation questions, and 57 were partial responses where respondents answered some but not all of the questions.

In addition to the responses received via the online portal, two (2) responses were submitted separately by stakeholder organisations. These responses provided comment on the package of measures as a whole or individual policy areas relevant to the stakeholder organisation, rather than responses that followed the ordering of questions included in the consultation document.

There were zero responses received via post.

Table 1: breakdown by respondent type

A member of the public/patient	89
A healthcare professional	44
A patient representative organisation	17
All other responses	67
Total	217

Questions

Respondents had the opportunity to answer 8 questions.

This response document summarises the answers we received to the questions we posed in the consultation document and sets out our response to the key themes which have emerged from those answers.

Question 1: Do you agree with the proposal to introduce a single Code of Practice for all the advisory committees?

The intention of applying a single Code of Practice for all advisory committees was to ensure that all advisory committee members are subject to comparable high standards and to make it easier for members of advisory committees to better understand and comply with the rules.

A total of 217 people responded to this question. A majority (86%) of respondents agreed with the proposal to introduce a single Code of Practice for all advisory committees, recognising the importance of ensuring that all advisory committee members are subject to comparable high standards.

Around 3% of respondents suggested that a ‘broad brush approach’ would not recognise the different remits of the advisory committees and may result in some experts with specific expertise being excluded from the committees.

Another concern raised (2% of respondents) was that whilst a single Code would result in a standardised approach to the management of conflicts of interest for all advisory committees, it may be too complex and difficult to follow for members.

Table 2: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	79	10
A healthcare professional	41	3
A patient representative organisation	15	1
All other responses	51	17
Total	186	31

Our response

In drafting the new Code of Practice, we have ensured that members of advisory committees are subject to consistent and comparable high standards, whilst recognising that there are some differences in the role and remit of advisory committees, and this may be reflected in the interests members are permitted to hold. Such distinctions are clearly addressed and explained in the new Code where they arise.

In developing the new Code of Practice, we recognise that conflicts of interest are complex and, to promote good governance, we will publish further guidance to assist members and staff to identify, report and manage conflicts accurately.

Question 2: Do you agree with the proposal to prohibit members of all advisory committees, except the British Pharmacopoeia Commission, from holding personal interests in industries relevant to the work of that committee, such as the pharmaceutical, medical device and/or biotechnology industry?

The intention of this proposal is to ensure public confidence in the operations of the advisory committees where advice is provided to Ministers and the MHRA on regulatory matters, or matters relating to the safety, efficacy and use of medical devices, or herbal and homeopathic products.

A total of 201 people responded to this question. A majority (80% ) of respondents were supportive of the proposal, recognising this as an effective way of dealing with perceptions of conflicted personal interests which have the potential to undermine public confidence in the advice provided to Ministers and the MHRA and subsequent decisions on the basis of that advice.

Around 3% of respondents felt that the prohibition on members to hold personal interests in a relevant industry to their advisory committee was too restrictive and would hinder recruitment of experts; it would be better to require members to declare their personal interests and then manage them so that they do not result in actual conflicts.

Around 5% of respondents felt that the prohibition on members to hold personal interests in an industry relevant to the work of their advisory committee should also apply to the British Pharmacopoeia Commission - although no respondent directly addressed the rational put forward in the consultation document for excluding the British Pharmacopoeia Commission from this requirement.

Table 3: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	76	13
A healthcare professional	31	13
A patient representative organisation	13	3
All other responses/no response	40	12
Total	160	41

Our response

In drafting the new Code of Practice, we have paid close attention to guidance from the National Audit Commission and followed examples of requirements on conflicts of interest adopted by other healthcare organisations, such as the National Health Service (NHS) and the National Institute for Health and Care Excellence (NICE). While we recognise the benefits in some instances of identifying and managing risks of conflicts of interest, we consider that some risks simply cannot be permitted. This is particularly the cases where members, through committees, advise ministers and the MHRA on the safety, quality and efficacy of a given medical product. In this instance, the perception of or real conflict with members’ personal interests in the relevant industries has the potential to undermine public confidence in the advice provided and subsequent decisions on the basis of that advice.

As we have explained in the consultation document, an exception is made for the BPC, which does not advise Ministers or the MHRA on regulatory decisions but instead enables the development of the British Pharmacopoeia, detailing standards for the quality of medicines. However, we have also made clear in the consultation document that members of the BPC are still required to declare their personal interests and can be excluded from meetings or discussions by the Chair of the advisory committee in light of those declarations. However, considering the concerns raised on this proposal, we will undertake to review this rule within two years of the publication of the Code of Practice to ensure that it continues to deliver the expertise required by the BPC to produce the British Pharmacopoeia standards, without the significant risk of conflict of interests occurring.

Question 3: Do you agree with the proposal to replace ‘Expert of the Day’ with ‘Co-opted Member’ and introduce new categories of ‘Invited Expert’, ‘Patient Expert’ and ‘Observer’?

The aim of this proposal is to ensure that Ministers and the MHRA have access to the best advice whilst protecting the impartiality of the advisory committee. This proposal would distinguish between ‘members’ who have full rights to participate in discussions and vote, including ‘co-opted member’ where necessary to cover for member absence for example, and ‘experts’ who are invited to meetings to answer questions or give evidence on specific issues but do not have the right to participate more widely in discussions or vote. This distinction would enable experts and patients, who may have personal interests in a relevant industry and who could otherwise be prevented from sharing their knowledge at meetings, to contribute their expertise in advisory committee discussions.

A total of 193 people responded to this question. The majority (82%) of respondents agreed with the proposal, however we heard from some respondents (5%) that given there were different categories of members, experts and observers, it was difficult to see exactly how patients/public were represented at advisory committee meetings and discussions.

Table 4: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	70	19
A healthcare professional	40	4
A patient representative organisation	14	2
All other responses/no response	34	10
Total	158	35

Our response

In redrafting the Code of Practice, we have clarified the ways that patients and the public can participate in meetings and discussions of the advisory committees and working groups.

Lay members

• Advisory Committees, and their supporting groups, in addition to any members with relevant specialist expertise in the topics to be discussed may also have one or more lay members.
• A “lay member” describes individuals who sit on our Advisory Committees or groups to provide a non-specialist contribution to discussions about medicines, medical devices and research.
• Lay members are typically members of the community who have an interest in the committees’ discussion area, for example: members of the public, patients, carers or those from related areas such as a support group within the community.
• This contribution gives the committee a different viewpoint from the experts who sit on the committee, thus aiding a fuller understanding of the area being discussed.
• Lay members have full rights to participate in the discussion and to vote.
• Like other members of advisory committees, lay members are subject to the rules governing the identification and management of conflicts of interest, including those set out for Members in this Code. And, like other members of Advisory Committees lay members, except lay members of the British Pharmacopoeia Commission, are prohibited from holding interests in an industry that is relevant to their committee.

Patient Experts

• Patients or their representatives may be invited to meetings for specific topics or items and or to forward comments contributing their lived experience as users of medicines and medical devices.
• They will be asked to declare any interests in the matter under consideration but having an interest in the topic or medicine will not prevent the patient experts from providing advice or answering questions as they do not have full rights to participate in the discussion or to vote.
• The perspectives that patients provide are very valuable and complement the scientific information considered in reaching advice on regulatory options.

Question 4: Do you agree with the proposal to make members in charge of departments or units responsible for declaring interests they could reasonably be expected to be aware of?

The aim of this proposal is to recognise the current definition of non-personal interests in the Code of Practice are challenging where members oversee departments or units. We consider that it would be unrealistic to expect such members to be aware of all projects and activities undertaken by their staff (considered non-personal interests) and therefore recommended that members should be required to declare only those interests which ‘they could reasonably be expected to be aware of’ as ‘reasonableness’ is an established test in law.

A total of 190 people responded to this question. Whilst the majority (84%) of respondents agreed that it would be unreasonable to expect members who are heads of large hospital or university departments to be aware of every project that their staff may be involved in, a minority (2% of respondents) considered that heads of departments or units should nevertheless be required to carry out work regularly to learn of the projects their staff may be engaged in to satisfy themselves that these interests do not have the potential to turn into conflicts.

Table 5: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	77	12
A healthcare professional	36	8
A patient representative organisation	13	3
All other responses/no response	34	7
Total	160	30

Our response

In light of the feedback received, we propose to strengthen this proposal by including some additional guidance in the Code. This additional guidance would recommend that, where regular audits of departments or units are undertaken, members should make themselves aware of the projects and activities being undertaken by their staff to satisfy themselves that these interests do not have the potential to turn into conflicts.

Question 5: Do you agree with our proposal to publish further guidance to help members, Chairs and MHRA Secretariat staff identify and report interests and manage conflicts accurately?

A total of 183 people responded to this question. Ninety three percent (93%) of respondents agreed to this proposal. Some of the respondents considered it good governance for the guidance to be published on-line and updated regularly, taking into consideration any feedback received from the public.

A minority of respondents (2%) raised concerns relating to the complexity of any guidance issued and whether it may ‘simply be ignored by members of advisory committees’.

Table 6: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	84	5
A healthcare professional	43	1
A patient representative organisation	14	2
All other responses	28	6
Total	169	14

Our response

As a response to the feedback received from this consultation, we will undertake to publish the guidance on-line at Gov.uk, and will update it regularly taking into consideration not only the public feedback but also other wider developments in the management of conflicts of interest. We will also ensure that guidance on identifying and declaring interests is embedded in the advisory committees and the Committee Secretariat through regular training sessions. Additionally, our Conflict of Interest Group will be available to advise members on novel or complex issues and the new conduct panel will be empowered to act should a breach of the Code be suspected (see Q7 and Q8 respectively).

Question 6: Do you agree with our proposal to publish declarations of interests in a new Public Register of Interests available on the advisory committees’ websites from appointment and as they are updated by members?

The intention of this proposal is to improve public access to and timeliness of publication of members interests.

A total of 181 people responded to this question. Again, a very high number of respondents (91%) agreed with the proposal, recognising the importance of ensuring transparency and building public trust in the advisory committees and the advice they provide to Ministers and the MHRA.

Some (1% of respondents) suggested that the Code should provide for the regular audit of the Public Register of members interests. One respondent suggested following the NHS example of routinely undertaking audits of its commissioning groups to ensure completeness and timely publication of their registers of interests.

Table 7: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	85	4
A healthcare professional	39	5
A patient representative organisation	14	2
All other responses	26	6
Total	164	17

Our response

We are confident that the requirement of the Code, including the process for dealing with members’ non-compliance with the Code, will ensure the completeness and timely publication of the Public Register of Interests. The Code provides for the committee chairs and the committee secretariat to ensure that interests are declared and published on a timely basis, and there is a clear process for dealing with noncompliance with the Code.

There is a significant difference between the way that the NHS conflict of interest guidance applies to its commissioning groups as separate bodies and the way the Code applies to the advisory committees. The NHS guidance leaves it for individual commissioning groups to set up their own processes for managing conflicts of interests including how they deal with breaches of conflicts of interest policies. The committees which provide advice to the MHRA are bound by the requirements of the Code, including the processes for dealing with noncompliance with the Code.

Question 7: Do you agree with the proposal to establish a Conflict of Interest Group to provide advice to members uncertain about declaring interests or unclear about the interpretation of this Code?

The aim of this proposal was to provide advisory committee members and Secretariat staff access to advice from senior MHRA staff about declaring interests or interpreting the Code of Practice.

A total of 181 people responded to this question. Although eighty-eight percent (88%) of respondents agreed with this proposal, a minority (4%) did consider that a Conflict of Interest Group was perhaps unnecessary given that the Code already provides for guidance (see Q5) and additional support from the Committee Secretariat to advice members who may be uncertain about declaring interests.

Table 8: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	77	12
A healthcare professional	42	2
A patient representative organisation	15	1
All other responses	25	7
Total	159	22

Our response

In light of the comments received, we will revise the Code of Practice to provide that members are able to consult the Conflict of Interest Group on novel or complex issues which the Secretariat is not able to advise members on. We consider that in most cases the guidance on conflicts of interest and advice from the Committee Secretariate should be sufficient to assist members uncertain about declaring interests or unclear about the interpretation of this Code.

Question 8: Do you agree with the proposal to introduce a new Panel to deal with breaches of the Conflict of Interest policy?

The proposal to establish a consistent panel process to deal with breaches of rules governing the identification and handling of conflicts of interests was intended to end the uncertainty about how such scenarios should be dealt with and what type of disciplinary action may be warranted.

Of the 180 respondents that offered a view on this proposal, 88 percent were in favour of a Panel to deal with breaches of rules governing the identification and handling of conflicts of interests, recognising that management of conflicts of interest requires that there have to be consequences for breaches.

A minority of the respondents (3%), whilst agreeing with the proposal, considered that the Panel to deal with breaches of rules governing conflicts of interest should be independent of the MHRA, or at least have some independent members.

Table 9: breakdown by respondent type

Respondent type	Yes	No
A member of the public/patient	79	10
A healthcare professional	39	5
A patient representative organisation	15	1
All other responses	25	6
Total	158	22

Our response

Conflicts of interest are complex and require a thorough understanding of the rules contained in the Code of Practice and guidance provided for its interpretation to make judgements in cases where breaches of rules are alleged. For this reason, we propose to keep the composition of the Panel as described in the consultation document - consisting of 3 senior MHRA officials and the Manager with responsibility for the Committee Secretariat (or Secretary and Scientific Director of BPC). The appointment of an independent Chair to oversee the panel process will, however, ensure that there is an impartial voice to assist the Panel in coming to fair and evidence-based judgements.

Conclusion and next steps

We are grateful to those who took time to provide considered and detailed responses to this consultation. We have analysed these responses carefully to gain a better understanding of the issues raised and solutions offered and to use this information to further strengthen the Code.

The Code is published alongside this response document and will apply with immediate effect to the advisory committees named in paragraph 1 above. As set out in the Code itself, we will review the implementation of Code every three years unless an earlier review is needed.

1. Previously the Devices Expert Advisory Committee (DEAC) ↩