UK Government To Issue Guidance On Industry Payment Transparency

Following a public consultation, the UK government has outlined plans to publish guidance on disclosing payments made by the medicines and medical devices industries to the healthcare sector. While some stakeholders favour a legislative approach, the government believes that a guidance-based model will enable patients to benefit from industry reporting more quickly, avoiding delays that could arise from introducing legislation and establishing a formal compliance system.

Background

Published in July 2020, the Independent Medicines and Medical Devices Safety (IMMDS) review, led by Baroness Cumberlege, raised concerns about real and perceived conflicts of interest in patient care where clinicians have financial links with pharmaceutical and medical devices companies.

The IMMDS review acknowledged the Association of the British Pharmaceutical Industry's (ABPI) Disclosure UK system, which publishes information about payments and benefits in kind made by pharmaceutical companies abiding by the ABPI code. However, it highlighted that there is no similar system in place for the medical device sector in the UK.

In 2023, the then government launched a public consultation to seek the views of individuals and organisations in relation to disclosure of industry payments to the healthcare sector. The survey was actively shared with key stakeholders to ensure those with particularly relevant views or experience had the opportunity to contribute. In total, 690 responses were received made up individuals (69.5%), professionals (16.4%), organisations including trade associations and private businesses (13.5%) and academics or researchers (0.5%).

Government Response

The majority of responses indicated a clear need for greater transparency regarding payments made between industry and:

• registered healthcare professionals
• healthcare provider organisations
• organisations connected to the provision of healthcare

The government will develop and publish clear guidance setting out best practice for industry, advising on:

• which payments should be reported
• the format of the reporting
• the frequency of the reporting

The government will monitor the uptake of this guidance.

To date, no formal government guidance has existed for industry to follow or for patients to utilise to hold the industry to account. This step aims to provide certainty for industry and stakeholders, improve transparency, enhance patient safety, and assist patients in making informed choices about their care.

The decision aligns with the government's commitment to reducing regulatory burden. It will allow industry to demonstrate leadership and commitment to transparency while minimising requirements that could disproportionately affect small and micro businesses.

Consultation Responses

Scope

The vast majority of respondents agreed that manufacturers and commercial suppliers of medicines, medical devices and borderline substances should be subject to the reporting duty, with no distinction between payments made to the public or private sectors.

Respondents also agreed that payments to the following organisations should be in scope:

• Charity arms of hospitals
• Medical or clinical research organisations (including medical research charities)
• Professional bodies responsible for the core training of healthcare professionals (for example royal colleges, Membership of the Royal College of Physicians (MRCP))
• Other medical education or training providers
• Patient advocacy organisations

Format

Regarding reporting format, most respondents agreed businesses should publish payment information on their websites with a prominent link on the UK homepage. About one-third supported allowing compliance via third-party schemes, provided these meet regulatory standards and are designated by the Secretary of State for Health and Social Care.

Most respondents supported publishing a register of payments, including:

• Recipient name
• Annual sum value of payments and benefits
• Complete list of reasons for each payment and benefit

If the recipient is an individual, their employer and professional registration number (if applicable) should also be published.

Frequency

38% of respondents considered annual reporting to be sufficient. 21% favoured every six-months and 23% every three-months.

Enforcement

Just over half of respondents agreed that financial penalties would be an effective and fair deterrent for non-compliance. However, there was a general theme across all respondent categories of scepticism that financial penalties alone would suffice. Additional suggestions included:

• Professional consequences
• Criminal liabilities
• Director or board liability
• Public reprimand
• Enforcement mechanisms
• Non-compliance registers

86 respondents (from across categories) felt that alternative non-criminal penalties would be required instead of, or in addition to, financial penalties. These suggestions included:

• the loss of professional and product licences
• reputational consequences, such as publication of their details and non-compliance

Next Steps

Over the coming months, officials will work with stakeholders to develop robust guidelines, considering the valuable suggestions provided during the consultation.

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