Recently, the Department of Health and Social Care (DHSC) in the United Kingdom proposed the implementation of a plan very similar to the United States Open Payments database. Amid ongoing concern over financial ties between pharmaceutical and device companies and health care professionals, the UK government proposed to gather information and opinions about payments made by pharmaceutical and device manufacturers to the medical community.
While some have lauded the effort, others have resisted the proposal, some saying it does not go far enough to manage those relationships. The proposal comes on the heels of the Equity in Medical Devices Independent Review, chaired by Professor Dame Margaret Whitehead, and the First do no harm report of the Independent Medicines and Medical Devices Safety (IMMDS) Review, led by Baroness Cumberledge. The IMMDS Review raised concerns about real and reported conflicts of interest between clinicians and manufacturers and the way it may influence patient care and safety. The review concluded that the healthcare system must adapt to listen to patient needs and prevent the failings of the past, and that transparency is a critical part of that movement.
To that end, DHSC is considering “the possible introduction of new secondary legislation to place a duty on manufacturers and commercial suppliers of medicines, devices and borderline substances to report details of the payments and other benefits they provide to healthcare professionals and organisations.” The government believes that by mandating sponsorship reporting, it may help to improve patient trust in healthcare professionals and organizations and help to ensure that healthcare professionals continue to make impartial and evidence-based decisions about patient care.
Some considerations DHSC has made to enhance transparency include: expanding voluntary schemes (such as ABPI’s Disclosure UK); working with trade associations to improve codes of conduct; and a statutory approach to require disclosure. The Health and Care Act 2022 would allow the Secretary of State the power to make regulations to impose a requirement for businesses to make details of payments (or other benefits provided) to healthcare providers public. The regulations would further define the scope and operation of the reporting requirements.
DHSC also proposes to bring into scope every manufacturer and commercial supplier of medicines, medical devices and borderline substances, as well as their subsidiaries and parent businesses. This means that if a business manufactures or commercially supplies medicinal products or devices, they would need to publish their information. Additionally, businesses that manufacture or supply certain food and dermatological products (borderline substances) that are prescribed to manage medical conditions are also proposed to be included within the scope of the reporting requirement.
Should the reporting requirement proceed as proposed, DHSC would require businesses to publish information about in-scope payments made to any registered healthcare professional or hospital, trust, clinic, health board, pharmacy or surgery (in both the public and independent sectors). Also included in scope would be medical research and training organizations and entities linked to a healthcare provider organization (i.e., charity arm of a hospital).
DHSC proposed a minimum threshold of £50 for reportable individual payments if the annual aggregated value does not exceed £500 for that recipient. That being said, businesses would still need to report payments if any recipient received payments and benefits valued at £500 or greater in a given reporting year.
The proposal would require the publication of a register of payments with the below entries: name of recipient, individual or organization, professional registration number (if applicable), work address, aggregated annual sum value of payments or benefits, and reasons for payment or benefit. The primary way declarations would be organized would be by recipient.
Under the proposal, businesses would need to publish data annually, and a proposal is in place to require businesses to publish relevant information on their websites with a link to the information in a prominent place on the website’s homepage.
While no specific enforcement mechanism has been proposed, DHSC notes that an enforcement approach/mechanism would be outlined in the regulations, including serving a notice of intent of a proposed financial penalty if compliance is not thought to be met, assessing culpability and allowing the person to make representations.
DHSC sought opinions from the public on whether a legislative requirement to ensure the information is made public is the best way to provide transparency, as other countries around the world do (i.e., the United States, the Netherlands, France), as well as whether certain proposals are reasonable and/or helpful. Those responses were due October 2023, so it is likely that in the future, DHSC will either make amendments to the legislation, ask for additional feedback, and/or attempt to continue moving the legislation forward.
Disclosure UK
Disclosure UK currently exists, however, and is a publicly available database that shows transfers of value from pharmaceutical companies to healthcare professionals and other relevant individuals, as well as healthcare organizations. The ABPI manages Disclosure UK and the ABPI Code of Practice covers all aspects of drug promotion, including giveaway items, hospitality, sponsorships, and advertisements in journals and on the internet. Disclosure by companies of some payments may be conditional upon recipient heath care professionals (HCP) consent in order to comply with data protection laws in the UK. . According to the BMJ, 70% of UK healthcare professionals with payments from industry have given permission to disclose their names.
ABPI provided the following comments:
As a trade association we support companies with their disclosures by provided numerous resources and working with medical community stakeholders to help encourage individual healthcare professionals to agree to disclosure. We have also publicly championed the use of an alternative legal basis to Consent called ‘Legitimate Interests’ which, although early days, has had a positive impact on the number of HCPs named against values on Disclosure UK. See press release on the topic here.
(note earlier versions of this article incorrectly listed ABPI as requiring HCP consent for publication)