UK Sunshine Act: Is UK following Italy’s footsteps?
The Italian Sunshine Act may have had its influence on the British with their proposal to implement a UK Sunshine Act.
PROPOSED UK SUNSHINE ACT:
The Department of Health & Social Care (UK) recently issued an open consultation on 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 organizations.
Last year, the Department of Health and Social Care (DHSC) launched Equity in Medical Devices: Independent Review, to explore what can be done to ensure that medical devices are free from bias.
The First Do No Harm report of the Independent Medicines and Medical Devices Safety (IMMDS) Review indicated that the industry and the healthcare system must adapt to listen to patient needs and prevent the failings of the past. It was decided that to address these issues, transparency is key.
The open consultation aimed to address the second part of recommendations contained in the IMMDS report, regarding real and perceived conflicts of interest in the health system. The IMMDS report raised concerns about the real and perceived conflicts of interest between clinicians and manufacturers, and how this may influence patient care and, ultimately, patient safety.
The IMMDS report acknowledged the Association of the British Pharmaceutical Industry’s (ABPI) Disclosure UK system, which publishes information about payments made by certain pharmaceutical businesses to the healthcare sector. In 2022, 145 manufacturers declared payments through Disclosure UK. The IMMDS report highlighted that no similar system exists for the medical device sector.
The government agrees with the IMMDS report that increased transparency would help to protect the integrity of the healthcare system from perceived and actual conflicts of interest.
The UK Health and Care Act 2022 (the 2022 Act) gives the Secretary of State the power to make regulations that require businesses to make public details of the payments or other benefits they provide to persons providing healthcare or carrying on activities connected with healthcare in the UK. The 2022 Act allows the government to place an obligation on manufacturers and commercial suppliers of healthcare products and connected persons.
Our team is closely monitoring the proposal and will continue to provide updates.