Mandatory reporting of industry payments to the healthcare sector
The Independent Medicines and Medical Devices Safety Review (the "IMMDS Review"), chaired by Baroness Cumberlege, reported in July 2020 on three medical interventions: Primodos (which is a brand of hormone pregnancy test used from the 1950s to 1970s), sodium valproate (a drug used to treat epilepsy) and pelvic mesh (a medical device used to support pelvic prolapse and urinary incontinence).
	Recommendation number 8 of the report on the review (page 188) provided the following: "there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians".
	This recommendation was made because of concerns about perceived and real conflicts of interest in the provision of healthcare and treatment, particularly when doctors have financial and other links with pharmaceutical and medical device companies. The report emphasised that responsibility for transparency in this regard should not only lie with the medical profession, but also with the pharmaceutical and medical devices industries.
	Although there are existing reporting initiatives, participation is voluntary. The IMMDS Review (at paragraphs 2.53 to 2.57) identified a perception amongst patient groups that payments to clinicians could influence their practice, and that a voluntary scheme is not adequate to ensure transparency. Patient groups subsequently continued to make strong demands for a mandatory scheme.
	The Government accepted the recommendation in principle and agreed to develop options "including making reporting mandatory through legislation". Sections 92 to 94 of the Act respond to this recommendation by creating powers that will enable regulations to require that payments and other benefits provided by pharmaceutical, medical device and other businesses to the healthcare sector are put into the public domain.
	The sections allow regulations to place a requirement on manufacturers or commercial suppliers of health care products (or persons connected to them) to publish or provide to the Secretary of State information about payments they make or other benefits they provide to persons providing healthcare or persons who carry on activities connected with healthcare. This includes organisations who may not directly provide healthcare but who may influence it, for example through the education of healthcare professionals.
	There are some circumstances in which the publication of information relating to a payment or other benefit may impact on delivering value of money in the healthcare sector or the attractiveness of the United Kingdom as a research destination, and it therefore may not be appropriate to require this information to be made publicly available. For example, where the NHS negotiates a confidential discount on medicines, it is not the intention that relevant companies will be required to publish or provide information about this payment given the impact this would have on the NHS’s ability to achieve the best value for money. Therefore, section 92 provides that the Secretary of State has the ability to make provision in the regulations for exceptions to the requirement to publish or provide information, for example, to support the attractiveness of the United Kingdom’s life sciences sector.
	Section 92 enables the Secretary of State to exempt businesses from these requirements if the equivalent information is published elsewhere via an alternative reporting scheme which the Secretary of State considers renders compliance with the requirements imposed by the regulations unnecessary.
	While the value of this policy is to enhance transparency and improve the data available to the public, this can only be realised if businesses comply. The Secretary of State will therefore be able to make regulations about enforcement of requirements in the regulations, including imposing financial penalties.
	We consider there is benefit to introducing UK-wide regulations. This is consistent with the approach taken in medicines and medical devices regulations and would place consistent obligations on businesses, reduce potential loopholes and ensure we can achieve comprehensive coverage to the benefit of patients. In order to ensure regulations work for the whole of the United Kingdom the sections provide that the Secretary of State must seek the consent of the Scottish Ministers, Welsh Ministers or Department of Health in Northern Ireland before regulations are laid, where the regulations are within the legislative competence of the devolved legislatures.
	Taken together, sections 92 to 94 enable the Secretary of State to make regulations which will deliver increased transparency of the relationship between businesses and the healthcare sector, provide patients with information on the relationships which may impact their healthcare and provide the public with information to enhance their trust in the health care system.