Improving Transparency in Healthcare: Mandatory Reporting of Industry Payments

Mandatory reporting of industry payments Stevan Cirkovic Senior Policy Lead Medical Device Regulation Medical Technologies Directorate 23 February 2022

The IMMDS Review The IMMDS ( Cumberlege ) Review concluded that manufacturers should take responsibility for ensuring they publish details of payments made to teaching hospitals, research institutions and clinicians. Patient groups and others suggested that the UK put in place an equivalent to the American Physician Sunshine Payment Act, which places a statutory responsibility on medicines and medical product manufacturers to declare any payments or other transfers of value (including expenses) made to physicians or teaching hospitals. This feedback was reflected in the second sentence of Recommendation 8: Recommendation 8: [ ] In addition, there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians. 2

DRAFT - NOT GOVERNMENT POLICY Draft policy objectives There is currently a lack of transparency over the relationship between clinicians and the treatments that they recommend, which is undermining confidence in the health and care sector and industry. We want to increase transparency in order to realise the following objectives: Improve public trust in doctors and the health system professionals Protect and enhance the reputation of the UK Life Sciences Sector Improved patient and public confidence (trust) in Clinicians make decisions independently from payments (patient safety) 3

Delivering on the recommendation January February March April May 2 1 Prepare public consultation and stakeholder engagement: Health and Care Bill: Clauses 81-83 Develop detailed narrative and appraise policy options June July August September October November December 3 4 5 Prepare consultation response and finalise regulations Prepare consultation response and finalise regulations Public consultation 4

Health and Care Bill: The First Step Clause 81 provides the Secretary of State with a delegated power to make regulations requiring manufacturers or commercial suppliers of certain health care products (or persons connected with them) to report payments they make to health care providersand others who carry out activities connected with the provision of health care and describes the type of provision which can be made in the regulations. The clause enables the Secretary of State to exempt companies from these requirements if the equivalent information is published elsewhere via an alternative reporting schemewhich the Secretary of State considers renders compliance with the requirements imposed by the regulations unnecessary. Clause 82 enables the regulations to make provision about the enforcement of any requirements imposed by regulations made under clause 81. Clause 83 requires the Secretary of State to obtain the consent of the Scottish Ministers, Welsh Ministers and the Department of Health in Northern Ireland, where provision in the regulations would be within the legislative competence of the relevant devolved legislature. Clauses 150 and 152 will also be amended to provide that regulations made under clause 81 are subject to the affirmative procedure and can extend to the whole of the UK. 5

What regulations will define When and how the information must be provided. What information which must be published or reported. For example, this may include the name of the recipient, the GMC number, if applicable, the value of the transaction, and the reason for which the payment was made. This is a non-exhaustive list. Any exceptions where the risks to commercial confidentiality or business burden outweigh the benefits to patient safety, or in order to set a de minimis threshold for declarations where transactions are unlikely to influence behaviour. Data retention requirements. This ensures that there is a record maintained which can be used to support enforcement activity. Any exceptions where businesses provide information under a designated relevant scheme. 6

Discussion Any questions from you? Any questions from you? Policy goals and scope Policy goals and scope Do you think the draft objectives strike the right tone? Why/ why not? What payments should/ should not be in scope and why? How would a system look like that you can see yourself as benefitting from? Business impact Business impact What information on payments do you already collect and store? What, if any, new processes (resources, governance etc) would you have to put in place to comply with such new regulations? 7

How would you like to continue the How would you like to continue the conversation? conversation? 8

Current situation in the UK for medicines Since 2016, the Association of the British Pharmaceutical Industry (ABPI) has operated a database, Disclosure UK, where members declare payments to healthcare professionals and organisations, as below. HCPs Healthcare professionals (e.g. doctors, nurses, pharmacists) Service and consultancy Footer Contribution to costs of events report payments made for the purposes of Industry ABPI members and non-members made to Research and development HCOs Healthcare organisations (e.g. an NHS Trust, a university) Donations, grants and benefits in kind Joint working arrangements There is currently no equivalent scheme for the medical devices sector. 9