On the 4th of September 2023, the UK Department of Health and Social Care (DHSC) launched a public consultation (The disclosure of industry payments to the healthcare sector – GOV.UK (www.gov.uk)) in relation to a proposed new legislation, which would make disclosure of industry payments to the healthcare sector a legal obligation (consultation closed on 16th of October 2023).
Until now only the Association of the British Pharmaceutical Industry (ABPI) had this obligation included into its voluntary code. The drawback of this kind of disclosure, is that only members of the ABPI would need to disclose relevant transfers of value.
Currently, all other companies who manufacture or supply medicines in the UK (who are not members of ABPI), can voluntarily choose to make (some or all) payments to the healthcare community public, but a formal obligation for such transparency does not exist. Medical technology companies currently do not have a voluntary or legal obligation for disclosure in the UK either.
What is the scope of the proposed legislation?
- It would apply to all manufacturers or first suppliers of prescription medication, as well as generic and unbranded medicines, medical devices, some cosmetics (borderline products), and foods for special medical purposes that are purchased by the healthcare system;
- It would also apply to “every manufacturer and commercial supplier…. as well as their subsidiaries and parent business”
What would need to be disclosed?
- Individual payments of more than GBP 50 or GBP 500 in aggregate per year;
- Name of recipient;
- Individual or organization;
- Professional registration number (if applicable);
- Work address;
- Aggregated annual sum value of payments or benefits (in GBP);
- Reasons for payment or benefit; and an explanatory note, in relation to the methods used to for arriving at the sums
The draft legislation envisions financial penalties for non-compliance. It is yet unknown, when this draft legislation would be passed through UK Parliament or would be enacted.
How can GCO help you?
GCO’s Compliance Advisors are specialized in the Life Sciences Industry, supporting our clients on day-to-day questions around stakeholder engagements, state and country rules and regulations, creation of guidance and standard procedures, awareness trainings and much more.
Would you like to know more?
Our advisors Marlize Eckert, Andreea Crăcuț and Yana Budel are happy to connect with you.
Contact us at [email protected] or call us on +31 184 496 999