The ABPI and the Prescription Medicines Code of Practice Authority (PMCPA) have announced the release of the latest edition of the ABPI Code of Practice. The new 2024 edition replaces the 2021 edition and updates the voluntary rules which govern the advertising of prescription-only medicines and interactions between the pharmaceutical industry and the healthcare sector.
While the ABPI Code of Practice is part of a voluntary scheme of self-regulation which is only binding on members of the ABPI, the Code is commonly regarded as the “gold standard” for advertising and anti-bribery compliance in the pharmaceutical industry. In practice, almost all pharmaceutical companies in the UK follow the ABPI Code of Practice, either as direct members of the ABPI or on a voluntary informal basis.
We are still digesting the new edition of the Code and analysing the changes which are most likely to be of interest. However, the PMCPA has identified the following changes as important in its press release announcing the new edition:
- Major changes to clause 12 allowing companies to include prescribing information in advertising using a QR code
- A new abridged complaints procedure to expeditiously address certain categories of complaint to the PMCPA
- Making certain “best practices” mandatory, including requiring written agreements where companies provide support to healthcare professionals to attend events, and requiring companies to provide links on Disclosure UK to their webpages disclosing transfers of value to patient organisations and to the general public
The PMCPA has also published a new mandatory template for the disclosure of transfers of value to healthcare professionals and other relevant decision makers. Companies must use the new template to disclose 2024 transfers of value by 2pm GMT on 28 March 2025.
The 2024 ABPI Code of Practice will come into force on 1 October 2024. There will be a short transitional period, allowing companies to continue to comply with the 2021 Code of Practice until 31 December 2024. From 1 January 2025, the 2024 Code of Practice will be fully mandatory. Companies would be well-advised to start familiarising themselves with the additional requirements of the 2024 Code of Practice now and to ensure that any necessary changes to their processes and procedures are in place before Christmas inevitably brings work to a juddering halt.
Jamie has also produced a more detailed analysis on this announcement - for LexisNexis - here (subscription required). |