Updated self-regulatory code and enforcement procedure for pharmaceuticals advertising

The UK’s medicines trade association, the ABPI, acts through the Prescription Medicines Code of Practice Authority (PMCPA) to self-regulate in the field of pharmaceuticals advertising to healthcare professionals. The PMCPA has published a new version of the ABPI Code of Practice for the Pharmaceutical Industry, and a revised Constitution and Procedure. The changes amount to evolution rather than revolution, although increased flexibility in the adjudication procedures is expected to help address the current backlog of cases.

ABPI Code 2024

The ABPI Code 2024 is available in both interactive and downloadable form and replaces the previous version issued in 2021. The ABPI Code update follows a consultation which took place between December 2023 and February  2024 (discussed in a previous post). 
The new code took effect on 1 October, but a transitional period is in effect until 31 December 2024.  During this period, new elements of the Code will not be enforced. Non-compliant materials should be withdrawn before 1 January 2025.
Overall, the changes to the ABPI Code 2024 are modest and generally clarificatory (a summary of the changes can be accessed here).  More extensive changes that were suggested during the consultation have not been taken forward.

Notable changes include

• a requirement for all personnel to maintain high standards of ethical conduct in discharging their duties, and comply with the Code. The 2021 Code only required this of representatives.
•  the Clause 5 supplementary information sets out a requirement for companies to have policies covering standards of expectations and behaviour, and to provide training. They are responsible for acts and omissions of personnel, even when acting contrary to instructions. This extends not just to staff, but also to contractors and third parties.
•  obligations to record the rationale for providing support to a health professional or other decision maker to attend an event/meeting in advance, and enter into a detailed written agreement.
•  new rules allowing the use of QR codes to provide access to prescribing information in specified situations.

PMCPA Constitution and Procedure

More substantial changes have been made to the PMCPA Constitution and Procedure, which are now in effect. The PMCPA has published a summary of these changes.
The procedures for hearing and assessing advertising complaints now include an “overriding objective”. This concept, similar to that used in English court proceedings, requires the adjudicating panel to ensure that cases are dealt with fairly and justly, while keeping costs proportionate. It includes a requirement to avoid unnecessary formality and adopt flexibility in proceedings where appropriate.
A new abridged complaints procedure will be available for defined categories of complaint, such as isolated incidents of promotion to the public of a prescription only medicine, and where the central facts are undisputed. Administrative charges will be reduced by half. Appeals from abridged procedure will not normally be permitted to impose additional sanctions, although a request for reassessment under the full complaints procedure will be available in exceptional circumstances, such as situations where there may be patient safety concerns. 
A “specific scope audit” is now available as a sanction, involving updates on a company’s commitment to improve, and reporting from a senior representative on progress.
These changes are designed to improve efficiency and flexibility in the adjudication process. They also aim to address perceptions that current procedures are inflexible, and that this is responsible for a significant backlog of complaints and PMCPA adjudications.