The ABPI Code, the self-regulatory code that governs promotional activity for medicines, and interactions between pharma companies and healthcare professionals, is undergoing a review.
The Association of the British Pharmaceutical Industry, or ABPI, has shown itself willing to take a tough stance on enforcement. In a recent case the ABPI Board took the unusual step of suspending a major company from membership of the ABPI for a two years, and requiring ongoing audits of activity. This case involved online promotion of a weight management course for UK health professionals, which included extensive discussion of the weight management drug, liraglutide. The company had also supported the provision of Patient Group Directions (PGDs) to those attending the course.
Now the ABPI is consulting on changes to its rulebook. Details of the proposed Code updates can be seen here. The changes include the following:
- Greater emphasis on the requirements for pharmaceutical companies to ensure the maintenance of high standards. This will include obligations to put in place policies and standard operating procedures to train both staff and external contractors on corporate standards, expectations and behaviour.
- Changes to checking and certification of material. The terms 'medical signatory' and ‘non-medical signatory’ will be used for those responsible for certifying material, with the term ‘appropriately qualified person’ (AQP) used in situations where material is not required to be certified. The categories of material that will be open to certification by a non-medical signatory are expanded, alongside more detail on the training and experience required for a non-medical signatory.
- Use of QR codes to provide prescribing information. This proposal has been developed with input from the MHRA.
- Stricter criteria for educational meetings for healthcare professionals are proposed, with a placeholder to indicate that additional guidance on this area will be developed.
- More detail in the rules governing transparency of payments.
Constitutional and procedural changes are also suggested – you can see these here. Notably, the plans include a separation of the complaints procedure into an abridged procedure for more straightforward cases, and a full complaints procedure for complex ones.
Feedback on the proposals can be submitted through a consultation until the end of February. Final proposals will then be presented for approval by ABPI membership, with the revised Code expected to take effect before the end of 2024.
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