The Association of the British Pharmaceutical Industry (ABPI) and the Prescription Medicines Code of Practice Authority (PMCPA) announced that they are consulting regarding changes to the pharmaceutical industry code of practice.
The ABPI Code of Practice sets standards for health professionals and other decisionmakers in the UK for promoting medicines, covering all aspects of drug promotion, including: giveaway items, hospitality, sponsorships, advertisements in journals and on the internet, as well as disclosure and publication of clinical trial information and results. The ABPI Code emphasizes the pharmaceutical industry’s “commitment to operate in a professional, ethical, and transparent manner” and acts as the “cornerstone of the UK system of industry self-regulation.”
The consultation began on December 13, 2023, and is expected to end on February 29, 2024. The consultation contains proposals to change specific clauses within the ABPI Code as well as proposals to change the Constitution and Procedure of the PMCPA. PMCPA encouraged stakeholders to submit comments on one form, which will be reviewed and considered in the development of the final version of the 2024 ABPI Code. The ABPI Board will agree upon the final proposals, which will then be considered at a general meeting of ABPI members for approval.
Proposed Changes to the Code
Among the proposed changes to the ABPI Code are the following:
- Update Clause 5.1 to emphasize the requirements upon companies to ensure that high standards are maintained, separating the expectations of the company and the requirements for company employees. Also update the Clause to include the requirement to have robust policies and standard operating procedures, including corporate standards, expectations and behaviors, and training.
- Update Clause 8.2 to introduce more categories which can be certified by a non-medical signatory (previously known as an AQP signatory) while ensuring the training and validation/re-validation of the signatories remains at the same high standard as medical signatories.
- Update Clause 10 to provide clarity around assessing the appropriateness of meetings and events, including the requirement to include a written agreement where support is provided to individual health professionals and the requirement for an education needs assessment to be conducted.
- Update Clause 12 to include the use of QR codes to access Prescribing Information from printed materials.
- Update Clause 27 to provide clarity on different arrangements between companies and patient organizations.
Proposed Changes to the Constitution and Procedure of the PMCPA
Some of the proposed changes to the Constitution and Procedure of the PMCPA include:
- Clarify the nature and scope of the reporting relationship between the ABPI and the PMCPA Director, as well as between the Appeal Board and the PMCPA Director for operations of the complaints process.
- The introduction of an abbreviated complaints procedure that meets certain criteria, which will allow the PMCPA to continue to assess more serious complaints in full while dealing with less serious complaints in a “proportionate and resource-efficient manner.”
- Clarification of decision rights between the ABPI Board and the Appeal Board in connection to suspension and expulsion from ABPI, including making it clear that the ABPI Board must ratify the recommendation made by the Appeal Board unless there was an error made by the Appeal Board in formulating its recommendation or the recommendation is “manifestly disproportionate.”
- Allowing an extension in the time permitted for companies to provide a response to a complaint (from 10 working days to 15 working days) and allowing administrative charges paid by respondent companies for a breach of the Code to be payable within 30 calendar days rather than 20 working days.
A link to a table with proposed changes to the 2021 Code can be found here.
Next Steps and Reactions
The updated 2024 ABPI Code of Practice is expected to be published in the second quarter of 2024 and will go into effect three months after publication. Until the 2024 ABPI Code of Practice is published, the 2021 ABPI Code of Practice will remain in effect.
Dr. Amit Aggarwal, Executive Director of Medical Affairs at ABPI is proud of the changes they are striving for, saying, “This consultation aims to tighten up and simplify some elements of the Code itself, while strengthening the powers of the PMCPA as a robust and efficient regulator. The use of QR codes on printed materials as an option to access prescribing information is an example of the continuous process of modernising the Code, which will give healthcare professionals greater ease of reference to essential and up-to-date information for their work. Putting these proposals into action will help us make sure that industry continues to be governed by the strongest ethical framework.”
Similarly, Alex Fell, Director of the PMCPA, said, “We are pleased to share these proposals for public consultation and encourage stakeholders to respond. The changes proposed to the ABPI Code include the modernisation of certain clauses, particularly for digital activities and strengthening code requirements in other areas. The proposed changes to the Constitution and Procedure are designed to strengthen and simplify how self-regulation operates including delivery of a robust, timely and proportionate complaints procedure.”