What’s new?
The 2024 Association of the British Pharmaceutical Industry (the “ABPI ”) Code of Practice (the “2024 Code”) which was published on 23 September 2024, came into effect last week on Tuesday, 1 October 2024, replacing the 2021 version.
What is the 2024 Code?
The 2024 Code sets out the requirements that all ABPI member companies must comply with and supports companies in their self-regulation. Its intended purpose is to allow companies to act in a professional, ethical and transparent way. The 2024 Code “reflects and goes beyond UK law” and it is independently administered by the Prescription Medicines Code of Practice Authority (the “PMCPA”).
ABPI has stated that the 2024 Code “seeks to raise the high standards which are expected of pharmaceutical companies even further while also ensuring that complaints can be appropriately resolved more quickly”.
What are the key differences between the 2021 and 2024 Codes?
There are three key sets of changes which have been made to the 2024 Code since 2021, being:
- the way that prescribing information can be provided has been updated (under Clause 12);
- a new ‘Constitution and Procedure’ for the PMCPA has been established, to include a new complaints procedure; and
- some elements of the Code have moved from mere guidance to mandatory requirements.
Providing prescribing information under clause 12
Clause 12 of the 2024 Code has seen the most substantial revisions, having been entirely reworked in collaboration with the Medicines and Healthcare products Regulatory Agency (the “MHRA”). The most notable change here is the new option to provide prescribing information for printed and certain digital promotional material via a QR code. This change will allow health professionals to easily access the most current version of relevant prescribing information.
New ‘Constitution and Procedure’ for PMCPA
The Constitution and Procedure of the PMCPA sets out:
- the structure and roles of the PMCPA, Code of Practice Panel and Code of Practice Appeal Board;
- the Complaints Procedure for handling a complaint from beginning to end; and
- general provisions covering withdrawals of complaints, time periods for responding to matters, levy and charge, conciliation and scrutiny.
The complaints procedure is a new addition to the 2024 Code and provides the PCMPA with flexibility to deal with complaints in a “proportionate and resource-efficient manner”. The ABPI has confirmed that this new complaints procedure will be reviewed on a regular basis by its Code of Practice Appeal Board.
Move from guidance to mandatory requirements
Disclosure UK, a public database, includes two data gateways with website links directing visitors to disclosure information published on individual company websites concerning either patient organisations or members of the public (including patients and journalists). Whilst this practice was optional but encouraged under the 2021 Code, it is now mandatory under the 2024 Code.
In situations where companies provide support for individual health professionals and relevant decision makers to attend meetings or events, a written agreement is beneficial to set out the terms agreed, including categories of costs such as registration fees, accommodation and travel. Such written agreements were deemed best practice under the 2021 Code however they have now become mandatory under the 2024 Code.
Chief Executive of PMCPA, Alex Fell, has said “The updated ABPI Code of Practice and Constitution and Procedure will help ensure that the model of self-regulation in the UK remains robust and strengthens the operational abilities and independence of the PMCPA”.
What are the dates for compliance?
The 2024 Code will come into full force on 1 January 2025. Any material or activity between the period of 1 October 2024 to 31 December 2024 which fails to comply with the 2024 Code’s provisions because of requirements that have been newly introduced by it shall not be in breach.
Click here to access the 2024 Code in full. You can also review an in-depth comparison of the 2021 and 2024 Codes here.
Co-authored by Sophie Wright – Trainee Solicitor.
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