2024 ABPI Code of Practice launched, with a new constitution and procedure for the PMCPA
The ABPI Code of Practice is the research-based pharmaceutical industry’s commitment to operate in a professional, ethical, and transparent manner, for the benefit of patients and the public [1]. It reflects and goes beyond UK law and is independently administered by the PMCPA.
The updated 2024 ABPI Code of Practice seeks to raise the high standards expected of pharmaceutical companies even further while also ensuring that complaints can be appropriately resolved more quickly.
Following an extensive consultation which received over 3,000 comments [2], the majority of proposals consulted upon have been incorporated. [3] In response to consultation feedback from stakeholders, a number of additional changes have also been added to the 2024 ABPI Code of Practice. [4]
Three key sets of changes in the 2024 ABPI Code of Practice are:
- an update to how prescribing information can be provided (Clause 12);
- a new ‘Constitution and Procedure’ for the PMCPA;
- elements of the ABPI Code moving from guidance to mandatory requirement
Prescribing information (Clause 12)
The most extensive changes to the ABPI Code have been made to this clause, which has been completely rewritten in consultation with the Medicines and Healthcare products Regulatory Agency (MHRA). The biggest change is that, for printed and certain digital promotional material, there is now the option for prescribing information to be provided via a QR code. This will allow health professionals to easily access the up-to-date version of the prescribing information. [5]
Constitution and Procedure
The Constitution and Procedure defines how the system of self-regulation operates and how it is administered by the PMCPA. The updated Constitution and Procedure includes a new abridged complaints procedure for complaints that meet certain criteria. [6]
The abridged complaints procedure will allow the PMCPA the flexibility to continue to assess more serious complaints in full but deal with less serious complaints in a proportionate and resource-efficient manner. The scope of the abridged procedure will be regularly reviewed under the oversight of the ABPI Code of Practice Appeal Board.
New text has also been added to strengthen the operational independence of the PMCPA in line with the regulatory principle of transparency and the public law principles of procedural fairness and lack of bias. [7]
Elements of the Code moving from guidance to mandatory requirement
Gateway links on Disclosure UK: The public database, Disclosure UK, hosts two data ‘gateways’ which sit alongside the main, interactive search. Both gateways are a collection of website links which take visitors to disclosure information published on individual company websites about either patient organisations or members of the public, including patients and journalists. Submitting links to these gateways is now mandatory under the 2024 ABPI Code – it was previously optional, although encouraged in line with 2021 ABPI Code principles.
Where companies provide support for individual health professionals and other relevant decision makers to attend events/meetings: There must be a written agreement in place setting out what has been agreed, including the categories of cost such as registration fees, accommodation and/or travel. A written agreement for such support was previously considered best practice as stated in the guidelines on company procedures, however, it will now be mandatory under the 2024 ABPI Code.
PMCPA Chief Executive Alex Fell 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. It will allow us to address serious complaints more quickly while also ensuring that all complaints receive an appropriate outcome in a shorter timeframe. Most importantly, this updated ABPI Code strengthens our ability to hold the industry to the very highest standard of conduct and protect patient safety.”
ABPI Executive Director for Medical Affairs Dr Amit Aggarwal said: “The new ability to provide prescribing information in certain promotional materials via a QR code will allow health professionals to easily access up-to-date information about medicines, benefiting patients and clinicians. Together, the changes in the updated ABPI Code of Practice continue to raise the standards of professional and ethical conduct that all companies in the UK should meet.”
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: “We were pleased to work closely with the PMCPA throughout the consultation process, and the specific changes made to Clause 12 will further support healthcare professionals in prescribing safely.
“The updated ABPI Code will help us continue to make sure that patients and the public benefit from appropriate use of medicines as part of high-quality healthcare in a robust regulatory framework.”
The 2024 ABPI Code of Practice comes into effect on Tuesday, 1 October 2024. During the period 1 October 2024 to 31 December 2024, no material or activity will be regarded as being in breach of the ABPI Code if it fails to comply with the new requirements of this edition. However, the PMCPA will start to operate under the new constitution and procedures from 1 October 2024, including the abridged complaints procedure. The 2024 ABPI Code of Practice will then come into full force on 1 January 2025.
The updated mandatory template for disclosure agreed for the 2024 ABPI Code must be used to submit the 2024 data to Disclosure UK by 14:00 GMT Friday, 28 March 2025.
There will be an ongoing programme of training opportunities for companies in the new ABPI Code.
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Item published 23 September |
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Approved and downloadable 2024 ABPI Code Updated mandatory disclosure template |
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During October |
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Three on-demand webinars to explain the changes to the ABPI Code and Constitution and Procedure Interactive ABPI Code available on the PMCPA website New FAQs for companies to assist in implementation Current guidance documents and FAQs will be updated or retired, in line with the requirements of the 2024 ABPI Code The complaints page will be updated on the PMCPA website to reflect new abridged complaints procedure, which will be effective from 1 October 2024 A free e-learning module will be launched, targeted at individuals requiring an overview of the ABPI Code, such as charities, and health professionals |
Ends
Notes to Editors
[1] The ABPI Code of Practice, 2024 edition, published September 2024
[2] The PMPCA received 150 submissions in response to the consultation, including more than 3,000 individual comments. Over 50% of the responses to both areas of public consultation were from pharmaceutical companies with additional responses being received from the MHRA, agencies, patient organisations, healthcare professionals and other individuals, including company employees.
[3] A summary of changes that were taken forward, and not taken forward, for the 2024 Code is available here
[4] See the changes originally proposed here: ABPI/PMCPA, ABPI and PMCPA consult on changes to the pharmaceutical industry code of practice, Dec 2023. There were additional changes not originally proposed in the consultation to clauses 9, 17, 20, and 30.
[5] See reference [3] above for explanation of Clause 12 changes.
[6] The abridged complaints procedure is available here
[7] The changes made to the Consultation and Procedure are explained here
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About the Association of the British Pharmaceutical Industry (ABPI)
The ABPI exists to make the UK the best place in the world to research, develop and access medicines and vaccines to improve patient care.
We represent companies of all sizes which invest in making and discovering medicines and vaccines to enhance and save the lives of millions of people around the world.
In England, Scotland, Wales and Northern Ireland, we work in partnership with governments and the NHS so that patients can get new treatments faster and the NHS can plan how much it spends on medicines. Every day, our members partner with healthcare professionals, academics and patient organisations to find new solutions to unmet health needs. www.abpi.org.uk
About The Prescription Medicines Code of Practice Authority (PMCPA)
The PMCPA is the self-regulatory body which administers the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry, independently of the ABPI. It was established by the ABPI on 1 January 1993.