Posted: 06/12/2024
The much awaited 2024 edition of the Association of British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry came into effect on 1 October 2024 following the conclusion of the public consultation period. It replaces the previous version from 2021, and promises to increase the standards expected of pharmaceutical companies, while providing more efficient and timely resolution to complaints.
The ABPI’s code of practice is a rulebook of principles and requirements that determines how the UK pharma industry is self-regulated and is delivered by the Prescription Medicines Code of Practice Authority (PMCPA). The PMCPA, along with the code of practice, aims to ensure responsible practice, high ethical standards and professionalism in the pharmaceutical industry.
Despite the lengthy consultation process and significant delay to publishing, the 2024 code is not as far removed from its predecessor as some anticipated. However, there have been some significant updates which companies will need to comply with. This article will explore the three salient changes below.
There is now a short implementation period, from 1 October 2024 to 31 December 2024, before the 2024 code becomes mandatory on 1 January 2025. The PMCPA began operating in accordance with its new constitution and procedure on 1 October 2024 and as such, will deal with complaints in line with the new process, which is outlined below.
Clause 12 provides perhaps the most notable update. Under the newly reworked clause 12, healthcare professionals are now able to furnish prescribing information through a QR code, demonstrating an embracing of technology and a modernising of the approach to prescribing information.
The QR code will allow people to scan and immediately access the prescribing information for a medicine on promotional material. The QR code may be used in limited circumstances, for example on printed material, posters and exhibition panels, and in digital material to be shown to a recipient in person. A QR code is not permitted where the use of multiple devices is required for access. For example, where a customer is accessing digital material on their own device and would require a secondary device to scan the QR code, the accessibility threshold will not be met.
Clause 12 also specifies certain requirements for the QR code, as well as outlining the instances in which it is not an acceptable means through which to provide prescribing information. The QR code must be clear and prominent, and must provide explicit instructions to scan for prescribing information. A QR code is not permitted if the recipient will be receiving it electronically, or when the recipient is not reasonably expected to have access to the internet.
The introduction of QR codes to access prescribing information will help companies to ensure that the information being accessed is up-to-date and is provided in the most reader friendly format possible. In implementing the update to clause 12, companies should not adopt a one-size fits all approach, and instead should consider the material used and/or access route followed to ensure compliance with the 2024 code.
The second key change published in the 2024 code is the introduction of a new PMCPA ‘Constitution and Procedure’. This aims to set out the powers and responsibility of the PMCPA and defines its role in the self-regulating system. It also provides full details of the complaints procedure, which now includes two routes: the standard complaints procedure, and the new abridged complaints procedure.
The new abridged complaints procedure has been designed to help the PMCPA deal with complaints proportionately and expeditiously. The PMCPA has provided an approved list of allegations to determine the eligibility of disputes for the abridged complaints procedure. If a complaint is eligible, both parties will be informed that the case will be dealt with through the abridged procedure and the steps outlined in the guidance will be followed. Complaints should be submitted using the complaints form available on the PMCPA’s website.
The PMCPA has reminded companies that its approach is adversarial in nature as opposed to investigatory and that the burden of proof is on the complainant to prove their claim on the balance of probabilities. It is suggested that in providing a more structured process for complaints, the PMCPA will be able to address the complaint commensurately with its severity.
The PMCPA’s chief executive, Alex Fell, has commented on the new constitution and procedure, suggesting that the hope is that, in clarifying the powers that the PMCPA possesses, the regulatory system will remain ‘robust’, and it ‘strengthens the operational abilities and independence of the PMCPA’.
The final substantive change to the 2024 code is that certain provisions that were previously best practice, or optional under the 2021 code, are now compulsory.
Companies and healthcare professionals were formerly encouraged to submit links to disclosure information about patient organisations or members of the public on the gateway links provided by the public database, Disclosure UK. Under the 2024 code, submitting of these links to Disclosure UK is now mandatory. The guidance suggests that the disclosure should include information pertaining to payments and benefits in kind to patient organisations and/or the general public. 2024 disclosure data must be submitted in this way before the deadline of 28 March 2025 and will be made public on 27 June 2025.
Another newly mandatory provision is the requirement for a written agreement between companies and healthcare professionals who have received support to attend events. The agreement should set out the agreed terms including anything concerning travel, accommodation and registration costs.
The purpose of implementing these newly mandatory clauses is to continue to enhance the transparency between pharmaceutical companies and the healthcare professionals they work with, which has long been a challenge to the industry. Failure to comply with these provisions from 1 January 2025 will amount to a breach of the 2024 code. The consequences for breach vary from payment of administrative charges to the giving of undertakings. In addition, the PMCPA will advertise the case report and may require the company to issue a corrective statement or be publicly reprimanded.
Despite the consultation receiving more than 3,000 responses, the 2024 code has not enacted many of the key recommendations stakeholders originally thought it might. As a result, it has been suggested that it may not be that long until we see a further updated version.
However, until then, the primary focus for pharmaceutical companies and healthcare professionals should be to understand the 2024 code in full. There are many changes across the code and while this article has outlined the most substantive, care should be taken to understand exactly what has changed, how it impacts current practices and resources, and how quickly processes need updating to ensure compliance. While there is no sanction during the transitional window, the time will be best used making adjustments so that once the 2024 code is enforced from 1 January 2025, there is no risk of breach.
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