Overview
Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024 under the Association of the British Pharmaceutical Industry (ABPI) 2024 Code of Conduct (Code). Whilst compliance with the Code is not a legal requirement, it is a condition of membership of the ABPI, and most non-member companies agree to comply with it as evidence of good practice.
The new Code follows a period of consultation which concluded earlier this year and seeks to align UK requirements with standards set in the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) Codes.
Since the new Code was published, the Prescription Medicines Code of Practice Authority (PMCPA), the self-regulatory body established to independently operate the Code, has released a new learning portal platform with educational materials aimed at supporting pharmaceutical companies through the changes to the Code (accessible here).
In Depth
Changes to Note
Key changes to note if you are a pharmaceutical company promoting medicines in the UK:
- the PMCPA has a revised ‘Constitution and Procedure’ with a new process for the assessment and management of complaints made under the Code;
- prescribing information may now be provided in certain promotional materials via a QR code; and
- previous recommended guidance has now becoming mandatory.
Relevant companies have until 31 December 2024 to implement the requirements of the new Code before they become mandatory. However, the revised PMCPA Constitution and Procedure framework is already in effect.
Constitution and Procedure
The Code has always included processes for dealing with complaints as part of the PMCPA’s role as both administrator and adjudicator. The new Code includes significantly more detail on the complaints process, including with respect to appointments to the Appeal Board.
A key new inclusion is an ‘abridged’ complaints process intended as a more proportionate route to complaint resolution.
The abridged process allows the PMCPA to “triage” complaints and if (i) the breach falls within the PMCPA’s approved list (published online); (ii) the central facts are not disputed; and (iii) it is likely to be determined there has been clear breach, then respondents have 15 days to respond on whether the breach is accepted, to provide assurances there are no systemic compliance issues and to provide the PMCPA with appropriate undertakings as to remedies. The PMCPA may escalate to a full complaint investigation where responses are inadequate or where patient safety concerns are identified.
Examples of breaches that fall within the approved list are broad and include failures to disclose transfers of value on time and breaches of administrative Code requirements (e.g. delay in notifying PMCPA of updated signatories, incorrect certificate wording on materials).
This new process may mean technical breaches of the Code may be resolved more efficiently reducing the burden on respondents to provide detailed responses (as required under the longer complaints process) and freeing up time for the PMCPA to focus on investigating serious breaches.
The PMCPA also encourages complainants to seek to resolve disputes internally in the first instance where possible, e.g., through whistleblowing procedures. Hence, pharmaceutical companies may want to review their internal processes for managing complaints and whistleblowing procedures.
For complaints that warrant a full investigation, the PMCPA has introduced the concept of ‘case management directions’ setting out greater administrative powers, for example on redactions to materials. This indicates a more formal approach to the governance of complaints and is aligned with court procedures.
Prescribing Information
Under the new Code, prescribing information (being the essential information that must be included in all promotional material such as the list of active ingredients and authorised indications or the medicine’s Summary of Product Characteristics (SPC)) may now be provided via a QR code where the material is printed or for certain digital promotional material. The QR code cannot be used where the recipient needs to use two devices (e.g., a website and a separate phone) to access the information but could be used on a fixed digital display at a promotional booth.
The use of QR codes is an efficient paper-free way of giving prescribing information and ensuring material remains up to date. Where companies are promoting new indications of a medicine that are not yet included in the medicine’s SPC, the prescribing information must still be accurate and the PMCPA have confirmed no grace period applies.
Different rules apply to short form and abbreviated materials.
New Mandatory Requirements
Some parts of the Code are now mandatory rather than guidance:
- Gateway Links on Disclosure UK: Companies were previously encouraged to disclose through the gateway under the principles of the 2021 Code; this has now become a mandatory process. Companies must also disclose relevant transfers of value using the updated mandatory template. 2024 disclosures are due by 14:00 GMT Friday, 28 March 2025.
- Support for Health Professionals and Decision Makers: It is now mandatory, rather than just recommended good practice, to have written terms when companies provide support to individual health professionals and relevant decision makers.
Looking to the Future – Sunshine Ahead?
In addition to self-regulatory frameworks, the pharmaceutical and health technology industry continues to wait for the outcome of the UK government’s 2023 public consultation on whether statutory requirements for the disclosure of transfers of value to hospitals, research institutions and healthcare professionals in line with similar systems in place internationally, such as the Sunshine Act in the United States and in the Netherlands and France.
If proposals under the consultation are enacted, manufacturers and commercial suppliers of healthcare products may also be subject to statutory obligations to disclose transfers of value provided to healthcare professionals and organisations from powers granted under the Health and Care Act 2022.