As of October 1, 2024, pharmaceutical companies promoting prescription medicines in the UK must adhere to the revised standards outlined in the new Association of the British Pharmaceutical Industry (ABPI) 2024 Code of Conduct. The updated code introduces a range of changes to the self-regulatory framework governing how UK-based pharmaceutical companies communicate with healthcare professionals (HCPs) and patients. Although compliance with the ABPI Code is not legally required, it is mandatory for ABPI members and widely observed by non-member companies as a benchmark of ethical practice. The recent changes align the ABPI Code with international regulations, including those of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Key Changes Brand Managers Should Be Aware Of

The updated ABPI Code brings notable changes that will impact marketing campaigns and other communications for prescription medicines. Here are the key updates and how they will likely affect brand strategies:

1. Streamlined Complaint Resolution: The ABPI governing body (the PMCPA) has introduced an 'abridged' complaints process aimed at speeding up complaint resolution for alleged non-compliant advertising materials. This should allow for minor technical infractions to be addressed more quickly, minimizing potential delays in campaign execution. The changes to the complaints procedure also include the introduction of case management powers, similar to those used in the English Court system.  This authority allows the PMCPA to issue directions on what material may be put before the adjudicating panel and whether hearings are conducted remotely or in-person. This procedural flexibility is designed to improve efficiency and reduce the backlog of complaints, although it would seem to bring a more formal, legalistic approach to the process.
2. Prescribing Information via QR Codes: Marketers now have the option to include prescribing information via QR codes or links in promotional materials. This is a significant development for printed and digital campaigns which should open up opportunities for more dynamic, sleek promotional materials without compromising compliance.  However, brands should note that QR codes can only be used if recipients don’t need two devices to access the information, such as receiving an email on one device and scanning with another. This restriction ensures that prescribing information remains easily accessible.
3. New Mandatory Practices: Transparency continues to be a focal point of the ABPI Code, with several previously optional measures now becoming mandatory. For instance, disclosing financial interactions with healthcare professionals and using the Disclosure UK portal are now obligatory.

The move from recommended guidance to mandatory requirements means that marketers must continue to be proactive in updating contracts, ensuring all disclosures are accurate, and maintaining clear records of interactions with healthcare professionals. Additionally, the Code update contains an express extension of the requirement that all companies maintain high ethical standards for all personnel, including contractors and third parties acting on a company's behalf. 

Preparing for Full Implementation

Companies have until December 31, 2024, to implement the changes outlined in the new Code. However, the revised PMCPA Constitution and Procedure framework is already in effect, meaning adjustments should begin immediately. Notably, the PMCPA has explicitly encouraged complainants to seek to resolve disputes internally (presumably through whistleblowing mechanisms), which signals that pharmaceutical companies would be wise to ensure internal whistleblowing protections and processes are in place and operating effectively.  Furthermore, brand managers should evaluate the need for retraining to ensure marketing teams understand the nuances of the revised Code, and update all promotional and partnership agreements to align with the new standards.

Looking Ahead: Potential Statutory Requirements

In addition to the changes under the ABPI Code, the industry awaits the outcome of the UK government’s 2023 public consultation on statutory requirements for disclosing transfers of value to healthcare professionals and institutions. If enacted, these requirements could lead to new transparency obligations similar to the Sunshine Act in the US. The potential introduction of statutory requirements would mean that companies need to have robust systems in place to track all transfers of value. Brands should start considering how these changes could affect sponsorships, educational grants, and other forms of support provided to healthcare professionals. 

Practical Tips for Compliance

• Audit Your Current Materials: Conduct a thorough audit of all existing promotional materials to identify any areas that may need updates to comply with the new Code. This includes ensuring that prescribing information is accessible, whether through traditional means or by incorporating QR codes where appropriate.
• Enhance Collaboration with Compliance Teams: Work closely with your compliance teams to understand the nuances of the new complaints process and the mandatory requirements. Establish clear communication channels to ensure that any potential issues are identified and addressed early.
• Leverage Technology: Utilize digital tools to streamline compliance processes. This includes tools for tracking transfers of value, managing disclosures, and ensuring that all promotional materials are reviewed and approved in line with the new Code requirements. Automation can reduce the administrative burden and help ensure accuracy in compliance reporting.
• Involve Legal Teams Early: Given the more legalistic nature of the updated PMCPA Constitution and Procedure, involving legal teams early in the complaint process could be beneficial. Legal input can help navigate case management directions and ensure that responses are appropriately crafted to minimize risks.

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Matt Bedan is Ostro’s compliance director.  He is a former prosecutor, white-collar litigator, and regulatory compliance professional with over 15 years of experience assisting global healthcare and life sciences companies.

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