The Association of British Pharmaceutical Industry (ABPI) Code of Practice updates came into effect on 1 October 2024.
Key changes relate to:
- prescribing information (PI) and QR codes
- accountability for activities of personnel
- meeting support documentation.
Pharmaceutical companies have until 31 December 2024 to become compliant. This blog discusses some of the important changes and provides links to further information.
Clause 12 modernises the way that a PI can be provided
For certain materials, a direct link to the PI can be provided via a hyperlink or a QR code. The updated Clause 12 clarifies where QR codes can be used. In addition to being suitable for print materials, QR codes can be used in electronic materials that are to be presented to health professionals by a company representative. This is because a health professional can use their personal device to scan the representative’s screen. QR codes should not be used in electronic materials that a health professional will access independently (i.e., where they would need a second personal device to scan the QR code).
QR codes must be dynamic, meaning they take the user to information that can be kept current.
These changes help to ensure that health professionals have access to the latest PI, while also minimising the cost and waste associated with the reprinting of materials when PI updates occur.
The onus on pharmaceutical companies to maintain high standards has been strengthened
Where maintaining a high standard of ethical conduct was previously required by “representatives”, this is now a requirement for “all company personnel” (new Clause 5.2). Additionally, the 2024 ABPI Code of Practice clarifies that third parties are considered “company personnel”, meaning that pharmaceutical companies are responsible for their actions.
The updated Clause 5.1 (High Standards) states “Companies must have policies and standard operating procedures (SOPs) to clearly communicate corporate standards, expectations, and behaviour, and provide training in this regard.”
These updates highlight the importance of providing appropriate training for all company personnel, including third parties, and ensuring appropriate documentation.
Increased meeting support documentation
There is now a requirement to document the rationale for financially supporting a health professional or other relevant decision-maker to attend an event or meeting. A written agreement is also needed, including categories of costs to be covered by the pharmaceutical company (new Clause 10.4).
As these new mandatory requirements were already considered best practice points, companies may have existing processes.
CONCLUSION
Some key updates to the 2024 ABPI Code of Practice have been briefly introduced here. While some of the updates may increase documentation and training requirements, others, such as clarifications around the use of QR codes, may decrease the administrative burden that can result from PI updates.
Learn more about these updates and other 2024 updates via the links below:
- 2024 Interactive ABPI Code of Practice
- the UK Prescription Medicines Code of Practice Authority (PMCPA) has documents outlining the changes to the ABPI Code and webinars available
- the PMCPA’s 23 September 2024 related press release: 2024 ABPI Code of Practice launched, with a new constitution and procedure for the PMCPA.
Keeping up to date with the requirements of the ABPI or other local regulations is critical for both pharmaceutical companies and agencies. At Elion Medical Communications, we work across many different markets worldwide and pride ourselves on staying current with the relevant regulations. Get in touch to explore how Elion can support you in delivering a wide range of compliant yet creative communications.
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