Those of us who advise on medicines advertising issues have been waiting for much of 2024 for the Association of the British Pharmaceutical Industry (“ABPI”) together with its self-regulatory body for pharmaceutical advertising, the Prescription Medicines Code of Practice Authority (“PMCPA”), to publish the new Code of Practice for the Pharmaceutical Industry (“ABPI Code”).  On 23 September 2024, the suspense finally lifted, with the publication of the ABPI Code 2024 (available here).  The 2024 ABPI Code replaces the previous version from 2021. 

The new ABPI Code incorporates an updated PMCPA Constitution and Procedure, which sets out the procedure for adjudicating upon advertising complaints.

The ABPI initially proposed, and consulted upon, updates to the ABPI Code from December 2023 to February 2024 (please see our previous blog post discussing these proposals here).  The 2024 ABPI Code includes most of the changes that were proposed and consulted upon, usually with only minor changes to wording.  The PMCPA has issued summaries of the changes to the Code and Constitution, which can be found here and here.

The main headline is that the new ABPI Code is very similar to its predecessor.  The consultation received over 3,000 comments, with many commentators calling for more extensive changes than those proposed.  The ABPI appears to have resisted these calls, preferring evolution over revolution.

The changes take effect on 1 October 2024.  However, a transitional period will operate from 1 October 2024 to 31 December 2024, during which time no material or activity will be regarded as breaching the ABPI Code if it fails to comply with the new requirements of the 2024 version.  The 2024 ABPI Code will come into full force on 1 January 2025.  Notably, though, the PMCPA will begin operating in accordance with the new Constitution and Procedure from 1 October 2024, including the legalistic elements and abridged complaints procedure discussed below.

Of the (relatively few) changes, what should legal and compliance teams take note of?

The new PMCPA Constitution and Procedure makes changes to the process for investigating and adjudicating upon advertising complaints.  These changes aim to enhance the flexibility and efficiency of the complaints process.  They include: (i) powers for the PMCPA to issue case management directions; and (ii) a new abridged complaints procedure that could apply in certain cases.  The changes will likely result in a more legalistic feel to PMCPA proceedings.  If the PMCPA notifies a company of a complaint, it may be beneficial to involve legal teams early in the process.

By contrast, changes to a company’s compliance obligations under the new ABPI Code are relatively modest.  The updates are generally clarificatory in nature.  Some changes essentially consolidate and codify into the Code principles that already exist in guidance and previous PMCPA cases.  An example of this is how companies fulfill their obligation to maintain high standards.  There is now more detail on this point in the Code, pulling together concepts from various cases. 

There are also new rules permitting the use of QR codes to provide access to prescribing information in certain cases.

Changes to Complaints Process

There is currently a significant backlog of complaints and PMCPA adjudications.  Many in industry attribute the backlog to the relatively rigid procedure for handling complaints and arriving at adjudications.  The changes to the complaints procedure are designed to improve efficiency and flexibility in the process, and ultimately aim bring the backlog down. 

The aim is to have more flexibility in managing cases, including an abridged procedure for certain straightforward cases, and giving the PMCPA some “case management” powers (similar to the English Court system) to accommodate more or less complex cases and move away from a “one size fits all” approach.

A.                 Case Management

The updated PMCPA Constitution and Procedure introduces an “overriding objective” (Paragraph 1.10).  This expressly requires the PMCPA to: (i) handle cases in a manner proportionate to the importance of the case and complexity of the issues; (ii) avoid “unnecessary formality” and adopt procedural flexibility where appropriate; (iii) ensure that parties fully participate in the proceedings; and (iv) avoid delays. 

In this vein, the PMCPA may now issue “case management directions” (Paragraph 1.11).  This is similar to English Court rules, by which judges issue directions to set the terms and processes for a particular case.  PMCPA case management directions may include directions as to what material may be put before the adjudicating panel, what material may be redacted, and whether a hearing is to be conducted remotely or in-person.  The PMCPA envisages that this enhanced discretion as to the handling of a complaint will allow for a more efficient process.

B.                 Abridged Complaints Procedure

The changes also include the introduction of an abridged complaints procedure (Paragraphs 6 and 9), which can be used where the PMCPA case preparation manager determines in relation to a complaint or voluntary admission that: (i) the allegations fall within the PMCPA’s approved list for use of the abridged procedure; (ii) it appears that the central facts of the case will not be disputed; and (iii) it is likely in the case preparation manager’s view that there has been a breach of the ABPI Code.  Where a complaint comprises multiple allegations, it will follow the full complaints procedure if any of the component allegations fail to meet the criteria above.

If (i) the respondent company accepts the alleged breach(es) of the ABPI Code and has provided a written undertaking to cease relevant activity and to take steps to avoid a similar breach in the future; and (ii) the PMCPA confirms there are no systemic compliance issues involved, the case would close without further PMCPA investigation (Paragraph 6.6). 

There is no right of appeal under the abridged procedure (Paragraph 9.4) and respondent companies will pay reduced administrative charges (Paragraph 9.5).

This procedure has the potential to reduce the resource and time burden necessary for dealing with less serious infringements of the ABPI Code, and aligns with the PMCPA’s overriding objective of approaching cases proportionately and efficiently.

C.                 Additional Procedural Changes

As noted in our previous blog, further proposed changes incorporated into the 2024 PMCPA Constitution and Procedure that may be of interest to pharmaceutical companies include:

• An extension in the time permitted for companies to respond to a complaint from 10 working days to 15 working days (Paragraph 5.12).  This recognizes the increased complexity of complaints in recent years and aims to allow companies adequate time to submit a thorough response.
• An extension of the timeframe for the payment of administrative charges from 20 working days to 30 calendar days (Paragraph 8.1). 

Changes to ABPI Code

A.                 Clarificatory Changes

Notable clarificatory changes to the ABPI Code include:

• Under the supplementary information to Clause 5.1, a requirement that member companies should develop and maintain policies or similar procedural documents to clearly communicate corporate standards, expectations and behaviour in line with the requirement to maintain high standards at all times.  The Code also provides that companies should provide appropriate training.
• A new Clause 5.2, which expressly extends the requirement to maintain high standards to member company personnel.  Such personnel – including members of staff, those retained by way of contract, and third parties acting on a company’s behalf – must maintain a high standard of ethical conduct in the discharge of their duties and comply with all relevant requirements of the Code.  The supplementary information to this new clause confirms that companies are responsible for the actions of their personnel, even if they are acting contrary to instructions. 

B.                 Supporting HCP Event/Meeting Attendance

In its consultation, the ABPI had proposed that where companies support healthcare professionals (“HCPs”) or other relevant decision makers to attend events or meetings, the companies must carry out formal “educational needs assessments” in every case. 

The 2024 ABPI Code pulls back from a formal assessment.  However, it says the company must document the rationale behind any decision to support an HCP or relevant decision maker to attend an event (supplementary information to Clause 10.4).

C.                 Use of QR Codes for Provision of Prescribing Information

In its consultation, the ABPI proposed changes to Clause 12 to include the possibility of providing prescribing information via a QR code in certain scenarios.  Various different rules and restrictions were proposed for various presentation formats.  The consultation received a significant volume of feedback, including that the differing requirements were complicated and could cause confusion. 

Under the final 2024 ABPI Code, companies have the option to provide prescribing information via a QR code in printed material (e.g., a hardcopy leaflet distributed at a conference) and digital material shown to a recipient in person (e.g., on slides presented at a conference or materials displayed to HCPs on a tablet device at a company’s booth at an event).  In these circumstances, an HCP could use their personal mobile device to scan the QR code on the printed or digital material and access the prescribing information.  However, companies cannot provide prescribing information using a QR code for digital material accessed by a recipient on their own device (e.g., an email sent to an HCP’s device), on the basis that the recipient would then require a separate personal device from that on which they received the digital material to scan the QR code and access the prescribing information. 

The updated Clause 12 therefore introduces particular, context-specific circumstances where QR codes may be used, so should be read carefully.  The PMCPA has also confirmed that additional implementation guidance for Clause 12 will be provided via accompanying Q&As in October.

D.                Other Changes

The 2024 ABPI Code also removes clauses from the 2021 Code that have now expired and updates cross-references throughout the document.

Next Steps

The new ABPI Code and PMCPA Constitution and Procedure represent evolution rather than revolution.  The consultation received numerous comments unrelated to the proposals under consideration, which the PMCPA could not address within the planned timeframe for the 2024 Code launch.  However, the PMCPA plans to address these in a phased manner and will assess such comments for either future Code updates or the development of guidance.

As noted above, while the PMCPA will follow the updated Constitution and Procedure from 1 October 2024, companies have a grace period until 31 December 2024 to comply with the new requirements of the 2024 ABPI Code.

If you would like to discuss the latest developments and what they may mean for your company’s operations, please contact: Grant Castle, Robin Blaney, Brian Kelly, Raj Gathani or Dan Spivey.