ABPI Code

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.Continue Reading New ABPI Code and PMCPA Constitution and Procedure Published

The Holiday season of 2023 proved to be a busy one for innovative pharmaceutical companies in the UK and their legal and regulatory teams.

UK pharmaceutical companies are already number-crunching through two new price control systems for 2024 (please see our blog and audiocast).  In addition to the UK pricing regime changing, there are proposals to update advertising rules and the procedure for adjudicating upon advertising complaints.   

On 13 December 2023, the Association of the British Pharmaceutical Industry (“ABPI”) published proposals to update the 2021 ABPI Code of Practice for the Pharmaceutical Industry (“ABPI Code”) and the Prescription Medicines Code of Practice Authority (“PMCPA”) Constitution and Procedure (which sets out the procedure for adjudicating upon advertising complaints).  Companies have until 29 February 2024 to contribute to the consultation.

Many of the proposed changes to the ABPI Code are clarificatory in nature, but the planned changes to the complaints process may be of particular interest to in-house legal teams.  These changes are designed to make the PMCPA complaints process less formulaic and more flexible.  This could help manage relatively straightforward cases with greater efficiency, whilst also accommodating for cases which involve serious allegations and/or complex facts.  If implemented as proposed, the changes are likely to give PMCPA cases a more judicial or legalistic feel, particularly when it comes to case management.Continue Reading Consultation on Changes to the ABPI Code and UK Advertising Complaints Process

Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.”  Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).…

Continue Reading UK Government Consults on Proposals Mandating the Disclosure of Industry Payments to the Healthcare Sector

On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).

The Guidance is the first of its kind in the UK and is long-awaited. 

The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK).  The ABPI Code sets out a number of overarching principles but does not address social media in detail.  The PMCPA had some years ago published “digital guidelines” but these were archived for updating.

The first – and probably most important – thing to say about the Guidance is that it (finally) exists.  Social media has become a major compliance headache for UK pharmaceutical companies.  These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn.  The absence of clear and codified guidance until now led to a lack of clarity.  Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent.  While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.

Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach.  Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history.  It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).Continue Reading UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media

On 28 September 2022, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) published joint guidelines concerning the use of social media and digital media channels by pharmaceutical companies (Joint Digital Guidelines).  IFPMA  and EFPIA are umbrella trade bodies for the innovative pharmaceutical industry on the global and European stages, respectively.

The Joint Digital Guidelines are timely.  Digital communications and the use of social media have become hot compliance topics for the pharmaceutical industry, both in Europe and globally.  Actors in the healthcare world increasingly use digital communication channels; many clinicians, patients and patient organizations actually prefer to receive content digitally.  With more content comes higher compliance risk.  Digital communications, particularly over social media, can spread fast across borders and are often publicly accessible. 

It is no surprise that a very significant number of pharmaceutical advertising cases in European markets now concern digital channels or social media.  This certainly reflects our experience; and this is an area where our pharmaceutical advertising experts are continually advising clients.Continue Reading IFPMA and EFPIA Publish New Joint Guidance Note on Social Media and Digital Channels