What’s new for the pharmaceutical industry in the 2021 ABPI Code update?

What is the ABPI Code?

The Code of Practice for the Pharmaceutical Industry (the code) is published by the Association of the British Pharmaceutical Industry (ABPI). The overarching aim of the code is to provide a framework for self-regulation and to set a common standard for behaviour in relation to the promotion of prescription medicines. The code is regularly refreshed by the ABPI, with a recent update published in July 2021.

This most recent update has significantly changed the structure of the code. Extensive changes such as these will have very real impacts for pharmaceutical companies and their third-party providers.

Drivers of change

This major overhaul has been driven by several important factors. First among these, the ABPI sought to structurally align the code more closely with the European Federation of Pharmaceutical and Industry Associates (EFPIA) code.

This is beneficial to many in the industry as it will make understanding the rules around the promotion of medicines between UK and EU countries easier. However, the ABPI also needed to react to new pressures on the industry that have arisen in recent years – namely Brexit and emergency use authorisations (spurred by the global coronavirus pandemic).    

New code, new structure

The code is now structured with the ABPI principles embedded at its core. It states that all pharmaceutical companies must operate based on these four core principles – benefitting patients; acting with integrity; ensuring and maintaining transparency; and treating industry stakeholders with respect. 

Within the code itself, clauses have been organised into six core sections – this is a departure from the 2019 code where each clause was presented independently. Most important among these are section 1 “Overarching requirements” which describes “the minimum standards which apply to all interactions, items, materials, activities, etc.”.

Equally important is section 6 “Annual Disclosure Requirements” which gives detailed instruction on what payments of which sort must be disclosed, including new rules about sponsorship and contracted services.

The rest of the code

The remaining four sections focus on promotion to HCPs and decision makers as well as all interactions with HCPs, decision makers, healthcare and patient organisations, and the public. Section 5 is specifically dedicated to interactions with members of the public including journalists, patients, and patient organisation.

This new code structure sets each clause into the wider context of all activities that might be carried out under the same banner which should allow for greater consistency in application of the code for companies.

Significant changes for industry

Some of the most significant changes for industry in the new code include:

• • • new definitions of donations and sponsorship;
    • broadening of annual disclosure requirements and contracted services scopes;
    • inclusion of non-promotional materials and activities;
    • and a strengthening of the responsibility that companies have for any acts or omissions made by agencies and third-party providers.

Adapting to changes

At the time of release in July 2021, the industry was given a buffer period to complete any activities that fell under the old code – particularly in relation to medical education events that would now be covered by the expanded sponsorship and disclosure rules. However, that period elapsed on the 31^st of December 2021 and now companies need to ensure that everything they do is compliant with the updated code going forward.

Need help?

With increased responsibility for the activities of their third-party providers under the updated code, companies need to know that they can trust their communications partners to act within the code.

At Enzyme Communications, the code is at the heart of everything we do and the services that we offer. Talk to us about your communications needs – a trusted communications and strategy partner, who understands and values working within the code.

ABPI principles: https://www.pmcpa.org.uk/the-code/2021-interactive-abpi-code-of-practice/abpi-principles/

Interactive 2021 code: https://www.pmcpa.org.uk/the-code/2021-interactive-abpi-code-of-practice/