The Code of Practice of the Association of the British Pharmaceutical Industry (ABPI) lays down the rules that the industry must comply with and encourages companies to self-regulate and operate in a responsible, legal, and open manner.
The ABPI has released the latest Code of Practice for the Pharmaceutical Industry (the 2021 Code) after a public consultation in 2020 which will be implemented from 1 July 2021. The 2021 Code is a major structural overhaul of the existing 2019 Code, reflecting the framework of the 2019 European Federation of Pharmaceutical Industries and Associations Code of Practice (the EFPIA Code), but there are limited changes to content. The 2021 Code incorporates the majority of the 2019 Code’s substantive criteria. There are, however, a few notable differences. Some of the key changes introduced by the 2021 Code are featured below.
The New Structure
The 2021 ABPI clauses are assigned to six colour-coded sections, generally relating to the activities of particular stakeholder groups. For instance, these include:
- Overarching requirements (i.e. minimum standards)
- Requirements for interactions with health professionals, other relevant decision makers, healthcare organisations, patient organisations and the public (including patients and journalists)
- Annual disclosure requirements
The 2021 Code includes the new ABPI Principles, which are:
- Benefiting patients
- Acting with integrity
- Ensuring transparency
- Treating everyone with respect
Senior executives of British pharmaceutical firms are being asked to champion the current ABPI Standards, accelerate their implementation through their organizations, and ensure that their employees follow the guidelines.
Definitions and use of defined terms
Definitions from the EFPIA Code, as well as definitions presently in use in the 2019 Code, have been adopted into the 2021 Code.
Donations and grants
“Donations” and “grants” are new specified phrases that partially override the 2019 Code’s “health and educational products and services” (MEGS), and the applicable meaning makes it clear that donations or grants given to patient organizations are included.
Instead of having separate requirements relating to the rules for patient organisations and/or individuals representing patient organisations, they have now been included within the 2021 Code of the general requirements.
The term “contracted services” has replaced with the term “use of consultants”. Engaging members of the public (including patients and journalists) in fee-for-service agreements is now considered to be “use of consultants” (generally where these relate to healthcare, disease or medicine). Thus, disclosure requirements have been extended to interactions with the public, by contrast previously these only applied to healthcare professionals, other relevant decision makers, healthcare organisations and patient organisations.
In the 2021 Code, the definition of “collaborative working” with organizations was adopted as a way of recognizing programs that could not demonstrate a direct benefit to patient care and thus could not be considered “joint working,” as described in the 2019 Code. Collaborative working must: (i) improve patient care; (ii) be for patients best interest; or (iii) benefit the NHS and, as a minimum, maintain patient care. According to the new 2021 ABPI Code, joint working will be considered as a type of collaborative working and must continue to be patient-centred and always of direct benefit to patients.
Clarification provided – Requirement to name market research sponsor – Clause 5
Following input from the BHBIA during the consultation phase, the ABPI Code has been clarified regarding the naming of the pharmaceutical company sponsoring the market research.
With the introduction of more demanding data protection law that sometimes requires the end commissioning client to be named during the course of a market research project (e.g. if they are a data controller, a source or a recipient of personal data) previous clause 9.10 caused confusion on occasion for BHBIA members as it seemed to suggest that the commissioning pharmaceutical company never had to be named. The wording has been clarified, to assert that this is not the case and now reads as follows.
5.5 Material relating to medicines and their uses, whether promotional or not, and information relating to human health or diseases which is sponsored by a pharmaceutical company or in which a pharmaceutical company has any other involvement, must clearly indicate the role of that pharmaceutical company.
The only exception to this is market research material if it is such that the name of the company involved is not required to be stated, then the material must state that it is sponsored by a pharmaceutical company.
The 2021 Code will take effect from July 1, 2021, but British pharmaceutical companies will need to prepare accordingly over the next two months, ensuring that employees are trained on the amendments, updating relevant policies and procedures, and ensuring that the organisation is able to comply with the new code on July 1, 2021.
The 2021 ABPI Code is available at: https://www.pmcpa.org.uk/the-code/forthcoming-2021-abpi-code-of-practice/