The Association of the British Pharmaceutical Industry (ABPI) Code of Practice sets out the requirements the industry must comply with, and supports companies’ commitment to self-regulation and operation in a professional, ethical and transparent manner. Following a public consultation in 2020, the ABPI has published the new Code of Practice for the Pharmaceutical Industry (the 2021 Code), which will be implemented from 1 July 2021.
The 2021 Code represents a significant structural revision of the current 2019 Code to more closely reflect the structure of the 2019 European Federation of Pharmaceutical Industries and Associations Code of Practice (the EFPIA Code). Most of the substantive requirements of the 2019 Code are reflected in the 2021 Code. However, there are a number of significant changes. Some of the key changes introduced by the 2021 Code are summarised below.
The clauses of the 2021 Code are allocated to six colour-coded sections, principally relating to activities of particular stakeholder groups. These include, for example:
- Overarching requirements
- 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 incorporates the new ABPI Principles, which are:
- Benefitting patients
- Acting with integrity
- Ensuring transparency
- Treating everyone with respect
Senior leaders in British pharmaceutical companies are asked to champion the adoption of the new ABPI Principles, drive implementation across their organisation and ensure staff behave in a manner consistent with the principles.
Definitions and use of defined terms
Definitions from the EFPIA Code have been incorporated into the 2021 Code together with definitions currently used in the 2019 Code.
Donations and grants
New defined terms include "donations" and "grants", which partly replace what were ‘medical and educational goods and services’ (MEGS) in the 2019 Code, and the relevant definition makes it clear that donations or grants made to patient organisations are covered.
Requirements relating to patient organisations and/or individuals representing patient organisations have been incorporated throughout the 2021 Code into certain of the general requirements, rather than having separate requirements.
The term "contracted services" has replaced what was known in the 2019 Code as "use of consultants". "Use of consultants" now includes engaging members of the public (including patients and journalists) in fee-for-service arrangements (generally where these relate to healthcare, disease or medicine). Accordingly, disclosure requirements now extend to interactions with the public, where previously these only applied to healthcare professionals, other relevant decision makers, healthcare organisations and patient organisations.
The concept of "collaborative working" with organisations has been introduced in the 2021 Code as a means of recognising projects that cannot show a direct benefit to patient care and so could not be considered "joint working", as defined in the 2019 Code. Collaborative working must: (i) enhance patient care; (ii) be for the benefit of patients; or (iii) benefit the NHS and, as a minimum, maintain patient care. In the 2021 Code, joint working is now considered a type of collaborative working, and must continue to be patient-centred and always of direct benefit to patients.
Although the 2021 Code will not become effective until 1 July 2021, British pharmaceutical companies will need to use the next few months to plan ahead, ensuring staff are trained on the code changes, updating relevant policies and procedures and making sure the company is ready for compliance with the new code from 1 July 2021.