January 14th, 2021
The forthcoming 2021 ABPI Code has been released. It looks very different as it has been restructured, however there are limited changes to content.
It will come into operation on 1 July 2021 and the BHBIA’s Legal & Ethical guidelines will be updated in due course.
The 2021 ABPI Code is available at: https://www.pmcpa.org.uk/the-code/forthcoming-2021-abpi-code-of-practice/ as are full details of all the changes.
We have highlighted below:
- the new structure,
- a change to disclosure requirements that could impact BHBIA members, and
- clarification on the need to name the market research sponsor that could help BHBIA members.
The ABPI Code now includes the following sections:
- ABPI principles
- Overarching requirements (i.e. minimum standards)
- Requirements with regard to:
- Promotion to health professionals and other relevant decision makers
- Interactions with health professionals, other relevant decision makers and health care organisations
- Interactions with health professionals, other relevant decision makers and health care organisations, patient organisations and the public including patients, journalists etc.
- Interactions with the public including patients, journalists etc. and patient organisations
- Annual disclosure requirements
- PMCPA constitution & procedure
As previously each section (except the ABPI principles) is made up of a series of clauses and these are complimented where appropriate by supplementary information.
Change for BHBIA members to note - Disclosure requirements now include non-HCPs – Clause 24:
With regard to changes that impact BHBIA members and our work, there is only one change of note:
Disclosure requirements now extend to interactions with the public including patients, journalists etc.; not just as previously to health professionals, other relevant decision makers, health care organisations and patient organisations.
Put simply this change extends disclosure requirements to non-HCPs. This means that transfers of value including MR incentives provided to non-HCP respondents e.g. patients or members of the public, must be declared IF the identity of the individual is known to the commissioning/end client company (i.e. the pharma company).
24.4 Pharmaceutical companies must publicly disclose annually, details of the fees and expenses paid to UK individuals, organisations etc. for contracted services such as chairing and speaking at meetings, assistance with training and participation in advisory boards etc. Such disclosure includes payments in relation to research and development work, including the conduct of clinical trials.
24.5 In addition to the information required to be made public by Clause 24.4, companies must publicly disclose annually, details of payments made to contracted individuals in relation to market research (unless the company concerned does not know the identities of those participating in the market research).
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 with regard to naming 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 occasionally caused confusion for BHBIA members as it appeared to suggest that the commissioning pharmaceutical company never had to be named. This is not the case and the wording has been clarified 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.