Disclosure requirements were introduced in 2015 and the requirements were extended to include non-HCPs from January 2022

• They apply to BHBIA member companies who are also ABPI members or non-members who have agreed to adhere to the ABPI Code
• Disclosure requires pharmaceutical companies to make publicly available the details of MR-related payments (incentives and/or expenses, referred to in the ABPI Code as ‘Transfers of Value’), on a named basis, if the identities of HCPs or HCOs who take part in the MR are known or disclosed to the pharmaceutical company
• The details can be disclosed in aggregate in the case of non-HCPs, or those HCPs that refuse consent (if this is the lawful basis being used) for their personal data to be used in this way

Individuals whose identity is or will become known to the commissioning pharmaceutical company must be told before fieldwork starts (generally at recruitment) how their personal data will be used for disclosure.

A lawful basis for any disclosure related data processing must be in place. This might be: 

(a)    Legitimate interests – which the ABPI encourages, or

(b)   Consent

Refer to the Guidelines Section E4.3 for full details of disclosure requirements, when disclosure is required, and how the requirements differ depending on the lawful basis used for processing personal data.

If the individual’s/organisation’s identity is not known to the commissioning pharmaceutical company disclosure is not required. Therefore disclosure is not required where individuals/organisations are recruited by an agency and the identity of respondents is not revealed. This applies to the majority of MR studies.

• When disclosure is or is not required
• What must be disclosed and how 
• Lawful basis for processing personal data for disclosure purposes 
• What happens if an HCP objects to the use of legitimate interests / refuses to give consent 
• Record keeping and timescales 
• Requirements if payments are made to patient organisations