Starting from 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies made public the details of payments and transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).
The first disclosures have been made in 2016 and conveyed information about payments made in 2015.
EFPIA’s “Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations,” agreed to in July 2013, requires its members to disclose any direct payments or other forms of support made to healthcare professionals.
This information will be published on a public platform, which could be a company website or a central platform.
According to EFPIA, “it must be possible for the public to easily find and access the disclosed information in the country where the relevant HCP/HCO practices.”
Furthermore, according to the EFPIA disclosure code, each member company will have to publish a note summarizing the methodologies (methodological note report) used in preparing the disclosures and identifying Transfers of Value for each category”.
Therefore, every year, all members will declare all financial relations with individual HCPs and HCOs relating to:
• donations and grants;
• sponsorships, events and hospitality;
• fees for service and consultancy,
Transfers of value linked to research and development (for example, pre-clinical studies, clinical trials and observational studies) must be disclosed only as aggregate data.
EFPIA states that each member company decide how to organize its disclosures.
Disclosures should be publicly accessible in the country where the HCP/HCO receiving a transfer of value or payment from industry has their practice. The physical address where the HCP practices or HCO is located should be used as the reference when determining in which country the data should be disclosed.
For example EFPIA states: “if a Spanish affiliate of an EFPIA Member Company engages with a HCP whose practice is in Italy for an activity in Germany, this Transfer of Value will have to be disclosed under the name of the recipient HCP in Italy (following the applicable laws, regulations and the national code in Italy).”
While EFPIA seeks to standardize the procedure across borders, member companies must comply with applicable data protection and other laws, which may impose certain limitations on their ability to make disclosures on an individual basis.
EFPIA notes that “data privacy requirements must in each case be checked previously at national level (i.e. the jurisdiction of the HCP/HCO receiving payment or transfer of value) by the member company. This must be done prior to any disclosure. Companies are encouraged to obtain consent from HCPs/HCOs prior to disclosure, and EFPIA and its Member Associations and Companies are working together with HCPs/HCOs to prepare the implementation of the Disclosure Code.”
EFPIA provided a template for disclosure reports, which provides a nice snapshot of what companies must track.
Regulatory Pharma Net is available to support companies to comply with these requirements and to provide additional information and assistance regarding the “Transfers of Value disclosure report” and the methodological note implementation.