Starting in 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies will make public the details of payments and transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs). The first disclosures will be made in 2016 and will convey information about payments made in 2015. As companies prepare for reporting, EFPIA has launched a new website—Pharmadisclosure.eu—to highlight the new disclosure rules, follow best practices in the implementation of EFPIA's Code, and monitor compliance in the 33 countries involved in the initiative.
EFPIA's Code on Transfers of Value
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 on a company's own website or a central platform. According to EFPIA, "[i]t must be possible for the public to easily find and access the disclosed information in the country where the relevant HCP/HCO practices."
According to the Pharma Disclosure resources, "[t]he move to introduce the new transparency code in Europe mirrors the introduction in the US of 'Physician Financial Transparency Reports' under the Sunshine Act."
Unlike the Sunshine Act, however, EFPIA covers 33 separate countries.
EFPIA states that each member company will 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. EFPIA states, for example, "if an Italian affiliate of an EFPIA Member Company engages with a HCP whose practice is in Spain for an activity in Germany, this Transfer of Value will have to be disclosed under the name of the recipient HCP in Spain (following the applicable laws, regulations and the national code in Spain)."
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 "[d]ata privacy requirements must in each case be checked at the national level (i.e. the jurisdiction of the HCP/HCO receiving payment or transfer of value) by the member company prior. 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 for the implementation of the Disclosure Code."
Furthermore, the EFPIA Disclosure Code defines HCPs as any member of the medical, dental, pharmacy or nursing professions or any other person who, in the course of his or her professional activities, may prescribe, purchase, supply or administer a medicinal product. Some countries have different policies on what professionals may prescribe products.
Template Disclosure Report
EFPIA recently provided a template for disclosure reports, which provides a nice snapshot of what companies must track. Click here for a clear image of the template.