The EFPIA disclosure code: What needs to be disclosed?
The EFPIA Disclosure code requires member companies to document and disclose the transfers of value it makes, directly or indirectly, to healthcare professionals (HCPs) and healthcare organisations (HCOs).
By transfers of value we mean payments such as donations and grants made to healthcare organisations and in the case of HCPs, fees for services or sponsorship to attend educational events such as medical congresses.
When the disclosures are published they will include the name of the HCP or HCO, and the total amounts of value received by that individual or organisation in the previous calendar year. This figure will be broken down in to categories of activity. For HCOs specifically, there are two categories; donations & grants and contribution to costs related to Events (sponsorship agreements). For HCPs and HCOs the categories will be; contributions to costs related to events such as registration fees, travel and accommodation for attending medical congresses, etc.) and fees for services and consultancy (for example, agreement for delivering clinical trials, speaker fees, consultancy).
We have stipulate direct and indirect transfers must be disclosed to ensure maximum transparency. For example payments made either directly to an HCP registration fees or indirectly via a service provider (as congress organizer) must both be disclosed.
European Data Protection Regulation requires health professionals to give their consent to publish disclosure payment information. Where an HCP does not grant consent, the payments will be disclosed in aggregate. Companies are required to publish the number of HCPs that did not give their consent and total amount paid to them. However, our hope is that HCPs will give their consent to publish the data. Bringing greater transparency to this, already well-regulated, vital relationship is about strengthening the basis for collaboration in the future. Industry is being proactive, based on its commitment to this relationship. Society has increasingly high expectations for transparency, none more so than in healthcare. We want to ensure we meet those expectations going forward.
Payments made for R&D non-clinical studies, clinical trials and non- interventional studies prospective in nature will also be disclosed in aggregate. Companies are required the total spent on these activities by country.
The first disclosures of transfers of value made in 2015, will be published by member companies before the end of June 2016.