The final deadline for publication and submission of reports of transparency disclosures required by the European Federation of Pharmaceutical Industry Associations (EFPIA) arrived on June 30, 2016.
Companies have now completed publication of all 2015 ‘transfers of value’ (ToV) to healthcare professionals (HCPs) within the 31 countries that signed on to this initiative. Several changes to the requirements have already been made, and questions and concerns remain for amendments likely to be implemented later this year.
The industry received updates and changes to the required reports for the Netherlands just days before the deadline. Two weeks ago, the Netherlands ethics consortium, CGR, issued a press release stating that Dutch companies must disclose research and development (R&D) payments separately from the current report of transfers of value, since they were not previously captured. These disclosures must be made using the standard EFPIA template form, with R&D payments reported in the aggregate, and requiring no individual consent for disclosure. These reports must be published on the Dutch companies’ websites, and only for R&D costs incurred within the Netherlands.
On May 26, 2016, the Spanish industry association Farmaindustria, announced changes to their consent requirement. Endorsed in a report by the Spanish Data Protection Agency, the association will change the requirement of consent from a proactive request by the member company, to clearly informing the HCP that the transfer will be disclosed and no explicit consent by the HCP to publish any identifying data (e.g. name, address, etc.). Farmaindustria has published a draft code that is pending adoption, which incorporates these changes, and will apply to ToV from January 2017 onward. It should be noted though, that this ‘exemption’ has yet to be implemented in an official manner, through administrative or legislative proceedings.
Several countries’ deadlines passed earlier this year, or apply on a rolling basis, so companies completed disclosures for Sweden, Finland, Estonia, Belgium, the Netherlands, the UK, Denmark, France, and Portugal prior to June 30. For the June 30 deadline, only two member countries had central platforms developed by the association available for member companies to upload their data (Ireland and the Czech Republic). The vast majority of disclosures were made on companies’ individual websites.
While the complexity of meeting various local laws and regulations, in addition to EFPIA, was a challenge for all, Polaris found that companies that deployed robust processes and systems for pre-approval, spend capture, consent management, pre-disclosure and reporting were much more in control of the process and worked more efficiently than those who had not. Companies that relied on pure spend capture after-the-fact, and did not use proven systems as a basis, seemed to struggle to get it right.
The industry continues to worry about the potential backlash from the public that may result from the disclosure publications. Reassurance can be drawn from the US and French experience, that though the process is difficult to implement, it in fact encourages open and improved communication with customers, does not significantly decrease the customer engagements, and helps to create parity for customer expectation when dealing with industry.
Additional changes to the requirements are anticipated later this year. Several countries have lobbied to have local government requirements replace the EFPIA reporting requirement, including Romania, Slovakia and Turkey. In Europe, additional relevant legislative proposals are underway in Belgium and Scotland, which would apply the disclosure requirement more broadly than just to EFPIA association member companies. Beyond Europe, Polaris is tracking draft legislation in Morocco, South Korea, and Colombia, and a draft transparency code in Saudi Arabia.
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