On October 15, 2014, MedTech Europe, an alliance between the European Diagnostics Manufacturers Association (EDMA) and the Board of the European Medical Technology Industry Association (Eucomed), recommended that their member companies phase out “direct sponsorship” of healthcare professionals to third party organized conferences. The European equivalent to AdvaMed also called for “stricter rules for indirect sponsorship” of conferences.
Importantly, the European industry groups remain “fully committed” to supporting CME for healthcare professionals. Serge Bernasconi, CEO of EDMA, Eucomed and MedTech Europe said:
After more than a year of consultation with our members and stakeholders, and a thorough analysis of the implications of different ways forward, both the EDMA Executive Committee and the Eucomed Board believe that phasing out direct sponsorship while at the same time swiftly introducing stricter rules for indirect sponsorship is the best way forward for our industry to continue to reinforce our Codes. Also, we are well aware of the importance of our engagement to support Continuing Medical Education and this engagement remains. However, it is now time that, in full cooperation and open dialogue with the various CME stakeholders, we elaborate new ways to support CME.
MedTech Europe is aiming to phase out direct sponsorship by January 2018.
Before this announcement, sponsors in Europe have been allowed to “provide financial support for attendance of individual HCPs, limited to conference registration fee and reasonable travel, meals and accommodations.” In the United States, PhRMA and AdvaMed member companies are prohibited from directly sponsoring their attendees, and instead offer indirect sponsorship, often through accredited CME companies, with firewalls in place between promotion and education. See a policy comparison chart between AdvaMed and Eucomed here.
Indirect sponsorship “functions, for the most part, via grants to medical societies, hospitals, conference organisers…who then allocate the funds to pay certain expenses of HCPs to attend third-party medical education conferences,” states MedTech Europe. “The relationship between the granting company and the recipient of the funds is governed by a contract whereby the recipients of the grant determine independently which HCPs will be invited to attend.” Under indirect sponsorship, the donor has no control over which particular doctors or other HCPs receive the benefit of its contribution.
MedTech Europe’s implementation of its new policy will be important to follow for a number of reasons.
First, in addition to banning direct sponsorship, MedTech Europe indicates that “stricter self-regulation measures for indirect sponsorship activities are also currently being developed by industry working groups” to be entered into “as soon as possible.” While it is unclear exactly what their plan is, it’s conceivable that European medtech companies will be bound to stricter rules requiring even more attenuation between sponsor and conference attendee than required in the United States. What this model will look like is unclear, but U.S.-based manufacturers and CME companies would be wise to follow what’s happening across the Atlantic to perhaps stay ahead of the curve stateside.
Second, because the new requirements will only bind member companies, it will be interesting to see if nonmembers continue to directly sponsor doctor attendees, and how this affects CME in Europe.
Finally, while it is usually the device industry following pharma’s trends, here, MedTech Europe seems to be the ring leader in conference sponsorship protocol. The pharmaceutical trade association in Europe, the European Federation of Pharmaceutical Industries and Associations (EFPIA), has received most of the attention in the United States due to its Disclosure Code, which requires many of the same reporting obligations as the Sunshine Act. However, attorneys from Ropes and Gray point out that while EFPIA “has taken a firm stance in favor of transparency by requiring companies to publicly disclose their financial contributions to HCPs and health care organizations, the trade association still permits direct sponsorship.”
Indeed, “MedTech Europe seriously considered implementing a complete disclosure rule like EFPIA’s (i.e., in lieu of prohibiting direct sponsorship), but ultimately determined that a ban on direct sponsorship would present less compliance risk,” the Ropes and Gray article states.
This new Code will be proposed for adoption at the General Assembly of Eucomed, EDMA, and MedTech Europe in November 2015.