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In late 2014, the trade associations for the Med-Tech and Diagnostics industries in Europe have recommended phasing out by 1 January 2018 all direct sponsorship of HCPs to attend educational conferences organised by third parties, as well as introducing stricter rules to control indirect sponsorship. The announcement by the European Medical Technology Industry Association (Eucomed) and the European Diagnostics Manufacturers Association (EDMA), which joined forces in 2012 to create the umbrella organisation MedTech Europe, will give legal and compliance officers plenty of food for thought, in an industry where reimbursing an HCP’s travel, accommodation and conference registration expenses has for many years been a routine part of doing business.  While the prohibition on direct sponsorship would not come into force until 2018, we anticipate it will be introduced in a revised Code of Ethical Business Practice to be proposed for adoption in November of this year. MedTech Europe insisted in a press release that it remained “committed to supporting continuous medical education (CME) for HCPs” and had “already begun and will intensify a comprehensive consultation process with HCP organisations and other relevant stakeholders at European and national levels to elaborate alternative models of CME and support“. Indirect sponsorship, where companies make grants to medical societies, hospitals, conference organisers (etc.) for them to determine which HCPs to invite, will remain permissible but will be made subject to “stricter self-regulation measures” and it is MedTech Europe’s intention to implement these measures “as soon as possible“. These proposed changes to the Code will apply only to sponsorship of passive attendances of HCPs at conferences organised by third parties. The practice of contracting with HCPs to present at conferences and provide other paid-for services will not be affected… for now. However, the desire of MedTech Europe to reinforce compliance is clear and it has said that “other elements of the relationship between industry and HCPs are currently being reviewed and [the Code] will be adapted to reflect the changing legal and compliance environment“.

Author

Tim Pountain-Holes is a solicitor-advocate practising in Baker & McKenzie's Dispute Resolution Department and Pharmaceuticals & Healthcare industry group. He has a broad practice advising corporate clients on a variety of contentious and regulatory matters, providing practical advice and solutions in respect of everyday legal issues right through to complex, high-value disputes. Tim is experienced in commercial litigation, product liability, white collar crime, public/administrative law and regulatory compliance. He advises clients across many sectors, with a particular focus on health and life sciences.

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