Again The Life Science Industry Will Have To Take A Close Look At A New Set Of Regulations Reshaping Transparency-Related Obligations

Author:Mr Daniel Kadar
Profession:Reed Smith (Worldwide)

The relationship between the life sciences industry and health-care practitioners is being reshaped in France through regulatory developments under both the French Anti-Gift Law and the French Sunshine Act.

The regulatory landscape in France regarding the relationship between the life sciences industry and health-care practitioners (HCPs) continues to undergo significant changes.

Transparency requirements are regulated in France by two main sets of regulation: Law No. 93-121 of 27 January 1993 (the "French Anti-Gift Law or French DMOS Law) regulates the provision of gifts, discounts and other incentives to HCPs by life sciences companies, while Law No. 2011-2012 of 29 December 2011 (the French Sunshine Act) imposes on companies disclosure obligations relating to benefits granted to and agreements concluded with HCPs.

While the French Sunshine Act has been frequently amended to reflect subsequent changes brought by implementing decrees, orders, and circulars, the Anti-Gift Law has been less subject to change, at least until now.

Reshaping of Anti-Gift provisions

Changes to the Anti-Gift Law are contemplated in the near future pursuant to the recent adoption of Ordinance No. 2017-49 on 19 January 2017, which aims at extending the scope of the Anti-Gift Law and at changing the procedure related to the prior submission to the national or departmental board of the relevant HCP professional body.

Under its original provisions, the Anti-Gift Law established the principle that HCPs cannot receive any benefits from companies manufacturing or marketing health products that are reimbursed under the French social security system. However, it provided specific exemptions to this general rule by allowing (i) remuneration under agreements related to research activities or scientific evaluation, provided that such remuneration (a) was not calculated proportionally to the number of products prescribed by the HCP concerned and (b) was of a reasonable amount, and (ii) hospitality offered at promotional, professional and scientific events, provided that such hospitality was (a) reasonable and (b) limited to the scientific and professional purpose of the event.

The new provisions expand the scope of the Anti-Gift Law to broadly cover any company manufacturing or marketing health products, regardless of whether or not payment for the products is reimbursed under the French social security system. However, the Anti-Gift Law does not extend to companies...

To continue reading