On 20 January 2017, an order relating to transparency of the benefits offered by companies manufacturing or marketing health products or services to healthcare actors (Order) was published in the Official Journal. The Order implements Article 180 of the Health Reform Act of 26 January 2016 (Loi de modernisation de notre système de santé), which aimed to further enhance transparency in the French healthcare system. The Order, which will enter into force by 1 July 2018, or on an earlier date to be determined by decree, significantly amends the existing French anti-gift legislation laid down in Article 4113-6 of the French Public Health Code.
First and foremost, the scope of the “anti-gift” provisions is no longer restricted to companies that manufacture, market or provide services in relation to products reimbursed by compulsory health insurance. The rules now apply unambiguously to any company manufacturing or marketing healthcare products (excluding cosmetic products) or providing healthcare services, regardless of the reimbursement status of the products.
Further, the existing “prior opinion system”, supervised by relevant professional councils, has been replaced by a “prior authorisation system”, supervised by either the relevant professional councils or competent authorities. Relevant agreements will need to be submitted for prior authorisation if their value is above a threshold to be set by a ministerial order which is yet to be made. The communication of agreements is facilitated by the use of electronic transmissions (with the exception of clinical trial agreements).
In addition, the Order clarifies the role of public authorities in charge of investigating possible breaches to the anti-gift regulations and provides for tougher criminal sanctions in case of non-compliance (a fine of up to EUR 750,000 for companies and two years of imprisonment for individuals).
The Order supplements the recently published transparency decree, which extends the transparency obligations for life sciences companies, by requiring the disclosure of any remuneration provided in agreements with healthcare actors.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2017 Issue (Thomson Reuters).