Over the past few years, several scandals (e.g., Poly Implant Prothèse (“PIP”) breast implants, Mediator weight-loss drug, etc.) have tarnished the public perception of France’s healthcare sector and raised serious questions about the independence of medical decision-making by practitioners. As it sets a new course, France is now at the European forefront of increasing the transparency in the delivery of healthcare. Recently-passed reform measures and others currently under consideration promise to further increase the already significant reporting and disclosure obligations of pharmaceutical and medical device companies interacting with French healthcare professionals or healthcare organizations. We describe the key developments and trends below.
First, by way of background, as early as 1993, France adopted the so-called “anti-gift rules” (Article L4113-6 of the French Code of Public Health, as successively amended), which apply to companies providing services, manufacturing or marketing products that are reimbursed by the compulsory health insurance system. They contain a general prohibition against offering benefits to healthcare professionals, medical students, or associations representing them, with the exception of compensation for research or scientific services and hospitality offered in connection with professional and scientific meetings. All agreements between Healthcare Professionals (“HCP”) (or medical students) and companies must obtain an opinion from the relevant professional council prior to their execution. As an illustration, in 2014, the criminal court of Nanterre imposed a fine of €100,000 on a pharmaceutical company for infringement of the anti-gift rules.
In 2011, France further completed its regulatory framework and passed the Act No 2011-2012 of 29 December 2011, with the intent of enhancing transparency in the interactions between healthcare professionals and industry. One of the key objectives pursued by this legislation was to impose “sunshine-like” obligations on companies to minimize potential conflicts of interest. Since January 2012, all companies manufacturing, marketing or providing services relating to healthcare products (including medical devices) must report and publicly disclose the benefits granted to and agreements entered into with HCPs and healthcare organizations (“HCOs”). In parallel, the Act No 2013-907 of 11 October 2013 on transparency in public life incorporated the term “conflict of interest” into French Law, defining it as “any situation that causes interference between a public interest and public or private interests, which could influence or appear to influence the independent, impartial and objective performance of a duty.”
Despite the legislative changes and resulting progress made in this area, recent developments have revealed that there is still room for improvement. In particular, two reports issued in March 2016 evaluated the existing regulatory framework and, finding certain concerning issues, suggested paths for reforms. The first report (“La prévention des conflits d’intérêts en matière d’expertise sanitaire”) was based on a study conducted by the French Court of Auditors, which highlighted “massive loopholes” in the current legislation. The second report (“Les conflits d’intérêts au sein de l’AP-HP”) was based on a study carried out by a task force of the AP-HP (the Paris public hospitals system, one of the largest hospitals group in Europe) and identified several “risk situations” likely to jeopardize HCPs’ neutrality. Among other things, the raised concerns focused on the influence of medical sales representatives on HCPs’ prescriptions, the opaque funding of permanent medical education and research activities, and the risks of conflicts of interest within French regulatory bodies (e.g., Comité économiques des produits de santé (“CEPS”), etc.).
According to the Court of Auditors, in 2014, 967 companies disclosed information on the transparency database (compared to 776 in 2013). Companies paid approximately €184 million in benefits and entered into more than 727,000 agreements with HCPs/HCOs. The average value of the benefits was approximately €102 per recipient. The AP-HP report highlighted that companies annually spend approximately between €30 and €40 million to cover the costs of AP-HP professionals attending scientific events.
Earlier this year, with the passage of the Health Reform Act No 2016-641 of 26 January 2016 (“Loi de modernisation de notre système de santé”), France has taken several additional actions to further enhance transparency in its healthcare system and strengthen the existing regulatory framework:
- Expansion of the Sunshine rules. The amended Article L1453-1 of the French Code of Public Health expands the scope of disclosure and reporting obligations. Companies are required to disclose on a public website (1) any benefits to HCPs/HCOs with a value equal to or above a certain threshold that will be determined by a decree under preparation (the current threshold is 10 Euros), (2) any agreements (with the exception of certain commercial agreements for the supply of goods or services, e.g. agreements between distributors and suppliers), but also (3) any fees that exceed a certain threshold that will also be determined by decree. Companies that produce, market or provide services relating to non-corrective lenses, cosmetics and tattooing products must publicly disclose the safety assessment agreements and biomedical research agreements with HCPs and HCOs. The re-use of the disclosed data by third parties for purposes relating to transparency will also be facilitated. As the Court of Auditors ultimately points out, the transparency website may therefore turn out to be a powerful tool to regulate the healthcare sector.
- Expansion of the Anti-gift rules. Currently the anti-gift provisions described above apply only to companies providing services, manufacturing or marketing products that are reimbursed by the compulsory health insurance system. In 2015, the Conseil National de l’Ordre des Médecins issued a favorable opinion in 95% of cases involving hospitality agreements, but a negative opinion in 71% of cases involving agreements for services. Among other reasons, negative opinions were associated with what was viewed to be excessive fees paid to HCPs in return for work actually performed. A decree currently under preparation is expected to considerably amend the anti-gift legislation. First, the scope of the anti-gift provisions may no longer be restricted to companies that manufacture, market or provide services in relation to reimbursed products, but may cover any company manufacturing or marketing healthcare products or providing healthcare services, regardless of the reimbursement status of the products. Second, the existing prior opinion system is likely to be replaced by a prior authorization system supervised by the relevant professional councils. The communication of agreements to professional councils will also be made easier with a possibility of electronic transmissions.
Finally, other initiatives are currently under discussion. In particular:
- Stricter controls on the interactions between medical sales representatives and HCPs. The AP-HP is considering amending its internal policy in order to impose stricter rules and controls on medical sales representatives when they interact with AP-HP professionals. Meetings of sales representatives with AP-HP professionals would notably be subject to prior authorization and be closely monitored.
- Third parties acting as intermediaries. Both the Court of Auditors and the AP-HP recommend that hospital research foundations intervene as intermediaries in order to limit direct interactions between HCPs and healthcare companies. In this respect, such foundations would notably centralize funding and then proceed to their internal reallocation among services.