At the end of May 2013, the French government released the long awaited Decree implementing the 2011 French Sunshine Act. The Decree requires companies to publicly disclose — in French — any benefit over 10 Euros and agreements (except commercial ones) concluded with healthcare professionals or other actors active in the health sector in France.
A transitional regime has been set up pending the designation of a competent authority and the establishment of a centralised website for public disclosure of all information covered by the French sunshine rules. Under the transitional regime, companies are required to report benefits and agreements granted or concluded with healthcare professionals (HCP), HCP associations and healthcare students to the relevant professional councils, which then publish the information on their websites. Companies are also required to publish all information covered by the sunshine obligations on their own websites. In the future, companies will only need to communicate such information to the newly designated authority that will publish the information on its new website.
The French rules apply to the medical devices industry. More precisely, they apply to companies producing or marketing, or performing services related to the following, among other things:
- contraceptive and contragestive products;
- medical devices;
- IVD medical devices;
- products used for the maintenance or application of contact lenses;
- non-corrective contact lenses;
- ancillary therapeutic products;
- software that — although not a medical device — is used by a medical biology laboratory for the management of medical biology testing and during the validation, interpretation, communication and filing of the results;
- devices, without a strictly medical purpose, used in laboratories of medical biology for carrying out medical biology testing.
For non-corrective lenses — which expressly fall under the scope of the new Proposal for a new EU Regulation on Medical Devices — a more limited disclosure regime applies than for the other types of listed products.
An interpretative Guideline was published by the Ministry of Health at the end of May. While clarifying certain issues — e.g. non-disclosure of fees for services, scope of reporting obligations, avoidance of multiple reporting — other points remain unclear. This is for instance the case of the exact territorial scope or the extent to which commercial agreements are excluded from the reporting obligations.
The French association of the pharmaceutical industry (“LEEM”) recently published Guidance on the publication of the relationships between HCPs and pharmaceutical companies, which provides additional guidance on the reporting obligations as well as some case studies.
The National Council of Doctors (CNOM) has also released a Guideline on the practicalities for the transmission of reportable information (“Proposition des modalités et du format de transmission des information relatives aux liens d’intérêt”). This guideline provides very useful information on the collection and transmission of the relevant information, as well as templates for reporting. In particular, it is recommended to provide the information on a CD-Rom, including separate files containing the details of the declaring company, declarations per category of beneficiary (individuals, legal persons and students), and, if required, the programme of sponsored scientific events.
The next deadlines for reporting and disclosure under the transitional regime are as follows:
- public disclosure — on the website of the reporting company and of the relevant professional council — by 1 October 2013 for benefits granted and agreements concluded during 2012 and the first 6 months of 2013;
- benefits and agreements of the last 6 months of 2013 to be reported to the relevant professional councils by 1 February 2013, for a public disclosure by 1 April 2013.
For more information about the French Sunshine rules, please consult our E-alert.