In a congress the 13th of November jointly organized by the French Association of Pharmaceutical Manufacturers (Leem) and the French Association of Med-Tech Manufacturers (SNITEM), the General Directorate for Health (DGS) stated that the publication of the implementing Decree for the French Sunshine Act is expected in January 2013 and not in December 2012 as previously announced.
This Decree will likely provide that its provisions will be enforceable 6 months as from the date of its publication, for the purpose of enabling the industry to prepare all the information that must be disclosed pursuant to the Sunshine Act.
Subject to the final provisions of the implementing Decree:
- The first disclosure by the industry could thus be required only in July or August 2013 and will likely have to cover the interactions with HCPs occurred during the first 6 months after the publication date for the implementing Decree. In consequence, all the interactions with HCPs occurred in 2012 could remain out of the scope of the disclosure obligation.
- Regarding the contracts with the HCPs, the Decree may clarify that the disclosure obligation is limited in scope to a summary of the purpose of each contract, with no obligation to mention the remuneration paid to the HCPs pursuant to such contracts.
- The Ministry Of Health, possibly jointly with the Ministry of Finances, will also publish in the same time an interpretative guideline (namely “circulaire”) that could state that the information to disclose is limited to interactions between French HCPs and French companies, for the purpose of clarifying for example that (i) a clinical trial agreement between a French investigator and a sponsor located in the USA or (ii) the “hospitality” offered for a medical congress to a French HCP by a company located in the UK remain out of the scope of the disclosure obligation.
- However, the CNOM (French Professional Association of Physicians) disagrees with this approach, pointing out that it shall bring opacity in interactions with HCPs as opposed to the objective of improving transparency followed by the legislator.
The draft Decree will also be submitted to the CNIL (French Data Privacy Agency) for prior opinion regarding privacy as the Decree provides that the companies will be obliged to namely identify all the HCPs with whom they have interacted.
For further information regarding the French Sunshine Act, please click here to access to our previous legal alert.