As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I. As marijuana remains a Schedule I...07 September 2016
Industry - HCP Relations Soon Subject to Tougher Regulations in France?
The French sunshine regulations require the industry players to make public the existence of agreements and benefits they provide to various stakeholders in the health industry.
The above regulations are not all consistent with each other, and this has led to various interpretations between health authorities, professional bodies and the industry. For instance, whereas the sunshine regulations are considered as applicable to foreign companies regardless of whether they sell products or services directly in France, the anti-benefits regulations require a company to sell reimbursed products or services in France (hence the company most often concerned by these regulations being a French affiliate or distributor, and not a foreign parent company or affiliate).
Some concerns have also been raised in the media recently on the efficiency of these regulations and the application of sanctions.
In this context, in the course of the on-going review of a new bill on public health, the government submitted an amendment on 24 September enabling the government to adopt, via an ordinance, modifications to the applicable French regulatory framework. This amendment and the explanatory notes provided by the government suggest modifications on the following points:
- Extension of the range of companies concerned by the regulations to any entity manufacturing or marketing healthcare products or healthcare services;
- Extension of the range of entities concerned by the prohibition to receive benefits;
- Carve outs on benefits not concerned by these regulations, and definition of conditions for their acceptability;
- Redefinition of the exceptions applicable to the benefits that can be granted, and establishment of an authorisation process involving the administration or professional bodies;
- Redefinition and harmonisation of the criminal sanctions and/or setting up of administrative sanctions in case of breach of the regulations;
- Reinforcement of the means to control regulatory compliance and to implement of sanctions.
The French industry has been anticipating the reinforcement of the regulations. This amendment and the regulatory modifications that may follow are likely to deeply transform the industry's compliance processes. In addition, if the scope of the regulations is harmonised to meet standards similar to those under the sunshine regulations, many additional companies, notably foreign ones, may become subject to French anti-benefits regulations even if they do not sell reimbursed products or services in France. The amendment is accessible here (in French).