Our Paris Life Sciences team has completed an analysis of trends the different trends in the health industry sector and has written an article, published in the Life Sciences Guide of Chambers and Partners, that provides an overview of the legal situation (see link below).
The main themes identified were as follows:
- increased drug shortages (+30% in 2017);
- increase in penalties issued by the French health authorities including a decision that ordered a pharmaceutical company to pay a fine of €350,000 because it did not set up a shortage-management plan for a product;
- GDPR and its impact on clinical trials and in particular on the publication of new reference methodologies;
- emergence of telemedicine whose acts are now reimbursed by the French social security system;
- new constraints to which healthcare companies are subject in their relations with healthcare professionals as a result of Transparency and the "anti-kickback statute" illustrated by a decision of the Besançon Court of Appeal.