Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.

AI in health: the launch of the French Health Data Hub

Laurie-Anne Ancenys

The French Office parlementaire d’évaluation des choix scientifiques (the Office) has published a report on artificial intelligence and health data following the public hearing organised in February 2019, in the form of two round tables on artificial intelligence and health data. The hearing, attended by AI researchers, entrepreneurs, public and private stakeholders of the health Read More

Dutch competition authority extends excessive pricing inquiry to consider possible supply restrictions on orphan ingredients

Francesca Miotto

Last week, the Dutch Authority for Consumers and Markets (ACM) announced that it is investigating whether the Italian pharmaceutical company Leadiant Biosciences restricted the supply of an important raw material for a patented orphan drug, by entering into exclusive agreements with an unnamed supplier. Such supply restrictions for raw materials could, according to the ACM, Read More

New Dutch Policy rule on the interpretation of “medical device”

Alex Crespo van de Kooij

The Dutch Health Minister has introduced a Decision setting out a policy rule on the interpretation of the definition of medical device (medisch hulpmiddel), as laid down in the Act on medical devices (Article 1, first paragraph, under a). The Decision was published on 4 April 2019 and entered into effect on the same date. Read More

French Competition Authority delivers its opinion on consumer supply of medicines

Eveline Van Keymeulen

On 4 April 2019, the French Competition Authority delivered its opinion on the distribution of medicines to consumers, following several months of investigation and an extensive public consultation. According to the Authority, the consumer supply of medicines sector is particularly important to the French economy and is evolving rapidly and significantly. This evolution is due Read More

New German Appointment Service and Supply Act: Implications for investors in the dental industry

Eda Zhuleku

On 14 March 2019, the German Parliament (Bundestag) adopted the German Appointment Service and Supply Act (Terminservice- und Versorgungsgesetz; TSVG), which will come into force in May 2019, as the German Federal Council (Bundesrat) did not veto the law. During the legislative process, it was feared that the Act would have significant impact on the Read More