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.

EDPB opinion on GDPR and Clinical Trials Regulation clarifies the basis for processing personal data in a clinical trial context

Emma Keeling

On 23 January 2019, the European Data Protection Board (the EDPB) adopted an opinion on the interplay between the EU Clinical Trials Regulation (536/2014) (the CTR) and the General Data Protection Regulation (2016/679) (the GDPR) (the Opinion). The Opinion aims to provide greater certainty for those conducting clinical trials, clarifying: the distinction between consent requirements Read More

French 2019 Social Security Financing Act introduces new healthcare measures

Eveline Van Keymeulen

The 2019 Social Security Financing Act (2019 LFSS), mostly validated by the French constitutional court on 21 December, was published in the French Official Journal on 23 December 2018. The LFSS introduces, among other things, the following key measures: Creation of hybrid medicines as a new category (Article 66): the French Public Health Code is Read More

New Belgian life sciences regulations on pricing and clinical trials published

Tine Carmeliet

Two new Belgian regulations relevant to life sciences stakeholders were published in the Belgian Official Journal on 31 December 2018. A Ministerial Decree adopted on 21 December 2018 has amended the Ministerial Decree of 17 June 2014, which sets the maximum prices for medical implants, refundable and non-refundable medicines, generic medicines and medicines that are imported Read More

French State held liable in PIP case

Eveline Van Keymeulen

On 29 January 2019, in an instance brought by a victim in the infamous case of defective (Poly Implant Prothèse) PIP breast implants, the Administrative Court of Montreuil held the French State liable, considering that AFSSAPS, the predecessor of the current National Agency for Medicines and Health Products Safety (ANSM), did not “take the necessary Read More

European Commission issues report on antitrust enforcement in the pharmaceutical sector

Dominc Long

A decade on from its inquiry into the pharmaceutical sector in 2009, on 28 January 2019 the European Commission (EC) issued a report providing an overview of antitrust law enforcement (antitrust and mergers) in the EU from 2009-2017 in the pharmaceutical sector. The report confirms that effective enforcement of EU antitrust rules in the sector Read More