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.

French regulator (ANSM) imposes major financial penalty on a pharmaceutical company for shortage of medicine

Jeanne Fabre

The National Agency for Medicines and Health Products Safety (ANSM) recently published its decision of 28 December 2018, imposing a major financial penalty of EUR 348,623 on a pharmaceutical company for a breach of its obligation to supply the national market in an appropriate and continuous manner, and to prevent and avoid any supply difficulties for Read More

Positive outcomes of third evaluation of Dutch Act on Medical Research involving Human Subjects

Anna-Maria Withagen

On 9 January 2019, the Dutch Minister of Health, Welfare and Sports published its report evaluating, for the third time, the Dutch Act on Medical Research involving Human Subjects (WMO). According to the report, the overall functioning of the WMO is satisfactory. As per the evaluation, the goal of the WMO, which is to protect Read More

Coordination amongst member states on medicines’ prices supported by the European Commission

Nele De Backer

European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission will support national competition authorities in their probes against excessive pricing practices in pharmaceutical markets. In addition, the European Commission will continue to monitor pharmaceutical markets itself, as part of its competition policy, and is ready to act against infringements of Read More

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