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.

Rewarding innovation: pharmaceutical incentives as a crucial instrument to foster public health

Laëtitia Bénard

Pharmaceutical law aims to promote public health both by ensuring the highest standards of safety in medicinal products placed on the market and by encouraging the research and innovation that will lead to new treatments. European Union legislators have supported Member States in achieving these aims but have been careful to introduce measures in such Read More

Getting ready for the EU MDR: New obligations for Notified Bodies

Eveline Van Keymeulen

In this post of our “Getting ready for the EU MDR” series, we look at some key changes concerning Notified Bodies introduced by the Medical Devices Regulation (MDR), and how they may affect medical device manufacturers. Some of these changes are already taking place and some will happen in the near future. Designation and monitoring Read More

Dutch Data Protection Agency issues guidance on large-scale data processing in healthcare

Iradj Nazaryar

Last month, the Data Protection Agency (DPA) issued guidance on large-scale healthcare data processing. The General Data Protection Regulation requires organisations involved in large-scale processing of data to appoint a Data Protection Officer (DPO) and in certain cases to conduct a Data Protection Impact Assessment (DPIA). In this respect, the guidance clarifies when healthcare providers are Read More

France debates measures to facilitate early access to medicines

Eveline Van Keymeulen

On 13 June 2018, the committee in charge of assessing social security financing laws at the French Senate submitted a report on early access to new medicines to the Senate Presidency. The report assesses the conditions applicable for making new treatments accessible at all stages (from clinical trial to authorisation and marketing) and provides recommendations that Read More

Revised French Personal Data Protection Act: Constitutional Court upholds health related provisions included in the bill

Laurie-Anne Ancenys

On 22 June 2018, a new law entered into force, after the French parliament amended the personal data protection bill to reflect a decision of the French Constitutional Court. The court had indeed earlier upheld the majority of the provisions of the French personal data protection bill, which amends Act n. 78-17 on Information Technology, Read More