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.

EU Competitiveness Council to review Current Status of the Unitary Patent and Unified Patent Court

Laëtitia Bénard

The Council of the European Union has published a note, from the Presidency to the Council, entitled “Unitary Patent and Unified Patent Court – Information from the Presidency on the state of play”. The note relates to the upcoming meeting of the Competitiveness Council on 30 November, and explains as follows: “The Presidency will give Read More

French Competition Authority launches sector inquiry into medicinal products and biomedical laboratories

Patricia Carmona Botana

On 20 November 2017, the French Competition Authority (FCA) launched a sector inquiry into medicinal products and medical biology (biomedical) laboratories in France.  As previously announced, the inquiry aims to address the challenges that the sector entails for the French insurance system and public health and to assess the feasibility of more competitive conditions with Read More

European Medicines Agency heads for Amsterdam

Frits Gerritzen

Today the 27 member states of the European Union have decided on Amsterdam as the new home of the European Medicines Agency. The decision came after three rounds of voting, with Amsterdam eventually emerging the winner after tying with Milan on 13 votes each in the final round. It appears that Slovakia may have abstained. Read More

France sets up committee to combat cyber-attacks on medical device software

Eveline Van Keymeulen

The French regulator for medicines and health products (ANSM) recently announced the creation of the first temporary specialised scientific committee (CSST) on cyber-security for medical device software.  The CSST is composed of external experts in information technology and cyber-security.  It provides recommendations to the ANSM’s general director, intended for manufacturers of medical device software, with Read More

Chinese medicinal product approval reform announced

David Shen

The Chinese central government rolled out a 36-points reform plan for Chinese medicinal products and medical devices approval system on October 8. Notably, China will adopt a US style patent linkage system including an automatic stay for patent challenge, start a pilot program for patent term extension and encourage patent challenges by generics.  This will Read More