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.
25 March 2020 - Posted by: Eveline Van Keymeulen
Today, on 25 March 2020, the Commission announced that “The Commission is working on a proposal to postpone the entry into force of the new Medical Device Regulation for one year. We are working hard to submit this proposal early April and we call on Parliament and on Council to adopt it quickly, as the › Read More
Evalve v Edwards – Review of competing public interests in grant of final injunctions
24 March 2020 - Posted by: Marjan Noor
The issue of whether public interest considerations can be relied upon against the grant of a final injunction, or for a carve out in the injunction, is a very live one in disputes in relation to innovative medical devices and pharmaceuticals. In this decision, Edwards argued that, although its PASCAL product used to treat mitral › Read More
French Administrative Supreme Court annuls CEPS decision for market exclusivity reasons
23 March 2020 - Posted by: Eveline Van Keymeulen
On 5 February 2020, the French Administrative Supreme Court (Conseil d’Etat) annulled a decision from the Economic Committee for Health Products (CEPS) from 15 March 2018, considering that it negated the useful effect of the regulation applicable to orphan medicines. Under Article 8 of the Orphan Medicinal Products Regulation ((EC) No 141/2000), a manufacturer who › Read More
Amendment of Belgian legislation on medicines shortages
20 March 2020 - Posted by: Tine Carmeliet
The Law of 20 December 2019 modifying various laws related to medicines shortages was published in the Belgian Official Journal on 3 February 2020. The aim of this law is to tackle certain issues related to the problem of medicines shortages. The Law introduces a set of measures in order to address deliberately created medicines › Read More
Germany lifts Covid-19 prompted export ban for personal protective equipment
19 March 2020 - Posted by: Eda Zhuleku
Today the German Government lifted the export ban for personal protective equipment, including protective masks, that had been instated by the general decree (Allgemeinverfügung) dated 4 March 2020 as amended on 12 March 2020. The purpose of the export ban (to both EU and non-EU countries) was to secure the supply of personal protective equipment in › Read More