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 Senate issues recommendations to tackle pharmaceutical supply disruptions

Eveline Van Keymeulen

In October 2018, the French Senate published a report on supply disruptions of medicinal products and vaccines. The report provides recommendations to combat the causes of such disruptions, which have increased by 30% since 2016, and to secure sufficient stock. In particular, the report proposes to: Set up tax exemptions for companies investing in French manufacturing Read More

French regulator (ANSM) introduces fast-track authorisation procedures for clinical trials

Eveline Van Keymeulen

On 15 October 2018, in preparation for the application of the EU Clinical Trials Regulation, the National Agency for Medicines and Health Products Safety (ANSM) introduced two fast-track procedures to allow faster patient access to innovations. The Clinical Trials Regulation is expected to become applicable in 2020. Fast-track procedure 1, “access to innovation”, aims to Read More

CJEU confirms that prior authorisation for a drug-incorporating device is not an MA under the SPC Regulation

Michael Krenz

The Court of Justice of the European Union (CJEU) has ruled that a supplementary protection certificate (SPC) cannot be granted for a medical device comprising an active ingredient because the EU authorisation procedure for devices does not result in a marketing authorisation (MA). The request was made in proceedings brought by Boston Scientific Ltd. and Read More

Belgium: Mobile health apps can now be published on mhealthbelgium.be

Kaat Van Delm

From the end of October 2018 onwards, companies can apply for publication of their mobile health-applications (mhealth apps) on the governmental website “mhealthbelgium.be“. The website aims to encourage mobile health and make mhealth patient care an integrated pillar of the healthcare sector. It has been created through cooperation among Belgian authorities for food, medicines and Read More

Rethinking the Growth Capital Challenge in UK Life Sciences

Matthew Appleton

Investors, entrepreneurs and deal makers in the UK Life Sciences industry met on the 28 September 2018 to share ideas on how to close the funding gap which exists for UK businesses in the period between early stage investment and IPO. At a lively panel discussion sponsored by LSX Connect and hosted by Allen & Read More