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.

Cannabis – What is being patented?

Marc Döring

The past few years have seen a global trend towards the liberalisation of cannabis policies, with cannabis becoming legalised in numerous countries and US states for recreational and/or medical use. Cannabis is currently authorised for medicinal use in more than 25 countries, including Australia, Canada, Germany, the Netherlands and the UK. And while recreational use Read More

Europe: Medical Devices Coordination Group issues guidance on the classification of software as a medical device

Jacqueline Bore

The Medical Devices Regulation, the “MDR”, which comes largely into force in May 2020, will introduce significant changes to the way in which software used in a medical context will be regulated in the European Union. The medical devices industry has been eagerly awaiting additional guidance on how these new provisions are likely to be Read More

Slovak parliament rejects draft law which would soften regulation of CBD (cannabidiol)

Zuzana Hecko

In August 2019, the Slovak government introduced a draft law which suggested removing CBD (cannabidiol) from the list of psychotropic substances. The draft law therefore attempted to make CBD a non-regulated substance. The draft law was, however, subsequently rejected by the Slovak parliament. Act No. 139/1998 Coll. (the  Narcotics Act) places CBD in the same Read More

France: Draft 2020 Social Security Financing Bill encourages price cuts and biosimilar uptake

Eveline Van Keymeulen

In order to ensure savings for the healthcare system in 2020, French legislators are encouraging biosimilar uptake and price cuts. The draft 2020 Social Security Financing Bill (2020 PLFSS) introduces new measures that tackle tactics developed by medicinal product originators, which consist of offering low prices for biological brands to healthcare institutions as a way Read More

France: Industry calls for moratorium on price cuts

Eveline Van Keymeulen

Following the shortage of medicines announcement made on 25 September 2019 by the French Prime Minister and the Minister of Health (See our previous blog posts: French government determined to sanction pharmaceutical companies for shortages of medicines and Draft 2020 Social Security Financing Bill encourages price cuts and biosimilar uptake), the French pharmaceutical industry association Read More