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.

Cannabinoid patenting – a rolling stone?

Marc Döring

Late in 2018, medicinal cannabis[1] was downgraded from Schedule 1 to Schedule 2 (medically allowed) in the Misuse of Drugs Regulations in the UK. The resulting flurry of activity in the mainstream news media about the use of cannabinoids and similar substances has been inescapable. Whilst there is arguably still a lot of hype around Read More

China: Amendment to Drug Administration Law

David Shen

On 26 August 2019, the China’s National People’s Congress passed the amended Drug Administration Law (the Amended DAL) which will take effect on 1 December. The new law brings in some changes while codifying many existing practices. We summarise in this article the key highlights, including intellectual property related rules, of the Amended DAL. 1. Redefine Read More

Belgian Constitutional Court suspends sales restriction for wholesale distributors of medicines

Kaat Van Delm

On 18 July 2019, the Belgian Constitutional Court suspended Article 3.2 of the legislation applicable to shortages of medicines in Belgium, after receiving multiple applications for both suspension and annulment of the Article. The Article obliged Belgian wholesale distributors to only supply their medicines for human use to other Belgian wholesale distributors, licensed pharmacies or Read More

Modification and simplification of the reimbursement evaluation procedure for certain medicinal products

Laëtitia Bénard

On 3 July 2019, a new Decree was published which modifies the evaluation procedure of generic and biosimilar medicines by the Transparency Commission of the High Health Authority (HAS). This Decree seeks to simplify the assessment procedures of such medicines in order to speed up their financing by French Social Security. The principle set out Read More

Germany Improves Patients’ Access to Medical Cannabis

Eda Zhuleku

The new Law for More Safety in the Supply of Pharmaceuticals in Germany (Gesetz für mehr Sicherheit in der Arzneimittelversorgung- GSAV) which has been in force since 16 August amends the law regarding the prescription and sale of medical cannabis in Germany. Since 10 March 2017, it has been possible for medical cannabis to be prescribed Read More