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.
29 January 2019 - Posted by: Francesca Miotto
Last week, a spokesperson for the Belgian consumer association Test Aankoop/Test Achats announced that the association is likely to lodge a complaint with the Belgian Competition Authority against the Italian pharmaceutical company Leadiant. Allegedly, Leadiant abused its dominant position in the market for chenodeoxycholic acid (CDCA), the active substance in the treatment of the rare › Read More
French regulator (ANSM) introduces third fast-track authorisation procedure for clinical trials
25 January 2019 - Posted by: Eveline Van Keymeulen
Following the introduction of two fast-track procedures to allow faster patient access to innovations in preparation for the application of the EU Clinical Trials Regulation, the National Agency for Medicines and Health Products Safety (ANSM) implemented another fast-track authorisation procedure (see our previous update, ANSM introduces fast-track authorisation procedures for clinical trials). On 5 December › Read More
Dutch Model agreement for cooperation between hospitals and private clinics published
23 January 2019 - Posted by: Alex Crespo van de Kooij
In December 2018, the Medical Specialist Federation (FMS), the Dutch Hospital Association (NVZ) and Private Clinics Netherlands (ZKN) published a model agreement regarding the cooperation between hospitals and private clinics. The parties aim to enable hospitals and clinics to reach clear agreements on cooperation in relation to the transfer of medical care of patients, accessibility › Read More
New Belgian Healthcare Act: Impact on the health sector
21 January 2019 - Posted by: Veerle Pissierssens
The Belgian law of 30 October 2018 concerning several amendments to legislation applicable in the healthcare sector (the Healthcare Act) was published on 16 November 2018. The Healthcare Act introduces the following changes: Introduction of mandatory electronic prescriptions. However, a royal decree has yet to set the date for the introduction of the electronic prescription › Read More
Key developments in relation to new Chinese IP tribunal rule and Chinese patent law amendment
18 January 2019 - Posted by: David Shen
Recently, there have been some key developments in the intellectual property sphere in China that may be relevant to life sciences clients. Below we report on the new Chinese IP tribunal rule and an important Chinese patent law amendment. New Chinese IP tribunal rule The Standing Committee of the National People’s Congress previously announced the › Read More