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.

New Belgian Healthcare Act: Impact on the health sector

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

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

French pharmacist representatives call for implementation and expansion of biosimilar substitution

Eveline Van Keymeulen

On 12 December 2018, seven representative pharmacy organisations (ANEPF, USPO, FSPF, APR, Federgy, le Collectif and UDGPO) addressed a joint letter to the French Health Ministry to call for the implementation of biosimilar substitution in France. While the principle of biosimilar substitution at the initiation of treatment has been established in French law since 2014, Read More

MHRA provides further guidance on no-deal Brexit plans

Jacqueline Bore

The MHRA has issued updated guidance on its plans for the regulation of medicines, medical devices and clinical trials in the event that the United Kingdom leaves the European Union on 29 March 2019 without any agreement on its future relationship with the EU and, therefore, without any transitional period. The guidance reflects responses to Read More

New formulations of existing active substances are not entitled to an SPC according to Advocate-General

Toby Sears

The Opinion of Advocate General Saugmandsgaard Øe in Abraxis Bioscience (Case C-443/17) was delivered on 13 December 2018.  The Advocate General concluded  that the UK Intellectual Property Office had been  correct in declining to grant a Supplementary Protection Certificate (SPC)  to Abraxis for a novel formulation of an active substance which had already been the Read More