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.
Majority of invented names for medicinal products rejected
04 August 2017 - Posted by: Eveline Van Keymeulen
In 2016, more than half of the proposed invented names for centralised medicinal products were rejected (246 rejections to 241 acceptances), and this trend continues in the first half of 2017. Invented names for centralised medicinal products are reviewed by the Name Review Group (NRG) of the European Medicines Agency (EMA), which meets approximately every › Read More
France envisages joining BeNeLuxA initiative
03 August 2017 - Posted by: Eveline Van Keymeulen
According to recent statements of the Dutch Minister of Health, the French Minister of Health indicated during the last meeting of the Council of the European Union that France is considering joining the BeNeLuxA initiative, the collaboration between the Belgian, Dutch, Luxembourg and Austrian governments on pharmaceutical policy. If France joins the initiative, the new › Read More
UK ICO investigation into the Royal Free’s use of patient data used as an opportunity to educate
28 July 2017 - Posted by: Charlotte Mullarkey
In a case which has wide implications for the health care sector, the UK Information Commissioner’s Office (ICO) has ruled that the Royal Free NHS Foundation Trust failed to comply with the UK Data Protection Act when it provided personal data of about 1.6 million patients to Google DeepMind. The personal data was provided as › Read More
European Commission seeks public views on health and care in the Digital Single Market
27 July 2017 - Posted by: Patricia Carmona Botana
Last week, the European Commission (EC) launched a public consultation which main purpose is to define potential policy measures on digital initiatives (i) supporting the transition from a hospital-based healthcare model to a person-centred and integrated model and (ii) contributing to the sustainability of EU Member States’ healthcare systems. The EC considers that digital innovation › Read More
CJEU vaccine ruling: medical evidence not a prerequisite under the Product Liability Directive
26 July 2017 - Posted by: Julie De Keukeleire
On 21 June 2017, the Court of Justice of the European Union (CJEU) issued its judgment in the product liability case N. W and Others v Sanofi Pasteur MSD and Others (C-621/15). The CJEU found that a defect in a product and the causal link between the defect and the damage suffered may be proven › Read More