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.

UK Court of Appeal asks the CJEU when Markush claims will be sufficiently specific for Article 3(a) of the SPC Regulation

Steven Baldwin

The Appellants in this action, Sandoz and Hexal, are appealing Arnold J’s decision to uphold SPC/GB07/038 on the basis that the Markush formulae in the basic patent are sufficient to satisfy the requirements of Article 3(a) of the SPC Regulation (Regulation (EC) No 469/2009). We have previously commented on the facts here and the first Read More

EU General Court rules on transparency of clinical trial data

Marco de Morpurgo

Today, the General Court delivered three landmark judgments relating to transparency of clinical trial data in the EU.  The long-awaited rulings clarify the scope of commercial confidentiality with regard to data pertaining to centrally approved medicinal products and included in the MA application dossier.  The three rulings uphold the European Medicines Agency (EMA)’s decisions to Read More

France issues guidance on reporting non-compliant prescribing or use of medicinal products

Eveline Van Keymeulen

On 22 December 2017, the National Agency for Medicines and Health Products Safety (ANSM) published guidelines to assist pharmaceutical companies when reporting intentional non-compliant prescribing or use of medicinal products. Non-compliance can in particular relate to the indication, patient characteristics, administration route or posology of the products. French law requires pharmaceutical companies to report to Read More

Belgium: Digital platform for medical files to be launched

Tine Carmeliet

In early January 2018, the Belgian Minister of Health published an announcement on the creation of a digital platform called the “Personal Health Viewer”. The goal of this digitalisation initiative is to engage patients in the management of their own health. In particular, the platform will enable patients to access their own medical file online and Read More

EMA survey of UK based pharmaceutical companies on Brexit plans

Jacqueline Bore

Yesterday, the European Medicines Agency (EMA) announced its plan to consult all marketing authorisation holders of centrally authorised products that are located in the UK or who have an important part of their site operations in the UK on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of Read More