The awaited decision of the EU Member States on the new home for the European Medicines Agency (EMA) was published today. The final destination, Amsterdam, does not come as a complete surprise, despite the fact that the key institutions involved in the process, the Commission, the EMA and the Council, have consistently avoided naming preferred locations. As of today, the EMA has 17 months to conclude its move and take up its operations from Amsterdam by the end of March 2019.

The decision to relocate the EMA, although a consequence of the UK’s decision to leave the EU, does not form part of the Brexit negotiations. The procedure leading up to a decision on the relocation of the EMA was proposed by the Presidents of the Commission and the Council and was endorsed at the European Council meeting of 22 June 2017. Member States had up to the end of July 2017 to submit their offers to host the Agency.  Nineteen Member States put in bids.Continue Reading EMA’s New Home

EU Life Sciences: Product Liability Update

Please join us on 28 November 2017 for our Product Liability Update. This full-day seminar will provide in-house counsel with key insights into the latest developments in product liability and related areas in the context of medicinal products and medical devices. Our EU Life Sciences team will discuss issues

Last month, the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP). During the DCP, the Reference Member State (RMS) has primary responsibility for preparing the assessment report on the medicinal product, and CMSs can raise questions or objections on the grounds of a potential serious risk to public health. This case, a referral from the Finnish Court, asks whether, and if so how, administrative and legal questions, such as the length of the regulatory data protection period, should be resolved in the CMSs, considering that national marketing authorisations (MA) are granted at the end of the DCP.

The hearing highlighted that the Member States and Commission do not agree as to the interpretation of the legislation and case law, and there is a real dispute for the Court to answer. The Advocate General has said he will deliver his opinion on 30 November.

Continue Reading European Court considers role of Concerned Member States

We have previously reported on the European Medicine Agency’s (EMA) increased focus on the area of personalised medicines. The original blog post can be found here.

The EMA and the Committee for Medicinal Products for Human Use (CHMP) has now released for consultation a concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle. The use of predictive biomarkers is an aspect of personalised medicine used to decide treatment or dose selection.Continue Reading Update on personalised medicines: Predictive biomarkers

Traditional medicine applies the same treatment approach to all patients affected by a disease (‘one size fits all’). However, we are all unique. Our health is determined by our inherited genetic differences combined with our lifestyles and other environmental factors. Personalised medicines are medicines that are targeted to individual patients based on their genetic make-up.

Variants in our genetic code can also be used to predict the potential for adverse drug reactions. For example, the hyper-sensitivity experienced by certain patients to the HIV drug Abacavir has been found to be linked to a particular genetic variant, allele HLA-B5701. The requirement that patients take a test to ensure this allele is absent before being given Abacavir has greatly reduced the incidence of hyper-sensitivity.

Since 2011, personalised medicine has been on the agenda of the European Commission, which has committed two billion Euros of health research funding to the cause. Personalised medicine has been defined by the European Council as a “Medical model using characterisation of individuals’ phenotypes and genotypes or tailoring the right therapeutic strategy for the right person at the right time, and to determine the predisposition to disease and/or deliver timely and targeted prevention, and it relates to the broader concept of patient-centred care, which takes into account that, in general, healthcare systems need to better respond to patient needs.”Continue Reading Update on personalised medicines