Libby Amos-Stone

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In January 2018, the European Medicines Agency (the EMA), as part of its Brexit preparations, launched a survey to gather information from companies on their Brexit preparedness plans, and to identify concerns that may impact public or animal health. The results of the study were published earlier this week.

Continue Reading EMA publishes results of study on Brexit preparedness

In February 2018, the Integrated Research Application System (IRAS) issued revised versions of the template model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA, used where clinical research organisations undertake site management responsibilities on behalf of the sponsor). The new mCTAs are designed to be used without modification for industry-sponsored trials in the national health service (NHS), and have been updated to reflect current practice and regulations. The new mCTAs should be used from 1 March 2018.
Continue Reading Revised model Clinical Trial Agreements applicable across the UK

In October, we reported that the oral hearing before the Court of Justice of the European Union (CJEU) took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP).

The Opinion of Advocate General Bobek has now been handed down. Although the AG takes no position on whether Ribomustin or Levact should have been used as the reference medicinal product, or when the applicable regulatory data protection (RDP) period started running, he opines that the CMS may raise issues as to RDP during the assessment phase and are co-responsible for the documents approved in that procedure. However, once agreement has been reached, CMSs cannot unilaterally revisit that decision. After authorisation, the courts of CMSs are competent to review the determination of the national competent authority.Continue Reading AG opines that CMSs are co-responsible for MAs granted under the DCP

On 21 September 2017, Advocate General Saugmandsgaard Øe delivered his Opinion in Case C-179/16 Hoffmann-La Roche, finding that licensed and unlicensed medicinal products used for the same indication may fall within the same relevant product market.

Background

Genentech’s drugs Avastin (which is licensed to Roche) and Lucentis (licensed to Novartis) are based on different active substances but are derived from the same antibody and have similar mechanisms of action. Avastin obtained marketing authorisation first, for treatment of certain types of cancer and Lucentis later obtained marketing authorisation for treatment of certain ophthalmologic conditions. However, during the interval between grant of the two marketing authorisations, a number of medical practitioners used Avastin in smaller doses to treat ophthalmologic conditions. Furthermore some practitioners have continued to use Avastin even after grant of marketing authorisation for Lucentis because of the substantially lower treatment cost of Avastin.Continue Reading Hoffman-La Roche – AG finds unlicensed use should be included in relevant product market

In July, we reported that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) had announced a joint proposal to promote the use of innovative approaches to paediatric drug development. We noted that the EMA expected to publish a Reflection Paper setting out a systematic approach to extrapolation of paediatric data by the end of the year. This has now been published.
Continue Reading EMA Reflection Paper on paediatric extrapolation

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

On 6 July 2017, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced a joint proposal to promote the use of innovative approaches to paediatric drug development. The proposal focuses on paediatric Gaucher disease, but the intention is for the principles underlying the so-called “strategic collaborative approach” to be extended to other areas of development for rare paediatric diseases.

The collaborative approach was considered necessary as, given the limited number of patients with Gaucher disease, identifying multiple candidate target products, and running multiple clinical trials, may actually hinder the development of an effective treatment.
Continue Reading Innovative approaches to paediatric drug development

On Monday, 3 July 2017, the scientific advice service within the National Institute for health and Care Excellence (NICE) launched its Medtech Early Technology Assessment (META) Tool.

The META Tool is an online service that provides developers of medical devices, diagnostics, digital health interventions, and medical apps with a framework to help them identify potential gaps in the available evidence, and prepare for discussions with investors, health technology assessment organisations (including NICE itself), and payers.Continue Reading NICE introduces META Tool

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