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

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

On 28 June, the Advocate General of the Court of Justice of the European Union gave his opinion on the SNITEM and Philips France case against France. In this case, the Conseil d’Etat in France asked whether a particular software programme intended to be used by doctors to support prescribing decisions falls within the definition of medical device as provided by Directive 93/42/EEC (Medical Devices Directive).

Continue Reading Advocate General’s opinion on software as medical devices