EU

New formulations of existing active substances are not entitled to an SPC according to Advocate-General

Toby Sears

The Opinion of Advocate General Saugmandsgaard Øe in Abraxis Bioscience (Case C-443/17) was delivered on 13 December 2018.  The Advocate General concluded  that the UK Intellectual Property Office had been  correct in declining to grant a Supplementary Protection Certificate (SPC)  to Abraxis for a novel formulation of an active substance which had already been the Read More

Has the Orphan Regulation met its aims? A critical review of the EU’s incentives regime for rare disease patients

Eveline Van Keymeulen

By the 1990’s the European Union had fallen behind other developed economies in the encouragement and support its pharmaceutical regulatory framework offered to the development of new treatments for rare diseases. The aim of the Orphan Regulation was to remedy this. In the article “Has the Orphan Regulation Met its Aims? A Critical Examination of the European Union’s Read More

General Court confirms strict significant benefit test on the grant of an orphan marketing authorisation

Jacqueline Bore

The General Court has confirmed in its judgment in Bristol-Myers Squibb Pharma EEIG v European Commission and European Medicines Agency (Case T-329/16) that the European Medicines Agency should take account of recently authorised medicinal products in determining whether a product under assessment should retain its orphan designation on the grant of a marketing authorisation. In the Read More

Competition authorities debate the circumstances in which intervention against alleged excessive pricing practice in the pharmaceutical sector may be justified

Francesca Miotto

In recent years, consumer organisations have been monitoring the evolution of medicine prices in the EU and have, in some cases, called for the intervention of competition authorities to protect citizens’ rights to affordable healthcare. In the context of this resurgence of interest in excessive pricing in the pharmaceutical sector, on 28 November 2018, the Read More

European Commission opens public consultation on Orphan and Paediatric Regulations

Jacqueline Bore

The European Commission has embarked on the latest round of evidence gathering to support its review of pharmaceutical incentives, launched in response to the Council Conclusions of June 2016. The Health and Food Safety Directorate opened a public consultation on the Orphan and Paediatric Regulations on 18 October 2018. This joint evaluation will assess whether Read More