EU

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

European Commission’s proposal for a Regulation on Health Technology Assessment clears another hurdle

Jacqueline Bore

The European Parliament has adopted the legislative report of its committees on the European Commission’s proposal for a Regulation mandating joint health technology clinical assessments of medicinal products and medical devices. The aim of the proposal is to promote co-operation at EU level in assessing the added benefits of new health technologies, with the aim that Read More

Federal Circuit upholds finding that Broad Institute CRISPR patents in plant and animal cells do not overlap with UC Berkeley patents

Jacqueline Bore

CRISPR-Cas9 is a remarkable gene editing technology which has the potential to revolutionise the development of medicines, particularly those for genetic diseases and cancer. Pharmaceutical companies have been quick to partner with innovators who have begun to find ways to commercialize CRISPR-Cas9, both as a research tool and as a route to the development of Read More