Juristictions

Edwards Lifesciences v Boston Scientific: Decision of UK Court of 24th May 2018

Marjan Noor

The issue of whether public health policy considerations can prevent the grant of a final injunction is a live one as the number of disputes in the biologics field increases. In this decision of the UK High Court of Justice, public health considerations led to the stay of the injunction and also its qualification for Read More

Dutch Parliament adopts bill to amend Medicines Act

Iradj Nazaryar

At the end of April 2018, the Dutch House of Representatives adopted a legislative proposal to amend the Dutch Medicines Act (DMA). The Bill increases the maximum statutory amount for administrative fines for violations of the DMA, currently set at EUR 450,000, to the amount determined for the sixth category in Article 23 of the Read More

ANSM clarifies that it does not recommend “neutral packaging” of medicinal products in the midst of pharma industry criticism

Eveline Van Keymeulen

Yesterday, the French National Agency for Medicines and Health Products Safety (ANSM) provided some clarifications with respect to its Recommendations for applicants and holders of marketing authorisations on the labelling and packaging of human medicinal products dispensed in solid oral form and its Recommendations on the choice of medicinal product names (dated February 2018) (see our Read More

Belgium launches single online portal for health data

Tine Carmeliet

At the initiative of the Minister for Social Affairs and Health Care, on 8 May 2018, the Belgian government announced the launch of a single online portal for health data entitled “MaSanté – MijnGezondheid“. The portal aims to provide citizens with an easily accessible overview of all existing health data (including their personal data) and Read More

European Commission adopts revised definition of “similar medicinal product”

Eveline Van Keymeulen

Yesterday, the European Commission adopted Regulation 2018/781 amending Regulation (EC) No 847/2000 as regards the definition of the concept “similar medicinal product” in the context of the Orphan Medicines Regulation.  The Regulation extends the definition of “similar active substance”, by clarifying that “[i]f the principal molecular structural features cannot be fully established, the similarity between Read More