Welcome to our blog dedicated to Life Sciences. We report on EU and national regulatory, compliance, intellectual property and transactional developments in the sector. We focus on (bio)pharmaceuticals and medical technologies, and also cover food and beverages, cosmetics and other healthcare products.

SPCs and Brexit: SPC applications pending in the UK at the end of the “transition period” will still be granted

Steven Baldwin

EU and UK Brexit negotiators have agreed that applications for Supplementary Protection Certificates (SPCs) for plant products and medicinal products submitted in the UK before the end of the Brexit “transition period” (currently 31 December 2020) will: Still be granted after the end of that period; and Provide for the same level of protection as Read More

Brexit and the medical devices industry: coping with uncertainty

Jacqueline Bore

With just 281 days left to go before the United Kingdom formally leaves the European Union on 29 March 2019 the medical devices industry still faces much uncertainty.  Any deal for the medical devices sector must be hammered out by October this year to give the EU parliament time to ratify its terms before next Read More

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