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The cannabis market: helping investors navigate the UK regulatory regime

Matthew Townsend

Last year the global legal cannabis market was estimated to be worth USD12 billion but it is tipped to rise to over USD166 billion by 2025. Liberalisation of the legal framework for cannabis is a significant driver for this growth. Since 1 November 2018, the UK has joined the ranks of over 30 countries legalising Read More

Dutch medicines regulator updates policy on how to carve out patented indications

Lars Braams

On 8 May 2019, the Dutch Medicines Agency (CBG/MEB) published a revised policy on generic manufacturers’ ability to carve out patented indications from their product information (that is, leaflet and summary of product characteristics). This new policy is a direct result of the CJEU’s preliminary ruling in Staat der Nederlanden v Warner-Lambert Company LLC (Case Read More

Belgian Minister of Health introduces new measures that will produce significant annual savings

Tine Carmeliet

In the beginning of March, the Belgian Public Health Committee approved five measures introduced by the Belgian Minister of Health that aim to reduce the price of medicines on the off-patent market. These measures, which will enter into force on 1 April 2019, will result in savings of EUR 10 million a year for the Read More

Coordination amongst member states on medicines’ prices supported by the European Commission

Nele De Backer

European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission will support national competition authorities in their probes against excessive pricing practices in pharmaceutical markets. In addition, the European Commission will continue to monitor pharmaceutical markets itself, as part of its competition policy, and is ready to act against infringements of 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