EU

Parallel trade in the life sciences sector – recent developments

Tine Carmeliet

Please join us on Tuesday, 26 January 2021 for a webinar on the key developments in the parallel trade of pharmaceuticals in 2020.  Tine Carmeliet, Nele De Backer, Francesca Miotto, Geert Glas and Nieke Vanavermaete will talk you through recent decisions and developments in the field of parallel trade, review the impact of both Brexit Read More

European Commission completes current cycle of pay-for-delay probes with fines imposed on Teva and Cephalon

Thomas Masterman

On 26 November 2020, the European Commission (Commission) issued a decision fining pharmaceutical companies Teva and Cephalon EUR60.5 million for infringing Article 101 TFEU by agreeing to delay the entry of a cheaper generic version of Cephalon’s sleep disorder drug modafinil (the Decision). While the Decision completes the current cycle of the Commission’s “pay-for-delay” investigations, Read More

EU Court says off-label treatments must not be considered when assessing the significant benefit criterion in orphan drugs

Tine Carmeliet

On 23 September 2020, the General Court of the European Union (GC) annulled a decision of the European Commission (Commission) that had withdrawn the orphan drug status of Trecondi (Treosulfan). This is an important decision as, for the first time, the GC has disagreed with the Commission’s restrictive approach to finding a “significant benefit” in Read More

French Interministerial Mission on Drugs (MILDECA) reacts to CJEU Kanavape judgment

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On 24 November 2020, following the decision of the European Court of Justice (CJEU) in the Kanavape case, the French Interministerial Mission for the Fight against Drugs and Addictive Behaviours (MILDECA) published an update on the legal status of cannabidiol (CBD) in France. The judgment, which was rendered on 19 November 2020, confirmed that CBD Read More

CJEU landmark ruling confirms that CBD is not a narcotic drug and that member states may not prohibit its marketing

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Today, the Court of Justice of the European Union (CJEU) delivered its long-awaited decision in Case C-663/18 (Kanavape) ruling that a member state may not ban the marketing of cannabidiol (CBD) extracted from the Cannabis sativa plant in its entirety. In today’s judgment, the Court finds that EU law, in particular the provisions on the Read More