Regulatory & compliance

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

Eveline Van Keymeulen

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

China: Patent Law Amendment brings sea change to pharmaceutical patent regime

Jill Ge

On 17 October 2020, the top legislature in China passed the Fourth Amendment to the PRC Patent Law (“Amendment”) which will take effect on 1 June 2021. The Amendment is significant as it introduces patent linkage and patent term extensions for pharmaceutical patents. The Amendment reflects the commitments China made in the U.S.-China Phase 1 Read More

Covid-19 coronavirus – the UK’s preparation for a vaccine

Megan McMellon

The UK’s vaccine portfolio The UK Government has agreed supply deals for at least 340 million doses of six different vaccines, with most likely to require two doses: AstraZeneca and the University of Oxford (adenoviral vector vaccine, 100m doses); Johnson & Johnson (adenoviral vector vaccine, 30m doses, with an option to acquire an addition 22m Read More

France – Covid-19 coronavirus: HAS position on antigenic tests in three clinical situations

Jeanne Fabre

On 25 September 2020, the French National Authority for Health (HAS) issued a favourable opinion on the use of antigenic tests on nasopharyngeal swabs in people who present symptoms of Covid-19. The HAS specified the required performance: a minimum sensitivity of over 80% and a minimum specificity of over 99%. The HAS also acknowledged that Read More

Belgium – Covid-19 coronavirus: ban on at-home tests lifted

Tine Carmeliet

On 21 September 2020, the Federal Agency for Medicines and Health Products (FAMHP) announced that, as of 19 September 2020, the ban on the sale of Covid-19 at-home tests, which has been in place since March 2020, has been lifted. The at-home tests aim to detect antibodies against coronavirus SARS-CoV-2 without the intervention of a Read More