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.
China’s new anti-bribery agency announces pharma probe
31 May 2018 - Posted by: David Shen
China’s State Administration for Market Regulation (SAMR) has announced the launch of a nationwide campaign to crack down on unfair competition and commercial bribery in the pharmaceutical, medical device and educational sectors. The campaign comes at a time when the Chinese government has enacted key amendments to its Anti-Unfair Competition Law (AUCL) and is gearing › Read More
30 May 2018 - Posted by: Rafi Allos
In an important recent UK case concerning regulatory data protection (“RDP”), the High Court has rejected a challenge by Teva to an assessment underlying the RDP for Tecfidera (dimethyl funarate), a multiple sclerosis treatment approved in the EU in 2014. Teva sought a judicial review of a decision by the MHRA refusing to accept Teva’s › Read More
European Commission proposes export manufacturing waiver for SPCs
28 May 2018 - Posted by: Eveline Van Keymeulen
The European Commission has published today a proposal for a Regulation amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate (SPC) for medicinal products. The proposal introduces a so-called “export manufacturing waiver”, an exception to the SPC system in relation to exports to third countries (outside the EU). Due to the waiver, EU-based companies will be entitled › Read More
Resisting parallel imports of trade marked goods – pre- and post-Brexit
28 May 2018 - Posted by: Natasha Rao
On 17 May 2018, the CJEU confirmed that trade mark owners cannot oppose a parallel importer’s further commercialisation of a medical device in its original packaging if additional labelling added by the importer does not threaten the medical device’s guarantee of origin. By way of background, Lohmann & Rauscher International argued that by re-selling its › Read More
French implementing rules on safety features and anti-tampering device adopted
24 May 2018 - Posted by: Eveline Van Keymeulen
On 23 April 2018, Decree No. 2018-291 relating to safety within the medicinal supply chain entered into force. The decree follows a February 2018 information note from the Ministry of Health reminding retail pharmacists and healthcare institutions of their obligations under Commission Delegated Regulation (EU) 2016/161, which further implements the requirement of Directive 2011/62/EU that › Read More