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

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

EU regulatory data protection – UK court considers generics’ challenges to prior EC decisions authorising reference product

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

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

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

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