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New EU Directive on Whistleblower Protection will also apply to Life Sciences sector

Inge Vanderreken

On 7 October 2019, the Council of Ministers adopted the Directive on Whistleblower protection at the Justice and Home Affairs Council in Luxembourg. The Directive will introduce new EU-wide rules to protect whistleblowers who report breaches of EU law. “EU law breaches” include, amongst others, those relating to EU laws on product safety and compliance, Read More

China: NMPA Seeks Comments on Draft Regulations of Drug Registration, Manufacturing and Distribution

David Shen

On 30 September 2019, the Chinese National Medical Products Administration (the NMPA) published three sets of draft regulations seeking public comment. They are the Draft Drug Registration Regulations, the Draft Manufacturing Regulations and the Draft Drug Distribution Regulations. The Ministry of Justice further updated these Draft Regulations on 15 October 2019 and is seeking public Read More

Amendment to Social Security Financing Bill seeks to provide clear legal basis for French medical cannabis pilot programme

Eveline Van Keymeulen

On 10 October 2019, French Deputy Olivier Veran introduced an amendment to the 2020 Social Security Financing Bill, in order to provide a clear legal basis for the medical cannabis pilot programme that was endorsed by the French National Agency for Medicines and Health Products Safety (ANSM) in July. The amendment is strictly speaking not Read More

Netherlands: Hospitals request three-year suspension of Dutch Competition Act

Hannah Smit

The Dutch Association of Hospitals (NVZ) has published a press release announcing that it has appealed for a three-year temporary suspension of the Dutch Competition Act in the healthcare sector, as various healthcare institutions have entered into arrangements to save on costs that may be in violation of the Act. For example, the institutions have Read More

EU agriculture ministers want to exclude crops created by targeted mutation methods from EU GMO legislation

Sophie ten Bosch

At the latest meeting of EU agriculture ministers, and following a report by the Danish Council of Ethics, 14 EU member states, led by the Netherlands and Estonia, called for the European Commission to re-evaluate the EU’s stance on genetically modified organisms (GMOs), in particular those created by new plant breeding techniques. In a ruling Read More