Pharmaceuticals

France: Industry calls for moratorium on price cuts

Eveline Van Keymeulen

Following the shortage of medicines announcement made on 25 September 2019 by the French Prime Minister and the Minister of Health (See our previous blog posts: French government determined to sanction pharmaceutical companies for shortages of medicines and Draft 2020 Social Security Financing Bill encourages price cuts and biosimilar uptake), the French pharmaceutical industry association Read More

Belgian Constitutional Court overrules sales restriction for wholesale distributors of medicines

Kaat Van Delm

On 17 October 2019, the Belgian Constitutional Court rendered a final judgment , annulling Article 3.2° of the new legislation applicable to shortages of medicines in Belgium. The Article had banned the parallel export of medicines by Belgian wholesale distributors, requiring them to only supply medicines for human use to other Belgian wholesale distributors, licensed Read More

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

First phase of French medical cannabis pilot programme officially started

Eveline Van Keymeulen

On 15 October 2019, The General Director of the French National Agency for Medical and Health Products (ANSM) issued two Decisions (Decision DG n°2019-365 and 2019-381) in order to pursue the necessary work to set up the medical cannabis pilot programme in France. The decisions (i) create a new French specialised scientific committee (CSST) responsible Read More