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

The Nagoya Protocol five years into play: key points of attention when working with genetic resources

Tine Carmeliet

Genetic material from plants, animals, microbials or other biological origin is today frequently used not only by companies active in the pharmaceutical or plant breeding industry, but also by businesses in the cosmetics and food industries. Think of a German cosmetics company developing a cream based on a plant extract from Indonesia, or a dairy Read More

French government determined to sanction pharmaceutical companies for shortages of medicines

Jeanne Fabre

According to an article published by French newspaper, Les Echos, the French government has decided to impose financial penalties on companies in cases of negligence that result in shortages of medicines. Shortages of medicinal products are increasing in France (See our previous blog post: French regulator (ANSM) imposes major financial penalty on a pharmaceutical company Read More

France: Innovative medicines marketed too slowly

Laëtitia Bénard

The Montaigne Institute, an independent think tank dedicated to public policy in France and Europe, published a report on innovative medicines on 19 September 2019, strongly recommending acceleration in market access and the renewal of the medical and economic evaluation of medicines. In France, a reimbursed innovative medicine can only be marketed after the High Read More

Netherlands: Debate between Dutch Minister of Care and pharmaceutical companies

Lars Braams

On 27 August 2019, the Dutch Minister of Care wrote an open letter in one of the main Dutch newspapers (De Volkskrant), addressed to pharmaceutical companies. In the letter he requested price transparency. He stated that when an explanation for a price increase is proposed by a pharmaceutical company (for example, high development costs or Read More