Netherlands

Excessive pricing practices in the pharmaceutical sector – NCAs’ scrutiny continues

Nele De Backer

Last week, the Belgian and Italian consumer associations Test Aankoop/Test Achats and Altroconsumo filed complaints with their respective national competition authorities, alleging that the pharmaceutical group Biogen is abusing its dominant position by charging excessively high prices for the medicine Spinraza, which it has the exclusive right to market as an orphan drug until 2029. 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

Dutch competition authority extends excessive pricing inquiry to consider possible supply restrictions on orphan ingredients

Francesca Miotto

Last week, the Dutch Authority for Consumers and Markets (ACM) announced that it is investigating whether the Italian pharmaceutical company Leadiant Biosciences restricted the supply of an important raw material for a patented orphan drug, by entering into exclusive agreements with an unnamed supplier. Such supply restrictions for raw materials could, according to the ACM, Read More

New Dutch Policy rule on the interpretation of “medical device”

Alex Crespo van de Kooij

The Dutch Health Minister has introduced a Decision setting out a policy rule on the interpretation of the definition of medical device (medisch hulpmiddel), as laid down in the Act on medical devices (Article 1, first paragraph, under a). The Decision was published on 4 April 2019 and entered into effect on the same date. Read More

Enforcement of upcoming Dutch BIG obligations postponed

Iradj Nazaryar

The Dutch Inspectorate for Health and Youth Care (IGJ) will not enforce the visible display of the BIG-number by BIG-registered care providers until further notice. The Dutch Ministry of Health, Welfare and Sport indicated it wants a solution for the administrative burdens associated with the revised Dutch Healthcare Professionals Act (Wet BIG) and sufficient time Read More