Netherlands

Revised Dutch policy rules on inducement prohibition regarding medicinal products enter into force

Iradj Nazaryar

On 1 April 2018, revised policy rules concerning the inducements prohibition with regard to medicines (“Beleidsregels Gunstbetoon Gnw 2018“) entered into force. These policy rules provide guidance on what qualifies as an “inducement” and the scope of the prohibition. The new policy rules revise the previous version dating back to 1 May 2014 in light Read More

Dutch cabinet approves proposal for reimbursement of replacement medicines

Iradj Nazaryar

On 9 February 2018, the Dutch government issued a press release announcing the Council of Ministers’ approval of a proposal for the reimbursement of medicines from abroad that are not (yet) registered in the Netherlands (i.e., replacement medicines). In case of any shortage of a certain medicinal product in the Netherlands, an equivalent medicine approved Read More

Dutch Court reminds innovators that their competitive interests against generics can only be protected for ten years

Elise Troll

On 9 January 2018, the North-Holland district court dismissed Teva Pharmaceuticals Ltd. and Teva Nederland B.V.’s appeal against a May 2016 decision of the Dutch Medicines Evaluation Board granting Mylan B.V. and Synthon B.V. (third parties) marketing authorisations (MAs). The third parties’ MAs had been granted under Article 10(3) of the Medicinal Products Directive, as Read More

Dutch Supreme Court approves electronic exchange of patient data via healthcare infrastructure

Iradj Nazaryar

In December 2017, the Dutch Supreme Court ruled  that the electronic exchange of patient data via the so-called healthcare infrastructure is lawful. The infrastructure is a platform for the electronic exchange of patient data. The platform allows the observer of a general practitioner (GP), that is, a GP who temporarily replaces another GP, to access Read More

Dutch Minister to explore possibility of compulsory licenses and pharmacy preparations

Anna-Maria Withagen

The Dutch Minister of Medical Care, Bruno Bruins, announced that he is going to explore the possibility of granting compulsory licenses in order to make pharmaceutical companies lower the prices of certain medicines they offer. During a debate, Bruins said that, although the instrument has not been used in the previous years, this does not Read More