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 in the Netherlands will usually be available for patients. However, in situations of exceptional shortages, a replacement medicine may be required that is not (yet) approved in the Netherlands. At present, replacement medicines are not reimbursed under the basic health insurance scheme (unless it concerns orphan medicines). Health insurers usually reimburse these medicinal products out of leniency and when this is not the case the costs are usually borne by pharmacies or patients. To ensure that all patients have access to replacement medicines, the Dutch Minister of Health, Welfare and Sports decided to include them in the basic health insurance scheme to guarantee their reimbursement. Reimbursement will last until the shortage situation is over.
The next step after the Council of Ministers’ approval is the publication of the Bill and its submission to the House of Representatives for consideration (the first legislative step before the Bill can become law).
A prior version of this post was originally published by the same author in Practical Law – Life Sciences, February 2018 issue (Thomson Reuters).