NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
including brand name or generic) and includes them in the Annex to the Pharmaceutical Pricing Regulation. It is prohibited to sell (or buy) a medicinal product at a higher price than the maximum price (Article 4 Phar- maceutical Pricing Act). Furthermore, Article 3 (2) of the Pharmaceutical Pric- ing Act allows, in special cases and upon (substanti- ated) request, for the amendment of the maximum price of a medicinal product. This concerns medicinal products (that fall within a specific product group) with a total annual turnover in the Netherlands of less than EUR1 million (Article 2 of the Temporary Policy Rule 2024 ( Tijdelijke beleidsregel maximumprijzen genees- middelen 2024 ). If granted, the maximum price will be increased by 15% (Article 3 (1)(b) Temporary Policy Rule 2024). Medical Devices The pricing of medical devices is, in principle, not sub- ject to similar legal control mechanisms. 8.2 Price Levels of Pharmaceuticals or Medical Devices See 8.1 Price Control for Pharmaceuticals and Medi- cal Devices . 8.3 Reimbursement From Public Funds Reimbursement In the Netherlands, there is a private healthcare sys- tem that is heavily regulated and consists of vari- ous healthcare-related acts, of which the Healthcare Insurance Act ( Zorgverzekeringswet , Zvw) is the most prominent (though the Long-Term Care Act ( Wet lang- durige zorg , Wlz) is also a substantial contributor to the Dutch healthcare system). In short, all types of care (i) to which the insured is entitled and (ii) that healthcare insurers are obliged to offer pursuant to the Zvw (and underlying regulations) are referred to as the basic package ( basispakket ). What is included in the basic package is determined by the government and can change on a yearly basis. The ZiN advises the MoH on the contents of the basic package. Reimbursement in the context of Zvw-care is carried out by private healthcare insurers that have a duty
of care vis-à-vis their insured population. This means that they should ensure that their insured receives the care to which they are entitled, within reasonable time and travel distance. To that end, healthcare insurers must purchase sufficient care from healthcare provid- ers, for which they usually conclude annual agree- ments. Healthcare that is provided by healthcare pro- viders that are contracted by healthcare insurers is generally fully reimbursed. If the insured opt to receive healthcare from non-contracted providers, such care will usually not be fully reimbursed. As to medicinal products (in the context of extramural care), it is of importance to note that only medicinal products that are included in the Medicine Reimburse- ment System ( Geneesmiddelenvergoedingssysteem , GVS) can fall within the scope of the basic coverage. Indeed, the MoH (advised by ZiN) (i) decides which medicinal products are included in the GVS, and (ii) divides the medicinal products into two lists, which are included in the Regeling Zorgverzekering (Rzv) as Annex 1A (interchangeable medicinal products) and Annex 1B (medicinal products that are not inter- changeable). Medicinal products included in Annex 1A have a reimbursement limit (the insured must pay an additional sum, if the price exceeds this limit). Some medicinal products are only reimbursed when specific conditions are met (eg, specific indications); these are included in Annex 2 of the Rzv. Healthcare insurers typically purchase medicinal prod- ucts via preferential purchasing procedures, where they designate at least one variant of all active ingre- dients that the MoH designated as interchangeable (Article 2.8 (3) Besluit zorgverzekering , Bzv). Health- care insurers also have the power to limit the coverage to a specific strength per active ingredient (if the Rzv includes medicinal products with different strengths of the same active ingredient). If a medical practitioner indicates that it would be medically unjustifiable to treat the patient with the preferential product and prescribes a specific different variant of the medicinal product, that variant will have to be reimbursed (Article 2.8 (4) Bzv). Article 2.8 (1) Bzv provides for a reimbursement route for unauthorised medicinal products, if these medici- nal products can be considered rational pharmaco-
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