NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and The specific rules in relation to pricing of medicinal products are mainly laid down in the Pharmaceutical Pricing Act (and underlying regulations). In that regard, it is ultimately the Dutch government, more specifical- ly the MoH, that is responsible for regulation of pricing for authorised medicinal products. Indeed, while the MoH does not set fixed prices for medicinal products, the MoH does set the maximum allowable price for medicinal products by using a system of external ref- erence pricing and reference countries. The reference countries are currently France, Norway, Belgium and the United Kingdom. In order to determine the maxi- mum price, the following steps are observed: • For each reference country, the comparable medi- cines are classified into a product group. • For each country, the package size(s) with the lowest unit price are selected based on the brand name of the relevant comparable medicine. If the selected package size(s) of that medicine appears multiple times in the price list, the average price(s) thereof are included in the calculation. • The prices of the selected packages are averaged per country. • If necessary, the average price will be converted into euros. Medical Devices Pharmaceuticals • The maximum price is set at the arithmetic mean of the (converted) averages of the reference countries. The MoH then prepares a decision to amend the list of maximum prices by (twice a year) publishing draft reg- ulations with the amended prices in the Government Gazette ( Staatscourant ). The draft regulations are also published on Farmatec’s website. As the decision to amend prices is subject to a uniform public prepara- tory procedure, any interested party can, within six weeks after the publication of the draft regulations in the Government Gazette, submit an opinion ( zien- swijze ) in relation to the proposed maximum prices. After the procedure has been completed, the MoH sets the maximum price for each authorised medici- nal product (per quantity and pharmaceutical form,
tries requires the importer to, inter alia, verify that (i) the devices have a valid CE marking and Declara- tion of Conformity, (ii) the manufacturer of the medical device is identified and (iii) the labelling of the device is carried out in accordance with the MDR/IVDR. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports In the Netherlands, non-tariff regulations and restric- tions applicable to the importation of pharmaceuti- cals and medical devices are imposed on the basis of their classification under the Combined Nomen- clature (CN), pursuant to Council Regulation (EEC) No 2658/87, and their qualification under the applicable sector-specific legislation. As part of the customs territory of the European Union, imports are governed by Regulation (EU) No 952/2013 (Union Customs Code). Customs authorities may verify compliance with product-specific require- ments upon importation. Pharmaceuticals are regulated under the Medicines Act. Importation from third countries requires, inter alia, a manufacturing/import authorisation, compli- ance with GMP and a valid marketing authorisation. Medical devices are regulated under the MDR and IVDR, as enforced in the Netherlands through the Medical Devices Act. Imported devices must bear CE marking and comply with the applicable conformity assessment requirements. 7.5 Trade Blocs and Free Trade Agreements The Netherlands, through its EU membership, is a party to free trade agreements containing provisions on trade and regulatory facilitation that are relevant to medicinal products and medical devices. The Nether- lands is also a member of the WTO.
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