NETHERLANDS Trends and Developments Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
• competition needs to be strengthened; and • additional rate regulation and supervisory tools may need to be granted to, respectively, the Dutch Healthcare Authority and the Dutch Competition Authority. Furthermore, the association of healthcare insurers, Zorgverzekeraars Nederland , has funded a pilot pro- ject called the “Orphan Drug Access Protocol” (ODAP) in order to provide better access to promising orphan drugs. Candidates for the ODAP are identified by the National Health Care Institute, after which health- care insurers decide whether the identified candidate is eligible for ODAP. This is done after consultation with stakeholders, including healthcare providers and patient representatives. Tofersen, which is used to treat a rare hereditary form of ALS, was the first medicinal product that came through this pilot project and became available on 1 March 2025. There are other medicinal products cur- rently in the pipeline waiting for approval under the ODAP pilot project. Heavy Emphasis on Litigation (and Enforcement) in Relation to Reimbursement The Dutch healthcare and life sciences sector has seen a rise in litigation related to the reimbursement of care. Rising costs, due, for instance, to the geopo- litical landscape and personnel shortages, appear to have acted as a catalyst for healthcare providers to move discussions on reimbursement from the nego- tiation table to the civil courts. In particular, litigation related to the reimbursement of medical device care has been noteworthy. The expec- tation is that this increase in litigation will continue, as reimbursement remains a key pillar in the Dutch life sciences and healthcare sector. Similarly, the Dutch Healthcare Authority, which sets maximum rates for various types of care, has faced scrutiny in relation to its price setting. Indeed, the Dutch Healthcare Authority has been involved in administrative proceedings concerning, inter alia, the
rates for GP care, oral care, mental healthcare and forensic care. Other Notable Developments The MoH launched the “Dashboard Medicines Pro- cessing Times” ( Dashboard Doorlooptijden Genees- middelen ), which is publicly available on the website of Farmatec and offers insight into the phase of the reimbursement process (submission of the dossier, assessment thereof, or negotiation) in which expen- sive new medicinal products that have been author- ised for the Dutch market currently find themselves. The Dashboard also includes the processing times for each phase and consequently, in principle, provides valuable information on the total processing time (from submission to assessment) for patients, prescribers and pharmaceutical companies. Furthermore, the European Commission has con- firmed that the first modules of EUDAMED, the European database for medical devices, are fully functional. These concern the “Actor Registration”, “UDI/Device Registration” and “Notified Bodies and Certificates” modules. As from 28 May 2026, the use of these modules will be mandatory for all relevant parties (eg, manufacturers and authorised representa- tives). Finally, on 25 June 2025, a draft bill was submitted that aims to establish a so-called call-in power for the Dutch Competition Authority. Under this bill, the Dutch Competition Authority would be given the pow- er to investigate and prohibit mergers that fall below mandatory notification thresholds. In that respect, on 6 October 2025, the Advisory Division of the Dutch Council of State issued a rather critical advice on this draft bill, arguing, inter alia, that: • such a broad power has not been sufficiently sub- stantiated; and • such a measure might increase legal uncertainty. If passed, such a call-in power for below-threshold mergers could indeed have significant implications for the life sciences sector.
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