| On 15 October 2025, the Dutch Competition Authority (Autoriteit Consument & Markt – ACM), the Dutch Healthcare Authority (Nederlandse Zorgautoriteit – NZa) and the National Health Care Institute (Zorginstituut Nederland – ZIN) jointly published a proposal outlining a new framework for determining what constitutes a “societally acceptable” price for high-cost medicines. The initiative builds on a 2021 request from the Dutch House of Representatives, which asked these three bodies to examine how medicine prices could be made and kept socially acceptable. The authorities have developed this proposal under the programme for Societally Acceptable Expenditure on Medicines (Maatschappelijk Aanvaardbare Uitgaven Geneesmiddelen – MAUG).
In addition to the proposed framework for assessing acceptable prices, the authorities also recommend measures to strengthen competition between pharmaceutical manufacturers and to reinforce market oversight and price regulation.
Proposed Framework for Assessing “Societally Acceptable” Prices
The report identifies six principles to guide assessments of whether a medicine’s price can be considered “societally acceptable”:
- Health benefit matters most – the higher the patient benefit, the higher the acceptable price.
- Serious diseases justify higher prices – society is willing to pay more when illness burden is high.
- Uncertainty reduces price – if clinical benefits are unclear or evidence is limited, prices should be lower.
- Budget impact counts – when total spending on a product is high, the acceptable price should be lower.
- R&D recoupment over time – prices should decrease once development costs are likely recovered.
- Degree of innovation – less innovative medicines should have lower acceptable prices.
To better support the Dutch Minister of Health (the Minister) in future pricing and reimbursement decisions, ZIN is updating the assessment framework which it uses to evaluate new medicines. The six principles will be incorporated into this framework, which already informs current reimbursement decisions but not yet the determination of societally acceptable prices.
ZIN is also translating these principles into concrete pricing recommendations, which are expected by end-2026. The authorities advise the Minister to adhere closely to these recommendations during price negotiations with pharmaceutical companies and to communicate more transparently to the public about the reasons for approving or rejecting reimbursement for new medicines.
Proposals to Strengthen Competition Between Pharmaceutical Companies
The authorities emphasise that effective competition remains the best safeguard for reasonable prices. They therefore recommend a series of measures to ensure that market forces can function properly:
- Improve comparability and substitutability of medicines – the report recommends that pharmaceutical companies and regulators take steps to ensure that new medicines can be more easily compared with existing therapies.
- Align reimbursement channels – comparable medicines are often financed through different reimbursement routes. The authorities propose harmonising these financing rules so that interchangeable medicines are reimbursed in the same way, ensuring a level playing field for competing products.
- Enhance coordination in public purchasing – price negotiations are currently fragmented among hospitals, insurers, and the Ministry of Health, which weakens their bargaining position. The authorities recommend better coordination and information sharing among these public buyers to improve efficiency and strengthen collective purchasing power.
Price Regulation and Oversight
In markets where competition remains weak, the report calls for stronger regulatory oversight by both NZa and ACM:
- Maximum tariffs for high-cost hospital medicines – NZa may introduce maximum tariffs for expensive hospital medicines to prevent excessive reimbursement levels and ensure alignment with the framework for “societally acceptable” prices.
- Enhanced powers for ACM – ACM will continue to enforce existing competition law against cartels, exclusionary conduct and excessive pricing, but the report recommends that it also be given additional tools, namely (i) a “call-in power” to review smaller mergers that currently fall below notification thresholds; and (ii) a “new competition tool” allowing ACM to address structural market problems even where no formal competition law infringement can be proven.
Potential Concerns for Pharmaceutical Companies
For the life sciences sector, the proposal raises several important considerations:
- Impact on innovation incentives – a stricter or more prescriptive pricing framework could potentially dampen R&D investment.
- Higher evidence expectations – since uncertainty is a factor, companies may face stronger demands for data to justify prices.
- Implementation uncertainty – the framework sets principles but not detailed methods; it is unclear how “recoupment” or “degree of innovation” will be measured in practice.
- Global implications – reinforcing downward price pressure in Europe could exacerbate tensions with initiatives such as the US “Most Favoured Nation” pricing proposals and reignite debates about whether Europe contributes its fair share to the cost of pharmaceutical innovation.
- Expanded competition oversight – proposed ACM powers could render more transactions and conduct in the life sciences sector subject to regulatory oversight.
- Private actions – parties bringing private excessive pricing litigation (see, e.g., the Pharmaceutical Affordability Foundation’s action against AbbVie – see, Van Bael & Bellis Life Sciences News & Insights of 1 August 2025) may seek to use the proposed framework to bolster their claims in court.
Attached is a copy of the proposal. |
