A pivotal year for medicines policy: what will 2026 bring?

In the final phase of the recent Dutch House of Representatives elections, freezing the basic health insurance package suddenly became a political issue, partly due to the analyses of election manifestos by the Netherlands Bureau for Economic Policy Analysis (CPB). Opponents warned that this would leave patients without access to innovative medicines, while others argued that “in practice, the impact would be limited.” The Jetten cabinet has not opted for a full freeze, but it does intend to tighten package management, both in primary care and in specialist medical care.

At the same time, the Dutch Ministry of Health, Welfare and Sport (VWS) has been working on reforms for years. Decision-making on the modernisation of the Medicines Reimbursement System (GVS) is approaching, and the Future-Proof Medicines System (TSG) is due to come into force in 2027. The recommendations from the Socially Acceptable Medicines Expenditure (MAUG) report are also being elaborated, resulting in a revision of the assessment framework for medicines. On top of that come European developments, such as the reform of EU pharmaceutical legislation, the Critical Medicines Act (CMA) and the European Biotech Act, while the threat of international price pressure, for example through discussions on Most Favored Nation (MFN) policies, continues to loom in the background.

Taken individually, these are familiar policy files. But what happens when everything converges at once?

A system in motion: from market entry to pricing and oversight

The changes affect the entire chain. At the front end, the threshold for market access is shifting. With the MAUG-report and the TSG, the emphasis is on selection and control: which medicines will still qualify for reimbursement, under what conditions, and at what price? For innovative medicines, this means negotiations are effectively moving earlier in the process. Not only clinical added value, but also budget impact and societal acceptability are becoming decisive at an earlier stage.

Within the system, prices are coming under pressure: adjustments to the GVS and the Dutch Medicines Prices Act (Wgp) affect price levels and the reference pricing system. For generic and biosimilar manufacturers, this may put pressure on margins and availability. For innovative companies, it has implications for international pricing strategies and the sequence of market launches.

At the back end, oversight and transparency are increasing: the Dutch Healthcare Authority (NZa) is taking steps towards greater insight into pricing agreements. This shifts more risk towards manufacturers, while giving insurers more tools to control costs. At the same time, greater transparency may feed through into international price referencing.

On top of this comes a European layer with a different logic. Through the reform of pharmaceutical legislation and initiatives such as the CMA and the Biotech Act, the European Union is focusing on strategic autonomy, security of supply and strengthening its own industry. The message is clear: invest in Europe, develop and manufacture here.

And finally, international price pressure is having an ever greater impact. Discussions on, for example, MFN policy make national pricing part of a broader international dynamic. Decisions taken in the Netherlands therefore no longer stand on their own.

Not an accumulation, but a tipping point

Taken together, these measures are causing a clear shift in the system: stricter selection at the front end, lower and less predictable prices within the system, and a further transfer of risk to the market. This has two important consequences:

The business case is changing

Uncertainty around access, timelines and pricing is increasing. This makes the Netherlands a less obvious early launch market for innovative companies. For generic and biosimilar players, availability may decline if margins come under further pressure. The key question is therefore shifting from “At what price will a medicine be reimbursed?” to “Under what conditions is market entry still attractive at all?”

Tension between national policy and European ambitions

It is precisely here that a fundamental tension emerges. On the one hand, Europe – and by extension the Netherlands – is explicitly positioning life sciences and biotechnology as a growth sector. The Wennink report (a Dutch strategic advisory report on future prosperity and competitiveness, comparable in ambition and scope to the Draghi and Letta reports at EU level) underlines that this sector is essential to future earning capacity and calls for substantial investment and stable framework conditions. In that context, it is striking that the Dutch Ministry of VWS is not represented in the new cabinet Taskforce on Future Prosperity and the Business Climate, while seven other ministers and two state secretaries are.

On the other hand, national medicines policy is focused on cost containment, price pressure and risk reduction. That combination is difficult to sustain. Investment in medicines development is capital-intensive and risky. When returns come under pressure and predictability decreases, investment shifts to other markets.

What does this mean for public affairs?

For organisations, this means that traditional, dossier-based advocacy is no longer sufficient. The real dynamic lies in the convergence: measures that may be logical in themselves, but together produce new outcomes. This calls for a different public affairs approach. Not just reacting to individual policy proposals, but looking ahead:

• How do measures interact with one another?
• Where do bottlenecks arise?
• When can influence still be exercised?

With a new cabinet, further policy development and European decision-making, opportunities do exist. But timing and positioning are becoming more decisive than ever. 2026 is therefore not only a tipping point for policy, but also a defining year for anyone seeking to shape their position in the medicines landscape.