The COVID-19 pandemic and the war in Ukraine exposed Europe’s supply chains dependencies and the risk of economic dependency being weaponized. This increased awareness of medicine shortages across all Member States, affecting both branded and generic medicines. A shortage arises when the supply for a medicine does not meet the demand. This is most critical when it concerns critical medicines, i.e. medicines which are essential to ensure the continuity of care, and/or when their unavailability results in serious (risk of) harm to patients.
Addressing these vulnerabilities takes place at both EU and national levels. This article outlines how the Dutch government responds to acute shortages and prepares to safeguard supplies in the future.
Tools to address acute shortages of critical medicines
If a shortage of a critical medicine occurs, it is essential this shortage is resolved as quickly as possible. To do this, the Dutch government disposes of several tools. The first step is that authorities check whether alternative medicines are available, which can include medications with a different strength or a different active ingredient. If these alternatives are insufficient, pharmacy preparations may offer a solution. Distinction is made between when pharmacies prepare medications (small-scale) for their own patients and when they do so for other pharmacies. Although the latter conflicts with EU law, it is under strict conditions permitted in the Netherlands. The Netherlands wishes to establish this at EU level as well.
If the supply issues cannot be combatted by these measures, manufacturers, wholesalers or pharmacists can under certain conditions be granted a temporary exemption to import a comparable medicinal product from other countries in the event of a temporary shortage. A court ruling in 2024 temporarily suspended this specific exemption, but legislation was amended in September 2025 to reinstate the possibility. As a temporary alternative during the suspension, an instruction was issued allowing the import of comparable medicines without the risk of enforcement. This instruction expired once exemptions were reinstated in September 2025.
If no temporary exemption is granted, the supply of medicines to a doctor’s declaration may offer a solution. The doctor describes the appropriate form of treatment for a certain patient, and then asks the Dutch authority for permission. Because a separate declaration must be submitted for each patient, this measure cannot be implemented on a large scale.
An additional measure available is that the Medicines Evaluation Board temporarily allows medicinal products to have packaging from a different country. The medicine itself must be identical to the version usually available on the Dutch market, and Dutch labels and leaflets must be added to the packaging so relabeling is required.
Lastly, the Dutch Government could render a compulsory patent licence (“dwanglicentie”) in the public interest, requiring a patent holder to allow other manufacturers to use its patented invention to produce medicines, which is a measure which is applied very rarely.
Plans to prevent future shortages
In addition to the tools available to address acute shortages, the Dutch government aims to prevent shortages altogether through improvements in four key areas.
- Identification and monitoring
The previously set up Medicine shortages and Defects Notification Centre is being improved to ensure timely and transparent reporting, early detection, and better communication. In addition, prompted by the ‘Union List of Critical medicines’, the Netherlands created its own national list of critical medicines to guide policy and stockpiling decision. In anticipation of this list, the Dutch government already decided to build a stockpile of several critical medicines in order to create a buffer.
- Stockpiling and supply security
The Dutch government wishes to create an obligation for manufacturers of certain medicines to create a stockpile to be able to address shortages. Problem is that stockpiling must not disrupt availability elsewhere, which means stockpiling purchases are only possible in surplus markets. The government is also researching the stockpiling of Active Pharmaceutical Ingredients (APIs). Additional measures include promoting appropriate prescribing, encouraging pharmacy preparations, and reducing supply chain vulnerabilities by focusing on manufacturing close to the Netherlands.
- International activities
Together with eight other Member States, the Netherlands created the ‘Manifesto for a coordinated Industrial Policy’, calling for a joint EU approach to critical shortages. The Netherlands also seeks to strengthen relationships with India and China, the largest manufacturers of generics.
- (Financial) policy instruments
To make the Dutch market more attractive for suppliers, the Netherlands implements a preference policy, which means health insurers must include clauses allowing price adjustments, apply two-year contract periods, and stagger tenders; all to prevent suppliers from discontinuing their products when they are unable to supply for an extended period of time. Moreover, the government is looking to impose permanent rules on maximum prices for essential medicines, and to adjust reimbursement limits when it is too low to ensure continued availability of the medicine.
Medical devices
While most initiatives regarding medical devices are coordinated at EU level, the Netherlands has also acted nationally. A reporting center for device shortages was established, which also makes it possible to find alternatives for medical devices in case of shortages. Other plans include a redistribution and notification obligation, stockpiling certain medical devices, and measures to reduce waste.
Conclusion
It is clear the Dutch government takes the protection of the supply of critical medicines seriously. Several tools are available to address acute shortages, and measures are being taken to hopefully prevent shortages from occurring at all in the future. These measures aim to ensure patients continue to have access to essential medicines and medical devices, even in times of crisis.
