In case of a medicine shortage, the Health and Youth Care Inspectorate (IGJ Health and Youth Care Inspectorate (Health and Youth Care Inspectorate)) can issue a shortage decision. Pharmacies, wholesalers, and manufacturers are then allowed to import a comparable medicine from abroad. Research by RIVM shows that this temporary measure helps to increase the availability of medicines during shortages, but not all parties take advantage of it. Moreover, there is insufficient insight into how many medicines enter the Netherlands after a shortage decision and through which party. Therefore, RIVM recommends establishing a system (monitor) that provides more insight into this.
In recent years, there have been increasing shortages of medicines. As a result, many people do not receive their prescribed medicine. The Medicines Evaluation Board (CBG Medicines Evaluation Board (Medicines Evaluation Board)) indicates when there is a critical shortage, for example, when there are insufficient available alternatives, such as an alternative medicine or dosage. A solution for the critical shortage may then be for a pharmacy to manufacture the medicine itself. If this does not resolve the issue, the Health and Youth Care Inspectorate (IGJ Health and Youth Care Inspectorate (Health and Youth Care Inspectorate)) can issue a shortage decision. At the request of the IGJ, RIVM investigated the effect of this on the availability of a medicine in the Netherlands during a shortage.
More shortage decisions issued
Research by RIVM shows that the number of issued shortage decisions has increased in recent years. This is related to the general rise in medicine shortages. Temporary decisions are also more frequently extended. Many of these shortage decisions concern anti-infectives, such as antibiotics and vaccines for hepatitis B or tetanus.
Better coordination and explanation
RIVM also asked the parties involved about their experiences with this exceptional measure. Generally, they view it as a positive measure. However, there is still room for improvement. Pharmacies, wholesalers, and manufacturers most often mention that coordination between the IGJ and the field parties needs to improve. For example, by providing prior notice of a shortage decision or communicating critical shortages earlier. There is also much uncertainty among them about the reasoning behind the choice to implement or not implement a shortage decision.
Grace period for stocks
The involved parties also frequently mention a grace period for stocks as an area for improvement. Currently, an imported medicine cannot be dispensed once the shortage decision expires. This can mean that pharmacists and/or wholesalers are left with a stock. RIVM recommends investigating the introduction of a grace regulation for this. Among other things, uncertainty regarding the duration of shortage decisions and the risk of fines make the threshold high for importing.
Patient perspective is important
The RIVM study includes (a start of) an overview of shortage decisions and products that are imported under this decision. To gain a more complete picture of the effects, it is important to investigate the consequences for (the care of) patients. They are the end users and thus the most important group affected by a shortage decision. Therefore, it is essential that their perspective is also included in the future.
Import of medicines temporarily tolerated
In November 2024, the Council of State decided that the shortage decision is legally incompatible with the Medicines Act. The IGJ may only issue a shortage decision at the request of a physician and not on its own initiative. Following concerns from various parties involved, the import of medicines from abroad during shortages is temporarily tolerated until the minister has amended the law.