Medicine shortages and supply problems

Medicine Shortages and Defects Notification Centre

Marketing authorisation holders or manufacturers of medicinal products must report expected supply problems to the Medicine Shortages and Defects Notification Centre. They should do so as soon as possible, but in any case no later than two months before the supply of a medicinal product is interrupted.

The MEB and the Health and Youth Care Inspectorate (IGJ) coordinate this Notification Centre on behalf of the Ministry of Health, Welfare and Sport.

Since the launch of the Notification Centre, we have a better and faster overview of expected medicine shortages in the Netherlands. As a result, we can find solutions to medicine shortages faster and minimise the impact on patients. At the same time, medicine shortages have increased in recent years. This has led to a significant increase in forced medication changes and thus inconvenience for patients and extra work for prescribers and pharmacists.

Each year, we publish a summary of the notifications received and actions taken in the Medicine Shortages and Defects Notification Centre report, which we write together with the IGJ.

What action do we take if a medicine shortage is imminent?

The Medicine Shortages and Defects Notification Centre works with prescribers, pharmacists, Marketing authorisation holders, wholesale suppliers and the Ministry to find solutions to medicine shortages. 
For each notification of an expected supply interruption, the MEB checks whether there are sufficient alternatives available in the Netherlands, such as a similar medicinal product from a different marketing authorisation holder or a different strength or pharmaceutical form of the medicinal product. We also look at the expected duration of a shortage and how big the market share is.

If the shortage affects patients with a life-threatening or very serious condition, or if the shortage has a major impact on patients and there are insufficient alternatives for patients to deal with a supply interruption, the MEB will consider this to be a critical shortage. The MEB and the IGJ will then investigate together which additional measures can be taken to minimise the adverse consequences of shortages for patients. These are measures that can only be used with the permission of the MEB or the IGJ. Such measures are also subject to consultations with wholesale suppliers, pharmacists and the National Coordination Centre for Prescription Drugs.

Temporary supply in alternative packaging and exemption decision

•    If a manufacturer indicates that the medicinal product is still available in a foreign packaging at the time of giving notice of the shortage, the MEB may give permission to market the medicinal product on the Dutch market in this alternative packaging. In addition, the IGJ may issue an exemption decision to allow the import of similar medicinal products from abroad. This allows manufacturers, wholesale suppliers or hospital pharmacies to obtain similar medicinal products from another country. 

An exemption decision by the IGJ may help keep the affected medicinal product available to patients in the Netherlands even in the event of a shortage. The IGJ maintains a list of medicinal products subject to an exemption on its website. 

Cooperation with healthcare professionals

In exceptional cases, there are too few or no alternatives available to patients, including from abroad. We then speak of a serious shortage. 

In that case, the MEB and the IGJ will work with healthcare professionals and wholesale suppliers to investigate if additional measures are needed to minimise the impact on patients. Such measures might include issuing lower quantities to patients, using a medicinal product with a different active ingredient or, in extreme cases, distributing the scarce remaining stock evenly among hospitals and pharmacies or reserving it for a particular patient group. 

European cooperation against medicine shortages

Medicine shortages are also a topic on the European agenda. The European Medicines Agency (EMA) and the EU Member States are working together to improve the availability of medicinal products in Europe. 

The MEB is represented on the Medicines Shortages Steering Committee (MSSG) and the Single Point of Contact Working Party (SPOC WP). This network exchanges information on the availability of medicinal products at the European level, thereby making it possible to identify shortages early and coordinate actions to help prevent and mitigate shortages – for example, by redistributing stocks of medicinal products across Europe. Through this network, countries can also ask each other for help in finding a solution in case of a serious shortage. The EMA describes the available options in the MSSG Toolkit on recommendations on tackling shortages of medicinal products.

The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP). This platform gathers information about medicine availability from national medicine authorities and marketing authorisation holders. Marketing authorisation holders of centrally registered medicinal products should also use this platform to report actual and potential supply problems. 

The ESMP specifically looks at data on availability, supply and demand for medicinal products in situations where accurate monitoring is important, such as crisis situations. In the latter case, all national medicine authorities provide data on the situation in their countries, which are then used to gain insights into availability, supply and demand across Europe.
Furthermore, the MSSG and the SPOC WP advise the EMA and the European Commission on medicine shortage issues, such as assisting with the creation of the Union list of critical medicines. They also make recommendations to improve the availability of these medicinal products. 

Lastly, there is also a Dutch list of critical medicinal products. This includes medicinal products that are very important for the Dutch healthcare system. This list was compiled by and for healthcare providers. The Ministry of Health, Welfare and Sport can use the list to implement policy measures to ensure the availability of these important medicinal products.
The existing European pharmaceutical legislation is currently under review. The aims of the review include improving the security of supply and ensuring that medicinal products are available to patients wherever they live in the EU. 

More information

The Medicine Shortages and Defects Notification Centre only handles notifications of potential shortages or supply problems by pharmaceutical companies.  If you use any medicinal products yourself and you have any questions or concerns about shortages, you should discuss these with your doctor or pharmacist.