Unused Medicines Can Soon Be Redistributed to Other Patients Under New EU Rules

For years, hospitals and pharmacies across the Netherlands have been legally required to destroy returned medication, even when the packaging is intact, the medicine is within its expiry date and has never been opened. That is now set to change. A preliminary political agreement between the European Council, the European Parliament and the European Commission on a revision of EU medicines legislation will, for the first time, create a legal basis for the redistribution of unused medicines.

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The scale of the problem

It has long been estimated that medication worth around 100 million euros is destroyed in the Netherlands every year. More recent counts suggest the true figure is considerably higher, with one pharmacist estimating the total could be as much as 260 million euros annually.

Until now, pharmacies returning medicines to patients has simply not been permitted. When patients return unused medicines to a pharmacy, those medicines can currently only be incinerated. It is impossible to guarantee they have been stored correctly, and there is a risk of contamination if they have not passed through official distribution channels. Pharmacists and doctors found to be redistributing returned medicines illegally have faced fines of up to 150,000 euros and potential prison sentences.

How the Dutch pushed for change

The Netherlands has been one of the strongest advocates within the EU for changing these rules. Over the past five years, Dutch researchers carried out scientific studies examining the redistribution of a specific group of expensive medicines, particularly oral cancer drugs known as oncolytica. The results showed that safe redistribution is possible and can contribute to cost savings, sustainability and better availability of medicines.

In a pilot study by Radboudumc and three other hospitals, nearly 1,100 cancer patients returned 332 packages of unused medication within a year. Of those, 228 packages worth 685,000 euros were suitable for redistribution. The packages were stored in specially designed pouches fitted with a chip that monitored temperature throughout.

The research was used to lobby for EU-level change. Health Minister Sophie Hermans sent a letter to the House of Representatives confirming that the Netherlands had succeeded in getting redistribution included in the new EU framework.

What the new rules allow

The revised legislation gives member states the option to allow redistribution of unused medicines under strict conditions, with the aim of reducing waste and improving availability, particularly for expensive medicines.

In the Netherlands, redistribution will initially only be permitted for stable, expensive medicines such as cancer drugs, following a carefully organised process and under strict conditions. The Dutch Medicines Act will need to be rewritten to incorporate the new EU rules, and that legislative process is expected to take around three years. Questions that still need to be answered include which medicines qualify, which pharmacies will be permitted to participate and what conditions they must meet.

Why it took so long

The main barrier has always been safety. The EU's medicines legislation, last revised in 2004, was designed to prevent counterfeit and substandard drugs from circulating. The rules require that medicines can only be dispensed if their origin and storage conditions can be fully verified through official channels, conditions that returned medicines generally cannot meet.

The new agreement does not throw those safeguards out. Rather, it creates a framework within which member states can build verified redistribution systems, with monitoring technology and controlled storage conditions, of the kind tested in the Dutch hospital research.