Medicines shortages under the EU pharma law package

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU's general pharmaceutical legislation. The European Commission proposal for the Pharma Law Package has now been passed through both the European Parliament and the Council of the EU, each having commented on its contents.

One of the main topics in the Pharma Law Package, next to the reduction of regulatory exclusivity rights, is the monitoring and management of shortages and critical shortages of medicinal products. While the Council, consisting of all the 27 EU Member States and as of 1 July 2025 under the Danish presidency, supports the proposal for new monitoring and management of shortages requirements for EU marketing authorisation holders (“MAHs”), its position proposes less stringent obligations in certain instances compared to the initial Commission proposal and the Parliament's position.

Notification obligations related to foreseen supply disruption

To enhance the monitoring and management of shortages, a variety of obligations for MAHs are included in the proposed legislation, such as the more stringent duties for MAHs to notify the competent authorities of (temporary) disruptions in their supply chain. The Council's reading stipulates that MAHs should notify the competent authority as soon as possible, but in any event not less than three months prior to a foreseen disruption in the supply chain, if the expected duration of this disruption is two weeks or more. The three-month minimum is a reduction compared to the six-month period that the European Parliament initially proposed, however, it is still longer than the current minimum notification period of two months under Directive 2001/83/EC.

Shortage prevention plan and other MAH requirements

Further to the notification requirements, MAHs must also have a shortage prevention plan in place for certain medicines. In this plan, among other things, the MAH must indicate appropriate shortage management measures and a supply chain risk assessment, to prevent the risk of shortages throughout the complete product chain. The Council takes the position that the requirement to have a shortage prevention plan should apply only to critical medicines and to medicines included on the list of critical shortages of EU concern. In the Commission proposal and the Parliament's position, the requirement for a shortage prevention plan applies to all medicines on the market.

Whenever a medicinal product is subject to a shortage prevention plan, the national competent authority or the EMA may request the MAH to present this plan at any given moment.

Further action required from MAHs upon request by the competent authority includes the submission of a shortage mitigation plan and a risk assessment of the impact of suspension, cessation or withdrawal of the medicinal product from the market. The Council's proposal further adds the obligation for MAHs to carry out a regular documented risk assessment of potential supply chain risks for medicinal products not subjected to the shortage prevention plan. The national competent authority or the EMA may request MAHs to submit this document at any time and this request should be complied with within two days.

Other actors in the supply chain

Besides obligations for MAHs, the proposed legislation allows wholesale distributors and suppliers to report a shortage of a medicinal product marketed in the Member State concerned to the competent authority. Further to this, Member States may require wholesale distributors who intend to distribute a medicinal product from one Member State to another (parallel trade), to provide certain information on this distribution. Based on this information, the source Member State may take measures to prevent or mitigate shortages in the source Member State, justified on grounds of public health protection.

Conclusion and next steps

The proposed legislation aims to strengthen EU-wide collaboration on the monitoring and management of shortages of medicinal products. Under the proposal, national competent authorities and the EMA seek to continuously monitor any expected or actual shortage of the medicinal products concerned also outside of potential public health emergencies.

Now that the Council has taken its position, negotiations can take place between the Council and the European Parliament. Also taking transition periods of 18 months (as Commission and Parliament propose) or even 36 months (as the Council proposes) after the entry into force of the legislation into account, it is generally not expected that the new legislation will go into effect until 2028.

This article is part of a series that discusses amendments to the EU Pharma Law Package and highlights the different positions adopted by the Commission, Parliament and the Council compared to the current pharmaceutical regulatory framework. Please contact the authors or the Hogan Lovells attorneys with whom you regularly work for guidance on your specific product needs.

Authored by Hein van den Bos, Julia Mischie, and Milan Tuijp.