shortages european union

Shortages of medicines are increasingly a matter of great concern in the European Union (EU) and are perceived as a “severe cross-border threat” by a number of national and EU authorities. The lack of availability of medicines can have devastating consequences for patients’ health and wellbeing, not only through the lack of medicine itself but also through the uncertainty of how to acquire it. Recent reports detail how patients or their loved ones resort to ordering their prescription medication online, which can incur hundreds of euros in out-of-pocket expenses.

The situation continues to deteriorate. In 2023 for instance, the Netherlands experienced the highest ever levels of shortages, particularly regarding the availability of antibiotics. The Dutch Pharmacists Organisation, KNMP, reported 2292 shortages in 2023, compared to 1514 in 2022. At the time of writing, 23 medicines are facing shortages as reported by the European Medicines Agency (EMA), which involve either several or all EU Member States.

There are several reasons behind medicines shortages, from manufacturing issues (including the detection of defects and delays in production), distribution issues, and delocalised production (whereby manufacturers of active pharmaceutical ingredients are located in a limited number of non-EU countries), to unexpected increases in demand.

In response to the problems with the supply of so-called essential medicines, the European Commission has suggested a range of initiatives, varying from a European Voluntary Solidarity Mechanism for medicines to a Union list of critical medicines (published in December 2023). In addition to these measures, certain Member States have also put forward proposals such as a Critical Medicines Act, following the example of the European Chips Act.[1]

Indeed, last Thursday (25 April) saw the launch of the Critical Medicines Alliance, a new structural/institutional mechanism that aims to find solutions to ensure the supply of critical medicines in the EU to better prevent and combat shortages.

As we’ve seen, this is seen as vitally important to combat the current situation. The Commission President, Ursula Von der Leyen, herself cited in her welcome message at the launch, that some people have ended up travelling outside of their countries’ borders in search of the medicines they need. A completely unacceptable state of affairs.

The newly formed Alliance is comprised a variety of different stakeholders, including representatives of Member States (Ministries of Health and Industry), as well as the EMA, patients, and healthcare professionals, among others. The Alliance is open to all organisations active in the critical medicines ecosystem, including NGOs and civil society groups. The Secretariat is provided by the EU’s Health Emergency Preparedness and Response Authority (HERA).  

Combatting shortages and other obstacles that prevent access to medicines is a pivotal part of the work of HAI, and we are happy to be members of the Critical Medicines Alliance. All stakeholders have a role to play in ensuring equitable, timely, and sustainable access to affordable medicines.

Over the next years, we shall:

  • Advocate for improved transparency across the access to medicines continuum, from the R&D lifecycle to manufacturing conditions and the integrity of supply chains
  • Continue monitoring and assessing relevant policy tools and legal developments and provide recommendations for their implementation and use.
  • Engage with relevant stakeholders in coalition and confluence spaces.  

[1] The European Chips Act is an effort by the EU will address semiconductor shortages and strengthen Europe’s technological leadership.