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The increasing levels of medicine shortages across Europe pose severe threats to patient outcomes, patient safety and the patient care continuum. The European Public Health Alliance (EPHA) calls for an urgent resolution of the medicine shortage crisis through a coordinated response between EU Member States.

This paper outlines the nature, magnitude and impact of medicines shortages in Europe and makes tangible recommendations to remedy this pressing cross-border health threat.

The issue of medicine shortages has further deepened due to the current coronavirus crisis. Supply issues are now occurring for medicines used to treat patients with COVID-19, including in ICU, with devastating impact both for COVID patients and for patients with other conditions who also need these medicines (e.g. hydrochloroquine for rheumatological conditions such as systemic lupus).

Medicine shortages are a European cross-border health threat. To have greater impact, national measures need to be coordinated, complemented and supported by EU initiatives.

EPHA makes 9 principal recommendations to address medicine shortages:

 

1. Strengthen the EU pharmaceutical legislative framework to improve notification of medicines shortages and reinforce obligations of the market Authorisation holders (MAHs) and wholesalers to supply the market.

2. Require all medicines marketed in more than one EU Member State to have accompanying European shortage management and prevention plans.

3. Create early warning systems on medicine shortage at both national and European level.

4. Publish new EU guidance elaborating on cases when free movement of medicines may be restricted in order to prevent and address medicine shortages.

5. Publish new EU guidance on prudent procurement practices to help prevent occurrence of shortages in generic medicines.

6. Set up a permanent system for monitoring of medicine shortages in the EU.

7. Assess the impact of shortages on patient health, treatment and care in the EU.

8. Develop a comprehensive EU strategy on medicine shortages with the active contribution of the European Parliament.

9. Launch an EU Joint Action focusing on the prevention of, and solutions to, medicine shortages.

Medicine shortages have gone out of control in most EU countries, with devastating effects on patient health. We need increased European coordination and strong EU initiatives to fight this plague, as no Member State is in a position to solve this crisis on its own.

Charlotte Roffiaen

France Assos Santé

For over a decade, hospital pharmacists have been engaging with and raising awareness about the impact that medicine shortages have on patients. The implementation of pan-European measures that proactively and reactively address the problem cannot wait any longer. Therefore, the European Association of Hospital Pharmacists stands in full support with the European Public Health Alliance that today puts forward a proposal outlining how Europe can jointly tackle the growing problem of medicine shortages.

Petr Horák

President, European Association of Hospital Pharmacists (EAHP)

The European Public Health Alliance’s proposed actions on medicine shortages are timely, important and useful. Let 2020 be the year when COVID-19 broke down engrained reluctance for more systematic health cooperation between countries, and a year of real progress in tackling medicine shortages.

Dr Matti Aapro

President, European Cancer Organisation

In recent years, European cancer patients have been increasingly affected by medicine shortages, and the situation is becoming even more serious with the ongoing COVID-19 pandemic. As causes for shortages differ across different indications and from one country to another, there is no measure a single Member State can take to effectively address this problem. Therefore, ECL calls for a comprehensive study on the causes and the impact of medicine shortages on patients and health systems, and a timely development of EU-wide strategy to both prevent and manage ongoing issues with medicines’ supply.

Ward Rommel

Chair, Access to Medicines Task Force, Association of European Cancer Leagues (ECL)