Obligations of pharmaceutical companies in medicine shortages

The European Medicines Agency (EMA) has a system for detecting and obtaining an overview of medicine shortages in the European Economic Area (EEA). The system, called the European Shortages Monitoring Platform (ESMP), is intended to collect information on the supply of and demand for medicinal products for human use in order to prevent shortages, analyse situations and manage cases should a shortage occur.

Marketing authorisation holders are obliged to report all shortages (routine shortage reporting) of centrally authorised medicinal products in the ESMP.

• Information from EMA on reporting obligations (ESMP Essentials: Industry and Network Reporting Requirements)

EMA monitors and publishes information on medicine shortages that affect, or are likely to affect, more than one Member State of the European Union (EU), where EMA has assessed the shortage and provided patients and healthcare professionals with recommendations.

EMA has also held online training courses for marketing authorisation holders and published guidelines. If a crisis arises, EMA may define a list of medicinal products that need to be specially monitored because of the situation, and it then requests various information on the medicinal products on the list from marketing authorisation holders and the Icelandic Medicines Agency (IMA). This applies to all medicinal products regardless of the authorisation procedure, i.e. not only centrally authorised medicinal products.

EMA's steering group on medicine shortages (Executive Steering Group on Shortages and Safety of Medicinal Products, MSSG) may also define a list of medicinal products that need to be specially monitored; in such cases, marketing authorisation holders and IMA must submit specific information on the medicinal products via the ESMP.

EMA list of critical medicines

The European Medicines Agency (EMA), in cooperation with member agencies such as IMA, compiles a list of medicines that should always be available on the market, i.e. critical medicines. This Union list of critical medicines (ULCM) is intended to serve as a reference for member agencies in Europe, which also maintain comparable lists for their own countries; these may differ to some extent from the ULCM depending on the situation in each country.

When the European ULCM was compiled, risk was assessed on the basis of the consequences a shortage would have for individuals and society, based on two main factors:

• The severity of the disease that the medicinal product is intended to treat.

• The availability of alternative treatments for the disease.

In addition, consideration was given to how many EEA countries had the medicinal product on their list of essential medicines.

Further information on the Icelandic list of essential medicinal products for human use