2023-12-12 18:07:57
Faced with drug shortages last winter, the European Union proposed a list of essential medicines whose availability must be ensured.
Haunted by shortages last winter, Europe published its first list of medicines on Tuesday.critiques» for which it is essential to avoid supply disruptions in order to ensure their availability to patients.
Paracetamol, morphine, antibiotics, antiarrhythmics, hormonal preparations, anesthetics, anti-infectives, insulin, antiepileptics, respiratory system drugs, the list covers a wide range of therapeutic areas, vaccines and treatments for rare diseases. It has more than 200 active substances.
Last winter, the European Union faced drug shortages due to several factors including a sharp increase in demand and numerous supply chain issues.
This list, drawn up in collaboration with the European Medicines Agency (EMA) and the Member States, is one of the avenues adopted by Brussels to combat recurrence of shortages.
Presented as a “important tool to support EU efforts to ensure security of supply and to prevent shortages of critical medicines», it will be extended in 2024 then updated each year, according to a press release published on the website of the European Medicines Agency (EMA).
The list also includes “as part of the EU’s efforts to improve its resilience and strategic autonomy in the face of geopolitical challenges and unforeseen events», according to Brussels.
Medicines identified as critical are difficult to replace with another product. They will be subject to specific measures, for example taking into account security of supply in calls for tenders or recommendations to diversify suppliers.
Dependent Europe
To appear in this European directory, the medicine must be considered critical in more than a third of the Member States. Its authors drew from six national lists of medicines deemed essential, from which they studied 600 active substances, according to the press release published jointly by the EMA, the European Commission and the network of national medicines agencies of EU member states.
This publication will not have an impact on the lists of medicines considered essential that already exist or are currently being developed, but it could make a contribution to the drafting of lists in countries which do not yet have one, underlines the press release.
To better anticipate crises, the European strategy also considers other measures such as the creation of stocks, the diversification of supply chains, the implementation of regulatory flexibilities.to allow patients to quickly access medications» by extending the shelf life or authorizing generics more quickly.
Europe has become dependent on imports of so-called mature drugs (antibiotics, anesthesia products, etc.) after having relocated the manufacturing of these drugs to China or India.
Brussels announced at the end of October the launch of a “European voluntary solidarity mechanism» which will allow a Member State facing a shortage to turn to its neighbors so that they can redistribute a medicine that they have in stock.
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