From paracetamol to insulin, first list of critical drugs arrives in Brussels

Brussels – Paracetamol, antibiotics such as amoxicillin, insulin, vaccines for common diseases, and anxiolytics such as diazepam. These are just a few of the more than 200 active ingredients used for human medicines featured in the EU’s first list of ‘critical’ drugs, prepared by the European Commission, the European Medicines Agency and heads of member state medicines agencies and published today (Dec. 12).

The list of critical medicines to strengthen the security of supply of medicines in Europe had been expected for months now among the key pillars of the new European Health Union created after the Covid-19 health crisis. A medicine, Brussels explained in a note, is considered ‘critical’ when it is essential to ensure the provision and continuity of quality health care and to ensure a high level of public health protection in Europe. The list is to be updated by the Commission from year to year and was developed together with the European Medicines Agency and all EU member states based on a methodology for assessing criticality.

Revision of EU standards

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Last April, Brussels aggiornato la strategia farmaceutica with the first major overhaul in more than 20 years (the last legislation was in 2004) with a new legislative framework that focuses on access to medicines at low prices, innovation and sustainability of the pharmaceutical industry, but also crisis-proof regulatory framework and initiatives against drug shortages and antimicrobial resistance. Against the risk of drug shortages, the European Commission wanted to strengthen obligations for companies to report drug shortages and withdrawals in advance and the development and maintenance of shortage prevention plans.

And as part of this new pharma legislation, the Commission has announced in recent months that it will work to draw up a list of medicines to be considered “critical” at the European level as part of the joint task force on the availability of medicines authorized for human and veterinary use, specifying further that the purpose of the list is to help ensure that the most critical medicines for health systems in the Union are always available.

At the end of October, it adopted a communication dedicated to drug shortages, announcing a series of actions to better prevent and mitigate potential drug shortages in the EU by promoting the use of a voluntary European solidarity mechanism for medicines to deal with possible supply crises.

“Ensuring an uninterrupted supply of essential medicines is essential for a strong European Health Union,” comments Stella Kyriakides, Commissioner for Health and Food Safety. “With the publication today of the Union’s first list of critical medicines, we are delivering on our promise to accelerate work in this area and to take every possible measure to avert the risk of shortages for our citizens. I am very grateful to the European Medicines Agency and member state agencies for their cooperation on this list and for the crucial work they are doing to prevent drug shortages in our Union.

The European pharmaceutical industry accounts for 800 thousand jobs in Europe and during the acute phase of the pandemic has rediscovered itself unprepared to deal with it and poorly self-sufficient in terms of drug production, depending largely on non-EU countries for the production of pharmaceutical raw materials. In its strategy launched two years ago, Brussels also admits that it also needs to boost financial support for research and innovation, particularly through the Horizon 2020 and EU4Health, the programs all intended to strengthen healthcare in Europe. The Executive estimates that 60 new medicines are authorized for marketing in the EU each year, and more needs to be done to make them accessible to all.