EU outlines plan to avoid shortages of more than 260 key medicines

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Under the EU’s critical medicines list, vital medicines such as paracetamol and morphine need to be stored or produced in the EU to prevent shortages.

The list published by the European Medicines Agency on Tuesday includes more than 260 treatments including vaccines, painkillers and asthma drugs. The EU pledged to develop a plan by April to improve supplies of these medicines after some countries reported shortages last winter.

The proposals could include measures to encourage companies to stockpile products and diversify suppliers, investment incentives for new manufacturing plants in the EU and the introduction of joint procurement agreements, as the EU does for Covid-19 vaccines, according to an October European Commission proposal as done.

Europe relies heavily on China and India as sources of drugs and key precursor chemicals needed for their manufacture. As part of the EU’s bid for strategic autonomy, it is developing a plan to increase domestic production.

France has vowed to bring production of 50 key drugs home and plans to open a new paracetamol factory next year. The last EU facility closed in 2008.

The European Medicines Agency, together with the Health Emergency Preparedness and Response Agency, will publish a longer list of critical medicines that will identify those at risk of shortages.

European Commission President Ursula von der Leyen said last week that together we will identify the best measures to address and avoid shortages, from diversification and de-risking to increasing European manufacturing.

The list includes albuterol, a muscle relaxant used in asthma inhalers, insulin to treat diabetes, warfarin to prevent blood clots, and several penicillins and other antibiotics including erythromycin. Vaccines listed include meningitis, measles, mumps, rubella, influenza and tetanus.

Narcotics and painkillers such as lidocaine, morphine and fentanyl, as well as commonly used drugs such as oxytocin, are also on the EU’s critical list.

The plan is being pushed forward after lobbying by Health Minister Stella Kyriakides following shortages last winter. Children’s painkillers are also affected.

Adrian van den Hoven, Director General of Medicines for Europe, said that the organization strongly supports initiatives to improve the security of drug supply in Europe in the post-epidemic era. He said the critical medicines list was an important first step, by harmonizing the various national lists across the region.

However, he warned that health systems and consumers could face higher prices. Many medicines on the list are subject to the most extreme form of cost controls in EU member states, exacerbating the risk of shortages.

Van den Hoeven advocates harmonizing medical packaging rules so that medicines can be moved more easily from one country to another.

The European Federation of Pharmaceutical Industries and Associations, a lobby group for pharmaceutical companies, said the next step would be to assess whether there are vulnerabilities in the supply chain for these medicines. EFPIA members will engage constructively in this work with relevant authorities where appropriate.

Didier Reynders, the EU’s acting competition commissioner, told the European Health Summit in Brussels last week that he was willing to allow subsidies for new manufacturing facilities.

He said it has become more sensitive due to the distortion of competition. But it’s possible.

He said member states could use pan-EU plans as serving the overall economic interests of market shortages, adding: “We need European supply chains rather than relying on third countries.”

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