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Vital drugs such as paracetamol and morphine need to be stockpiled or made in the EU to prevent shortages, according to a list of critical medicines for the bloc.
The list, published by the European Medicines Agency on Tuesday, includes more than 260 treatments including vaccines, painkillers and asthma medicines. The EU promised to have a plan to improve the supply of these medicines by April after several 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 protocols as the bloc did with Covid-19 vaccines, according to a European Commission proposal in October.
Europe is heavily reliant on China and India as a source of drugs and the vital precursor chemicals needed to make them. As part of the EU’s drive for “strategic autonomy”, it is drawing up a plan to make more domestically.
France has vowed to reshore the production of 50 key medicines and is opening a new paracetamol plant next year. The last EU facility shut in 2008.
The European Medicines Agency, together with the Health Emergency Preparedness and Response Authority will publish a longer list of critical medicines, which will identify those at risk of experiencing shortages.
“Together, we will then identify the best measures to address and avoid shortages, from diversification and de-risking to increase manufacturing in Europe,” commission president Ursula von der Leyen said last week.
The list includes Salbutamol, a muscle relaxer used in asthma inhalers, insulin for diabetes treatment, warfarin, which prevents blood clots, and several types of penicillin and other antibiotics including erythromycin. Vaccines listed include jabs for meningitis, measles, mumps, rubella, influenza and tetanus.
Anaesthetics and painkillers such as lidocaine, morphine and fentanyl and commonly used drugs such as oxytocin are also on the EU’s critical list.
Health commissioner Stella Kyriakides is pushing the plan after lobbying from health ministers following last winter’s shortages. Painkillers for children were among those affected.
Adrian van den Hoven, director-general of generic drugmakers association Medicines for Europe, said the body “strongly supports” the move to improve Europe’s medicine supply security in the post-pandemic era. “The list of critical medicines is an important first step, by harmonising the wide variety of diverging national lists across the region,” he said.
However, he warned that health systems and consumers might face higher prices. “Many of the medicines on this list are subject to the most extreme forms of cost-containment in EU member states, which exacerbates the risk of shortages.”
Van den Hoven advocated the harmonisation of medical packaging rules so that drugs could be more easily transferred from one country to another.
The European Federation of Pharmaceutical Industries and Associations, a lobby group for pharma companies, said: “The next step will be to assess the vulnerabilities — if any — of the supply chain for those medicines included in the list. EFPIA members will constructively engage with the relevant authorities in this exercise where appropriate.”
Didier Reynders, the EU’s acting competition commissioner, told the European Health Summit in Brussels last week that he was open to permitting subsidies for new manufacturing facilities.
“It is more sensitive because of the distortion of competition,” he said. “But it is possible.”
Member states could pitch a pan-EU project as a “service of general economic interest” where “we have a shortage on the market”, he said, adding: “We need supply chains in Europe and not to be dependent on third countries.”
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