the first responses from the European Union / France News

Almost three years ago, in the first half of 2020, in the midst of a coronavirus pandemic, certain member countries of the European Union (EU), first and foremost Germany, were ready to do anything to obtain these masks and vaccines which lacked so much, even if it meant hurting their partners. Today, while the shortages of certain drugs are felt everywhere on the Old Continent, the temptation of every man for himself is back.

At the end of December 2022, Germany said it was ready to pay more for certain drugs, in order to prevent laboratories from selling them elsewhere at a better price. Just like Greece, which, in early January, also decided to freeze exports of missing remedies. Recently, Romania warned that it could ban the export of certain generics manufactured on its soil.

In this context, the European Commission and the European Medicines Agency (EMA) have taken up the subject. But health essentially comes under national jurisdiction, which limits their field of action. For now, “we are deploying all the regulatory flexibilities at our disposal”assured the European Parliament, the Commissioner for Health, Stella Kyriakides, on January 17.

“Security before price”

Thus, a Member State can accept that instructions for use are not translated into its language, alleviate the constraints in terms of packaging, often manufactured in Ukraine before the war started at the end of February 2022, authorize a medicine which contains the same substances active than an out-of-stock product, allow the delivery of unit tablets or substitute suppositories for oral medications. The EMA also ensures that it is ready to quickly authorize the main antibiotic sites in Europe to increase their production capacity.

“If necessary, the European Health Emergency Preparedness and Response Authority [HERA, l’organe de crise sanitaire créé lors de la pandémie] can purchase medicines on behalf of the Member States”and make strategic reserves, recalled Mme Kyriakides. But, ultimately, these measures will not be enough, as the problem is structural. “In Europe, drug shortages have multiplied by twenty in twenty years”notes French MEP (European People’s Party) Nathalie Colin-Oesterlé.

Today, “nearly 80% of active pharmaceutical ingredients are manufactured outside Europe, mainly in China and India, and around 40% of medicines marketed in the EU are produced outside our borders”, explains Isabelle Marchais, health specialist at the Jacques Delors Institute. Consequently, the EU is at the mercy of these countries which may decide to interrupt their exports.

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