Poland supports proposal to improve security of medicine supply in Europe

The document was also signed by France, Germany, Austria, the Netherlands, Luxembourg, the Czech Republic, Spain, Estonia, Slovenia, Romania, Latvia, Lithuania, Greece, Malta, Italy and Portugal.

In it, member states call for:

• Introduce a voluntary solidarity mechanism to temporarily alleviate acute drug shortages in EU countries in emergency situations,
• Establish a European list of critical medicines whose supply, production and value chains must be monitored,
• Implementation of the Critical Medicines Law to reduce dependence on non-EU supplies, especially those medicines for which there are only a few manufacturers or supplying countries.

- The voluntary solidarity mechanism implies that a member state facing a critically low stockpile of an important drug sends a notification to the other EU countries, which can offer assistance and thus a temporary solution. In addition, the mechanism would encourage manufacturers and wholesalers to help in such situations, Krzysztof Kopeć explains.

The proposal, signed by 18 EU members, stressed that a list of critical drugs should be created before the coming autumn, during which shortages - due to the infectious season - could be severe.

– W przypadku tych leków konieczne będzie monitorowanie podaży, globalne zmapowanie łańcuchów dostaw, identyfikacja potencjalnych dostawców i słabych punktów. Regulacja o krytycznych lekach byłaby zestawem narzędzi składającym się z różnych instrumentów. Ma się opierać na europejskich aktach prawnych o surowcach krytycznych i półprzewodnikach – wskazuje Grzegorz Rychwalski, wiceprezes Krajowych Producentów Leków. – Projekt legislacyjny ma zawierać konkretne instrumenty finansowe wsparcia produkcji farmaceutycznej na terenie EU - podkreśla.

Jeśli wniosek przejdzie, należy spodziewać się znacznych inwestycji w produkcję krytycznych API i leków w Europie. - Cieszymy się, że polski Rząd poprał tę inicjatywę, o co Krajowi Producenci Leków zabiegali od dawna - mówi Grzegorz Rychwalski.

- All indications are that the strong support of the majority of countries will put pressure on the European Commission to consider this proposal. We hope that the European Parliament will also take such action," adds Krzysztof Kopeć.

Today, in addition to the global geographic concentration of pharmaceutical production, it is concentrated in just a few manufacturing facilities. More than 50% of drug substances used worldwide are produced by 5 manufacturers. The effects of this situation are already being experienced throughout Europe, which is dependent on a few manufacturers. In 2022. 75% of EU countries reported that drug shortages had worsened compared to the previous year. There were shortages of antibiotics, thrombolytic drugs and insulin, as well as antipyretics and painkillers.

Source: PZPPF