Poland develops its first national critical medicines list, boosting ...

The Polish Ministry of Health has taken a significant step to enhance the country's pharmaceutical security by drafting the first-ever National Critical Medicines List.

This initiative addresses the pressing need to strengthen Poland's medical supply chain while also meeting the expectations of the domestic pharmaceutical market.

According to the Ministry, the inclusion of a particular API in the list underscores its importance in treating serious illnesses. However, the Ministry emphasised that being listed does not necessarily indicate an imminent risk of shortage in the Polish market.

"The National Critical Medicines List is not merely a reflection of current market availability, but a strategic measure aimed at strengthening Poland's preparedness for potential disruptions in supply chains," the Ministry stated.

This initiative represents a proactive approach to securing access to essential medicines, ensuring that patients in Poland continue to receive critical treatments without interruption, even in the face of global supply chain challenges.

"This is a very important step towards improving the country's security, and it's worth acknowledging the Ministry of Health for undertaking this work," Krzysztof Kopeć, the president of the Polish Union of Employers in the Pharmaceutical Industry 'Medicines for Poland' told Euractiv.

In preparing the draft of Poland's National Critical Medicines List, the Ministry of Health considered active pharmaceutical ingredients (APIs) listed in the EU's critical medicines catalogue.

This EU list, first published on 12 December 2023 by the European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA), includes over 200 APIs identified as essential for healthcare systems across the Union. The catalogue is set to be updated annually to reflect emerging needs and priorities.

Poland's approach also considered specific national circumstances. Criteria for determining the criticality of certain APIs were carefully tailored to align with the country's treatment schemes and the availability of medicinal products in the domestic market.

In addition to the EU list, the Ministry drew on a catalogue of key APIs developed under the Ministry of Development and Technology's API Production in Poland Project. This supplementary list identifies 52 APIs deemed critical for ensuring the country's pharmaceutical security.

"The assessment also considered the clinical criticality of each substance, as evaluated by National Consultants across various medical fields. This process examined factors such as the availability of therapeutic alternatives, the potential health risks associated with a drug's absence, and its overall impact on patient safety," explained the Ministry.

The President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products provided further input, including data on manufacturing sites, that shaped the final selection.

Ultimately, the inaugural National Critical Medicines List encompasses 238 active substances, including acetylcysteine, acyclovir, folic acid, adrenaline, and amlodipine.

The proposed draft went through public consultation, as the Ministry of Health invited comments and suggestions to be filed by 10 December.  The feedback received will undergo thorough review to shape the final version of the National Critical Medicines List.

Krzysztof Kopeć emphasised that without Poland's National Critical Medicines List, the country would have no influence on the shape of the EU-wide list, which is scheduled for an update later this December. The European list's final form depends on the contributions of member states through their national lists.

"At the EU level, advanced work is underway on the 'Critical Medicines Act,' which will include mechanisms for financial support to produce critical medicines and their components within Europe," Kopeć noted.

He stressed the importance of ensuring that Poland benefits from these measures, with production facilities for critical medicines located domestically as part of the initiative.

"The new EU Health Commissioner, Olivér Várhelyi, has pledged to deliver the Critical Medicines Act within the first 100 days of the new Commission's term. Ursula von der Leyen (European Commission President) has also assured that critical medicines are the top priority among the Commission's five public health objectives, with the Critical Medicines Act to be presented as part of this initiative," he explained.

[Edited by Vasiliki Angouridi, Brian Maguire]