There is a draft National List of Critical Medicines

The list included more than 230 items.

Project assumptions

The creation of the National Critical Drug List was based on:

• lists of active substances indicated in the list of critical APIs being developed by the EMA and the list of key APIs being developed for the Ministry of Development and Technology (API Production Project in Poland).
• National conditions were also taken into account, including the adoption of criteria for assessing the criticality of specific active substances, appropriately selected and adapted to national conditions, including adapted to national treatment patterns, availability of medicinal products on the Polish market, as well as the average monthly sales volume and information on the categories of availability of medicinal products within individual active substances and ATC codes.
• The assessment of clinical criticality by National Consultants in various fields of medicine (taking into account the number of available equivalents, alternative medical therapies in a given indication, the impact of the absence of a given drug on the risk of life or health of patients) and the opinion of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products taking into account manufacturing sites were also taken into account.

The list is strategic for Poland

Krzysztof Kopeć, president of National Drug Manufacturers, stresses the importance of the project:

"This is a very important step towards building our security, and it is worth appreciating that the health ministry has done this work. The draft list indicates which drugs we need to produce in Poland. After public consultations and comments made, the list will become complete. It should be linked to additional incentives for the production of drugs containing the indicated substances, such as subsidies, deepening of reimbursement or environmental preferences. Without the Polish list of critical medicines, we would have no influence on the shape of the European one, which is due to be updated in December this year and is being created on the basis of national lists. In addition, work is advanced at the EU level on the "Critical Medicines Act," which will include mechanisms for financial support for the production of critical medicines and their components in Europe. The idea is that Poland will also benefit from them and that factories for critical medicines will also be located in our country."

Comments on the draft can be submitted until December 10.