There is the first national list of critical medicines

The list, which has been in effect since December 20, includes a total of nearly 300 drugs in cardiology, oncology, pulmonology, urology and gynecology, among others, as well as fourteen vaccines.

Deputy Minister Marek Kos said at a press conference on Friday that it would be possible to update the list within a few months to take into account subsequent versions of the EU list of critical medicines. Ultimately, the Polish list is to be published a few months apart from the EU list to ensure their compatibility.

The deputy head of the Ministry of Health, responsible for the drug area, stressed that in preparing the National List of Critical Medicines, all active substances included in the European List of Critical Medicines, the IQVIA report and the Ministry of Health's 2023 supplementary list of active substances following the analysis of the IQVIA list were analyzed. Other active substances were also considered, including those reported by responsible parties, national consultants and patient organizations, among others.

Three levels of clinical criticality have been identified based on analyses and opinions from national consultants.

The very critical level includes active substances contained in medicinal products with indications with very serious consequences for the health of the individual patient or public health; drugs or groups of drugs used to treat patients with general acute life-threatening conditions, specific acute life-threatening conditions or irreversibly progressive conditions.

Other criteria:

• there are no equivalent medicinal products for the indication or there is at most 1 equivalent;
• there are no alternative treatments for the indication;
• The lack of market availability of medicinal products containing the active substance in question by the month can cause a risk to life or health.

The intermediate-critical level is active substances contained in medicinal products with indications that have serious consequences for the health of the individual patient or public health.

Other criteria:

• there are at most two alternative treatments for a given indication;
• The lack of market availability of medicinal products containing a particular active substance for up to three months can cause a risk to life or health;

The low-criticality level includes active substances in medicinal products that do not meet any of the above conditions of high or medium risk to life or health.

Other criteria:

• there are more than two equivalent medicinal products in a given indication;
• there are numerous alternative treatments for the indication;
• lack of market availability does not affect the risk of life or health of the patient.

- Thanks to the list, we know which active substances are most needed and their lack can cause a threat to the health and life of patients, to public health," Marek Kos explained, assuring that the government will strive to ensure that Poland never runs out of critical medicines. An effective way to achieve this goal is to ensure the conditions for the production of these active substances in Poland. The ministry will also strive to secure stocks of these medicines over several months.

- Both the Polish and European lists of critical drugs indicate a support system for the pharmaceutical sector, for drug manufacturers, so that it is clear in which direction production should be developed. It is extremely important that we do not depend as we have so far on Asian countries, where about 50-60 percent of the world's active substances are produced. We need to secure Europe and Poland so that we are self-sufficient," Kos stressed.

In this context, the deputy minister also recalled that one of the priorities of the Polish presidency is drug safety, and Poland wants not only to continue but even accelerate work on the pharmaceutical package, one of the goals of which is this safety.