RPO asks about list of critical drugs and plans to build drug safety in Poland

The list of critical medicinal products, published by the European Commission together with the European Medicines Agency and the heads of member states' drug agencies, contains 200 active substances used in medicines considered critical to health systems across the European Union, for which continuity of supply must be guaranteed to avoid shortages. 

Inclusion on the list means that preventing shortages of these drugs is particularly important, as they can cause significant harm to patients and pose serious challenges to health care systems. A drug is considered critical if it is used to treat serious diseases and, in the event of a shortage, cannot be easily replaced by another. The list includes active substances with a broad therapeutic spectrum, including vaccines and drugs for rare diseases.

Shortages of medicinal products have been brought to the attention of the National Drug Manufacturers. They pointed out that the supply of medicinal products of fundamental importance to the health of citizens has been repeatedly disrupted in recent years. They pointed out as necessary the development of a list of drugs and active substances for their production - critical for health security, and the creation of a contract manufacturing system.

The importance of introducing a list of critical drugs was also highlighted by experts at the 9th Health Challenges Congress (HCC). In addition, there are expert voices in the public space about the need to introduce mechanisms to coordinate the actions of the two ministries as to drug policy.

The main topic of the meeting at the Office of the Ombudsman with representatives of the Polish Pharmaceutical Industry Employers' Association was drug security in Poland, i.e. the ability to maintain and supplement the production and distribution of medicines for patients' needs. The introduction of mechanisms to encourage an increase in drug production in Poland was identified as essential. 

According to the President of the Polish Pharmaceutical Industry Employers' Association, in addition to lower patient co-payments for Polish drugs, further incentives should be introduced for manufacturing drugs in Poland. The idea would be, among other things, to give preference to drugs produced by domestic manufacturers when spending money from health premiums, and to offer preferences to those who decide to invest in production in the country.

The Ombudsman is asking for positions on the issue from the Ministries of Health and Development and Technology. Specifically, the request is for information on plans to build drug security, including strengthening drug production in the country and publishing a list of critical medicines, with the aim of identifying key production needs and gaps and increasing the availability of medicines for patients.

Source: RPO