Polish drug manufacturers appeal to Mateusz Morawicki. It is about an amendment to the Reimbursement Act

The draft amendment to the Reimbursement Act, submitted to the Standing Committee of the Council of Ministers, did not take into account the comments submitted a year earlier. According to the report from public consultations and the opinions of all stakeholders, the adoption of the regulation would contribute to an increase in the level of patients' subsidies to reimbursed drugs and medical devices and to limit their availability, and would also threaten the continuity of trade in reimbursed products. Enterprises responsible for the production and distribution of drugs and medical devices critically assessed the proposals of the Ministry of Health, reminding them that without the drugs and medical devices for which they are responsible, health care will not function in Poland.

The industry emphasizes that the project includes favorable solutions increasing the amount of wholesale and pharmacy margins. However, it should be emphasized that without the drug price indexation resulting from inflation, the 1% increase in margins derived from these prices will not solve the problems of the pharmaceutical market. Especially that the authors of the draft act see this necessity by proposing in the document a 100% increase and indexation of the salaries of members of the Economic Commission negotiating drug prices and increasing fees for procedures related to introducing drugs to the market.

The authors of the appeal emphasize that they counted on working out such changes as part of the social dialogue
in an act that would be beneficial to patients, built a stable drug market in Poland and created conditions for increasing pharmaceutical production in Poland. Considering the outbreak of the war in Ukraine, the unpredictability of the economic environment, drug shortages across the EU and the unprecedented challenge to public health related to the COVID-19 pandemic and the need to pay off the health debt - rational legislation in the area of ​​strategic importance to state security becomes crucial.

Unfortunately, the new version of the draft amendment to the Reimbursement Act, which does not take into account the vast majority of constructive comments, shows that the Ministry of Health disregards knowledge
and the experience of producers and distributors, and did not take into account the current geopolitical situation both in the content of the proposed legislation and in the regulatory impact assessment. Moreover, the proposed solutions pose an even greater threat to drug safety, the possibility of ensuring access to reimbursed products and increasing access to effective and safe therapies.

The signatories of the appeal emphasize that they count on the mediation of Prime Minister Mateusz Morawiecki in the dialogue
with the Minister of Health in order to develop a new version of the draft act before referring it to further work of the Standing Committee of the Council of Ministers.

The introduction of the proposed changes and the abandonment of the discussion on the stabilization of the market may result in a dramatic shortage of drugs in Poland.

Signatories of the Appeal of 5/9/2022:

American Chamber of Commerce

Chamber of Commerce "FARMACJA POLSKA"

Employers' Union of Innovative Pharmaceutical Companies INFARMA

Polish Association of Pharmaceutical Industry Employers - National Drug Manufacturers

Lewiatan Confederation

Polish Chamber of Pharmaceutical Industry and Medical Devices POLFARMED

Employers of the Republic of Poland

Polish Chamber of Commerce for Medical Devices POLMED

Organization of Medical Industry Employers, TECHNOMED

Polish Association of Drug Manufacturers Without Prescription "PASMI"

Source: PZPPF