The position paper refers to the Draft of the Ordinance on amendments to the Ordinance on the criteria for determining the highest permitted price of medicinal products in wholesale and, as an exception, a price higher than the highest permitted price of medicinal products in wholesale and the yearly calculation of the price of medicinal products that the Ministry of Health submitted to the public consultation procedure on January 5, 2022. The amendments to the ordinance in question were not included in the Plan of Consultation Activities of the Ministry of Health for 2022 (nor in the plan for 2021). As a result, the companies were unable to plan their budget on time in relation to medicinal product prices since they would have concluded their financial plans for the business and the calendar year of 2022 in 2021 when the amendment had not yet been announced.

Determining prices in a way as foreseen by the amended will have a severe impact not only on manufacturers but on all of the parties involved in the market chain and will have negative consequences for patients in terms of medicine availability and shortages. Furthermore, adopting such an Ordinance will result in reducing the manufacturing potential, fewer investments into research and development, disruption in the supply of medicinal products and, as a consequence, an increase in costs in the entire healthcare system. 

AmCham’s position paper is available here.