The law introduces solutions that are a consequence of an analysis of more than 10 years of the Reimbursement Law, which has not been significantly amended during that time.
Many of the changes relate to specialized subject matter and result from the need to clarify provisions that currently raise interpretation doubts or cause a slowdown in the processing of applications for reimbursement coverage and determination of the official selling price of a drug, foodstuff for special nutritional use or medical device. The law is also a response to requests addressed to the minister in charge of health from entrepreneurs present on the pharmaceutical market, patients and other social groups affected by the provisions of the amended law. The solutions contained in the Act are also intended to respond to the postulated introduction of mechanisms aimed at increasing the drug safety of the Republic of Poland. One of the fundamental aspects of the changes being introduced is to increase the availability of reimbursed medicines, foodstuffs for special nutritional purposes and medical devices, and to meet health needs as much as possible.
The specific solutions contained in the law include, among others, the introduction of definitions of gross wholesale price, drug manufactured in the territory of the Republic of Poland, drug presentation, advanced therapy medicinal product, active substance manufactured in the territory of the Republic of Poland, and modification of the definition of wholesale price and official selling price. In addition, the law contains regulations aimed at establishing the benefits of drug production in the territory of the Republic of Poland. To this end, the law reduces, among other things, the level of patient payment by 10% or 15%, depending on whether the drug itself or the active substance is manufactured in the territory of the Republic of Poland. The law increased the official wholesale margin, which was set from a level of 5% to 6% of the net selling price of a drug, foodstuff for special nutritional purposes or medical device, not less than PLN 0.50 and not more than PLN 150 for a drug, foodstuff for special nutritional purposes or medical device available at a pharmacy by prescription. On the other hand, the upper margin limit for drugs used in chemotherapy and in the drug program will be PLN 2,000.
The retail margin has also been increased, in two stages: in the first stage (until the end of 2024), a retail margin in accordance with the table set forth in the transitional provision in Article 18 of the Law will apply, while the target solution, cont...