Just before Christmas, the Ministry of Health published, in its Bulletin, three new regulations that were passed on 10 December 2019: Price Regulation No. 1/2020/CAU, on the regulation of the prices of medicinal products and food for special medical purposes, Price Regulation No. 2/2020/CAU, on the regulation of the prices of provided medical services, the stipulation of the maximum prices of medical services provided by dentists and covered by public health insurance, and of specific medical procedures, and finally Price Regulation No. 3/2020/CAU, on the regulation of the prices of individually prepared medicinal products containing hemp for medical purposes (“Price Regulation – Medical Hemp I”).
On 29 January 2020, the Ministry of Health also published long-awaited Price Decision No. 5/2020/CAU, establishing a list of ATC groups with the respective way of administration, where the price of the originator is not subject to price regulation. It also published new Price Regulation No. 4/2020/CAU, on the regulation of the prices of individually prepared medicinal products containing hemp for medical purposes (“Price Regulation – Medical Hemp II”).
Regulation of the Prices of Medicinal Products and Food for Special Medical Purposes
The new legal regulation cancels and substitutes the previous price regulations, especially Price Regulation of the Ministry of Health No. 1/2019/FAR of 12 December 2018, on the regulation of the prices of medicinal products and food for special medical purposes. This Price Regulation introduced, with effect from 1 January 2019, new institutes of other persons launching the registered product on the market, as well as the regulation of discount and bonus schemes (we have previously provided information about the 2019 changes in the price regulation of medicinal products in our article The Ministry of Health Has Issued a New Price Regulation After Six Years. However, these institutes, just like the definition of the mark-up zones, remain more or less unchanged in the new price regulation.
Changes that have come into effect since 1 January 2020 will concern the price regulation of medicinal products applied to rare illnesses, used in institutional as well as outpatient care, and the price regulation of radiopharmaceuticals.
According to Article II., Paragraph 8 of the new price regulation, the medicinal products included in the price decision of the Ministry of Health which provides a list of ATC groups with the respective way of administration will not be subject to regulation in the form of a stipulated maximum price, or in the form of factual price controls when these medicinal products are administered during outpatient care. Until now, these medicinal products were subject to price regulation in the form of factual price controls (ie they were generally regulated in terms of the maximum year-on-year price growth). Under the new rules, they will not be subject to any price regulation whatsoever when administered during outpatient care. When introducing price controls on these medicinal products, however, pharmaceutical companies must keep in mind that a significant price growth in the course of the previous twelve months may be a decisive factor in assessments of whether the market has been jeopardized through limited competition. This would constitute the case for the given medicinal product to be excluded from the list of ATC groups with the respective manner of administration, as defined by the price decision of the Ministry of Health, and would lead to regulation through the maximum price set by the originator.
Although the new price regulation was published in December 2019, with effect from 1 January 2020, the Ministry did not publish a new price decision in terms of Art. II, paragraph 8 of the new price regulation until 29 January 2020, with effect from 1 March 2020. This means that starting 1 March 2020, certain ATC groups are moving to the non-regulated category, while some other medicinal products are subject to retrograde regulation by means of a stipulated maximum price. In line with the statement of the Ministry of Health, we recommend that all marketing authorization holders, introducing insurance-covered medicinal products to the market, check the list. In the case of ATC groups that are subject to retrograde regulation, the request for the stipulation of the maximum price by the producer must be filed within 30 days.
Regulation of medicinal products containing hemp
With effect from 1 January 2020, individually prepared medicinal products containing hemp designated for medical purposes were subject to price regulation by means of Price Regulation – Medical Hemp I, regardless of whether they were covered from public health insurance or whether the patient had to pay for them in full. The price regulation determined the originator’s maximum price; thus, the actual price paid by the consumer would be the sum of the originator’s maximum price and the respective value added tax. The price regulation for medicinal products containing hemp explicitly prohibits the application of a mark-up.
Price Regulation – Medical Hemp II, issued on 29 January 2020 – less than two months after the issuing of Price Regulation – Medical Hemp I of 10 December – cancels the price regulation from December and replaces it, with effect from 29 January 2020.