In our article on the amendment to Act No. 363/2011 Coll. on the scope and conditions of reimbursement for medicines, medical devices, and dietary foods under public health insurance and on amendments to certain acts (hereinafter also referred to as the “Act”), we informed you about the new institution of special price regulation (OCR), which was intended, among other things, to improve patient access to so-called innovative medicines, to which patients in the Slovak Republic had—and still have—significantly limited access compared to neighboring countries.
The amendment introduced a special procedural framework governing decisions on whether to designate or revoke the designation of a drug as subject to special price regulation. The Ministry decides whether a medicinal product is subject to special price regulation based on a request or on its own initiative. A request for a determination that a medicinal product is subject to OCR is submitted to the Ministry by the marketing authorization holder or a health insurance company. One of the conditions under which the Ministry may decide that a medicinal product is subject to special price regulation is that the applicant demonstrates the existence of circumstances warranting special consideration for such a determination.
Section 21(16) of the Act also stipulates that “A generally binding legal regulation issued by the Ministry shall specify the circumstances worthy of special consideration for the purposes of assessing and deciding on the determination or revocation of the determination that a medicinal product is subject to special price regulation. Circumstances worthy of special consideration for the purposes of assessing and deciding on the designation or revocation of the designation that a medicinal product is subject to special price regulation must be included in the reasoning for the decision.”
Although the amendment to the Act has been in effect since August 1, 2022, this generally binding legal regulation has not been approved by the Ministry of Health of the Slovak Republic. On September 20, 2022, a draft decree of the Ministry of Health of the Slovak Republic establishing circumstances worthy of special consideration for the purposes of assessing and deciding on the designation or revocation of the designation that a medicinal product is subject to special price regulation (hereinafter also referred to as the “Draft Decree”); the inter-ministerial comment procedure was concluded on October 10, 2022. During this process, a number of comments were raised regarding the draft by both the professional public and state (public) administration bodies, which had to be assessed. The final version of the Draft Decree was signed by the Minister only on January 25, 2023, as Decree No. 29/2023 Coll., following the incorporation and evaluation of the comments. Decree of the Ministry of Health of the Slovak Republic establishing circumstances worthy of special consideration for the purposes of assessing and deciding on the designation or revocation of the designation that a medicinal product is subject to special price regulation (hereinafter also referred to as the “published text of the Decree”).
Pursuant to Section 1 of the published text of the Decree, circumstances worthy of special consideration for the purposes of assessing and deciding on the designation or revocation of the designation that a medicinal product is subject to special price regulation are:
- the price of the material from which the medicinal product is manufactured, the price of energy or the price of services for the manufacture or supply of the medicinal product has increased by at least 12% over 12 consecutive calendar months within the preceding 24 months prior to the date of submission of the application pursuant to Section 14a of the Act, and this economically justifies an increase in the price of the medicinal product by at least 5%, and no other medicinal product from another marketing authorization holder classified in the same reference group or reimbursement group as the medicinal product under review is available in the Slovak Republic in a quantity sufficient to cover the actual consumption of the medicinal product,
- the obligation of the marketing authorization holder to submit an application for a reduction of the officially determined price of the medicinal product pursuant to Section 16(7) of the Act, which is demonstrably an obstacle to the submission of an application pursuant to Section 10 of the Act to the Ministry of Health of the Slovak Republic,
- comparison of officially determined prices pursuant to Section 94 of the Act, which is demonstrably a reason for the marketing authorization holder to submit an application pursuant to Section 11 of the Act, and no other medicinal product from another marketing authorization holder classified in the same reference group or reimbursement group as the medicinal product under review is available in the Slovak Republic, or
- stocks of the medicinal product that were demonstrably insufficient to cover actual consumption of the medicinal product in the Slovak Republic for at least 30 consecutive days immediately preceding the date of submission of the application pursuant to Section 14a of the Act, no other medicinal product from another marketing authorization holder classified in the same reference group or reimbursement group as the medicinal product under review is available in the Slovak Republic in a quantity sufficient to cover the actual consumption of the medicinal product, and a determination that the medicinal product subject to special price regulation will substantially increase the supply of the medicinal product in the Slovak Republic
These circumstances are a prerequisite for submitting an application to determine that the medicinal product is subject to special price regulation within the meaning of the Act.
The most significant changes incorporated compared to the original draft of the Decree are as follows:
- removal of the term “in particular,” which caused ambiguity throughout the Decree (the possibility was eliminated that any other fact, without legal classification or legal regulation, could be considered a circumstance worthy of special consideration on the basis of which the Ministry of Health of the Slovak Republic may decide to determine that a medicinal product is subject to special price regulation)
- a different mathematical formula for calculating increases in the prices of materials used to manufacture the drug, the price of energy, or the cost of services for the manufacture or delivery of the drug
- an amendment to point (c) of the published text of the Decree, whereby a circumstance worthy of special consideration is also deemed to be the comparison of officially determined prices pursuant to Section 94 of the Act, which is demonstrably the reason for the submission of an application by the marketing authorization holder pursuant to Section 11 of the Act, and no other medicinal product from another marketing authorization holder classified in the same reference group or reimbursement group as the medicinal product under review is available in the Slovak Republic, or—the foregoing means that if, following a price comparison pursuant to Section 94 of the Act, which gives rise to an obligation for the marketing authorization holder to submit an application for the removal of the medicinal product from the list of categorized medicinal products pursuant to Section 11, and at the same time no other medicinal product from another marketing authorization holder classified in the same reference group or reimbursement group as the medicinal product under review is available in the Slovak Republic, then such a fact shall be considered a circumstance worthy of special consideration on the basis of which it is possible, pursuant to Section 14a, to submit an application for a determination that the medicinal product is subject to special price regulation
- The effective date of the Decree has been postponed to February 1, 2023 (from the original proposal of November 1, 2022).
