In an article on the amendment to Act No. 363/2011 Coll. on the scope and conditions of reimbursement of medicines, medical devices and dietary foods based on public health insurance and on amendments to certain acts (hereinafter also referred to as the "Act"), we informed you about a new institution of special price regulation (OCR), which, among other things, was supposed to bring better access for patients to so-called innovative medicines, to which they had or still have significantly limited access in the Slovak Republic compared to neighboring countries.
The amendment introduced a special procedural process governing decisions on determining or revoking the designation of a medicinal product as subject to special price regulation. The decision on whether a medicinal product is subject to special price regulation is made by the Ministry on the basis of an application or on its own initiative. An application for a determination that a medicinal product is subject to OCR is submitted to the Ministry by the marketing authorization holder or the 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 that there are circumstances worthy of special consideration for determining that the medicinal product is subject to special price regulation.
Section 21(16) of the Act also stipulates that "A generally binding legal regulation issued by the Ministry shall lay down 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 determination or revocation of the determination 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 force 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 entered the inter-ministerial comment procedure within the legislative process LP/2022/539 establishing 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 (hereinafter also referred to as the "Draft Decree"), and the inter-ministerial consultation procedure was completed on October 10, 2022. During this procedure, a number of comments were raised on the draft by experts and state (public) administration bodies, which had to be assessed. The draft Decree was signed by the minister in its final form after the comments had been incorporated and evaluated on January 25, 2023, as Decree No. 29/2023 Z. Decree of the Ministry of Health of the Slovak Republic laying down 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 (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 determination or revocation of the determination 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% for 12 consecutive calendar months in the previous maximum 24 months prior to the date of submission of the application due to circumstances beyond the control of the marketing authorization holder has increased by at least 12% over 12 consecutive calendar months in the previous 24 months prior to the date of submission of the application pursuant to Section 14a of the Act, which economically justifies an increase in the price of the medicinal product by at least 5%, and no other medicinal product of another registration holder classifiedin the same reference group or reimbursement group as the medicinal product under assessment 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 a demonstrable 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 a demonstrable 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 assessment is available in the Slovak Republic, or
- the stocks of the medicinal product were not demonstrably sufficient to cover the 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 of another registration holder classified in the same reference group or reimbursement group as the medicinal product under assessment is available in the Slovak Republic in a quantity sufficient to cover the actual consumption of the medicinal product, and a determination that that the medicine subject to special price regulation will significantly increase the supply of the medicine in the Slovak Republic
These circumstances are a prerequisite for submitting an application for a determination that a medicine is subject to special price regulation within the meaning of the Act.
The most significant changes incorporated into the original draft Decree are as follows:
- removal of the term "in particular," which caused ambiguity throughout the Decree (eliminating the possibility that any other circumstance without legal qualification 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, may also be considered any other fact without its legal qualification and without legal regulation)
- a different mathematical expression for determining the calculation of increases in the prices of materials 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
- addition to point c) of the published text of the Decree, where a comparison of officially determined prices pursuant to Section 94 of the Act, which is a demonstrable reason for the submission of an application by the marketing authorization holder pursuant to Section 11 of the Act, is also considered a circumstance worthy of special consideration and no other medicinal product of another registration holder classified in the same reference group or reimbursement group as the medicinal product under assessment is available in the Slovak Republic, or - the above means that if, after a comparison of prices pursuant to Section 94 of the Act, after which the registration holder is obliged 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 of another registration holder classified in the same reference group or reimbursement group as the assessed medicinal product is available in the Slovak Republic, 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).
