The amendment to the Act on Medicines has been under legislative consideration for several months, since October 2022. We are monitoring the entire legislative process and would like to reiterate that the proposed amendment to Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts, as amended, and which amends certain acts, was submitted at the initiative of the Slovak Government’s Legislative Agenda for 2022 by the responsible sponsor, Minister of Health of the Slovak Republic Vladimír Lengvarský, as part of legislative process LP/2022/663 (start of the inter-ministerial comment period on October 19, 2022, and end of the inter-ministerial comment period on November 9, 2022) (hereinafter also referred to as the “original draft amendment”).
As part of the aforementioned legislative process (which we discussed in our October article), a government bill was submitted to the National Council of the Slovak Republic (hereinafter also referred to as the “National Council”) on April 14, 2023, amending Act No. 362/2011 Coll. on Medicines and Medical Devices and on the Amendment and Supplementation of Certain Acts, as amended, and amending and supplementing certain acts (hereinafter also referred to as the “current draft amendment”). The Speaker of the National Council of the Slovak Republic proposed the Constitutional Committee of the National Council of the Slovak Republic, the Committee on Agriculture and the Environment of the National Council of the Slovak Republic, and the Committee on Health of the National Council of the Slovak Republic as the committees responsible, with a deadline for deliberation of June 9, 2023. The Speaker of the National Council of the Slovak Republic proposed the National Council Committee on Health as the lead committee, with a deadline for deliberation of June 12, 2023.
The current draft amendment incorporates several comments raised during the inter-ministerial comment procedure; consequently, the bill from October 2022 differs from the one from May 2023 in several fundamental legal provisions. The purpose of this article is to briefly describe the changes made in the amendment and to compare them. The main objective, which was to reflect European legislation, has been retained; however, as mentioned, changes have occurred primarily in the provisions aimed at addressing shortcomings in the current Slovak legal framework for the handling of medicines.
1. New Competence of the Ministry of Health of the Slovak Republic Expanded
The original draft amendment introduced the authority of the Ministry of Health of the Slovak Republic (hereinafter also referred to as “MoH SR”) to ensure the availability of human medicines and medical devices, as it would be authorized to procure or otherwise acquire human medicines and medical devices for healthcare providers, the storage, delivery, and dispensing would be ensured through holders of licenses to handle medicines and medical devices, even outside of a declared state of emergency or extraordinary situation. The current draft amendment has expanded the procurement of medical devices to include in vitro medical devices.
2. Non-commercial clinical trials
Non-commercial clinical trials are defined. The definition of non-commercial clinical trials is justified by the fact that barriers have been identified in Slovakia, resulting in non-commercial clinical trials being conducted at a significantly lower rate (approximately 3% of the volume of clinical trials) than in developed countries (15% of the volume of clinical trials) – this provision has remained virtually unchanged.
3. Additional information required when notifying the State Institute for Drug Control of the intention to act as an intermediary in the purchase or sale of medicinal products
Section 18a of the Medicinal Products Act establishes the obligation for a natural person residing in the Slovak Republic and a legal entity with its registered office in the Slovak Republic to notify the State Institute for Drug Control (hereinafter also referred to as “ŠÚKL”) their intention to engage in the intermediation of the purchase or sale of a human medicinal product prior to commencing such activity. The original draft amendment expanded the scope of mandatory information required for the notification of the intermediation of the purchase or sale of a human medicinal product to include a list of human medicinal products to be subject to such intermediation. This obligation remains unchanged.
4. New Legal Provisions on the Export of Human Medicines from the Territory of the Slovak Republic
The original draft amendment clarified the conditions for the export of categorized human medicines such that the export of a human medicine included in the list of categorized medicines shall be deemed to have occurred when a human medicine included in the list of categorized medicines leaves the customs territory of the Slovak Republic —unlike the current legal framework, under which the export of a medicinal product for human use included in the list of categorized medicinal products from the Slovak Republic is considered to be the delivery of such a medicinal product to another Member State or to a third country. The current draft amendment incorporates several comments raised during the inter-ministerial consultation process, of which we consider the most significant to be the fact that the term “customs territory of the Slovak Republic” was defined for this purpose in an unclear manner and in a way that is ineffective for the purposes of the amendment. According to the current draft amendment, a new second sentence is inserted after the first sentence of Section 19a(1) of the Medicines Act, which reads: that the transfer of a medicinal product for human use included in the list of categorized medicinal products by a marketing authorization holder to the territory of another Member State or a third country shall also be considered a supply under the first part of the sentence, and thus the transfer of a medicinal product for human use included in the list of categorized medicinal products by a marketing authorization holder to the territory of another Member State or a third country.
5. Option for vaccination in pharmacies repealed
In order to ensure easier public access to vaccination, the original draft amendment proposed introducing the possibility of administering vaccinations as a voluntary component of pharmaceutical care in public pharmacies, branches of public pharmacies, and hospital pharmacies with a department for dispensing medicines, medical devices, and dietary foods, whereby the very availability of public pharmacies was intended to contribute to increasing vaccination rates among the population, leading to a reduction in healthcare costs; the option of vaccination directly at the pharmacy was intended to replace the current lengthy process, which in many cases discourages individuals from getting vaccinated. The current draft amendment does not include the option of vaccination in pharmacies.
6. Option of online dispensing via a mobile app
Given the rapid pace of development and changes in the field of information technology, the option of online dispensing via a mobile app was proposed — but only on the condition that the holder of a license to provide pharmacy care in a public pharmacy offering online dispensing via a mobile app has met all the specific conditions for online dispensing via the public pharmacy’s website — this legal provision remained in its original wording.
7. Revocation of the ŠÚKL’s authority to issue a decision restricting the dispensing of a medicine not subject to a prescription
The original draft amendment proposed granting the ŠÚKL the authority to issue a decision restricting the dispensing of a medicinal product not subject to a prescription if the medicinal product for human use could pose a risk to health that could be prevented by imposing restrictions on such dispensing. This restriction was intended to ensure the availability of medicines that can be used without medical supervision, while also preventing the improper or even illegal use of human medicines (e.g., emergency contraception, analgesics, anti-inflammatory drugs, etc.). The current draft amendment does not include this authority for the State Institute for Drug Control (ŠÚKL).
8. Prescribing Medicines After Discharge from Inpatient Care (by a Specialist Physician)
Improving patients’ access to necessary medicines, medical devices, or dietary foods after discharge from the hospital was intended to be ensured by the obligation of a specialist physician to prescribe to the patient a human medicine, medical devices, including custom-made medical devices, and dietary foods that were indicated for the patient during hospitalization and whose administration is necessary even after discharge from inpatient care, in a quantity sufficient for at least 28 days of treatment.
The current draft amendment regulates the prescribing of medications by providers of inpatient healthcare in greater detail, such that a provider of inpatient healthcare or inpatient emergency services is required to ensure that upon the patient’s discharge from inpatient care or during the provision of inpatient emergency services, a physician specializing in a field other than general medicine (hereinafter “specialist physician”) prescribes a human medicinal product, a medical device, or a dietary food indicated for the patient during inpatient care or the provision of inpatient emergency services, provided that the use of a human medicinal product included in the list of categorized medicinal products, a medical device included in the list of categorized medical devices, or a dietary food included in the list of categorized dietary foods is necessary even after the patient’s discharge from inpatient care or after the termination of inpatient emergency services, in the number of packages necessary for treatment lasting at least 28 days if the patient’s health condition requires long-term treatment and a custom-made medical device.
A specialist physician in inpatient care may, in the discharge report, authorize a physician specializing in general medicine or pediatrics (hereinafter referred to as a “general practitioner”), under whose outpatient care the patient is, to prescribe a human medicinal product, medical device, or dietary food, for a maximum period of six months from the date of the patient’s discharge from inpatient care.
9. Prescription of Medicines by Specialists Regulated
Due to legislative changes implemented in the Medicines Act as of January 1, 2022, regarding the prescription of human medicines, medical devices, and dietary foods, the latest amendment has had a significant negative impact on the quality and availability of healthcare—for this reason, the Ministry of Health of the Slovak Republic has received numerous complaints from patients whose doctors refuse to prescribe human medicines, medical devices, and dietary foods.
The current draft amendment has once again revised the rules for prescribing medicines so that the prescribing physician may, by mutual agreement, authorize another physician in the same or a different specialty (hereinafter referred to as the “authorizing physician”) to prescribe (hereinafter referred to as the “authorized physician”), always for a maximum of six months; this does not apply to the prescription of human medicines containing a narcotic substance of Group II or a psychotropic substance of Group II pursuant to Section 119( 4, where the authorization may, by mutual agreement, be valid for up to 12 months without interruption, or for the prescription of a medical device in cases of permanent and irreversible third-degree incontinence and in cases of a diagnosed permanent and irreversible stoma, where the authorization may, by mutual agreement, be granted for an indefinite period.
The authorizing physician is responsible for the correct indication of a human drug, medical device, or dietary food. The prescribing physician is responsible for the correct selection of the active ingredient or medicinal product, route of administration, dosage form, quantity of the active ingredient in the dosage form, determination of the diagnosis expressed in letters and numbers according to the current International Statistical Classification of Diseases and Related Health Problems, the package size, number of packages, and dosage of the drug when a general practitioner prescribes a human drug based on a specialist’s recommendation, the specialist is responsible.
10. Prescription of Medications by Nurses – Repealed
The original draft amendment also addressed current practice showing that nurses are currently issuing medical prescriptions to patients in violation of applicable legislation. The current draft amendment has repealed the provision allowing nurses to prescribe medicines under defined conditions.
11. New powers of the State Institute for Drug Control (ŠÚKL) during inspections
The original draft amendment introduced the authority for the State Institute for Drug Control (ŠÚKL) to conduct inspections of medicinal products at the location where the main component of the human drug safety surveillance system is stored, or at the location where the marketing authorization holder for a human drug conducts safety surveillance of human drugs—for example, at contractual partners— if the marketing authorization holder for a human medicinal product has delegated the supervision of the safety of human medicinal products to them, as well as at intermediaries involved in the purchase or sale of human medicinal products. This provision remains in the current draft amendment.
12. Amendments to Act No. 576/2004 Coll. on Healthcare
The current draft amendment introduces an addition to the definition of healthcare in Act No. 576/2004 Coll. on Healthcare, services related to the provision of healthcare, and on amendments to certain laws—specifying that healthcare does not include the provision of a special treatment regimen to persons in detention pursuant to a separate regulation.
At the same time, this Act was amended so that the provider of institutional care ensures that, upon the patient’s discharge from institutional care, a human medicinal product, medical device, or dietary food is prescribed to the patient in accordance with prescribing restrictions and indication restrictions, including the prescription of a custom-made medical device, indicated for the patient during the provision of institutional health care in the number of packages necessary for treatment, if the use of the human medicinal product, medical device, or dietary food is necessary even after the patient’s discharge from institutional health care; if the patient’s health condition requires treatment lasting longer than 28 days, the prescription of a number of packages sufficient for at least 28 days of treatment shall be ensured.
13. Addition of Important Definitions
A crisis situation is defined such that in Section 2 of the Act on Medicines, paragraph 32, the following words are added “during a declared state of emergency, state of emergency, or extraordinary situation (hereinafter referred to as a ‘crisis situation’)” and in Section 2(34) of the Medicines Act, the words “prescription record identification number” are replaced by the words “prescription record identifier.”
14. Authorization to perform the activities of a professional representative at two places of business
The current draft amendment added that a professional representative may also perform activities at two places of business and thus defined a professional representative as a natural person who meets the conditions set forth in the Medicines Act and who is responsible for the professional performance of the activities for which the authorization was issued. A single person may perform the duties of a professional representative at only one place of business; this does not apply to a professional representative
- of a license holder with two places of business, provided that the operating hours at the places of business do not overlap at any time, unless otherwise provided by a special regulation, or
- when providing pharmaceutical care in a public pharmacy and in a branch of a public pharmacy operated by a single license holder providing pharmaceutical care at two locations.
15. When changing the operator, it is not necessary to put the premises back into operation; only a notification needs to be submitted
The current draft amendment has simplified the licensing process only in the event of a change in the operator, in which case it is not necessary to re-commission the premises and thus submit a decision of approval from the competent public health authority regarding the commissioning of the premises, but only a copy of the notification that the applicant submits to the competent public health authority pursuant to a special regulation when changing the operator without altering the operating conditions for the premises for which the decision was issued.
The effective date of the current draft amendment has been postponed to August 1, 2023, with the exception of Article I, points 15, 16, 17, 22, and 83, Article IV, and Article VI, which take effect on March 1, 2024.
