Pursuant to the Slovak Government’s Legislative Agenda for 2022 (Task No. 3 for October), the responsible sponsor, Vladimír Lengvarský, Minister of Health of the Slovak Republic, submitted a bill to the inter-ministerial comment procedure 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, specifically within the framework of Legislative Process LP/2022/663 (start of the inter-ministerial comment procedure on October 19, 2022, and end of the inter-ministerial comment procedure on November 9, 2022). The proposed legislative amendment to Act No. 362/2011 Coll. on Medicines and Medical Devices and on the Amendment and Supplementation of Certain Acts (hereinafter referred to as the “Medicines Act”) primarily reflects European legislation, but it also addresses the shortcomings of the current Slovak legal framework governing the handling of medicinal products.
In connection with this amendment, we would like to use this article to summarize and further clarify the most significant proposed changes, many of which we will address in detail in separate articles.
Since the Slovak Republic’s accession to the European Union (EU), a significant portion of the legal framework of the Medicines Act has been harmonized with various EU regulations. As the legal framework for the handling of human and veterinary medicines and medical devices is constantly evolving and changing at the supranational level, it is essential to implement these legal provisions into Slovak legislation.
According to the legislature, the main objective of the current October amendment to the Medicines Act is therefore to address any shortcomings that arose from the implementation of:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC,
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, and
- Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC.
However, the current amendment to the Medicines Act also introduces many other changes related to shortcomings or the need for new legislation in the Slovak Republic, which reflect current practices in the application of the Medicines Act, whether long-standing or related to the most recently adopted amendment to the Medicines Act.
- New Competence of the Ministry of Health of the Slovak Republic
A shortcoming of the current wording of the Medicines Act is the absence of legal provisions enabling the early provision of human medicines and medical devices as essential medical countermeasures outside of a declared state of emergency or extraordinary situation. For this reason, the amendment to the Medicines Act proposes to expand the state’s powers—represented by the Ministry of Health of the Slovak Republic—to include the ability to respond adequately and flexibly to secure human medicines and medical devices. Under the new legislation, the Ministry of Health of the Slovak Republic will thus be authorized to procure or otherwise acquire, on behalf of healthcare providers, human medicines and medical devices, the storage, delivery, and dispensing will be ensured through holders of licenses to handle medicines and medical devices, even outside of a declared state of emergency or extraordinary situation. To eliminate any doubt regarding the interpretation of the term “procure,” an expansive interpretation is also introduced, leading to the conclusion that this includes forms of procurement other than mere provision for a fee, such as the donation of human medicines and medical devices.
- 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 that result 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).
- Additional information when notifying the intermediation of 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 medicinal product for human use prior to commencing such activity. The amendment to the Medicines Act expands the scope of mandatory information required for the notification of the intermediation of the purchase or sale of a medicinal product for human use to include a list of medicinal products for human use that are to be the subject of such intermediation. The implementation of this obligation will further clarify the scope and subject matter of brokerage activities and streamline administrative procedures.
- New Legal Regulation on the Export of Human Medicines from the Territory of the Slovak Republic
Another proposed change clarifies the conditions for the export of categorized human medicines such that the export of a human medicine included in the list of categorized medicines will be deemed to have occurred when the 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 human medicinal product included in the list of categorized medicinal products from the Slovak Republic is considered to be the delivery of such a product to another Member State or to a third country.
- Vaccination in Pharmacies
To ensure easier public access to vaccination, the amendment to the Medicines Act introduces 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. Vaccinations may only be administered by a professionally qualified person—a trained pharmacist or a contracted physician—in compliance with Decree No. 129/2012 Coll. of the Ministry of Health of the Slovak Republic on requirements for good pharmacy practice. Before commencing vaccination, the holder of a license to provide pharmaceutical care must notify the State Institute for Drug Control (ŠÚKL) and the authority that issued the license to provide pharmaceutical care. The availability of public pharmacies is intended to contribute to increasing vaccination coverage among the population, leading to a reduction in healthcare costs; the option of vaccination directly at the pharmacy is intended to replace the current lengthy process, which in many cases discourages individuals from getting vaccinated.
- Option for online dispensing via a mobile app
Given the dynamic nature of developments and changes in the field of information technology, the option for online dispensing via a mobile app is being adjusted — but only provided 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.
- Authority of the State Institute for Drug Control (ŠÚKL) to restrict, by decision, the dispensing of a drug not subject to a prescription
It is proposed to authorize the State Institute for Drug Control (ŠÚKL) to issue a decision restricting the dispensing of a medicinal product that is not subject to a prescription if the medicinal product may pose a risk to health that can be prevented by imposing restrictions on such dispensing. This restriction is intended to ensure the availability of medicines that can be used without medical supervision, while at the same time preventing the improper or even illegal use of human medicines (e.g., emergency contraception, analgesics, anti-inflammatory drugs, etc.). The scope of over-the-counter dispensing will be directly determined by the decision on the registration or amendment of the drug’s registration, which will specify, for example, the number of drug packages, duration of use, or other conditions; once these conditions are met, the drug may continue to be dispensed without a prescription.
- Prescribing Medicines After Discharge from Inpatient Care
Improving patients’ access to necessary medicines, medical devices, or dietary foods after discharge from the hospital is to be ensured by the obligation of a specialist physician to prescribe to the patient a human medicine, a medical device, including a custom-made medical device, and a dietary food 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. Furthermore, the new regulation stipulates that a non-board-certified physician is also authorized to prescribe a human medicinal product, a medical device (including a custom-made medical device), and a dietary food, provided that a board-certified physician in institutional care is responsible for the correct indication.
- Prescription of Medicines by Specialists
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. The Ministry of Health of the Slovak Republic receives and addresses daily a large number of complaints from patients who are refused prescriptions for human medicines, medical devices, and dietary foods by their doctors. Since the amendment imposed an obligation on specialist physicians to prescribe to patients all human medicines, medical devices, and dietary foods that were indicated during the medical examination, patients are left in life-threatening situations in many cases without the possibility of obtaining the necessary medicines, medical devices, and dietary foods. The solution was intended to be the issuance of repeat e-prescriptions for chronic patients for up to 12 months, which proved unfeasible for the vast majority of patients under the care of a specialist.
To ensure the availability of medications, the amendment allows authorizing physicians (specialists) to grant authorization to prescribe a human medication, medical device, or dietary food to a physician in the same or a different specialty (authorized physician) for a maximum period of 6 months. The authorizing physician is responsible for the correct indication of the human medicinal product, medical device, or dietary food. The physician is required to prescribe a human medicinal product, medical device, or dietary food to the patient if the physician determines that the patient needs it. A general practitioner may prescribe a prescription-restricted human medicine, medical device, or dietary food to a patient only if authorized by a specialist physician.
- Prescribing Medications by Nurses
The proposed legislation also responds to current practice, which shows that nurses are already issuing medical prescriptions to patients in violation of current legislation. The amendment clearly defines that a physician is the person who indicates treatment; however, if all information necessary for issuing a prescription record is included in the medical records, a nurse may also issue it. By creating the record, the nurse performs only an administrative task, based on the physician’s instructions and indications. The prescription thus remains issued by the prescribing physician and not by the nurse.
- New Powers of the State Institute for Drug Control (ŠÚKL) in Conducting Inspections
The amendment grants the ŠÚKL the authority to inspect medicinal products at the location where the main component of the human medicinal product safety surveillance system is stored, or at the location where the marketing authorization holder for a human medicinal product conducts safety surveillance—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.
The amendment to the Medicines Act is proposed to take effect on March 1, 2023, with the exception of certain changes that are scheduled to take effect on January 1, 2024, due to the need for a technical solution by the National Health Information Center (NCZI).
