The amendment to the Act on Medicinal Products has been under legislative review for several months, since October 2022. We are monitoring the entire legislative process and reiterate that the proposed amendment to Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amendments to Certain Acts, as amended, and amending certain acts, was submitted at the initiative of the Slovak Government's Legislative Agenda for 2022 by the responsible submitter, Minister of Health of the Slovak Republic Vladimír Lengvarský as part of the legislative process LP/2022/663 (start of inter-ministerial consultation procedure on 19 October 2022 and end of inter-ministerial consultation procedure on 9 November 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 amending Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amendments to Certain Acts, as amended, and amending 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 of the National Council of the Slovak Republic for Agriculture and the Environment, and the Committee of the National Council of the Slovak Republic for Health Care as the committees responsible for the draft, with a deadline for discussion of 9 June 2023.The Speaker of the National Council of the Slovak Republic proposed the Committee on Health of the National Council of the Slovak Republic as the lead committee with a deadline for discussion of 12 June 2023.
Several comments raised during the inter-ministerial consultation process were incorporated into the current draft amendment, and the draft law from October 2022 and May 2023 therefore differs in several fundamental legal provisions. The purpose of this article is to briefly describe the amendments to the draft amendment and compare them. The main objective of reflecting European legislation has been retained, but, as mentioned above, changes have been made mainly to the provisions aimed at eliminating shortcomings in the current Slovak legislation on the handling of medicines.
1. New powers of the Ministry of Health of the Slovak Republic extended
The original draft amendment introduced the competence of the Ministry of Health of the Slovak Republic (hereinafter also referred to as "MoH SR") to ensure the supply of medicinal products for human use and medical devices, as it would be authorized to procure or otherwise acquire for healthcare providers medicinal products for human use and medical devices whose storage, supply and dispensing would be ensured by holders of authorizations to handle medicines and medical devices, even outside a declared state of emergency or extraordinary situation. The current draft amendment adds in vitro medical devices to the procurement of 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 due to which non-commercial clinical trials are conducted to a significantly lower extent (approximately 3% of the volume of clinical trials) than in the developed world (15% of the volume of clinical trials) – this provision has remained almost unchanged.
3. Additional information when notifying the procurement or sale of medicinal products
Section 18a of the Medicinal Products Act imposes an obligation on natural persons residing in the Slovak Republic and legal persons established in the Slovak Republic to notify the State Institute for Drug Control (hereinafter also referred to as "ŠÚKL") of their intention to act as an intermediary in the purchase or sale of a medicinal product for human use before commencing such activity. The original draft amendment added to the scope of mandatory information to be provided in the notification of the intermediation in the purchase or sale of a medicinal product for human use a list of medicinal products for human use that are to be the subject of the intermediation. This obligation remains unchanged.
4. New legal regulation of the export of medicinal products for human use from the territory of the Slovak Republic
The original draft amendment specified the conditions for the export of categorized medicinal products for human use in such a way that the export of a medicinal product for human use included in the list of categorized medicinal products would be considered to have taken place when the medicinal product for human use included in the list of categorized medicinal products left the customs territory of the Slovak Republic, unlike the current legal regulation, where 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 a human medicinal product included in the list of categorized medicinal products to another Member State or to a third country. The current draft amendment incorporates several comments made during the inter-ministerial consultation process, the most important of which, in our view, is that the term "customs territory of the Slovak Republic" was defined in a way that was unclear for this purpose and inappropriate 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 Medicinal Products Act, which reads that the transfer of a medicinal product for human use included in the list of categorized medicinal products by the holder of the authorization to the territory of another Member State or a third country shall also be considered as a supply under the first part of the sentence, and therefore the transfer of a medicinal product for human use included in the list of categorized medicinal products by the holder of the authorization to the territory of another Member State or a third country.
5. Possibility of vaccination in pharmacies abolished
In order to ensure easier public access to vaccination, the original draft amendment proposed introducing the possibility of vaccination as a voluntary part of pharmacy care in public pharmacies, branches of public pharmacies and hospital pharmacies with a department for the dispensing of medicines, medical devices and dietary foods, whereby the availability of public pharmacies was intended to contribute to an increase in the vaccination coverage of the population, leading to a reduction in healthcare costs, and the possibility of vaccination directly in pharmacies was to replace the current lengthy process, which in many cases discourages individuals from being vaccinated. The current draft amendment does not provide for vaccination in pharmacies.
6. Possibility of online dispensing via a mobile application
In view of the dynamic developments and changes in the field of information technology, the possibility of online dispensing via a mobile application was proposed, but only on condition that the holder of a license to provide pharmacy care in a public pharmacy ensuring online dispensing via a mobile app meets all the special conditions for online dispensing via a public pharmacy website—this legal provision remained unchanged.
7. Revocation of the ŠÚKL's authorization to restrict the dispensing of a medicine that is not subject to a prescription
The original draft amendment proposed authorizing the ŠÚKL to restrict the dispensing of medicines not subject to medical prescription if the human medicine may pose a risk to health that can 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 at the same time preventing the incorrect or even illegal use of human medicines (e.g., emergency contraception, analgesics, anti-inflammatory drugs, etc.). The current draft amendment does not include this power for the ŠÚKL.
8. Prescription of medicines after discharge from institutional care (by a specialist doctor)
Improving patients' access to necessary medicines, medical devices, or dietary foods after discharge from hospital was to be ensured by the obligation of a specialist doctor to prescribe to the patient a human medicine, medical devices, including individually manufactured medical devices, and dietary foods that were indicated to the patient during hospitalization and whose administration is necessary even after discharge from institutional care, in a quantity sufficient for at least 28 days of treatment.
The current draft amendment regulates in more detail the prescription of medicines by institutional healthcare providers in such a way that the institutional healthcare provider or institutional emergency service provider is obliged to ensure that upon discharge of a patient from institutional healthcare or when providing institutional emergency services, a doctor specializing in a field other than general medicine (hereinafter referred to as a "specialist doctor") prescribes a human medicine, a medical device or dietary food indicated to the patient during institutional health care or when providing institutional emergency services, if the use of a human medicine included in the list of categorized medicines, a medical device included in the list of categorized medical devices or a dietetic food included in the list of categorized dietetic foods is necessary even after the patient's discharge from institutional health care or after the termination of institutional emergency services in the number of packages necessary for treatment lasting at least 28 daysif the patient's health condition requires long-term treatment and an individually manufactured medical device.
In the discharge report, the specialist doctor of institutional health care may authorize a doctor specializing in general medicine or pediatrics (hereinafter referred to as "general practitioner") who is providing outpatient care to the patient, with the prescription of a human medicine, medical device or dietary food, for a maximum period of six months from the date of the patient's discharge from institutional health care.
9. Prescription of medicines by a specialist doctor amended
Due to legislative changes implemented in the Medicines Act on 1 January 2022 in the area of prescribing 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 refused to prescribe human medicines, medical devices and dietetic foods.
The current draft amendment has once again modified the prescription of medicines so that the prescribing doctor may, by mutual agreement, authorize another doctor in the same or a different specialty (hereinafter referred to as the "authorizing doctor") to prescribe medicines for a maximum period 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 by mutual agreement may be effective for a maximum of 12 months without interruption, or for the prescription of medical devices in the case of permanent disability. 4, where the authorisation may, by mutual agreement, be valid for a maximum of 12 months without interruption, or for the prescription of a medical device in the case of permanent and irreversible third-degree incontinence and diagnosed permanent and irreversible stoma, where the authorisation may, by mutual agreement, be granted for an indefinite period.
The authorising doctor is responsible for the correct indication of a human medicinal product, medical device or dietary food. The authorising doctor is responsible for the correct choice of the medicinal product or human medicinal product, the route of administration, the pharmaceutical form, the quantity of the medicinal product in the pharmaceutical form, determination of the diagnosis expressed in letters and numbers in accordance with the valid international statistical classification of diseases and related health problems, package size, number of packages and dosage of the medicinal product when prescribing a medicinal product for human use by a general practitioner on the recommendation of a specialist is the responsibility of the specialist.
10. Prescription of medicines by nurses – repealed
The original draft amendment also responded to practical experience showing that nurses currently issue prescriptions to patients in contravention of the legislation in force. The current draft amendment repeals the prescription of medicines by nurses under defined conditions.
11. New powers of the State Institute for Drug Control (ŠÚKL) when conducting inspections
The original draft amendment introduced the authority of the State Institute for Drug Control to carry out inspections of medicinal products also at the place where the main component of the system for supervising the safety of medicinal products for human use is located or at the place where the marketing authorization holder supervises the safety of medicinal products for human use, for example at contractual partners, if the marketing authorization holder has delegated the supervision of the safety of medicinal products for human use to them, and also at intermediaries involved in the purchase or sale of medicinal products for human use. This provision has been retained in the current draft amendment.
12. Amendments to Act No. 576/2004 Coll. on healthcare
The current draft amendment adds a definition of healthcare to Act No. 576/2004 Coll. on healthcare, services related to the provision of healthcare and on amendments to certain acts – it has been clarified that healthcare does not include the provision of a special treatment regime to persons in detention under a special regulation.
At the same time, this Act was amended to ensure that the provider of institutional care ensures that, upon discharge from institutional care, the patient is prescribed a humane medicine, medical device or dietary food, including the prescription of individually manufactured medical devices indicated to the patient during the provision of institutional health care in the number of packages necessary for treatment, if the use of the medicinal product, medical device or dietary food is necessary even after the patient's release from institutional health care; if the patient's health condition requires treatment for more than 28 days, the prescription shall be for at least 28 days' treatment.
13. Addition of important definitions
A crisis situation is defined in Section 2 of the Act on Medicinal Products, paragraph 32, the words "during a declared state of emergency, state of emergency or extraordinary situation (hereinafter referred to as "crisis situation") are added, and in Section 2(34) of the Act on Medicinal Products, the words "registration number of the prescription record" are replaced by the words "prescription record identifier.
14. Authorization to perform the activities of a professional representative for two places of business
The current draft amendment adds that a professional representative may also perform activities at two places of business and thus defines a professional representative as a natural person who meets the conditions laid down in the Act on Medicinal Products and who is responsible for the professional performance of the activities for which the authorization was issued. One person may perform the activities of a professional representative at only one place of work; this does not apply to a professional representative
- of a license holder with two places of work, if the operating hours at the places of work do not overlap at any time, unless otherwise provided by a special regulation, or
- in the provision of pharmaceutical care in a public pharmacy and in a branch of a public pharmacy of a single holder of a license to provide pharmaceutical care at two places of business.
15. In the event of a change of operator, it is not necessary to put the premises into operation, but only to submit a notification
The current draft amendment has made it easier to obtain a license only in the event of a change of operator, when it is not necessary to re-register the premises and thus submit the consent of the competent public health authority to put the premises into operation, but only a copy of the notification which the applicant submits to the relevant public health authority in accordance with a special regulation when changing the operator without changing 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 shall take effect on March 1, 2024.
