The Slovak Act on Medicinal Products and the related laws will soon undergo significant changes. This was decided by the Parliament which has approved, with several changes, the government’s long-prepared draft amendment to the pharmaceutical laws, on 28 June 2023. If the President signs the law, the pharmaceutical industry will have to prepare for the changes, with some exceptions, as early as 1 August 2023. A brief summary of the most significant changes is provided in this article.
- Non-commercial clinical trials: The amendment is introducing a new type of clinical trials aimed at increasing the volume of investigator-initiated studies in Slovakia, which is significantly below the EU average. Administrative fee for an application for approval of a non-commercial clinical trial will be only five euros. In order to benefit from the reduced fee, a clinical trial must be organised only by a university, hospital, public research institution, non-profit organisation, patient organisation, or individual researcher, and there cannot be an agreement between the sponsor and a third party allowing the commercial use of the data.
- Changes in off-label and pre-label treatment: The amendment extends the possibilities for permission of use of an investigational medicinal product for patients who have not been participants in a clinical trial, if an application for marketing authorisation has already been submitted in the EU or in Slovakia. Permissions will now be granted not only for therapeutic but also for diagnostic use of a medicinal product. When permitting the use of a biologic product, the Ministry of Health will be able to permit the use of any biosimilar product at the same time. Another novelty is the possibility to apply for a permission for therapeutic or diagnostic use of an unregistered medicinal product or for off-label use in the framework of a so-called treatment programme, which will be authorised by the Ministry of Health after the opinion of the State Institute for Drug Control. Once authorised, the applicant for a treatment programme will be obliged to comply with a number of conditions, including the obligation to provide the medicinal product to the participants of the programme at its own expense, not only for the duration of the treatment programme, but also after its termination, even after the authorisation of the medicinal product, until the end of treatment.
- Vaccination in pharmacies: The amendment allows vaccination to be carried out in pharmacies from 2024, but only to a limited extent. Only influenza vaccination of persons over 18 years old on written recommendation of a physician, which must not be older than three days, will be allowed.
- Changes in online sales: The possibility of online sales of medicinal product using a mobile app is being introduced. However, it will only apply to pharmacies selling online through a website. Online sales using the app without a website will therefore not be possible.
- Changes in prescribing: The most important change is the return of so-called delegated prescribing, i.e. the power of a general practitioner or paediatrician to prescribe a medicinal product based on the recommendation of a specialist. The recommendation must be included in an electronic health record, medical report, or hospital discharge report, and will need to include the period for which it is granted. This period will, with some exceptions, be six months in maximum in case of an outpatient specialist recommendations, and three months in case of a hospital discharge. The specialist who issues the recommendation will be responsible for the choice of medicine.
On discharge from hospital care, the hospital will be obliged to prescribe medicinal products to the patient in the quantity needed for the treatment. If the treatment is to last more than 28 days, the product will be prescribed for at least that period of time. An outpatient physician will always be obliged to prescribe the product he or she has indicated. A hospital physician will also be able to delegate prescribing to another physician employed by the same hospital, but will remain responsible for the choice of medicine.
- Acquisition of medicinal products by the state: The extension of the Ministry of Health’s ability to procure medicinal products and medical devices for health care providers outside of a crisis situation did not make it into the finally adopted version of the law. The Ministry will be, however, able to acquire medicinal products and medical devices in other ways than procurement, e.g. by donation, as long as the crisis situation lasts.
- Changes in the activities of professional representatives: A professional representative of an authorisation holder with two places of business will be able to work in both places, provided that their operating hours do not overlap. In case of pharmacies, one representative will be able to cover two places of business even if their operating hours overlap.
- Changes to the Reimbursement Act: A number of smaller but significant changes to the Reimbursement Act are being introduced:
- The contradiction between the conditions for the exemption from cost-effectiveness is removed;
- Protection of provisions of managed entry agreement from disclosure and publication is extended to the discount arrangement;
- A new possibility to remove medicinal product from the reimbursement list is being introduced, if the product has no generic or biosimilar alternatives, and its reimbursement for 12 months exceeded EUR 1.5 million, and the marketing authorisation holder has not concluded a reimbursement agreement with the Ministry of Health, even if the 1.5 million threshold is exceeded after the first three years from the inclusion of the product to the reimbursement list;
- Possibilities for exceptional price regulation are expanded to allow in particular for the inclusion or return of particularly older molecules in the reimbursement list;
- A managed entry agreement will be mandatory for orphan medicines and ATMPs only if they are included in the reimbursement list, or their indication or prescription limitation is being extended, based on increased threshold, or based on an exemption from cost-effectiveness. The same principle will apply to the obligation to submit a pharmacoeconomic analysis after loss of orphan status;
- The standard quarterly reimbursement review will not take place until the first generic or biosimilar medicine has been placed on the market;
- The financial limit for medicinal products reimbursed in the exceptional regime for the current year will not apply from 1 August 2023. The 3.9 % limit will apply in 2024, the 2.9 % limit in 2025, and the 1.9 % limit from 2026 onwards.
This legal update was prepared in July 2023 for general information purposes only and does not constitute legal advice. The legal update is not comprehensive and provides only a brief summary of the material changes in the law. If you have any questions, please do not hesitate to contact us.