In recent months, patients as well as professionals have been increasingly approached by the Health Department and the State Medical Control Institute (SCH), with questions about interruptions or cancellations of medicinal products. The blackouts in the supply of medicines affect the entire range of medicines, including medicines for chronic diseases, medicines for the paediatric population, prescription medicines, as well as free sales. This is an increasingly urgent challenge for health systems throughout the European Union and the world.
The availability of medicinal products included in the list of categorised medicinal products is the responsibility of the Marketing Authorisation Holder or manufacturer, as Law 363/2011 The Z.z. on reimbursements of medicinal products, medical devices and dietetic foods obliges them to ensure that the medicinal product is available on the market in sufficient quantities for the entire duration of inclusion of the medicinal product in the list of categorised medicinal products.
If the medicinal product is not available in sufficient quantities on the market for 60 consecutive days, the Ministry may decide to remove the medicinal product from the list of categorised medicinal products.
The State Institute for the Control of Medicinal Products publishes and updates daily information on interruptions, cancellations and renewals on its website:https://portal.sukl.sk/BreakoutPublic/?act=BreakoutOznList&mId=2.
The reasons for the unavailability of medicinal products are often objective and unpredictable. However, neither the State Institute for Medicinal Products nor the Ministry of Health of the Slovak Republic have legal mechanisms that allow them to provide additional supplies of medicines on the Slovak market in case of exceptional and unpredictable situations. The reasons for the long or short term unavailability of medicinal products include:
- production reasons
- logistical reasons
- reexport – exporting medicines from Slovakia to other countries
- emergency situations such as the COVID-19 pandemic or the military conflict in Ukraine, which has led to increased demand for certain medicinal products, and has also brought restrictions on the distribution of medicinal products, as well as staff shortages for incapacity for work
- inappropriate accumulation of medicines patients
- Increased demand for some types of medicines For example, at the time of the spread of respiratory diseases or the failure of competing products. Interrupting the supply of medicines is a complex problem that does not have an easy solution. However, there are a number of options to ensure the availability of medicines to patients, for example:
- generic substitution For many medicines, especially for chronic diseases, there are several alternatives available from different manufacturers. It is important to note that generic medicines are equivalent to "original" medicines.
- import of foreign-language packaging of medicinal products These are exemptions granted by the ŠÚKL, which allow the marketing authorisation holder to place on the Slovak market packages of medicinal products not in Slovak language. This option is not only used to bridge the availability of medicines in Slovak packages, but also for new medicines that have not yet been produced in Slovak packaging, so as to accelerate the availability of such new medicines for Slovak patients.
- in exceptional cases, the therapeutic use of an unregistered medicinal product (so-called "exceptional import') may be allow the Ministry of Health, upon request of the healthcare provider or on its own initiative, for a particular patient or for a group of patients, if a comparable registered human medicinal product is not available. In this case, however, it is subsequently necessary to obtain authorisation to pay the medicinal product or group of medicinal products by the health insurance undertaking. Long-term strategic solutions from the point of view of the Ministry of Health that can help Slovak patients include in particular:
- support for the local pharmaceutical industry;
- Support for individual preparation of medicines in pharmacies
- new regulatory mechanisms for exceptional imports of medicinal products. The problem of drug unavailability is a global problem. At the level of the European Medicines Agency (EMA), a new Executive Steering Group on Shortages and Safety of Medicinal Products has been set up to coordinate, within the European Union, urgent measures for drug failures caused by emergency public health crises. The European Medicines Agency collects information on drug failures within EU Member States as well as the EEA. e EMA is preparing a workshop in the coming months to deal with drug failures at international level.