Slovakia: Healthcare regulations as response to COVID-19 pandemic

On 14 March 2020, the European Union issued a European prohibition on the export of medical personal protective equipment (PPE) as a protective measure against the COVID-19 crisis. The Implementing Regulation (EU) 2020/402 entered into force on 16 March 2020 and was amended on 19 March 2020 by allowing the export of PPE to the respective EFPA states in order to enable the provision of emergency supplies in the context of humanitarian aid to third countries or international organisations.

The purpose of the implementing regulation is to enable for the demand for medical PPE throughout the EU to be met despite limited production capacity in the individual Member States, to protect the availability of PPE in the EU, and to replace similar national export authorisation measures or export ban that had been put in place. It shall apply for six weeks. The implementation regulation requires exporters to apply for an export authorisation via their national authorities.

On 20 March 2020, the European Commission issued the Communication from the Commission Temporary Framework for State aid measures to support the economy in the current COVID-19 outbreak. In its communication (guidelines), the Commission clarifies that, when assessing applications for export authorisations, Member States are strongly urged to grant such authorisations in order to avoid any disruption to closely integrated value chains and distribution networks particularly in the case of EU neighbouring countries and economies.

In the Slovak Republic, the State Institute for Drug Control (Štátny ústav pre kontrolu liečiv) called upon medical care providers to introduce restrictions on the sale of medicines. The purpose is to make medicines available to everybody. The appeal concerns the following:

• adherence to prescription measures when dispensing prescription medicines (pharmacists should not issue medicines against direct reimbursement when the prescription was not issued by the authorised doctor);
• dispensing of prescription drugs for one treatment cycle only;
• restrictions on the sale of over-the-counter medicines, i.e. one package of drug (active substance) per patient.

The Slovak Ministry of Health has adopted a measure prohibiting the export of registered medicinal products for human use, medical devices and in vitro diagnostic medical devices intended for Slovak market, effective from 23 March 2020.

As there is a number of online retailers offering COVID-19 treatment or prevention products or enabling an easy access to medicinal products otherwise not available, the Slovak State Institute for Drug Control issued an alert dated 25 March 2020 regarding the purchase of falsified medicinal products. The authority also highlighted that, neither in Slovakia nor in the European Union, there are currently any registered medicinal products intended for treatment of COVID-19.