The legal framework for regulatory reform in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.

1. Are there proposals for reform or significant change to the healthcare system?

E-Health

With effect as of 1 January 2018, mandatory e-Health system has been introduced in the Slovak Republic. This reform included the introduction of an electronic health book of a patient, the possibility of prescribing and dispensing the medicinal products and medicinal devices via electronic means, and creation of the national e-health platform – National Health Information Centre. Further functionalities were introduced to e-Health system (such as applications My Health, eAlert or patient summary) and existing functionalities have been improved during the years 2019/2020, while eLab functionality is still being developed (as of February 2021).

Clinical Trial Regulation

The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation comes into application. The Regulation harmonizes the assessment and supervision processes for clinical trials throughout the EU, via a publicly available Clinical Trials Information System (formerly the EU clinical trial portal and database). The European Medicines Agency (EMA) will set up and maintain the information system, in collaboration with the member states and the European Commission.

Medical Device Regulations

In 2017, the European Parliament adopted the new EU Regulation on Medical Devices (2017/745) and the EU Regulation on In Vitro Diagnostic Medical Devices (2017/746).

The new Regulations will introduce major changes, such as high-risk medical devices are going to be subject to stricter pre-market control, large part of the information of the EU database on medical devices (EUDAMED) will be made publicly available, requirements for labeling will be increased, requirements for updating of technical documentation will be stricter, a new medical device identification system based on a unique device identifier (UDI) will be introduced, an “implant card” for patients containing information about implanted medical devices will be introduced, the manufacturers will be required to have measures in place to provide sufficient financial coverage in respect of their potential liability.

2. When are they likely to come into force?

E-Health – ongoing.

Clinical Trials Regulation – 2021. Although the Regulation was adopted and entered into force in 2014, the timing of its application depends on confirmation of full functionality of the Clinical Trials Information System through an independent audit. The Regulation becomes applicable six months after the European Commission publishes notice of this confirmation. The entry into application of the Regulation is currently estimated to occur in December 2021. According to the information published by the European Medicines Agency, once the Clinical Trials Information System is launched, it will be immediately available for authorities and clinical trial sponsors, while a three-year phased transition period from the current Directive 2001/20/EC to the Clinical Trials Regulation will apply.

Medical Devices Regulations – the EU Medical Devices Regulation (2017/745) will come fully into force on 26 May 2021 (after the laps of the transitional period) and the EU In Vitro Diagnostic Medical Devices Regulation (2017/746) will come fully into force on 26 May 2022 (after the laps of the transitional period).