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 USD 99.

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. During the years 2019/2020, there are plans to introduce further functionalities into e-Health (e.g., eLab, patient summary) and improvement of the existing functionalities.

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 Trial Regulation – 2019. 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 2019.

Medical Device Regulations – the EU Device Regulation (2017/745) will come into force in 2020 and the EU In Vitro Diagnostic Medical Devices Regulation (2017/746) will come into force in 2022.

Directory of local institutions

State Institute for Drug Control:
Štátny ústav pre kontrolu liečiv
Kvetná 11
825 08 Bratislava
Slovak Republic
www.sukl.sk

Ministry of Health:
Ministerstvo zdravotníctva Slovenskej republiky
Limbová 2
P.O. BOX 52
837 52 Bratislava 37
Slovak Republic
www.health.gov.sk

Health Care Surveillance Authority:
Úrad pre dohľad nad zdravotnou starostlivosťou
Žellova 2
829 24 Bratislava 25
Slovak Republic
www.udzs-sk.sk

National Health Information Centre:
Národné centrum zdravotníckych informácií
Lazaretská 26
811 09 Bratislava 1
Slovak Republic
www.nczisk.sk

Industrial Property Office:
Úrad priemyselného vlastníctva Slovenskej republiky
Švermova 43
974 04 Banská Bystrica 4
Slovak Republic
www.indprop.gov.sk