A brief overview of the situation regarding regulatory reforms in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
With respect to Czech legislation, the main topic of proposed regulatory changes is the ongoing process of digitalization. The Ministry of Health is keen to expand and improve the already existing system of electronic prescriptions (“elektronický recept” or “eRecept” in Czech). Electronic prescriptions are already the preferred form over their hard copy counterparts (hard copy prescriptions may be issued only in specific situations). The aim is to introduce new features of the system, such as allowing doctors and pharmacists to view all the drugs prescribed to a patient (with his/her consent) in order to prevent undesired interactions between individual drugs. The bill implementing the changes to the Act on Drugs is currently before Parliament and is expected to enter into force during the course of the year 2019.
Pricing and Reimbursement
The Ministry of Health intends to implement a major change to the legal framework for the setting of prices and reimbursement of drugs in the Czech Republic. The Ministry is expected to define the objectives of a new law (and to introduce these to the public) in the first quarter of 2020.
Supplementary Protection Certificate
An amendment to the European Union’s legislation on Supplementary Protection Certificates for medicinal products (Regulation (EC) No 469/2009) was put forward by the European Commission. The proposal aims to introduce a so-called manufacturing exemption for export purposes during the term of an SPC, which would allow EU-based manufacturers of generics and biosimilars to manufacture such products in the territory of a member state for the exclusive purpose of exporting the products to non-EU markets where patent or Supplementary Protection Certificate protection has expired or never existed, and thereby removing the competitive disadvantage that EU-based manufacturers are currently facing. The final text of the amendment has been agreed on by the European Parliament in April 2019 and this must now be formally adopted by the Council to complete the legislative procedure.
Clinical Trial Regulation
The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation comes into effect. 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 new information system, in collaboration with the member states and the European Commission. It is currently estimated that the Regulation will enter into effect in 2019.
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). When these come into effect, the new Regulations will introduce major changes; such changes will include, for example, high-risk medical devices being subject to stricter pre-market control, a large part of the information in the EU database on medical devices (EUDAMED) becoming publicly available, greater labeling requirements, stricter requirements for the updating of technical documentation, a new medical device identification system based on a unique device identifier (UDI) being introduced, a patient “implant card” containing information about any implanted medical devices being introduced, manufacturers being required to have measures in place to provide sufficient financial coverage in respect of their potential liability. The Medical Devices Regulation will enter into force and effect on 26 May 2020, and the Regulation on In Vitro Diagnostic Medical Devices on 26 May 2022.
2. When are they likely to come into force?
For information on the estimates of when the individual changes will come into effect please refer to Answer above.