Regulatory Reforms
PRK Partners / Czech Republic
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 GBP 99.
1. Are there proposals for reform or significant change to the healthcare system?
Digitalization
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). Furthermore, an Act on Electronic Healthcare (so-called “e-Health Act”) is currently (spring 2021) being discussed in the Czech Parliament; it is expected to set common technical standards for digitalization and sharing of health records among healthcare providers and patients.
Pricing and Reimbursement
Another piece of legislation that is currently (spring 2021) being discussed in the Czech Parliament focuses, among other things, on reimbursements for orphan drugs. Under the current regulation orphan drugs can be awarded reimbursement only as either (i) a highly innovative drug, or (ii) by means of an exceptional reimbursement (referred to as a “Sec. 16 reimbursement”). None of these options is considered sufficient or appropriate, as it often results in orphan drugs not being reimbursed at all; patients are thus de facto denied adequate treatment due to the high price of orphan drugs.
Clinical Trial Regulation
The way clinical trials are conducted in the EU will undergo a major overhaul 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 (CTIS; 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 by January 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.
