According to Art. 1 para. 1 of the Constitution, the Czech Republic is a sovereign, unitary, and democratic state governed by the rule of law, founded on respect for the rights and freedoms of man and of citizens. All state authority emanates from the people; they exercise it through legislative, executive, and judicial bodies (Art. 2 para. 1 of the Constitution). The fundamental rights and basic freedoms shall enjoy the protection of judicial bodies (Art. 4 of the Constitution). According to Art. 36 para. 1 of the Charter of Fundamental Rights and Basic Freedoms, everyone may assert, through the legally prescribed procedure, his rights before an independent and impartial court or, in specified cases, before another body. The second paragraph of the same Article provides to everyone who claims that her rights have been curtailed by a decision of a public administrative authority the possibility, unless a law provides otherwise, to submit the matter to a court for review of the legality of that decision. However, judicial review of decisions affecting the fundamental rights and basic freedoms, the protection of which is enshrined in the constitutional order of the Czech Republic, may not be excluded from the jurisdiction of courts.
The decision on the inclusion of medicinal preparations into the list of medications covered by public health insurance funds results in an interference with the rights of their producers and distributors and, for that reason, it is necessary to see to it that the principles of fair process are consistently observed. Within the framework of abstract norm control, the Constitutional Court must adjudge whether the statutory framework creates conditions such that any interference would be balanced by such rights so as to eliminate, in a satisfactory manner, any room for arbitrariness in each concrete decision on the inclusion of medicinal agents into the list of medicines covered by public health insurance funds. Section 15 para. 10 of the Act on Public Health Insurance does not meet this requirement, as it does not guarantee the applicant that the decision on his application will be based on objective and verifiable criteria, be subject to judicial review, and be issued without unnecessary delay. The Ministry decides on the inclusion of a specific medication into the set of medicines fully covered by health insurance and into the set or medications only partially covered, as well as on the specific level or reimbursement, not in an administrative proceeding, but within the boundaries of the law-making process. It is therefore incompatible with the principle of the law-based state and, thus, in conflict with Art. 36 para. 1 of the Charter of Fundamental Rights and Basic Freedoms.