The main goal of the proposed amendments is to ensure equal access to temporarily permitted medicinal products and medical devices for all healthcare organizations, regardless of their organizational and legal form.
Previously, as stated in the justification for the draft, there was a procedure that regulated the compilation and criteria for the exclusion and inclusion of medicinal products and medical devices in the special list, temporarily permitted for import and medical use without registration.
The procedure for forming this list was carried out by a commission based on predefined criteria. This commission included representatives who included products and devices based on applications submitted by state healthcare institutions through the electronic document management system.
There are the following categories of healthcare organizations:
- state institutions created by the authorized body in the field of health;
- state medical institutions established by other state bodies;
- municipal medical organizations formed by local administrations;
- private medical institutions.
The developers of the document emphasize: "The right of citizens to health protection and access to medical assistance should not be determined by the ownership form of medical institutions. [The existing] access to temporarily permitted products creates inequality among patients. Moreover, situations arise in the republic where a patient begins treatment in one clinic and finishes in another. Restricting access to necessary medications disrupts the continuity of therapy, which is especially relevant in cases of rare diseases or oncology."
In this regard, the draft proposes to replace the term "state healthcare organizations" with "healthcare organizations regardless of ownership forms" in the procedure for compiling the special list.
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