The New Regulation of the Ministry of Healthcare establishes the procedure and conditions for use of unregistered medicines as a new treatment method
Formation of the regulatory base for the new Law “On circulation of medicines” (hereinafter – “Law”) continues in Belarus.
In addition to the new conditional registration procedure, the Law provides that original medicines that are in the process of clinical trials can be used to ensure early access by patients to new treatment methods, if:
• they are intended for the treatment, medical prevention or diagnosis of life-threatening or severe disabling diseases;
• there are no effective methods of providing medical care to patients with these diseases;
• there are no registered medicines used to provide medical care to patients with these diseases;
• the benefits of the medications used exceed the risk to the life and health of patients with these diseases.
In turn, the Ministry of Healthcare has laid down that the medical use of these medicines is carried out on the basis of a program developed by the manufacturer of the medicines or its representative office in the Republic of Belarus.
The program is submitted by the manufacturer of medicines or its representative office in the Republic of Belarus to the Ministry of Healthcare.
The program is a set of activities and should contain information about:
• the name of the medical product, indications for its medical use, dosage frequency and method of use;
• clinical trial results of the medical product;
• risk-benefit ratio of the medical product;
• sequence and timing of implementation of the program activities;
• the number of patients and inclusion and exclusion criteria;
• quantity of medical products;
• healthcare organizations participating in the program;
• the procedure for informing the patient and/or their legal representative about the absence of a therapeutic alternative, emerging risks, restrictions and benefits that a medical product can bring;
• arrangements for patient monitoring and pharmacovigilance measures;
• the supply chain of medical products;
• measures of responsibility for each of the parties involved in implementing the program in cases of violation of terms.
Based on the results of consideration of the program by a special commission of the Ministry of Healthcare, within 1 month from the date of submission, a decision is made on approval or rejection.
It is also worth noting that import of these medical products to the Republic of Belarus is carried out on the basis of a permit issued by the “Center for Examinations and Tests in Health Service”.
The Regulation comes into legal force from 20 November 2020.
Source: National legal internet portal of the Republic of Belarus (NLIP) 27.10.2020, 8/35960