The main objective of the draft law is to improve regulatory oversight related to the circulation of medicines, which involves optimizing the processes of their state registration, as well as eliminating duplicative norms and legal gaps.
The development of the draft law was the result of legal monitoring conducted by the Ministry of Health in accordance with the established procedure for assessing the application and effectiveness of legislation in the field of medicine circulation.
As part of the proposed changes, it is stipulated that the Department of Medicines and Medical Devices of the Ministry of Health will gain the authority to create and maintain an electronic database, which will enhance the traceability system for medicines and medical devices.
The draft law also aims to increase the availability of medicines for citizens, protect vulnerable groups of the population, and strengthen the healthcare system. In particular, it is planned to transfer to the Ministry of Health the authority to develop procedures for providing assistance within the framework of programs for the use of experimental drugs for patients with life-threatening conditions, which will be carried out in accordance with the principle of compassionate access to treatment.
Furthermore, the draft law proposes to amend part 1 of Article 16 by including the word "current" in the context of pharmacopoeias recognized in the Kyrgyz Republic. This change will allow the use of pharmacopoeias that correspond to the current level of science and technology, which, in turn, will positively affect the quality, safety, and effectiveness of medicines.
