On November 18, a meeting of the Interstate Commission for Standardization, Registration and Quality Control of Medicines, Medical Devices and Medical Equipment of the CIS countries was held. The event was held under the leadership of the Director of the Department of Regulation of the Circulation of Medicines and Medical Devices Ministry of Health Of the Russian Federation Elena Astapenko.
The preparation of the draft model law was discussed at the meeting “On drug provision in the CIS countries”.
The Executive Secretary of the Expert Council on Healthcare at the Interparliamentary CIS, the Secretary of the IPA CIS Standing Committee on Social Policy and Human Rights took part in the discussion Evgenia Vladimirova and Nelly Diveeva, Professor at the Faculty of Law of St. Petersburg State University, member of the Expert Council on Healthcare at the IPA CIS.
In his speech Evgenia Vladimirova informed the audience about the special expert sessions held in the CIS countries to discuss the draft model law “On Drug provision in the CIS countries”.
The first discussion session was held on June 30, 2023 in Minsk. During the event, experts analyzed the national legislation of the CIS countries.
The second session was held on November 14, 2023 in Bishkek. Within the framework of the public conference, issues of value-based healthcare were discussed, including the definition of the patient as a subject of law and the definition of the functionality of participants in the drug supply system in the interests of the patient.
The third session was held in Astana on May 30, 2024. The meeting participants discussed the need to develop model methodological recommendations for the formation of agreed principles and approaches in the creation and management of patient registries in the region.
Currently, active preparations are underway for the fourth final expert session, which will be held on November 28, 2024 in Tashkent on the topic: “Effectiveness and accessibility of medicines: from technology and evidence base to the patient.” The draft model law “On Drug provision in the CIS countries” will be presented at the event. Due to the special socio-economic significance of this document, representatives of the parliaments of the CIS countries, the Expert Council on Healthcare at the IPA CIS, industry international organizations and the academic community were invited to participate in the session.
Nelly Diveeva outlined the main provisions of the draft model law in her report. The main emphasis is placed on the need to establish guarantees from the state of the availability of medicines for every citizen. Such provision has several dimensions: product availability, financial accessibility, and logistical accessibility. The draft establishes possible legal mechanisms for regulating each of these elements.
In addition, much attention is paid to the basics of rational use of medicines. She expressed interest in expert cooperation with the Ministries of Health of the CIS countries in the preparation of a model law.
The meeting participants also considered issues on the implementation of the instructions of the Council for Cooperation in the Field of Healthcare of the CIS countries on updating the Agreement on Cooperation in Combating the Circulation of Counterfeit Medicines (November 14, 2008) and the Agreement on Providing the population with Medicines, Vaccines and Other Immunobiological Drugs, medical devices and Medical Equipment Manufactured in the territory of the member States CIS member states (December 24, 1993).
At the next meeting, they will consider the issue “On the inventory of the contractual and legal framework in the field of circulation of medicines, medical devices and medical equipment adopted within the framework of the CIS.
In March 2025, work on the draft model law “On Drug provision in the CIS countries” within the framework of the commission will continue.
