Resolution of the III CIS Orphan Forum: Establishment of the BRICS Orphan Consortium and Development of International Cooperation in the Field of Rare Diseases

Following the Forum on May 25–26, 2026, a Resolution was adopted, agreed upon with the participants of the CIS Orphan Consortium. The document consolidates the key proposals developed over two days of work by experts from 21 countries — members of the Commonwealth of Independent States (CIS), BRICS, and partner states.
The central idea of the Resolution is the transition of international cooperation in the field of rare diseases from sharing experience to systematic joint action. The document sets the framework for further work of the CIS Orphan Consortium, relevant ministries, regulatory authorities, expert organizations, funds financing high-cost therapy, industry, and patient organizations.
Key proposals of the Resolution:
🔹 Establishment of the BRICS Orphan Consortium — a voluntary international expert network to coordinate cooperation between BRICS countries, the CIS, and partner states in the field of rare diseases.
🔹 Establishment of an Expert Industrial Council under the Orphan Consortium — a consultative platform for systematic interaction with developers, manufacturers, regulators, payers, and the patient community on matters of development, registration, medicinal supply, and access models for orphan therapy.
🔹 Differentiation between the registration orphan status and the reimbursement status — to enhance regulatory predictability within the EAEU while maintaining national responsibility for financing decisions.
🔹 Development of dedicated approaches to Health Technology Assessment (HTA) for rare diseases, including Multi-Criteria Decision Analysis (MCDA) and the use of managed access agreements.
🔹 Establishment of a BRICS scientific and technological platform for orphan innovations, gene and cell therapies, integrating academic science, industry, regulators, and patient organizations.
🔹 Methodological guidelines for the organization of orphan centers in CIS countries — with clearly defined functions, criteria, patient routing models, and mechanisms of interaction with centers of competence by nosological groups.
🔹 Maintaining patient registries of the "Circle of Kindness" Foundation using real-world data (RWD) for regular reassessment of medicinal products and revision of financing conditions.
🔹 Standardization of approaches to the collection and analysis of real-world data (RWD/RWE) at the CIS level — including electronic medical records, data quality requirements, study design, and application for decision-making.
The Resolution is recommended for submission to relevant government authorities in the CIS and BRICS countries, the CIS Executive Committee, the CIS Council for Cooperation in Healthcare, regulatory authorities, the Eurasian Economic Commission, expert bodies, funds financing high-cost therapy, scientific and clinical centers, patient and industry organizations.

Read the full text of the Resolution