Regulation of the Launch of Orphan Drugs on the Market of the Eurasian Economic Union as a Mechanism to Increase the Availability of Treatment for Rare Diseases (Review)
https://doi.org/10.33380/2305-2066-2023-12-2-198-205
Abstract
Introduction. Providing high-quality, effective and safe drugs intended for the treatment of rare (orphan) diseases among the population of the Member States of the Union is one of the most significant and promising development vectors for manufacturers-developers. Ensuring the availability of medicines (MP) for patients suffering from rare diseases should be regulated by state incentives for the development and launch of orphan drugs on the market by domestic manufacturers through updating and timely updating of regulatory legal acts in the field of drug registration, as well as providing benefits when initiating the registration process.
Text. The article assessed the possibilities and prospects for the introduction of orphan drugs into circulation within the framework of the Eurasian Economic Union for domestic manufacturers.
Conclusion. A review of the possibilities and prospects for launching orphan drugs for domestic manufacturers indicates the need to develop regulatory and legal regulation of aspects of pharmaceutical development in order to increase the availability of treatment for patients with rare diseases, both at the level of the Russian Federation and within the legal framework of the Eurasian Economic Space.
About the Authors
A. V. Foteeva
LLC "Parma Clinical"; Perm State Pharmaceutical Academy
Russian Federation
Russian Federation
1b, Prichalnaya str., Perm, Perm Territory, 614042;
2, Polevaya str., Perm, 614990
N. A. Koneva
LLC "Parma Clinical"
Russian Federation
Russian Federation
1b, Prichalnaya str., Perm, Perm Territory, 614042
O. S. Beloglazova
JSC "Medisorb"
Russian Federation
Russian Federation
6/2, Galperina str., Perm, Perm Territory, 614042
N. B. Rostova
Perm State Pharmaceutical Academy; Perm State National Research University
Russian Federation
Russian Federation
2, Polevaya str., Perm, 614990;
15, Bukireva str., Perm, Perm Territory, 614990
References
1. Lebedev A. A. The burden of orphan diseases. Newspaper. Medical newspaper. March 7, 2012. No. 16. P. 10. (In Russ.)
2. Rozhdestvenskiy D. A. Registration of orphan and biotechnological products under the rules of eurasian economic UNITY. Issues of organization and informatization of healthcare. 2018;2(95):76–81. (In Russ.)
3. Foteeva A. V., Rostova N. B., Isupova A. D., Gerbergagen E. S. The orphan drugs: international approaches and national regulation. Problems of social hygiene, health care and the history of medicine. 2021;29(6):1490–1497. (In Russ.) DOI: 10.32687/0869-866X-2021-29-6-1490-1497.
4. Mishchenko M. A., Sybatova E. P., Mishchenko E. S. Current state and development prospects of the orphan drug market. MODERN SCIENCE. 2022;3–2:223–228. (In Russ.)
5. Nefidova O. G., Babaskin D. V., Sazonov A. D., Kamaletdinova A. A. Analysis of the Main Changes in Assessment and Approval of Medicines for Human Use in the Eurasian Economic Union. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2022;12(2):222–226. (In Russ.) DOI: 10.30895/1991-2919-2022-12-2-222-226.
6. Mitsumoto J., Dorsey E. R., Beck C. A., Kieburtz K., Griggs R. C. Pivotal studies of orphan drugs approved for neurological diseases. Ann Neurology. 2009;66(2):184–190. DOI: 10.1002/ana.21676.
7. De Vrueh R. L. A. Why R&D into Rare Diseases Matter. In: Bali R. K., Bos L., Gibbons M. C., Ibell S., editors. Rare Diseases in the Age of Health 2.0. London: Springer Nature; 2014. P. 3–20. DOI: 10.1007/978-3-642-38643-5_1.
8. Kugach A. A., Kugach V. V. Expertise and registration of orphan medicinal preparations. Bulletin of Pharmacy. 2021;1(91):20–35. (In Russ.) DOI: 10.52540/2074-9457.2021.1.20.
9. Brabers A. E. M., Moors E. H. M., van Weely S., de Vrueh R. L. A. Does market exclusivity hinder the development of Follow-on Orphan Medicinal Products in Europe? Orphanet J Rare Dis. 2011;6(1):59. DOI: 10.1186/1750-1172-6-59.
10. Tambuyzer E. Rare diseases, orphan drugs and their regulation: questions and misconceptions. Nat Rev Drug Discov. 2010;9(12):921–929. DOI: 10.1038/nrd3275.
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For citations:
Foteeva A.V., Koneva N.A., Beloglazova O.S., Rostova N.B. Regulation of the Launch of Orphan Drugs on the Market of the Eurasian Economic Union as a Mechanism to Increase the Availability of Treatment for Rare Diseases (Review). Drug development & registration. 2023;12(2):198-205. (In Russ.) https://doi.org/10.33380/2305-2066-2023-12-2-198-205
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