ARPM. A state support is important in orphan drug production

A conference on “Orphan deceases in adults”  took place in the State Duma Committee on Healthcare. Participants from the different sate branches and agencies shared their thought on the sungect.

A Federal Law on “On the basis of the health of citizens in the Russian Federation” an orphan deceases is defined as a disease that appears with the frequency not more than 10 times in 100,000 patients. Patients with those diseases receive drugs from the regional budgets. “There are 24 life threatening, progressive and chronic diseases that are included in the Federal register with over 12.5 thousand patines involved. However, there are still no standards of medical help for all the nosologies” said Mr. Fugal.

The issue of financing treatment of the orphan diseases was discussed at the meeting. First deputy chairman of the State Duma committee healthcare, Nikolay Gerasimenko noted the importance to provide patients with the orphan disease with free medications using the federal budget. Many member of the conference agreed with the idea to at lest partially use the federal budget for those medications. “The Health Ministry understands that the regional financing is not enough, and the program has to use federal money,” said director of department of drug provision and regulation of turnover of medicines of The Health Ministry, Elena Maksimkina.

According to Mr. Gerasimenko, it is important to revisit the mechanism of registration of the orphan diseases and make it more transparent. Olga Borzova, a State Duma MP noted that the changes should not only consider the inclusion of new diseases, but also a revision of the treatment protocols.

Director of department on pharmaceutical development of the Ministry of Trade, Olga Kolotilova said that the share of domestic products on the market is 37% in sales and 50% in units. This is also due to the programs of import substitution and state support of domestic and foreign localized companies.

“Production of orphan drugs is a process that requires big investments and guaranteed sales. Today only the state can provide that,” said ARPM Director General, Victor Dmitriev. “Priorities financing of technologies to identification and treatment of rare diseases will allow to solve the existing issues even in today’s economic conditions. The success fully depends on cooperation between business and state with large investments.”

Another important issue of personnel training was discussed by the director of the FGBY “Medical and Genetic research center”, Sergey Kucuev. “There are very few qualified experts that treat patients with the orphan diseases. It is important to design an effective cooperation between Federal and regional medical facilities and to ease the registration procedure.”

The final ideas of the meeting will be submitted to the state legislative and executive agencies. 

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