The current legislation does not clearly define and describes the application of the act on an entrance of pharmaceutical substances to Russia. As a result, substances that are registered by the Health Ministry as a complete form of medicines are not allowed to enter the country event if they are to be used to further production of medicine. ARPM Director General, Victor Dmitriev spoke about this issue at the meeting of the Council of experts on the development of biotechnologies, pharmaceutical and medical industry which was hosted by the State Duma committee on economic policy, industry, innovational development, and entrepreneurship.
According to Mr. Dmitriev, the Customs requires to include pharmaceutical substances which are to be further used for production in the Registry list. There is a need for a meeting with the Federal Customs Service to allow a free entrance of these substances into Russia. A soon solution of this matter will protect interests of domestic producers and develop the industry.
Chairmen of the Council of Experts, First deputy chairmen of the Duma committee on economic policy, industry, innovational development and entrepreneurship, Vladimir Gutenev proposed to include this issue in the agenda of the Expert Council meeting.
Director of Department of the development of pharmaceutical and medical industry of the Ministry of Industry and Trade, Olga Kolotilova noted that the Ministry work to improve the export potential of the industry. The Government adopted resolutions 1268 and 1388 which will provide funds to Russia producers to cover parts of expenses associated with registration of their products on foreign markets. Head of ARPM also proposed to work on the opportunity to support producers during clinical trials which is one of the most costly procedures.
Mrs. Kolotilova also said that the issue of granting a status of a local product in conjunction with the special investment contract is under review. Mr. Dmitirev noted that it is important to distinguish contracts that are made on production of those medicines that have no analogs on the market from generics. This way a contract opportunity will attract investors and ease the healthcare expenses while promoting healthy market competition.