This applies to drugs from the countries of the European Union, the United States and Japan. As explained the Ministry of Industry and Trade, the issue can be resolved at the level of intergovernmental agreements.
The measure will help to speed up the patients’ access to new medicines, including those for cancer patients. It is expected that such medicines will have warning labels informing that the drug has not been clinically tested on the territory of the Russian Federation. Now the process of getting the new drug to the market takes up to five years, experts say.
Plans to develop a mechanism for providing access to the Russian market for the original drugs are fixed in the road map “Development of competition in health care”, approved by the government. As indicated in the document, it is about medicines that have been clinically tested in the countries of the European Union, the United States or Japan.
By January 2019, the Ministry of Health must submit to the government the mechanisms for implementing the idea. FAS and the Ministry of Industry and Trade will also participate in the work.
In order for buyers to understand what drug is being purchased, medicines that have not been clinically tested in Russia will be marked with a warning label, as envisaged by the road map. Each package will bear warning that the drug was tested only in the European Union, the United States or Japan.
The issue of providing access to the Russian market for the imported drugs without clinical trials in Russia can be resolved at the level of intergovernmental agreements, the Ministry of Industry and Trade explained. At the same time, the requirements for trials should be mutual, that is, agreed between the countries, the department noted.