Russia has one of the shortest periods for expert examination of medicines

Print 18 January 2018
GMP News

Elena Maksimkina, the Director of the Department of Drug Supply and Regulation of Medical Devices at the Russian Ministry of Health, gave her assessment of the pharmaceutical market in Russia.

“It is impossible to ensure the quality and availability of medical care without the effective provision of drugs. This is why all measures aimed at addressing the issues of legal and economic nature in that area, including the intellectual property, should be viewed through the prism of their impact on the availability of medicinal products, that is, the interests of the patient.

Like most countries in the world, Russia established the requirements for registration of medicinal products as a mandatory pre-condition for their admission into civil circulation.

The regulatory authorities of the states evaluate the balance of potential risks and benefits in the use of a medicinal product and establish the requirements for the content and design of labeling and instructions for use of the drug, with which it should be sold within the country.

Compared to the international practice, the Russian Federation has one of the shortest periods for expert examination of medicinal products to assess their quality, efficacy and ratio of anticipated benefits and potential risks in using the medicinal product. This period is 110 working days (about five months).

A corresponding timeframe established by the Committee for Medicinal Products for Human Use of the European Medicines Agency is about seven months; and, in the United States, it is approximately ten months.

A separate issue in the international practice is the mandatory licensing of medicinal products. The governments may decide on their own, whether to introduce the mandatory licenses, and determine the grounds for their issuance. Russian laws also provide for such possibility.

This practice is used in exceptional cases posing a threat to national security and, first of all, represents a lever of government influence on pricing policy of the manufacturers of original drugs when the latter are not allowing an adequate reduction of their prices, which creates obstacles for provision of medicines to the population, while the manufacturer of generic drug, often a local one, has the appropriate technology and is ready to manufacture and supply the required product at a significantly lower price.

As for the pricing policy on the medicines included in the List of Vital and Essential Drugs (VED), we should note that, in Russia, the improvement of state regulation of VED prices is underpinned by the principle of registration of maximum ex-works prices. This principle is based on the separation of approaches to the registration of maximum ex-works prices for reference medicinal products and generics included in the List of VED, with observance of the balance between the interests of consumers and manufacturers of drugs included in the List of VED.”

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