Drug operating procedures in the Russian Federation

March 15th 2010

The Minister of Healthcare and Social Development, Tatiana Golikova, pays attention to some innovations in the "On Drug Circulation" Act in the blog "Ministry of Healthcare and Social Development in Russia."

The United Russia faction (State Duma) recently held a "zero reading" of this law.

What is this law draft about?

First of all, we must note that the many discussions surrounding this law on the Internet, as well as in the real world, do not reflect the reality of the situation. The so-called experts express numerous opinions about aspects the law draft does not even contain. In this way, they also talk about "drug insurance", but this is already assigned as part of the compulsory medical insurance.

We would like to point out that the Act on Compulsory Medical Insurance shall be reviewed during the spring session, and we are going to discuss it in detail in another publication.

19 years ago, in 1998, the law draft "On drugs" was approved. It came into force. The world has changed, and its economy is different now. Relevant measures in the areas of price, safety management, control of drug market launch and registration methods are required.

All of these are still not defined clearly, if we take into account the legal gaps, meaning the lack of documents which state the clear drug registration periods, those responsible for the procedure, as well as set prices.

Most essential amendments to the law "On Drug Circulation"

1. The process of drug registration in Russia can be seen in stages, it is clear, and the drug registration process can be monitored via the Internet. This allows a person to find data concerning when a drug enters into circulation, and to track the range of procedures necessary for compliance with the law requirements.
2. Prices for the most important drugs and VED are subject to state regulation according to the law, since these drugs impact the incidence of disease and mortality in the country.
3. The drug registration process in Russia shall be recorded by stages, according to set periods, and shall not exceed 210 days. The period for generic drugs shall not exceed 60 days. Currently the procedure can last over 1.5 years.
4. A single state fee is taken in the drug registration process. The profit comes into the RF budget, not to third parties.

We will consider 2 aspects of these amendments thoroughly

1. In the case that a pharmaceutical company decides to enter the RF market, it needs to add "Russian" into the multi-centre clinical assessments. It shall be done to protect the interests of citizens, since drug safety can be proven in the context of population growth only. Clinical studies of drugs are performed to prove the safety and define the efficiency of the drugs registered. Pharmaceutical companies perform such clinical studies everywhere, particularly, in Russia. Thus, the more such clinical studies are performed by medical centers in the Russian Federation, the more impartial the results of the drug state registration process will be, and recent innovations from the pharmaceutical industry will be more easily available to the patients.
2. The act allows the sale of drugs in outpatient clinics, general practice centers, and in rural health posts in settlements without drugstores, in order to supply rural inhabitants with drugs.