Drugs have six supervisors in Russia: the Ministry of Healthcare sums up requirements to drugs and gives permission for them entering the market; the Ministry of Industry and Trade issues licenses to manufacturers, the Federal Service on Surveillance in Healthcare (ROSZDRAVNADZOR) – to distributors and federal pharmacies (regional authorities give licenses to other kinds of pharmacies); the Federal Service for Veterinary and Phytosanitary Surveillance (ROSSELKHOZNADZOR) controls the circuit of drugs for veterinary use, and the Federal Medical-Biological Agency controls drugs, as it is said in Nizhegorodtsev’s presentation (available at the FAS website).

The sphere of medical services includes four controlling organizations: the Ministry of Healthcare adopts a plan of health care delivery, Roszdravnadzor and regions themselves issue licenses to medical organizations, and the Federal Service on Customers’ Rights Protection and Human Well-Being Surveillance (Rospotrebnadzor) controls on compliance of rules providing commercial services. Circulation of medical items is observed least of all: the Ministry of Industry and Trade is working on a bill “On Circulation of Medical Items”; the Ministry of Healthcare points at ways how to monitor safety of medical items and products, and Roszdravnadzor executes this monitoring.

There are plenty of departments executing surveillance in healthcare, but they actually lack any mechanisms of control, the FAS states. For example, medical aid for a holder of a certificate of obligatory medical insurance should be free of charge, but Roszdravnadzor doesn’t have any real responsibilities and instruments to control it in practice, Nizhegorodtsev says. The Service’s officers may not be permitted to check this out or may not get any information or get wrong information, though, it is impossible to punish organizations doing these things.

Due to weakness of medical control, availability of medical aid becomes more and more declarative, the Service concludes: a growth of federal expenditures on healthcare can make it more available.

The surveillance problem exists indeed, assumes Ivan Glushkov, Deputy General Director of Stada CIS. For instance, one of the BAAs manufacturers produces a product containing active drug substance, tells Glushkov. Roszdravnadzor may not conduct a check on this matter because BAAs get registered by Rospotrebnadzor, and the latter service does not have any reasons for a check: a manufacturer did not declared the use of this substance while registering.

This situation over the healthcare control is not unique, says Pavel Kudyukin, Dean at the National Research Institute at the Higher School of Economics. A similar situation exists in environmental control. The problem also occurs because very often charges of different departments are hard to be identified and divided, Kudyukin says.

The problem could be solved through creation of an integrated control body in partnership with Rospotrebnadzor, Roszdravnadzor, Rosselkhoznadzor, as Nizhegorodtsev assumes. He gives an example of the US Food and Drug Administration. This body controls promotion and safety of food products, diet additives, tobacco products, drugs, etc. This is a right idea, Kudyuking considers, but a problem of the agencies’ various interests may occur. Possibility of this idea to be supported by the departments controlling the sphere of healthcare is insignificant: the departments would lose their influence and control over money transfers in this case, Glushkov guesses.

“Minzdrav” and “Minpromtorg” representatives leave no comment.

Maria Dranishnikova

Project Group №6