Translated material
No place for doubt
The head of Roszdravnadzor was fired for criticizing management proposals
The Law “On the Circulation of Medicines,” adopted so far only in the first reading, has finally split the Russian government. Last Saturday, Prime Minister Vladimir Putin signed an order to dismiss Nikolai Yurgel, head of the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor), for violating the civil service law. A few days earlier, the head of the federal service allowed himself to publicly express doubts about the quality of the bill and the competence of the leadership of the parent department. The decision of the head of government, experts believe, shows that Mr. Putin took the side of the developers of the law from the Ministry of Health and Social Development, showed them full confidence and gave them complete carte blanche to implement the norms laid down in the document in its current form.Over the past few months, several versions of the law “On the Circulation of Medicines” have appeared on the ministry’s website, each of which has raised new questions and complaints from market participants. Foreign and Russian manufacturers wrote letters to Minister Tatyana Golikova with proposals to eliminate what, in their opinion, were obvious errors and inconsistencies. And they received detailed rebuke in response, in which officials insisted on the correctness of their formulations and the legality of their postulates. Many government officials, including some State Duma deputies, the Federal Antimonopoly Service (FAS) and Roszdravnadzor, also expressed complaints against the Ministry of Health and Social Development.
It must be said that the new document greatly limits the influence of Roszdravnadzor, since it provides for the separation of the two main functions of this department - registration of medicines and control over their circulation on the market. More precisely, all registration responsibilities should go to a specially created unit within the ministry, and the federal service will only have control powers. In fact, the former head of the department tried to defend his full powers. This circumstance may have forced the always extremely cautious functionary to give a devastating interview to the online newspaper Vzglyad last Thursday. The statements contained in it that the bill is a “step back” that can only lead to monopolization and corruption in the industry, apparently, became the formal reason for the resignation.
As Roszdravnadzor told Vremya Novostey, the head of the department was simply afraid that he would be held responsible for all the problems that would arise during the implementation of the provisions of the new law, including possible interruptions in the supply of medicines. In addition, it is Roszdravnadzor that must register maximum selling prices for drugs from the list of vital and essential drugs (VED) by April 1. But to date, the department has received documents from only 30 manufacturers out of almost 500 - pharmaceutical market participants are playing for time, hoping for concessions.
Analysts believe that Mr. Yurgel's dismissal indicates that there will be no concessions. “This is a signal showing that the strategy in the field of drug supply has been determined and will not change,” Yuri Krestinsky, director of the Institute for the Development of Public Health, told Vremya Novostey. According to him, the industry is making it clear that they will have to live in a new way and all changes will be within the framework of the new law.
Therefore, it is likely that Nikolai Yurgel’s resignation is not the last. He may well be followed by other critics of the Ministry of Health and Social Development bill. For example, one of the active opponents, Timofey Nizhegorodtsev, head of the department for protection of competition in the social sphere and trade of the FAS. Although he himself believes that by criticizing some provisions of the document, he only helped improve it. Moreover, the work of the FAS took place in accordance with the instructions of the head of government and the president. “The new law is simply necessary,” Timofey Nizhegorodtsev explained the position of his department in a conversation with a Vremya Novostei correspondent. “And we never engaged in any amateur activities.”
In turn, Tatyana Yakovleva, a deputy from United Russia, who is also considered a critic of the document, can only receive punishment along party lines. This year she has already held two meetings of the coordination council for the development of the pharmaceutical and medical industries under the General Council of United Russia. At each of these meetings, the new bill was harshly criticized, and even opinions were expressed that the second reading of the document should be canceled altogether or postponed indefinitely.
So far, the second reading of the basic bill for the pharmaceutical industry is scheduled for March 8. Given the intervention of Vladimir Putin, the document is unlikely to change much by this time.