20 January 2010

Corruption in the law?

"Golikova's pill" reached the State Duma
Inna Vasilevskaya (published on igolkin.dailymotion)

On the eve of the New Year holidays, the government submitted to the State Duma a bill "On the circulation of medicines", which the Minister of Health and Social Development Tatyana Golikova actively promoted throughout 2009. This was preceded by a discussion of the document at the White House on December 17, which took place behind closed doors. As informed sources explained, such a regime was associated with the presence of a large number of claims of experts to the new bill, as well as suspicions of its high corruption. The scandalous nature of the document was indirectly evidenced by the almost complete absence of mentions on the news agency tapes about how its discussion in the government took place. However, the delicate silence of the media was nevertheless broken by reports about the introduction of Golikova's drug bill for consideration by the lower house.

The problem that has fallen on the deputies' heads can be judged by the statement of the first deputy head of the United Russia faction in the State Duma, chairman of the Coordinating Council of the Presidium of the General Council of the "ER" on innovative development of the medical and pharmaceutical industry, member of the Health Protection Committee Tatyana Yakovleva. The parliamentarian of the profile committee counted a lot of contradictions, inconsistencies in the new bill, as well as outright disregard for the norms of current Russian legislation and international medical and pharmaceutical practice. But the most important thing, according to Tatiana Yakovleva, is that the submitted document "does not contribute to the creation of competitive conditions, and monopolism is always a threat to objectivity." It is unlikely that in the practice of domestic parliamentarism of recent times one can recall another similar example of such a critical attitude to the bill already introduced, and even from such a high-ranking leader of the party in power.

What kind of time bomb has Tatiana Golikova, the head of the Ministry of Health and Social Development, prepared for dear Russians in the coming year?

To begin with, the draft law "On the circulation of medicines", according to the leadership of the relevant ministry, should replace the federal law "On Medicines" in force since 1998. Golikova's bill provides for a change in the regulation of all stages of drug circulation – from drug development to safety testing of its use. If, according to the current law, registration and examination of medicines takes place in Roszdravnadzor, which is formally an instance independent of the ministry, then the innovation provides for the creation of a new federal state institution with the function of monitoring the examination of medicines. However, according to the developers of the new bill, supported by Minister Golikova, this new institution, unlike Roszdravnadzor, should be part of the system of the Ministry of Health and Social Development and depend on the orders of its leadership. By the way, such a monopoly also contradicts generally accepted world rules. In foreign healthcare practice, it is customary to separate licensing and control functions in the field of pharmaceuticals, auctions and the organization of effective medical care to the population. Such a division of powers in the medical industry counteracts corruption and serves as a guarantee against monopolization of the market of medicines, which leads to unjustified price increases. However, the leadership of the Russian Ministry of Health and Social Development decided otherwise.

What the changes proposed in the new bill are fraught with for the pharmaceutical industry, and ultimately for all drug consumers, can be judged by similar initiatives of Minister Golikova, which have already gained scandalous fame. For example, at the initiative of the Ministry of Health and Social Development, the drug Arbidol was recognized as our response to swine, poultry and other types of influenza. And although this drug is actually only a general tonic, and not a vaccine, it was decided to allocate a significant share of the industry budget for its purchase. The scandalous situation is that the main producer of Arbidol, and therefore the recipient of budget investments, is the company Pharmstandard, headed by a long-time friend of the Golikova family-Khristenko – Viktor Kharitonov. The same story is with the live influenza vaccine (HCV), the purchases of which were generously funded by the Ministry of Health and Social Development in the fall, despite warnings from virologists and immunologists about serious side effects of this drug. Perhaps this is a pure accident, but the main manufacturer of HCV, and therefore the lucky recipient of the budget, was the manufacturer of immunological preparations of FSUE NPO Microgen, which is headed by businessman Lev Grigoriev, married to the sister of Kharitonov's wife. Such a family row.

Other pharmaceutical manufacturers have noticed more than once that the process of public procurement of medicines has now turned into a series of continuous preferences for companies close to the ministerial pair Golikova-Khristenko. At the same time, preferences for selected market participants are often given bypassing tenders, which violates the laws on public procurement of medicines and competition. In case of success of the draft law "On the circulation of medicines", not only the production of medicines, but also their examination with registration would fall under the monopolization of the ministerial tandem. In short, promoting the new bill, the Ministry of Health and Social Development claimed to register medicines individually, and to form lists of DLO (additional drug support programs), and to conduct auctions for the purchase of medicines. In general, such an integrated approach to the drug business. If the law were adopted, pharmaceutical companies controlled by the ministerial family would have a complete monopoly on the multibillion-dollar budget flows that the state directs to the purchase of medicines. What kind of kickbacks in this process are deposited in the pockets of key officials, we can only guess.

Specialists, experts, and representatives of public associations have repeatedly stated that the new draft law "On the circulation of medicines" does not stand up to any tests for corruption. Thus, in the appeal of the industry associations of the pharmaceutical industry to Deputy Prime Minister Alexander Zhukov, it was said that the bill was developed without the participation of the pharmaceutical community and needs to be revised, and its adoption may worsen the situation in the field of circulation of medicines and reduce the availability of treatment.

And here is what is said in the conclusion about the draft law by the specialists of the Association of Russian Pharmaceutical Industries: "... the presence of a single expert center for the examination of medicines provided for in the draft law does not contribute to the creation of competitive conditions." The Association of Clinical Research Organizations also sharply criticized the draft law "On the circulation of Medicines". Specialists were outraged by the idea of artificial separation of expertise from the registration process of medicines. In accordance with the draft of the new law, the control functions of the state are reduced to the issuance of a registration certificate, and the qualitative assessment of the drug is transferred to the jurisdiction of a new federal autonomous institution. According to this scheme, the state will no longer be responsible for the market of unsafe and ineffective medicines. At the same time, the mandatory registration of substances from which medicines are made is eliminated. If today Roszdravnadzor is obliged to compile ratings of pharmaceutical manufacturers on the quality of products, then under the new law this function will actually be canceled. But only in 2009, the supervisory authority identified several dozen series of falsified pharmaceutical substances. Such a list is posted on the Roszdravnadzor website, which allows pharmacy systems to avoid purchasing low-quality drugs. First of all, drug users benefit from this. Thus, one of the most popular medicines – "Paracetamol" of Chinese production, the main supplier of which to the Russian market is the already mentioned company "Pharmstandard", is recognized as a low-quality medicine, the use of which is fraught with serious health threats. It is obvious that the abolition of strict control over the quality of drugs, which the lobbyists of the new bill actually sought, only benefits unscrupulous suppliers. And, of course, to their patrons in the official environment.

Easily dismissing all the objections of the opponents of the new bill, Minister Tatyana Golikova assured that the regulatory document promoted by her would contribute to the effective control of drug prices. However, according to experts, the promise to "freeze prices" within the framework of the Golikov project of state regulation in 2010 will lead to negative consequences in the pharmaceutical market: in particular, it may result in a decrease in the share of domestic drugs, as well as a sharp increase in prices for 12 thousand names of medicines not included in the list of vital and necessary medicines funds (ZHVNLS). By the way, before the New Year holidays, the chairman of the formulary committee of the Russian Academy of Medical Sciences, Academician Andrei Vorobyov, sent letters to Russian President Dmitry Medvedev and Prime Minister Vladimir Putin, in which he expressed alarm about the fact that in the new bill of Minister Golikova, as many as 150 names of medicines necessary for the treatment of oncological diseases, asthma, diabetes, tuberculosis were excluded from the list of ZHVNLS and other serious ailments.

And in a statement published in December 2009 by the All - Russian Union of Public Associations of Patients, it is directly stated about the corruption of Golikova's bill: "The draft law describes regulatory issues in excess – the most corruption–intensive and creates almost limitless conditions for corruption - and does not solve the issues of free and preferential provision, which is its obvious disadvantage. This project removes responsibility from public authorities for the quality of registered drugs, leaving them only the issuance of a registration certificate and the maintenance of the state register of medicines. The mechanism of making a decision on the registration of drugs based on the expert's opinion is extremely convenient for corrupt officials."

It is gratifying that the relevant committee of the State Duma of the Russian Federation and the leadership of the United Russia party saw in time all the dangers of the bill proposed by Minister Tatyana Golikova and the new methods of calculating drug pricing attached to it. The only question is whether the deputy barrier will withstand the growing onslaught of lobbying efforts on the part of the family-ministerial duumvirate.

Portal "Eternal youth" http://vechnayamolodost.ru20.01.2010

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