The proposal did not pass
The issue was worked out, all the relevant agencies have considered that at the moment, the introduction of compulsory licensing is impractical, told RBC press Secretary Arkady Dvorkovich Aliya Samigullina. In a letter to Dvorkovich to President Vladimir Putin (a copy of the document is at the disposal of RBC) States that “the majority of imported drugs with unexpired patent protection in the Russian Federation signed investment agreements, is to localize the production of 14 such foreign drugs.
To introduce compulsory licensing in Russia was offered by the founder of the pharmaceutical company pharmasyntez Vikram Singh Punia. At the February meeting of Putin with Russian entrepreneurs in Novo-Ogaryovo Punia asked the President to allow to produce drugs that are still under patent protection at domestic enterprises. According to this scheme work in the BRICS countries, in particular, this practice is widely prevalent in India.
As reported by Punia, pharmasyntez produces drugs for treatment of socially significant diseases such as tuberculosis, HIV, hepatitis. According to Punie, the most important problem is the hepatitis C — “it affects almost 3 million Russians, it is an epidemic, “in addition, in some cases, hepatitis can be even more dangerous than HIV infection.”
The order of the President Putin “to provide proposals on expediency of application in cases of epidemics in the Russian Federation the mechanism of compulsory licensing of pharmaceuticals under patent protection” was sent to the government in late February; a study of the issue Dvorkovich, RBC confirmed in the office of the Deputy Prime Minister.
Among the specialized agencies, considered the compulsory licensing mechanism is impractical, the Ministry of industry and trade, the Ministry of health, Ministry of economy, the letter said.
Separately, Arkady Dvorkovich Prime Minister Dmitry Medvedev “did not report”, the issue of introducing a mechanism of compulsory licensing “is complicated, is discussed”, told RBC press Secretary of the head of the government Natalia Timakova.
Press Secretary of Vladimir Putin Dmitry Peskov declined to comment for this article.
“A dozen drugs”
According to analytical company DSM Group, the total volume of the pharmaceutical market in Russia in 2015 amounted to more than 1 trillion rubles, the share of foreign products account for 73%. The share of drugs under patent protection, in the Russian market is about 15%, 95% of them — the products of foreign manufacturers, said the General Director DSM Group Sergey shuljak.
Shulyak does not believe that these 15% of drugs would be under threat. “Under compulsory licensing will include only drugs for which a very high price, or those that are not present in the Russian market, but a patient needs, is the strength of a dozen drugs”, — he hopes.
The therapy of patients with hepatitis C, told Punia, President, is from 3 mln. in one patient, the budget has no such money, and the use of compulsory licensing will reduce the cost of these drugs dozens of times. “In those countries where this mechanism is introduced, the preparations, for example, are not $90 thousand and $1 thousand, or even $500,” said Punia.
That the government considered the proposal impractical, Punia learned from the RBC. In his opinion, the question cannot be considered closed, the relevant departments need to meet with domestic manufacturers and to “establish a dialogue”.
In turn, the threat of the HIV epidemic previously reported, Minister of health Veronika Skvortsova. According to her, the funding will allow in 2015 to provide antiretroviral therapy to about 200 thousand HIV-infected people — only 23% of such patients. According to the forecast of the head of the Ministry of health, by 2020 the number of patients will increase by 250%.
According to the head of the Federal Antimonopoly service (FAS) Igor Artemyev, the mechanism of compulsory licensing could solve the problem. “International law gives the state the right to limit negative licensing practices used by right holders in the state. We believe that the antitrust laws can be applied to objects of exclusive rights provided that actions of the rightholder lead to monopolization and monopolization, this has significant negative consequences for competition and consumers”, — explained in the beginning of March, RBC Deputy head of the FAS Sergey puzyrevskiy.
On Thursday, the press service of the FAS reported that they couldn’t give comment, and advised to request after the may holidays. The head of Department for control over social sphere and trade FAS Timofey Nizhegorodtsev, previously supported compulsory licensing, refused to answer questions RBC.
The result of the application of compulsory licensing, wrote in a letter to Dvorkovich, the decline in investment attractiveness of the industry, including foreign manufacturers are implementing localization projects or having appropriate plans. It would undermine the confidence of companies to increase investment in the industry, he said.
According to the Executive Director of the Association of international pharmaceutical manufacturers (which includes 60 of the largest pharmaceutical companies, including Eli Lilly, Novartis, Sanofi) Vladimir Shipkov, Association members opened more than 20 factories for the production of drugs in Russia, their investments in the last five years has exceeded €2 billion.
The introduction of compulsory licensing would violate the rights of foreign pharmaceutical manufacturers and jeopardize the economic feasibility of investment in the Russian market, confirms CEO Merz Russia Olga Stepanova. “The issue of the availability of modern pharmaceuticals for patients is extremely important, and we understand the state initiatives in this area, — says she. But the process of developing new legislative initiatives in this area should be suspended.” The law on compulsory licensing will lead to the fact that many foreign companies may refuse to enter the Russian market, agrees with her antitrust economist, member of the Expert Council under the government of Vadim Novikov.