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Federal Anti-monopoly Service: forced production of essential imported drugs may start in Russia

Source: IP news translation by Grill IP from Advis

“The development of this bill is in progress, we have corresponding government instructions in Russia today, we designed the bill”,  Artemiev stated.

The Federal Anti-monopoly Service (FAS) proposes to legislate the compulsory licensing of essential imported drugs in the Russia. The fact was stated by the head of FAS Russia, Igor Artemyev, during the V International Conference on HIV / AIDS in Eastern Europe and Central Asia. “We propose to introduce the corresponding changes in the law (in the Civil Code and the anti-monopoly law – Ed.), to record, in which cases an appropriate compulsory patent can be given (for production in Russia – Ed.), with fair market compensation to a patent holder. We are talking about medicinal drugs,” he said. “The development of this bill is in progress, we have corresponding government instructions in Russia today, we designed the bill”, Artemiev stated.
“On the basis of a government order the antimonopoly agency files a corresponding claim in court, which takes decisions on the issue of a compulsory patent for a specified period, and a drug synthesis by authorized laboratories begins in Russia. At the same time a right holder obtains fair compensation,” Artemiev said, explaining the proposed scheme.
He specified that such measures would be funded mainly through the budget. “After the drug was synthesized and people received it, these rights should be terminated by special resolution of the Russian government,” Artemev added.
Force the ones who stopped importing on political grounds
It is proposed to apply the mechanism of compulsory licensing in cases where a foreign manufacturer refuses to supply drugs to Russia on political or economic grounds (unprofitable sales in Russia, including those due to the state regulation of prices).
In addition, compulsory licensing can be used for patented foreign essential drugs during an epidemic of extremely hazardous diseases in case of budgetary constraints.

“Fortunately, there was no refusal to supply medicines on political grounds, but we have had cases in the history of the anti-monopoly agency, for example the manufacturer of a unique drug which treats such an incurable disease as multiple sclerosis. These companies refused to supply their products to Russia. Russia could not accept that and it had to go through many trials. Finally the Supreme Court of Russia put an end to the matter, and the company supplied these drugs in the Russian Federation,” Artemev said. He added that the issue was resolved not on the basis of direct but indirect statutes of the anti-monopoly law.
Now the Russian legislation provides that a compulsory license may be issued under the court decision on the basis of Article 1362 of the Civil Code. “When we analyze together all the conditions of applicability of this article, we have to admit that it is just about inapplicable, and therefore it has never been applied in Russia”, – Artemev said. He said that the article should be adjusted.
In addition, in the interests of defense and security, the government may allow the use of the invention, “but here we are talking about difficult situations related to national defense, therefore, most likely, this method is also not applicable enough,” Artemyev said. “A lot of countries (such as the BRICS countries) have a clear and direct legislation in such difficult situations and use it to cover the legally protected interests of citizens”, – he stressed.
Reliance and lack of alternative drugs
According to Artemyev, Russia’s dependence on manufacturers of patented drugs that have no analogues, endangers the realization of the security strategy, which includes providing people with high quality and affordable medication. Currently in Russia there are over 1 million HIV-infected people, and the treatment cost per patient is about 120 thousand rubles a year. In 2015, treatment expense was 2.9 billion rubles from the budget.
“Currently, about 95% of essential drugs are patented and manufactured by foreign companies that assign high prices for their products for Russia,” the Head of FAS exemplified. The Antimonopoly agency has no plans to require compulsory licensing in other areas. “We are talking only about taking measures to protect the lives and health of our citizens, we are only talking about medicines,” the Head of FAS said.

The Head of FAS also addressed transnational corporations that produce medicines with a request to remember the social aspects of their work. “We will never allow our people to die for lack of medicines that already exist at the discretion of a single person or a group, or governments of other countries, or other entities. We will immediately distinguish cheating from honest behavior,” Artemyev said.

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Author: grill-ip

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