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25.02.2013

Report hits Russia’s lapses in counterfeit drugs fight

The release of a report earlier this month has highlighted the problem of counterfeit medicine, not only in Russia, but internationally.

The report, "Pharmpiracy in Russia, 2004-2012," introduced at RIA Novosti's press center on Feb. 5, is the product of five organizations: the State and Law Institute at the Russian Academy of Sciences; the Association of Employees of Law Enforcement Agencies and Special Services, or ARPO; ARPO's Public Council for Healthcare and Social Welfare; the Scientific Center for Quality Control; and the Union of Professional Pharmaceutical Organizations.

Representatives of these organizations outlined some of the problems Russians face in encountering counterfeit medical products and possible remedies.

Poor information

The first issue is that the government simply does not have exact objective information about the scale of the problem, said Sergei Maximov, deputy head of legal management at the Federal Anti-Monopoly Service.

"A statistical form that would allow different quantifications of pharmaceutical piracy of all types simply does not exist in our country," he said. "Therefore, all estimates are judgment-based and approximate, but if averaged out, it comes to about $750 [million] to $3 billion."

Despite different approaches to tackling the problem, he added, analysts have been unable to conclude firmly whether the situation is improving or worsening in Russia.

The failure or lack of enforcement of legislation during the period covered by the report has contributed to the continuing problem, and there is no bill currently awaiting debate, Maximov said.

Disjointed campaign

Some reasons behind the failure to pass legislation came from former State Duma Deputy Sergei Kolesnikov, member of the presidium of the Russian Academy of Sciences. At the discussion stage, he said, many legislators felt that counterfeit medicine was already regulated under extant laws - on fraud, for example.

"This was the way that the several bills that were active - I wrote two of them - were buried, for this reason," Kolesnikov said.

Maximov offered another reason: the lack of a single enforcement body within the government.

"The Federal Service for Healthcare Supervision had significant authority during the formation of one body in 2004, and was moving toward increasing it, which would have allowed a more effective fight," he said.

A change of policy meant that the service's powers were split among different agencies, however, and the incipient Pharmaceutical Inspection Agency was shut down in favor of a system of fines for violators. Protests from the pharmaceutical industry meant that the fines were eventually dropped, too, Maximov said.

A third problem is transparency in state purchases, such as tenders for generic versions of medications.

The example cited in the report was an auction for the right to sell Imatinib, a generic version of Novartis's leukemia medication Glivec, to the Russian government for use in state healthcare facilities. Novartis holds the patent for Glivec in Russia through Apr. 1, 2013, but two separate tenders in August and September last year mean that generic producers are now selling their versions in Russia.

According to an inquiry submitted to ARPO's Public Council for Healthcare and Social Welfare, neither of the winners had secured permission from Novartis to sell them here.

The key question as a result of the auction is, Maximov said, "What Imatinib is found today in the medical facilities of our country?"

Under the Federal Anti-Monopoly Service, he said, consultations were already under way to require production of a documented agreement between a patent-holder and a generic producer, before sales of a generic version of a patented medicine could take place in Russia.

Solutions

The speakers acknowledged that effective solutions would be difficult without shifts in government policy. Greater participation in international campaigns and treaties was one example, due to the worldwide threat counterfeiting poses.

"The problem is also that our regulation does not correspond to international regulation," Kolesnikov said. "We are the initiators of a lot of good programs, in particular Medicrime [a treaty based in the Council of Europe] - it was, at base, created on Russia's initiative. It was first discussed here and was signed here. But extending to ratification, it's understood that there are lobbyists for whom regulation in this area is not profitable."

Technology is also a tool that has not been fully exploited, said Aslanbek Aslakhanov, president of ARPO.

"There are inventions that protect against fake goods," Aslakhanov said. "We need to work so that medicines are also protected, using nanotechnology... In this direction, we will conduct a competition for inventions among young people every year."

Maximov and Kolesnikov agreed, however, that for the time being, consumers would have to arm themselves: consulting their doctors and accepting the cost should they opt for a more expensive brand-name medication rather than a generic. Price is one of the indicators of possible fraudulent production.

In addition, Kolesnikov said, Internet sales and smaller kiosk pharmacies should be avoided in favor of larger stores with better storage facilities and inventory management.

"The Internet trade in medicines is one of the basic black markets," he said. "More than 50 percent - by international estimates, not even by ours - of medicines in online trading are either poor quality or fake. Therefore they are significantly cheaper, and no one should buy them there, above all."

Source:  www.themoscownews.com

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