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27.04.2007

State Duma Targets Counterfeit Drugs

The State Duma will examine plans to stiffen penalties for manufacturers and distributors of counterfeit pharmaceuticals Friday, one of the sponsors of the proposed bill said Thursday.

"It will be the first reading of a bill to create a new statute in the legal code covering the manufacture, intent to supply, supply, storage, transportation and importation of counterfeit pharmaceuticals," said Pyotr Shelishch, a member of the Duma's Legislation Committee.

Counterfeit medicine is a serious problem on the Russian market, Shelishch said.

"It's difficult to say what the amount of counterfeit drugs is, but estimates range from fractions of a percentage up to 10 percent," he said. The country's pharmaceutical market is worth around $10.7 billion, according to estimates by industry consultant Pharmexpert

According to the new proposals, the minimum penalty would rise to 500,000 rubles ($20,000) and the maximum penalty would be a 15-year prison term, Shelishch said.

"The maximum sentence would be applicable if it led to the deaths of two or more people," he said.

The new measures come as a result of glaring shortcomings in existing legislation, lawmakers and analysts said.

"I welcome this new move, as we still do not have any law to punish those people that produce counterfeit drugs in Russia," said Nikolai Demidov, general director of Pharmexpert.

In November, pharmaceuticals firm Bryntsalov-A was handed a 40,000 ruble fine after being found guilty of offenses including the improper storage of drugs.

Manufacturers welcomed the proposed legislation but said new laws needed to be backed up by tougher action. "Any changes in legislation should be followed by relevant enforcement measures. Legislative amendments are meaningless without strong support of control activities from executive authorities," a GlaxoSmithKline Russia spokesman said.

"We would like to see examples being made where those found to knowingly trade in counterfeit medicines are prosecuted and receive meaningful penalties," the spokesman said. "We would also like to see an increase in checks on pharmacies and warehouses."

With international standards such as the good manufacturing practices code as yet not obligatory in Russia, Demidov said overall production control needed to be sharpened.

The prevalence of counterfeit medicine in the country has consistently been one of the major factors hampering Russia's entry into the World Trade Organization.

"Of course we are thinking first of all about our citizens, but if these measures help facilitate Russia's entry into the WTO, then that is also positive," Shelishch said.

The urgency of these requirements makes it likely that the legislative changes will be passed by the end of the year, Demidov said.

"I hope that this law will be adopted not later than September. I am linking this with the WTO membership bid," he said.


Source:  www.themoscowtimes.com

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