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Russia Proposes Pharmaceutical Information System


Vedomosti revered the amendments to the law ‘On The Treatment Of Drugs’ prepared by “United Russia” (one of the developers is Tatyana Yakovleva, Deputy Head of the faction). The representative confirmed that the amendments introduced; the first reading took place at the end of January, but the date of the second reading has not yet been announced.

The amendments would introduce special labeling for medication confirming its compliance with drug safety and quality requirements. Pharmacies would require hardware to check the label’s authenticity. According to one of the proposed amendments, if the label is fake, the customer could appeal to Roszdravnadzor. The amendment does not specify who would gather information for the new system, how it would be gathered,  or what penalties would face companies that do not comply with labeling requirements.

If the amendments proposed by United Russia become law, they would establish more specific labeling requirements. They would take effect January 1, 2011.

Yakovleva said during the first reading that labeling is necessary because there are too many counterfeited products on the market. Boris Gryzlov, Speaker of the Duma, promised that "at the second reading we will raise the issue of the necessity of fighting against counterfeit goods, which will most certainly be subject to the amendments."

The Ministry of Health and Social Development does not support United Russia’s proposals, said a Ministry representative. “The percent of counterfeited products on the market is usually exaggerated; according to our data it composes only 0.5%,”—says David Melik-Guseinov, Director of Research at PharmExpert. Sergey Lomakin, a lawyer from Baker & McKenzie, considers that the existing system is already sufficiently strict: first of all, the quality is verified when the drug is registered, and secondly, before every batch is released into circulation the manufacturers must declare that it complies with state requirements. In addition, Roszdravnadzor can seize drug packaging from distributors’ warehouses and pharmacy chains for random testing.

“Judging by the text of the proposed amendments, the labeling procedure could prove to be too time-consuming and require substantial costs. For example, we would not be able to label products during production; we would have to wait until the statement of compliance with standards is received, when the merchandise is already packaged,” says Dmitry Efimov, General Director of Nizhpharm. “All of this will most likely raise the cost of medicine, especially the cheaper ones.”

The issue concerns not only labeling, but also the creation of an automated system, said a representative of the Ministry of Health and Social Development; all of this will raise costs that ultimately lie on the costumers’ shoulders.

Additional costs are estimated in the millions.  For example, the installation of equipment for a similar system, the Unified State Automated Information System, cost the alcohol market $127 million, and they must pay more than $200 million per annum for maintenance.

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