The PBN Company
Unofficial Translation

Rossiyskaya Business-Gazeta
October 16, 2001
Page 8

Not Only Vodka Can Be Counterfeited

By Irina Kolodina

Everyone knows that Russian shops sell a great number of counterfeit vodka. When we intend to buy alcoholic beverages, we consider this possibility. We have 'right' shops in view and scrutinize the proposed goods. In addition, it is quite possible to identify counterfeit vodka by tasting it.

However, when we buy drugs, we feel safe. When we buy a certain medicine at a lower price, we feel great about how much money we saved. Only a few of us understand that such medicines are cheap counterfeits, which can be as dangerous to our health as moonshine vodka.

This problem is relatively new to our country. Therefore, the ways of resolving it are not absolutely clear. It took European countries forty years to save their markets from counterfeits. Nevertheless, counterfeits still circulate on their markets. According to the World Health Organization, 25% of registered cases of counterfeit pharmaceuticals occurred in developed countries. In July 2000, the Italian police seized 240,000 packages of counterfeit medicines and 2 tons of raw materials for a sum of $1 million. Drugstores in Great Britain recently received counterfeit ulcer treatment medicines. According to the World Health Organization, imported counterfeit drugs capture from 5% to 8% of the U.S. pharmaceutical market. The most catastrophic situation is in Africa, where 50% of all medicines do not contain the necessary active ingredients.

Counterfeit drugs emerged in Russia in 1997. Then a blood substitute "Poliglyukon" was disclosed. Since that time the number of counterfeits has increased. A scandalous incident recently occurred in Volgograd - 1,000 people were admitted to the hospital after they were injected with counterfeit insulin.

According to the Ministry of Health, over the past two years the number of reported cases of counterfeit medicine has increased 10 times. The Ministry of Health asserts that counterfeit medicines make up 3% of the pharmaceutical market. According to the Ministry of Internal Affairs, counterfeits constitute as much as 7% of the market.

What are counterfeits and where do they come from?

Counterfeits differ. Some of them simply have no effect at all; others can inflict serious injury, while another type illegally uses a well-known trademark. The latter do not cause serious injury.

The World Health Organization divides medicines into the following groups: medicines not containing active ingredients as described on a package; medicines with active ingredients that have a percentage ratio that differs from the norm described on the package; medicines containing active ingredients other than those described on the package; and medicines produced by a manufacturer that is not entitled to produce the product. According to WHO, counterfeiters prefer to sell well-known, high-demand medicines, like antibiotics, for instance. This is extremely dangerous. Even if the drug does contain the active substance stated in the annotation but in a smaller proportion, it does not cure the infection. Moreover, bacteria may acquire a resistance to the drug, which exposes the lives of many people to risk.

Extremely dangerous are counterfeited "heart" remedies. These counterfeit drugs will not help in the event of an acute stenocardia attack, which may lead to fatal consequences. Nonetheless, even the less expensive nistatin and baralgin are being counterfeited in our country. According to the Association of the International Pharmaceutical Manufacturers, the major part of the counterfeit medicines enters our country from abroad. This would include China, India, and the former USSR republics. However, this claim may be disputed. Some experts claim that 70% of the counterfeits are produced domestically, and only 30% originate brought from abroad.

Originally-Russian Question

What are we to do? How are we to stop the spread of medicines made by God knows who? And made out of God knows what? We were not able to get a clear answer to this question. Lots of interesting and nice words were said at the international conference dedicated to the fight against counterfeit medicines in Moscow last week. The RF Deputy Minister of Health, Anton Katlinsky, said that counterfeiting of medicines "is a threat to the national security of our country," and his objective is to make certain this growing problem is resolved before it gets out of hand." But how?

According to Robert Rosen, Executive Director of the Association of International Pharmaceutical Manufacturers, "Fighting counterfeit medicines requires better laws, better enforcement and better cooperation among the public and private sectors." At present the Law "On Medicines" does not even contain a definition for "counterfeit medicines." A proposal was made to introduce the following changes to existing legislation: 1.) Administrative Code - responsibility for participation in sales of counterfeit medicines should be stated; 2.) Criminal Code - a new article has been proposed regarding the establishing of liability for the manufacturing and receiving of profit from counterfeit medicines. For the time being, these drafts have not yet been submitted to the Government, and only the Government can present draft laws to the Duma. Thus, many days will pass. Experts estimate the period of time necessary for these drafts to pass through the Duma to be from two to three years.