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Eastern Europe: EU Standards Narrowing Market For Inferior-Quality Drugs

  • Valentinas Mite

Latvia has terminated all sales of medicine made by a Belarusian company after patients developed serious health problems. Other new members of the European Union are also halting the importation of medicine that does not comply with European standards. However, low-quality drugs are still being sold in the black markets of new EU member states and in former Soviet republics, which do not have strict production controls.

Prague, 1 June 2004 (RFE/RL) -- Belarusian, Russian, and Ukrainian drug companies producing inferior medicine are losing markets in the new member states of the European Union.

A recent scandal surrounding the importation of cheap Belarusian drugs to new EU member Latvia highlights the problem of drug quality.

Several people in Latvia were sickened recently after taking Belarusian painkillers that were produced without conforming to World Health Organization (WHO) principles. Good Manufacturing Practice, or GMP, is a WHO initiative that covers all aspects of drug production -- from the starting materials to the personal hygiene of staff. Drug companies must spend additional money to adhere to GMP guidelines.

Latvian patients developed serious complications after taking the painkillers Citramon and Ascophen, which are produced by the Belarusian drug firm Belmedpreparaty. The drugs contained an agent that lowers blood sugar. The agent is usually used for the treatment of diabetes but is dangerous to people who have normal blood sugar levels.

Last week's incident was the second concerning Belmedpreparaty in the last few months. In both instances, several people were hospitalized but no one is believed to have died.

Belmedpreparaty blamed the incidents on human error, not on their production techniques.

Barvida Zaiga, a spokeswoman for Latvia's Health Ministry, told RFE/RL that the real scope of the disaster is unknown: "Thank God, nobody has died; but that is only what we officially know. It might have happened that old people who live alone in the countryside used Ascophen and found themselves in a coma. They might have died, and nobody was able to help them. We don't know that because they usually don't do autopsies on old people."

Zaiga said Latvia is seeking compensation from Belmedpreparaty. In the first incident, a request from Latvia for almost 16,000 euros ($19,545) in compensation was received but has yet to be paid. The Belarusian Healthy Ministry says it has not received a specific request for compensation on the second incident.

Zaiga said that after Latvia joined the European Union on 1 May, Riga banned the importation of all drugs that do not have GMP certificates. She says inferior quality drugs were coming into Latvia not only from Belarus but also from Russia, Ukraine, and other countries where GMP guidelines were not followed.

Saulius Janonis is Lithuania's deputy minister of health. He said drugs made by Belmedpreparaty were never sold in Lithuania but acknowledges that noncertified drugs did make up some 10 percent of the country's drug market before 1 May: "From the first of May, it is forbidden to import to Lithuania drugs which do not conform to the Good Manufacturing Practice requirements. They cannot have any market in Lithuania."

However, Janonis said drugs that were imported before the beginning of May are still permitted to be sold in the country.

Raimundas Voiska is a representative of the U.S. pharmaceutical giant Pfizer in Lithuania, who several years ago represented the company in Belarus. Despite the claims of officials, Voiska said the illegal importation of cheap, low-quality drugs is on the rise in Lithuania.

"The trade has moved from pharmacies to marketplaces. The drugs are sold at railway stations. Just look what is going on near the main railway station in Vilnius. It is terrible. The drugs are brought here and sold illegally and [Lithuania's] drug-control agency and the police are able to do very little to put an end to it," Voiska said.

The list of drugs sold outside pharmacies begins with painkillers and ends with sedatives. Voiska said people with low incomes can often find a variety of cheap drugs for sale without the need for a doctor's prescription. Voiska said the trade offers good profits to the smugglers but will eventually lead to tragedy.

Voiska said the loss of official Baltic markets will not force Belarusian or Russian drug companies to begin following GMP guidelines. "The drugs they sell in the Baltic states make a tiny piece of their production," he said. "Belarusian or Russian producers will not suffer serious losses from losing the markets in the Baltic states because the main chunk of their production is sold at home or in neighboring countries, which do not ask for GMP certificates":

"On the whole, the main markets for these producers were at home or in the former Soviet Union, except the Baltic states. These producers -- Russian and Ukrainian -- do not seek to register their products in Lithuania, and it is more evidence that these markets are not interesting for them," Voiska said.

Voiska said Belarusian companies export their cheap products to Ukraine, Russia, or other CIS countries where Pfizer and other Western drug companies have very small market niches because their drugs are more expensive.

"Another problem is how these cheap drugs affect health," said Voiska, "but nobody seems to care very much when both people and the drug companies are poor."