Brazilian health officials seized 702% more counterfeit drugs in the first half of 2009 than they did during the entire previous year. (Dominique Faget/AFP/Getty Images)

RIO DE JANEIRO, Brazil – In an effort to fight the selling of counterfeit drugs, the Brazilian government has put into force resolution RDC 44, which creates new rules for drugstores and pharmacies.

In a partnership with the Brazilian mint, the national health surveillance agency (Anvisa) also is developing a complex bar code known as Datametrix. It allows medicine to be tracked from the time it’s produced to when it’s sold to consumers and will be required on all medicine beginning next year.

“There isn’t a specific place, a city, with higher or smaller concentration of counterfeit drugs,” Adilson Bezerra, institutional security advisor of Anvisa, says. “In our inspection operations, we have found counterfeit drugs [almost everywhere in the country].”

There were 316 tons of counterfeit drugs seized in the first half of 2009, which is 702% more seizures than for all of 2008, according to the ministry of justice.

The increase in confiscations is a direct result of the higher number of inspections spurred by a joint effort of the ministry of justice, Anvisa and federal police that was begun in December 2008.

In 2009 there were 691 inspections, which resulted in the seizure of 1,000 flasks of liquid medicine, 104,004 tablets, 31,980 boxes and 333,515 tons of drugs that either were counterfeit, were smuggled into the country or lacked the proper paperwork.

Of the 691 inspections, 60 resulted in the collective arrest of 203. The maximum prison in Brazil for those found guilty on charges related to counterfeit medicine is 15 years.

The operations revealed established drugstores – not vendors peddling merchandise in tents or on the street – sold the highest amount of counterfeit or smuggled medicine.

“The drugstore at the international airport of Brasília was closed last year by Anvisa because it was selling counterfeit drugs,” Bezerra says.

The most common counterfeit and smuggled medicine found was going to be sold to customers to treat erectile dysfunction, like Viagra and Cialis, followed by expensive drugs to treat cancer.

“Counterfeit drugs [cause] great damage [to] the population,” says José Paulo Pereira Júnior, a physician and teacher at the Federal University of Rio de Janeiro (UFRJ). “They may have no effect on the treatment or even cause the patient to die.”

RDC 44 mandates the presence of a licensed pharmacist in drugstores and pharmacies at all times. Medicines must be placed behind the counter, so customers can question pharmacists on using the product correctly.

Prescriptions are now required for all types of medicine and the sale of products not related to the pharmaceutical area is prohibited.

“We see around the country drugstores selling all kind of things, from meat to rat poison,” Bezerra says.

Anvisa believes drugstores and pharmacies that employ licensed pharmacists and only sell medicine eliminate the chance of selling counterfeit drugs by 95%.

Businesses found in violation can be fined up to R$1.5 million (US$860,000). Still, some drugstores and pharmacies ignore the rules.

The Brazilian association of pharmacy and drugstore networks (Abrafarma) says more than 60,000 pharmacies and drugstores affiliated with either this association, the Brazilian association of pharmaceutical trade (ABCFARMA) or other unions and entities in the area don’t need to follow the RDC 44, according to a recent ruling by the federal regional court.

“[This court decision] is progress for Brazil that follows tendencies of developed countries and thinks about the health and well-being of its population,” Sérgio Mena Barreto, executive president of Abrafarma, says.

Barreto claims the RDC 44 harms customers and burdens drugstores, causing prices to rise.

But Anvisa won’t give up.

“Anvisa has always been trying, it is trying and it will manage to annul all those preliminary [court] orders, so that all the drugstores and pharmacies in the country become true places of health and not ordinary trade,” says Bezerra. “We already got to annul some and Anvisa is certain that it will get judicial victory.”