Author: Mônica Scaramuzzo

Source: Valor Econômico - São Paulo / SP - COMPANIES - 31/03/2010

Monica Scaramuzzo, from São Paulo

The sale of pirated drugs has become a worldwide security problem. Several countries are working to combat the black market. According to the latest survey by the World Health Organization (WHO), the sale of counterfeit goods worldwide caused a tax loss of $ 35 billion last year. That figure could be raised to $ 60 billion in 2010, according to estimates. Just to compare, the sale of medicines in Brazil moved around R $ 30 billion in 2009.

In an interview with Valor, Jay Crowley, a senior advisor to the United States' Food and Drugs Adminstration (FDA), one of the most respected regulatory bodies in the world, said there were discussions about implementing programs in several countries to combat the marketing of fake drugs . "Several countries are working to have an efficient program."

Among the most counterfeit drugs in the world are Viagra, by Pfizer, and Cialis, by Eli Lilly, which fight erectile dysfunction. In Brazil, these drugs are usually smuggled across the border, especially from Paraguay. Since April last year, Pfizer has adopted differentiated packaging to try to inhibit the counterfeiting of the famous blue pill. In the UK, only one in 10 blue pills seized is usually original. In Brazil, Pfizer has revenues of approximately R $ 170 million from the sale of Viagra. Worldwide, it reaches US $ 1,9 billion.

Crowley does not specify losses by country. Research commissioned by Pfizer in 14 countries in Europe indicates that the black drug market could reach around € 10 billion a year. In Brazil, the estimate, without a research database, can reach between 10% and 15% of the total prescription from the sale of medicines (of a total of R $ 30 billion), according to industry sources.

Traceability, according to Crowley, is one way to combat the sale of fake drugs. "The idea of ​​traceability is to know what happens to the supply chain," he said. "Developed and emerging countries speak the same language in the fight against fake drugs and everyone needs to know what is going on," says Crowley.

Brazil is already in the implementation phase of a drug traceability program, which will have an authenticity seal, which is under development by the Casa da Moeda at the request of Anvisa (Health Surveillance Agency). In a recent interview with Valor, Dirceu Raposo, president of Anvisa, said that the discussion of traceability in the country started about three years ago and there is a law that has been in force for a year in the country “In addition to guaranteeing the authenticity and traceability of the product, it also guarantees fiscal and production control. ”

“I think that the World Health Organization (WHO) is a good environment to discuss these issues. Counterfeiters are very smart and know how to introduce these products. Government regulation is only one part of combating this type of procedure because there are several people involved in this issue, ”said Crowley. "There must be a good supply chain, a good structure and laws that regulate these criteria," he said.

According to Crowley, the United States has a number of drugs produced in several countries. “We need to know about monitoring in other countries, if it is safe, if they are well identified. I believe that the FDA and Anvisa could exchange more information. The FDA works with different groups to harmonize regulatory rules. If you have an approved product (in a particular country), you have to work with other regulatory bodies together. There are many global companies working in several countries in this regard. ”

According to Luiz Fernando Buainain, president of Abafarma (Brazilian Association of Wholesale Pharmaceuticals), the retail chain should meet on the 30th at Anvisa to discuss traceability. "In addition to tax evasion, the most important thing in this context is to remember that the population is the most affected, considering that they are consuming an illegal drug."

On the 16th, GS1, an international non-profit organization, held a meeting in São Paulo with the pharmaceutical industry chain to discuss global standardization of medicines. Sales of pirated drugs, according to GS1 estimates, may exceed US $ 75 billion, compared to the US $ 60 billion estimated by WHO. For Ana Paula Vendramini Maniero, advisor to the solutions cell for Brazil, the organization suggests an international standard for identifying products, with bar codes, to combat counterfeiting. "When you create a national solution, you restrict its applicability and make it difficult to import (the drug)."