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Quality Control of Brazilian-Made Antivirals

December 2000

Before our talks I asked Jorge Bermudez(1) about the quality control of the Brazilian-made antivirals. He said it was not a problem and that results of bioequivalence studies would soon be made public. This turned out to be a significant bone of contention.

Ezio Távora dos Santos Filho, the vice president of Pela VIDDA/RJ, got up and expressed concern about the bioavailability and bioequivalence of the Brazilian-made antiretrovirals. “What’s in this medication we’re taking? We’re fighting to break the patents, but we have to have good quality control. One month the drugs come from one company, one month they come from another. This is a serious problem . . . It’s vital that the Brazilian government works on quality assurance. I want to know that what I’m taking is good for me. Even if the government doesn’t consider this a priority, we do. We must not export low-quality drugs.” Ezio’s passionate critique elicited heavy applause from the activists in the audience.

Bermudez, shifting the issue, replied that, “Up until now, Brazil has been forced to swallow international pharmaceutical drugs without questioning their quality. A law regulates the mechanism of buying drugs. All medications produced here will be regulated. We will have certificates of bioavailability by January 2001.”

Costa Filho, stung, replied, “I acknowledge what Ezio just said, but there’s a lack of context in his eloquence. It’s not fair to say the government is forcing you to swallow something. This [quality control data] was never requested for any international company . . . We have never asked for this before.”

Afterwards, Dr. Irene Adams — a physician with an HIV practice in Belo Horizonte (Minas Gerais state) as well as a clinic for street kids and a 33-bed inpatient unit — and Ezio Távora dos Santos Filho reported some alarming facts:

  • In Belo Horizonte, her patients have to wait nine months for viral load test results.
  • In theory, patients are entitled to three viral load tests a year. In practice, they’re lucky if they get one. The wait for viral load test results can be up to a year.
  • ELISA HIV antibody test results can take up to eight months in Belo Horizonte and up to six months in Rio de Janeiro.
  • One of the locally-manufactured ddI tablets doesn’t dissolve after nine hours. (It’s supposed to dissolve in about 30 minutes.)
  • One locally-manufactured nevirapine smells like ether.

It was unclear from the government representatives — Bermudez and Costa Filho — whether the quality assurance, bioavailability and bioequivalence data would be complete and available by January 2001, or whether that was merely when the testing would begin. There was no mention of testing the local products for purity as well as the other parameters. I was also confused when Ezio said that local university labs were willing to carry out the necessary tests; he may be underestimating the difficulty of doing this.

  1. Coordinator of the WHO/PAHO Collaborating Center for Pharmaceutical Policies in the Brazilian Ministry of Health.
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