Generic Drug Companies in Brazil, India Face Obstacles in Antiretroviral Production Under WTO Agreement

Brazilian generic pharmaceutical company Laboratorio Cristalia and other generic drug makers in Brazil and India could "face potential political, bureaucratic and financial obstacles that could prevent them from selling a single dose of a lifesaving AIDS medication" under the recent World Trade Organization agreement, the AP/Kansas City Star reports (Clendenning, AP/Kansas City Star, 9/26). The WTO last month reached an agreement on the importation of generic versions of patented drugs. The agreement allows countries to issue a compulsory license in order to import generic drugs if the country confirms that it cannot domestically manufacture the drugs (Kaiser Daily HIV/AIDS Report, 9/9). The importing country must notify WTO, and the foreign drug maker must then obtain an export license from its government. Some experts say that the countries needing the drugs first will have to negotiate with patent-holding drug companies for lower prices, potentially using the threat of deals with foreign generic drug makers as "bargaining leverage," the AP/Star reports. Yusuf Hamied, chair of Cipla, an Indian generic drug manufacturer, said that the WTO agreement has "not simplified things, it's been complicated and only the large companies benefit." He added, "Who wants this red tape? We need predictability for supply. We don't want the headaches and the litigation."

Meeting the Need
Eric Noehrenberg, director of international trade and market issues for the International Federation of Pharmaceutical Manufacturers' Association, said that Brazil does not have the capacity to produce generic drugs for countries that need them. Brazil is considering importing some drugs because government officials say the domestic generic drug makers cannot produce enough medication for the 140,000 HIV-positive Brazilians who need the drugs, the AP/Star reports. However, HIV/AIDS advocates and generic drug makers in Brazil say that already established generic drug companies could begin production quickly, according to the AP/Star. If countries like Brazil cannot meet the need, they can help developing countries obtain the medications in other ways, according to Ellen 't Hoen, a spokesperson for Medecins Sans Frontieres. She said, "There's increased funding for AIDS, and more and more countries are talking about providing more AIDS funding," adding, "Brazil could play a big role with exports, but Brazil also has the knowledge and the technology to help other countries to start production sites and their own programs" (AP/Kansas City Star, 9/26).

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