What a TRIP

We now move on to the big, bad wolf...Big pharma.

In 1993, the a private Brazilian drug company, Microbiologics, began manufacturing a generic version of AZT. At this point, AIDS was spreading so quickly over the country that many predicted it would be the next South Africa. Yet over the next seven years, the company manufactured generics for other HIV drug regimens, and the government provided ARVs to PLHIV free of charge. This saved the health system an estimated $677 million, freed up thousands of hospital beds and cut AIDS deaths by over 70%. For more on the success of Brazil, check out the New York Times Magazine article: Look at Brazil.

Big pharma began to take notice. In 2001, the U.S. government filed a complaint with with the WHO to try and stop Brazil from making generic antiretrovirals and threatened trade sanctions if they failed to comply. According to D'Adesky, the U.S. was not as concerned about loosing their competitive edge on the ARV market, but were worried about patent laws that currently protected makers of new products under the Trade Related Aspects of Intellectual property and Public Health (TRIPS). If these laws were altered, big pharma concerned that other generic drugs could find their way into the international market as well.

Brazil fought back citing a 1997 patent law that allowed for the production of generics to to address a "national emergency." The U.S. ended up dropping the complaint, but Brazil kept on fighting. Not only did they threaten compulsory licensing to negotiate huge discounts for U.S. patented ARVs, but they led the way for other developing countries at a WTO conference in Doha, Qatar. Under the new Doha agreement, poorer nations facing national emergencies were allowed to circumvent patent rights for better access to essential medicines. However, these countries were still not allowed to export these generics, and it required them to develop the capacity to manufacture their own generics--something few are capable of. Drug production requires a substantial investment, industrial manufacturing base, and skilled manpower.

In theory, giving developing countries the capacity to produce generic drugs seems like the perfect plan. Along with Brazil, India, China, Cuba and Thailand have all built up their capacity to produce these drugs. However, few countries lack the raw materials or pharmaceutical ingredients used to make ARVs, so even if they did have the capacity it they would have to rely heavily on other countries for imports. Also, should the developing world get the capacity to manufacture drugs, it would be highly unlikely that they would be able to regulate the process on a large scale. The HIV virus is extremely sensitive, and can mutate into a more virulent form if not properly regulated. I fear that improperly made, or untested ARVs could lead to a new drug-resistant strain and need for second-line treatment that could be even more detrimental to the developing world. Also, would it be cost effective if every African country manufacture their own drugs? With more governments and organizations such as the Clinton Foundation actively intervening to negotiate for lower generic prices, it is not as necessary for these countries to manufacture drugs.

Just as a side note, in contrast to Brazil's policy of providing free ARVs to its citizens, South Africa’s national HIV treatment program has been very controversial. The South African government was initially hesitant about providing antiretroviral treatment to HIV-positive people, and only started to supply the drugs in 2004, (over 10 years after Brazil started providing ARV treatment) following pressure from activists. Even since 2004, the distribution of antiretroviral drugs has been relatively slow, with only around 33% of people in need receiving treatment at the end of 2006. (WHO) More on South Africa later in the blog...