Globalization, Trade, HIV, & Profit

The stark example of how the globe is intertwined. Kenyans are protesting the trade agreement between India and EU. EU is proposing a trade with India (the largest producer of generic ARVs). Currently EU is gunning for "data exclusivity" clause that will delay production of cheaper generic drugs for at least 5 years. Kenyan's movement is aided by MSF which obtain 80% of its ARVs cheaply from India. And as of today, 80% of ARVs purchased by "donors" comes from India.

The World Trade Organisation’s trade agreement — which India must comply with — does not require data exclusivity. The EU wants India to add this optional restriction on drug-safety data for the benefit of European-based drug companies, not for the benefit of India. That’s why, until now, India’s commerce and health ministries have strongly opposed it. So has Brazil, India’s closest economic cousin.

Second, gutting India’s own laws. Astonishingly, even if India’s own patent office determines that a product does not warrant patent protection, data exclusivity could be used to subvert India’s Patent Act. The act’s framers strived very hard to limit patents to truly inventive products. That’s why India’s law does not permit patents on a new drug that offers only modest revisions to an existing drug compound (for example, by altering dosage), which does nothing to enhance therapeutic benefits.

Earlier this month, for example, India rejected Abbott Laboratories’ request for a patent on its HIV drug Kaletra, because it did not consider it inventive. Kaletra is a combination of two earlier HIV medications, lopinavir and ritonavir. Now, as a result, Indian firms can proceed with production of cheaper, generic versions of this critical drug, which attacks HIV-virus mutations that have become resistant to older drugs.

Tragically, if the EU-India agreement is signed, legal decisions like this one will be meaningless. Data exclusivity will impede production of generic drugs for TB, cancer, and other chronic diseases. Unlike patents, however, data exclusivity cannot be challenged under Indian law.

The Europeans are conniving for the clause which even their own influenced WTO refuses to accept and the ramifications of this agreement will have dramatic impact on how we treat HIV patients in low-income countries. It goes to show that even if LICs have perfect policies and leadership, there are somethings that are out of their control. Until we establish some sort of economical sovereignty, we will always be forced to agree into dubious trade agreements--which are quintessential to morer poverty.

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