American Foundation for AIDS Research, November 2003
Daniel Raymond

As demand for HIV treatment in the developing world grows, all eyes are on Dr. Jong-Wook Lee, the new Director-General of the World Health Organization (WHO) and former director of WHO’s Stop TB department. The WHO strategy for scaling up HIV therapy to reach 3 million people draws upon the lessons of TB control, with a number of TB experts advising Dr. Lee. In July 2003, Lee’s team announced plans to create a system to help countries buy and distribute HIV drugs modeled after the Global TB Drug Facility—a move with far-reaching implications for generic antiretrovirals.

Widely hailed as a success, the Global Drug Facility (GDF) has provided free drugs to about 2 million people since its 2001 launch, with a target of 10 million by 2005. Through pooled procurement—several buyers negotiating collectively in order to extract higher discounts—the GDF has made a significant dent in the cost of first-line TB drugs. Using competitive bidding processes, average drug prices for a standard six-month course of treatment have fallen by 30%, to under $10 per patient.

Would this model work for HIV drugs? An April 2003 evaluation of the GDF conducted by McKinsey & Company made a strong case for extending the pooled procurement strategy to antiretrovirals. The potential for cost savings provides the major incentive, but a GDF-type system would also promote “rational” drug use. Rational drug use means simple, standardized treatment regimens—ideally fixed-dose combinations of two or more drugs in a single pill—that are easy to prescribe, easy to take, and minimize the risk of drug resistance. Resistance can result from suboptimal therapy due to poor quality assurance controls for drugs, interruptions in drug access, and improperly prescribed regimens. Pooled procurement enables the GDF to monitor the quality of TB drugs, assure a steady supply, and promote the adoption of a standard first-line regimen using a fixed-dose combination.

These benefits have garnered enthusiasm for the concept of a global procurement system for antiretrovirals from leading TB experts familiar with the demands of HIV therapy. Dr. Anthony Harries of Malawi’s National TB Control Programme argues, “We need standardized regimens in poor countries and the more standardization between countries the better.” Recent negotiations between a bloc of 10 Latin American countries and drug manufacturers, both brand-name and generic, achieved significant cost savings. On a smaller scale, pooled procurement systems are already taking shape through the Generic Antiretroviral Procurement Project, UNICEF, and the International Dispensary Association.

A global pooled procurement scheme for HIV drugs faces several hurdles. As Médecins Sans Frontières’ Ellen ’t Hoen notes, “It’s not just about markets and prices.” Each country has a regulatory body, like the Food and Drug Administration, governing which drugs can enter the country based on quality and manufacturing practices. But the standards and resources of regulatory agencies can vary widely, so a drug acceptable in one country would be considered substandard in another. Pooled procurement works best with the widest possible range of qualified suppliers—for HIV drugs this may require harmonizing national regulatory requirements and drawing upon WHO’s list of prequalified antiretrovirals, which includes some generics. Intellectual property issues pose further obstacles, especially for promoting standardized fixed-dose combinations like the three-in-one pills produced by Thailand and Indian company Cipla that contain lamivudine (3TC), stavudine (d4T), and nevirapine.

WHO will not release its pooled procurement plan until December. In the meantime, Dr. Lee’s team will be forced to make some tough decisions. Who will control procurement, and what is WHO’s role? How will intellectual property and regulatory issues be coordinated and resolved? Should the use of some antiretrovirals or combinations be restricted? The GDF only provides first-line TB drugs; for access to the second-line drugs used to treat multi-drug resistant TB, countries need to meet the stringent requirements of another group called the Green Light Committee.

Regardless of the mechanism for antiretroviral procurement, the recent history of TB control efforts offers hope for HIV treatment access. The GDF demonstrates that the availability of drugs can crystallize demand for effective treatment, mobilizing resources and strengthening government commitment. If the GDF can provide treatment for 10 million people by 2005, the goal of antiretroviral access for 3 million starts to look more attainable.

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