PEPFAR success critically dependent on use of generic ARVs, study shows

Keith Alcorn
Estimated reading time 3 minutes
This article is more than 14 years old.

The US President’s Emergency Plan for AIDS Relief has been able to reach its target of treating 2 million with antiretrovirals in low and middle-income countries as a result of a massive switch to buying generic versions of antiretrovirals, a study in the July 21st issue of the Journal of the American Medical Association shows.

The use of generic drugs was initially resisted by some elements within the US government when PEPFAR was launched in 2003 as a result of sustained and coordinated lobbying by the pharmaceutical industry and its allies in think-tanks such as the Hudson Institute.

They attempted to undermine the credibility of generic products by raising concerns about bioequivalence and quality of generic products, arguing that the drugs would be unsafe.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

middle income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. There are around 50 lower-middle income countries (mostly in Africa and Asia) and around 60 upper-middle income countries (in Africa, Eastern Europe, Asia, Latin America and the Caribbean).

low income countries

The World Bank classifies countries according to their income: low, lower-middle, upper-middle and high. While the majority of the approximately 30 countries that are ranked as low income are in sub-Saharan Africa, many African countries including Kenya, Nigeria, South Africa and Zambia are in the middle-income brackets. 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

The US Food and Drug Administration established a tentative approval mechanism for generic antiretroviral products that allowed generic companies to file for expedited US regulatory approval for use in PEPFAR programmes. To date more than 80 products have been approved.

Products approved the FDA tentative approval process also received automatic WHO approval.

 The study released today shows that PEPFAR saved an estimated US$323,343,256 from 2005 to 2008 through the use of generic antiretroviral drugs (ARVs). 

 Among PEPFAR-supported programs in 16 countries, availability of generic ARVs was associated with increased ARV procurement and substantial estimated cost savings. While ARV expenditures increased from $116.8 million in 2005 to $202.2 million in 2008, procurement increased from 6.2 million to 22.1 million monthly packs. The proportion spent on generic ARVs increased from 9.2% in 2005 to 76.4% in 2008, and the proportion of generic packs procured increased from 14.8% in 2005 to 89.3% in 2008.

 In 2008, there were 8 PEPFAR programs that procured at least 90.0% of ARV packs in generic form, and deliveries in Ethiopia, Haiti, Namibia, Rwanda, Tanzania, and Zimbabwe were more than 99% generic.

 Procurement of generic fixed-dose combinations increased from 33.3% in 2005 to 42.7% in 2008.

 “When PEPFAR started, many doubted that it would be possible to provide antiretroviral treatment on a large scale in the low- and middle-income countries,” said Ambassador Mark Dybul, former US Global AIDS Coordinator, now at Georgetown University and the George W. Bush Institute. “The initial goal of supporting treatment for 2 million people in 5 years was met early, and generic ARVs helped to make that possible.”

 “This work is so important because we simply must gain the greatest possible value for every dollar we spend so we can save as many lives as possible, said Ambassador Eric Goosby, U.S. Global AIDS Coordinator.

 “Drugs are no longer the main driver of treatment costs, so in addition to savings from generics, the systems we’ve put into place for procurement and distribution are making efficiencies possible throughout national health systems. Our increasing efficiency is saving money that PEPFAR and the broader U.S. Global Health Initiative can use to save more lives – and that’s the bottom line.”

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