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Generic ARV Drugs
Generic antiretroviral drugs
A generic drug is an identical copy (bioequivalent) of a brand name (or proprietary) drug. Generics are exactly the same as their branded counterparts in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. The notable difference between the two is the price of the antiretroviral drug.
Generic antiretrovirals (ARVs) are now widely used to increase access to HIV treatment in the developing world. They have been integrated into many treatment programmes including PEPFAR - the President's Emergency Plan for AIDS Relief. PEPFAR, the single greatest supporter of treatment provision for HIV and AIDS in the developing world, began to distribute generic drugs through its programmes in 2004-2005. Generics now account for 98 percent of the drugs procured and supplied through PEPFAR's Supply Chain Management System (SCMS), which provides antiretroviral drugs to sixteen PEPFAR supported countries.1
From 2005-2008, generic ARVs allowed PEPFAR to significantly scale up its procurement of ARV drugs, without a commensurate increase in its spending on ARVs. Over this period, the increase in the proportion spent on generics by PEPFAR from 9.2 percent to 76.4 percent resulted in more than $300 million in cost savings.2
Generic drug manufacturers vs pharmaceutical industries
Generic drug manufacturers incur fewer costs in creating the generic drug, as they do not have to cover the expense of drug discovery and development, or lengthy safety and efficacy trials. Instead generic makers reverse-engineer known drug compounds. This means that generic manufacturers are able to maintain profitability while offering the drug at a much lower cost.
This is problematic for pharmaceutical companies who argue that generic copying reduces their profits and decreases the amount of money they can spend on researching and developing new antiretroviral drugs. In order for the proprietary drug makers to recoup the money they spent on drug creation, they are granted a ‘patent’ (an intellectual property right), which is an exclusive right that prevents others from making, using, selling, offering to sell, or importing their drug. The patent typically lasts for twenty years.
Legislation in favour of the pharmaceutical industries’ right to patent their drugs - TRIPS - was introduced in 1995. TRIPS (The Agreement on Trade Related Aspects of Intellectual Property Rights) introduced intellectual property law into the international trading system for the first time and applies to all members of the World Trade Organization (WTO). Because the implementation of TRIPS was to have a huge impact on generic drug production, the majority of developing countries were given a ten-year transition period in which to comply. This means that developing countries (such as India) were able to continue developing generic drugs until 2005, whilst least developed countries have until 2016.
- 1. PEPFAR(2011, April)Statement of Ambassador Eric Goosby, MD, US Global AIDS Coordinator, US Department of State, Before the US Senate Committee on Foreign Relations, Subcommittee on African Affairs
- 2. Holmes, MD, MPH, Charles B. et. al(2010, July)Use of Generic Antiretroviral Agents and Cost Savings in PEPFAR Treatment ProgramsJournal of the American Medical Association 304(3)