Merck breaks promise to reduce AIDS drug price in developing countries

MSF calls for immediate action to reduce price and register Efavirenz.
To date, Merck has not registered this easy-to-use formulation in low- and middle-income countries hardest hit by HIV/AIDS, including South Africa, Malawi, and Nigeria.
New York/Geneva - More than 16 months after the multinational pharmaceutical company Merck & Co. announced that it would reduce the price of its first-line AIDS drug Stocrin (efavirenz, EFV) to less than $1-per-day in developing countries, the offer has failed to materialize, according to the international medical humanitarian organization Médecins Sans Frontières (MSF). EFV is among the antiretrovirals recommended by the World Health Organization for first-line treatment, and is a critical component of antiretroviral combination therapy, particularly for patients co-infected with HIV and tuberculosis (TB). Drug price offers have no meaning unless they are followed by swift registration of the drug in the countries where the offer is made. The 600mg tablet formulation of EFV allows patients to take one tablet instead of three 200mg capsules per day. To date, Merck has not registered this easy-to-use formulation in low- and middle-income countries hardest hit by HIV/AIDS, including South Africa, Malawi, and Nigeria, so the drug is not available to patients there. The company has also failed to reduce the price of the 200mg formulation of the drug, which is widely available. Merck has refused to offer developing countries the same price for a daily dose of EFV whether they are taking three 200mg capsules or one 600mg tablet, although people living with HIV/AIDS in the US and Europe pay the same price regardless of which formulation they use. As a result, people with HIV/AIDS in developing countries who need to take EFV are obliged to take three 200mg capsules at a cost of 44 percent more than the price announced by Merck. MSF is demanding that Merck immediately lower the price of the 200mg capsule of EFV to $0.32, so that the real price of the drug will be, as advertised, $0.95 per day. MSF is also urging Merck to take all steps necessary to register the 600mg formulation of EFV, as promised, in developing countries. "They have misled us, and the result for patients is unacceptable. We have been waiting for almost a year and a half since this announcement to be able to give our patients with HIV and TB the once-a-day formulation of EFV that will make their lives easier and lead to better adherence. We are tired of waiting," said Dr. Eric Goemaere, head of mission for MSF in South Africa. "The real problem is that there is virtually no generic competition for EFV, so Merck gets away with charging what it wants and delaying registration. Because of the high prevalence of TB among HIV positive people in South Africa, we have no alternative but to use this drug, but it is three times more expensive than the other first-line drug of this class, which is available generically." Merck's offer was announced as the company and its marketing partners were launching the 600mg formulation in the U.S. and Europe. "It appears Merck's announcement was really about gaining attention and expanding their market in wealthy countries," stated Ellen 't Hoen, director of MSF's Campaign for Access to Essential Medicines. "Had Merck been serious about making EFV more widely available in developing countries, it would have not only registered the EFV 600mg tablet directly following its announcement, but also immediately lowered the price of the 200mg formulation. We urge Merck to come clean and immediately lower the price of the 200 mg formulation, which is widely available." Note: In October 2002, Merck announced a price reduction for the 600mg formulation of EFV, bringing the price down to $346.75 per person per year ($0.95 per unit). The Merck communication at the time claimed that this price would be valid for low Human Development Index (HDI) countries plus medium HDI countries with adult HIV prevalence of 1% or greater. For medium HDI countries with adult HIV prevalence less than 1%, the price of the 600mg was announced as $767 per person per year ($2.10 per unit). MSF provides antiretroviral therapy for over 11,000 people with HIV/AIDS in over 20 countries in Africa, Asia, Latin America, and Eastern Europe.