MSF second letter to Merck regarding efavirenz 600mg

Jeffrey L. Sturchio
Vice President, External Affairs
Europe, Middle East & Africa, Human Health

Dear Jeff,

Thank you for your letter of March 8, 2004. We appreciate your effort to provide additional information.

However, your letter fails to adequately respond to the two main points MSF originally addressed: lowering the price of the EFV 200mg formulation and speeding up registration of EFV 600mg in developing countries. We were hoping for a change of Merck policy as well explanations of the cases in specific countries.

First, we still believe there is a strong argument for lowering the price of the 200mg formulation. Merck and its marketing partners charge the same price for both the 600mg and 200mg formulations in the US and in Europe: the price of three 200mg tablets equals the price of one 600mg capsule. Your failure to provide price parity in developing countries is a double standard.

Second, we are well aware of the circumstances in which MSF receives special import authorizations and other mechanisms to use EFV 600mg. However, special authorizations, pre-licensed sales, agreements with MSF via ministry of health approval, or temporary import licenses do not give access to the vast majority of patients where we work.

Further, MSF is not only concerned about access to EFV in the countries in which we provide antiretroviral therapy (ART), but rather all countries where people living with HIV/AIDS need access to EFV. There are 55 countries that are considered “low HDI or medium HDI with adult HIV prevalence of 1% or greater,” 38 of which are in sub-Saharan Africa. You have informed us of only four sub-Saharan African countries (Burkina Faso, Cameroon, Guinea and Rwanda) where EFV 600mg is fully registered.

We cannot simply accept that the main obstacle to registration of EFV 600mg is bureaucratic delay. While this may be the case in some countries, we know, for example, from the Merck Sharpe and Dohme Product Manager in South Africa that although Merck filed for registration of EFV 600mg in October 2003, it did not complete the product dossier until November 2003, over one year after the announced price reduction. This, along with additional information from our field teams in other countries, leads us to believe there are other similar cases where Merck is indeed largely responsible for registration delays. In the particular case of South Africa, we nonetheless agree that at this point in time the responsibility for approval lies with the Medicines Control Council (MCC).

We again ask you to:

1. Immediately lower the price of the 200mg capsule to $0.32;
    
2. Take all necessary steps to register the EFV 600mg tablet in developing countries and publicly report on the status of registration on a monthly basis.

We look forward to hearing from you promptly.

Sincerely,

Daniel Berman
Coordinator Advocacy & Communications
Access to Essential Medicines Campaign, Médecins Sans Frontières