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PAHO/WHO celebrates the Approval of the 100th Anti-Retroviral Drug Authorization in Association with the U.S. Presidentís Emergency Program for AIDS Relief PEPFAR/FDA

"WE KEEP THE PROMISE in this long battle against HIV"

Washington, D.C. PAHO HQ.
October 6, 2009..

PAHO Director welcoming remarks
*Dr. Mirta Roses Periago.

Good morning Ambassadors and distinguished guests,

More than four million people in low- and middle-income countries now have access to antiretroviral treatment, up from about three million as of December 2007, the goal set up by Dr. J.W. Lee by 2005 (3 by 5). This represents an increase of 36% in one year and a tenfold increase over five years. In Latin America and the Caribbean, the numbers of persons estimated to be receiving antiretroviral therapy has increased from 390,000 to 445,000, an estimated increase of 55,000 persons in 2008 compared to 2007 following the heads of government commitment at the Summit of the Americas in 2005. This is an impressive response from our health systems as countries mobilize to provide services to facilitate comprehensive care and treatment of patients including antiretroviral therapy. Despite considerable progress, global coverage of antiretroviral therapy remains low: in 2008, only 42% of those in need of treatment were able to access it, compared to 33% in 2007.

The vast majority of adults, more than 90%, on antiretroviral treatment are receiving first-line treatment regimes. Access to anti-retrovirals used in first line treatments therefore remains a critical issue, not only to ensure sustainability in treatment, but also to continue expanding treatment. Prices of most first-line antiretroviral drugs decreased globally by 10-40% between 2006 and 2008, and many comprehensive first line treatments are now available for under US$ 200 for adults and US$ 150 for children per year. These prices are quite remarkable, when we take into consideration that not so long ago, around the turn of the millennium, governments needed to allocate up to US$ 10,000 per patient to provide ARV triple therapy! The reductions in prices that we have observed in the global antirretroviral market can be partly attributed to massive increases in financing for antiretroviral therapy through global initiatives such as projects financed by the Global Fund and PEPFAR. This support, has provided the necessary guarantees for the antiretroviral pharmaceutical market to develop the capacity and sustainability in both active pharmaceutical ingredient and finished product capacity.

While recognizing the impact of manufacturing capacity, advocacy and financing on access to antiretroviral therapy, we acknowledge the key role played by the availability of generic medicines of proven quality, safety and efficacy; generic medicines that have been assessed by the WHO prequalification program for priority medicines, or the PEPFAR - FDA expedited review process for antiretroviral therapies for use in PEPFAR focus countries.

In 2004, we received a letter jointly signed by Sens. Ted Kennedy and John McCain requesting information on the use, availability and cost of generic antiretroviral drugs.

The Prequalification Program, set up in 2001, is a service provided by the World Health Organization (WHO) to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis. From the outset, the Program which provides independent assessments of the quality safety and efficacy of medicines including antiretroviral drugs has been supported by the UN system - UNAIDS, UNICEF, UNFPA - as well as the World Bank as a concrete contribution to the United Nations priority goal of addressing widespread diseases in countries with limited access to quality medicines.

That PEPFAR/FDA have now assessed and approved more than 100 antiretroviral drugs for use by PEPFAR focus countries and Global Fund financed HIV/AIDS projects, is a testimony to the enormous effort that has been made to expand treatment to patients in need, to increase the availability of affordable essential medicines for HIV/AIDS national programs, and to ensure principles of quality, safety and efficacy in the medicines that are being provided through globally financed HIV/AIDs initiatives. Medicines assessed against global and other reference norms, facilitate the work of national regulatory authorities in the assessment of product dossiers, and in ensuring the quality of medicines that they are providing through national treatment programs. In addition, PAHO recognizes that national regulatory authorities for medicines must continue to be strengthened, for they retain sole authority for assessing quality and authorizing the antiretroviral medicines for use at the national level. PAHO continues to work with the FDA and other regulatory agencies and authorities in the Region, to strengthen regulatory capacity through PANDRH, the Pan American Network for Drug Regulatory Harmonization, which produces common guidelines and technical norms to ensure the quality, safety and efficacy of medicines in PAHO Member States.

PAHO Strategic Fund, a procurement and supply management mechanism established to support countries in improving access to strategic public health supplies uses the principle of WHO prequalification and the PEPFAR/FDA tentative approval process for HIV/AIDS drugs, as a basis for selecting qualified suppliers. In the last three years, PAHO has supplied more than US$ 30 million HIV/AIDS antiretroviral drugs through the mechanism to more than 10 countries in the Region. Joint negotiations with providers started in June 2002 in the Caribbean and in June 2003 in the Andean Countries with PAHO and ORAS-CONHU support. The Clinton Foundation provided technical support jointly with PAHO. The Fund mechanism has been instrumental in ensuring sustainability in treatment costs, as countries continue to expand antiretroviral therapy: countries such as Ecuador and Guatemala have reported cost savings in the order of 50% through the Fund, while at the same time ensuring the availability of quality generic medicines in first line treatment regimes. Antiretroviral therapy is however a life-long intervention, and more and more countries will be faced with the difficult challenge in the future of moving patients from basic first line antiretroviral therapies, to more complex second line treatment regimes. This represents a challenge since second line antiretroviral medicines are least 10 times more expensive than first line ones!

As national treatment programs move patients from first to second line, treatment costs will explode, and in many cases such costs will be unsustainable for national governments. We need to urgently and actively implement strategies to promote greater affordability of both first and second line HIVAIDS antiretrovirals, through increased production and technological innovation, through the establishment of intellectual property frameworks and novel financing mechanisms that stimulate such innovation and facilitate production of essential generic medicines. But nothing would be achieved only with good and affordable drugs in the fight against HIV if we do not strengthen health systems based on PHC and deploy trained staff that are capable, are free from stigma and discrimination and reach out to the highest risk groups in the community. As we ensure that we have the supplies to care for the sick, we must also redouble efforts for prevention and changes in risk behaviors. All this is part of the comprehensive package of prevention, treatment and care that will demonstrate that WE KEEP THE PROMISE in this long battle against HIV.


Event photogallery.


More information:

- WHO Director-General Video Remarks

- PEPFAR Web site: http://www.pepfar.gov

- FDA Release: FDA Marks 100th HIV/AIDS Drug Authorized For Purchase Under PEPFAR

The U.S. Department of Health and Human Services (HHS) today marked the recent approval of the 100th antiretroviral drug in association with the Presidentís Emergency Plan for AIDS Relief (PEPFAR), aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS worldwide.

The PEPFAR program is a cooperative effort that involves the Food and Drug Administration (FDA) and other HHS agencies, the State Departmentís Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many other international partners.

ďThis milestone exemplifies the dedication, caring, and hard work of all who strive to better the lives of those infected with or affected by HIV/AIDS,Ē said HHS Secretary Kathleen Sebelius.


Event organized by PAHO/WHO with the U.S. Food and Drug Administration (FDA) to commemorate the approval of the 100th antiretroviral drug for use in a program aimed at the prevention, treatment, and care of people infected with and affected by HIV/AIDS in more than 30 economically disadvantaged countries in support of PEPFAR.

Honored guests included Ambassador Eric Goosby, U.S. Global AIDS Coordinator, the Ambassadors to the United States from Haiti and Tanzania, the U.S. Commissioner of Food & Drugs, and the U.S. Department of Health & Human Services (HHS), Dr. Margaret Hamburg; and a video message from the Director General of WHO, Dr. Margaret Chan.