US will only fund approved drugs for HIV treatment here -official By Oluatoyin Alleyne in Zambia
Stabroek News
November 29, 2006

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Guyana's HIV treatment programme faces a major challenge next year as the US will not allow its funds to purchase drugs from entities not certified by the US Food and Drug Administration (FDA) to produce anti-retrovirals (ARVs).

Guyana's drugs are currently sourced from the New Guyana Pharmaceutical Cor-poration (New GPC) which is not FDA-certified.

Ambassador Jimmy Kolker, Deputy US Global AIDS Coordinator and Direc-tor of Diplomatic Outreach, told Stabroek News during a videoconference yesterday, that it has been decided that from 2007 no drugs will be purchased with the use of US funds unless those drugs are approved by the US Food and Drug Administration (FDA).

"Our policy is that only FDA-approved drugs are to be used under the PEPFAR programme," the ambassador told Stabroek News.

He said that it is not just that they want to use drugs that are approved by America but they want to ensure that the people in other countries who are receiving US assistance are receiving the same level of treatment as Americans.

At the moment Guyana purchases its ARVs with money from the US Presi-dent's Emergency Prevention Fund for AIDS Relief (PEPFAR) to distribute freely to HIV and AIDS affected persons.

Ambassador Kolker's videoconference which was conducted from his Washington office and via the United States Information Service in Zambia was facilitated by Public Affairs Officer of the US Embassy in Lusaka, Christopher Wurst.

Some 35 journalists from 13 of the 15 PEPFAR focus countries at a workshop on editorial leadership in HIV/AIDS reporting in Zambia attended the videoconference.

Responding to a question from Stabroek News in relation to the bioequivalency test required by the WHO for all generically produced antiretroviral drugs, Ambassador Kolker said unequivocally that come next year, US government funds would not be used to buy any drug which was not FDA approved. This was because, the ambassador said, the US wanted to be sure that the drugs given to people living with HIV were of the highest quality. He cited instances where fake drugs had been manufactured and sold to sick people noting the devastating effect this could have on lives.

He pointed out that at the moment there are over 3,000 generic drugs on the market and some of the companies may soon go out of business because US government funds would not be used to buy from them. He said PEPFAR would have no problem with where the drugs are bought as long as they are certified by the FDA.

The issue of bioequivalence and certification of anti-retrovirals in Guyana has been on the cards for some time now.

The Guyana Government has been asked by donors, specifically the Global Fund, to ensure that the ARVs produced in Guyana met the standard set by the WHO. Only a few weeks ago the new UNAIDS Country representative in Guyana when asked about the issue told Stabroek News: "If there is a lot of money available in the country for HIV, I think getting [the drug's] accreditation even if it is expensive it is a cost that is worth paying for it."

The issue of locally manufactured drugs undergoing bioequivalence studies also arose at last June's United Nations General Assembly Special Session on HIV/AIDS (UNGASS+5) in New York; Health Minister Dr Leslie Ramsammy had touched on it during his address to the assembly.

Guyana manufactures generic antiretroviral drugs, which should contain the same active substances as original brand name ARV drugs. A key element for a generic drug is establishing bioequivalence, which means that the drug when evaluated must produce essentially the same biological availability of the active substance in the body when given in the same quantity as the original.

The Global Fund to fight HIV/AIDS, Tuberculosis and Malaria has set such approval as a condition for its financing of the purchase of ARVs.

The implications are that Guyana would have to source its ARVs from Brazil, as the Organisation of Eastern Caribbean States now does, or another state, which produces generic FDA-approved drugs as it would be unable to afford the branded ARVs.

In September 2005, Stabroek News spoke with Minister Ramsammy and Dr Ranjisinghi Ramroop of the New GPC about the local drugs and whether bioequivalence studies were going to be done.

Ramsammy said then that government was not prepared to adhere to this condition as it would be too costly - around US$4M per drug. He attributed this to the high cost of the process, adding that he was aware of the stipulations that some funding comes with. Ramsammy had added that as far as he knew no demands were being made.