Bush accused of blocking access to cheap AIDS drugs
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《英国医生杂志》
London
International health charities have accused George Bush's administration of trying to block developing countries' access to cheap AIDS drugs by questioning the quality of "three in one" generic combination drugs.
At a meeting this week in Gaborone, Botswana, the US global AIDS coordinator, Randall Tobias, said that the World Health Organization's drug pre-qualification programme is not a sufficiently stringent approval process to ensure consistency and quality of fixed dose combination drugs.
He told delegates from national drug regulatory agencies, the pharmaceutical industry, and non-governmental organisations that the United States was unwilling to spend the ￡8bn ($15bn; 12bn) promised in the presidential emergency plan for AIDS relief (PEPFAR) on drugs of unknown quality.
Médecins Sans Frontières and other non-governmental organisations working with AIDS patients in Africa accused the US government of trying to escape the 2001 Doha agreement on affordable drugs by the side door ( BMJ 2001;323: 1146). The objections raised by Tobias also threaten implementation of the World Trade Organisation's August 2003 agreement that specifies how countries with limited or no capacity to manufacture drugs can gain access to cheaper generic medicines ( BMJ 2003;327: 517).
Sharonann Lynch of the charity Health Gap said the US government is trying to ensure that the money from the US AIDS relief plan goes to brandname manufacturers. "These objections make no sense. The generic drugs are bioequivalent compounds, and the WHO pre-qualification process uses staff from Canadian and European regulatory bodies that the US recognises."
The cheapest generic combination pills cost about ￡77 per person per year under a price agreement negotiated with manufacturers by former US president Bill Clinton. The same combination from brandname companies costs about ￡310 per person per year.
Addressing Congress on 18 March, Mr Tobias, a former chief executive of Eli Lilly, said the US government's objections were motivated by concern for the safety of patients with AIDS. "We have been reading stories lately about some problems with some drugs around the world where people with the best of intentions have made acquisitions of drugs that have turned out to not have the consistency, safety, and effectiveness that people had hoped."(Owen Dyer)
International health charities have accused George Bush's administration of trying to block developing countries' access to cheap AIDS drugs by questioning the quality of "three in one" generic combination drugs.
At a meeting this week in Gaborone, Botswana, the US global AIDS coordinator, Randall Tobias, said that the World Health Organization's drug pre-qualification programme is not a sufficiently stringent approval process to ensure consistency and quality of fixed dose combination drugs.
He told delegates from national drug regulatory agencies, the pharmaceutical industry, and non-governmental organisations that the United States was unwilling to spend the ￡8bn ($15bn; 12bn) promised in the presidential emergency plan for AIDS relief (PEPFAR) on drugs of unknown quality.
Médecins Sans Frontières and other non-governmental organisations working with AIDS patients in Africa accused the US government of trying to escape the 2001 Doha agreement on affordable drugs by the side door ( BMJ 2001;323: 1146). The objections raised by Tobias also threaten implementation of the World Trade Organisation's August 2003 agreement that specifies how countries with limited or no capacity to manufacture drugs can gain access to cheaper generic medicines ( BMJ 2003;327: 517).
Sharonann Lynch of the charity Health Gap said the US government is trying to ensure that the money from the US AIDS relief plan goes to brandname manufacturers. "These objections make no sense. The generic drugs are bioequivalent compounds, and the WHO pre-qualification process uses staff from Canadian and European regulatory bodies that the US recognises."
The cheapest generic combination pills cost about ￡77 per person per year under a price agreement negotiated with manufacturers by former US president Bill Clinton. The same combination from brandname companies costs about ￡310 per person per year.
Addressing Congress on 18 March, Mr Tobias, a former chief executive of Eli Lilly, said the US government's objections were motivated by concern for the safety of patients with AIDS. "We have been reading stories lately about some problems with some drugs around the world where people with the best of intentions have made acquisitions of drugs that have turned out to not have the consistency, safety, and effectiveness that people had hoped."(Owen Dyer)