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It isn’t written anywhere that the poor should be without choice
The author would have done well to identify the pharmaceutical firms
or their countries of origin when citing WHO and other NGOs’ examples of
inappropriate drug donations. Pharmaceutical firms in the United States
follow not only WHO guidelines on a minimum shelf life of 12 months—and
often longer, but also those of its Food and Drug Administration (FDA).
In 2007, member firms which donated supplies to the Product Quality
Medicines Donation (PQMD) program followed both guidelines and contributed
$6.1 billion in products of known quality, safety and efficacy. (1)
Moreover, the supplies were in a direct response to NGOs’ expressed needs
for their projects in the developing world.
The article describes the cost of donated drugs but omits their value
to ministries of finance. PQMD donations provide governments with the
ability to use their scarce foreign exchange for much needed import
commodities, such as oil and farm machinery, rather than expending it on
the importation of drugs.
WHO has a split institutional personality when it comes to the
enforcement of drug quality, whether donated or purchased. It sits on the
Board of the Global Fund to Fight HIV/AIDS TB and Malaria, and UNITAID. In
this position of responsibility, WHO sanctions three procurement options,
one of which permits the “procurement of products not reviewed by a
regulatory authority”. (2)
Drug donations for emergencies are event forced and time limited and
shouldn’t be used to question the legitimacy of the far larger global
donation programs. For instance, the UN’s Accelerated Access Initiative,
operative since 1999, and supported by industry donations, now covers some
800,000 AIDS patients with drugs of known quality, safety and efficacy.
WHO is a founding member of this Initiative.
The unstated concern that WHO and some NGOs have with drug donations
is that they limit the procurement of copy drugs of no known regulatory
standards out of India. On behalf of UNITAID, other UN agencies, and some
NGOs, WHO recommends the drugs to be used and collects fees for managing
their procurements. (3) The presence of donated drugs from stringent
regulatory authorities and copy drugs not reviewed by a regulatory
authority compete in the same market and could provide choice to poor
patients if they were made aware of the differences. WHO issues a public
Disclaimer on these AIDS therapies: “inclusion in the list does not
constitute an endorsement, or warranty of the fitness, by WHO of any
product for a particular purpose, including in regard of its safety and/or
efficacy in the treatment of HIV/AIDS.” (4) How many poor patients know
of this Disclaimer by WHO, “the legitimate inter-governmental authority on
global health matters”? (5)
It is not immediate obvious how those who challenge drug donations
can ensure that new innovations in therapeutic medicine will continue to
benefit the poor through donations of quality products and provide them
with that essential ingredient of freedom: choice.
Sincerely,
Jeremiah Norris
Director
Center for Science in Public Policy,
Hudson Institute,
1015 15th Street, N. W.,
Washington, D. C. 20005
Notes:
1. Carol Adelman, et al., The Index of Global Philanthropy &
Remittances 2009, Hudson Institute, April 2009, Washington, D. C.
2. Global Fund, 6th Portfolio Meeting, Geneva, 22-23 February 2007, Global
Fund to Fight HIV/AIDS, TB and Malaria.
3. Memorandum of Understanding among the Federative Republic of Brazil,
the French Republic, the Republic of Chile, the Kingdom of Norway, the
United Kingdom of Great Britain and Northern Ireland, and the World Health Organization, no date, mimeo; and UNITAID: “Together in Health,
UNITAID International Drug Purchase Facility”, September 1, 2006, mimeo; and
UNITAID: Together in Health, UNITAID Constitution, September 6, 2006, mimeo.
4. Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality,
Prequalification Program, WHO, Geneva, all editions since 2003 to present.
5. Jeffrey Sachs, Chairman, Macroeconomics and Health: Investing in Health
for Economic Development, WHO, Geneva, December 20, 2001.
Competing interests:
None declared
Competing interests:
No competing interests
12 October 2009
Jerry Norris
Director of Center for Science and Public Policy Hudson Institute
Hudson Institute 1015 15th Street NW 6th Floor Washington DC 20005
It isn’t written anywhere that the poor should be without choice
It isn’t written anywhere that the poor should be without choice
The author would have done well to identify the pharmaceutical firms
or their countries of origin when citing WHO and other NGOs’ examples of
inappropriate drug donations. Pharmaceutical firms in the United States
follow not only WHO guidelines on a minimum shelf life of 12 months—and
often longer, but also those of its Food and Drug Administration (FDA).
In 2007, member firms which donated supplies to the Product Quality
Medicines Donation (PQMD) program followed both guidelines and contributed
$6.1 billion in products of known quality, safety and efficacy. (1)
Moreover, the supplies were in a direct response to NGOs’ expressed needs
for their projects in the developing world.
The article describes the cost of donated drugs but omits their value
to ministries of finance. PQMD donations provide governments with the
ability to use their scarce foreign exchange for much needed import
commodities, such as oil and farm machinery, rather than expending it on
the importation of drugs.
WHO has a split institutional personality when it comes to the
enforcement of drug quality, whether donated or purchased. It sits on the
Board of the Global Fund to Fight HIV/AIDS TB and Malaria, and UNITAID. In
this position of responsibility, WHO sanctions three procurement options,
one of which permits the “procurement of products not reviewed by a
regulatory authority”. (2)
Drug donations for emergencies are event forced and time limited and
shouldn’t be used to question the legitimacy of the far larger global
donation programs. For instance, the UN’s Accelerated Access Initiative,
operative since 1999, and supported by industry donations, now covers some
800,000 AIDS patients with drugs of known quality, safety and efficacy.
WHO is a founding member of this Initiative.
The unstated concern that WHO and some NGOs have with drug donations
is that they limit the procurement of copy drugs of no known regulatory
standards out of India. On behalf of UNITAID, other UN agencies, and some
NGOs, WHO recommends the drugs to be used and collects fees for managing
their procurements. (3) The presence of donated drugs from stringent
regulatory authorities and copy drugs not reviewed by a regulatory
authority compete in the same market and could provide choice to poor
patients if they were made aware of the differences. WHO issues a public
Disclaimer on these AIDS therapies: “inclusion in the list does not
constitute an endorsement, or warranty of the fitness, by WHO of any
product for a particular purpose, including in regard of its safety and/or
efficacy in the treatment of HIV/AIDS.” (4) How many poor patients know
of this Disclaimer by WHO, “the legitimate inter-governmental authority on
global health matters”? (5)
It is not immediate obvious how those who challenge drug donations
can ensure that new innovations in therapeutic medicine will continue to
benefit the poor through donations of quality products and provide them
with that essential ingredient of freedom: choice.
Sincerely,
Jeremiah Norris
Director
Center for Science in Public Policy,
Hudson Institute,
1015 15th Street, N. W.,
Washington, D. C. 20005
Notes:
1. Carol Adelman, et al., The Index of Global Philanthropy &
Remittances 2009, Hudson Institute, April 2009, Washington, D. C.
2. Global Fund, 6th Portfolio Meeting, Geneva, 22-23 February 2007, Global
Fund to Fight HIV/AIDS, TB and Malaria.
3. Memorandum of Understanding among the Federative Republic of Brazil,
the French Republic, the Republic of Chile, the Kingdom of Norway, the
United Kingdom of Great Britain and Northern Ireland, and the World Health Organization, no date, mimeo; and UNITAID: “Together in Health,
UNITAID International Drug Purchase Facility”, September 1, 2006, mimeo; and
UNITAID: Together in Health, UNITAID Constitution, September 6, 2006, mimeo.
4. Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality,
Prequalification Program, WHO, Geneva, all editions since 2003 to present.
5. Jeffrey Sachs, Chairman, Macroeconomics and Health: Investing in Health
for Economic Development, WHO, Geneva, December 20, 2001.
Competing interests:
None declared
Competing interests: No competing interests