E-DRUG: White House Order Aims To Help Africa Get AIDS Drugs
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[2 press articles and lastly Clinton's actual decree; WB]
White House Order Aims To Help Africa Get AIDS Drugs
Dow Jones Newswires
WASHINGTON -- U.S. President Bill Clinton Wednesday issued an
executive order aimed at making drugs to fight AIDS more
accessible and more affordable for Africa.
The action "strikes the proper balance between the need of African
countries to respond to the HIV/AIDS crisis through availability of
effective drugs at affordable prices, and ensure that basic individual
property rights are protected," U.S. Trade Representative Charlene
Barshefsky told reporters after the announcement of the order.
According to the order, the U.S. will no longer seek to impose
increasingly tough standards for protection of intellectual property
rights in the area of HIV/AIDS-related drugs and medical
technology on countries in sub-Saharan Africa. Instead, the U.S.
will look only to enforce the minimum standards now imposed by
the WTO agreement on intellectual property rights, Barshefsky
said.
The executive order essentially accomplishes what a failed
amendment to the Africa and Caribbean trade bill attempted to
write into law. House debate on the bill, which passed easily last
week, was interrupted several times by angry AIDS activists
shouting protests.
"The fact that the amendment did not survive conference was
disappointing, and led the administration to issue essentially the
same policy in executive-order form," Barshefsky said. She
admitted that some members of Congress don't believe the order
strikes the right balance between protection of property rights and
helping Africa tackle its AIDS problem, but said she doesn't expect
a legal challenge.
Countries outside of Africa experiencing health-related crises can
request similar consideration regarding intellectual property rights
on a case-by-case basis. So far, only Thailand receives similar
treatment, also because of high rates of AIDS infection.
-By Elizabeth Price, Dow Jones Newswires, 202-862-9295
(Elizabeth.Price@dowjones.com)
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The Washington Post
May 11, 2000, Thursday, Final Edition
SECTION: FINANCIAL; Pg. E02
HEADLINE: Africa Gets AIDS Drug Exception; Clinton Order May
Lower Prices
BYLINE: John Burgess , Washington Post Staff Writer
President Clinton yesterday ordered that sub-Saharan Africa get
special leeway in importing or manufacturing patented drugs to
combat the devastating AIDS epidemic there.
Clinton acted following lobbying by African countries, which
contend that patent protection is cutting them off from newly
developed treatments even as the disease cuts deadly swaths
across their societies. U.S. AIDS activist groups have also pressed
for the action.
When U.S. patent laws are strictly enforced for AIDS drugs, the
result is high prices, typically $ 10,000 a year or more to treat an
AIDS patient in this country. Such sums are far out of reach for
African countries, which want to buy or make knockoff versions of
the drugs at far lower prices. Clinton's order could make it possible,
under some circumstances, for them to obtain AIDS drugs at lower
prices.
"The executive order finds the balance between protecting
intellectual property rights and also promoting accessibility of the
drugs" in Africa, said White House spokesman Joe Lockhart.
The order declared that the United States would not invoke a key
clause in U.S. trade law against sub-Saharan African countries
concerning protection of patents on AIDS drugs. It would instead
hold them to the less stringent standard of a World Trade
Organization agreement on intellectual property protection.
The Pharmaceutical Research and Manufacturers of America, the
U.S. drug industry's main trade group, criticized Clinton's order. It
sets "an undesirable and inappropriate precedent, by adopting a
discriminatory approach to intellectual property laws, and focusing
exclusively on pharmaceuticals," said President Alan F. Holmer in
a statement.
Member companies are working with African countries to combat
the disease, he said, and "continue to play an essential role in
pioneering applied research and development, our best hope of
winning the war against AIDS. Strong intellectual property
protection is the only way to encourage this research." The
industry contends that without it, it won't have the huge sums of
money needed to develop the drugs.
Paul Davis of ACT-UP Philadelphia, an activist group, welcomed
the decision. But he faulted it for only covering sub-Saharan Africa
and AIDS drugs. "There are more killers than HIV/AIDS and lots of
folks have AIDS in other countries," he said.
Last year, the White House negotiated a deal with South Africa to
exempt it on AIDS issues from the provision known as Section 301
of a 1974 trade law. Yesterday's order extends that policy to sub-
Saharan Africa as a whole, where, according to the White House,
11.5 million people have died of AIDS, about 83 percent of the
world total for the disease.
Under WTO rules that will apply to the countries, certain health
circumstances allow countries to order that certain drugs be
licensed for local use or imported from third countries.
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Executive order: Access to HIV/AIDS drugs & IP/trade issues
- THE WHITE HOUSE (May 10, 2000 - Press Secretary)
- - - - - - -
ACCESS TO HIV/AIDS PHARMACEUTICALS AND MEDICAL
TECHNOLOGIES
By the authority vested in me as President by the Constitution and
the laws of the United States of America, including sections 141
and chapter 1 of title III of the Trade Act of 1974, as amended (19
U.S.C. 2171, 2411-2420), section 307 of the Public Health Service
Act (42 U.S.C. 2421), and section 104 of the Foreign Assistance
Act of 1961, as amended (22 U.S.C. 2151b), and in accordance
with executive branch policy on health-related intellectual property
matters to promote access to essential medicines, it is hereby
ordered as follows:
Section 1. Policy. (a) In administering sections 301-310 of the
Trade Act of 1974, the United States shall not seek, through
negotiation or otherwise, the revocation or revision of any
intellectual property law or policy of a beneficiary sub-Saharan
African country, as determined by the President, that regulates
HIV/AIDS pharmaceuticals or medical technologies if the law or
policy of the country:
(1) promotes access to HIV/AIDS pharmaceuticals or medical
technologies for affected populations in that country; and
(2) provides adequate and effective intellectual property protection
consistent with the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS Agreement) referred to in
section 101(d)(15) of the Uruguay Round Agreements Act (19
U.S.C. 3511(d)(15)).
(b) The United States shall encourage all beneficiary sub-Saharan
African countries to implement policies designed to address the
underlying causes of the HIV/AIDS crisis by, among other things,
making efforts to encourage practices that will prevent further
transmission and infection and to stimulate development of the
infrastructure necessary to deliver adequate health services, and by
encouraging policies that provide an incentive for public and private
research on, and development of, vaccines and other medical
innovations that will combat the HIV/AIDS epidemic in Africa.
Sec. 2. Rationale: (a) This order finds that:
(1) since the onset of the worldwide HIV/AIDS epidemic,
approximately 34 million people living in sub-Saharan Africa have
been infected with the disease;
(2) of those infected, approximately 11.5 million have died;
(3) the deaths represent 83 percent of the total HIV/AIDS-related
deaths worldwide; and
(4) access to effective therapeutics for HIV/AIDS is determined by
issues of price, health system infrastructure for delivery, and
sustainable financing.
(b) In light of these findings, this order recognizes that:
(1) it is in the interest of the United States to take all reasonable
steps to prevent further spread of infectious disease, particularly
HIV/AIDS;
(2) there is critical need for effective incentives to develop new
pharmaceuticals, vaccines, and therapies to combat the HIV/AIDS
crisis, including effective global intellectual property standards
designed to foster pharmaceutical and medical innovation;
(3) the overriding priority for responding to the crisis of HIV/AIDS in
sub-Saharan Africa should be to improve public education and to
encourage practices that will prevent further transmission and
infection, and to stimulate development of the infrastructure
necessary to deliver adequate health care services;
(4) the United States should work with individual countries in sub-
Saharan Africa to assist them in development of effective public
education campaigns aimed at the prevention of HIV/AIDS
transmission and infection, and to improve their health care
infrastructure to promote improved access to quality health care for
their citizens in general, and particularly with respect to the
HIV/AIDS epidemic;
(5) an effective United States response to the crisis in sub-
Saharan Africa must focus in the short term on preventive programs
designed to reduce the frequency of new infections and remove the
stigma of the disease, and should place a priority on basic health
services that can be used to treat opportunistic infections, sexually
transmitted infections, and complications associated with
HIV/AIDS so as to prolong the duration and improve the quality of
life of those with the disease;
(6) an effective United States response to the crisis must also
focus on the development of HIV/AIDS vaccines to prevent the
spread of the disease;
(7) the innovative capacity of the United States in the commercial
and public pharmaceutical research sectors is unmatched in the
world, and the participation of both these sectors will be a critical
element in any successful program to respond to the HIV/AIDS
crisis in sub-Saharan Africa;
(8) the TRIPS Agreement recognizes the importance of promoting
effective and adequate protection of intellectual property rights and
the right of countries to adopt measures necessary to protect
public health;
(9) individual countries should have the ability to take measures to
address the HIV/AIDS epidemic, provided that such measures are
consistent with their international obligations; and
(10) successful initiatives will require effective partnerships and
cooperation among governments, inter-national organizations,
nongovernmental organizations, and the private sector, and greater
consideration should be given to financial, legal, and other
incentives that will promote improved prevention and treatment
actions.
Sec. 3. Scope. (a) This order prohibits the United States
Government from taking action pursuant to section 301(b) of the
Trade Act of 1974 with respect to any law or policy in beneficiary
sub-Saharan African countries that promotes access to HIV/AIDS
pharmaceuticals or medical technologies and that provides
adequate and effective intellectual property protection consistent
with the TRIPS Agreement. However, this order does not prohibit
United States Government officials from evaluating, determining, or
expressing concern about whether such a law or policy promotes
access to HIV/AIDS pharmaceuticals or medical technologies or
provides adequate and effective intellectual property protection
consistent with the TRIPS Agreement. In addition, this order does
not prohibit United States Government officials from consulting with
or otherwise discussing with sub-Saharan African governments
whether such law or policy meets the conditions set forth in
section 1(a) of this order. Moreover, this order does not prohibit the
United States Government from invoking the dispute settlement
procedures of the World Trade Organization to examine whether
any such law or policy is consistent with the Uruguay Round
Agreements, referred to in section 101(d) of the Uruguay Round
Agreements Act.
(b) This order is intended only to improve the internal management
of the executive branch and is not intended to, and does not
create, any right or benefit, substantive or procedural, enforceable
at law or equity by a party against the United States, its agencies
or instrumentalities, its officers or employees, or any other person.
WILLIAM J. CLINTON
THE WHITE HOUSE, May 10, 2000
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