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Note: This document is from the archive of the Africa Policy E-Journal, published
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Africa: Right to Health
Africa: Right to Health
Date distributed (ymd): 011110
Document reposted by APIC
Africa Policy Electronic Distribution List: an information
service provided by AFRICA ACTION (incorporating the Africa
Policy Information Center, The Africa Fund, and the American
Committee on Africa). Find more information for action for
Africa at http://www.africapolicy.org
Note: For more recent posting with TAC statement, see
http://www.africafocus.org/docs01/acc0111b.php>
+++++++++++++++++++++Document Profile+++++++++++++++++++++
Region: Continent-Wide
Issue Areas: +political/rights+ +economy/development+
SUMMARY CONTENTS:
This posting contains three new documents relating to the conflict
between public health and the hard-line on intellectual property
rights being pushed at the World Trade Organization by the U.S.,
Canada, Switzerland, and a few other rich countries. They are: (1)
a editorial from today's issue of the prominent medical journal The
Lancet, (2) a press release from Human Rights Watch, and (3)
excerpt from a letter from access rights expert James Love of the
Consumer Project on Technology.
It is preceded by a brief cover note from Africa Action executive
director Salih Booker.
For additional background see:
http://www.africapolicy.org/action/access.htm
An archive of postings with new information daily can be found
at: http://lists.essential.org/mailman/listinfo/ip-health
A new comprehensive 80-page background paper on TRIPS and Rights,
just released last week by the Canadian HIV/AIDS Legal Network,
is available at
http://aidslaw.ca/Maincontent/issues/cts/TRIPS-brief.htm
+++++++++++++++++end profile++++++++++++++++++++++++++++++
Cover Note from Africa Action
Press reports say the conflict between public health and the
pharmaceutical industry's grab for excessive profits may be the
deal-breaker at WTO talks now underway in Doha. The New York Times
this morning, in a news article reflecting the views of U.S. trade
representative Robert Zoellick, outlines Zoellick's strategy of
"driving a wedge between them [African countries] and India and
Brazil." Germany and Japan, as well as the U.S., Switzerland and
Canada, are reported to be still resisting the demand for a
declaration that in emergencies public health should take
precedence over patent protection.
Yet the drug companies and rich country governments are losing the
battle for public opinion. While the Washington Post in a November
1 editorial echoed Zoellick's views and said his concessions should
"silence the controversy," editorials in other leading papers in
New York, San Francisco, Boston, Philadelphia and other cities have
cited the anthrax alarm and continuing deaths from AIDS as reasons
for the U.S. to concede the priority for public health over
patents. The developing country position is supported not only by
activists long engaged in this struggle, but by mainstream medical
and human rights opinion (as indicated by the documents below).
Even the World Bank is urging that the WTO "must ensure that rules
protecting intellectual property don't keep poor countries from
producing or importing cheap drugs to fight AIDS and other
pandemics." (Bloomberg News/Boston Globe, November 7).
The bankruptcy of the administration position is apparent in its
strategy of "splitting" the South. If U.S. officials were truly
interested in saving the more than 6,000 Africans and 2,000 others
dying each day of AIDS, they would not be fighting Brazil and
India. Instead they would be joining with Brazil, India, African
countries, and others to maximize cooperation in getting treatment
to those who need it now. They would be pressuring for the lowest
possible prices, with even more urgency than they have pressed for
lower prices for Cipro. And they would be providing financial
resources that were adequate, rather than the token amounts offered
to date.
-- Salih Booker
The Lancet
http://www.lancet.com
(selected full-text articles available free with registration)
Volume358, Number 9293 10 November 2001
Editorial
Patent protection versus public health
On October 24,Tommy Thompson, Secretary of the US Department of
Health and Human Services, and Helge Wehmeier, president of the
Bayer Corporation, announced the federal purchase of 100
million tablets of ciprofloxacin (Bayer's Cipro) at half price.
This emergency price cut was agreed after the US government
threatened to override Bayer's patent on Cipro. The US
government's action was sparked by the Canadian health
ministry's decision to commission a local drug company to make
ciprofloxacin, violating Bayer's patent rights. Bayer responded
by donating a large amount of Cipro to Canada, and promising
more in the event of an emergency, which led the Canadian
government to agree to acquire ciprofloxacin exclusively from
Bayer for the duration of the patent agreement.
No new anthrax cases have been reported in Canada, yet the
threat to public health was deemed enough for the Canadian
government to challenge Bayer's patent rights. Events in the
USA after September 11 have proven the bioterrorist threat to be
real with documented cases of anthrax, but it is hard to justify
the need for patent challenge on public-health emergency
grounds, especially because the anthrax isolates seem to be
sensitive to doxycycline.
Bayer's patent for Cipro is protected by the Trade-Related
Aspects of Intellectual Property Rights (TRIPS) agreement,
which sets minimum standards of patent law for member states
of the World Trade Organisation. Under TRIPS, patent
protection lasts for 20 years, although compulsory licensing
(production of medicines by companies other than the patent
holder) is allowed in public-health emergencies or where there
are unfair pricing practices. The US government's action on
Cipro is in stark contrast to US trade pressure on less-developed
countries to limit compulsory licensing and parallel importing
(importing of medicines from countries other than the country of
manufacture). Parallel importing is also allowed under TRIPS,
and is, like compulsory licensing, widely practised by western
countries.
Even where there is clear evidence of a public-health
emergency, such as the HIV crisis in Africa and many parts of
Asia, the US government has used its might to limit those
countries' options to provide affordable drugs. For example, in
1998, under threat from the USA to increase tariffs on imports
of wood products and jewellery, the Thai government limited the
right to issue compulsory licences for pharmaceuticals. Last
year, the US government filed a complaint with the World Trade
Organisation over a law that enabled Brazil to produce cheap
generic versions of antiretroviral drugs, stating that Brazil's
patent law broke the TRIPS agreement. The number of
AIDS-related deaths in Brazil has halved since 1995, partly due
to the availability of cheap antiretroviral drugs. In June of this
year, the US government retracted its complaint, after outcry
from international aid agencies. In April, after a 3-year lawsuit,
the Pharmaceutical Manufacturers Association of South Africa
and 39 international drug companies dropped action to prevent
the South African government from importing cheaper drugs for
HIV and AIDS. TRIPS allows such imports but it took this case
to prove that the AIDS epidemic, which has now affected more
than 58 million people worldwide, killing 22 million, is of
sufficient proportion to warrant recognition as a public-health
emergency in TRIPS terms.
Clarification of and changes to the TRIPS agreement to favour
public-health needs over patent protection are urgently needed and
have been called for by aid agencies and less-developed countries
on the eve of the World Trade Organisation summit to take place in
Qatar on November 9-13. So far, however, the US government, backed
by Japan, Switzerland, and Canada, is opposing change.
In June at the UN General Assembly Special Session on HIV/AIDS, the
USA pledged $200 million for a global AIDS fund, which was judged
by many as a paltry sum. A task force to ensure a "comprehensive
and coordinated effort" by the USA to combat AIDS was announced,
chaired by Secretary of State Colin Powell and Tommy Thompson. It
is time that the US government recognised that a "comprehensive and
coordinated effort" means that public-health needs may have to
override trade profits, and that putting money into a fund while
doing its utmost to prevent life-saving treatments reaching those
who need them is duplicitous. The US government should apply the
same standards abroad as at home in defining what is, or is not, a
public-health emergency.
Human Rights Watch
http://www.hrw.org/press/2001/11/wto-aids1107.htm
Press Relase
WTO Summit: Don't Undercut AIDS Drug Access
(New York, November 7, 2001) Trade ministers at the upcoming WTO
summit in Doha, Qatar should abandon threats of sanctions against
countries trying to obtain medicines for health emergencies such as
HIV/AIDS, Human Rights Watch said today. The WTO summit will take
place from November 9 to 13.
The part of the WTO agreement dealing with patents, known as TRIPS
(Trade-related Aspects of Intellectual Property Rights), allows
exceptions to patent rules in the case of a national emergency or
non-commercial uses. Fifty-developing countries and Norway are
urging the WTO ministers in Doha to make a pledge not to impede
legitimate use of emergency exceptions to TRIPS. In negotiations
leading up to the Doha summit, the U.S. and a number of other
countries that are home to the major multinational pharmaceutical
companies have been intransigent in opposing this pledge.
The United States has also bilaterally threatened sanctions against
several countries with severe AIDS problems, such as Thailand,
South Africa and Brazil.
"AIDS is already tearing these countries apart," said Joanne Csete,
director of the HIV/AIDS program at Human Rights Watch. "They
shouldn't face sanctions from the developed world on top of that."
Approximately 9,000 persons a day die of AIDS, the large majority
in countries where anti-retroviral drugs are unavailable or
unaffordable. More than 22 million people have died of AIDS, about
18 million of them in sub-Saharan Africa.
The office of the U.S. Trade Representative Robert Zoellick
announced last week that instead of the 53-country proposal
reinforcing the health emergency exceptions in TRIPS, it would
support a counter-proposal that would give "least developed
countries" more time until they are required to be fully compliant
with TRIPS and would impose a five-year moratorium on initiation of
WTO complaints against countries seeking TRIPS exceptions.
Csete noted that the U.S. proposal is a step in the right direction
but would cover only the poorest countries and would not include
others such as Brazil and South Africa that have capacity for
domestic production of generic drugs. She urged the United States
not to use bilateral threats and sanctions when the global system
allowed exceptions that Washington opposed.
The United States, Canada, Japan and the United Kingdom have been
granted exceptions to TRIPS and the pre-WTO trade rules many times
to protect their own interests in areas as wide-ranging as
pharmaceuticals, computers, software, and biotechnology
innovations. Canada recently said it would seek a compulsory
license - a license to produce and import the generic version of a
brand-name medicine - to ensure its stock of anti-anthrax drugs.
New Zealand, Australia and Italy have also used compulsory
licensing as an antitrust measure.
In contrast, no low-income developing country has succeeded in
obtaining a compulsory license for generic AIDS drugs. The United
Nations Development Programme's "Human Development Report 2001"
attributes this disparity to threats from Europe and the United
States of trade sanctions, loss of foreign direct investment, or
litigation against low-income countries hoping to obtain compulsory
licenses. Earlier this year, for example, the U.S. threatened to
put Thailand on "priority watch" - a disadvantageous trade status
- in response to the Thai government's attempt to shorten the
waiting period for production of generic drugs in Thailand after
the release of their brand-name counterparts. (An estimated 750,000
persons in Thailand suffer from AIDS.) A similar U.S. action
against Brazil, brought through the WTO, was dropped this year only
in the face of heavy international pressure against the case.
Letter to USTR Zoellick regarding WTO Patent discussions
[full text available at:
http://lists.essential.org/pipermail/ip-health/2001-November/002379.html]
James Love
Consumer Project on Technology
[email protected], http://www.cptech.org
Doha mobile phone +974 539 2726
November 10, 2001
Robert B. Zoellick
United States Trade Representative
[email protected]
Dear Ambassador Zoellick,
I am writing to urge the US government to withdraw its opposition
to language in the WTO Ministerial declaration that addresses
important public health problems, and support substantive efforts
to deal with trade relates aspects of public health. In her
November 9, 2001 statement on the WTO negotiations, WHO Director
General Gro Harlem Brundland said "access to health care is a human
right and we all have an obligation to see this right progressively
realized," noting further that "many millions of people still
cannot get the medicines and vaccines they need at an affordable
price." These problems will certainly become more acute as the WTO
rules are more fully implemented.
Despite confusion created by public relations efforts by US and
European export industries, it is increasingly clear that the WTO
TRIPS accord presents barriers to medicines for many poor
countries. It is also clear that the public in the US and Europe do
not support government trade policies that make medicines
unaffordable in developing countries.
Unfortunately, in the current negotiations the US government has
engaged in a number of strategic maneuvers designed to prevent the
developing countries from obtaining interpretations that would
address existing problems with the implementation of the TRIPS
agreement. The US has been in some cases proposing language that
would appear to benefit the poor, but which would actually narrow
protections for consumer interests, and in other cases, asking
African countries to take short term extensions of compliance
periods as a substitute for more permanent and sustainable
solutions. Given the power of the US government and the situation
in many developing countries, you may well succeed, but only to our
shame -- undoubtedly contributing to the growing list of grievances
against the US which harm other foreign policy objectives and lower
our standing in the world community.
It is objectionable that the US delegation is seeking to discredit
the positions advanced by the Brazil and Indian delegations on the
grounds that these countries are pursuing commercial rather than
public health objectives, positions that were advanced in today's
New York Times, for example. As you know, India is today the most
important global source of low cost generics, and policies that
enable India to supply low cost generic drugs globally clearly
benefit the poor. We recognize that rules that allow India to be a
major global supplier of generic drugs, including those produced
for sale in countries that issue compulsory licenses, runs contrary
to US export company interests. But without the ability of poor
countries to obtain cheap alternative sources of drugs, the poor
will suffer, and the rules that will determine if this can be done
are at the core of this week's WTO discussions. Also, the US needs
to acknowledge the role that Brazil has played in leading the way
in terms of its commitment to funding HIV treatment, and which also
created a global market for generic HIV drugs, benefiting not only
Brazil, but also leading to huge reductions in the prices of HIV
drugs in Africa and other poor countries.
THE NEED FOR PRO-PUBLIC HEALTH INTERPETATION OF THE TRIPS
In some cases the problems with the present TRIPS accord are
manageable within the current framework of the agreement, if one
can obtain clarifications and pro-public health interpretations of
important sections of the agreement, and also if developing
countries manage to enact and implement laws that take advantage of
the much discussed "TRIPS flexibility," something which has yet to
happen. Here too it is noteworthy that the US government has
mounted a series of attacks on the WHO programs for technical
assistance on patent law changes, raising basic questions about the
good faith of US government officials who claim the existing
agreement has sufficient flexibility. It is hardly creditable to
bash the WHO for its efforts to help the poor countries write fast
track compulsory licensing laws, and pressure countries in
bilateral discussions, and then tell reporters at the WTO meeting
that we support the right of poor countries to write such laws.
...
SHORT TERM EXTENSIONS OF COMPLIANCE PERIODS
The most cynical approach by the USTR has been to offer short-term
extensions of TRIPS compliance to African countries, hoping they
will make a separate deal with the US, splitting the developing
country delegations.
The problems with the US proposals are many. The least developed
countries already have the right to ask for extensions of TRIPS
compliance, and the US proposal probably has the effect of limiting
the term of such extensions, since they can be open ended now under
Article 66 of the TRIPS. Of course many African countries do not
even qualify as LDCs, including countries like Kenya, Botswana,
Ivory Coast, Ghana, Nigeria or Zimbabwe, which are hardly rich
countries by US or European standards.
But also, developing countries face very difficult non-WTO
pressures, including for example annual AGOA certification on IPR
issues, threats to withhold GSP benefits, and numerous bilateral
and regional trade negotiations where the US aggressively advances
TRIPS plus positions. Unless the US government has some binding way
to ensure that it will not separately pursue high IPR standards in
these other proceedings, LDCs and African countries will not
benefit from even these putative extensions. It is of course
relevant that H.R. 3005, a bill to give the USTR fast track
negotiating authority, requires the USTR to seek accelerated
compliance with TRIPS, as well as to oppose price controls on
medicines. Also, note that right now some 37 countries in Africa
already issue patents on antiretroviral drugs, five years before
required to do so by the TRIPS, so the notion that the formal
extension will be meaningful needs to be balanced with the reality
that US bilateral trade pressures make this a difficult if not
impossible situation for LDCs and African countries. For these and
other reasons, we support measures that actually modify the
understanding of what constitutes compliance under the TRIPS -- a
more realistic benefit to developing countries than a phony
extensions that will be taken away in bilateral negotiations.
More important, however, the interests of LCDs and indeed every
county in Africa will be linked to the rules faced by India, Brazil
and other developing countries that are excluded from the benefits
of the US proposal, for two reasons. First, LDCs and African
countries need to import medicines or at least active ingredients
from countries that have the best capacity to manufacture them --
such as China, Korea, India, Brazil, etc. Second, the LCD and
African markets are so small that they lack the necessary economies
of scale to make generic manufacturing efficient for many drugs. As
has been pointed out on several occasions, it was the decision by
Brazil to purchase generic HIV drugs which created a sufficient
market to make today's low cost generics ARV drugs possible,
ultimately benefiting African countries and making HIV treatment a
feasible goal after years of high prices by US and European drug
companies. This is the empirical reality that you must deal with,
and take responsibility for as millions perish and suffer from AIDS
and other illnesses. ...
Sincerely,
James Love
Director, Consumer Project on Technology
This material is being reposted for wider distribution by
Africa Action (incorporating the Africa Policy Information
Center, The Africa Fund, and the American Committee on Africa).
Africa Action's information services provide accessible
information and analysis in order to promote U.S. and
international policies toward Africa that advance economic,
political and social justice and the full spectrum of human rights.
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