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India/Africa: Threat to Generic Drugs
AfricaFocus Bulletin
Mar 7, 2005 (050307)
(Reposted from sources cited below)
Editor's Note
Proposed changes in Indian patent law being considered by
Parliament this month threaten to limit production of generic
alternatives for newer drugs. Generic drugs from India have played
a key role in lowering the price of antiretroviral treatment to
make it feasible to scale up treatment more rapidly for 3.7 million
Africans with AIDS who do not have access to treatment. But the new
law could add one more obstacle to turning that promise into
reality.
This AfricaFocus Bulletin features an urgent action alert from the
Global AIDS Alliance, calling for pressure on Indian policymakers
to reject this threat to the country's contribution to the worldwide
fight against AIDS. The alert also contains background and
links to further information on the issue.
Continued affordable availability of generic drugs is, however,
only one of the factors that will determine how successful Africa
and the world are in fighting AIDS. This Bulletin also contains the
March 4 press release for a new report on AIDS in Africa prepared
by UNAIDS, outlining three possible scenarios developed from
extensive consultations and workshops in Africa. Additional
coverage of "Aids in Africa: Three Scenarios to 2025," and a link
to the full report, are available at http://allafrica.com/aids and
http://allafrica.com/stories/200503040043.html
The worst-case scenario, essentially a continuation of current
practices, sees uncoordinated efforts, lack of sufficient funding,
and as many as 80 million more deaths from AIDS in Africa by 2025.
This scenario is also characterized by consideration of AIDS as a
medical problem only, separate from the broader structural issues
of poverty and inequality to which it is connected.
The best-case scenario postulates increases in funding, political
will, coordination of different strategies including prevention and
treatment, as well as integration of AIDS strategies into wider
plans for sustainable health and development. Even under this
scenario, AIDS will continue to increase. But more than 43 million
new infections could be averted.
In the middle scenario, UNAIDS envisages a continuing failure of
the international community to provide adequate funding, but
greater political will by African countries to make the best
possible use of their own resources. In this scenario some 24
million new infections could be averted, and 5 million more lives
saved by 2025.
Although most news reports on the scenarios report emphasize the
numbers, the report's authors stress that the scenarios are not
projections, but are designed to make people think about the
alternatives that are available for action.
++++++++++++++++++++++end editor's note+++++++++++++++++++++++
Global AIDS Alliance
http://www.globalaidsalliance.org
Action Alert on Indian Patent Legislation
Contact: David Bryden
Global AIDS Alliance, Communications Director
1225 Connecticut Ave., NW #401 Washington, DC 20036
202-296-0260 ext 211
dbryden@globalaidsalliance.org
ACTION ALERT!!!
This action alert is truly urgent. It may sound technical, but in
fact it is about a truly life-threatening change to India's patent
laws. The change is being considered this week. If approved, it
will put essential AIDS medication out of the reach of millions of
people!
So, please act on this right away. If we all push together we can
indeed persuade the Indian government to change course.
It's so easy - there is a sample letter below and the email
addresses and fax numbers of key Indian officials. Thanks for
taking action!
ACTION ALERT!!
Global AIDS Alliance ++ Association for India's Development ++
Health GAP
March 6, 2005
India Could Cut-off Africa's Access to Affordable AIDS Drugs;
Indian Parliament May Begin Considering the Issue March 9
Fax and Email Indian Government & Urge It Preserve Access to
Generic AIDS Medicines
ISSUE: Under pressure from the US government and brand-name drug
makers (such as Pfizer and Novartis), the Indian government is
about to adopt new patent rules that will make it impossible for
Indian manufacturers to produce many of the newer generic AIDS
drugs.
This is a matter of life and death, as noted in the March 5 New
York Times editorial (see below).
http://www.nytimes.com/2005/03/05/opinion/05sat3.html
Indian production of these drugs is critical to Africa's survival
(plus that of other regions). Many Indian organizations are urging
the Government to reject the change to the patent rules.
African organizations have been outspoken as well. Rolake Nwagwu of
Positive Action for Treatment (PATA), Nigeria has said: "India
should be proud to be producing and exporting cheap, generic AIDS
drugs for people in need. The changes to the patent law will
increase the price of new drugs, as well as some AIDS medicines
that are already produced and exported in generic form. Rising
treatment costs will spell disaster for people with HIV in India
and around the world."
Doctors Without Borders has spoken out too: "MSF has examined the
proposed amendments to the Patents Act of 1970. We believe they
will drastically restrict, perhaps even prevent, the production and
supply of this vital therapy by Indian pharmaceutical companies to
other developing countries."
WHAT YOU CAN DO:
Fax and email Indian government officials to urge they modify or
reject the new Patent Ordinance. Appeal to India as a
forward-thinking, independent country that has for many years
produced life-saving, affordable medication. This is extremely
urgent, so please take action before March 9 and continue until
March 14, since it's unclear when exactly this issue will be taken
up.
SAMPLE LETTER TO FAX:
"I am deeply concerned about the recent amendment that modified the
Patent Act of 1970 and its impact on access to AIDS and other
medications. Indian generic medications are a life-line for Africa
and other regions fighting the AIDS epidemic. The amendment goes
far beyond what the WTO requires. As a person/organization working
to increase access to life sustaining HIV treatment, I am urging
you to not pass this amendment. Please ensure generic production of
medications patented after 1995. The world is counting on India to
continue an independent approach that protects public health and
promotes access to affordable generic medicines for all. I/We are
closely monitoring the decisions of the Government of India, as
millions of lives may hang in the balance. Please respond to this
urgent request. Respectfully, XYZ."
More info: http://www.gcaipa.org and http://www.healthgap.org
SEND APPEALS TO:
Sonia Gandhi
10, Janpath, New Delhi - 110011
Phone. +91-11-23014161, 23014481
Email: soniagandhi@sansad.nic.in
Dr. Manmohan Singh
Prime Minister of India South Block, New Delhi India-110 011
Phone: +91-11-23012312, 23013149,
Fax : +91-11-23016857
Email: pmosb@pmo.nic.in
Shri Kamal Nath
Minister for Commerce & Industry
Udyog Bhawan New Delhi - 110011
Phone: +91-11-23010008, 23011492
Fax: +91-11-23019947
Email: csoffice@ub.nic.in
L K Advani
Leader of Opposition
30, Prithviraj Road, New Delhi - 110003, India
Phone: +91-11-23794125, 23794124
Fax: +91-11-23017419 advanilk@sansad.nic.in
Indian National Congress (ruling Party office)
24, Akbar Road, New Delhi -110011, India
Phone: +91-11-23019080
Fax: +91-11-23017047
aicc@congress.org.in
After you have faxed to these officials, send appeals to the Indian
embassy in your country as well. You will find a list of embassies
at this link.
http://indiaimage.nic.in/embassies.htm
Okay, now that you have taken action, read on for more details:
BACKGROUND:
India is a major source of supply of the world's generic medicines;
it exports two-thirds of its products to developing countries.
These exports are critical to the fight against AIDS in sub-Saharan
Africa, South America, and Southern and Southeast Asia. Generic
competition fueled by Indian production has been largely
responsible for reducing the prices of antiretrovirals by as much
as 98%.
But, India passed an ordinance December 26, 2004 that eliminated 35
years of national exemption of medicines from product patent
protection. The changed rules will affect the production of the
drugs that patients need after the initial course of treatment
becomes ineffective (the so-called 'second-line' drugs patented
after 1995).
Many patients need this second line of medications to survive. At
least 20% of patients need these drugs after three years of taking
the initial course, and if they do not get the medication they will
die. The costly, brand-name versions are out of reach of most
people living with AIDS. Brand-name versions of these drugs can
cost 26 times as much as the generic versions that India could make
under appropriate and flexible patent standards.
The global goal for the end of this year is to deliver AIDS
medication to 3 million of the people that need them. 20% of these
people can be expected to need these second line drugs in three
years time, and that adds up to 600,000 people! These 600,000
people could die without continued access to affordable medication.
The currently proposed new rules could also adversely affect
generic production of widely used combination tablets such as
GlaxoSmithKline's Combivir.
The decree will also prevent the production of newer medicines for
many other public health needs. This decree may come before the
Indian Parliament as early as March 9, 2005 when the body
reconvenes.
The changes to the Patent Act include:
- A weakening of the procedure that allows a challenge to a patent
application; .
- A change that makes it easier to patent a drug, even if it's not
significantly different from an existing drug .
- A slow moving, bureaucratic process that will prevent the export
of compulsorily licensed medicines to poor, importing countries
These changes are not necessary to stimulate investment into
research and development, and the new rules go beyond what the
World Trade Organization (WTO) requires. But, the Union Minister of
Commerce and Industry, Kamal Nath, has been influenced by the US
government and US brand-name manufacturers, and he seems determined
to secure rapid approval of the ordinance by the Parliament.
If the new rules are formalized, 20-year patent monopolies will
drive up the price of treatment in India and in hundreds of
importing countries. The world's source of generic HIV medicines
will essentially disappear.
The Parliament could, however, refuse to approve the change, in
which case the change will expire in May, 2005. Or, the issue
could be passed to a Committee in Parliament that would give the
matter more thorough consideration.
Indian Nobel laureate economist Amartya Sen says: The government of
India must subject the issue of patent rights to "greater scrutiny"
in the interest of the people. "I want more scrutiny in areas like
patent rights. This is a serious issue where the Government of
India must make itself heard in the world community. I hope the
government will do this with humanity."
To maintain and support India's important leadership on issues of
HIV/AIDS, the Parliament should reject these changes. The Indian
government should amend the Patents Act in a manner that does not
undermine protections for public health and access to medicines.
India should also do much more to ensure its people have access to
AIDS testing, counseling, prevention services and treatment on a
nationwide basis.
http://www.nytimes.com/2005/03/05/opinion/05sat3.html
New York Times March 5, 2005
Editorial AIDS Drugs Threatened
India's Parliament is about to take up a bill that could affect
sick people the world over. India is the leading supplier of
low-cost generic AIDS medicine. The country's huge generic industry
has been able to copy antiretrovirals and other medicines because
India grants patents for the process of making drugs, rather than
for the medicines themselves. But the Patents Bill that India is
considering, at the behest of the World Trade Organization, would
change that.
Parliament must make sure that it protects India's ability to make
these crucial drugs. While the W.T.O. requires its members to
respect product patents, it allows them to put public health first.
Unfortunately, the Patents Bill would fail to do this; some of its
provisions would go far beyond what the trade organization
requires. The bill bears the heavy footprint of multinational and
Indian pharmaceutical companies that are eager to sell high-priced
drugs to India's middle class, which is larger than the population
of the United States.
Lobbying by these companies has produced a bill that would
sacrifice public health. For example, as current AIDS drugs become
ineffective, India will be asked to make cheap, easy-to-take
combination versions of newer antiretrovirals. To do so as a W.T.O.
member, the government will have to issue something called a
compulsory license, which allows a generic manufacturer to copy a
patented drug. The patent holder gets a reasonable royalty, but
does not have to consent. But India's compulsory license process is
very slow and lets pharmaceutical companies tie up such licenses in
court for years. Moreover, India's laws do not allow it to export
medicines made under these rules to countries where they aren't
patented, which includes most of Africa.
Indian lawmakers must reform the Patents Bill to cut the red tape
that can block compulsory licenses. They should also eliminate the
loophole that prevents medicines from going to the poorest
countries. India needs to allow challenges to patents before they
take effect, and to remove a provision that could allow a company
to extend a patent by simply finding a new use for a drug.
Instead of passing the flawed government bill, lawmakers should
refer the bill to a committee for public testimony about possible
reforms. Seldom has India's Parliament considered anything of such
global import. If Parliament can preserve India's ability to
provide generic versions of these medicines, it will make the
difference between life and death for millions of people at home
and abroad.
MORE INFO:
News stories about the campaign against this measure:
http://www.nri-worldwide.com/cgi-local/ts.pl?action=fetch&area=nrinitiative
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=28383
http://www.globalaidsalliance.org/press_India.cfm
Photos from a recent rally at the Indian Embassy in Washington, DC:
http://pg.photos.yahoo.com/ph/oormi_kapadia/album?.dir=/ac32&.src=ph&.tok=ph P3HnCBa6c7NJUd
Interviews with activists organizing on this issue:
http://dc.indymedia.org/feature/display/118436/index.php
UNAIDS
http://www.unaids.org
Press release March 4, 2005
New Report Presents Three Scenarios for AIDS in Africa by 2025
Scenarios look at how AIDS could shape Africa's future
[For more information, please contact Djeneba Dicko,
UNAIDS, Addis Ababa, mobile +251 9 637387 or tel. +251 1 510 152,
or Dominique De Santis, UNAIDS, Geneva, tel. +41 22 791 4509. The
Scenarios report can be accessed on the UNAIDS website,
http://www.unaids.org.]
Addis Ababa, 4 March 2005 By 2025, Africa and the world could
face three very different scenarios for AIDS. And depending on the
actions taken today, up to 43 million HIV infections could be
averted over the next 20 years.
These findings are from AIDS in Africa: Three scenarios to 2025.
The new report by the Joint United Nations Programme on HIV/AIDS
(UNAIDS) presents three possible case studies for how the AIDS
epidemic in Africa could evolve over the next 20 years based on
policy decisions taken today by African leaders and the rest of the
world.
"The scenarios are not predictions. They are plausible stories
about the future," said Dr Peter Piot, UNAIDS Executive Director,
at the press launch of the report. "The scenarios highlight the
various choices that are likely to confront African countries in
the coming decades. Millions of new infections can be prevented if
Africa and the rest of the world decide to tackle AIDS as an
exceptional crisis that has the potential to devastate entire
societies and economies."
More than 150 people, mostly Africans, gave their time and
expertise to build the scenarios. This project was initiated by
UNAIDS in February 2003 in collaboration with the African Union,
African Development Bank, UN Economic Commission for Africa, United
Nations Development Programme, and the World Bank. Royal
Dutch/Shell Group shared their scenario development expertise with
the project.
"The scenarios provide us with glimpses into the future, so that we
can make good decisions today," said Ethiopian President Girma
Woldegiorgis. "At a time when there is increased willingness to
tackle AIDS in Africa, we must galvanise all resources -- human and
financial -- and use them effectively for sustainable change." The
scenarios set out to answer one central question: 'Over the next 20
years, what factors will drive Africa's and the world's responses
to the AIDS epidemic, and what kind of future will there be for the
next generation?' The scenarios project was based on two key
assumptions: 1) AIDS is not a short-term problem; AIDS will affect
Africa 20 years from now. What is uncertain is in what ways and to
what extent AIDS will shape Africa's future. 2) Decisions taken now
will shape the future of the continent.
The scenarios also address the factors fuelling Africa's AIDS
epidemics, including poverty, gender inequality, and
underdevelopment. "The scenarios highlight the driving forces that
are influencing the evolution of the epidemic," said President
Olusegun Obasanjo of Nigeria, in a message read out at the launch.
"They help to improve the ways we engage with the challenges that
are posed, they stimulate debates, and clarify policy and programme
decisions for the continent."
Three scenarios
The three scenarios featured in the report are: 'Tough choices:
Africa takes a stand', 'Traps and legacies: The whirlpool', and
'Times of transition: Africa overcomes'.
'Tough choices' tells a story in which African leaders choose to
take tough measures that reduce the spread of HIV in the long term.
This scenario shows how, with scarce resources, governments and
civil society are forced to confront tough choices in improving
Africa's future and tackling underdevelopment.
In 'Tough choices', antiretroviral therapy is scaled up, from less
than 5% treated at the start of the scenario to just over one third
by 2025. The roll-out of antiretroviral therapy increases steadily,
reflecting the continued investment in health systems and training,
as well as drugs manufacturing capacity within Africa. Compared to
'Traps and legacies', an estimated 24 million HIV infections are
averted over the next 20 years. Initiatives to support children
orphaned by AIDS also increase, but the number of children orphaned
by AIDS almost doubles by 2025. ' Traps and legacies' is a scenario
where AIDS depletes resources and weakens infrastructure. As a
result, AIDS deepens the traps of poverty, underdevelopment, and
inequality. In this scenario, the HIV prevalence across the
continent by 2025 remains at around 5% of the adult population,
with some countries above or below this level. Life expectancy
drops across many countries, and the number of people living with
HIV in Africa increases considerably. HIV prevention efforts are
not effectively scaled up. Efforts to roll out antiretroviral
therapy continue (over 20% of people who need ARV therapy have
access to it), but huge obstacles remain, including a combination
of underdeveloped and overwhelmed systems, and escalating costs.
In 'Times of transition', AIDS is seen as an exceptional crisis
requiring an exceptional response. AIDS is viewed in its broader
development context. A series of transitions occur in the ways
Africa and the rest of the world approach health, development,
trade, and security. External aid increases considerably and there
is sustained social and infrastructural investment.
In this scenario, Africa's adult HIV prevalence rate drops
considerably, external aid to Africa doubles, and ARV coverage is
approximately 70% by 2025. Compared to 'Traps and legacies', an
estimated 43 million HIV infections are averted by 2025.
Potential outcomes
Overall, 'Traps and legacies' shows what might happen if there are
inefficient domestic AIDS policies in Africa and volatile or
declining external aid, 'Tough choices' shows what is possible when
there are efficient domestic policies but stagnant external aid;
and 'Times of transition' shows what might happen if there are more
efficient domestic policies and increased and high quality external
aid.
"Not only is strong leadership vital, strong health systems and
development are also necessary in our quest to control the AIDS
epidemic," said Dr Kenneth Kaunda, former President of Zambia, who
delivered the keynote address today. "AIDS is going to be around
for a long time and needs consistent policy responses over several
terms of government. Investing in children as a resource for the
future, and keeping their parents uninfected and alive, will make
a huge difference."
The scenarios suggest that, while the worst of the epidemic's
impact is still to come, there is still a great deal that can be
done to change the longer-term trajectory of the epidemic and to
minimize its impact.
AfricaFocus Bulletin is an independent electronic publication
providing reposted commentary and analysis on African issues, with
a particular focus on U.S. and international policies. AfricaFocus
Bulletin is edited by William Minter.
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