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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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