[Ip-health] Naz Foundation Letter to Ms. Bruni-Sarkozy (EU-India FTA)
k0b0 at yahoo.com
Tue Dec 7 00:03:16 PST 2010
Apologies for cross-posting. This was on another AIDS list and would be of
interest to this list as well.
Greetings from Naz India!
The Naz Foundation (India) Trust submitted a letter to Ms. Carla Bruni-Sarkozy
regarding the ARV treatment, during her visit to the Naz Care Home today.
Attached is the same.
December 6, 2010
Ms Carla Bruni-Sarkozy
The Global Fund
Ambassador for the Protection of Mothers and Children Against AIDS
Dear Ms Bruni-Sarkozy,
Through this letter we thank you for your visit to our care home in Delhi and
commend your work in raising awareness on HIV, particularly for women and
children. As you know the Naz Foundation (India) Trust (NI) is a New Delhi based
NGO working on HIV/AIDS and Sexual Health since 1994. Through the years, Naz
India has evolved and implemented a holistic approach to combat HIV, focusing on
prevention as well as treatment.
We believe there is a new HIV crisis on the horizon, one that requires our
collective resolve and even harder work to address. When Naz first started its
work, an HIV-positive test result was often called a death sentence. Then there
was treatment and while the quest for a cure continues, people living with HIV
can lead long, healthy and productive lives with the help of anti-retroviral
The story of how we in India and indeed many in Asia, Africa and Latin America
got treatment is well known. But given the current crisis, this story perhaps
bears some repetition. In 2001, it was Indian generic companies that announced
to the world that they could offer HIV treatment for as low as $350 per patient
per year. This was a shocking announcement given that the best discount from
Multinational Pharmaceutical Companies at the time was $10,000 per patient per
The announcement of Indian companies transformed the approach to the HIV
epidemic. Suddenly the prospect of saving millions of lives became a reality.
Governments around the world agreed to start providing life long treatment. And
many developed countries agreed to start funding this effort. The Global Fund
was set up. And then the French government’s own initiative, now expanded to
include many other countries, UNITAID joined the fight to provide funding and
As UNITAID announced a few months ago, a new study has shown that over 80% of
ARVs available in the developing world are procured from Indian generic
companies. In 2008, Indian-produced generics accounted for 91% of paediatric ARV
volume. This has been possible because in 2005, India in complying with its
World Trade Organisation obligations under the TRIPS Agreement has balanced
public interest with private rights. India’s patent law which is fully TRIPS
compliant incorporates several health safeguards. With the help of these health
safeguards, people living with HIV in India have been able to ensure that
generic production of several HIV drugs including, nevirapine hemihydrate, a
syrup form of an HIV medicine and useful in the treatment of children,
But as the same UNITAID press release noted, this supply of generic ARVs is
today in danger. And from an unexpected source - the European Commission. As you
know the EU and India are currently negotiating a free trade agreement (FTA). It
has been extremely disheartening for us to learn (directly through the
negotiating texts of the FTA) that the EC is demanding from India intellectual
property protection far in excess of India’s international commitments at the
As the UNITAID press release notes, "The findings of this study raise grave
concerns for us because UNITAID relies heavily on Indian generic manufacturers
to supply quality-assured, patient-friendly, low cost AIDS medicines in over 50
countries," said Jorge Bermudez, UNITAID Executive Secretary. "What we need
today is a more flexible approach to scale up treatment and not the opposite."
[UNITAID, India's central role in AIDS medicines supply could be threatened by
trade agreements, new study says, 14 September 2010]
What has been even more disappointing is that the EC continues to be ambiguous
about its demands from India. The EC continues to claim that the agreement will
not impact access to medicines. The evidence is entirely to the contrary. Just
one demand of the EC, for data exclusivity, has had disastrous effects in other
countries where it has been introduced.
A study of medicine prices in Guatemala has shown price differences in the same
therapeutic class ranging up to 845000% because of data exclusivity. [Shaffer
and Brenner, A Trade Agreement’s Impact on Access to Drugs, Health Affairs (web
exclusive), 2009]. A study on the impact of data exclusivity in Jordan found
that of 103 medicines registered and launched since 2001 that currently have no
patent protection in Jordan, at least 79 per cent have no competition from a
generic equivalent as a consequence of data exclusivity. [All costs, no
benefits: how TRIPS-plus intellectual property rules in the US-Jordan FTA affect
access to medicines, Oxfam Briefing Paper, March 2007.]
The World Health Organisation has advised developing countries not to adopt data
exclusivity. In fact, the WHO noted in a recent press report on the EU-India FTA
that, “If data exclusivity clauses are indeed included that go beyond the patent
period, then we have real public health and ethical concerns about this…First,
it would delay the market entry of generics; and secondly if generic
manufacturers are forced to repeat clinical trials, it is ethically unjust to
conduct such trials on patients when the data are already available." [EU deal
threatens HIV drug supplies, Al Jazeera, 24 November 2010]
Even President Bill Clinton in his article on World AIDS Day has noted that
among the barriers to access to treatment are "trade agreements that prevent
generic manufacturers from supplying effective ARVs for the developing world…”
[Bill Clinton, We need to save more lives – with less, The Independent, 1
We need strong leadership from the global community that is concerned about HIV
against these demands of the European Commission. With the EC pursuing such
agreements not only with India but several other developing countries, it is no
wonder that Medecins Sans Frontieres, whose patients also rely on Indian generic
medicines, has launched its campaign – Europe, Hands Off Our Medicine!
Specifically, the European Commission must drop its demands for TRIPS-plus
provisions in the FTA including:
1. DATA EXCLUSIVITY, as it will not permit the placing of affordable versions of
pediatric doses and combinations of “off-patent” medicines on the market.
2. PATENT TERM EXTENSION, as it will extend patent life beyond 20 years.
3. INVESTMENT RULES, as it will enable foreign companies to take the Indian
government to private arbitration over domestic health policies like measures to
reduce prices of medicines.
4. BORDER MEASURES, as it will deny medicines to patients in other developing
countries with custom officials seizing generic medicines in transit.
5. INJUNCTIONS, as it undermines the independence of the Indian judiciary to
protect right to health of patients over corporate profits.
6. OTHER IP ENFORCEMENT MEASURES, as it puts third parties like treatment
providers at risk of police actions and court cases.
Over the past several months, our friends and colleagues in India, Thailand,
Indonesia, Cambodia, Nepal, Latvia, Africa Latin America and even Europe have
been getting increasingly concerned about whether India will continue to be the
lifeline of millions around the world.
Ms. Bruni, we urgently request you to look into this matter and we hope that you
can take this matter up with the French government. The Indian government is
aware of its obligation to Indian patients and to those in other developing
countries. We hope that the European Commission can also be made aware of its
obligations on the right to health and medicines as well.
There are simply too many lives at stake.
The Naz Foundation (India) Trust
The Naz Foundation (India) Trust
A -86, East of Kailash
New Delhi -110065
91 11 26910499
91 11 41325042
More information about the Ip-health