[Ip-health] Naz Foundation Letter to Ms. Bruni-Sarkozy (EU-India FTA)

Kajal Bhardwaj 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.
 
Kajal 
 
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Dear Moderator,

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 
therapy.

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 
year. 


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 
treatment. 


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, 
continues. 


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 
WTO.

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 
December 2010]

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. 

Anjali Gopalan
Executive Director
The Naz Foundation (India) Trust
________________________________

Regards,

Anuradha

-- 
Anuradha Mukherjee
Programs Manager
The Naz Foundation (India) Trust
A -86, East of Kailash
New Delhi -110065
91 11 26910499  
91 11 41325042  
www.nazindia.org


      


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