Letter to Ms. Bruni-Sarkozy

[Guest guest]

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 now 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 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