EU-India Free Trade Agreement Threatens Access to Medicines

Dear friends and colleagues,

Please find below a number of articles relating to the EU-India Free Trade Agreement (FTA), against which protests the past week gained in intensity as the leaders of the EU and India governments met in New Delhi on February 10.

The Geneva-based UNITAID explains how millions of poor depend on the lifeline that India maintains through its generic medicine producers, and how this may be jeopardised by the EU-India FTA (Item 1).

While existing trade rules already limit the possibility of making generic versions of new medicines, the EU-India FTA threatens to make this situation even worse, by creating new barriers to the production, registration and distribution of affordable generic medicines. This could result in 'drastically higher' medicine prices for the poorest people across the globe (Item 2). The generic medicines in question are relevant not only for HIV/AIDS, but also for other diseases such as tuberculosis, malaria and cancer.

The threat of the EU-India FTA brought thousands of people onto the streets of Delhi on February 10 to tell the EU and their government how they feel about the FTA being negotiated in their name (Item 3).

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Item 1

UNITAID warns against measures to restrict access to medicines in EU-India FTA

http://www.unitaid.eu/fr/resources/news/385-eu-india-fta

In the lead-up to Free Trade Agreement (FTA) discussions during the European Union-India Summit in New Delhi on 10 February 2012, UNITAID urges both parties to ensure that access to medicines, and particularly AIDS medicines, is not hampered by trade interests via provisions that could undermine the production, registration and availability of generic medicines.

"This agreement coincides with a delicate time for access to treatment efforts - the suspension of grants by the Global Fund and diminishing resources for health and development," said Philippe Douste-Blazy, Chair of UNITAID's Board. "I call on the European Union – with its long human rights tradition – to safeguard the right of millions of people in developing countries to continue accessing affordable life-saving medicines produced by the Indian generic industry."

AIDS treatment has experienced startling progress over recent years, with almost seven million people starting treatment between 2003 and 2011, largely due to India's ability to produce low-cost, quality-assured generic medicines and to healthy competition among India's producers. However, such provisions as data exclusivity, patent term extensions and border measures could severely legally restrict manufacturers' ability to produce recently developed medicines and patient adapted formulations at low cost and to export those medicines to other developing countries.

"UNITAID has been able to create and supply markets for paediatric and second-line drugs in 50 countries largely thanks to Indian generic manufacturers," said Denis Broun, UNITAID Executive Director. "They produce high-quality products and have made remarkable efforts to make them patient-friendly at guaranteed low prices. We are extremely concerned that attempts to restrict India's ability to produce such medicines quickly and cheaply will have tragic consequences for global health programmes worldwide".

One of UNITAID's main achievements to date – that of providing child-friendly medicines to 90% of children globally on treatment for AIDS – has been made possible by India's ability to develop these previously neglected medicines and make them available at low cost. Since 2008, Indian-produced generics have accounted for approximately 90% of the paediatric AIDS medicines market.

Indian generic manufacturers have supplied more than 80% of donor-funded AIDS medicines to developing countries in the last eight years. By 2008, Indian generic antiretrovirals (ARVs) accounted for 65% of the total value of ARV purchases reported, while non-Indian generic and innovator ARVs accounted for 13% and 22% of market value, respectively (see A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries).

About UNITAID

UNITAID is an innovative global health initiative established in 2006 by the governments of Brazil, Norway, Chile, France and the United Kingdom to increase access to medicines in 94 low and middle income countries. UNITAID has provided treatments; diagnostics and prevention commodities in the fight against HIV/AIDS, TB and malaria using a targeted market-impact approach to ensure quality low cost treatments and diagnostics are made available to those who need them most.

UNITAID aims to promote "healthy", dynamic market conditions whereby manufacturers have incentives to invest and innovate, while at the same time supply quality public health products at affordable prices and in acceptable formulations that enable the maximum number of people to access them.

Item 2

EU urged to avoid 'pressurising' India at summit
Martin Banks

http://www.theparliament.com/latest-news/article/newsarticle/eu-urged-to-avoid-pressurising-india-at-summit/

A leading charity is calling on the EU 'not to pressurise' India into agreeing new trade rules at a key summit in New Delhi on Friday.

Oxfam says that failure to heed its demand at the 12th EU-India summit could 'deny hundreds of millions of people access to affordable medicines'.

The EU is, according to Oxfam, trying to impose new intellectual property and investment (IP) rules in India, which the charity says would result in 'drastically higher' medicine prices for the poorest people across the globe.

India plays a critical role in the global medicines market, producing over two-thirds of all generic medicines; affordable versions of drugs licensed by multinational companies, which are largely sold to poor and middle income countries.

Currently, over 80 per cent of all HIV and AIDS medicines are manufactured by generic companies in India, but if new trade rules are agreed the price of life-saving treatment would increase drastically, says Oxfam.

Oxfam policy advisor, Rohit Malpani, said, "The summit on Friday will be closely watched to see whether the EU and India will negotiate a trade agreement which puts people's lives before the commercial interests of multinational drug companies.

"At a time of austerity and declining aid budgets, especially for health, efforts to increase medicine prices for the world's poor would be a double blow and have a devastating impact on the achievement of health-related millennium development goals."

Oxfam India CEO, Nisha Agrawal, said, "The Indian government - until now - has repeatedly rejected EU demands to introduce any of the additional intellectual property rules under the free trade agreement. We strongly support that stance.

"Given the background of ongoing policy level discussions on universal, affordable and free access to health care in India, to introduce additional intellectual property rules as a condition of the free trade agreement (FTA) would be contradictory, since it would escalate the cost of medicines in India and also across the developing world."

Malpani added, "If the EU succeeds in imposing strict IP rules upon the Indian government, the massive hike in medicine prices could undermine European leadership to provide international aid for global health. Worryingly it could also debilitate donor programmes that provide access to treatment around the world."

However, Shada Islam, head of policy at the Brussels-based think tank, Friends of Europe, said that negotiations on a first-ever EU-India free trade agreement are "injecting much-needed excitement" into Europe’s relationship with India.

She said, "Despite earlier hopes, the trade deal will not be signed at the summit. But the buzz generated by the negotiations as they enter a critical final stage is helping to lift Europe's profile in a country which has so far kept the EU at a polite arms length.
"Significantly the trade talks, now into their fifth year, have helped to focus official and public attention in India on the EU – rather than individual European member states - as a global economic player."

She adds, "Once the FTA is completed, the EU and India must pay increased attention to other aspects of their relations. Both sides can set key priorities which meet India's requirements as a dynamic emerging power but a country which is also struggling to combat poverty and exclusion.

"As India rises along with the rest of Asia, it deserves stronger EU recognition as a regional and global power, not just an expanding market for EU exports and investments."

She predicts that commission president Jos้ Manuel Barroso and Herman Van Rompuy, president of the European council who will attend the summit, will 'want to do more than talk trade' with India.

Islam says they will also try and convince their host Indian prime minister Manmohan Singh to join the international sanctions regime against Iran.

Item 3

2,000 Rally in Streets of Delhi as EU-India Summit Starts

http://www.msfaccess.org/about-us/media-room/press-releases/eu-india-trade-deal-could-cut-medicines-lifeline-people

As India and the European Union meet for a Summit in New Delhi today to iron out the differences over a Free Trade Agreement, nearly two thousand people living with HIV and the international medical humanitarian organisation M้decins Sans Fronti่res (MSF) protested in the streets of the Indian capital to warn that remaining harmful provisions in the agreement could have a severely negative impact on access to affordable medicine for people in developing countries.

“We have watched too many people die in places where we work because the medicines they need are too expensive,” said Dr. Unni Karunakara, International President of MSF. “We cannot allow this trade deal to shut down the pharmacy of the developing world.”

India produces quality affordable generic medicines that governments, UN agencies and MSF rely on to treat people across the developing world. Thanks to competition among generics producers in India, the price of first-line HIV medicines has dropped by more than 99%, from US$10,000 per person per year in 2000 to roughly $150 today. This significant price decrease has supported the massive expansion of HIV treatment worldwide: more than 80% of the HIV medicines used to treat 6.6 million people in developing countries come from Indian producers, and 90% of pediatric HIV medicines are Indian-produced. MSF and other treatment providers also
use Indian generic medicines to treat other diseases and conditions.

“Whether we get to live or die should not be up to trade negotiators,” said Mundrika Gahlot of the Delhi Network of Positive People. “We’re all here today with one clear message to India and the EU: Don’t trade away our lives.”

Existing trade rules already limit the possibility of making generic versions of new medicines, but the EU-India FTA threatens to make this situation even worse, by creating new barriers. At the Summit, both sides are set to announce ‘trade offs’ in the negotiations, in which the EU has been pressuring India to agree to several measures that will affect the production, registration and distribution of affordable generic medicines. MSF is particularly concerned about ‘enforcement’ measures being pushed by the EU that could stop medicines at Indian ports from leaving the country on their way to patients in other developing countries, and could even draw treatment providers like MSF into court proceedings.

“What the EU is trying to do with this trade agreement is effectively slow poison the production of affordable generic medicines in India, which has helped keep so many people alive,” said Piero Gandini, Head of Mission for MSF in India. “This trade agreement could target us as treatment providers, simply for buying generic medicines from India to treat patients in our programmes.”

The protest in Delhi followed similar rallies this week by activists and people living with HIV in Nepal, Malaysia, the UK, South Africa and Cameroon.

For more information, or to arrange interviews, please contact:
Sheila Shettle, MSF +91.(0)98.718.007.23
Shailly Gupta, MSF +91.(0)98.999.761.08

Editor's Note:

Harmful provisions in the EU-India FTA include:

‘Enforcement’ measures which could lead to generic medicines being prohibited from leaving India on their way to patients in other developing countries, on the mere allegation that a patent or trademark is being infringed. This could also embroil treatment providers—such as MSF—in legal battles simply for providing generic medicines to patients.

The ‘investment’ part of the FTA would expand companies’ ability to sue the Indian government when it regulates health in the public interest, for example by overriding a drug patent to increase access to a medicine, or through drug price controls. These disputes would be handled outside of domestic courts in secret settlement panels, with large sums in damages at stake. As a result of investment provisions in FTAs between other countries, several such disputes have already been filed by corporations against governments, in order to force a reversal of public health policies (Phillip Morris vs. Uruguay). Companies claim these policies lead to so called “expropriation” of their investments and profits.

A further measure—so-called ‘data exclusivity’—could effectively block generic production even if a patent is not granted or has expired. While the EU has stated that they are no longer officially demanding data exclusivity, behind closed doors, the EU continues to pressure India to change its laws. The EU must keep to its commitment not to put this back on the table.

MSF currently provides HIV treatment to 170,000 people in 19 countries.