EU-INDIA TRADE DEAL COULD CUT MEDICINES LIFELINE FOR PEOPLE IN DEVELOPING COUNTRIES
NEW DELHI, 10 February 2012 – 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 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.
“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.”
India has been called the ‘pharmacy of the developing world’ because it produces quality affordable generic medicines that governments, UN agencies and the international medical humanitarian organization Médecins Sans Frontières (MSF) rely on for the treatment of millions of people.
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.
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 intellectual property (IP) barriers.
“This trade deal would go far beyond what India has agreed to at the World Trade Organization,” said Anand Grover, the Director of the Lawyers Collective HIV/AIDS Unit. “The EU wants India to agree to IP enforcement measures that could block medicines at Indian ports on their way to patients in other developing countries, and could even draw treatment providers into court proceedings. These provisions are designed to delay the entry of generic producers into the market, and will adversely affect the right to health of patients not only in India but across the developing world.”
At the Summit, both sides are set to announce ‘trade offs’ in the negotiations. Leaked text indicates that the EU has been pressuring India to agree to several IP measures that will affect the production, registration and distribution of affordable generic medicines.
“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. I was in Peru when the Central American Free Trade Agreement (CAFTA) was signed by Latin American countries with the US. As a result of CAFTA, many Latin American countries face enormous problems in providing medicines for their people, particularly for HIV/AIDS.”
People living with HIV travelled from across the country – Bihar, UP, MP, Punjab, West Bengal, Karnataka, Gujarat, Nagaland, Mizoram and Manipur – to join the protest in New Delhi and to say very clearly: “Europe, hands off our medicine!”
NOTE TO EDITORS:
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. Measures are also designed to embroil third parties such as – treatment providers – 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.
HOW A FREE TRADE AGREEMENT BETWEEN THE EUROPEAN UNION AND INDIA COULD THREATEN ACCESS TO AFFORDABLE MEDICINES FOR MILLIONS OF PEOPLE WORLDWIDE
Briefing Document – February 2012
India has been called the ‘pharmacy of the developing world’ because it produces a large number of quality affordable generic medicines. Thanks in large part to competition stemming from Indian generics, the price of first-line ARVs dropped from US$10,000 per person per year in 2000 to $150 today. This significant price decrease has helped to facilitate 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 paediatric HIV medicines are Indian-produced. Médecins Sans Frontières (MSF) and other treatment providers also rely on Indian generic medicines to treat other diseases and conditions.
But a Free Trade Agreement (FTA) currently under negotiation between the European Union (EU) and India could greatly restrict the ability of Indian generic manufacturers to continue producing high-quality, affordable medicines that millions of people rely on to stay alive. The EU is pushing India to accept particularly harmful provisions in the FTA that go beyond what international trade rules require:
1. INTELLECTUAL PROPERTY (IP) ENFORCEMENT MEASURES: Stamping out competition through intimidation
IP enforcement provisions proposed in the FTA could have a range of harmful effects on the production and dissemination of generic medicines and how the Indian courts can handle disputes over intellectual property rights. These measures range from legitimate medicines being blocked from leaving India on their way to people in developing countries if a multinational company claims that their IP is being infringed upon, to third parties—such as treatment providers—being embroiled in court cases simply for buying or distributing generic medicines. If India agrees to these clauses being included in the FTA, the Indian judiciary will have its hands tied and will no longer be able to balance intellectual property rights with people’s right to health. This is in direct contravention to a country’s right to place public health above IP rights as outlined in international law through Trade-Related Aspects of Intellectual Property, otherwise known as TRIPS, which India is party to.
In 2008 legitimate generic medicines from India passing through European borders were seized when European patent-holders claimed that the medicines infringed upon their patents. This occurred even though the generics were in transit to African and Latin American countries where the drugs were off-patent, and as such there was, in fact, no patent infringement.
2. INVESTMENT RULES: A fast-track for drug companies to sue the Indian government
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.
The tobacco company Philip Morris is currently capitalising on investment rules in trade deals to sue Uruguay and Australia for introducing plain packaging laws banning all branding on cigarette packets as part of their public health campaigns against smoking. By ensuring that public health warnings are included on cigarette packs and removing branding from cigarette packs, Philip Morris claims that the countries are infringing on tobacco company’s trademark and investment rights.
3. DATA EXCLUSIVITY: A backdoor to getting monopoly status and higher drug prices
Don’t bring it back! The EU has stated that they are no longer officially demanding data exclusivity, but, behind closed doors, the EU continues to pressure India to change its laws. The EU must keep to its commitment- NO data exclusivity in the FTA.
Exclusive rights over pharmaceutical test data—so-called data exclusivity—is a backdoor way for multinational pharmaceutical companies to ensure they have a monopoly on their product and thus charge high prices even when their drug has been found not to deserve a patent or the patent has expired. Data exclusivity would delay the entry of generic medicines into the market by preventing India’s drug controller from registering a more affordable generic medicine for the period of data exclusivity—usually 5-10 years. Regardless of patent status, in order to register generic versions of the drug, generic producers would have to submit their own safety and efficacy data, which would require them to repeat clinical trials—something that takes years and involves costs that the generic companies usually cannot afford. But more importantly, repeating clinical trials is unethical, as it requires withholding medicines already known to be safe and effective from some patients (the control group), solely for registering the generic version. By effectively extending patent periods and allowing for monopoly rights even when patents aren’t granted or have expired, data exclusivity protects originator companies from price-busting generic competition, thus keeping prices often unaffordably high.
Data exclusivity provisions included in the 2001 Jordan-U.S. Free Trade Agreement resulted in the delay of registration of generic versions of 79% of medicines between 2002 and mid-2006. Without generic competition, Jordan spent additional sum of between USD $6.3 and $22.04 million on drugs during this time period.