India and Europe Trading Away Access to Medicines

Recent news reports on negotiations between India and the European Union on a proposed free trade agreement (FTA) have many health and human rights experts worried that millions of people may be left without access to life-saving medicines. Indeed people in low-resource countries are critically dependent on affordable medicines produced by India, which for that reason has been dubbed the “pharmacy of the developing world.” If, as reports indicate, EU negotiators succeed in pressuring India to beef up intellectual property protection at the expense of public access rights for life-saving drugs, the FTA would seriously undercut India’s ability to produce generic, low-cost drugs, with detrimental effects on access to medicines for the developing world.

Some will remember the news headlines of ten years ago when people living with AIDS in South Africa, Brazil, Thailand and other countries gained the world’s attention by protesting against international pharmaceutical companies. The medicines that could save their lives were then priced at over $10,000 per year, and were simply unaffordable. Many people were dying.

Backed by global indignation at this injustice, treatment activists denounced the excessive pricing policies of the large pharmaceutical companies and demanded solutions. In response, government companies in Brazil and Thailand, and private companies in India started to produce generic copies of these medicines, which led to robust competition and a dramatic drop in prices. In a matter of months, the price of the first line AIDS drugs dropped by 99 percent—to under $100 per patient per year. This price drop was the single most important factor that allowed the scaling-up of AIDS treatment, to the point where more than five million people are now on treatment. Ninety-two percent of people living with HIV in low- and middle-income countries are using generic antiretrovirals manufactured in India.

Unfortunately, the mechanisms available to us ten years ago for achieving such a price drop have been under sustained threat. Hidden in the fine print of bilateral free trade agreements, such as the proposed EU-India FTA, are clauses that enforce even stronger intellectual property protections than those required under the World Trade Organization’s TRIPS agreement (which enforces 20-year patents on pharmaceuticals). India is under great pressure to accept these “TRIPS-plus” provisions as part of a package of market access, trade, and investments. While they come in different shapes and forms, the most critical TRIPS-plus measure on the table in the EU-India trade deal is called “data exclusivity”—which essentially is another means, aside from patents, for blocking off generic competition. With data exclusivity, generic companies are blocked from using the existing clinical data on a medicine to register it, regardless of whether a patent exists or not.

During a period of data exclusivity (which can be up to 12 years depending on the negotiation outcome), no generic medicine can be registered. This is a backdoor to patent protection, and risks undermining the fine balance between safeguarding access on the one hand, and stimulating innovation and business on the other. This balance was deliberately worked out by India's parliamentarians when they revised their Patent Act in 2005. The FTA would make redundant one of the core provisions of the Act—section 3d—which precludes patents on minor modifications of existing drugs, which do not add therapeutic benefit. This provision is intended to avoid “evergreening” of patents as a strategy to delay generic entry. With data exclusivity, the extension of the monopoly would be achieved independent of whether a product deserves patent protection (more on data exclusivity in the video below).

As European and Indian negotiators continue their talks behind closed doors, people living with AIDS are mounting public protests—joined by other access to medicines activists, including many organizations supported by the Open Society Foundations. Thousands of people have marched in the streets of New Delhi, Bangkok, Phnom Penh, Jakarta, Nairobi, Rio de Janeiro, Geneva, and Brussels to focus attention on this very real threat posed to access to affordable medicines, across the developing world.

Europe is usually keen to profile itself as concerned about global health and access to medicines for people living in developing countries, as evidenced by this European Parliament resolution as well as commitments from commissioners responsible for health and international development. However, the sad reality is that trade and commercial interests in the end overrule good intentions—certainly when it comes down to poor people’s health.

Let us hope Indian negotiators will draw strength and courage from the many activists out there who are fighting for their lives (join them on Facebook)—and withstand the pressures to agree to these TRIPS-plus provisions.

1 Comment

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Global strategies which are suppose to guide the global response to HIV does not seem to be connected with the reality. Just liked we moved the Goal Post for Universal Access by 2010 to 2015, will we able to achieve "Getting to Zero" by 2015? Especially in the context of the article, where Western and European countries are entering into so call "FREE' economic agreements with almost every developing country which has some producing capacity, skills and infrastructure.

We all know that, besides other economic sectors in a country that will be affected, many of us will struggle and die not only in India, but in many countries simply because of the fact that the Access to the drugs will no longer be there or it simply will not be affordable. And this will not take very long to see, maybe 5 years!!! So how will strategic direction 2 of UNAIDS's Getting to zero be achieved when people continue to die? Will we move the Goal Post to 2020 then by the time 2015 comes up?

The getting to Zero also talks about facilitating registration of new drugs to support zero AIDS related deaths by 2015. Thanks to the pressure of the community, proactive agencies and innovative funding mechanisms, we are seeing people who have had no problem with managing HIV. But in the context of people who use drugs and living with HIV, people don’t or not many die of HIV ( Thanks to the affordable life saving drugs!!) but we are dying of Hepatitis C related complications. If you ask me to give the data of HCV related deaths amongst us, I will not be able to. But if we go to the ground, i can tell you who all died of HCV when their Cd4 and also viral load was completely manageable. Don’t we need more studies to be done to ensure that in the long run, we continue to keep our friends alive, our programs reflects the need of the people in the community and Global strategies are in line with what is the reality?

Strategies and pressures are required but we cant continue to shift the Goal post because we simply failed to score!!

Thanks Els and hope that people will continue to join this struggle!

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