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.