EU-India deal to ban generic drugs angers the HIV-positive

NEW DELHI // At a rally that culminated outside the houses of parliament, more than a thousand HIV-positive people demonstrated against trade negotiations between India and the European Union that could result in cutting their access to affordable drugs.

"Don't trade away our lives," read some of the placards. "We want to live" went the loudly chanted slogans.

The agreement between India and the EU covers a range of goods and services, and it has been in negotiation since 2007. Bilateral trade between the two is expected to touch US$220 billion (Dh808bn) by 2015.

Medicines, however, have formed a key sticking point in the negotiations. The EU has repeatedly asked for India's commitment to a strong intellectual property rights regime with respect to drugs. An EU press release in 2009 said that "India is one of the major sources of counterfeit medicines seized by the customs services of the member states." Indian regulations, until recently, allowed pharmaceutical companies to patent only processes and not the final products. Now, in accordance with World Trade Organisation rules, those regulations have changed, but not as drastically as the EU would like.

The industry has thus often been able to develop "generics", copies of drugs that have been patented elsewhere in Europe or the United States. While the original drugs are sold at higher prices, the copies are sold are far, far lower rates.

The EU is pushing for a measure known as "data exclusivity", which would be able to knock generics off the market even for drugs that are off-patent or would not earn a patent under Indian patent law.

India is the world's leading manufacturer of such generic drugs, to the benefit of its pharmaceutical companies. In 2009, according to figures from the Indian Drug Manufacturers' Association, drug exports stood at US$10 billion and were growing by more than 20 per cent each year. Unsurprisingly then, last March, Anand Sharma, the Indian minister for commerce and industry, told Reuters: "We will not allow any injury to be caused to the Indian generics industry." India is thus often the source for cheap medicines elsewhere in the developing world. One estimate by Médecins Sans Frontières surmises that nearly 80 per cent of the AIDS drugs treating 5 million people across the developing world come from India. Generic drugs from India can cost as little as a few cents per dose.

Rajiv Kafle, a member of the Asia Pacific Network of Positive People, said at a press conference after the rally: "We all rely on affordable medicines, made here in India, to stay alive."

The rally had the support of Anand Grover, the United Nations special rapporteur on the right to health. In a statement, Mr Grover called the planned introduction of data exclusivity a "colossal mistake," because "millions of people across the globe depend on the country as the pharmacy of the developing world".

Because of a public holiday, the EU's officials in Delhi could not be reached for comment. However, an EU press release issued three weeks ago claimed that "the free trade agreement currently under negotiations between India and EU is certainly not intended to restrict the ability of India to continue doing the same for domestic and international consumption… It is not EU's intention to use enforcement measures… to hinder the legitimate trade in generic medicines."

ssubramanian@thenational.ae