The low-cost drugs from India might all come to an end in April because of a free trade agreement with the EU. One of the terms of the agreement would force the generic drug makers to begin testing their drugs in order to make sure they don't violate patents recognized by the EU.
From the Inter Press Service, writer Ranjit Devraj details why health groups are against the deal.
"We hope that Indian negotiators will withstand pressures and ensure that the existing intellectual property rights regime is not tampered with to allow extension of patents, especially as a number of drugs are going off patent, this year," said Mira Shiva, a member of the All India Drug Action Network.
"The World Trade Organisation’s TRIPS [Trade-Related Aspects of Intellectual Property Rights] was bad enough but we are facing a TRIPS-Plus bilateral deal which may prove even worse for public health," Shiva told IPS.
If the India-EU free trade agreement (FTA) introduces TRIPS-Plus measures, people on HIV treatment, for example, may not be able to access second-line treatment when they become resistant to medicines they already are on, Shiva said.
By refusing to recognise patents and by leveraging its large domestic market India has, in the decades since 1970, been able to build up a powerful pharmaceutical industry known for its cheap and efficacious generic versions of patented drugs.
After 2005, India has been implementing changes mandated by the WTO, but these are less stringent than the EU intellectual property regime.
UNAIDS, the joint United Nations programme on HIV and AIDS, notes that the flexibility afforded by TRIPS has brought down drug prices and helped lower the cost of first-line generic anti-retrovirals (ARVs) by as much as 99 percent in the last decade.
The EU can be expected to demand data exclusivity on drugs as it has done in the case of all its other FTAs, said Shiva. Data exclusivity will allow drug manufacturers a monopoly, based on clinical test data generated on the safety and efficacy aspects of a new drug.
"What this means," explains Amit Sen Gupta, public health expert at the Delhi Science Forum, a voluntary organisation, "is that an Indian drug company planning to produce the generic version of a patented drug will have to conduct its own clinical trials before it can be licensed and marketed."
"Fresh trials would naturally add to the cost of the drug, and delay its introduction into the market," Sen Gupta said. Currently the EU grants up to 11 years of exclusive rights based on successful clinical trials and other test data.