India’s ability to produce quality and low cost medicines will come under threat, caution health workers, as the United States’ Special 301 report is expected, possibly later today.

The Special 301 report is an annual exercise where the US evaluates its trading partners on their track-record regarding the protection of Intellectual Property (IP). And there has been much lobbying by US industry organisations against what they called a deteriorating environment for IP protection in India.

IP protection involves protecting data generated during research for instance, and it has been the bone of contention in the pharmaceutical industry, with innovator companies crossing swords with generic drug makers, who make chemically-similar but inexpensive versions of an original drug.

In fact, the US Chamber of Commerce’s Global Intellectual Property Center (GIPC) pegged India at the bottom of 25 countries, in its International IP Index report.

Relationship at risk

Some IP-experts observe that the US would not want to risk its relationship with a newly-elected incoming government by bringing out a critical report on India.

But health workers are concerned that the US may “target India with trade sanctions, ignoring the fact that low-cost generics from India have dramatically lowered treatment costs in developing countries and proved critical to HIV programmes.”

“As India is seen to be acting within global trade rules when its patent office limits the issuance of evergreening patents that prolong monopolies on old medicines - or when it authorises the sale of a affordable generic version of an expensive patented medicine through the use of compulsory licenses, other countries (South Africa and Brazil) are now considering similar policies and legislation.

The US pharmaceutical industry is clearly worried and is now seeking to curb India's influence on patent reforms that increase access to medicines but pose a grave threat to their business model of highly priced patented pharmaceutical products with price tags of tens of thousands of dollars,” said a note from international humanitarian organisation, Medecins Sans Frontieres’ Campaign for Access to Essential Medicines.

Deterioration?

In its 301 submission, GIPC had suggested that India be designated a “Priority Foreign Country, given the rapid deterioration of the nation’s IP environment”.

Much of their criticism comes from India’s implementation of its Patents Act (amended to honour product patents) – particularly after a couple of key judgments went against pharmaceutical multinationals – Novartis (on its blood cancer drug Glivec) and Bayer (on its kidney cancer drug Nexavar).