India is home to a flourishing generics industry with medicines priced among the lowest in the world. Yet, India fares poorly on key health parameters, compared with other similar countries and neighbouring geographies.

Instead of reflecting on the serious issues that impede healthcare in the country, the government has chosen to strike at the roots of innovation by first issuing a compulsory licence (CL) for a pharmaceutical product and then confirming its validity via the IPAB. CLs are extreme measures to be used judiciously. Lack of access to medicines in countries like ours is caused by many factors, including poverty, poor infrastructure and the absence of will to address these issues. OPPI members are committed to working with all stakeholders including government to find appropriate solutions to this challenge. A singular focus on compulsory licensing only serves to divert attention from these more important issues and does significant damage to India’s future leadership in innovation.

CLs are powerful rights granted to governments, designed to be invoked only if a government is satisfied that a situation of national emergency or extreme urgency exists. National emergency and extreme urgency are used synonymously in the TRIPS Agreement. When read with the Doha Declaration, these terms were plainly intended to mean an urgent public health need which arises due to a natural catastrophe, war, or epidemic. Clearly, national emergency or extreme urgency should not be extended to cases of chronic diseases or to cases where a drug is essentially a life extending drug rather than a life-saving one. Use of CLs around the world is rare, and contrary to what has been said, the US has never issued a CL for a pharmaceutical product. Since 2001, only 10 CLs have been issued globally, demonstrating the seriousness with which most countries are using this powerful tool.

Lack of clarity within the Indian Patents Act regarding definitions of critical terms such as “working of patents”, what constitutes “reasonable requirement of the public” and benchmarks for “affordable price” results in subjective interpretation on how and when CL can be implemented.

Issuing CLs will not make a significant impact on access; even at reduced prices generics are simply out of reach for two-thirds of the population of India and will ultimately damage our ability to foster homegrown pharmaceutical innovation.

Intellectual property rights are the drivers of innovation; if the government continues to stifle IPRs, it will hamper innovation to the extent that we will have no new medicines to meet unmet medical needs. Is that the end we are looking for?

(The author is President, OPPI.)

(This article was published on March 8, 2013)
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