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July 19, 2006

India has nothing to fear from either patent protection or data exclusivity

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Last year, when the Government of India adopted its patent amendments as required by TRIPS, health activists carried out concerted campaigns to try to avert what they characterized as a "public health disaster in the making."  But the bottom line is that the law has been in effect since January 1, 2005, and so far there is no evidence of any catastrophe in terms of pricing, availability and access of essential medicines in India, or in developing countries importing from India. Instead, it has fueled a continuing boom in investment in R&D and contributed to brain-gain as Indian scientists return home to pursue innovation in their own culture, as they have historically done abroad.  And India grows richer.

Patent law isn’t a social panacea, but nor is it a public health threat.

Now the same group is at it again with their tired arguments, both misrepresenting the Indian government’s obligations under TRIPS to provide basic protection for commercially valuable test data, and decrying the policy as harmful to public health.  In fact, it is uniformly the case that developing countries with data exclusivity enjoy better access to more innovative products sooner.  And not having data exclusivity in India has not been a panacea for public health.

The funniest part is that at the last rally in DC, there were more acronyms than protesters.  See
They played their drums, chanted their chants ("medication for every nation!") and sang their songs, railing against the companies who are investing their money and efforts trying to find treatments and cures for AIDS.

The connection to the World Health Organization (WHO) is that activists there successfully got the WHO to “interpret” the WTO TRIPS Agreement so as to read out the explicit obligations detailed in TRIPS Article 39.3 that nearly all developing and developed countries interpret as requiring data exclusivity.  Then they push the WHO’s false conclusions onto the Government of India as somehow sacrosanct, though they fly in the face of experience and WTO member practice.  

The bottom line is that this is an ideological, anti-IP campaign that conjures up catastrophic, fear-mongering scenarios that are based on the fiction that IP is a barrier to public health.  But there is precious little proof of that, and plenty of evidence of the benefits to health that have been derived through the IP-based system of innovation.

Fortunately,  it looks like the Indian Government has the confidence of its convictions and won’t be sidetracked on data exclusivity any more than it was on patent protection.  And, like patent protection, data exclusivity will be good for development of new medicines in India, and good for patients.

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