Press Release

PhRMA: Compulsory Licensing in India

PhRMA March 13, 2012

Washington, D.C. (March 13, 2012) — PhRMA President and CEO John Castellani issued the following statement today, on India issuing a compulsory license:

“The research based pharmaceutical industry believes that all people around the world should have access to quality healthcare and lifesaving medicines. In partnership with other stakeholders, the industry is committed to playing a full part in addressing the healthcare challenges of the developing world by taking an innovative, responsible, and, above all, sustainable approach.

“While India has not routinely issued compulsory licenses (CL), PhRMA believes it is not an appropriate tool even if granting CLs may be a legal option. Assessments of particular compulsory licensing policies and decisions need to be made on a case-by-case basis, taking into account a number of factors. Legitimate health emergencies that require making exceptions to intellectual property rights can and should be accommodated under the international framework, but only after exhausting all other efforts and under extraordinary circumstances.  

“PhRMA will not address the specifics of this case. However, one aspect that is particularly troublesome is the contention that “working” a patent requires a company to manufacture within India. It is our firm belief that this is fully at odds with India’s TRIPS commitment (as well as its broader WTO obligations), and distorts what was intended as a public health exception into an industrial policy.

 “The research based pharmaceutical industry fully supports the objective of improving access to innovative medicines; however, CLs cannot solve India’s larger problems regarding access to medicines and healthcare. If countries begin to routinely use CLs, we could see a “race to the bottom” in which governments in the developing world walk away from their responsibility to support research and innovation in public health. In the absence of the investment made by our members, and the resulting research and development, there would be no generic medicines for the world’s patients. The responsibility to promote development of new drugs lies with all countries, not solely those in the developed world.

“Our member companies are fully committed to working with governments around the world in addressing access issues and solving emergencies as they have demonstrated countless times.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.4 billion in 2010 in discovering and developing new medicines. Industry-wide research and investment reached a record $67.4 billion in 2010. 

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