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August 09, 2007
Raj Rage
by Peter Pitts
This week's ruling by the Supreme Court of India institutionalizes that incremental innovation in pharmaceuticals isn't important on the sub-continent -- at least when it comes to patent protection..
Many of the usual suspects (Jamie Love, et al.) applaud this decision. But, in reality, it's a horrible blow to global public health -- and particularly to the Third Word, because economically-driven, short-term decisions have deadly unintended consequences.
As Trevor Jones ( a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out relative to treatments for HIV-AIDS:
"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."
The Indian ruling is only the most recent example of how healthcare technology assessment (HTA) aka: evidence-based medicine (EBM) being used to deny not only appropriate patient care, but now case patent protection.
And this is an important link, because minus patent protection, an innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.
(But large Indian generic manufacturers can make a bundle.)
According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without financial incentives and intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.
There are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, boy, are the important. Why? Because that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits – and members of the Indian Supreme Court.
Posted by peterpitts at August 9, 2007 05:25 PM
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