Sunday, February 16, 2014

Of Keeping The Now-Escalating Rhetoric -- On India, PhRMA And Drug Patents -- In Context

Since it is now a quiet, softly-snowing, lustrous Sunday night here at home, and I've been meaning to write on this all week -- I'll finally just sit down, and bang it out -- with Sochi's Super-G, as some welcome background noise. . . .

About ten days ago, I mentioned that the US Chamber of Commerce was "turning up the volume", and the stridency, of its complaints about India's various official government positions on patent rights -- in-country. I speculated that PhRMA -- or multi-national pharma & biotech interests more generally -- might be behind the timing. But I didn't explain why I thought that. Now I am certain of it. This is that story:

Let's first look back -- to New Years Eve 2013, when PhRMA quietly dropped this press release, into the holdiay hopper -- and specifically, this bit:

. . . .If our collective end goal is to continue providing life-saving innovative medicines to all patients, it’s clear that the Indian Government’s tactics are unsustainable.

“Additionally, India’s industrial policy approach to intellectual property ignores issues of fairness. The U.S. is the key market for Indian pharmaceutical companies. . . and they have open and fair access. Meanwhile, India is shutting out U.S. companies and appropriating our technology in order to benefit their homegrown companies. India has a burgeoning middle class of more than 150 million people and vibrant urban regions. Indeed, by some estimates, the Mumbai area's GDP per capita is higher than Hungary's. It does not have to depend on seizing intellectual property. . . .

That last sentence was an extremely unfortunate logical blunder: Hungary's population, overall, is about that of the Chicagoland metro area -- at 9.9 million people (or about half the population of the city of Delhi, alone -- in India). India's population stands at about 1.24 billion -- each as of 2012 year end. Thus Hungary's population is about eight-tenths of one per cent that of India's. In fact, there are more people with serious, life threatening cancers in India -- than there are PEOPLE, overall -- in Hungary. The burden of life-threatening diseases, like cancer, diabetes and hep C -- in Hungary, are thus miniscule -- relative to the burden of the same diseases, in India (both from a financial perspective, and in any "misery index," of human suffering). In India, that burden falls almost exclusively upon the public institutions (arms of government, primarily).

In fact, many cities in India suffer from the highest per capita rates of deadly cancers on the planet -- now that more accurate, timely scientific data sets have been amassed. That's an NIH study, by the way.

And so, it should not be shocking that India is responding more stridently in turn -- to the US-led accusations of allowing, and encouraging IP thievery (by local India-based companies). That was an unwise, erroneous and unfortunate exaggeration, by what I hope were just a few of the junior people at PhRMA (though I suspect it was dictated at the top of the house, honestly). Here is the Times of India (Business Opinion section) -- of Wednesday, just past:

. . . .This is yet another sustained effort by the US to heighten pressure against India to reverse some of its public health safeguards. What is worrisome is that the attack is against India's judicial system, and its balancing of right to health, with intellectual property. . . .

This involves patent cases before independent bodies like the IPAB, and Indian courts, mostly over life-saving cancer medicines priced by companies like Novartis, Bayer, Roche, Pfizer and BMS on an average at an eye-popping price of Rs 1 lakh per patient per month," Leena Menghaney with MSF, Campaign for Access to Essential Medicines, said.

Big Pharma is unhappy that their efforts at evergreening or predatory pricing in India have not worked and are now working through the US authorities to prevent India from working legal flexibilities in the TRIPS agreement, which include a strict patentability criteria to weed out evergreening patent claims, pre-grant patent opposition that increases the quality of patent examination resulting in patent rejections and revocations, and compulsory licensing if a patented drug is unaffordable and unavailable. . . .

The impact of a rollback of IP flexibilities and high standards of patentability would be disastrous both for India and for the millions of patients in low and middle-income countries who rely on India for affordable generic medicines that meet global quality standards."

On the key issues of the Novartis case and compulsory licensing, the submission drives home the point that both instances are not TRIPS-violative, legal experts added. . . .

To be clear, it is true (as PhRMA points out, above) that there may be 150 million middle class people in India -- but that also means there are more than 1.2 billion people who cannot remotely afford Western style medical care -- of any kind. And with cancer rates that exceed 10 per 100,000 of population -- in cities like Delhi, Mumbai and Goa. . . the math is clear: India is producing medicines for export, that her people cannot afford -- and her people are dying, by the millions, all while their relatives provide the skilled labor to manufacture, package and ship the life saving medicines out of India, for pharma to sell, at often astronomical profits (certainly at least, by local Indian standards), in the EU and the US -- due in no small part to the very cheap, highly-skilled labor of mother India. [Some other quiet night, I'll lay out the case that India's actions do not violate TRIPS, an encouraging, and emerging, substantive piece of international patent law permissiveness, for situations. . . like this.]

Finally, PhRMA also claims that 95 per cent of the people in India who got the life saving Novartis Gleevec cancer med -- got it for free. That may only be true because India's courts made it so. Moreover, that means the other five per cent (exclusively from India's middle- and higher- classes) paid regular retail rates for it.

So, "Condor's context" is that India is not a nation of IP thieves -- no, it would seem that (if anything) patent evergreening makes pharma the more likely "true IP thieves." Here endeth the sermon.

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