Saturday, March 1, 2014

India And Pharma IP Wars: Why The Vitriolic Rhetoric -- On Each Side -- Isn't Helpful

"Words," like eyeglasses -- Joseph Joubert said -- "obscure everything that they do not make clearer. . . ."

That is especially true of the recent TRIPS rhetoric -- around drug and biologic intellectual property rights, and India's drive to make life-saving medicines more affordable, for her people -- from all sides. We need more grown-ups in the room, people.

First, the US Chamber of Commerce has (yet again) been rattling sabres -- suggesting that "someone" (i.e., PhRMA) ought to bring action at the WTO, against India, for violating TRIPS. Which has led to some, in India, suggesting that India herself ought to bring the equivalent of an arbitration claim -- prospectively -- under the WTO protocols, before the US Chamber, via PhRMA or another, acts against her.

For India's part, most of the cooler-headed in-country governmental spokespeople point out that the Doha Declaration, under TRIPS, an interpretation letter issued in 2001 (when the US first really fully grasped the implications of TRIPS, to Africa -- and the AIDS epidemic), at Sections 4 through 6, inclusive, provides in pertinent part:

". . .The TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. . . .Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. . . . Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. . . . The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge . . . ."
Again -- India -- as a "member" may act "without challenge" (from the US, the EU or others), to grant generic manufacturers in India a domestic market license to make Isentress®, or raltegravir, as the stuff is known generically (along with other medicines), at an "affordable" price.

True enough, if India later allows these generic manufacturers to resell into other geographies and markets (especially developed markets), without restriction, PhRMA has reasonable grounds to complain -- and complain loudly -- to the WTO. Thus far, at least as to Januvia®, Janumet® and Isentress® though -- no India-based manufacturer has done so -- to my knowlege (I don't think any India based manufacturer has even started making raltegravir yet -- though a license deal was announced last week). But to assert -- as PhRMA has, at year end 2013 -- that Hungary handles its access to medicines/IP problems more ethically than India -- is to ignore facts, circumvent logic, and appeal to. . . prejudice. [PhRMA is better than that. And they know it.]

Finally, many a careful lawyer holds views that may not correspond to his/her narrow economic interests, on these subjects -- as branded pharma's Indian lawyers are reciting the fair-priced access mantra, far and wide. From a recent entry in a pro-pharma IP blog, then -- a bit -- do go read it all (for context):

. . . .Despite the stark lines that some draw around this debate concerning India’s patent regime, the viewpoints of many Indian lawyers are quite nuanced. Last year at the India IP and Innovation Forum, the discussion among the attendees was quite lively. Interestingly, the positions taken did not necessarily correspond with everyone’s direct economic interest; some lawyers who represented innovator drug companies acknowledged that India’s public health was a unique challenge, while access to medicine advocates spoke of the need to properly incentivise research and costly innovation. . . .

A few weeks ago, I said I would write about what TRIPS has to say on the subject. . . this snowy Saturday afternoon is that day. And I will keep after this.

We all need to slow down -- and express ourselves more thoughtfully. Off to shovel soon. . . be kind to one another, for as Monsieur Joubert also said -- "the largest part of kindness, is loving people more than they deserve. . ." And that plainly includes me. . . looking at you, PhRMA. . . Smile. . .

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