[Ip-health] Obama & the P-word
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Wed Nov 10 10:00:28 PST 2010
Obama & the P-word
Created 9 Nov 2010 - 00:00
Patralekha Chatterjee 
Patralekha Chatterjee 
Can a US President visiting India avoid the “P” word? The answer is a resounding
“no”, as Barack Obama learnt the hard way. His attempt to avoid a direct
reference to Pakistan while remembering the November 26, 2008, Mumbai terror
attack victims met with high-decibel protest in this country on the very first
Soon, at an event meant to be a powwow between the youthful US President and
India’s GenNext, a student popped the question: Why does the US not declare
Pakistan a “terrorist state”? Mr Obama’s diplomatic response — Pakistan has a
lot of potential, but has some “extremist elements within it” and it is by no
means the only country to have such elements, et cetera — promptly became the
prime topic of discussion in almost every TV channel and newspaper. The
headline-grabbing “P” word surfaced several times on Monday, during his press
conference, and in his address to the Indian Parliament.
But there has barely been a mention of the other “P” word — pharmaceuticals —
though there are big issues between India’s pharmaceutical industries, in
particular generic drug manufacturers, and Big Pharma in the US. In the run-up
to Mr Obama’s visit, public health activists, both within and outside this
country, have sounded the alarm on many of these issues.
On November 4, the US-based NGO Health GAP (Global Access Project) stated:
“Civil society organisations in the US and India are gravely concerned that
President Obama is seeking policies that will undermine access to affordable
Indian generics”. Such organisations argue that India’s status as “pharmacy to
the developing world”, its ability to make low-cost, generic versions of newer
medicines, is under threat; even US-funded AIDS treatment programmes, heavily
dependent on generic versions of AIDS medicines made by Indian manufacturers,
will be forced to waste money procuring more costly medicines.
The early shots were fired months back. This May, the United States Trade
Representative (USTR) released its annual “Special 301 Report”, listing
countries that USTR claims are not protecting intellectual property
sufficiently. India remains on its “Priority Watch List”, in part because
India’s laws require patented medicines to show actual increased effectiveness
in treating a disease.
In recent weeks, business journalists in India have reported on the warning by
big pharma companies in the US that New Delhi could lose out in the global
competition in attracting investment from them if the country refuses to
strengthen regulatory protection for patented drugs.
The soaring oratory of statesman-salesman Obama and his positive message to
India, as he addressed representatives of over a billion people in the Central
Hall of Parliament, will be discussed and dissected for days. But predictably,
the US President avoided the other “P” word, given its huge potential to strike
a dissonant note. But behind the scenes, the pressure is not going away. The US
as well as the European Union are asking India to grant monopoly protection to
the data that drug companies use to obtain regulatory approval for a medicine.
This measure, called “data exclusivity”, would undermine cost cutting generic
competition by delaying the entry of generics to market. Data exclusivity is not
required by the World Trade Organisation (WTO) — but pharmaceutical companies
have pushed aggressively for it. India’s refusal to create a regime of data
exclusivity was another reason for the Special 301 Report listing.
A few days back, a top official with the US drugs regulator had hinted at
tighter regulation for generic drugs, a move that could spell trouble for the
Indian industry that depends on the world’s largest drug market — the US — for
about a quarter of its exports.
I caught up with James Love, director, Knowledge Ecology International, a
US-based NGO which has been working on the issue of affordable medicines. In a
recent article in the Huffington Post, Mr Love had flagged his key concerns
about specific aspects of the US-India business relationship, the central focus
of Mr Obama’s trip to India.
A number of NGOs working on public health issues, Mr Love pointed out, are
concerned that the President may push India to adopt more strict intellectual
property protections on pharmaceutical drugs.
India enacted legislation in 2005 to implement its WTO obligation to grant
patents on pharmaceutical products, but with safeguards. These safeguards, which
were allowed by the WTO rules, were praised by public health groups, but
condemned by big drug companies.
As candidates, both President Obama and secretary of state Hillary Clinton told
health and development groups they would change the Bush administration policy
of pressuring developing countries over the issue of drug patents. But now, the
Obama administration has reportedly called upon its regulators to push India
hard to do more. Washington wants India to lower its standards for awarding
Another provision under attack is compulsory licensing, a green signal which can
be given by a government for production and supply of a generic version of a
patented drug in lieu of reasonable royalty to the patent holder. It is a legal
means of getting cheaper medicines.
Compulsory licensing has been invoked not just by developing countries such as
Mozambique, Zambia, Indonesia, Brazil or Ecuador. Even developed countries such
as Italy and Canada have invoked it in the past for medicines which were
unaffordable or unavailable. The US threatened to issue a compulsory licence for
the antibiotic Cipro following the anthrax attacks a few years ago. Drug
companies responded by lowering their prices by as much as 40 per cent.
But such mechanisms which provide safeguards for consumers are now supposedly
under review. The Organisation of Pharmaceutical Producers of India, a group of
multinational drug-makers, feels that provisions like compulsory licensing can
impact foreign investment and innovation in the country.
Are public health groups, including the Nobel Prize-winning Medecins Sans
Frontieres (MSF) which campaigns for access to affordable medicines, being too
idealistic in objecting to these efforts to push higher Intellectual Property
Rights (IPR) norms for the Indian pharma industry? What about innovation? Drug
manufacturers say they have to have a strong IPR regime to be able to finance
research that will lead to new medicines. But strong patents are likely to lead
to costlier drugs in the current scenario. How can innovation be made compatible
with access to affordable medicines? These are issues too important to be left
just to politicians and bureaucrats. If I am going to pay a lot more for
life-saving drugs, I would want to be as informed as possible about all the
issues on the table.
Patralekha Chatterjee writes on development issues in India and emerging
economies and can be reached at patralekha.chatterjee at gmail.com 
Copyright © 2010 The Asian Age. All rights reserved.
Source URL: http://www.asianage.com/columnists/obama-p-word-095
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