The production of generic drugs in India
BMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d1694 (Published 22 March 2011) Cite this as: BMJ 2011;342:d1694
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Sir
In Mr. James Love's recent editorial entitled "The production of
generic drugs in India", he repeats many myths that surround the Free
Trade Agreement. He also ignores the benefits that will accrue
to India and Indian citizens from balanced provisions for intellectual
property in the FTA.
Mr. Love informs us that the negotiations on the terms of the FTA are
being conducted "in secrecy", but then proceeds to criticize and alert
your audience about the alleged content of the negotiation. What he offers
are hyperbole and straw men: "The EU has asked India to sacrifice access
to life saving drugs for market access in other areas of the economy",
"Trade officials in Europe want India to implement a similar regimen" to
that currently in place in Europe, or that the EU wants to "remove India
as a legal market for early production of generic drugs".
By his own admission he does not know this to be the case, and the
reference he offers fails to support his assertions. Historically, in no
other FTA has a European-type regime been adopted. In fact, negotiations
have always centred on creating IPR provisions which match the stage of
development of the country concerned. It seems more reasonable to imagine
this will also be the case in the EU- India FTA, rather than the doomsday
scenario painted by Mr. Love.
Mr. Love also ignores the one aspect of these negotiations
that is clearly not secret, i.e. the public positions taken by both the
European Commission and the research-based pharmaceutical industry. Both
have said that the FTA should not undermine access to medicines in
developing countries; indeed the research-based industry already works
hand-in-hand with Indian generic manufacturers to ensure the production
volumes required. Presumably these facts do not fit the narrative, and are
therefore ignored.
Furthermore, he argues that the introduction of intellectual property
protection would somehow have an impact on the developing world, because"
Few developing countries have a large enough domestic market to attract
and stimulate entry by suppliers of generic drugs". In fact the growth of
the Indian generic sector has been built upon its export success, not its
supply to the Indian domestic markets. Furthermore, this growth has been
particularly strong since the introduction of the Indian Patent Act in
2005, another event predicted to cause the demise of the generic
manufacturers.
A well constructed, well-balanced EU -India Free Trade Agreement will
bring considerable benefits to both parties and to all sectors, including
pharmaceuticals. To suggest otherwise is to deny India's strong science
base access to the tools and security it needs to create its own research-
based industry.
Brian Ager
Director General
European Federation of the Pharmaceutical Industries and Associations
(EFPIA)
Brussels
Competing interests: No competing interests
The production of generic drugs in India
Thank you for the editorial setting out so clearly how the EU trade
agreement currently being secretly negotiated with India could add
significantly to the burdens of the poor. I refuse to believe, despite
the evidence that we don't care about the poor. The other alternative is
that we do not understand well enough what is going on; hence the
importance of this publicity. The EU 'democratic deficit' and secret
negotiations by semi-autonomous elites fuel this suspicion but it is
important that we do understand what is going on because what they decide
implicates us all.
The current global situation is bad and we should at least try not to
make it worse. But it is becoming increasingly difficult to believe that
we do care by the stark figures of growing global poverty - the bottom 50%
of global population have 3% of household income whilst the top decile
have 71.1%, and increasing(1). Our current financial problems pale into
insignificance compared to the state of the 3 billion globally living in
absolute poverty, and should not be used as an excuse to limit access to
drugs in a cynical move to milk yet more money out of the poor.
The more people who know about this the better but the problem is
that knowing is not enough. Political action is required in order to
influence the legislating powers. Unfortunately it is deemed morally
acceptable in the current climate of market-based global economy to ignore
the consequences in the search for increasing profit. The pharmaceutical
companies will have an effective political lobby seeking their (apparent)
legitimate interests irrespective of the consequences for the Indian
people and other poor nations(2).
Doctors have a duty to tell the truth about impact on public health
and advise both those taking decisions and their voting constituents. Not
only is the agreement made on all of our behalves but the consequences in
a global world will also rebound on us all, and not just in a narrow short
-term financial way. Those who believe that we should strive for more
justice and equity in our own interests and the interests of all must
speak out. I hope you and the readers of the BMJ will follow this issue
and work for a better outcome.
1 Pogge, T. Politics as Usual. Polity Press, 2010.
2 Baggott, R. Public Health: Policy and Politics (Second Edition).
Palgrave Macmillan, 2010.
sandro.limentani@btinternet.com
Competing interests: No competing interests