LIFE, OR SOMETHING LIKE THAT

From: Dr. Jai Maharaj (usenet_at_mantra.com)
Date: 12/09/04 

Date: Thu, 09 Dec 2004 23:30:33 GMT

LIFE, OR SOMETHING LIKE THAT

Life, or something like that

The new patent regime might consolidate the drug industry in the hands of a
few players. India must find answers to where protectionism begins and
public interest ends

By Yoga Rangatia
Insight
The Pioneer
Sunday, December 5, 2004

The world looks up to India for making good quality cheap drugs, even for
dreaded infections like HIV/AIDS. But the countdown to January 1, 2005, and
the Government's obligation to align with a global patent regime, could
change the situation. The question everyone is asking, and no one seems to
have an answer to, is the impact this new system will have on drug
availability and affordability.

The crux of the Indian success story was the ability to "reverse engineer"
chemical molecules that were found effective in treating illnesses. And
marketing drugs in the rest of the developing world which does not have a
strong pharmaceutical industry. The Indian companies themselves did not
invent new molecules, thereby cutting costs that it would have otherwise
incurred on research and clinical trials.

The gain was at the cost of pharmaceutical companies that were heavily
investing in research for newer chemical entities. In 1995, India had
promised that it will switch to product patent system, which will further
strengthen the innovator's right to market the new product, profit from
which will recover the investment made on research. The domestic industry
would not be allowed to "copy" the product for about 15 years. The
Government also agreed that a "mailbox" facility will be setup for patent
application after that period and this will be opened for consideration on

January 1, 2005.

In the meantime, the Centre was expected to make changes to its Patent Act,
1970, enforcing these provisions in India. The previous Governments have
undertaken some amendments to this effect, but contentious provisions have
not yet taken shape.

Take for instance the provision to leave a window period for registering
protest with the patent office before a patent is granted, called "pre-
grant opposition". Experts say, the provision avoids expensive litigation
in courts after the patent is granted. The provision exists in the present
patent system and, more importantly, the Trade Related matters of
Intellectual Property Rights (TRIPS) does not require India to do away with
this flexibility.

What worries consumers and the domestic industry more is the kind of
patents that will be granted in the new regime. Will minor modification to
an existing molecule be eligible for patents? Or a newer way of taking the
drug (say injectibles in place of oral pill) be eligible for the patent?
Those against the provision say that if the law is ambiguous, it can be
easily misused by companies to extend their market monopoly beyond say 15
to 20 years and profit from lack of competition. Domestic industry is
against granting patents on isomers, polymorphs and metabolites of already
existing patents. Both these provisions will have an immediate bearing on
about 4,000 patent applications that are said to have accumulated in the
mailbox since 1995.

Surely, all of these cannot be new chemicals, but improvisation by
companies to make the most of the change in patent regime. If not remedied
in the new Amendment Bill, critics warn, a situation may arise where some
drugs will have to be recalled by domestic manufacturers, shooting up their
prices immediately. Experts argue that while putting in place a newer
system, India must include measures to prevent patent system misuse.

The Doha Declaration of the WTO Ministerial round allowed Governments
"compulsory licensing" of drugs, should a situation of national emergency
arise. Other arguments are in favour of a price control mechanism super-
imposed on the product patent regime. Canada, for instance, had switched to
the product patent regime. But its Government clamps price control if
manufacturers make unreasonable profits. Even the US Government buys drugs
from its neighbour, where they are cheaper. India should also keep the
"stick" handy, should one need it.

While looking at the issue afresh, the Manmohan Singh Government will be
drawing the fine line between encouraging innovation and discouraging
restrictive monopoly. The Government has responded with setting up a group
of Ministers, led by Defence Minister Pranab Mukherjee, to look into the
issue. Both the ally Left and the Opposition NDA have not revealed their
cards on whether they will vote for the Bill if introduced in the
Parliament. They are probably still watching the Government's next move.

The manner in which successive Governments have responded to the issue of
such vital importance to public health is disappointing. The whole process
of policymaking is shrouded in secrecy, lending suspicion that the
Government is yielding to powerful pressure groups. Take for instance the
manner in which the Commerce Ministry moved a hush-hush Cabinet note order
in July 2004 to pass an Ordinance in the third amendment. It was only after
the matter was referred to the GoM that the Chemicals and Health Ministry
came into the picture. Even now, there is no saying whether the Bill will
be introduced in the Parliament this winter session, in time for the
January 2005 deadline. Commerce Minister Kamal Nath might be tempted to
take the Ordinance route.

The no-show by the Health Ministry on the issue is also appaling. The
Government has not conducted any in-depth study on what impact a tougher
patent regime on drugs can have on availability and affordability. The
babus of Nirman Bhavan have opined that since most drugs that are
ordinarily consumed are already off-patent, there will be no immediate
price rise. There are no answers to the long term impact of the new system.
Only recently, the Ministry setup a WTO cell but whether their views are
sought before the GoM meet is not known.

Lawmakers must also share the blame for not having studied the issue. The
impact of the TRIPS agreement has not figured in Parliamentary discussion
thus far. The Lok Sabha hardly takes up these issues. The Parliament
committees have also not scored well. The powerful Standing Committee on
Commerce has also not taken up the matter for discussion, yet.

Will the new patent regime consolidate the drugs industry in the hands of a
few multinational players? After 2005, will there be sufficient competition
in the market to push drug prices down? These are some question India must
find answers to.

As the world economy integrates, there are serious posers. One needs to ask
where protectionism begins and public interest ends.

More at:
http://www.dailypioneer.com

Jai Maharaj
http://www.mantra.com/jai
Om Shanti

Hindu Holocaust Museum
http://www.mantra.com/holocaust

Hindu life, principles, spirituality and philosophy
http://www.hindu.org
http://www.hindunet.org

The truth about Islam and Muslims
http://www.flex.com/~jai/satyamevajayate

The terrorist mission of Jesus stated in the Christian bible:

     "Think not that I am come to send peace on earth: I came not so send
peace, but a sword.
     "For I am come to set a man at variance against his father, and the
daughter against her mother, and the daughter in law against her mother in
law.
     "And a man's foes shall be they of his own household.
 - Matthew 10:34-36.

     o Not for commercial use. Solely to be fairly used for the educational
purposes of research and open discussion. The contents of this post may not
have been authored by, and do not necessarily represent the opinion of the
poster. The contents are protected by copyright law and the exemption for
fair use of copyrighted works.
     o If you send private e-mail to me, it will likely not be read,
considered or answered if it does not contain your full legal name, current
e-mail and postal addresses, and live-voice telephone number.
     o Posted for information and discussion. Views expressed by others are
not necessarily those of the poster.

FAIR USE NOTICE: This article may contain copyrighted material the use of
which may or may not have been specifically authorized by the copyright
owner. This material is being made available in efforts to advance the
understanding of environmental, political, human rights, economic,
democratic, scientific, social, and cultural, etc., issues. It is believed
that this constitutes a 'fair use' of any such copyrighted material as
provided for in section 107 of the US Copyright Law. In accordance with Title
17 U.S.C. Section 107, the material on this site is distributed without
profit to those who have expressed a prior interest in receiving the included
information for research, comment, discussion and educational purposes by
subscribing to USENET newsgroups or visiting web sites. For more information
go to: http://www.law.cornell.edu/uscode/17/107.shtml
If you wish to use copyrighted material from this article for purposes of
your own that go beyond 'fair use', you must obtain permission from the
copyright owner.