[Ip-health] editorial: Thai CLs, Novartis case, and the IGWG

[Benjamin Krohmal]

http://www.bangkokpost.net/News/07Feb2007_news19.php

Wednesday February 07, 2007
Bangkok Post
Generic drugs under assault

A Bangkok Post editorial last week (''The bottom line is people's
health'', Jan 31) rightly pointed out that in granting compulsory
licences for the anti-Aids drug Kaletra and the heart medication
Plavix on Jan 29, as well as earlier for Efavirenz, another HIV
medication, the Public Health Ministry is well within compliance with
the World Trade Organisation's agreement on Trade-related aspects of
Intellectual Property Rights (TRIPS), signed by all WTO members in
2001. Yet there have already been high-level visits on behalf of
multinational pharmaceutical companies to attempt to persuade the
interim government to abide by ''TRIPS-plus'' measures. A major
assault on access to life-sustaining generic drugs is taking place in
India, however. Previously, India's patent law was restricted to
process, not product, and then only for seven years. In other words,
if a drug patented by a Western pharmaceutical company could be
produced by a different process in India, it could be produced
without breaking the country's patent law.

This provision enabled India to become the undisputed generics
manufacturing centre of the world, much to the displeasure of Western
pharmaceutical companies.

Since April 2005, Indian patent law has been modified to adhere to
TRIPS provisions that recognise international patents on drug
products for a period of 20 years, unless it can be shown that the
patents don't involve any ''innovative molecular research'' _ a
provision fully within TRIPS guidelines.

Since the passage of the 2005 law, many generic drugs manufactured in
India have been shut down. Yet India, like Thailand, is also being
pressured to implement measures which it feels go beyond WTO
guidelines. In a landmark case, the Swiss drug giant Novartis AG is
appealing in an Indian court over the rejection of a patent for its
modified leukaemia drug Gleevac on the grounds that it is not
sufficiently innovative. The treatment costs for Gleevac and the
generic copy per month are about US$2,000 and $175, respectively
(about 70,000 and 6,125 baht). There are signs that the Indian
parliament is bending to corporate pressure. It has introduced a
report for court consideration which recommends a lessening of the
degree of innovation required for a new patent. The worry is that a
patent for most drugs could be extended merely by making minor
modifications, as happens routinely in the US and other Western
countries. This would represent a significant threat to accessibility
of generic drugs not only in India, but throughout the developing world.

Another legal obstacle to generic drugs in India is looming.
Multinational companies want to forbid generics manufacturers from
using their data from clinical trials in proving the safety of drugs
coming off-patent. This would make the licensing process for the
generics much more time-consuming and expensive.

It is too simple to demonise multinational pharmaceutical companies.
Some of them, including Novartis, have in some cases been willing to
make life-sustaining drugs available to those most in need at little
or no cost. As long as profit remains the bottom line, however, it is
a sure thing that choices will be made which limit access to
essential drugs, and diseases that affect mostly poor people, such as
TB and malaria, will continue to be underfunded.

Perhaps what is really needed is a system that is driven by global
health needs rather than by profit. Preliminary efforts toward this
objective were begun at the World Health Organisation's World Health
Assembly 2006. An inter-governmental working group was set up to
develop a global strategy to address TRIPS-plus disputes. The working
group was also charged with coming up with proposals on how to
''ensure an enhanced and sustainable basis for health research'' and
direct research to address diseases that affect mostly developing
countries, something that would require large increases in R&D
spending by governments and international organisations.




Benjamin Krohmal
Coordinator - Project on Medical Innovation
Consumer Project on Technology
Tel: +1-202-332-2670 ex. 14
Fax: +1-202-332-2673
ben.krohmal@cptech.org