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<P><FONT class=storyhead color=blue size=4><B>Patently unfair </B></FONT>
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<TD>The third amendment to the Indian Patents Act, due to be passed
in the winter session of Parliament, threatens to compromise the
public's access to essential medicines and, thereby, people's right
to health. AMMU JOSEPH explores the implications of the proposed
legislation for citizens in the context of the passage of Human
Rights Day — December 10 — which looks at among other things, the
right to health and healthcare. </TD></TR></TBODY></TABLE>
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<CENTER><FONT size=-2>TANNEN MAURY/BLOOMBERG NEWS </FONT><BR><IMG
height="300"
DEFANGED_src="http://www.thehindu.com/thehindu/mag/2004/12/12/images/2004121200310301.jpg"
width="232" align="center" border="1"> <BR><B>Life-saving medicines could become
extremely unaffordable. </B></CENTER>
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<P align=justify>NEW year resolutions may have to include "I will stay
healthy," backed up with crossed fingers and touched wood, if the Patent
(Amendment) Bill, 2004 becomes law in its current form. According to
public interest groups working on health issues, the prices of drugs
required for the treatment of many common diseases could shoot up if the
Government goes ahead with pushing the Bill through Parliament during the
winter session or even, as some reports suggest, issuing an ordinance that
will render the amendment a reality without the inconvenience of a
legislative debate, let alone a public one.
<P align=justify>Unlike most year-end resolutions, which generally depend
on individual will, good health clearly cannot be guaranteed through
personal endeavour. Among those likely to be affected by the proposed
amendment are the large numbers of people suffering from a wide range of
illnesses — including life-threatening and chronic conditions — such as
diabetes, asthma, hypertension, coronary heart disease, schizophrenia,
depression, cancer, HIV/AIDS, arthritis, spondylitis, and respiratory and
urinary tract infections. This is because the relatively low-cost, locally
manufactured generic drugs that are currently available to patients here
may have to be withdrawn from the market when the patent applications
pending for several medicines used in the treatment of these and other
ailments are granted, as they are likely to be, under the proposed
legislation.
<P align=justify>Health advocates suggest that it is time citizens became
aware of the sword of Damocles hanging over their heads and got involved
in protecting the public's right to health and healthcare, which is
critically dependent upon access to affordable medicines. It is
significant that the October 2004 report of the Fourth People's Commission
on Review of Legislations Amending Patents Act 1970, chaired by former
Prime Minister I.K. Gujral, with a number of eminent persons as members,
reflects the concerns of health activists.
<P align=justify><FONT class=subsectionhead color=red size=3>Obligation
under TRIPS
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<P align=justify>The controversial third amendment to the Indian Patents
Act, 1970 relates to India's obligations under the global agreement on
Trade Related Aspects of Intellectual Property Rights (TRIPS), adopted in
1994 as one of a package of agreements that member states of the World
Trade Organisation (WTO) must adhere to. Under the agreement, developing
countries like India have to introduce patent protection for
pharmaceutical and agro-chemical products by January 1, 2005.
<P align=justify>The Indian patent law has already been amended twice — in
1999 and 2002 — to comply with TRIPS. Thanks to earlier amendments, the
term of patent protection has been extended from seven to 20 years, and
Exclusive Marketing Rights (EMR) are available for drugs and
agro-chemicals, allowing manufacturers a monopoly over products even
before their patent applications are approved.
<P align=justify>The primary purpose of the present Bill is to introduce
product patents, as required by TRIPS. At present Indian law provides
patent protection for processes — not products — in the pharmaceutical and
food sectors. Since a process patent gives the owner exclusive right only
over the manufacturing process, anyone can make and sell a particular
product as long as they use a different process to produce it. On the
other hand, a product patent prevents others from manufacturing, selling,
distributing or importing the patented product — even versions produced
through different processes — without authorisation.
<P align=justify>The process patent regime that has prevailed so far, and
the competition that it has allowed, has kept the prices of medicines in
the country amongst the lowest in the world (even though certain recent
developments in drug policy have already driven the cost of several drugs
up to unprecedented levels). With the introduction of a product patent
regime, patent owners will be able to monopolise the market for 20 years
and, in the absence of competition, get away with exorbitant prices that
could put many essential medicines out of the reach of the majority of
Indians.
<P align=justify><FONT class=subsectionhead color=red size=3>Likely impact
of monopolies
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<P align=justify>The case of a drug used in the treatment of patients
suffering from Chronic Myeloid Leukaemia (CML) illustrates the likely
impact of monopolies in the pharmaceutical sector. The generic version of
the drug, produced in India, costs Rs. 9,000 to Rs. 12,000 per month. The
government has now granted EMR to Novartis AG for their version of the
drug, Gleevec. If it is enforced, generic versions of the drug will have
to be withdrawn from the market, forcing most Indians suffering from CML
to do without the life-saving medicine because Gleevec is priced at an
astronomical Rs. 1,20,000 per month. Their fate now hangs in the balance,
with both the pharmaceutical industry and civil society groups having
challenged the grant of EMR for this product before the Supreme Court.
<P align=justify>Health activists allege that the Bill in its present form
does not use the limited flexibility available within TRIPS, especially in
the context of the 2001 Doha Declaration on Public Health. Despite several
ambiguities and deficiencies, the latter does state that the agreement
should be interpreted and implemented in the light of WTO member
countries' right to protect public health and promote access to medicines
for all.
<P align=justify><FONT class=subsectionhead color=red size=3>A loophole
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<P align=justify>For example, the Bill appears to provide a loophole for
pharmaceutical companies to keep products patented in perpetuity by
proposing grant of patents for existing drugs for which a "new use" has
been found — even though there is no obligation under TRIPS to issue
patents for different uses and/or dosages of known medicines. Even the
official committee that looked into the regulation of the pharmaceutical
sector, headed by Dr. R.A. Mashelkar, had recommended just last year that
patents should be given only to new chemical molecules or entities, so as
to limit the number of patent protected drugs. Health activists believe
that this provision will extend patent protection to medicines even after
the 20-year period, for less than valid reasons.
<P align=justify>This provision also nullifies the common assertion that
product patents will not push the cost of medicines up because most drugs
used for common ailments are already in the generic category. This
argument is misleading because new and better drugs required for the
effective treatment of many illnesses are constantly being produced and
patented. At present, locally manufactured versions of many new drugs are
available in the country for a fraction of their cost in most other parts
of the world. The situation is expected to change once product patents
come into force.
<P align=justify>Take the example of "atypical anti-psychotic" drugs, used
in the treatment of schizophrenia, a common and life-long mental illness.
There is currently little price difference between old and new drugs in
this category here, and the prices of locally produced brands are far
lower than those of multinational companies. As a result even public
hospitals such as the National Institute for Mental Health and
Neurosciences (NIMHANS) in Bangalore are increasingly prescribing the
latter, which have fewer side-effects and ensure better quality of life.
If the patent application pending for one of these drugs — Olanzapine — is
successful, cheaper local versions of it will no longer be available to
patients here. No doubt more drugs in this category — and others — will
soon follow suit.
<P align=justify><FONT class=subsectionhead color=red size=3>The
implications
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<P align=justify>The financial implications of sharp increases in the cost
of medicines are particularly serious in the Indian context. In the
absence of an effective public health system and universal — let alone
public — health insurance, patients here, and their families, typically
shoulder the entire burden of medical expenses, including purchase of
drugs.
<P align=justify>Another worrying aspect of the Bill is that it apparently
proposes to do away with the "pre-grant opposition procedure," an
important mechanism that enables civil society to block frivolous patents.
According to health activists, with nearly 5,000 patent applications for
pharmaceutical products currently pending in the mailbox (a majority filed
by foreign corporations and individuals), public scrutiny is essential to
ensure that only necessary, useful drugs are granted patents.
<P align=justify>The Bill's provisions relating to compulsory licenses —
an important mechanism within TRIPS that allows countries to get around
patent monopolies under certain, specified circumstances — are also being
opposed by health activists, who believe that a complete revamp of the
compulsory license system is called for in the interest of public health.
The significance of compulsory license becomes clear in the context of
treatment for people living with HIV/AIDS (PLHA).
<P align=justify>As recently as four years ago, millions of PLHA across
the world, and in India, could not afford the cost of treatment with
antiretroviral (ARV) drugs, known to prolong the lives of HIV+ people. At
that time prices ranged between US$ 10,000 and 12,000 (approximately Rs.
4,50,000 to Rs. 5,40,000) per person per annum. Prices began falling when
Indian manufacturers introduced generic versions of ARV drugs until, by
2003, the annual cost per person had come down to US$ 140 (about Rs.
6,300).
<P align=justify>Such a dramatic decrease was possible because of India's
process patent regime, which is about to pass into history. The
introduction of a product patent regime will make compulsory licenses all
the more important for the promotion of public health. Yet the Bill
reportedly does little to strengthen this mechanism and ensure that it can
be used at least to the extent envisaged in the Doha Declaration.
<P align=justify>Health activists point to a number of legal documents,
both international and national, including the International Covenant on
Economic Social and Cultural Rights and India's Protection of Human Rights
Act, 1993, to argue that the country must not trade away its right, and
duty, to protect and promote public health. A number of other landmark
documents relating to health, including international ones such as the
1978 Alma Ata Declaration and the 2000 People's Charter for Health, as
well as domestic ones like the 1946 report of the Health Survey and
Development Committee headed by Sir Joseph Bhore and the 1983 National
Health Policy recognise the provision of essential drugs at affordable
costs as a key ingredient of a humane and just health policy.
<P align=justify>Speaking at the World Health Assembly in Geneva in 1981,
Indira Gandhi said, "My idea of a better ordered world is one in which
medical discoveries would be free of patents and there would be no
profiteering from life or death." It would be ironical if, by passing this
Bill in its present form, those who claim to represent her legacy foist a
very different world on the people of this country.
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