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Healthy Skepticism Library item: 19763

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Khor M
TWN Info Service on Intellectual Property Issues
Third World Network 2012 Jan 14
www.twnside.org.sg


Abstract:

POSER OVER MEDICINE SUPPLIES


Notes:

This was first published in The Star (Malaysia), January 9, 2012


Full text:

Patients worldwide suffering from various ailments have benefited from cheap
generic Indian drugs. But will Indian companies be able to supply new drugs
in the future?

INDIA may be more famous for the Taj Mahal, its religious ceremonies,
Bollywood films and one of the highest economic growth rates in recent
years. But more than all these, India has had positive worldwide impact through its
large supplies of low-cost, good quality generic medicines. Millions of
lives have been saved or prolonged by this.

Many people go to India to buy life-saving generic medicines from pharmacies
and bring them back in suitcases to give to relatives who cannot afford the
expensive original products.

A decade ago, an Indian company called Cipla produced HIV-AIDS generic drugs
that could treat a patient for US$300 (RM930) a year, far cheaper than the
branded product’s cost of US$10,000 (RM31,000) a patient a year. Today, the
Indian drug cost has been cut further to below US$80 (RM248).
This has enabled millions more AIDS patients to be treated. India supplies
70% of the HIV-AIDS drugs obtained by Unicef, the Global Fund and Clinton
Foundation for developing countries.
And 75%-80% of medicines (not only for AIDS) distributed by the
International Dispensary Association to developing countries come from
India. No wonder India has been termed the pharmacy of the developing world.

Last week, the Indian Drug Manufacturers’ Association (IDMA), which has 700
drug companies as members, celebrated its 50th anniversary. There was much
to celebrate, including the industry’s high growth, wide range of medicines,
and its contribution to good affordable drugs.

But there are also many factors that may hinder the continuation of the
companies’ role as chief supplier of medicines for developing countries.
A main factor of the industry’s success has been the government’s move in
1970 to exclude pharmaceutical drugs from product patents.
This paved the way for local companies to produce generic versions of the
expensive foreign drugs, and within a few decades they had taken over 80% of
the local market, while also supplying cheap medicines abroad.

The situation took a negative turn when the intellectual property agreement
known as TRIPS was established in 1995 together with the World Trade
Organisation. It disallowed countries from excluding medicines from
patentability.

However, TRIPS allowed countries to determine the criteria for an invention
that can be granted a patent, and the ability of the government to grant a
compulsory licence to local companies to produce the patented products if
their requests to patent owners to give a voluntary licence do not succeed.

To implement its TRIPS obligations, India passed changes to its patent law
in 2005 so drugs could now be patented.
However, the new law also contained flexibilities such as strict criteria
for patentability (trivial changes to a patent-expired product would not
qualify for a new patent), allowance for public opposition to a patent
application before a decision is made, and compulsory licensing.
India has one of the best patent laws in the world that still gives some
space to its producers to make generic drugs.
But it is also true that the old policy space has been eroded because many
new drugs since 2005 have been patented by multinational companies which are
selling them at exorbitant prices.

Indian companies can no longer make their own generic versions of these new
medicines unless they successfully apply to the government for compulsory
licences, and that is quite cumbersome; or unless they obtain a licence from
the patent-owning multinational, and that usually comes with stringent
conditions, especially for export.

Another worry is that India is negotiating a free trade agreement with the
European Union. Such agreements usually contain provisions such as data
exclusivity and extension of the patent term, which prevents or hinders
generic production.

Finally, six Indian companies have recently been bought up by large foreign
firms. If this trend continues, the Indian drug market may be dominated by
multinationals again.

It is uncertain whether they will continue to supply the developing world
with cheap generic medicines when this may be in conflict with their own
branded products.

International health organisations such as UNAIDS, Unitaid and Doctors
Without Borders have raised their serious concerns that these recent trends
may threaten India’s role as the chief supplier of affordable medicines to
Africa and other developing countries.
“Millions will die if India cannot produce the new HIV-AIDS medicines in
future, it is a matter of life and death,” said Michel Sidibe, Unaids
executive director, during a visit to India last year.

Thus, a strategy is needed that involves the government and the drug
companies, that ensures the local drug industry continues to thrive, that it
produces not only the existing medicines but also new medicines even if they
are patented, and that they are supplied at cheap prices not only in India
but to the developing world, too.

That was the sobering message that emerged at last week’s 50th anniversary
conference of the Indian drug association, even in the midst of
congratulations on the achievements of the past.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909