E-DRUG: Generic drugs - Times of India Editorial March 9
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9 Mar, 2007
Times of India, Editorial
LEADER ARTICLE: Dead Man Walking
"Generic drugs only hope for many AIDS, Cancer Patients"
Richard Rockefeller
(available at
http://timesofindia.indiatimes.com/OPINION/Editorial/LEADER_ARTICLE_Dead_Man_Walking/articleshow/1738298.cms)
[copied as fair use]
Chances are you have never heard of the drug, imatinib mesylate, let
alone Section 3 (d) of India's Patent Amendment Act of 2005.
But a court case in India this month involving both could determine
whether people throughout the world have access to life-saving medicines
for diseases like HIV/AIDS for decades to come.
I am intimately familiar with the drug, marketed by the Swiss-based
multinational Novartis as Gleevec, because my life depends on it.
In October 2000 doctors diagnosed me with chronic myelogenous leukaemia
(CML), a rare and deadly form of cancer. Six months later, the Federal
Drug Administration approved Gleevec.
Years of taxpayer and privately funded research went into the drug's
development, and it has all but eliminated my cancer.
Novartis has filed suit against India's government because an Indian court
rejected its patent application for a new form of the original compound.
The company is challenging both the patent office decision and a key
public health safeguard within India's Patents Act that aims to reserve
patents for real innovations only.
If Novartis succeeds, a surge of additional patents is likely, resulting
in further restrictions on the production of generic drugs in India and
inordinately high prices for newer medicines. India's generic medicine
industry is often called "the pharmacy to the developing world" because it
produces quality drugs at dramatically more affordable prices.
Generic competition is what brought prices down for antiretroviral (ARV)
medicines for people living with HIV/AIDS from a staggering $10,000 to
$136 a year.
Most AIDS treatment programmes throughout the world rely on generic ARVs
made in India, including more than 80 per cent of the 80,000 patients
treated by Doctors Without Borders in more than 30 countries.
And 70 per cent of the ARVs purchased by UNICEF, the International
Dispensary Association, the UN Global Fund, and the Clinton Foundation to
treat patients in 87 developing countries come from generic Indian sources
as well.
In Malawi, the importance of generic ARVs was brought home to me a few
years after I was diagnosed with leukaemia. I saw first-hand how hope had
replaced despair for thousands of people throughout the impoverished
country when, just a short time earlier, AIDS devastated whole
communities.
Like me, without treatment, many of the people I met most likely would
have been dead. And without a generic source of ARVs, only dozens would
have been treated, not thousands.
Even as millions around the world still have no access to treatment, these
fortunate few are put at risk by Novartis's legal attack in India.
A constant flow of affordable newer medicines will be particularly
important for AIDS treatment, as patients inevitably become resistant to
first-line therapies and need newer drug combinations.
This lawsuit threatens the supply of these medicines because of the
precedent it could set for future patenting decisions.
Novartis says that concern with its lawsuit is misplaced because the
company gives Gleevec for free to patients in India.
Of course, those receiving it do not represent the total number of
leukaemia sufferers, and in any event, a drug delivery system based solely
on donations is vulnerable to shifting political winds and the drugs can
be withdrawn for any reason.
The company also claims on their website that their court case is actually
about increasing access to medicines because strict intellectual property
(IP) protection lays "the foundation for the massive investments made by
the pharmaceutical industry in R&D that are vital to medical progress".
While this may sound good in a press release, it is just not true for most
people in the world. A growing body of evidence - most recently the WHO's
Commission on Innovation, Intellectual Property and Public Health -
indicates that increased patent protection has done little or nothing to
increase innovation in treatments for the afflictions of the developing
world.
Of the 1,556 new chemical entities marketed worldwide between 1975 and
2004, only 20 were for diseases that affect 90 per cent of the world's
population.
To many people, Novartis' lawsuit is a case of deja vu. Novartis was one
of 39 drug companies that sued South Africa in 1997 to block legislation
aimed at improving that country's access to essential medicines.
At the time, the companies trotted out the same arguments, predicting the
sky would fall - on them and us - if South Africa were allowed to shop
around for the lowest-priced medicines.
Since that unsuccessful court case, though, Novartis has posted billions
of dollars in profits, including $6.1 billion in 2005 alone.
I am grateful everyday that a treatment was found to prolong my life. But
one can't be as cheerful about this as one would like, knowing that AIDS
kills more people each year - nearly three million - than the number of
people in my home state of Maine.
Or when one thinks of the people in Malawi and around the world who would
be most affected if Novartis gets its way today in India. Quite simply,
the company should drop its case.
The writer is chairman of Doctors Without Borders.
Alexandra HEUMBER
Medecins Sans Frontieres
<Alexandra.HEUMBER@brussels.msf.org>