[Ip-health] Times of India Editorial, Generic drugs only hope for many AIDS, Cancer Patients

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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

      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 w=
hether 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 m=
ultinational Novartis as Gleevec, because my life depends on it.

      In October 2000 doctors diagnosed me with chronic myelogenous leukaem=
ia (CML), a rare and deadly form of cancer. Six months later, the Federal D=
rug 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 compou=
nd. The company is challenging both the patent office decision and a key pu=
blic health safeguard within India's Patents Act that aims to reserve paten=
ts for real innovations only.

      If Novartis succeeds, a surge of additional patents is likely, result=
ing in further restrictions on the production of generic drugs in India and=
 inordinately high prices for newer medicines. India's generic medicine ind=
ustry is often called "the pharmacy to the developing world" because it pro=
duces quality drugs at dramatically more affordable prices.

      Generic competition is what brought prices down for antiretroviral (A=
RV) 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 A=
RVs made in India, including more than 80 per cent of the 80,000 patients t=
reated by Doctors Without Borders in more than 30 countries.

      And 70 per cent of the ARVs purchased by UNICEF, the International Di=
spensary Association, the UN Global Fund, and the Clinton Foundation to tre=
at 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 fe=
w years after i was diagnosed with leukaemia. I saw first-hand how hope had=
 replaced despair for thousands of people throughout the impoverished count=
ry when, just a short time earlier, AIDS devastated whole communities.

      Like me, without treatment, many of the people i met most likely woul=
d have been dead. And without a generic source of ARVs, only dozens would h=
ave 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 im=
portant for AIDS treatment, as patients inevitably become resistant to firs=
t-line therapies and need newer drug combinations.

      This lawsuit threatens the supply of these medicines because of the p=
recedent 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 le=
ukaemia sufferers, and in any event, a drug delivery system based solely on=
 donations is vulnerable to shifting political winds and the drugs can be w=
ithdrawn for any reason.

      The company also claims on their website that their court case is act=
ually about increasing access to medicines because strict intellectual prop=
erty (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 W=
HO's Commission on Innovation, Intellectual Property and Public Health - in=
dicates that increased patent protection has done little or nothing to incr=
ease innovation in treatments for the afflictions of the developing world.

      Of the 1,556 new chemical entities marketed worldwide between 1975 an=
d 2004, only 20 were for diseases that affect 90 per cent of the world's po=
pulation.

      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 legislatio=
n 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 billi=
ons 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 AI=
DS 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 w=
ould 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.

      available at http://timesofindia.indiatimes.com/OPINION/Editorial/LEA=
DER_ARTICLE_Dead_Man_Walking/articleshow/1738298.cms)




Leena Menghaney
Campaign for Access to Essential Medicines
Medecins Sans Frontieres
C 106 Defence Colony
New Delhi 110 014
Tel: +91 9811365412, +91 1124332419
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