[DEBATE] : Richard Rockefeller on Novartis case in India - Times of India Editorial published today

[Riaz K Tayob]

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) 



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.