[Ip-health] Today's Speech by Y.K. Hamied

[mpalmedo@cptech.org]

Bill Haddad asked me to post this to the list...

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DR Y K HAMIED'S PRESENTATION AT YOUNG PRESIDENTS' ORGANISATION MEETING,
IVY RESTAURANT - LONDON
14TH APRIL 2004

Ladies and Gentlemen:

We have talked about the Disease and its Social Implications. Let us now
discuss Prevention, Treatment to prolong and improve the quality of life,
but above all discuss the attitude towards the HIV/AIDS pandemic.

I am a representative of the 3rd world Pharma Industry.  This Industry has
been chastised, condemned for its copycat drugs, so called piracy and also
safety and quality of the drugs they produce.

My story today has its origin in 1939, when Mahatma Gandhi visited our
Company Cipla in Bombay and requested us to produce vital medicines for
the Indo-British war effort.  At that time, the importation of drugs into
India from Europe had totally stopped. At a very early stage we learnt the
importance of self-reliance and self-sufficiency.

When I joined the pharma industry in 1960, I soon realized that every
major drug I wanted to manufacture was covered by patents - a monopoly
granted to the innovator for 20 years.  At that time, the MNC's controlled
85% of the healthcare market in India and exports of drugs from India was
negligible.  England had changed its patent laws in 1949 but we in India
were still fettered to the archaic British Patent Laws of 1911.  National
minded Indians fought long and hard to change this.  Finally we succeeded
in 1972 when a new Indian Patent Act was passed.  According to this, only
in the two vital areas of Health and Food, there could be no monopoly on
the end product, only on the production process and that too for a period
of 7 years.  It gave the Indian pharma industry the legal right to
manufacture and market any drug required by the country made by a
non-infringing process.

It heralded a free, open Pharma market in India without monopolies and
initiated the Golden Age for the Industry. Today, 32 years later, 85% of
the Indian market of US$ 4 Billion and virtually all the pharma exports
amounting to US$ 3 Billion are controlled by wholly Indian companies.  We
have all built up an enviable reputation of producing good quality drugs
at reasonable prices and are now a Global force to reckon.




With this background, let me now talk about HIV/AIDS.  In the late 80's,
India became aware of the HIV/AIDS virus - the first known case being
detected around 1989.  In 1991, our Company was approached by the Indian
govt. to produce AZT,  the only known drug at that time to combat the
disease.  We took up the challenge and in 1993 marketed AZT for US$ 2 per
day as against the then prevailing international price of more than US$ 10
per day.  Inspite of this, it was beyond the reach of most Indians to
spend on a continuous basis US$ 60 a month.  Our sales figures were so
dismal that we soon discontinued making AZT and lost interest in HIV/AIDS.

In 1997, we came across the HAART (Highly Active Anti-Retroviral Therapy)
Medical Report, which rekindled and revived our interest in the AIDS
Issue.  It claimed that a cocktail of 3 drugs was effective in controlling
and managing HIV.  No longer was being HIV positive treated as a death
sentence but rather as a chronic ailment.  The 3 drug combination could
vary but essentially consisted of 6 pills to be taken daily.  At the time,
these were only produced individually by different MNC's and the combined
price of around US$ 12,000 - 15000 per patient per year was simply
unaffordable particularly in the poor Sub-Saharan countries where AIDS was
pandemic.

We took up the challenge to produce a range of anti-retroviral drugs and
were successful in the year 2000.  Our criteria for the selection of the
best suited triple drug cocktail was based on Quality, Safety, Efficacy,
Affordability and Sustainability of supply.  Cipla's product TRIOMUNE was
born.  In September 2000, at the E.U. in front of a world audience, we
offered this product to the international community for US$ 800 per
patient per year.  We also offered free technology to any 3rd world
country wanting to manufacture their own ARV drugs.  Later we also offered
to supply free the single dose drug Nevirapine capable of stopping the
transmission of HIV from Mother to Child.  Surprisingly, the world watched
silently and there was no response, nothing happened considering the
magnitude of the problem - 42 million HIV positive people worldwide and
over 8000 dying per day alongside 1600 HIV positive children being born
daily.  So far 22 million worldwide have died of AIDS during the past 20
years.

In the face of these alarming statistics, in February 2001, we took
another bold, humanitarian step and announced a major price reduction for
our triple drug cocktail Triomune at below US$ 1 per patient per day and
that too in a convenient delivery system of only 2 pills per day - morning
and night as opposed to 6 pills daily available from the MNC's.  This was
a significant advance - it assured dosage compliance, ensuring minimum
drug resistance.  Suddenly, awareness to the problem of HIV/AIDS became a
worldwide issue and with it opened up the much larger subject of Access to
Medicines at Affordable prices.  It dawned on the 3rd world countries that
anti-AIDS drugs were not only available but also affordable.  The absolute
power of patents and drug monopoly was exposed.




Soon after this, the Global Fund for HIV/AIDS, TB and Malaria was created.
 The world bank promised to take a major initiative and WHO, MSF and other
NGO's became more active.  The MNC's were now on the defensive.  Apart
from lowering their prices, they accused us for not having WHO approvals
for our anti-AIDS drugs.  We applied and within a relatively short time a
number of our anti-retroviral drugs
and three of our factories obtained WHO qualification after due
inspection.  It then took us a further 2 years to get our Triomune, a
fixed dose combination of 3 anti-retroviral drugs in one pill qualified by
WHO.  It was a major breakthrough in the fight against AIDS.  This was
announced on World AIDS day, 1st December 2003 by WHO, who openly said
that such fixed dose ARV combinations opened the door to 3 by 5 - treating
3 million by 2005.  We have informed WHO that we can undertake manufacture
of one-third of this commitment and with proper inputs even go up to
two-thirds.  One of the greatest predictable tragedies the world will
witness will begin when WTO's TRIPS becomes law on 1st January 2005 in
India.  It will deprive the poor of India and the world of medicines they
need to survive.  Again, we will be dividing the world between those who
can afford life saving drugs and those who cannot - a systematic denial to
the poorer nations to help their own populations.  This forthcoming change
will be one of the most inhumane projections of power for profit in modern
times.

President Bush in his State of the Union address in January 2003 said and
I quote "On the Continent of Africa, nearly 30 million people have AIDS
including 3 Million children.  There are countries in Africa where
one-third of the population carry the infection, 4 Million require
immediate treatment.  Only 50,000 are receiving the
medicines they need.  In an age of miraculous medicines, no person should
hear - you've got AIDS.  We can't help you.  Go home and die".   AIDS can
be prevented.  Anti-retroviral drugs can extend life for many years.  And
the cost of those drugs has dropped from 12000 dollars a year to under 300
dollars, which places a tremendous possibility within our grasp.  Seldom
has history offered a greater opportunity to do so much for so many".  He
went on to commit $ 15 Billion over 5 years to stem the growing AIDS
pandemic.

Inspite of all these promises, initiatives and dialogue, virtually nothing
has happened over the past few years.  The MNC's have launched a vitriolic
attack against the WHO qualification system and also on the generic
industry producing fixed dose ARV drugs. Regretfully, the US govt. has
sided with the MNC's and additionally said that US monies will only be
used to buy US drugs.  It is only natural that WHO, NGO's and Activist
groups are angered by these delays and frivolous accusations against
approved, affordable anti-Retroviral drugs produced outside the US.







In March 2004, the US government promoted a meeting in Botswana to discuss
this issue. Again there was a stalemate.  The situation becomes more and
more frustrating day by day.  It has become a political issue rather than
scientific.  It is estimated that by 2010, the total number of HIV
positive sufferers in the world will
reach 65 million, of which not less than 25 million will be in India
alone.  Today only 1,50,000 to 2,00,000 are being treated. Over 95% are in
the third world.  Again, it is surprising that while the so-called
educated, civilized world indulges in empty rhetoric and agonizes over
IPR, moral issues, diminishing profits, the genocide spreads unabated when
appropriate treatment is available but not being administered.

I would like to stress most emphatically that we all have a moral
obligation to fight this tragic disease.  For the sake of the AIDS
afflicted people and their families we must enhance awareness and provide
counseling to ensure care, proper treatment, comfort, support and remove
the stigma against people who are HIV positive. We must work together to
minimize the social and economic impact on the individual and society.  We
must not relax our efforts to find newer effective therapies, preventive
medications, vaccines and hopefully one day a cure.  We must redefine the
present and future roles of governments, NGO's and everyone involved
directly in policy making, donations, etc.  Nelson Mandela has recently
said "AIDS is no longer a disease, it is a human rights issue".

In conclusion, I quote from the Editorial of the 7th April 2004, issue of
the Herald Tribune, "The US needs to allow some of its AIDS fund to be
spent on generic combination drugs that have proven so effective.
Unfortunately officials are raising argument after argument against the
combination pills - are not US FDA approved, they violate American patent
laws, even if safe and effective.  Yet another objection we don't know if
the combination therapy will provide lasting AIDS relief.  But the
combination pills are simply standard therapies in convenient form.  Any
therapy may later be superceded, we have to save lives with the best
treatments available now".  To this I would like to add that we all want a
world where healthcare is provided to one and all, where every citizen can
dream of a decent quality of life, particularly those afflicted with
HIV/AIDS.


Thank you.