DR Y K HAMIED'S (of CIPLA) 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 illion 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 canbe 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.
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Cross posted from Ip-health mailing list
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