Interview with Dr. Yusuf Hamied, CEO of CIPLA

[Guest guest]

Dear Forum Members,

I do hope, Indian AIDS NGOs, Activits, People living with HIV/AIDS in

India and the policy makers would read the following interview with

the CEO of CIPLA with interest. If we can't act on it, it would be an

unpardonable mistake. [Moderator eFORUM]

_______________

WASHINGTON, Feb. 21 (UPI) -- AIDS is wreaking its incurable

devastation fastest among the world's poorest populations, but they

are the ones least able to obtain the expensive drugs that treat the

disease. More than 90 percent of the 36 million people currently

infected with HIV live in developing countries - a grim statistic that

last week prompted the head of the United Nations AIDS program to urge

the world's big pharmaceutical companies to widen access to their

drugs.

Pressure has been building on " big pharma " to make its patented drugs

affordable for the poor, or at least for their governments. A typical

multi-drug treatment " cocktail " costs $10,000 or more on the U.S.

market. An agreement among five major drug makers to slash the cost of

their HIV/AIDS medicine for sale to poor countries was widely praised

when it was reached last May.

But critics -- including governments of many countries, rich and poor

alike -- have since blasted the program's company-by-company,

country-by-country approach as slow-paced and its prices as still too

high to be able to quell an accelerating pandemic. So far only a few

African countries have agreed to take part.

Dr. Yusuf Hamied has a solution. Hamied is the chief executive of

Cipla, a company in Bombay, India, that makes generic versions of

hundreds of drugs --many of them patented in their originators' home

countries in North America or Europe. For $350 per patient -- less

than $1 a day -- Hamied is offering the poorest nations a year's worth

of a three-drug cocktail: Cipla would manufacture copies of the drugs

from the tightly held patents of the Western firms that developed

them.

Under the novel program, the Indian company would sell its copycat

drugs to the international relief agency Doctors Without Borders,

which has won the Nobel Peace Prize for its work providing food and

medicine to victims of war and natural disasters but has sought to

expand its role to include delivering drugs to people with HIV or

AIDS.

Earlier this month, Brazil said it would copy and sell two of the most

expensive AIDS drugs if their prices were not reduced. The United

States said that would break patent guidelines and complained to the

World Trade Organization, which will review the dispute this spring or

summer. U.S. trade officials say their case is aimed at a Brazilian

law that forces foreign patent-holders to do some of their

manufacturing within Brazil, in violation of WTO rules, and will not

hinder the South American nation's access to affordable AIDS drugs.

Those urging for greater access to the drugs, however, see the move as

an example of a rich nation bullying the poor to protect drug company

profits.

The industry maintains that the high cost of AIDS drugs is justified

by the expense of research that leads to their development. Lowering

the price of these brand-name " antiretrovirals " and allowing generics

into developing nations would " damage " that work, Judy Bello, head of

the Pharmaceutical Research and Manufacturers of America, told an

audience recently.

Even if drug companies lowered the price, she said, most people would

still be unable to obtain the drugs because most countries lack the

means to administer them widely. " Even free drugs do no good if they

don't get to people, " Bello said.

Hamied, a Cambridge-educated chemist whose father founded Cipla in

1935, has not worked out the details of his plan with Doctors Without

Borders (also known by its French name, M decins Sans Fronti res), but

a meeting is expected within a few weeks.The second part of his bold

proposal is aimed straight at the big, multinational drug makers,

though he insists they are not his enemy. In border to be granted

licenses for manufacturing and then exporting the copies of their

patented AIDS drugs, Hamied has offered to pay a 5 percent royalty on

sales of his generic versions to U.S.-based Bristol-Myers Squibb and

Pfizer, Britain's GlaxoKline and Boehringer Ingelheim of Germany.

The CEO made the offer in a letter dated Dec. 19, asking for a " timely

response; " so far, Glaxo and Pfizer have written to Cipla - to say a

decision would be forthcoming - while BMS and Boehringer have been

silent. Representatives for all four companies told United Press

International their bosses were considering the offer and would have

an answer soon. A Pfizer spokesman said his company was " not

optimistic " a deal could be worked out.

In a telephone interview with UPI, the 64-year-old Hamied, who was

born in Lithuania to a Jewish mother and an Indian Muslim father,

talked about his plan to bring AIDS treatment to the masses for a

fraction of their typical cost in the West.

UPI: When did you first make your proposal?

HAMIED: I was at a meeting of the European Commission in Brussels last

September (at a forum on poverty and infectious diseases). There were

also 30 health ministers of various African countries. The health

minister of Brazil was there, the health minister of South Africa was

there. I made this offer in an open forum of $800 per patient per

year.

I also made an offer that I was willing to give technology to

manufacture the active substances, and the tablets, to any Third World

or developing country who wanted this technology, totally free. And

what else? Four months have passed - no takers. So then we did our

costing - and then don't forget, we just had a very nasty earthquake

in India. An earthquake is an unforeseen tragedy. We know for a fact

that at least in India, AIDS is going to be a foreseen tragedy. There

are today in India over 5 million HIV-positive; it's increasing at

the rate of 3,500 HIV-positive new cases per day. The forecast in

India alone is 35 million (cases) by 2005. We are facing an absolute

holocaust. And, this is a foreseen tragedy, unlike the Gujarat

earthquake, which was an unforeseen tragedy. We felt that something

had to be done, and we in our own small way are offering a triple-drug

regimentation at the price of $350 only to MSF (Medecins Sans

Frontieres) as an NGO. Let them distribute it. To various governments

and other institutions, we've kept the price at $600.

Q: Why did you choose MSF as the party through which to distribute the

drug cocktail?

A: Because they're the only one taking an active interest in this

area. Nobody else has approached us, nobody else has a dialogue with

us, nobody else has time for us. The other person who's playing a

very, very active role is a gentleman from your town (Washington),

Love (an activist affiliated with the group Public Citizen).

He's the one who initiated the whole thing (idea). He talked with me,

and he was the coordinator and the go-between; without him, this

wouldn't have happened. He said, " Let me give this offer in writing to

Medecins Sans Frontieres. " It was a three-tiered pricing (scheme) - a

commercial price, of $1,200; a government price, of $600; and what we

now classify as a humanitarian price, of $350. We don't earn on that,

we lose on that. But it is what I am prepared to give MSF if they buy

and they distribute.

Q: Does Cipla lose money on sales of its HIV/AIDS treatment drugs to

governments of developing nations at the $600-a-year price per

patient?

A: It all depends how you do your calculation, where you put your

overhead. We manufacture 400 products; I've got 10 or 15 factories, my

factories are FDA-approved. So it all depends how I locate my

overhead.

But we have a very big advantage - that advantage is that we

manufacture our own active substances. So we are totally

self-sufficient, totally vertically integrated. From the raw materials

we produce, we make the tablets or the capsules, as the need may be.

That's a very, very big advantage. And we in our own little way, we

have no fight against the multinationals, we have no fight against

other companies. We want to do our little bit. And if we were a bigger

pharmaceutical company, then we would do a bigger bit, but this is a

small bit.

Q: You recently made an offer to pay royalties to the big makers of

patented AIDS/HIV drugs.

A: My offer is, 'If your product is covered (by patent) on the market,

we are willing to pay you a royalty of up to 5 percent of the average

selling price, we'd like to manufacture your product.' Please

understand that the patent of stavudine is not held by Bristol-Myers

Squibb; it is a United States government patent. It was licensed to

Squibb by the American government on an exclusive basis, so the

government has the option to revoke that license if it wants to.

Lamivudine - Glaxo doesn't own the patent, the patent is BioChem's (a

Canadian drug company). This is what I'm trying to say: They say they

spend millions and millions on research, and these products are not

theirs. Even AZT is not actually a Glaxo product, it was an NIH (the

U.S. government's National Institutes of Health) product. What I'm

trying to say in a nutshell is the following: I'm a scientist, I'm

willing to make these tablets, I'm willing to make the raw materials,

and I'm willing to offer it. What I said in Brussels is that I'm

offering an opportunity; it is for the international community to make

use of the opportunity I'm offering. I'm not running after them, I'm

not running after any African government. Let them come to me. I've

offered them technology free - let them come to me and take it. I'm

not chasing anybody, I'm not running after anybody, whether it is MS

or any of the African governments, the Indian government or anybody.

That's my attitude. I hope I'm correct. I'm doing my bit, let others

do their bit. I'm a great believer that every country or every

organization like yours will have to decide their own destiny for

itself. I can't sit 10,000 miles away and decide for somebody else

what they should or shouldn't do; let them decide for themselves.

Q: How important is compulsory licensing to these plans to distribute

these drugs cheaper or at no cost?

A: I sincerely and strongly believe that Third World countries and

poor countries cannot afford a monopoly. I've never been against

patents. I'm just saying that we countries of the Third World - a

country like India with a billion population - we simply cannot afford

a monopoly situation. What we are therefore saying, particularly in

key areas like health and food, there has to be compulsory licensing

or licensing rights. By the way this is absolutely legal within the

framework of GATT (the General Agreement on Tariffs and Trade) and

TRIPS (the World Trade Organization's rules on trade in patented

goods; they take effect in 2005). It's totally legal, because the

patent laws are national laws, they're not international laws. And,

being national laws, it is for the national governments to decide for

themselves what they want.

Q: But isn't the goal of the WTO rules to make the patent laws of all

countries conform to one standard?

A: The problem is the interpretation. If you look at it carefully,

then you will see that parts of it are quite flexible. They allow you

all sorts of things. The bottom line is that the Western countries

want to behave like elder brothers. They want the full cake, and they

want to eat it. That is in a nutshell: How can you make Third World

countries fourth world? Please bear in mind that whatever I've done in

the last week in making this offer, it has essentially created a great

deal of awareness. And my hope lies within my own country-I'm

interested in India, India is my country. I would like to see India

doing something in the matter, particularly as no U.S. patent laws

today allow me to manufacture and market these products (for export).

If the Indian government wants to buy from me my cocktail at $600 per

patient per year, and distribute it through their network which they

have, I'll provide.

HAMIED: We're looking not only at the anti-AIDS drugs, we're also

looking at opportunistic (infection) drugs, for opportunistic diseases

that result from full-blown AIDS, like fungus infection, etc. I'm

basically not interested in the multinationals, I don't know why

everybody I speak to only raises this question of multinationals.

Every NGO I speak to raises multinationals; I've nothing to do with

them. They have their place, we have our place. I'm today offering my

cocktail essentially to countries where, like India, there are no

patents. Brazil, Argentina, many countries in (sub-Saharan) Africa,

Thailand, Indonesia, China, the whole of Eastern Europe, Turkey -

there are no patents in these countries to date. What will happen

after 2005 is a separate issue. What I'm trying to say is I've nothing

against the multinationals. Let them do what they want to do; I'm

doing my little bit.

HAMIED: In India, there is no product patent, no usage patent; you can

only have a process patent. The process patent will only be valid for

seven years. This is a patent in force until 2005. (When India, as a

WTO member, will be subject to the TRIPS rules). Then we shall have

product patents for 20 years. Nothing. The products that we are

already doing - nothing happens to them. Nothing stops. How can you

stop? If I want to license patents in those countries where patents

are valid; I can't license a product if it's not valid. In India, I

won't pay them a penny. Why should I pay them for India? If I export,

say, a Bristol-Myers Squibb product for South Africa, I'll have to pay

them a royalty, I'm willing to pay them a royalty for South Africa. "