Access to treatment: Cipla's Yusuf Hamied;UNAIDS haven't done much

[Guest guest]

Indian Drug-Maker Leads the Charge for Low-Cost AIDS Drugs

Interview: Cipla's Yusuf Hamied

March 2003

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Dr. Yusuf K. Hamied burst onto the world stage in February 2001 when

his company, Mumbai-based Cipla Ltd., offered a three-drug anti-HIV

regimen to poor African countries and aid groups like Médecins Sans

Frontières for $350 a year-one thirtieth of the standard price. After

receiving his Ph.D. in organic chemistry from Cambridge University at

the age of 23, Dr. Hamied joined Cipla as a research officer in 1960.

He has been Managing Director of the company since 1972 and Chairman

since 1989. Dr. Hamied agreed to be interviewed for this first issue

of the TREAT Asia Report.

TREAT Asia Report: Can you tell us about Cipla?

Dr. Yusuf Hamied: Cipla was founded in 1935. From our inception, our

whole philosophy has been based on self-reliance and self-

sufficiency. Post-independence, in the 60s, we fought very hard to

have our patent laws changed. The basic principle was that we were

not against patents; we were against monopoly. Since 1972, Indian

Government policy has dictated that, in two areas—food and health—you

cannot patent a product; you can only patent a process. And for a

period of just seven years. When this policy was initiated in 1972,

the multinationals controlled 85 percent of the Indian pharma

business. Today, Indian companies control 85 percent of it. We are

now a large exporter of pharmaceuticals.

TA Report: What are Cipla's annual revenues?

Hamied: Our total revenues are about U.S. $350 million. Sixty-five

percent of this is from sales in India and 35 percent from exports.

We produce at least 30 times the volume that figure would represent

in America because the medicines we sell in India for a dollar cost

between $20 and $30 in the U.S.

TA Report: How large is the pharmaceutical market in India today?

Hamied: Domestically, it's about $4 billion, and exports total about

$2 billion. In terms of HIV, we produce antiretrovirals for about

20,000 patients. Of these, 5,000 to 10,000 are in India. So our total

HIV business is about $6 to $7 million a year and growing.

TA Report: That's comparatively low, considering all the publicity

you've gotten. Do you expect this number to increase significantly?

Hamied: I'm preparing for that. We have four criteria for HIV drugs.

They must be effective, affordable, production must be sustainable,

and we must be able to predict demand. If I had to supply two million

people with HIV drugs at $300 a year, I would need at least a year to

build up the capacity, and it would also require considerable

financing. We need to partner with governments to do this.

TA Report: Which drugs do you produce?

Hamied: AZT, d4T, 3TC, ddI, nevirapine, and efavirenz. We have the

know-how to produce others like abacavir. We make and also buy some

of these from other countries. For example, the Koreans and the

Chinese are extremely good in their manufacture of AZT. There is room

for everybody in responding to HIV. It has to be a team effort

between the multinationals and the so-called generic companies. We

are now producing a combination of three drugs, called " Triomune, "

which includes d4T, 3TC, and nevirapine as two tablets a day—one in

the morning and one in the evening.

TA Report: This is a combination you can't get in North America or

Europe?

Hamied: That's right. Legally, I can produce all three as each

individual drug comes from a different company.

TA Report: So you might be in the unusual situation of having a

higher standard of care in a developing country than in rich

countries?

Hamied: Exactly. That's what the multinationals don't like, and they

oppose us like mad. All of Cipla's factories have been inspected and

approved by the World Health Organization, and that's very important

because nobody can point a finger at us and say that our drugs are

not on par with what's available abroad. Last week we introduced a

combination kit of two tablets and a capsule, to be taken

simultaneously once a day under the name Odivir. These three contain

3TC, efavirenz, and sustained-release ddI. Now, that combination is

more expensive—just under $3 a day. But we will introduce Triomune as

a once-a-day combination kit for just over $1 a day.

TA Report: About 4 to 5 million people are infected with HIV in

India, but only 5,000 to 10,000 people are being treated. Why the

gap?

Hamied: Do you know that 90 percent of cancers in India are detected

in the last stage of the disease? HIV is also not detected in most

people. Here, it is detected by way of the opportunistic infections

that the virus causes. A close friend of mine died of AIDS and never

even knew he had HIV until he got sick from tuberculosis. In India,

we don't even know how many TB patients have HIV. Detection is not

done until it's too late. So HIV is still a silent killer, like

breast or prostate cancer.

TA Report: What needs to be done in countries like India to

significantly increase the number of people getting treatment?

Hamied: Increasing awareness, counseling, and testing are vital.

TA Report: But why would people get tested when there is no

assurance, if they're HIV-positive, that they're going to get access

to treatment?

Hamied: Because you are going to infect others. Any person who

enrolls in a hospital or goes to a doctor should be tested. To get a

driving license or a passport, you should be tested. In countries

like Singapore, when you apply for a visa, you have to have an HIV

test. Many things can be done when you're waging war against a

pandemic that affects humanity.

TA Report: That's pretty controversial.

Hamied: Maybe. But I believe every avenue has to be looked at. I'm

not saying done, but looked at. When I enter a country like

Mauritius, my blood is checked for malaria. Every time I go there

from India, the next day the man from the Ministry of Health comes to

my door and tests me for malaria. So I asked the Deputy Prime

Minister of Mauritius, " If you're testing me for malaria, why don't

you also test the same blood sample for HIV? " I'm just throwing ideas

at you—I'm not saying it should or should not be done. We need a

brainstorming debate on this issue.

TA Report: Is there the capacity in India to deliver AIDS drugs in a

knowledgeable way?

Hamied: Cipla is running workshops for doctors and nurses. We are

teaching the doctors what to look out for. When a patient is detected

as being HIV positive, counseling is essential. We urgently need

initiatives like TREAT Asia to develop guidelines for treatment and

to provide training for health care workers. We have done it in our

workshops with doctors. But these are our guidelines.

TA Report: Are you concerned that if these drugs are not used

properly, widespread drug resistance will emerge?

Hamied: There's a Jewish phrase that says, " If you can save one life,

you've saved the world. " But we do believe that these drugs need to

be used properly, and that's why we desperately need to train and

educate people about how to use them. I say that a person should do

what he does best. We are best at producing medicines at affordable

prices. Let us do our job—let others do theirs.

TA Report: What do you think of what the WTO is doing on compulsory

licensing?

Hamied: In November 2001, the WTO agreed on two things. One, every

country can decide for itself what is a national crisis or national

emergency. And two, every country has the right to grant compulsory

licenses. In India, we have 80 million cardiac patients, 60 million

with diabetes, and 50 million people who suffer from hepatitis B. We

could have 35 million people infected with HIV by 2010. And one in

three Indians has latent TB. Because of this, health care is a

permanent crisis in India. It is not an emergency; it is a permanent

crisis. So we need permanent compulsory licensing laws. Which means

what? It means we respect patents. and we will pay royalties to the

patent holders for all drugs. In India, with a population exceeding

1.2 billion, we simply cannot allow companies a monopoly.

WTO also declared 49 countries to be " least-developed countries. " But

they have no definition of what a least-developed country is. The UN

looks at it as gross national product per capita. According to the

UN, no country with a population exceeding 75 million can be

classified as least developed. Can you believe that? Today, only six

percent of Indians finish high school. India has only 0.4 to 0.5

percent of world trade, and by 2012 that may reach one percent.

Ninety percent of the country is least developed. Just because ten

percent is super-developed doesn't mean that India is a developed

country. We are a continent, not a country.

TA Report: Why not have different rules for AIDS drugs and so-

called " lifestyle drugs " like Viagra?

Hamied: It's not about Viagra per se. It's what it costs to make a

pill of Viagra and what price is being charged. Do you know what the

price of a Viagra equivalent is in India today? About twelve cents

per tablet, against $10 in Europe or the United States.

TA Report: The multinationals say that they are investing a

significant amount of money in R & D to develop new, better HIV

therapies. Why shouldn't they be able to profit from this?

Hamied: Much of their investment is not in really new types of drugs.

For the really innovative, risky, conceptual research, they need to

make a reasonable return and that needs to be protected. I agree with

this, but 90 percent of all so-called pharmaceutical research is

in " me too " drugs, and if there is a blockbuster, every effort goes

into protecting it indefinitely.

TA Report: But should developing countries like Brazil and Thailand

that are comparatively better off get what some might call a " free

ride " in terms of these drugs?

Hamied: But many of the HIV drugs—AZT, d4T, 3TC—were not developed by

the big companies. If you look at the world's top 50 drugs, more than

half of them are not original products of the companies marketing

them. They are all licensed. When it comes to diseases like HIV, we

are willing to pay the inventors a royalty. I cannot accept a

monopoly situation for these drugs in the context of a health crisis.

AZT was invented in 1963. It is covered under patent in the U.S.

until 2005. Now it is used mainly in combination with lamivudine. Do

you know when the combination patent of lamivudine with AZT expires?

In 2017. Protection for 54 years—is that what intellectual property

is all about? And then the companies sometimes go to court to extend

the patent or to add new, extremely technical patents to extend their

rights by way of analogues, enantiomorphs, newer polymorphs, or

salts, etcetera.

TA Report: What should governments in Asia be doing to provide

greater access to HIV treatments?

Hamied: What has happened in the two years since Cipla first

announced a price of $300 per year, per patient? Very little. WHO and

UNAIDS haven't done much. Even MSF [Médecins Sans Frontières] and the

big activists—what have they really done? One or two countries have

acted, like Malawi, Senegal, Cameroon, Zambia, Nigeria, and maybe

Namibia and Botswana, in their own limited way. By and large, very

little has been done—unlike in Brazil.

TA Report: Three years from now, how many people in developing

countries will be getting effective treatment for HIV?

Hamied: I would say one to three million people in developing

countries worldwide. That's the upper extreme figure. And the could

be 60 million people living with HIV by 2010, so only 5 percent of

that.

TA Report: Dr. Hamied, thank you for your time.

http://www.amfar.org/cgi-bin/iowa/asia/news/index.html?record=3