The price of AIDS drugs in Africa is in free fall. Pharmaceuticals giants have slashed prices by up to 90 per cent and one has even offered to allow poor countries to make copies of its patented products. It’s a window of opportunity for Africa as it battles with AIDS, but for the company that made it all happen it could signal the end of the line. Bombay-based Cipla triggered the price war last month by selling a medical charity copies of expensive patented AIDS drugs at massive discounts. Now the big players are on its tail. Cipla’s chairman and one-time chief scientist is Yusuf Hamied, whose father founded the company in a rented bungalow in 1935. He’s a blend of high-voltage enterprise, shrewd business sense, fierce nationalism and social conscience. K. S. Jayaraman quizzed him on his next move.
What made you offer the charity Médecins Sans Frontières AIDS drugs at bargain basement prices? Was it charity, marketing or both?
I don’t like the word charity. It is an offer. I have offered the three-drug cocktail-lamivudine, stavudine and nevirapine-for $350 per person per year. It is not designed to make money. I don’t need money. I said to MSF that they could distribute the drugs free in countries where they are strong. They said they are strong in Africa and they will distribute there. I also offered any Third World government the free technology to produce their own anti-AIDS drugs. But nobody took us up on it. I also have a standing offer to the Indian government to provide nevirapine free, which is used now to stop mother-to-child transmission of HIV. But there’s been no response. I can’t understand it. In 2010 India could be what Africa is today. It makes my blood boil.
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How serious is AIDS in India?
Right now there are 4 million cases of HIV. But infection is rising at an alarming rate and we could get 20, even 30 million cases before the middle of this century. It’s mostly concentrated in urban areas, particularly among truck drivers, drug users, domestic staff and the sex trade.
GlaxoSmithKline and Merck are ready to match your prices, possibly going lower. Won’t this drive you out of business?
No, it’s a good thing. Hats off to them, because on our own there’s no way we could satisfy demand. The quantities required are mind-boggling. There are 33 million HIV-positive people in the world, but let’s say you can treat just 3 million. Take Merck’s earlier offer to sell lamivudine at $600 per patient per year. This is one of its three drugs used in a cocktail for treating hepatitis, and the dose needed is 2.4 grams per day. At Merck’s prices, that works out at roughly $700 per kilogram. I can’t produce lamivudine for anything less than $1200 per kilo. Now calculate how much will be needed by your 3 million HIV patients. The answer is 7.2 tonnes per day. I couldn’t do that on my own. It’s a complicated synthesis. We’re a small company. Perhaps we’ve shown the way, but single-handedly, we can’t do a damned thing.
As a generics drugs company, your profits come from selling cheap copies of famous names like AZT. Why don’t you respect drugs patents?
That’s wrong. Totally wrong. I believe in patents. But I don’t believe in companies holding a monopoly on something. Also, patent laws are national laws. They are not international laws. There is no one patent that applies to the whole world. Similarly, patent laws are designed with national interests in mind. Do you know that under American patent law you are prohibited from patenting anything connected with nuclear power and atomic energy?
In the same way, India’s patent law was changed in 1972 to prohibit product patents in food and health. These are our national interests. And patents on processes last only seven years, not 20. There’s no “evergreening”, where companies take out a new patent when the old one is about to expire by making minor changes to a drug. Remember the philosophy behind patents. They were meant to be between countries that were technologically on a par with each other. A patent is the granting of a favour by the state to an inventor. It’s the state’s way of saying: “You’ve done something novel. Well done. Here’s a grant.” If the state gives you a grant, the state also has the power to take it back. That’s what I’m trying to say.
Does this mean any country that wants to join the World Trade Organization needs to harmonise its patent laws according to WTO guidelines?
The WTO emerged out of the General Agreement on Tariffs and Trade. Until 1986, patents and GATT had nothing to do with each other. But in 1986 a meeting of GATT members in Geneva decided that goods and services being traded had to be protected under patents. Incidentally, India opposed this, but for some reason our delegation failed to turn up at this crucial meeting. Anyway, the WTO’s patent rules say that governments are allowed to ignore patents in “national emergencies”. We produce drugs for malaria, TB, leprosy, diarrhoea, blindness and AIDS. They’re not just national emergencies, they’re permanent emergencies. Forty million people have died in India of hepatitis B. That’s a permanent emergency.
To join the WTO, India will need to change its patent laws by 2005 and many of your drugs will become illegal. What will you do then?
Nobody can sue me if I sell my products in India until 2012. Process patents granted in India have a seven-year validity, so a process patent obtained in 2005 can run till 2012. But I will not be able to copy drugs after 2005.
But does your company have a long-term future?
We are comfortable till 2010. After that we have to see.
You’ve offered large pharmaceuticals companies 5 per cent of the royalties on some sales of some of your products copied from theirs. Is this a sign that you want to mend fences?
No. It is up to the companies to give me a licence if they want. I am making an offer. Take it or leave it. I am not fighting them.
How did they respond?
All the four companies I wrote to have replied. But none took up my offer.
But aren’t you trying to give them something that’s already theirs?
But it isn’t theirs. In many cases, they don’t own the patents. I can give you so many examples. Bristol Myers Squibb manufactures stavudine. But the original inventor is Yale University, and the patent is held by the US government. Bristol Myers Squibb pays the US government for Yale University royalties. AZT is not a Glaxo product, but was developed by the National Institutes of Health in the US. I’m simply asking these companies to give me a licence, in the same way they have one from the US government.
Your company employs 250 people in R&D. What kind of research do you do? Do you actually discover any new products?
What would you say is a new product? I’m asking you the question…
That depends on your definition of what’s new.
Exactly. My definition is very simple. I define a new product in terms of whether it is new for a particular country, like India. Something may be well known all over the world. But if it is not available in India, I’d say it is new for India. So over the past 30 or 40 years I have selected drugs that had proved to be successful internationally, but not available in my country. My first focus has been to bring them to my country. My second focus has been self-reliance and self-sufficiency-that India has to produce them for itself.
How do you copy a drug?
You first have to identify your target. Then you search the literature to find out what information is in the public domain. Then you decide how much of the synthesis you can do yourself and how much elsewhere. It is not easy. Often we enlist the help of Indian government laboratories.
Instead of copying these drugs, why didn’t you ask the patent holders to sell them to India?
They don’t want to. This is why India’s patent law was changed in 1972. Every country must be allowed to decide its own destiny. That’s my attitude to research. It has to be.
So what kind of research do you do?
I believe there are two types of research. One is conceptual and the other is “me too”, or what I call protective research. Ten per cent of the world’s research is conceptual, like the first beta-blocker or the first tranquilliser. The rest of research funds is spent on protective research, or how to maintain a monopoly. That’s 90 per cent of today’s research. For example, paroxetine is a major antidepressant and is a big seller worldwide for GlaxoSmithKline. But it’s protected by 103 patents. Is that what research is all about? That’s not research. Come on, let’s face facts.
So do you take out patents on your products?
We have recently.
Are these patents aimed at defending your products against other producers of generics?
No, no, no. We’re taking out patents to sell our products to the Western world. Nobody would buy them otherwise.
How would you feel if other generics manufacturers copied your products, in India, for example?
They do. There are at least 20 or 30 competitors doing that.
And you have no problem with that?
There is enough for everybody.
Do you think that big companies will sue the Indian government if it doesn’t harmonise its patent laws with the rest of the world?
Absolutely. In July 2005, the minute this law is passed, 50 per cent of my time will go on legal battles-frivolous, unimportant legal battles, and we won’t know what hit us. I know what it was like before they changed the patent laws back in 1972.
So what will you advise the Indian government to do to prepare for 2005?
The patent rules of the WTO should be changed. If they’re not, then India should get out. India has 2 per cent of world trade, but how does GATT or WTO help us? Not in the slightest. China is outside and it has billions of dollars of trade with the US. If somebody wants something and I’ve got it, they can have it regardless of GATT or the WTO. We’re asking the Indian government that no one should be allowed to maintain a monopoly, that companies should be allowed to produce drugs under licence, without evergreening, and that research should be allowed on patent-protected products, if it is for non-commercial purposes. Big companies can’t work unless they have a monopoly. They’re not used to working with competition.
Do you have any other ideas in the pipeline?
I am debating setting up the Hamied AIDS centre or Cipla AIDS centre in India where anybody can come for free HIV tests. If they’re negative, you go home. If positive, we give counselling.
If you were unlucky enough to fall ill, would you take the original drug or the Cipla alternative?
Cipla, of course. Our manufacturing facilities have been inspected and approved by 11 regulatory authorities including the US, Britain, Germany and the World Health Organization. No factory belonging to multinational companies in India has this kind of approval.