India - Patents and Patients

January 26 2004 – 25’00”


COMMENTATOR (COMM.): Previously on Life:
VERA SMIRNOVA: The whole system was destroyed and the system of values was destroyed as well many people simply don't believe in their future.
ALEXEI BOUKHAROV: Russia should think about its children - if we do not support them now, they will become street people...
MOHAMMED IQBAL: When there's a common interest, and if it is the health, and if everybody is united to do something about it, then it is not difficult.
YUSUF HAMIED, Managing Director, CIPLA: There are in India today hundred thousand lorry drivers - and trucks and lorry drivers - who take goods all over the country. And that, I'm told - and I stand corrected - is one of the major causes of the spread throughout India of HIV. They go to a town, they get infected, then they go home. And then they might infect their wives, etcetera, etcetera, etcetera. My little thing would be that no truck or lorry driver is given a driving licence for more than one year. And is only issued a driving licence if he has a blood test and shown he's HIV negative. Do that every year! If I was in the government, I would do that on a war footing immediately...
INTERVIEWER: On a war footing?
HAMIED: War footing.
Dr. ALKA DESHPANDE, AIDS specialist, JJ Hospital, Bombay: We don't have adequate number of nursing staff to look after such a large number of patients. So because the family members are there, then they look after their patients. So if the patient is demented, or if the patient is having a persistent diarrhoea, so naturally, we get help from the family member. And the family members are also trained in giving the health care - observing the universal precaution. We start the training of home-based care here itself.
There are many young women, you know - they're the innocent victims of this disease. Because HIV in the initial stages remains asymptomatic, many of these people are not aware - and because of their ignorance, they're indulging to this multi-partner sex - or most of them, so to say, go to the commercial sex workers. They're unaware that they're HIV-infected, they get married - and then the infection is passed on to the wives. And I'm getting an increasing number of innocent women who are HIV-infected, and the source of infection is their own husband. And they're passing on this infection to the children.
INTERVIEWER: So the family that is helping here can sometimes be infected themselves?
DR. DESHPANDE: Yeah...But at least you know when the husband is in an advanced stage, the wife is in the earlier stages, the wife looks after the husband. But when the wife is really sick, she gets very limited support from her family. That is the tragedy.
He's a case of meningitis - complaining of persistent headache.
Dr YUSUF HAMIED: Three and a half thousand new cases of per day! And India will have thirty-five million HIV positive by the year 2003. It looked to me - it's an emergency! - and the sooner the Indian government wakes up and realises that something can be done, the better.
Dr. JAN RAAIJMAKERS, Director, Science & Business Development, GlaxoSmithKline (Translation): If you're trying to fight an epidemic like HIV/AIDS today, you don't do it by loading a plane with all the pills in the world - and just emptying them over the Third World. What you need is a basic health infrastructure. If you don't have that, you aren't going to provide any help for HIV sufferers - who are mostly illiterate, can't read the information on the leaflets in their drugs packets - and have to cope without a health care system that can tell them about the disease they have, and the possible cures for them. If you don't have any of this, you just can't fight the epidemic.
COMM: The global pharmaceutical companies are at war, and the battlefield is AIDS. The Indian drugs company CIPLA started producing generic medicines for HIV/AIDS sufferers in India. There's nothing illegal in this - Western drugs are too expensive for many Indians. This is why the Indian government has allowed Indian drug producers to make generic copies of these drugs - bypassing patents on them - in an effort to ensure a viable health care system.
Dr. HAMIED: This is a drug called stavudine, which is used against AIDS. And this is a new method of making it which we've developed in-house. We spend about - maybe in a year - two hundred and fifty to three hundred thousand dollars for scientific journals and books etcetera each year.... you can see the pile of journals on the right here. So we get about maybe three hundred to four hundreds journals - scientific journals - a month. All the journals that CIPLA subscribes to first come to me. Because that's my hobby! - I probably read about four hundred journals in a month... or scan, I don't read, I scan. And I pick up whatever is important. And on the basis of that, we develop our own research-and-development programme. And then I give it to my boys at various research centre - 'Can you do this? and 'Can you do that?' They also suggest...
INTERVIEWER: Can you find out how to make this drug?
HAMIED: ...can we find out how to make it....
INTERVIEWER: ... that was developed by someone else?
HAMIED: ...by someone else.
COMM: Besides CIPLA, there are twenty five thousand other companies producing generic drugs in India. CIPLA has produced around eighty different drugs. It manufactures an anti-anthrax drug - for which Bayer owns the patent - a variant of Viagra, where the patent belongs to Pfizer. And a whole series of anti-retroviral drugs for HIV/AIDS sufferers, whose patents are owned by Bristol Myers Squibb and GlaxoSmithKline.
Dr. RAAIJMAKERS (Translation) We're talking about a much bigger issue than whether this constitutes theft or not.... I care about the principle that patents are vital to protect the profitability of the pharmaceutical industry - so it can go on developing new drugs. I understand that, from a business point of view, Mr Hamied doesn't respect that. I don't agree with him. Is it theft? In the strict sense, I don't think it is - according to the law. As long as he stays on his territory, in India - or anywhere else where patents aren't recognised.
Dr. HAMIED: See, patent laws are national laws. Please understand - they're not international laws. There's no one international patent law which is common for everybody. The Americans say, in atomic energy and nuclear power, no patents should be allowed in America. Why? Because for the Americans, defence - for them - is a national need. In a country like India today, we Indians say - 'what are our national needs?' Our national needs, we decided in 1972 - and I was party to it - is two: health and food.
COMM: In February 2001, CIPLA made news headlines around the world when it offered to provide cheap anti-retroviral drugs for HIV/AIDS sufferers in South Africa. The multinational drug companies threatened to fight the case, in court - but backed down under international pressure. And then they cut the price of their own drugs - by up to 90 per cent.
Dr. HAMIED: If you have exclusivity, and a monopoly, you can charge what you want. Per patient, per year. The multinationals - because of their monopoly, were charging ten thousand to fifteen thousand dollars per patient, per year. Until we came forward, and said 'no', we can give it to you at three hundred and fifty dollars. Then, when the damn thing costs two hundred or three hundred dollars, why the hell are you charging fifteen thousand dollars?
INTERVIEWER: Is it not...
HAMIED: Am I the thief, or are they the thief? That's the question I'm asking you...
COMM: Global pharmaceutical companies claim that drug patents are the only way to ensure they'll be able to go on producing new drugs. Developing new drugs is a long and expensive process. New drugs are often derived from plants - from Nature. But not every shot is a hit. It can take as long as ten years to develop a drug from a plant - and often, it goes wrong mid-way, and there's no guarantee of success.... But in spite of this - according to the American business weekly Fortune - the pharmaceutical sector has been the most profitable industry over the last twenty years. How? The US Congress tried to find out how much it cost to develop new drugs so they could decide on fair prices. But the pharmaceutical companies used the law to stop them.
INTERVIEWER: Can Glaxo provide me with figures on how much it costs to develop a particular drug?
Dr. RAAIJMAKERS (Translation): No, Glaxo doesn't do that... no other pharmaceutical company would either...
INTERVIEWER: What's the problem with it?
Dr. RAAIJMAKERS: It's the way business is done, it's sensitive information for our competitors - No company gives away these kind of figures, on costs and pricing...
Dr. HAMIED: Half the drugs for AIDS that are marketed worldwide have not been developed by the people who are marketing the products. They've licensed the products in! They pay royalties to.... like in stavudine, this thing I just showed you - the actual research was done by the United States government! They then give an exclusive licence to Bristol Myers Squibb. So the research was not done by Bristol Myers Squibb, it was done by the United States government, at Yale University. When I wrote a letter to Bristol Myers Squibb in December last year, that I'm willing to license your product on payment of royalty, I didn't even get a response from them...
COMM: Pharmaceutical companies typically spend twice as much marketing their products as developing them. This is where they excel - at marketing new drugs, not necessarily at research and development.
Dr. HAMIED: Do you know, in my forty years here at CIPLA, I have come up with four new products. No Indian doctor accepts it. They say, 'Dr.Hamied, if it's as good as you say it is, then why is it that companies like Pfizer and Glaxo haven't brought it out before you? They don't accept - here, here is a product I have here in my hand, chondonium iodine - injections. Approved for marketing in India? What do I do? Tell me one Japanese drugs that has ever become popular? None. I don't have the marketing muscle. So what do they do? If you look at the world's top 50 drugs, half of them are not invented or researched by the company that is marketing those products. The Japanese invent something, then they have to go with a begging bowl to the big companies, please take our product for marketing...
Dr. RAAIJMAKERS (Translation): I'd answer that by saying - look at the way he is marketing drugs in Africa, where he effectively uses the media, including you, to show that he wants to sell his products in Africa. Nothing more, nothing less...
COMM: Major pharmaceutical companies earn less than one per cent of their profits from sales in African countries - and so could easily afford not to enforce their patents in those countries. But CIPLA's behaviour makes them nervous.
Dr RAAIJMAKERS: In Third World countries, you often find that the packaging - the boxes - for drugs have been copied - but inside, there are either no drugs at all, or very low quality drugs. We need patents to prevent these kinds of practices, and guarantee high-quality medicines.
Dr. HAMIED: I answered that in the European Commission last year. Please listen to me very very carefully. All Cipla's factories have been inspected and approved by the US FDA; by the MCA, UK; by the German health authorities, by the South African health authorities - by physical inspection. By the TOA, Australia. The Hungarian FDA has been here, Unicef have been here, WHO have been... physical inspection! Our factories are physically inspected...
[interruption]
HAMIED: - do you know.... Let me finish, sir! Do you know, not one factory of the multinational companies that are here in India - not one - has been inspected or approved. Because they're not interested in export from here - they're only interested in the local Indian market. Or maybe the markets where approvals are not required... If any of my products where I compete with the multinationals was not similar to theirs, they would be shouting from the rooftops!
COMM: But even if Cipla's organized its affairs well, you cannot say the same thing about the Indian government. While the AIDS epidemic is starting to reach every part of the country, India's health service is not prepared for the consequences. Even a city like Bombay - with 16 million people - has only eight AIDS specialists.
GIRLS IN BROTHEL (Translation): - I'm getting fever again.
- Take some medicine...
- They don't help.
- You will never be better again.
Dr ALKE DESHPANDE, AIDS specialist: I can only talk about patients attending this hospital. And about one per cent of our patients, we could start anti-retroviral therapy. And those who are receiving anti-retroviral therapy, they are doing very well with the therapy. The survival time has increased, the incidence of opportunistic infection has gone down. But for that we have to be literally after the patient - you know, we have to continuously counsel them, we have to establish a dialogue with them... So that they adhere to the therapy. But there are many times, I would say, they themselves modify the dosages - they themselves modify their own treatment. And they just stop the treatment. And that is where we are fearing a problem of drug-resistant HIV.
GIRLS IN BROTHEL (Translation): - You have to take two...
- How many of the green did they give you?
- Two.
- I only take one. - You mustn't take two.
Dr. RAAIJMAKERS: These tablets are anti-retroviral therapy for five days. That means that all these pills have to be taken in the course of five days. That means the patient has to know how to take them, and understand that if they don't take them all, there's a real danger that the virus will become resistant and then they won't work any more. So when you say it's a good thing - just to give a company in a Third World country the licence to produce these drugs, you're making a big mistake. We should only provide manufacturing licences to drug companies that can help build up an infrastructure. Otherwise the drugs you see here will be useless in a couple of years.
COMM: Indian doctors are under no obligation to treat AIDS patients. Usually, out of fear of the disease, they send them to government hospitals that do. But many patients - particularly the poor - don't even make it that far. Because they don't have the money to go to a doctor to begin with, they often go straight to the pharmacist for drugs.
Dr DESHPANDE: I have seen quite a few prescriptions which shown inadvertent use of drugs. There are absolutely irrational combinations. There are sub-optimal dosages which have been used. The duration is - varies from seven days to maybe three or four months. If the prescriptions, or drug therapy, are started haphazardly like this, very soon we will have a drug-resistant HIV epidemic here in India. That worries me most.
INTERVIEWER: So introducing a cheap drug might lead to the destruction of the drug itself?
Dr DESHPANDE: Probably, yes. See, we have already burned our fingers with tuberculosis. Now we are facing a big problem with multi-drug-resistant tuberculosis. And that is mainly because these patients - even when the drugs were given free-of-cost - did not continue the therapy for the specified period of time - that is six months to nine months. When we talk about HIV disease, the therapy has to be continued for years together.
INTERVIEWER: But isn't it a bit your responsibility as a drug-maker to come up with a drug at the right time?
Dr. HAMIED: It is my responsibility. That's why I'm coming out with these drugs...
INTERVIEWER: But it's too early, there's no infrastructure....
Dr. HAMIED: That's not my way... among my doctors, there is an infrastructure. Cipla has today one thousand eight hundred what are called 'sales representatives' - executives - that go round meeting doctors. We go - we cater to over two hundred thousand doctors in India. And at least my group of doctors, totalling over 200,000, are being educated, virtually on a daily basis, on AIDS. So I'm doing my service - let others do their bit!
INTERVIEWER: But if you don't need to spend so much on drugs, then you've got more money to spend on building an infrastructure?
Dr. RAAIJMAKERS: I think that is correct.
Dr. HAMIED: At least you're doing something... I don't like this inertia we're facing today - that nothing is being done.... You get my point? And that's what... bugs me.
END

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