Can poor countries handle anti-HIV drugs? Are drugs companies putting their own profits before people's lives?
As part of a BBC season on Aids, a pharmaceutical industry leader and a campaigner from the charity Oxfam will answer your questions.
International pressure has resulted in increasing global access to anti-HIV drugs, known as "antiretrovirals".
Companies have cut drug prices and developing countries can now import cheap "generic" versions of the drugs under a recent World trade Organisation deal.
But will future research and development suffer if the drugs giants sacrifice profits? And will the HIV virus become drug resistant quicker if the medicines are dished out without proper infrastructure?
We were joined by:
Dr Harvey Bale Jr, head of International Federation of Pharmaceutical Manufacturers Association
Dr Mohga Kamal-Smith, Health Policy Adviser, Oxfam
Dr Ernest Darkoh, head of Botswana antiretroviral drug treatment program
Hello and welcome to this BBC News interactive forum. I'm Karen Allen. Today we'll be discussing the global challenge of getting life preserving Aids drugs to the millions of people who need them as part of the BBC's special session on AIDS.
Antiretroviral drugs add many years to the lives of HIV patients but most poor countries simply can't afford them. This week South Africa approved a plan to distribute the drugs free to more than five million people. Drugs companies have dropped their prices in recent years and relaxed patent rules so that cheap copies can be imported. But will lost profits mean less funding for new research and are developing countries ready for the drugs?
Well I'm joined here in the studio by Dr Mohga Kamal-Smith, health policy advisor at Oxfam and in Geneva we have Dr Harvey Bale Jr, head of the International Federation of Pharmaceutical Manufacturers Association. Welcome to you both.
First of all we'll go straight to the first e-mail. It's from Kootee Korvah, Guinea who asks: Is it possible for these anti-HIV drugs to be distributed free of charge as is happening in the case of polio? Can I put that first of all to you Dr Harvey Bale?
Dr Harvey Bale Jr.:
Well I think that the goal, is to make the drugs as affordable as possible and in poor settings the current prices that have been reduced over the past several years are still in many cases very high in relation to the incomes of the people that are intended to be benefited.
A couple of our companies are offering the medicines for free directly from the companies. But where, I think, the additional help must come is from the donor governments of the so-called West or the northern countries who are donating money and giving money to the Global Fund for Aids, TB and malaria. And this money is supposed to procure medicines and also procure services to provide them to people in need.
So I think the combination of the differential pricing that's being made available for people in Africa, particularly, but also other poor countries the world, combined with additional financial resources can make the difference. And I think it's quite frankly unfair for the poorest of the poor to have to pay a large fee for these medicines. I think the intent is to try to get them to people as cheaply as possible.
Dr Kamal-Smith - fine words from the pharmaceutical industry. Are you believing that this will actually happen one day? Your charity has had a "cut the cost of drugs campaign" - do you one day to expect to see them free of charge?
Dr Mohga Kamal-Smith:
Yes well I should hope that they will be free of charge otherwise how can poor people access these medicines?
But haven't the pharmaceutical companies done enough?
Dr Mohga Kamal-Smith:
Well the thing is, I agree with Dr Bale, that there is a need for northern governments and southern governments, in fact, to put money into health services and into buying these drugs via the Global Fund and other means. But the prices of drugs, they have come down, yes, they have come down quite a lot. But we mustn't forget that they have come down partly, and a big part was because of the generic competition.
Maybe you heard, it was on the news very recently, that Bill Clinton he managed to get even a cheaper deal from the generic companies in India and that's really made a big difference - starting from the $10,000 a few years ago when people just couldn't dream about - even talking, debating, giving these drugs, delivering these drugs in Africa - now we talk about $140 which is a lot more affordable for governments and donors that fund health programmes.
Well there are some countries that have already achieved this. I'm delighted to say that we're now being joined by Dr Ernest Darkoh, who is head of Botswana's antiretroviral drugs programme. Welcome to you, I believe you're speaking to us from Lusaka. Botswana has a very impressive record on providing treatment for free, how's that been achieved?
Dr Ernest Darkoh:
Essentially the government is paying for all the drugs. We're fortunate to be in a situation where the Merck Company is donating one of its drugs for free - one of its drugs that we're currently using - and then the government purchases the rest.
We started our programme two years ago - and the government actually at that point went and negotiated directly with different pharmaceutical companies to get a preferential rate. So they're still quite expensive but at least it made it affordable in line with what the government could afford at the time. Since then there have been sequential decrements in the price of drugs which has increasingly made it more affordable and sustainable.
Thank you. Well I've got an e-mail that's just come in that I'd like to put to Harvey Bale. There has been a row about generic drugs - we have to point out generic drugs are copy drugs - versus cheaper brand name drugs, drugs like AZT, that people have heard of. We've had an e-mail from Jason in Canada who
says: I fail to see how allowing poorer countries generic versions of antiretroviral drugs would hurt pharmaceutical companies. They would still make a killing in rich countries selling their drugs at regular prices. Moreover, helping people should precede profits.
Would you agree on that? Why is there such a problem with going the generics route?
Dr Harvey Bale Jr.:
I don't think there's any problem. I think the question is whether or not generic drugs are really available in developing countries. The agreements under the World Trade Organisation that have been reached over the past couple of years and one which we supported very recently, in fact allowed countries to import generic drugs, particularly when they don't have domestic production. But whether or not they have domestic production they have that right under the WTO agreements.
In fact the pharmaceutical industry has supported that and I don't think that it makes much more than a marginal difference in the so-called bottom line of the pharmaceutical companies and particularly the research projects to have these drugs provided either at cost by our brand name pharmaceutical companies or even donated, as they are in the case of Nevirapine for mother to child transmission of the HIV/Aids virus to countries that really need them.
In fact, as you know, Boehringer Ingelheim has offered to every developing country, Nevirapine, for mother to child transmission for a period of at least five years. And so I think that the person who's written the e-mail is someone that I think I could agree with. Perhaps the thought that somehow the companies are making a killing in the so-called northern markets, I might debate, but that's another matter.
We've got a question for you Dr Mohga Kamal-Smith. It's come from Akoth in Kenya, the question is that access to anti-retrovirals realistically will never be cheap enough, as long as you are poor and you live in Africa, free is the only affordable price. But they also make the point whatever reductions are given will have no effect until poverty is dealt with. Are we actually kind of missing the trick here, that you can reduce the price of drugs as much as you want but actually we should be tackling the underlying problem which is poverty?
Dr Mohga Kamal-Smith:
I think it's not an either or debate. Well of course we have tackle poverty and there's a lot of effort globally and at national level in countries like Kenya to tackle poverty and there's poverty reduction strategies in many countries now and a lot of development agencies are working on that. So that's happening.
Of course you can't reduce poverty or alleviate poverty in a year or 10 years or even 20 years. So it's not either or. We can't wait for all these years until we tackle poverty, we have to do both at the same time.
We have to tackle poverty but at the same time we mustn't forget that HIV is a big driver of poverty and of gender inequality as well. And in Africa, including in Kenya, most of the new cases now are among women who are poor.
So I think if you don't treat the people they will go down the drain and all the families will go downhill with poverty. So you have to do both, you have to get the anti-retrovirals to people. And it's right -with poor people, no, they can't afford it, it has to be free.
I have another question now for you Dr Ernest Darkoh, this is from Shiraz Jetha in Kenya: How much longer do people live on average by taking the drug therapy? What has been the experience that you've found in Botswana?
Dr Ernest Darkoh:
Well our programme has truly only been available - the public programme at least - has only been available for a few years. So in the experience within our programme, we have a limited time period that we can follow.
But looking at time periods from more developed countries, where people have been on the same drugs that we currently have our current population on, that timeframe can extend anywhere from about 10 years to 15 and maybe even more.
The verdict is still out in terms of what is the maximum limit that someone can stay alive on the drugs. Of course all of it is predicated on issues like nutrition, other core morbidities that may be present in that particular environment - the person's overall health status at the time of initiation etc. But generally speaking the life prolonging benefit is clear and it's significant.
Exactly. It's worth making the point that actually it's difficult to compare developed and developing worlds because specifically all those issues about diet and exercise. What is Botswana actually doing to make sure that that holistic approach is taken?
Dr Ernest Darkoh:
Well in Botswana we've essentially addressed - we're as much trying to treat HIV/Aids in the same way that we treat all other health matters, which is we look at the patient comprehensively and address all their needs.
In terms of nutrition the government has a food basket programme that is for destitute people. Just because they're HIV positive does not necessarily mean you need food. We have many of our clients who drive Mercedes and live in mansions. So the reality of those who are poor, who can't afford food, whether or not you have HIV, we actually do provide food as a government.
Thank you. A question now for you Dr Mohga Kamal-Smith. This one from the USA from Richard Loftus who says: In the US, people on HIV drugs get regular monitoring with expensive lab tests - developing nations rarely have these tests available. By giving HIV medicines without routine tests, are we creating a "lower standard" for care in these countries?
An argument that's been used by countries like South Africa right up until now.
Dr Mohga Kamal-Smith:
Well again you know, where do you start? Do we wait until we get all the labs done, all the sophisticated labs that we have in the north here? I don't think we do, we shouldn't wait. But there is an organisation like the World Health Organisation - they're working on guidelines for how to use simple testing in poor settings. Also there are some programmes around the world where there have been successful programmes, without such sophisticated testing.
We're not saying that you dump the drugs on people and just let them get on with it. Of course no responsible health people would say that and we're not saying that. We're saying how can we get the necessary lab and monitoring available in poor settings and adapted for poor settings. There are examples in Haiti, in South Africa, in Malawi - in many other countries where programmes have been delivered and the patients have been monitored. Compliance is very, very high. So I think the argument is how we can get the tests, who will pay for it - so we've got the Global Fund and other donors to pay for it.
A question for you Dr Harvey Bale, one in from London, a question about patents. Michael from London has said:
Do you think that the impact of lifting patent restrictions for anti-retroviral drugs will act as an incentive for the drug companies to develop HIV drugs in the future?
Dr Harvey Bale Jr.:
Well I think the companies in Africa and other regions of the world which are the least developed regions have not had patents supplied, except in a few cases. So the companies actually have not made use of patent rights in many parts of Africa and other regions such as South Asia.
I think the patents where they're most important are in the developed countries where the ability to pay for medicines is much greater and this is where the industry is largely based.
We see now the development of some research facilities and research efforts, not necessarily in HIV/Aids but in some other infectious diseases in countries like India and I suspect more developing countries will get into this field of Research and development for new drugs. And I think the patent issue is going to be a very important part of that.
But I think the companies can segment the world, so to speak, with regard to intellectual property protection and seek patent protection in those markets that are the most important and where the returns on the investments which are in the hundreds of millions of dollars need to be made in order for them to be able to supply the medicines at cost or below cost or even donated in parts of the world that are less advantaged. And this is why I think that the Merck Company in fact provide these medicines in Botswana for free so that they have their markets in Europe, the United States, Japan, Canada, Australia etc. protected.
It's taken a long time to get there because the argument that has always been put by the pharmaceutical industry is that these drugs would somehow creep back on to the richer markets and that was always the argument against patents, so what's changed?
Dr Harvey Bale Jr.:
Well I don't think that risk has disappeared at all. I think that governments have come much more to realise that they have to be much more secure in the distribution system.
I think certainly in Botswana there's been a great effort, successful effort, to make sure the drugs are getting to patients and not being diverted back into markets which may be trying to draw these drugs away at very cheap prices and use them elsewhere. I don't think it's been such a recent phenomenon either - I mean Glaxo Smith Kline announced two dollars a day price for its Kolavire in 2000 - this is several years ago, so I don't think it's a new phenomenon.
And of course GSK, they did experience some diversion of products from some parts of Africa into the Netherlands and so this was addressed. But I think the risk remains but I think that companies and countries are much more aware of the problem of diversion of products away from the patients that need them and I think there's a greater effort being made to address it, including in the World Trade Organisation agreement that was reached in late August.
A question now for you Dr EB, this one from Germany, whilst we're talking about generics we also need to talk about quality management. We've had an e-mail from Jack Kapembwa, Germany who says: How different are the drugs being sold to developing countries from the ones in developed countries? Are they qualitatively different and how do you regulate the quality?
Dr Ernest Darkoh:
We in Botswana are using exactly the same drugs that are available in the West at the moment, we aren't using generics. We do have very good quality assurance mechanisms in the country and a very solid central medical store, which is basically responsible for all drugs procurement in the country, that also basically handles antiretroviral drugs.
With the mechanisms in place we're comfortable that if a good generic comes about or we feel that at some point the country does want to move to that, then we would have the requisite assessment and evaluation mechanisms in place to ensure that they're good quality, some viral abilities, some efficacy of medication. So in short, the drugs we're using are exactly the same.
I have a question for you Dr Kamal-Smith. We have a question from James, Hong Kong who says: In Hong Kong people are not getting access to treatments. Is there any way to access to these drugs or sue the government if they don't actually get them?
Dr Mohga Kamal-Smith:
Well I think the major movers into getting the prices of medicines down and accessing drugs all over the world is actually patients groups getting together and lobbying - lobbying their governments, lobbying the international community, lobbying pharmaceutical companies. And I think if people feel strongly in Hong Kong that they're not getting the medicines they need they should start lobbying for their rights.
The UN now have a UN Commission on Human Rights on the right to health and it is acknowledged that access to medicine is part of the human right to health, so they can use all the tools that they can to lobby the government to get access to treatment. Particularly as the prices of medicine are going down and in Hong Kong I believe they have a good health system to deliver.
It's a hugely political issue and it forced its way back onto the political agenda recently before the recent Cancun meeting of the WTO about how to regulate patents, how to provide greater access to drugs. I have a question for you Dr Harvey Bale, which has come from Laura Hinze, who works for an organisation called PATHOS in Vietnam. She says: Some of the children I work with are in desperate need of antiretroviral treatment. The Indian generic drugs company CIPLA are eager to assist - but in Vietnam we do not have permission to import the drugs. They request that I approach the ministry of health in Hanoi. Please what do you suggest for these dear children to have affordable immediate access to this vital therapy for their life?
I suppose what's she's hinting is should the government be pushing to get what's called a compulsory licence for this?
Dr Harvey Bale Jr.:
Well I'm not sure why the drugs aren't available in Vietnam, it may be a question of the registration process. Governments in Botswana or any other country that has a responsible drug supply system has a system of registering the drugs. The drugs have to be registered as to who makes the drugs, the guarantee of the quality of the drugs and the efficacy and the safety of the medicines. So this could be a registration issue.
But certainly if she would like to work with companies that are either CIPLA or brand name companies, these companies are more than willing to make an effort to try to get medicines to people who are working on the issue and their need.
A number of the companies are working now with private organisations, they aren't necessarily waiting for governments to take action. Even in South Africa and other parts of Africa which didn't have national programmes, there were companies, mining companies, oil companies and other companies that were doing business and losing their workforce through Aids who approached the companies and sought to have a compassionate programme with cut rate prices and get these medicines to people in need.
So I would suggest that people in Vietnam in a programme like this that they approach the issue in a couple of different ways. Approach the companies directly but perhaps approach the Global Fund through what is called a country coordinating mechanisms, if one exists in Vietnam, and try to get a project going which can be funded by the Global Fund.
So I think there are number of options today, I think as was indicated earlier the prices have come down, the opportunities are greater and it's absolutely a crime that there is a need that is going unmet.
Well there are many more drugs swilling around in the system, if I can put it crudely like that, but there are costs potentially to be paid for that. We've got an e-mail from Jeffrey Ehmsen, a medical student from the USA. He asks: With the risk of drug resistance developing, it's pressing to ensure that individuals are able to maintain the necessary regime, over a very long term. What specific plans are in place to help people in this way?
Perhaps I can put that point to you Dr Harvey Bale once more - how do you ensure that you maintain that continuous stream of drugs and you don't open the gates to drug resistance?
Dr Harvey Bale Jr.:
It's an important issue and clearly the drugs have to be taken properly, consistently with oversight and counselling and this of course poses challenges to countries in relatively resource poor settings.
But governments like Botswana do have the oversight. They're working with the Gates Foundation, they're working with the Harvard Medical School and they're working with the Merck Company to ensure that patients get the drugs on a regular basis. That they're taken properly, for example, with clean water and with the proper dietary supplementary programmes.
But the question is a good one - resistance is always a threat. In some parts of the world, including some fairly sophisticated countries, like India, most of the patients who are taking Aids drugs are on what is called Wild Therapy. Wild Therapy is meant to denote therapy that is unsupervised - people have access here regularly to the medicines and they're taking them on their own cognisance and they're own information about how to take the drugs. There is a strong risk in those circumstances of seeing the rise of resistance to strains. We already see this in parts of Europe where in some regions in France and elsewhere there are very high levels of resistance to anti-retrovirals which points to, of course, the need to do further research and continue to develop new medicines to overcome this.
But the proper regime does minimise the risk of resistance and this is why I think Botswana's programme - it's unfortunate that we've lost the line to Dr Ernest Darkoh - is an extraordinarily important one because it is a top to bottom programme: counselling, therapy and prevention, education. That's the kind of programme that's likely to work in most countries if it's followed and that's why I think the Botswana programme's a model programme.
Well I'm afraid we've not been able to make contact against with Dr Ernest Darkoh. But I know that Dr Kamal-Smith, you're keen to interject here, what's your view on trying to prevent resistance?
Dr Mohga Kamal-Smith:
Yes, as Dr Bale said, yes we do need to have good systems to monitor and to get people to adhere to medicines. There's a couple of points here: why do people use this Wild Therapy or one drug therapy which is not effective and creates resistance? Partly because of the price - partly.
The other thing is to make life easy for people rather than taking many, many pills which makes adherence to the regime very difficult. If we have what they call six combinations, i.e. you get three drugs in one pill, then if you have one pill twice a day obviously it's easier to adhere to that, rather than if you have five or six pills.
And at the moment because some of the drugs are produced by different companies, the companies haven't got the incentive to work together and produce drugs that are combined although they are under different patents. However, the generic companies have done that and there's one drug now - the cheapest antiretroviral on the market is a combination of three drugs and it's easy to take because it's twice a day, one pill. And that obviously enhances adherence and decreases resistance.
Thank you very much. Well we have a question, if I can put it to you Dr Harvey Bale, regarding the messages that are being sent out if we provide more drugs, the basic safe sex messages, as we've called them here. It's a question from Ruth Chapman in the UK and she says: Do you think the perceived protection that antiretroviral therapy gives to those taking the drugs will lead to an increase in risky sex acts in the developing world - as has been demonstrated in Seattle and Amsterdam and I hasten to say, London?
Dr Harvey Bale Jr.:
Well this is a question that's of course beyond the capabilities of the research based pharmaceutical industry. But clearly safer medicines mean that the people can be tempted back into riskier behaviour, which would be unfortunate. This is why I think it's very important for governments not just to rely on a treatment programme but an education programme. Condom use, safe sex, other means of addressing the societal behaviour characteristics of people is extraordinarily important.
And so I think yes this is a risk but on the other hand I don't think we can condemn people to HIV/AIDS because of this risk. We have to keep in our industry looking ahead for a vaccine that ultimately will prevent HIV/Aids. There are a couple of vaccines which the industry's working on, one company's been working on a vaccine for the past 15 years and are moving into trials which hopefully will find a vaccine that can be used in the public.
And of course that will imply that again if people are vaccinated against HIV that that might again tempt people back into unsafe sex practices and perhaps we might then see a variant on the disease in the future. That's always a risk but I think that has to be worked on by governments and by education systems and by sociologists. Then we all have to play our role here and I think for us in the pharmaceutical industry, the chief role we have to play is R and D - research and development - and there are over a hundred new medicines and about 10 or so vaccines that are in the pipeline. And we're just keeping our fingers crossed that a number of these will come forward as useful weapons against HIV/Aids.
Well we have seen collaboration in terms of some vaccine research, possibly less so when it comes to drugs. A question to both of you, if I can put it to Dr Kamal-Smith first. It's a question from John in the UK, he says: Is it not time that all HIV research was made fully on a collaborative basis so that all drug and research companies shared their data to speed up the day when all people affected by this terrible disease will be cured?
Great idea of is it just a pipedream?
Dr Mohga Kamal-Smith:
Well it's obviously a great idea to do that and as we know it is happening in vaccine development, partly because there's a lot of public interest in that and obviously the private companies are part of it. On drugs - because the drugs have been developed just as how the market has been developed, it has been working for years and years. Drug companies will go where there is profit for their shareholders and therefore they do drugs on their own.
However, part of the business of drug companies, is that they do sometimes collaborate or licence drugs. The biotech companies produce a molecule and then they licence it to a big company. But of course one issue here that perhaps would prevent collaboration again is the patent issue. If you have a patent on a molecule and you don't want to share that patent the other researchers have to pay and that has started to affect our research and development for some diseases, so it is an issue there.
Dr Harvey Bale, if you're having to satisfy your shareholders, is collaboration necessarily what they want to hear?
Dr Harvey Bale Jr.:
Well the major of Aids companies are also vaccine companies and I have to correct the record here on a few points. First of all, I think Dr Kamal-Smith keeps referring to patents in a negative way. The fact is without patents we would not have these medicines on the market at all.
The vaccine companies themselves are not being driven by the public sector in collaboration on HIV/Aids vaccines. In fact Merck and GSK have had their own programmes on vaccines underway for a number of years.
Now in recent months there's been collaboration among a couple of them with regard to combining efforts - it's been found to be more effective in moving forward. But I think a model in which somehow we pool all of our efforts into one collaborative approach, that that might somehow speed or accelerate the pace of research and progress beyond what has already been made, is, I think, an approach which probably, at the end of the day, will not work.
We have seen since the HIV/Aids appeared on the scene in the early '80s, that within four years AZT appeared on the market - that's a remarkable record that came out of the Welcome Corporation. We now have over 20 ARVs on the market - these are antiretroviral medicines. They are very effective medicines against opportunistic infections like thrush.
We have vaccines that are in development, all of this coming from the private sector. Now there is a lot of collaboration with organisations like the National Institutes of Health, of course, in developing some of these medicines but the private sector and the patent system have in fact produced what we are now debating how to distribute. So I think that that is a model that has been effective.
Collaboration is always possible and it's always sought. There aren't any patent barriers against collaboration - the questions are scientific and there are questions of what are the most effective means of working together to get something done? The fact that shareholders are in the background looking for companies to perform is a very strong driver for R & D in this field of HIV/Aids. And now we see the companies and governments and the Global Fund and the international institutions all working together to try and solve the problem of how we get these medicines to people who have no income.
Now that is not affecting the R & D pipeline and I think the concept of collaboration is one that is effectively pursued when it's advantageous. But I think simply substituting public collaboration for private R & D will probably get us nowhere and move us backwards.
Okay well that's all we have time for today and my thanks of course to our three guests and to all of you for taking part, those of you who watched and sent e-mails. Dr Harvey Bale Jr, Dr Mohga Kamal-Smith and Dr Ernest Darkoh, thank you very much.
Next week we'll be talking to the President of Botswana, Festus Mogae. If you'd like to put a question to the president, e-mail us at firstname.lastname@example.org
If you'd like to know more about Aids, visit our website at www.bbcnews.com/aids. Thank you very much.