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Access to Medicines and the Doha WTO: Why Patents Matter
A press teleconference held November 6, 2001
November 6, 2001
Ellen 't Hoen, Access to Essential Medicines Campaign Coordinator
Kris Torgeson, Communications Director
Kris:Thank you for joining us today. We see this as a backgrounder for journalists who are interested in covering the Doha WTO and access to medicines questions. Joining us today is Ms. Ellen 't Hoen, a coordinator for the MSF Access to Essential Medicines Campaign and an expert on intellectual property rights and pharmaceuticals. We are also joined by James Love, the director of Consumer Project on Technology, and Asia Russell, an AIDS activist with the Health GAP Coalition and Act Up Philadelphia. I'm going to ask Ellen to start with her statement, and then we'll move on to Asia, and then James.
Ellen:My name is Ellen 't Hoen; welcome to this call. I think it's really encouraging to hear so many people calling in. Because of what's going to happen later this week and the beginning of next week, we feel it's going to be, hopefully, very, very important and will change the way medicines are provided to people in developing countries.
What I'm going to do in these first few minutes is tell you a little bit about why this is so important and why we should be worried about the WTO TRIPS Agreement and access to medicines. I think for those of you who've been following this, some of it might sound very familiar or get boring but I think it's good to have that as a basis.
The TRIPS Agreement is one of the agreements of the World Trade Organization; all members of the WTO have to abide by it. The TRIPS Agreement sets out the minimum standards of protection for intellectual property. And the TRIPS Agreement does not distinguish between products that are a matter of life and death, and products that are rather trivial; it regulates Barbie dolls and medicine very much in the same way. It sets out so-called minimum standards, but actually, those standards are rather high because they've been derived from the western way of dealing with intellectual properties. The standards include a minimum period of patent protection term of 20 years, for example, and it covers both process and product patent. All countries will need to implement those and there are different deadlines. Industrialized countries should have done it five years ago, developing countries by the end of the year 2000, and 2006 is the deadline for the least developed countries.
Now, why is this a problem for medicines? What we fear is that there will be an effect of this TRIPS implementation on access to drugs because you actually increase the number of monopoly positions, which will lead to higher drug prices. In general—and you know that from also the situation in the United States—drugs that are under patent are a lot more expensive than drugs that are available from multiple sources. It will limit the competition. Competition is one of the most proven effective ways to bring drug prices down, as we have seen in the last two years, where different producers started to offer anti-retroviral combination therapies, which had a really downward effect on drug prices globally.
One very important concern is that all of this will have an effect on the local manufacturing capacity. Many of the more affordable drugs that are used and supplied in the developing world come from countries where, at the moment, pharmaceutical patents are not being granted, and where newer pharmaceuticals are produced at much lower cost and for much lower prices through process known as "reverse engineering." That will no longer be possible. And that leaves us with a question: If nothing is done, do people in developing countries have to wait long periods of time, sometimes up to 20 years, before they have access to new medicines?
Now, this debate has been going on since Seattle. Seattle, I think, was the first time that countries and NGOs raised this issue within the context of the WTO. And it was a group of African countries earlier this year who proposed to have a series of special sessions of the TRIPS Council in the World Trade Organization to specifically discuss access to medicines. That was a unique incident that has never happened before. This process then expanded beyond the African group and were joined by a number of developing countries including Bangladesh, Barbados, Bolivia, Brazil, India, Thailand, Sri Lanka, etc. Up to 60 countries in total proposed in the TRIPS Council Session to have a separate declaration in Doha on the TRIPS Agreement and public health, with a particular reference to access to medicines.
What they're attempting to do with this declaration is to get clear ministerial guidance for the work of the TRIPS Council at the Doha that says: "We find the protection of health and lives of people more important than the protection of intellectual property. Intellectual property rights protection stand in the way of countries to provide the kind of health care and products that are needed by their population, so they should be able to set those aside." One key sentence in the proposed declaration is: "Nothing in the TRIPS Agreement shall prevent countries from taking measures to protect and promote public health."
The declaration that was proposed by the developing countries attempts to overcome certain barriers that exist at the moment. It refers to the use of compulsory licensing and it gives solutions for small countries that do not have production capacity to use compulsory licensing, just like other countries have the right to use them.
Now, there is a growing consensus in the TRIPS Council—with two very clear dissenting opinions from the United States and Switzerland, the two countries that have been the strongest in opposing this proposal. In the last few weeks, negotiations have gone back and forth but there isn't a text that everybody is happy with.
I think it will be up to the ministers next week in Doha to find the solution to this. Whether they're going to succeed remains a question because the views are very much in the opposite corners of the room.
A few words about the U.S. proposal because I've seen—I'm calling in from Europe, by the way—but it's no difficulty in Europe to follow the media coverage in the United States. And I've seen that one or two newspapers interpreted the proposal by the United States as a real breakthrough. I don't know whether these are the moments to look at those, but we have an expression in the Netherlands for these kinds of proposals, it's: "Trying to make someone happy with a dead bird." I don't know whether that expression exists in English as well. Which means to say "it sounds good but if you actually look at it a bit more carefully, it turns out to be an empty eggshell." That's another expression we have in the Netherlands. I don't know what it says about the Netherlands but we seem to have a lot of expressions about pretending to give something but it doesn't really mean much. And that's what the United States is trying to do in this process.
Kris:Thank you, Ellen. Can I ask Asia to make a few more comments on that?
Asia:My name is Asia Russell. I'm an activist with Health Gap and Act Up Philadelphia, two of the AIDS activist groups based here in the U.S. campaigning for affordable AIDS treatment. I think Ellen gave a really clear sense of the lay of the land right now regarding this critical declaration. I want to get into just a bit more detail about the consequences of the U.S. obstruction of the 60-nation block of countries that is struggling to get approval for the public health declaration on this TRIPS Agreement at the Doha meeting.
From our perspective, the U.S. obstruction is actually priming Doha to become another Seattle Ministerial. That is derailed and divisive, only this time there will be no hoards of protesters. The U.S. is actually threatening negotiations on this declaration and other declarations likewise—single-handedly almost. The momentum comes from poor WTO countries, which are the very countries that are facing crisis in untreated infectious disease—especially HIV, which is killing more than 8,000 people every day. This momentum, as Ellen pointed out, has been building since spring when the Africa group generated this extraordinary discussion on TRIPS Public Health and Access to Drugs. This agreement is far reaching and it will completely change the landscape if left unclarified, and will dramatically increase prices of medication in poor countries all over the world.
And they're seeking, as Ellen pointed out, a declaration that nothing in this agreement will prevent countries from acting in the interest of the public health. Poor countries are fighting for the WTO to work in their favor and the favor of millions of poor people living with AIDS, who live on less than a dollar day. They want clarification to allow them to gain access to generic competition to secure prices of life-saving drugs as close as possible to the marginal cost of production—not some artificial concession offered based on the arbitrary altruism of brand name drug companies.
And what's happening is the USTR—the U.S. Trade Representative's Office, led by Robert Zoellick, our U.S. Trade Representative—is responding to this group of countries with a straightforward laugh in the face. These countries want the authority of a ministerial declaration that will affirm the primacy of public health—a very reasonable request. And the U.S. is standing quite alone, more or less, in opposition to this request. It's astonishing, as a U.S. activist, that poor countries have both solidified this consensus, worked and worked, while the USTR has worked just as hard to shatter this consensus. And it seems that this arrogance and dangerous negotiating position of the U.S. will drive talks quite in the direction of the downward spiral that people saw and reported on Seattle two years ago.
I think we need to scratch the surface and dissemble the so-called concessions that the USTR has offered and recognized that on two of the most key technical points the USTR has insisted in continued opposition in silence. And that's one clarification that will permit poor countries that don't have a lot of the domestic capacity manufacture drugs the same access to safeguards that would garner them a flow of generic life-extending AIDS drugs, or malaria drugs, or tuberculosis drugs through a country with more elaborated domestic manufacturing capacity to export to the more impoverished country.
This is a very key and technical clarification that was part of the reason for the birth of these talks last spring. The USTR has squarely said—in quite an arrogant fashion, I would say—that this is a clarification that will not increase access for poor countries, that African countries have got it wrong, and that this doesn't need to be brought up until the end of 2002, at the earliest.
This is beyond intransigence when you talk about poor African countries that have quite an expertise and that they're losing people at a rate of 3,000 per week or more, spending toe-to-toe with the wealthiest country in the world that's home to quite a sizable block of massive super-profitable researching branded drug companies. So we see quite clearly that the USTR negotiating position and their empty concessions are at the heart of this quite controversial and tormenting debate over public health and access to medicines and the TRIPS Agreement.
Kris:Thanks, Asia. Because we have a lot of people on the call, if you have a question, could you give me your name and affiliation and then I'll just move down through the list?
Question:I'm particularly concerned about the implications for Africa as was mentioned by Asia. Unless we get this turned around somehow, what does all this mean for African countries that are already ravaged with treatable diseases? I mean, what is this telling these countries in your opinion?
Asia:It's sending a strong statement that what poor countries that are being decimated by AIDS and other treatable infectious diseases want is unacceptable to the interest—the narrow corporate interest—of the pharmaceutical industry that the USTR is so jealously protecting right now. It's unacceptable to our delegation at Doha. And I think any reasonable person who has some compassion and some sense of the extent of the crisis in the poorest countries of the world will recognize that the USTR has got it all wrong.
Question:My question has to do with these two options—Ellen quoted from one of them—I believe it's paragraph 4 in the draft. I wanted to ask you, in principle, why is it that one's this more expansive option that the Brazilians and the Indians have proposed? Because, I mean, you can do compulsory licenses right now, that's not TRIPS illegal by any stretch of the imagination. And additionally, a ministerial declaration can't change the TRIPS Agreement. Only a negotiation can do that. Why not just take something is a little more targeted to the purpose of ensuring access to pharmaceuticals, rather than hold out for something that doesn't have any legal weight anyway?
Ellen:Well, in fact the declaration as proposed by the developing countries has to do with two different things: One, is to get really clear political support to use the safeguards that exist within the TRIPS Agreement as widely as possible. There isn't such a thing as one single agreed upon interpretation of these safeguards. As we've seen in the last few years, countries who've tried to use them have come under pressure, not only from the United States but also from the European Union and some other countries. We've seen what happens in South Africa. South Africa is trying to implement its medicine legislation, which was upheld in court by 39 drug companies because it was supposedly not in agreement with the TRIPS Agreement. That turned out to be absolutely not true. But there was a lot of un-clarity about that for a very long time. So the political message the developing countries want to get out is: the lives and health of our people are more important than the commercial interest of the company.
The second is to provide interpretation to the exports issue and some of these paragraphs in the declaration that are not provided at the moment in the TRIPS Agreement.
Question:Just a follow-up to that... You mentioned the South Africa case; the Americans caved in on that one and dropped the case. Even the Bush Administration continues this policy of the Clinton Administration of not contesting compulsory licenses. They settled the case with Brazil. You already look like the winners here regardless of what comes out of Doha. Why is that not the case?
Ellen:Well, the examples you mentioned happened last year. The public eye has really been on these cases. The public pressure has been enormous, but that will not always continue to be the case. Resulting countries are seeking more security and they're seeking to reaffirm they're all right to make measures in the interest of their health of their population. That's basically what they are trying to do. It's really very much about the hierarchy: what comes first, what do we find more important?
Now, if you look at the opposition of the U.S., the proposals of the U.S. are really short of saying "we don't want the declaration." I think that if the U.S. could go for that option, they would. That doesn't give a lot of confidence to the countries that in the future, they will be able to have this wide possibility of interpreting the flexibility of this agreement.
Question:Are you all going to Doha by the way?
Question:One, where is the EU in this fight? And second, I was hoping you could address the earlier point that this doesn't have any legal weight. It's my understanding that the reason the U.S. objects to it is because they think it would be this huge legal car route for anything that a company said was a public health measure, and they give these weird examples like copyrights on the royalties on textbooks, etc.
Ellen:In the draft, the developing countries proposed this sentence; nothing in the TRIPS Agreement was an article on its own. And they've actually acknowledged that it might give the impression that they have the intention to basically throw away the TRIPS Agreement. That is not the case.
They also say, we can live with the Option One in the draft where the commitment to full implementation of the TRIPS Agreement now sits in the same paragraph as "nothing in the TRIPS Agreement shall prevent countries from taking measures." So they've tried to deal with that concern. They say, look we do not ask for this wording to throw the TRIPS Agreement out of the window. That's not what we're after. And that's why we're quite prepared to reaffirm our commitment to the TRIPS Agreement.
Question:And where are the Europeans on this?
Ellen:That's a good question, particularly since Pascale Lamy in the last year-in-a-half has really made himself the champion of the Access to Medicines issues. He has addressed the issue at different occasions. He's taken initiatives to get with Commissioner Neilson to work on EC Policy and all of this. But I don't find the Europeans strong enough. And that probably can be explained by the fact that there's this difference of opinion between the countries that are home to multi-national pharmaceutical companies and countries that are not. And the European position is suffering from that and I hope that they get their act together before they reach Doha.
Question:Tommy Thompson's threat to break patent on Cipro—which he later denied having made—what light does that shed over this dispute?
James:: I'm sorry to be on the call late. Thanks to MSFs for arranging this. The Cipro thing was pretty timely in the sense that it comes up right before the Doha meeting. I think that's one of the reasons why there was so much pressure on the U.S. and the Canadians not to actually issue the compulsory license.
In both—certainly in the U.S. case—the decision to go with a much more reduced stockpile for Cipro was because they were trying to get off the hook so they wouldn't have to actually go through and issue the compulsory license. Unfortunately, it was pretty obvious that both the Canadians and Americans did use a threat of generic production to move the price. So, you know, that certainly changed the dynamics within the Doha meeting. But I think the U.S. is in this standard PR mode. They're just saying "well, it didn't actually happen and even if does, that's us, it's not you."
Question:For the other two speakers—any guarantee in this declaration that rich countries would not invoke the same threats of rights? Because I can actually see where—if everyone issued compulsory licenses whenever they felt like it, rich and poor alike—then we might actually kill the goose that lays the golden egg.
James:I think it's a complete mistake to look at the compulsory licensing issue as an North/South thing, like poor countries can do it but rich countries should never do it. In fact, the issuing of compulsory licenses is primarily a northern tradition. It's primarily U.S. and European and Japanese tradition because in areas of high technology, it's considered a necessary thing. The United States issued 178 compulsory licenses on software patents in the month of September of this year. The European Commission in July ordered a compulsory license on a database of pharmaceutical prices in Germany. The U.S. is considering a compulsory license on a Unocal patent for clean gasoline because Exxon Mobil Corporation complained about the licensing terms.
You've got problems in Europe, in England, in Sweden, and France, and Canada on the aggressive placing of breast cancer screens because it cut down the number of women who could benefit from having screens of breast cancer in Europe and the United States. And so, because people look at this through the lens of AIDS, they see this in a very narrow way that doesn't reflect an accurate picture of how a compulsory license is done in the north and it should be done in the future. The point isn't to make a patent a higher level than God so that they can essentially never be challenged—no matter what the circumstances, from everything from biological warfare to denying women access to diagnostic tests—but rather, to ensure that at the end of the day you have enough economic incentives to do R&D.
What we've pushed for, and I think MSF and other groups have been very good about focusing on, is that the treaty negotiation should be about research and development not about property rights. And the key thing is to ensure at the end of the day we have enough resources that are going into R&D for the right kinds of diseases and the right kinds of problems that people have, while not giving the patent owners the right to just essentially act completely irresponsibly and abuse patent rights. And so you have to reign in patent rights with things like compulsory licenses in case that they demand it but the other end is that you have to use other instruments and policy to ensure that you get the golden egg.
Kris:Thanks, James. Ellen, did you want to make a comment at all on the issue of research and development?
Ellen:Yes, I would like to make one, two comments, actually. In response to the question about compulsory licensing, I think the Canadian Minister of Health said it all when he ordered the generic companies to manufacture ciprofloxacin to assure a stock, which was later turned back. But he said our population expects us to do everything to protect their health, if it's necessary to take such a measure. We need to do that, and that is actually exactly what developing countries are asking for.
On the R&D, there are two points I would like to make. I don't think that the discussions taking place now will have a negative effect on the incentives for R&D. If you look at where the R&D costs are paid at the moment, where the pharmaceutical markets are, the significant pharmaceutical markets are in Europe and in North America, and by increasing access to those products in areas in Asia and in Africa, that will not affect the possibility to do R&D.
We also have to keep firmly in mind: what is the objective of the patent's protection? It is in a way, a societal contract. It's a policy tool. We're saying, OK, we'll grant these exclusive rights because, by allowing these monopolies, we expect as a society to get a greater good. The society as a whole needs to benefit from it. Now, if you look at that in a global scale—this increasingly global marketplace—that doesn't work for medicine. So you could almost say what TRIPS Agreement attempts to do is encourage research and development so that the world society as a whole has product process, has access to the drugs they need. That doesn't work, because, for a large part of the population, they're not affordable when they come to the market. Or, the kind of R&D that is necessary to treat diseases in the south doesn't take place, no matter how high the levels of intellectual property protection. We do not see research and development efforts in areas like sleeping sickness and other tropical diseases.
Question:The pharmaceutical industry argues that the real thing that should be done is that pharmaceutical companies should have more differential pricing. And the pharmaceutical companies say that they are now aggressively discounting prices in many cases of where they're selling at cost. And there are a lot of instances where drugs have not been patented in Africa and where generics are available, they're just not being bought. My question is: what are some clear examples now of a rapacious pricing of drugs where people are really getting denied drugs and where generics really can't get into these countries?
James:According to the study [in the Journal of the American Medical Association] that Amir Attaran did on patents, which was not really new, it was like there's about five or six of these that looked at patents in African countries. [Take for example] a product like Combivir® which is a really important anti-retroviral drug and which is priced, in our opinion, very aggressively by Glaxo, which is the most aggressive patenter of anti-retrovirals right now because they have patented in quite a few countries AZT, 3TC, Combivir, Ziagen/abacavir (which is an protease inhibitor), etc. As well as that three direct version would be something there will be certainly rights on, too. I mean, the three [drugs in one pill - Trizivir®]. Combivir® itself is patented, according to Amir, in 37 African countries; it's unbelievable. There's another way to look at it; if you look at the low cost cocktails, which are the ones that people could probably afford as a first-line treatment, every single one of the low cost cocktails is blocked in more than two dozen African countries. So they all need access to nevirapine; they all need access to 3TC. Some of them are going to require access to AZT as part of the combo.
What Amir did is he said, well, look. You could use a DDI-D4T cocktail with a protease inhibitor or something like that. He didn't look it like what's the manufacturing cost for those cocktails. Those cocktails are all more expensive to manufacture and he didn't look at the issues about the dietary issues and stuff like that. So he's essentially advising African countries to use half the available cocktails that you might want and none of the ones that are really cheap to manufacturers.
So it was ridiculous and that's one of the reasons why it was savaged on the debate. It was plotted on methodological grounds and it was just kind of some part of the pharma lobbying campaign. And we were ...
Question:Are you saying that there are these cheap cocktails available but even those are being blocked by patent laws?
James:Well, it's certainly true, yeah. I mean, there's a lot of patenting. Over 30 countries apparently have patents on either 3TC or Combivir®, which are parts of these low cost cocktails. But it's interesting that people at Harvard have discovered that people are poor in Africa and we're all really impressed with that deep insight. Some of us were on to that a little bit earlier that people are poor and that's a problem in Africa. Nobody denies the fact that people being poor in Africa is a big goddamn problem. And I'm a little shocked that this is a big surprise to other people. Poverty is an un-ambiguously a huge issue in Africa. Nobody whatsoever has ever denied that. But people do deny that patents are a problem.
Kris:I'm going to ask Ellen to make a quick comment and then we also have on the line Dr. Anne-Valerie Kaninda who could also comment on what drugs are needed and what's blocking them from being used.
Ellen:I think a very important point on that study is that the study conveniently left out areas like South Africa. Most of the drugs—most of the AIDS drugs—are patented in South Africa. South Africa accounts for half of the pharmaceutical market in Africa. So if you want to encourage generic companies to be active in Africa, you should not leave them without the possibility to be active in the market in South Africa. In fact, if you want to bar companies from entering the market in Africa, what you do is you block them in a few strategic places such as South Africa and Kenya and a few others. And that's exactly what the companies have done, which is very normal behavior; this selective patenting.
We are running an AIDS project in South Africa in a township called Khayelitsha with a population of 400,000 people. All these people live on walking distance of a health facility. There's personnel; there are doctors. Twenty-five percent of this population is HIV positive. And at this moment, an estimated 5,000 people need treatment. None of these people are presently getting the treatment. The drugs are priced at more than $2,300 per year per person in South Africa.
Question:So are you saying that we're selling these for a few dollars a month, they're not the right ...
James:They're not saying a few dollars a month. They're saying quite a bit more. It's 50 bucks a month just for indinavir from Merck. That's one of three drugs you need. That's not a few bucks a month.
Ellen:I think South Africa is a very clear example where AIDS is a tremendous tragedy and where people do not get access to these drugs and where they would get access if the prices were lower. Thailand is another example. It's a country which has the infrastructure if it could just be provide the medications, treatments—everything that goes with it—and where the price is the single most important barrier. These are the countries where you need to start with the treatment. These are the countries where the possibilities and the opportunities are there. And that's what we should be focusing on; lowering the prices and allowing more producers into those countries would do the ...
James:Pharmaceutical companies are not flashing the prices to the break-even point like they say.
Asia:Combivir® provides a really interesting example, because Glaxo's offering a $2 a day price on this two-drug combination. That addresses some key compliance issues. As James pointed out, it's a really important drug to have available in a clinical arsenal—in a treatment arsenal. So what we have is generic companies in India able to offer a much better price of $1.40 a day. So if, in fact, the price cut from developing countries are far, far off the mark when you estimate what the marginal cost reduction would be, then we see that drug companies are actually offering what amounts to no more than kind of piecemeal solution... drug-by-drug whether country-by-country and not achieving the best possible price in these ...
Ellen:On average, just to give you an idea, the price offered by the multinational companies for triple-combination is on average three times more expensive than the lowest offers from generic manufacturers.
Asia:In the private markets in certain countries, the offer will not be extended where, in fact, it might be best used. So there are these conditions that take a little bit of the rosiness off the offer itself.
Question:Could you tell me: is this is the last run of negotiations on this? Does this get settled in Doha? Or is there another round of negotiations after this? What's really crucial about these particular negotiations in getting this kind of language in there?
Dr. Anne-Valerie Kaninda, MSF Medical Advisor in the U.S.:Before we go to the other question, could I just make one last comment on this issue? One other thing that those people really overlook and obviously, the others do not have in any experience at all—I mean, they're not physicians and they don't have any experience at all in treating people in resource-poor settings and in developing countries. One of the things that is overlooked is that AZT and 3TC, which are the two most widely used antiretroviral drugs used worldwide, and the non nucleoside reverse transcriptase inhibitor, nevirapine, the cheapest available one—this cocktail with 3 drugs is really the most convenient to use in resource-poor settings. And we have chosen these as our first line regimens in all our anti-retroviral programs in Africa. Why? Because you can take them only twice a day and not three times a day, and there is absolutely no dietary requirements. And this is crucial for compliance. There; that was just my point.
Ellen:This declaration—what is happening later this week and again next week in Doha—will not, whether positive or negative, end this discussion. Because the TRIPS Council is actually the place whether this discussion will continue—the TRIPS Council, the buddy of the WTO that meets every three months. And what the countries have actually asked for from the Ministerial Conference is a clear political direction also for their work post-Doha. There will be a number of issues including technical/legal issues that will need to be resolved in the TRIPS Council.
I just want to make one remark because I didn't address that earlier on what the legal importance of this document is. The Ministerial Declaration will certainly play a role, although you cannot change the TRIPS Agreement with it. But you can change the way the TRIPS Agreement can be interpreted. It can also be important in dispute supplements procedures.
And the United States is actually trying to limit the power of this declaration by inserting language that would actually render this statement useless in dispute supplement procedures by this... you'll find in option two—I can't find it quickly... Without that text, this document will certainly play a role in dispute supplement procedures in the future and that can be of great importance.
Question:When is that taking place? At the next TRIPs Council? What comes next then?
Ellen:Well, I think it will, of course, depend what comes out of Doha. Some of the developing countries have said, "look, this is the last chance to save the TRIPS Agreement. If we cannot get a clear text that says, 'Public health is more important than protecting the patent rights of the multi-national drug companies,' then we might have to look at the TRIPS Agreement as a whole and see whether the TRIPS Agreement shouldn't be amended or shouldn't be replaced with something else." That would have to happen in broader negotiations and in a new trade round. If everybody is happy with the declaration on access to medicines, then there will be work that would've happened in the TRIPS Council in the years to come. But then the TRIPS Agreement as a whole won't be under TRIP, I think.
Question:My question is on the international trade and financial institutions basically limiting access to drugs in poor countries. Do any of our speakers see a negative role for the World Bank or IMF in that? And the reason actually I'm asking this question is because I was talking to this World Bank official from the Health Department of the World Bank, and she was basically telling me that the World Bank was discouraging developing countries from manufacturing the drugs that require hi-tech know-how. So does any of the speakers see a role for the World Bank or the IMF in limiting access to drugs?
Ellen:Well, it seems to me that you partly answered your question. If that is the World Bank policy, then that is a very unwise policy. The World Bank could play a much more positive role, particularly in it's rules for drug procurement. And this does not only relate to the World Bank but actually for all institutions that are involved in financing in the procurement of medicines. Because that is actually becoming increasingly a problem—that you could through international pandering identify the cheapest possible producer of the medicines that are needed but then you're blocked from purchasing and using those medicines in those countries where they are under patent.
This is a discussion which we tried to have, for example, in the context of the G8 Meetings. The last two meetings of the G8, Access Medicines were also on the agenda and countries were discussing setting up the global health fund. They actually shied away from discussing these kinds of principles.
The question really is: if you're going to provide $1,000 for purchasing drugs, are you going to treat one person or are you going to treat three patients with it? And if you want to respect the patent, you treat one. And if you feel that you should buy from other sources, you treat three. Those are policies that often need to be discussed in the financial institutions including the World Bank.
Question:I wanted to follow-up on something you said earlier about the dead bird? You know, you were saying that these U.S. concessions—you know, extension on patent rules for least developed countries in the moratorium—were not worth anything. Can you tell us why?
Ellen:Yeah. The extension of the deadlines, which was actually presented as a bit of a breakthrough and something new, is actually in the TRIPS Agreement. In Article 661, you find that least developed companies can ask for the extension of the implementation deadline. And the United States can just say "whenever you ask for it, we will grant it." And that of course would be very welcome.
The other problem with this proposal from the United States is that countries are obliged—also those that are in the transition period—to provide what is called the exclusive marketing rights. So even if you don't provide patents, you still have to provide the exclusive marketing rights. And this proposal doesn't do anything for that. You can't even issue a compulsory license for an exclusive marketing right. So that could even lead to bigger problems.
And the other point, of course, is that many of the least developed countries already have patent legislation in place. This is so that every least developed country doesn't have patent legislation. As you know, there are very strong pressures on countries to actually adopt national legislation and become TRIPS compliant way before the deadline.
So that's on the extension period. Then the second proposal from the United States—and they were the only two proposals I'm aware of—they made those text related to a kind of moratorium on dispute settlement procedures with the WTO. Important to know is that due restrain clause is already in the TRIPS Agreement. Countries have already said on earlier occasions, we will go slow on that, particularly with the least developed countries and give them a bit of time, in that sense. This is nothing new. You'll find it in Article 24.1.
There are some negotiators in Geneva who say here, this text actually only relates to a moratorium on the non-violations claims. And the jury is out on that. I'm not sure whether that is true. But a moratorium on non-violation claim already exists and most negotiators here understand that that moratorium will be extended anyway. So those are two dead birds, aren't they?
James:First of all, the moratorium on dispute resolution doesn't apply to India. A lot of these countries don't have the industrial capacity to make all the drugs they might need. One of the key disputes is whether or not they're going to relax the rules on exporting medicines. And so they very carefully didn't make any concessions because India is not a least developed country and they're not in Sub-Saharan Africa.
Number two, certification gives the U.S. government, wholly apart from the WTO, an annual opportunity to force countries to do things, which is why in fact you observed 37 countries in Africa already granting patents on anti-retroviral drugs even though they have the until the year 2006. So they don't even really need dispute resolution process in Sub-Saharan Africa. They really need that against other countries and they didn't concede it outside of Sub-Saharan Africa.
Asia:I think the importance about the WTO moratorium is that it specifically applies to only 11 countries—developing countries that are in the borders of Sub-Saharan Africa. So it excludes countries where, in fact, the issue of a moratorium is the most important. And that's not an accident. That's what makes it the dead bird that it is.
Question:Which countries are those?
Asia:The Sub-Saharan African developing countries, that's Namibia, Botswana, South Africa, Zimbabwe, Kenya, Ghana, Cote d'Ivoire, and a few others.
Question:Just getting back to the Cipro remark that Secretary Thompson made earlier. Could you—someone, perhaps James—clarify how this represents a double standard and what potential leverage this gives the developing countries going into Doha?
James:Well, when the U.S. thought it needed medicine, or they didn't like the price of medicine, they were very fast to say they'd override the patent rights. And then you act as if—well, Brazil did precisely the same thing in terms of Viracept and the headlines were, you know, Brazil essentially threatens to break down the western capital system practically. You know, they were just savaged in the press.
And what's bizarre about the U.S. case is that it's portrayed as essentially having these big international consequences, as if we have to take the risk and biological warfare against us in order to make sure that Africans don't get access to AIDS drugs. As if that's somehow a sensible thing for us to pursue. The point of the exceptions in the TRIPS Agreement and in the hundred of years of history of exceptions and patent rights is that patents are not supposed to make you prisoners to common sense. I mean, you're supposed to be able to step in and fix problems as they come up. But obviously it was considered total hypocrisy. I mean, the Brazil delegation was beside itself because it's exactly what they did.
Question:Do any of the other speakers know of any of the countries involved in the negotiations? Will they use this action by the U.S. and Canada to try and gain some leverage or get them to come to a table, to come to reason? Because it's obviously completely hypocritical.
Ellen:Well, I know that all of the negotiators in Geneva are following the Cipro developments very closely. And of course, one of the comments which we heard here a lot have said, "this is exactly what we're trying to do. This is exactly what we're asking for." And when the Health Minister of Canada said, we need to do everything to protect the health of our population, which is almost verbatim to text in the proposed declaration that Canada and the U.S. object to—yes, I think that the Cipro case will be used in the negotiations. And quite rightly so, because it shows, as James just said, you shouldn't be prisoners of patents. If the patent stands in the way of what it actually aims to do—mainly, give the population access to medicines, give the population access to the innovations that they need—then they have to be able to take patents aside.
Question:Just a quick follow-up question: how are these international agreements going forth? I mean, Ellen, earlier you said that these countries now can't reverse engineer these drugs. Why is that?
Ellen:Because you have to have both product and process patented. So what India is doing, for example, to reverse engineer, they can rather quickly bring a new product onto the market because they have process patents but not product patents. That is no longer possible. The TRIPS Agreement obliges every member of the WTO to provide both product and process patents for a minimum of 20 years.
Question:When did this happen?
Ellen:It happened in 1995 for industrialized countries. For the developed countries, by the end of 2000. For the least developed countries by 2006, and those countries that did not have pharmaceutical product patents have an extra period.
So the deadline for India is 2005. And that is really the scenario to keep in mind because we're talking a lot about AIDS, but in fact, this discussion and these proposals that are going to be discussed later this week are not only about AIDS. What we see with AIDS is a small preview of what the pharmaceutical situation will look like once the TRIPS Agreement is fully implemented and once all new medicines may be patented everywhere.
James:By the way, the U.S. is having a hearing today on the issuance of compulsory license in the Microsoft case, though.
Asia:Yeah, I mean, the hypocrisy of the Cipro case and the issue of what the lives of primarily African people with infectious disease are worth is of course going to color and already is coloring negotiations on the run up to Doha and at the Doha meeting. It dramatizes really well what the risk to the public health is when the sanctity of the patent is so viciously upheld at any cost, whether here at home or abroad. It's a very clear rundown of what happens when our officials defy common sense and refuse to recognize that the patent system is imbalanced unless real checks are put in force. And that's precisely what developing countries want to achieve at this Ministerial and what they've been working for the past six months.
Kris:Thanks, Asia. I wanted to point out also that the delegate from Zimbabwe to the WTO, His Excellency Boniface Chiyaudsiku very much wanted to be on this call but could not be because he's traveling. So I will try to get you contact numbers for some of the delegates so you can get their views as well. James, do you have a quick comment?
James:Yeah. In a rush to stop Africans from having access to cheap medicine, what we're doing is creating a regime that's going to harm Americans and Europeans when they try to deal with gene patents, when they try to deal with diagnostic patents, when they try to deal with tools we need in our country to protect Americans and Europeans from access to medicine. Our trade delegations are run by these export industries. They do not reflect the established opinion of what's appropriate for the United States.
Question:I was just wondering if some of you there could step back a little bit and just talk about the political climate. That would go from Seattle to Durban to the UN General Assembly Special Session on AIDS. And then we have the events of September 11th, as they're called. To what extent is that having an impact on perhaps taking this off the radar screen of international attention?
Asia:What's clearly happening is that, on the one hand, poor countries want to leverage the outpouring of support that's been illustrated through successful campaigns and in street protests. They want to leverage that in actual policies and in actual clarifications that will help right some wrongs that are being clearly made manifest as this agreement comes into effect for poor countries in the WTO. They want to leverage that power in an appropriate place—at the Ministerial. I think that addresses one of your points.
This is a clear next step. You know, someone brought up earlier that we look like the winners no matter what. In fact, this is the logical trajectory of a campaign that prioritizes Access to Medicine over the sanctity of patent monopolies. So it's the clear path. It's not that people are scrambling for more.
And on the point about September 11th, I think what has to be clear to Americans right now is how important how we relate with other countries is in the world today. People are now keen to the impact of foreign policy and aware in a way that they previously weren't.
But unfortunately, what's happening right now is our trade team in Doha is taking up a basically unilateral position that flies in the face of the sorts of comments that the President makes that we have to create a world where posterity works for everyone. You know, when everyone is—and poor countries are subjugated to the interest of multi-national pharmaceutical companies—then that's running quite the contrary to sources of comments that the administration is making.
Question:What I was just getting at is there any sense that your momentum is blocked and this is now in the hands of the bureaucrats?
Asia:No, this is a really long-term process and I think the movement is way stronger today than it was a year ago. I think month-by-month the movement stays stronger.
One of the things that's really important is that the delegates themselves—they're part of the TRIPS Council, are involved in negotiations... Since they started having this meeting in June, they moved a way up the learning curve in terms of what the issues are. The other thing is that you're going to see more actions on the ground in the South African compulsory licensing case and some other compulsory license cases, which is going to make more concrete and obvious what the kind of policy issues are. And I think that's going to help things out quite a bit.
Ellen:I was actually on the TRIPS Council, which took place only a few days after the terrible disaster in New York on the 11th. I was a little surprised that the discussions on Access to Medicines continued the way they were planned. But I was talking to several of the delegates and I should actually not be so surprised because these people represent countries where horrible tragedies happen every day. We should not forget, as Asia said earlier, 8,000 people die of AIDS every day. And there is now, as James said, a global movement. There isn't only a much greater understanding among the politicians and among the tradespeople who've actually never had a history of dealing with health issues. What we also see is that health people—health ministers, for example—join this debate. A number of health ministers will actually come to Doha. That has never happened before. I think this ball has started rolling and I don't think it can be stopped. There's also an increasing amount of activity on the ground, an increasing number of NGOs who are involved in this issue. And I don't think that it can be stopped. This issue is here and I think it's here to stay until it's resolved, basically.
Question:I do have a technical question, which is about this marketing approval. Does that mean if you were saying, "well, yeah, you don't have to provide patents protections, you still have to have exclusive marketing rights." Does that still effectively mean that these countries can't buy the cheap generics? Is that what the effect of that is?
Ellen:Yeah, the effect of the exclusive marketing right is that you, although there isn't a patent granted, are the only person authorized to market it. The country has to grant that marketing right. In Thailand, for example, it was done under a medicine safety procedure where under the guise of monitoring the safety of new medicines that no other competitors were allowed.
Question:I'm looking for examples besides AIDS drugs where the prices that pharmaceutical companies are demanding are very out of line with what generics really are available.
James:In South Africa, ciproflaxin, which is the drug people here want for Anthrax, s actually used for antibiotic resistant gonorrhea which is an important kind of drug to have. It's priced at about two bucks—anywhere from two to five dollars in a drug store in South Africa. You can buy it in bulk for as cheap as three cents a pill in India. If you look at the Health Fact International Survey on pharmaceutical prices, you'll see some astronomically high prices on ordinary cholesterol drugs, all kinds of things.
Kris:If everyone has asked most of their questions, I'm just going to ask to do a final roundup of the three speakers, if there's anything else they wanted to add that they didn't get to clarify.
Ellen:I just want to say, we will be in Doha. We'd be happy to talk to you during that period. I think that it is now really up to the Ministers to find a solution next week. And again, the big question, which they need to answer is: what comes first? The commercial rights of companies that have their homes in the rich western world or the health and life of people in—well, basically, in 90 percent of the world's population? And well, I don't think it is a surprise to you how I hope this question will be answered. But that's basically the one that's on the table next week.
James:If I could just add to that. It seems there's a tendency of the U.S. reporting to portray this as something that we have to do to keep these irresponsible people in developing countries from ripping off our intellectual property and stuff like that. It's a very one-sided debate. It doesn't really recognize at all what the U.S. and European interest is in having more consumer-friendly rules on intellectual property. We are screwing our own consumers in order to screw Africans in these negotiations. And you may think that's a good idea. I personally think it's wrong on both fronts. I think it's not good for Africans. I also don't think it's good for Americans and Europeans. The fact that you somehow taste the forbidden fruit and you occasionally override a patent for some public interest does not mean you eliminate the patent system as we know it. It means you don't have to be in extreme position of the patent is gone and the patent doesn't exist. There's a middle ground, which is the only place that the developed economy wants to be at. And if you look at what we do with patents on software already and you look what patents can do with telecommunications and all these hi-tech sectors in the U.S. economy, it should be obvious what we're going to need in the new hi-tech information-intensive medicine where you really have huge problems in dealing with IP rights.
Asia:It's interesting also to point out that the U.S. response has often—to many infectious diseases, not just HIV—been colored by the "well, we need for the countries themselves to, you know, stand up straight and muster their own forces and do what it takes before we fall into step behind them. We can't do their work for them." And I think it's really useful to point out that, in fact, as soon as the poor countries come to the table with their own plan and their own intent, the hypocrisy in that the U.S. is the first to decry that effort and to cast that as some vampiric effort to suck the lifeblood out of our multi-national pharmaceutical companies. When, quite reasonably, you take a step back and it's not that at all. It's poor countries strategizing to increase access to clinically desperately needed tools. And it's really useful to point out how distorted and misrepresented that effort could be—how that effort has been misrepresented by our trade delegation on the way to Doha.
Kris:Thank you all for your for joining us on the call. If you need to get any additional documents or information, and I will be trying to get some of the delegation phone numbers later in the week, my number is 212-655-3764 or 917-913-0183.
Tags: Access to Medicines