* Dr. Ruben Mayorga, Director, Organizacion de Apoyo a una Sexualidad Integral frente al Sida (OASIS) and Advocacy Coordinator, the Central American Network of People Living with HIV/AIDS (REDCA+)

* Robert Weissman, Co-director, Essential Action

* Alain Rias, Field Coordinator, MSF Honduras, Doctors Without Borders/Médecins Sans Frontières (MSF)

* Moderator: Asia Russell, Health GAP, Director of International Policy

Speakers address these and other questions:

-- How will the intellectual property rules the U.S. is fighting for in the CAFTA affect access to medicines in the region and Latin America as a whole?

-- What is the current status of the AIDS treatment access crisis in Central and South America and the Caribbean?

-- What is the impact of generic competion on the prices of AIDS medicines in Latin America?

-- What impact does the outcome of the Miami FTAA Ministerial have on current CAFTA negotiations?

TRANSCRIPT:

Ms. Asia Russell: Thank you everyone for joining this call today, My name is Asia Russell. I'm the Director of International Policy with Health GAP. This is a call today regarding the Central American Free Trade Agreement and its impact on access to affordable medicines. Today marks the beginning of the final round of negotiations in Washington DC that will establish a Central American free trade agreement. This regional trade deal with affect five central American countries - Guatemala, El Salvador, Costa Rica, Honduras and Nicaragua, and will establish new rules for the protection and enforcement of drug company patents and other forms of intellectual property rights in Central America. This region comprises some of the countries in Latin America that are the hardest hit by the AIDS epidemic and are in desperate need of affordable AIDS treatments. Thousands of people living with HIV are facing death in this region and in the larger region of Latin America and the Caribbean, and the new intellectual property rules the Bush administration is aggressively negotiating for in the CAFTA will, we feel, obstruct access to medicine by increasing medicine prices and delaying or blocking generic competition. The speakers who have joined us on the call today will be able to share their expertise regarding the crisis in access to medicines in Central America and regarding the latest information about the negotiating position of U.S. trade negotiator. The speakers you'll hear from today include Alain Rias, who is field coordinator for Médecins Sans Frontières/Doctors Without Borders in Honduras, where he coordinates an HIV treatment project in a clinic in Honduras. Also we'll hear from Robert Weissman, who is the co-director of Essential Action and an intellectual property lawyer, who is an expert in the impact of intellectual property rights on access to medicine and pubic health. We'll also hear from Dr. Ruben Mayorga, who is an Infectious Disease doctor and the Advocacy coordinator for the Central American network of people living with HIV and he is based in Guatemala. He'll be joining us a little bit later. So with that, I'd like to turn the program over to the first speaker, who is Alain Rias. As the conference operator mentioned, we'll have time for people to make brief remarks and then we'll open it up for your questions. Thank you.

Alan Rias: Yes, good afternoon. As Asia has said, I have been managing an HIV clinic at a program for the last 18 months in Tela, which is located on the northern coast of Honduras. Now I just wanted to briefly present a picture about the health crisis in Honduras. Perhaps looking at the region first: there is an estimate that about 200,000 people live with HIV and AIDS in Central America. Now around 60% of all registered HIV infections in that region come from Honduras and it is therefore the country with the highest number of people living with HIV in Central America. HIV prevalence in Honduras is estimated at 1.9 percent of the general population and it reaches peaks of about 5% in pregnant women in the industrial town of San Pedro on the north coast. The estimated number by the Ministry of Health of people living with HIV is between 90,000 and 100,000 people, and the number of registered cases is around 20,000. At least 700 are under the age of five and they have been infected during pregnancy or at birth by their mother. Basically in Honduras one person with AIDS dies every two hours. It is the first cause of mortality in women of child-bearing age. Now what about access to medications in Honduras? In the last 18 months the government through the Ministry of Health has started providing antiretroviral therapy and currently there are roughly 1,200 people, patients receiving combination therapy. Doctors Without Borders sees over 300 patients with HIV in its clinic at Tela on the coast, and out of these 147 people receive antiretroviral treatment, 26 of them are children. Now talking from personal experience with what I have observed in 18 months of working on this project, looking at how this has changed their lives, well, it's almost beyond words really. People recover very quickly, people are able to start working again and trying to earn a bit of money to feed their families, and 70% of the people we see at Tela are women and a lot of them are without a male partner because they've have to go work abroad or elsewhere for work, so the conditions are very hard, very difficult economically. Really, having access has changed their lives. Because these women, their main preoccupation is staying alive to see their children grow up. So it has made a tremendous change and I think it has also made a tremendous change in the perceptions that people have about what it means to live with HIV and live with it well. The problem we have in Honduras regarding intellectual property rights and access to medication - perhaps we could look at prices first. The Honduran government purchases the brand name drugs for HIV treatment at a cost of $850 U.S. dollars per annum, and cocktails are usually of zidovudine (AZT), lavimudine (d4T), and nevirapine. At Doctors Without Borders, we provide the treatments free of charge to patients at a cost to us of around $400 U.S. dollars per annum. What we use is generic drugs. So you may ask, why such a staggering difference in price? Well, in the conversations we've had with our partners over the months, we've come to realize that the Honduran government is under pressure to continue buying brand names. They fear retaliation from the U.S. Trade Representative for crossing them despite the agreement that all countries reached at Doha in 2001. And what we believe is that using generics can mean universal antiretroviral treatment access. An estimated 5,000 to 6,000 people need this in Honduras now, so we are advocating that in the CAFTA negotiations that have been taking place, and that are going on today, that this be taken into consideration. Thank you.

Ms. Russell: Thank you. The next speaker is Robert Weissman, the co-director of Essential Action.

Mr. Weissman: Thanks, Asia. I should also mention that I'm a member of Health GAP, the sponsor of the call. I wanted to talk briefly about the framework of the ongoing negotiations as well as some of the specific provisions that we believe the U.S. administration is trying to push in the CAFTA negotiations and why we fear that will undermine efforts in the region to gain access to generic medications and lower price drugs. The broad framework is that, as you all know, there's been a high level international dispute about intellectual property protections and those patent protections interfering with country efforts to get cheap generic drugs, especially AIDS drugs. There is a long history of those disputes which have focused especially on the U.S. role and pushing for enhanced patent protection at the expense of generics. That reached a peak and a culmination of a sort in 2001 at the World Trade Organization negotiations, resulting in the DOHA Declaration on the Trips Agreement in Public Health. At that time all the WTO members including the U.S. and all the members who were negotiating in CAFTA agreed that countries should be able to exercise the flexibility that they maintain over the WTO intellectual property agreement, which is known as Trips, and that the agreement itself should be interpreted as broadly as possible to protect public health, in particular to promote access to medicines for all. In the fast track negotiating authority under which the U.S. is conducting the CAFTA negotiations, as well as other trade negotiations around the world, the U.S.T.R., the U.S. trade representative, is instructed to respect the DOHA Declaration. Unfortunately, however, what the U.S. has done is to try to move out of the WTO forum to other fora where it thinks it may be able to more successfully limit country ability to access generics and to impose enhanced patent protections. They're trying to do that in the free trade area of the Americas with unclear success and are moving increasingly to bilateral and mini-regional agreements of which the CAFTA negotiations are probably the most important right now. In addition to covering the region of Central America, it's important to understand that once the CAFTA agreement is finalized it is expected that the Dominican Republic with Panama will sign on to similar or perhaps identical terms without really the ability to negotiate the details.

The U.S. announced in Miami at the just-finished recent negotiations of the Free Trade Agreement that it would start bilateral negotiations with the Dominican Republic and with Panama and all indications are that the terms of that are really going to be set by the CAFTA. The Dominican Republic is a particularly important case because the incidence of HIV is so high there. There are approximately 200,000 people in the Dominican Republic living with HIV. There are a number of detailed provisions that we are worried about in the U.S. negotiating position in CAFTA and in other trade agreements. Some of the materials that I think Sharonann Lynch has sent to you refer to these so I won't go through them in detail. I just wanted to quickly highlight a few.

First is a limitation on the grounds for compulsory licensing. Under the WTO agreements countries have complete flexibility to choose the reasons for which and the terms under which they will issue compulsory licenses. Compulsory licenses, of course, are the authorization of generic competition for products that remain on patent. The U.S. proposal would limit the grounds to a very limited set of circumstances only to the public sector and for emergency conditions. The U.S. has pushed this in a number of trade agreements. It's not clear if this is being pushed in the CAFTA agreement but it may well be and certainly was at one point. A second concern has to do with the linking of marketing approval to patent status. This would say that drug approval agencies like the U.S. FDA are not permitted to give marketing approval unless they are certain there is no patent claim on a product they're being asked to assess. The problem with this is it puts the drug regulatory agency in the position of enforcing patents, which they're not equipped to do and have no expertise in doing. The U.S. does have such a provision in its national law that the FDA cannot give approval to products that have competing patent claims on them. That's been subjected to extensive abuse as documented in Federal Trade Commission and other enforcement actions. So the U.S. has a domestic problem that it is seeking to export abroad through the U.S. Trade Representative to export. A third concern, which is perhaps the U.S. top priority in the CAFTA and other similar negotiations, is to impose data exclusivity protections, which are special protections, intellectual property style protections, for the safety and efficacy data that companies submit to get drug regulatory approval. Generic firms instead of repeating the safety and efficacy studies conducted by brand name companies, just rely on those studies and show that their medicines work the same in the body, that they're equivalent to the brand name products. The U.S. negotiating position would prevent generic companies from undertaking that kind of reliance for a set period, probably a five year period of time, barring the introduction of generics during that period.

Two other areas of concern have to do with patent extension - the United States is pushing to offset regulatory delays by extending the length of a patent, as well as investment protections that are outside of the intellectual property area but would actually cover intellectual property as well in a variety of ways, may chill or undermine countries' ability to do compulsory licensing or introduce generics.

All of these provisions, we think, are going to have the combined effect of dramatically delaying the introduction of generics. We know what that means in very concrete terms. That was described early in the case of Honduras, more generally globally if you look at just the issue of AIDS drugs over the last five years. We had not very long ago a global price for brand named AIDS products of a triple cocktail o $10,000 a year or more. The Clinton Foundation has now negotiated a price from the generic company of $140 a year per person, so a more than 98% reduction has been achieved by the introduction of generic competition. Unfortunately what the U.S. is trying to do in CAFTA and other trade negotiations is undermine the competition that has driven those dramatic price decreases and really enabled it to become possible to develop plans to save tens of thousands and really millions of lives that would otherwise be lost.

Ms. Russell: Thank you, Rob. Our final speaker before we open it up for questions is Dr. Ruben Mayorga. Conference operator, has Dr. Mayorga joined us?

Operator: Yes, he has.

Ms. Russell: Ruben, I'll introduce you. Ruben Mayorga is an Infectious Disease doctor working in Guatemala. He is the advocacy coordinator of the Central American network of people living with HIV and is the director of Oasis, an NGO in Guatemala.

Ruben Mayorga: Hello, I would like to say good afternoon to everybody. I have heard the previous presentations by the speakers before me so I would like to focus on a few things. One is the issue of data exclusivity and what has passed in local legislation in Guatemala last year, through a decree in 2003, this severely curtails the availability of clinical information proving safety and efficacy by the brand name company which generic producers would need in order to register their products in Guatemala. Before the decree came into effect the standing practice was generic producers could register their products by provide bioequivalence only. This new decree will mean there can be no generic competition on a given product in the country for medicines that necessary for treatment of the AIDS population.

Second of all, there is the consideration for the right to do compulsory licensing which will be undermined by the signing of the CAFTA, which would rather protect intellectual property with disregard to the protection of public health. Furthermore, if we are able to produce the most affordable medicines—generic AIDS drugs—under the proposal submitted by Guatemala to the Global Fund to Fight AIDS, TB, and Malaria for 2004 to 2008 we'll be able to treat eight thousand more people at the end of the five years.

Again this all depends on whether or not we will be able to use generic medications. We're going to actually have more than 70,000 people living with HIV and AIDS in this country. Guatemala started giving treatment to people in 1997 as part of the national Social Security program. Currently there is treatment already for 1300 adults and 300 pediatric patients. Doctors Without Borders has treatment projects in Guatemala under which they are treating already some 6700 people with antiretroviral medications, all of them generic. And the government is treating through the Ministry of Health 200 more patients. With the Global Fund proposal the country will treat 2,000 more people by next year, 4,000 more people by 2005 and so on until we are treating 8,000 more people by 2008. With the curtailing of government's ability to use generic medications this would not be possible and more than 15,000 Guatemalans would die in the next few years, unnecessary deaths, with an obvious disregard to the rights of health and the right to life—instead, the right to intellectual property would be the prevailing right. Thank you.

Ms. Russell: It's clear from the presentations of our speakers that the outcome of the negotiations that have been ongoing are quite profound when it comes to the issue of access to medicines and public health in Central America, but not only in Central America, also in bilateral and plurilateral agreements that are emerging in throughout Latin America and the Caribbean, where the Bush Administration has indicated that its objective is not to prioritize access to medicine for all and the promotion of public health, but instead to prioritize the shortsighted profit-driven interests of the powerful pharmaceutical industry. So we see these so-called free trade deals like the Central American Free Trade Agreement essentially as a threat to public health and a threat to the efforts of governments, community organizations and other stakeholders to fight AIDS effectively in the region and to create a model for treatment access and treatment scale up so saving lives now can be a reality, and sustainable access to medicines in the future can be assured. Universal access to treatment and care in Latin America and the Caribbean is achievable. But if countries in regions like Central America are locked into tough commitments to protect and enforce intellectual property rights that exceed already strict obligations within in the World Trade Organization, we feel this winnable goal of universal access to treatment which every person living with HIV has a right to, as Dr. Myorga referred to, will continue to remain out of reach to people who are dying unnecessarily. At this point we'd be happy to hear from any journalists about questions you might have and any comments based on what you've heard. Conference operator?

Operator: If you wish to ask a question please press star and one and you'll be placed in the question queue. If at any time you wish to be removed from the queue please press star two. When you are introduced you are interactive and may ask your question and any follow up questions you may have. Our first question is from Melinda Young.

Melinda Young: Hello. I write for "AIDS Alert" and what I'd like to know is, this early in the trade negotiations, do you have an idea how it will end up and what will be your strategy if it turns out that the intellectual property rights are protected at the expense of the people infected with HIV in Latin America?

Ms. Russell: Rob, would you like to take that?

Robert Weissman: Sure. Well, the negotiations are now winding down actually, and are scheduled to be completed in the round of negotiations taking place this week and next here in Washington. It's possible that they won't for any of a number of possible reasons, but it appears most likely that they will be completed. The U.S. insists that the text of these agreements under negotiation not be made public in most cases, and that is the case in the CAFTA agreement, so we have not actually seen the text but we have heard from various sources enough to give us a good idea of what's in it, plus the U.S. has made clear in published documents as well as in other agreements that it's negotiated what it's basically looking for. So we expect that the set of things that I outlined will be included or at least most of them. The dynamic within the negotiations are that the U.S. makes extensive demands on intellectual property and patent protection, there is more or less resistance from the countries that the U.S. is trying to impose these standards on, but they are normally not well positioned politically or economically to resist to hard.

Assuming that there is a bad outcome, the only possible way to influence the then finally negotiated agreement will be in the U.S. Congress, at least for the Americans, where there will be an up or down vote on the agreement. Because it will be governed by the fast track procedures, it will not be possible for members of Congress to support amendments to the agreement or the deletion of any of the harmful enhanced patent protection. So we'll have to be looking at an up or down vote in Congress and the expectation is that will occur this spring, perhaps into the summer.

Melinda Young: Thank you very much.

Operator: There are no other questions at this time. Again, if you wish to ask a question please press star one.

Ms. Russell: I think while we're waiting for additional questions, one other important comment is the larger public health community and the access community is clearly, since next year is an election year, is very interested in the position that all candidates have regarding the implementation of agreements like the CAFTA, given the effects these the harmful intellectual property provisions will have on access to medicines. So while our focus will shift to an up or down vote that will happen in Congress, there is also a lot of interest in the position that all presidential candidates have regarding not just the CAFTA but also other trade agreements that prioritize the commercial interests of brand name pharmaceutical industry over the basic right to access to affordable medicine.

Operator: Our next question is from Emad Meke.

Emad Meke: Yes, Hi, this is Emad Meke with Inter Press Service. I guess my question should go to Asia Russell. I was wondering if you could explain sort of what exactly you think the Bush administration did to sort of take the fight out of the campaign against the spread of AIDS. My understanding is that President Bush pledged billions of dollars to the fight of AIDS, which other administrations did not. Also, my other question is, are there any sort of economic grounds that you could give to the pharmaceutical companies which perhaps would make them more amenable to listen to your, from what I hear, sort of moral arguments. That's it, thank you.

Asia Russell: Thank you. In fact there's a major contradiction between the Bush administration's current position regarding fighting global AIDS and the policies that the administration is pursuing. The U.S. has made an announcement of a commitment of $15 billion in spending targeted to 12 African and 2 Caribbean countries, and 5 billion dollars of that money is pre-existing money. So this is an important initial step. There are a number of questions regarding policies that will direct implementation of this program and regarding how quickly the money will flow. At this point unfortunately the administration has made it quite clear that the money will come more slowly than most believe it should flow, and that the money will come starting at a very low level rather than at the level that is needed, while sidestepping important pre-existing mechanisms like the Global Fund to fight AIDS, tuberculosis and malaria.

That having been said, while the Bush administration is acknowledging access to treatment as a core component of fighting the global AIDS epidemic, it is also pursuing intellectual property provisions that would undermine treatment access. So there is a very explicit contradiction, a hypocrisy there. And as all of the speakers referred to, the essential tool for increasing access to treatment is generic competition. So the contradiction here is quite deadly.

The second question was regarding a more economically focused arguments or justifications. In fact while public health evidence and moral grounding is enough to carry this argument, there are also very clear economic justifications for supporting a trade policy that puts public health and access to medicines first. Unfortunately the pharmaceutical industry often claims that implementing the sorts of policies that we're demanding, that is using the flexible framework that was reaffirmed by the World Trade Organization in the Doha Declaration on TRIPS and public health as a ceiling, and not a floor, a ceiling not to go above rather than what the U.S. is seeking, which is a floor on which to build. The pharmaceutical industry often claims that this sort of framework will undermine research and development and will have the end result of undermining access to medicine because fewer medicines will be brought to market. This is a lie. What the pharmaceutical industry is seeking in fighting for these sorts of policies is expansion of their markets and expansion of their profits. And the situation we have right now is one where if this minimal step was taken that prioritizes the interests of patients, people who are living with HIV and their families and their communities, that sort of doomsday scenario predicted by the pharmaceutical industry would not come true. What would happen instead is we would have a better chance of seeing hundreds of thousand and even millions of people living instead of dying.

Mr. Meke: Thank you.

Robert Weissman: I'd like to just add on to the second question (this is Robert Weissman), it's important to emphasize that under the WTO's TRIPS agreement, if there is a compulsory license issue the generic licensee has to pay a reasonable royalty and adequate remuneration to the patent holder, so built into this system is some reasonable payment. Also worth noting is that in general and including the area of AIDS drugs, the market in the developing world is a very small portion of the overall market for Big Pharma, something on the order of 15% I think, of all the developing world. So even if they lose the whole thing there's really not that much at stake for them and no one's even suggesting that they're going to lose the whole thing. And then the final issue in terms of the R&D question is to look much more critically at the industry claims about what it does in R&D and what it costs for R&D, and whether it does good R&D, and that that's a debate that many of us are very eager to get underway because we think that the Big Pharma model is actually a very inefficient one for supporting R&D and we think there are many other models of how to generate money for R&D, and many other kinds of business models for developing much more research and new products, much more effectively than the big firm is able to do. Even if you just look at the number of new products on the market, and especially new innovative products put on the market in the last few years, they've declined precipitously and it's not because pharmaceutical companies aren't making tons of money, it's because they're actually not very good at doing R&D.

Asia Russell: The issue of efficient R&D for the conditions that poor people are getting sick with and are dying from, this is particularly important.

Robert Weissman: Right, drug companies don't even try to do R&D for those conditions.

Ruben: It is true that is not a moral issue—it is an issue fundamentally of human rights. The reason R&D has been done for AIDS treatment is because there is a lot of AIDS in the developed world. If that were not true, if AIDS were only in the developing world, there would be many fewer medicines, and we would be worse off even than we are now. We are not saying countries need to ignore economic considerations. But countries need to be able to retain the right to assure access to medicines when their citizens are at risk, for example through obligatory licensing, and use of other strategies.

Operator: Our next question is from Melinda Young.

Melinda Young: Hello. I wondered if someone could explain to me, where in the developing world now are generic AIDS drugs available? Maybe all of the drugs that are needed can be purchased as generics and where in the developing world are there countries where it's still not possible to purchase enough generic drugs to treat AIDS? Thank you.

Asia Russell: Alain, would you like to start with a response?

Alain: Well, yes, I can certainly speak about Honduras. In Honduras all those generic drugs, combination therapies for HIV, are available and there are pharmacies, companies, for instance, CIPLA, the drugs, the generics from CIPLA, a pharmaceutical company in India, are available in Honduras. Doctors Without Borders has been discussing the matter with the Ministry of Health and reassuring them about the quality of those drugs that have all received the seal of approval from WHO that we have been using in our project in Tela and also Guatemala with very good results. So these are available. The price is far, far lower, but still we notice the reluctance, the hesitation from the authorities to go and purchase these drugs.

Robert Weissman: I think looking globally the situation varies considerably from country to country. In probably most of the countries there is at least one of the first line drugs that are patented and often more, and whether drugs are patented or not varies a lot by the choices made by the patent holders, who sometimes ignore patenting in the poorest companies, but not always, and also especially whether and when countries adopted U.S.-style patent systems. So in Brazil, for example, the first line drugs are available generically because they did not have the U.S. style patent system at the time the drugs were introduced onto the market. They do have patent protection for many of the later drugs and there is a major allocation of the funding in Brazil for the patented drugs, as opposed to the generic versions. So they spend in Brazil about 70% of their budget on just three of the fifteen drugs that they are using. I think throughout Africa it's sort of a mixed story, but I think in most of the countries at least one of the key drugs is patent protected.

Operator: Our next question is from Shereen Elfeki.

Shereen: Hi, I have two questions, one for Asia and one for Robert. The first question is to put CAFTA negotiations in a broader context, of the so-called Trips Plus agreements that are being signed. I'm wondering if you could tell us a bit about what is happening elsewhere in the world and where these agreements have been signed, and what the impact is we see on the ground in terms of access to these medicines. My second question has to do with the impact of these sorts of bilateral agreements on broader attempts getting off the ground now to improve access to medicines, and in particular to three by five launched last week, how much will these bilateral deals complicate the roll-out of such programs?

Asia Russell: Outside of the western hemisphere there are a number of places where the U.S. is pursing bilateral and/or regional free trade agreements. Recently signed was the U.S.-Singapore free trade agreements, and negotiations were recently launched during the APEC for a U.S.-Thailand free trade agreement. There is also an agreement being wrapped up between the U.S. and Morocco. There is a U.S.-Southern African Customs Union agreement about which Congress has been notified by the U.S. Trade Representative. You can actually take a look at the map of the globe and see the U.S. is strategically carving out different markets where these agreements, which all contain intellectual property provisions, are being negotiated. What are the effects that we're seeing with these agreements, as they all contain obligations for countries to protect and enforce intellectual property rights above and beyond what they are already bound to under the WTO. And since the agreements have just been signed, we kind of can't quite tell yet in terms of medicines that have recently become patent protected but are relevant to the diseases that we're talking about, in some of these regions. For example, in a case like Chile, the terms of the free trade agreement were released and we can see in black and white that patent right holders will be permitted to request an extension of the patent term beyond 20 years, which we know will drive medicine prices up and will obstruct generics from entering the market. This bilateral agreement is new, so we don't have empirical data yet to show that in the case of Chile, but it doesn't matter because we know drawing from the experience of other countries that it's true. So what we can say is unfortunately very quickly we'll have empirical data that reveal our predictions to be accurate and it's quite important to focus on places like Chile where we actually see concretely what the terms of the agreements are after many months of secret negotiations, and in places like Morocco, for example, where there's still an opportunity to transform some of the terms of these negotiations before the ink gets dry on the page. One other important point to make is regarding the issue of export of compulsorily licensed medicines. In Thailand, which has just launched negotiations of a bilateral free trade deal with the U.S., and where there is some domestic industry—if, for example, Thailand were in a situation where they would be denied the right to export compulsorily licensed medicines, period in their new free trade agreement, this would significantly undermine efforts to increase access to medicines in other poor countries that could import from Thailand. There was a very bitter, acrimonious dispute at the WTO about how countries with insufficient or no domestic manufacturing capacity would be able to obtain medicines that are produced under compulsory license, and there was an agreement right before the Cancun ministerial this year that is in many ways a flawed, temporary agreement, but does exist, and the U.S. has not indicated that it intends to extend the ability of countries to produce medicines for export under compulsory license in free trade agreements that are currently being negotiated. This is another piece of evidence of the TRIPS-plus agenda of the U.S. administration.

Robert Weissman: Just to add on with that, in addition to the ones that you've mentioned, and it's hard to keep track of all of them, the U.S. has finalized bilateral agreements with Singapore, Vietnam and Jordan and is also negotiating a bilateral with Australia. They've also created the Thai agreement, intended to be the first of a whole series, first in southeast Asia and then in all of Asia, and the Morocco and Jordan agreements are explicitly intended to be the brackets of a long term project to have U.S. and Middle Eastern free trade agreements negotiated, all these presumably with the enhanced patent protections that we're concerned about. One thing that's not going to be seen, except maybe in some rare cases, as the TRIPS-plus provisions go into effect, is actual price increase for a particular drug. That's because if the drug was available generically already there won't be a sort of overriding of the previous generic status for drugs. So drugs that were available generically, except maybe in a few cases, are not going to be unavailable generically. What is going to happen is that the drugs that might have been taken off patent were going to stay on patent longer, or drugs that might have had generic competition introduced while the product remained on patent are going to not have generic competition introduced. So prices will just not fall in that way.

And I think there is pretty clear evidence of how this is working. For example in Brazil, as I was suggesting, if you look at the drugs that the Brazilians are using, the cheap drugs are the ones that aren't on patent. These are the ones they're able to make generically, or in a couple of cases to import generically. The ones that are super expensive are ones which are patent protected and where they don't have the ability to have generic competition drive down prices. Even there they've used the threat of generic competition to minimize how much they're paying out, but still there's this discernible difference between the generic versions and the drugs for which there is generic competition, than ones for which there is not.

In terms of the WHO three by five program, WHO is emphasizing a limited set of regimens as first line treatment, which I think once public health people are applauding and are very excited about, it should make treatment simpler and it should make it easier to procure drugs more efficiently and cheaply. However, those drugs are going to be patent protected in many of the countries with the greatest need, so there is going to be a need for countries to take steps to introduce generics, and to the extent that the U.S. proposals and the bilaterals and many regions are undermining their ability to do it, it's going to interfere with any kind of sensible implementation of three by five. You're going to see countries either spending much more in drugs than they need to and being able to go much less far in treatment than they otherwise would, or just simply choosing not to do treatment because it's going to be viewed as too expensive to do in any broad scale way.

Asia Russell: It should also mentioned quickly that an explicit strategy of the WHO as part of the three by five plan is acknowledging the role that fixed dosed combination therapies have in promoting scaling up the rapid scale of access to treatment, combining several medicines into one pill in order to ease administration of therapy and to increase the adherence, the ability of patients, people with HIV, to stick with their regimens of treatment. It's only because of generic competition that some of the fixed dose combinations that are being prescribed in treatments projects exists, such as a treatment that was recently pre-qualified by the World Health Organization, the combination of 3TC, d4T and Nevirapine. So this strategy which explicitly embraces generic competition, and an overriding of patent barriers in order increase access to medicines will be undermined by increasingly tough patent provisions and trade rules in the future. So, as was pointed out, it won't retroactively take away the ability for a drug like the one just pre-qualified to be on the market if the drug is already able to be put on the market. But the ability for that sort of combination, that prioritizes the needs of people with HIV to get medicines that are easy to take and simple to administer, that will take a back seat to the commercial interests of the Big Pharma, and that undermines the basic tenet that's been emphasized by the WHO in the three by five plan.

Robert Weissman: That's a really vital point, and just to elaborate on that, and I should have, the patent barrier there is not so much a price one, although there's a price issue too. It's that the drugs that are being combined are patented by different companies, so no company has patent rights for all three of the drugs that are being used in the first line combination therapies. So there has to be some kind of cross licensing scheme that hasn't happened through any kind of voluntary arrangements and there are a whole variety of reasons why that would be so. So what's been needed is for the generic companies to step in, in countries where there aren't patent barriers and just say they are going to combine the products themselves, and in countries where there are patent barriers compulsory licenses are going to need to be issued, or some kind of voluntary licenses are going to need to be issued to the generics, which are the only company that have the ability right now at least, to, without violating patent considerations, combine the products into a single pill.

Asia Russell: Are there any additional questions?

Operator: There are no other questions at this time.

Asia Russell: At this point I would just like to wrap up the call by inviting any of our speakers to make final brief statements, and before that you should know that a transcript of this call will be available by Wednesday morning and that you can get access to material regarding the background we were referring to on this call by visiting the Health GAP website, which is www.healthgap.org/camp/ftaa.html#resources, If there are any final comments from our speakers we'll take them now.

Robert Weissman: I'll offer just one final word, which is, I think that in addition to this being a significant negotiation that's going on this week and next in D.C., assuming the negotiations finish, that the CAFTA vote in Congress is going to be a high profile, controversial hill battle over the spring and perhaps into the summer, and that the public health activists are intent on insuring that the intellectual property and access to medicines issues are central in the debate that takes place, so we expect this to be a story that's going to play out not just over the next couple of weeks but over the next several months. Our belief is that it will be central to send a message to the administration that these TRIPS-plus provisions that are going to get in the way of public health in terms of providing treatment, are unacceptable and cannot be included in the various bilateral and regional agreements that it's negotiating. So we hope that you will all be following this over the next months. Let me just say in addition to the URLs that Asia gave out, if you want to contact me directly I can be reached at 1-202-387-8030 or by e-mail at rob@essential.org. Thanks Asia, and thanks to everyone on the call.

Asia Russell: If there are no other comments, then thanks you again for being on the call; this battle will spill over into a congressional fight and also will be a main aspect of what public health campaigners will be focused on during presidential elections.

Others: Thank you.

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