Participants:

Jeffrey Kushan

Dr. Gary Toenniessen

Dr. John Mugabe

Dr. Peter Rosset

RN: We're going to begin the program now. My name is Rodney Nichols. I'm the president of the New York Academy of Sciences, and I welcome all of you here. We're glad to have this lively and full house for a very important program. First, I congratulate Alan McGowan, a longtime friend of mine personally and of the Academy, for putting together what appears to be a splendid panel, including a few people whom I know and some I don't. We are glad to serve as the physical host of this meeting, and hope very much you all will have a good time. This fits very much within the priorities of the New York Academy of Science’s priorities. Agricultural biotechnology is a subject that we did a somewhat comparable seminar on some months ago. We did a seminar recently on proteomics. We're very interested in intellectual property rights for all kinds of reasons. We've done work on economic development around the world, including some of the areas that will be of concern today ... I think China, India, Africa. My colleague Rashid Shaikh in front of me has been working with Alan and others on this program, so I'm looking forward to the session, and I welcome you. Alan McGowan.

AM: Thank you very much, Rod. You'll soon learn that my chief function at the Gene Media Forum is to take credit for the work that other people do, and I'm very pleased to take the credit this time for the work that Akiko Takano has done, assisted by many people. And Akiko, as you probably know or may not know, is the director of our international programs, and in addition to doing this kind of thing ... she organized one of these a month ago ... is directing our international program, which is holding a big meeting in Johannesburg in October. So, it's a good thing she doesn't believe in sleep and gets all of this done. Thanks very much for coming. We're very pleased with this partnership with the New York Academy and look forward to further activities. Many thanks to Bruce Lewenstein and his colleagues at Cornell for hosting the web site in connection with this event. This is a bit of an experiment ... Bruce, where are you? There you are ... the bearded one in the corner. This is an experiment, and we will see how many people actually use this web site, and what utility it brings to the entire event, and then we'll decide on the basis of that whether it's something we will continue. We're very excited about this development and hope that it will be useful.

A couple of housekeeping things. When we get to the question and answers from the audience, we're going to have a boom mike. So, when I point to you, the boom mike will come over to you. And just speaking of that, this is being recorded as you see, and will be up on our web site within a few days, and the transcript will be up on the web site also within a few days.

Let me just, in the interest of full disclosure, point out that that international program I spoke to you about is funded by the Rockefeller Foundation–not out of Gary Toenniessen’s program–and no Rockefeller money was used for the production of this event, but just so you know where at least some of the money comes from.

Yesterday, I was leafing through Nature magazine, and in an opinion piece under the heading "Towards New Standards in University-Industry Collaboration," the lead quote is from a memorandum actually, "If you had time to patent it, it must be obsolete." So, maybe that's one of the ways that we just solve this problem. We just sort of eliminate the whole patent process. I'm not going to give lengthy introductions. Actually, I'm not going to give any introductions at all, because you have the bios in your package, and that gives you a great deal of information about the speakers. I'm very pleased that we've been able to bring people from around the world, actually to this event.

AM: Okay, let's get started. Jeff Kushan, you've been involved in this from the legal side for many years. You've been at the negotiating table ... you're probably still at the negotiating table ... and your job in the next 4.9 minutes is to sort of give us ... you asked for 5.2, I'm cutting you back ... is to sort of, what is this all about? I mean, why should we care about IPRs, and what are they, anyway?

JK: I guess I like challenges. The task that was given to me was to describe the world intellectual property systems in the state of play and how they're evolving in five minutes, and so I will not try to do that. What I'll do is touch on a few concepts. What are these instruments and where can you find them, is probably the best way to approach it. First of all ... and I'll try to limit it to the area of innovations in the sector of biotechnology and agricultural biotechnology in particular. There are basically three legal instruments: patents, something called plant variety protection–for new plant varieties–and trade secrets. Those are the three instruments that are most relevant to innovations in the agricultural sector. Patents are things which are very difficult to obtain because they require that you go to an office and prove that you've met a number of conditions.

In the US PTO [Patent and Trademark Office] which has probably more resources than any patent office in the world ... it can take up to three to five years just to get your application through and matured into a patent. In the other 179 countries or so, you're not in as good a shape as the PTO for speed or efficiency. The patent gives you obviously a number of exclusive rights–make, use, sell, offer for sale, or import the product that's covered by the patent claims. There's a lot of technical information in patents, and that is often perceived to be the thing that you get rights over, everything in the patent. Obviously, that's not the case. You get patent claims, which cover specifically defined attributes of an invention. In the agricultural sector ... let's say even a new plant that you developed ... the patent will define your rights in terms of the characteristics of the plant ... a corn plant that has inserted into its genome a particular gene that does something. So, it doesn't cover every corn plant in existence, it covers the corn plant that has that attribute inserted into it. You can also get patents that cover nucleic acids that are used to transform plants, you can get patents on systems for transforming plants. A lot of the technology ... a lot of ways of transforming plants can get patent protection through these claims.

The second legal instrument is a plant variety protection right. This is something much less powerful and intimidating than a patent, and it also has to meet less standards. It's a fairly simple test. It basically looks at the new plant variety, and the sophisticated analysis you do is, is it different from the other stuff? If the plant as it is expressing its characteristics is distinguishable from the other plants before that, then you're probably going to clear the threshold. There are requirements that as you generationally propagate the plant, that it will retain those characteristics in a uniform way, but then it is a fairly simple test.

The rights you get under this kind of an instrument are also limited. They're limited in relation to the plant itself, the variety that is being sold or used for propagation. There is an international agreement covering the characteristics of this legal instrument, it's called UPOV; it's a French acronym.

The third instrument is trade secrets, which is really just captured in an informal way in many countries. This is confidential business information that an innovator may perceive to exist in relation to the materials they are using for developing new plants. There are a lot of proprietary stocks ... when you hear the word proprietary, in fact that's most often the term that they use in relation to trade secrets, stuff that is not really being disclosed to the public and is being used for commercial advantage. So, those are the three legal instruments that you encounter in this area.

Now, the rest of the world. There are two major instruments–the TRIPS [Trade-Related Aspects of Intellectual Property Rights] Agreement , which was part of the World Trade Organization agreement, which defines a number of standards in relation to patents, in terms of the conditions you need to meet to get them and the characteristics they give you as rights. There are also obligations in the TRIPS Agreement about systems to enforce rights, which carry over obligations in relation to patents. In TRIPS, the question of patents on living organisms was essentially punted. It says in TRIPS 27.3b that parties–WTO members–may elect to not grant patents on plants and animals ... the things directly ... but they must grant patents on things which are not plants and animals–microorganisms in chemical compounds such as nucleic acids.

The TRIPS Agreement structure also in 27.3b incorporates an obligation loosely phrased to create something called sui generis protection for plant varieties. The code word ... the only legal international instrument that is in that category ... is UPOV.

The second legal instrument is UPOV. That is not part of the WTO agreements, it's the only thing out there that defines the characteristics of that second form of protection. And finally, trade secrets also gain some protection in one clause in the TRIPS Agreement, both in terms of the definition of what trade secrets are–they're called undisclosed business information–as well as your rights to enforce under those.

One of the biggest misperceptions is that the TRIPS Agreement has created this worldwide uniformity in the intellectual property systems. Basically, everybody looks at the US environment, and it's a very mature intellectual property environment. Virtually nowhere else in the world–particularly in the developing world–do you find this refinement in the legal environment for protection of intellectual property. In fact, in virtually all developing countries, you cannot get patents on things which are covered under the US patent system, and in many countries in the developing world, you cannot get patents period, because they don't have the wherewithal ... there are just not many patents at all out there.

Plant variety protection ... there's only 52 countries that are currently working under the UPOV system, so there are a lot of countries where there are no rights under plant variety protection.

Trade secrets you can protect by physical activities. You know, fences around your compound. So, you get more functional protection ... but fundamentally, you're dealing with a world which does not look like the US intellectual property system and in which there are no rights.

So, as my closing point, it's not a uniform world out there, and there's a lot of work between now and the time when you will see these types of legal systems in place. (Applause)

AM: Gary Toenniessen, you as an individual and the Rockefeller Foundation as an institution have long been involved in this issue–trying to feed a hungry world. Is the system working? Do we have to change it? Give us your thoughts.

GT: Okay. The system that has been created over the last 50 years to address the needs of increasing food production in developing countries is working, but it's in trouble. It's in fact threatened by a number of forces associated with globalization that are occurring. And the one that I want to stress today, because it's the subject of this conference, is the expansion of intellectual property rights systems–first of all, worldwide to many countries that have not previously had such intellectual property right laws. But even more importantly, to the public sector international agricultural research system that has generated the technologies and the improved varieties that led to the Green Revolution, and that continue to produce improved varieties for poor farmers in developing countries. That public sector system really operates in parallel with the private sector seed industry.

It's very different than the situation in health. In health, there's no public sector system that can produce and deliver improved drugs or improved vaccines. You can have research in the public sector that creates a new vaccine, but when it comes time to testing that new vaccine, producing that new vaccine, and getting it out, the health sector has to turn to the private sector and say, "Can we work a deal?" or "Can we license you our vaccine?" which is what usually happens. Even if the vaccine is developed–Columbia University or New York University gets license to Merck or somebody like that, and they develop it, they market it–they often market it at a price which poor people in developing countries cannot afford. We know that story. The AIDS drug situation which we're now faced with is an example.

In agriculture, we have a public sector system which delivers the end product to farmers. And fortunately, that end product self-replicates. And so, all you have to really do is prime the pump, maybe get it to five percent of the farmers. And because it self-replicates, the farmers can spread it from farmer to farmer to farmer. That's why there was a revolution in the Green Revolution.

Today, the public sector institutions ... the universities ... the research institutes in the north that used to make those technologies, and particularly the enabling technologies–the techniques that allow other scientists to do the same thing–those used to be freely shared with scientists at the international agriculture research centers or scientists in the developing countries.

Today, if a discovery is made at Cornell University, or Columbia University, or UC Davis, that discovery, that technology is patented and it's licensed to the corporate sector in order to generate a return for the university, the result of the Bayh-Dole Act, which really has worked very well for the United States. But one of the unintended consequences of that act is that those scientists are no longer free to share their technology with other scientists in this international network. And even if they're prepared to share their discovery, it's almost certain that they have used, in the process of making that discovery, they have used enabling technologies–pieces of technologies that somebody else has developed and has licensed to one of the major companies. And those companies are not all that keen about sharing that technology if it's going to be commercialized ... if it' going to be delivered to poor farmers in developing countries.

So, you have a situation where Cornell University develops something like the particle gun ... or particle transformation ... licenses that to DuPont, DuPont in turn will make that technology available to researchers at UC Davis under a material transfer agreement, but for research purposes only.

And there are often reach-through agreements, where if anything does come out of that, DuPont has rights to come back and get a license to the new discovery. But that material transfer agreement first of all probably limits who that scientist can share it with. It often says "cannot be shared with any third party." But it most definitely says "for research purposes only, this cannot be commercialized." So, even if that scientist shares that material, say, with a scientist at the International Rice Research Institute, no rights come along with it. It's being shared, but the burden of having to get freedom to operate is just simply transferred to the scientist in the developing world.

And that has really provided significant constraints to the flow of technology through this public sector system ... to the point where if we fund it, many of the things that we have funded over the last 10 years that have led to the developments of new technologies ... we were naive. We thought that if we got the scientist’s agreement to share what they discovered with the developing world, that they could do that. It turns out they don't have the right to do that.

The classic example would be Golden Rice that some of you may be familiar with, where when we finally looked at it, there were ... if it had been in the US, there would have been 40-some IPR constraints associated with it. Fortunately, it was done in Switzerland, and, you know, there would be only about 12 ... six of them were significant, took a year to work those out ... and we only worked those out because the companies wanted to see that one happen because there were some good public relations aspects of being able to demonstrate that this technology had produced a product that really benefits consumers.

So, it is a problem. We're working to try to come up with ways that might resolve it, but it's still a significant challenge ... and I really think the responsibility is back on to these public sector institutions–the universities and the research institutes–to help resolve this problem. You know, the companies have to make money. They're doing what you would expect them to do. It's the public sector institutions that in my opinion need to find a solution to this problem. Thank you. (Applause)

AM: Great, thanks. John Mugabe, not only do you direct an organization in Kenya involved with this, but you've just been asked to advise the South African government on what it should do about this issue. What's your take on this question?

JM: Thank you. Let me begin by making some general statements on this subject. One is that there's no evidence–at least convincing evidence–that the existence of intellectual property protection facilitates the transfer of modern technologies, including biotechnology to developing countries. There is also no evidence that in fact protection of intellectual property constrains developing countries from acquiring and using modern biotechnology. A number of conditions must be in place for intellectual property protection to be a carrier of modern technologies, and those conditions include the existence of private firms in developing countries. In fact, existence of some critical technological capabilities ... minimum capacity in those countries ... to be able to innovate.

The point I am making is that the mere existence of intellectual property protection is not enough to facilitate technology transfer. There are a number of cases that show that in fact with strong intellectual property protection, countries are able to acquire components of modern biotechnology. A number of examples of those countries include India. We all know that in fact as India has continued to look at its intellectual property protection system, particularly the 1970 Industrial Property Act, Indian farms have started acquiring components of modern biotechnology. We know that in fact with the strengthening of Argentina's plant breeders’ rights regime, companies in that country have been able to invest increasingly in plant breeding, putting out new varieties. So, there must be a number of conditions in developing countries for intellectual property protection to facilitate the acquisition of modern technologies.

We also have cases in fact where countries have not been able to tap modern biotechnology or at least benefit from components of biotechnology when those components of biotechnology are out in the public domain. We know for example that in fact countries such as Kenya are not actively benefitting from donation of biotechnology, even with the fairly strong intellectual property law at the domestic level. Kenya in Africa has one of the most modern industrial property regimes, but Kenya is not in fact exploiting the scientific knowledge that has been donated to it by Monsanto through the transfer of what is now called the GMO [genetically modified organism] sweet potato out there. And in my view, the reasons are again the absence of private firms that are able to engage in this kind of enterprise.

Going back to what developing countries should do–one is that those countries that are going to exploit the international intellectual property system are those countries that invest in science and technology generally, and modern biotechnology R&D specifically. Those countries that sit back and essentially wait for intellectual property protection to work are not going to benefit from the technology. The point I am making is that there must be in fact indigenous investment in scientific R&D as well. Intellectual property protection by itself will not work.

The second point is that it's those countries that invest in international collaboration using some intermediary institutions. Again, in the case of Kenya, with the existence and support of the acquisition of agricultural biotechnology applications ... the International Service for Acquisition of Agricultural Biotechnology [International Service for the Acquisition of Agri-biotech Applications–ISAAA], the Kenya Agricultural Research Institute [KARI] has been able to link with Monsanto. But again, those linkages are fairly weak, because the science and technology are not easily commercialized ... the absence of private industry.

We also know of countries that are now starting to exploit the intellectual property system as a source of scientific information. South Africa is one example where this increasing investment in the use of the patent office there, as is also scientific information. Scientists at the University of Cape Town are now being given various forms of incentives, including free access to the patent office library to be able to in fact search and acquire scientific information in such areas as GMO-related research ... genome kind of activities.

So, there is in fact an opportunity there for intellectual property systems to facilitate transfer of biotechnology, recognizing that in fact this is science-intensive technology. It's not the hardware that matters, but the acquisition and use of the science itself.

The last point I want to make is that in fact the international community can also facilitate the use of intellectual property protection systems through a variety of means, one of them being licensing again–enabling countries to buy royalties, developing countries to access scientific technology through the royalty kind of arrangement. The other, which may just be compulsory licensing, that countries may invoke to promote the transfer of biotechnology. Thank you. (Applause)

AM: Peter Rosset, you and your organization have been in the forefront in posing alternatives to the current system. Would you give us a few minutes of your wisdom?

PR: Well, I would like to say that to me, the most important alternative... not to bore people with a lot of details ... is simply no patents on life. I think that we've gotten ourselves into a very difficult situation, first in the United States, and now around the world as the United States tries to push US-style patent protection through the TRIPS of the WTO on unwilling countries, extending the problem.

It's created some of the problems, for example, that Gary described. I think it's interesting that myself and my organization, which generally has a lot of concerns about genetically modified organisms and crops and even concerns about Golden Rice, would have the same concern as the Rockefeller Foundation, which promoted the development of Golden Rice, when it comes to the question of whether the current intellectual property regime is a benefit or a detriment for humanity. The Rockefeller Foundation and my organization, Food First, are both concerned about the issue of hunger–though we have different approaches to hunger, very different, technologically especially–but we agree that a major obstacle to any approach is the current intellectual property regime.

Unfortunately, the main alternative to patents on life is UPOV–in the sense that maybe third world countries aren't going to be forced to accept full patenting of life–they are being forced, as Jeffrey explained, to accept a version of the UPOV treaty, which has been modified to the point where it's a virtual patent. And so, the distinction is no longer very important.

Gary mentioned some of the problems with patents on life is that their killing public sector research ... literally killing it. At this point, the expense of dealing with patent protection and component processes is such that it's highly unlikely that a public sector university or research institution in the first world or the third world could actually bring a significant new plant variety to market that involves any of these component technologies. This is virtually giving a monopoly to the private sector, and I must say–as someone who personally doesn't like Golden Rice–that if we're going to have genetic engineering research done, I would much rather have it be funded by the Rockefeller Foundation and done in public universities, because the questions they are asking are, "How do you resolve nutritional problems and hunger?," rather than have it be done exclusively by Monsanto and Novartis, because the question they ask is, "How can we use this technology to gain a larger market share on the herbicide market by making plants only work with our proprietary brand of herbicides?" So, even if I don't agree on whether the technology is a good idea or not, I certainly agree that if we're going to have anything like it, it needs to be in the public sector and not in the hands exclusively of the private sector.

Seventy-four percent of all agricultural biotechnology patents in the world are in the hands of six companies, according to data collected by RAFI. Pharmacia, which is Monsanto. DuPont, Syngenta, which is Novartis, AstraZeneca. Dow. Aventis, and Pulsar, which is from Mexico, the only one not entirely in the hands of Northern countries. Ninety-seven percent of all patents are in the hands of OECD countries, ninety percent transnational corporations, seventy percent of them are used only as licenses to their own subsidiaries. So, what it really does, is it takes what is a collectively produced good historically–plant genetic material, local varieties developed by farmers and indigenous peoples over generations–and encloses it into a private good that is only in the hands of a very limited subset of human society.

This really is an obstacle in terms of free exchange of germplasm, for example, between farming communities, between peoples, and even between scientists in Northern scientific institutions, and makes it the exclusive domain of one particular subset, companies who are only asking certain questions. I mean, the broadest question, obviously, is, "How can we make more money?" but the more specific question is, "How can we sell more herbicide? How can we package our other technologies"–because these are also pesticide and agrochemical companies–"in such a way that the seeds once adopted by farmers also give us market share for these other products?" These are not questions that are relevant to human welfare, that are relevant to the nutritional status of poor people, that are relevant to hunger in developing countries.

One major problem is that patenting and the strengthened UPOV variety protection, as a result of the 1991 rewriting of the treaty, restricts farmers’ rights to save seeds from their own field to use for the next year. This is something that 1.4 billion farmers in the developing world depend upon. Gary has touched upon that problem, as Gary also touched upon the problem that the ability of scientists to exchange germplasm is substantially restricted under both patenting and the revised UPOV, which will be pushed through the WTO.

So, the problem at this point is that intellectual property protection is too strong, whether it's patents or UPOV, TRIPS, WTO. Therefore, the broad solution is no patents on life, or no patent-like intellectual property on life ... and that's really the only way to go forward when we talk about alternatives.

First of all, we're better off without it, so the first step is just get rid of it. Then the next step is, let's talk about what kind of protections would be necessary. And then–we particularly work a lot with farmers' organizations in developing countries and indigenous peoples' organizations, and of course, they would say that whatever we did come up with would first have to–like the Convention on Biodiversity–recognize the collective rights of the farming communities and indigenous peoples who developed the original raw material–the basic local races that are used to find this genetic material. We must also protect the right of farmers to reuse seed, protect the sort of free exchange of scientific information that all of humanity depends on, and start from that point of view.

Patents were originally designed to promote innovation. We have a social contract in the idea of the patent, between society and the inventor. We encourage the inventor to invent something by giving them 20 years’ exclusive monopoly on it, to pay them back for their effort and their investment. The problem with patents the way they've evolved now is that they're no longer promoting innovation, certainly not in life sciences. What they're doing is, they're inhibiting innovation, at least in the public sector and amongst farmers. They're stopping the exchange of germplasm, the exchange of processes that are necessary for innovation. And in fact, 70 percent of all patents taken out are not taken out to bring a new product to market that might help humanity, but rather to block competitors from bringing out competing products.

So, a company will bring out a product to do something and then get a whole bunch of patents surrounding all of the alternatives to that product, patent them, and not use them. So, rather than promoting innovation and more choices of useful products for humanity, the whole system has become distorted to the point where it's doing exactly the opposite, which is blocking useful innovation, innovation that's useful to poor people and to society. So, I'll stop with that, because I've run two minutes over, and say that the starting point is no patents on life or anything like patents on life. Thank you. (Applause)

AM: Thank you. When you have a question, give me a high sign and we'll get the boom mike over to you. Yes.

MS: My name is Martin Suter. I'm from Switzerland. I have a question to all of you ... I mean, there is again no representative of the industry here, which is unfortunate, because what I wonder is besides the profit that they can make in these fields, what is the possible good of intellectual property rights ... I mean, in more general terms?

JK: I'll take a first shot at that because I do a lot of work with both individual biotech companies and also via the Trade Association.

I think my first reaction is to disagree with a lot of things that were just said about IP systems and how patent systems work, because one of the fundamental principles in the patent system is early disclosure of information. Companies have to look in the commercial landscape and see how their competitors might leverage the investments they make to sell products without the cost of developing those products. So, if it's not patents, it's going to be trade secrecy. And that's where the fundamental misperception is. If you say no patents on life or no patents on certain technology, all of a sudden there will be free movement of information and everything will move much more efficiently.

And that's exactly wrong, because what you have without a patent environment is people, companies look to physical restraints and other ways of protecting the information that they perceive to give them the commercial advantage. With a patent–and actually in the US, we finally have gotten our patent system aligned with the practices in other countries–we're going to have publication 18 months after the filing of a patent application, which has been a very big improvement that the biotech industry supported. You're getting all this technical information out as soon as you can, and there is a stimulus for people to get the information out as soon as they can. One of the issues we know is, if you put the information out before you file your patent application, you kill the ability to get a patent, because that's the basic test in patentability.

And so, some of the restrictions that have to be imposed to preserve the option of patenting do result in some restrictions on how individuals publish their information. But what we see both in the corporate and university sectors, there's a tension that makes patent lawyers' lives very complicated, because we always have a call the day before there's a publication saying, "We got to write a patent application. Fred forgot to tell us that he's giving this talk at the New York Academy of Sciences today, and you have to get a patent application written today to be filed so you do not kill the patentability of the invention."

The second general point that I see somehow skewed is that people use the word patent as a substitute for commercialization. And patents don't stop activities. It’s use of patents that stop activity. And inventions happen because people invest in developing new things, and then you look at the option of getting a patent, because you think that paying a patent lawyer and enduring the three- or four-year process to get it will have some value at the end of that process. The inventions are happening, and then the question of patents is actually whether it's going to give you a commercial advantage.

So, I don't attribute a lot of the negatives that people have identified about patents as being a patent problem. It's either a use problem, which can be facilitated by leverage that the public sector universities have to change the practices in material transfers and things like that.

I don't want to monopolize the time ... but I note that in the non-ag sector, the NIH about a year and a half ago used its clout to force better handling of materials that are being used in material transfers, which are research tools. They basically said, anybody who gets NIH funding has to sign on to those practice guideline that we have where you will not restrict movement of these research tools among the research community through use of patent rights. And so, anything where their money touches will have to incorporate this practice change in how they make their materials available ... and that reaches both public sector, universities, and companies that are licensing those rights in. So, there are mechanisms that restore the issue of use to fix the problems in access.

GT: Yeah ... I mean, patents clearly stimulate innovation and investment in research areas that can generate profits. They do that exceptionally well. I just read where there's two new Viagras coming out ... a lot of money to be made, so the drug industry has invested, I'm sure, tens if not hundreds of millions of dollars in that particular line of research, research that would not have been done otherwise. The drug industry has been investing very little money in the development of an AIDS vaccine because they don't see much money in vaccines at all actually today, but they particularly don't see money in an AIDS vaccine for the types of AIDS that exist in developing countries.

Coming back to the plant sciences, what is the plus of patents? You know, to be frank, 20 years ago, the plant sciences were a backwater, you know, a little bit of research done, a little bit of academic research done here or there. The development of biotechnology and the involvement of the industry in plant biotechnology has really stimulated the plant sciences in the developed world. Many more scientists, higher quality scientists, a lot more done. But the industry does capture that research. Through the patent system, they have mechanisms by which they are able, quite frankly, to capture the research that you and I are paying for through our taxes.

Now I think in the United States, we probably think that's all for the better because it gives us a competitive advantage in the world marketplace. Our biotech companies are doing better. So, a patent system probably pays off in world competitiveness for a country that has a strong R&D capacity. I really question whether a patent system pays off for a country like Malawi in Africa, or Bangladesh. They need their own type of a system, not the kind of a system that the United States and other developed countries are trying to force onto them, which is basically our system.

M: I have a question. On the second of the two points that Mr. Kushan raised, he mentioned the three methods of protecting intellectual property in plant life, and the second one was new to me on plant varieties. You mentioned a French acronym. UHOG? Could you please tell me what the acronym is at least, and also explain how it's enforced. What court do I go to to enforce my UHOG rights ... or whatever it is. What is the acronym?

JK:  It's the international convention for the protection of new varieties of plants.

M: And why is it ... oh, that's a French word.

JK: The English acronym is really bad. (Laughter) (Background Conversation) Like any other treaty, UPOV in many countries has to be implemented. In the US, we've implemented it through two legal instruments. One is something called a Plant Patent, which is a limited kind of patent, and the other one is something called a Plant Variety Protection Certificate, which is granted by the Department of Agriculture. What you get with an instrument is the right to prevent those actions around use of the propagating materials ... seed or the plant. In the UPOV and in most implementations of UPOV, you have specific exceptions that allow for use of the variety for breeding, for research ... and then under the '91 act of UPOV, there was a provision that said that countries may also allow farmers who harvest the material that they've already planted and re-use their seed on their own holdings.

The line that was drawn in that provision said that you're not allowed to take the seed that you harvest as a farmer and then go in and sell it in competition with the plant breeder. So, it's something which preserves the farm-based rights of the farmers to re-use their seed, but draws a line between activities that are self-focused to those which look like more of a commercial behavior.

In patents, you have the ... first of all, patents don't have the limitations on use. I mean, so you have … in the US for example, there is a judge-made(?) practice of saying that if you use a patent in an invention for research purposes, then you're not going to be liable for infringement, but that's a fairly narrow defense. The patent rights are the right to make, use, sell, offer for sale, or import the product, and if you have a product patented, it doesn't matter how you're going to use it. The Plant Variety Protection only relates to use for really a propagating purpose or then harvesting and selling the thing you harvest. You enforce those rights as you would in any court in the US.

GT: Just to amplify on that a little bit. Why do we have plant breeders' rights? Because plants are different. You cannot invent a plant variety. You know, you can invent a radio and you can take out a patent, and then somebody else can take your patent and–in theory, anyways–replicate that radio. You can't invent a plant. You've got to start with somebody else's variety, and the best you can do is improve that variety. And that's why they came up with plant breeders' rights, in order to encourage plant breeding. The plant breeders ... the right that you get with the plant breeders' rights is only for your variety. You have to then make that variety available–or not, you don’t have to. Another breeder can take your variety and make an improvement on your variety. Whereas if you have a patent on that variety, another breeder cannot do that. And it was only what, about 10 years ago in the United States that a court decision said that plant breeders can now take out both patents and plant breeders rights on a new variety. I personally believe that’s going to stifle plant breeding because that means another plant breeder can now not use that variety as the basis for making further improvements. I might add that other people think that that should not be the case, and the Supreme Court is, this year, going to hear a case that’s being brought, which basically challenges patents on plant variety, saying that Congress intended for plant varieties to receive plant breeders’ rights, not patents. All the courts up to the Supreme Court, however, have agreed that plant varieties could be patented, so we’ll have to see …

AM: Peter?

PR: Yeah, I just wanted to make a couple of points. One is that I think it’s important to understand–I know it’s confusing–what UPOV is, and what that kind of protection it offers compared to patents. Just to put it in the simplest terms, plant variety protection used to be a lot more liberal than patents in that it permitted more kinds of exemptions for farmers, for breeders, more rights for farmers, more space for breeders. But it’s a convention that’s been rewritten, and it’s increasingly difficult to say–and that’s why the confusion exists–to say what exactly the difference is today between UPOV and patents. And I would submit that the proof of that is the fact that in the very difficult WTO negotiations, the compromise position of the United States is "Well, if we can’t get exactly patents on life accepted by all the signatories of the WTO, then we would settle for UPOV plant variety protection." To me, that pretty much says it all, as to the fact that they’re increasingly indistinguishable.

Another thing that's worth mentioning is that the idea of being able to patent life didn't exist very long ago, and that the Supreme Court decision that extended patentability to life forms was only a five-to-four decision. As Gary pointed out, this is something that's being challenged now, and can be challenged many times in the future. So I think a lot of institutions–public sector institutions, the international agricultural research centers, the foundations–I don't know if you call them public sector or private sector–but they certainly have a social public role, universities–a lot of organizations sort of feel that patenting on life is a big problem, but they don't always feel free to come out and take that position politically and publicly. International research centers depend upon various sources of financing that may or may not agree. It's not necessarily a safe position for them to take. But the reality is that most public sector institutions, although they see it as a source of revenue and they're allowing their research to be sucked in that direction, still see it as a problem.

I think it's key to recognize, for example, that prestigious, leading organizations, like the Rockefeller Foundation, see it as a problem. I actually think that if Rockefeller, for example, were willing to take a very vociferous public role (Laughter) while this was being challenged–no, really–it would make it safe for a lot of other institutions to say what they really think, like the international agriculture research centers, like a lot of universities. Right now, the political terrain makes it not safe for them to add their names to the list of this part of civil society that thinks patents on life is a bad idea.

Organizations like Rockefeller, who have less to lose than institutions that depend on funders, can make it safe for them by really taking an unambiguous position. This can be turned over; a five-to-four decision is nothing. Most other countries in the world don't agree with it. They feel cowed in WTO negotiations, but they can be empowered by a small shift in the way that the terms of the debate are staked out in public. (Clapping)

AM: Okay, let's get some more questions. Go ahead please.

MFB: Matt Fleischer-Black. I'm a reporter at the American Lawyer, and I have a question about public sector institutions. Mr. Kushan had mentioned the NIH rules which are intended to try and increase among American medical professors and research fellows their sense of public obligation by sharing more freely. However, there's a–well, not however–there are researchers at the Harvard School of Public Health who have been studying and will continue to be studying withholding amongst those scientists and research fellows.

In 1997, they had found that 74 percent of–I'm quoting from memory, I'm not sure this is precisely on–but it was well over 50 percent of medical scientists admitted to having withheld data or materials. Are there any studies of withholding of germplasm or delays in publication amongst agricultural researchers? And if there are, what are the findings?

AM: Silence reigns. (Laughter)

GT: I'll try. I'm not sure exactly what you mean by withholding. You know, almost every academic scientist today, in order to be competitive in research, at least in the biotechnology area, signs numerous material transfer agreements, okay, in order to do the research to be competitive. When he or she signs that MTA, they are often saying they will not share the results of that material with a third party.

MFB: Just to clarify, you're talking about MTAs with companies or for profit entities?

Man: Most between universities.

GT: Well, a lot of them are between universities, but many times these enabling technologies, despite the fact that they're developed at a university, are licensed, exclusively licensed, to a corporation. And so if another university then wants to use that technology they have to go to the corporation, not to the university that originally developed the technology.

I go back to the particle gun as a prime example -- something developed at Cornell -- but if ... you know, it's even worse because you don't ... you can't go out and buy a particle gun from anybody other than BioRad, which is a subsidiary of DuPont. What you get from them is a lease to use the particle gun for research purposes. As part of the lease you sign, you say you're not going to commercialize or share the products with third parties. So there are ways by which the corporations, despite the fact that I don't think they're really creating and inventing most of the enabling technologies, they capture those enabling technologies from a legal standpoint.

PR: But you're referring to more specifically is withholding of negative research results. I think I know what you're talking about. The study found people who, for example, are funded by drug companies, not feeling that it's in their best interest to publish or to share negative results, and maybe will say "those 50 rats were lost from the laboratory," instead of 25 of them got cancer or something.

But the analogy is different, I think, in agriculture. In the agricultural sciences, the situation that I would be concerned about, for example, is the controversy over genetically-modified crops, and the ecological risks and the human health concerns. I think this is one of the big regulatory challenges of this millennium. The big regulatory challenge of the last one was chemical products and carcinogens and that sort of thing. The big regulatory challenge in this millennium is regulations on life science products. In to do good regulation you would want good objective research done on risks, both for health and the environment, of these products. But we have a situation now where most of our major research universities are increasingly becoming joined at the hip to the very companies which are producing these products.

For example, I am a research associate at University of California at Berkeley, where the school of natural resources entered into a strategic partnership with one single life sciences partner, Novartis, which produces a tremendous number of these products. I think that limits in real terms the ability of Berkeley scientists to do objective research on the possible ecological and health risks of Novartis products. It's analogous to the scientist on the drug company contract not wanting to say that 25 of the rats got cancer, if the School of Natural Resources at Berkeley, either overtly or subtly, becomes less excited about finding out what are the ecological or health risks associated with Novartis’ genetically-modified seeds.

AM: John Mugabe?

JM: Yeah. Just a couple of points. One is that patents are not the preserve of private industry. We know public R&D institutions that in fact have applied and acquired patents, including in developing countries. The University of Cape Town, for example, has applied for a patent. Cuba has a number of public R&D institutions that own patents. Argentina has a number of public institutions that in fact own patents. In my view, it's how patents are used that should be of concern.

The kinds of institutions that we put in place to direct private industry away from in fact misuse of patents, or in fact not invoking, if you want, their moral obligation to do good for society. So the mere existence of a patent does not necessarily make matters worse for humanity. The patent, in my view, as I've said many times, does not have any internal logic to do things better for us or to cause harm for us. It's how the patent is going to be used. Which to me is an institutional question.

Whether we in fact relax, we make patents weaker than they are being called for, I don't think that things are going to be better for the poor in developing countries.

The biggest question in my view is the kinds of incentives we clear for private industry to direct their resources, their attention, to those problems that confront developing countries. Many of the products that have patents are actually not relevant to the poor out there. If you look at herbicide resistance crops, those crops are in fact for the large-scale farmers who can afford to invest in herbicide use.

So the questions that we may want to start exploring are those questions asserted. How do we tie the industry's attention at this particular time to the problems that confront the poor in developing countries? How do you in fact enlarge this public R&D exploiting patents, as opposed to us calling for a relaxation of patents, or if possible, in fact, dismantling the whole system?

AM: Jeff, quick rejoinder? Then we've got some questions.

JK: Actually, not a rejoinder. I was just going to share some of the views that Robert [John] just mentioned. The challenge that seems to be the fertile ground for the discussion is how do you remove the hindrances in interactions between entities doing research. And you've seen efforts by public universities, public, non-governmental and also governmental entities, trying to remove those frictions that exist that are associated with material transfers and other activities, which are caused or have some interference with ... that are linked to the fact that there are patent issues that have to be resolved.

I guess the simplest way to look at this is patents can sit there on your wall and have no effect at all. It's when you pick it up and you start to use your patent rights to do something. When you have universities which are getting a lot of the patents, and the NIH and the other government agencies which are getting patents, they can decide how to use those patent rights. If they want to use their leverage to say, "Let's adopt a uniform material transfer agreement, which has no terms that will change, so there's no discussions about the movement of the product under the MTA," that's one way. I mean, NIH has already done this at some level. That removes the question mark and the hassle of having to talk about moving things around. You just say it's all under the standard MTA and you remove the influence of downstream restrictions.

I know a lot of companies as well. It's not a uniform view ...

AM: Jeff, 30 more seconds. Okay?

JK: Sure, all right. Corporate views, I mean, there's not a homogenous view on the corporate side either. A lot of companies want to have freer movement of goods, you know, materials, and they don't really like the idea of downstream reach through clauses that are really the problem in many of these situations, you know, like, you use my ... use this thing so anything you ever make using this thing I get rights, first refusal over. I mean, big companies don't like those as much as the Rockefeller Foundation, because it's just very greedy. (Laughter) So, it's not a uniform view.

AM: Okay. Rashid and then over here.

RS: Unless I'm missing something, which is possible (Laughter), what is the solution to this problem? I'm just .... you know, how do we solve this real, very complex issue, especially in the context of the developing countries, which is the focus of this forum?

AM: (Laughs) Go ahead, Gary.

JK: We have 30 seconds. (Laughter)

GT: Let me tell you a few of the things that we're trying to promote, which obviously we think might have a chance of solving this problem. One would be for the universities to, whenever they give an exclusive license, to retain a humanitarian use license and a right to share for research purposes. The share for research purposes handles the research problem. It allows Cornell to share with Davis in order to do research. The humanitarian use purpose is a little bit trickier, because you have to define what humanitarian use licensing is all about.

But I think that is doable and I suspect what it'll wind up being is no single definition. You take what you can get. You know, if somebody will give you the humanitarian use licenses to do everything in Africa, and it’s just Africa, well, you take that, because it's better than not being able to use that technology in Africa.

To give you a concrete example of when you might use this, I just saw an editorial that Don Kennedy had in Science about this new piece of legislation where they're talking about limiting the amount that the university can make from a patent associated with the Bayh-Dole Act. And what he says is don't throw out the baby with the bath water, this is a good system, we ought to be able to control this. Well, if the universities that develop those AIDS drugs had kept a humanitarian use licensing right they'd be in control today. They wouldn't be at the mercy of the pharmaceutical companies that they license those patents to. They could say,

"We're going to make the decision that this patent can be used in Africa without royalties" if they had retained that right.

That's why I say that I think the public sector institutions have to begin taking that responsibility. The second thing you might then begin doing is pooling these university-generated intellectual property rights so that you can go to an International Rice Research Institute and give them a package of technology so that they can produce products with freedom to operate, and they don't have to go all around and get a license from everyone.

AM: This is one of the questions in there. Knowing this panel, they'll respond to anything (Laughter), but I want to see if I can get some questions. Yes, over here.

Woman: I'd like to introduce the possible downside of holding a patent, and that would be the liability question. I'm thinking of an example of the USDA holding the patent to Starlink corn, and that unfortunately costs US taxpayers I think around $20 million to replace seed corn that was inadvertently compromised with GMO. So could you address that aspect, which I think might be becoming more important in the near future?

JK: I'll respond very quickly because it's a good example of the ... it's not necessarily the patent that is the thing that's connecting or causing the problem. This is behavior. Something happened where a product which had not been approved for human consumption got into the human consumption chain. And the liability…

Woman: (Inaudible) … at this point.

JK: Well, sure, there's a patent, but the patent has no impact. It’s behavior under the patent that has the impact. In this instance, it's movement of goods that were in a channel that weren't authorized. So the liability is to the entity which put the product out there and got it mixed into the environment, you know, where you were able to mix the agricultural feed with human consumption. You could invalidate the patent, you could take back the patent, you go to a country where there is no patent and the same result is ... there's the same liability question that exists in the US. So I don't look at that as a patent issue, that's obviously a behavior problem, something that happened which should be sanctioned directly without trying to go through the existence of a patent or the absence of a patent.

,I also want to very briefly say, patents are territorial too so a lot of these debates about patents in Africa are just very hypothetical because other than South Africa, there are a lot of countries where there are maybe ... they're granting maybe 100 patents a year and there are not any corresponding patent rights. So there are a lot of other issues at play in commercialization technology besides patents. But I don't see the liability issue linked to being a patent issue.

AM: Yes, question over here?

KM: I have a question for John Mugabe. Kitta Macpherson from the Newark Star Ledger. You were talking about the sweet potato, the genetically-engineered sweet potato, and you were saying that there were problems, even though aside from everything that everybody else had outlined today. Can you explain a little bit more why is it that a farmer might not be able to commercialize this, or why may the commercialization of it may not spread? I was missing your point, I guess.

JM: The point I was making is that even if a biotechnology product was offered, whether it's offered free of charge to some developing countries, they may not be able to use that particular technology. In the case of the sweet potato, Monsanto has donated the genetically-modified sweet potato to Kenya's public research R&D institution, the Kenya Agricultural Research Institute. There is no evidence that in fact that particular biotech product is getting to the farmers that require it. And there isn't … one … the absence of strong institutions, the extension system in the country to be able to get to the farmer.

The second is just the lack of scientific ability to assess the risks associated with this sweet potato. It's taking too long in fact to go through the process of testing and be able to determine whether in fact this is a sweet potato that is not going to have ecological human health risks on Kenya's society at least. So you require some infrastructure in the country to be able to use in fact non-protective technologies, or even if they are protected, but given to a country such as Kenya.

KM: What do you think will happen to the sweet potato project?

JM: If Kenya's public R&D institution does not move fairly fast to get it through the content and field testing processes, what's going to happen, one, is that some of the scientists involved are going to move out of that particular project. There is evidence that in fact Monsanto is losing interest in the particular project. We know that Monsanto has been using this as a public image enlightenment (?) opportunity. But the longer it takes for society to see some benefit out there, in fact, the more it's going to work against Monsanto.

There is an opportunity for public institutions to come in and get the testing through. And those public institutions, not necessarily to Kenyan institutions, they could be institutions from other parts of the world.

AM: Yes?

Woman: What sort of incentives do you think would be needed to make that happen more smoothly?

JM: There are a variety of incentives. Apart from economic incentives, you require what I call institutional incentives. Institutional incentives in the sense that you require a group of scientists who are well paid, who are determined to see this particular process through. Many of the Kenyans working on the project at the moment are less paid, very few of them are really interested. So you require a number of institutional incentives within the institutional setup.

The second point is one of that particular project. The project was conceived largely by Monsanto and one of two scientists in KARI [Kenya Agricultural Research Institute]. KARI as an institution and the Kenyan public don't own that particular incentive. But there are questions regarding Monsanto having had access to germplasm, sweet potato germplasm from Kenya, and possibly having used this germplasm without sharing benefits with the Kenyan society as a whole. Possibly a few scientists have derived benefits in terms of their scientific knowledge and information.

AM: Gary?

GT: Let me just reinforce what he just said. First of all, let me say, however, that the sweet potato is not unique. Most things get through KARI very slowly, because KARI has limited capacity. One of the real things that's needed is to build capacity in the developing countries so that they can not only take a product like the sweet potato, do the test on it and get it out to farmers, but do it themselves so that they do have ownerships.

I think one of the big mistakes the companies have made is to try to push these things from foreign origin, foreign ownership, rather than trying to first build the capacity so that the Indians are the first to introduce a transgenic cotton in India, not Monsanto. So the Kenyans are the first to introduce a transgenic sweet potato or cassava in Kenya, not Monsanto. I think you would see the local population having a parade on the street for the success of their scientists rather than out in the street rioting against this foreign multinational that's coming in and taking over their seed industry.

AM: Yes?

Woman: What efforts are currently underway to promote this capacity building within developing nations? Are there groups doing that sort of thing now?

AM: Peter?

PR: I think this actually also goes back to the question of what can be done to solve the problem. There are two problems that we're talking about. One are those problems that some of us feel are created by patents on life, and that can be solved, at least partially, by eliminating patents on life. The larger question is what can be done to solve the larger issues of hunger, poverty, lagging productivity in some areas of African agriculture, etcetera? That's a lot more complicated question. I frankly think that's the question that we should be free to address and not be tied up in fighting this colossus of agricultural biotechnology. That's certainly worth several hours or several seminars in and of its own.

But see, absolutely, strengthening institutions, research institutions and the public sector in developing countries is critical. The problem is that we’re going in exactly the opposite direction. Emanating from our country have been policies that can basically be summed up as budget cutting, and the public sector has been destroyed, over the last 15 years in most developing countries by structural adjustment programs which enforce budget cutting, coming from the World Bank and the US Agency for International Development.

And if third world research institutions had problems 15 years ago, those problems were nothing compared to the problems we have today. So we're going–for most of the problems, the bigger problems and the bigger question–we're going in exactly the wrong direction. Unfortunately, it almost feels like the GMO solution to world hunger is a red herring, that's distracting all of our attention from the real work that would have to be done if we were going to address the real problems, where an easy technical fix might be one small piece of a much larger series of things that would have to happen in a lot of different places.

AM: Jeff?

JK: One of the biggest problems is that the very difficult thing of building capacity can't be solved by, you know, changing a word or two in the TRIPS Agreement. And in fact the thing that's frustrating is that when you look at agricultural technology you can't take something out of the plains, let’s say the plains of Kansas, and plant it in another country. You have to develop a new variety that's actually going to be ... that can survive in that new environment. So every country needs to have its own capacity developed. New varieties are going to be adapted to the local environment.

The capacity comes through a number of different places. You've got the government itself of that country has to subsidize and support its own sector. You have ... what other things can you bring in? You can have international sources of funding and support. The centers that do the work now preserve germplasm, et cetera, are another component. The third component can be the private sector, obviously, if you can see that there's an economic market where you can develop and make money, you can obviously stimulate development of varieties through that mechanism. But arguably that's the problem you see in many of these countries. You don't see that capacity for a for-profit enterprise.

So all these things are big, difficult problems, but they're not patent problems. They're country-specific problems that have to be tackled, and it’s very painful and it's long and it's hard to do the development. But I don't see any downsides from … if there is a capacity for a for-profit enterprise to come in and enter that environment, why you should do anything to make it more difficult to commercialize technologies than it already is.

AM: Gary?

GT: There are organizations that are trying to build that capacity, but it's most of what we do. The World Bank provides a lot of loans to developing countries to try to build that capacity. I guess I would disagree with Peter on this. That capacity building is across the board. We spend more money on agro-ecological research than we do on biotechnology research. And I think I could say that the Bank and others do as well.

The big change that has occurred over the last ten years or so is the disappearance of USAID from that capacity-building activity. They used to be the big actor. In Asia, the capacity building in India and the Philippines and Thailand and places like that, was largely funded by USAID. Today, USAID is primarily interested in food aid. If anybody did it to us we'd call it dumping. We do it to them and we call it food aid. (Laughter) And that's because USAID has been captured by American interests. There's really nobody there ... there's not enough political pressure there from anybody that's really looking out for the interest of the developing countries anymore.

AM: Question back there.

Shirley Camper Soman: I like the idea of the no patents for life, but I'm wondering how ... whether you've had much support on it, whether there's any really realistic reason to think that it could work, that it could influence either legislators or companies or whoever is involved?

PR: Well, first of all, and I think it's important to reiterate that it was only a five-to-four decision in the Supreme Court. Most other countries in the world are not in agreement, not in fundamental agreement, with the idea that life should be patented. It's really only through the WTO process that the United States is trying to enforce its will on reluctant foreign countries.

So in fact, you know, the majority of the world doesn't think it's a good idea. Even within the United States, very important institutions involved in this kind of work don't think it's a good idea. So I actually don't think we're very far from a serious consensus that if it were brought out into the public, it came out of the closet, or whatever, so to speak, and acted like a political coalition, would make it possible to overturn this, and certainly would draw enormous support from other countries. So I actually feel quite optimistic, and that's why I was sort of jokingly prodding Gary, because I think we just need a little bit of leadership to bring the latent consensus out into the political arena.

JK: Again, I don't share this view. First of all, the Chakrabarty decision was [about] a microbe. There's a bacterium that was altered to digest oil, and I don't understand ... I mean, it's nice to take, kind of, this no patents on life–so simple–concept and say that that's what the world really wants. In reality, the inventors I talked to want protection for their inventions. But if it happens to be in the form of a living organism that makes a protein that is important, they want protection for that because that's what they need to compete. I know inventors all over the planet. We file patent applications for Indian inventors. They don't have any protection at home, but they know that they need protection to do commercially viable activities.

We don't see this outpouring of opposition around the world. Obviously, there are NGOs who have that view and they fervently hold that view, and you can find that view espoused in NGOs in any country. But that's not representative of the view around the world.

We have seen most of the world follow the practice of granting patents on living organisms without any hesitation. The issue that … it's just simply not ... as simple as it's been laid out here. I also see that you ... No patents on life hits via medical research, you know, it adds ... it's a lot of different sectors beyond agricultural biotechnology. So I disagree.

AM: Yes, sir?

Man: Yeah, that's exactly my question. I was wondering if maybe the agricultural field needs a test case as we had with the AIDS case in South Africa to really have something initial to rally around people, but also organizations and governments in this field. What would you on the panel think about that?

PR: Well, I think it's worth mentioning that I don't know where the idea that it's only NGOs that espouse this position comes from. It's been the official negotiating position of probably close to 70 or more third world countries that they're not happy with the notion of patents on life, and it's certainly the case for many, many, many farmer organizations around the world as well. So it's not just NGOs.

I think that the key thing ... you know, what happens is that there has to be a political space in which a consensus can become real. What I would give as an analogy is what happened with the WTO’s failed new round in Seattle. Many developing countries came into that with very strong reservations about a lot of the things that were going to be negotiated in the WTO meeting, and with very strong reservations about the US position. They arrived in Seattle thinking, however, that despite all of that, they would have to swallow it and sign on, because the political space in the world seemed to offer only that option.

I'm not advocating rioting in the streets, but the rioting in the streets changed the political space that existed in the world during that week and made it possible for third world delegations, actually led by the African country negotiators, to say, "You know what? This was negotiated without our participation. It was just the United States and the EU. We've got all these reservations. We don't want to sign anything, and good bye." That would have been inconceivable in the political space that existed in the world the previous week.

So there's a lot to be said for the positions that are taken, or made possible, in the public debate sphere that make it possible for others to take the positions that they already hold in private and take them in a more forceful, public, and consequent manner.

AM: Yes, sir?

Man: What are the health risks of the patented, profit-motivated improvements to the world food supply? For example, bovine growth hormone, which is an improvement supposedly in production of milk, is a fairly controversial issue in terms of human health.

AM: Gary, you want to ...

GT: I'm not sure I understand the question.

AM: The health implications of genetically-modified food.

GT: Peter might be (laughter) better prepared to ...

Man: (Overlap) … because there is a profit motive in it, sometimes those things are released too early, exactly as it is happening with drugs?

GT: Yeah. My personal opinion on this is that the health risk associated with transgenic plants are no more significant than the health risks produced by plant breeding. I believe that almost every, if not every, scientific panel that has been brought together to address that question has come up with that same answer. I do think there are potentially serious environmental problems associated with these products. But again, no more serious than those associated with conventional agriculture, and perhaps in some cases, considerably less serious than 20 sprayings of pesticide on a cotton field in a given year. But I do think we need to be alert, vigilant, and put in place the testing procedures that make sure that these are healthy products and that there are no serious health risks.

We've been eating transgenic crops in this country, all of us, for at least the last six years and I don't know of any inherent health problem associated with the process that has been demonstrated by this. If you put a gene for a protein that's a human toxin in a plant and then feed that plant to humans, humans are going to get sick. But obviously no company is going to do that. Their product would be ... I mean, they're as concerned about the quality of their product as anybody else.

JM: My own view is let’s judge each product, and let's go case by case. This is ... not all GMOs are and will be harmful to humanity. Some of them are going to be. Let's also not throw away the whole technology of genetic engineering because one or two of its products are found harmful. Not all GMOs again are going to make it better. Some of them are going to be useful to societies out there.

What I find I have difficulties with is essentially the extension of certain cultural ... certain values as if in fact all societies perceive of risk in the same way. The way Africans perceive of risk is different from the way in fact Americans perceive of risk. The problem that I have with the current debate on GMO is that it assumes that in fact we are dealing with a homogenous system. All of us share the same values, we come from the same ethical cultural backgrounds. There are certain cultures that can easily absorb risks. They have risk aversion measures others do not have.

So the point is that let's get the products into the social systems there, and the systems will ... each system is going to select the useful product.

PR: I would be lying if I said that I knew that there were very significant health or environmental risks, just as I would be lying if I said that I knew that there weren't. The problem is that very little research has been done to seriously evaluate the risks.

I have a Ph.D. in biological sciences and six years ago, I believed, like Gary said, that there were no serious significant potential health risks and I also believed, unlike what Gary said, that there were no significant ecological risks either. However, because of my work I was forced to read the scientific literature very carefully on both, and now I believe that there are very serious potential risks and we have no idea if that potentiality is likely to become reality or not because our regulatory agencies have not done their job.

No mandatory health safety testing has been required for any GMO product by the FDA. We don't know if any Americans have gotten sick because it would require an epidemiological study that would link specific food item consumption to illness reports. Right now, I don't think people are dying by the thousands but they could be and doctors would have no idea of what thei epidemiological relationship is, because CDC has not conducted any kind of broad-based study. They just recently looked into the possible allergens related to Starlink corn, but the broader issues have not been dealt with.

I agree with John that we want to look at them case by case and we want to allow each country to set up its own pre-market safety testing for human health and ecological risks that each product would have to pass through before it could be used commercially. That's why, for example, I would support the approach in the biosafety convention that would allow countries to say no if they want to, as opposed to the approach by the United States, which is not a signatory of the biosafety convention, which would want all countries to be forced to accept anything that was accepted in the United States, essentially.

So I agree very much with John that different countries have different views and should have systems tailored to what their own reality is. But they have to have the right in international law and conventions to have their own systems. Unfortunately, the way things are going right now with WTO negotiations is that there is a very strong attempt by northern countries to take away the rights of other countries to develop their own systems–for example, to address biosafety.

AM: Jeff?

JK: I think one risk that has to be managed in this whole process of evolution of these regulatory systems is to not allow countries to use scientific fear as trade barriers as well. That's one thing that has not been touched on but it's very important. It's very easy to say that if we are an industry that does not use GMO products, a practice which bars all entry of GMO products, which are primarily coming out of the United States, obviously creates a very significant economic advantage for that country. So we have to put that into the mix of issues to be managed as well. That's why sound science should be the basis for these debates and not something which is not susceptible of that rigor.

My second point is I don't understand why you use the word patent in your question, because it's ... I've seen this line … again, it goes to the point of patent equals commercialization, and in many situations it just doesn't have anything to do with the issue. Patented things don't have ... it's not the attribute of being patented. It's the thing itself that is the basis of debate.

AM: Well, we've gone ... I'm sorry, we are out of time. We've gone from the rather arcane issue of intellectual property rights to some of the broadest issues that this issue brings forth. The same Don Kennedy that wrote the editorial in Science magazine was one of the first people, when he was president of Stanford University, to call attention to the fact that now that information was worth money, the culture within a university might change. There have been many comments to that effect in the literature and it's just one of the many broad issues that this particular question brings to light.

Join me in thanking the panel and thank you all for coming. (Applause)

(END OF TAPE)

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