FIFTH MEETING

CHAIRMAN KASS: On the record. Would Council members please return to their seats so that we can get started. All right. This is the Council's third session on the topic of patenting human organisms on which we had two sessions at the last meeting and from which the staff has prepared a working paper in your briefing book.

Just to review the bidding at the June meeting #150 we began to explore the potential problem of the patenting of human organisms and we had five guest presenters who tried to provide us with a sense of the issues at stake, the history, the state of the present law, the interests and needs of the biotech industry and the moral questions surrounding the matter.

The factual question for us is this: Are human organisms patentable subject matter under the terms of the U.S. Patent Code as interpreted by the courts and the applicable question is should they be? According to staff's understanding of what happened at the last meeting, it looks as follows: under the present and in the light of several important court decisions over the past two decades there is no explicit barrier to the patenting of human organisms; and that this is a troubling circumstance but any attempt to address it must take careful note of the needs of the biotechnology industry and should not be a backdoor effort to address the large moral issues raised by embryo research, genetic manipulation and other morally charged developments in biomedical science and technology.

The presenters all urged us to focus very narrowly any kind of inquiry on the patent in question. Many of the people said that this was an inappropriate way to get at those larger moral issues, and one can concur. But that seemed to imply that the Council's only interest in taking up the question of patenting living organisms was in fact as a backdoor means of getting at those other issues. The suggestion is that this might not be true.

Patenting might not be the route to those questions but it is the only route to answering the question of patenting human life itself which might be a significant ethical concern of some real importance to us. There is a moral aspect unique to the patenting question itself.

So the point of this meeting is to have a discussion amongst ourselves to see how after several weeks of opportunity to think further about it whether this is something that we think is important and important enough to become some kind of Council project.

Do we want to include human organisms at whatever stage of life, embryonic, fetal and child under the subject matters that might be patentable? If so, why has there been a reluctance to do so? And to what does this reluctance point? What could it teach us?

What would it mean to grant quasi-property rights patent protection over human organisms over body or body parts? How does this relate to larger concerns what some people expressed about the commodification of human life? What does this actually say about the topic that we'll be discussing tomorrow, the relation between ourselves and our bodies? Patenting isn't the backdoor to these questions. It seems to lead to them directly.

On the other hand, a biotech industry is a precious resource. The patenting is a terribly important instrument for encouraging innovation and any discussion that we would have about these matters has to keep firmly in mind that this is something to be treasured. Any attempts even to think about closing a loophole must keep the fundamental purpose of patenting in mind which is not to regulate but in fact to assist and encourage commerce and industry and the advancement of knowledge.

That, by way of introduction and I simply was setting the table to see where your thinking is on this question. Whether you think there is something here of limited or perhaps not so limited scope that would make sense for this Council to take up. The floor is open for your comments and discussion.

PROF. DRESSER: Well, if no one else wants to jump in I will. I guess I have a few thoughts on this although my head is still full of cloning. I guess there are things I think to be said for taking it up and questions I would have.

One reason to take it up is that my impression is that people who are patent law scholars such as Professor Rai who was here with us before and I think she is not the most extreme example. But there tends to be a focus primarily on how should the patent law be designed so that innovation can be stimulated. That is the concern that they have.

They don't really look at these broader ethical questions that we would be addressing in a project like this. I heard an interesting presentation in which someone was discussing this, Professor Boyle from Duke Law School. He said that it's like the top of the bus and the bottom of the bus. The scholars are up here talking about how do we foster innovation. On the bottom of the bus I don't endorse this hierarchy but there are democratic debates going on about what should be patentable subject matter. And we're not talking to each other.

It's almost as though we speak in different languages. So I guess one thing that we could contribute would be an attempt to try to bridge that gap and to try to bring enough of the technical legal scholarship together with more democratic concerns. There I think we would want to try to get some good expertise in patent law scholarship because I certainly don't consider myself an expert on that.

I guess a question I have is that I agree with Professor Rai and others that a patent is a property right. It's only one of the many property rights that exists. So is there a problem in treating patenting in isolation so that if we were to say well it's wrong to grant patents on human organisms wouldn't there still be a lot of other possible property rights that we might worry about, types of ownership and commodification. I think this leads to Michael Sandel's previous point at the earlier meeting about the question of whether we should just address the commodification more broadly.

Then I guess another question I have is if we were to do this I think we would want to look not only at this question of human embryos and human life at various stages but what is a human organism. If there's a genetically modified creature how much of the human genome has to exist for us to consider it a human organism that would be encompassed in any policies that we might suggest?

CHAIRMAN KASS: Thank you very much. Let me make a suggestion. There were about three or four meetings ago we decided not simply to do everything in queue in the hope that actually we might discuss one topic at a time. The group is also somewhat smaller. I'm sorry about that but we are somewhat smaller. Maybe we can actually discuss one topic at a time. Let me try to keep order and then let's try to stay with one thing and see if we can advance the ball.

Rebecca has given us at least three things to speak on: building stairs on a bus; thinking about the relation between this property right and other property rights and the questions of commodification on them; the next question of all right if you wanted to say something about not cloning human organisms and what exactly does that mean. Michael, could I ask you to pick one of those things and whatever you pick we will discuss.

PROF. SANDEL: That's a dangerous offer, Leon. I think we should take up the question of patenting life but my question is whether we would do it better if we took it up as part of a more general inquiry into the commodification of life.

We found ourselves saying many times around the table over the past in the cloning debate that in many ways we wish that we could address cloning for biomedical research in the larger context of embryo research. Many times we found ourselves frustrated that we hadn't taken that broader view.

I think that we might learn from that experience here. I think that might argue for taking up and I certainly think that's of importance and it's of great moral and intellectual interest, the question of the commodification of life in general. Patenting is troubling for reasons that I think are very hard to distinguish from the same reasons that make us worry about the commodifying of life in other ways.

CHAIRMAN KASS: For example?

PROF. SANDEL: For example, the buying and selling of eggs, sperm, fertilized eggs, stem cell lines, genes, commercially contracts for surrogate motherhood. I think that if we simply focused on that aspect of commodification or of property rights in life presented by patenting in exploring the ethics of that we would be driven to analogous cases about ownership of let's say in the sale of sperm and eggs or of surrogacy contracts or owning genes and --

CHAIRMAN KASS: Organs.

PROF. SANDEL: And organs. So if the moral arguments would naturally lead to closely analogous cases of those kinds I think we might regret restricting the bounds of our inquiry in advance. Now an inquiry into commodification might take longer but I don't see that as an objection to it.

I think ethically and intellectually the issues raised are similar I think from the standpoint of focusing public discussion. It's as important to focus public discussion on these areas as it is on patents. So I'm all for discussing and examining the patenting of life but I don't see any compelling reason not to situate that in a larger inquiry into the commodification of life though it may be there are considerations I haven't thought about.

CHAIRMAN KASS: Mary Ann, to this. Please. Would you put the mike on please?

PROF. GLENDON: I agree with Rebecca and Michael that we ought to look at patenting in the context of the larger questions. But I want to throw out another idea about what the larger questions might be whether it be commodification which relates to the property is quite the right category.

I think the patent language in the Constitution is a very interesting intersection between science and commerce. That whole set of questions about the relationship between science and commerce has been woven through our discussions and concerns about cloning and is likely to be woven through any subject that this Council might take up.

It was interesting for example to read in this morning's Boston Globe of Ellen Goodman's column commenting on the recent controversy over the use of estrogen. It says that prescription of estrogen over the years represented the triumph of market over science. I think really that's the set of questions that we want to look at and just a few more words about that.

We all agree around this table that free scientific research is of very value, something that we want to encourage, that patenting language of our Constitution wants to encourage. I think we all agree that the free market has great advantages but that both the freedom of science and freedom of the market somehow to work at their best have to be conducted within a moral and juridical framework.

That's where the real hard questions are. Where does the moral framework come from? Internally? Self-regulation? Formation of citizens? Where does the juridical framework come from? That's really more in our province and I think that's the context in which we should situate our discussion of patenting.

PROF. SANDEL: Could I just ask as a follow-up?

CHAIRMAN KASS: Michael, please.

PROF. SANDEL: I find that persuasive. Could you say just a little more about what in practical terms that focus which seems like a very good focus how might we structure that discussion? Can you say a little bit more about what you would have in mind?

PROF. GLENDON: Michael, I think that's just the sort of thing that would take a period of preparing some papers and call some people in. But I think that would be a good general question to start out with. What should be the relationship between these two values that we pursue and believe in but both of which need some kind of a framework in order not to be self destructive. You can kill the geese that are laying those golden eggs of scientific advance and productivity.

CHAIRMAN KASS: Directly to Mary Ann.

DR. ROWLEY: Yes, it's directly to a comment that she made though. It's tangential to the discussion. I just want to point out your statement of triumph of marketing over science.

You see what it really was was initial small scientific observations made concern conclusions because heart disease doesn't really increase dramatically until after menopause that estrogens might protect you from heart disease and other things. It was only when larger studies were done and good scientific data were obtained that it became clear that there are both benefits and disadvantages to a hormone replacement therapy.

So that good science, well done science on a large scale was what was required to then clarify the good things for hormone replacement therapies such as reduction of osteoporosis and the bad things such as potential increase in heart disease and breast cancer. These are very small increases proportionately over the general risk so you have to have well done large studies in order to begin to get some of these data.

CHAIRMAN KASS: Mary Ann please and then Gil.

PROF. GLENDON: The phrase wasn't mine but nevertheless I think there are issues just on that particular problem that bear examination. Was estrogen therapy oversold to women who really didn't need it and what was the role of the drug companies? So it's again an intersection between science and commerce that we don't very often look at as closely as we ought to.

CHAIRMAN KASS: Gil and then Dan. I'm just trying to keep us on track.

DR. FOSTER: I want to respond to Mary Ann. There's another thing and I don't know these legal terms and I don't know whether commodification is the same thing but you hinted about the effect of the market here and we see it on all the advertisements on TV and everything for drugs right now we've talked about that in this conference before. I have a further concern and I don't know whether it ought to be part of yours and Michael's consideration but if you use the term you will understand what I mean if it's correct or not.

There's a commodification of the scientists themselves which to me is in many ways deeply regretful. There is a powerful incentive to make money. I mean scientists didn't used to be too interested in money or academic people. I remember when I decided to go into academic medicine I told my wife when I decided to do that we're going to always be poor but that's what I want to do. She said okay I'm with you. But it didn't turn out that I was always going to be poor because I make a good salary and so forth.

But the emphasis, the commodification that I worry about is that the power at least when the market was very high of making money in biotech companies and so forth no doubt influenced not only what one worked on which in one way is good. Many of the basic scientists are working on clinical things when they wouldn't touch it before. But it's also inhibiting.

For example often times there are restrictions that would allow the graduate student or post doctorate fellow not to talk about the work that is going on or you don't talk in the hall. It used to be when you walked around the scientific institution people are jotting on boards in the hall and I'm happy to say that we still have a few boards at Southwestern where we jot in the hall regardless of somebody owns a company and I'm in no company.

I have no restrictions. But I wonder if the commodification of scientists itself might -- I think there are ethical issues there that we might want to talk not only about worrying about the market and other things but that might be something that we might want to include in your broader scope. The topic might be minor but I'd like to talk about it.

CHAIRMAN KASS: Gil.

PROF. MEILAENDER: When I told my wife that I wanted to go into academic life and teach ethics I said we will always be poor and by George nothing has changed.

(Laughter.)

DR. FOSTER: Now listen at this late time in your life, Gil, if you wish to be admitted to a medical school class I will try to see what I can do.

(Laughter.)

PROF. MEILAENDER: Thank you. Back to the patenting thing, whether we should proceed with this or not I don't know. I'm not sure it's at the very top of my list of questions to proceed with. Just thinking about how one might proceed if one did, I grant that the commodification issue is inevitably an important one there and the relation of commerce and research is important.

But I must say that I'm leery for a body like this beginning with some kind of grand, large, philosophical starting point. If we start with commodification, we can spend a long time reading an amazing body of literature about the body and what it means to be embodied and so forth. If we start with commerce we can all read Tocqueville to think about what a commercial republic is.

I think I might be more help to think about it if I started with something very narrow and precise and then waited to see how these larger questions which I agree are there came out of it. For instance when I read the staff paper I realized that I never actually read section 271(G) of this patent law.

I think I would be more help to have that section in front of me and a proposed revision of that section by somebody who wanted to figure out a way to control patenting of a human organism and then listen to a couple lawyers argue about it. Perhaps a couple biotech researchers argue about how it worked. Then I'll see what big questions do or do not emerge from it. I know whether I think I have a very small project here that doesn't require much more than a letter to the President saying the Council has thought about this and recommends this or whether it requires something more like a report. At least for me I would rather start that way and see how the big questions fall out.

CHAIRMAN KASS: This is really methodological. You don't dissent from the importance of the large questions but you worry about whether it makes sense for this body to tackle them in that global way.

PROF. MEILAENDER: Right. I make my living thinking about large questions.

CHAIRMAN KASS: You make your non-living.

PROF. MEILAENDER: My non-living. My less-than-Foster living. But no I don't know for a group like us if it will work very well to start big.

CHAIRMAN KASS: Frank.

PROF. FUKUYAMA: I'm really with Gil on this. I think there were a lot of practical issues revealed in the discussion at the last session on patenting that really need some fairly nitty-gritty discussion. For example, although I think that Professor Rai was correct in saying that if you for example want a blanket ban on embryo cloning probably the best way to go about it is just to ban it and not try to get at it through patent law.

There is something a little bit disingenuous about that because she was preceded by Mr. Holtzman who said well if we don't have property rights in these procedures you're not going to have any of this product. So obviously there's a relationship between whether the thing exists and whether those property rights exist. One alternative path towards regulating these activities is by controlling the property rights. It doesn't get at the ethical issue. I mean there is an ethical issue of commodification in addition but there also is a very important practical significance.

The other thing that was quite clear from that discussion is that in fact the patent and trademark office does get into a lot of ethical issues where they have absolutely no institutional capacity for making decisions. It was clear from that discussion for example that some of their past decisions had amounted to asserting that life begins at conception because I believe in the materials we were given it clearly indicated that they had applied the rules about no ownership of human beings to basically an embryo which I think would probably surprise a lot of pro-choice people in this country that some patent lawyer tucked away in a obscure bureaucracy and Washington have made this decision on behalf of the American public.

It's just such a minor -- It didn't get particularly politicized but that's an important decision. It's very clear that as a particular matter that whole institution needs to have some scrutiny but also I would say put in the context of scrutiny of a lot of other institutions that we have that control biomedicine.

CHAIRMAN KASS: Robby George.

PROF. GEORGE: Yes, thanks Leon. If we go into the issue there will be good reasons to avoid making the issue simply replicate in large measure, the debate of the moral status of embryonic human beings. There will be a lot of pressure that we will apply to ourselves to avoid that. At the same time for the reasons that Frank has articulated and others, we will discover there will be in the end no avoiding that issue. The issue won't perhaps dominate the discussion because there's a lot more to the issue of commodification than the status of the embryo. But that's a very important issue and I think it's going to be difficult to avoid.

But I wonder if we will find ourselves bumping up against that issue and against our disagreement on that issue and then constantly having to pull ourselves back from it but pull ourselves back feeling quite unsatisfied because in a certain way for the reasons Michael articulated to engage the issue of commodification fully, we have to engage that issue.
I guess there are lots of reasons we are going to eventually have to engage that issue. I hope that eventually we will.

CHAIRMAN KASS: I shall take that as a friendly warning. (Laughter.) Look. Let me try you out on this and let's shift from thinking about the embryos to something that I doubt no one is going to make an argument that an isolated organ is a human being. Right? One could imagine that with certain kinds of genetic alterations that would be the work of human art rather than of nature. In fact one has seen it with mechanical organs.

One could imagine that one could find ways of altering fleshy organs as opposed to mechanical ones such that they would come under the category of patentable matter. I guess the question would be does one regard that with equanimity or does one say that there is something here that one wants to draw back on.

In other words, I'm not sure that the issue about the patentability of human organisms and let me add their parts is simply going to turn on the vexed question of whether this one-cell creature is or is not a human being. I'm not arguing one way or the other. But Michael sent out a list of a whole series of things that I don't think he was simply trying to get us to avoid the focusing of all this but he believes that that's the right domain.

PROF. GEORGE: Yes, I wasn't asserting that every issue is going to turn on the moral status of the embryo. But I think that there are going to be a number of issues that are central that will implicate the question of the moral status of the embryo. And we're going to bump up against them. Are we just going to draw back each time?

CHAIRMAN KASS: But my point was and I guess I didn't make my point that just as one doesn't regard a human body part as a person so someone who didn't regard an embryo as a person might still find it regrettable that one is getting patents but doesn't necessarily turn on the judgement about whether the embryo is a full person or not, whether one thinks that this is an area that has an ethical dimension worthy of our attention or not.

PROF. MEILAENDER: Leon, just could I intervene to say. I think you should eliminate the full person language in your exchange with Robby. I think that loads way too much. Use human being or something like that.

CHAIRMAN KASS: I accept the correction. It was loose speech. Do you want to fix my sentence?

PROF. MEILAENDER: I would never try to do that.

CHAIRMAN KASS: Make my point for me here.

PROF. MEILAENDER: I don't think it's a point that I disagree with. But I don't know if I want to make your point exactly. I think all Robby is saying and I believe I agree with it is that at some point in discussing this issue you're likely to end up talking about some things that the staff paper I think calls human organisms. The question is going to be what is their status.

CHAIRMAN KASS: Right.

PROF. GEORGE: And we're going to want to distinguish those things that are not human organisms from those that are. While some people are going to make undoubtedly arguments or at least will have concerns about patenting even in cases where they don't believe that you have a human organism in play. There will be others for whom that will be crucial and the trajectory and content of their arguments will be affected by that which I guess is just a long round-about way of saying let's do this. Let's do it knowing that as with cloning we aren't going to be able to simply separate out even if for other reasons it would be desirable to the question of the status of the embryo, and please at some point let us be the ones to lead or at least invite our fellow citizens into a national debate about the moral status of the human embryo.

DR. KRAUTHAMMER: Could I make one point? I think you're right. You will have people agreeing and disagreeing about the moral status of the embryo but thereby for different reasons coming to the same conclusion about how we ought to deal with the patenting of human organisms or parts in the same way we this morning had people who disagreed about the status of the embryo who came together on recommending what we ought to do with cloning.

So I'm not sure that it's going to be an impediment to reaching a serious proposal conclusion recommendation that we can make. I think you're right in highlighting that there's no getting away from this conundrum but I'm not sure in the end it will stop us from achieving a good result.

PROF. GEORGE: I agree with that. I think the parallel with what we've done in cloning is pretty close. I know that it would have been nice in dealing with some important aspects of the cloning issue to be able to get rid of the question of the embryo if it could have been laid aside. It turned out that we were unable to do that. We can now understand why we weren't able to do that and we'll be unable to do it I think when we move on.

But, Charles, I'm not making an argument for not moving on to this issue. I guess I just want us to have in mind that we're going to bump up against it as we did with cloning. But I hope at some point we'll really confront it directly.

DR. KRAUTHAMMER: And I'm hoping that we don't.

(Laughter.)

CHAIRMAN KASS: I was going to say something but I think I'll let it sit. Robby's point is at least taken and for the record it should be noted that all parties to the discussion in the cloning report adverted to, made use of, based arguments on some tacit or explicit views of the status of the embryo.

We had many abortive attempts to discuss that amongst ourselves. It is one of the large themes that is not thematically treated as a separate section of its own in this report. It was one of the things that struck me reading the whole report at the end. You dealt with procreation. We dealt with meaning of healing. You dealt with science in society. But there really wasn't some section with embryology and so on.

Maybe if we had that we might not have been able to finish but it will come back insofar as we take up the question of embryonic stem cell research. Without making any promises, let's at least keep in mind the possibility of doing it better although I think it would also be very nice for the short run to have a little respite.

I'm speaking simply from the chair that we find some topic in which that question doesn't get in the way of our making some progress on the thing that mattered to all of us. Then I think lots of interesting things could happen around the table. Mary Ann, was that a hand?

PROF. GLENDON: Yes.

CHAIRMAN KASS: Please.

PROF. GLENDON: Well some topics since I'm a property teacher property suggests itself because of the topic. Maybe the way to think about the issues that Rebecca and Michael are raising and the patent is about the question why it is that we assume that certain things can be owned. In the history of property law over time, there has been great variation in notions of what is a proper subject of ownership and what is not.

Also by the way I should say there have been great variations in what is the constellation of rights that we call property rights. Property is not a unitary thing. It's a bundle of rights. To have a patent on something is not necessarily to have the whole bundle of rights that one could possibly have. If you have a patent on an organism, it doesn't mean necessarily that you own that organism for all purposes or that you can do as we often say about property anything I want with it. That's not really what property is about in any legal system.

But here's my concrete suggestion. There are more legal systems than not in the world that view the human body as not a subject of property rights and as not in commerce. I would think that if we are going to go forward with this it would be very interesting and helpful for us to have somebody from France or Germany, one of the Romano-Germanic systems somebody who has served on one of their Bio-ethics commissions, come and talk to us about what it means concretely as a practical matter to have a legal system in which that idea of outside of commerce, outside of property is deeply embedded and how they deal with all the problems that modern science poses.

I would say that at the heart of our political philosophy there is a problem. John Locke at the very heart of the chapter that is the heart of his essay on liberty, the chapter on property, says his starting point is that we own our own bodies. He just asserts it. He doesn't have any argument. He just says we own our bodies.

That poses a problem for him and for us immediately because if you own something, can you alienate it? Locke really never solved that problem. He didn't want to say that we can alienate our body but he wasn't able to really put together this idea that you can't really alienate your body with the idea that you own it. But that idea of owning bodies which is unique to the Anglo-Americans really bedeviled our legal system. So I'm suggesting that we take a look at how other legal systems approach this.

CHAIRMAN KASS: Michael?

PROF. SANDEL: I like that idea very much. I think that whether we undertake that or any broader inquiry we should in any case provide Gil with section 271(G) which he can read during or after any of these philosophical discussions. I think the idea of the human body and commerce(?) might be one way of framing this.

It occurred to me thinking about this just as we've been discussing that one reason not to have a quickie narrowly focused study is and I haven't followed in detail or as much as I should the Senate debate and what Senator Brownback's fallback position is but as I understand he has gone for a moratorium and then for some legislation on patenting.

I think there's the risk especially now since the Council has recommended a moratorium and now we're going to do a quickie, small, brief, narrowly-focused thing against patenting. It's really going to look like we're doing what we are committed not to doing, taking our agenda from a certain sector in the Senate and plugging ourselves into that.

I think that's a further reason not to do this but as the report keeps saying time and time again and I kept wondering why I kept reading very small, brief, narrowly-focused and so on. For political reasons I think it would be a bad idea.

I would just add to that the more fundamental reasons which are intellectual ones and ones having to do with the character of the moral inquiry. So I would very strongly urge that we adopt something like Mary Ann's formulation just now, the human body and commerce or ethical questions at the intersection commerce or science or commodification or even as Gil put it the question of the moral implications of being embodied cells and what implications that should have for policy and law in patenting and in buying and selling of organs, bodies, so on rather than the small, brief, narrowly-focused quickie.

CHAIRMAN KASS: Bill Hurlbut.

DR. HURLBUT: I basically want to ask a question of the legal experts here. My understanding of the whole concept of patents is that the right to make some commercial benefit from something. It does not hinge primarily or exclusively on a patent but rather that patents are a way of opening up the process of producing something.

In other words, if I have the history of this right, originally patents were over technique for making a certain kind of leather and the idea was that the technique itself would be made public in order to foster alternatives and deeper uses of this as opposed to keeping it secret. Don't we have in our society a right to not ownership of something but commercialization of something that we just keep secret without having to grant a patent in the first place?

PROF. GLENDON: Yes, as the people who came to our last meeting explained if you want to speak very precisely about what it is that a patent gives you it is the right to exclude others for a certain period of time from the process that you patented. The Supreme Court of the United States has said frequently that the right to exclude is the most important stick in the bundle of rights that composes property rights.

But it's not the only stick. So to have that stick by virtue of a patent doesn't mean again that you can do anything you want with what you have. In other words, there is room for regulation.

DR. HURLBUT: And then the other side of it being that there is a possibility for commercialization and commodification even in the absence of a patent. Is that right?

PROF. GLENDON: Sure. All the patent does is give you the exclusive right to exploit process that you have patented for a period of time. So in a way it's a suspension of free market activity for the sake of another value.

CHAIRMAN KASS: Question. Gil has mentioned for taking case studies and starting small not to do a quickie because he worries about our starting a large stratosphere. Is that the top of the bus or the bottom of the bus? I can't remember. It's the wrong metaphor but never mind.

Are there other areas that strike you as just Michael sent out and gave us a list of things in which the question is property in the body and its parts. Mary Ann refers to other legal systems where that is somehow beyond the understanding of what can be followed. Are there other specific aspects of this that one might cluster together and see if they add up to something? Gil, do you have some thoughts for particulars?

PROF. MEILAENDER: See, I don't know if I'm the person who is persuaded that they cluster so much and that's partly why I suggested starting where I did. We have a session tomorrow where we're going to talk about possible future work for example. I was going to raise that somebody needs to think about organ transplantation industry and the increasing number of arguments being put forward for some kind of commercial payment for organs because actually I think it has been for some time an important issue and if you pay attention you will see that it's really cycling back and there's a lot of attention on it.

Now there's an example of another issue that relates. I'm just not sure that the and I can be persuaded but I have to think about whether the question about whether I ought to be able to arrange to have my organs sold after I've been in a car accident to benefit my heirs who need, Dan, all the benefiting they can get. I'm not sure how that notion of selling organs from someone who's essentially a corpse relates to the question about getting some kind of property right even if it's only some of the sticks in the bundle, Mary Ann, in a human organism.

Maybe it does. I'm certainly open to being persuaded but I just don't off the top of my head see how it does. That's why I would rather take and I don't too much care what issue but if it were the patenting issue I would rather start with that and then see what connections I made.

Even in some of the other things that Michael mentioned in this list like surrogacy for instance, people who disapprove of surrogacy have never been able really to agree on what the reason is. Some people think it's more for one reason. Some people think it's for another. So it's hard to sort out. I guess yes it's interesting. I agree with that. And if you were teaching a class where you had a semester to sort it all through I think that you might proceed in one way. If on the other hand, you were chairing a bioethics council which came together at most once a month for a day and a half to think about something, I believe I would start in a different way. That's all.

CHAIRMAN KASS: Janet.

DR. ROWLEY: I think there is an aspect of this discussion which is probably a practical aspect that should be considered. If you look at what is currently patented not patentable but patented related to humans, their genes and their cell lines. Both of these have utility both scientifically and commercially. They can be replicated so that you can use them, you can give them to somebody else, that other person can use it.

The hypothetical question you were posing about taking an organ and modifying it in some way so that it might be different as you were discussing this I was trying to think well then it's a unique process that you've done unless it was a process that could be widely applicable to all sorts of organs. The heart for example you did something unique to it that made it more useful, made it less subject to rejection for example.

Again coming back to something that I think Mary Ann was saying you can patent the process by which you make that organ more universally acceptable, you aren't actually patenting the heart itself. So I think that we should at least keep some of the perspective in mind as we discuss this issue.

CHAIRMAN KASS: Yes, that's very helpful. Thank you. Mike.

PROF. SANDEL: Here's one possible practical suggestion. We had a session late in our discussion of cloning for biomedical research where we invited people who could tell us about the experience in other countries. As it turns out in most of those other countries they did deal with the broader question of embryo research rather than cloning specifically.

Could we maybe have a session along the lines that Mary Ann suggested where we would have people tell us about how other legal systems and regulatory systems deal with the question of commerce in the human body including patent law but not limited to patent law or other regulatory aspects. Then on the basis of such a session try to figure out whether we had a workable topic or one that we might define.

CHAIRMAN KASS: Comments to that? Whatever we do on this, the purpose of this meeting was not necessarily to lead to the conclusion yes we should or should not do something right away on this but to see whether there is interest here. Even if there was enough interest to say this is important subject but it may not be important enough given the other things that are competing for attention from us and we'll be talking about that tomorrow.

It seems to me fairly clear that if we wanted to pursue this some additional work behind the scenes has to be done by way of inviting in some outside consultants to enlighten us on one or another of the larger aspects of this the way we did get some help on the narrower question of the patenting last night.

It might also would be good and maybe we can work this out by the end of tomorrow if the people on the Council who have a special interest either in the science-commerce end of this or the commerce-body end of this might constitute themselves a small working group.

It's true, Gil, that we come together once a month or six weeks or so for a day and a half. And you've given very generously of your time in the interstices. We can't demand very much more of this body than you are already giving.

On the other hand there is no reason why if there's real interest that that interest occupies three or four people only the staff and the group as a whole thought this was sufficiently worthwhile to allow some of us to explore and bring back to the group we could provide some staff help and support to that. So not everything has to be done always in the plenary the way we've tackled this. So unless there are some more substantive things. Charles?

DR. KRAUTHAMMER: I would just like to make one practical suggestion from what Michael had said.

CHAIRMAN KASS: Please do.

DR. KRAUTHAMMER: I seems to me that the question of patenting the human organism is a subset of commerce of the human body which I think is a very interesting subject. Another subset is the sale of organs which is a very eminent practical and I think pressing issue. So perhaps we could address the larger issue of the commerce and the body by starting with a look at the sale of human organs. Then we can see whether we get a two-fer out of it by having principles or ideas deriving from that subject that would apply to patenting of the human organ.

CHAIRMAN KASS: I'm not sure we can plate this out for the morning but how should I read these looks of silence? Fatigue? Hunger? Are there enough people here who think that there is topic not necessarily to put as a definite topic for us but to keep in mind as we go to work tomorrow and that what we really need to do is some strategic thinking about how it should be framed.

I myself like the possibility of juxtaposing say a concrete matter on the sale of organs and the concrete question of the patenting as two ways and maybe the thing that concerned Paul McHugh in the comments this morning that has concerned Rebecca about the egg donors who are paid for their services but not for their eggs that is to say the way commerce functions in that area as well.

But maybe there are three mini-pieces of something but then it becomes a very large project to be done right. I think some kind of help from how other people think about this legally and ethically would also be useful.

It is with all due respect, Robby, not just the body. Gil in his early paper that he wrote for us when he talked about some of the large themes of bioethics raised up the question of embodiment and the question of the relationship between embodiment and identity. That is one of the relatively neglected topics in the field of bioethics commerce or no commerce and what is moving body parts around.

I don't want to speak for Mike in his absence but I listen to him on some occasions. It sounds as if for him his identity is almost entirely cerebral and the rest is an apparatus that enables it to work. I don't mean to defend this. There's a distinguished pedigree to that idea, very distinguished. Yet here we are with hunger and we're endowed with a respiratory system that is so designed so that one can in fact be the rationale animal and speak with one breath.

DR. FOSTER: Mr. Chairman, I don't want to interrupt you but let me make a couple of suggestions. I'm just going to suggest that we adjourn. I think we're in post traumatic shock from this morning. Secondly I do think there is an important issue for tomorrow about the priorities of things. For example, I believe that the natural movement would be to move from the cloning debate into gene therapy debate and particularly the more dangerous issue in my view that we have to discuss of germ cell therapy. Somatic gene therapy is an entirely different thing.

But my view would be although I'm very intrigued by this and I don't mind moving that into the next place because you could do it that we could decide tomorrow because I do believe that the natural sequence would be into moving into gene therapy. There's where the enhancement and all those things are going to become so much more important. We will hear about more of that this afternoon with support. So my motion for you, Mr. Chairman, is that we now adjourn for lunch.

CHAIRMAN KASS: I will do that only after the two guys who have had their hands up.

DR. FOSTER: I believe that my motion trumps if I want to call for -- No I'm kidding. Go ahead.

CHAIRMAN KASS: We will exhort that the last two commentators take less than a minute or two. Bill and Gil and then we will adjourn.

DR. HURLBUT: Well, it's an odd moment to make a comment after that. I just wanted to point out that what Janet said about process versus product is very important but the strange thing about all this is that now we're moving into the regime where organismal processes in a way are becoming patentable products. That I think we are going to have to confront. This relates to what Robby brought up but it relates more broadly to the issue of commodification of human beings and their embodiment.

We are going to have to confront the question that was a little less complicated in past generations where it was parts apart from wholes. Now we're going to have to confront the question of partial generative potential apart from full organismal generative potential and that makes it somewhat more complicated and brings us close into the question of whether there is something about the human organismal process that is different in quality than the small significance that other organismal processes.

CHAIRMAN KASS: Gil, do you still want to speak?

PROF. MEILAENDER: Yes, although I hate to do it when someone has mentioned lunch. This may simply reflect my own lack of knowledge in a way but I just want to say again or ask again with respect to the patenting issue. I came away from our session last time thinking that at least for people who work on patent law which has a very long developed history in this country it's a realm from which moral considerations are largely excluded.

It is quite technical in certain ways. Therefore it's hard to figure out how to drag into it these larger sorts of questions. That's really been the source of my reluctance of lumping issues here. I just wonder if it's not a sufficiently different issue because of that long technical and somewhat amoral history that makes it to some degree a world unto itself and a little less able to be lumped into some larger circle. That may just be ignorance but I just wanted to make that clear once more.

CHAIRMAN KASS: Thank you very much. I remind Council members that owing to the exigencies of Dr. Wendy Baldwin's schedule we have to start at 1:00 p.m. Please as a courtesy to our guest be back promptly at 1:00 p.m. She will be speaking to us about the NIH implementation of the stem cell policy. The meeting is adjourned.

(Whereupon, at 11:55 a.m., the above-entitled matter recessed to reconvene at 1:05 p.m. the same day.)