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Friday, October 18, 2002

Session 7: Regulation 10: General Discussion

CHAIRMAN KASS:  All right.  This is the session in which the Council has an opportunity to have a general discussion of where we stand on this topic of regulation.  The topic was put on our agenda, you will recall, at the very first meeting by Frank who indicated it might in fact be the most important contribution that such a body could make above and beyond what it might do on particular issues. We were reminded by one member at that meeting who harbored a grave suspicion of regulation that it very often hit the wrong targets. But we've nevertheless pursued our activity.

We've looked at the activities of several other countries, Canada, Germany and the UK in particular, we've had an overview from Laurie Knowles, we've investigated certain things having to do with the Patent Office and Institutional Review Board overhaul.  Both the majority and the minority in the cloning report touched on the question of regulation and the need at least to open up the discussion of not just cloning but a whole range of related technologies and their uses.  The stem cell monitoring that we are engaged in and the exhortation to this body that it consider the development of guidelines in that area is also another area where the regulatory topic will come up, and we can anticipate that that will be before us.

The staff did prepare a working paper that's in your briefing books.  Let me just turn some pages and without reading it just say that the staff's observation that there seems to be .. that around  the world  there seems to have been recognized the need for some system of regulation in this area, that the most common focus of the debate in regulation has been on the question of assisted reproduction, genetics, and embryo research in particular, that what we see from these various conversations is the different approaches reflect very much the differences in the character and history of each society, a point that came out very clearly in the discussion this morning, that to do this properly, if it should be done at all, will take a great deal of time and effort, and that at least our preliminary review indicates that the existing institutions, at least as now constituted and with the charges they now have, seem not to be set up in a way to handle the kinds of questions, at least some of the kinds of questions that have been raised here by this body.

I would also add an editorial comment that it seems to me the difficulty of proceeding in this area in this country is that there is a kind of polarization in opposition to regulation on the one hand from those who want unfettered inquiry and unfettered commerce and on the other hand from those who want no regulation because the want nothing to go on at all, which is to say the people who believe that all embryo research really should be prohibited.  And that means to move toward regulation, at least to explore this, is to run the risk of antagonizing both parties, both of the most vocal parties to this discussion.

Editorial comment number two, one could argue that this is an area in which the principle that Alfonso is the defender of... might turn out in the end to be the enemy of itself in which the best is the enemy of the good and in which by holding up principle in the area in which we care greatly, with the federal government's involvement, one nevertheless allows the private industry to proceed down paths that no one wants, and therefore Michael Sandel can say, "Look, the British have done it right."  On the other hand, one could say that once the principle has been abandoned it's not clear that there are places along this slope, and I'm not sure, Michael, whether what you've seen in the expansion of the UK's 2001 Act of what this is for is an example of how the slippery slope has been forestalled or how it's greased a little bit easily, because the British have the most regulated system in Europe and they have the most liberal policies in Europe, and that's interesting.

Okay.  All of that by way of background.  The question is what shall we ..

PARTICIPANT:  I like both pieces.

CHAIRMAN KASS:  I'm not surprised.  What shall we do?

PROF. SANDEL:  By the way, much less liberal than we have.

CHAIRMAN KASS:  Not in the private sector.

PROF. SANDEL:  In the private sector less liberal.  The private sector here can do anything they want to.

CHAIRMAN KASS:  Okay.  The question is ..

PROF. SANDEL:  I'm sorry, it may be the most liberal in Europe but it's certainly a lot less liberal than the status quo in the United States.

CHAIRMAN KASS:  I'm sorry, I missed the last.  Yes, great.  The question is what does this Council want to do in this area, and the staff in that paper laid out a series of possible alternatives, procedural alternatives.  I don't think anybody in this room is at the moment prepared to say on the substance where this Council is likely to come out or should come out in terms of recommendations, but it seems to me we've done enough preliminary paperwork that the time has come to make a decision about procedurally how to go forward.

And mindful of the hour and mindful of people's need to leave, rather than dialectically solicit from all of you your various suggestions let me make a proposal and see whether this .. it is one of the proposals that is in the working paper.  That the Council at this point charge the staff, working closely with members of the Council who .. with all members of Council but especially those who because of their interests are willing to take a leading role in working with the staff — to go away and come back to us within six months, which is to say before the April meeting, with a document which could serve as the basis of serious deliberation by this body.

I think it's time to produce paper on this to explore what is going on, what might be going on and offer some recommendations, if possible, as to what should be going on in the area of the regulation, and here I want to define the area, in the area of the uses of those technologies that touch on the beginnings of human life, including things having to do with assisted reproduction, having to do with the use of spare embryos and embryo research, having to do with pre-implantation genetic screening and diagnosis — that thing which was abysmally called "repro-genetics" in one of the drafts of the cloning report as we were working on it.

At least that that's the domain, that we don't define the domain as the embryo and its uses, that we don't define the domain simply as assisted reproduction and its sequelae but we look at the various technologies that touch on the beginnings of human life, that that's the domain and that we try to find out, first of all, as much as we can based upon what we've already done as to what now goes on by way of regulating this activity in this country, to offer a variety of possibilities as to what might go on and to maybe, if possible, offer some suggestions amongst them.

And as I say, that the staff be charged to produce a document working closely with members of the Council.  I could say that at least four members of the Council have already expressed a willingness to work on this.  This goes back to earlier conversations but Frank and Rebecca and Jim Wilson and Paul McHugh have expressed a willingness to work on this topic with members of the staff.  Carter Sneed who has joined the staff is in fact prepared to take the leadership on this project if the Council says, "Go for it."

I could also mention that we've begun to have, we've had at least one preliminary conversation with people in the bio industry, with bio organizations — because their participation in these conversations I think will be crucial — and we've got a lot of work to do in order to bring this about, and we would bring this up at meetings between now and April, as necessary, but that this would give us a target date early enough before our expiration, before November of next year, where we would have time to refine, argue and see what we could do.  Please, Rebecca.                     

PROF. DRESSER:  I wonder if it would be worth a few moments on a basic question, which I think  is brought out by our UK visitors, which is that at least part of the substance came from Parliament, and it seems that if we were to follow that route, and that is the usual route for administrative law and regulation that at least partial guidance is provided by Congress, would you want this draft to talk about substance; that is, these are the substantive principles that we think ought to be adopted or these are possible principles that we would recommend?

CHAIRMAN KASS:  I think if I have the ... the staff's working paper indicated at least the areas that ought to be addressed ...

PROF. DRESSER:  Right, but positions.

CHAIRMAN KASS:  I'm sorry?

PROF. DRESSER:  What about substantive positions?  What should be the considerations that the regulatory body takes into account?  I mean that's a very important component.

CHAIRMAN KASS:  Someone want to just stay on this topic and respond to this?  Alfonso, Michael?

DR. GÓMEZ-LOBO:  It's really not a response but it's closely connected.  I would be happy to contribute to the drafting of the principles of the regulation.  I'm sure I'll be totally incompetent of going to regulations.  Because the question, of course, what are going to be the values that this regulation is going to uphold?  In other words, for me it makes a big difference whether you regulate how embryos are going to be destroyed or whether you regulate that no embryos be destroyed.  It makes a big difference, and that's why I'm interested in the grounding principles of any regulation.

CHAIRMAN KASS:  Well, I have, I guess, sort of two responses, and I'm open to discussion on this.  Frank, you want to respond to this and save me the trouble?  Thank you.

PROF. FUKUYAMA:  I believe that we should not hold up Leon's proposal to have the staff do a working paper until we decide what those regulatory principles are going to be.  Because we will never make any progress if that's the sequence.  For example, I do not think that if you decide that you're going to go down a regulatory path that does not imply, for example, the British position where you are permitting research cloning.  The Canadian system that Patricia Baird described is institutionally almost identical to HFEA but it bans therapeutic cloning.  And so the way I would imagine this is that by April we could have a paper in which you would clear away a lot of the institutional design underbrush and say, you know, this is a strategy.

And, incidentally, on Rebecca's point, it's not as if Parliament acted and then there was this discussion of how to implement.  I mean it came from the Warnock Commission and then it went to Parliament, so I would say we are, in a certain way, in the position of the Warnock Commission but we can substantively come down in a different way.  And then I would think that the staff paper would not commit to one substantive position but would give us some options for how we would .. I mean because any regulatory system is going to have certain common characteristics and we have to get that all sorted out and there has to be a political strategy for implementing and so forth, but then at that point we could then have the substantive debate about what ought to be the outcome.

The other possibility is that the final Council .. since we don't have consensus on those substantive principles, one option for us as a Council is to send to the President simply a regulatory proposal that doesn't decide the substantive issues but simply says, "Look, we need Congress to decide this because ultimately they're the ones that are going to make the decision."


PROF. SANDEL:  Well, I think that Frank's given a sensible approach.  I think that this is a good idea, that we should go ahead and then it will come back here, and then we can decide to what extent there's substance built in or agnostic on the substance once we have a regulatory framework.  Then we can debate that question, discuss it here.  So it's not as if the staff is going to resolve these questions while we're not looking.

DR. GÓMEZ-LOBO:  Well, I wish ourselves well, but I mean how can you regulate unless you decide in what direction you're going to regulate?  I'm sure that there are vast areas where there's going to be common ground.  For instance, this business about the privacy of the genetic information, I tend to think that there can be a lot of agreement there.

PROF. SANDEL:  Well, let's give it a try.  Leon has identified the topics, and I think to have identified the topics is already to go enough in the direction of the substance to enable the staff to formulate a proposal, and then we can take a look at it and raise these questions at that point.  But I would just add that of the options in the staff working paper, A, B, C, this sounds like kind of a blend between A and B, a formal subcommittee being A, B being the staff, and this is sort of a combination of the two.

PROF. MAY:  Where the last sentence of B, in effect, picks up, if you'll notice ..

PROF. SANDEL:  That the staff may be directed by the subcommittee.  Yes.  I think that's a good idea.  I don't think that we .. I think we should .. you mentioned the four, and if there are others who come forward to work with the staff would be good.  I think we should avoid C, farming this out to some other group of experts.

CHAIRMAN KASS:  Absolutely.  And I also think that .. we've talked about this further since the staff working paper was drawn up .. that a formal subcommittee of this body, our body being small and our conversations being intimate, seems not necessary.  This is not as if some subgroup of this is then going to come in to report on things that nobody else has heard of.  It seems to me that we've got an opportunity to exchange things and process, to have updates at the various meetings, but at least the staff should know who is most likely to be both interested, knowledgeable, and willing to spend time on this.  I think that's sort of helpful internally, and it's a way of getting the most out of the members that they're willing to give while placing the responsibility where it's most likely to be actually executed.

Now, I think .. let me speak .. I mean this is a proposal that we have made, and I think I stand behind it.  There is a concern and I think Alfonso is in a way, if I may speak for him, and if I speak wrongly, you'll correct me, that there seems to be a suggestion that once one starts down this road and invests Council time and energy there will be a certain kind of, shall we say, slippery slope to approval of some such proposal when it really ought to be an open question for us, pending the result of this research, whether in fact this is something that this Council wants to recommend.  And it's in that spirit that I mean to do this.

I mean there are people probably sitting out there with pencils and saying, "I'm going to run back to tell the industry, this Council is now ready to put police into IVF clinics, et cetera, et cetera."  There's no substantive presupposition about the outcome of this inquiry, but it seems to me we can't simply hash out our own discussions about this in the absence of some kind of work and some kind of paper, and I think we've reached the point that we either produce that or we give up this topic.  I think that was my sense, Alfonso, that a document could come back here and the majority of the Council might say, "Look, this is a very bad idea."  And I mean that genuinely, that there's no prejudgment, at least on our part, that this is a high-stakes, high-gain, high-loss venture, but it seems to me worth looking into at this stage.


PROF. MEILAENDER:  Just a couple things.  I agree that probably in order usefully to go farther in discussion we do need a focused proposal.  I mean I think just the conversation will go best if that happens.  That said, I wanted to just accentuate the point you just made.  As one who sort of tends at least to hold what Bill May regards as the classically American and incoherent position on regulation, I really .. I have doubts about the degree to which it's possible to separate sort of formal and material considerations in drawing up a scheme.  I have .. I'm happy to wait and see it, so I don't oppose proceeding, but the notion of a regulatory scheme that was a pure blank as far as substantive considerations is concerned strikes me as a puzzling one.  I just think it .. I'd just like to see it.  I'm happy to see it, but I just want to be on record as suggesting that it strikes me as a very hard thing to do, something that is both useful and yet entirely free of any tilt.

CHAIRMAN KASS:  Paul, do you want to respond?

DR. MCHUGH:  Yes.  I just want to say that I agree with what Frank has put forward, and I want to emphasize the small point I was making late this morning, and that is I was extremely disappointed by the scientific community in America that as we brought forth our discussion and our interests and our concerns about these issues, particularly about SCNT, that we had hardly closed the door before 4,000 signatures appeared, not a discussion, not a consideration of what we were concerned about, not an answer really to our questions, but just 4,000, maybe 10,000 signatures.  In the process of writing and putting up the regulations that we have in mind, this will be a good invitation to the scientific community to see what this Council was intended to be, namely a  spur of public discussion and a place to register proposals to answer public concerns.  If we do not go in this direction, if we do not try to build up something of this sort, there will be no forum for us for the future, there will be no forum for the scientific interests to come and speak to us.

CHAIRMAN KASS: I would like to ask, if I might, if I could at least have a comment from everybody if there are reservations or concerns, it would be good to have them.  Bill Hurlbut.

DR. HURLBUT:  What procedure would we use to try to get input from the National Academies of Science on the various professional societies in writing up these regulations?  It seems like the people in the trenches ought to have a lot to say about this.

CHAIRMAN KASS:  This is not a question of writing up the regulations.

DR. HURLBUT:  I understand, but even setting up the structure, the formal structure for it.

DR. MCHUGH:  I think come and talk the way they've been .. I mean they came once.  They can come with something substantive.

CHAIRMAN KASS:  Okay.  It seems to me perfectly possible, and there are no plans on the drawing board far enough to, but just thinking out loud, perfectly reasonably to say we are thinking about the way current institutions .. the lacunae and the way current institutions address the ethical questions of the growing powers over the beginning of human life, reproductive and genetic.  And we would like to have the input of the National Academy of Sciences, of the National Institutes of Health, or the Bio Organization, or the National Right to Life, and have various kinds of people come and make presentations that would be relevant to our thinking about this.  Staff can go and meet independently with people, but there's no reason why we couldn't invite testimony on these matters even before a document is produced but also once that goes forward.

DR. HURLBUT:  I personally would like to have a session or two where there was some background for people like me trained primarily in science to understand how you translate the varied interests of different perspectives in a pluralistic society into laws and regulations.  I feel like I just don't know some basic things about our tradition on that score.  You often hear the comment, "Well, that's your private belief and so be it," but listening these discussions today I was continuously aware that there are certain impositions of general social belief over .. it was interesting, for example, that in England they do not fund, I guess, for the National Health Service, gamete interfallopian transfer, which would represent the interests of a particular concerned minority that's not willing to do in vitro fertilization.  And I was thinking, gee, that's an interesting way of seeing it.  Somehow the majority ruled in that case.

CHAIRMAN KASS:  Question about .. we can ask Frank to provide ..

DR. HURLBUT:  Frank can give us a tutorial.

PROF. FUKUYAMA:  Well, I mean the biggest .. I mean the most respected expert on precisely this topic is a member of our Council, and that's Jim Wilson.

PROF. SANDEL:  Jim.  Jim can give us a tutorial or they can give us a joint tutorial.

CHAIRMAN KASS:  Alfonso, was that a hand?

DR. GÓMEZ-LOBO:  Yes.  I'm sorry to go back to this, but I was thinking how does the staff draft regulation about IVF clinics?  There could be a rule, depending on the goals we set for the staff, that says one and only one embryo may be fertilized and implanted, depending on certain principles, or we can say any number of embryos may be fertilized because the rest of them, even if three, four are implanted, the rest of them are going to be used for research.  So in that set of values or goals ends up with very different regulations.  I'm just puzzled how you do this.

PROF. FUKUYAMA:  Well, if I could just answer.  You know, I guess the way I would conceive of what we're doing is trying to see whether there are models for alternative regulatory systems, the ones we have now that actually do inject some ethical values into the regulatory process.  But, currently, we have this mixture of completely unregulated sectors and heavily regulated sectors.  The heavily regulated sectors can only regulated on the basis of safety and efficacy so that, for example, under the current system there was just a case that was reported in the Wall Street Journal about ten days ago where the FDA intervened to prevent a fertility clinic from mixing the cytoplasm of a third party in addition to the parents of a child and did it on safety grounds.  But other fertility clinics are able to do things that I suspect you would really blanch at right now, because there simply is no statute regulating that.  If you wanted to create a chimeric embryo implanted in a uterus, all sorts of things can go on right now.

So I think that in general I guess this is how political scientists think about this more.  It's more a question of what are alternative institutional models whose specific content can be filled in later?  For example, is the FDA .. the FDA claims authority over certain IVF procedures, but the statutory basis for that is really not clear, so we can ask the question, is the FDA actually a good body to be doing this, can the statute be modified to expand its authority or is it necessary to .. does that have downsides, is it better to do what the British did and create a completely separate institution that would have a different statute that would incorporate other kinds of ethical concerns.  And these are all options, I think, that can be laid out fairly specifically, and you wouldn't have to touch the question of what does this body .. you know, how many embryos and what do you do with them and how many days and that sort of thing.  I think that there are much more generic principles of institutional design that we can very usefully study that you would have to go through first  before you even got to the kinds of questions that you're worried about.

CHAIRMAN KASS:  Dan, do you want to enter?

DR. FOSTER:  No, because I'm going, but I mean I support going ahead with the plan that's here.  What I worry about is just going back to the very start of the Council again to start asking these questions again, and if you're not going to do anything, there's not so much point in having a regulatory body, I wouldn't think.  I mean it's just like the British said, I mean I don't know .. I mean I can understand the principles of an institutional thing, but if there's nothing to regulate, there's no point in the .. you know, if the Council wants to say, "Well, okay, you're going to do one embryo or no embryos and so forth," then it seems sort of irrelevant to discuss the regulation of those things.  But I would like to see like the rest .. I'm open to see what happens.

CHAIRMAN KASS:  Look, I mean it's .. leaving aside regulation, if you simply talk about monitoring and oversight activities, never mind setting down rules, it's astonishing that when in the amidst of all the stem cell debate a year ago no one within an order of magnitude knew how many embryos were frozen in freezers.  One just simply didn't know the facts about this sort of thing.  Whereas the Brits, whether you like what they've got or not, can tell you all kinds of things and they know what's going on, and that can't help but be somewhat helpful to a sensible formulation of policy.  Is there someone who's not spoken on this who wants .. do I have the sense that without prejudging the outcome that this particular plan of developing this project has the support of the members?


CHAIRMAN KASS:  Anybody else besides the four names mentioned who wants to let us know that they'd like to be, I think the term in the office is "taking a leading role" in this, let us know.  But we will call out all of you for help in due course on this and other matters.  Thank you very much for your time. Travel safely. Make your planes.

(Whereupon, at 12:29 p.m., the Council meeting was concluded.)

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