Friday, October 18, 2002
Session 7: Regulation 10:
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
Okay. All of that by way of
background. The question is what shall we ..
PARTICIPANT: I like both
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
PROF. SANDEL: In the private
sector less liberal. The private sector here can do anything they want
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
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
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
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
CHAIRMAN KASS: Michael.
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
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
CHAIRMAN KASS: Paul, do you want to
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.
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
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
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
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
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.)