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Thursday, June 20, 2002

Welcome and Opening Remarks
CHAIRMAN KASS: I'd like to ask Dean Clancy, the designated federal official, to open the meeting, please.

MR. CLANCY: Thank you, Mr. Chairman. And welcome back to Washington, everybody.

I am happy to confirm that once again, Mr. Chairman, you have obeyed the laws of the republic, and this meeting may go forward.

I say that without any surprise.

CHAIRMAN KASS: Thank you.

And welcome to members of Council and members of the public, to this, the fourth meeting of the President's Council on Bioethics.

At your places you will have some supplements to the briefing book which contain fuller biographical sketches of some of our people and a paper by Professor Arti Rai on the patenting matter, which we'll be taking up tomorrow.

You should find that at your place. If you don't have it, please let us know.

Also, before we get started, I would like to introduce one new member of our staff, Joshua Kleinfeld, who has just joined us. Welcome, Josh.

This first session is our second session on regulation on genetic and reproductive technology, some international models. The purpose of this session is to inform the Council with a view to our possible project on regulation of biotechnologies.

I remind you at the last meeting we had a general discussion of regulation, prompted by Frank Fukuyama's materials, and the idea behind our considering this topic is, first of all, that most of the ethical and social challenges of the future seem to us not to be suitable for legal proscription, but rather for oversight and regulation.

And, second, that the larger challenges and concerns that are of interest to us are not now the proper business of our existing regulatory mechanisms, or at least that's our suspicion. We're going to try to find out in the months ahead by having presentations on IRBs and probably Food and Drug and various other matters.

So we are interested in finding out about how other countries have dealt with the challenge of regulation.

Two or three comments by way of introduction, and then I think we should just proceed. The discussion we're going to have this morning does bear upon our ongoing interest in cloning and in stem cell research, but we are also interested in the broader question of institutional regulation, as such. So I want to make sure that that's kept in mind.

Second, the question of regulation, though it is about science and technology is actually really a matter of governance and politics, and therefore, it's going to be about the relation between government, academic science, industrial science, and general industry.

And the relation amongst these various groups in the United States is perhaps unique and rather different from what we will hear about in other countries. So it's, I think, of special interest to us to see how much of what is available elsewhere might be relevant to us here, why and why not.

In this session, we want to learn as much as we can about how other countries have dealt with the regulatory challenges of biotechnology to find out if we can something about the success or failures of their approaches, to see if we can learn something about how those approaches might reflect the general attitudes about the relation of regulation and government, and how this might be similar or different to the United States.

That's not the task for the presenters, but that's what we are trying to assess, and in the long run to see whether the lessons of these other models might be applicable to the American context both as models to be followed and perhaps as mistakes to be avoided.

We're very fortunate to have with us this morning two people who have worked very hard and long in this field. Lori Knowles, who is the Associate for Law and Bioethics at the Hastings Center; Lori is a lawyer with wide experience in international law. She was a consultant to the NBAC on exactly this topic. She's the Director of the Hastings Center's major project on comparative regulatory practices in reprogenetics, and the report is in its final stages and will be issued soon.

Second we have Dr. Patricia Baird, who's University Distinguished Professor at the University of British Columbia, a pediatrician and medical geneticist. She served as the chair of the Royal Commission on New Reproductive Technologies, which is responsible for the policy recommendations now under consideration for the national government of Canada.

We will proceed, I think, with Lori Knowles going first to give us the general overview of the international scene, and then Dr. Baird will speak about the Canadian experience.

And I think we probably should have both presentations in order, and then discuss them together.

Please.



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