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Friday, September 13, 2002


Session 6: Regulation 7: International Models (Germany)

Professor Spiros Simitis
Chair, German National Ethics Council


CHAIRMAN KASS: Good morning. Welcome once again.

This morning's first session returns to our inquiry into the ways other countries have been looking at the regulation of biotechnology, their principles, their institutions, their practices, and we're extremely fortunate to have Professor Spiros Simitis with us this morning.

Professor Simitis' resume, a very modest version of it, is provided at Tab 15 in the briefing book. He is Professor of Labor and Civil Law, Computer Science and Law at the Goethe University in Frankfurt, and as of last summer, the Chair of the new German National Ethics Council.

We're delighted to have you with us.

Professor Simitis will begin with just some introductory remarks, but this is an opportunity for us to ask lots of hard questions about how these things work and what we might learn that might be relevant to our own situation.

Thank you very much, and welcome.

PROF. SIMITIS: Thank you very much for your invitation. It is a pleasure to be here.

I must say that at first I was slightly puzzled by the combination of the hotel and the room, Monaco and Athens.

(Laughter.)

PROF. SIMITIS: But on second thought, I decided that this was an allusion to our work, a mixture of gambling and critical thought.

(Laughter.)

PROF. SIMITIS: And that increased my pleasure even at being here.

Now, let me start with a few rather general remarks. The first, why I accepted immediately to come is that the German National Ethics Committee is of the firm belief that we deal with problems which at first may look like national problems, but every question we are faced by is only seemingly national.

None of these problems can be limited to a particular country. None of these problems is specific to a particular country.

The answer to that is that if we want to find solutions, we have, of course, to depart from our national structures, our national principles that we have to attempt to find international answers.

The German committee is already doing this. It is closely cooperating with the French National Commission, and we are expecting that by the beginning of next year we will have a first common proposal on one of the main topics we are discussing at the moment.

I will come back to that in a minute, too, because we are in a rather particular situation, the situation being that both Germany and France are members of the European Union, and because they are members of the European Union, they have a particular interest in common solutions on the Union level.

And we are also very well aware of the fact that speaking of international solutions means in the traditional way of thinking international conventions and international conventions may be a solution, but there may be a risk also because of the fact that most of them consist of lots of compromises, and we are in a field where compromises are sometimes very difficult, to put it that way.

Having said this, I want to say a few things about the actual situation in Europe. I will start with some remarks on the National Commissions.

Up to this day, you cannot say that every member of the European Union has a National Commission. On the contrary, we have some states not yet having a National Commission or having a National Commission which has not up to now started working.

We have some states like Great Britain, which has more than one commission, and you find something similar, for instance, in Sweden, too. But if you look at these various commissions and on the condition that you bear in mind that they do have their particularities, there is at first one striking common element.

To understand it, I would ask you to think back at the beginning of the '60s when for the first the problems or the questions of information technology came up. We were in a very similar situation.

We knew at the time that it would be a radical change in our society due to the use of computers. We knew that the computers would transform both the activities of the state and of the private firms, but knew nothing about the real consequences of the use of computers.

At that time, most of people spoke in visions, too. It was the perfect state that we all expected and the perfect rational firm that we also expected.

By now we have replaced the perfect state by the perfect person or the perfect man, and by now we are talking in visions, too, like we did it in the beginning of the '60s.

It took some time, years I would say, until in Europe the various states reacted, and they reacted in a very similar manner by installing not National Commissions, but what we called at the time Data Protection Commissioners.

And exactly as in the case of the Data Protection Commissioners, the states reacted, too, in the case of biotechnology by installing this time Ethics Commissions. Now, these Ethics Commissions, talking mainly of Europe, have two, I would say, or, no, three outstanding characteristics.

First, despite all of the difference, they are supposed to answer questions brought up by governments and parliaments. Just to give you one example so you can understand better what I have in mind, when a little more than a year ago the German National Ethics Commission was installed, in the very same moment, the Chancellor of the German Republic greeted the first members. He assigned them — I'm putting that undiplomatically — a task.

He assigned them a task by saying that we were all aware that we were in the middle of an important discussion, the question whether stem cells could be imported into the Federal Republic or not.

This is a question which at the time played an enormous role because there were first projects for importation of stem cells. All of those projects were projects by university institutes and professors, and the German scientific community was very favorable to the importation of stem cells.

At the same time we had a parliamentary commission dealing with these problems, and the parliamentary commission was at the time already obviously critical, and at the same time, we knew that by the end of the year or the beginning of the year 2002, the parliament would have to decide.

So what we were asked to do is to try and submit an opinion by the end of the year. In order to underscore our independence, we answered by saying we will think about it, but it was absolutely clear that we had no choice in the situation because we did not only have the scientists looking at us very critically. We did not only have the general public looking at us and saying, "At last there's someone who's going to say something." But we had the press and the mass media outside our doors continuously. We were for six months under siege I can only say.

So we concentrated on the importation of stem cells, and we were lucky enough to finish our work by the end of the year, as we had promised.

Why I'm saying this? This is a common characteristic of most of the commissions in Europe. It is a characteristic which has advantages and disadvantages, too. It has the enormous advantage that the commissions are so to say in the middle of the general discourse, and they are seen as an important actor of the general discourse.

It has the disadvantage on the same time that it narrows the march of your own decisions, what kind of questions you can take up and when you are going to discuss them.

So at the same time it was said that we will provide ourselves our own agenda, which we did at the same time, but I'm repeating that this is the expectation in Europe once you do have a committee like ours.

The second common characteristic is that we are not only expected to react to questions put by parliament and government, but to promote at the same time the public discourse. The public discourse in the sense that it is thought that a committee like Ethics Committee is there in order to address the general public, to understand what the questions are that the general public has, to take up those questions, to provide information, and to try to react also to the remarks coming from the general public.

We have very much thought about this point. I'm coming back to the example which is most familiar to me. I'll come to another commission in a moment. It is something very difficult to fulfill because that would mean that the commission would be permanently, so to say, on the road, in order to discuss in all parts of Germany with people who are interested in what the important questions are and what the answers could be.

What we have done, we will start in a month from now with a series of public presentations of subjects we know that they are widely discussed to which the general public is invited, and during which we will try to have a broad discussion, except the fact that members of the commission are by now increasingly going, which I think is very good, into schools and universities to discuss with school children, and with university students, value subjects. They have been been raised by the school children and by the university students.

In that forum, the first subject we're going to deal is a subject very familiar to all of you. It is the question whether a child can be damaged, and that is a torts question which has arisen in Germany after a very recent decision of the German federal court, and we will have the judge discuss the decisions with the general public together with members of the committee.

CHAIRMAN KASS: Excuse me, Professor Simitis. Could I just ask you to repeat the question?

PROF. SIMITIS: The child has the damage, you know, in the cases where a child is born. You know, the American cases, you are very familiar with it.

PROF. GLENDON: Wrongful birth.

PROF. SIMITIS: Yes, wrongful birth, and we use the word in a more crude way. We say not wrongful birth; child is damaged. I admit that this is less nice, but nevertheless it is the core of the problem.

In a second forum we will discuss the problem of patents because there's a very recent decision of the European Patent Officer. We'll come to that, too, back in a second.

And the third common point the commissions have, they are expected not only to answer questions that are put either by the public or by government or by parliament, but to anticipate the development of biotechnology, and by anticipating the development of biotechnology, to raise on time subjects to which parliament should react to, governments should react.

This is the most difficult part of it, but I think it is exactly the same that happened with information technology. This is what the protection commissioners do to a large extent, too, and this is what we expected to do also.

There are many ways of doing that, but we are thought the be the instance which timely could draw the attention to certain developments and ask for reactions by parliament.

And let me sort of say again one information which I find quite interesting. I have brought with me an English translation also of the German act on the importation of stem cells. Now, if you read that act and if you read also the general act on the research on embryos, there is one point I would like to draw your attention to.

These laws not only in Germany, but in all other European countries, too, finish by saying that this decision of parliament is a provisional decision. It has to be rediscussed and they indicate most of the time in a period of two years or three years.

That means that, like in information technology, in the field of biotechnology for the first time explicitly European legislators accept that there is no definitive answer to our problems, and that parliament is under the duty to react again after some time against the most recent developments of biotechnology to rethink and think over whatever has been said before, and to try and adopt other and new solutions wherever necessary.

So we do have a permanent discourse, a permanent public and permanent parliamentary discourse, and our commissions are part of that parliamentary discourse, too.

Now, let me come to the commissions as such. First, I have to deceive [sic] you or to confirm what you have already thought. There is no uniform model in Europe of the commissions.

You can, in fact, distinguish between two models. The first one is the more traditional, and it is by now the minority model, I would say. It is a traditional experts commission. The commissions are small. They have a limited number of members, and the members are, as a rule, scientists.

Now, there are differences there, again. You can see it best in Sweden still to this day, where you have a commission, for instance, consisting only, only of medical experts, biology experts, microbiology experts, experts in the very fields to say of biotechnology.

Experts are now understood even in this model in a different way. You do have philosophers. You do have lawyers, too. But still it is a committee consisting most of the time exclusively of professors and most of the time this is an expert committee in the very traditional sense, to put it like that, working like the similar committees we have had in the past in other fields, too.

Now, the prevalent model now is a different one. The prevalent model is a model which one could call a representative model, a representative model in the sense that you do not only find experts in the narrowest sense of the word, but you do find representatives of the general, so to say, population, too, and let me give you immediately two examples so that it becomes more clear.

The oldest commission, the most venerable, I should say, by now it has been installed about 20 years ago, is the French commission. The French commission has 40 members.

Now, at first, this is rather shocking. I admit it, but the 40 members are members and non-members, to put it like that, in the sense that they are subdivided in two groups, and this is a very interesting phenomenon because this is unique in Europe.

They are all equal — they have all the equal right to be addressed as members of the commission, but out of those 40, only about 20 do really participate in the debates and have the right to express their opinion and to vote when and if it comes to vote.

Why is that so? Let me give you an example, and it becomes, again, more clear. You do find among those 40 members four members who represent different religious communities, a Catholic and a Protestant bishop, a rabbi, and a specialist of the Koran. He's a professor of Islamic religion.

It is thought by the French parliament, will be French government because it's also the commission which is like yours and like ours; it's, again, a president's commission of the French Republic. It is thought that, of course, it is indispensable to have in a discussion like ours, representatives of the main religious communities in a country.

But it is also clear — I'm slightly now exaggerating in order to better illustrate what I mean — that the representatives of the religious communities most of the time have very clear ideas about what technology commissions are talking about, and that therefore, they are there to be consulted. They are there to be heard. They are there to be included in whatever the commission says, but they are not there to co-decide.

This corresponds to the Laicist model of the French Republic, but nevertheless, I think it is very interesting.

So among the 20 other members, you do find representatives of the religious communities. You do find not many, but to a certain extent representatives of handicapped persons. You do find besides the representatives of handicapped persons also representatives of the general political scene in political discussions, so to say, in France of very different organizations, non-government organizations dealing with these problems. Nevertheless that is the model.

The German model is similar to that. We have 24 members, and those members, well, I must say that in the course of its birth, the Commission grew more and more, but that has all the reasons which I can explain to you, but nevertheless, the fact is that we have 24 members, and among those 24 members, for instance, you do have a Nobel Laureate in molecular biology, but you do have also two bishops, a Catholic bishop and a Protestant bishop.

You do have three professors, biologists and well known biologists, but you do also have lawyers. They are apparently always indispensable. And you do have philosophers. You do have political scientists, but also you do have representatives of the trade unions, one representative of the trade unions, and one representative of the employers association.

Now, since I am detailing this, I'm sure that you would be inclined to ask me how does this work. It works, I would say after a year of experience, in a surprising manner. When the commission was first constituted, the media had only one problem: to discuss whether it was not very clear from the beginning how this commission would decide.

Since the members have been appointed by the chancellor and the federal government and as it was presumed at the time, the chancellor and the federal government was rather in favor for biotechnology for blunt economic reasons, the answer to that was that you only have to look at the commission to see what they are going to do.

But it was not so easy for them because they could conclude that they were right by looking, for instance, at some of the scientists, but they had on the other side the bishops who were sure they would not be very much in favor of what the government was expecting to do.

They had in between people like myself, where they were not sure, too, what I was going to do, and I will give you an example in a minute. And they were constantly, while we were working on the importation problems, making calculations, what at the end we would decide and who would vote for what.

My impression was after the first meetings that it is, indeed, true that you do have members with very clear ideas, and it cannot be. There is no alternative to that because a representative commission to a certain extent mirrors the reactions and the feelings in general society.

So you will find partisans of the most different views who at least at the beginning have very clear views. Those may change after some time, but in the beginning you think you know very well what they are going to say.

This is not correct. First, there is the dynamics of the group, because in a group even of 24, you are forced to say exactly what you think. And not only you are forced; you are constantly harassed by the questions of your colleagues, and your colleagues listen very carefully, according also to their own opinions. So at the end, you have a common discourse.

Now, I can give you an example for that. On the side of those who are extremely critical about technology, who in fact are not ready to accept most of things scientists expect to be done, you do have, of course, the two bishops. You do have one of the theology professors. The other one is more skeptical, contrary to what the mass media expected.

And you do have — and this is why I'm saying this, and this is typical for Germany, you do have a former Minister of Justice, a federal Minister of Justice, who was also the Chairman of the Social Democrat Party, the most respected person in the Federal Republic.

Now, he is extremely critical, but he is extremely critical not for the same reasons as the bishops. He is a person of 70. He's at the age of 75 now. Because of his experiences during the Nazi period, because of the constant discussion we have had after the Nazi period, because of the fact that he, as many of us, thinks that these are not unique events, but under certain conditions very similar things can happen again; so he is very critical.

But he is open for other solutions, too. So what I want to say is even if in advance you can speculate, at the end it does not mean you're right.

What was the consequence for our commission? One I did not like and still don't like, and I'm going to tell you that, too. In the case of the importation of stem cells, what we did is we said we will start in fierce discussions to try to distinguish arguments, and we will confront the different arguments because we understand ourselves as a commission that has to provide parliament and government with arguments.

We are not there to substitute their decision. We are not there to take ourselves a decision. But we are there to make the decision more difficult, but more transparent and to be put in a better way.

So after we put the arguments together, which you see how, opinion, we came up with different models, with four different models. The one categorically rejecting the imports; the other one less categorically being in favor of the importation, and two in between.

The one favored by many members of the commission to do something similar to what you have done — that is why we look so instantly at your decision — to ask parliament for a moratorium, and the other one which said yes to the invitation, but under very, very strict conditions, which have been described in detail and for a provisory decision which would have to be rediscussed after a certain period of time.

We, all of us, all of us thought this is the best way of doing things and let the parliament decide. But a few days before we had finished, and everyone was talking about nothing else in the Federal Republic — what are these people doing from the morning to the evening? — what happened is the journalists started again with the speculations, and journalists who do their job very well, start by calling members of the commission who were not used to be called by journalists, and the result of that was that they started asking, "Will you vote?"

And the answer was, no, we will not vote.

But what are you going to do then? Since you don't vote, how does parliament know which is the solution you prefer?

"We don't want the parliament," some of them said, "to know what we prefer. We don't want parliament to think."

So they said, "Now, don't worry about it. You are 24. This means 24 calls, and by tomorrow we know how you will have voted if you vote."

So at the end we voted, and the result of the vote you can find it is for the solution that was the prevailing. You had the two — I don't want to say "extremes" — but the two more radical solutions going more towards the center, to the moratorium, and to the conditioned yes, and the conditioned yes had I would say a majority, a small majority, but nevertheless a majority.

But since then, it is our conviction that we should avoid votes by any means.

The other thing — I uncover for you all our secrets — and the other thing which became manifest during these discussions, too, and that we were successful. Of course there are members that want to submit minority votes, minority — dissenting opinions. Put it like that. That is unavoidable, but we thought that we should do our best to try and write our opinion in a way which would incorporate the arguments and avoid to have so to say a sequence of opinions favorable or disfavorable, and that we were successful, and that is the model we have decided to stick with.

To the extent that this is possible, avoid dissenting opinions, and include the arguments in the general presentation. Whether we will be able to do that I don't know.

We are, for instance, discussing at the moment pre-implantation diagnosis, and it is a very hard discussion, an extremely hard discussion, and I don't know what the result will be at the end.

But in that discussion on the pre-implantation diagnostics, there was one point which became obvious and which I want to mention, too, because I think that that might interest you.

We do get continuously calls by persons directly affected by genetic problems. I myself, for instance, get continuous research calls, and I think, and it is the conviction of the commission, too, that we cannot ignore these calls; that even if we disagree, even if we think that we should say no to certain things, we are under duty to explain, to speak to the people, to have them come if they want to discuss with us and to raise in public their arguments and try to explain them.

Why? Not only because this is part of the respect and they're entitled to as citizens of the country. It is also part of a problem we all have, the problem consisting that if, for instance, there is someone who has a particular case of anemia and that particular case of anemia could, could, could after some time be dealt by unassisted production of another child — we come back to that in a second — if we say no to that therapeutic cloning, as it is also called to a certain extent rightly or wrongly, that same person may cross the frontier and go to Belgium or go to another country or go to Chicago. We know what the prices are. We know what the places are.

And the question is: what does that mean? It does not only mean that the German insurance companies, to give you that example, tell them you have that case of Mediterranean anemia. You could, so to say — your child is going either to die after some time or it is going to be increasingly ill and it will cost us more and more money.

The best thing could be the assisted production. You could do it in another country, but we have to say to you that if you do it, that will reduce, of course, our costs. That will save the save the life maybe, the life of your child, but we're not going to pay for that because that is illegal under German law. So it's up to you to find the money to go abroad and do whatever you think you have to do.

Now, this is no way of discussing these problems, and therefore, we're under the duty to discuss them with the persons concerned for one more reason, and I would pass then to my next point.

The one more reason being is that our whole discussion is under the impression of predictions. No one knows whether they are correct or not. You do have from one day to the next new possibilities announced in the media, that by next year or within the next month I don't know what's going to happen.

We all know that this is not correct. We all know that there may be some chances if science, quote, unquote, progresses in a certain direction, but we don't know when that will be, and we don't know what that will cost from the political and the social societal and the ethical point of view.

So our duty is, and we have done that in our report, to say; be careful. Don't believe. No one knows at the moment. Let us admit that we talk about things we have no idea or we hope. We talk about hopes, but not about reality.

And this we have underscored, and this is something we insist very much upon.

Now, the other point I want to raise in connection with the commissions, there are two different ways of approaching the problems. I will illustrate it by taking the examples of the French and the German commission.

The French commission has a clear case-by-case approach. That means that the French commission as a rule, not always, but as a rule works on the basis of questions of problems that are put to the commission either by the general public or by scientists.

The German commission is the exactly opposite. It works in a more abstract way, looking so to say in an abstract way at the problems and trying to act also in a rather abstract way on the basis of general ethical principles, on the basis of the German constitution, on the basis of other additional arguments.

Now, the French approach has one advantage, and we have seen that very clearly in our discussions with our French colleagues. Their arguments are much more precise, and their arguments are not only much more precise. In fact, most of us do not like them. We do not like them because they confront you with the problems in a very direct and harsh way.

If you have the model of the so to say child with Mediterranean anemia and they have to discuss it, things are very difficult psychologically, too, for the members of the commission. You do not discuss in abstract about therapeutic cloning. You discuss about assisted reproduction, a horrible word, but nevertheless, assisted reproduction in a particular case, and that is very disagreeable I can tell you.

But, on the other hand, the disadvantage of the French approach is that you risk from a certain moment on not to see what the general implications of what you're going to say are. You only look at your case as you find you have found a very solid solution for your particular case. But whether that solid solution is a solid solution truly you can only answer by looking at other cases.

Now, let me give you an example which is the problem we would have or we are dealing, all of us. We will deal with it next year, the so-called therapeutic cloning.

The French commission, in an opinion which has been rendered rather recently — this has not yet been published — has under certain conditions said that that could be done. They had, for instance, one Huntington case, and they had some other cases, too, but their approach is an approach where for the first time at the address of parliament and government it said, "Think about it."

It is not an approach which says, "Strictly no." Why? I don't know how we will decide. That I must say, but there is one thing we know. It is easy and you can do it as a rule in three minutes to stand up and condemn reproductive cloning. You can do that in three minutes. There's no problem.

You can have an international convention of that in ten minutes, I would say. But (a) what exactly is reproductive cloning? (b) What exactly is therapeutic cloning? Are we precise enough? How do we react in those cases? Which are the cases we are talking about? And what do we think that should be done?

So we know that we are nearing now a very decisive point and that, therefore, we are going to have a very hard time. Nevertheless, I think that the mixture of the two, the case-by-case and the more abstract discussion, is the right thing, but I wanted to illustrate that.

Now, let me come say a few words about the general situation in Europe. The first thing you have to have in mind when you speak about Europe is that in Europe we do by now have a series of texts which are for us extremely important and which have to be taken into consideration any time you speak about the problems we, both of our commissions, are interested in.

We do first have one text which is generally unknown outside the European Union, mostly unknown, though not unknown to everyone, but nevertheless unknown to most people. The text, which is the text you have to start by, though lawyers have some second thought, but I'm going to come to that in a second, is the European Union's charter of fundamental rights.

In the European Union's charter of fundamental rights, which has been adopted in 2000 by the chiefs of state and the prime ministers, there is an Article III. The Article III is called right to integrity of the person. The second paragraph of that article reads:

"In the fields of medicine and biology, the following must be respected in particular:

"(a) The free and informed consent of the person concerned, according to the procedures laid down by law;

"(b) The prohibition of eugenic practices, in particular those aiming at the selection of persons;

"(c) The prohibition on making the human body and its parts as such a source of financial gain; and"

Fourth, "the prohibition of the productive cloning of human beings."

There's not an Article II in which the — together with this article, the respect of the genetical constitution of every citizen of the European Union is asked for.

Now, to deal very quickly with the usual remarks of lawyers, the usual remarks of lawyers is, "That sounds very good. What kind of paper is that? Is that binding?"

The correct, formal, formal and correct answer: it is not binding formally. It is not binding because it is thought to be part of also the discussion and of the constitution of Europe, which is discussed also at the moment.

But that answer is only half the answer. It is half the answer because, for instance, the European Community and the European Commission has already clearly stated that no decision of the European Commission will be taken incompatible with the charter.

The court in Luxembourg has already taken up the charter. There are all the many examples that show that this charter in practice is already applied, and that means that you have to revise your own policies and so to say make them compatible with what is said here.

Now, let me give you an example immediately for that. The problem with the European Union, which that is what makes it so difficult for non-so to say Europeans to understand what exactly is going on there, is that the European Union, to put it in a very exaggerated way, has gone the exactly opposite way than the United States.

The United States started as a political union and developed more and more into an economic union. The European Union started as an economic union and develops into a political union.

So we are now in the period where we say, so to say, we are a political union and we have to think and to act as a political union.

Why I'm saying this? Because the European Commission which is, so to say, the incorporation of the economic unit has up to now a very clear policy. the policy is to promote the common market, and to promote the common market in the eyes of the European Union was also to promote those industries that will make Europe more competitive.

And to promote industries which will make Europe more competitive would mean to promote biotechnology, and in this sense they first reacted. There is a European Commission on Ethics, too. I was a member of that commission, too. I left it because I was afraid that I would have conflicts of interest between the two commissions, but that European Commission was not taken seriously up to now because the European Commission had other, so to say, other scopes in mind.

And I will give you one example. We are discussing now to what extent and under what condition the European Union or the European Commission should subsidize research. That means biotechnology, too. The first answer of the commission was, of course, this is an important field. We have to put all of our energy in it.

In the discussions in the council, which consists of the representatives of the governments, four governments, the German government, the Greek government, the French government, and the Italian government, said, "Wait. That is too quick. Have you taken into consideration the ethical implications? Have you taken into consideration the whole discussion we do have?"

And that was a very difficult discussion because you had on the other side the British and the Swedish, the Swedish being enthusiastic since President Bush's famous address, and they offer their cell lines within Europe, and the British having a very, very differentiated opinion on these problems, but they are more favorable for research and more favorable for things we do not yet, so to say, accept in the same way.

What was the result, to cut it short? The result is well known to you. The result was that much to the surprise of the commission and much to the surprise of Britain and Sweden, the majority of the council decided moratorium.

You are not going to say yes, but you are going to say if there is going to be research, then you have to consider the ethical implications. You have to consider the discussions in the European countries, and in each country this discussion has to be promoted so that we can arrive to a common solution.

So you see on the one hand it is obvious we do need common rules. On the other hand it's also obviously that we have divergences. I think that we will reach common rules. It will be difficult. I'll give you again an example. The French have, for instance, in the case of the stem cells, offered or said, "Why should there not be a common stem cell bank for Europe? We are ready to install it."

Now, to install a stem cell bank is one thing. The other thing which is even more important, what for and under what conditions is it going to be used? And this is what we're talking about at the moment.

You do have problems, for instance, with privacy, very important problems concerning that. You do have the problem of genetic tests, and you do have additional problems in the case of the embryos. And you know all of those problems.

Just to sum it up, there is a charter. There is the decision of the council that we should try and have a common approach, but we have not yet reached that point.

There is a second document I have to mention. Let me say, by the way, if this all what I'm saying raises your appetite for more documents and more information, this is why I'm here, and I just want to offer you whatever you want. You send us an E-mail, for instance, for the French opinions, and we will try and procure you the materials. We cannot promise that they will be in English, but what we can promise is that we will send you the materials.

The other document is a part of what is called in Europe euphemistically by the lawyers the family of documents. The family of documents means that we take into consideration documents which are not genuine documents of the European Union, but they are documents of another organization with which the European Union cooperates intensively. That is the Council of Europe.

The Council of Europe has in 1950 adopted a Convention on Human Rights. That convention of 1950 was in 2002 complemented by an additional protocol on human rights and biomedicine concerning transplantation of organs and tissues of human origin.

Now, that convention, that additional protocol has yet not been ratified by five members of the Council of Europe, five members belonging to the European Union, for a different reason. Germany did not ratify it; it did not even sign it because it says it is too lenient.

Belgium said it's not lenient enough. So you have the same problems.

Now, that brings me to the other point you have raised in your letter. There is a chapter in the convention on organ and tissue removal from living persons. The general rule is removal of organs for tissue from a living person may be carried out solely for the therapeutic benefit of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness.

And then it says — and that is a crucial point — organ removal from a living donor may be carried out for the benefit of a recipient with whom the donor has a close personal relationship. That is the German law, too, as defined by law or, in the absence of such relationship, only under conditions defined by law and with the approval of an appropriate independent body.

The second part was considered by Germany to be too lenient. By Belgium it was thought it is not enough.

And there is another article I just wanted to quote because that is in the middle of the controversy. That is Article XIV, protection of persons — I can leave you my copy of the convention here — protection of persons not able to consent to organ or tissue removal.

"No organ," it says at the beginning, "or tissue removal may be carried out on a person who does not have the capacity to consent." Now comes Part 2 of the article. "Exception." I always give an opinion that we should start reading articles and laws from the end and go upwards. That would save enormously time. "Exception: and under the protective conditions prescribed by law, the removal of originality of tissue from a person who does not have the capacity to consent may be authorized providing the following conditions. There is no compatible. The recipient is a brother or sister. The donation has the potential to be life saving for the recipient, and the authorization of his or her representative or personal body provided below has been given specifically and in writing."

Now, this, according to many members, can be interpreted — I don't want to go into the details — in a way which is too lenient in the case of persons not able to consent for themselves and facilities, so to say, the access to the organs.

Nevertheless, this convention is also part of the discussion, but it is a contested convention. I have to say that, and I must again repeat that what ultimately decides are the genuine texts of the commission, and that is the charter. As such that doesn't change anything.

Transplantation is at the moment one of the crucial points. We have not yet raised it in the commission, but the situation in Germany is the following. The German law is clear. I said you can only donate. You cannot commercialize, so to say, the body. And you can only donate under very strict conditions prescribed by the German law.

Now, the ongoing discussion at the moment is should it not be radically changed in order to accept a certain commercialization of the body. Why that? The argument promoted especially by medical professors is that we do not have enough organs, that the donations are scarce, and that we need far more organs, and the fact that we do have, for instance, a European kidney bank or very similar things is not enough.

The professors who argue in favor of these solutions have increasingly happening meetings as the main allies American professors, especially professors of economics, for instance, like Barry Becker, and you know them better than I do.

An I will come to my final point now. That is something that worries us particularly, that in all these fields the discussion is dominated by the Internet, by the Internet, because whatever you need, quote, unquote, you get the offer on the Internet. And the question is: how do you proceed afterwards?

And we have had those cases in Germany. You can literally get everything, the offers, continuously. I don't know if you know them. I don't want to list them here.

But, for instance, we had very recently in Germany one case which made us very much think about what is going on, the import of kidneys from Turkey. That was done in Britain already. That was done in Britain already, but increasingly there was a real, very well organized — we spoke of the kidney mafia — offering the kidneys. And the same applies to African countries.

And that brings me to my last point, which I spoke for. How long? You encouraged me to speak long. So I spoke longer than I thought.

The kidney problem and the similar transplantation problems we have had has induced us — I mean the German Commission now and the French Commission and the European Union — to table a subject which up to now has scarcely been discussed. What exactly the implications of our discussions are with regard to Third World countries? Can we limit ourselves to elaborate principles we agree about, but at the same time tolerate that the industry does exactly the opposite of what we are expecting to be done in a Third World country? In view of the particular social and political problems in this country, can we ignore that?

Now, to be clear, we are not so much arguing for an international convention. It would be good, but it would take very long. We are arguing for rules within the European Union, and we are at the same arguing for broad public discussion to draw the attention in all countries to this particular point because it cannot be that the Third World countries are the field of experimentation for our industries.

It may be very well worth to promote our industries, but not at the cost of the people in these countries. And this exactly the problem we are confronted by at the moment.

And one last word because that was raised in your E-mail, too, and we can talk about that, too: patenting. Now, this is on the agenda for the German Commission.

There is a very recent decision of the European Patent Office. I would have brought it with me, but the reasoning has not yet been published. It is expected for the weeks to come. We will have someone in Berlin to speak with us about it, but as soon as a decision is there, I will mail it to you.

Patenting, well, I will call it human beings, is according to the charter, if you read it correctly, and to the other documents, illegal, inappropriate and illegal.

Now, in the particular case, the European Patent Office — I don't want to go into the details — had granted a patent, and the patent was afterwards revoked in an opposition procedure because the European patent law or the directive for the European Patent Office provides that member countries of the European Union can oppose, but also organizations interested in a particular field.

So Greenpeace and the German government, among others, had opposed that patent. The interesting thing is that good lawyers that they are at the European Patent Office, they said that the patent had been misrepresented by those who had submitted the application, and it was not clear that it includes human beings, too.

The other interesting is that it was a patent application by a Scottish university.

Now, we have a few thousands of applications all over the world which are in this direction. Most of the applications of the European Patent Office come from the United States. The second in the line is Britain and Scotland, in particular. And this is amazing to a certain extent because one could ask, well, we all know about Dolly, but why are they so interested.

Now, in my view, and that's my personal view — I want to just put the problem to you — it has something to do with the situation of the universities. For the Scottish universities and British universities who have been denied subsidies and grants by the state under the Thatcher government and since then, this is an important source of income, but that is an un-American question, and I know it, but it is a very European.

The question is: to what extent if in a field of common interest and of decisive importance for the future of our society the research is commercialized and leads to a monopoly through the patent which instigates the research at the same time, reserves the monopoly, and commercializes its research, to what extent is this state — and this is the question we have put — is the state — but we have not answered it yet. We are going to discuss it — under the obligation to provide funds to university to insure a minimum of common knowledge for researchers all over the European Union, for instance, and not have the universities, so to say, retire into the patent in order to get the defense all the more; that what we expect is a maximum of transparency. We will see it in the stem cell importation, a maximum of transparency because we say that we know that to think that you can prescribe science, what it will do, is an illusion, but what you can expect is transparent research and public discussed research.

And if you have, to put it in an American way, a robust public discussion, then you may prevent certain things like in the case of the European patent law, it was not the European Patent Office. It was the general public that reacted, and then you have to think about other policies.

That was my very last remark. I thank you for your patience, and excuse myself that I was long. That underlines my pleasure.

CHAIRMAN KASS: Thank you very much for a comprehensive, rich, very thoughtful, and stimulating presentation.

I'm sure lots of people would like to get in. Let me just ask for clarification. Now it's simply about the German Ethics Council.

You have simply advisory function; is that correct? You have —

PROF. SIMITIS: Yes.

CHAIRMAN KASS: And the relation to the government that you've chosen so far at least is to lay out the arguments, the issues being complicated; that you want to make sure that the arguments are out there, but to leave the burden of decision to those who are charged with the burden of decision; is that correct?

PROF. SIMITIS: Exactly.

CHAIRMAN KASS: And is there some body, some national body, that has something like the regulatory authority, let us say, of the British Human Fertilization and Embryology Authority?

In other words, if one were looking for places not simply to discuss the ethical issues and lay out the arguments, but actually to govern the practice?

PROF. SIMITIS: The answer is yes to a certain extent. In the German law — I will leave you the English copy here on the importation of stem cells — and in our opinion, we have pleaded for the installment of a body of independent experts with a regulatory function. We think that when you enter very specific problems like the importation, for instance, or there may be other cases, too. We haven't talked about it. Then you may need that.

But we think that so far as we are concerned, we have to give advice, but then it is the responsibility of the government and of the parliament to take decision.

We may disagree with those, and we will say it, but it is not our task to interfere with the regulatory process as such. You may have like the importation. You may have a particular independent body, but not us.

CHAIRMAN KASS: But this recommendation then would be for a regulatory body that would deal on an ad hoc basis with each case that comes along or is there some thought that there might be the need or the Canadians who we had representative from here earlier have designed an institution that would set policy and even have enforcement powers in the whole area of research involving embryology, genetics, reproductive technologies and the like?

Just institutionally speaking, is it too early to think about these things or is it thought to be not a good idea?

PROF. SIMITIS: Remember at the beginning I pointed at the experiences with privacy and information technology.

CHAIRMAN KASS: Right.

PROF. SIMITIS: When we drafted those very first laws, the State of Hessian Germany was the very first state drafting a law, and in that draft, we act exactly like you did now, and we said also in addition to that since we have to admit that we do know a few things, but not enough, we need a body that makes proposals, but that can interfere to a certain extent, and those were the Death Protection Extension. There were registers in Sweden, which were at that time, at that time, introduced and other means.

So my feeling is — but I'm very careful as far as that is concerned — that at a certain point — I don't know when, but at a certain point — when the discussion has become a little more broad and more precise than it is at the moment in Germany where it is a very general discussion, indeed, the moment may have come to have such an institution, but for the moment the only thing we have is in the importation case.

CHAIRMAN KASS: Okay, and if people would indulge me, let me just continue on just a few sort of factual things.

Well, these are sort of related questions. The special interests, the people who have a high stake in this, whether they be the lab technologists or the medical researchers, on the one hand, or the various religious bodies or the Greens, how do they affect the work, let us simply say, of your own council? And to what extent does the assessment of the ethical issues take into account those various kinds of pressures both in terms, for example — you've in a way alluded to this — in terms of the composition of the body? You've apparently seen to it to provide room at the table for people who somehow represent these interests, but —

PROF. SIMITIS: I know this is a very complicated question. My first reaction would say that these possible conflicts of interest should have been considered before putting the commissions together, but that was not the case.

And we were very sensitive to whether scientists, members of the commission do have their own private firms, which is increasingly the case. It was in the case of one member, but that member sold the firm, and not to my surprise, I would say I thought this was a very distinct case.

The big, the renowned enterprise that bought that small firm dissolved the firm within minutes because it thought it would be at the moment competition it would not particularly like to have.

But nevertheless, we are aware of that, and it is thought that especially the Chairman of the Commission has to look thoroughly at the members where such things may happen and react on time if there is a suspicion that the interests may influence the decision.

And up to now I must say we have had no such case, neither in the case of the employers, of the person, former minister who is now, again, a candidate for parliament, nor in the case of the unions, nor in the case of the scientists.

On the contrary, I must say we are aware of that. We look thoroughly at every one of us every time, but I think that personally if you ask me, that's my very personal view. I think that if there is such a collusion possible, collusion, then someone should not be a member or at least it should be very well known in advance what kind of interest he or she possibly represents.

But just to say it again, the more you are inclined to have a representative model, the more you run those risks, and whether there is someone who is absolutely fully under the old conditions independent is something very difficult to say, too, I must say, by experience.

CHAIRMAN KASS: Okay. One last thing. It is commonly said in the debates in this country that the kinds of restrictions that are certainly prominent in Germany with respect to certain embryo research, for example, that this is somehow incompatible with or throttling to a thriving biotechnology. Yet the reports are that Germany at least of the nations of Europe has perhaps the highest rate of growth in biotechnology.

And the question is: to what extent is the scientific community in Germany, not just the industry, but the scientific community, comfortable with the belief that science can proceed notwithstanding the existence of these ethical limitations politically enforced, or is the scientific community quite unhappy with the restrictions and eager to have them lifted? Is there a difference between you and us on this kind of question generically speaking?

PROF. SIMITIS: Well, I must say that I don't know exactly what the position of every one of you is, but what I can say is that there is no such thing as a uniform reaction of the scientific community in Germany.

Let me give you an example. In the case of stem cells, like everywhere, one of the main issues was to what extent can you work with adult stem cells, and by that, so to say, avoid the problem of embryonic stem cells.

In the scientific community in Germany, there are two groups. There's one group clearly saying there can be no fruitful research if you do not do it with embryonic stem cells. There is another group, the smaller group, very prominent scientists in that group, too, saying that you could restrain yourselves to adult stem cells.

And there is a third group, and that is the one that played a role in our discussions, too, saying that you may need research with embryonic stem cells for a certain period of time in order to be able to put the right questions afterwards when you work with adult stem cells. This is the position of the French Commission, too.

So it is certainly true that from the economic point of view there is pressure to advance biotechnology, and this is why we have written into our report that we are not taking economic and similar considerations into account. We refuse to do that. We said that explicitly.

But of course, in a country where there is a high degree of unemployment and where the economy has to be restructured to a certain extent, biotechnology is a particular hope.

And you do have within Europe the constant hint if we do not do it, then the others will do it. But I have learned by now that there's everything that if we do not do it, the others will do. So at a certain point we have to say we're done to it, and we do other things. This is not the only thing we can do.

But nevertheless, there is pressure. But since our opinion, and you can see it in the decision of the parliament, the discussion has quieted. It is not only more reflective, more critical than it was before, but it is not the kind of discussion we had until we published our opinion where everyone was saying it has to be done today. If it's not done today, it will be never done.

CHAIRMAN KASS: Thank you very much.

And thanks to the group.

I have Michael and Mary Ann and Alfonso.

PROF. SANDEL: Well, first of all, thank you very much for a really terrific and masterful presentation. It gave us a full sense of the process and the approach in Germany and in Europe.

And I, if I could, would like to ask you a question about the legal and ethical heart of the question that your council has been confronting on importation of stem cells, and that for you arises as the big question, the big ethical question and of public policy precisely because, as Chairman Kass was saying, you have a more restrictive background law on embryonic stem cell research.

Because the production of embryonic stem cells is prohibited in Germany, the question for you arises: well, can we import them? And so that's what you've been grappling with, and that's what this opinion deals with.

So those pressures are all shifted, and the ethical arguments then are shifted to the question: well, if we can't produce them here, can we import them from somewhere else?

And I'd like to ask you about that and about the opinion and the law if I could. It's not a question that you haven't considered before, I'm sure, and it's about the puzzling feature of the solution legally and ethically.

The legal position, as I understand it, or the legal solution is you can't produce them here even from excess embryos, not in Germany. But under certain special conditions, they can be imported from elsewhere. And in the vote, this complicated vote, but I've gotten used to reading complicated votes over my experience here; as I understand it on the importation question 15 said permit importation; ten said let's have a moratorium, but within those categories, within the ten who wanted a moratorium, there was four who wanted a permanent ban and six who wanted a moratorium, and apparently the four who wanted a permanent ban joined with those who favored a moratorium to produce the ten, which is an ingenious position ?-

PROF. SIMITIS: True.

PROF. SANDEL: — to take.

But then there's a comparable thing on the other side, which is of the 15 who wanted to permit it, nine took the position that ethically it should be permitted to use embryonic stem cells from excess embryos in Germany or abroad. Therefore, of course, we favor importing them, but the nine said we would also favor permitting that here. Whereas six of the 15 didn't say we should permit it here, but they said still we should import them.

Do I have that right?

PROF. SIMITIS: Absolutely. I was one of the six, yes.

PROF. SANDEL: You were one of the six?

PROF. SIMITIS: Yes.

PROF. SANDEL: Oh, then my question is all the more relevant to you.

Now, the six who say we shouldn't permit it here, but we should import them from abroad, now, that's actually the legal position as well. This moral argument corresponds to the actual legal position in Germany.

So here's the question. How ethically speaking is it possible to take the position that it's wrong to do embryonic stem cell research on German embryos, but it's okay to import foreign ones?

PROF. SIMITIS: Thank you for the question, and I will try to explain it.

You could have been more blunt, and you could have said, as many people have said: is that not a hypocritical way of dealing with problems, saying we are not doing anything with our embryos? Let us import foreign embryos and do what we don't want to be done with the embryos in this country.

Now, to understand that, you have follow the tormented path of the minds of lawyers. I fully agree with you, with what you have said. The first question was — I'm trying to reconstruct to explain — is the importation permitted or not.

From what you said, it sounds like one could have said the importation is not. It may be permitted or it is not permitted, and we have to permit it.

Now, what the lawyers in Germany said is this, and I have to say that to explain it. The law you have mentioned, research with embryonic stem cells, they say is a penal law, and it is a penal law that means that it applies only under certain conditions which are described in the law, and it doesn't say anything about import or the importation because it's a penal law.

And because it doesn't say anything about the importation, we have to limit ourselves to the question can they be imported or not.

I fully agree with you and lawyers who have said this is not the way to act. You have to say to start do you agree with research or not, and then you have to proceed.

In order to illustrate this, and what we said, I constantly pointed at the situation in France where research, embryonic research, under certain conditions may take place, but importation is prohibited. This is the opposite, you see.

And the question arose in France: why do they react in that way? And their answer to that is if we agree with research, we have to have research in accordance with our own principles. So don't want stem cells to be imported as long as we don't know how those stem cells were, quote, unquote, produced at all.

So in order to solve our dilemma because we said it is a penal law, and if it is a penal law we can or we have to say something of the importation, but the German law continues to exist, the one you mentioned unless you revise that German law, and because the majority of parliament, the absolute majority of parliament, and the majority in the public discussion was to don't revise yet the law, we said, the six said, "Let us accept the importation for a specific period of time. Use the importation as a means to promote the discussion, too, and then in two years decide whether the German law should be reviewed as such or not."

I'm well aware that this is a complicated decision, but it is due to the fact that the majority of lawyers in Germany said you could import, and they reduced whole questions to the import. They did not want to discuss the other law.

But I think that we probably will do that because we have, like the French who are ready now to admit importation to a certain extent; we do have always the question you cannot ignore where they come from, and you cannot stop asking how did they get those and under what conditions.

And we have written all of that into the law and tried to find a way out of the problem. This is how it came about.

Otherwise let me say our discussion — I know nothing about yours — but our discussion is always a mixture. Our points of reference are, first, constitutional, five points of reference. The German federal constitution which states that you have to respect the dignity of every person, and all these discussions are linked to the dignity principle.

Now, we don't need to argue long about that this is a question of interpretation, too, and that we do understand dignity in very different forms from one decade to the other, but nevertheless, you have this mixture of constitutional law oriented discussion with ethical principles because the ethical principles are used as means of interpretation of the principles of the constitution.

And, therefore, I mentioned the charter before. But, again, I understand very well what you have said, and this was a dilemma we were well aware and we are living with that.

CHAIRMAN KASS: Mary Ann Glendon.

PROF. GLENDON: Well, I, too, want to thank you very much for this presentation, which illuminated so many problems that we've been discussing over the past several months. In fact, I wish that we had had you visit us earlier, and I do ?-

PROF. SIMITIS: You can come and visit us on your terms.

PROF. GLENDON: Well, I also wanted to say that it's so impressive to hear about the degree of collaboration your group has already had with groups in other countries, and I do hope that this, as they say at the end of Casablanca, will be the beginning of a beautiful friendship, that we can continue to exchange experience.

It's just so interesting to hear about the experience, which coincides with ours in many ways, but also it's different. And my question really relates to some of the points of difference, in fact, to one of your points of reference.

I'd very much like to have you say a little bit more about one of the items that is mentioned in the European charter. You mentioned that the parts of the charter that pertain to our issues are not binding in a technical sense, but that they are in another sense.

As I understand it, one of the reasons that some of those principles are already binding is that they weren't something new in the charter. They were aufgehoben as it were, taken up from principles that were already pervasive in most of the civil law systems, but not, interestingly, in the United Kingdom, Scotland, and Sweden.

So you referred to Article III of the charter and the general heading of the integrity of the person. That, of course, is a familiar concept in other human rights documents, and under that heading, the third item you mentioned was that the body, the human body, should not be a source of financial gain.

And that's the point I'd like to hear you say a little bit more about if you could because it's my understanding that this is a fundamental principle in many civil law systems, and it's a somewhat unfamiliar principle at least legally speaking. In the United States, it's unfamiliar to us.

So could you say a little bit about where this idea that the body is outside commerce came from? How pervasive is it? And then why do you see — you mentioned that there's a little bit of questioning of that principle now, encouraged by some American economists who think it's just fine to be buying and selling.

PROF. SIMITIS: Some English speaking German.

PROF. GLENDON: Yes. Thank you.

PROF. SIMITIS: Thank you.

Now, let me explain again the birth of the charter, so to say. The birth of the charter was very much contested. It is the result of the change of the European Union into a political union that was directly addressed in the Amsterdam treaty.

And in order, so to say, to specify what exactly a political union means, the first question which arose was should there not be a constitution of the European Union and we do not have in that constitution also a part on human rights, so to say.

Now, as you quite rightly said, the ones opposed to that were especially the British because the British — and I have to be impartial — the British and the Danish, the British especially because they said, "We do not need such a thing as a constitution," and they said by referring to the fact that Britain had some years ago ratified at last the European convention on human rights, and that had led to spectacular changes in British law because of the decision of the Court of Human Rights in Strasbourg.

So they said, "Once is enough. We don't want so quickly another document which may lead to equal far reaching changes."

And then as a compromise it was said, "Now, let us not speak any more of the constitution. This will have to be done later on, but let us concentrate on the charter," the charter being, so to say, the genuine document concerning human rights for the political union, which later on could, could be integrated into the constitution.

And in order to find a compromise to discuss the charter — it could have been you — as they explained it, they said, "We don't want something absolutely innovative, something which, so to say, starts from the ground, but we wanted to codify our common constitutional traditions."

How do we codify our common constitutional traditions? By taking into account (a) the existing constitutions; (b) the European Convention of Human Rights of 1950; and (c) the decisions of the constitutional courts and the decisions of the court in Luxembourg, the European court.

In discussing now that, the parliament or representatives of the parliament in the convention, those were the most active members, I must say. The representatives of the European parliament in the convention came up — after the statement that everyone has the right to respect what's adopted — came up by pointing up the biotechnology protocol I mentioned before of the Council of Europe.

And they said in a modern charter, we cannot stop at that very abstract statement. We need to do two things. One thing is Article III, and this is partially or literally taken out from the convention, and the other thing, to give you another example is that we have to introduce into the charter the protection of personal data, privacy. And that was Article VIII.

And so you have to read in the case, for instance, of genetic data III and VIII. Both provide, so to say, the protection actually. So it was a mixture of what existed, but with some articles which were not incorporated into the constitution.

So to give you one more example which is not particularly relevant for what we are discussing here, but I always found that an astonishing thing, they could not agree whether or to what extent they should include what we call the social rights, the right to unionize, the right to strike, and so on; could not agree about that and until someone find an ingenious solution, they introduced a new chapter called "Solidarity."

And in that chapter, "Solidarity," you do find the rights of employers to organize. You find the rights of the citizens, but it is now under the head "Solidarity." It sounds very good and gives the impression that this is not by all means the whole thing. It is something — it is the whole thing, in other words.

But this is old and partially new.

CHAIRMAN KASS: I have, let's see, Alfonso, Rebecca and Janet.

DR. GÓMEZ-LOBO:: Unfortunately Michael Sandel stole my question. So I'm going to have to resort to something along those lines but rather different.

The first is a clarification question. Does Article III, Section 4, prohibit every form of cloning? Does it distinguish cloning according to further application, whether for biomedical research or for productive reasons?

That would be my sort of factual question.

My other question is broader, and it's really trying to elicit an opinion from you because from what I've heard today, I'm tempted to think that a German constitution and in general German law by insisting on the dignity of every person I would say surely is reacting to the Holocaust, to the horrors of the Holocaust. It seems to me that putting that in the forefront is very significant.

And then this charter in its Article III again puts in the forefront the right of integrity of the person, and among others, the prohibition of commerce in bodily parts.

Now, from the work of your commission, it seems to me that thinking heads in Europe are sort of deviating from that. Is there an erosion of this firm principle of protection of the person?

And, for instance, I'm thinking if we're talking about importation of stem cells, surely there's going to be payment involved. I mean, no one is going to ship them for free.

And this, of course, ties in with your legitimate concerns about Third World countries. It seems to me that the free market has many virtues, but it also has the vice that if you come in a weakened position to the market, you're bound to sell whatever you had, be it your labor force or be it your organs if you're desperate for money.

So, I mean, I totally agree with you that that should be a very major concern in those countries that have developed biotechnology. What sort of exploitation of Third World — and I think above all about women — could come about precisely because of the needs arising from that.

And of course, the reaction would be to say, well, this leads to the moral imperative to be very, very strict in maintaining the wording, so to speak, of Article III of the charter.

Thank you.

PROF. SIMITIS: Thank you.

Now, the first question is the easier one to answer because the charter says the prohibition of the reproductive cloning, nothing more. We all can start arguing what exactly is that, but nevertheless, this is what it says.

Now, the second question is far more difficult and complicated to answer. Let me first say that, of course, the Holocaust has played a very important role, but especially the six members mentioned before, or the two, especially for the former German Minister, are people who, on the one hand, say we have to support science, but on the other hand say we have to be critical of science, not because so much of of the Nazis and the Holocaust, but we have other examples.

One example I mentioned, for instance during the discussion is a familiar example to many of you because it is an American example, too, is lobotomy. If you take the example of lobotomy, for years, for years European courts and Swedish courts, in particular, pointing at the experience in the United States, said in the case of schizophrenia what's the answer: lobotomy.

What was the result of that? A growing number of cripples, people you destroyed. You destroyed by applying a method which obviously was not respecting the integrity, was not fulfilling why it had to do and had those consequences.

And we had in the case of Sweden where until the '70s merely you had eugenic practices applied. So we said we cannot say we accept whatever science, and we can define science, if you define science other than what the scientists say, but we have to sit down and discuss and have them explain, and we have to think in common about the implications.

In the case now of the importation, the dilemma is obvious. It is the one you mentioned. It's the same dilemma the French had. You can say yes to the importation, but you cannot stop at that yes. You cannot stop at saying, "I am for the importation, but I'm not interested in where do they come from and how have they been, quote, unquote produced."

Therefore, the law says — I will leave you the text here — that a competent agency — that is the one we were talking about — has to satisfy itself (a) — that is already the answer to one of the questions you put me yesterday — the embryonic stem cells were derived before January 1st, 2002.

The reason, that was against the position of most of the scientists. The reason why we said that is we do not want to provoke the impression that they may have been produced for that particular purpose.

In the country of origin — that's complicated, and the importance comes afterwards — in accordance with relevant national legislation — that's not satisfying yet — their end are kept in culture or are subsequently stored using cryopreservation methods of an embryonic stem cell line.

(b) The embryos from which they were derived, the stem cells, have been provided by medically assisted in vitro fertilization in order to induce pregnancy and were definitely no longer used for this purpose.

So whether it is enough or not is another question, but the purpose is obvious. There can be no importation of embryos specifically produced for research purposes, but you have to prove as a professor, for instance, if you want to import at your university to work; you to prove how were they produced, when were they produced; and what were they produced for.

And then the law continues and says, in answer to your question, no compensation or other benefit in money's worth has been granted or promised for the donation of embryos for the purpose of stem cell derivation.

So whether this is enough I don't know, but nevertheless, this shows you what the intention is, and that complies with what the charter says and what the biotechnology convention says.

But I brought the example of transplantation because I don't want to evoke the impression we have solved the problem. We have solved nothing. We have, so to say, said what we want, but we are now confronted — and those are German doctors as we all try to read whatever is published. They know very well what's happening in the United States ?- and they say — I'll give you one more example — "Let us talk about how we can increase the number of transplants. How can we do that?"

In order to do it, we have to induce people. What can we do to induce them? We can pay them, all of the people we can map. We can give them tax advantages.

If you say — so to say, you can deduct a certain amount from your taxes on condition, of course, that you offer a kidney or whatever, I don't want to say anything about that. I'll let you think yourselves, but I can imagine what you're thinking.

But anyhow, they have many other such proposals, but they all say without an economic instigation there will be no increase of organs, and therefore, let us do it.

And you see, the professor who is the champion of these ideas, a very impressive and cleverly arguing person, is at the same time professor in Germany and in Israel, and the imported embryonic cells or the ones that will be imported, they all come from Israel.

CHAIRMAN KASS: We are coming up on the break. Let's ask briefly Rebecca and then Janet for brief questions and then we'll break because I don't want to steal time from the next session.

PROF. DRESSER: Well, you said so many interesting things it's difficult to choose.

I was interested in some more information about your procedures, how you are chosen, not just the public representatives, but everyone. Do you have staggered terms? Is this an ongoing group so that it's in perpetuity or how is that set up?

Another question I had I'm very interested in this public representation issue/problem. Could you comment a little on the participation of the public members, the independence, the ability to deliberate with experts, sort of maybe the education that's needed for people to be effective in that role?

And also, you said you were starting to interact yourselves more as a commission with the public. Have you — if you've done some of that, how has that gone? Do you have some comments on that aspect?

PROF. SIMITIS: Yes, very briefly, first, the commission has been installed by the federal government for eight years, first term, but two terms. We, the members, have been installed as members of the commission for four years.

We were chosen — well, formally we were named by the federal Chancellor. We were chosen by the federal government, a group of ministers directly interested, so to say, in these questions, maybe justice, maybe research, and those were their criteria.

Don't ask me which. I don't know, and I constantly say in public I don't want to know. I don't know it. I look at my colleagues and that's all I can do.

Whether this will go on after the four years I don't know because there was a parliamentary commission. Whether there will be a new parliamentary committee or what is going to happen after the elections I don't know. Until 2004, I'm sure that we are there and you are welcome as many times as you want in Berlin.

Now, the other thing is as far as the public discussion is concerned, I'll give you an example. In October we will have a public discussion on what we and the French call biobanks, which are organs and stem cells, for instance.

By the way, the French, who are always very keen to choose another language said that the word "bank" induces that money plays a role, and then they said it's better to speak of biolibraries.

(Laughter.)

PROF. SIMITIS: Whether you like that better and want to say "bibliotheque," it sounds much better, but nevertheless, this is what they have.

Now, we have a public meeting on biobanks. How is that organized? The way it will go is we have certain topics, genes and so on. These topics will be presented in the morning by experts, external experts. We are listening, too, so to say, because we are in the process of thinking.

We have invited handicapped organizations, for instance, organizations interested in biotechnology like Greenpeace, for instance, and other organizations, and we have invited the general public, and the ideas that the whole day until six o'clock after the presentations, the public will debate with the experts, and we have at the end, at six o'clock in the afternoon, from six to eight, a round table with members of the commission who work on that subject and that particular instant. That's our model.

As to schools and universities, we haven't done enough, but the times it was done, that went very well. There were young children, for instance, and they were extremely interested, and they have very pertinent and I must say I liked those meetings. Some of those were the best meetings I have ever been, and they look at you and they know very well whether you want to use your authority in order to not say anything or whether you are really taking them seriously.

And we have got letters from the schools asking us to come, and I think it's a very good idea, but we haven't yet done it. Importation prevented us from doing it more, but we will do it more and more.

CHAIRMAN KASS: Thank you.

Finally Janet. Thank you.

DR. ROWLEY: I want to make a comment, and then I had several questions, but I'll ask only one. The comment related to the document that you just read again about prohibition of money to donor in terms of the embryos brings up again a favorite issue, I think, of Rebecca's. So the woman and the families get nothing, but the companies can charge $5,000 per cell line, which is, you know, in theory immortal.

So I think that that raises at least for me some serious issues.

The question I want to ask is something that you touched on amongst the topics that the commission is studying and relates to patenting, and you indicated that the European Patent Office had recently issued an opinion that patenting is illegal. And I wondered just what the dimension of that was because there's been, of course, a great deal of patenting of DNA or of parts of genes for various purposes, and I assume that that's not what the patent was covering, or was it?

Because this is an issue that we've also talked on.

PROF. SIMITIS: So let me answer.

DR. ROWLEY: Yes.

PROF. SIMITIS: Let me answer. First, you're right, of course, in what you are saying, that this is an issue one has to think about. The term used for that issue and we use or use half of the terms we use is in English by now; the term we use and you probably also use is benefit sharing.

The idea is that there should be a benefit sharing by those who are in favor that something should be paid for exactly the reasons you mentioned, is that this would be morally speaking and politically speaking and economically speaking a benefit sharing.

This benefit sharing idea has come up in the Iceland Project where the genetic data of the entire population are collected, and the Prime Minister and parliament said that this is the only thing Iceland can offer. It has no coal. It has no steel. It has nothing else, but it has genes, and those genes could be, so to say, an important source for research in the pharmaceutic industry; that the individual person should also be profit.

The offer from all I know was at the time that they were given to Hoffman LaRoche for research purposes; that Hoffman LaRoche would, so to say, give the Icelanders medication, Hoffman LaRoche medication, of course.

Now, whether this is benefit sharing, I don't know.

(Laughter.)

PROF. SIMITIS: I'll leave it to you.

The problem is, indeed, as you know, from the American cases, too, if you go into that direction, then inevitably you commercialize. You may think that it is unjust, but that is the door for commercializing at the same time.

And our idea and parliament's idea was since we have something like three embryos every time in the case of in vitro fertilization, sometimes a little more than three, then in parliament the idea was proposed to adopt the embryos, but that's a very complicated question.

And then the other issue that we discussed was in that case, it may be acceptable if the parents donated for research purposes abroad. Whether we would do that in Germany afterwards, I don't know, but I'm just trying to explain it, why we did that.

Sorry. You had the second question was?

DR. ROWLEY: About the potential patenting in the European Patent Office.

PROF. SIMITIS: I have brought with me, and I will leave it here so I can be very short, the opinion submitted by the European Ethics Council. In that opinion there are materials, too, explaining how the discussion went on in Europe, especially in Europe.

But I have to repeat, the lawyers are careful people, and the lawyers of the European Patent Office never said it cannot be done. They said it was misrepresented, and we never that the intention could have been to use it for human material, to put it like that.

And because it was misrepresented, we revoke it, you see. So they didn't say more than that. That's all, but the argument of the German government and of Greenpeace was because of the biotechnology convention, it is illegal to use material for purposes of research by a private company because you commercialize them at the same time, and then there would be all of the legal and ethical arguments, but I will leave you the French opinion here or the committee's.

CHAIRMAN KASS: Professor Simitis, thank you for an extraordinarily fine morning.

We've run a little over. We started a little late. I don't want to keep Dr. Sweeney waiting, and I don't want people to have to leave. So let's do a ten minute break rather than 15. We'll start at ten minutes of the hour.

(Whereupon, the foregoing matter went off the record at 10:40 a.m. and went back on the record at 10:53 a.m.)




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