MINUTES Nº1
Meetings of 2nd and 3rd July 1998

Topics:

-Research – Experimentation
-Clinical trials         
-Artificial twinning
-Ethics Committees
-Is there a right to procreation? 
-Patents
-SIBI Journal

Scientific Commitee

Marcelo Palacios (Spain) Chairman
Agni Vlavianos--Arvanitis (Greece) Vice-Chairwoman
Amos Shapira (Israel)
José Egozcue (Spain)
Guido Gerin (Italy)
Juan Ramón Lacadena (Spain)
Rev. Maurice Dooley (Ireland)
Jesús A. Fernández (Spain)
Erwin Deutsch (Germany)
Carlos Romeo Casabona (Spain)
Erwin Bernat (Austria)

Monica Vigil (SIBI Secretary)

Venue: Antiguo Instituto (GIJÓN, Spain)
Day: 2.7.98

MORNING SESSION

MARCELO PALACIOS

      Once more, I want to thank you for your presence. We can start immediately, and I want to ask, as the kind translator suggested, that we speak a bit loud to facilitate her work.

     The Secretary of the Committee hasn´t been able to come because of urgent reasons, and he has given me the Minutes from previous meeting; they are very dense, and I am going to summarize them.

    Minutes Summary"They refer to all that were present, to the place when the first meeting was held, to the timetable and the date of the 11th of last December; the Scientific Committee of the International Society of Bioethics was officially set up and Presidency goes to Marcelo Palacios; the Vicepresidency to Dª Agni Vlavianos-Arvanitis, and the Secretary to D. Luis Martínez. After a short exchange of opinions about the project of the regulations of the Scientific Committee the following changes are unanimosly aproved: in article 6.2, it was agreed to delete a paragraph about the representation of the president; in article nine, it was declared that the Sibi Foundation is responsible for the cost of publication of the journal or the publication of the texts resulting from the activities of the Scientific Committee; in number nine it is added that the Journal will be distributed among the members of the Scientific Committee and its associates or collaborators; the writing is also changed, and it is definetely arranged like this: "The Scientific Committee will be able to organize among its members specific groups about the problems of Bioethics, such as medicine, biology, biodiversity, enviroment, agroalimentation, and others which are considered appropiate. The proposals of those groups will be debated and approved by the whole of the Scientific Committee". The award of the SIBI will be granted on a biennial basis to the person, group or entity that, according to the judgement of the Committee´s members, has brought forward the most relevant contribution to this exciting field, and so it is added to article 18. "The award will be granted during the celebration of the SIBI Conferences and the choice of the awardwinning person, group or entity will be a sole suggestion from the Scientific Committee to the Foundation Board". In short, it is an exclusive competence of this Scientific Committee. The word "chat", which is very colloquial, is changed for "presentation". All these changes were unanimously approved by the Scientific Committee. As regards comparing notes and work proposals, Romeo-Casabona thinks it would be necessary to define the activities and objetives; Bernat thinks that to set a catalogue of topics would mean a great progress to focus on the content of article number 10 in the regulations; Pompidou prefers to state the topics beforehand, too. Palacios presented the topics he had received from Deutsch, and he suggested that the numbers of members in the Scientific Committee should be increased to thirty in the shortest term; Pompidou and Shapira, together with Lacadena, Bernat and Egozcue point out that people with philosophical, etnical and even sociological knowledge should be included in the Committee to balance the presence. (It is stated in the minutes that some speeches are missing, to be precise Gerin´s, Shapira´s and Agni Vlavianos-Arvanitis´s, and therefore they were added to the text). It was unanimously agreed to appoint the Journal´s Editorial Board, which will be in principle formed by Santiago Grisolia, Margarita Salas, Carlos Mª Romero Casabona, Amos Shapira and J. R. Lacadena, and it is stated that the Journal will be published on a biannual basis, provisionally in Spanish and English. Palacios says that considering the pieces of work that are being received by members of the Scientific Committee, some guests or by own initiative, it is possible that in the future the Journal would be published every four months. The matters related to the Conference on Bioethics which will be held in the year 2000 are roughly discussed;  Lacadena takes part so as to be informed about this matter and it is arranged that the next meetings will be held on the 2nd and 3rd of July as well as the 26th and 27th  of  November. There were not any other business  or questions and the meeting is adjourned".

        I welcome professor Lacadena who has just arrived. He will have also lived in the planes the vicissitudes that have made more than one to give up. We have gone over last session´s minutes and any matters can be added (if it is thought advisable). Is there any speech to be added? Otherwise can it be approved? O.K.

         In the agenda planned for today and tomorow there is a wide agenda, which can be attributable to me, since I paid attention to all the proposals I have recieved from the members of the Scientific Committee. If we see that it is too long we could decide to leave any of these topics for the next meeting, or to start dealing topic by topic and those which haven´t been dealt with can be left for the next meeting.

AGNI VLAVIANOS-ARVANITIS: Could you hand out a copy of the agenda in English? If you don´t have it, we may as well follow it in Spanish.

AMOS SHAPIRA: Before we start discussing some of the matters on the agenda, I´d like to repeat, Marcelo, the request which I made to you by fax a month ago, from America, where I was spending my sabbatical, related to our next meeting. I understand that what we try to do today is to specify a few current issues that affect Bioethics, some of the most interesting, complicated or problematic topics for bioethics. But, for future meetings, I would suggest that we decide beforehand about one or two specific problem areas and, from there, we could work in detail in such a way that each meeting would allow us to discuss in depth, the current situation in, and maybe contribute with suggestions that can be published in our journal or can be disseminated in others forums. This is my opinion. I think it would be more effective than covering a lot of general topics in a small amount of time.

AGNI VLAVIANOS-ARVANITIS: I find this idea is extremely useful, since our time is limited, Inside the Committee itself, we have a lot of experience in different areas, so this can be a unique opportunity for the Committee to be enriched with the enormous knowledge of its members to tackle different matters, from the legal to the theological, the medical field, etc, and joining all these aspects when it comes down to analyzing a problem from the point of view of Bioethics, I think we will be able to give that problem a more extended dimension instead of, simply, start talking about the problem from isolated positions.

GUIDO GERIN: I agree that it is better to deal with one or two topics of the agenda, But in Biology advances are very fast, so our Committee must be prepared to give an inmediate answer every time these advances border on the problematic from the  point of view of Bioethics. Everybody agrees with me that nowadays there are ethical problems regarding cloning, there is not a single voice in favor of it and I think that some Ethics Committee should establish the differences between cloning for reproduction and cloning in general. This is a problem to which Bioethics must find an immediate answer. There is another problem: the laws on Bioethics. The European Parliament has reached an intermediate attitude, the Europen Union suggested to patent the genes and this is very dangerous, from my point of view. It is being discussed. I don´t have the definite decision of the Council yet; I hope you can all have access to it and this way we will be able to give an immediate answer.

JUAN RAMON LACADENA: I totally agree with what has been said before about next meetings. The question raised by the Presindent was what we were going to deal with in these two days. Obviously any of these topics could be the object of a Conference which could last several days, and, therefore, either we just talk about them too briefly or we would have to choose some specific topics. I don´t know how the development of this meeting has been planned, if somebody will set out something about each topic and then we discuss it, or how it had been thought that the Committee was going to be developed. When I saw the preview of the program, I volunteered to set out some specific topic, but I do not really know how it is going to developed.

MARCELO PALACIOS: As a last resort the Scientific Committee will work the way we decide. What I have had to do is to prepare a merely approximate program, with the recommendations that the different members of the Committee have done to me; so now we can decide if we do a selection for this meeting and how we will work in the future.  

AGNI VLAVIANOS-ARVANITIS: I was pleased to see that the publication of the Journal has prospered and this provides us with something that can be used as a reference to our way of thinking and seeing things. I think that although it is not possible to publish all the material that we receive, some other source of reference, a Web page or an added Bibliography could be useful to informe or to increase knowledge about the topics which concern us. So, if it would be possible to coordinate these effort in the next two days, we would give other people the chance to take part and to amplify our work. You were saying, Marcelo that the web page had been already negotiated; well, I do not know what other sources could be helpful. It is necessary that we become aware of the fact that our time to discuss the topics as a Committee is limited.

MARCELO PALACIOS: I think that in the next issue of the Journal there should be an editorial page in which we express what must be the future line of work and what the Scientific Committee of the Society aims. Gerin, Deutsch too, Lacadena, Amos have made some suggestions, but it would be convenient to put them into practice, about what we understand the task of this Committee must be, or how it must be interrelated to other matters. I insist, once more, that we are absolutely independent in our work, so this International Society will be what we want it to be, and its voice, through the Journal, Internet, or through the appropriate channels of diffusion, will be as we design it, letting it clear that, obviously, each of us would have our unobjective autonomy to express what we considered. Therefore, what was said by the first speakers could be materialized.

AMOS SHAPIRA: As I said before, I would prefer that in the future we would concentrate more on those ethical aspects that affect our age and that, besides being always ready to react to different issues that demand our position, we start by dealing with medical experimentation (the research on embryos might be included in this framework). Ethics Committees, a subject that appears in the program as part of the agenda for tomorrow, could also be included in this section. And then, as a second major issue, we could tackle the matter of reproduction. I do not know if there is any other topic that could be included in the chapter of reproduction. Do we have on the Agenda the topic of cloning? Yes, I was talking about other matters related to genetics and that have nothing to do with cloning. I think that some aspects of the informed consent subject could be discussed under the first heading (medical experimentation) because they are related to medical practice in general and, of course, to medical experimentation. What I  am trying to say is that we take some aspects of the Agenda and try to group them in a more generalized context. I suppose that in these two days we will be able to cover medical experimentation and topics related to it, and then go into the topic of human reproduction and, up to a certain point, deal with cloning and other matters related to it. And a possible third topic could be: old age and its problems. 

GUIDO GERIN: I agree, but in the future a lot of problems will arise in the framework of the first section you quoted, the limits of medical experimentation; because breakthroughs are happening every day, it is experimented on something every day. So, in my opinion, it is a priority chapter that we have to discuss, it is an important problem already, and what is urgent is that we give an inmediate answer to topics such as research on embryos and artificial reproduction. The other topics are discussed day by day, and the answers and the positions can wait. It does not happen the same with what I have mentioned. Scientific community and public opinion ask us to make clear our position.

MAURICE DOOLEY: I suggest that we do not act as if we were the only ones that work with these topics, because there are many others groups that work about them. I  myself am a member of the Bioethics Committee of the European Council and  I can assure you that we discuss all these topics that we have in today´s Agenda. The European Commission also has groups working in these topics, and so does the UNESCO, and I am sure that many other international organizations do the same. It is clear that to double efforts makes no sense; it makes no sense for people do the same work in different places. Therefore, a coordination between the differents groups that deal with these topics is needed. It also has to be said that there is so much material in  the Biothics field to which a large amount of people has access to and I think that, therefore, the SIBI must concentrate on specific topics and take advantage of the deliberations of others forums to avoid duplicity and unnecessary efforts.

JUAN RAMON LACADENA: I think that if we paid attention to the last speech, in theory we would have nothing to do, because it is obvious that there are other organizations that cover all these topics. But on many ocassions the approach towards the problems or even the conclusions reached can be polarized or influenced by many situations that may be different from the ones that gather us here. What I believe, in accordance with what Doctor Gerin said is that we would have to select topics. He has talked about Biotechnology as a very important topic, and there is not doubt that the transgenesis in plants and animals is there, and that worries society in many aspects, and so does the cloning as regards human reproduction and the manipulation of embryos. But cloning is something which I think we should make statement of, although there really exist other forums where all that has already been discussed, it is and it will be discussed. In the plane here I read a newspaper which informed about a new breakthrough in the cloning techniqe: twelve clonal calves have been obtained. The technique of Dolly the sheep is more and more improved and what many people tried to exclude saying that it was going to be only an anecdote, it is being demostrated that it is something which is there and that it is going to affect a lot the possibility of using the techniqe in reproductive or non-reproductive cloning in human beings, and this would be one of the topics that I would propose to be dealt with by this Committee.

AGNI VLAVIANOS-ARVANITIS: Some questions have been raised which were certainly in everybody´s minds, such as that we should avoid duplicating other efforts and that we should be informed of what is discussed in other forums. But there is something that we must share: the concept of Bioethics. I understand Bioethics from a different angle: as the group of ethical practices necessary for the continuity of life in our planet, so as for me, the medical aspects are only a part of that whole, although up to today it has been the aspect taken most into account: the worry about cloning, euthanasia, organ transplant, etc., have been the main topics in the Bioethics Committees. But, I understand our Committee can open new channels and can establish the global framework of our work about the technological advances and the ethic assessment that is necessary to regulate these advances. This would be the general framework for all disciplines and to launch the new aspects opened by SIBI. The topics related to medicine are extremely important but they must be placed in a different framework: the ethic that allows the maintenance of life, bios, in our planet. I think it is an essential concept for the new millennium.

MARCELO PALACIOS: In my opinion, in this Committee we should place the medical aspects in their exact place; not unmedicalise them but bear in mind that what concerns Bioethics finally comes together with medicine, when there are many other things: we can find biology, pharmacy, the enviroment, etc; therefore, in this sense I think that, we shouldn’t unmedicalise the bioethic speech of the Committee, we should place the medical component in its corresponding place.

ERWIN BERNAT: We all represent countries which belong to the European Council and, as we all know, there are important documents already finished or about to be published and that, in case of being legally binding ratified by the Member - States, they will provide us with the procedural regulations that regulate the articles of the so-called "Bioethics Convention" and its adaptation to the individual laws of each country, at the same time that they will ensure that the International Law or Agreement is observed. Would it not  be, therefore, a first aproach to the cross-disciplinar, multicultural and, let´s hope, productive debate. This way, we would have a preliminary material which we could work with and that would be used by us as a stimulus. We could ask ourselves why we are discussing this amendment, already approved, related to the artificial production of twins. We could also work about the "informed consent", as defined and regulated by these documents. I would say that this would be a good way to initiate the debate.

ERWIN DEUTSCH: I agree with Bernat in that we could make a monitoring of the history of the Bioethics Convention. But it all depends on the topics, as some of them go beyond the sphere of the Convention, for instance, medical reseach. Medical research is done on a worldwide scale and the Declaration of Hensilki cleary regulates and binds in all its articles. It was never ratified by Germany, and  I am pleased about that, the reason does not matter. I only know that there are aspects about which we would have liked the Declaration to have been more flexible, that was our particular point of view. So, up to a point, I agree that there are several questions, among which I would include medical research, where the Bioethics Convention is not applicable. In fact, there is nowadays a sense that the Declaration of Hensilki should be revised. The American Medical Association has prepared a draft which is much more strict than everything established up to today by the European Commission. Therefore, it is necessary to establish clear distinctions.

AMOS SHAPIRA: It is true that we are a multidisciplinary and multicultural group, since we come from different countries and have different occupations. Therefore, I suggest that, in the future, for those topics that we select, one of us will make an introduction on the topic that we are going to deal with. Because, for instance, those of us who are not scientists may have just a vague idea about concepts such as cloning, etc. Sometimes we discuss without knowing exactly what we are talking about. Therefore, I think it would be extremely useful that those of us who are professionally familiar with the topic from their scientific experience, make a general exposition to allow us all to have a basic starting point when it comes to think it and discuss.

JUAN RAMON LACADENA: I totally agree with what Amos Shapira has just said because to make a good ethic we have to start from good scientific data, and it is true that on many occasions we are perhaps using ethic or legal criteria which are not right, because the scientific starting point was not correct enough. In connection with what professor Deutsch has said we should try to keep to or to make the most of, the European document, the Bioethics Convention, in the sense that it tries to see if there are things which could be improved; for instance, as regards cloning the additional Procotol made to that document to condemn cloning is however (...) medicine can sometimes be in non-reproductive cloning, the chance of using cloning techiques to establish the culturing of tissues or maybe organs if medicine does not establish through another research channel culturing from the stemcells, main cells of the differential tissues; I think that although some people in the scientific community defend cloning in its broader aspect, that is to say, to obtain clonal human beings, on the other hand there are other people that only consider the possibility of using cloning techniques to obtain a certain type of tissues or organs. And that is not forbidden neither by UNESCO nor by the Protocol additional to the Bioethics Convention.

GUIDO GERIN: I want to say that we have two international documents: first, the Declaration of Helsinki and second, the Bioethics Convention. It has to be said that the Convention is a treaty that applies to all the member-states. The Declaration of Helsinki only includes directives that the goverments are to follow, which would be our job? It would be useless to discuss the Declaration; to debate the Convention can be useful only if we are given the chance to criticize it. It remains to the opinion of our Scientific Committee. I do not know if the Bioethics Convention is enough or not, but this Scientific Committee can know it, and what I think is that we are not capable of modifyng it, we can only criticize it. Are we legitimated to criticize it? I will set an example; the Convention, published regulations to transplantation of organs, I have the document here. That´s all there is to it. Therefore there is nothing to be done -satisfied or not- nothing can be done to modify it. Maybe something can be done about the Declaration, and I am not talking about the UNESCO´s since it has already been ratified by 186 States, and in any case the declaration can be amended but not as far as conventions are concerned.

MAURICE DOOLEY: I totally agree with professor Gerin about if we are or not qualified for critizing or showing our disagreement with materials and decisions talken in other countries and, I think this leads us directly to something about which Dr. Palacios keeps insisting: our independence. Trough my experience in the European Council, I can say that many representatives find themselves limited by their conviction that they have to defend the point of view of their own countries. They are not independent: they depend on the attitude of the country which they represent and I think, therefore, that this Scientific Committee has a real function, due to its independent condition, that´s why we can come back to the essential principles; we can adopt a philosophical point of view vs a national point of view. This Scientific Committee, while reviewing international documents, can keep its independence and its legal authority to criticize, coming back to the essential principles and explaning the reason why -according to those principles- an article from the Declaration of the UNESCO or from the European Convention is acceptable or not from our specific point of view. I think that is the greatest advantage of this Scientific Committee: its independence from national directives, which come from sources that are not philosophical.

AGNI VLAVIANOS-ARVANITIS: I am satisfied with what has been said about using those important documentary resources, but I think that, apart from that, the role of the countries represented here is to open new channels and those committees have been debating the same topics during the last 25 years, and the SIBI can, as part of its activities,  help to create that new dimension and that new dimension would give a bioethics sense to culture, to technology and to many other areas or topics which haven´t been taken into account by the European Council. So, instead of analyzing what the European Council has stated and evaluated, I think we must open a new section in our Journal, in our debates, about the way in which we make out future. Completely new dimensions that have not been discussed by any other committee. I my opinion, this would be an important contribution in the name of Bioethics.

JUAN RAMON LACADENA: We won´t be able to change what is already written and approved in the European Convention of Bioethics, but I understand that the Convention itself says that its contents will be revised every 5 years and precisely thinking about possible revisions, it would be very useful that we could as an organization offer opinions about its text so that they can later discuss  it and approve it. Therefore, I think we really have something to say.

MARCELO PALACIOS: The good fortune of this Committee is that people that know about many topics in depth are gathered here; besides having the ideas very clear, in the Committee we can act with an independence that I describe as total, according to our own regulations and statutes. We have to take advantage of possibilities to give an answer to specific questions, from the Bioethics Convention or from other topics.

Maurice is right when he says that there are many groups working in bioethics, but this only benefits the work we do here, because not all of those are in the same groups, or everybody from all the different groups are here, or there are always the same agreements in the work of the groups, or the possibilities of action are the same. On the other hand, we know very well -the majority of us- what the groups of the European Council or other institutions, Europeans or not, lack of, but with the advantage of acting with that knowledge and with our independence. Taking up again the Asturias agreement on Bioethics, I think there is something which is closely related to us: we agree that there are many aspects of the Convention that we must "criticize", and I use the word that you have used, because they are reprehensible. As you know I was its speaker and I followed it for ten years; well, this document has been elaborated trying to reach the biggest agreement, and sometimes the forced agreement results in a final product with many weak points. And as the document has them, we should, and I agree with everybody´s thought, criticize it where it is necessary; and we have to do it from the information and from the strict knowledge which this Scientific Committee has. It is said in article 32  that five years later a criticism to the Convention has to be made and then, every time that the ad doc Committee that interprets it think it necessary. We can go ahead this and even go ahead legislative proceedings that can be caused in our countries on basis of the Convention. For instance, as the SIBI Scientific Committee we can present our governments who is to interpret the Convention. It is only an example, and on this matter, I can express a first opinion: I think the SIBI is not in  a position to interpret the Convention, that is to say that not all the members of the SIBI are in a position to do it, because the Convention has a specific legal component, leaving the ethical component apart, which only people who know very well the legal aspects can give a reliable line of argument about their contents or about the presented amendments, so that the decision taken is not the result of a forced consensus. I think that an  "ad hoc" Committee to which each country sends representatives that know the topic in has to be made up; and they will be without doubt ready  to receive the information fron Scientific Committees such as ours about why and how some questions or contents of the Asturias Convention of Bioethics must be understood or changed. I have some more things to say about the convention, but, and as  a starting point, I already distinguish myself: I feel the maximum respect for the CDBI from which I was a member, I think there are very able people working there, but by its own composition and the election of this components I consider they do not fulfill the demanded conditions needed to judge such a significant document or the amendments presented to it. So, following the criteria of a lot of you, I think we can start working and giving ideas thought about during these five years, and to the respective countries. All of them should start receiving a reliable information of what we think. So I sum up two things: first, we must organize a group which gives an answer to current questions; and second, we also must give an answer to the Asturias Convention of Bioethics in which we consider reprehensible and that ought to be changed.

       Amos, as regards you proposal that we exchange our knowledge, I can tell you an experience that I have lived as President of the Study Commission, whose report was used in the Spanish Parliament to draw up laws 35/38 about Assisted Reproduction Techniques, and 42/88 that includes genetic technology; it was exciting, a group of important professors and jurists (you must remember it, Juan Ramón, because you had an active role in that Commission) said: "excuse me, what are you talking about?, what is zygote? or what is gamete fussion?" They didn´t have a clue about it, as I do not have a clue about laws or many other things, and for a day they listened to Lacadena talking about genetic in basic terms and to Pedro Barn about assisted reproduction, about how a gamete comes together with another one, etc. And others of us have been learning things about law language, we have informed ourselves and that makes things easier. Therefore, I think it is a good idea.

JUAN RAMON LACADENA: I would like the proposal for this Committee to be able to educate in bioethics through differents means, which is apart from a mandate of UNESCO, a universal declaration, did not fall in deaf ears.

MARCELO PALACIOS: This is of fundamental importance. I also asked for this as a speaker of bioethics in the document of the Interparliamentary Union, in this meetting of April 1995 in Madrid, and in our own Parliament, as it was approved a motion of mine which dealt with teaching bioethics in schools and universities I think we can do gradually what you say. Yes, it is an essential aspect. Do you think we can deal now with the aspects of research-experimentation in human beings?

ERWIN DEUTSCH: This concern me. I have been working, as a lawyer, in medical experimentation for 25 years. Medical experimentation is very different from therapeutic experimentation; since this was consolidated as such at the beginning of this century, while medical experimentation is much older. Voltaire, a french philosopher, tells us the story of the first vaccine against smallpax, that took place in Turkey, as informed by the British Ambassador, and tried out with condemned people that volunteered to take part in the experiment, and that was the beginning of the vaccination against smallpox. There are documents that contain examples of medical experimentation in other fields, especially in anesthesic field, and then the scandals appeared. One of them happened at the end of last century, and I am not going to go into details. Another big scandal took  place during the World War and a third scandal happened in New Zealand, about ten years ago. In all of them medical experimentation was used in the wrong way.

      On the other hand we have had bad experiences were the topics of the experimentation were hurt, not only in programs of experimental simulation, but also in clinical studies, and this is the most important part for a jurist. Medical experimentation is done on an international scale and therefore there has to be international laws, or at least, a set of binding principles that regulate it. And this is why I am, personally, against the European Convention: because it opens the other (...), with very specific rules and, in the ethics committees (I belong to 2) we have four or five choices: one is the Declaration of Helsinki, the Europan Convention and the national laws of each country. And, besides, we have the international decisions. In what refers to us, it could be rather easy: we take one to deal with a particular problem and it fits or does not fit. We do not feel obliged by specific regulations but, sometimes it is not easy to interpret legislation and then we have to be assisted by international laws. The first set of international laws was approved by the Tribunal of Nuremberg, in 1947, and being a criminal court the charges were very general: crimes against peace, crimes against Humanity. Therefore it was necessary to have rules, and these rules are provided  in the document that we know as the 10 principles of Nuremberg. These ten principles, or rules, show, first of all, the informed consent on the basis of medical acceptability. This is typical of American autonomy. Some of its 10 principles are still aplicable nowadays. There are some basic things which we do not like: there is no distinction between pure scientific experimentation and therapeutic experimentation. The experiments on children and on people with mental illnesses is not allowed probably because in the second sentence it is stated that "the topic of experimentation must be qualified", and if the ten principles of Nuremberg had been applied strictly, Americans would have never been able to carry out the biggest experiment in history: the vaccine against polio. This experiment was carried out on a sample of more of 300 children, and it was a success and therefore, the Americans themselves suggested modifying at least 5 of the 10 principles of Nuremberg (it was done between 1962-64).

       Finally, the great step was to revise the Declaration of Helsinki, adopted in 1975, and which is already a bit obsolete but, at least it is the instrument most used by judges in most of the countries. And it is used because the document was prepared by scientists, because it makes the necessary distinction between medical and therapeutic aspects, it is flexible enough and it introduces two new rules: first, the creation of Ethics Committees, although the concept does not appear in those terms; it says "In every experimetal protocol there will be a supervisor especially nominated and formed by an independent committee which will establish the appropiate considerations, comments or directives". Therefore, it is a consulting Committee. Of course, some national laws have become more strict in some places where experimentation takes place, and they insist on the kindness and the need for Ethics Committees, the same that happens in the two universities in whose respective committees I take part. And it is something almost already universal: every experiment must be submitted to the filtrate done by the Ethics Committees before being put into practice in our clinics.

      The second great step taken, the revision of the Declaration of Helsinki, brought with it the following regulation, and it is that the publication of every medical investigation must not be done if the investigation has not been carried out according to the fundamental ethical principles. You will understand that the editor or director of medical publications can not understand if the material to be published fulfills or not this requirement. That is why, it is a rule that every editor demands the previous ratification, issued by a local Ethics Committee. Sometime, I could talk for hours about this topic, we get "strange" requests and, when we ask the supposed researcher, we find that the investigation, the experiment, has already been carried out and, then , the doors to any publication of the results are automatically closed because the Committee does not approve it or does not give its consent. Sometimes, when the experiment has beneficial results, we proceed to give the consent for its publication and we ratify it because if, it is useful, it is a pity that  it is not published. But, we warn the researcher so that he does not make the same mistake. This change has proved to be very effective: researchers know that they must go to a Ethics Committee and, in general, they do it. Of course, in my country, doctors must go to the Ethics Committee, but this "awareness" was difficult, although I can assure that the 90% of the medical investigation done, counts with the required Ethics Committee. It does not reach the 100% yet, it is still being experimented on the fringes of the regulations, although in some cases they have the subsequent appraval of the Ethics Committee. This is merely anecdotal.

        The Ethics Committee have become, in themselves, an institution and we should ask ourselves -I would really like to know your experiences- if we have become too democratic and too respectful. The restrictions imposed by the Ethic Committees are being citicized by some doctors, simply because they are there, and if we look back we have to say that many of the great achievements in the history of medicine would not have been possible if the Ethic Committees had not existed by then. If I have been well informed, the first kidney transplant would not have got over the control of an Ethics Committees. Many Ethics Committee try to boost research and experimentation to confort many other problems -and I can talk about my own experience, in U.S.A. and in Germany- and they do not put obstacles to experimentation. We, normally, approve 98% of protocols. Some of them require a more exhaustive assessment than others and they have to be revised on a second turn. But the average rate of approval is around 95%-98%. I must say that our Ethics Committee, in University, supervises principally basic research protocols, not pharmaceutical, and that many of the applicants have no idea of how to fill in the forms they have to submit, so they make many mistakes so we have to go through the application again. It is incredible! Sometimes they forget to include important data, such as the informed consent. This explains that on a first turn only 50% of the applications are approved. The big problem that we have now is that laws have become aware of the existence of the Ethics Committees, and national laws cover their activities now. If we take a look at French legislation, the Ethics Committees are strictly regulated by the statutory regime. And so were in Germany, but that statute has been modified last week and now it provides pharmaceutical experimentation, the other aspects have been excluded.

AGNI VLAVIANOS-ARVANITIS: Do you think pharmaceutical companies will go to countries with no restrictions to the experimentation with new medicine? 

ERWIN DEUTSCH: That is another worrying problem. In a German company a professor was taken on to lead an investigation about a new dru against hypertension. The professor of Bonn´s University did not go to the Ethics Committee of that University because he probably knew that he was not going to be accepted. So he went to the Medical Association´s Ethics Committee in Düsseldorf -he is himself a member of that Association- and he was able to make the protocol accepted. The real problem was that in the text of the experimental protocol appeared an "elimination period" and that the chronic hypertense patients that took place in the experiment, did it from their homes, without being hospitalized, allthought they had to phone everyday to inform about their progress and about the level of their blood pressure. Why? Because the experiment was carried out by Polish and Czech doctors with patients that crossed the German frontier from Poland and Turkey. But there was a patient who did not phone to inform about his progress and he died two days after the two weeks period for the elimination of the drug. Our Committee did not want to take risks since we had been working with pharmacological protocols for a very short time and we did not like the fact of having to work with clinical studies with placebo-control in chronic patients. It is something very dangerous, but probably we would not have allowed it. Most probably we would have insisted on the hospitalization of  patients during the time the study lasted, because the elimination period seemed to presuppose some risks.

ERWIN BERNAT: That means that patients were without medication for 14 days.

ERWIN DEUTSCH: Yes, and this patient died of a heart attack due to his high hypertension. And he was not given medication for two weeks? The real problem is that doctors and patients crossed the frontier only for economical reasons.

AMOS SHAPIRA: That is a good example of the problem concerning to which laws should be applied.

ERWIN DEUTSCH: Yes. But we normally apply the German law, that is much more strict, anyway.

ERWIN BERNAT: Those foreingners, did they have a cover? 

ERWIN DEUTSCH: On the other hand, the insurance company refuses to pay because, they tell us, it is not proved that the death was connected directly with the medical experimentation; it could have been due to natural courses.

ERWIN BERNAT: No judicial criteria was established (...).

ERWIN DEUTSCH: The problem was the lack of evidence (...).

But there is a problem that we should discuss in  some occasion, and it is the question relating to jurisdiction of Ethics Committees. What I wanted to tell you is that the American Medical Association has put forward the total revision of the Revised Declaration of Helsinki (1975). Everybody thinks it should be done. I have had the chance to read the A.M.A´s proposal and I have to say there are undeniable things; first of all, Americans do not want to do a new Declaration of Helsinki, they do not want to establish the distinction between medical and pharmaceutical experimentation. They are vague on this matter and they defend themselves saying that, sometimes, it is difficult to separate medical aspects from therapeutical aspects. Look, this was the main aim and they destroyed it. For instance, British and German wanted more time to study the draft but the British came out saying: "our Ethics Committees have been trained to distinguish medical from therapeutical", and we lost the opportunity. The second item that the Americans proposed was to widen the limits in the experimentation with placebos. The experiments with placebo are very controversial - some of them-, but the Americans wanted to guarantee themselves a bigger number of experiments with placebos. Another proposal was to give the Ethical Committees more power to give informed consents when the consent cannot be given by the topic of the experiment.

AMOS SHAPIRA: Like when somebody is having a heart attack. 

ERWIN DEUTSCH: That is right.

AMOS SHAPIRA: I want to say that what Prof. Deutsch has told us has been very educational for me and, I think, also for the rest of us. I have been involved in reviewing protocols for medical experimentation for many years, as a member of the Israeli National Review Board. In fact, I started the first institutional ethics committee at Tel Aviv University. We still have some mechanism -not very effective, I am afraid- for ethical review of research projects connected with the University, even where its physical location is outside the campus itself, in a hospital, for example.

      I would like to limit my remarks to something more practical, on the basis of my experience for many years in my own country. It seems to me now, when I examine what our Ethics Committees have been doing in the last years, that we have been overly permissive. I think that one of the reasons for that is the fact that these Committees are dominated -not only numerically but also in active participation, intensity and interest- by the scientific sector, the Ministry of Health and related authorities, physicians and scientists. Others, e.g. philosophers, lawyers and theologians play a less dominant role. The problem does not lie only in the fact of non insistence on the informed consent requirement. I think this requirement has been absorbed and internalised by scientists. Nevertheless, their idea of informed consent is very formalistic. So many of them think that as long as they get a signature on a consent form it is enough to proceed.

    I would say that there is a certain over-enthusiasm by scientists and that can be triggered by different reasons, positive reasons, such as scientific curiosity, personal ambition, academic enthusiasm and economic interests. There is a certain tendency to over-enthusiasm, to run, to hurry up, even at the risk of compromising a major ethical principle that should guide the process of experiments on human beings, namely the scientific validity of the research proposal. We, the non-scientists, establish our risk-benefit calculus on the basis of the reliability of the scientific proposal considered by the scientists. And,  I think that that over-enthusiasm, that eager running, that drive to arrive first, weaken our trust in the scientists’ asserted goal of beneficence to the community of patients in the field of their research.

I, personally, feel frustrated because of this. I have found myself voting more than once in favour of proposals that were not convincing at all. For instance, in the matter of lung transplant, when the doctors proposed an idea that was not ripe and they got their way. I asked them for their opinion about obtaining informed concert and they said "there is no need to worry about that, these are very ill people, sometimes parents of seriously ill children, who need a transplant and would sign any thing".

ERWIN BERNAT: To continue, I want to ask a question to ethical-legal aspects that the Ethic Committees, as consultant organs, have to obey: one, the (...), and the second, how the informed consent is obtained. The first aspect is related to practice, and the second with avoiding the violation of the patient´s autonomy. The first aspect is fairly easy to evaluate, the second is more difficult because, mainly, there must be certain risks attached to every experimentation; but the Ethics Committees know that, despite knowing the risks and despite their competence, they do not have the ability to give the consent.

A small case I had in my office: the scientific curiosity was the key world, Amos refered to it. In Austria we have 2-3 Gynecological Departments that are specialized in in vitro reproduction techniques and that apply it now in  cases of tube incontinence, a purely masculine condition. They administer the ICSI (intracytoplasmatic injection of sperm the place the spermatozoon in a canula and they inject it directly into the oocyte). As regards the parents - to - be, there are cases where he is seropositive and they want to have a child, and they use a condom in their sexual intercourses. The Nature magazine has published an article in which an Italian group states that the sperm can be previously washed to decontaminate it of the H.I.V., but nobody knows if this assertion is valid, or whether the technique is reliable. Doctors, gynecologists like the idea and they ask me if they can rely on this article and if they can hand out photocopies of it to the mother and the father - to - be and tell them: "This publication states that from the 80 couples taking part no member was infected by the H.I.V."

AMOS SHAPIRA: Was any baby born using that technique?

ERWIN BERNAT: One that was born was infected by the process itself. Will they be able to give their consent to make up for their inability to have children? That is the question and I have no doubt I can face the answer without risks because I do not believe it to be a therapy in itself; I would say this is about making a baby. What would you say? Are there risks? How to act from the ethics point of view?, that is to say, would the Ethics Committee be able to consent this or should we say, in conection with the aim -only to have a baby-  that it is a risk? What would you say when faced with a similar case  to a Ethics Committee from which you were a member?

ERWIN DEUTSCH: In fact, that over-enthusiasm exists on the part of scientists, but sometimes we encourage it, and here comes the idea of differentiation. We have to distinguish between procedures that allow to save a human life and, around this, the experimentation sometimes coincide. Experimentation is done to cure some serious diseases, not to save human lives. In these fields I would oppose two ideas: I think that the maxim we have inheritated from the old law (...) it is not applicable because, regrettably medical experimentation......

AGNI VLAVIANOS-ARVANITIS: The maxim to which you referred in German is (....latin), and you say it is not applicable. Applicable to what?.

 ERWING DEUTSCH: To medical experimentation in seriously ill, terminally ill patients, because these people are dying of natural causes and we have to do as much as we can to help them. If we do nothing, we do not do wrong to anybody; in a hospital, if we do nothing, if we let the people die of natural causes, their situation is not remedied. With medical experimentation things change. In the University of Hannover we have an Oncology Department directed at research and, every year, we ask them if any of the 22 protocols for research that have been approved are still valid, because many patients have died since then and that is why in the end I always ask myself the same question: if nothing is done, nobody can be blamed, these people are already dying.

ERWIN BERNAT: Yes, I understand you. These people are not taking any extra risks because of experimentation, because they are going to die anyway. Then, according to that theory, the more dying the patient is, the less applicability of the principle you were talking about? 

ERWIN DEUTSCH: No. Not because they are going to die. I am personally against experimentation in terminally ill patients. There was a Conference in Israel about this, do you remember it? No, no. Sometimes I am afraid of treating the usual common illness. We have to take risks, of course, and the maxim to which I referred is against taking on any kind of risks and, therefore, I think that the principle is not always applicable. And there is something else that I would like to say and it is that, generally, in the Ethics Committee, we examine in detail each protocol for research; if it is about a high-level research, generally much more linear, more permissive, but if it is about a basic research then we go into the detailed analysis of each problem in more depth, at least in my experience. I do not know if this is right or not, but the Ethics Committee do it. I have realized that scientists are much more strict among themselves than the majority, let´s say, the rest of the people that make up these Committees.

    There are today some Ethics Committees, in New Zealand, for instance, in the German city of Hamburg, in which 50% of their components belong to sectors different to the scientific one and I do not know whether this is convenient because, you all know, it is always necessary to turn to experts inside the Committee itself. And generally, people that come from the medical field do not let themselves be tempted. In the case of New Zealand´s Ethics Committees, it is surprising to see that there is only one doctor really involved and, sometimes, he speaks to the rest of the members about things which are confidential for him, and other times he simply says: "I cannot answer that question".  

     The funny thing about this is that all the requests of validation for protocols of experimentation were accepted as right. And for me, personally, this is a worrying fact. Especially those that concern research about HIV and in which the scientific themselves are tremendously strict with their developments (...)

MAURICE DOOLEY: My remark, that can give rise to a debate in itself, is that we can mix up two different principles, one the "primun nun nacere", that goes back to the Hippocratic oath, prior to Roman law and the other, the one that derives exactly from the Roman law, that means "the right of the person must not be violated in the exercise of our own rights". And in this two different rights come into conflict. If we concentrate on medical obligation, binding to Hippocratic oath, of not causing any harm to his patient that, by the way, is th fundamental principle associated to medical experimentation, I think that then it should be made explicit that in certain circumstances, certain types of medical experimentation should be forbidden, because of the added damage that means for the patient and, in that context, when it is about terminally ill patients those damages can be very difficult of being evaluated or interpreted. Are we going to accelerate the exitus of the patient? That is the question. So, if a person is dying from a cancer and we want to use him as a topic of an oncological research that can provoke that anticipation of the exitus, we must bear in mind those ethical principles we are talking about: are we causing him added damages with the medical experimentation?  In my opinion, I think the answer to this question is YES.

      But there are many cases in which the cost/benefit equation becomes the key question, that the danger (reasonable) of killing the patient -although it exists some hopes of curing him- is not taken into account. It is not even taken into account that the experiment can cause him some kind of damage. And in that case, I would agree with what Deutsch has said about the fact that sometimes protocols for researches of "high standing" are validated, basing it on the concept of "scientific curiosity". But, in general, I suppose that a Ethics Committee that has to judge a protocol has to deal with an arduous task and, sometimes, the solution cannot be cleary glimpsed. And, in ocasions, we have to accept the difference of opinions and accept the fact that the Ethics Committee has resolved in the best possible way, even when on an individual level one could be against the agreement globally adopted.

GUIDO GERIN: Perhaps I can contribute some new additional ideas. I was appointed Hospital Commisioner for a period of 3 years by the Italian Government. It was a pediatric hospital, a public hospital and at the same time a research center, because it depends on the Faculty of Medicine. In Italy we do not have laws. The Bioethics Convention has not been ratified and, therefore, the researchers have to submit the protocols to the criteria of the Ethics Committee. But all these ask for are two signatures: the one from the chief researcher and the informed consent of topic/s. But nobody knows who signs in the first place. In the case I put forward, the potential topics were children, minors, so they were demanded the signature of their legal representative, and in Italy we do not even have a specific legislation about "legal representation", there is only a vague general framework. What happens if the topic does not have a family? I do not want to go into great detail about this specific case, but I think it is necessary that we intervene in this matter, because if in a country there are no specific laws they will have to turn to the convention, but, as it happens in Italy, what happens when the country has not ratified it?

        The other topic I wanted to point out is that if a person has the right to go to court, and not only for criminal reasons but also for the questions we are dealing with here, are we ready in Strasbourg to judge these cases? There is no experience in these topics. I think, and I raised it before, that we could from the Scientific Committee contribute and independent dimension that throws some light over these gaps of the Bioethics Convention. Because, I suppose that the decisions that a judge not involved with the topics that worry us can take, can be difficult to be established. We spoke about cloning before and I suppose the only notion the judges have about this topic is what the dictionary suggest. But, and I would not like to insist more on the problems that we have with the informed consent, I have to say that the only legal instrument which we can count on in relation with the informed consent, is the one included in the Protocol for Human Reproduction, but, what does it mean for daily practise? I spoke about this before the UNESCO, while we were working in the Declaration about the Human Genome. This Declaration forbids things related to human reproduction. I consulted myself with an expert in genetics and he told me that the biodiversity is a fundamental fact for the future of humanity. So, if the cloning for reproduction is already there, the biodiversity is in danger, not, inmediate, but in a period, I do not know, of 100-200-300 years.

These are problems that affect us all and people ask themselves, which is going to be the future of Humanity? That is why I asked our President, not that we go deeply into the topic, but that we open a discussion about it in the present meeting and this way start contributing public opinion with some ideas, some directives, not definite conclusions.

MARCELO PALACIOS: Don´t you think Guido, that it would be interesting to go in the first place to the definition of the concept, that is to say, what do we understand by clinical trial? That is important, in some regulations it is included and not always is totally homogeneous. Then, it seems to me that -in a total agreement with you- those criteria of authorization of the protocol we had to present them in a clear way, and in this sense I think we can be of a great orientation and help.

       On the other side, it is true that the Convention marked a reality, but we do not need to wait five years to add our criteria, because the protocols that develop it are up and running and we can influence them: the experimentation-research protocol of the Council of Europe is advanced; then the  protocol of the rights of the person will come, the statute of embryo protocol, ...etc. We can express our opinion about many questions, because the protocols are even more defining than the articles of the Convention themselves, that they develop. I am sure that we are going to make the most of our possibilities and to suggest the Council of Europe or the CDBI that for any of the protocols they take into consideration some criteria that we have matured and that can be useful.

      There is a protocol about Human Genome from two perspectives: in what concerns the privacy of the people and in what concerns the techniques themselves. Well, the articles (eleven to fourteen) of the Bioethics Convention refer to that specifically. Possibly we do not agree with article number twelve of the Convention in all its terms, or at least there would be clarifications about predictive tests and about article number fourteen, it is right to carry out the selection of sex to treat illnesses connected to sex? In Spain we have had difficulties in the preparation of our law about assisted reproduction techniques, and Deutsch will confirm that in Germany, the Council of State opposed even the selection of sex with the purposes I pointed out before; and however the Bundestag did not hear the opinion of the Council of State and authorized the selection of the sex in cases of illnesses conected to sex. Anyway, I only wanted to point out these things.

AGNI VLAVIANOS-ARVANITIS: I am going to set the topic in another perspective. I think we all remember the things that have been said here and I think, therefore, that there is no need to revise the topics again to compile what has been important and innovating as a result of the debate. But some new and useful dimensions that can lead us to the preparation of some useful suggestions have been given and I think that the time we have left can be used to list those suggestions of a practical nature, since we only have ten minutes more or less to bring the session to end. Personally, I would like to start with some suggestions -that I do not know if the rest will consider valid- and that we all have, let´s say, a minute to sum up one or two matters that we believe essential.

         To start with, I would like to suggest that, before we leave, we could pass around a sheet of paper on which everyone writes the topic(s) or ideas. For instance, during the morning session, the topic of education in Bioethics aspects came out and I think that the SIBI can play a very important role in the development of this aspect. Now that we have the support of the Journal and of the web page, perhaps we may ask each of the members of the Scientific Committee, that they prepare, on the basis of those topics that we would be listing here, a presentation from the point of view of their professions and on the basis of their specific experience. That would provide us basic material for a library of accesible reference. These materials, transferring their usefulness to the educational sphere, would be useful as tools for the teachers and would allow them to start laying the foundations of Bioethics as an emergent value.

Another idea would be to arouse the interest for specific topics, and advance above them the Bioethics dimension. We have talked here about certain ethical problems related to AIDS, for instance. Because, if we raise a question in a paper, and that paper can be disseminated through the different channels that we have, then all will have the opportunity of contributing their opinion. These are only examples of things we can do.

      But I think the Scientific Committee is grouped around experts in many fields and it is something of which we should take advantage of. The legislation is expanding day by day and, therefore, the SIBI is in a position to provide -by Internet- a good library of reference, so that, when we view the web page we find the "actual state" of things, and even with questions from the users all around the world about certain topics. That way, every time we meet, each of us will have been enriched with the knowledge provided from public opinion.

      So, if we have access to the Internet number we can benefit not only from our own experience and knowledge as a Committee, but, also, we will benefit from the experience provided by other experts. This would place us in the vanguard. These are my suggestions.

AMOS SHAPIRA: The detailed minutes will be handed over to us later. The only way to sum up our sessions would be that someone -I am afraid it will have to be you, Marcelo- makes a brief summary to which we can add, all that we consider interesting and instructive. I do not see a more practical way to do it. On second thought I would like to reiterate what I said before about the ethical aspects and social responsibility concerning biomedical experimentation in the human being. The ethics of experimentation depends, to a great extent, on the capacity of the scientific community to inculcate the basic moral and social principles, that underlie a reliable and reasonable calculation of the costs and beneficts of valid scientific protocols.

ERWIN DEUTSCH: I would like to come back to the question you raised, Marcelo, in the beginning. Regrettably, everything concerning clinical testsgenerally lacks of a basic definition of what a clinical test is: Is it a comparative study?, is it a double-blind study?,  a placebo control?, etc. Or is it something that simply concerns a patient or a small group? The only exception is a brief section of the Declaration of Helsinki that says that "Every topic of experimentation must previously have medical attention and vigilance" and the topics are also included here in the control group. Exclusive reference is made to what happens regarding medicine. If we examine the European Agreement, we can get the impression that we are still in last century. Articles number 15, 16 and 17 have ignored these fundamental differences. Not to differentiate between comparative trial -double blind-individual-colective- provides us with general and ambiguous regulations with which the Ethics Committees find real difficulties when it comes to apply them, for instance, in trials with control group, placebo-control. These are some of the reasons that moved the American Medical Association to propose the total revision of the Declaration of Helsinki, for instance.

       It seems incredible to us jurists than something can be regulated in a way so "out-of- focus" and unaware of the evolution of facts. I do not have any idea of how to apply article 17. How to apply it to a multicenter placebo-control study, for instance? They are "very high" principles, but then, Maurice I have to show my disagreement with you in what concerns experimentation, or the use of clinical trials in Oncology, because to someone who has a cancer a protocol can give him/her other perspectives. We all know that many of those experimentation protocols do not prosper with success, but it gives the patient new hopes, another perspective of life and any Ethics Committee must bear that in mind. I think your idea is not bad, but I do not consider us to be the apropriate group to define those differences between what is a clinical trial and what it is not. And there we have one of the big gaps of those Documents and the reason why German and Austrian people are not satisfied and say: "this people never bear in mind the different forms of medical experimentation". The other day, in my Committee, we revised a protocol of research in badly burnt people (60%-80% of the skin lost). Normally, these patients are put a kind of protective "tent" and even so many of them die. Our doctors want to carry out an experiment with something called "Beta (...) or something similar; the problem is that this kind of burnt people are receptive, can hear, but cannot give their written consent. So to take a decision about that protocol we had to base on the patient´s supposed consent and the problem arises when we ask ourselves, how is it possible to expect the consent of somebody in that state, when it comes to guarantee their free participation in the experiment? 

ERWIN BERNAT: Fiction, pure fiction.

ERWIN DEUTSCH: But we have to expect that that consent exists if we want to give way to the protocol. It is incredible what it means to have all those doctors begging us to consider the final importance of the experiment and to obviate the informed consent.


EVENING SESSION

MARCELO PALACIOS: We go on to the third point in the agenda: artificial twinning. 

JOSE EGOZCUE: I refered this topic, and I do not know if will discuss it today completely or not, but one of the possibilities of cloning applied to reproduction would be the artificial production of twins. Technically speaking it is an unattainable achievement for the time being, because the results would be terrible; but the procedure is very simple and it has been used in animal reproduction with success: an embryo is taken and divided into two, and from there we get two identical twins, so the artificial twinning takes place. It is very simple, and examples of cloning monkeys appeared in the papers two years ago, if  I remember well; and it was practised with human beings too, but the embryonic division was paralized. It was also given in the media the news of another preceding example. It is very easy: everything you have to do is to separate the two first cells of the embryo and than can be done, for instance, in a habitat deprived of cacium and magnesium, that are the ions that facilitate the cellular adhesion; it is so easy to do it, that when it appeared the news that this technique would be able to be applied to human beings, our students of 4th grade in Biology were already doing it with mice in their practical classes.

          But if this is done in human beings, then we are cloning because we are going to produce identical twins, it is artificial twinning and therefore it is in the category of what we understand as cloning, although the result is not exactly identical twins as it is usually said and theory... Let´s imagine a situation in which a woman who is in a program of assisted reproduction and who responds bad as regarding the hormonal treatment and who produces, let´s say, only 3-4 oocytes instead of 10-15-25. In that case we have a very small number of embryos; if the technique worked -which, at moment, is not like that- we could double the number of embryos that could be transferred to this woman, increasing the chances of a pregnancy and later descendants. This is only part of the question. So, in case of doing it, this would be a real cloning -which is forbidden - it would be to imitate in an artificial way something Nature already does and besides, according to the protocol approved by the Council of Europe, the production of identical individuals would be forbidden. If the technique worked we could save all those problems; this maybe a bit more difficult to explain, but I will try. Now, we can extract a cell from the embryo and characterize it genetically so as to obtain the DNA corresponding to that embryo (something similar to a driving license). If we take a cell and we characterize genetically the embryos and then we transfer numbers 1, 2 and 3 for instance, and one of them gets going and a baby is born, we will be able to know if the embryo that went going was number 1, 2 or 3. Do you understand? Then, if there is a second cycle and the baby who is born corresponds with embryo number 1, then in the following cycle only embryos 2, 3 and 4 are transferred. So, as you see, we are not imitating, we are not producing a copy of embryo number 1. I know all this turns out to be excessively theoretical, trying it at this precise moment would be disastrosus, so I am not dealing here with applicability, I am talking about the theoretical situation that is going to occur in a not very far-off future and which we, or our children will have to face.

AMOS SHAPIRA: What is the difference between animals and human beings regard to the rate of success in either group respectively?

JOSE EGOZCUE: Because an embryonic cell can be easily extracted and get the embryo to develop perfectly. But in the human being, if we divide the embryo into two parts, the potential of development is reduced and the number of resultant embryos is also reduced, and in those circumstances it would be much more difficult to get a good pregnancy. So, for the time being, I would not recommend it, not even in the case of a woman that produces only 2 oocytes, I would not divide the two embryos taking the risk of losing all of them. But these techniques are being developed in animal models so, in a short time they might be improved enough to be able to apply them in human beings with success. And then everybody working on assisted reproduction will come straight to us, asking: why cannot I do this if with it I can help this couple having descendants?

AGNI VLAVIANOS-ARVANITIS: What problems can arise with the artificial transfer of these embryos, if we divide the embryo in its bi-cellular phase?

JOSE EGOZCUE: No, no. It is nothing to do with that.

AGNI VLAVIANOS-ARVANITIS: I am sorry, I think I have not understood well your explanation. 

JOSE EGOZCUE: There is no problem, I will explain it to you again. If you want to obtain more embryos but you just take half of one, you get exactly the same number of them.

AGNI VLAVIANOS-ARVANITIS: Yes, I understand that. What I’m asking is, if we start from that bicellular phase, in the second stage of cellular multiplication, and we leave one of those two cells to develop into an embryo, would the result be a normal baby?

JOSE EGOZCUE: Yes, but there is more to add. The embryo is surrounded by the zona pellucida, and if we want to divide that embryo, we have to eliminate the zona pellucida and then, the cell without the zona pellucida can have or not an anarchic development. If the development is anarchic, it is possible that the resulting embryo is not good, the same way that it will be a good embryo if the cellular development takes place in an organized way. An artificial zona pellucida can be created, but nowadays it is something difficult to achieve. If  embryos from animals are lost, it is not such a terrible event "a priori", but if we are working with human beings we do not want to lose any embryo. So the problem of having to eliminate the zona pellucida to proceed to the cellular division becomes one of the problematic issues in all this matter.

AGNI VLAVIANOS-ARVANITIS: Can´t the cell be extracted and the zona pellucida saved?

JOSE EGOZCUE: No, no. Look, we have the zona pellucida and we have the cell. The first one is open and the cell can go out. the zona pellucida acts as an inmunological protector to the cell while it is in the uterus and before the implantation (or nesting) takes place. Without the zona pellucida, the zona pellucida could be identified by the mother as "invaders", strangers (I am not personally very convinced about that theory that circulates about the immunological infertility but, anyway, there can be some truth in all that). Well, we were saying that without the zona pellucida the cell is totally exposed to be recognized. So there really are some problems that make this technique not recommended nowadays to be applied in human beings. The only aplication that would work in two identical individuals would be the one I have described, so -the way things are-, all the requirements of prohibition established in the Protocol of the Council of Europe are fullfilled. And when the technique is bettered, the application of it with reproductive purposes is something nobody dismisses. And that is the reason why I refered the document to be discussed, either to deal with the topic today or in another future occasion. Because I think the Committee must debate about the convenience or not of this.

    If cloning applied to human reproduction is acceptable with the two posibilities that I have described before: the production of identical twins using for it both cells, or the asynchronous reproduction of twins, we can make one of them to be born now and the other one in, let´s say, 5 years; or if we opt to not transfering the half embryo derived from the  embryo that has already been born, this implies that we will be throwing away one of them, and to dismiss an embryo means eliminating its chances of development and later "being". So,  as I see it, both possibilities entail ethical implications. Have I been clear enough now?

AGNI VLAVIANOS-ARVANITIS: Yes, of course. Thank you very much. The truth is that these steps have only very recently been developed and I am not familiar with them.

JOSE EGOZCUE: But they have already been discussed, For instance, in what concerns artificial twinning these topics were already debated in a conference held in Barcelona in April. And there were people who thought that it was an interesting exploration field, while other people spoke out absolutely against it. And the person who most vehemently expressed his rejection was Ian Willmuth because he is very concious as regards any possible application of the cloning techniques in human beings. He is afraid, of course, because he has been "the father of the invention" and he get very nervous and asks: "what applications in human beings do you suggest the technique may have?". And they tell him: "well, one of them is the artificial twinning", and he hits the roof. It is a matter of opinions.

GUIDO GERIN: Yes, but as you were saying before there are differences between obtaining Dolly the sheep through the application of these techniques and the production of a clonic human being, and you have explained them very well.

JOSE EGOZCUE: Yes, but there are another nature, because theoretically one product is as clonic as the other. And I do not think that is the crucial matter for the debate: with cloning (of what ever type) are we copying, making an exact replica of something/someone that has already existed or that still exists?, or not? I think that ethically as well as philosophically we have in this answer the crucial matter. If twins are produced we are not copying anything because it is a trick a fate. We do not know how that embryo is going to behave. It can have its own characteristics that distinguish it, that make it unique.

AGNI VLAVIANOS-ARVANITIS: After the cellular division and subsequent development of these embryos, who decides what to do with the not transferred embryos? And, for example, if they are frozen, who decides, for instance, about its later destruction?

JOSE EGOZCUE: That is another part of the problem, but it is also another problematic aspect that is directly related to research-experimentation in embryos. For the moment, the only situation -in human beings- in which one or two embryonic cells are extracted is in the pre-implant diagnosis, in case of a transmissible genetic illness. And in these cases, who decides which of the embryos must be transferred?, the couple?  No, the doctors? Doctors can only decide and declare about the health of the embryo: "this one is healthy and that one is ill". Well, if one goes to a clinic to be made a pre-implant diagnosis, I imagine that what one is looking for is the nuclear transfer of a healthy embryo because, otherwise, what is the use of going to a clinic?; if the resultant embryo is going to have a genetic defect or an illness, then, we may as well make it at home!

     So as you see this is about a joint decision based on the previous decision of the parents who, being conscious of their condition of carriers of a genetic illness, go to the diagnosis Center to make sure that the final product, their future child, will be born healthy. In this case -and we are already going into a different field- the discussion would be focus in the figure of the healthy carrier, because in this case we would be carring out a selection between healthy non-carriers and healthy carries. But this is a different problem and I would not like to mix it with what we are dealing with now.

GUIDO GERIN: We cannot speak about "reproductive cloning" because everyone agrees in forbidding it for human beings.

 

JOSE EGOZCUE: There are some opportunities for cloning in which we are not producing individuals "identical" to others already existing, or that have existed, and other cases of cloning where this does not happen. If we wanted to debate about cloning we would present, for instance, the case of the woman that becomes pregnant and her mate wants that child, but not at this moment; well, they can opt for abortion and keep the embryonic cells and proceed to their cloning when it suits them. And in this case we would not be copying somebody pre-existent, and however we are performing a cloning; and we are doing it through nuclear transfer. I think we should establish the limits.

AGNI VLAVIANOS-ARVANITIS: If we are going to discuss some of the risks that entail the techniques of antenatal diagnosis, amniocentesis, or even that new technique that takes one of the two cells, would you say that that the risks are so high so as to advise the parents against using it -for the moment- and not only for ethical reasons but also for technical reasons?

JOSE EGOZCUE: No. The risk of spoiling a pregnancy because of an amniocentesis, done by experts, borders on 0%. With the clonic sampling, also performed by expert hands, I would say the risk is of 5%. Performed by inexpert hands the percentage can shoot up, and in the pre-implant diagnosis, it depends. Usually, if the embryo is good the risk is minimun, and if it is bad, then it is better to lose it, do not you think? 

GUIDO GERIN: I pass the article 10 of the Declaration of the Human Genome on to you, it is about "cloning". 

JOSE EGOZCUE: Yes, yes. I know. We discussed about it during lunch and we agreed that terminology is very important. Were it says "reproductive cloning", what does that mean? Does it mean (...) or what on earth do they want to say? I think that if one takes it in the sense that cloning is something that goes against the dignity of the person, that should not hold back our debate about the question because what they want to say in that article with "artificial cloning" and what we understand as "reproductive cloning" can refer to very different things. 

AGNI VLAVIANOS-ARVANITIS: Why don’t they call it "somatic"? That would be easier. 

ERWIN BERNAT: Because when they speak about "reproductive" referring to its application in human beings, it indicates that it must not be allowed because it is against human dignity, no? An example can be saying: "the cloning of a human being must not be allowed" without pointing out previously what it is understood by human cloning. Is embryonic division an alternative option to reproduction, a better option than -let´s say- nuclear transference? Well I would not say yes, that both of them are examples of "asexual reproduction". In both of them the same criterium comes true, the embryonic division is as asexual as the nuclear transference. In both cases the basic principle, the beginning of the process, is the same: the use of a group of chromosomes that has been -somehow- divided. Technically speaking there are big differences but, why a technique is (...) and the other one is not? Both of them are directed towards the same aim, reproduction. And, besides, what do we understand by "sexed reproduction". I do not know if we are going a bit too far with semantics....

 JOSE EGOZCUE: I am not arguing that. What I am saying is that Nature produces twins but it does not do nuclear transferences.

ERWIN BERNAT: Well, that depends on what you understand by "Nature". What is Nature? There are people that say that insemination with one´s semen it is not natural. Probably you would think the opposite, so it all depends on what each of us understand by "natural". Some people will say that every technique of non-coital assisted reproduction is antinatural. It is all a semantic game in which we are involved.

JOSE EGOZCUE: That is why I insisted on several occasions in that what is important is that with artificial twinning we are not copying anybody. 

ERWIN BERNAT: Could it be said that the zygote that started its existence in this world when the spermatozoon came in the oocyte is copied?  

JOSE EGOZCUE: Yes, yes. And I can also tell you that when I do pre-implant diagnosis and I extract a cell, as it already exists the posibility that -in a natural and spontaneous way- the embryo has divided into two, then it is probable that it kills in the attempt a possible embryo.

ERWIN BERNAT: Yes, of course. And that is the reason that justifies the promulgation in Germany of the Law of Protection of the Embryo. That is the reason why consistent jurists and legislators, in Germany, have forbidden the pre-implant diagnosis with a Penal Law. And you, if you do that in Germany you become automatically a criminal, by law. And you may be punished with 5 years in prison. I want to add that I, personally, disagree with that law, in my opinion, irrational. I only wanted to give you that example to make you see that there can be people to whom the pre-implant diagnosis is smorthing similar to a murder.

ERWIN DEUTSCH: Right, right. But let me tell you, for instance, than in Germany it is forbidden the freezing of embryos unless these are in the pre-nuclear stage.  

ERWIN BERNAT: Well, but that remains to the doctor´s interpretation.

ERWIN DEUTSCH: Yes, but listen, that is not fair play. Because if we have to use deception to be able to freeze embryos at the same time that their freezing is forbidden, we are not playing fair. Look, the countries that forbid the pre-implant diagnosis -France was one of them- since then the French are at present doing their most to put themselves on the same level with those countries where they have been doing it for years; because the only thing they got with their banning was to lose 5-6 years of experience. And Germans go to countries where pre-implant diagnosis is not forbidden to have it made there.

ERWIN BERNAT: I know, but it is not a convincing argument to avoid saying that the solution taken by Germany has been erroneous. There has to exist some argument ethically supported that allows to abdish that law, but never use an argument such as "well, there are German people that go to other countries". That argument has no sort of ethical foundation that makes it persuasive or convincing enough to abolish the law.

JOSE EGOZCUE: None of the arguments we have considered in these last minutes has nothing to do with the initial problem: the artificial twinning.

ERWIN BERNAT: Yes, but those twins are not genetically identical. It is like my twin nephews, that do not look like each other or share the same genome.

JOSE EGOZCUE: From my point of view the question is, can we establish the difference between "cloning" when pre-existent individuals are not copied and "cloning" when replicas of pre-existent individuals are made? For me this is crucial and that is why I referred the document for its study.

ERWIN BERNAT: If we give our congratulations to cloning by embryonic division, we should say NO to cloning by nuclear transference only if this entails negative consequences produced by the fact, let´s suppose, that we want to be cloned by nuclear transference, let´s say that because of sterility reasons and we want to get benefit from this technique. Then, if we are extracted our own somatic cell, transplanting first the oocyte to our mate and proceeding to its fertilization and leaving the zygote to stay and develop in  our mate´s or substitute´s (hired-mother) uterus, this is not relevant to the example I am setting; and if we see that the resultant individual, in the course of its subsequent evolutionary development does not show any alteration or damage regarding its social and psychological aspect, nor in its autonomous capacity, well, we would have a schematic opinion that there is nothing wrong in nuclear transference. But it could be said that it implies certain negative things because, being unnatural, we should not do things that go against nature.

      So I keep on insisting that everything depends on the ethical-theoretical foundation that we obey. If we have the ethical line that the Catholic Church promulgates, then we will be before something wrong because it is unnatural. But if the concept of natural is not understood with the same inflexibility that under the catholic perspective, what will have to be done is ensure that there are no negative consequences because of that nuclear transference. And that is a merely empirical question, that is why if there are no negative consequences, probably we will not have anything to object to nuclear transference.

ERWIN DEUTSCH: I think that the limit between copying or not copying a pre-existing person  is absolute. Therefore, what I think is equally erroneous is that a certain ethical theory has to be followed, because if we do it we would see ourselves very limited by it and we do not have enough independence left to decide about these matters.

ERWIN BERNAT: But those ethical theories are there to be obeyed, they exist therefore they have to be obeyed, I mean they have their competence. If we have a certain ethical theory or ethical conviction that we follow, this provides us with the framework to decide between good and evil in its broader sense. The ethical theories are not the ones that our politicians apply, since these, in the majority of the cases have no choice but to establish compromises and the ethical theories are not the same for everybody. Here and there, and especially in the legal field, a lot of groundless regulations are produced.

    For you to have an idea (it has to do with reproduction), I will give you an example. As you know in Austria we have an Accord about Reproductive Medicine whose objective was to forbid everything that was not "natural" (and this way it can be read in the official comments). "Natural", from the point of view of the legislature, is only the type of non-coital reproduction where the biological material of the parents-to-be is used: the sperm and the mother´s oocyte. But, in the official comments to the law we can read: "as the artifical in vitro insemination is used on a large scale in the whole world, then we cannot forbid it; we do not like it, but we cannot forbid it; but we can forbid it, says the law, in vitro fertilization with sperm from a donor". Therefore, the law makes a difference between the case of a couple that depends entirely on the sperm and that one relatively dependent. In the case of a woman suffering from tubic obstruction and the man being azoospermic, for instance, the law does not allow this couple to use the sperm from a donor, while in the case of masculine sterility, not having a problem that prevents his partner from breeding, it allows the use of the obsolete technique of insemination.

AGNI VLAVIANOS-ARVANITIS: This does not make sense. 

ERWIN BERNAT: It does not make any sense, and this has been put forward to the Constitutional Court. Perhaps in November, when we meet here again they will have declared on this matter, because there is clearly a violation of the principle of equality . I hope they see it this way in the Court and they overturn that part of the law, because it does not make any sense. I only wanted to give you an example of compromises that one acquires without a solid fundamentation.

JUAN RAMON LACADENA: In the first place, the concept of "artificial" has been used here against the concept of "natural". Of course what I am going to say is not in the sense of what has been said here, but that in an ethical debate and especially regarding society. I think that it is important and we would have to make clear,  that artificial is not intrinsically bad. There are people that consider negative everything that is not natural. If we are talking about genetic engineering, then there are people that think that it is wrong to manipulate genes and therefore they condemn it. I think what should be made clear to society is that what the man does is a product of his intelligence and his intelligence is a product of evolution, and as natural is what the man does with his intelligence as what the animal does or a silk worm when it spins its cocoon, or a spider when it spins its net and that seems marvellous to us and on the other hand we think it is wrong that man makes use of his intelligence. Of course we have not argued here in that sense, but I think in an ethical debate it is important that that idea reaches society in a clear way. It has happened here at the beginning too, and then it has been sorted out and it is that when there is a discussion, a forum about cloning, if we do not start by defining the terms, in the end everybody is speaking about a different thing, and it is clear that doctor Egozcue has started talking about twinning as a technique, but it is a technique that is going to produce individuals that will be the same as one another; therefore, they are clonics to each other although they are not the same as the parents that have produced them, but it is a group of individuals that would be the same as one another. Therefore, I think twinning is a technique inside cloning. Then we have, as it has been perfectly said, the cloning by transference of nucleus, although it has not been distinguished that the nucleus can come from diferentiated cells or from embryonic cells not diferentiated, and this also has its technical connotations and its different applications.

       What I really would like to put forward on this table of debate is the topic of the identity of clonal individuals. With this what I want to say is that there are a lot of people who are in favour of cloning in its broader sense, reproductive cloning no matter the method, and that now defend saying that it cannot be argued that clonal individuals are going to be genetically identical because, it turns out that if they are clonal individuals obtained by transference of nucleus, then the new clonal individual has a cytoplasm that is different from whom obviously the donor cell comes from and as in genetic information cells are nucleus - cytoplasmatic interaction, the clonal individual and the father/mother from whom it comes from are not already absolutely identical.

       On the other hand there is also who says, "the clonal individual and its father/mother are going to develop in different uterine environments, therefore all the influence that can exist in the later development of that new being by the uterine environment during the pregnancy, will be different in the father/mother and in the new clonal individual. Therefore, this means that clones, actually, are going to be less alike to each other than the monozygotic twins. Monozygotic twins, share the nuclear genetic information, share the cytoplasmatic genetic information and share the intrauterine environment and despite that we know that in the later development of monozygotic twins there can be differences. But, also, when differences are discussed we have to distinguish which differences are of the somatic development -and there might be a big resemblance, a big similarity- from differences in the development of personality, where obviously we know that there can be a lot of factors that affect the development of the personality of the two individuals, of the two monozygotyc twin brothers, that make their personalities   become different.

      Therefore, when we talk about "twin souls", it is a popular saying that really does not have any real support, but in spite of that I think that it cannot be used that lack of total exactitude of the global genetic information of the clonal individuals as a strong argument in favor of cloning. Because, if we react like that, we would have to say that any of us here in this hall are, in this moment, different from how we were when we came in here because possibly our DNA has suffered mutations, since our DNA is always unstable and the somatic mutations are happening constantly. But however that does not mean, and this is a Kantian maxim, that we are not the same but we are the same; that is to say, that although there are those little genetic variations they do not allow us to say we are not now the same as we were a while ago.

      Regarding some ethical aspects that I also would like to put forward on the table relating to cloning, the only thing I would say, and they are repeated data, facts or considerations but I think they can be listed is the following: in the first place, remember, and we all know it, that the man is in himself an aim and not a means; that the man has a right not to be genetically programmed, that is to say, a being as a result of a genetic chance. He has the right to be born with a genetic information received through the genetic combination of the parent´s gamete and not somebody deciding that that human being has to be born with nuclear genetic information the same as so and so gentleman who wants to be repeated for whatever the reasons. On the other hand although -and I have said it before- the personality of the twins we would say "is characterized" or it distances itself in the development of the personality, I think that the psychological problems that could have the clonal individuals should be seriously studied. Besides, and it is an ethical fact to bear in mind, the familiar environment of those clonal individuals would not be a normal one and, therefore, I think this fact should be considered from the ethical point of view.

       Finally, we have to take into account that still the scientific information about what cloning implies present many questions; the first of them is something that has been said many times, what is the real genetic age of the clonal individual, because if that DNA has been topiced to mutation processes for ten, twenty, forty years before it is cloned again, it may have accumulated mutations; then, what will happen?, a clonal individual is going to be created to whom, perhaps, a monitoring will have to be done to see if it is necessary to provoke an abortion because that clonal individual has accumulated a series of important genetic anomalies.

      Therefore, at least it is my opinion that the reproductive cloning through transference of nucleus would not be advisable from the ethical point of view, that cloning through twinning is more debatable, with all the technical difficulties that professor Egozcue has pointed out, and as I said in the previous session maybe what stands out as the biggest possibility in the medicine of  the future could be non-reproductive cloning, that is to say, to produce a clonal individual but not  with the intention that it becomes and adult clonal individual but during the first fourteen days of development use that clonal embryo created to establish, from stem cells, from main cells, the possibility of growing tissues or maybe organs.

JOSE EGOZCUE: I only wanted to insist that the topic was artificial production of twins. If we discuss all the problems of cloning we will not reach any point, because it is a way of dispersing attention, and I think it is so different the cloning through nuclear transference from the division of an embryo that we should try to keep the questions apart, because, for instance, one last assertion of him that refers to the research in embryos: I am in a total disagreement but, as this point has been debated this morning, I am not going to discuss it now. Well, but as the point of discussion is not research in embryos, then the fact that an embryo can or cannot be produced by nuclear transference by investigation, although I would like to discuss it, it is not the topic now, and I prefer to leave it for another discussion.

MARCELO PALACIOS: About cloning by nucleus transference, if someone pretends that from a nucleus of one of his somatic cells a baby of his is going to be born, the person is absolutely wrong because all in all it is his brother. It is really a baby of the parents that gave him the genetic provision, that is to say, from whom pretended to be his father; that is clear, and therefore that wish is frustrated; on the contrary, the result of twinning of one´s own embryos would be one´s own children. Without the intention of prolonging this matter more, we must take into account something that Juan Ramon has said, and it is not to insist excessively on the topic of "artificial" because deep down even in an insemination almost everything is natural: the spermatozoon, the oocyte, the uterus, and the gestation are "natural". Everything is natural. Complicating things unnecessarily about artificiality, also a mutation can be produced with an artificial fact, although we do not know it. In fact with those techniques the minimun is artificial, and that is the intelectual-technical contribution. What happens is that it is emphasized a lot more because it has a component that is known as "it is or I am being manipulated already".

GUIDO GERIN: I will deal with two basic problems with cloning: one is the one that Egozcue explained when he talked about embryonic division and with which I agree, and the other, the one that Bernat exposed, because I am not very sure that it can ever occur... but, he said that both procedures were asexual. What does this mean? Does it means there are chromosomes coming from one of the members of the couple, but from the other?  I suppose Dolly represents the perfect example; it can be right in animals but I do not see it very right among people and I think we should make statement about it, due to the dangers that entails for the future of humanity, because we will only count with the chromosome of one of the parts. I, of course, do not know about technical aspects. 

ERWIN DEUTSCH: If we practise nuclear transference we count with the father´s chromosomes and the mother of the cellular donor (several interventions in off). Yes, but the only difference is that in one case we proceed from the fusion of the spermatozoon and the oocyte and in the other we proceed from a somatic cell. But the main difference is that in one case it is about nuclear transference and in the other one not, and that applying one we "are making a replica", while applying the other one, no. 

ERWIN BERNAT: You will agree with me in that many problems arise because of semantics.

ERWIN DEUTSCH: I think the sense or the direct interpretation of the word "copy" used in this context is that if we do not have a model then we cannot copy it.

ERWIN BERNAT: Marcelo said that there are so many things that obviously are natural in all this, and that only because they are done in a laboratory we cannot clasify them automatically as being unnatural. This point of view is quite rough, but I think it is something to be debated as regards if it is or it is not completely right. Why do you think Marcelo, the Catholic Church describes the in vitro fertilization as something unnatural, and therefore morally reprehensible, and to perform it is described as a sin?

MARCELO PALACIOS: Without a doubt Reverend Dooley is more suitable to answer than I am. 

MAURICE DOOLEY: The fact that is done by a technician in a laboratory, it does not make the practise in itself to be more acceptable than if it was done by the own donor acting live, personally.

ERWIN BERNAT: No, no, we are talking about homologous insemination, that is also regarded as a sin.

MAURICE DOOLEY: I am sorry, I misinterpreted it.

ERWIN BERNAT: Even the fertilization influenced by the doctor is regarded as a sin, that is what is wrong and what makes it unnatural. It is not adultery, of course, but it is another type of sin. Could you explain to us why is it a sin, why is it  wrong and why has it got to be forbidden? Surely there is an explanation for it. The Catholic Church would not maintain that opinion if they were not fully convinced that it is a sin. Therefore, there has to be an explanation, that it does not make itself evident, that certain things are natural "per se". Or is it because of something directly bound to ethics that the Catholic Church follows? Because, for me the word "natural" as used by the Catholic Church is a synonym for something morally wrong, but it does not solve my problem because we must justify or clarify what drives us to "label" a particular thing.

MAURICE DOOLEY: Well, it is relative easy to explain. "Natural" is what husband and wife normally do when they are together in bed. Everything else is "unnatural". Then we have the other different question regarding the fact that all "unnatural" activity is considered as bad, wrong. Why is it not right to count with someone else´s help for procreation? Well, the Catholic answer to that is that respect for human life is of such a caliber that everything that rotates around this axis has to be determined by God and that God -or Nature- wishes the natural method to be followed: the wife and the husband that share the same bed.

ERWIN BERNAT: That deciding factor, when it comes to interpreting or giving sense to "natural" it becomes like a divine mandate. If those premises are not carried out, the argument goes up in smoke. Well, we already know something more concrete: we know that we always have to count on pre-established premises when it comes to trying to convince people about what we understand as "natural" or "unnatural". We always use these two words in debates in a more regulated or legalistic context and we will have to start saying on basis of what premises we consider that something is "natural" or "unnatural".

AMOS SHAPIRA: I would like to pose a question, first of all to my Spanish colleagues. Supposing there is a law passed by Parliament that simply says "cloning a person, through the application of whatever existent or future cloning techniques, is forbidden". Finished.

ERWIN DEUTSCH: That is what it has been done in Germany.

AMOS SHAPIRA: Would it be possible, let´s say, for the medical-scientific community to argue with success in court that the law is not applicable to an embryo, because it isn´t  a person and the law we are talking about refers to "persons".

MARCELO PALACIOS: On this matter we have two examples of legal answers. One is the German example, that forbids any cloning technique linked to human reproduction. In the Spanish example, the law referring Assisted Reproduction Techniques of 1988 and the Penal Code of 1995 forbid to create human beings through cloning.

ERWIN DEUTSCH: I would like to come back to the concept of "natural". The concept of natural goes back to the old law and it is generally defined as (... it is in latin) and I remember that in Roman Law classes we had, with the exception of the definition that the Catholic Church maintains that is done on the basis of a divine mandate, constant headaches when it came to taking decisions on the basis of the laws of Nature. I took part in the two committees that were formed before the Statute  was promulgated, the law I talked about in other interventions, and in both cases we failed in our attempt of reaching a consensus on the opinion of what is "natural". Nature is in permanent change and has been evolving since it appeared as a global entity since the beginning of time and that is why Nature, as a mirror, can only be used under certain circumstances, in general we cannot do it.

     We have found  ourselves with the surprise that, for example, (...) is unnatural. Are we going to forbid it?  On the other hand, we can put forward that it is not always possible to distinguish natural from unnatural. And there is were we have the problem: with the two sides of the coin. In the end it does not work. In Germany, legislativelly speaking, we lived a long historical period under the protection of natural laws, in the 18 th century and  beginning of 19 th century, and it failed. Now we have in effect another natural law, but we call it Constitutional Law and I am sure it is going to be, in the long run, very (...).

MARCELO PALACIOS: There is a tendency,  regarding to these biotechniques when it has to do with "natural" an assessment is established only from the human perspective; I mean, in an analogy with living non-human beings, that the doctor or the biologist that makes a transfer of preembryos or sperm to the uterus is like the birds or especially the insects that carry the pollen further away, making easier a pollination that is considered  "natural"; or it is the branch or the water that carries or sweeps along the sperm of a fish to where another one has ovulated, the place where the ovules are going to be fertilized.

     I see it as a double sensibility: not only from the perspective of the Church, but also from the perspective of many people that do not need to appeal to the the religious fact to think like that, that the artificial Centers itself only in the technical activity of the man, when what it would be also artificial in nature is not considered as such, but as natural; the very numerous cases of pollination, the transfer of sperm to other areas, ...etc. nobody would say that they are artificial events; with that not only runs out the fact that we say: "as we are human beings, we have different values", because it is not about that but about arguing what is "the natural", O.K.

JUAN RAMON LACADENA: I think that it is also important to take into account that when a couple undergoes any assisted reproduction technique, they do it because through the let´s say "natural" ways cannot have descendants. Then what must not be thought is that that couple has less love towards the descendants for bringing them to the world that way, because precisely to undergo an assisted reproduction technique is to go through hell; so I think the couples that use these techniques to have children must never be understimated; another thing, in certain cases, it is to go too far: as they cannot achieve it and they have exhausted all techniques, it would have to be cloning. And there is the option of saying: "and why not adopting a child?", but this can be another problem of the couple, since they may want to have their own children, understanding "own" not in the sense of property but that they would like somehow to transmit their genetic information to their descendents.

ERWIN BERNAT: I think the real possibilities of artificial twinning are very limited, even when it is technically possible, because they are a small group of women who respond badly; but this is a problem that will be brought up, because every group, even though small, demand their rights and the right to reproduction, though it is not a fundamental right, people probably interpret it as a right and they are being made to believe that it is a fundamental right; and therefore, they are going to forbid it, I have already thought about it in this sense. I think the text of the Protocol forbids twinning; this does not mean that we agree with the text of the Protocol because in this case it says that "it understand by identical individuals those who have the same genetic provision" and twins would have it.

     The only question is that the production of twins reproduces a natural situation, the in vitro fertilization reproduces a natural situation, the artificial insemination reproduces a natural situation, while probably a ICSI (intracytoplasmatic injection of spermatozoons) does not reproduce a natural situation, or it does, but considering it very forcedly, and the transference of nucleus absolutely, do not.  Therefore, we are in both sides dealing, on one side with natural situations or situations that reproduce something that is natural or situations that occur in nature, and, on the other side, with the reproduction of situations that do not occur in nature. The discussion between what is "natural" and "artificial" is very complex because, by definition, medicine is unnatural, it is not natural. So, the distinction, for instance, that the Catholic Church does of the in vitro fertilization is not correct because it does not take place through the sexual intercourse, but on the other hand, it is right to treat impotence, because it will allow a sexual act. In both cases a pathology is being treated; they are different pathologies, but I leave this aside because we were in the other topic.

MARCELO PALACIOS: If there are not any more considerations on the matter, following the agenda it is the turn for assisted reproduction.

CARLOS Mª ROMEO-CASABONA: I do not know if it is getting too far away from the points here, before dealing with confidentialy and anonymity, but I think there is a topic which I consider very important also related to assisted reproduction and which is a previous question than can affect twinning, to other forms of cloning, and many aspects of the assisted reproduction techniques and it is something that Egozcue has only mentioned briefly, it is the right to reproduction or a subjective right to reproduction,  a right in the strict sense or not; or if it exists, how far can we go to recognize that right in such a way that it could allow a couple, a married couple or a person to demand whatever techniques of assisted reproduction , linked or not with cloning. I do not know if it is a topic that could be interesting in connection with this, I think it connects more with what we have just dealt with about twinning; and I consider it of importance and if you agree we can deal  it.

AMOS SHAPIRA: Well, if it is going to form part of the legitimate debate about assisted reproduction, it is interesting to analize if there exist limits to the exercice of the alleged "right to reproduction". Two of us -Erwin Deutsch and myself- had the chance of discussing some years ago this topic in a seminar we attended. Allow me in this context to introduce the following question for discussion. Is the putative welfare of the future child –if born- a relevant consideration when it comes to discussing the pros and cons of assisted reproduction?  What has always worried me is that in the debates about the pros and cons of assisted reproduction, the consideration of the welfare of the children resulting from the application of these techniques is always missing. Some of you will say that this is an irrelevant consideration, because it is always better to be born than not to be born, and when the alternative is not to be born, what is then the problem? I personally do not endorse this line of thinking. I think that in the debates as well as in the published literature about assisted reproduction the welfare for the future child is assumed in a rather speculative manner. The factor of what is better for the future child who will result from the exercise of this parents’ constitutional right to reproduction, should, I believe, be taken in consideration when it comes to formulating the limits of the rights of adults to fullfill through reproduction. All that seems to be forgotten in the debates about asserted rights to procreation. 

MARCELO PALACIOS: I would emphasize the right to freedom or to autonomy to decide that somebody wishes to reproduce, because a right to reproduction cannot be guaranteed; and if nobody can guarantee it even with the best knowledge and applications of the actual techniques, a disappointment would be produced by the couple or  the individual in the sense that he is guaranteed a right that is not going to have practical efficacy in his case. So what  really exists is a right to freedom to wish to procreate, with the obvious limits, derived from the rights of other people. I do not think there is a right to reproduction, as there is not a right against the wish to not doing it, and I finish with what I have been saying in this sense and it is, that human reproduction from its beginnings is previous to every right, and even today, it is something that largely escapes the law.

        This seems so evident that even in the more advanced civilizations, reproduction is not punished, and no reproduction, isn´t either. In Spain we have 19.000 gestations every year of girls under 18, teenagers, that to a large extent did not want to gestate, who have been surprised by their inexperience, and they are not legally punished; on the contrary, actions and measures, social norms of support are promoted. This leads me to think that there is not a right to reproduction, as there is not a right to health. There is a right to the protection of health and a right to freedom of reproduction, with many nuances, of  course. 

JOSE EGOZCUE: We have started in one point and then we have ended up in another. The first one is the right to reproduction, and here I would distinguish at least three possibilities: first, is there a right to reproduction, an absolute right to reproduction? I think there is not. There is a right -inside some reasonable limits- to "be helped" to reproduce. This is another question.

But there are some reasonable limits, as inside medicine there are reasonable and unreasonable things; and the third one is, it exists and this one I think is recognized or should be recognized, it exists a right to reproduction "with" and there  would be against this right every prohibition of interracial marriages, etc.

      I think people that wish to reproduce among each other have a right to do it and the laws that forbid it are probably unfair. The eugenic laws, for instance, "forbid that two carriers of an illness reproduce between each other". This would threaten freedom, therefore these would be three different considerations.

     The second aspect I wanted to talk about, with which Amos has started, is regarding this supposed right, if the welfare of the future baby would have to be taken into account or not, and here we also have to take into account two situations: in the cases of assisted reproduction techniques, the State legislates and takes part because they can control in vitro fertilization, and, on the other hand, as they cannot control live reproduction, they do not get involved in it; and however, in principle there will be much more problems about the welfare of the child in the live reproduction because there are many undesired children, that with in vitro fertilization,  they are always wanted. But in many occasions the lack of welfare of a child produced live, that is, without the control of the State and that does not enjoy this welfare is because the State does not protect other rights that are fundamental, as the right to health, to work, to have a decent room and housing. That is to say, many times, as the State is not protecting fundamental rights, when making use of a non-fundamental right a child who will not have the welfare to which he would have a right, is born.

ERWIN DEUTSCH: I only want to say something about what you have said, Amos, and about what we all have just heard. In some situations the interests of the future child have been respected. The Gynecologist Association of London, when establishing the guidelines for in vitro fertilization -that Germany copied later- say in a section: "the doctor will have to make sure that the child is born in the bosom of a stable couple relationship". It makes no reference to whether the couple is married or not because, as you know, in the big cities one out of two marriages end up in divorce. The stable relationship is the key idea. I want to add that in Germany we have seen that many of the couples that turn to in vitro fertilization do it as a last resort to save their personal couple situation. They wanted to have a child but, if finally that child did not come their relationship broke up. Therefore, everything is so extremelly complicated that I think that there must not be analyzed only and exclusively individualized cases, but groups of cases.

ERWIN BERNAT: A remark in connection with the right to procreation. We distinguish between the several existent rights: there are rights to have something and defensive, protective rights. In Law, the jurisprudence define "the basic right" as an element that avoids "negative status" to happen, so the right to procreation is a negative right and does not allow the State to interfere. Of course, this does not mean that person A has regarding person B the right to procreate with person B. But it is also a right for the State, in the sense that the State does not put any obstacle to procreation, and we can read between lines, "to opt for alternatives to reproduction".

     Of course, every right can be limited and restricted if there are reasonable foundations for a restriction to be made. That means that only the nucleus of a right but not, perhaps, what surrounds that right, must be guaranteed by the State. Naturally there can be good reasons that incite the State to say "well, there is a right to procreate but it depends on the way it is done, as it is stated in the European Convention about Human Rights in  article 12, that specifically guarantees that every person has a right to get married and form a family"; then, the right to procreate, and in European authorities, it is interpreted as the right to form a family in its broader sense and the right to adoption is also contemplated. And if things are like this, why not to interpret article 12 in the sense of "right to exercise one´s autonomy regarding procreation", in the same way that the North American jurisprudence has been doing it for decades?

     My second remark. A restriction to the basic right to procreation can be legitime if the welfare of the future child remains guaranteed with it. This argument in my opinion only has foundation if empirical studies of the development  of who have already been born thanks to these techniques are put in practice. Of course if the couple says "we want to have a child", and the State says "we do not allow you to have that child" the State does not violate or infringe the rights or interests of that child. Why? The answer is simple: the child has not been born yet. But the argument must be considered the other way around: if that child was born and his stay in this world was miserable, it would be better that he was not born, that he was not fathered. That is an argument based on empirical suppositions and those suppositions are horrible, because I think that a wanted child -born on the natural way or helped to be born by other means- that is going to have such a horrible existence would be better if it was not born. I mean, would this be an ethically convincing argument? . If it already existed a population of children who had such a horrible existence that a big number of them opted to suicide to escape it, we would have a convincing argument to justify the fact that it would have been better not to have let them be born.

     The Memory to the German initiative of legislating the protection of the embryo is supported in the donation of oocytes. The donation of oocytes is a criminal act in Germany because "it puts in danger the interests of the future child". Why not  use the argument of insemination? There is no evidence that the life of the children born by donation of oocytes is less worthy than the life of the children born through insemination with semen from a donor. therefore, is simple speculation. And if we trust our intuition we soon reach the conclusion that those arguments are worthless. Why do we have to presuppose that the child that has a "social" mother who is not its genetic mother is going to have such a horrible life that we must decide that that being does not deserve the punishment of being brought to the world?. I never managed to understand that argument.

CARLOS Mª ROMEO-CASABONA: I am going to start with the assertion that Marcelo did about Law having nothing to say about reproduction. I think we have historical examples that  “has said”, although it might have been wrongly, about the reproduction of the people. During the 20s and the 30 of this century we have laws about forced sterilization in different countries, United States, Scandinavian countries, some European countries where well, they even imposed with different excuses or reasons not always very clear with the sterilization of the people. However, to systematize what has been said here, with which I agree broadly speaking I would start saying that there really does not seem to be an absolute right to reproduction in the traditional sense of the word, the right of something that can be demanded to someone, for instance, to the State; the State won´t be able to provide us with a child if we said that we want to reproduce ourselves, what is something similar to what Marcelo Palacios was saying, a right to the freedom of reproduction not to wish to reproduce, but to the freedom of reproducing ourselves. Well, inside that freedom it is the person, or we would should say to the couple, who can take the decisions that they consider appropiate in themeselves without the interference or the hampering of the State (enacting laws of sterilization, for instance, or as it has been done recently in China where they also forbid reproduction for genetic reasons as Egozcue was saying about eugenics), or of other people, or of individuals.

     However, I do believe that when it comes out of the couple´s circles, when that reproductive decision comes out of the privacy or what the Americans call the “right to a private life” (that we also have, by the way, in the European Convention of 1950) when it comes out of that circle is when those reproductive decisions that the couple has wanted to adopt or take can indeed see themselves limited by the State, to say it in this way. For example, when that decision comes out of the couple and requires the help of techniques, of people or of institutions as it is the case of the assisted reproduction techniques, then I think there really is a legitimacy to interfere, to limit that right to the freedom of procreation. What can be the reasons that legitimize the reproductive limitations in this sphere that already comes out of the intimity of the couple or the person? Well, the reasons that have been aforementioned, by Deutsch and by Bernat, among others, and it would be a question of calculating, of comparing the interests that can be present there: that (now I will use that word) wish almost unlimited or without any brake  that parents could have of having a baby, and on the other hand, of course, the interests of the future child, interests that can correspond to his welfare but that can even lie in other aspects that can be more connected  to twinning, with cloning if it is possible or even with the technical risks that assisted reproduction itself can present. That is how I see in synthesis the question of that right to reproduction. It woud not be a right, but freedom.

ERWIN BERNAT: Only a question. If it was asked the section of the Austria population that are the result of assisted reproduction techniques with sperm from a donor (something like the 0,3% of the total and that numerically represents several hundreds of people): do you like being alive?, do you lead an existence worth living?, do you enjoy life?, probably very few of them will answer “I do not like it too much”; the rest will say, “well, I would like to have been able to choose with regard to some things, but as a whole, I am satisfied with my life”. In my opinion it is impossible to find empirical proofs that the lives of these people are worthless and that the “supposition” that they are "worthless" take us to forbid the assisted reproduction. There might be other reasons than can back up the prohibition or restriction to these techniques. One could be that the general population is intuitively against it, due to its tradition and culture essentially Christian. This could be a fair argument. We could debate it. But the other one, in my opinion is unfair.

CARLOS Mª ROMEO-CASABONA: I think that social perceptions, as it is the example that Erwin has put in, can be a criteria of orientation for the State, the authorities, the legislator, of how to take positions in connection with a topic, in our example with the assisted reproduction techniques; but in legal terms I think the State can see itself binded to that perception, opinion or social criteria, only if that opinion reflects social values that in legal terms we can translate to a legal good "recht gut" as they say in German, if that social opinion of the colectivity cannot be identified as a legal good I think the State does not need to feel obliged to, let´s say, be consequent to that social perception and, therefore, it can have a different criterion from the socially prevailing one. Why?, because we would not be really infringing on no value or interest, that is to say no legal good, any "recht gut". In the case of -and I finish- the organ transplants,   something similar has happened in some countries that got ahead the social conceptions about the topic of the donation of organs from a corpse: it was transferred the criterion of the express consent before the donor´s death, corpse once dead. And if when he was alive he did not express his opposition to being a donor, it is expected that he agreed. And that has been changing. Not agreeing with social criteria, it has been established in some laws and it has not been slowly influencing public opinion in another way either, in France, Spain, Austria with the law of transplants, and in other countries.

GUIDO GERIN: Human Rights are universal and fundamental. From the moment they are classified as "universals" we can discuss if they are the State´s responsability or not. But "fundamental" means that all the people have a right the moment they come to existence but for jurists it is not so easy to explain why we are moving in a context in which only "positive" rights are respected. So the moment we speak about "fundamental rights" we have to interpret them on the basis of natural laws and, as you know, "naturalism" is a very broad question, Why do I say this?. The Italian Constitution, that includes the basic rights for the Italians, lack however a relation with this concept of "fundamental rights". How can we then decide about a problem of the basis of the "fundamentaly" of any right?. This leads us to what it was asked before: what does "fundamental" mean?, what does "natural" mean?. And I think, I said it before, that "fundamental", applied to a person´s right, is a group of positive rights that the person acquires the moment he is born. 

AMOS SHAPIRA: The topic is difficult, I agree. I would like to summarize my intervention in offering two observations. In the first place, I would subscribe to the opinion given here today that alluded to the necessity of singling out ways of human reproduction that do not require the massive intervention of the State in order to be defended or supported. Thus, coital-natural reproduction does not require the support or defence of the system. We could also include in this category the homologous artificial insemination, with the sperm of the male-husband/mate.

ERWIN BERNAT: The Austrian legislation says that if a couple wishes to appeal to assisted reproduction to have descendants, they will have to use only their own gametes, that is to say: with the sperm of his and the oocytes of hers. And if they are not married, what do they have to do?. Well they have to appeal to Court so that an informed consent is given to them. And you were saying before... 

AMOS SHAPIRA: Let me reformulate what I said before. Let´s imagine a hypothetical society with its hypothetical system of rules. And, in terms of that system, let´s focus on types of reproduction that do not require the intervention of the State to be implemented.

ERWIN BERNAT: And what would these be?

AMOS SHAPIRA: Obviously, the natural ones.

ERWIN BERNAT: And which are the natural ones? 

AMOS SHAPIRA: The coital ones. A brief comment: in our system, the artificial insemination with sperm from the husband does not need any legislation or regulation, that is, the government does not intervene because it is a situation very similar to coital relationship.

ERWIN BERNAT: Would it be unnatural in your system if I wanted to get married to your daughter?

AMOS SHAPIRA: Yes, that is true. But it would not be unnatural, it would be difficult. Well, let´s be serious. If we accept that there are two different categories of techniques for assisted reproduction: (a) the ones that do not require the massive and direct intervention of the State for their application and (b) the ones that could not be implemented without the State’s interventions, then I would say that regarding the first category certain principles -autonomy, the right to procreate- have an absolute priority. In relation to the second category, that is, ways of reproduction that require the direct intervention of the State to be materialized, I think that certain restrictions or qualifications, may be legitimate.

ERWIN DEUTSCH: I agree a hundred per cent.

AMOS SHAPIRA: Well, let´s now focus on the "welfare of the future child" consideration. I would agree with you, Erwin Bernat, that there is a lot of speculation here. Because it can only be a speculation to say that a group of children that could be born as a result of one of these techniques are likely not to have a happy existence. This is not enough of a justification to impose a restrictive set of regulations. I agree. But a speculation with some foundation, based on the respectful opinion of psychologists, social workers and the like although it is hardly supported by empirical investigation, can for some cases serve as a relevant factor -I do not say an exclusive or decisive one- to be taken into account by the State. Thus, before the machinery is set in motion, or the reproductive technology in question is subsidized, the State may ponder on the possible implications of this and decide if, on balance, it should be promoted.

ERWIN BERNAT: Are you talking about restricting the right to freedom?

AMOS SHAPIRA: It is not an attack on liberty. It is about requiring the State to fashion policy intelligently.

ERWIN BERNAT: The State does not need to supply the machinery, this is provided by the private sector. The only thing the State has to do is ask itself if it must limit or restrict the field of action of that machinery it allows the machinery to operate freely in the free market.

AMOS SHAPIRA: I do not know. Let´s go back to the example I gave before. If the State has nothing to do in the matter neither to legislate, nor to modify laws, nor to create a regulatory machinery, nor to establish a licensing authority, well, then, let people do what they want to do and assume the responsibility- moral, social, economic- of what they do. But it is another matter if people, in pursuing their wishes to become parents by any means and at any cost, put forward claims and demands for active govermental support action (by, e.g., legislation creating some new state agency).

ERWIN BERNAT: But, Amos, what you are saying is absolutely erroneous. If a system (...) and then offers people the chance of doing what they want to do according to their definite interests let´s say a postmenopausal FIV by oocyte donation, ...etc, everything could be allowed in a libertarian State context.

AMOS SHAPIRA: It would be allowed on a private, individual level. 

ERWIN BERNAT: The State does not need to intervene.

AGNI VLAVIANOS-ARVANITIS: I entirely respect the fact that many of you come from the field of medicine and it is understandable that we focus on this type of topics. But perhaps it would be advisable and important to reflect on a different scale and that would be in the context of "the holy things in life", especially when it comes to understanding what the Vatican does when they say" we think the human being is a sacred entity and therefore, it is not a mechanical part in the production of life and, consequently, must be respected". I am not here to decide if that assertion is or it is not correct but, I see that technology serves as revelation of the potentials for their application. Day after day, new potentials appear and in the next years, when the study about the Human Genome is completed, potentials that allow to predict the 25.000 or more illnesses will come to light. We already accept a large number of manipulations of human embryo and make new steps based on previous actions, which we are taking for granted. Maybe we will keep on adding up to 10.000 genes, and we will decide about things such as at what moment to interrupt gestation, or when to interfere with the development of the human being.

    And I see all this in the future as potential options, but, it is clear that a Bioethics Committee must bring to light all these things and raise public awareness of what it is correct and what isn’t. We are not here to mark laws; our role is to bring to light the possible problems and to facilitate the understanding and the reach of those potentials. So we need to be respectful to the two point of view that life is a sacred gift.

    Nowadays, we are risking the continuity of life. That is most important, because we assume that those are the problems. The problem rests on whether life is going to continue and not on whether we will be able to make an early diagnosis with a view to some diseases, or on whether we will be able to practice artificial insemination. In1994, in Prague, I took part  in a discussion panel with Denis Meadows, who said that: "I do not think we have more than 20 years left" in relation to the state of destruction of the environment, and in relation to the increase of natural catastrophes taking place on our planet, and of which I think we should become more aware. On the one hand, we have a highly sophisticated technology and with it the potential of doors that open for the protection of life. However we should be using 100% of that technology to diagnose the dangers and damages on a larger scale, and not only as they apply to the human embryo, for instance. We cannot exist as human beings if we do not enrol ourselves in that more general framework.

      That is why I am saying that I would like SIBI to contemplate more the aspects about the continuity of life and human responsability about this continuity. In my opinion, no other topic more important to Bioethics exists than the environment. Are we here to protect life or to close our eyes and remain indifferent to things such as the phenomenon of  El Niño and other natural disasters? Global average temperature is  increasing and everybody thinks that Bioethics should not be concerned with this. And I’m asking here: does it have a relation with Bioethics or does it not? We must include environmental aspects in our vision as a group?

ERWIN BERNAT: A European study and the percentage of parents that told it to their children passes to be from the 0%, among the "sincere" Italians, to the 50% among the Spanish "liars". I do not believe at all the Spanish percentage. And the data were presented by one of the members of the group some months ago, so parents do not tell it to their children. This shows how difficult it is to make an empirical study but, a very different thing is to trust the "rough calculations".

      What I am refering to is that we can have rough calculations good or bad.

MARCELO PALACIOS: We would have to consider evaluating groups of children that were born with some alterations of some kind, both with assisted reproduction and without it; that is, to recognize the statistical blocks.  The articles 32 and 37 of our Constitution have distinguished between what it is the right to get married and what it is the family; it is a remark at the thread of what you were saying, considering that article number 12 of the Declaration of Human Rights, when establishing that people have a right to get married has implicit the right to set up a family. I have my doubts, because either marriage is not a family or the family does not have to be necessary the one established by marriage. The marriage is a family, but they do not need children to be so and a family can be without matrimony; I simply wanted to add that our Constitution has separated or distinguished both possibilities.

Day: 3.7.98 (Friday)

 

MORNING SESSION

MARCELO PALACIOS: Today we have to deal with the preparation of theBioethics World Congress of the year 2000 and revise some other questions.

AGNI VLAVIANOS-ARVANITIS: I think that in view of the Congress of the year 2000, our next meeting could be dedicated to the preparation of the topics that are going to be discussed at that event. In preparation of these new dimensions, I suggest as a topic for the next meeting "Ethical aspect for the Millennium". Before the next meeting   is adjourned, we can make a general draft of the Program. Once we have specified the topics, this Scientific Committee will be able to contribute particular points of view about each of the topics in relation with the new ethical dimensions for the new millennium.     That way, perhaps we will be  better prepared for the Congress of the year 2000. Because, as you were saying, it is hoped that around 1.500-2.000 people will attend the Congress. That is why I think that this suggestion is something we must discuss. How do we think the Congress is going to develop? Maybe, each of us wishes to contribute to its diffusion through our friends, informing all kinds of people that may be interested in  attending. I would like us to talk about this.

MARCELO PALACIOS: Would it be a document of declaration of activities? How should you call it?

AGNI VLAVIANOS-ARVANITIS: I would call it: "Ethical Topics  for the New Millennium".

MARCELO PALACIOS: We could prepare a draft that you can all receive, so that when you get here it would be more or less revised and ready to contribute suggestions.

AGNI VLAVIANOS-ARVANITIS: Another idea can be: let´s draft a letter which will be later printed in SIBI´s paper and in which the priorities to tackle during the Congress are included. All the members of the Committee could be given a copy so that we can start spreading the news.

ERWIN BERNAT: I think that we should provide the organizers of the Congress with a list of addresses of the possible people present in the meeting, so that the information about this event goes further from the national context; we could guarantee with it an European and even international diffusion. I should suggest two notifications to be made: the first one, according to the terms I have said, and the second one, to be used as a "reminder" that the congress is there. For instance, that the first ones comes out a year before the event and the second one six months before. It is also possible to "buy" directories of the possible attenders, for instance, through the different Proffesional Associations; but, any way, I think that all we here have available list in floppy-disks and we can already contribute. It is a suggestion. Another thing, would not it be advisable to count with the participation of Invited Speakers out of our own circuit, in a way that each of us can give the names of 1-2 people that we would like to take part in that category to speak about an specific topic? I think that this would be a way for the SIBI to open the doors of our Society to the "external" participation, so that the Congress of the year 2000 has a "world-wide" character.

AMOS SHAPIRA: After each of us will have digested the ideas regarding priorities of topics, we can then send to SIBI by fax or E-mail our recommendations. We should not now spend all the time of the meeting discussing the organizational aspects of the Congress. Perhaps -after a proper preparation- we could be able to discuss ethical aspect related to the more recent developments in the field of, for instance, transplantation of tissues and organs from dead or live donors, xenografts, etc. Or discuss how the situation is in our respective countries regarding euthanasia, a topic that -if I remember well- we did not deal with in our previous meeting and that is currently in the international limelight. Basically, I would like us to make a substantial and through reflection about a well defined topic in the next meeting in November, apart from allocating some time to discuss the Congress of the year 2000.

ERWIN BERNAT: If we have to contact with the Invited Speaker, these will want to know the date of the Congress. Do we have them?

MARCELO PALACIOS: I will answer both questions. In the first place, it is important that we have that document, but we have to create it; I think that an approach of principle about the ethical aspects for the millennium is good. And about the date of the Congress it is a planned from the 3rd to the 8th July, of the year 2000.

AMOS SHAPIRA: This is very important for me. And I would like to know more about the format of the Congress. I have no idea about matters such as the budget. We are talking about bringing Invited Speakers, and those Speakers cost money. So we have to know beforehand the estimated budget to be able to figure out how many Invited Speakers we can afford. You said yourself that some of the suggested topics can be dealt with by us, the members of the Committee.  But I admit that it would be attractive to secure the participation of a (not very high) number of Invited Speakers who are internationally known. The question is, how many can we afford? And what about the rest of the participants? Is it going to be a large Congress? Who are the people we expect to attend?

ERWIN BERNAT: Maybe in what concerns the topics, it could be suggested that each of us recommend 1-2 and we would send them to the SIBI so that in November we can proceed to the definite selection of them  and that way we can  make up the pre-program for the Congress. Perhaps we can also, at the same time we send our respective proposals of topics, send our proposals about 1-2 Invited Speakers to deal with them. What, in my opinion, sometimes happens with International Congress mainly in the field of philosophy- is that in the program appears the topic A and the Invited Speaker gives apaper against the topic. That is useful to give rise to a good debate, no doubt.

AMOS SHAPIRA: That happened to us yesterday.

ERWIN BERNAT: Yes, on a small scale. If we have our own idea about topic A and we bring a speaker with conflicting criteria, the generated debate is very enriching. I think it would be a good idea. Is it planned to publish the guests´s presentations in some type of  retrospective compilation or another format? In my opinion, congresses that do not publish that compilation of presentations -to call it something- "are lost". They are forgotten, because there is no proof of anything. And that is why I think it would be important to publish, at least, the presentations of the expert Guests. My idea would be to publish them in a separate book and not in a special edition of our Journal.

MARCELO PALACIOS: In the next Journal there will be information about the Conference. The Scientific Committee, according to our statutes, is the only reason for that Foundation to be and the absolute responsible for the scientific aspects of the Congress. As regarding the economic and organizational responsability of the Conference, it is the Foundation´s, that organizes and assumes the expenses, not us as Scientific Committee. We hope to summon around 2.000 people, the majority of whom will be Spanish and from other European countries for certain. It is only a prediction that will depend on the diffusion and the level we give to it; as regards installations, they are modern, prepared for these events, they are in the pavilions of the FIDMA. Three of them are more than enough to accommodate that volume of people.

       Therefore the SIBI Foundation sees about financing and technical organization, and the scientific organization is exclusively our responsability.

       As regarding the guest, independent of that we hope the Honor Presidency of the Conference fall on the Royal Family, maybe the king, (that is the idea we have), what would be a reason too for our going to Madrid one day and we summon you to go to the Royal House to introduce ourselves as Scientific Committee and International Society of Bioethics; it might be coinciding with a meeting, in which case I would ask you to come before, we can meet in Madrid and we can greet the King and the Queen to reassert the request that we will have made before.

       Our idea was that each day the Conference was presided by a personality: The General Director of UNESCO, the President of the General Secretary of the Council of Europe, and we would include the people that because of their outstanding, maybe a Nobel prize, can come and as guest. In fact it will last four days: Tuesday, Wednesday, Thursday and Friday, as Monday 3rd will be to pick up the documentation in the morning, and in the afternoon for inauguration acts, and Saturday 8th is the closing day and to give the SIBI Prize. As regards other quests, we will have to decide who they are, and see our possibilities.

      Of course, the reports of the Conference will be published in a book.

Well, then, as we said, for the meeting in November the topics to deal with are: ethical aspects of the new millennium, transplant of organs and euthanasia.

     I would ask you to leave half a day of the next meeting to deal specifically with these and other topics of the Congress.

JOSE EGOZCUE: I would ask to add the topic of the pre-implantational disagnosis, because in the year 2000 the Human Genome will be better understood, maybe we can start putting forward ethical debates about what is coming upon us. 

MARCELO PALACIOS: I think it is a good idea, but we have considered that the problem of each meeting is that there are a lot of topics in the agenda, and if we are also going to dedicate half day to the Congress we can find ourselves with an excessively big work agenda.

ERWIN BERNAT: Can we conclude, then, that each of the members of the Committee, are in charge of presenting proposals for guest speakers together with the topics that each of us suggest as priorities and we will send them to you so, when we meet in November, we can already do the selection. Is that the agreement?

MARCELO PALACIOS: Yes. In November I am going to present to the Foundation a first draft of the Congress. The first problem to solve about the guests in the first place would be in the number.

ERWIN BERNAT: We are already 23 people in the Committee and...

JOSE EGOZCUE: Some very specific points. In the first place, I insist on the proposal I have made before: to decide the topics first and then think about the speakers is more practical than sending everything at the same time; second, as Bernat suggested we are 23 people, and it can result a very long list. We should have an idea about the budget to know the limits.

MARCELO PALACIOS: I have received some suggestions planning that each of us could invite one or two people, better one. I do not want to compromise myself, but I have the conviction that we will get our aims.

JOSE EGOZCUE: This already gives us a idea, that we can calculate around twenty to fifty invited  speakers, and this is all right; second, about something you have said, in the Congressess it worries me the dispersion of people, that is, that we should try to concentrate to the maximun, I do not know if Gijon has three thousand five hundred hotel beds within a not too extense radius, because when people are accommodated twenty kilometers away from the Congress they are not comfortable. Therefore we should take into account this aspect. And then I think that the advertisement of the Congress in the journal has appeared to late, but I think that from the 2nd to the 8th  is a very long period for a Congress.

MARCELO PALACIOS: On Monday 3rd in the morning, the documentation collection will take place, and in the afternoon the official openning of the Congress. Tuesday, Wednesday, Thursday and Friday are the working days, with the afternoon of the Wednesday free, so that this Scientific Committee can gather and can grant too the SIBI Prize.

JUAN RAMON LACADENA: As I said before, I think that really each of us must present proposals of topics that we think must appear in the Congress, but not limit ourselves to propose two or three things, that each of us proposes the list that he wants and then we will see the big coincidences that are going to be in the topics suggested. How many topics will be left in the end? I think that it is important to bear in mind that the Congress is going to last from Monday to Friday, that it would be good, that every morning and every afternoon of each of those fives days will be dedicated to a specific topic, with which in the end we would have ten topics; of those ten topics as Bernat has said there should be a presentation in favour and a presentation against; I totally agree with this but, but before those presentations in favour and against, if we are going to talk about bioethics, I insisted that the scientificc presentation is needed, someone that explains the state of art in the specific topic that is going to be tackled. With this there would be three invited conferences, if there are going to be ten sessions morning and evening, five days, there would be thirty speakers in total; that would be let´s say the plan, the framework of the Congress, and evidently those thirty speakers as a compensation that they are invited they have to come having the manuscript delivered before so that the publication of the book is not delayed later.

MARCELO PALACIOS: The presentations that have not arrived in the settled delivery time will be consider as declined. With regard to what you have just said, Amos, I would suggest that  that general presentation is worked out by this Committee, and we decide who of us presents it.

JUAN RAMON LACADENA: As you have exposed it, five days with two sessions, for a Congress of this magnitude would be very little, but I had not caught on the possibility of doubling sessions. It can be done if the topics that we are going to deal with are not too much overlapted, so there are no people saying that being in this one I cannot attend the other one, which is sometimes an inconvenient for Congresses. Logically in the web page the advertisement of this Congress has to appear  as soon as possible.

And finally you have mentioned the possibility of the Honor Presidency falling on the King. Carlos Romeo and I have certainly of the Queen´s concern about Bioethics. We have taken part in sessions about Bioethic’s topics before the Queen and I do not know, if offering it to her, instead of offering it to him. I mean she is a person enormously concerned about these questions. 

MARCELO PALACIOS: We will really bear it in mind.

AMOS SHAPIRA: Obviously this is going to be a massive and an important Congress in all aspects. It would be advisable if we could -and it is not going to be easy- find a unifying theme for the many sessions and topics that are going to be discussed in the Congress. I have my fears that -as it happens in other Congresses of this type- it could becomes a "mumbo jumbo". We should look for a unifying theme for the Congress. I know it is not going to be easy, but we should think about it.

MARCELO PALACIOS: If we plan the necessary ethical aspects for the millennium, the nexus of union of all the aspects to be dealt with, surely it could be "Bioethics of the year 2000".

AMOS SHAPIRA: I did not have a specific title in mind and I was not thinking about a definite title. I was pondering about giving the Congress a direction. We should find some common denominator, some thematic framework.

MARCELO PALACIOS: The Congress itself defines what is that summons us: Bioethics. Regarding the "mumble jungle" you point out, Amos, we have attended Congresses like this and we have to avoid this at any price; and if there are many people, to manage not to have interferences while we are working, to which it will contribute without a shadow of doubt the good organization and the splendid rooms we will have at our disposal.

The driving block for the Congress will be the ethical aspects for the millennium, which is get to the point already; in the second place, organ transplants; third: euthanasia; up to 10 blocks of topics to which we have to add Bioethics pedagogy and the media.

CARLOS Mª ROMEO-CASABONA: They are ten topics, but I only have nine. And we could get subtopics out of there, but, it coincides with what you are saying more or less. First there would be the bioethical principles for the year 2000 as we have agreed, then we would have the human reproduction: things related to genome or genetics, the rights of the patients, transplants, research or experimentation; aspects related to the end of human life and euthanasia, assistance help in suicide, hunger strikes, ..etc, then biotechnology and environment as you have said. There is one left and from there we can extract subthemes for the partial sessions. I want to say they are big blocks and they include the big problems of the actual Bioethics.

MARCELO PALACIOS: I am thinking about an excellent work from professor Roca about people´s rights, adding patients´ and disabled people´s rights regarding Biotechnology.

CARLOS Mª ROMEO-CASABONA: Do you know what happens?, that in "people´s rights" practically all are involved.

AGNI VLAVIANOS-ARVANITIS: Only two things. One: not to refer to "ecological systems" but to "the environment", because that way we give a wider view and we will avoid any "negative" dimensions. And the other: to incorporate the concept of "New Dimensions" so that the need of expansion into a new way of thinking is introduced. This would attract attention and perhaps many people would want to express their point of view in this respect.

JOSE EGOZCUE: I want to support the suggestion because I was myself going to propose it, because I think it is a wonderful idea. And, in fact, environment has been already proposed by Carlos.

MARCELO PALACIOS: Have we got something else about the Congress?. In principle the topics were: human reproduction; human genome;  patients´ rights; people’s rights; organ transplants; research-experimentation in the human being; euthanasia. I think this maybe will be increased with the end of human life, biotechnology and environment, new dimensions, and pedagogy of Bioethics.

AMOS SHAPIRA: To avoid duplicity and vagueness, perhaps we could combine the already suggested blocks. Agni, what was the exact title that you mentioned? Ah, "ETHICAL ISSUES FOR THE NEW MILLENNIUM".

MARCELO PALACIOS: Actually the ethical principles will have to be devised at the end of the Congress. That is to say we start from some ethical suppositions and some principles for the next century will come out to a large extent from the Congress. Could we perhaps say "ethical suppositions or ethical approaches at the beginning of 21st century"? Some new approaches and even a new bioethical language will surely come out from the Congress.

AGNI VLAVIANOS-ARVANITIS: When we say "Bioethics" and then "issues for the New Millennium" we are giving a long-term view. That is why we must put special emphasis on the word "new" because we have to address these issues with a view to the future.

ERWIN DEUTSCH: I think we already have the topics. Is it advisable to group in a only block "Medical experimentation and transplant of organs"?; I say that, because the medicine of the transplant is already, at this precise moment, applied medicine, and the Ethical Committees does not almost supervise the protocols of organ transplants. Grouping those two topics takes us back to 15-20 years ago, so I would rather to treat them separately.

JOSE EGOZCUE: A little nuance, you propose "Ethical Issues for the New Millennium".

AGNI VLAVIANOS-ARVANITIS: "Bioethics"

JOSE EGOZCUE: Yes, yes, and I like it. But I think it is very ambitious, that´s why I think if we change the article "the" by the indefinite "a", we make a new introduction to the millennium. Therefore it would be: "BIOETHICAL ISSUES FOR A NEW MILLENNIUM". But if we say "for the millennium" it is understood that they will be those applicable for the WHOLE millennium.

JUAN RAMON LACADENA: In the beginning I was taking about ethical aspects for the millennium, you have just stressed, insisted several times in bioethic aspects. The Congress is about Bioethics and everytime the word ethics is used it has to have "bio" before, otherwise it would seem we are talking about economic, industrial or whatever ethics. Therefore it must be "Bioethics" so that it is know that the framework of the Congress is the bioethics.

MARCELO PALACIOS: Agni agress on that "bioethic aspects for a new millennium" can be the initial motto of the Congress. We have the initial outline of the Congress, and if you think it right, we can start dealing with other aspects of the agenda.

JUAN RAMON LACADENA: As we were dealing with internal organization questions I suggest we exhaust other points that will take us little time; to talk about the Journal and the SIBI web page and then go into some of the scientific topics that we had still pending.

MARCELO PALACIOS: Then let´s go to number zero of the SIBI Journal. It came up rather quickly, because I wanted to put it to you for consideration to pick up suggestions. Number 1 will be a repetition of number 0, with an added article from Pompidou. For that number 1 Guido has given us some splendid photographs of embryos. Number 2 will include the works of Michaud, Egozcue, Deutsch, Gerin and Elizalde. I would ask you to prepare articles for the following numbers. After this consideration, I think there are some things in the journal to be  modified. Now it has fourty-seven pages, but in the future it will have between a hundred and a hundred and ten pages; it will be published in English too and it won´t be stapled, but it will have a spine that will make reference to the number and to the SIBI. Articles will have to be here at least two months before its publication, to be translated, what will be done by professional translators. If you notice page 49 you will see that the format is different that the one from the rest of the Journal, that goes in two columns. You must tell me if we should put a column in Spanish and the other one in English, or if at the end of the work in Spanish we put the whole work in English without repeating the photograph and the author indeed.

JOSE EGOZCUE: Three points. First, I would be in favour of publishing the work first in a language and then the whole work in another language, because what the magazines of the airlines do with a column in English and the other one in another language presents many problems; second part of the first point: I would publish both the works in Spanish and in English in two columns, the second one without photograph, but both of them in two-columns. And then I have two very specific points, one is that I do not like the word "magazine", it is frivolous in English and it would be said JOURNAL; the other specific point, it is a pitty that the Registration forms compell the Principles of the Society to be cut.

MARCELO PALACIOS: It is a consequence of the speed with which the Journal was made up. Of course, the Forms are not going to be separate like that, but you will have to allow my having had these liberties, as it was only about showing  you the aesthetics of the Journal. There is in it a "Presentation" and this will disappear from number 2 onwards, there will be a leading article without photograph, and the interventions from Authorities will disappear. The journal will be limited to its own purposes. Do you agree with the format and the aesthetics? For instance, the article from Grisolia, page13, is it O.K. if we put the topic "Scientific opinion" in a lateral?. I wanted to ask you if the  items of each blocks are correct, because I want to suggest other things. I am not very sure that the Documentation section has to be called like this, "documentation, regulation and legislation"...

ERWIN BERNAT: Legal sources?, perhaps.

AMOS SHAPIRA: The word "legal" can indicate "legislation" but it can also be interpreted as "jurisprudence", "Court decisions", "regulation". It could be applied to academic text of legal type.

MAURICE DOOLEY: The Protocol of the Agreement points out clearly enough the kind of document it is about.

AMOS SHAPIRA: A comment for the future: in many magazines of this kind there is a section titled "recent developments" that compiles the new legislation promulgated in various countries. And also court decisions in matters related to Bioethics. I am not saying that we should create that section now, only that we should have it in mind.

AGNI VLAVIANOS-ARVANITIS: I like the Journal very much, I think it has been done with an exquisite taste. In the future, will you be publishing it in French too?

JUAN RAMON LACADENA: No, no. First in Spanish followed by the English version, all like the other one, but without photographs.

AGNI VLAVIANOS-ARVANITIS: Who will the Journal be aimed at? Will all the libraries of the world be informed of its publication and in what way will its promotion  be carried out?

MARCELO PALACIOS: Agni, if you allow us, we will talk about the Journal itself first and then we will go on how its distribution is planned.

JOSE EGOZCUE: A little suggestion, simple but important. The Journal, at least at the beginning of each article has to say the number, the year, first and last page of the article and volume in its case, and it has to be through if from number one onwards the numbering of the Journal will start again or if it will be the continuation of the previous one, we will have to think if from number one the numbering of the Journal will start with each number or a correlative numbering will be done, that is, of page; we have to think about it.

MARCELO PALACIOS: I would incline, as the journal has different works, to be started and finished in itself; the correlative numbering goes better with documents of other type that do not have a continuity, as the officials, official Gazettes, ..etc.

     In the "Documentation" pages we should make it easy for the readers that they can stockpile a documental block so we should publish rules or laws of interest. In the SIBI we have recent documents, for instance a German law, an English law, Spanish, Danish laws, documents from the UNESCO, the Council of Europe, ...etc, but it will be interesting to enlarge the SIBI´s library; now there are around four hundred books and two thousand documents that I have taken and that a scholar is sorting out, that of course will go to the web page.

     I wanted to present to you for consideration the incorporation of a new section; I talked about it with Agni and some other people, and they suggested differents names; it would be interesting to incorporate what it would be called "Correspondence", "Guest", or something like that, so that we can have opinions from institutions of UNESCO itself, of UNICEF and other entities. Are "Correspondence" or "Guest Article" the proposals?, even though  "Correspondence" can be understood as "letters to the Director".

JOSE EGOZCUE: I think we could have both things: "Correspondence" and "Guest Article" that are different things. If we want to include a "Correspondence" section, there could be comments and opinions from any person or entity. Under "Guest Article" we would publish the ones sent by those people to whom the SIBI had asked for their contribution, and it is something that does not need to appear in all the numbers. We might want to issue some Editorial from time to time, but not as a fixed section.

We can include these ideas with a "mobile" character. In all the numbers there would appear the "Correspondence" section, where we would publish letters and opinions. And then, every time we have a guest article, we would include it in a different section. And if there is not any for the next number then it is not published.

JUAN RAMON LACADENA: I agree with you proposal, because it is very flexible. I have another one and it is that we should count with a section relating to our Society. For instance, after each of our periodical meetings, we could make a brief summary or "Declaration of principles" about the most relevant topic we have dealt with and publish it so that our readers can see the global point of view of the Committee; this way we would give our meetings present.

GUIDO GERIN: Even making good use of these meetings, although it was only about one specific topic, that we would reach some common conclusion about any point, of what it is that we think after having discussed, and this way we bind ourselves here not only to discuss, let´s say for our own curiosity, but also to reflect a little bit our joint opinion about topics that have been the object of the different meetings of the Scientific Committee.

JOSE EGOZCUE: Two comments, one, about publicity, and about this I think we have to bear in mind that the inside cover is a very expensive page and, therefore, we would obtain a lot of money by publishing advertisements in that page; second one, I think the Journal must show if it is protected with a "Copyright" and what has to be done in case of using the materials published there by someone else. This is a political decision.

MARCELO PALACIOS: The SIBI is missing, but we have it available. Reference is made also to the documents published in the Journal, so they can be reproduced in another media, as long as their authors and the SIBI are mentioned. The requests to publish articles and opinions must be negotiated through the International Society of Bioethics, SIBI, and it will be Editorial Board of the Journal who assesses them. There might be a "Miscellany" to which we will also incorporate donations to the Society´s library, about questions related to books, the library, the bibliography, our decisions, ...etc. As Egozcue in due time was not in favour of counting with "Associates", we will change this name by "Collaborators", that are those who sympathize with the SIBI, and they will receive the Journal free and they will pay a small fee.

AGNI VLAVIANOS-ARVANITIS: I think all of us can spread information about the Congress of the year 2000, through our circle of friends or in our professional environment. Perhaps it would be convenient, before we adjourn this meeting, for all to make proposals about the best way of spreading this information.

ERWIN BERNAT: Would it be possible to count, for the meeting in November, with some information poster that each of us would see to it that it is published in our respective environments?

MARCELO PALACIOS: Yes we can, and we will do it as soon as possible. Two more things. The Journal will be sold to the public, and we are looking for reputable and prestigious spreading channels. On the other hand, the Group Alsa has assured us that they will diffuse the Journal in all and every one of their routes; supposing the collaboration of Iberia is possible, we would also have an area of diffusion; University is statutorily committed to diffuse the Journal, and also it has their internal academic channels; in its commitment with the SIBI the University not only took part economically in the legitimization of the Society, but also it has the compromise of placing its media and editorial means at our disposal in a way that in that academic environment the University of Oviedo is going to play a very important role. We will also take the journal to the web page, and finally the Journal will be sold to the public, with which it will be in all the bookshops in its moment.

From now onwards the bar code and the ISBN will be put. It would be very interesting that we could already value what the price can be. Magazines of this type, with this quality of paper and 110-120 pages in polychromy, range between six hundred and one thousand and five hundred pesetas, but there are others that are good and they are than a thousand pesetas. With the selling of the Journal we will aim, above all, to spread the work of the SIBI and to compensate its cost, and we have throught it could be sold at a price around thousand, one thousand five hundred pesetas.

AGNI VLAVIANOS-ARVANITIS: I think we must keep the price below 1.000 pesetas. I believe six hundred pesetas would be appropriate.

MARCELO PALACIOS: There are several factors to be taken into account, the percentage of distribution, etc, so that the Journal does not cause losses. Well, let´s go on with the agenda: registrations.

GUIDO GERIN: I think it would be a good idea to point out some guidelines and that a new Agreement is needed because the discovery is not patentable until it takes place. Of course, this would make the job of scientist difficult because they would see their researches blocked. Because if we say "I know I have the patent about a specific part of the human genome" this would have a negative effect over any research that it would find itself, as I was saying, blocked and researches would have to pay for that patente if they want to act. I have something written about this that I can send to you, but I suggest we ask EEC for the definitive document, because for the moment, the document is not  the definitive one. I think the patent of the whole or of parts of the person should not be allowed, in connection with the genome, I think it is very dangerous. My conclusion is that the SIBI must go into that debate.

JUAN RAMON LACADENA: I had the idea that the Council of Europe had accepted the proposal of Board. I do not understand quite well what is the obstacle that remains, because I thought that it was once and for all accepted. What is the situation?

GUIDO GERIN: The Parliament has approved, that is to say, the idea suggested by the Commission. There is a draft but the Document is not definitive I think it has not come out yet. I can talk about the draft. The text says it is patentable every microorganism produced by antibiotics -this "does not belong" -to the human being of course - but it also says the gene that allows to obtain a new "product" and I think that is dangerous, not only because the product in itself, but also because I think genes must be heritage of Humanity, and that is why I say we cannot allow that they are patented. If they are patented, scientifics would find their work blocked because they would not be able to publish results of studies about a specific gene that had a patent. As SIBI,  we can request that a Protocol is made about the procedures that regulate every use of the human genome to avoid the marketing of part or of the whole of the genome. I know there were 18 amendments to the initial text, but I cannot disclose any information about how the final drawing-up will be.

AGNI VLAVIANOS-ARVANITIS: What is the temporal validity of a patent? Is it applicable on an international scale? That is to say, are American or European patents applicable, for instance in China, or in other parts of Asia?

GUIDO GERIN: Yes, yes. The Agreement binds Europe and Asia. It is different with U.S.A.

AGNI VLAVIANOS-ARVANITIS: So, it does not have universal validity.

As we go on deciphering the genetic code, will the different genes be patented? Does that mean that other research Centers cannot continue their work without the "permission " of the holder of the patent?

ERWIN DEUTSCH: The Agreement doesn´t forbid to research, research is free. The only problem is the limits to research. Even the experimentation of a new drug is something free, but this sometimes borders on the limits of what is permissible. In U.S.A. two years ago, the NIH tried to obtain patents for all the sequences of the human genome. Fortunately the American Patent Office got tired and  stopped patenting under the excuse that they didn´t know if these things were or not patentable. Right now there is a legal vacuum and you will understand why Germany wasn´t too happy about that European Regulation, because we didn´t want it to be so ambiguous regarding questions as this. As you will understand, who drew it up were people linked to the world of patents and therefore they were always biased to give patents about whatever, human or animal. Sometimes they say things such as that patents should be applicable until seventy years after who has registered them die. Thanks God they only last for twenty years!. But some drugs can get a deferment for another five years. Do you see how "poor" the Law is?

GUIDO GERIN: The European agreement forbids the patent, but it allows to patent the sequential of the genome.

MARCELO PALACIOS: We can address a note to the European Parliament asking them to clarify this question, as it would be of a general interest. Is this what you mean, Guido?

GUIDO GERIN: No, not completely, because the definitive decision has already been taken. I was referring to whether it would be possible that the SIBI asked for an Agreement about the new procedures. I suggest we wait to the edition of the definitive text and I will send a copy to you the moment I have it and then we can criticize it and add our point of view with regard to "freedom for research", not against but in favor of researchers.

AGNI VLAVIANOS-ARVANITIS: I think that on our Scientific Committee there are highly qualified people in this specific field and, therefore, an article in the Journal delineating legislation and perspectives in other countries, would  be useful in bringing all these problems to light.

GUIDO GERIN: In U.S.A., Japan and in some other countries it is possible to make patents and that is why the EEC decided they had to do something about it, this Agreement, this Treaty, but I think in Luxembourg the Parliament has done some modifications although not all of them will have been accepted.

MARCELO PALACIOS: If you agree we can go into the topic of the Ethics Committee, about which we have already spoken when dealing with research-experimentation.

CARLOS Mª ROMEO-CASABONA: To make an exposition and then discuss it, first we have to take into account that there are several types of Ethics Committees. In some countries there are National Bioethics Committees, whose functions are different from one country to another because in some countries they have executive functions, -they have executive capacity when authorizing specific activities- but most of them, or all of them partially, only have advising or emission of opinions functions; the truth is they do not exist in all the countries, to be exact Spain is one of the countries that does not have a National Ethics Committee. Then we have, what we usually call Clinical Research Bioethics Committees, that exist only in some countries, and that must authorize all the protocols of research done in each hospital; it has to be pointed out that the European Union is already finishing or perhaps it has finished a Regulation about the research with human beings. If I am not wrong it was planned to introduce the necessity of these Clinical Research Committees that must approve the research protocols; this is important because in some European countries they do not have these Committees yet, in Spain they exist, in Italy, for instance, too, they are  compulsorys. And finally we have the Committees that have been working in some European countries for many years, the so-called Ethical Committees: Hospitable Ethics Committees, welfare Ethics Committees, etc, that if I am not wrong I think it is an importation from U.S.A.

     In relation to these committees it worries me what would really be their function, for the European countries, even though, I insist, they have been functioning in many countries and in Spain too for many years. What would their specific function be? I consider they can be useful and in fact they are going to be so, especially as a first function to introduce a conscience of  the ethical significance of the decisions taken in hospitals; I think that is important that  through these Committees doctors acquire more and more this conscience, that, on the other hand and because of the universal atmosphere that exists regarding to it they are acquiring too; but I consider, on the other hand, that in U.S.A. these Committees could be justified because there the system called "Common Law" is in force, that is, not a system let´s say of laws, as in Europe, in spite of the fact that until a few years ago there were many laws about medical or biological topics; in U.S.A. that could have that function of completing the lack of regulations, but in Europe that justification would not be necessary although evidently the biomedical activity is so complex, it has become so complex, so difficult especially in the taking of some decisions that I think they can also be useful.

      I suggest that we simply discuss if in Europe these Committees could carry out exactly the same functions they have been carrying out in U.S.A. (where they have their origin), and we could discuss what differences could be between these Committees with the function they could perform in Continental Europe, taking into account, that, as background of course, there can frequently be legal consequences and therefore we would have to consider that in the U.S.A. there is a "Common Law" system, that is to say, it is not based on the law, while in Continental Europe the legal system is that of the law, basically, without perjudice to the importance that the decisions of the courts, the "Case Law" can have.

JUAN RAMON LACADENA: I am going to allow myself a simple comment of a personal type, that has to do with the Ethics Committees, because I come from the genetic sxientific world and  since many years ago I became interested in Bioethics topics and I have had the opportunity of belonging to some Bioethics Committees; one, for instance, is the National Board of Assisted Human Reproduction, that was created last year, nine years behind the "Palacios Law" came into effect, but that National Commission was finally created; I also belong to a Bioethics and Clonation Committee of a Foundation of (...) to health, to study -by a method, let´s say, American type, of public audiences of statements, institutions and on a personal level of all Spain-, what is the Spanish opinion regarding the topic and try to get some conclusions.

     What I have learned, of course in these meetings too, is that to reach an unanimous solution is practically impossible, but that the Bioethics Committee have reached the more sensible conclusions; and I think that is the important thing, that is to say, to think that nobody is in full possession of the truth, that there usually are different views, as they are dependent, pluralist Committees, and then the logic thing is that there is not an unanimous agreement amongst all the members; but if we all get to the conclusion in the end that what it is decided or thought is what wisdom advises, I think that is something very important in that type of approaches.

AMOS SHAPIRA: Carlos Maria has already explained that there is much confusion in many systems as regards what is understood by "Ethics Committees". One of the reasons, in my opinion, lies in the fact that in different systems, and sometimes even in the same country, we find Committees exercising different functions. In the case of hospital ethical committees, they should deal with grievences, complaints, requests, suggestions from users (patients, relatives and others). And then function, related to the previous one in hospital contexts, would be the responsibility to take ethical decisions in the clinical setting, especially regarding the end of life: (to connect or disconnect machines, etc.). And then we have, of course, the supervisory function in the field of human experimentation. So we see three –different if related- functions. There are ethics committees that combine –and sometimes confuse- these three functions. I think that when it comes to presenting what the situation in our respective countries is, it is important that we take into account these three distinct functions and that we examine what organs exercise them –separately or jointly-.

MAURICE DOOLEY: One comment: let´s remember there are Ethical Committees in some but not in all European Countries. It exists what it is called EUROPEAN STANDING CONFERENCE OF NATIONAL ETHICS COMMITTEES to which countries that do not have those instruments attend, for instance Great Britain, where there are many on a private level but not a National Committee. The last meeting was held in Paris, in January, and the next one is scheduled for the 9th-10th of November. I am going to read to you a brief summary of what they intend to do: the meeting will Center on the aspectes related  to the bio-medical research on an international scale, apart from the exchange of opinions about the way in which National Ethics Committees work.

     In the meeting in Paris it was dealt with the preparation of a statute (draft) that has to be presented in the next meeting and whose aim is the regulation of the annual or biannual meeting of this group. It is also planned the collaboration of the National Committee of Portugal. In the light of the preparation of this statute, the Standing Conference asked the Council of Europe for a compilation of the registered Ethical Committees, number of members of each of them, ways of working and a Memory of their activities and achievements. So there is that project to make all that information accessible and that it also can be analized in order to look for the homogenization of the working of the Committees.

AMOS SHAPIRA: And what does the Standing Conference understand by "Ethical Committees"?

ERWIN BERNAT: We have talked about the different types of Committees that work under the generalized title of "Ethical Committees", but I think the real meaning of the term is linked more to the research activities in human beings; I think a Committee created for the drawing up of a bill should not be called "Ethical Committee"; of course that group will have to operate on the basis of certain ethical principles, in a way that their proposals are good for the people, but it would not be an Ethical Committee. Sometimes the legislature considers them on those terms, as in the case of France. The Committee of type 2, and I follow the classification done by Amos, isn´t either a purely ethical Committee.

        In the famous Queenland´s case-related to the ending of her life-, the Supreme Court of Jersey dealt with the topic and said "in the future there will have to be an Ethical Committee in charge of contacting us to see if a patient as Karen Queenland is really in a vegetative stage". But what the "Ethical Committee" should have to do-according to the Supreme Court of Jersey- is not an ethical evaluation of the potential case but a diagnostic assessment of the state of the patient. A Committee of this type would have nothing to do with an Ethical Committee, in my opinion, because if a doctor is asked to do a diagnosis and he does it, this has nothing to do with ethics. In the research, as we saw yesterday too, these Committees have to consider ethical questions, so, what are the two basic principles they must obey in connection with the proposed research?. In my opinion: the principle of the informed consent and the second one, the (... in German). In this context, the Committee would be applying existent regulation criteria, "standards", that are there to protect the fundamental rights of the patients.

AMOS SHAPIRA: It is necessary to determine what an Ethic Committee is and what it  is not. The other problem, for me, is bureaucracy. I am a member of a National Ethics Committee and we had to evaluate a protocol about biomedical applications concerning embryos. Every time we needed additional information we said "we don´t have to act as if we were a local committee; let´s ask the local committee for information". And who makes up the local committees? And how often does it convene?

ERWIN DEUTSCH: In America we have two types of ethical committees: one, the purely ethical Committee and the other one the REVIEW BOARD. You were saying that Ethical Committees are not sometimes decision-making. Well, each month we receive about 20-30 research protocols: 2/3 coming from the pharmaceutical industry and the remaining 1/3 from the university. And we have to assess and to validate them.

AMOS SHAPIRA: What jurisdiction does your Committee have? Is it a university Committee? Then, what jurisdiction do you have regarding the private industry?

ERWIN DEUTSCH: In the first place, we can decide if the research mustn´t take place in our clinics; in the second place, if the main researcher belongs to our university we can block the research unless the German FDA tells us the opposite. The Ethical Committees for research work in a way similar to a court, they discuss the opposing views but in the end there is always a consensus veredict: to accept or to paralyze the protocol.

ERWIN BERNAT: (...) the analogy could be drawn, do not you think?

MARCELO PALACIOS: This topic is basic, we can talk about it for a very long time, even the suggestion of the Council of Europe about an International Bioethics Committee hangs in the balance.

AGNI VLAVIANOS-ARVANITIS: What has been said about Ethical Committees can be used as a guide and be very useful. So I suggest our President takes care of finding out if this paradigm can be conferred to other institutions or contexts, and if the definition that has been given here about the different functions of the committees is valid. Perhaps SIBI can disseminate it as "guidelines for the functioning of ethical committees".

MARCELO PALACIOS: Dear friends, we get to the end of the session. Thank you, and to those of you who have to travel, I wish you a good return home.