SCIENTIFIC COMMITTEE M  I  N  U  T  E  S         Nº  1 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 tests generally 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.