ROUNDTABLE REPORT

							                           ROUNDTABLE REPORT

                BIOETHICS AND BIOTECHNOLOGY:
              WHAT IS AT STAKE FOR HUMANITY NOW?

                               Elizabeth Rose Hall
                         United Nations University, Tokyo
                                   2 June 2003




                                    Organizers:


                        Embassy of France in Japan
Embassy of Germany in Japan/ Japanese-German Centre Berlin (JDZB)
    United Nations University (UNU), Institute of Advanced studies, Tokyo




                                  INTRODUCTION


The Roundtable was conducted under four different themes to explore the
different cross-disciplinary aspects of biotechnology, i.e. scientific, social, ethical
and legal. The day-long seminar was broadly divided into four sessions to
delineate these issues:
     Where is biotechnology revolution leading us to? Future applications in
       human health.
      The cultural limitations to biotechnology revolution – what is desirable ?
      Regulating biotechnology applications for humans – what is feasible?
      Ethics - where are boundaries and tradeoffs with biotechnology?


There was a sizable turnout of about 120-130 participants which included officials
from the Japanese Ministry of Education, Culture, Sports, Science and
Technology (MEXT), ambassadors and other officials, scholars from universities,
heads of research institutes, faculty of the research institutes, the Press and
research students.



The speakers and the topics were

         1. Genomics: potentials and challenges
             Professor Ken-ichi ARAI, Dean, Institute of Medical Sciences,
            University of Tokyo.
         2. Cloning: Where are we heading?
              Professor Detlev GANTEN, Max Delbrück Center Berlin, Member
            of the National Ethics Council, Germany.
         3. The Japanese cultural perspective on biotechnology and its
            advancements
            Professor Rihito KIMURA, Director, International / Asian Bioethics
            Program, Waseda University.
         4. Morality, decision-making and biotechnology in Europe
            Professor Didier SICARD, President of the National Ethics
            Committee, France.
         5. The precautionary principle: Is it a bridle to technological
            progress?
            Professor Jean-Pierre CONTZEN, Chairman of the Board, UNU
            Institute of Advanced Studies, Tokyo.
         6. Who owns the human genome?
            Professor Jochen TAUPITZ, University of Mannheim, Member of
            National Ethics Council, Germany.
         7. Ethical choices and legal strategies: The case of human
            embryos and stem cells
            Professor Catherine LABRUSSE-RIOU, University of Paris.
         8. Ethics beyond national boundaries, how to go forward?
            Professor Ryuichi IDA, University of Kyoto, President of UNESCO
            Bioethics Committee.
         9. Prospects for a universal consensus on bioethics?
            Dr. Nicole QUESTIAUX, Member of UNESCO Bioethics Committee,
            President of the European Conference of the National Bioethics
            Committees.
             The final session was followed by a panel discussion which was
             thrown open to the audience also. The session was chaired by
             Prof.Menon, Former Minister of Science and Technology, India.


                                     OBJECTIVES
In order to foster an international dialogue on bioethics issues between France,
Germany, Japan and the body of nations represented by the United Nations, the
French and German embassies based in Tokyo in conjunction with UNU/IAS and
the JDZB (Japanisch-Deutsches Zentrum Berlin(Japanese-German Center
Berlin) decided to conduct a roundtable conference on bioethics and
biotechnology. This Roundtable aimed to facilitate an in-depth debate to forge an
international consensus by bringing together experts from France, Germany,
Japan and the UNU/IAS.


Human cloning research, stem cell research and ownership of the human
genome are some of the crucial issues raised by the development of
biotechnology. Who owns the human genome? What are the implications of
altering the genes of unborn children? Is it acceptable to use human stem cells to
restore organs? Does bioethics impede biotechnology? These questions raised
by the biotechnology revolution have scientific, legal, ethical and cultural
implications that the experts of the Roundtable tried to grapple with.


Given the rapid progress in life science, it is essential that the international
community keeps pace with these developments. Last year, Germany and
France launched a joint initiative at the United Nations for an international
convention banning the reproductive cloning of human beings. The General
Assembly of the United Nations failed to arrive at a consensus but it will be taken
up again in the session this September. The debates in the assembly clearly
showed that the issue of banning reproductive cloning despite having nearly
universal acceptance throws up other serious ethical issues. The issue of
therapeutic cloning comes hand in hand with reproductive cloning.


                                  OUTCOME
Very interesting issues emerged from the presentations under the four different
themes. Since developments in biotechnology are so rapid and new knowledge
is added very fast, some of the speakers provided a learning experience for the
audience, for some it was an eye-opener. The talk on cloning revealed some new
ethical issues that warrant discussions. The legal issues were clearly elucidated
and it was worthwhile to have an unpacking of the complexities in the matter of
the ownership of the genome. The cross cultural and borderless nature of
bioethics issues were highlighted time and again and the United Nations as a
forum for discussion on such an important issue found echoes in more than one
speaker. The move in the General Assembly towards developing a legally
binding instrument to ban reproductive cloning was seen as a first step.


1. The promises of medical biotechnology


A - Personalised medicine


Professor Arai, a recognized geneticist presented the major paradigm shift in
medicine. This shift is from the age-old deductive approach used i.e. to describe
the patient patho-physiology to the ability to predict ‘what may happen’ based on
the patient genotype. The technology is now available to detect SNPs (single
nucleotide polymorphisms) and thereby facilitate research on the cause of the
multifactorial diseases. Genome clinical epidemiology will help in developing
personalised medicines where the drug will be tailored to the patient’s need.
Systems biology approach integrating biotechnology, information technology,
nanotechnology and environmental technology is key to the development of
personalised medicine. Translational medicine is necessary to translate
technology into medicinal applications and safe experimental techniques need to
be developed to realise the dream of personalised medicine.


There are many bottlenecks before personalised medicine becomes a reality: i).
legal questions of ownership of the material used in immune cell therapy, for
example; the patient may claim that it is originally his ‘material’. But the company
might say that they have processed it; ii) the cost factor of personalised medicine
and who will bear it? Tax payers, the patient?; iii) the balance between public
health goals and individualized medicine (How far should you go in your effort to
‘keep alive’ is an ethical question. – Van Ginkel) .

Finally, the promise of genomics in relation to the 10/90 health gap is a major
issue. 87% of the 3 trillion dollars spent globally in the health sector are on 16%
of the population. 10% percent of the global disease burden takes 90% of global
research. Out of the 30 billion dollar investment on health research, only 5%
deals with problems of the LDCs (least developed countries). Out of the 1223
new drugs between 1975 and 1997, only 11 are primarily those for developing
countries. This is the degree of inequity. What promise does genomics hold to
bridge the gap?


B - Cloning and its future


Reproductive cloning is unacceptable to the community of nations and there are
rumours that it has been attempted by some ‘weird people’. Professor Ganten
immediately set the stage by stating that cloning to produce human beings was
probably not possible and therefore ethically not relevant. The big issue remains
cloning for biomedical research. It will have a great impact in addressing the
problem of transplant rejection during cell therapy. Stem cell research is at a very
early stage and it is too soon to tell which approaches (adult vs. embryonic) will
prove most useful and for which diseases. Some of positive signs in the use of
stem cells have been for the treatment of Parkinson’s disease with dopamine
neurons derived from embryonic stem cells. Treatment of heart infraction, bone
and cartilage disease, cancer and other immune system diseases and diabetes
are some that might benefit from stem cell research and cloning. A startling
hypothetical statement made was that somatic cells i.e. ordinary body cells like
skin, bone, muscle etc, could be dedifferentiated and made totipotent! (See
diagram below)-the implication of which is that all our 3 billion cells in the body
are potentially ‘embryonic’ stem cells. The experiment has not been done, but
from the fact that one can use the adult nucleus under specific conditions (at the
present time it is the female oocyte) and reprogram it to a totipotent cell, there is
no reason to believe that the adult stem cells, which are even earlier in the
programming process, cannot be converted back to a totipotent cell. Ganten has
proposed an international Stem Cell Project, where the very controversial stem
cell research could be reinforced by coordinating the research and involving
commercial as well as ethical issues. A forum can be established for the purpose.
However Ganten is of the opinion that genomics and stem cell research as a
practical applied science is largely overestimated, just healthy nutrition will help
in many of the instances.
                           Differentiated Somatic cells



                                Adult Stem Cells
                                 Bone Marrow



                             Multipotent Stem cells



                             Pluripotent Embryonic
                                Stem cells (ES)



                                 Totipotent cells
                                     Zygote
                                  Early Embryo



2. The importance of socio cultural aspects


A wide range of social and cultural aspects have to be considered in the context
of the biotechnology revolution. The goal of bioethics is to balance the interests
of law, science, economics and public opinion. Reflection on the
interconnectedness of these interests must constantly evolve and keep pace with
the scientific progress. Advancements in the science itself are commendable.
However, the ‘technically possible’ should not be the justification for the
development of applications. The distinction between technology and science
should be clear and workable so that there is scientific progress and
technological development that integrates well into society. Science should be
unhindered since it is a furtherance of our knowledge, it is technology and
application that needs to be brought under scrutiny and evaluated ethically. This
evaluation should be integrated into a wider vision of the sense of humanity. The
one question that must be pondered upon is: "What type of humanity do we
want?" emphasized Professor Sicard. Bioethics tries to answer this question and
these answers must then be translated into laws. The French laws on bioethics
(1994 – currently reviewed) introduce a constraining juridical interpretation in
addition to the ethical one. The European bioethics is based on a strong
conception of the human individual, beyond its physical and social existence. It
relies on the respect of the individual dignity, the inviolability of the body and its
non-commercialisation and the protection of the person's autonomy. This
supposes that within the quest for scientific knowledge, we must detect the
underlying material motivations (power, money, desire of infinite maintenance of
the human body). The progress of biotechnology involves inherent risks. They
should not be considered in the sole context of the precautionary principle.
Instead, they should be fully recognized and implemented in the political decision
making process. This is the only scenario for scientific progress to carry on while
at the same time avoiding the development of undesirable applications for
humanity.


Japanese culture has its own unique characteristics. Initially, the Japanese
culture was not for ‘too much of intervention with nature’ and it advocated the
principle of harmony with nature. Even now, the growth of science and
technology must be in harmony with nature. Lessons must be learnt from the
ghastly deeds of armies around the world which committed unspeakable
atrocities in the name of experimentation.


3. Legal Issues


A - The Precautionary Principle


The Precautionary Principle - a fairly recent political and legal tool (initial
formalisation in 1987) - constitutes an attempt for meeting the preoccupation of
society towards risk. Principle 15 of the 1992 Rio Conference first used the
precautionary principle at the international level. It was first incorporated into
national law by the French “code rural”. The European Commission in 2000 took
the following approach:

‘Preventive measures should be taken in the specific circumstances where
scientific evidence is insufficient, inconclusive or uncertain and that there are
indications through preliminary objective scientific evaluation that there are
reasonable grounds for concern that the potentially dangerous effects on the
environment, human, animal or plant health may be inconsistent with the chosen
level of protection’.


However all these texts leave ample room for interpretation about the triggering
factor for the application of the principle. It is not easy to decide on whether the
application of the precautionary principle is justified or not. The answer lies in
good governance. The four essential elements of good governance are:

        Serenity: decision-makers should avoid any bias, any pressure in
       their treatment of the question
        Responsibility: the Scientific community should follow             the
       “Verantwortungsethik” –ethics of accountability
        Proportionality: extensive, unconventional, cost/benefit analysis
       should be performed before applying the principle
        Reversibility: once taken, decisions should be reviewed periodically in
       function of the evolution of scientific knowledge


Currently there is a lot of ambiguity in the application of the precautionary
principle. The rationale for the introduction of the principle has been quite a
laudable one: preserving our common good, containing the excesses of
globalisation etc. It was not intended to be an agent against further scientific and
technological progress. The alteration of this rationale has occurred mostly when
national or ideological interests have been in question. It is time to restore the
original value of the principle. This can be achieved through good and strong
governance.

B - The ownership of the human genome


The human genome is in jeopardy between ownership and personal rights.
Nature is a common asset and a common property. This principle cannot be
applied all the time since nature can be compartmentalised for its utility. For
example, exclusive rights are given over certain parts of nature. Genome is only
a part of nature. So can exclusive rights be applied to the genome? Is the
sequence of the genome a patentable asset? – were the questions raised by
Professor Taupitz.
As opposed to this – Is there any social duty for the individual to accept request
for sharing ‘his/her’ genome? Every culture and country confers personal rights
to a human: right to live, right to be protected against damage or harm, rights
over part of the body which is separated from the person… It is possible to
transfer the rights of a body sample to a researcher but not to sell it. The
interpretation is that isolated body parts actually take the title to the rights with it.
However, the information contained in it is still of some relevance to the person
and public disclosure of this information cannot be done without the permission
of the person.


There is a distinction between ownership and personal rights, though both are
rights. The major difference is that with ownership, transfer of rights is possible
by way of ‘sale’. However, personal rights will always stay and can never be sold.
It is an inseparable part of an individual. Within the framework of personal rights,
there is a right to utility that can be transferred. In some other instances the
trade-off between personal rights and the public good is considered. If the public
good is greater than ensuring personal rights then the former will be given more
importance.


In conclusion, the genetic material can be subject to property/ownership rights at
the same time there are some personal rights inherent in it.


What is the public interest in the genome? Can exclusive patent rights be
exercised over the human genome? This is an international problem. There are
many objections to patentability of the genome. It is not an invention, but a
discovery. Patenting is against human rights. Patenting will affect research
carried out on the genome. These are the various arguments against patenting. If
criteria of patent law are seriously and ethically studied.


What is the real problem with respect to filing for a patent for human genome? If
patented, then it will exclude others from using it for a particular number of years.
One solution would be to stipulate within the patent itself the licensing process for
the patent and social obligation goes along with patent.
Genome is not the common asset according to western constitutions. Genome is
under the exclusive disposal right of the individual and then the patent holder can
transfer it to others. Tradeoff between individual interest and public interest is
very important. This proportionality approach is a justifiable approach.


Individual rights have to be upheld, but public interest aspect and dignity of the
human being have to be safeguarded.


C - The embryos and stem cells


For embryo and stem cells, it is difficult to balance the public interest and the
interest of the individual said Professor Labrusse- Riou. The status of unborn
human beings is one of the major issues of bioethics. The reconciliation of ethic
values and potential uses of the embryos for research is particularly difficult. On
the one hand, scientists, MDs and the biotechnology industry are actively
lobbying to obtain the authorization for research on embryos. On the other hand,
such research runs the risk of treating the embryo as a mere object of research,
the anthropological implications of which have not yet been fully evaluated. The
human embryo is the centre of growing and recurring tensions. The tussle is
between two freedoms: whether the destiny of a human being can be decided by
another and whether unused embryos could be used for research to serve
interests of living persons, since the production of embryos in vitro is authorized.
As a consequence of this tussle, Europe is divided on the issue of allowing
research on human embryos. National policies in different European countries
differ.


The human embryo is caught between ethical requirements and necessity for a
practical approach. Ethical principles are weakened by the definition of the
human being through rights rather than with regards to dignity. Opposite facets of
human rights arise when the embryo is viewed as object of an abortion or of
research purposes. This context leaves no room for conciliation, and requires a
clear choice of the legislator. The evolution of the legal framework in France
remains cautious, distinguishing the embryo in utero and the embryo in vitro; the
rights of the mother precede the rights of the embryo. Concerning the latter,
research is prohibited as a whole, but exceptions are developed.
4. The need for an international consensus on bioethics


National perspectives and the international dimension of bioethics were
considered. The clear message that emerged was that an international
consensus must be developed and it should incorporate the concerns and
features of different cultures.


Bioethics is a code of conduct; simply academic discussion will not be enough.
Ethical rules must be pragmatic. This code of conduct must be a common code
for all humanity. It is not interstate code of conduct i.e. not international, but
rather it calls upon each individual to follow it. That’s why the word universal is
better suited. On the other hand cultural diversity, religions, traditions and
customs must be respected. The Universal declaration of human genome and
human rights, 1997 drafted by the International Bioethics Committee (IBC) and
adopted by the General Assembly in 1999 is a landmark document which
recognised the need for a universal outlook. The word universal has a lot of
meaning. The IBC is presently engaged in a universal declaration on human
genetics data. The process towards universal bioethics will need to be addressed
four-fold:
            Necessity to have universal bioethics
            Methodology to reach this goal
            Scope and scale for the universality
            In universality how to ensure Diversity


Nuremberg code onwards there has been a necessity for such an instrument for
ensuring human rights as advancements occur in different fields. It is a core
concept for peace. Bioethics is not given by God. It is created by people. As far
as the methodology is concerned, there is yet no decision but the UNESCO has
produced universal documents that have no legal binding value but constitute
universal guidelines. Professor Ida emphasized that at the level of a nation 4
pillars are necessary: i) law or guidelines, ii) National bioethics committee
(established in 1983 in France, 1998 in Japan and 2001 in Germany), iii) public
involvement and iv) education on bioethics at the junior and senior high schools.


Based on the conclusions of each session, Dr. Questiaux summarized the 4
elements needed to promote the universality of bioethics.
      Promoting procedures that can be universalised. The questions raised by
       progress of science are difficult and are not limited to the Christian world
      Looking for universal principles and steps to reach them. Despite the
       different cultures, the different religions, and the place of these religions
       within the socio-cultural background, this symposium was able to bring to
       light the recurring principles of the freedom of research, the freedom of
       thought and the free access to knowledge.
      Translating the empirical and pragmatic reflection into law. A national
       framework is essential to actually transform the consensus in discussion
       into reality. France has succeeded in establishing Bioethics laws in 1994
       but has shown the limitations of this process with regard to international
       recommendations: i.e. the difficulty of adopting European Guidelines on
       the genome in the French national law system.
      Fostering a dialogue with a focus on the ‘economic’ component. Two
       recommendations were made: i) to include ethical considerations within
       the intellectual property rights, ii) to avoid too stringent guidelines that will
       hinder research.


We have a huge responsibility to successfully realise a universal consensus on
bioethics – Questiaux


There is not going to be a bioethics for developed countries and a bioethics for
developing countries (Menon)


Genetic Determinism cannot exist – Ganten


Science itself is not the culprit - Ida

Harmony with nature is the essence of Japanese culture – Kimura


Public opinion is replacing public elected opinion – Sicard


Research not for the sake of research – Sicard


‘Should everything that can be done also be done?’ – Van Ginkel


What is the value of keeping alive in relation to creating new life? – Van Ginkel
We are responsible for what we do not do. That is the deeper sense of the
‘freedom of research’ – Taupitz


Bioethics must be considered in the context of broader ethical thinking – Menon


From the viewpoint of developing countries as one sees the miracles of
biotechnology, the question one would ask is: is it a mirage- is it for real? Is it
going to have an impact? - Menon


Ultimately one has to educate the society at large – Menon

                                                                             Compiled by
                                                                K.Chamundeeswari, UNU/IAS
Stéphane Roy, Rafik Leneguer, Grégoire Fages, Embassy of France in Japan