Speech at Trans-Atlantic Dialogue on GenEthics and Health

Thank you for joining me at this seminar organised by The Norwegian Research & Technology Forum in the U.S. and Canada, under the auspices of the Royal Norwegian Embassy and Centre for Strategic & International Studies.

The topic of this meeting is an important one. The rapid and impressive advances in research and development provide us with unprecedented opportunities for human, social and economic progress, not just in our respective countries, not just in the industrialized world, but indeed on the global stage. At the same time, these same advances also raise fundamental political and ethical challenges and dilemmas.

I am a politician and, of academic training, a theologian. I’m even ordained as pastor in the Lutheran Church of Norway although I have yet to serve as such. So some of you may think that I’m well positioned to talk about such political and ethical dilemmas. Indeed, I hope I am. And I will talk about some of them here today. But I also humbly recognize that throughout history, clergymen have not always been on the right side of the issues, on the right side of human progress.

When Galileo brought the telescope to Rome early in the seventeenth century, the men of God refused even to look through it. They preferred sticking blindly to the prevailing world view based on a literal understanding of holy scripture, rather than seeing through this wonderful new tool how things really were. This example, I’m sad to say, has been just one out of far too many examples of arrogance and ignorance on the part of religious institutions and people of faith, when faced with scientific and technological discoveries and theories. I’m a man of faith but I can assure you that it is my firm conviction that we must not turn our eyes away from neither the telescopes nor other instruments of scientific discovery and progress. We must utilize them for the common good of mankind and to guard the sanctity of human life. However, this is precisely where the challenges and dilemmas come into play. The common good of mankind and the sanctity of human life should be our ethical guiding stars. Sadly, not unlike Galileo’s adversaries, many scientists, policymakers and corporate leaders seem to refuse to look through the lenses required to see those stars. For Galileo himself, these lenses were at least as important as his cherished telescope. My main message here today is that, like Galileo, we need to promote progress utilizing both our scientific and ethical faculties and capabilities.

During my visit to Washington in December 2001, I had the pleasure of officially launching the new Norwegian Research and Technology Forum in North America. The Forum is an integral part of my Government's strategy to strengthen the bonds between our two countries.

Since my visit to Washington one and a half year ago, I am very pleased to note the significant progress that has been made in strengthening our links with respect to research. Through a series of targeted network initiatives and symposia, such as the one today, the Forum has succeeded in creating several new cooperative ventures. New contacts and common projects have been developed during these first 18 months of Forum operations.

One excellent example of this, is the agreement on collaboration between the Johns Hopkins Medical School in Baltimore and the Medical Faculty of the University of Oslo, which was signed in May last year.

I am hopeful that today's trans-Atlantic symposium can lead to similar types of collaborative ventures.

Biotechnology - an important tool

Modern biotechnology is one of the most promising technologies developed over the past years. It may have the potential to provide food for the hungry and cure for the sick. It gives us all expectations for a better life for people all over the world. If it is used in the right way.

Let me illustrate this with an example from the newly discovered SARS epidemic, which today poses a real threat to public health in several Asian countries and possibly the entire world. With modern gene technology the virus causing this disease was quickly identified. Its routes can already be traced with speed and accuracy. In addition, mutants can be more easily detected.

This is an advantage both from a surveillance point of view and as an opportunity to hopefully develop an efficient vaccine against the virus. This is just one example. Gene technology already is in use for diagnosis and prevention of a number of diseases. Unfortunately, though, the really big killers on the world scene—such as malaria and tuberculosis—have so far not received attention corresponding to the human suffering they cause. 90 percent of health related research resources are spent on diseases affecting the richest 10 percent of the world population. This is a real challenge to us, both as policymakers and science community.

Norway as a partner

Front-line research in medicine and technology moves fast. It is multidisciplinary and extremely demanding with regard to manpower, know-how, infrastructure and financial resources. Norway hopes to stimulate and reinforce networking, researcher mobility and exchange between front-line research centers in the US and Norway, within and across disciplines and professions.

We want to see even more new approaches that pave the way for improved preventive initiatives and improved diagnostic and therapeutic methods in medicine and health care - in compliance with ethical guidelines. I strongly hope we can make progress on the staggering health challenges associated with poverty in the world a part of this joint agenda.

Why is Norway an attractive partner in medical research and development? What can we offer?

Norway can boast of high quality health and disease registers and biobanks hardly found in any other country. Every Norwegian citizen is identified by her or his individual digital birth code. Our registers cover decades, for instance for cancer, heart diseases, child birth, and general health parameters. We have a relatively steadfast and homogenous population. I guess you can say there is at least this one advantage of not being such a multiethnic country as the United States.

Combined, this opens for research across populations and generations in health registers and biobanks in search for parameters and mechanisms underlying disease – for the benefit of international knowledge development.

The increasing knowledge of the human functional genes, their variants and consequences for the treatment of diseases, makes the use of biological material more promising than ever.

Norway does have other advantages that make us attractive as research partner and associate. A recent peer-review-based international evaluation of Norwegian biomedical research gave excellent ratings in neuroscience. It also presented high ratings in cancer research, microbiology, and some other fields. Norway is also strong in research in the borderline between medicine and technology.

Again, let me give a few examples:

The Norwegian Centre for Telemedicine in Tromsø, well above the Arctic Circle, is a WHO-collaborating centre. Norway’s up-front ultrasound imaging research has given advanced clinical application systems, received the European IT Award 2001, and a Norwegian leading ultrasound enterprise was recently bought by a world-leading US-based technology firm.

The Ugelstad beads invented in 1986 are used worldwide in immunology and molecular biology. A group at the Norwegian cancer hospital in Oslo recently launched Photocure, an FDA-approved photodynamic therapy technology for the treatment of skin cancer.

A 10 year national program on functional genomics (FUGE) was launched last year with an annual budget of 20 million USD in 2003. Recently 13 Centers of Excellence were appointed following international peer review, sharing a top-finance grant of 20 million USD annually allocated for the forthcoming 5+5 years.

Norway has recently re-organized the health care system. The new National Institute of Public Health coordinates most of the health registers. The hospitals are organized as five regional governmental enterprises and have specific responsibility for clinical research. Combined, this has the potential to facilitate clinical research coordination and conduct of high-quality clinical trials.

Medical research is becoming big science. The human genome project has laid the basis for major new projects. Cross-disciplinary research and access to large patient materials and registers are needed to reveal the genetic mechanisms and environmental interactions underlying disease. We now witness growing international collaboration driven by the mutual benefits associated with large-scale joint projects and joint utilization of patient registers. Norway is a small country, but we have unique assets to offer.

I will even argue that our policies with regards to ethics in science make Norway attractive as a partner. Just as we have seen in the business sector generally in recent years, public opinion increasingly puts pressure on conduct. Enlightened publics are demanding more corporate responsibility, of conducting business according to high environmental and social standards. They also demand transparency. They want to know what is going on. This is positive, and we welcome it. Biotechnology and genetic science are already under increased public scrutiny. I believe, and I hope, that ethically responsible conduct will increasingly become not only a standard to meet, but indeed a comparative advantage of the most advanced and enlightened actors, whether public or private. My goal is to firmly establish Norway as a frontrunner in these regards.

Biotechnology and Ethics

As mentioned above, biotechnology represents perhaps one of the most promising new tools for diagnosing and preventing illnesses and diseases. It also has the potential for new and powerful therapy.

However, the ethical issues raised by these new techniques should be considered seriously. Our decisions today may have a great impact – in both a positive and a negative sense – at the individual level as well as on nations and indeed the whole world. We therefore have to carefully consider the consequences of developments in this field. This includes ecological and environmental consequences, as well as in medicine.

In Norway there has for many years been a vivid and fruitful public debate concerning different issues relating to biotechnology. Opinions differ, whether we are talking about ecology and gene modified organisms, patenting regulations or issues of life and death related to medical biotechnology. But that’s quite okay. Open discussion is important in order to find the right way forward.

One of the hot topics has been intellectual property rights and the new EU regulation in this area. My view, a view shared with many others, among them powerful medical associations in Europe, is that the patenting directive goes too far and may lead to less research and development in the medical area, rather than the opposite. In addition, legal forms of ownership in human genes, microorganisms, microbes, plants, or animals is deeply problematic from an ethical perspective. I have therefore, together with a few other European governments, questioned the right to give permission to scientists and commercial enterprises to patent living forms and organisms.

We believe that life is inherently a common good to be managed and utilized responsibly and for the best of the whole of mankind, both present and future generations. It should not be exploited for commercial interests only. The genetic diversity that is found, not least in developing countries, represents a source of potentially enormous wealth for these countries. In my opinion this wealth must directly benefit the people of the countries where it is found and not simply be extracted and taken away. We need to strike a sound balance where benefits are shared.

Modern biotechnology is actually one of the major issues with which my Government has been concerned. And let me now concentrate on medical biotechnology in this regard. As late as a month ago – on April 11, 2003 – the Government proposed a new bill to the Norwegian Parliament. The bill describes the Government’s view on the development and regulation of biotechnology in Norway, seeking to strike the right balance between ensuring scientific progress and making ethically responsible decisions.

The proposed bill will most likely be supported by a majority in Parliament when it is brought to the floor in June.

Respect for human life from conception to natural death

For me personally, as for the Norwegian Government, the respect for human life from its conception to a natural death is a key principle and a main goal of politics, whichever field we are talking about.

Protection of every human being and the dignity of each person – born or unborn – should be a hallmark of our policies. Every human being is unique and holds the same value and must enjoy the same, universal human rights.

This might sound self-evident. However, when it comes to biotechnology we have to realize that we are faced with some real ethical dilemmas. For instance:

• to what extent should it be allowed to exploit cells or tissues from embryos and fetuses in order to cure individuals that are already born?
• how should we meet modern advances in fetal diagnosis so that we do not end up in a society in which some humans are welcome, while others get eliminated before birth?

Recently I saw a newspaper article where someone argued for intensified fetal screening in order to radically reduce the number of children born with Down’s Syndrome. It would save millions, it was argued. That could be. But are we not equals, of the same human diginity – with the same right to live? What about the 9-year old boy with Down’s Syndrome who just recently became a hero because he was the first to notice that the house he lived in was on fire and thus saved the lives of his entire family? Should they be hunted down with the help of new technologies? This gets me back to the lenses and the guiding stars. We cannot reduce public policy to a matter of economic cost-benefit calculations only. That is simply inhuman.

We know that modern technology has the potential power to eradicate diseases. However, this should not come at the expense of the unborn human life.

I believe this is one of the dilemmas we are facing when discussing modern biotechnology. We know this can do good, curing and preventing many serious and even life threatening illnesses. But human life should never be sacrificed in the process. We must make every effort to attack the illnesses through other means.

Medical biotechnology in Norway

More than 15 years ago the Norwegian Government established a council to deal with ethical and social issues concerning modern biotechnology. This council, composed of a combination of independent experts in relevant fields and by lay people representing different interest groups, advices the Government in questions concerning biotechnology. It also informs the public and stimulates public debate about ethical and social implications of biotechnology.

Assisted reproduction was regulated by law in Norway already in 1986/87. In this bill assisted reproduction as in vitro fertilization was allowed: Research on fertilized eggs and embryos was, however, forbidden. Artificial insemination became regulated. At the time, the sperm donor, or biological father, was granted full anonymity.

Following discussion in Parliament, the Parliament requested the Government to propose ethical guidelines for research and development in biotechnology and gene technology. These guidelines were presented in 1990/91, followed by a report called “Humans and Biotechnology” in 1993.

The law banned research on fertilized eggs and embryos. This was strict compared with some other European countries. Rapid developments in the field impelled Parliament to request a revision of the law after approximately five years.

This is, in brief, the historical background for why my government has now presented revised legislation.

The new Biotechnology law

This new bill is firmly based on values we find in our Christian-Humanistic Western heritage. I have already mentioned that the protection of – and respect for – each individual human life from conception to natural death are the main pillars for setting these values. This is also reflected in the European Convention on Human Rights, which we recently incorporated in Norwegian law.

Ladies and Gentlemen,

I am strongly of the opinion that all human life should be protected by law. Each human being has a value merely by being a member of the human race. Each individual human is his or her own goal and can never be a means for others.

I stress this so strongly because it represents the platform upon which we are building our biotechnology policy. Let me give you some concrete examples from the proposed bill.

Assisted reproduction

Assisted reproduction is a technique that has given many parents the blessing of having their own child. We are grateful for each and every one of these infants. However, this technology is not without ethical challenges. For instance, with the in vitro fertilization technique more human eggs are fertilized than is placed into the uterus. Some unused embryos are even discharged.

This is problematic, to say the least. I wish there were a method that would allow supernumerary embryos – those not implanted into the uterus – not to be produced at all. Furthermore, by implanting two or three embryos in order to increase the pregnancy success rate, we generate multiples such as twins, triplets and quadruplets. This in turn causes problems related to premature birth and injury to some of these children.

My Government has therefore proposed to Parliament that only one fertilized egg be transferred back to the uterus. This is in line with the latest recommendations of the European Society for Human Reproduction of 2001.

Concerning artificial insemination we believe we are improving the ethical dimension of the law also by giving the child the right at the age of 18 to learn who the biological father is. In my opinion, it should be self-evident that everybody has a right to know this.

It is interesting to see how public opinion in Norway has shifted on this matter over the past 20 years or so. At the time, very few of us advocated the view that is now accepted by a majority. I believe this illustrates the importance of an open, public debate. Here, the Council on Biotechnology has played a very useful facilitating role.

Research on fertilized human eggs

As in 1994, my Government still opposes research on human fertilized eggs. We also oppose so-called pre-implantation diagnostics, a technique enabling us to investigate genetically the fertilized egg and consequently discard embryos with certain genetic defects.

We want to avoid moving in a direction where individuals with certain defects are screened already in fetal life and subsequently often aborted. In this matter we have chosen a different path than Denmark, UK, and also Sweden. In Germany, on the other hand, freezing and storage of fertilized eggs and embryos are not allowed.

The Council of Europe is strictly against the production of fertilized eggs for research purposes. It does not, however, take a stand regarding the use of the pre-implantation technique.

Fetal Diagnostics and Ultrasound in Fetal Life

Diagnostics of fetal diseases have been accomplished by biochemical and genetical testing. We also know that testing of fetal cells isolated from maternal blood in the near future might represent an easy and quick method to diagnose a wide spectrum of diseases of the fetus. This method is being developed due to the efforts of several research groups – not least in this country.

Ultrasound has become a powerful tool in fetal diagnostics. Without doubt, this technique provides great benefits for both mother and child and we welcome that. The pregnancy can be surveilled and any deviance from the normal can be detected and often corrected.

Ultrasound provides important information which may aid local doctors and midwives in making critical decisions. For example, many pregnant women with special conditions detected by ultrasound are now transferred in time to a large hospital with advanced capacities.

In Norway we are not doing fetal surgery. But Norwegian fetal and newborn experts are watching closely the interesting developments in this field taking place in San Francisco and other centers in the United States.

In the new bill my Government proposes to make a key distinction between two main uses of ultrasound. On the one hand, there is ultrasound as a screening tool to monitor the pregnancy on a routine basis. This is to maximize the chances for a successful delivery of the child. On the other hand, there is fetal diagnosing.

The former is in our opinion ethically uncomplicated. Screening around 18 ^th> to 19 ^th> week of pregnancy is applied on a routine basis in Norway. Ultrasound for fetal diagnosing, however, raises several ethical concerns. We therefore propose to regulate this practice by the same law and according to the same guidelines as the rest of fetal diagnostic techniques.

This means, if for instance a midwife or obstetrician at a local hospital or in private practice detects any signs of deviation from the normal, the pregnant mother should be referred to a regional center with the highest competence in this field.

This proposal has generated some public debate. Some of our midwives and fetal experts have felt that this might limit and decrease the quality of the routine ultrasound screen. We do not think this is the case. On the contrary, this proposal will secure the best quality of care for all fetuses in Norway. Modern technology also drives us in this direction. Some reports, not least from the U.S. lately, indicate that ultrasound might be replaced by ultra-fast magnetic resonance techniques as the superior tool to investigate the fetus. Such equipment has to be restricted to a few major centers, at least for the next several years.

There has also been public discussion in Norway of so-called early ultrasound scanning of the fetus. We know that the resolution of modern ultrasound equipment is sufficiently high to enable the investigators to see details of the fetus already between 10-14 weeks of gestation. Down’s syndrome can be detected in this way. We do not see any good reason to introduce early ultrasound in Norway as long at it has not been proven to benefit the health and well being of the fetus and newborn infant.

Stem cells

In Norway, as in this and many countries, we have had a vivid public discussion on the use of stem cells from fetuses. We know that these cells have remarkable properties and might be efficient means to cure serious diseases such as Parkinson’s disease, diabetes, cancer, cardiovascular diseases, etc.

However, according to the view of my Government, it is ethically problematic to exploit fetal cells, even from supernumerary fetuses after in vitro fertilization, for such purposes. To produce human embryos for the sole purpose of using their cells to cure others, would be even more problematic.

We have had the same discussion about these difficult issues as in most other Western countries. The use of stem cells brings us right into the classical and fundamental dilemmas stirred up by modern biotechnology: Is it acceptable to use another human life, however weak and small it may be, to save already born individuals?

There are no easy answers to this question. And I feel humble when discussing them. When faced with people suffering from serious diseases we must do our utmost to help them, to cure them if possible. This is our responsibility. But at the expense of other human life?

Due to the respect we feel should be paid to the fetus as a human being, the Government has decided that research with fetal stem cells should not be allowed in Norway. Therefore, we will rather support research with adult stem cells. If more resources were invested in this area, important results could be obtained. The use of adult stem cells has great potential and can save the lives of many.

Conclusion

Ladies and Gentlemen, in the invitation to this symposium it was expressed, and I quote: “each nation strikes its own balance on the scope and pace of development and ethical considerations. Each wants to keep it that way and have dialogue but avoid national and international misunderstandings and conflicts over these choices”.

I fully agree with that. This is also in full agreement with for instance the principles of the EU treaty where it is stated that “ each Member State retains full prerogative to legislate on ethical matters”. It is important that each country finds its own way, but we should also strive towards international consensus on important matters of principle. It seems that governments of most countries, as indeed my own, are against cloning of human beings. I would strongly welcome international binding agreement on this, beyond the European continent.

Dear Friends,

Development within modern biotechnology is exciting and promising. We are grateful for all new means to cure diseases and give people a better life. Thus, I am very satisfied that all four universities in Norway take part in networks involving U.S. research groups and collaborate actively with US research centres.

Few investments provide better returns to society than research. I strongly welcome increased research collaboration between the U.S and Norway – building on our tight historical and cultural connections.

However, we should insure that we have a global perspective in what we do. Biotechnology affects developing countries in a number of ways, lack of medical research the same. Their interests must to a much larger extent guide our efforts.

Furthermore, in our eagerness to move forward in research and technology, there are certain principles that should not be ignored. First of all I will underline the principle of respect for human dignity and the principle of individual autonomy. With the modern biotechnological developments these principles might come into conflict with each other. I therefore consider it highly important that these ethical issues be continually discussed and explored, not only among researchers, but also among philosophers, theologians, ethicists, and also we who are policy makers. And we should conduct the discourse out in the open, where the general public has the opportunity to listen, to participate and ultimately make its own judgment. In Norway, these issues matter for many voters. This is reflected in how many actually vote.

Let us all participate in the discussion on these issues, this matters of life and death! Let us live up to Galileo’s example, both in daring to veer and venture into the unknown and daring to do so guided by moral principle. Also in these matters there are strong and compelling grounds for a close trans-Atlantic relationship. If this symposium here today can contribute to advancing and strengthening this balanced, shared agenda, it will definitely have been worth our while.

Great progress is always possible. For, as Albert Einstein has said, “ the eternal mystery of the world is its comprehensibility.”

Thank you very much for your attention.