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A Trans-Atlantic Dialogue on Genetics and Health: Research Frontiers and Ethical, Economic, Legal, and Social Issues May 16, 2003

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A Trans-Atlantic Dialogue on Genetics and Health: Research Frontiers and Ethical, Economic, Legal, and Social Issues May 16, 2003 A Trans-Atlantic Dialogue on Genetics and Health: Research Frontiers and Ethical, Economic, Legal, and Social Issues May 16, 2003 A Symposium Co-hosted by The Royal Norwegian Embassy, Washington D.C. through its Norwegian Research and Technology Forum in the U.S./Canada and The Center for Strategic and International Studies Executive Summary The genomic era has introduced an explosion of biotechnological advances with implications for health, including genetic tests, microarrays, pharmacogenomics, pre-implantation genetic diagnosis, and the promise of embryonic stem cells. Has our public policy kept up with this rapid pace of scientific progress? How do we deliberate about the ethical, legal, and social implications of new genetic technologies within our pluralistic societies? Furthermore, how can we promote further advances while ensuring the ethical acceptability of the findings, especially when there is a stark divergence of views across Europe and the United States? What are appropriate policy frameworks for dealing with the wide divergence in national legislations? These questions were addressed in "A Trans-Atlantic Dialogue on Genetics and Health: Research Frontiers and Ethical, Economic, Legal, and Social Issues," a symposium co-hosted by The Royal Norwegian Embassy and the Center for Strategic and International Studies (CSIS) in Washington, D.C. on May 16, 2003. The seminar opened with remarks by Charles A. Sanders, former CEO of Glaxo Inc, and CSIS trustee, and Knut Vollebaek, Ambassador of Norway to the US. The Honorable Kjell Magne Bondevik, Prime Minister of Norway, gave the Keynote Address. The presenters that followed represented a wide variety of topics, backgrounds and perspectives. They presented the scientific, ethical, and policy challenges introduced by pharmacogenomics, regenerative medicine, and pre-implantation genetic diagnosis. While pharmacogenomics promises to offer patients personalized therapies, this new application of genetic knowledge may complicate clinical trial design and be challenging for physicians to incorporate into clinical care. In addition, pharmacogenomics may heighten concerns about genetic discrimination and privacy. New techniques in the field of regenerative medicine might extend life spans, but the cost of health care for an aging populace will increase as a result of these technologies. Parents desperate to overcome infertility or avoid a disease that has devastated their family will have increasing options to do so, but these individual choices have significant implications for society and may conflict with ethical guidelines. Representatives from Norway described the advantages that this nation offers for biotechnology research and international collaboration. Speakers promoted the progress that can be made with creative partnerships across different disciplines. All of the seminar participants expressed a firm belief that the new technologies represent an exciting potential for the relief of human suffering; however, they would have to be developed within acceptable legal, moral and social norms. Within this broad area of agreement, the symposium participants expressed marked differences in emphasis. Some would prefer minimal 1 regulation in order to avoid impeding scientific progress, whereas others would prefer that scientific and technological development only proceed within strict regulatory limits. Examples of such differences in national legislations were presented. Prime Minister Bondevik gave an overview of the recent legislation on biotechnology introduced in Norway, providing an example of a very strict regulatory context. Other seminar participants expressed sharp disagreement with this model, arguing that it would impede scientific progress. The different viewpoints presented during the symposium made it clear that one must accept a diversity of viewpoints in this controversial area of policy. Even though the Prime Minister represented a country where social and political values exemplified a strict regulatory approach, he also stressed the value of tolerance and respect for the choices of other countries, providing a possible framework for resolving the tensions among different national approaches. Several issues for future discussion emerged from the symposium. For example, how can one develop mechanisms and frameworks to foster an atmosphere of mutual understanding, while accepting the right of countries to make their own choices and the right of countries to have their choices respected by others? It would be important to develop clear international regulations before agreement can be reached about particular topics, such as human reproductive cloning. In areas where there is a need for further discussion before reaching international agreements, mechanisms and frameworks for dialogue will have to be developed. These mechanisms for dialogue will be essential for collaborative research to be possible in the context of what might otherwise appear to be mutually exclusive policies. Finally, policy-makers must be mindful that genetic information is truly global. One must bear in mind that policies also will affect those countries that are not yet developing genetic technologies. Furthermore, one must consider how everyone, both in the developed and the developing worlds, can have access to the benefits of biotechnology. Symposium participants discussed these challenges as the major areas of concern for the future of international science policy. Opening Remarks Charles A. Sanders Former CEO, Glaxo Inc. and Trustee, CSIS, Symposium Chair -- Knut Vollebaek Ambassador of Norway to the U.S., Forum Chair -- Keynote Address Kjell Magne Bondevik Prime Minister of Norway Speakers Rita Colwell Director, US National Science Foundation 2 -- Steve Fodor Chairman and CEO, Affymetrix, Inc -- Sandy Thomas Director, Nuffield Council on Bioethics -- William Haseltine President and CEO, Human Genome Sciences -- Richard Jackson Adjunct Fellow, CSIS Global Aging Initiative -- Mark Hughes Professor and Director, Center for Molecular Medicine and Genetics, Wayne State University School of Medicine -- Ola Didrik Saugstad Professor in Pediatrics, Department of Pediatric Research, The National Hospital in Norway -- Anne McLaren Principle Research Associate at Wellcome/CRC Institute, University of Cambridge, Member of European Group of Life Sciences (EGLS) and the European Group on Ethics (EGE) Panelists Torleiv Ole Rognum Professor, Institute of Forensic Medicine, University of Oslo, and member of the Norwegian Biotechnology Advisory Board -- Barbara Rhode Head of Unit on Ethics, Science and Society, Directorate General Research, EU Commission -- Alex MacKenzie Professor of Pediatrics, University of Ottawa, and Vice President of Research, Genome Canada -- Thomas H. Murray President, The Hastings Center 3 Scientific Progress and Ethics: Galileo’s Telescope and the Stars that Guide Us The Honorable Kjell Magne Bondevik, the Prime Minister of Norway, clearly delineated the research priorities, goals, and ethical implications of biotechnology in Norway today. His opening address, highlighting the crucial need for ethical guidance especially in the area of assisted reproductive technologies, provided a sharp contrast to points made later in the morning promoting the promise of genetics. This divergence in perspectives set the stage for the morning discussions: although policy-makers, ethicists, scientists and physicians differed in their ideas of which technologies should be pursued and which might require more oversight, all parties agreed that open deliberation would be the only way to achieve real progress. “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,” stated Mr. Bondevik. “At the same time, these advances also raise fundamental political and ethical challenges and dilemmas.” Prime Minister Bondevik provided an analogy between the current state of biotechnological progress and the attitudes of the early 17th century in Galileo’s Rome: genetic progress today represents the “telescope” that we should not turn away from in ignorance but should instead embrace. Biotechnology could provide “food for the hungry and cure for the sick…[giving] us expectations for a better life for people all over the world.” However, it is necessary to devote attention to ethics, or as Mr. Bondevik articulated, we must look through the lenses of technology to see the guiding stars of “the common good of mankind” and the “sanctity of human life.” Mr. Bondevik’s convictions about the sanctity of life, from conception to a natural death, imbued his proposed policies toward biotechnology. Believing that life is a common good, he opposes patenting of human genes, microorganisms, microbes, plants, or animals. Further, he insists that the wealth created from biotechnology should be shared throughout the world, and especially in those countries that provide the source of the discoveries. In a new bill proposed to the Norwegian Parliament on April 11, 2003, the Government outlines how the dignity of human life can be preserved through strict regulation of genetic technologies. Opposing prenatal diagnosis used to prevent the birth of babies with disabilities, Mr. Bondevik instead emphasizes treating illnesses through other means. The proposed bill also would impose regulations on in-vitro fertilization (IVF),
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