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  1. 1. The Transnational Governance of Synthetic Biology Scientific uncertainty, cross-borderness and the 'art' of governance
  2. 2. Ethical and regulatory challenges raised by synthetic biology - Synth-Ethics
  3. 3. Minimizing the Risks of Synthetic DNA: Scientists’ Views on the U.S. Government’s Guidance on Synthetic Genomics
  4. 4. Polémiques sur fond de cellule au génome artificiel
  5. 5. The Ethics Of Creating Synthetic Life
  6. 6. Les opportunites et les risques de la biologie synthetique
  7. 7. Une réglementation inadaptée face à l'émergence de la biologie synthétique
  8. 8. New life, old bottles : Regulating First-Generation Products of Synthetic Biology
  9. 9. Préparation d'un cycle de discussion en France sur la Biologie Synthétique
  10. 10. Rapport du Conseil de la recherche britannique sur les enjeux sociétaux et éthiques de la biologie synthétique
  11. 11. Conférence "électronique" sur  les aspects sociaux de la biologie synthétique
  12. 12. Online Ethics Center
  13. 13. "The Genomics Monitor" : Site web sur la régulation des biotechnologies
  14. 14. Un rapport pour des recomendations sur la gouvernance des pratiques en biologie synthétique
  15. 15. Les enjeux de l’être vivant minimum
  16. 16. Contour de la biologie Synthétique - Ethique : une Syn-Ethique dynamique
  17. 17. Here Be Dragons
  18. 18. Synthetic Biology Makes Scary Headlines, but Universities Promote It as a Lifesaver
  19. 19. Guidelines for the Appropriate Risk Governance of Synthetic Biology
  20. 20. Bulletin ambassade de France USA: Au secours de la biologie, "Sainte éthique" !

Rubrique consacrée aux questions sociétales, éthiques et légales en relation avec la biologie syntéhtique, matières à débat sociétal et politique.

1.  The Transnational Governance of Synthetic Biology Scientific uncertainty, cross-borderness and the 'art' of governance

http://royalsociety.org/uploadedFiles/Royal_Society/Policy_and_Influence/2011-05-20_RS_BIOS_Transnational_Governance.pdf

BIOS working paper: Transnational Governance of Synthetic Biology

Prepared by academics from the Centre for Synthetic Biology and Innovation (CSynBI) at LSE, this working paper on transnational governance of synthetic biology is the product of a year's work funded by the Royal Society. Synthetic biology aims to 'make biology easier to engineer' promising to revolutionise biotechnology for the energy, medical and agricultural sectors. But what about the potential environmental and health risks, the creation of monopolies dominated by large multinational corporations, and the ethics of creating artificial life? How should synthetic biology be governed to maximise benefits and minimise risks? In the last seven years, some 40 reports have addressed these kinds of issues. The authors of this paper propose a radical new approach to investigate the root causes of such concerns, and address the challenges at an overarching level.

They suggest that effective governance regimes must address two central features of synthetic biology: scientific uncertainty and cross-borderness. They argue that many future implications of synthetic biology, like other emerging biotechnologies, are not only difficult to predict but are fundamentally unknowable. They propose a flexible, transparent and evolving 'art of governance': to foster good science, not hamper it, whilst ensuring both trust and accountability.

This 'art of governance' seeks to involve all those in or affected by scientific and technological developments, to ensure that all parties have the opportunity to express their perspectives and interests at all stages in the pathways of research and development. The art of governance recognises that no decisions will suit all actors, but effective compromise depends on ensuring openness and transparency in the process by which decisions are reached, demonstrating genuine consideration of all perspectives. The researchers argue that scientifically informed, evidence-based approaches to policy-making, while essential, are insufficient. "It is time to bring back a sense of the 'art' to the governance of biotechnology: an approach which employs proactive, open-ended regulatory styles able to work with uncertainty and change, to make links across borders, and to adapt to evolving relations among changing stakeholders, including researchers, research funders, industry, and multiple publics" says report author Dr Joy Zhang.

2.  Ethical and regulatory challenges raised by synthetic biology - Synth-Ethics

link to the website

Synth-Ethics is an EU funded project under the 7th Framework Programme. It addresses the ethical, legal and social implications of the emerging field of synthetic biology, with a special focus on biosafety and biosecurity and on notions of life. The project starts with discerning relevant ethical issues in close collaboration with the synthetic biology community. Next, the public debates around these issues are analysed. The current ethical and regulative frameworks existing in synthetic biology and closely related fields like nanobiotechnology and genetic engineering will then be reconstructed and assessed for their ability to deal adequately with existing and newly emerging ethical issues in synthetic biology.

On that basis, challenges for current regulatory and ethical frameworks will be identified and recommendations for dealing with these challenges will be formulated targeted at three relevant groups:

  • the synthetic biology community,
  • EU policy makers
  • NGOs/the public

The project is at the intersection of ethics, technology assessment and foresight, law, and new technologies, and expertise from all relevant fields is included in the project team. The project builds on insights and discussions from other fields such as biotechnology and nanotechnology. It will also try to assess which aspects of synthetic biology might give rise to ethical problems of a different nature, specific to the field.

In turn, it will contribute significantly to a more adequate and proactive broadly applicable approach to the ethical aspects of new technology. It will contribute to a common understanding of synthetic biology and the ethical, legal and social issues involved in EU member states, and to the shaping of a distinct European approach without ignoring the discussions and developments in the US and elsewhere. Stakeholders’ views will be solicited during the project and will be taken into account, and the project will help to prepare for a rational and informed public dialogue on synthetic biology.

Finally, the project provides a sound basis for EU policy-making in the coming years, also by cooperation and using synergies with other EU-funded and international projects.

3.  Minimizing the Risks of Synthetic DNA: Scientists’ Views on the U.S. Government’s Guidance on Synthetic Genomics

Rapport de l'American Association for the Advancement of Science (AAAS)

AAAS Center for Science, Technology and Security Policy Kavita Marfatia Berger, Ph.D.

]Le document ici

4.  Polémiques sur fond de cellule au génome artificiel

Article d'alerte et appel à prudence par Hervé Le Crosnier

Commentaire vif de Philippe Marlière aux appels à un moratoire sur la biologie synthétique suivant les travaux de Venter.

Texte ici

5.  The Ethics Of Creating Synthetic Life

Une interview de David Rejeski, directeur du programma Science tehcnologie et Innovation du Woodrow Wilson Center, dédié à l'étude de la perception publique des progrès scientifiques, en réaction à l'annonce de Craig Venter de la création d'une cellule artificielle à partir d'ADn de synthèse (Mai 2010).

lien vers la transcription du texte et le podcast

6.  Les opportunites et les risques de la biologie synthetique

L'Allemagne se doit d'instituer un debat publique sur la biologie synthetique [1] : telle est l'opinion de l'Agence de moyens pour la recherche allemande (DFG), l'Academie allemande des sciences techniques acatech et l'Academie allemande des sciences naturelles Leopoldina . Les trois institutions ont publie ensemble leur prise de position a ce sujet. Les scientifiques attribuent a ce domaine de recherche un "fort potentiel", en particulier pour la production de vaccins et de medicaments dans un avenir proche, mais aussi le developpement ...

Redacteur : Lena Prochnow, lena.prochnow@diplomatie.gouv.fr

Lire la suite de cet article sur le web

7.  Une réglementation inadaptée face à l'émergence de la biologie synthétique

Une conférence sur la réglementation des premiers produits issus de la biologie synthétique a eu lieu, le 25 mars 2009, au "Woodrow Wilson International Center for Scholars" [1] à Washington. Michael Rodemeyer, consultant en sciences, technologie et politique environnementale a présenté les conclusions de son rapport intitulé "New Life, Old Bottles: Regulating first-generation products of Synthetic Biology" [2].

Pour en lire plus

8.  New life, old bottles : Regulating First-Generation Products of Synthetic Biology

Attach:newlifeoldbottles.jpg Δ

Un rapport sur les dispositifs de contrôle et de régulation des applications de la biologie synthétique dont les conclusions tissent apparemment un parallèle avec ce qui existe déjà en biotechnologies classiques. Plus de détails quand je l'aurais lu...

Lien vers le rapport (pdf) Δ

The safety of early applications of synthetic biology may be adequately addressed by the existing regulatory framework for biotechnology, especially in contained laboratories and manufacturing facilities. But further advances in this emerging field are likely to create significant challenges for U.S. government oversight, according to a new report authored by Michael Rodemeyer of the University of Virginia. Synthetic biology promises major advances in areas such as biofuels, specialty chemicals, and agriculture and drug products.
In New Life, Old Bottles: Regulating First-Generation Products of Synthetic Biology, Rodemeyer examines the benefits and drawbacks of using the existing U.S. regulatory framework for biotechnology to cover the new products and processes enabled by synthetic biology. According to Rodemeyer, initial synthetic biology products will be relatively simple modifications of current technology and can be addressed by existing biotechnology regulations with only modest revisions. However, as the technology develops, regulatory agencies such as the Environmental Protection Agency and Food and Drug Administration will face challenges in assessing potential risks and the adequacy of controls, especially if complex synthetic microorganisms are released into the environment. Today’s risk assessment practices and laws like the Toxic Substances Control Act and Federal Food, Drug, and Cosmetic Act, simply are not designed to handle 21st century technological advances.
“Before synthetic biology matures, Congress and policymakers should consider how to rationalize and modernize the regulation of new converging technologies, instead of attempting to shoehorn each new area of technological development into laws previously written for a different set of issues and potential risks, ” Rodemeyer argues. “It would be easy to relegate discussions about oversight to the back burner. But procrastination bears a risk. A productive dialogue may become more difficult as synthetic biology evolves and stakeholders become divided in their opinions about benefits and risks. The existing regulatory framework for biotechnology is the natural starting point for synthetic biology oversight. But the framework is at best a patchwork quilt of decades old guidelines and laws that could impede innovation, undercut public confidence, and compromise the promised benefits of synbio,” says David Rejeski, the director of the Foresight & Governance Project at the Woodrow Wilson International Center for Scholars. “Policymakers, industry, and other key stakeholders should start a discussion now on the basic question of whether existing regulations will work with advanced synthetic biology, and if not, what changes may be needed to ensure safe development and application of the science.”
This report was made possible by a grant from the European Commission to support projects on “Transatlantic methods for handling global challenges.” It is based on independent research and does not represent the views of the European Commission or the Woodrow Wilson International Center for Scholars. More information

Landmark report addresses regulatory oversight for emerging technology

Interview video (5:15) en anglais de l'auteur

9.  Préparation d'un cycle de discussion en France sur la Biologie Synthétique

Par l'association Vivagora

Un cycle de débat publics prévu pour février 2009

La biologie synthétique utilise le vivant comme une réserve de composants ou « biobriques fonctionelles » pour fabriquer des circuits, à la manière de l’électronique. Elle pousse plus loin les biotechnologies qui visent à modifier les organismes : son ambition est de créer la vie ! Après les OGM, se profile la vague des OGF ou organismes génétiquement fabriqués… Soixante-dix entreprises, près de dix mille laboratoires dans le monde, et pas moins de programmes européens se consacrent tantôt à fabriquer des génomes (matériel héréditaire) minimaux pour remplir les fonctions utiles à la vie, tantôt à ajouter des fonctions à des organismes pour les faire produire de l’énergie ou manger des polluants. L’objectif est de fabriquer de toutes pièces des systèmes auto-organisés, à partir d’un « chassis moléculaire » et qui imitent les systèmes vivants.

AU GRAND BAZAR DE LA VIE SYNTHETIQUE : LES PROCHAINS OGM EN QUESTION

Main basse sur les composants de la biologie synthétique

10.  Rapport du Conseil de la recherche britannique sur les enjeux sociétaux et éthiques de la biologie synthétique

Pour plus de détail

Synthetic Biology: funders move to address social and ethical challenges Une interview audio de l'auteur du rapport Paul Martin, Université de Nottingham

Le Rapport Δ

11.  Conférence "électronique" sur les aspects sociaux de la biologie synthétique

Attach:synbiosafe.jpg Δ

Une initiative originale dans le cadre du programme européen Synbiosafe : la tenue d'une "conférence" sous forme de forum internet sur les questions éthiques, sécurité, société soulevées par la biologie synthétique. 

 We would like to invite you to participate in our international electronic
 conference on the societal aspects of synthetic biology, which will take
 place from Monday 5 May to Tuesday 3 June 2008 at
 http://www.synbiosafe.eu/forum

 This e-conference on ethical, safety, security and other societal issues of
 synthetic biology is hosted by "SYNBIOSAFE: Safety and Ethical Aspects of
 Synthetic Biology", a two years FP6 project funded by the European
 Commission. The aim is to stimulate an international and inclusive debate on
 these issues at an early stage.

 After a first fact finding mission we would now like to share our points of
 view and discuss selected societal issues and open questions with a wider
 group of experts and interested stakeholders. The issues we would like to
 discuss fall under the following three areas:

 Forum I: Ethical Aspects
 Forum II: Biosafety Challenges
 Forum III: Biosecurity Awareness

 In addition there is also a section on other societal issues, including

 Forum IV: Intellectual Property Rights
 Forum V: Regulation and governance, and
 Forum VI: Public perception, communication and the media

 For more information on these thematic areas, specific questions to be
 discussed, and how to post a contribution, please have a look at our
 background document:
 http://www.synbiosafe.eu/uploads///pdf/SYNBIOSAFE-background_paper.pdf

 In case of any technical difficulty with the registration, please contact
 Gregor Giersch on gregor.giersch@idialog.eu

 We would greatly appreciate your help in forwarding this announcement to
 your colleagues and networks.

12.  Online Ethics Center

Attach:OEC.jpg Δ

  • On Education

Ideas, teaching advice, research,and other pedagogical information about incorporating ethics into the engineering classroom at every level.

  • Safety and the Environment

Essays and articles, cases, guidelines, and reference materials related to environmental issues (including sustainability) and safety concerns.

  • Professional Practice

An extensive section with a large number of essays and articles, as well as sets of cases, discussions, and ethical guidelines bearing on the various professional responsibilities of engineers.

  • Employment and Legal Issues

Cases, essays, and reference materials that address ethical issues for employees, managers, and organizations. There are also resources for considering the intersection of ethics and the law.

  • Responsible Research

This section of the OEC contains cases, discussions, guidelines, and regulations bearing on the responsible conduct of research, including both issues of research integrity and issues of the treatment of the research subject.

  • Computers and New Technology Material addressing the specific ethical issues arising from computers, computer/software engineering, and the Internet, as well as other emerging technologies, such as nanotechnology. The section includes cases, essays, ethical guidelines, and web resources.

Lien vers ce site web

13.  "The Genomics Monitor" : Site web sur la régulation des biotechnologies

Site de référence très documenté sur les régulations internationales dans le domaine des biotechnologies mainenu par le "Bradford Disarmament Research Centre, Department of Peace Studies" de l'Université de Bradford.

Bien que pas spécifiquement consacré à la biologie synthhétique, ce site est important pour le sujet au sens large car il concerne toutes les biotechnologies modernes (liées à la génomique). Le Genomics Monitor a pour objectif de mettre à disposition des informations et analyses mises à jour régulièrement sur les régulations internationales en relation avec le contrôle des biotechnologies, en s'efforçant de mettre en évidence et d'attirer l'attention sur les objectifs et limitations des règles actuelles dans le domaine.

Le site web "Genomics Monitor" (anglais)

Un forum avec des questions reliées, maintenu par l'Université de Edimbourgh et qui vise à encourager le débat publc sur les aspects sociétaux et économiques de la génomique:

ESRC Genomics Policy and Research Forum

14.  Un rapport pour des recomendations sur la gouvernance des pratiques en biologie synthétique

Par le "J. Craig Venter Institute (JCVI)", le "Center for Strategic & International Studies" (CSIS), et le Massachusetts Institute of Technology (MIT).

Rendu public le 17 octobre 2007

Ce rapport présente les champs d'intervention et des options politiques pour prévenir des risques éventuels dans ce domaine de recherche. Rapport à étudier mais dont il faut noter le financement et la rédaction par des sociétés et chercheurs intéressés dans le domaine, sans la participation d'experts indépendants.

Lien vers le communiqué de presse sur le rapport (en anglais)

Lien vers le rapport

15.  Les enjeux de l’être vivant minimum

Attach:pandorabug.jpg Δ

Un article de Rémi Sussan du 26 juin 2007 dans InternatActu.net sur la demande de prise de brevet faite ce même mois de la part de Craig Venter sur le principe d'une cellule minimale comme plateforme pour la biologie synthétique. Cet article discute aussi de l'étude groupe activiste canadien ETC group sur la biologie synthétique.

Liens

16.  Contour de la biologie Synthétique - Ethique : une Syn-Ethique dynamique

Attach:logo_synthekidia.jpg Δ Une longue entrée du blog Synthekidia très bien argumentée sur l'éthique de la biologie synthétique.

Lien vers l'article sur le blog Synthekidia

17.  Here Be Dragons

Governing a Technologically Uncertain Future

Maps in the old days often included depictions of sea dragons or lions to connote unknown or dangerous terrain. Unfortunately, when it comes to a future that will be altered in unimaginable ways by emerging technologies, society and government cannot simply lay down a "Here Be Dragons" marker with a fanciful illustration to signal that most of us have no clue.

How does a democratic society both nurture and regulate -- and find the right balance between those two imperatives -- fast-evolving technologies poised to radically alter life?

Synthetic biology, with its potential to engineer and manipulate living organisms, and the Internet, which continues to alter how we live and relate to each other, offer two compelling cases in point.

Future Tense is convening at Google DC a number of leading scientists, Internet thinkers, governance experts and science fiction writers to grapple with the challenge of governing an unchartered future.

Future Tense is a partnership of Arizona State University, the New America Foundation and Slate magazine.

Link to the conference program

18.  Synthetic Biology Makes Scary Headlines, but Universities Promote It as a Lifesaver

by Paul Basken

The Chronicle of Higher Education, January 16, 2011

The discipline is a tactical upgrade in the search for better medicines, making computerized machines out of living cells.

The renowned scientist J. Craig Venter got top-shelf attention last spring when his lab implanted modified DNA into growing bacteria and he pronounced it "the first synthetic species" of life. On Capitol Hill, lawmakers convened a hearing to study the implications. Down Pennsylvania Avenue, President Obama asked his bioethics commission to investigate, saying the event raised "genuine concerns." But there is a far more compelling story about how this field, known as synthetic biology, is taking shape, largely on university campuses. It is not primarily about making new life forms. It is, rather, a major tactical upgrade in the long-running search for better medicines, fuels, and renewable materials. The idea involves sophisticated new gene-altering techniques that essentially make computerized machines out of tiny living cells.

Full text

19.  Guidelines for the Appropriate Risk Governance of Synthetic Biology

International Risk Governance Council

http://www.irgc.org/IMG/pdf/irgc_SB_final_07jan_web.pdf

1. What is synthetic biology? Box: Genetics and molecular biology 2. Current developments in synthetic biology 2.1 Current and past activities 2.2 Some potential future applications 3. Risks of synthetic biology 4. Existing policy and regulatory frameworks, and their deficits 4.1 Regulatory and governance contexts 4.2 Risk Governance Deficits 5. Risk governance in synthetic biology 5.1 The concept of appropriate risk governance 5.2 Regulation and governance of first-generation synthetic biology 5.3 Policy and regulatory strategies in biosafety and biosecurity related to research, innovation and technology development 5.4 Intellectual property (IP) issues and maintaining incentives for innovation 5.5 Risk regulation and barriers to innovation 5.6 Local, regional and international perspectives on regulatory oversight and risks 5.7 Technological risk management options 5.8 Policy and regulatory strategies related to public and stakeholder dialogue 6. Guidelines Avoiding future risk governance deficits for synthetic biology 6.1 Guidelines relevant to research and technology development 6.2 Guidelines relevant to public and stakeholder engagement 6.3 Systemic guidelines

International Risk Governance Council : cet organisme est proche du gouvernement suisse http://en.wikipedia.org/wiki/International_Risk_Governance_Council http://www.edi.admin.ch/dokumentation/00334/00336/index.html

20.  Bulletin ambassade de France USA: Au secours de la biologie, "Sainte éthique" !

http://www.bulletins-electroniques.com/actualites/65878.htm

En mai dernier, le généticien Craig Venter avait fait la une en déclarant avoir créé la première "cellule synthétique". Cette annonce, présentée parfois comme la création d'une nouvelle forme de vie, avait incité le président Obama à solliciter un rapport de sa commission de Bioéthique.

Le rapport, fruit de la consultation des principaux acteurs du domaine, a été rendu public le 16 décembre dernier. Très bien reçu par les milieux scientifiques et par l'administration, il avait en revanche été plus fraichement accueilli par certaines ONG, estimant que les mesures de précaution proposées n'étaient pas suffisamment contraignantes.

Text complet


Page last modified on May 25, 2011, at 10:22 PM