1 / 28

Governing Biotechnologies Some ethical and material ingredients for an innovating cooking

This lecture explores the challenges and potential forms of governance in the field of biotechnologies, which are difficult to stabilize and not suitable for existing regulatory frameworks.

acasey
Download Presentation

Governing Biotechnologies Some ethical and material ingredients for an innovating cooking

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Virginie Tournay CNRS Researcher. Science Po Grenoble virginie.tournay@iep-grenoble.fr virginietournay@yahoo.com Governing Biotechnologies Someethical and materialingredients for an innovating cooking

  2. Inherentinstability of life-related-technologies… Governing biotechnologies - November 9 - ENSP lecture

  3. Biotechnologies Technologies difficult to stabilize Not suitableexistingregulatoryframeworks Potentialforms of governance Governanceregulation (policymakers or self-governance) Format of decision-makingaroundemerging technologies Governance of life-related-technologies Governing biotechnologies - November 9 - ENSP lecture

  4. Outline Governance of life-related technologies Whatdoesembryonicmean? WhatdoesGenetic Modification mean? Biotechnologies : an innovative cooking Governing biotechnologies - November 9 - ENSP lecture

  5. The injection of a bacteriuminto mosquitos: a regulatory issue (J. L. Rasgon, Nature, 476, august 2011) Not a new species Not involve « Gene Technology » in the sense of Australian Gene TechnologyAct A regulatory « no man’s land » Legislation on veterinarychemicalproducts A « novelorganism association » challenges existingregulatoryprocess Governance of life-related technologies Governing biotechnologies - November 9 - ENSP lecture

  6. Governance of life-related technologies Three observations • The evolution of scientific paradigms in the construction of legal frameworks • Institutional consolidation and medical innovation are not independent from each other • Close links between personal commitment and the setting-up of a stabilized regulatory framework for biotechnology research activities Governing biotechnologies - November 9 - ENSP lecture

  7. The diffusion percolation model of innovation • Knowledge Production • KnowledgeGovernance • Social Acceptability • Market and industrialisation Governing biotechnologies - November 9 - ENSP lecture

  8. The process of innovation: a more complexphenomenon • Production • The public « concerned » • Industrial applications • Governance Governing biotechnologies - November 9 - ENSP lecture

  9. Material & Methods -20 structuredinterviews Is scientificwork a politicalcommitment? • Prohibition of Embryo’sResearches (Fr.) • No Physical Bank in France • Special dispensation (2004 bioethics Law) • Agence de la Biomédecine • Rival Models for French Physical Banks - Researchers - policymakers

  10. Working on hESC: WhatDoesEmbryonicMean? Is scientificwork a politicalcommitment? • Pluripotency • Differenciationability Culture [+ or –] ‘embryonic’ Proliferating stem cells THE CULTURE of hESC

  11. Is scientificworks a politicalcommitment? • Working on hESC: WhatDoesEmbryonicMean? • Traceability, safety and qualityrequirements • Compliancewith the reserchprotocoloriginallydefined • Authorizationfor the use of one specificline • AFSSAPS ‘celltherapyproducts’ vs AdeBiomédecine ‘hESC’ A VERY BINDING LEGAL REGIME

  12. Is scientificworks a politicalcommitment? • Working on hESC: WhatDoesEmbryonicMean? • Criterionfor defining the lost of hESCcharacteristics • Criterionfor definingembryonicspecificities A BIOLOGICAL OR AN ONTOLOGICAL CONTROVERSY 100 % pluripotency hESC 100 % differenciated cells Pluripotency cells + differenciated cells

  13. Is scientificworks a politicalcommitment? • WhatDoesEmbryonicMean? • Personalsensitivities • Boundariesdrawnbetweenembryonic cultures and differenciated cultures Culture [+ or –] ‘embryonic’

  14. Is scientificworks a politicalcommitment? • BankinghESC: WhatDoesEmbryonicMean? • Direct application to the bank • A backup for the storage of celllines • Availabilityof variouslines • Maximizingstorage conditions A CONSENSUS REGARDING THE NEED FOR A BANK

  15. Is scientificworks a politicalcommitment? • BankinghESC: WhatDoesEmbryonicMean? • Researcher (1) • In favor of a Bank Service • Researcher (2) A LINK BETWEEN PERSONAL COMMITMENT AND ORGANISATIONAL PROSPECTS In favor of a simple storageplatform

  16. Importation of lines Teams receiving lines Teams doing derivation of lines Local Amplification Local Amplification Requesting Institutions Distribution to requesting teams Bank = storage platform. Is scientificworks a politicalcommitment? TWO RIVAL MODELS OF BANKING

  17. Importation of lines Teams receiving lines Teams doing derivation of lines Requesting institutions Bank service Amplification Selection of lines Clinic/GMP Research GMP Bank Working Bank Distribution of derived products Clinical services Distribution of lines to requesting teams Is scientificworks a politicalcommitment? TWO RIVAL MODELS OF BANKING

  18. Conclusion and Perspectives Is scientificworks a politicalcommitment? • Close link: personalcommitment/setting up of organisationnal standards • Personalopinions Scientificobjectification • Standardized guidelines • Politicalrules • Concreteoperators

  19. The field of syntheticbiology Legal and regulatory issues : highly complexes A collection of tools and technologies Not a specific discipline A set of manufacturingtechnology different ways to create a synthetic organism possible approaches to governing synthetic biology A question of scientific responsibility A question of regulatory responsibility SyntheticBiology Field Governing biotechnologies - November 9 - ENSP lecture

  20. Limits of governmentregulation Data bank traceability with a top down regulation? Kind of technologies used On a product-by-product basis Scales What about control and ownership of the biotechnology? Limits of self-governanceproposals Dissemination beyond the professional biotechnology community. Outsourcing of digital data: a culture of responsibility Unintended dispersion of modified organisms Uncontrolled appropriation issues SyntheticBiology Field Possible riskgovernanceapproaches to BiologySynthetic. Options for policymakers Governing biotechnologies - November 9 - ENSP lecture

  21. The relevance of regulatorypolicies for GM technologies Not traditional discipline-basedcategories Experience of debates on GM crops Ethical and safety issues knownbt the synthetic-biologycommunity The relevance of biotechnologyregulation to syntheticbiology Genomeassembledfrom a variety of sources Emergent behaviour Legalstatus of computational data EuropeanRiskGovernance Governing biotechnologies - November 9 - ENSP lecture

  22. The European view on risk regulation in synthetic biology Covered by existing regulations for GM No EU member state has introduced specific legislation A controversialregulation Based on technology of GM Preventing innovations? EuropeanRiskGovernance Governing biotechnologies - November 9 - ENSP lecture

  23. The existingEuropeanRegulatory Framework Directives and Regulation for GM Requirementsbased on the product uses (medicinalproducts, medicaldevices, clinical trials …) General frameworksrelated to patenting, open access and biosecurity EuropeanRiskGovernance - Directive 2001/18/EC on the deliberate release of GMOs into the environment; - Regulation n°1946/2003 on transboundary movements of GMOs, which implemented the provisions of the Cartagena Protocol on Biosafety within the EU; - Council Directive 98/81/EC on the contained use of GM micro-organisms Governing biotechnologies - November 9 - ENSP lecture

  24. Epistemological background of laws dealing with risk assessments Idea of GM made « artificially » Nature and Place of stochastic gene expression are in debate living organisms: open systems constantly exchanging with their environments the "all genetics" model is irrelevant. A change in driver has never been the root cause of a car theft !!! Whatdoes « Genetic Modification » Mean? • Directive 2001 defines a GMO as “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.” • Directive 98 defines a GMM as “a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.” Governing biotechnologies - November 9 - ENSP lecture

  25. The ambiguity of legislationbased on « genetic modification » Geneticdeterminism: GMO representation Samerisk management to different GM systems Over-estimation of riskrelated GM technologies Methodsbased on GM: GMO directive? New mammalian cellular system Technologies thatrely on a non-Mendelian transmission of characters Technologies of genetic design Whatdoes « Genetic Modification » Mean? Governing biotechnologies - November 9 - ENSP lecture

  26. The ambiguity of a langage in SB-communitybased on « genetic modification » Descriptive language for living systems Metaphor of a chassis Whatdoes « Genetic Modification » Mean? Governing biotechnologies - November 9 - ENSP lecture

  27. The ambiguity of a collective representationbased on GM Level of collective knowledgeindependent of perceptions of risks and benefits Reference to existing technologies The metaphor of « Creation » Better to use « construct » (Pearson et al., Journal of Biological Engineering, 2011, 5:9) Whatdoes « Genetic Modification » Mean? Governing biotechnologies - November 9 - ENSP lecture

  28. CONCLUSION • We have to build everything from scratch • Choosing the most appropriate regulatory precedent • High level of scrutiny • Researchers and regulators: Work together • Great diversity of GM technologies • Scientificrepresentations issues • Whatconstitutes a GM? • Transformedbiologicalsystems: Legalcategory for public intervention • Personal opinions underlyingorganisational prospects • Life as an indeterminateprocess, a creativeevolving of shapes (Bergson)

More Related