International Summit of Human Gene Editing

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December 2, 2015 . Gary E. Marchant, Ph.D., J.D. . g. Human Gene Editing: International Governance. Arguments for International Governance. International standards assure equal protection for citizens of all nations. ID: 701145 Download Presentation

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International Summit of Human Gene Editing

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International Summit of Human Gene EditingDecember 2, 2015 Gary E. Marchant, Ph.D., J.D.

Human Gene Editing: International Governance


Arguments for International GovernanceInternational standards assure equal protection for citizens of all nationsUniform national requirements discourage medical tourismInternational standards provide consistent requirements for companies and scientists in the fieldHarmonized national standards prevent trade disputes (eg GMOs)

Prevent “race to the bottom” or “risk havens”Regulators benefit from economies of scale and sharing resources and workload


Different social, political, and ethical norms in different countriesDifferent national approaches allows for experimentation on different governance approachesLarge resources, time and effort needed to create international standards might be better utilized in developing national oversightComplete agreement and compliance by all nations highly unlikelyArguments Against International Governance


Timing of International vs. National StandardsFrancis Fukuyama:“[R]egulation cannot work in a globalized world unless it is global in scope. Nonetheless, national-level regulation must come first. Effective regulation almost never starts at an international level ….” Foreign Policy, Mar/Apr 2002.But developing national regulations first may:

unduly delay international regimebe more difficult in the face of entrenched and inconsistent national regulations (e.g., GMOs)



Breggin et al., London School of Economics (2009)

Mechanisms of International Convergence


Negotiation of international treaty requires enormous commitment of resources, time and political capitale.g., climate changeIrresoluble compliance and enforcement challengese.g., Biological Weapons ConventionTraditional “Hard Law”: Treaties and Other Formal Agreements


Treaty Precedent: UN International Cloning ConventionIn 2001, the U.N. General Assembly established an Ad Hoc Committee to draft an international convention to prohibit human reproductive cloning The Human Cloning ban deadlocked in the U.N. in December 2003 due to disagreement

U.N. Legal Committee discussed ban again in Oct. 2004; again failed to reach agreementKey points of disagreement:





“Transnational New Governance”Originates from “soft law” concept in international lawSubstantive obligations and requirements created by instruments that are not directly legally enforceable

International scope/focus/participationBroadening oversight from top-down government requirements to include a much broader range of decision-makers

e.g., companies,

researchers, NGOs

, public-private partnerships,

other third



Advantages of Transnational New GovernanceVoluntary; cooperativeReflexiveCan be adopted or revised relatively quicklyMany different approaches can be tried simultaneouslyCan be gradually “hardened” into more formal regulatory oversight


Limitations of Transactional New GovernanceNorms/standards not directly enforceableRisk of “whitewashing” or “greenwashing”Participation limitationsNot always as flexible and adaptable as hopedPotential for confusion/overlapLess legitimacy


Examples of Transnational New Governance Tools & ExamplesTransnational regulatory dialogue and networksOECD working GroupsInternational regulatory harmonization committeesInternational Conference on HarmonizationUnited Nations DeclarationsUNESCO International Declaration on Human Genetic Data

International principlesWorld Medical Association/Helsinki PrinciplesInternational Scientific Assessment bodiesIntergovernmental Panel on Climate Change (IPCC)Professional society guidelinesISSCR Guidelines for Embryonic Stem Cell Research

International statements of policy

HUGO statements

Private/industry standards

IGSC Harmonized Screening Protocol

Framework conventions

Framework Convention on Tobacco Control


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