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Transnational Regulatory Models for Molecular Nanotechnology Gary Marchant, Michael Volk & Jonathan Swartz Center Transnational Regulatory Models for Molecular Nanotechnology Gary Marchant, Michael Volk & Jonathan Swartz Center for Study of Law, Science & Technology Arizona State University College of Law Foresight Conference October 24, 2004

Assumptions • Molecular nanotechnology (MNT) will result in significant benefits and risks – “dual Assumptions • Molecular nanotechnology (MNT) will result in significant benefits and risks – “dual use” dilemma • Studying transnational regulatory regimes used to control other risky/dangerous technologies can provide insight into possible approaches to control the potential risks of MNT

Methodology • Analyze 8 classes of regulatory regimes used to regulate dual use technologies Methodology • Analyze 8 classes of regulatory regimes used to regulate dual use technologies and evaluate potential applicability to MNT: 1. 2. 3. 4. 5. Non-Proliferation Weapons Treaties International Bans Established Principles of International Law Joint Development Agreements Control of Technology via Intellectual Property and Licensing 6. Information Secrecy/Export Controls 7. Funding and Financial Incentive Programs 8. Voluntary Guidelines and Codes of Conduct

Threshold Q. #1: Do MNT Risks Justify Int’l Action? • Potential risks from MNT: Threshold Q. #1: Do MNT Risks Justify Int’l Action? • Potential risks from MNT: – – Intentional consequences of malevolent or dual use MNT Accidental consequences of innocent or dual use MNT Arms races leading to new or exacerbated conflicts • These risks (and the MNT technologies they relate to) remain distant and speculative? • MNT risks unlikely to have sufficient urgency and priority for adoption of formal international regulations at this time?

Threshold Question #2: National vs. Int’l Regulation • Traditional model of regulating risky technologies Threshold Question #2: National vs. Int’l Regulation • Traditional model of regulating risky technologies is national (and subnational) laws – e. g. , hazardous products – e. g. , genetically modified crops – e. g. , air and water pollutants • Justifications for international action: – transnational impacts of risks – destabilizing consequences of one or more nations developing potentially threatening weapons

Threshold Question #3: Which Comes First? • Francis Fukuyama: – “[R]egulation cannot work in Threshold Question #3: Which Comes First? • Francis Fukuyama: – “[R]egulation cannot work in a globalized world unless it is global in scope. Nonetheless, nationallevel 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 regime – be more difficult if entrenched and inconsistent national regulations (e. g. , GMOs)

Non-Proliferation Treaties Case Studies: Nuclear, Chemical and Biological Conventions Non-Proliferation Treaties Case Studies: Nuclear, Chemical and Biological Conventions

Three Major WMD Non-Proliferation Treaties • Nuclear Non-Proliferation Treaty (NPT) -- 1968 – Designed Three Major WMD Non-Proliferation Treaties • Nuclear Non-Proliferation Treaty (NPT) -- 1968 – Designed to prevent the distribution of nuclear weapons to nations that do not possess them. • Biological Weapons Convention (BWC) -- 1972 – Prohibits the development, production, stockpiling, acquisition, or retention of biological weapons or biological agents in types or amounts that are not justified for prophylactic, protective or other peaceful purposes • Chemical Weapons Convention (CWC) – 1993 – Requires destruction of existing stockpiles of chemical weapons and prohibits any further development, production, stockpiling, and use of chemical weapons

Non-Proliferation Treaties: Status at Time of Treaty • NPT: Established a two-tier (“discriminatory”) structure Non-Proliferation Treaties: Status at Time of Treaty • NPT: Established a two-tier (“discriminatory”) structure between those nations that already have nuclear weapons and those that do not – Has been a growing source of disagreement and tension since treaty negotiation • Would be easier to put treaty into place before any nation or nations have the technology to be regulated • BWC: US and UK unilaterally relinquished BW; created impetus for treaty • CWC: Focus on destroying existing weapons

Non-Proliferation Treaties: Inducement/Technology Transfer • NPT: “As an incentive to discourage independent nuclear research Non-Proliferation Treaties: Inducement/Technology Transfer • NPT: “As an incentive to discourage independent nuclear research in non-possessory nations, member nations are required to assist other nations in the development of peaceful nuclear technology under international supervision. ” • BWC: Article X – provides for the “fullest possible exchange of equipment , materials and scientific and technological information” for the use of biological agents and research for peaceful purposes

Non-Proliferation Treaties: Lack of Universality • NPT – 187 State parties; only 4 non-signatories Non-Proliferation Treaties: Lack of Universality • NPT – 187 State parties; only 4 non-signatories (Cuba, Israel, India and Pakistan), with N. Korea threatening to withdraw • BWC – 151 State parties; several countries have failed to sign (e. g. , Israel, Sudan), and many others have signed but not ratified (e. g. , Syria, Egypt) • CWC – 126 State parties; many important nonsignatories (e. g. , Egypt, Israel, Libya, N. Korea, Syria) • Key Issue: What are implications of some hold-outs for security and decision-making of other nations for a technology such as MNT?

How Much Non-Compliance Tolerable? • All three treaties have suffered important noncompliance by signatories: How Much Non-Compliance Tolerable? • All three treaties have suffered important noncompliance by signatories: – NPT: N. Korea, Iran, Iraq – BWC: USSR, Iraq – CWC: Iraq • Freeman Dyson: “Even if the [BWC] is unverifiable and even if it is violated, we are far better off with it than without it. ” • Nanotechnology – how much non-compliance could be tolerated without jeopardizing regime stability?

Non-Proliferation Treaties: Enforcement Agency • NPT: The International Atomic Energy Agency (IAEA) tasked with Non-Proliferation Treaties: Enforcement Agency • NPT: The International Atomic Energy Agency (IAEA) tasked with enforcement – Can bring claim to International Court of Justice in limited circumstances • • CWC: Organization for the prohibition of Chemical Weapons (OPCW) established to oversee treaty and conduct inspections BWC: No enforcement agency – Consultative process created in 1991; a party can also file complaint with UN Security Council

Chemical Weapons Convention: Verification and Inspection • Most detailed and intrusive inspection provisions – Chemical Weapons Convention: Verification and Inspection • Most detailed and intrusive inspection provisions – Requires member nations to allow challenge on-site inspections with 12 hours notice when unresolved allegations of potential violation • Inspection provisions have been watered down: – Parties have limited inspectors to only analyzing chemicals specifically listed in treaty and their degradation products – Member state may confiscate inspection equipment it believes still contain proprietary information – Declarations by nations are heavily over-classified – U. S. Congress has limited inspections of U. S. chemical companies (limiting number of sites; no samples removed from US; Presidential over-ride)

Non-Proliferation Treaties: The Dual-Use Problem • Growing potential for the same materials, equipment and Non-Proliferation Treaties: The Dual-Use Problem • Growing potential for the same materials, equipment and techniques relevant for nuclear, chemical and biological weapons to have non-military applications – e. g. , biotechnology • BWC relies on “general purpose criterion” – prohibitions depend on intended use rather than nature of technology • High sensitivity of national governments and industry to protecting proprietary value of non-weapons technology

BWC Verification and Inspection Provisions • BWC contains no formal verification or inspection provisions BWC Verification and Inspection Provisions • BWC contains no formal verification or inspection provisions • From 1995 to 2001, Ad Hoc Group of States Parties developed Protocol for verification and inspection regime • In 2001, U. S. rejected approach and withdrew from further negotiations; process collapsed – U. S. position: verification/inspection would be ineffective and would impose risks to national security and industry • Political/technological feasibility of verification & inspection regime for dual-use technologies in doubt

Non-Proliferation Treaties: Other Weaknesses & Limitations • Treaties only apply to state actors; non-state Non-Proliferation Treaties: Other Weaknesses & Limitations • Treaties only apply to state actors; non-state actors have emerged as a major threat • Difficult time adapting to and overseeing rapid scientific and technological advances • UN Security Council is body for addressing alleged noncompliance; but political restraints • Industry reluctant/resistant • Inadequate State funding and political will

Non-Proliferation Treaties: Not Working? • Significant and growing perceptions that NPT, BWC and CWC Non-Proliferation Treaties: Not Working? • Significant and growing perceptions that NPT, BWC and CWC are increasingly ineffective • Treaties have not been implemented as written • Concern that treaties are increasingly being described as “hollow, ” “empty shell” or “fig leaf” • Political, technical and security trends are undermining commitment to non-proliferation treaty objectives • End of the “Geneva Process” (formal multilateral negotiation of legally binding agreements by governments)?

Non-Proliferation Treaties: Lessons for MNT • • • Nuclear, chemical and biological weapons are Non-Proliferation Treaties: Lessons for MNT • • • Nuclear, chemical and biological weapons are clear “bad actors”; MNT applications may not be so clear “Dual-use” technologies difficult to regulate using arms control agreements Intrusive verification provisions likely to be necessary but highly controversial (politically infeasible? ) Technology exchange mechanism important inducement for participation Independent and competent enforcement agency (e. g. , IAEA) is essential Legal enforcement mechanism useful (e. g. , IJC jurisdiction) to avoid political deadlock and general ineffectiveness of U. N. Security Council

International Bans Case Study: International Human Cloning Ban International Bans Case Study: International Human Cloning Ban

Global Cloning Ban: Background • Less than 30 of the U. N. ’s 192 Global Cloning Ban: Background • Less than 30 of the U. N. ’s 192 nations have banned human reproductive cloning • In 2001, the U. N. General Assembly established an Ad Hoc Committee to draft an international convention prohibiting the reproductive cloning of human beings • The Human Cloning ban deadlocked in the U. N. in December 2003 due to disagreement • U. N. Legal Committee agreed to discuss the ban again on Oct. 20 -21, 2004; again failed to reach agreement

Global Cloning Ban: Issues of Disagreement • Major disagreement over scope of the prohibition: Global Cloning Ban: Issues of Disagreement • Major disagreement over scope of the prohibition: reproductive cloning only or all human cloning (including therapeutic cloning) – “widening the scope of the potential convention to include issues for which no consensus existed could threaten the entire exercise, leaving the international community without a coordinated legal response. ” UN Ad Hoc Committee Report (2002) • Also disagreement on whether it should be a permanent ban or a limited-duration moratorium • Disagreement on penalties/sanctions – Some countries have argued that it should be prerogative of each nation on whether or not to impose sanctions

Proposed Human Cloning Ban: Lessons for MNT • Even when strong international consensus on Proposed Human Cloning Ban: Lessons for MNT • Even when strong international consensus on urgency and opposition to specific technology, negotiating international prohibition may be complicated by attempts to include related applications lacking such clear consensus • A complete prohibition on MNT is undesired as some acceptable uses will likely be outlawed; need more nuanced and hence complicated and controversial convention for MNT • Permanent ban vs. limited duration moratorium • How to keep convention current with rapidly progressing technology?

Regulation Using Established Principles of International Law Case Study: The Precautionary Principle Regulation Using Established Principles of International Law Case Study: The Precautionary Principle

Invoking the Precautionary Principle • A growing number of activist groups and some scholars Invoking the Precautionary Principle • A growing number of activist groups and some scholars are calling for a moratorium on research in nanotechnology based on the precautionary principle • While precaution and foresight are needed, the precautionary principle fails to provide a useful decision rule or even a general approach

The Proliferation of the Precautionary Principle • Incorporated into more than twenty international environmental The Proliferation of the Precautionary Principle • Incorporated into more than twenty international environmental treaties • Included in 1992 Maastricht amendments to European Treaty • Incorporated into national laws of many countries (e. g. , most EU nations, Australia, Canada) • EU and some scholars argue that the precautionary principle is now customary international law

Problem 1: No Standard Version of the PP • There is no standard text Problem 1: No Standard Version of the PP • There is no standard text of the precautionary principle • Treaties, regulators, and courts apply “the” precautionary principle without specifying which version they are using • Over 50 different formulations have been collected; subtle differences in wording have significant policy consequences

Problem 2: Ambiguity of the Precautionary Principle • No version of the PP answers Problem 2: Ambiguity of the Precautionary Principle • No version of the PP answers key questions: – What level of risk is acceptable? – What early indications of potential hazard needed to trigger precaution? – How much data must proponent produce to demonstrate “safe”? – How are costs and risk-risk tradeoffs factored in? – What type of action is required to satisfy the principle?

Examples of Arbitrariness of Precautionary Principle • Stewart Commission (UK) recommended restrictions on use Examples of Arbitrariness of Precautionary Principle • Stewart Commission (UK) recommended restrictions on use of cell phones even though it concluded no risk • Netherlands banned Kellogg's Corn Flakes • France banned “Red Bull” caffeinated drink • Denmark banned Ocean Spray Cranberry drinks • Zambia rejected U. S. food aid to help starving population because of presence of GM corn

Precautionary Principle: Stifling Discovery • “As a principle of rational choice, the PP will Precautionary Principle: Stifling Discovery • “As a principle of rational choice, the PP will leave us paralyzed. In the case of genetically modified (GM) plants, for example, the greatest uncertainty about their possible harmfulness existed before anybody had yet produced one. The PP would have instructed us not to proceed any further, and the data to show whethere are real risks would never have been produced. The same is true for every subsequent step in the process of introducing GM plants. The PP will tell us not to proceed, because there is some threat of harm that cannot be conclusively ruled out, based on evidence from the preceding step. The PP will block the development of any technology if there is the slightest theoretical possibility of harm. ” Holm & Harris, Nature 400: 398 (2000)

Prudent Precaution, Not the Precautionary Principle • The precautionary principle is an overlysimplistic and Prudent Precaution, Not the Precautionary Principle • The precautionary principle is an overlysimplistic and under-defined concept that seeks to circumvent the hard choice that must be faced • Precaution and foresight are essential for effectively and responsibly addressing prospective risks of emerging technologies such as MNT – Need more than a slogan

Joint Development Agreements Case Study: The Outer Space Treaty Joint Development Agreements Case Study: The Outer Space Treaty

Outer Space Treaty: Background • Treaty on Principles Governing the Activities of States in Outer Space Treaty: Background • Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space Including the Moon and Other Celestial Bodies, 1967 • Extended the scope of general international law into space and set forth additional principles to govern national activities in space, including the right of all nations to explore and use outer space without discrimination. • The treaty promotes international cooperation, prohibits national appropriation of space, and protects the right to use military technologies for peaceful purposes in space.

Outer Space Treaty: Dual Use Technology • Whether a technology is prohibited in outer Outer Space Treaty: Dual Use Technology • Whether a technology is prohibited in outer space depends on the intended use of the technology • All spacefaring states are entitled to utilize military technologies in their peaceful space activities • Aggressive weapons not allowed (WMD), non-aggressive weapons permitted. • The actual end-use of a piece of equipment used in space is more important than its military origin or potential military capabilities. • Thus, the practical effect of Article IV is that under the Outer Space Treaty, "dual-use" equipment with both military and non-military applications may be deployed for peaceful purposes anywhere in space

Implications of Outer Space Treaty for MNT • Useful precedent on need to simultaneously Implications of Outer Space Treaty for MNT • Useful precedent on need to simultaneously address risks, benefit sharing, and property rights in an international regulatory regime • An example of an approach for addressing dual -use technologies – limited effectiveness and precedential value • Example of a treaty that imposes little if any restrictions on anything a State would want to do

Intellectual Property and Licensing Case Study: TRIPs Intellectual Property and Licensing Case Study: TRIPs

Intellectual Property: Relevance to MNT • What aspects of MNT can be protected by Intellectual Property: Relevance to MNT • What aspects of MNT can be protected by Intellectual Property Law? – Patent protection for novel, non-obvious, and useful MNT products or processes. – Trade secret protection for secret MNT processes. – Copyright protection for expressive components of MNT, i. e. software • Trade Related Aspects of Intellectual Property Rights (TRIPs) – Annex 1 C of the World Trade Organization (WTO) agreement that protects indtellectual property (Copyright, Patents, Trademarks, Trade Secrets, Industrial Designs, etc. )

Intellectual Property: TRIPS Enforcement • • • “Members shall ensure that enforcement procedures as Intellectual Property: TRIPS Enforcement • • • “Members shall ensure that enforcement procedures as specified in this Part are available under their law so as to permit effective action against any act of infringement of intellectual property rights covered by this Agreement, including expeditious remedies to prevent infringements and remedies which constitute a deterrent to further infringements. ” Art. 41 TRIPs. Dispute Settlement Body of the WTO Members that do not comply with TRIPs by enacting laws that comply with the agreement are subject to economic sanctions.

Intellectual Property: Application of TRIPS to MNT • TRIPs will provide enforcement mechanisms for Intellectual Property: Application of TRIPS to MNT • TRIPs will provide enforcement mechanisms for patent holders in foreign countries (second world and transitional states) • If an MNT invention has a harmful application, the rights holder can prevent another from making, using, selling, or offering to sell the patented invention or the parts necessary to make the patented invention • This strategy was proposed by Jeremy Rifkin recently when patent protection of a human-animal chimera was sought to prevent others from creating human-animal chimeras – Rifkin said "If the patent is issued. . . we determine who will be able to exploit this technology for 20 years. We will determine how it's to be used or if it's to be used. “

Intellectual Property: Limitations of TRIPS • Does not cover non-signatory nations • Immediate action Intellectual Property: Limitations of TRIPS • Does not cover non-signatory nations • Immediate action may be needed with MNT to stop a particular use of the good; local court action may be too slow • Different countries may give different levels of IP protection notwithstanding TRIPs • IP rights of limited duration

Conclusions Conclusions

Feasibility of International MNT Agreement • International agreements difficult to negotiate – Need immediate Feasibility of International MNT Agreement • International agreements difficult to negotiate – Need immediate and serious threat • Enforcement of treaties difficult and controversial – May be particularly challenging for MNT • Dual-use technologies incompatible with traditional arms control approach? • Some non-compliance and non-signatories likely – Tolerability? Havens?

Lessons from Case Studies for International Agreement • Need to balance burdens on beneficial Lessons from Case Studies for International Agreement • Need to balance burdens on beneficial uses vs. restrictions on harmful uses • Defining scope of technology to be regulated critical • Include technology sharing inducements • Need to involve industry • Consider non-state actors • Managing information as important as controlling material and equipment • Agreement must have built-in flexibility to evolve • Enforcement by legal (cf political) bodies preferable • Need better verification and inspection mechanisms

Some Possible Interim and Second-Best Solutions • Less formal approaches for the shorter term Some Possible Interim and Second-Best Solutions • Less formal approaches for the shorter term – Intellectual property – Benefit and information sharing • e. g. , CRN’s International Nanotechnology Research Consortium – Export controls (e. g. , “Australia Group”) – Confidence building measures – International consultations (e. g. , International Dialogue on Responsible R&D of Nanotechnology) – Development of defensive technology – “Civil-society-based monitoring” (e. g. , Bio. Weapons Prevention Project) – Codes of conduct – Group of experts (e. g. , IPCC)

Overall Conclusions • Creative approaches needed to address risks of MNT • Existing models Overall Conclusions • Creative approaches needed to address risks of MNT • Existing models provide valuable lessons; but MNT will require unique approaches • It is essential to develop regulatory and risk management approaches prospectively before technologies exist – Creates tension with realpolitik

Acknowledgments ASU Collaborators: – Michael Volk – Jonathan Swartz – Jason Wejnert – Jeffrey Acknowledgments ASU Collaborators: – Michael Volk – Jonathan Swartz – Jason Wejnert – Jeffrey Hardee – Andrew Askland Center for Responsible Nanotechnology: – Chris Phoenix – Mike Treder

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Two Versions of the Precautionary Principle • Rio Declaration: “Where there are threats of Two Versions of the Precautionary Principle • Rio Declaration: “Where there are threats of serious and irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. ” • Wingspread Statement: “When an activity raises threats of harms to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. ”