1. International Coordination of Gene Editing Regulation
ISSP Panel on Gene Editing September 28, 2016 Gary E. Marchant, Ph.D., J.D.

2. U.S. National Academy of Sciences: Human Gene Editing: Summit

3. U.S. National Academy of Sciences: Human Gene Editing: Consensus Study
Committee appointed/convened in December 2016
22 members, including experts from USA, Canada, China, UK, Germany, France, Italy, Israel, Egypt
Draft report to go to external peer reviewers by end of October 2016
Final Report to be published in early 2017

4. U.S. NAS Consensus Study: Statement of Task
1. What is the current state of the science of human gene editing, as well as possible future directions and challenges to further advances in this research?
2. What are the potential clinical applications that may hold promise for the treatment of human diseases? What alternative approaches exist?
3. What is known about the efficacy and risks of gene editing in humans, and what research might increase the specificity and efficacy of human gene editing while reducing risks? Will further advances in gene editing introduce additional potential clinical applications while reducing concerns about patient safety?
4. Can or should explicit scientific standards be established for quantifying off-target genome alterations and, if so, how should such standards be applied for use in the treatment of human diseases?
5. Do current ethical and legal standards for human subjects research adequately address human gene editing, including germline editing? What are the ethical, legal, and social implications of the use of current and projected gene-editing technologies in humans?
6. What principles or frameworks might provide appropriate oversight for somatic and germline editing in humans? How might they help determine whether, and which applications of, gene editing in humans should or should not go forward? What safeguards should be in place to ensure proper conduct of gene-editing research and use of gene-editing techniques?
7. Provide examples of how these issues are being addressed in the international context. What are the prospects for harmonizing policies? What can be learned from the approaches being applied in different jurisdictions?

5. International Harmonization?
At December 2015 global summit on gene editing, first four speakers all emphasized importance of international harmonization of human gene editing regulation
Nobel Prize winner Dr. David Baltimore
President, US National Academies of Science
President, Royal Society of UK
President, Chinese Academy of Sciences

6. Arguments for International Harmonization
Assure equal protection for citizens of all nations
Discourage medical tourism
Provide consistent requirements for companies/ scientists in the field
Minimize trade disputes
Address transnational impacts
Prevent “race to the bottom” or “risk havens”
Regulators benefit from economies of scale and sharing resources and workload in regulatory decisions

7. Arguments Against International Harmonization
Different social, political, and ethical norms in different countries
Different national approaches allows for experimentation on different governance approaches
Large resources, time and effort needed to create international standards might be better utilized in developing national oversight
National pride and reputation impedes attempts to conform inconsistent national regulations
Complete agreement and compliance by all nations highly unlikely

8. Timing of International vs. National Standards
Francis 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 regime
be more difficult in the face of entrenched and inconsistent national regulations (e.g., GMOs)

10. “Transnational New Governance”
Originates from “soft law” concept in international law
Substantive obligations and requirements created by instruments that are not directly legally enforceable
International scope/focus/participation
Broadening 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 parties 10

11. Mechanisms of International Convergence
Convergence Process
Definition
Example
Transnational Regulatory Dialogue & Networking
Informal process of communication and policy learning between regulators
International Dialogue on Responsible Nanotechnology
International Coordination/ Cooperation
Non-binding guidelines, principles, standards
ISSCR Guidelines for Embryonic Stem Cell Research
Mutual Recognition
Nations accept regulatory decisions of other countries
Canada-US vehicle safety standards
Treaty-based Harmonization
Formal negotiation of binding treaties
UN Convention on Cloning (failed)

12. Different Gene Editing Uses: Different International Problems
Gene Editing Application
Primary Int’l Problem
Human Medical
Medical Tourism
GM Crops/Foods
Trade Conflicts
Gene Drives
Transboundary Effects

13. Aligning Solutions to Problems
Gene Editing Application
Primary Int’l Problem
Strategy
Human Medical
Medical Tourism
Prof. Society Guidelines
GM Crops/ Foods
Trade Conflicts
Codex Risk Guidelines
Gene Drives
Trans-boundary Effects
Regulator Dialogue

14. Thank you!