powerpoint presentation - legal issues in human embryonic stem
TRANSCRIPT
Outlook for Stem Cell
Research:
Emerging Legal IssuesAmy T. Campbell, JD, MBE
SUNY Upstate Medical University
* * * * *
Rockefeller Inst. of Gov’t Stem Cell Forum
May 11, 2009
Session Objectives
Provide background context to legal
discussion
Understand major legal issues in
stem cell research, with focus on
human embryonic stem cell
research (hESCR)
Recognize how law influences and is
influenced by science, ethics, policy
(politics)
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Law + Science, Ethics, Policy
SCIENCE
What technically can we do?
ETHICS
What should we do?
LAW
What can (should?) we do?
POLICY
What will we do in light of competing
values, political climate?
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FEDERAL
STATE
INSTITUTION
INTERNATIONAL
LEGAL CIRCLES OF INFLUENCE
EVOLUTION OF LEGAL ISSUES
hESCR
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Trajectory of Legal Issues
Permissibility: Is it ok or not ok?
(hESCR / ―derivation‖ or ―use‖)
If ok, how Fund
If ok, how Regulate
Concern shifts to ownership rights and
(limits on) transfer of ownership
◦ Personal ―property‖ (commodification)
◦ Intellectual property (commercialization)
◦ Physical property (commercialization)
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Recurring Themes in
Discussion of Legal Issues
Revisit circles of influence
State – Federal – International
patchwork of regulations
―Bio-federalism‖ of US
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Initial Legal Focus:
Permissibility / Funding
Federal
◦ Dickey-Wicker Amendment (1996-)
◦ Fmr. Pres. Bush’s Executive Order (Aug 2001)
◦ Pres. Obama’s Executive Order (March 2009)
State
International
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Traditional Legal Response:
Regulation
Federal
◦ NIH/OHRP (NIH draft guidelines, 4/09)
◦ FDA
◦ NAS
◦ Legislature
States
International
◦ ISSCR
◦ Hinxton Group5/11/09 Amy T Campbell 9
Emerging Legal Focus: The 3 Cs
Commodification
◦ Personal property of gametes, embryos
Commercialization
◦ Intellectual property – patents
◦ Physical property – materials (licensing)
Collaboration
◦ Dealing with the patchwork of regulations
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EMERGING LEGAL DEVELOPMENTS: THE 3 C’S
hESCR
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First C: Commodifcation
Donation Issues
Informed consent
Compensation
*Close connection to ethics
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Second C: Commercialization
The Commercialization Chain:
Derivation of SC line – Use of SCs –
Preclinical trial – Clinical use
Uncertainty of regulation: barrier to
scientific development
Conflicting ethical views: barrier to
investment
Level of Regulation
◦ Less regulation ~ more progress
◦ Clear regulation ~ more progress
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Commercialization cont’d
Intellectual Property (Patents)
and Physical Property (Licenses)
Can (Should) we Patent?
Regulating Commercialization
◦ Limits on Patent Scope
◦ Dealing with Existing Patents and Licensing
Schemes
*Close connection to economics/business;
some to ethics
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Third C: Collaboration
The Patchwork and Thicket Issue
Commodification:
◦ Collaboration with other state, nation
researchers who differ in view on ―requisite‖
(who, what, when) consent and ―appropriate‖
compensation
Commercialization:
◦ Collaboration with other state, nation
researchers who differ in view of
permissibility, patent scope, licensing regimes
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WHAT NEXT?
hESCR & the Law
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“The Law” needs to …
Analyze scope/substance of:
◦ Obama E.O.
◦ NIH regulations
◦ Federal legislative action
◦ State activity
◦ Int’l activity
Chart out/clarify boundaries and areas of
overlap/conflict among above
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“The Law” needs to …
Develop public repository for:
◦ Regulations, ethical guidance, consent
forms, info for donors, etc.
Develop model guidance, law, etc.
Develop commercialization chain
clearinghouse
◦ To Inform, Guide, Monitor◦ See O’Connor SM, The use of MTAs to control commercialization of stem cell diagnostics
and therapeutics, SSRN-id921170-1. Available at:
http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=327066 (accessed May 7, 2009).
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“The Law” needs to …
Promote collaboration via open,
multi-level discussion
◦ Funding, Guidelines/Regulation (re:
consent, compensation, IP and P law)
Reflect/be in iterative discourse with
science and ethics
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Selected References
Donation: ◦ Steinbrook R. Egg donation and human embryonic stem-cell
research. N Engl J Med. 2006;354(4):324-326.
◦ Streiffer R. Informed consent and federal funding for stem cell
research. Hastings Center Report. 2008;38(3):40-47.
Regulation – Federal guidance:◦ National Institutes of Health. Draft National Institutes of Health
Guidelines for Human Stem Cell Research [Notice]. Federal
Register: April 23, 2009 (Volume 74, Number 77), 18578-18580.
◦ National Research Council and Institute of Medicine. 2008. 2008
Amendments to the National Academies’ Guidelines for Human
Embryonic Stem Cell Research. Washington, DC: The National
Academies Press.
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Selected References cont’d
Regulation – Int’l guidance:◦ Daley et al. The ISSCR guidelines for human embryonic stem cell
research. Science. 2007;315:603-604.
◦ Mathews et al. Integrity in international stem cell research
collaborations. Science. 2006;313:921-922.
Regulation – Other Articles:◦ Jain K. Ethical and regulatory aspects of embryonic stem cell
research. Expert Opin. Biol. Ther. 2005;5(2):153-162.
◦ Knowles L. A regulatory patchwork—human ES cell research
oversight. Nature Biotechnology. 2004;22(2):157-163.
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Useful websitesState
National Conference of State Legislatures:
http://www.ncsl.org/programs/health/genetics/embfet.htm
(overview of state legislation @ SCR; can also search for pending
legislation)
CIRM: http://www.cirm.ca.gov/ (regs, other info)
Federal
NIH: http://stemcells.nih.gov/ (NIH policies, Obama EO info, general
info)
International
ISSCR: http://www.isscr.org/guidelines/index.htm (guidelines;
sample informed consent and licensing materials; other resources)
Hinxton Group: http://www.hinxtongroup.org/ (Consensus
principles covering SC and Law; interactive map of world stem cell
policies)
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Contact Information
Amy T. Campbell, JD, MBE
Asst. Professor, Ctr. for Bioethics and Humanities
SUNY Upstate Medical University and
Adjunct Asst. Professor, The Bioethics Program
Union Graduate College – Mount Sinai School of Medicine
725 Irving Ave * Suite 406
Syracuse, NY 13210
(315) 464-8456
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