Emerging Legal Issues - Rockefeller Institute of Government

Outlook for Stem Cell
Research:
Emerging Legal Issues
Amy T. Campbell, JD, MBE
SUNY Upstate Medical University
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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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LEGAL CIRCLES OF INFLUENCE
INTERNATIONAL
FEDERAL
STATE
INSTITUTION
hESCR
EVOLUTION OF LEGAL
ISSUES
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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 Group
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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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hESCR
EMERGING LEGAL
DEVELOPMENTS: THE 3
C’S
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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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hESCR & the Law
WHAT NEXT?
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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 websites
State
 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
[email protected]
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