January 23, 2017 The Fifth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. The Fifth Annual Health Law Year in P/Review was sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. Learn more on our website: http://petrieflom.law.harvard.edu/events/details/5th-annual-health-law-year-in-p-review

1. Reproductive Technology and
Regulatory Oversight
I. Glenn Cohen, JD
Professor, Harvard Law School
Director, Petrie-Flom Center for Health Law Policy,
Biotechnology and Bioethics
igcohen@law.harvard.edu

2.  Has no relationships to disclose
 Will not be promoting
unlabeled/unapproved uses of drugs,
devices, products, protocols, or
therapeutic strategies
Disclosure

3. Mitochondrial Replacement
Therapy
In Vitro Gametogenesis
CRISPR Gene Editing (briefly)
Topics

4. Mitochondrial Replacement Therapy

Source: MRC Harwell
https://www.har.mrc.ac.uk/news-events/news-
archive?page=5

5. Mitochondrial Replacement Therapy

Source: MRC Harwell
https://www.har.mrc.ac.uk/news-events/news-
archive?page=5

6. UK Approval
US
FDA
IOM Report
Congressional Appropriations Rider
Mitochondrial Replacement Therapy

7. Legal/Ethical Issues
Crossing the Germ-Line “Red Line”?
Anonymity and Payment of
Mitochondrial Donor
Parentage Questions (?)
Sex Selection
Mitochondrial Replacement Therapy

8. In Vitro Gametogenesis (IVG)
From Hikabe et al, Reconstitution in vitro of the entire cycle of
the mouse female germ line, Nature, 539, 299-303 (2016)

9. Legal/Ethical Issues
Mass Embryo Creation
Embryo Destruction
Enhancement (+ Gene Editing)
Unauthorized Parenthood
Multiplex + Single Person Parenthood
In Vitro Gametogenesis (IVG)

10.  What is CRISPR
 Chronology of Controversy
 Patent Dispute
CRISPR Gene Editing
Margaret Knox, The Gene Genie, Scientific American 311, 42 - 46
(2014)