May 17, 2019 Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing. As these questions become more pressing, now is the time to re-consider what ethical and regulatory safeguards should be implemented and discuss the many questions raised by advancements in consumer genetics. Presentation: Seema Mohapatra, Associate Professor of Law, Indiana University Robert H. McKinney School of Law - Abolishing the Myth of “Anonymous” Gamete Donation in the Age of Direct-to-Consumer Genetic Testing Learn more: https://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference

1. Faculty Name Here
Course Name Here
ABOLISHING THE MYTH OF “ANONYMOUS”
SPERM DONATION IN THE AGE OF DIRECT-TO-
CONSUMER GENETIC TESTING
Seema Mohapatra, JD, MPH
Consuming Genetics: Ethical Considerations of New Technologies
2019 Annual Petrie Flom Conference
May 17, 2019

2. IUPUI, Robert H. McKinney School of Law
TODAY’S DISCUSSION
The US system of anonymous sperm donation
Why anonymous sperm donation does not exist anymore in the U.S.
due to DTC genetic testing
Legal and policy options including state laws and private
governance

3. IUPUI, Robert H. McKinney School of Law
https://www.huffingtonpost.com/wendy-kramer/a-brief-
history-of-donor-
conception_b_9814184.html?ncid=engmodushpmg0000000

4. IUPUI, Robert H. McKinney School of Law
https://www.theguardian.com/science/2018/aug/15/americ
as-hottest-export-sperm-fertility
Sperm: “America’s Greatest
Export”

5. IUPUI, Robert H. McKinney School of Law
https://www.nytimes.com/2016/11/08/health/sperm-donor-facts.html
The Thriving US Sperm Market
Donors” paid between
$30 - $120 per sample (Multi-
billion dollar industry)
Option of Donor Anonymity

6. IUPUI, Robert H. McKinney School of Law
https://blogs.cdc.gov/
genomics/2018/06/12
/consumer-genetic-
testing/

7. IUPUI, Robert H. McKinney School of Law
https://www.nytimes.com/2019/02/16/health/sperm-donation-dna-
testing.htmlhttps://www.23andme.com/?mdc2=true
THE STORY OF DANIELLE TEUSCHER

8. IUPUI, Robert H. McKinney School of Law
https://www.washingtonpost.com/science/2018/1
0/11/even-if-youve-never-taken-dna-test-distant-
relatives-could-reveal-your-
identity/?utm_term=.88db8b0ecd36
Parties Affected by the End
of Donor Anonymity
Donor-
Conceived
Individuals
Those Who
Use
Purchased
Sperm
Sperm Banks
and ART Industry
Sperm Donors

9. IUPUI, Robert H. McKinney School of Law
https://www.thetgmi.org/genetics/direct-to-consumer-genetic-testing/
The Moot Ethical Debate

10. IUPUI, Robert H. McKinney School of Law
https://www.theatlantic.com/family/archive/2018/05/sperm-donation-anonymous/560588/
DONOR-CONCEIVED INDIVIDUALS AND
ANONYMITY

11. IUPUI, Robert H. McKinney School of Law
The Legal Landscape
• No federal laws
regarding
anonymity
• Rigorous testing
for diseases
(FDA)
Federal Laws:
• Washington was
first state to enact
disclosure laws
for non-medical
information
• Utah enacted
medical
disclosure laws
State Laws:Federal Laws State Laws
THE LEGAL
LANDSCAPE

12. IUPUI, Robert H. McKinney School of Law
Clinics should “fully inform donors and recipients of donor
gametes of their clinic's policies about information sharing and
contact, but they should caution that policies cannot be
guaranteed if laws or individual circumstances change and that
the possibility exists of contact from offspring in the future.”
American Society of Reproductive Medicine (“ASRM”)
PRIVATE
GOVERNANCE

13. IUPUI, Robert H. McKinney School of Law
Ethics Committee of the American Society for Reproductive Medicine, Interests, obligations, and rights in gamete and embryo donation: an Ethics Committee opinion,
Fertility and Sterility, April 2019
“Programs should caution participants that policies related to
information sharing are not guaranteed since laws or individual
circumstances change and that there is a possibility they may be
contacted by offspring in the future. Similarly, maintaining
anonymity of parties cannot be guaranteed since commercially
available genetic testing and agencies that allow dissemination of
identifying information through social media increases the risk of
inadvertent disclosure of participants.”
ASRM Ethics Committee Opinion,
April 2019

14. IUPUI, Robert H. McKinney School of Law
Federal (unlikely):
A federal mandate against anonymous donation by the FDA as
requested by a Citizen Petition of the Sibling Donor Registry
State Efforts?
State bans tied to licensing of banks/clinics
POTENTIAL LEGAL SOLUTIONS?

15. https://pged.org/direct-to-consumer-genetic-testing/
PRIVATE GOVERNANCE OPTIONS GOING FORWARD
SART/ASRM need to
have stronger language
that discourages using the
language of anonymity/the
category of anonymous
donors
Donor and recipient
counseling about the
likelihood of
disclosure

16. IUPUI, Robert H. McKinney School of Law
https://blog.celmatix.com/finding-the-right-fertility-clinic-for-lgbtq-parents-to-be-e31bec4e0c1a
POSSIBLE RAMIFICATIONS
Weakening of the sperm bank
industry
Lack of supply for LGBTQ/
infertile individuals/single
women seeking sperm

17. IUPUI, Robert H. McKinney School of Law
Options Going
Forward
ASRM/SART should issue stricter guidelines for member clinics about the
of donor anonymity
State licensing/accreditation could be tied to not making promises of
anonymity
Broader question about unintended consequences of DTC testing
Better engagement/counseling with those interested in using donor sperm
and those who are donors about the reality of anonymity

18. IUPUI, Robert H. McKinney School of Law
Contact Information:
Seema Mohapatra
mohap@iu.edu
On Twitter:
@profmohapatra