Industry Issues

2017 FDA Citizen's Petition: 

Read the 173  comments, stories and powerful testimonials on our July 2017 FDA Citizen's Petition, "Request that the FDA look into the state of affairs surrounding the sperm donation industry, and then develop the appropriate and much-needed regulation/oversight."  A pdf of the Petition. 

 

The myth of donor anonymity is perpetuated by researchers: 

12/2016:  This recent article published in the Journal of Law and the Biosciences called: Sperm Donor Anonymity and Compensation: An Experiment With American Sperm Donors illustrates that fact that the US sperm banking industry is still not properly educating prospective donors and parents about the myth of anonymity.  With DNA testing, Google and social media, anonymity is a thing of the past. Sperm banks (and egg clinics) need to stop the fallacy of selling "anonymous" donors, and the "experts" need to stop perpetuating this idea.  Donor conceived people have been locating their donors via DNA testing since 2005 (see New Scientist Magazine 11/3/2005)- so this is not new.  This published "study" was conducted in partnership with a sperm bank who profits more from offering anonymous donors.  Communication with their donors about anonymity had already taken place. How was this major conflict of interest acceptable to the Journal of Law and Biosciences?  In response to the article, Harvard Law published my blog contribution, and the link to my HuffPo response blog ("10 Things").

A letter from the Editor-in-Chief of Human Reproduction:  "Due to genetic testing donor anonymity does no longer exist":  

Many thousands of people worldwide have been conceived with donor gametes but not all parents tell their children of their origin. Genetic testing will make this impossible. Over three million people have already used direct-to-consumer genetic testing. The rapidly increasing availability of cheaper and more detailed tests poses numerous challenges to the current practice of sperm and egg donation: 1. Whether they are donating in a country that practices anonymous donation or not, donors should be informed that their anonymity is no longer guaranteed, as they may be traced if their DNA, or that of a relative, is added to a database. 2. Donor-conceived adults who have not been informed of their status may find out that they are donor-conceived. 3. Parents using donor conception need to be fully informed that their children’s DNA will identify that they are not the biological parents and they should be encouraged to disclose the use of donor gametes to their children. All parties concerned must be aware that, in 2016, donor anonymity has ceased to exist. - JLH (Hans) Evers, Editor-in-Chief Human Reproduction

 

‘Scattered Seeds’: New Book Gives Inside Look at the Business, Families of Sperm Donation.   Journalist Jacqueline Mroz argues that sperm donation makes having children accessible for more people. But it also raises questions about bias, privacy, and the gene pool.  “This is the dawn of a challenging moment in time for assisted reproduction,” Mroz concludes. “With technology evolving rapidly, it’s time for legislators and policymakers to start acknowledging these changes and examine the consequences of an unregulated industry.”

 

Sperm Banks Are Run Like Grocery Stores From The 19th Century,” -  Arthur Caplan, Professor of Bioethics at NYU, Langone Medical Center

 

"I don't think donor anonymity is an issue that is front of mind for the general public. It's individual fertility specialists and clinics seeking to retain control and living out their antediluvian paternalistic attitudes in practice that are the reasons behind the persistence of donor anonymity. They don't trust the lived experience of donors, donor-conceived people or the parents of donor-conceived people and believe that in all cases "doctor knows best". When you have a combination of capitalism and patriarchy you're going to have problems with getting progressive values into place." 
Donor-Conceived Person, 2017
 

Where around the world is donor anonymity banned?

 

Austria, Finland, Germany, The Netherlands, New South Wales, New Zealand, Norway, Sweden, Switzerland, UK, and Australia.

May 2017: The German Parliament has passed the Sperm Donor Registry Act, which will allow children born from 2018 onwards to access their donors' information.

Court reaffirms: no anonymity rights for sperm donors......IN GERMANY.  "A Hanover court on Monday ruled that a child's right to know about their lineage was more important than a sperm donor’s right to privacy, reaffirming a high court ruling from last year."

The report on the review of South Australian legislation that was tabled in Parliament  4/11/17.
If this gets through, South Australia will become the second place in the world to grant retrospective access to identifying information via legislation.

 

The media and other industry "experts" frequently report that ending donor anonymity will automatically result in a drop in donor numbers. Quite to the contrary, there has been a 10 fold increase in the number of sperm donors AFTER removal of anonymity in the state of NSW, Australia. Published in the Herald Sun 5/22/16:

2016: A new paper has just been published in the Journal of Law and Medicine on the effect of removing donor anonymity on sperm donor numbers in Australia: Does the removal of anonymity reduce the number of sperm donors in Australia? 

From one of the authors: Now that we have data that the UK and Australia were not adversely affected by removing anonymity, hopefully, the USA will follow suit. Especially seeing as though DNA makes any guarantee of anonymity null and void, it is unethical that clinics still offer it.

The HFEA in the UK only has numbers through 2013.  (Are they still keeping track?)  We can see that the numbers of UK donors have gone up since the ending of anonymity in 2005.

The HFEA notes the reason for the 2013 decrease in local sperm donors citing the reasons for an increase in imported sperm:

The number of imports has steadily increased year on year and now forms almost a third of new registrations. Most imported sperm comes from the USA, followed by Denmark. It is important to note that this does not necessarily reflect ‘popularity’ of donors, but perhaps more their availability. Some clinics reported that they import donor sperm because the cost, time and resources required to recruit donors themselves is too high when there are specialist sperm banks who can carry out an efficient and reliable service. 

Year Sperm Donors Egg Donors Year Sperm Donors Egg Donors
1992 375 451 2003 257 1,032
1993 426 528 2004 237 1,107
1994 417 732 2005 285 1,023
1995 414 749 2006 307 803
1996 419 806 2007 355 1,024
1997 343 910 2008 403 1,167
1998 256 943 2009 438 1,202
1999 302 1,120 2010 492 1,258
2000 323 1.241 2011 541 815
2001 327 1,302 2012 631 1,005
2002 288 1,174 2013 586 1,103
 

Articles

Wendy's Huffington Post Blog

 

 

In the News

5/17:  NY Times: Dutch Fertility Doctor Swapped Donors’ Sperm With His, Lawsuit Claims

2/17:  NBC News Colorado: Sperm Donor's Medical History- California Cryobank

2/17:  NBC News Atlanta: Sperm For Sale- Xytex

2/17:  Unethical Practice by Xytex leads to disaster. 

11/16:  Friends with Benefits: Texas Man Who Donated Sperm to a Friend Has Parental Rights: 2016 Analysis of sperm donation laws 

11/16: Canadian Medical Association Journal: Switched before Birth, "...why is it wrong when it happens in a hospital by accident, but ok when doctors are paid to do it?  That is the question on the minds of so-called 'donor offspring' - people created through the eggs or sperm of individuals they will never know".

10/16:  CBS This Morning: Lost Samples, Poor Screening: Sperm Banking Industry Oversight Examined

9/16: CBC News: Canadian Sperm Donor Registry Long Overdue, "I always wanted a sister:" Offspring with same sperm donor meet for the first time.

 

Other Relevant Articles

Here are some other articles on the law, the ethics, the comparisons to adoption, the need for regulation, and the nuts and bolts of donor conception. Issues we should all ponder!

48 Donor Siblings and the ASRM

  • 12/11: BioNews: Of family and finance: Israeli citizens without rights and HFEA remuneration 
  • 9/10: The Globe and Mail: Doctor sued over allegedly mixing up sperm samples 
  • 7/10: BioNews: 'My Daddy's Name is Donor': Read with caution! 
  • 2009: Medicine and Law: Donation of Eggs in Assisted Reproduction and Informed Consent 
  • 12/09: Genomics Law Report: Reproductive Genetic Screening: More Questions Than Answers 
  • 11/09: BioNews: Children's human rights and assisted human reproduction 
  • 6/09: National Review: Scrambled Ethics 
  • 2/09: Adoption Institute: Old Lessons For a New World: Applying Adoption Research and Experience to Assisted Reproductive Technology 
  • 1/09: ASRM Ethics Committee: Interests, obligations, and rights of the donor in gamete donation 
  • 12/08: The Wall Street Journal: Ova Time: Women Line Up To Donate Eggs -- for Money 
  • 6/08: Medical News Today: Donor Offspring May Feel Betrayal, Anger: Study 
  • 6/08: ADVANCE: Conceivable Truths 
  • 4/08: Naomi Cahn: Necessary Subjects:  The Need for a Mandatory National Donor Gamete Registry 
  • 11/07: Center for Genetics and Society: It’s Time for an Egg Donor Registry and Long-term Follow-up 
  • 2007: Thomas K. Sylvester, Yale Law School: The Case Against Sperm Donor Anonymity 
  • 2007: CNN: States urged to open adoption records 
  • 2007: Best Practice & Research: Donor gametes: anonymous or identified? 
  • 3/07: Manchester Evening News: Men still donating sperm 
  • 4/07: American Fertility Association Newsletter: DNA And The Exploding Myth Of Donor Anonymity 
  • 11/05: NewScientist.com: Anonymous sperm donor traced on internet 
  • The Sperm Bank of California: Research (link to research)

NY State Law

NYCRR Title 10 PART 52-8.9 Required records.

(a) Reproductive tissue bank records shall be open to inspection by the department and shall be kept for at least seven years after release of reproductive tissue for artificial inseminations or assisted reproductive procedures not resulting in a live birth, and 25 years for inseminations or assisted reproductive procedures known to have resulted in a live birth. For all donated reproductive tissue, the donor's name, address, and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the reproductive tissue bank to any person or entity, except upon the written informed consent of the donor, or except to authorized employees of the department or as permitted by law. The recipient's name, address, and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the insemination/ implantation site to any person or entity, except upon the written informed consent of the recipient, or except to authorized employees of the department, or as permitted by law.

(b) In addition to the recordkeeping requirements of section 52-2.9(c) of this Part, each reproductive tissue bank shall maintain applicable donor/client-depositor records which include:

(1)          for donors, pertinent family history of any genetic disorders;

(2)          documentation of donor and client-depositor written informed consent;

(3)          for semen donors, outcome of any prior artificial insemination or other assisted reproductive procedures, if known, including number of successful pregnancies, if any, and any reports from insemination/ implantation sites which would affect the donor's acceptability; and

(4)          documented approval of the reproductive tissue bank director, or his/her designee, of the acceptability of the donor.

(c) In addition to the recordkeeping requirements of section 52-2.9(e) and (f) of this Part, each reproductive tissue bank shall maintain applicable records which include:

(1)          donor's identification code or client-depositor's name;

(2)          for semen donations, documentation of laboratory cryosensitivity testing, and, if performed, results of viability checks after thawing and during storage, if any;

(3)          the name of the insemination/implantation site, the physician or other person authorized by law to perform artificial insemination or assisted reproductive procedures, and/or receive reproductive tissue, and the name of the person communicating the order for distribution of the tissue;

(4)          the recipient's name, if the name has been provided to the reproductive tissue bank with her informed consent, or the recipient's identification code, if used;

(5)          documentation of training, certification, licensure, if required by law, and continuing education for each staff member; and

(6) any adverse outcomes, including infectious diseases in recipients or their offspring and genetic defects in offspring, which shall be reported to the donors if there is any possibility that the donor's reproductive tissue contributed to the adverse outcome.

(d) The following records shall be kept, separate from the recipient's records, by

an insemination/implantation site for each insemination or assisted reproductive procedure performed:

(1)          donor's identification code or name, if the reproductive tissue originates from a client-depositor;

(2)          evidence that reproductive tissue from donors and/or client-depositors has been obtained from a reproductive tissue bank licensed pursuant to Subpart 52-2 of this Part;

(3)          disposition of the reproductive tissue, including, but not limited to, the name or identification code of the recipient, destruction logs, and autoclaving or incineration records;

(4)          the name and signature of the ordering physician or other person authorized by law to order issuance of the reproductive tissue;

(5)          results of sperm viability checks, if performed; and

(6)          signature of the person receiving the sample and condition of the sample upon receipt.

(e) The insemination/implantation site shall document the outcome of the artificial insemination or assisted reproductive procedure, including, but not limited to, any known adverse outcome in the infant or infectious disease in the recipient, as well as any known successful pregnancies. This information shall also be reported to the reproductive tissue bank releasing the tissue, even if the reproductive tissue bank is the same entity as the insemination/ implantation site.

 

Please browse our "News and Videos" pages (for members only) as there have been many news stories over the past decade addressing the many issues within the reproductive medicine industry.