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Regulating the donor-conception industry in the US

27 February 2017
By Wendy Kramer
Director and co-founder of the Donor Sibling Registry
Appeared in BioNews 890

Since 2000, the Donor Sibling Registry (DSR) has connected more than 14,000 donor-conceived individuals with their donors and half-siblings. We've helped them to create and explore these new familial relationships and to better understand their ancestry and learn about their medical backgrounds. The DSR has also helped to eliminate much of the stigma associated with being a gamete donor or donor-conceived person. Behind the scenes, the DSR's research, education, and counseling service have provided the momentum for the establishment of positive reforms in the egg-donation and sperm-banking industries around the world.

We ask: 'What is in the best interests of the child to be born?' Our many research surveys, which reach thousands of donors, parents and donor offspring, have helped to answer this fundamental question. We are interested in the views of all those involved, particularly regarding medical issues, donor anonymity, and connecting with donor relatives. For almost 10 years, the DSR has partnered with researchers and universities around the world, including Cambridge in the UK, to publish more than two dozen peer-reviewed research papers on parents, donors, offspring, and their family members.

In the US, the donor-conception industry is largely unregulated, and there is wide variation in egg- and sperm-bank policies and procedures. Problems often arise as a result of lack of consistency around medical testing, health history follow-up, sharing and updating medical information, openness and transparency, and record-keeping and communication. The DSR has more than 53,000 members in 105 countries around the world, and US sperm banks ship to many countries, so this lack of oversight and regulation is of concern to donor families around the world.

Many of these issues are not unique to the donor conception industry. The US Federal Government has already acknowledged the importance of quality medical electronic record-keeping (HITECH Act), enacted the Patients' Bill of Rights (ACA), and highlighted the importance of testing for communicable diseases and screening for family health history. However, these federal regulations don't address the complexities within the donor-conception industry, and there remains a great need for more oversight and regulation of sperm banks and egg-donation clinics.

They need only look across the pond for a model of how this can be achieved – the UK's Human Fertilisation and Embryology Authority (HFEA) has been doing an excellent job of regulating the donor-conception industry for many years. Such a regulatory body is desperately needed in the US to improve medical and psychological outcomes of donor-conceived children. Recipients and donors should be fully educated and informed when making the decision to either conceive a child or donate sperm.

As a response to the current lack of oversight, in January 2017 the DSR submitted a Citizen's Proposal to the US Food and Drug Administration (FDA), stating:

'Because the FDA currently mandates minimal medical testing (communicable disease, e.g. STDs) of sperm and egg donors (no other regulation exists), we request that the commissioner of the FDA look into the state of affairs surrounding the sperm donation industry, and then develop the appropriate and much-needed regulation/oversight.'

There are many complexities associated with creating a regulatory body. Effective policy change must involve all stakeholders – not only the Department of Health and Human Services, the Centres for Disease Control (CDC) and the FDA, but also the Donor Sibling Registry, cryobanks, parents, donors, and donor-conceived people themselves.

We invite everyone to add their comments or personal stories to our petition to highlight the importance of oversight and regulation of the reproductive-medicine industry. We hope that mental-health professionals and academics will also give their perspectives on the importance of donor-conceived people having access to their medical records, ancestry, and first-degree genetic relatives.

You can submit your comments on the petition here.

3 April 2017 - by Andrew Hellman and Professor Glenn Cohen 
Many children conceived using donor sperm or eggs want to know their biological parents. In the US, some clinics make the identity of the sperm donor available to a donor-conceived child at age 18. Most intending parents, though, choose sperm donation programs that do not reveal the identities of the sperm donors – so-called 'anonymous sperm donation'...
27 March 2017 - by Dr Petra Nordqvist and Hazel Burke 
Until twelve years ago, most people donating eggs or sperm via a UK clinic would be anonymous. In the eyes of the law, this donation was a generous gift that was handed over without continuing responsibilities or ties for the donor. In fact, continued involvement of the donor was usually discouraged...
22 April 2013 - by James Brooks 
A podcast produced as part of the When It Takes More Than Two project organised by the Progress Educational Trust...
8 May 2012 - by Wendy Kramer 
In 1988 the Office of Technology Assessment estimated that 30,000 children were born via donor insemination during the year 1986/87 in the US. A quarter of a century - and no further research - later, '30,000 annual births' is still trotted out in academia, lectures and the media...
21 June 2010 - by Professor Vardit Ravitsky 
The debate surrounding the rights and welfare of donor offspring has been gaining momentum over the past few years, and a growing number of countries have already banned anonymous sperm donation to ensure the right of offspring to access information about their donors...
16 November 2009 - by Wendy Kramer 
Writing in the 26 May 2009 edition of BioNews, the Donor Sibling Registry reported about the recent birth of a severely handicapped and profoundly retarded baby girl who had inherited an unbalanced translocation from New England Cryogenic Center sperm donor D-250. Now, the same problem has been disclosed as occurring at the London Women's Clinic. A donor was found to be a balanced translocation carrier only after his semen had been widely commercialised. A couple had to destroy 22 embryos c...
5 October 2009 - by MacKenna Roberts 
Beginning from last Thursday, new disclosure laws for donor-conceived individuals and gamete/embryo donors came into force which will broaden access to donor genetic information. The provisions were enacted together with the vast majority of the new Human Fertilisation & Embryology Act 2008, approved by Parliament last year and aimed at updating its predecessor 1990 statute to be more inline with contemporary liberal attitudes and advances in reproductive technolog...
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