Altruism by Law

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Canada’s new AHR Law prohibits paid sperm donations, sets stringent standards and regulates reimbursement. Will donors still come forward?

Last year, Canada created a new legislative framework for regulating the practice of assisted reproduction, with the passage of the Assisted Human Reproduction Act which became law on March 29, 2004.1 The Act’s provisions will be introduced in stages under the aegis of the Assisted Human Reproduction Agency of Canada (to be established this year), with full implementation by 2008.   

Under the AHR Act, some assisted reproduction activities are prohibited -(either as ethically unacceptable or as entailing significant risk to patients), while others are controlled (permitted only under license and in accordance with regulations). Prohibited activities (stipulated in sections 5–9) include cloning, sex selection and the purchase of         sperm or eggs from donors. Controlled activities (sections 10–13) include the storage, transfer, destruction, importation and exportation of sperm and/or eggs. These sections of the Act (except section 8, which concerns use of reproductive material without consent) have been in force since April 2004. However, a “grandfathering” provision (section 71) ensures that Canadians will still have access to controlled AHR procedures while the new regulations and licensing system are being worked out.  

The Act now makes it a criminal offence to purchase or advertise for the purchase of sperm from a donor, directly or indirectly. When fully implemented, it will also place much stricter regulations on how sperm donors may be reimbursed for their legitimate expenses.

This article will explore the anticipated impact of the legislation on recruitment of sperm donors; the future availability of donor sperm; and the impact to women accessing donor insemination as a treatment option in Canada. This article will not address the issues surrounding secrecy and anonymity of sperm donors, because donor anonymity is guaranteed under the Act, nor will it address the debate on whether sperm donors should be paid for their donation.

Prior to the passage of the AHR Act, only two assisted reproduction technology services – recruitment of sperm donors and the processing and distribution of semen for assisted conception – were regulated by Health Canada. The 1996 Semen Regulations under the Food and Drug Act2 required potential sperm donors to satisfy stringent screening criteria, and semen samples were subject to strict serological and microbiological testing to safeguard the health and safety of Canadians. These regulations will remain in effect for the time being.

Perhaps the most significant changes affecting sperm donor recruitment concern how legitimate expenses incurred by donors will be reimbursed. Although the new legislation outlaws purchasing or advertising to purchase sperm from a donor (or a person acting on behalf of a donor), it will allow sperm donors to be reimbursed for their expenses, with or without receipts, until late 2005, when section 12 of the Act comes into force. After that, a donor may be reimbursed for receipted expenditures only – and only by a person who has already reimbursed the donor at least once during the preceding year. When the Act is fully implemented in 2008, reimbursement of receipted expenditures will be permitted under license only, in accordance with the regulations. Meantime, the types of eligible expenses acceptable for reimbursement have yet to be determined.

Anonymity is guaranteed under the Act, and a sperm donor’s identity may be disclosed only with his written consent. However, medical and non-identifying information will be collected and can be disclosed to women using the sperm. Their offspring and descendents will also have the right to access this information.

And so, by law, sperm donation in Canada is now altruistic and anonymous. Accessibility and availability will depend on the ability to recruit new donors.

While there is substantial literature on strategies to recruit sperm donors who agree to be identified to the offspring, and on their motives to become sperm donors,3 there are few published articles on the successful recruitment of sperm donors who donate for altruistic reasons. What is well documented, however, is that recruiting sperm donors in any jurisdiction is very difficult, even if the donors are paid.4

In the United Kingdom, where donors are required by law to be registered and are paid no more than £15 (about C$35) plus reasonable expenses, only half of the clinics are able to meet the demand for treatment with donor sperm. In fact, the Sperm, Egg and Embryo Donation (SEED) policy review released this year by the Human Fertilisation and Embryology Authority (HFEA) reports that the number of available sperm donors decreased in one clinic out of four, with donors from ethnic minority groups being in especially short supply. The result, as the HFEA acknowledges, has been long delays for women seeking treatment with donor sperm.5 In France, where a man who has at least one child and is living together with a woman may donate sperm anonymously and without reimbursement, the waiting time for treatment is at least one year.6

According to the authors of a study on Altruistic Gamete Donation commissioned by Health Canada, “It is rare to find any clinic, or in fact any jurisdiction, that says it has sufficient numbers of gamete donors to meet the needs of third party reproduction. This shortage exists whether gamete donors are paid or not paid.” 7

Recruitment of sperm donors may become even more difficult in Canada than in other heavily regulated jurisdictions. Already, nearly all of Canada’s sperm donor recruiting centres have voluntarily ceased operations. When Health Canada revised the Semen Regulations in 2000 (after a woman undergoing donor sperm insemination in 1999 became infected with Chlamydia trachomatis), most sperm banks found the new inspection regimen too onerous and stopped recruiting donors. More recently, with the passage of the AHR Act, a US-based company that was the largest sperm donor recruiter in Canada has closed its Toronto office. Only a few small clinics in Quebec, which recruit donors for treatment of their own patients, now remain – plus one commercial sperm bank, which has been recruiting donors for the past 15 years and has some 20 donors available for patients to select from. These remaining donor sperm recruiting centres have experienced a significant decrease in the number of prospective sperm donors.8

Canada’s situation is not unlike the donor environment in Sweden, where the number of sperm donors in one centre plummeted from 30 to 2 after the law was changed. Similar trends toward declining numbers of sperm donors have been seen in the UK, Holland and parts of Australia following the introduction of legislation.9

In order to recruit altruistic sperm donors, Health Canada is set to launch a pilot study based on research commissioned by the AHR Implementation Office.10 The recommendations include establishment of altruistic gamete donor recruitment programs in different regions of Canada, professional development of brochures, recruitment of dedicated staff and provision of adequate funding.

But Canada’s pilot recruitment program may be an elusive undertaking, if not a monumental task. A 1998 UK study of a similar two-year program, in which the donors were reimbursed for documented expenses, concluded that despite using professionally designed posters and carefully targeting prospective donors with radio advertisements and newspaper articles, the program “reaped poor rewards at large expense.”11 Advertisements alone were not enough, and payment was needed as an incentive. The Canadian researchers likewise recognize that “it is inherently difficult to build an altruistic system of gamete donation into a profit making, competitive environment.”12

Further evidence about the difficulty of recruiting sperm donors when payments are withdrawn was outlined in another 1998 UK report, which recommended that gamete donors should be recruited on a regional or national basis.13 No organization in the United Kingdom, as yet, has been willing to undertake such a venture, despite increased public awareness of the need for sperm donors.14

In the future, patients may not be able to access sperm from Canadian donors, because Canada’s listed criteria for recruitment, screening and testing of sperm donors are now the most stringent in the world. Only 5% to 8% of prospective sperm donors in Canada are currently accepted, compared to between 60% and 70% in France over a 15-year period (1980–1995) and 20% to 30% in the UK.15 Current recruitment centres may well be forced to cease operation if they cannot recruit donors in sufficiently large numbers to justify or sustain their economic viability.

Another concern may well be the increased risk of inadvertent consanguineous conception resulting from the increased numbers of offspring from the same donor. This may be inevitable, given the short supply of sperm in an environment of high demand. In reality, imported sperm from large foreign sperm banks, mainly from the United States, now accounts for approximately 80 to 85% of the sperm samples distributed in Canada.16 

However, there should be an adequate supply of donor sperm samples in the short term. Because the AHR Act’s restrictive provisions cannot be applied retroactively, it will still be permissible to import donor sperm samples from paid-donor jurisdictions until Canada’s new importation regulations have been developed and the regulatory and licensing framework is in place.

The view that it is inherently difficult to build a profitable, competitive environment in an altruistic system of gamete donation, and the economic principles of supply, demand and pricing, may well force foreign commercial sperm banks to reallocate their resources and distribute their samples outside Canada, in jurisdictions where profit-making is allowed. We may also see a significant decrease in the numbers of sperm banks worldwide, with the implementation of the US Food and Drug Administration (FDA) regulations, which as of May 25, 2005, will establish federal standards for all sperm banks in the United States.17 Similar regulations in European Union member states must be implemented by April 7, 2006, under the EU Tissues and Cells Directive.18 Since most of the world’s sperm banks are located in these two jurisdictions, existing sperm banks may stop recruiting sperm donors – an outcome similar to what we are seeing in Canada.

With the decrease in the numbers of sperm banks worldwide and a non-competitive donor sperm environment, Canada could well see a drastic reduction in the supply and availability of donor sperm. Yet despite the paramount importance and urgency of safeguarding a reliable supply of donor sperm for Canadian women who require this treatment option, the government has indicated that it will not participate directly in donor recruitment campaigns, nor establish a national sperm bank.19

The task of recruiting altruistic sperm donors in Canada therefore falls to the private sector. For this to succeed, the cooperation of government agencies, regulatory bodies, fertility clinics, sperm banks and the public is vital. But since Canada’s assisted reproduction law does not come up for Parliamentary review until three years after the establishment of the AHR Agency, the full repercussions of the legislative changes, the results of the recruitment efforts and the future supply of available donor sperm samples will not be known for some time to come.

ABOUT THE AUTHOR: Haimant Bissessar obtained his Bachelor of Science Degree in Biology from McMaster University in 1985. He has worked in the Assisted Reproductive Technology field for 20 years and is currently employed at the Centre For Reproductive Care, Hamilton Health Sciences in Hamilton Ontario. He is also the Vice President of CAN-AM Cryoservices Corp. a full service cryobank and exclusive Canadian distributor of Fairfax Cryobank donor sperm. In 2001 Haimant was the recipient of the 2001 Laboratory Innovation in Fertility and Embryology a national award recognizing excellence.

1. Government of Canada, Assisted Human Reproduction Act (2004, c.2): An Act respecting assisted human reproduction and related research (Ottawa, March 29, 2004). Also available on line at http://laws.justice.gc.ca/en/a-13.4/2389.html)

2. Revised in 2000. See Technical Requirements for Therapeutic Donor Insemination (Ottawa: Health Canada, 2000).

3. A. Lalos and K. Daniels “Recruitment and motivation of semen providers in Sweden,” Human Reproduction 18, no. 1 (2003), 212–216; V. Feyles, K. Daniels, J. Haase et al. “Altruistic Gamete Donation,” Research commissioned by the Health Policy and Communication Branch, AHR Implementation Office of Health Canada and undertaken by the Reproductive Endocrinology and Infertility (REI) Program, London Health Sciences Centre (LHSC), London, Ontario, 2004; I. Craft and A. Thornhill, “Would ‘all-inclusive’ compensation attract more gamete donors to balance their loss of anonymity?” Reproductive BioMedicine Online 10 (2005), 301–306.

4. Feyles et al. (2004); C. Murray and S. Golombok, “Oocyte and semen donation: a survey of UK licensed centres,” Human Reproduction 15, no. 10 (2000), 2133–39; K. Daniels and D. Hall, “Semen donor recruitment strategies: A non-payment based approach,” Human Reproduction 12, no. 10 (1997) 2330–35.

5. HFEA, “Sperm, Egg and Embryo Donation (SEED) policy review: Findings of the clinical survey” (London: Human Fertilisation and Embryology Authority, 2005).

6. J. F. Guerin, “The donation of gametes is possible without paying donors: experience of the French CECOS Federation,” Human Reproduction 13, no. 5 (1998), 1129–32.

8. Health Canada workshop on AHR Act, section 12, Toronto, 2004; see also Feyles et al. (2004).

E. Blyth, “Recruitment of Identifiable sperm donors,” Project Group on Assisted Reproduction (PROGAR) Briefing Paper No. 2 (UK, 2005);

L.Frith, “Gamete Donation and anonymity: The ethical and legal debate,” Human Reproduction 16. no. 5 (2001), 818–824.

11. E. A. McLaughlin, J. Day, et al., “Recruitment of gamete donors and payment of expenses,” Human Reproduction 13, no. 5 (1998), 1130–32.

13. HFEA, “Consultation on the implementation of Withdrawal of Payments to Donors” (London: Human Fertilisation and Embryology Authority, 1998).

14. HFEA, “The regulation of Donor- Assisted Conception,” (London: Human Fertilisation and Embryology Authority 2004).

15. Guerin (1998); Craft and Thornhill (2005); HFEA (2005).

16. C. Borrero, “Gamete and embryo donation” (World Health Organization), 166–175; see also Health Canada (2004)

17. U.S. Food and Drug Administration, 21 CFR Part 1271, “Human Cells, Tissue, and Cellular and Tissue-Based Products,” Subpart C: Donor Eligibility Final Rule.

18 . “Directive 2004/23/EC of the European Parliament and of the council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and calls,” Official Journal of the European Union L102/48 (7.4.2004), also available on line at http://www.hfea.gov.uk/

19. “Assisted Human Reproduction at Health Canada: Frequently Asked Questions,” http://www.hc-sc.gc.ca/english/lifestyles/reproduction/faq_e.html.