Draft regulations won’t fix a broken Act

Art Leader critiques the Assisted Human Reproduction Act draft regulations and maintains that the Act fails to address societal challenges relating to emerging reproductive science.

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Recently, Health Canada released draft regulations to complete the Assisted Human Reproduction Act. The consultation period on this draft ended on January 10th.

At first glance, the long-awaited regulations represent a big win for consumers of fertility services. The draft regulations include a number of improvements to infection control and safety of donated gametes.

First, the regulations would allow directed donation (from known donors) to proceed following enhanced infectious disease screening by a licensed health professional.

Second, with directed sperm donation there would be no six-month quarantine of donor sperm and no automatic exclusion of men who have had sex with men. Given the precision and short turn-around time of today’s direct DNA tests for sexually transmitted diseases, these changes make sense.

Image Description: Lab technician in front of a microscope transferring a sample from a needle to a small piece of glass.
Photo Credit: Galina Fomina (https://commons.wikimedia.org/w/index.php?title=User:Zina_Kel&action=edit&redlink=1)

Third, egg (ova) donation will be regulated but unlike sperm, eggs have never been linked to the transfer of infections.  It made no sense to quarantine anonymously-provided or directly donated eggs before use.

Finally, under the draft regulations, any company that provides donor sperm or eggs would have to register with Health Canada and would be responsible for the safety of the anonymous sperm or eggs used in the clinic. This measure would expedite access to donated gametes and reduce costs to patients.

However, there are also notable gaps in the draft regulations. In Canada, private agencies are involved with egg donor recruitment, screening, and care. Such donors are often anonymous women who travel to a Canadian city to donate “fresh” eggs. The draft regulations do not propose to register and regulate these agencies.

In addition, Health Canada has not mandated specific genetic testing of donors. This omission will do nothing to decrease the risk of disease transmission by carriers of genetically linked diseases.

Furthermore, the draft regulations set no quality standards for donor sperm or eggs, such as mandating the quantity of motile sperm per insemination vial or post-thaw egg survival rates. And unlike the Food and Drug Administration in the United States, Health Canada has not set minimum laboratory standards for the handling, storage, and distribution of gametes. In addition to these gaps, adverse reaction reporting is limited to reporting the transmission of infection and ignores the most commonly observed clinical adverse reactions.

The draft regulations also do not prohibit clinic workers from committing fertility fraud by using their own sperm, despite current Canadian lawsuits involving hundreds of women who allege wrongful insemination.

With respect to the reimbursement of receiptable expenditures for surrogates and gamete donors, the draft regulations include unfair treatment of sperm and egg donors. By treating these two types of gamete donation equally, the differences in donation practices and risks for each group are ignored.  Indeed, sperm donation does not carry the same risks, or require the same preparation or the same convalescence as egg donation. For example, egg donors take multiple hormone injections and blood tests, have a 30 cm needle thrust into their ovaries under conscious sedation and run the risk of severe ovarian hyperstimulation or bleeding.

Moreover, the proposed framework for verifying compliance with the Act is complex and probably unworkable. For example, under the regulations proposed by Health Canada, gametes deemed to be non-compliant with the regulations could be seized by an inspector and removed to a facility operated by Health Canada. Within 60 days of seizure a patient would have to persuade a provincial court judge to order the release of the gametes and then receive permission from the Minister of Health to use the gametes. This process would likely be daunting, expensive, and prohibitive for patients.

The proposed federal regulations barely catch up with the assisted reproduction practices of the last century. The use of reproductive technologies has mushroomed, creating societal challenges and gaps that the draft legislation and the current Act cannot address. Recent scientific discoveries (mitochondrial transfer, genome editing) have added greater complexity to these challenges. Nothing in the law or the draft regulations recognizes that we can do more than merely manipulate human embryos and gametes for reproductive purposes. We can create new life forms and fundamentally alter human embryos. The Assisted Human Reporduction Act is broken and the draft regulations won’t change that fact.

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Art Leader is an Adjunct Professor of Obstetrics, Gynecology and Reproductive Medicine at the University of Ottawa and an Affiliate Investigator in the Ottawa Hospital Research Institute Clinical Epidemiology Program.