Forward Regulatory Plan 2019-2021: Development of Regulations under the Assisted Human Reproduction Act

Title of Regulatory Initiative

Development of Regulations under the Assisted Human Reproduction Act

Enabling Act

Assisted Human Reproduction Act

Description

Health Canada intends to strengthen the Assisted Human Reproduction Act (AHRA) by bringing into force the dormant provisions of the Act and introducing supporting regulations as required.

The regulations aim to:

  • reduce the risks to human health and safety arising from the use of donor sperm and ova for the purpose of assisted human reproduction, including the risk of the transmission of disease;
  • clarify which expenses incurred by donors and surrogates are eligible for reimbursement, including reimbursement for the loss of work-related income; and
  • provide procedural detail for administration and enforcement provisions regarding further measures for seized material or information

Health Canada will also amend the Assisted Human Reproduction (Section 8 Consent) Regulations. The amendments aim to:

  • clarify minor language inconsistencies
  • introduce a records retention requirement; and
  • establish a process for retaining the anonymity of donors

The amendments to the Section 8 Consent regulations respond to concerns raised in 2016 by the Standing Joint Committee on the Scrutiny of Regulations (SJCSR).  This initiative also responds to SJCSR concerns raised in 2005 with respect to the Processing and Distribution of Semen for Assisted Conception Regulations made under the Food and Drugs Act.

Regulatory cooperation efforts (domestic and international)

The Safety of Sperm and Ova Regulations will better align Canadian regulations with regulations in the United States and Europe, as well as industry practices in the United States, Europe, and Canada.

Specifically, Canadian screening and testing requirements for sperm and ova donors would be more closely aligned with those in the United States.

Where the Regulations will not align with regulations in the United States and Europe, the Canadian requirements are not expected to pose an additional burden.

Potential impacts on Canadians, including businesses

The regulations will help protect the health and safety of people who use, or are born of, assisted human reproduction, reflect the latest scientific and technological advancements, and offer Canadians more options for building their families.

The updated safety requirements in the Safety of Sperm and Ova Regulations would have incremental costs for businesses, but the benefits to human health and safety for recipients of donor sperm and ova and children born of AHR warrant these requirements.

The regulations also provide clarity to parties involved in surrogacy and sperm and ova donation with respect to permitted reimbursements. They also set out procedures for administering and enforcing the Act.

Consultations

Notice of Intent was published in the Canada Gazette, Part I on October 1, 2016 with a 60-day comment period. The Notice of Intent outlined the Department's plans to draft regulations to support bringing into force the dormant sections of the Act.

A consultation document on the key policy proposals was published on July 12, 2017, with a 60-day comment period. The intent of the consultation was to obtain feedback on the policy proposals from key stakeholders, to be taken into consideration prior to the development of regulations for Section 10, Section 12 and Sections 45-58 of the Act. A summary of the feedback from the consultation was published in a What We Heard Report, on January 15, 2018.

The proposed regulations were pre-published in the Canada Gazette, Part I on October 27, 2018 for 75 days consultation period that ended on January 10, 2019.  As part of this consultation, all interested Canadians were invited to review the proposed regulations and submit their comments to Health Canada.

The publication of the amendments to the regulations in the Canada Gazette, Part ll, is expected to take place in spring 2019.

Further information

Related information can be found on Health Canada's Assisted Human Reproduction webpage.

Additional information can be requested from the Departmental contact.

Departmental contact information

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Telephone: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2017

Consult Health Canada's acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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