Order Fixing the 240th Day After the Day this Order is Made as the Day on which Certain Provisions of that Act Come into Force: SI/2019-37

Canada Gazette, Part II, Volume 153, Number 13

Registration
SI/2019-37 June 26, 2019

JOBS, GROWTH AND LONG-TERM PROSPERITY ACT

Order Fixing the 240th Day After the Day this Order is Made as the Day on which Certain Provisions of that Act Come into Force

P.C. 2019-748 June 9, 2019

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 753(1) of the Jobs, Growth and Long-term Prosperity Act, chapter 19 of the Statutes of Canada, 2012, fixes the 240th day after the day this Order is made as the day on which sections 715 and 716 of that Act come into force.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

This Order fixes the 240th day after the day this Order is made as the day on which sections 715 and 716 of the Jobs, Growth and Long-term Prosperity Act come into force. Section 715 amended the Assisted Human Reproduction Act by adding to it section 4.2, which states that the Food and Drugs Act does not apply in respect of sperm and ova to be used for the purpose of assisted human reproduction. Section 716 amended the Assisted Human Reproduction Act by adding to it section 10, which sets out requirements to reduce the risks to human health and safety arising from the use of donor sperm or ova for the purpose of assisted human reproduction, including the risk of the transmission of disease. Section 10 helps achieve this purpose by prohibiting the distribution, use or importation of donor sperm or ova for the purpose of assisted human reproduction unless it complies with regulations.

Objective

It is necessary to bring into force these sections of the Assisted Human Reproduction Act at the same time as the supporting regulations for section 10, the Safety of Sperm and Ova Regulations (Regulations). The Regulations, which will come into force with sections 4.2 and 10, establish a human health and safety framework for donor sperm and ova used for assisted human reproduction.

Background

The Assisted Human Reproduction Act was enacted in 2004 to help protect the health, safety, dignity and rights of individuals who use or are born of assisted human reproduction. After a 2010 Supreme Court of Canada ruling found certain provisions in the Assisted Human Reproduction Act to be unconstitutional, those provisions were repealed and sections 4.2 and 10 were added through amendments made in 2012 as part of the Jobs, Growth and Long-term Prosperity Act. Sections 4.2 and 10 did not come into force immediately, but were to come into force on a date fixed by the Governor in Council to allow the time for the supporting regulations to be developed.

Implications

Since 1996, the safety of donor sperm that is used or intended for use in assisted conception has been regulated by the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations) made under the Food and Drugs Act. The Semen Regulations will be repealed when the Safety of Sperm and Ova Regulations come into force, and section 4.2 will clarify that the Food and Drugs Act no longer applies in respect of sperm and ova to be used for the purpose of assisted human reproduction. Section 10 and the Safety of Sperm and Ova Regulations will introduce modernized requirements on the safety of donor sperm and, for the first time, requirements on the safety of donor ova to be used for the purpose of assisted human reproduction.

Consultation

A detailed description of the consultations and comments from stakeholders is included in the Regulatory Impact Analysis Statement accompanying the Safety of Sperm and Ova Regulations. In general, stakeholders were supportive of the requirements that were proposed in relation to section 10 when the Regulations were prepublished in the Canada Gazette, Part I, on October 27, 2018.

Departmental contact

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Department of Health
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca