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Sara R. Cohen, LL.B.Fertility Law Canada at

D2Law LLP

sara@fertilitylawcanada.com

Alana CattapanPhD candidate

Department of Political Science, York University

cattapan@yorku.ca

SPEAKERS

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BILL C-38 (THE OMNIBUS BILL)

- Jobs, Growth and Long-term Prosperity Act

- Budget

- 425 pages

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BILL C-38 (THE OMNIBUS BILL)

• Affects 69 Acts, including Assisted Human Reproduction Act (“AHRA”)• Division 56 of Part 4, Section 713

– 745• With respect to affect of Omnibus

bill on AHRA, media only mentioned closing of AHRC

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PARLIAMENT’S SUMMARY OF BILL C-38 RE THE AHRA

“Division 56 of Part 4 amends the Assisted Human Reproduction Act to respond to the Supreme Court of Canada decision in Reference re Assisted Human Reproduction Act that was rendered in 2010, including by repealing the provisions that were found to be unconstitutional and abolishing the Assisted Human Reproduction Agency of Canada.”

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REFERENCE RE ASSISTED HUMAN REPRODUCTION ACT (2010 SCC 61)

- split decision 4-4-1

- Section 5-9 remain

- Sections 10, 11, 13, 14-18 , among others, found to be unconstitutional for infringing on provincial jurisdiction

- Sections 10 – 14 “controlled activities” for which required license and/or regulations

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PART OF BILL C-38 THAT DEALS WITH FALL OUT FROM REFERENCE DECISION

- Sections 10, 11, 13-19, 21-43 and others as found by SCC to be beyond federal jurisdiction were repealed

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PART OF C-38 DEALING WITH BUDGET

- No more “Agency”- Assisted Human Reproduction

Canada - Save $10 million per year- Fallout = all power in hands of

Minister (Health)

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HUMAN PATHOGENS AND TOXIC ACT AND FOOD AND DRUG ACT

4.1 The Human Pathogens and Toxins Act does not apply in respect of sperm, ova and in vitro embryos to be used for the purpose of assisted human reproduction.

4.2 The Food and Drugs Act does not apply in respect of sperm and ova to be used for the purpose of assisted human reproduction.

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HUMAN PATHOGENS AND TOXINS ACT

4.1 The Human Pathogens and Toxins Act does not apply in respect of sperm, ova and in vitro embryos to be used for the purpose of assisted human reproduction.

Changes to Human Pathogens and Toxins Act:

s. 4 This Act does not apply to

(c) any activity that is a controlled activity within the meaning of the Assisted Human Reproduction Act.

repealed

- Controlled activity in AHRA repealed

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THE FOOD AND DRUGS ACT

4.2 The Food and Drugs Act does not apply in respect of sperm and ova to be used for the purpose of assisted human reproduction.

• Processing and Distribution of Semen for Assisted Conception Regulations SOR/96-254 (the Semen Regulations)• Screening, labelling, quarantine, laboratory controls, etc.• Only for semen used in “assisted conception”, defined as “a reproductive

technique performed on a woman for the purpose of conception, using semen from a donor who is not her spouse or sexual partner”

• Health Canada Directive - Technical Requirements for Therapeutic Donor Insemination (the “Directive”)

• Exclusion criteria, including:• 2.1(e) i. men who have had sex with another man, even once, since 1977

• The Donor Semen Special Access Programme (DSSAP)

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SECTION 10

10. (1) The purpose of this section is to reduce the risks to human health and safety arising from the use of sperm or ova for the purpose of assisted human reproduction, including the risk of the transmission of disease.

• Combination of: parts of repealed s. 10 AHRA, Semen Regulations and new legislation

• NB: no mention of donor embryos here

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10(2)

(2) Subject to subsection (3), no person shall distribute, make use of or import any of the following for the purpose of assisted human reproduction:

(a)sperm that has been obtained from a donor and that is meant for the use of a female person other than a spouse, common-law partner or sexual partner of the donor;

(b)an ovum that has been obtained from a donor and that is meant for the use of a female person other than the donor or the spouse, common-law partner or sexual partner of the donor; or

(c)an ovum that has been obtained from a donor and that is meant for the donor’s use as a surrogate mother.

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COMPARE TO ORIGINAL S. 10 OF AHRA (WHICH EXCEEDED LEGISLATIVE AUTHORITY AND UNCONSTITUTIONAL)

10. (3) No person shall, except in accordance with the regulations and a licence, obtain, store, transfer, destroy, import or export

(a) a sperm or ovum, or any part of one, for the purpose of creating an embryo; or

(b) an in vitro embryo, for any purpose.

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10(3)

(3) Subsection (2) does not apply if

(a)tests have been conducted in respect of the sperm or ovum in accordance with the regulations, and the sperm or ovum has been obtained, prepared, preserved, quarantined, identified, labelled and stored and its quality assessed in accordance with the regulations; and

(b)the donor of the sperm or ovum has been screened and tested, and the donor’s suitability has been assessed, in accordance with the regulations.

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10(4)

(4) No person shall, except in accordance with the regulations, engage in any activity described in paragraph (3)(a) or (b) in respect of any of the following with the intention of distributing or making use of it for the purpose of assisted human reproduction

(a) sperm described in paragraph (2)(a);(b) an ovum described in paragraph (2)(b); or(c) an ovum described in paragraph (2)(c).

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10(5)

(5) In this section, “common-law partner”, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship at the relevant time, having so cohabited for a period of at least one year

Common-law partner def’n is new

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IMPORTING OVA – MEDIA APRIL 2012

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IMPORTING OVA

• Technology has advanced that ova is now being imported into Canada from egg banks just as sperm is imported from sperm banks

• Earlier legislation didn’t deal with this reality

• Bill C-38 demonstrates that ova will likely be dealt with in the same manner as sperm

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CRIMINAL OFFENCE RE SECTION 8 (CONSENT)

60. A person who contravenes any of sections 5 to 7 and 9 is guilty of an offence …

(a) is liable, on conviction on indictment, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding ten years, or to both;

61.A person who contravenes any provision of this Act – other than any of sections 5 to 7 and 9 …

(a) is liable, on conviction on indictment, to a fine not exceeding $250,000 or to imprisonment for

a term not exceeding five years, or to both;

Would include section 8 (consent)

Note Cromwell, J. held in Reference re AHRA at para. 288:Sections 5 to 7 are validly enacted under Parliament’s criminal

law power as the Attorney General of Quebec concedes. The same is true, in my view, of ss. 8, 9 and 12.[emphasis added]

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WHEN DO THESE CHANGES COME INTO FORCE?753. (1) Sections 715 and 716, or

any provision enacted by section 716, come into force on a day or days to be fixed by order of the Governor in Council.

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UNKNOWN:

• Regulations (what, when, if)

• When changes coming into effect

• Which tests will be required for sperm/ova importation

• Quarantine requirements

• Donor’s suitability requirements

• OPPORTUNITY FOR CHANGE: right some of the wrongs from Semen Regulations, etc.

• Would like to see balance between health and safety, equality and reproductive freedom

• Not necessarily going to happen wording similar to that of Semen Regulations, etc.

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THE PAST AND PRESENT OF ASSISTED HUMAN REPRODUCTION CANADA• April 2004:        - Mandated through the Assisted Human

Reproduction Act (2004)

• December 2006    -  Board formally announced (and widely critiqued) and operations begin...

• 2010            -   Three Board Members resign

• November 2010    -    Parliamentary hearing about the resignations

• December 2010    -    Judgement in Reference re AHRA rendered

• March 2010        -     First known police action implementing the Act's criminal provisions

• March-June 2012    -     Bill C-38 announced, then passed, eliminating the agency

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DESPITE ITS WIDELY KNOWN SHORTCOMINGS, AHRC...

• did facilitate discussion on reproductive tourism, develop fact sheets, brochures, etc.

• did create a symbolic space for stakeholder participation in the formal process of implementation (even if the board wasn't representative of important stakeholders)

• did engage in consultation with important stakeholders through the formation of committees

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A LONG (SELECTED) HISTORY OF STAKEHOLDERS INVOLVEMENT ON ARTS• 1989-1993    -   Royal Commission consulted widely (with

40,000 Canadians)

• 1994-1996    -   public consultations by Health Canada to confirm the findings of the Royal Commission, creation of a federal-provincial- territorial working group, discussion group on embryo research, and stakeholder-based advisory committee on the  interim moratorium established

• 1996-1997   -    Small measure of witness testimony on proposed bill (C-47), which died on the Order Paper

• 1999        -        Workshop with stakeholders on potential new bill

• 1999        -        Federal-provincial territorial consultations on potential new bill

• 2001-2004    -   Standing Committees of the House and Senate really sought out a wide array of witnesses to testify on the proposed Assisted Human Reproduction Act

• Since 2004  -   Through AHRC

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WHY INCLUDE STAKEHOLDERS IN THE IMPLEMENTATION OF THE ASSISTED HUMAN REPRODUCTION ACT?

• promotes a sense of democratic inclusion

• enables policy legitimacy....makes the policy credible to the public

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IF THERE ARE NO STAKEHOLDERS IN IMPLEMENTATION, HOW IS DOES A GOVERNMENT ENSURE WIDESPREAD COMPLIANCE (WITH THE AHRA)?• Option 1:  they don't.  They simply leave a bill on the books

that is not supported by the public or stakeholders, and they leave it openly contravened

• Option 2:  they engage stakeholders outside of the formal policy process to try to sway the public to accept the policy.

• Option 3:  they engage the public without stakeholders, using more direct forms of "citizen engagement," like polls, or focus groups to garner support

• Option 4:  they don't again, but the government does seek to implement the policy and to use its authority to enforce the law, through sanctions and penalties, hoping that  once the law is enforced, people will come to respect it.

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THIS IS NOT TO SAY THAT THE AGENCY WAS NOT PROBLEMATIC, BUT THE CLOSURE OF AHRC WILL:

• eliminate any provisional space for the formal inclusion of stakeholders in the policy process

• disrupt the already tenuous legitimacy of the Assisted Human Reproduction Act, perhaps inciting more enforcement

Stakeholder groups, like the CFAS, need to continue to pressure Health Canada to include them in policy making (including implementation) to ensure a democratic approach to such an important moral, ethical, medical, and legal issue, and to address the question of how the increasingly de-legitimized AHRA will be enforced.

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THE GOOD-Getting rid of Agency which wasn’t doing anything-Seems to be move from trying to fit ARTs into existing legal frameworks and recognizing uniqueness -Reflect some changes in technology

THE BAD-No semblance of democratic legitimacy OR legitimacy to be achieved through enforcement-Stakeholders no longer included-All power in hands of Minister

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