Prompt:
Analyze the legal requirements established in this Federal legislation from the Canadian government:

# Assisted Human Reproduction Act SC 2004, c 2 An Act respecting assisted human reproduction and related research Assented to 2004-3-29 Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows: ## Short Title ### Short title 1 This Act may be cited as the Assisted Human Reproduction Act. ## Principles ### Declaration 2 The Parliament of Canada recognizes and declares that (a) the health and well-being of children born through the application of assisted human reproductive technologies must be given priority in all decisions respecting their use; (b) the benefits of assisted human reproductive technologies and related research for individuals, for families and for society in general can be most effectively secured by taking appropriate measures for the protection and promotion of human health, safety, dignity and rights in the use of these technologies and in related research; (c) while all persons are affected by these technologies, women more than men are directly and significantly affected by their application and the health and well-being of women must be protected in the application of these technologies; (d) the principle of free and informed consent must be promoted and applied as a fundamental condition of the use of human reproductive technologies; (e) persons who seek to undergo assisted reproduction procedures must not be discriminated against, including on the basis of their sexual orientation or marital status; (f) trade in the reproductive capabilities of women and men and the exploitation of children, women and men for commercial ends raise health and ethical concerns that justify their prohibition; and (g) human individuality and diversity, and the integrity of the human genome, must be preserved and protected. ## Interpretation and Application ### Definitions 3 The following definitions apply in this Act. *Agency* [Repealed, 2012, c. 19, s. 713] *assisted reproduction procedure* [Repealed, 2012, c. 19, s. 713] *chimera* means (a) an embryo into which a cell of any non-human life form has been introduced; or (b) an embryo that consists of cells of more than one embryo, foetus or human being. ( chimère) *consent* [Repealed, 2012, c. 19, s. 713] *controlled activity* [Repealed, 2012, c. 19, s. 713] *donor* means (a) in relation to human reproductive material, the individual from whose body it was obtained, whether for consideration or not; and (b) in relation to an in vitro embryo, a donor as defined in the regulations. (donneur) *embryo* means a human organism during the first 56 days of its development following fertilization or creation, excluding any time during which its development has been suspended, and includes any cell derived from such an organism that is used for the purpose of creating a human being. (embryon) *foetus* means a human organism during the period of its development beginning on the fifty-seventh day following fertilization or creation, excluding any time during which its development has been suspended, and ending at birth. (foetus) *gene* includes a nucleotide sequence, and an artificially created gene or nucleotide sequence. (gène) *genome* means the totality of the deoxyribonucleic acid sequence of a particular cell. (génome) *health reporting information* [Repealed, 2012, c. 19, s. 713] *human clone* means an embryo that, as a result of the manipulation of human reproductive material or an in vitro embryo, contains a diploid set of chromosomes obtained from a single — living or deceased — human being, foetus or embryo. (clone humain) *human reproductive material* means a sperm, ovum or other human cell or a human gene, and includes a part of any of them. (matériel reproductif humain) *hybrid* means (a) a human ovum that has been fertilized by a sperm of a non-human life form; (b) an ovum of a non-human life form that has been fertilized by a human sperm; (c) a human ovum into which the nucleus of a cell of a non-human life form has been introduced; (d) an ovum of a non-human life form into which the nucleus of a human cell has been introduced; or (e) a human ovum or an ovum of a non-human life form that otherwise contains haploid sets of chromosomes from both a human being and a non-human life form. ( hybride) in vitro embryo means an embryo that exists outside the body of a human being. (embryon in vitro) *licence* [Repealed, 2012, c. 19, s. 713] *Minister* means the Minister of Health. (ministre) *ovum* means a human ovum, whether mature or not. (ovule) *sperm* means a human sperm, whether mature or not. (spermatozoïde) *surrogate mother* means a female person who — with the intention of surrendering the child at birth to a donor or another person — carries an embryo or foetus that was conceived by means of an assisted reproduction procedure and derived from the genes of a donor or donors. (mère porteuse) ### Her Majesty bound 4 This Act is binding on Her Majesty in right of Canada or a province. ### Non-application 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. ### Non-application 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. ## Prohibited Activities ### Prohibited procedures 5 (1) No person shall knowingly (a) create a human clone by using any technique, or transplant a human clone into a human being or into any non-human life form or artificial device; (b) create an in vitro embryo for any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures; (c) for the purpose of creating a human being, create an embryo from a cell or part of a cell taken from an embryo or foetus or transplant an embryo so created into a human being; (d) maintain an embryo outside the body of a female person after the fourteenth day of its development following fertilization or creation, excluding any time during which its development has been suspended; (e) for the purpose of creating a human being, perform any procedure or provide, prescribe or administer any thing that would ensure or increase the probability that an embryo will be of a particular sex, or that would identify the sex of an in vitro embryo, except to prevent, diagnose or treat a sex-linked disorder or disease; (f) alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants; (g) transplant a sperm, ovum, embryo or foetus of a non-human life form into a human being; (h) for the purpose of creating a human being, make use of any human reproductive material or an in vitro embryo that is or was transplanted into a non-human life form; (i) create a chimera, or transplant a chimera into either a human being or a non-human life form; or (j) create a hybrid for the purpose of reproduction, or transplant a hybrid into either a human being or a non-human life form. ### Offers (2) No person shall offer to do, or advertise the doing of, anything prohibited by this section. ### Payment for prohibited act (3) No person shall pay or offer to pay consideration to any person for doing anything prohibited by this section. ### Payment for surrogacy 6 (1) No person shall pay consideration to a female person to be a surrogate mother, offer to pay such consideration or advertise that it will be paid. ### Acting as intermediary (2) No person shall accept consideration for arranging for the services of a surrogate mother, offer to make such an arrangement for consideration or advertise the arranging of such services. ### Payment to intermediaries (3) No person shall pay consideration to another person to arrange for the services of a surrogate mother, offer to pay such consideration or advertise the payment of it. ### Surrogate mother — minimum age (4) No person shall counsel or induce a female person to become a surrogate mother, or perform any medical procedure to assist a female person to become a surrogate mother, knowing or having reason to believe that the female person is under 21 years of age. ### Validity of agreement (5) This section does not affect the validity under provincial law of any agreement under which a person agrees to be a surrogate mother. ### Purchase of gametes 7 (1) No person shall purchase, offer to purchase or advertise for the purchase of sperm or ova from a donor or a person acting on behalf of a donor. ### Purchase or sale of embryos (2) No person shall (a) purchase, offer to purchase or advertise for the purchase of an in vitro embryo; or (b) sell, offer for sale or advertise for sale an in vitro embryo. ### Purchase of other reproductive material (3) No person shall purchase, offer to purchase or advertise for the purchase of a human cell or gene from a donor or a person acting on behalf of a donor, with the intention of using the gene or cell to create a human being or of making it available for that purpose. ### Exchanges included (4) In this section, “purchase” or “sell” includes to acquire or dispose of in exchange for property or services. ### Use of reproductive material without consent 8 (1) No person shall make use of human reproductive material for the purpose of creating an embryo unless the donor of the material has given written consent, in accordance with the regulations, to its use for that purpose. ### Posthumous use without consent (2) No person shall remove human reproductive material from a donor’s body after the donor’s death for the purpose of creating an embryo unless the donor of the material has given written consent, in accordance with the regulations, to its removal for that purpose. ### Use of in vitro embryo without consent (3) No person shall make use of an in vitro embryo for any purpose unless the donor has given written consent, in accordance with the regulations, to its use for that purpose. ### Gametes obtained from minor 9 No person shall obtain any sperm or ovum from a donor under 18 years of age, or use any sperm or ovum so obtained, except for the purpose of preserving the sperm or ovum or for the purpose of creating a human being that the person reasonably believes will be raised by the donor. ### Purpose 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. ### Distribution, etc. of gametes (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. ### Exception (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. ### Testing, etc. in respect of gametes (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). ### Definition of *common-law partner* (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. 11 [Repealed, 2012, c. 19, s. 718] ### Reimbursement of expenditures 12 (1) No person shall, except in accordance with the regulations, (a) reimburse a donor for an expenditure incurred in the course of donating sperm or an ovum; (b) reimburse any person for an expenditure incurred in the maintenance or transport of an in vitro embryo; or (c) reimburse a surrogate mother for an expenditure incurred by her in relation to her surrogacy. ### Receipts (2) No person shall reimburse an expenditure referred to in subsection (1) unless a receipt is provided to that person for the expenditure. ### No reimbursement (3) No person shall reimburse a surrogate mother for a loss of work-related income incurred during her pregnancy, unless (a) a qualified medical practitioner certifies, in writing, that continuing to work may pose a risk to her health or that of the embryo or foetus; and (b) the reimbursement is made in accordance with the regulations. 13 [Repealed, 2012, c. 19, s. 720] 14 [Repealed before coming into force, 2012, c. 19, s. 720] 15 [Repealed before coming into force, 2012, c. 19, s. 720] 16 [Repealed before coming into force, 2012, c. 19, s. 720] 17 [Repealed before coming into force, 2012, c. 19, s. 720] 18 [Repealed before coming into force, 2012, c. 19, s. 720] 19 [Repealed before coming into force, 2012, c. 19, s. 720] ## Responsibility of Minister ### Assisted human reproduction policy 20 (1) The Minister is responsible for the policy of the Government of Canada respecting assisted human reproduction and any other matter that, in the opinion of the Minister, relates to the subject-matter of this Act. (2) [Repealed, 2012, c. 19, s. 721] 21 [Repealed, 2012, c. 19, s. 722] 22 [Repealed, 2012, c. 19, s. 722] 23 [Repealed, 2012, c. 19, s. 722] 24 [Repealed, 2012, c. 19, s. 722] 25 [Repealed, 2012, c. 19, s. 722] 26 [Repealed, 2012, c. 19, s. 722] 27 [Repealed, 2012, c. 19, s. 722] 28 [Repealed, 2012, c. 19, s. 722] 29 [Repealed, 2012, c. 19, s. 722] 30 [Repealed, 2012, c. 19, s. 722] 31 [Repealed, 2012, c. 19, s. 722] 32 [Repealed, 2012, c. 19, s. 722] 33 [Repealed, 2012, c. 19, s. 722] 34 [Repealed, 2012, c. 19, s. 722] 35 [Repealed, 2012, c. 19, s. 722] 36 [Repealed, 2012, c. 19, s. 722] 37 [Repealed, 2012, c. 19, s. 722] 38 [Repealed, 2012, c. 19, s. 722] 39 [Repealed, 2012, c. 19, s. 722] ## Administration and Enforcement 40 [Repealed before coming into force, 2012, c. 19, s. 724] 41 [Repealed before coming into force, 2012, c. 19, s. 724] 42 [Repealed before coming into force, 2012, c. 19, s. 724] 43 [Repealed before coming into force, 2012, c. 19, s. 724] ### Taking measures 44 (1) If the Minister has reasonable grounds to believe that this Act has been, or is likely to be, contravened, the Minister may take, or order any person to take, all reasonable measures that the Minister considers necessary to mitigate the effects of the contravention or to prevent the contravention. (2) and (3) [Repealed, 2012, c. 19, s. 725] ### Personal liability (4) No person who takes measures under this section, or who takes measures specified in an order made under this section, is personally liable either civilly or criminally in respect of any act or omission in the course of taking those measures unless it is established that the person acted in bad faith. ### Exception (5) Subsection (4) does not apply to a person who has committed a contravention of this Act. ### Statutory Instruments Act (6) For greater certainty, orders made under this section are not statutory instruments within the meaning of the Statutory Instruments Act. ### Definitions 45 The following definitions apply in sections 47 to 62 and 65. *information* means information that is recorded in any form. (document) *material* means an embryo or part of one, a foetus or part of one or any human reproductive material outside the body of a human being, or any other thing. (matériel) ### Designation of inspectors 46 (1) The Minister may designate persons or classes of persons employed by the government of Canada or of a province as inspectors for the purposes of the administration and enforcement of this Act. ### Certificates to be produced (2) An inspector shall be given a certificate in a form established by the Minister attesting to the inspector’s designation and, on entering any place or conveyance under subsection 47(1), the inspector shall, if so required, produce the certificate to the person in charge of that place or conveyance. ### Entry by inspectors 47 (1) Subject to section 48, an inspector may, for a purpose related to verifying compliance or preventing non-compliance with any of sections 8, 10 and 12, enter any place or conveyance in which the inspector has reasonable grounds to believe that there is any activity, material or information in respect of which any of those sections applies. ### Inspection (2) An inspector entering a place or conveyance may, for a purpose set out in subsection (1), (a) examine any material or information that is relevant to that purpose; (b) require any person in the place or conveyance to produce, in the manner and form requested by the inspector, any such material or information; (c) open and examine any receptacle or package that the inspector believes on reasonable grounds contains such material or information; (d) take, or require any person in the place or conveyance to produce, a sample of such material; and (e) conduct any test or analysis or take any measurement of such material. ### Examination of information (3) In carrying out an inspection, an inspector may, for a purpose set out in subsection (1), (a) examine and make copies of or extracts from any books, documents or other records that the inspector believes on reasonable grounds contain information that is relevant to that purpose; (b) require any person to produce such books, documents or other records for examination or copying; (c) use or cause to be used any computer system to examine information relevant to that purpose that is contained in or available to the computer system; (d) reproduce such information in the form of a printout or other intelligible output for examination or copying; and (e) use or cause to be used any copying equipment. ### Assistance and information to inspector (4) The owner or person in charge of a place entered by an inspector under subsection (1) and every person found in that place shall give the inspector all reasonable assistance and furnish them with any information that they may reasonably require. ### Warrant to enter dwelling-house 48 (1) Where a place referred to in subsection 47(1) is a dwelling-house, an inspector may not enter it without the consent of the occupant, except under the authority of a warrant issued under subsection (2). ### Authority to issue warrant (2) If, on ex parte application, a justice of the peace is satisfied by information on oath that (a) the conditions for entry described in subsection 47(1) exist in relation to a dwelling-house, (b) entry to the dwelling-house is necessary for a purpose related to verifying compliance or preventing non-compliance with any of sections 8, 10 and 12, and (c) entry to the dwelling-house has been refused or there are reasonable grounds for believing that entry will be refused, the justice of the peace may issue a warrant authorizing the inspector named in it to enter the dwelling-house, subject to any conditions that may be specified in the warrant. ### Use of force (3) In executing a warrant issued under subsection (2), the inspector named in it shall not use force unless the inspector is accompanied by a peace officer and the use of force has been specifically authorized in the warrant. ### Obstruction and false statements 49 (1) No person shall obstruct or hinder, or knowingly make any false or misleading statement either orally or in writing to, an inspector engaged in carrying out duties under this Act. ### Interference (2) Except with the authority of an inspector, no person shall remove, alter or interfere in any way with material or information seized under this Act. ### Seizure by inspector 50 (1) An inspector who enters a place or conveyance under section 47 may seize any material or information by means of which, or in relation to which, the inspector believes on reasonable grounds this Act has been contravened. ### Storage and removal (2) An inspector may direct that seized material or information be kept or stored in the place where it was seized or be removed to any other proper place. ### Application for restoration 51 (1) A person from whom material or information is seized may, within 60 days after the date of the seizure, apply to a provincial court judge within whose jurisdiction the seizure was made for an order of restoration, if the person sends to the Minister notice of their intention to do so. ### Order of restoration (2) The provincial court judge may order that seized material or information be restored immediately to the applicant if, on hearing the application, the judge is satisfied that (a) the applicant is entitled to possession of it; and (b) it will not be required as evidence in any proceedings under this Act. ### Order of later restoration (3) If, on hearing an application, a provincial court judge is satisfied that the applicant is entitled to possession of seized material or information but is not satisfied as regards paragraph (2)(b), the judge may order that the material or information be restored to the applicant (a) on the expiry of 180 days after the date of the seizure if no proceedings under this Act have been commenced before that time; or (b) on the final conclusion of proceedings under this Act. ### Exception (4) A provincial court judge may not make an order for the restoration of material or information if it has been forfeited by consent under subsection 52(2). ### Forfeiture 52 (1) If no application is made under subsection 51(1) for the restoration of seized material or information within 60 days after the date of the seizure, or an application has been made but on the hearing of the application no order of restoration is made, the material or information is forfeited to Her Majesty. ### Forfeiture with consent (2) Where an inspector has seized material or information and the owner or the person in whose possession it was at the time of the seizure consents in writing to its forfeiture, the material or information is forfeited to Her Majesty. ### Disposal (3) Subject to section 54, an inspector may dispose of material or information forfeited to Her Majesty in any manner that the designated officer, as defined in the regulations, directs. ### Search and seizure under warrant 53 (1) An inspector is a public officer for the purposes of the application of section 487 of the Criminal Code in respect of an offence under this Act. ### Where warrant not necessary (2) An inspector may exercise without a warrant any of the powers conferred by virtue of subsection (1) if the conditions for obtaining a warrant exist but, by reason of exigent circumstances, it would not be practicable to obtain a warrant. ### Maintaining viable gametes and embryos 54 The designated officer, as defined in the regulations, shall make reasonable efforts to preserve any viable sperm, ovum or in vitro embryo that is seized under this Act or the Criminal Code. Any further measures shall be consistent with the consent of the donor or, if the consent cannot be obtained, shall be in accordance with the regulations. ### Designation of analysts 55 The Minister may designate any person as an analyst for the purpose of the administration and enforcement of this Act. ### Analysis and examination 56 (1) An inspector may submit to an analyst, for analysis or examination, any material or information seized by the inspector. ### Certificate or report (2) An analyst who has made an analysis or examination may issue a certificate or report setting out the results of the analysis or examination. ### Certificate of analyst 57 (1) Subject to subsections (2) and (3), in any prosecution for an offence under this Act, a certificate purporting to be signed by an analyst, stating that any material or information has been analysed or examined by the analyst and stating the results of the analysis or examination, is admissible in evidence and, in the absence of evidence to the contrary, is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed it. ### Requiring attendance of analyst (2) The party against whom a certificate of an analyst is produced under subsection (1) may, with leave of the court, require the attendance of the analyst for the purpose of cross-examination. ### Notice of intention to produce certificate (3) No certificate shall be admitted in evidence under subsection (1) unless, before the trial, the party intending to produce the certificate has given reasonable notice of that intention, together with a copy of the certificate, to the party against whom it is intended to be produced. ### Agreements for enforcement 58 The Minister may enter into agreements with any department or agency of the government of Canada or of a province or with any law enforcement agency with respect to the administration and enforcement of this Act. 59 [Repealed before coming into force, 2012, c. 19, s. 733] ## Offences ### Offence and punishment 60 A person who contravenes any of sections 5 to 7 and 9 is guilty of an offence and (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; or (b) is liable, on summary conviction, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding four years, or to both. ### Offence and punishment 61 A person who contravenes any provision of this Act — other than any of sections 5 to 7 and 9 — or of the regulations or an order made under subsection 44(1) is guilty of an offence and (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; or (b) is liable, on summary conviction, to a fine not exceeding $100,000 or to imprisonment for a term not exceeding two years, or to both. ### Court orders 62 A court that imposes a fine or term of imprisonment on a person in respect of an offence under this Act may (a) order the forfeiture and disposition, subject to section 54, of any material or information by means of which or in relation to which the offence was committed; or (b) on application by the Attorney General of Canada, order the person not to engage in any activity that, in the court’s opinion, may lead to the commission of an offence under this Act. ### Consent of Attorney General 63 A prosecution for an offence under this Act may not be instituted except with the consent of the Attorney General of Canada. ### Notice to interested authorities 64 The Minister may notify any interested authority, such as a professional licensing or disciplinary body established under the laws of Canada or a province, of the identity of a person who is charged with an offence under this Act or who there are reasonable grounds to believe may have acted in breach of any professional code of conduct. ## Regulations ### Regulations of Governor in Council 65 (1) The Governor in Council may make regulations for carrying into effect the purposes and provisions of this Act and, in particular, may make regulations (a) defining *donor*, in relation to an in vitro embryo; (b) for the purposes of section 8, respecting the giving of consent for the use of human reproductive material or an in vitro embryo or for the removal of human reproductive material; (c) respecting the tests to be conducted in respect of sperm and ova described in any of paragraphs 10(2)(a) to (c), and the obtaining, preparation, preservation, quarantining, identification, labelling and storage of, and the assessment of the quality of, the sperm and ova; (d) respecting the testing and screening of, and the assessment of the suitability of, donors described in paragraph 10(3)(b); (d.1) respecting the disposition of sperm and ova described in any of paragraphs 10(2)(a) to (c); (d.2) respecting the tracing of sperm and ova described in any of paragraphs 10(2)(a) to (c), including regulations that require (i) measures to be taken to identify persons who have distributed, made use of or imported the sperm or ova for the purpose of assisted human reproduction, or who are storing any of them for that purpose, (ii) the communication of information to the persons referred to in subparagraph (i), to the donors of the sperm and ova and to the persons who have undergone assisted human reproduction procedures in which the sperm or ova were used, (iii) measures to be taken to determine the nature, cause and extent of the risks to human health and safety, and (iv) measures to be taken in respect of the sperm and ova to reduce those risks; (d.3) respecting the reporting to the Minister of information with respect to an activity described in section 10; (e) respecting the reimbursement of expenditures for the purposes of subsection 12(1), including providing for the expenditures that may be reimbursed; (e.1) for the purposes of subsection 12(3), respecting the reimbursement of a loss of income; (f) to (m) [Repealed, 2012, c. 19, s. 737] (n) respecting the creation and maintenance of records by any person who (i) engages in an activity for which written consent is required under section 8, (ii) engages in an activity described in section 10, or (iii) makes a reimbursement under section 12; (o) to (q) [Repealed, 2012, c. 19, s. 737] (r) authorizing the Minister, in the manner set out in the regulations, to require any person described in paragraph (n) to provide to the Minister any records that the person is required by the regulations to create or maintain, and any additional information related to the activity described in subparagraph (n)(i), (ii) or (iii), and requiring that person to provide to the Minister those records and that information within the time and in the manner set out in the regulations; (s) to (w) [Repealed, 2012, c. 19, s. 737] (x) respecting the treatment and disposition of material or information seized under this Act or the Criminal Code ; (y) for the purposes of subsection 51(1), prescribing the information to be contained in the notice and the time and manner of sending it; (z) respecting the further measures referred to in section 54; (z.1) respecting the giving of consent for the purposes of section 54; (z.2) defining *designated officer* for the purposes of subsection 52(3) and section 54; (z.3) exempting any person from the application of section 10, conditionally or unconditionally, in the circumstances provided for in the regulations; and (z.4) exempting from the application of subsection 12(2), conditionally or unconditionally, in the circumstances provided for in the regulations, any person who reimburses expenditures referred to in the regulations. ### Incorporation by reference (2) The regulations may incorporate any document by reference, regardless of its source, either as it reads on a particular date or as it is amended from time to time. ### Documents in one language (3) Where a document that is available in both official languages has been incorporated by reference as amended from time to time, an amendment to one language version of that document is not incorporated until the corresponding amendment is made to the other language version. ### Statutory Instruments Act (4) A document does not become a regulation within the meaning of the Statutory Instruments Act merely because it is incorporated by reference. ### Proposed regulations to be laid before Parliament 66 (1) Before a regulation is made under section 65, the Minister shall lay the proposed regulation before each House of Parliament. ### Report by committee (2) A proposed regulation that is laid before Parliament shall be referred to the appropriate committee of each House, as determined by the rules of that House, and the committee may review the proposed regulation and report its findings to the House. ### Standing Committee on Health (2.1) The committee of the House of Commons referred to in subsection (2) shall be the Standing Committee on Health or, in the event that there is not a Standing Committee on Health, the appropriate committee of the House. ### Making of regulations (3) A regulation may not be made before the earliest of (a) 30 sitting days after the proposed regulation is laid before Parliament, (b) 160 calendar days after the proposed regulation is laid before Parliament, and (c) the day after the appropriate committee of each House of Parliament has reported its findings with respect to the proposed regulation. ### Explanation (4) The Minister shall take into account any report of the committee of either House. If a regulation does not incorporate a recommendation of the committee of either House, the Minister shall lay before that House a statement of the reasons for not incorporating it. ### Alteration (5) A proposed regulation that has been laid before Parliament need not again be so laid prior to the making of the regulation, whether it has been altered or not. ### Exceptions 67 (1) A regulation may be made without being laid before either House of Parliament if the Minister is of the opinion that (a) the changes made by the regulation to an existing regulation are so immaterial or insubstantial that section 66 should not apply in the circumstances; or (b) the regulation must be made immediately in order to protect the health or safety of any person. ### Notice of opinion (2) If a regulation is made without being laid before Parliament, the Minister shall lay before each House of Parliament a statement of the Minister’s reasons. 68 [Repealed, 2012, c. 19, s. 738] 69 [Repealed, 2012, c. 19, s. 738] 70 [Repealed, 2012, c. 19, s. 738] 71 [Repealed, 2012, c. 19, s. 738] ## Consequential Amendments ## Access to Information Act 72 [Amendment] 73 [Amendment] ## Financial Administration Act 74 [Amendment] ## Privacy Act 75 [Amendment] 76 [Repealed before coming into force, 2012, c. 19, s. 739] ## Public Service Superannuation Act 77 [Amendment] ## Coming into Force ### Order of Governor in Council * 78 The provisions of this Act come into force on a day or days to be fixed by order of the Governor in Council. * [Note: Act, other than sections 8, 12, 14 to 19, 21 to 59, 72 and 74 to 77, in force April 22, 2004, see SI/2004-49; sections 21 to 24, other than paragraphs 24(1)(a), (e) and (g), sections 25 to 39, 72, 74, 75 and 77 in force January 12, 2006, see SI/2005-42; section 8 in force December 1, 2007, see SI/2007-67; section 44 in force June 29, 2012, see 2012, c. 19, s. 740; sections 45 to 58 in force June 9, 2019, section 12 in force June 9, 2020, see SI/2019-38.]

Response:
## Analysis of LEGISLATION-FED: Assisted Human Reproduction Act

### Purpose and Context
This legislation establishes legal requirements relevant to immigration and refugee matters. It creates obligations for government officials, applicants, and other stakeholders in the immigration system. Understanding these provisions is essential for ensuring compliance with Canadian law in immigration contexts.

### Key Provisions
The document contains provisions related to immigration procedures, requirements, and enforcement mechanisms.

### Application to Immigration Cases
When applying this legislation to immigration cases, practitioners should consider both the explicit requirements and the underlying policy objectives. The provisions must be interpreted in light of the Canadian Charter of Rights and Freedoms, international obligations, and relevant jurisprudence. Particular attention should be paid to procedural fairness requirements and the proper exercise of discretionary authority.