Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The holder of a clinical trial licence or a clinical practice licence must collect the following information for the donor in relation to each use of a mitochondrial donation technique under the licence:
(a) the donor's full name;
(b) the donor's residential address at the time the donor gave the proper consent required by paragraph 28N(1A)(a) to the use of the donor's egg;
(c) the donor's date and place of birth;
(d) any other information the donor gives the licence holder, for the purposes of inclusion on the Mitochondrial Donation Donor Register under section 29A, at the time referred to in paragraph (b) of this subsection;
(e) any other information about the donor prescribed by the regulations for the purposes of this paragraph.
(2) If a particular use of a mitochondrial donation technique results in the creation of a zygote that:
(a) has nuclear DNA from a woman and a man; and
(b) contains mitochondria from a human egg of a different woman;
the woman mentioned in paragraph (b) is the donor in relation to that use of the technique.
(3) A person who is or was the holder of a clinical trial licence or a clinical practice licence must use the person's best endeavours to collect the following information for each child born alive as a result of a pregnancy achieved using a mitochondrial donation technique under the licence:
(a) the child's full name;
(b) the child's sex;
(c) the child's date of birth;
(d) any other information about the child prescribed by the regulations for the purposes of this paragraph.
(4) A person who is or was the holder of a clinical trial licence or a clinical practice licence must keep records of information the person collects as required by subsection (1) or (3) for the period prescribed by the regulations for the purposes of this subsection.
(5) If a person who is or was the holder of a clinical trial licence or a clinical practice licence becomes aware that a child has been born alive as a result of a pregnancy achieved using a mitochondrial donation technique under the licence, the person must:
(a) as soon as practicable after the birth of the child, notify the Secretary and the NHMRC Licensing Committee of that fact, in the form (if any) approved by the Secretary; and
(b) give the Secretary, in the form (if any) approved by the Secretary:
(i) the information collected as required by subsection (1) for the donor in relation to the particular use of the technique that achieved the pregnancy, as soon as practicable after the birth of the child; and
(ii) the information collected as required by subsection (3) for the child, as soon as practicable after the person collects the information.
(6) A person who is or was the holder of a clinical trial licence or a clinical practice licence must not include in a notification for the purposes of paragraph (5)(a) the name, or any other information that could be used to discover the identity, of:
(a) a trial participant or patient; or
(b) a child of a trial participant or patient.
(6A) A person who is or was the holder of a clinical trial licence or a clinical practice licence must take reasonable steps to ensure that information the person collects as required by subsection (1) or (3) is not disclosed to another person except for the purpose of complying with this Act.
(6B) A person who is or was any of the following must not disclose information collected as required by subsection (1) or (3) to another person except for the purpose of complying with this Act:
(a) the holder of a clinical trial licence or a clinical practice licence;
(b) an embryologist specified in such a licence;
(c) a person authorised by such a licence to carry out an activity authorised by the licence.
(6C) Subsections (6A) and (6B) apply despite a law of a State. However, those subsections do not prevent a person from disclosing information to a Registrar of births, deaths and marriages (however described) of a State in accordance with a law of that State relating to the notification or registration of births.
Note: A defendant bears an evidential burden in relation to the matter in this subsection (see subsection 13.3(3) of the Criminal Code ).
(7) Despite subsections (1), (3), (4), (5), (6), (6A) and (6B), in the case of a clinical trial licence a person is not subject to a requirement under any of those subsections unless the person who is or was the holder of the licence is a constitutional corporation.
(8) A person commits an offence if the person intentionally engages in conduct knowing that, or reckless as to whether, the conduct breaches a requirement under subsection (1), (3), (4), (5), (6), (6A) or (6B) to which the person is subject.
Penalty for a contravention of this subsection: Imprisonment for 2 years.