ART: Donors, Consent and the Commissioning Couple

In one line

The Act decides that the child belongs to the people who commissioned it, that the donor is not a parent, and that neither gametes nor embryos may be sold.

In the wording a student can write in an exam: the Act settles the position of the three parties by statute: the child born through assisted reproductive technology is deemed to be a biological child of the commissioning couple under section 31(1); the donor relinquishes all parental rights under section 31(2), and is protected by limits on age, frequency and screening under section 27; and the commissioning couple must give written informed consent under section 22, which also requires insurance in favour of the oocyte donor.

Section 22: written informed consent

Section 22(1): the clinic shall not perform any treatment or procedure without:

• (a) the written informed consent of all the parties seeking assisted reproductive technology; and
• (b) an insurance coverage of such amount as may be prescribed, for a period of twelve months, in favour of the oocyte donor, taken by the commissioning couple or woman from an insurance company or agent recognised by the Insurance Regulatory and Development Authority.

Clause (b) is unusual and it repays attention. The statute makes the lawfulness of the procedure depend on the donor being insured, and it places the obligation to obtain that insurance on the commissioning couple, not on the clinic or the bank. The oocyte donor undergoes a stimulation and retrieval procedure with real risks and no therapeutic benefit to herself, and this is the legislature's answer to that asymmetry.

Section 22(2): clinics and banks shall not cryo-preserve any human embryo or gamete without specific instructions and consent in writing from all the parties, in case of death or incapacity of any of them. That is a direction to decide in advance what happens to stored material if a party dies, which is one of the practical questions the technology created.

Section 22(3): the clinic shall not use any human reproductive material, except in accordance with the Act, to create a human embryo, or use an in-vitro human embryo for any purpose, without the specific consent in writing of all the concerned persons to whom the technology relates.

Section 22(4): any of the commissioning couple may withdraw consent given under sub-section (1) at any time before the transfer.

Note the structure against the general law in [Informed Consent: the Principle]: consent here is required from all parties, must be written, must be specific to the use, and is withdrawable, which are the same four attributes article 6 of the UNESCO Declaration of 2005 states.

Section 23 requires clinics and banks to keep accurate records of the details of the commissioning couple, the donors, the procedures and the outcomes, in the prescribed manner and for the prescribed period, and to make them available for inspection.