Quintavalle, R (on the application of) v Human Fertilisation and Embryology Authority

Human Fertilisation and Embryology Act 1990 permits the licensing of IVF treatment and pre-implantation genetic diagnosis where the activities appear necessary or desirable for assisting a woman to carry a child. That purpose extends beyond overcoming physical obstacles to pregnancy. It can include enabling prospective parents to proceed with confidence about material characteristics of a child, including freedom from a hereditary disease.

Accordingly, tissue typing of embryos to identify one free of disease and tissue-compatible with a seriously ill sibling may be licensed. Such testing can determine whether an embryo is suitable for implantation in the particular woman. The Act leaves the ethical judgment whether, and on what conditions, to grant a licence to the Human Fertilisation and Embryology Authority; it creates no entitlement to treatment for social selection.

Mr and Mrs Hashmi sought IVF treatment involving pre-implantation genetic diagnosis and tissue typing. Their son had beta thalassaemia major and might be helped by stem cells from the umbilical cord of a tissue-compatible sibling. The proposed treatment would identify embryos that were both free of the disease and compatible with the son.

The Human Fertilisation and Embryology Authority decided in principle that it could license the procedure, subject to stringent case-specific conditions, and granted a licence to the treating clinic. On judicial review, Maurice Kay J quashed that decision. He held that tissue typing was not necessary or desirable for the purpose of assisting a woman to carry a child. The Authority appealed, supported by the Secretary of State. The central issue was whether the proposed activities were licensable treatment services under the Human Fertilisation and Embryology Act 1990.

1. Appeal allowed unanimously. The Authority could lawfully decide that IVF, biopsy and pre-implantation genetic diagnosis including tissue typing were necessary or desirable for providing treatment services. The order quashing its decision in principle was set aside and the judicial-review claim was refused.

2. Lord Phillips MR held that treatment which enables a woman to bear a child in the confidence that the child will not have a hereditary defect assists her to carry a child. That construction reconciled the provisions for treatment with those permitting research into methods of detecting genetic and chromosomal abnormalities. It was supported by the legislative background and by the ministerial statement admissible under [1993] AC 593.

3. The same reasoning applied where the relevant characteristic was tissue compatibility with a seriously ill sibling. The statutory purpose did not turn on the particular desired characteristic. Where the proposed treatment enabled a woman to proceed with a pregnancy in those circumstances, an embryo was suitable for implantation only if it had the required tissue type. Tissue typing therefore fell within paragraph 1(1)(d) of Schedule 2 to the Human Fertilisation and Embryology Act 1990.

4. Schiemann LJ emphasised that Parliament had prohibited some activities absolutely but otherwise established a licensing regime. It was open to the Authority to decide that the process would assist some women who would otherwise avoid conception or terminate a pregnancy. Lawfulness did not oblige the Authority to grant a licence or give parents a right to IVF for social selection.

5. Mance LJ additionally concluded that testing cell material extracted from an embryo was not itself a use of the embryo. Creation, biopsy and implantation remained controlled by licence. He regarded tissue typing as within the same statutory genus as genetic screening and as a matter for regulatory control rather than an absolute statutory prohibition.

• Court of Appeal (Civil Division): allowed the Authority’s appeal, set aside the order quashing the Authority’s decision in principle, and refused the judicial-review claim: [2003] EWCA Civ 667. Permission to appeal to the House of Lords was refused.
• Administrative Court, Queen’s Bench Division (Maurice Kay J): allowed the judicial-review claim and quashed the Authority’s decision in principle that tissue typing could be licensed. The citation is not stated in the judgment.