R (Quintavalle) v Secretary of State for Health

The House considered whether live human embryos created by cell nuclear replacement (CNR) fall within the regulatory scope of the Human Fertilisation and Embryology Act 1990 and whether section 3(3)(d) of that Act prohibits licensing their creation. Applying a purposive and "always speaking" approach to statutory interpretation, and following the guidance of Lord Wilberforce, the House held that embryos produced by CNR are live human embryos within the Act's scope despite the literal wording of section 1(1)(a) referring to embryos "where fertilisation is complete". The court treated those words as indicating a stage of development rather than restricting the means by which embryos may be created. The House further held that section 3(3)(d), which proscribes replacing a nucleus of a cell of an embryo, was aimed at nuclear replacement in an existing embryo and does not, by its language, prohibit CNR of an unfertilised egg. Accordingly the appeal was dismissed.

The appellant, on behalf of the Pro‑Life Alliance, challenged the Secretary of State's ability to license creation of human embryos by cell nuclear replacement (CNR). The appellant's primary contention was that the Human Fertilisation and Embryology Act 1990 applies only to embryos "where fertilisation is complete" (section 1(1)(a)) and therefore did not cover embryos created by CNR, a technique not known to Parliament in 1990. In the alternative, the appellant argued that even if such embryos fell within the Act, section 3(3)(d) specifically prohibited replacing a nucleus and therefore outlawed CNR.

The proceedings reached the House of Lords on appeal from the Court of Appeal (which had held that CNR embryos fell within the Act but that section 3(3)(d) did not prohibit CNR). The House was asked to decide (i) whether embryos created by CNR are within the regulatory scope of the 1990 Act and (ii) whether section 3(3)(d) prohibits licensing of CNR.

The Law Lords analysed principles of statutory construction, endorsing a purposive approach and treating statutes as capable of applying to new technologies — an "always speaking" statute — while observing Lord Wilberforce's limits on extending legislation beyond its terms. They concluded that the defining features protected by the Act are that an organism is a live human embryo and not the particular method of its creation. The words "where fertilisation is complete" were treated as indicating the developmental stage to be protected rather than excluding embryos created by other means. On the prohibition point the court found that section 3(3)(d) targets replacement of a nucleus of a cell of an embryo and thus does not, in language, prohibit CNR which replaces the nucleus of an unfertilised egg prior to any embryo existing. The House therefore dismissed the appeal, leaving regulation and licensing of CNR embryos within the 1990 Act's mechanisms.

Appeal dismissed. The House held that embryos created by cell nuclear replacement fall within the regulatory scope of the Human Fertilisation and Embryology Act 1990 because the Act protects live human embryos defined by what they are rather than by the method of creation; the phrase "where fertilisation is complete" relates to developmental stage not to the permitted methods of creation. Further, section 3(3)(d) does not prohibit CNR because it is directed at replacing the nucleus of a cell of an existing embryo and not at replacing a nucleus in an unfertilised egg.

First instance: Crane J, [2001] EWHC Admin 918; [2001] 4 All ER 1013 (held embryos created by CNR were outside the Act and that section 3(3)(d) did not prohibit CNR). Court of Appeal: R (Quintavalle) v Secretary of State for Health [2002] QB 628; [2002] EWCA Civ 29 (reversed on the scope point — CNR embryos within the Act — but agreed that s 3(3)(d) did not prohibit CNR). House of Lords: [2003] UKHL 13 (appeal dismissed).