Quintavalle & Anor, R (on the application of) v Human Fertilisation & Embryology Authority (HFEA)

At the permission stage, a regulator may treat a novel scientific process as falling within an existing statutory scheme where that construction best gives effect to Parliament’s purpose and avoids leaving the activity wholly unregulated. Whether an embryo is human depends on the facts and the scientific knowledge available at the time; the Act does not impose an immutable definition based solely on genetic material or method of creation.

A court should not re-argue expert scientific merits under the guise of irrationality. A public body may act on the law as it stands while amending legislation is before Parliament. Permission may also be refused for undue delay, failure to follow the pre-action protocol, prejudice to interested parties and the interests of good administration.

The claimants sought permission for judicial review of the HFEA’s decisions to grant one-year research licences to the University of Newcastle and King’s College London. The research involved creating human-animal embryos by inserting a human cell nucleus into an enucleated animal oocyte.

The claimants argued that the Human Fertilisation and Embryology Act 1990 neither authorised the licences nor permitted the process, and alternatively that the HFEA had acted irrationally by granting licences without adequate regard to the scientific evidence and the passage of amending legislation. The HFEA and interested parties opposed permission and relied additionally on delay and prejudice.

The central questions were whether the process was within the statutory regulatory scheme, whether the licensing decisions were arguably irrational, and whether permission should be refused because the claim was brought late.

1. Permission refused. The challenge was not arguable on the merits, and permission was independently refused for undue delay, failure to follow the pre-action protocol, prejudice and the interests of good administration.
2. The statutory purpose of the Human Fertilisation and Embryology Act 1990 was a strict regime of control in which activities in the field were regulated rather than left to a regulatory vacuum. The court adopted the purposive approach described in Quintavalle [2003] 2 AC 687.
3. The Act did not provide an immutable definition of a human embryo. Whether an embryo is human depends on the particular facts and the scientific knowledge available at the time. The presence of animal mitochondrial material did not make the process fall outside the Act. The new legislation’s separate treatment of human-animal embryos did not demonstrate that the process had been excluded from the 1990 Act.
4. The prohibition concerning the mixing of human and animal gametes did not apply. An enucleated animal egg used in this process was not, on the statutory and medical meaning of gamete, being mixed with a human gamete. The claimants’ construction strained interpretation beyond acceptable limits.
5. The irrationality challenge improperly invited the court to assess the merits of competing expert scientific opinions. The HFEA had considered the relevant evidence and the majority of peer reviewers had supported the applications. Its decision could not be characterised as irrational. The HFEA was entitled, and required, to decide the applications under the law then in force while the Bill was before Parliament.
6. Even assuming the merits grounds were arguable, the claim was not brought promptly. The claimants had prior legal advice, knew the HFEA’s position and the licences were imminent, and gave no adequate explanation for failing to use the pre-action protocol. Allowing the claim to proceed would risk significant disruption and prejudice to the research, and quashing the decisions would serve no useful administrative purpose.
7. Costs were awarded to the defendant and interested parties. The defendant’s schedules were reduced to reflect excessive time claimed, while the interested parties were awarded £1,520. The claimants were given three months to pay, jointly and severally.

First-instance permission hearing. No prior appellate decision is stated in the judgment.