Cruelty Free International v Secretary of State for the Home Department

A regulator imposing licence conditions must take reasonable steps to ensure that animal testing is confined to products intended for medicinal purposes. A marketing authorisation is relevant but does not, by itself, determine the product’s intended end use. The licensing scheme may require written confirmation of intended use and inspection of the relevant records before testing. It need not monitor the actual use of every vial after testing. Later diversion for non-medical cosmetic use does not itself establish a breach where the required assurances and regulatory controls were in place before testing. The court will be slow to interfere with a specialist regulator’s enforcement choices absent a demonstrated public law error.

The claimant sought judicial review concerning the Secretary of State’s regulation of animal testing of botulinum toxin under the Animals (Scientific Procedures) Act 1986. It alleged that a 2014 licence permitted testing for off-label cosmetic use, or alternatively that the Secretary of State had failed to conduct the required harm-benefit assessment and had acted unfairly.

The Secretary of State maintained that the policy against testing cosmetics on animals had not changed. She accepted a duty to take reasonable steps to ensure that batches tested under licence were intended for medicinal purposes, but disputed any duty to trace their later end use. The central issue was the scope and enforcement of the medicinal-use limitation.

1. Claim dismissed. The alleged statement at the meeting of 4 May 2016 was not a reviewable decision and did not represent a change in policy or regulatory approach.
2. The Secretary of State was obliged to take reasonable steps to ensure that botulinum toxin tested on animals was intended for medicinal use. Sections 10, 11 and 18 of the Animals (Scientific Procedures) Act 1986 left her discretion as to appropriate enforcement measures.
3. A marketing authorisation was an important part of the enforcement process, but did not itself limit the product’s use. The regulatory scheme also required the licence holder to obtain and record written confirmation of the intended or anticipated medicinal use of batches before testing. Inspectors checked those records during compliance inspections.
4. The scheme did not require the Secretary of State to monitor the actual end use of every vial after testing. If a batch was properly submitted for medicinal use but later used for pure vanity purposes, that later use would not, without more, establish a breach of the licence or of the Secretary of State’s enforcement duty. A licence holder who knowingly tested a batch intended wholly or partly for vanity prescription would be prima facie in breach.
5. The evidence showed that the post-2011 judicial review arrangements had changed the Secretary of State’s methods and that requirements extended beyond merely checking the existence of a marketing authorisation. The 2014 harm-benefit assessment was consistent with the policy against animal testing for cosmetics. No unfairness or other public law error was established.
6. The court recognised the seriousness of animal suffering but held that the appropriate remedy for concerns about doctors’ prescribing practices lay with the medical regulator, not with an expansion of the ASRU scheme beyond its statutory scope.