Case details
Summary
A substance falls within the functional definition of a medicinal product only where, in the circumstances in which it is supplied and used, its physiological effects entail an immediate or long-term beneficial effect on human health. The assessment is fact-specific. It includes the product’s properties, use, distribution, consumer familiarity and risks.
A substance with legitimate medical uses is not necessarily a medicinal product in every form or context. Nitrous oxide manufactured as catering cream chargers and intended for recreational inhalation was not a medicinal product. It was therefore not exempt from the Psychoactive Substances Act 2016.
The Criminal Division remains a court of review. Fresh expert evidence which does not materially undermine the evidence accepted at trial will not render a conviction unsafe.
Factual background
Four applicants sought permission to appeal against convictions, obtained either after trial or guilty pleas, for possessing nitrous oxide with intent to supply contrary to section 7 of the Psychoactive Substances Act 2016. The prosecutions concerned cream-charger canisters accompanied by balloons and, in each case, intended for recreational use.
The applicants contended on appeal that nitrous oxide was an exempted substance because it was a medicinal product within regulation 2 of the Human Medicines Regulations 2012. They also sought to rely on a late scientific brief challenging whether nitrous oxide was psychoactive.
The central issues were whether the particular nitrous oxide supplied was a medicinal product and whether the proposed fresh evidence could support a ground that the convictions were unsafe.
Held
The applications for permission to appeal were dismissed. Nitrous oxide can be a medicinal product when manufactured and supplied for medical purposes. That did not determine its status in the circumstances of these cases.
The incorporation of regulation 2 of the Human Medicines Regulations 2012 into the Psychoactive Substances Act 2016 required a construction conforming to Directive 2001/83/EC. Following D & G (C-358/13, C-181/4), the functional limb of the definition requires a beneficial effect on human health. The issue must be determined case by case, taking account of the product’s properties, use, distribution, consumer familiarity and risks.
The canisters were manufactured for catering, were widely distributed for that purpose, and were intended to be supplied for recreational inhalation. In that context the gas had no beneficial effect on health and involved health risks. Those features placed it outside the definition of medicinal product, irrespective of the original packaging. It was consequently not an exempted substance, and the section 7 convictions were for offences known to law.
The court rejected the additional application to adduce Professor Nutt’s material. The Criminal Division is a court of review, not a forum for primary fact-finding: R v Pendlebury [2002] 1 WLR 72. The proposed evidence did not undermine the accepted evidence that nitrous oxide was psychoactive. The statutory definition did not require a direct, rather than indirect, effect on the central nervous system. It could not support a ground that any conviction was unsafe.
The court’s approach to earlier authorities
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Appellate history
Court of Appeal (Criminal Division): dismissed the four applications for permission to appeal against conviction and rejected the additional application to rely on fresh expert material.
Crown Courts: the applicants had been convicted at Wood Green, Inner London, Lewes and Peterborough Crown Courts of possessing nitrous oxide with intent to supply, either after trial or on guilty pleas.
Lower court decision
Key cases cited
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Cases citing this case
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