England and Wales Court of Appeal (Criminal Division) Decisions

IN THE COURT OF APPEAL (CRIMINAL DIVISION)
ON APPEAL FROM WOOD GREEN CROWN COURT
Ms Recorder Horwood-Smart QC
T20170182
ON APPEAL FROM INNER LONDON CROWN COURT
His Honour Judge Bishop
T20170558
ON APPEAL FROM LEWES CROWN COURT
Mr Recorder Bull QC
T20170201
ON APPEAL FROM PETERBOROUGH CROWN COURT
Mr Recorder Oldham
T20170113

		Royal Courts of Justice Strand, London, WC2A 2LL
		01/11/2017

The Lord Chief Justice:

1. The issue raised before us by the four applications for permission to appeal against conviction is whether nitrous oxide is an "exempted substance" for the purposes of the Psychoactive Substances Act 2016 ("the 2016 Act") because it is a "medicinal product" within the meaning of that term as defined by the Human Medicines Regulations 2012 (S.I. 2012/1916) ("the 2012 Regulations").
2. At the conclusion of the hearing we dismissed the applications. These are our reasons for doing so.
3. The four applicants were convicted on unconnected occasions of possessing a psychoactive substance, namely nitrous oxide, with intent to supply contrary to section 7 of the 2016 Act. Two were convicted after trials and two on their own pleas of guilty. In none of their cases was it contended that the nitrous oxide in the possession of each applicant was an exempted substance. Indeed, it was agreed that it was not. These applications were prompted by widespread publicity given to a handful of other cases where such a contention was accepted by trial judges. If the nitrous oxide the applicants had in their possession was a 'medicinal product', as they now contend, then they have been convicted of offences not known in law, because it is not an offence under the 2016 Act to possess a medicinal product with intent to supply. On the other hand, if the nitrous oxide was not a 'medicinal product' within the meaning of the Act, then all of the applications must fail.
4. We are satisfied that in the circumstances of these cases the nitrous oxide in question could not be categorised as a medicinal product and therefore was not an exempted substance. In our judgment, the matter is clear on existing authority.
5. Nitrous oxide, commonly known as laughing gas, is a substance which was first synthesised by Joseph Priestly in 1772. Its use as a recreational drug soon followed. A few years later, Sir Humphrey Davy gave a detailed description of its euphoric and pain relieving effects upon him, which are described in an article by W D Smith in the Journal of the American Society of Anaesthesiologist, (1965) 109 pp 707 – 722. That article is entitled "A History of Nitrous Oxide and Oxygen Anaesthesia". The title of the article reflects the fact that nitrous oxide is used in medicine. It has been used, for example, as an anaesthetic in childbirth and dentistry for very many years. It has analgesic properties. Nitrous oxide has many other uses. One explored in the trial of the applicant Chapman is its use in catering. It is widely found in "cream charge canisters" and is the propellant found in aerosols for whipped cream. Small canisters designed for whipping cream can readily be bought on-line in bulk and it is these that are often sold on for recreational use. Most users introduce gas from a small canister into a balloon and then inhale it from the inflated balloon.

The 2016 Act

6. The underlying purpose of the 2016 Act was to criminalise the production, supply, offering for supply, export and import and possession with intent to supply of psychoactive substances not otherwise caught by the drugs legislation. It was directed as what had become known as 'legal highs' (such as synthetic drugs known as spice and mamba) although it also had nitrous oxide firmly in its sights: see the Home Affairs Select Committee, First Report of Session 2015-16 Psychoactive substances (HC 361).
7. The legislative technique adopted was not to list substances to which the 2016 Act applied, as is done with controlled drugs for the purposes of the Misuse of Drugs Act 1971("the 1971 Act"). Whilst it is possible to introduce into the scheme of the 1971 Act new substances as they are encountered, the process is cumbersome and encourages the producers of synthetic drugs to develop new ones, or slightly to change the chemical composition of old drugs, to stay ahead of the game. The Advisory Council on the Misuse of Drugs concluded that nitrous oxide could be harmful if used long-term, but did not consider that the harmfulness warranted its inclusion: see letter of 3 March 2015 to the Home Secretary and Secretary of State for Health. The 2016 Act applies to substances by reference to their effects, rather than listing individual chemical composition, and is drafted to exclude from criminal sanction their supply etc for purposes other than as recreational drugs. "Psychoactive substance" is defined by section 2:

"2 Meaning of "psychoactive substance" etc

(1) In this Act "psychoactive substance" means any substance which—

(a) is capable of producing a psychoactive effect in a person who consumes it, and

(b) is not an exempted substance (see section 3).

(2) For the purposes of this Act a substance produces a psychoactive effect in a person if, by stimulating or depressing the person's central nervous system, it affects the person's mental functioning or emotional state; and references to a substance's psychoactive effects are to be read accordingly.

(3) For the purposes of this Act a person consumes a substance if the person causes or allows the substance, or fumes given off by the substance, to enter the person's body in any way."

8. It was not disputed in any of these cases at trial that nitrous oxide is a psychoactive substance capable of producing a psychoactive effect of the sort described in subsection 2. The Crown relied upon evidence from Professor Philip Cowen, Professor of Psychopharmacology in the University of Oxford, to make good that ingredient of the offence. Our papers show that one of the applicants (Chroussis) obtained his own expert report on that question which supported the professor's conclusion.
9. "Exempted substances" are dealt with in section 3:

"3 Exempted substances

(1) In this Act "exempted substance" means a substance listed in Schedule 1.

(2) The Secretary of State may by regulations amend Schedule 1 in order to—

(a) add or vary any description of substance;

(b) remove any description of substance added under paragraph (a).

(3) Before making any regulations under this section the Secretary of State must consult—

(a) the Advisory Council on the Misuse of Drugs, and

(b) such other persons as the Secretary of State considers appropriate.

(4) The power to make regulations under this section is exercisable by statutory instrument.

(5) A statutory instrument containing regulations under this section may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament."

10. Schedule 1 lists exempted substances. They include controlled drugs, because they are covered by other legislation, alcohol, nicotine and tobacco products, caffeine and food. Medicinal products are exempted by paragraph 2 of schedule 1 and are defined as follows:

"In this paragraph "medicinal product" has the same meaning as in the Human Medicines Regulations 2012 (S.I. 2012/1916) (see regulation 2 of those Regulations)."

Regulation 2 of the 2012 Regulations provides:

"2.(1) In these Regulations "medicinal product" means—

(a) any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

(b) any substance or combination of substances that may be used by or administered to human beings with a view to—

(i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

(ii) making a medical diagnosis.

(2) These Regulations do not apply to—

(a) whole human blood; or

(b) any human blood component, other than plasma prepared by a method involving an industrial process."

11. At first blush it might be thought that because nitrous oxide is undoubtedly used for medical purposes it would fall squarely within regulation 2(b). But as is common ground before us, the 2012 Regulations were introduced to implement Directive 2001/83/EC on the Community code relating to medicinal products for human use ("the Directive"). By incorporating the definition from the 2012 Regulations into the 2016 Act Parliament made clear that the term 'medicinal product' must be interpreted in conformity with its meaning in European law.
12. Regulation 2 of the 2012 Regulations transposes Article 1(2) of the Directive. That reads:

"Article 1

For the purposes of this Directive, the following terms shall bear the following meanings:

2. Medicinal product:

(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological immunological or metabolic action, or to making a medical diagnosis.'

13. We note that if nitrous oxide in the form and use described in these cases were a medicinal product, it would be subject to the regulatory regime required by the Directive and introduced by the 2012 Regulations. That imposes onerous obligations upon the manufacturers and suppliers of medicinal products, with criminal sanction for failures to abide by the requirements of the regulations.
14. Before turning to the interpretation of Article 1(2) we shall complete the relevant summary of the 2016 Act.
15. Sections 4 to 10 create offences relating to psychoactive substances. Section 7 provides:

"7 Possession of psychoactive substance with intent to supply

(1) A person commits an offence if—

(a) the person is in possession of a psychoactive substance,

(b) the person knows or suspects that the substance is a psychoactive substance, and

(c) the person intends to supply the psychoactive substance to another person for its consumption, whether by any person to whom it is supplied or by some other person, for its psychoactive effects.

(2) This section is subject to section 11 (exceptions to offences)."

16. By contrast with drugs controlled by the 1971 Act, simple possession of a psychoactive substance is not an offence, save in a custodial institution (section 9). Importantly, an ingredient of the offence which must be proved by the prosecution is that the defendant in question intended to supply the substance for consumption for its psychoactive effects. Thus, in Chapman's case the prosecution was required to disprove his contention that he intended to supply nitrous oxide for use in the catering industry.
17. Section 11 and Schedule 2 provide a range of exceptions to offences in the context of healthcare related activities and research.
18. In both the Regulations and the Directive, 'medicinal product' can be defined through two possible routes. The first route is by 'presentation' and the second is by 'function'. There is no suggestion in any of these cases that the nitrous oxide in question was presented as a medicinal product for the purposes of Regulation 2(1)(a) and Article 1(2)(a).
19. The Luxembourg Court has provided authoritative guidance on the interpretation of the functional limb of the definition.
20. In D & G (C-358/13, C-181/4), the Luxembourg Court considered the meaning of 'medicinal products' within the Directive, drawing on its earlier judgments in HLH Warenvertriebs GmbH (C-211/03) and Upjohn EU:C: 1997:147. Both of the anonymised parties in D & G had been prosecuted in Germany for selling products which contained synthetic cannaboids. The products (not unlike spice) modified physiological functions without bringing about any improvement in those functions or to health, indeed the contrary. They were consumed solely to achieve a state of intoxication. They were a classic example of what here has been described as a legal high, because their possession and sale was not covered by German criminal law concerning illicit drugs. Germany had incorporated the Directive into its domestic law. The defendants were prosecuted under that legislation for selling medicinal products without the appropriate testing, authorisation etc. They were convicted and sentenced to significant terms of imprisonment.
21. The Luxembourg Court was asked to consider whether synthetic cannaboids were 'medicinal products' in accordance with the Directive. It concluded that they were not. The fact that in consequence German law failed to criminalise activities which deserved criminalisation was neither here nor there. The court considered that both limbs of the definition of medicinal product should be read together so that the reference in Article 1(2)(a) to treating or preventing disease informed the meaning of Article 1(2)(b), the language of which also points in that direction. It said:

"… According to recital 3 in the preamble to Directive 2004/27, in aligning national laws, it is necessary to attain a high level of human health protection. Accordingly, the whole of Directive 2001/83, and in particular Article 1(2) thereof, must be read bearing that objective in mind. That provision is not merely neutral with regard to action taken in connection with human health and implies that a beneficial effect should be secured for human health. [33]

…

It follows from the foregoing considerations that the term 'medicinal product' in Article 1(2)(b) of Directive 2001/83 must be interpreted as not covering substances whose effects merely modify physiological functions and which are not such as to entail immediate or long-term beneficial effects for human health." [38]

… it should be recalled that , according to established case-law, for the purposes of determining whether a product falls within the definition of a medicinal product … the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail …" [42] emphasis added.

22. The court went on to note [46] that the substances in issue were not consumed for therapeutic reasons, but purely for recreational purposes, and that they were harmful to health.
23. The case-by-case approach entails the possibility that different products with precisely the same chemical composition may fall within or outside the definition of medicinal product depending on the circumstances.

The Facts

24. On 4 August 2017 Chapman was convicted of a range of offences which have no bearing on his application, in addition of two counts of possession with intent to supply nitrous oxide. 408 canisters were found in his car when he was stopped on 9 September 2016 along with several bags of balloons. A self-storage unit owned by the applicant was searched; 13,800 canisters of nitrous oxide were seized. Chapman's case was that the canisters, save for a small number for personal use, were for use in his small catering business, in particular for whipping cream. That is what they were designed for. Amongst the agreed facts placed before the jury was that reported adverse effects following inhalation of nitrous oxide were:

"residual sedation, confusion, disorientation and headaches. Nausea and vomiting have also been reported. Larger doses may result in loss of consciousness and cause asphyxiation by oxygen displacement."

25. On 14 August 2017 Tesfay pleaded guilty to a single count of possession of nitrous oxide with intent to supply. On 15 July 2017 police officers were patrolling the perimeter of Brockwell Park where the Lambeth County Fair was taking place when they saw this applicant pass a holdall through the fence to another man. In that way the security checks at the entrance were bypassed. He was in possession of another bag. Both bags were searched and between them contained 200 small canisters of nitrous oxide. They were accompanied by balloons. The applicant denied that the bags were his and that he was doing a favour for a friend. Once more the nitrous oxide in question had been produced for use in the catering industry.
26. On 25 July 2017 Chroussis pleaded guilty to a single count of possession of nitrous oxide with intent to supply. On 17 September 2016 he had been searched by event security staff as he tried to enter the Boundary Festival which was taking place in Stanmer Park, Brighton. He was found to be in possession of 245 canisters of canisters of nitrous oxide, and the police were informed. The police officer found 245 boxed canisters of nitrous oxide in the applicant's rucksack, together with a dispensing device and 250 balloons. The applicant said that it was for personal use although his telephone gave up evidence that he was dealing. The canisters in question were packaged as cream chargers.
27. On 17 August 2017 Bryce was convicted of a variety of offences not material to this application as well as a count of possession of nitrous oxide with intent to supply. On 23 July 2016 the Secret Garden music festival was taking place near Huntingdon. A festival goer, who had already been the victim of a theft, saw two males acting suspiciously in that they were looking into tents. The festival goer reported matters to the police, and the applicant and a co-accused were identified. The applicant was searched and found to have 191 canisters of nitrous oxide in a man-bag together with balloons. The applicant's tent was searched and a further 1084 canisters were found along with balloons.
28. The applicant said that the canisters found in the man-bag were for his personal use and those in the tent were not his.

Discussion

29. Mr Stein QC submitted that nitrous oxide undoubtedly may be used for medical purposes. It may be contrasted with the synthetic cannaboid considered by the Luxembourg Court in D & G which had no therapeutic or medical use. By reference to paragraph 38 of the judgment, since nitrous oxide may bring benefits to human health it should be treated as a medicinal product irrespective of the purpose for which it was manufactured or circumstances of its use. Furthermore, he submitted that nitrous oxide is not a dangerous legal high of the sort at which the 2016 Act primarily aims.
30. Mr Mably QC submitted that the application of the definition provided by the Luxembourg Court leads inevitably to the conclusion that nitrous oxide produced for catering purposes and intended for use as a recreational drug falls outside the concept of a medicinal product. He points to the consequences of the contrary submission, namely that the common use of the gas for legitimate catering purposes would fall to be regulated under the 2012 Regulations.
31. We have already observed that the regulatory regime contemplates that a substance may be a medicinal product for one purpose (and thus subject to control under the 2012 Regulations) but not another. That flows from the repetition by the Luxembourg Court in paragraph 42 of its judgment of a long-standing principle that determination of the question must be considered on a case-by-case basis by reference to many factors. We have no difficulty in accepting that manufacture and supply of nitrous oxide for medical purposes is covered by the 2012 Regulations because in that context it falls within the definition of a medicinal product. But a combination of factors lead inexorably to the conclusion that in the circumstances of these cases the nitrous oxide in question was not a medicinal product.
32. The gas no doubt modifies the physiological functions of those who inhale it, but it brings neither short term nor long-term beneficial effects to human health in these circumstances. The canisters in question were in fact manufactured for use unconnected with medical purposes, widely available and distributed for use in catering, which in itself is a strong indicator that they were not medicinal products. Furthermore, the purpose for which it was intended to supply the canisters was purely recreational with nothing whatsoever to do with health. This last feature coupled with the fact that the gas was intended to be used in circumstances which were not beneficial to health, indeed import some risk to health, was sufficient to take it outside the definition of medicinal product whatever label may have been on the boxes in which the canisters were originally packed.

An Additional Application

33. On the eve of the hearing of these applications, solicitors for the applicants produced a "scientific brief" from Professor David Nutt, the Edmund J Saffra Chair in Neuropsychopharmacology at Imperial College, London with a longstanding and well-known interest in drug policy. Mr Stein sought to rely upon this document to question the conclusion of Professor Cowen (and others) that nitrous oxide is a psychoactive substance within the meaning of the 2016 Act. He submitted that we should admit the evidence, enable the prosecution to respond to it by obtaining further evidence from Professor Cowen and perhaps others and then hold a hearing to resolve the issue as primary fact-finders. We rejected the application.
34. The Court of Appeal Criminal Division remains a court of review and not one in which primary fact-finding exercises are undertaken: R v Pendlebury [2002] 1 WLR 72 HL. The question for this court, if it admits fresh evidence, remains whether the conviction in question is unsafe in the light of that evidence. The extent to which the evidence might be disputed or disputable would be relevant to the issue whether there should be a retrial.
35. Professor Nutt considers himself "to be the leading UK expert in the field of recreational drug use and the brain". He was originally asked to consider the question whether nitrous oxide is a medicinal product for the purposes of the 2012 Regulations. But he describes his paper's purpose as being to explain "the issues relating to prosecutions for nitrous oxide possession and supply". He explains some of the background to the 2016 Act and then summarises the flaws he believes underlies the legislation. This paper is in large part an argument which might have been deployed in Parliament by a legislator seeking to defeat its passage.
36. The summary of Professor Nutt's opinion is found in paragraph 18 of the paper:

"Prosecutions relating to the sale of nitrous oxide as a psychoactive substance under the 2016 Act are flawed on at least three grounds

a) Nitrous oxide is a medicine – and has been for over a century and a half.

b) Nitrous oxide is not proved to be psychoactive under the meaning of the Act.

c) The effects of nitrous oxide on the brain are not mediated by a direct effect on the central nervous system."

37. Mr Stein did not seek to rely upon the first of those conclusions, recognising that it states an uncontroversial proposition that does not answer the question whether the nitrous oxide in issue in these cases was a medicinal product. We have added the emphasis to the second proposition. It is not Professor Nutt's confident conclusion that nitrous oxide is not a psychoactive substance within the meaning of the 2016 Act but rather he believes it is not because it cannot be proved to be so. Strikingly, the professor does not explain how nitrous oxide causes the anaesthetic and analgesic effects for which it is well known; nor does he engage with its properties as an anti-depressant. As to his third conclusion, it seems important to his analysis that the statute should require the substance to have a direct rather than indirect effect. He believes that at least some of its effects may be caused by relaxation in blood vessels. The statutory definition does not distinguish between the two; and the concepts of direct and indirect effect might in themselves spark lively academic scientific debate.
38. It is the professor's opinion that a study on humans on the psychoactivity of nitrous oxide relied upon by Professor Cowen "does not provide convincing proof" and he considers studies conducted on rodents are "potentially flawed". He considers that data relating to glutamate are only "indirect measures of possible psychoactivity" and is sceptical of the reliance on release of endorphins. He regards Professor Cowen's comparison with other drugs, such as ketamine and PCP, as "problematic". In paragraphs 35 and 36 of the paper he says:

"It would be possible to prove that nitrous oxide is psychoactive through a direct effect on the brain by conducting a state-of-the-art brain imaging study in humans. This would involve human volunteers being given nitrous oxide in a scanner and the impact of the gas on the binding of a radio-tracer that labels either the glutamate, endorphin or dopamine receptor then being measured. A reduction in the tracer binding would be proof of psychoactivity of nitrous oxide.

Only in this way can proof of direct psychoactivity in humans be obtained. I would recommend that the Home Office commission such research as a matter of urgency to settle this."

39. We should emphasise that it is no part of Mr Stein's application that the resolution of this issue should await such a research product.
40. Mr Mably resisted the application on the basis that it was not expedient or in the interests of justice to receive that much of Professor Nutt's report as amounted to evidence, rather than argument, for the purposes of section 23 of the Criminal Appeal Act 1968.
41. We leave aside any complication that might arise from the fact that two of these applications for leave to appeal arise from unequivocal guilty pleas and, in the case of Chroussis, a guilty plea having obtained expert evidence that supported Professor Cowen's conclusion on this matter. We also leave aside the fact that the evidence from Professor Nutt fails to comply with any of the provisions of the Criminal Procedure Rules and would thus need to be revised (a) to limit its scope to proper expert evidence and (b) to comply with the important provisions of those rules.
42. We recognise that in very rare cases it might be possible to seek to call expert evidence on appeal on a matter that was not in issue at trial, indeed (as here) formally agreed at trial. But in this case the reality is that the issue was not disputed (we do not know save in one case the extent to which it was explored by the applicant's advisers) because Professor Cowen's opinion would not be seen by most as remotely controversial. We have summarised the effect of Professor Nutt's evidence, couched in the language of the prosecution's failure to prove, rather than a clear different conclusion, because as presented in this report we do not think it grapples with Professor Cowen's opinion or undermines it. It may be that for the sake of scientific purity Professor Nutt believes that the only way to resolve the issue to his satisfaction would be to conduct a carefully controlled human study. Yet that is not a legal necessity to prove the matter in a court of law. He is sceptical, rather than dismissive, of all the studies relied upon by Professor Cowen and recognises that there are no other studies, whether in humans or other mammals, which point in the opposite direction. Were Professor Nutt to have set out a clear explanation of how each of the well-recognised effects of nitrous oxide are caused, supported by such academic and research material as is available, with a clear conclusion that it does not stimulate or depress a person's central nervous system and thereby affect the person's mental functioning or emotional state, the position might have been different. But as presented before us we are unpersuaded that it could support a ground of appeal.