It’s been reported that some prosecutions under the Psychoactive Substances Act 2016 have collapsed recently, at Southwark and Taunton Crown Courts. The Taunton case at least was about the section 7 offence of possession with intent to supply a psychoactive substance, and both cases related to nitrous oxide—or “laughing gas”. The cases have led to a predictable chorus of claims that the Act is fundamentally misconceived and unworkable. But is it? Or have two Crown Court judges got the law wrong?

You can be only be guilty of the section 7 offence if what you intend to supply actually is a psychoactive substance—and psychoactive substances are defined in section 2. There’s no dispute that nitrous oxide has psychoactive effects. The argument that has succeeded is that nitrous oxide is an exempt substance under section 2 because it’s a medicine, medicinal products being listed as exempt substances in Schedule 1 to the Act. Nitrous oxide is used for analgesia and anaesthesia, for instance in dentistry. Many of us will have “had gas” in the dentist’s chair. It’s lawfully sold under marketing authorisations granted under the Human Medicines Regulations 2012. For example a firm called Air Liquide has a marketing authorisation for nitrous oxide mixed with oxygen, which it sells under the name Equanox.

No judgments are publicly available, these cases having ended presumably after rulings by the judge in each case that there was no case for the defendant to answer. They must I think have concluded that nitrous oxide is in fact a medicine, and so as a matter of law exempt. That all seems straightforward … but actually, it’s not. It’s hard to know without seeing their reasoning, but I suspect the judges have gone astray. Here’s why I suspect that.

The Act defines a medicinal product as having 

the same meaning as in the Human Medicines Regulations 2012 (S.I. 2012/1916) (see regulation 2 of those Regulations).

Those regulations in turn define a medicine in the same way as does article 1.2 of the EU Directive 2001/83—the Medicinal Products Directive (see page 13 of the pdf). What interests us in this case is the “functional” limb of the test. A medicine is:

Any substance … 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 …

Notice that this definition is very broad. It’s much wider than simply products intended to treat disease, and potentially catches anything that pharmacologically modifies our body functions—like an anaesthetic. It also, if you think about it, catches many foods. The classic example I was given when I advised the UK medicines regulator was a banana. When a banana gives you a bit of a boost, then it’s pharmacologically or metabolically modified your physiological functions.

No one would seriously suggest regulating bananas as medicines, even thought strictly the definition may include them. But what if some extract of banana were found to actively cure an illness? Then, without any doubt, banana extract tablets marketed for treating the disease would rightly be treated as medicines. This example shows that the question whether or not to classify something as a medicinal product is not a “black and white” issue of what it contains or is made of. It’s actually a multi-factorial, contextual question requiring a bit of judgement. Paradoxical as it seems, one and the same substance may be a medicine in some circumstances, and not in others.

The Court of Appeal had to look at one example of this sort of thing last year in the Blue Bio case, a judicial review against the UK medicines regulator, the MHRA, about glucosamine-containing products or GCPs (glucosamine is something extracted from shellfish, and can be used to treat osteoarthritis). At para. 19, the Court of Appeal explained that

The existence of a significant pharmacological or metabolic effect on the body is not the only criterion that justifies a classification of a product as a medicinal product: it must be considered in the round. Thus the MHRA will consider the familiarity that consumers have with the product as a non-medicinal substance and the manner in which it is actually used. These factors assume particular significance in the case of substances that have both a medicinal and a non-medicinal use. Examples of such products are: salt, ascorbic acid, alcohol, caffeine and even water.

The court quashed the MHRA’s decision to treat some GCPs as medicines and others not. But this difference in classification of identical GCPs was unlawful only because the MHRA could not show that there was a significant difference in the way they were used. Para. 66 of the Court of Appeal’s judgment is key:

orally ingested GCPs whose active ingredient is glucosamine sulphate and which carry a recommended daily dose of 1500 mg share several significant characteristics with a product classified in the UK as a medicinal product; and in accordance with article 2.2 of the Medicinal Products Directive must be classified in the same way unless they have another significant characteristic which takes them outside the definition of “medicinal product”. That characteristic may well be the manner in which they are used, but it has not so far been demonstrated.

In principle, the MHRA approach of seeing use as potentially decisive was approved by the court, in line with various rulings over the years by the European Court of Justice. Glucosamine used to treat osteoarthritis is a medicine; glucosamine used only as a food supplement is not. The fact that the two things may be physically identical is not in itself decisive.

So the Blue Bio case alone shows us that laughing gas supplied by one person to another in Somerset or London as a recreational drug is not necessarily a medicine just because a canister of Air Liquide’s Equanox is.

The clearest guidance we have on whether new psychoactive substances are medicines comes from the European Court of Justice’s 2014 ruling in Cases C-358/13 and C-181/14, D and G. This was a preliminary ruling in criminal cases about supplying synthetic cannabinoids. The German court was asking the ECJ whether EU medicines law was (para. 24)

to be interpreted as meaning that substances or combinations of substances within the meaning of that provision which merely modify — that is, do not restore or correct — human physiological functions are to be regarded as medicinal products only if they are of therapeutic benefit or at any rate bring about a modification of physiological functions along positive lines? Consequently, do substances or combinations of substances which are consumed solely for their — intoxication-inducing — psychoactive effects, and in the process also have an effect which at least poses a risk to health, fall under the definition of ‘medicinal product’ contained in the directive?’

The ECJ reiterates the multi-factorial approach to determining whether a product is a medicine (para. 42) before concluding in paras. 46 and 47 that

the substances at issue in the main proceedings are consumed not for therapeutic but purely for recreational purposes …

… such substances cannot be classified as ‘medicinal products’.

and ruling in the operative part of the judgment (para. 51)

Directive 2001/83/EC … on the Community code relating to medicinal products … must be interpreted as not covering substances … which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health.

Synthetic cannabinoids are not medicines as a matter of EU law, then, at least when used recreationally. Of course, if some synthetic cannabinoid actually had a therapeutic use—and who knows, perhaps one will be shown to have a clinical application one day—then it would be a medicine if supplied for the purposes of treatment. As we saw earlier, one and the same substance can be a medicine when used for such a purpose, but not when used non-therapeutically.

It follows that while nitrous oxide sold as Equinox for clinical use is a medicine, laughing gas consumed not for therapeutic but purely for recreational purposes and solely to induce a state of intoxication, to use the ECJ’s words, is not.

Let’s now return to the Psychoactive Substances Act. Since no one disputes its psychoactive effects, nitrous oxide is a psychoactive substance unless exempted under Schedule 1. Under schedule 1, para. 2, there’s an exemption for medicinal products, a phrase which as we’ve seen

has the same meaning as in the Human Medicines Regulations 2012 (S.I. 2012/1916) (see regulation 2 of those Regulations).

Regulation 2 reproduces exactly the definition of a medicine in article 1.2 of the EU Directive, (page 13 in the pdf). It’s elementary law that UK courts need to interpret national implementing legislation, such as the Human Medicines Regulations, consistently with the EU Directive to which they give national effect. What’s a medicine under the Directive, therefore, is a medicine in the Human Medicines Regulations. Finally, because Schedule 2 of the Act defines medicinal products by reference to the Regulations, the same things are medicines under the Directive, the Regulations and the Act.

All medicinal products covered by the Directive—but only those covered by the Directive—are exempt under the Psychoactive Substances Act. If a substance does not fall within the Directive, it’s not exempt.

The D and G case told us that, as a matter of EU law, substances used purely for recreational intoxication are not covered by the Directive, it follows that laughing gas intended or used as a “high” cannot be an exempt medicinal product under the Psychoactive Substances Act. You can only think it so if you assume that because nitrous oxide can be a medicine, it always is; but that, as we’ve seen is the wrong legal approach. If it’s the basis of the rulings at Southwark and Taunton Crown Courts, then in my view those courts have erred in law.

An English criminal court can properly convict someone under section 7 for possession of the psychoactive substance laughing gas with intent to supply it; and if it finds all elements of the offence made out (importantly, you must intend to supply it to be consumed for its psychoactive effects) then it should do so.

The Psychoactive Substances Act may represent a bad policy—I’m not a drugs policy expert, and I don’t know. But it’s not the legal ass some think it is.

2023-02-19T19:18:55+00:00Tags: , |