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21 November 2017

When is a medicinal product not a medicinal product?

In October, I highlighted two cases where Crown Court judges had, earlier in the year, dismissed prosecutions involving the supply of nitrous oxide (“2016 Act”). The judges said that they could not convict under the Psychoactive Substances Act 2016 as nitrous oxide is a medicinal product.

Fifty people had pleaded guilty to the supply of nitrous oxide under the Act and I speculated that those people may be considering an appeal.

On 1 November, the Court of Appeal (Criminal Decision) heard four appeals from applicants convicted of possessing a psychoactive substance, nitrous oxide, with intent to supply contrary to Section 7 of the 2016 Act in a case that highlights an interesting question: what exactly is a medicinal product?

Who were the applicants?

Mr Chapman was found with, among other things, 13,800 canisters of nitrous oxide in his self-storage unit. He said, save for a small number of canisters for personal use, they were for use in his catering business; in particular for whipping cream.

Mr Tesfay was caught passing a holdall through a fence to the Lambeth County Fair and was found to have in his possession 200 canisters of nitrous oxide.  He said he was doing a favour for a friend but pleaded guilty to intent to supply.

Mr Chroussis was found with 245 canisters of nitrous oxide while entering the Boundary Festival in Brighton.  It was claimed these were for personal use.

Mr Bryce was convicted of possession of nitrous oxide with intent to supply following his attendance at the Secret Garden Music Festival with 191 canisters of nitrous oxide in a man bag along with 1,084 canisters in his tent. His defence was that the canisters in the man bag were for his personal use and those in the tent were not his.

What did the lawyer for the applicants say in the Court of Appeal?

If the nitrous oxide the applicants had in their possession was a “medicinal product” then they would have been convicted of offences not known in law. It is not an offence under the 2016 Act to possess a medicinal product with intent to supply. The applicants were relying on the exemption in the medicine in the Psychoactive Substances Act (“PSA”) offering an exemption for medicinal products as defined in the Human Medicines Regulations 2012 (“2012 Regulations”).

What did the court say?

Nitrous oxide could not be called a medicinal product when used in the circumstances that Mr Chapman and co used it. Application for permission to appeal was refused. 

Why?

The court looked at the definition of medicinal products in the 2012 Regulations which is:

(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.

The court said that nitrous oxide is undoubtedly used for medical purposes so on first blush it would fall squarely within Regulation 2(b). The court turned to Europe as the 2012 Regulations were introduced to implement a European Directive [1]. The definition in the Directive is the same as the definition in the 2012 Regulations. In both sets of definitionsa medicinal product can either be defined by “presentation” or by “function”.

It is clear from the summaries of the offences above that in none of these cases the nitrous oxide was “presented” as a medicinal product.

The court then looked at the function of the product and found that there was a relevant European case [2] concerning a synthetic cannabinoid. The products were “legal highs” and modified physiological functions without bringing any improvement in physiological function or to health. (The prosecution was because the defendants were selling medicinal products without testing or authorisation - they were convicted).

The European Court said that paragraph (a) and reference to “treating or preventing disease” informed the meaning of paragraph (b) “modifying a physiological function…”

The provision is not neutral with regard to action taken in connection with human health but implies that a beneficial effect should be secured for human health.

The process of determining whether a product falls within the definition of medicinal product must be decided on a case by case basis, including the manner in which it is used.

The Court of Appeal adopted this reasoning and said that a substance may be a medicinal product for one purpose (and then subject to control under the 2012 Regulations) but not another. It concluded that the combination of factors in these cases led to the conclusion that the nitrous oxide was not a medicinal product. Although it modifies the physiological functions of those who inhale it, it does not bring short or long term beneficial effects to human health in these circumstances. The canisters were manufactured for use unconnected with medicinal purposes i.e. catering. The purpose for the supply was purely recreational.

Would the court’s decision have been different if the canisters had been packaged as nitrous oxide for use in health care environments?

Probably not - the court said the other factors were sufficient to take the nitrous oxide outside the definition of medicinal products whatever the label may have said on the boxes.

This was a pragmatic decision by the Court of Appeal which means that the Psychoactive Substances Act does not fall apart, as well as giving an important clarification of the definition of a medicinal product.


This article was written by Susan Hunneyball and published in Pharmacy Business on 16 November 2017.

The above is a general overview and we recommend that independent legal advice is sought for your specific concerns. If you require further information in relation to the points raised in this article you should contact Susan Hunneyball who is a solicitor and member of the Pharmacy Regulatory team at Charles Russell Speechlys LLP. Susan can be contacted on susan.hunneyball@crsblaw.com or +44 (0)207 2035 049.


 References

[1] 2001/83/EC

[2] D&G(C/358/13,C/181/4) 

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