CHAPTER 25: Miscellaneous Issues

There is a diverse group of issues relating to controlled drugs including: an exemption for certain diagnostic kits and low dosage preparations containing cocaine, dihydrocodeine, morphine or other opiates; cutting agents and adulterants; preparations designed for administration by injection; supply of meat products; and medicinal products. There are several areas where there is overlap between medicines regulations, the Misuse of Drugs Act 1971 and the Psychoactive Substances Act 2016, some of which have led to problems of legal interpretation. The original definition of a medicinal product, which was updated by a European Union Directive in 2001 (as amended) is now set out in Regulation 2 of the Human Medicines Regulations 2012. Although now obsolete, anabolic steroids and benzodiazepines were once exempted from certain offences if in the form of a medicinal product. The European Court has made it clear that the pharmacological properties of a product must be demonstrated by national medicines agencies if a substance is to qualify as a medicinal product, and that the onus in cases of classification is on the medicines agencies to prove that a product has such an effect, not for the supplier to show that it does not. Remarkably, the United Kingdom Medicines and Healthcare Products Regulatory Agency had initially defined benzylpiperazine (BZP) as a medicinal product and actively prosecuted some suppliers, even though BZP had never been licensed for therapeutic use in the United Kingdom or anywhere else.