Guidance

Psychoactive Substances Act 2016: guidance for researchers

Published 20 May 2016

1. Introduction

This guidance is to help researchers understand the Psychoactive Substances Act 2016, which comes into effect on 26 May 2016. The act bans psychoactive substances, also known as ‘legal highs’, in the UK.

The act exempts legitimate scientific research involving psychoactive substances in the 3 ways outlined within the research exemptions section of this guidance. It is not the intention of the act to prevent or hinder any legitimate research.

The act creates a number of criminal offences covering the manufacture and distribution of a psychoactive substances (as defined in the act) for human consumption. The main offences in the act are:

• producing a psychoactive substance for human consumption
• supplying or offering to supply a psychoactive substance for human consumption
• possession with intent to supply a psychoactive substance for human consumption
• importing or exporting a psychoactive substance for human consumption

The Misuse of Drugs Act 1971 will continue to be the main drug legislation in the UK. The Psychoactive Substances Act complements the 1971 act.

There is no change to the existing Home Office administered licence regime for access to controlled drugs for the purposes of research.

2. What are psychoactive substances?

The Psychoactive Substances Act 2016 captures all psychoactive substances that are not controlled by the The Misuse of Drugs Act 1971 or otherwise exempt (see below).

Section 2 of the act defines a psychoactive substance as any substance which is ‘capable of producing a psychoactive effect in a person who consumes it’. The act only captures substances which are solely for human consumption for their psychoactive effects.

The manufacture and distribution of psychoactive substances for consumption by animals or any non-human system is not captured by the act.

The scope of the act is narrowed by the nature of each offence and by 2 sets of exemptions:

• schedule 1: certain substances
• schedule 2: certain activities

The effect of schedule 1 is that for the purposes of the act, the term ‘psychoactive substance’ does not include:

• drugs controlled under the Misuse of Drugs Act 1971
• medicinal products as defined by the Human Medicines Regulations 2012
• alcohol (ethyl alcohol)
• nicotine/tobacco
• caffeine
• food

3. Research exemptions

Only the manufacture and distribution of a psychoactive substance for human consumption for its psychoactive effects is caught by the act.

The manufacture and distribution of a psychoactive substance for any other purpose than human consumption is not caught by the act.

This includes the majority of research activity including research on a substance which does not involve human consumption at present but which could lead to the substance in general being consumed in the future if the research progressed to this point.

For research which is in scope, the act exempts it in 3 ways (all or any may apply).

3.1 Exempted substances under schedule 1

Schedule 1 exempts particular substances from the scope of the act such as medicinal products, which includes investigational medicinal products as defined by the Human Medicines Regulations 2012.

The Medicines Healthcare Products Regulatory Agency will determine whether a substance is a medicine within this definition in line with their statutory function.

3.2 Exempted activities under schedule 2

Schedule 2 exempts the following 2 activities from the scope of the act:

• activity carried on a human by a healthcare professional acting in the course of their profession
• approved scientific research, which counts as scientific research carried out on humans by someone who has approval from a relevant ethics review body to carry out that research

The following is allowed when carried on in the course of or in connection with either of the above activities:

• producing a psychoactive substance
• supplying a psychoactive substance
• offering to supply a psychoactive substance
• possessing a psychoactive substance with intent to supply it
• importing or exporting such a psychoactive substance
• possessing a psychoactive substance in a custodial institution

For research to fall within this exemption it needs to be approved by a relevant ethics review body. These bodies are defined by schedule 2 of the act and include a research ethics committee recognised or established by the Health Research Authority under Chapter 2 of Part 3 of the Care Act 2014, or a body appointed by any of the following for the purpose of assessing the ethics of research involving individuals:

• the Secretary of State, the Scottish ministers, the Welsh ministers, or a Northern Ireland department
• a relevant NHS body
• a body that is a research council for the purposes of the Science and Technology Act 1965
• a research institution for the purposes of chapter 4A of part 7 of the Income Tax (Earnings and Pensions) Act 2003 – this includes universities and other higher education institutions
• a charity which has as its charitable purpose (or one of its charitable purposes) the advancement of health or the saving of lives

Any research which falls within the act’s scope but is not approved by any ethical review body listed in schedule 2 of the act must get ethical approval from a listed body for the exemption to apply.

3.3 Nature of each criminal offence

Each of the act’s main offences (listed under sections 4 to 9) contain mental elements which need to be proved to bring a prosecution. These differ depending on the offence but include:

• the act of production or supply must be intentional, eg the person intentionally produces a psychoactive substance (production as a by-product of research would not be intentional), or the person intentionally supplies a substance to another person (mistaken supply, or a genuine belief that the supply of the substance is for another purpose would not constitute intentional supply)
• the person knows or suspects, or ought to know or suspect, that the substance is psychoactive
• the person knows, or is reckless about whether the psychoactive substance is likely to be consumed by the person to whom it is supplied or by some other person for its psychoactive effects

4. Further information

This guidance should not be treated as legal advice. If you’re a researcher and are uncertain about your rights and duties you should seek independent legal advice.

For general enquiries, please email the Home Office Drugs and Alcohol Unit at psact@homeoffice.gov.uk