Centre for Public Health

Liverpool John Moores University

Centre for Public Health - Liverpool John Moores University

World Health Organization Collaborating Centre for Violence Prevention

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The new Psychoactive Substances Bill – a quick introduction

4 June 2015 | Professor Harry Sumnall, Amanda Atkinson

At CPH we undertake a number of projects in relation to recreational drugs newly emerging on the market (i.e. products known as new psychoactive substances [NPS], legal highs, research chemicals etc). This includes coordination of the UK arm of the EMCDDA Early Warning System on behalf of the UK Focal Point, lab work with our LJMU pharmacy colleagues to identify marketed products, surveys of use in young people, pan-EU projects analysing online markets, local needs assessment work, PhD research into drug diffusion, as well as public speaking and education and training initiatives with those working in the field.

The UK Government has recently announced that it intends to introduce legislation that will seek to eradicate the market in these drugs. As the Labour party has also previously discussed its support for similar approaches it is likely to be voted through the House of Commons. Although the precise details of the bill, if it receives Royal Assent, remain to be determined, it is clear that the new approach represents a major shift in our approach to the control and regulation of drugs.

There has already been lots of public attention on the Bill, drug policy is always a public interest story. You can read the full text of the bill here, as well as some useful background documents. There have already been several news reports (e.g. http://www.bbc.co.uk/newsbeat/article/32928913/psychoactive-substances-bill-whats-banned-and-how-are-they-checked), and humorous analyses in popular media (e.g. http://www.politics.co.uk/blogs/2015/06/01/things-you-own-which-the-legal-highs-bill-is-going-to-make-i).

This blog attempts to briefly identify key components of the Bill and describe what it is proposing, as well as offering a few initial commentary notes. We are still digesting the contents and the implications of this Bill and so no doubt as time progresses further details and refinements will become available, which may modify our thinking (not in a psychoactive way!).

It is important to note that although we take an interest in drug policy we are not lawyers, and so we may have missed or misinterpreted some of the finer details of the Bill, hence we have not focused on specifics. This topic deserves much more time and attention than this blog allows, and no doubt we will be returning to it in future. For further discussion, the reader is recommended to refer to the NPS Expert Panel Review report from which this Bill emerged (where it is termed General Prohibition on the distribution of non-controlled NPS).

What major drugs legislation do we have already?

Legislation covering ‘illegal’ drugs is primarily covered by the UK Misuse of Drugs Act 1971 (MDAct). Under the MDAct, drugs are not illegal per se, only behaviours associated with possession, distribution, and manufacture; hence it is not currently an offence to be acutely intoxicated. The MDAct is the drug law most people are familiar with. It sets out the A, B, C classification system, which is meant to reflect the relative harms of a drug (with equivalent penalties), although it has been argued that Classification in the UK does not reflect actual harms. The Misuse of Drugs Regulations 2001 also sets out five Schedules that allow for lawful possession of controlled drugs for the purposes of medicine and scientific research. Some scientists have also criticised Scheduling as a barrier to legitimate research with controlled drugs (e.g. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4307971/), arguing that it imposes additional financial and bureaucratic burdens, although the Home Office’s own consultation suggested that this was not perceived to be an impediment in the wider field.

What are new psychoactive substances (NPS) and why does the Government think we need new legislation?

The emergence of new psychoactive substances (NPS) has presented major challenges to drug control in the UK and internationally. There is no normative or universally accepted legal definition of NPS, and there are many layers of complexity, but the Home Office’s own working description is useful:

Psychoactive drugs, newly available in the UK, which are not prohibited by the United Nations Drug Conventions but which may pose a public health threat comparable to that posed by substances listed in these conventions. (from the NPS Expert Panel Review 2014)

There are other considerations to bear in mind such as differentiation between whether a drug is truly new (i.e newly synthesised) or newly used (i.e. synthesised in the past, yet with new evidence of retail sale and use; novel psychoactive substances), but for simplicity we use the Home Office’s definition in this blog.

Drugs controlled under the MDAct in the UK may still be considered an NPS as long as they are not controlled under the United Nations own drug control treaties (the UN Conventions which all Member States must comply with). Methoxetamine, for example is a Class B drug in the UK, but it has not been recommended for international control by the UN, and is therefore considered an NPS. Mephedrone is considered the prototypical NPS and whilst it was first synthesised in the 1930s, it first emerged as an ecstasy substitute in the 2000s. It is a Class B drug in the UK but as it has been recommended for control under UN Conventions (May 2015), it would no longer be considered an NPS under the Home Office definition. 1-Poprionyl-LSD, which has LSD-like effects is not controlled under the MDAct or UN Conventions, and is another NPS. Salvia divinorum, which is a natural product has been used recreationally in the West since the 1960s, and so cannot be considered a new drug, but is also classed as an NPS as it also remains uncontrolled in the UK and by the UN. Such substances are often sold within the retail market as substitutes for illegal drugs, and exist in either compound form under the label ‘Research Chemicals’ or under various brand names (e.g. ‘Black Mamba’; ‘Pink Panther’; ‘Gocaine’ etc). However, it is the chemicals and not the brand names that are subject to control.

Under the usual system of drug control (i.e. ‘banning drugs’) individual drugs, or groups of drugs with similar chemical structures (‘generic definitions’), are placed in the MDAct based upon assessment of likely harms to users and society at large. An evidence review is undertaken by the Advisory Council on the Misuse of Drugs (ACMD), and a recommendation made to the Home Secretary on whether the drug should be classified and scheduled, and what other actions could be taken (e.g. specific prevention, treatment, and harm reduction advice). It is at the discretion of the Home Secretary whether this advice is followed, and there have been disagreements in the past – for example, the ACMD recommended in 2013 that khat should not be controlled, but the Home Secretary decided to make it a Class C drug.

The current system of drug control is a lengthy process, which involves evidence gathering, review, and consultation. Although not without its weaknesses, and it is recognised that relevant evidence is often lacking, particularly for new drugs, the strength of this approach is that the recommendations made are mostly a result of a careful consideration of scientific evidence and a decision is reached that is proportional to actual or likely harms (where these can be predicted).

Because of the large numbers of NPS identified (e.g. the EU Monitoring Centre for Drugs and Drug Addiction [EMCDDA] formally identified 101 new NPS in 2014) the Government decided that it needed new laws and approaches to NPS. In 2011 Temporary Class Drug Orders (TCDOs) were introduced which places substances or groups of substances under temporary control for up to 12 months following a rapid review (typically a 28 day turnaround). Although possession under a TCDO isn’t a crime, there are penalties for manufacture, supply, or intent to supply (equivalent to a Class B offence; similar to the penalties for cannabis). As there will be little research conducted into most NPS when they first emerge, TCDOs are often based on limited evidence, and so during the 12 month control period a full evidence review is conducted (although further evidence is not always forthcoming), and a formal decision made at the point of expiration as to whether the drug should subsequently be controlled under the MDAct.

To date, all drugs under TCDOs have been controlled following expiration of the TCDO, yet only five sets of TCDOs have been evoked (e.g. methoxetamine was subject to the first TCDO in 2012 before being formally placed in the MDA as a Class B drug; ethylphenidate was the most recent TCDO in March 2015), largely because the number of people using NPS is generally small and, apart from a few high profile cases, deaths and harms are relatively rare.

There are various other laws and powers that have been used in response to NPS, for example the Intoxicating Substances Act 1985, first introduced in the 1980s to respond to the rise of volatile substance abuse (‘glue sniffing’) has been used to prosecute market stall holders selling synthetic cannabinoids to under 18s, and recently in places such as Kent, Lincoln, Belfast, and Taunton, councils have been using consumer protection and anti-social behavioural legislation to seize stock, close down retailers, and make ‘public intoxication’ with NPS (and alcohol) an offence. However, there are only a small number of examples of the effective use of such laws and to date they have not been deemed adequate to the expanding NPS market.

In 2014 the Home Office published an expert review to look at how the legislative framework for responding to NPS could be extended beyond the current approaches. This report is highly recommended to readers as the panel carefully outline all the relevant issues in a balanced manner. The review panel described a number of different legislative options ranging from refining the status quo (as described above), to licensing and marketing of NPS proven to be at lower risk. Taking these recommendations into account the Government has announced, as included in the 2015 Queen’s Speech, its new Psychoactive Substances Bill, which will introduce a blanket ban on all ‘psychoactive’ products.

So what is included and excluded in the new Bill?

The new Bill defines a psychoactive substance as:

(1) “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.

 (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.

A very basic interpretation is that all substances that are used to produce changes in behaviour, cognition, and functioning will be controlled; i.e. most of the drugs we understand now as NPS, plus many others that we do not.

The exempted substances clause is included so that alcohol and nicotine/tobacco, which are already subject to separate regulations and licensing conditions, are not prohibited. Also excluded are food (including drinks), and caffeine or caffeine products, as long as these types of products don’t contain other non-exempted psychoactive substances. This means that it is possible to sell a caffeine based ‘energy’ drink, but not one with an added controlled psychoactive substance, unless it’s an EU authorised food or food additive. This is where things begin to get complicated because although nitrous oxide (laughing gas), for example, is set to be banned, it is also an EU approved food additive and used in some alcoholic and caffeinated drinks, therefore will still be allowed for these purposes – so you can sell and use nitrous oxide in some forms, but not in others. Finally, homeopathic products, traditional herbal medicines, standard medicines, and investigational medical products are excluded. Homeopathic products are excluded presumably because they have no direct psychoactive effects, although they may also be associated with harmful outcomes. Traditional herbal medicines are of interest because some cultures use particular psychoactive drugs and drug admixtures as part of traditional medical practice, whereas in the UK we might only consider them as recreational drugs; ayahuasca (a hallucinogenic brew of South American origin made out of vines and other plants) comes to mind here. Traditional herbal medicines are defined elsewhere, but essentially include those products that have been in medicinal use for a continuous period of at least 30 years in the UK, or 15 years in the EU. Hence, drugs like ayahuasca will be banned as there’s no history of medicinal use in the UK, but products such as St John Wort will probably be exempt. Regardless, health food and supplement shops (and garden centres) across the country will need to review all their stock to ensure compliance with the law.

Drugs already controlled under the MDAct will be exempt from the new law (as they’re already illegal), and if a NPS is of particular concern, it will be reviewed for consideration for classification under the MDAct, which includes a possession offence (see below). It is currently unknown under what Schedule(s) (see above) banned NPS will be placed in, but it is important to consider as this will likely have an impact on scientific research into harms, and potential uses of such substances. For comparison, drugs subject to TCDOs are automatically placed into Schedule 1, which limits the type of research that can be undertaken.

What offences and punishments are included in the new Bill?

There are six main offences, and these are in keeping with existing drugs legislation:

Producing a psychoactive substance that is likely to be consumed by individuals for its psychoactive effects;

  1. supplying such a substance;
  2. offering to supply such a substance;
  3. importing such a substance (with the intention of committing an offence);
  4. exporting such a substance;
  5. assisting or encouraging the carrying on of an activity listed in any of paragraphs (a) to (e).

Penalties range from a fine (unspecified maximum amount) and/or up to 7 years imprisonment (equivalent to the current maximum possession penalty for a Class A drug).

Note that there is no personal possession offence, and no offence related to the actual ingestion of controlled products. Giving a controlled product to others in the knowledge or belief that it is psychoactive, regardless of whether there was a monetary transaction involved, will technically be an offence, although this may be difficult to enforce. Similarly, ordering an NPS from a website based abroad (in those countries where it is legal to supply NPS to foreign customers), may be counted as an importation offence even if the drug is for personal use. It will be interesting to see if there is a ‘personal custody’ provision if the law is passed. This currently applies to anabolic steroids, where it is an offence to import a drug directly using Internet or mail order from companies outside of the UK, but it is legal to go abroad and bring a steroid back personally – as long as it’s for personal use only.

The Government’s preliminary financial assessment suggests that it anticipates five personal prosecutions a year. It anticipates that most retailers will comply with the law (there are at least 200 such establishments in the UK), but has estimated 50 orders will be taken against premises in 2016/17 (i.e. retailers and UK websites that don’t immediately comply); 25 in 2017/18; and five in 2018/19.

What are some of the potential strengths and weaknesses of the new Bill?

It is clear that this approach represents a fundamental new way of responding to drug use. It is based on the assumption that all ‘psychoactive’ drugs (apart from exempted substances, which themselves may be harmful) are equally harmful, and confer no benefits to users or society at large. Previously, drug classification, TCDOs, and local council actions were based on an assessment of evidence of harm (albeit often in the absence of a large body of evidence), but this new approach sidesteps this and does not require evidence review. The Bill also excludes the ACMD from decision-making, which is a major change to the function of that body.

Although we do not know how the Bill will be refined over the next few months, we have attempted below to list a few key perceived strengths and weaknesses of the approach, and provide a few additional notes and considerations (this is by no means meant to be an exhaustive list, there will be many other pros, cons, and considerations).

Some potential strengths

  • It will lead to a significant reduction in the number of retailers, and
  • Will lead to a reduction in overall availability of NPS in the UK, and possibly use in some ‘high risk’ populations

 - The new approach is expected, as was seen in Ireland and Poland, to lead to the closure of many specialist NPS retailers based in the UK (high street and online). However, it may be difficult to identify other types of retailer; the Drug Scope street trends surveys suggested that retailers such as petrol stations and takeaway restaurants were selling NPS, as well as individual entrepreneurs. This is probably why the aforementioned financial assessment includes a small number of premise prosecutions in future years.

 - If shops are no longer allowed to sell these products then availability, and subsequently use will fall ( but only if the availability of NPS is not substantially dispersed to other sources [e.g. black market, overseas sales]). We know from alcohol and tobacco studies that environmental interventions, such as policies that limit product outlets or that make it more difficult to market products, do have an impact on use, and population level harms.

 - Fewer people using NPS will mean lower population level harms; emerging evidence in high risk groups (e.g. housing hostel clients, individuals with mental health needs, looked after and accommodated children) also suggests some harms may also be reduced in these groups due to reduced access to NPS.

 - Internet sales of NPS are important but probably less popular than the high street for the majority of users, especially for those purchasing groups who do not have access to a credit card or money transfer service. UK registered websites will be subject to the new law, although this does not prevent them from registering their business and shipping their stock from abroad. However, this would lead such business owners (and purchasers) liable to importation and associated offences if a UK presence could be proven.

  • Reduces availability without directly criminalising users

 - The Government has stated that it wishes this to be a proportionate approach to NPS, with a focus on suppliers. However, as noted above, there are circumstances under which personal offences are still relevant and as such the presumption of the bill not leading to possession offences remains dependent on the ways in which the bill influences or changes the nature user behaviour.

  • Simplified enforcement and trade monitoring

 - The Government is confident that all retailers will become aware of the change in law and will be able to voluntarily comply and dispose of stocks to relevant authorities.

 - Local councils and trading standard offices will no longer have to be proactive in addressing local problems associated with NPS use.

  • Popular with (some) media, general public, and campaigners

 - It is clear that NPS, or ‘legal highs’ as they are most popularly known (although this term is not mentioned in the Bill), are the subject of much public concern. Several media outlets, politicians, and drugs awareness projects have been actively campaigning over the last few years for the introduction of a general ‘legal highs ban’. It is important for elected officials to respond to the electorate, and so this approach may be seen by many members of the public as a sensible solution to a tricky problem. General public perceptions of NPS and preference for various legal options are not known, but one recent EU study suggested that in young people at least (16-24 year olds), only 25% preferred a general ban on NPS, whilst 19% preferred regulation (in a similar fashion to alcohol and tobacco), 51% a ban if a substance posed a risk, and 2% thought nothing should be done at all.

  • Does not necessarily preclude research into NPS or availability of legitimate products

 - The Bill includes a number of exemptions, which will still provide access to popular (albeit still potentially harmful) psychoactive substances (e.g. alcohol, nicotine, caffeine), foodstuffs, and traditional medicines.

 - Dependent upon Scheduling decisions, legitimate research into NPS, either as scientific tools or potential new medicines will be allowed under appropriate licence.

Some potential weaknesses

  • A simplistic response to complex problem

 - Decisions to use drugs, including NPS are complex and multi-faceted. Access and availability are just one factor; equally important are implicit and explicit motivations and drives, unconscious biases, mental health, social and environmental structures, genetics, personality, etc. Banning the supply of drugs makes accessing them more difficult, but does not prevent use (and potential harms) in those who wish to take them.

 - In a global online market and faced with the powerful tools of e-commerce and darknet marketplaces, a country specific ban on NPS will fail to have a great impact on new product innovation and global retail. In Ireland, which has its own Psychoactive Substances Act that bans all NPS, use reported by young people (aged 16-24) is the highest in the EU, and has increased since the 2010 ban. In Poland, a similar ban was temporally followed by a rapid decrease in the number of ‘legal-high related poisonings’ reported by medical services, suggesting policy success. However, three years after the ban the number of poisonings reports had increased above pre-ban levels. Polish officials have suggested that this is partly due to the continued availability of NPS through illegal-, and international Internet markets.

 - Legislation needs to be accompanied by improved service resource and development. Although prevention and education have their place, it is naive to expect that the currently limited implementation of evidence-based activities in the UK will have much impact on (current and future) NPS use and related harms. It is therefore encouraging to see that organisations such as Public Health England and the NEPTUNE project (amongst others) are developing specific NPS resources and intelligence sharing systems. The Bill can only achieve its proposed aims of reducing NPS related harm if equal resource is spent on complimentary health and social support programmes. In this regard, media reports of an increase in Dublin HIV cases associated with mephedrone injection are of concern.

  • The Bill does not take into account differential harms of NPS
  • The Bill will add harm to the market
  • The Bill will create an illicit market and force people who wish to continue to take drugs to access it
  • The Bill takes the ‘precautionary principle’ (which ‘assumes the worst’ about harm) to its extreme
  • The Bill will make the introduction of innovative new legislation in future much less likely
  • Uncertain impact on patterns of use
  • Products still available online and international purchase
  • Lost opportunities for retailers as harm reduction agents?
  • Will agencies such as forensic providers and border control be resourced and equipped to enforce?
  • Impact on the ways in which users can openly discuss such substances on forums, a source of peer harm reduction
  • Further (artificial?) distinction between alcohol, tobacco, and other drugs

 - As all NPS are banned under the Bill, no distinction is made between drugs which are relatively more or less harmful to users. The continued policy distinction between alcohol, tobacco, caffeine and ‘drugs’ (as popularly understood) is also unhelpful, although it is clear that society accepts a higher level of risk and harm for some voluntary behaviours than others. Acknowledging the importance of (some forms of) intoxication in modern UK society, perhaps a better approach to explore would be to evaluate the feasibility of the model outlined in the New Zealand Psychoactive Substances Act 2013, which allows for the licensing and retail of products proven to be lower risk after appropriate safety testing. In this way, users who wish to try NPS and have new drug experiences are directed towards products which have been shown to be less harmful, and may even be less harmful than illegal drugs and alcohol. However, it is appreciated that in the current UK environment of political drug discourse it would be difficult for the government to be seen to ‘approve’ use of drugs that have been previously closely associated with illegal substances

 - NPS might be adopted by existing or new criminal networks (cf mephedrone which is criminally distributed in the UK), with resulting harms associated with systemic and structural violence, poor product quality, and individual exposure to criminality.

 - As we have seen with mephedrone, although population prevalence has fallen since it was controlled in 2010 the number of individuals seeking treatment for problems has increased. This is not to argue that we would not have seen this anyway if mephedrone had not been controlled, only that we should still expect NPS harms and treatment presentations after the ban, particularly if products are picked up by criminal networks.

 - Deaths from NPS use are relatively rare, and without accurate estimates of prevalence of use it is unknown whether the risk of death after NPS is less or greater than other types of drug. One of the proposed justifications of a blanket ban are the deaths associated with use (although perhaps other types of harm might be more relevant to our discussions), with one UK think tank suggesting in 2014 that NPS deaths could soon overtake those associated with heroin. However, as pointed out by King and Nutt, and reinforced in the recent annual report of National Drug Related Deaths Database (Scotland), the majority of NPS deaths are associated with already controlled drugs (although still classed as NPS in accordance with working definitions).

 - As discussed early, the Bill changes the role of the ACMD in drug policy and removes the principle of evidence based recommendations from the decision making process. As an example, the ACMD recently reviewed the evidence for harms associated with nitrous oxide (laughing gas). It concluded that whilst it was important to monitor the diversion of legitimate sources and use of the drug, the associated harms of use were relatively small and therefore the drug did not warrant control under the MDAct. Whilst the Home Secretary was previously entitled to act in opposition to ACMD recommendations, there was at least a statutory duty of consultation; the new Bill removes this.

  • How is ‘psychoactive’ defined?

 - Although the Bill provides a definition of ‘psychoactive’ it is difficult to currently imagine how this will be operationalised. For example, is it a definition based on pharmacological prediction and similarity to drugs with known psychoactivity? Would new drugs be assessed through the use of known receptor binding profile matrices and reference tables (which will be difficult to construct, and to apply to truly novel drugs)? Or are animal models proposed? If so, which ones? It may be relatively easy to demonstrate locomotor stimulating properties of an NPS, but what about hallucinogenesis or entactogenesis for which there are no reliable (and quick and easy) tests of activity? Or are human clinical studies the only true test of psychoactivity? Without basic in vivo and in vitro safety data these types of study are both dangerous and unethical. This risks ‘trial by expert’ in the courtroom, as each side attempts to prove or discredit the evidence that a substance is psychoactive (although to the best of our knowledge the Irish Psychoactive Substances Act 2010 has not yet been challenged in court).

 - Psychoactive substances are defined in the Bill as those substances which are capable of producing a psychoactive effect in a person who consumes it, and psychoactive as a substance [that] 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…. As pointed out in this humorous article, taken to its extreme this definition could include many (non-exempted) familiar household products. That article is a deliberate exaggeration, but carries a serious point; unless this definition is revised then it can be assumed that the decision of what is classed as a psychoactive or non-psychoactive product is largely arbitrary.

 - Where does the burden of evidence provision lie? Is government expected to prove that a compound is psychoactive or do potential manufacturers and suppliers have to prove that it is not? The former option would be a very expensive process, whilst the latter parties would have no motivation to act.