Written evidence submitted by DrugScience
The Psychoactive Substances Bill
Commentary from DrugScience for the Home Affairs Select Committee review
The core purpose of the Psychoactive Substances Bill is to outlaw the unauthorised production, supply, importation and exportation of all “psychoactive substances”, with some specified exceptions, such as alcohol, tobacco and caffeine, which will be exempted.
Introduction of the Bill has been driven by concern about a recent rapid rise in the production, distribution and use of so-called New Psychoactive Substances (NPS), commonly defined as substances that stimulate or depress the central nervous system, associated with dependency, hallucinations or disturbances in motor function or behaviour.
The introduction and unregulated use of substances with such actions, whether derived from non-native plants (e.g. coffee, tea, heroin) or synthesized in laboratories (e.g. metamphetamine, LSD) is not a new phenomenon. But simple synthetic chemistry is now being employed to produce novel compounds, usually based on the molecular structure of existing drugs. According to the recent annual report of the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), 24 NPS were identified in Europe in 2009, but the rate has been increasing steadily, with two NPS appearing, on average, each week last year.
The EU is conducting discussions about the introduction of shared policy and mechanisms for the control of NPS, but the United Kingdom has opted out of these negotiations, on the grounds that it is planning to introduce its own new regulations.
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DrugScience is a charity supported by independent scientific and other experts who review significant issues relating to drugs and the harms they cause http://www.drugscience.org.uk The DrugScience experts have now considered the proposed Bill and are concerned about a number of serious problems.
1. Is new legislation needed?
1.1 For more than 40 years, the control of harmful substances has been dealt with by the Misuse of Drugs Act 1971 (MDA). Specific substances, or precisely defined categories of chemicals, identified on the basis of full consideration of the evidence of harm and its magnitude, may be deemed illegal through classification under the MDA. The law recognises the use in society of a variety of substances with 'psychoactive' effects that it is not appropriate to classify. In many cases this is because the likelihood of harm, as currently assessed, is very low or non-existent (e.g. coffee, herbal teas, aromatic candles, chocolate). There are also widely used substances that cause enormous harm to individuals and society but which are not classified because their use is so entrenched that public and commercial pressures make it impossible to ban them (alcohol and tobacco).
1.2 The MDA was designed to deal with the appearance of new drugs and has dealt quite effectively with NPS – as indicated by the fall in deaths from unclassified drugs (other than tobacco and alcohol) over the past decade, to probably fewer than 5 per year at present (see below).
1.3 The argument for new legislation is largely based on concern about a supposed increase in deaths from legal highs in this country. However, the evidence underlying this concern is largely irrelevant, in that almost all of the substances reported in these death statistics are already illegal http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736%2814%2960479-7.pdf DrugScience experts have estimated that true legal highs (NPS not currently classified under the MDA) are implicated in fewer than 5 deaths each year. And even in those cases, there are questions about whether other factors, including multi-drug use, contributed to the cause of death. This raises the question of why a blanket ban on substances, most of which might not be causing significant harm, is either desirable or necessary.
1.4 The main purpose of this new law would appear to be to ban 'head shops' - freely accessible retail outlets. Control of conventional overt shop trading of potentially harmful substances could be tackled, and already has been tackled in some towns in the United Kingdom (and in government legislation in Poland) through trading regulations.
1.5 The NPS that have been associated with the recent increase in deaths are not sold in head shops. Indeed, by making available lower-risk substances, head shops might conceivably have diverted interest away from, and reduced the demand for, more dangerous NPS, mainly traded through the internet.
1.6 According to the recent EMCDDA report, early last year more than 650 websites openly accessible in Europe were selling NPS. But much of the trading occurs in the so-called 'deep web', which is even more difficult to regulate than the open internet. For internet trading, whether covert or overt, the fact that the production, marketing, website management and financial transactions for each trade often take place in different countries, involving several organisations, hinders regulatory control.
1.7 Before enacting new legislation in this country, if is surely important to learn from the effect of the introduction of similar legislation in Poland and Ireland. The laws in those countries are widely seen to have reduced overt trading in NPS, but to have had only a short-lived effect on rates of drug use in general (http://www.politics.co.uk/blogs/2015/06/26/how-the-legal-highs-ban-proved-disastrous-in-ireland). The New Psychoactive Substances Review produced by a Home Office Expert Panel in September last year, found that the ban in Ireland (introduced in 2010) had the effect of virtually eliminating head shops and Irish-based overt NPS websites, as well as reducing attendance at drug treatment services for problematic NPS use. However it also reported growing concern about "displacement to heroin and prescription drugs, as well as the development of an illegal street market in NPS." (https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/368583/NPSexpertReviewPanelReport.pdf). Indeed, the latest Flash Eurobarometer Report (401) on drug use among young people (14-24 years old) shows that Ireland has the highest rate in Europe, 9% saying that they had used NPS in the past year (http://ec.europa.eu/public_opinion/flash/fl_401_en.pdf)
1.8 Expert opinion and current experience suggest that banning head shops will drive even more of the market underground, into the arms of covert dealing and the internet. According to the recent EMCDDA report, the illicit market adapts rapidly to government measures, including making greater use of social media and dedicated apps to supply drugs and share users’ experiences.
1.9 Eliminating the covert trading of NPS could, perversely, result in more harms and deaths, since market regulation of 'quality' and safety are likely to drop, and NPS are more likely to be sold alongside far more dangerous drugs, such as heroin. Since head shops want their customers to return, and since they wish to avoid prosecution under other legislation, it is in their interests to avoid the most dangerous substances.
1.10 The Local Government Association has stated that this Bill follows the recommendations of the Home Office Expert Panel on NPS, but in fact it goes much further than their proposals. The Panel recommended that substances that are not harmful or have minimal harm should not be drawn into legislation. Not all psychoactive substances are harmful, and some have clear benefits.
2. Issues of principle
2.1 The Psychoactive Substances Bill is a radical departure from the principle underpinning the MDA, namely that the use of substances for pleasure should not be banned without evidence that such use causes significant harm to the user and/or society.
2.2 The implementation of a new law with such wide-ranging impact is disproportionate to the challenge posed by NPS, which is principally a health issue, and of lesser scale compared to long-standing problems created by many other substances, both legal and illegal.
2.3 The principle of banning any psychoactive substance that might become available in future, with no evidence, or no consideration of evidence, about its harmfulness, is a fundamental change in the way the UK law works. This sets an extremely worrying precedent for future legislation, and for the principle that policy (and especially policy that restricts personal freedom) should be evidence-based.
2.4 This Bill makes no discrimination between drugs carrying very different capacities to harm. People will be equally threatened by prosecution in relation to substances with risks equivalent to those of coffee and those as dangerous as heroin. This undermines the basic principle of proportionality in UK law.
2.5 Another set of regulations will be needed that will become conflicted with the MDA, leading to confusion in the minds of the public, the police and the courts, as well as being wasteful of public resources.
2.6 If new legislation is introduced, more consideration needs to be given to proposed penalties. The MDA was intended to match penalties to the potential harm of different drugs. It is, in principle, important that penalties under any new legislation for NPS should not be disproportionate to the real harms of legal highs, which should be assessed on the basis of evidence.
2.7 Media reporting, especially exaggerated allegations of harm, should not be taken as a substitute for properly analysed evidence in the consideration of new legislation. The DrugScience experts were particularly concerned about the evidence base for the proposed ban on nitrous oxide (laughing gas), which is a focus of current media hyperbole. Earlier this year, the Advisory Committee on the Misuse of Drugs (ACMD) reported that there is minimal evidence of harm from the recreational use of nitrous oxide balloons https://www.gov.uk/government/publications/acmd-advice-on-nitrous-oxide-abuse. The media-generated term 'hippy crack' should not be taken to imply true similarity to the risks of cocaine! It is doubtful that nitrous oxide was solely responsible for the deaths attributed to it.
3. Specific concerns - Problems with definitions
3.1 The Bill, as currently drafted, sweepingly defines a 'psychoactive effect' as one that is produced if “…by stimulating or depressing the person’s central nervous system, it affects the person’s mental functioning or emotional state”. That describes a huge range of substances regularly used in medical treatment. This definition would capture new potentially clinically valuable antidepressant and antipsychotic drugs. The definition might also sweep up medically useful drugs with negative psychoactive effects (e.g. opioid receptor antagonists such as naltrexone), which can produce anhedonia and dysphoria.
3.2 Uncertainty about the status of substances is likely to impede the development of useful new medical treatments. For instance, medical innovation using newer cathinones has been stifled by the recent control under the recent cathinone amendments to the MDA. Some cathinone preparations not having immediate psychoactive activity but they are effective antidepressant, anti-smoking and anti-obesity agents. Similar impediments to innovation can be expected if this new bill is passed.
3.3 Who will decide whether a drug is psychoactive? At present the Bill gives this responsibility to the police. But how will they make their judgements in a way that will support successful prosecutions and secure public respect. Where will their expert guidance come from? Irish experience is very relevant on this point. There have been no prosecutions under their Act, because proof of psychoactivity of specific compounds has not been possible.
3.4 It is critical that the definition of psychoactivity be based on the effects in living humans. Many useful medicines resemble abused psychoactive drugs in 'test tube' conditions, but do not have psychoactive effects in human beings. For instance, Loperamide, a potent opioid agonist that was developed to treat pain was not effective as an analgesic and was not psychoactive, because, when administered systemically, it does not enter the brain. (It is now used to treat diarrhoea.)
3.5 Will dosage influence illegality? Will low (non-psychoactive) doses be exempt from any controls to allow forensic and other laboratories to hold standards for assay purposes? If, as seems essential, dosage is taken into account in specifying whether a substance is illegal, how will the threshold concentration for illegality be established?
3.6 There is a major problem in the definition of exempted substances. Will 'alcohol' include all ethanol solutions? Will coffee have to be defined in terms of chemical caffeine content, tea as containing theophylline? Will herbal teas be exempted? If so, how exactly will they be defined? Many popular traditional products contain guarana or ginseng, both of which may have mild psychoactive effects. Many other popular drinks contain potentially psychoactive substances: for example, energy drinks such as Red Bull have taurine along with caffeine. Tonic water has quinine. The amendment tabled by Baroness Meacher to limit the scope of the Bill to 'synthetic' psychoactive substances has much merit in that it would remove a vast number of traditional herbal products from control.
4. Likely perverse and unanticipated negative effects of the proposed law
4.1 It seems likely that some individuals have used legal highs because they are attracted to recreational psychoactive agents but do not want to break the law. A blanket ban on substances of low harm might make such individuals more likely to use legal substances that are exempted from the ban, despite evidence of great harm - namely alcohol and nicotine. At least 85% of the adult population (and many under-age) drink alcohol, which is responsible for 22,000 premature deaths per year, and is the leading cause of death in men aged 16-50 http://www.nwph.net/nwpho/publications/alcoholattributablefractions.pdf. One of the unintended consequences of new legislation to ban substances of low or unproven harm might, then, be to drive users towards indubitably harmful legal drugs.
4.2 We welcome the plan to exempt doctors and medicines – but the Bill needs modifying to ensure that all medicines in the pharmacopeia are exempt – not just those with Marketing Authorisations (MA), as presently construed. A Marketing Authorisation (license) is given by the MHRA to companies to allow them to market (sell, advertise, market) their products, it does not define the use of such drugs, only the claims that can be made by the company as part of their marketing. Drugs with MA are not the totality of medicines that doctors prescribe. Any doctor working for the benefit of their patients and with adequate knowledge of the efficacy of a drug can use drugs outside their MA. This is because many drugs with established uses are too old to have been through modern testing but are still useful medicines and because this sort of exploratory testing has historically led to much medical innovation). Perusal of one hospital formulary found 16 such substances: http://www.nottinghamshireformulary.nhs.uk/chaptersSubDetails.asp?FormularySectionID=20&SubSectionRef=20&SubSectionID=A100#3114
4.3 It is important to learn from the significant negative impact on research and development activities in universities and pharmaceutical sites created by the MDA and other drug laws (Nutt, D et al., 2013 Effects of Schedule I drug laws on neuroscience research and treatment innovation. Nat. Rev. Neurosci. Aug;14(8):577-85. doi: 10.1038/nrn3530). It is therefore imperative that research establishments and suppliers of chemicals specifically for research purposes, are exempted from any new legislation. As a result of evidence from academic societies, including the Academy of Medical Sciences https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/441400/2-7-15-_ACMD_advice_on_PS_Bill.pdf, the government has already agreed that an exemption must be made for bona-fide research, but is yet to say how this will be achieved.
4.4 Potentially valuable medical research employing non-medicine psychoactive substances should be exempted from any new law. DrugScience experts know of many such substances that have been used in research, and are of potential value in future research. These include experimental products and potential new medicines acting on a variety of brain neurotransmitter systems (noradrenaline, GABA-A, imidazoline, 5HT2A, NK1 and dopamine), certain brain-active amino-acids and even the gas carbon dioxide.
4.5 This Bill as drafted could have a detrimental impact on those providing services for people who have multiple vulnerable needs that are not adequately addressed by conventional treatments. Such people are more likely to resort to self-medication and hence to take NPS. Any new legislation should not penalise directors of prisons and mental health wards, social workers, etc, for unauthorised use of NPS on their premises or while under their care.
5 Recommendations
5.1 DrugScience believes that consideration of the Bill should be postponed until there is further evidence on whether this approach can work, including proper evaluation of the Irish data. In the meantime, the MDA can be used to control the availability of legal highs, as it has done in recent years.
5.2 The consideration of whether to introduce new legislation should be firmly evidence-based. The government has in place a competent and highly experience advisory body in the ACMD. The advice of the ADMD should be sought, and taken seriously into account, in considering whether new legislation is required.
5.3 If enacted, the Bill should focus on what it was primarily intended to achieve, i.e. control of the importation and supply of new harmful psychoactive substances by professional drug suppliers and dealers.
5.4 If the Bill does progress, there should be specific exemptions for all medicines, whether or not they have an Marketing Authorisation.
5.5 Exemptions should apply to:
All research pharmaceuticals being used to develop new medicines or progress neuroscience research
All registered medical practitioners
All bone-fide research scientists
The holding of low (non psychoactive) doses of banned substances by forensic and other laboratories, as standards for assay purposes.
5.6 Any regulations for the control of psychoactive substances should be underpinned by a respected, transparent, accountable mechanism for evaluation of the character of psychoactive effects and their potential and actual harm to users and to society. Any new law that is not firmly based on expert evidence is likely to be impossible for the police and the judiciary to apply, and is unlikely to gain the respect of the public in general.
5.7 Systematic evidence-gathering of the effects of any new law be made part of the Bill. This must include monitoring of deaths and other harms from all drugs, not just NPS, to ensure that any diversion of use into other substances is rapidly detected.
5.8 The impact on British medical research, innovation and productivity should be formally and annually monitored via appropriate bodies, e.g. the British Pharmacological Society, the Academy of Medical Sciences and the Association of the British Pharmaceutical Industry, perhaps coordinated by BIS.
5.9 Consideration should be given to the impact of new legislation on legitimate commercial activities (clubs, pubs, bars, and music festivals) in which NPS might be used. If the owners or directors of premises are liable under this Bill, even if they are not involved in the trading of NPS, this could have a severe and unfair impact on legitimate entertainment.
David Nutt on behalf of DrugScience
August 2015