Legal Controls of Psychoactive Substances in Europe
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The more powerful psychoactive substances have been controlled due to the harms they cause to public health. Those that were found in certain regions of the world have been controlled by international treaties, limiting their use to medical and scientific purposes. The treaties also established a system to carefully assess the benefits and harms of new substances and control them accordingly; control is then enforced by criminal penalties at national level. This established system is now under pressure due to globalisation and the internet, with two new substances found in Europe every week, and countries look for new ways to control substances quickly without the need to prove a public health threat. In some countries, “psychoactive” moves towards becoming a synonym for “harmful”; in others, supply of low-risk substances for non-medical use is now permitted.
KeywordsDrug Narcotic Psychoactive Law European
This chapter aims to introduce the reader to the system(s) of drug control in Europe, explaining their evolution from 100 years of international drug control, through the coalescence of the European trading agreements and subsequent regional public health and security cooperation, to the emergence of various fast-acting national level control systems that are required to quickly address a particular problem in a particular country.
1 Development of An International Control System
Possibly one of the most famous or widespread psychoactive substances worldwide is alcohol, a substance made by fermenting sugars and thereby possible to make, or encounter, in nearly any habitable land in the world. In Europe, viticulture existed in the south even in Roman times, while until the nineteenth century (weak) beer, originally made with honey, was a healthier drink than impure water. However, with industrialisation, alcohol could be made stronger and cheaper than ever before. This caused local public health and social problems, as for example when England banned the import of French wine and cancelled the domestic monopoly on distillation; consumption of gin rose eightfold in the first half of the eighteenth century, before new laws prohibited retail sale by the distillers. As a reaction to the social problem of drunkenness, the Temperance Movement arose, particularly around the north of Europe and spreading via English-speaking culture to the USA, leading to prohibitions on domestic alcohol sales, to differing degrees, in Norway, Finland, Sweden, Russia, and most famously, the USA, in the early twentieth century (Anderson and Baumberg 2006). Nevertheless, control systems tended to evolve locally, with no real need for agreements on transnational trade.
At the same time, as various European empires spread over land and sea in the seventeenth, eighteenth and nineteenth centuries, these countries started to discover and exploit plant-based psychoactive substances from the new lands, most notably caffeine in the form of tea from Asia, chocolate from Central America, and coffee from Africa, but also opium, coca leaves and cannabis. This resulted in lucrative international trade in all substances, but the latter were identified for their intense effects on the human mind and body. Hemp had already been known for its fibrous properties for hundreds of years, but the psychoactive effects of cannabis were only widely studied in Europe from the late eighteenth century, and cocaine was eventually isolated from coca leaves in the second half of the nineteenth century. Whilst these substances were used for medical purposes, control was comparatively lax, and they were gradually acknowledged as causing serious public health issues; but at the time, medicinal and intoxicating properties of drugs were rarely separated in discourse.
These visible public health issues, grouped under the concept of addiction, led to stricter domestic pharmaceutical controls, the increasing influence of the Temperance Movement in the USA, and the condemnation of British Empire funding by aggressive sales of Indian opium, factors which, among others, culminated in the signing of the International Opium Convention in 1912 in the Hague. This Convention aimed to regulate international trade in opium, morphine, heroin and cocaine, “determined to [suppress] the abuse of these substances” [preamble], and limiting their use to “medical and legitimate purposes”(Art. 9) only. The same laws should be applied “To all new derivatives of morphine, of cocaine, or of their respective salts, and to every other alkaloid of opium, which may be shown by scientific research, generally recognised, to be liable to similar abuse and productive of like ill-effects.”(Art. 14d). Signatory countries were expected to transpose the provisions into domestic pharmacy laws by national legislation, and were requested to make illegal possession “a penal offence”. In 1925, the Second Opium Convention, now limiting trade and use to “medical and scientific purposes”, added coca leaf and, controversially (Ballotta et al. 2008), Indian Hemp (cannabis). It also broadened future application by establishing the international risk assessment system, enabling the Health Committee of the newly-formed League of Nations to recommend the Convention to apply to any other narcotic drug which “is liable to similar abuse and productive of similar ill-effects” (Art 10). The Health Committee would base its recommendations on those of the Paris-based International Office for Public Health; in 1948, these tasks were taken over by the World Health Organisation, as the role of the League of Nations was taken over by the United Nations (Danenberg et al. 2013). Provisions of these and subsequent international treaties were eventually gathered into the Single Convention on Narcotic Drugs of 1961, supplemented by the Convention on Psychotropic Substances of 1971, which remain in force until today. The public health aspect is paramount: the 1961 Convention opens with the Parties declaring themselves to be “Concerned with the health and welfare of mankind”, having the aim to “prevent and combat” addiction to narcotic drugs, yet at the same time “Recognizing that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes”. The terms “narcotic” and “psychotropic” in the titles have no pharmacological relevance (e.g. cocaine is not narcotic) and are never defined in such terms; they only serve to distinguish the different legal controls.
The two United Nations Conventions on drugs classify narcotic drugs and psychotropic substances by virtue of their danger to public health, risk of abuse and therapeutic value, with each Convention listing substances to which it applies in one or more Schedules. These schedules are for the regulatory purposes of the Conventions, e.g. reporting trade statistics and applying for import/export permissions. The criteria for classification under the 1961 Convention are the substance’s “degree of liability to abuse” and its “risk to public health and social welfare”. Substances must be listed in Schedule I or Schedule II. Preparations of substances are listed in Schedule III, and substances may be additionally listed in Schedule IV if they are particularly liable to abuse without substantial therapeutic advantages. Criteria for the four Schedules under the 1971 Convention are on a simpler sliding scale that balances “risk to public health” against “therapeutic usefulness”. Changes are made with reference to the World Health Organisation, using procedures which are broadly similar for the two Conventions. New drugs are being controlled all the time. The original 1961 Narcotics Convention listed some 90 substances for control, and the original 1971 Psychotropics Convention listed 32; today, there are about 120 substances (excluding isomers, salts etc.) listed in each Convention. Since 1948, the relevant WHO committees have discussed 703 substances and 257 preparations, though 28 internationally controlled substances – including cocaine, opium, morphine and cannabis resin – have never been reviewed by WHO (Danenberg et al. 2013). Individual countries are permitted to control other substances in the same way, as they see fit.
These regulatory control systems continue to be reinforced by instructions to establish penalties for breach of obligations, which later became the main focus of the 1988 Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. The 1961 Convention requested signatories to establish unauthorised supply-related activities (such as production, sale, distribution) as “punishable” offences, but the 1988 Convention obliged signatories to establish them as “criminal” offences. It is important to note that the Conventions make no requirements to vary penalties for offences according to the type or classification (e.g. risk to public health) of the drug involved. In line with their nature of international trade regulation, there is no requirement for countries to punish use of the substances. Nevertheless, following the consideration that increased supply reduction would be ineffective while demand was relatively uncontrolled, the 1988 Convention requested, for the first time, that countries criminalise possession of drugs for personal use. This was preceded by a safeguard clause for each country to interpret “Subject to its constitutional principles and the basic concepts of its legal system”, and so it has been implemented in a wide variety of ways, worldwide but also across Europe.
2 Control of Psychoactive Substances Around the European Union
Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. (Art.1(2))
These products may be classified by Member States as subject to medical prescription or not, and various reasons are given for classifying them as prescription-only; these include that the product contains a substance classified in the 1961 or 1971 Conventions, above, or that “the medicinal product is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes” (Arts 70–71). In this way, the control obligations imposed in the EU by this directive intersect with those imposed by the UN Conventions. However, there is a fundamental difference, in that the EU does not establish a specific list of substances/products that should be subject to different levels of control, but leaves this for Member States to interpret individually while keeping the above common guidance in mind. In practice, this means that very many medicinal products are controlled in different ways across the EU.
In each country, unauthorised supply of the (more harmful) medicinal products included in the UN Conventions will be subject to the criminal penalties that the country has established due to its obligations under the Conventions, which we will discuss below. Unauthorised supply of other medicinal products will also be penalised, but usually to a lesser extent. There is no systematic monitoring of penalty provisions in national medicines legislations across Europe, but discussions with EMCDDA national expert networks suggest that penalties for unauthorised supply may involve (significant) administrative fines with no criminal conviction, or prison sentences of a few years, for medicines not included in the UN Conventions. Penalties for unauthorised personal possession appear to be exceptional.
At the same time, stemming from their obligations under the UN Conventions and the need to protect public health, European countries have enacted national laws to limit the distribution and use of some of the more potentially harmful psychoactive substances, addressing regulatory and punitive matters using various combinations of health and criminal justice powers. These laws will apply to defined lists of substances that should at minimum include those substances listed in the UN Conventions but may well also include other psychoactive substances found in that country that have required control due to (risk of) abuse.
In the 1990s, more substances were being found in European countries, sometimes referred to as “designer drugs”, which were synthetic drugs being manufactured in European countries, whereby molecules of controlled drugs were adjusted, so the new variant was not covered by laws. Based on the new Article K.3 of the 1993 Treaty of the European Union, and in the context of the removal of border controls in the Schengen zone, Member States signed the Joint Action 97/396/JHA on the Information Exchange, Risk Assessment and Control of New Synthetic Drugs. This established a mechanism for Europe-wide risk assessment and eventual control of non-therapeutic substances with potential for abuse similar to those in Schedules I and II of the 1971 Convention. If the European Council (i.e. the Member States) issued a decision instructing Europe-wide control, Member States would have 3 months to change national law to apply the control measures and criminal penalties for substances under the 1971 Convention to the new substance. In 2005, the Joint Action was replaced by the Council Decision 2005/387/JHA on the Information Exchange, Risk Assessment and Control of New Psychoactive Substances, broadening the remit to substances that posed a threat to public health comparable to any listed in the 1961 and 1971 Conventions, and to substances of natural as well as synthetic origin. This appears to be the first mention of psychoactive substance in an international drug control law, but the word itself is not defined in the law, except as a group term for narcotic or psychotropic drugs under the UN Conventions. The Council Decision does specify that the first report in the control process, the Joint Report, should include the health and social risks and the “mode and scope” of the use (Art. 5), while the second report, the Risk Assessment, should also include the description of the substance “and its mechanisms of action” (Art. 6). The latter should also consider all factors which would warrant control under the two Conventions, and these include reference to psychoactive effects, which were defined in the Operating Guidelines as “central nervous system stimulation or depression, resulting in hallucinations or disturbances in motor function or thinking or behaviour or perception or mood.” (EMCDDA 2009).
In 2009, EMCDDA examined the different procedural systems by which countries assessed risks and enacted legislation to place new drugs under control (Hughes and Blidaru 2009). That study found that national systems to assess the risks presented by new psychoactive substances exist in most EU Member States. These systems examine the health and social risks posed by new substances at the various stages from manufacture, through trafficking to use. They may also evaluate the potential involvement of organised crime, and the consequences of possible control measures. The 2009 study found that, out of 26 countries for which information was available, six did not report having a risk assessment system as part of the legal procedure of control. A risk assessment system was directly referred to in the drug law of six countries, was semi-formalised in seven, and in another seven could be performed on an ad-hoc basis. In the majority of countries, it would be carried out by public officials, but by an independent scientific body in four (Hungary, Netherlands, Austria, United Kingdom). About half of the EU Member States legally distinguish substances by the level of harm they may cause, and a risk assessment may assist with accurate classification and communication of the harms to the public. However, these assessments may not always be in the public domain and scientific recommendations are not always acted upon, attracting criticism (Hughes and Griffiths 2014).
In terms of actually placing drugs under control, the 2009 study found a wide variation across Europe in both, the times taken to control drugs (from a few weeks to over a year) and the form of control adopted. Three main factors affected the speed of control: the procedure defined, the nature of the law involved, and the level of final approval. A complex, legally mandated procedure to change a parliamentary law that requires approval of the Head of State will take longer than a simple procedure to change a regulation signed by one Minister. Recognising this, Germany and the Netherlands had already established an emergency procedure, putting a substance under temporary control for a year by requiring approval from one Minister rather than the Government; if the full procedure is not followed within 1 year, the control will lapse. Several other countries had some form of rapid system, putting a substance under permanent control by shortening certain prescribed consultation periods during the law-making process.
Generic systems: legislation includes a precise definition of a family of substances (such as describing substitution patterns in a parent molecule). Examples are Ireland and the United Kingdom.
Analogue systems: legislation includes a more general definition of ‘similarity in pharmacological activity’, as well as ‘similarity in chemical structure’. Examples are Latvia and Bulgaria.
Derivative: a compound that is formally (not synthetically) derived from the structure of a well-known compound.
These systems, to control drug supply, are reinforced by penalties in national laws for breach of obligations, but there are considerable differences in the punishments across the region, both in theory and in practice. Even comparing the legislation itself, these vary greatly, ranging from a maximum of 1 or 2 years in prison for a minor offence, as in Austria, Denmark and Finland, to 10 years in prison for an aggravated offence, as in Finland and Sweden, to a maximum of life imprisonment for any non-minor offence, as in Cyprus, Ireland and the United Kingdom. Differences may stem from countries’ criminal justice beliefs, relating to the value of short or long prison sentences for crimes in general (Thomson Reuters Aranzadi 2013); from their belief in legislative authority or judges’ discretion, whereby some countries may establish specific penalty ranges in the law while others may establish broad penalty ranges for the judges to choose from; and from particular qualities of the offence or the offender, most commonly linking a certain penalty range to a particular type and/or quantity of drugs involved in the offence. An EU Framework Decision that attempted to bring these penalties closer in 2004 was ultimately ineffectual (European Commission 2009).
Countries are also attempting to stem demand by penalising use-related offences. The possession of drugs for personal use – and sometimes drug use itself – is a criminal offence in most European countries, where it can (theoretically) be punished by a custodial sentence. However, since around 2000, there has been an overall trend across Europe to reduce the possibility of imprisonment for offences related to personal use, with some countries removing this possibility entirely. Some countries have gone further so that personal possession offences can only be punished by non-criminal sanctions (“decriminalisation”), usually a fine; while others have mechanisms by which a case somehow considered “minor” will simply be closed (“depenalisation”). There may also be mechanisms for diverting offenders to alternatives to punishment, such as counselling or treatment, though these vary widely in eligibility and coverage (Hughes, Alternatives to punishment for drug using offenders, 2015).
In summary, within the EU, there is a long-established, multi-layered system of controls of psychoactive substances for medical and non-medical purposes. The controls may apply to individually-named substances, tightly-defined chemical groups of substances, or broadly defined groups such as those meeting the criteria for prescription-only medicines. The groups are only minimum requirements; countries are permitted to put other substances under control as they may consider necessary, for example to respond to local situations. With respect to penalties for breach of these requirements, some may be linked to the size of the potential harms caused, in others this relation is not set out in the law but may be left to judges to assess when the case is prosecuted. The combination of the two systems of drug and medicinal controls, and the fact that some countries may classify additional narcotic and psychotropic substances without distinguishing between penalties according to risk to health, sometimes results in remarkable differences. For example, at the time of writing, a citizen buying an over-the-counter cough syrup in Portugal, and carrying it on a weekend break to Estonia, could there be charged with importation of a controlled substance legally “equal” to heroin.
However, responding to the unprecedented increase in NPS found in Europe since around 2005, and the concomitant threat to public health, the legal landscape has dramatically changed.
3 The Pace of Change
Until about 10 years ago, psychoactive substances not listed for control within the conventions tended to emerge on the illicit drug market. They were limited to a handful of substances each year, which were typically passed off as controlled drugs such as MDMA (methylenedioxymethamphetamine), amphetamine or heroin.
However, over the last decade, entrepreneurs have started selling substances not listed for control on the open market, reasoning that whatever is not expressly prohibited must be allowed for open sale. This manifested in the emergence of the ‘legal highs’ and ‘research chemicals’ markets, which took off in the mid-2000s with substances such as BZP (1-benzylpiperazine) and mephedrone, and products such as ‘Spice’, containing synthetic cannabinoids. The combination of globalisation and innovation in communications technologies means that substances have been developed, produced, and marketed internationally at great speed, and sold openly in specialised ‘head shops’ in towns and cities as well as via the Internet. Some of these substances are so new to the field that, at least initially, there is very limited evidence of public health risks – the risks being the primary justification for punitive control measures. Entrepreneurs have used the lists in the drug laws simply as exclusions from their potentially vast product range; yet very broad definitions that might control many substances can be so vague that a prosecutor may have difficulty proving that distribution of the substance in the case was a crime. Adding substances to the list obliges law enforcement to test for those substances but, particularly under conditions of international economic recession in recent years, technical and financial resources for the new tests are not always increased accordingly. Altogether, this rapid growth in the number and types of new psychoactive substances discovered and distributed in Europe, accompanied by the limited evidence of public health risks, has challenged the capacity, and sometimes the credibility, of national identification, risk assessment, and control systems. And suppliers respond swiftly: by the time one substance is controlled, a replacement is already on the shelves (Hughes and Evans-Brown 2015).
The latest update from the EU Early Warning System provides some insight into the size and scale of the European market (Evans-Brown et al. 2015). During 2014, 101 new psychoactive substances were reported to the EU Early Warning System for the first time. This brings the total number of substances being monitored by the EMCDDA to more than 450 – close to double the number of substances controlled under the United Nations international drug control conventions – with more than half of these being reported in the last 3 years alone. Between 2008 and 2013, there was a sevenfold increase in the number of seizures reported by law enforcement across Europe, while in 2013 almost 47 000 seizures weighing more than 3.1 tonnes were reported to the EU Early Warning System. The market for these substances has thus accelerated to a speed which the public authorities’ established response has struggled to match.
This has led to deliberations within the EU on the regulation of the market and the difficulties of assessing, in an appropriate time-frame, the risk profile of NPS. The European Commission, therefore, announced its intention to revise the 2005 Council Decision in October 2011, and presented a proposal for a new regulation in this area in September 2013 (European Commission 2013). The proposal is based partly on the idea that a significant legitimate market in NPS for commercial and industrial purposes requires protection, and so it is legally based on a treaty article to improve the functioning of the internal market. It includes a three-level assessment process. Substances judged as ‘low risk’ would not be acted upon at the EU level, while consumer market prohibition would be introduced for ‘moderate-risk’ and drug control measures for ‘high-risk’ substances. But consensus among member states has been elusive, and 2 years later the proposal has made slow progress.
In parallel, member states’ governments have responded to the challenges posed by the market in new psychoactive substance in different ways. Among these measures designed to reduce the availability and use of new psychoactive substances, three broad, sometimes overlapping, groups of legal responses can be identified (EMCDDA 2015).
In the first group, a number of European countries have successfully used consumer safety or medicines laws, which, as they are based on harmonised EU definitions, were operational (and available for use) in all member states.
Directive 2001/95/EC on General Product Safety defines a “safe product” as one likely “to be used by consumers” which, under “reasonably foreseeable conditions of use”, presents minimum risks, consistent with a high level of health protection (Art. 2a). In practice, different types of consumer safety laws have been enforced in different member states, some targeting psychoactive products in general, others directed towards individual substances. In Poland, use of the health protection law in October 2010 resulted in mass ‘headshop’ closures, while in Italy, regulations requiring that goods or food on sale be clearly and accurately labelled in relation to their expected use have been invoked to confiscate products containing synthetic cannabinoids that were not labelled in the national language. A similar approach was used in the United Kingdom to stop the sale of mephedrone labelled as bath salts and plant food (Hughes and Winstock 2012).
Directive 2001/83/EC on medicinal products has already been mentioned. The harmonised definition comprised two elements, that of treating or preventing disease, and that of modifying physiological functions by exerting a pharmacological action. As only one of these elements appeared to be required for a product to be considered as medicinal (“a)…or b)…”), at least eight member states relied on the second part to allow a national medicines agency to classify a new psychoactive substance as a medicinal product. In this way, it can then demand a licence for any importation, marketing or distribution, and penalise unlicensed action. However, two sellers of NPS were convicted in Germany under such a law, and appealed on a point of law. In July 2014, the European Court of Justice ruled that this was not a correct interpretation of the harmonised EU definition. In its judgement of Joined Cases C 358/13 and C 181/14, it ruled “Article 1(2)(b)… must be interpreted as not covering substances… which produce effects that merely modify physiological functions, but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health.” Since this judgement, this method is no longer available as a systematic form of NPS control in the EU (European Court of Justice 2014).
In the second group of responses to the NPS market, drug laws have been modified. There is often a dearth of reliable information on new drugs, and scientific risk assessment panels were created in Hungary (2010) and Finland (2011) to provide the evidence base for decisions to control new substances. In order to accelerate legal processes, some countries introduced temporary control regimes, allowing time for investigation of the need for permanent control. Unlike those described earlier in Germany and the Netherlands, these new regimes applied to supply-related offences only. In 2011, the United Kingdom enacted a procedure allowing temporary class drug orders, under which named substances could be quickly controlled under drug laws for up to 1 year (though personal possession offences would be exempt). A similar system was enacted in Hungary in 2012, revising the risk assessment and allowing the addition of non-therapeutic drugs to the list of controlled substances on the basis that they can pose as serious a threat to public health as substances already listed in the drug schedules. Temporary control procedures were enacted in Latvia and Slovakia in 2013, implemented respectively by the Centre for Disease Prevention and Control and the Minister of Health. In the Czech Republic, controlled drugs had been listed in a parliamentary law; their transfer to a new government decree in 2014 should reduce the time required to add new substances in future. At the end of 2014, Finland extended its Narcotics Act to cover also “psychoactive substances banned from the consumer market”, listed in a new Government Decree following the above risk assessment, with unauthorised supply punishable by up to a year in prison as an offence endangering health and safety.
Some countries have chosen to extend the coverage of existing drug laws by listing groups of substances, rather than individual drugs as had been done previously. Tight ‘generic’ group definitions have been used for years in Ireland and the United Kingdom (UK), while broader ‘analogue’ groups, or derivatives, are controlled in Bulgaria, Latvia and Malta (see definitions above). However, since 2009, group definitions have been introduced into the drug laws of other countries, including Luxembourg, Italy, Cyprus, Lithuania, Denmark, France, Norway, Croatia and Turkey. Latvia has supplemented its ‘derivatives’ with generic definitions, and from 2015 the definition of ‘drugs’ in Finland includes ‘positional isomers for such a substance’. In contrast, following an inquiry in 2012, the Netherlands rejected the idea of a generic classification system because of the complexity of targeting some substances while not restricting others that may have valid uses, while other countries have expressed concern that such law might breach their constitutional principles of certainty of criminal law. Sometimes countries will apply drug law controls to illicit and harmful non-psychoactive substances also, such as in Croatia and the UK where they apply to substances known for use in sport doping, such as anabolic steroids.
In the third group, innovative new laws have been developed to address these substances. In this group, we will consider the laws passed in Austria, Finland, Hungary, Ireland, Latvia, Poland, Portugal, Romania, Slovakia, Sweden and the United Kingdom. As with national systems implementing the control regime of the UN Conventions, within the group there are variations. The legislative procedures for classifying new substances as controlled under these new laws may see decisions requiring approval by Parliament in the UK, and by government in Finland; by individual ministries in Austria, Hungary, Portugal and Slovakia; and by government agencies in the health sector in Latvia and Sweden. In three countries (Ireland, Poland and Romania), no list is established, but any substance meeting defined criteria will be considered to qualify – these will be further described below. There are also variations in the levels of punishment established for offences; in the UK, the maximum penalty is 14 years in prison, while in Portugal and Slovakia the maximum is an administrative fine. In Sweden, there is not even a penalty, the substance is simply confiscated and destroyed. Initially, all of these systems included penalties only for supply-related offences, though Hungary and Latvia have since established some penalties for possession of NPS for personal use (Hughes and Evans-Brown 2015).
Perhaps, what is most interesting is the criteria by which a substance is considered as requiring control. Three elements can be identified in the legislations. Again, following the international system, there should be some possible harm or threat to health, either expressed as an absolute or, in Hungary and Portugal, comparable to those caused by substances under international control; Ireland, Portugal and Romania also mention the possibility of causing dependence. There may also be criteria referring to abuse or intoxication, such as in Austria (“likely to be used by certain sections of society”), Finland (“used for intoxicating purposes”), Poland (“used instead of or for the same purposes as a controlled drug”), Slovakia (“persistent or sporadic and deliberate abuse”) and the UK (“misused or likely to be misused”). However, in Austria, Hungary, Ireland, Portugal and Romania, a third element is set out clearly for the first time in the legislation itself, and that is that a substance should be psychoactive. The definitions of “psychoactivity” follow the same basic template, already elaborated in the EU Early Warning System operating guidelines for risk assessment, namely stimulating or depressing the central nervous system resulting in changes in perception, behaviour or mood. Among the five countries, they vary in degrees, whereby the definitions in Ireland and Portugal require “significant” changes, and those in Romania should be likely to provoke effects “similar to those caused by substances controlled under drug laws”. In Austria and Hungary, the threshold for psychoactive effects is unqualified, but, instead, a minimum is set in a parallel requirement for a certain threat to public health.
Three European countries (Ireland, Poland, Romania) have chosen to reverse the established control model, by defining a psychoactive substance by its effect rather than its chemical structure; the supply of any unregulated psychoactive substance that meets certain criteria is banned unless specifically permitted. In Ireland and Romania this was implemented by a clear definition of psychoactive effects, as discussed above, while in Poland the definition relied on analogy of motive, with the law specifying that a substance would be used for the same purposes as a drug. While this departure from the established model of drug control appears to challenge the principle of certainty of criminal law, so far these approaches have not been legally challenged successfully. Nevertheless, in 2012, the autonomous region of Madeira attempted to introduce an offence to distribute ‘psychoactive substances not regulated by other laws’, which was struck down for vagueness. Ostensibly, the Polish and Romanian systems also have ‘pre-market approval regimes’. In Poland, a substance may be risk assessed by the State Sanitary Inspectorate for up to 18 months, at the cost of the distributor if it is judged to be harmful (and the State if not). Romanian law establishes a detailed pre-authorization risk assessment procedure that would take about 6 months to determine whether a substance may be sold. These do not appear to be fully formed “regulatory” regimes that might allow a “low-risk” psychoactive substance to be sold to adults only, comparable to alcohol regulation; neither establishes any limitation on sale or advertising of any substance that may be judged as not harmful, implying that the threshold would be set at a level where the degree of harm would be no more than that of, for example, coffee.
4 Permitting Non-medical Use of Psychoactive Substances in Europe and Beyond
In recent years, there is increasing debate over legalisation of drugs for non-medical purposes, and of cannabis in particular, with proponents claiming that the unintended consequences of the obligations set out in the UN Conventions and their national implementations are ultimately more harmful and more costly than those of a regulated market. Such proposals raise concerns over increases in use and harms and questions about the ways in which the distribution of cannabis for non-medical purposes could be carefully regulated to mitigate these. In the EU, a system of limited distribution has evolved in the Netherlands since the 1970s, manifested by some 600 retail outlets (known as “coffeeshops”) around the country. From 2012, different models of non-medical cannabis regulation in US states and Uruguay are also being closely observed to understand the advantages and disadvantages of a particular regulated system. In addition to these systems, the model of ‘cannabis social clubs’ has been increasingly mentioned in drug policy debates. Its advocates argue that policies of non-prosecution of individuals in some countries can be equally applied to registered groups of individuals, to effectively permit a closed production and distribution system. At present, the model is rejected by national authorities in Europe.
Comparable to recent changes in cannabis control, in New Zealand a new category of Class D “Restricted substance” was created in the drug law in 2005, restricting sales to over 18 s only: the substance BZP was classed as such for 2 years until it was moved to class C, where upon Class D was empty. Yet this led the New Zealand government to develop a new regime to regulate the manufacture and sale of ‘low-risk’ psychoactive substances, and the Psychoactive Substances Act was passed in July 2013. Based on the 2011 final report of the New Zealand Law Commission, and following consultations with the industry, the new approach aims to balance the demand for access to such substances with the risk of likely harm to individuals and society. The regime requires manufacturers to pay for preclinical and clinical trials of the finished products they wish to sell, to prove that they are low risk before they are approved. The sale of approved products should be to people aged over 18, and there should be no sales from convenience stores or establishments selling alcohol or vehicle fuel. Advertising is limited to within the point of sale, and other promotion is prohibited. Packaging should clearly list ingredients and health warnings. The supply of any psychoactive substance that has not been approved may be punished by up to 2 years in prison, and personal possession of such a substance will be punishable with a civil fine; no criminal conviction is registered. In this scenario, a ‘psychoactive substance’ could be defined as anything whose primary purpose is to induce a psychoactive effect, i.e. on the individual’s mind, and is not already covered by other legislation (e.g. alcohol, tobacco, herbal medicines). From July 2013, there had been an interim regime permitting sale of a limited number of products while implementing regulations were developed, but in May 2014 an amendment ended this, following adverse health reports from products and social disruption around stores. It placed a moratorium on applications until new regulations were in place, and introduced a ban on considering data from animal tests in the applications. At time of writing, the new regulations were being finalised, but the ban on animal testing data remains a major obstacle to proving that a product poses a low risk to humans.
More than 100 years ago, an international control system was developed to regulate the international trade in substances that were only found in a few countries but used by people in many. These substances had recognised medicinal values usually as painkillers but not only; to a population primarily used to alcohol as an intoxicant, they affected the mind in various new ways, having narcotic, stimulant, hallucinogenic effects, with serious public health consequences if use was uncontrolled (including death from overdose). However, it was also acknowledged, as the scientific world developed, that there may be other therapeutic uses discovered. To protect public health, the control system thus regulated supply – and eventually attempted to influence demand – to permit trade in the substances for medical and scientific use only, while otherwise stopping their “abuse and ill-effects”. They became known, not always accurately, as narcotic drugs, even in the international legislation, but there was no definition of a psychoactive effect for a substance to be considered as such, the legislation was clearly basing itself on the potential for harm via non-medical use. While the 1961 Convention referred to “narcotic drugs”, supplemented by the 1971 Convention on “psychotropic substances”, the word “psychoactive” to describe the properties of a substance controlled by a law was used in the EU’s Council Decision of 2005, and subsequently defined in the operating guidelines for risk assessments under the decision in 2009.
Within the EU, there is a long-established, multi-layered system of controls of psychoactive substances for medical and non-medical purposes. Substances are defined individually or in tight groups, and in most cases a scientific risk assessment system is established to consider the risks posed by new substances appearing on the market, compared to any medical benefits they may have, and thus to bring a new substance under the appropriate control regime. Yet over the last 10 years, entrepreneurs have challenged these systems by introducing a wide range of substances at a speed that the systems struggle to match, and openly marketing them for their psychoactive effects. A system, designed many years ago primarily for regulation of medicines, is now being used increasingly for control of non-medicines. As some of the substances are so new to the field, there is, initially, very limited evidence of public health risks – the risks being the primary justification for control measures under the established systems. In response, countries have made a wide range of changes, but some have devised new systems, which reduce or omit the requirement for public health risks that may be difficult to prove, and which emphasise the psychoactive effects of a substance in order to justify its control. In this way, legally, there seems to have been a move from emphasising the harms caused as a result of substance properties, to emphasising the properties themselves with the implicit assumption they will cause harm.
Although there is no agreement across Europe as a whole on any one particular way in which to respond to the new drugs threat, two longer-term trends are nevertheless identifiable. First, there appears to be a general move towards the use of the threat of prison to deter suppliers; and, second, it seems that countries are choosing not to use criminal sanctions for those possessing a new substance for personal use.
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