Controlling new drugs under marketing regulations

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FOR DEBATE

doi:10.1111/j.1360-0443.2011.03620.x

Controlling new drugs under marketing regulations

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Brendan Hughes1 & Adam R. Winstock2 European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), Cais do Sodré, Lisbon, Portugal,1 South London and Maudsley NHS Trust, Addictions CAG, London, UK and National Drug and Alcohol Research Centre, UNSW, Randwick, Sydney, NSW, Australia2

ABSTRACT Aims The rapid emergence of myriad substances openly marketed as ‘legal highs’ is straining traditional drug control systems which require time and basic scientific data on harms to react, presenting governments with the dilemma of no response or a disproportionate response. Some countries have side-stepped this using novel policy and legislative approaches. Should other countries consider them? Methods We review the different laws invoked to stop the open sale of new psychoactive substances, focusing on the European Union (EU). Results Some countries have designed new catch-all control systems, or faster systems to classify substances as drugs. Others have enforced consumer safety or medicines legislation to stop the open sale of these products. The latter originate from harmonization of the internal market of the EU. Rigorous, objective evaluation is required, but first results suggest that these have been effective, while avoiding criminalization of users. Conclusions Every EU country should have existing laws for protecting public health that can be applied swiftly yet proportionately to new drugs appearing on the open market with minimum political involvement. It seems the key is the speed, not the weight, of response. Given support for their enforcement mechanisms, these systems might be as effective and more efficient than the old ones. Keywords

Drug control, legal highs, policy.

Correspondence to: Brendan Hughes, European Monitoring Centre for Drugs and Drug Addiction, Cais do Sodré, 1249–289 Lisbon, Portugal. E-mail: [email protected] Submitted 27 February 2011; initial review completed 3 May 2011; final version accepted 15 August 2011

INTRODUCTION In order to protect public health, long-standing international legislation has obliged individual nations to criminalize unauthorized supply of most known psychoactive substances from heroin to (codeine-based) cough medicine. The default national response to new drugs follows this, assessing health risks and controlling unauthorized supply under the criminal law—a process that can take several months, even a year or more, to achieve. However, myriad new psychoactive substances are now appearing, promoted aggressively as ‘legal highs’ and distributed through global internet-based traders, at a rate that is straining traditional control systems [1]. As they often have no history of human consumption, criminal control on public health grounds of a substance which has little or no public health data associated with it stretches the credibility of the system [2,3]. Nevertheless, a recent report [4], supplemented by an international review of legal options [5], observed how this use of the precautionary principle protects the public from substances which may subsequently prove to be dangerous; limited © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction

regulation in New Zealand encouraged overuse of a lowquality product by young people leading to proposals for a tightening of the system [6,7]. In this ‘For Debate’ paper we argue that a range of other potential legislative controls, many already in existence and some already employed by European member states to control new psychoactive substances, might also have a legitimate and effective role to play in the field of drugs control.

BACKGROUND The United Nations Drugs Conventions are clear that unauthorized trade in psychoactive substances, whether illicit or medicinal, should be a criminal offence; respecting the legal principle that criminal laws must be certain, the drugs are listed individually. 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. Individual countries are Addiction

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permitted to control other substances in the same way as they see fit, but the quantity identified at national level is snowballing. National drug laws in Europe control more than 600 named substances or plants between them, excluding those covered by generic or analogue definitions. In 2010 alone, 41 new compounds were reported to the Early Warning System managed by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), a rise from 13 in 2008, and 24 in 2009 [8]. Gauging appropriate public health protection requires a risk assessment of the new substance. Substances considered for control 10 years ago, such as gammahydroxybutyrate (GHB), ketamine or hallucinogenic mushrooms, often had a history of human consumption, and policy decisions have been able to consider a body of scientific evidence in their deliberations [9,10]. However, determining the most informed and effective policy response to today’s untested synthetic psychoactive compounds is challenging, given the paucity of goodquality basic scientific and human experience data. Simultaneously, scientific advisory bodies such as the Advisory Council on the Misuse of Drugs can be brought under intense public pressure to conclude their findings before they have time to gather more robust and meaningful data—and even then scientific recommendations may not be followed by legislators if the pressure from public opinion is too great. Faced with media headlines and grieving parents, the majority of countries simply continue with the default option to classify these new substances as ‘illegal drugs’ as quickly as possible, as much on precautionary grounds as on the basis of objective scientific information [11–13]. The sense of urgency can be frustrated by the procedures required to control substances as drugs; creating a serious criminal offence is not a trifling matter. A study published in 2009 by EMCDDA found wide variation across Europe in both the times taken to control drugs (from a few weeks to more than a year) and the form of control adopted [14]. There are three main factors affecting 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. Germany and the Netherlands recognize this and have 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. Temporary class drug orders have now been legislated by the British Government [15]. Several others have some form of rapid system, putting a substance under permanent control by shortening certain prescribed consultation periods © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction

during the law-making process. Systems for ex-ante control exist but are not perfect; the precise generic definitions used in the United Kingdom and Ireland did not stop the marketing of many diverse ‘legal highs’ in those countries in 2010, while the practical disadvantages of the broader Federal Analog Act in the United States have been well documented [16]. As a result, even wider catch-all definitions are evolving. In 2010, a new law in Ireland criminalized supply of any dangerous or harmful psychoactive substance [17], while in Poland the amended drug law established heavy fines for distributing ‘substitute’ drugs—and prison for advertising them [18]. To address these problems, we highlight some alternative solutions that lie almost fully formed under the nose of the authorities. They are solutions that apply more or less across Europe today, they require minimal extra legislation and they do not criminalize users, but have already stopped the open trade of harmful substances. We will show that they have been faster to react than national drugs legislation but appear to have the same impact, and they maintain drug laws for control of substances found subsequently to be particularly harmful. CONTROLLING MARKETING One of the founding principles of the European Union (EU) was to establish a common market. From this, the controls for the marketing of goods for human consumption are more or less harmonized across 27 European countries. Various standardized laws already exist to control sale of ‘unsafe’ legal goods; consumer protection, food safety, medicines. If a new psychoactive substance is marketed and labelled as a commodity like any other, then it must meet the same standards as any other, whether a chocolate bar, a children’s toy or a cough syrup. Manufacturers and distributors are bound by these laws; whatever the product, they should show it is safe and fit for purpose. Under these laws and other national restrictions on harmful substances, a wide range of control measures is already available to legislatures in the EU, which may be categorized as [19]: • unrestricted sale; • restricted sale without medical supervision; • restricted sale with medical supervision; and • restricted sale with serious criminal penalties for breach (drug control legislation or equivalent). The categories are approximate and may overlap. We look here at the first three, and describe how they have been used already to curb the open sale of new drugs. Unrestricted sale Perhaps the lowest level of control is that of basic consumer protection; a marketed product not covered Addiction

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by other laws (foodstuffs, chemicals, medicines . . . ) is expected to conform to EU and national requirements on general product safety [20]. Under reasonably foreseeable conditions of use, it should not ‘present any risk or only the minimum risks compatible with the product’s use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons’, taking into account aspects such as its characteristics, the labelling, any warnings and instructions for its use. If it does not, it may be withdrawn immediately from the market and destroyed. In Poland in October 2010, the State Sanitary Inspectorate closed 1200 head shops using existing health protection laws [18]. Authorities in Italy and the United Kingdom confiscated Spice and mephedrone products, respectively, due to labelling contraventions [21]; the former were not labelled in the national language, the latter were risibly labelled as ‘bath salts’ or ‘plant food’. Any such labelling should not fool a court—no judge would reasonably foresee that a 1-g sachet of powder purchased from a head shop for €20 will be sprinkled into a bath or a plant pot, no matter how prominent the warning ‘not for human consumption’. Under the Directive, distributors are also bound to inform the competent authorities of serious risks and actions for their prevention. We await the owners of head shops and online marketers of ‘legal highs’ notifying Trading Standards offices of the hallucinations, extreme agitation, panic and palpitations their products may cause if ingested, and the actions they are taking to prevent this. Penalties for breach of these laws across Europe vary by country, but range from heavy administrative fines to some years in prison. At a similar level of control but with a more specific focus, another EU law regulates safety of food (‘any substance or product . . . intended to be, or reasonably expected to be ingested by humans’) [22]. It aims to protect human life and health, and to allow consumers to make informed choices in relation to the foods they consume, by preventing adulteration of food and fraudulent or misleading practices. It defines a ‘hazard’ as a biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect; a hazard may lead to a risk assessment. Under this law, food shall not be placed on the market if it is unsafe, as determined by various aspects including the information provided to the consumer, whether on the label or more generally available, concerning the avoidance of specific adverse health effects. While the burden of proof is generally on European consumers, it may in certain cases be shifted to the producer [23]. This may avoid situations such as that in the United States, where the burden is on regulators, and so unsafe dietary supplements have been on the market for months or years before action [24]. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction

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Conformity with these laws would imply at minimum that a marketed drug should clearly declare potential psychoactive/health effects on its packaging, and that distributors should notify the competent authorities about these effects. Ideally, information on dosing, precautions, contraindications and harm reduction advice would also be provided. Restricted marketing and sale without medical supervision Under this level of control, substances are usually sold subject to age limits of the purchaser (and sometimes the user), and the sales outlets might require specific licensing. It is the means of controlling two major public health threats, drinkable alcohol and tobacco; at least the United Kingdom and Romania also apply this level of control to certain volatile substances [25]. In terms of new drugs, it was applied in New Zealand to regulate the sale of benzylpiperazine (BZP) in 2005, when a new category of Class D, ‘Restricted Substance’ was created in the drug law, restricting sales to over-18 only. BZP was moved to the Class C category in 2007, but the Class D remains, if currently empty [26]. This level of control also describes cannabis sales via coffeeshops in the Netherlands, which should conform to the AHOJ-G criteria [(A) no advertising, (H) no hard drugs, (O) no disturbance, (J) no sales to youth under 18 years and (G) amounts less than 5 g per transaction] [27] and are dependent on a municipal licence. Breach of these laws could result in a prison sentence, regulatory fines and/or revocation of the licence to sell; when an outlet is dedicated to selling the product, loss of licence means closure. Restricted marketing and sale with medical supervision This third level would normally apply to products sold at pharmacies. Here we highlight part (b) of the common EU definition of a medicinal product, established in Article 1 of Directive 2001/83/EC: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) 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. It is for each country to declare a substance as a medicinal product, i.e. subject to the medicines laws; once this is declared, a marketing authorization is required before it can be sold. The terms of the marketing authorization may be varied as required; cold remedies containing the Addiction

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stimulants ephedrine and pseudoephedrine are now sold in more limited quantities in the United Kingdom, Australia and the Czech Republic [28] in order to prevent their use in the illegal manufacture of amphetamines. One control technique is to declare that a new psychoactive substance is ‘a medicinal product’ and thus requires a marketing authorization, but not to issue one. BZP was first controlled under medicines legislation in Spain, as was mephedrone in Finland; both substances are classified under the Dutch medicines law, which punishes unauthorized supply by up to 6 years in prison. The mixtures known as ‘Spice’ (containing a range of potent synthetic cannabinoid agonist substances with no history of medical use) were rapidly controlled under medicines legislation in the United Kingdom and Germany, before the state completed the procedure to bring them under drugs control legislation. In Austria, banning import and supply under medicines legislation was chosen specifically in order to avoid criminalizing users; the open offer for sale of Spice products stopped soon afterwards, implying that the sanction of a regulatory fine, without the threat of prison, was sufficient deterrent, and there has been no further move to classify its components as drugs. There are differences in willingness between countries to use this as a control technique, although there are also differences between countries in classifying a substance as a prescription medicine or as controlled under the drug laws. While there is no European overview of procedures and penalties, personal communication with various national experts suggested that control under medicines legislation could be fairly swift—taking between hours and a few weeks, depending on the country—and would usually result in a regulatory fine for breach.

DISCUSSION This paper set out to explore rapid, effective and proportionate ways of controlling the distribution of new psychoactive substances in Europe. It agrees with an international review of recent experiences [29] and the Law Commission of New Zealand [30]. It also summarizes evidence of these systems in practice, where they appear to have achieved the objective of curtailing open sale. This preliminary evidence suggests that, in this time of aggressive marketing and rapid turnover of new substances, the key issue is the speed and practical impact, not the weight, of the authorities’ response. Importers who know their supply of any new substance will be cut within days are less likely to look for a replacement. Although drug control was founded on public health principles it has, for much of the last 50 years, been addressed as primarily a criminal justice issue. The United Nations Office on Drugs and Crime (UNODC) © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction

acknowledges that an approach centred on criminalization of users has not been the most efficient solution to protect individual or public health, and calls on governments to broaden their response beyond simple punitive ways of disabling the market [31]. Nevertheless, under public pressure some governments seek accelerated ways of classifying substances as harmful ‘drugs’, increasingly on the basis of minimal evidence, as they face the dilemma of no response or a disproportionate response. These may be paired with guidelines for police or prosecutors to focus on suppliers, not users, but excessive use of this technique risks damaging the credibility of a criminal law which users know will not be enforced. Shifting this focus formally, by decriminalizing personal possession of all drugs, is unlikely in Europe at present. However, other countries have side-stepped the dilemma by trying alternative control systems, enforcing different but existing laws rather than designing new ones. We argue that these systems described above, which facilitate rapid responses driven by expert opinion rather than political oversight, may operate in the best interests of society and legislators for emergent substances with little or no evidence of harm. Supply of potentially harmful substances would be controlled automatically or rapidly, as is the aim of governments in Europe and beyond, under the same ‘precautionary principle’ that European citizens accept for all consumer safety, with clear proportionality between measures taken and the level of protection chosen [32]. Rapid control would avoid unregulated products going on sale for long periods with subsequent associated harms, as with BZP in New Zealand [33] and food supplements in the United States [34]. The above systems control the market without penalizing possession for consumption—as reflected in the new Irish, Polish and UK laws. Those intending to profit from sale would pay for a risk assessment, not the taxpayer, as in other European regulatory systems; indeed, this has now been enacted in Poland. EU guidelines for the precautionary principle also include the review of measures taken following scientific developments. Following rapid control, should an unhurried risk assessment then determine that a compound has a low acute toxicity (aside from short-term behavioural risks associated with any form of intoxication), various approaches other than the drug control laws, such as those above, could also be considered. They could minimize any unintended harms arising from criminalization of the user and ensure efficient use of law enforcement resources. There are limitations with these systems. Countries choose to apply or interpret the ‘common’ laws in different ways, and the motives for this are rarely clear; true harmonization thus remains unlikely. Laws must be implemented to be effective, and it is highly unlikely that Addiction

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at the current time every country has the capacity to enforce control on new drugs using these suggested alternatives. Those responsible for enforcing consumer protection laws and medicines laws are now overstretched, and may be a target for funding cuts. Within the United Kingdom, police forces are also facing severe cuts and, for some, enforcement against non-problematic users of established drugs is not a priority [35]; in such an environment, a request to enforce laws against possession of novel drugs, with as yet limited impact on public health or crime, is unlikely to be heavily resourced or implemented on the ground. It seems to be more efficient to enforce medicines or consumer laws against suppliers and distributors than to prosecute many individual users under criminal drug laws. Import bans, in Austria on Spice and the United Kingdom on mephedrone, may not be perfect—the substances involved are shipped in high purity and low volumes, and may be delivered via the postal services or through customs who have little ability to test diverse white powders—but they could go far to reduce the work-load of local enforcement teams. Overall, the suitability of a control system—old or new— could be evaluated by its efficiency in invocation, proportionality in its response to users and suppliers, its effectiveness at removing the substance from supply until harms are properly assessed [36] and its flexibility in reacting to subsequent new evidence. Current drug laws have not always been as efficient as authorities might wish in restricting access to and diminishing public harm from new psychoactive substances. Novel psychoactive substances, overwhelming current systems, have provided the opportunity to try novel policy and legislative approaches. Objective, rigorous scientific evaluation is required to assess their utility, but first available results suggest that these might be just as effective at protecting public health as the old familiar ways, yet are potentially much more efficient in doing so. Is this not what policymakers, and the public, want? Declarations of interest

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No conflict of interest to declare. 14.

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