Copyright is owned by the Author of the thesis. Permission is given for a copy to be downloaded by an individual for the purpose of research and private study only. The thesis may not be reproduced elsewhere without the permission of the Author. A critical analysis of New Zealand’s Psychoactive Substances Act 2013 and its implementation process A thesis presented in partial fulfilment of the requirements for the degree of Doctor of Philosophy In Public Health at Massey University, Albany, New Zealand. Marta Rychert 2017 ii iii Abstract Introduction: In July 2013, the New Zealand Parliament passed the Psychoactive Substances Act (PSA), the world’s first law to regulate the availability of new psychoactive substances (NPS, “legal highs”, LH). Under the “interim PSA regime” 47 products were permitted to be sold subject to new retail and other regulations. In May 2014, the Government abruptly ended the interim regime following public protests. This thesis aims to critically evaluate the PSA and its implementation. Methods: A mixed methods approach combined qualitative and quantitative methods of data collection and analysis. Legal analysis of the PSA and related legislation, and content analysis of parliamentary debates and public submissions were completed. Semi-structured interviews were then conducted with key informants (KI) including politicians, government officials, health professionals, and LH industry actors (n=30). Questions about health perceptions and social acceptability of approved products were added to an annual survey of police arrestees (n=834). Analyses of primary data included thematic analysis of interview transcripts and statistical analysis of data from the arrestee survey. Results: The legal definition of “psychoactive substance” (s. 8, 9(1) PSA) overlaps with other regulatory regimes (e.g. medicines, dietary supplements) resulting in an unclear legal status for some products. Interviewed KIs identified a number of issues with the “interim regime”, including the safety of interim products, speed and efficiency of withdrawing problem products, the lack of regulations on price and retail opening hours, slowness of developing regulations for the full PSA regime, and the effectiveness of communicating the new policy to stakeholders and the public. As the market commercialised, the LH industry adopted business and lobbying strategies previously attributed to the alcohol and tobacco sectors, including targeting vulnerable customers. Surveyed police arrestees considered approved synthetic cannabis (SC) products higher health risk and less socially acceptable than alcohol, tobacco and many illegal drugs, reflecting problems with interim product approvals. The ban on animal testing of prospective products is likely to prevent further implementation of the PSA, unless a new political consensus is achieved. Conclusions: The issues experienced during PSA implementation highlight the significant challenges of establishing a legal market for psychoactive products. The time, resources and planning required to successfully implement the PSA may have been underestimated. iv Preface Personal statement I studied law in Warsaw (Poland) and Lisbon (Portugal), and graduated with a Master’s Degree in Law from the University of Warsaw in April 2013. I also worked as a journalist for a couple of years, including as an individual contractor with the Ministry of Justice in Poland. I completed formal education in media studies, obtaining a bachelor’s degree from the National School of Film, Television and Theatre in Łódź (Poland) in September 2011. This varied educational and professional background gives me a unique approach to studying laws, with a particular interest in “law in action”, where the focus is on how law works in the real world and how it is applied in society rather than purely how it stands in statutes. I developed my interest in laws controlling access to illegal drugs during a three-month study visit at the Centre for Legal and Economic Research, University of Porto (Portugal) in 2012. Since then my interest in the field has evolved. I am originally from Poland, a country in Central Europe particularly hard hit by the problem of new psychoactive substances (NPS), with mass poisoning reported in 2010 and 2015. A “blanket ban” on supply of NPS products implemented in Poland in 2010 has not proved to be a long- term solution to the NPS problem. This raised my interest in alternative legal approaches to the NPS problem. During the 10 months of my internship with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) in 2013, my interest in the issue of controlling NPS developed further. It was June 2013, at the 3rd International Multidisciplinary Forum on New Drugs (Lisbon, Portugal), that I first learnt about New Zealand’s regulated market approach to new psychoactive substances from a presentation by Associate Professor Chris Wilkins. In March 2014 I applied for a PhD scholarship to study how the New Zealand’s market for NPS established under the Psychoactive Substances Act (PSA) 2013 worked in practice. By the time my PhD study began in June 2014 the interim regulated market established under the PSA had been ended. This unforeseen change in the regulatory environment necessitated substantial changes in the initial PhD research proposal. However, it also raised a new set of questions about what issues and challenges with the PSA had resulted in the abrupt ending of the interim regime. My PhD aimed to investigate and analyse these issues and challenges with the intention of enhancing any future implementation of the PSA and identifying learnings for proposed regulatory regimes for other psychoactive substances. v Acknowledgements Associate Professor Chris Wilkins and Professor Karen Witten supervised this Thesis and I would like to acknowledge their advice and guidance. In particular, I would like to thank my primary supervisor Associate Professor Chris Wilkins for his comments on drafts of research articles included in this thesis and continuous support in my research, publishing and learning process. I would like to acknowledge the supportive research environment provided by the SHORE and Whāriki Research Centre and the administrative and editing help from SHORE staff Jan Sheeran and Lisa Morice. This study would not be possible without participants who agreed to share their experiences about implementation of the Psychoactive Substances Act 2013. I am grateful to all study participants, who I cannot acknowledge here by name due to confidentiality reasons. Also, I would like to thank staff from the Ministry of Health for their help with the legislation and feedback provided. Anonymous reviewers of journal articles published during this PhD also provided valuable comments on the manuscripts. I would like to thank my family for their support and encouragement. vi About dissertation “by publications” This thesis has been prepared by joining together six journal articles published or submitted for publication during the course of the PhD candidature. It is a “PhD by publication”, where each results chapter constitutes a research article with a structure typical for peer-reviewed journals. It has been written in line with Massey University Guidelines on PhD Thesis by Publication (Massey University, no date). The thesis works as an integrated whole, with Chapters 1, 2 and 3 outlining the research context and methodology and Chapter 10 synthesising and discussing findings from all published papers. The results chapters (Chapters 4–9) constitute published research papers. The table below contains information about publications comprising the results chapters of this thesis, and other research outputs published during this PhD. As the author of this PhD thesis, I hold primary authorship of all research papers, with my thesis supervisors and SHORE & Whāriki Research Centre support staff who contributed significantly to the research listed as co-authors. Appendix A contains a detailed statement of contribution to each research paper and other outputs published during this PhD. I have received permission from all copyright holders to reprint journal articles and other outputs in this thesis. PhD content Article title and journal, or full reference (if published) Publication status Chapter 4 Rychert, M., & Wilkins, C. (2016). What products are considered psychoactive under New Zealand's legal market for new psychoactive substances (NPS, ‘legal highs’)? Implications for law enforcement and penalties. Drug Testing and Analysis, 8(8), 768-778. Doi: 10.1002/dta.1943 published Chapter 5 Rychert, M., Wilkins, C. & Witten, K. (2017). Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances (NPS) (‘legal highs’) in New Zealand. Drug and Alcohol Review. Published online 23 Feb 2017. Doi: 10.1111/dar.12507 published Chapter 6 Rychert, M., Wilkins, C. & Witten, K. (2017). “Lost in translation”: issues with the establishment of a legal market for ‘low risk’ psychoactive products (‘legal highs’) in New Zealand. Drugs: Education, Prevention & Policy. Published online 2 Feb 2017. Doi: 10.1080/09687637.2017.1282422 published Chapter 7 Rychert, M. & Wilkins, C. (2016). Legal high industry business and lobbying strategies under a legal market for new psychoactive substances (NPS, ‘legal highs’) in New Zealand. International Journal of Drug Policy, 37, 90- 97. Doi: http://dx.doi.org/10.1016/j.drugpo.2016.08.011 published vii Chapter 8 Rychert, M., Wilkins, C., Parker, K. & Witten, K. Are government-approved “legal highs” perceived to be safer and more socially acceptable than alcohol, tobacco and illegal drugs? Findings from a survey of police arrestees in New Zealand. Drug and Alcohol Review. Forthcoming. accepted Chapter 9 Rychert, M. & Wilkins, C. (2015). The challenge of a ban on animal testing for the development of a regulated legal market for new psychoactive substances (NPS) (‘legal highs’) in New Zealand: Issues and options for resolution. International Journal of Drug Policy, 26(12), 1273-1278. Doi: http://dx.doi.org/10.1016/j.drugpo.2015.08.006 published Appendix G Rychert, M. & Wilkins, C. (2015) Did we have the wrong debate about Elixinol™ and medicinal cannabis? [Letter]. New Zealand Medical Journal, 128(1521), 69-70. published Appendix H Rychert, M. & Wilkins, C. (2016). Thirty-one psychoactive plants exempted from New Zealand's Psychoactive Substances Act 2013 [Letter]. Addiction, 112(1), 181-182. Doi: 10.1111/add.13526 published Appendix I (some sections incorporated in Chapter 2, s 2.1, 2.3) Rychert, M., & Wilkins, C. (2017), New Zealand’s pre-market approval regime for ‘low risk’ new psychoactive substances (NPS, ‘legal highs’) - a regulatory alternative to prohibition, in: A. Malczewski (Ed.) Monitoring drugs and drug addiction on local level. Warsaw, Poland: Information Centre for Drugs and Drug Addiction. (Published in English and Polish) published Appendix K Rychert, M., & Wilkins, C. (2015). Is the recent ban on animal testing of legal high products a fatal blow to the development of a legal market for ‘low-risk’ psychoactive products in New Zealand? [Letter] Addiction, 110(4), 713-714. Doi: 10.1111/add.12853 published Appendix L Wilkins, C., and Rychert, M. (2017) Recent developments with the New Zealand regulated market approach to ‘low-risk’ psychoactive products. Addiction, 112: 34–36. doi: 10.1111/add.13495. published Appendix M Wilkins, C., Rychert, M., Byrska, B., Van Hout, M., Corazza, O., & A.Roman- Urrestarazu (2017). “Exploring novel policy responses to NPS and ‘legal highs’ in New Zealand, Poland, Republic of Ireland & the United Kingdom”. Novel Psychoactive Substances. Policy, Economics and Drug Regulation. Ed. Ornella Corazza & Andres Roman-Urresterazu. Springer Nature, 2017 published viii Table of Contents Abstract .............................................................................................................................. iii Preface ................................................................................................................................ iv Personal statement .................................................................................................... iv Acknowledgements ..................................................................................................... v About dissertation “by publications” ......................................................................... vi List of figures .................................................................................................................... xiv List of tables ...................................................................................................................... xiv List of acronyms ................................................................................................................. xv Chapter 1: Research context ............................................................................................... 1 1.1 The challenge of new psychoactive substances (NPS) .............................................. 1 1.1.1 The evolution of NPS phenomenon and definitions .......................................... 2 1.1.2 NPS market characteristics ................................................................................. 4 1.1.3 Health risks associated with NPS use ................................................................. 7 1.2 New policy responses to NPS .................................................................................. 10 1.2.1 Rapid and emergency procedures .................................................................... 12 1.2.2 Generic, analogue and neurochemical definitions ........................................... 12 1.2.3 Application of existing administrative laws ...................................................... 13 1.2.4 “Blanket bans” on NPS supply .......................................................................... 14 1.2.5 Summary of issues with prohibiting NPS on national level .............................. 15 Chapter 2: New Zealand’s regulated market response to NPS ......................................... 17 2.1 The early emergence of legal highs in New Zealand ............................................... 17 2.2 Issues raised during consultation stage for the PSA ................................................ 19 2.2.1. Issues raised in public submissions to the Psychoactive Substances Bill ........ 19 2.2.1.1 Reasons behind support and opposition to regulation of the market ...... 19 2.2.1.2 Recommendations made in public submissions ....................................... 20 2.2.2 Issues raised in parliamentary debates ............................................................ 21 2.3 Regulatory mechanisms under the PSA .................................................................. 23 ix 2.4 The interim regulated market under the PSA ......................................................... 24 2.4.1 Managing products approved on the interim market ..................................... 24 2.4.2 Interim licensed retailers and community protests ......................................... 26 2.4.3 The Psychoactive Susbtances Amendment Act and ending of the interim regime ....................................................................................................................... 27 2.5 Existing evidence and evaluations of the PSA ......................................................... 28 2.6 Knowledge gaps and PhD research focus ............................................................... 29 2.7 Research aims and objectives ................................................................................. 31 2.8 Structure of the thesis ............................................................................................ 32 Chapter 3: Theoretical framework and methodology ...................................................... 35 3.1 Theoretical framework ........................................................................................... 35 3.2 A note on epistemological position ........................................................................ 35 3.3 Mixed methods approach ....................................................................................... 36 3.3.1 Document analysis ........................................................................................... 39 3.3.1.1. Content analysis of written submissions to the PSA ................................ 39 3.3.1.2 Thematic analysis of parliamentary debates ............................................ 40 3.3.1.3 Legal analysis of the PSA and other legal sources .................................... 40 3.3.2 Interviews with key informants ....................................................................... 41 3.3.3 Thematic analysis of interview transcripts ...................................................... 42 3.3.4 Statistical analysis of data from NZ-ADUM ...................................................... 42 3.3.5 Review of academic literature ......................................................................... 43 Chapter 4: What products are considered psychoactive under New Zealand’s regulated legal market for new psychoactive substances (NPS, ‘legal highs’)? Implications for law enforcement and penalties .............................................................. 45 Abstract ......................................................................................................................... 46 Introduction .................................................................................................................. 47 Ambiguities in legal classifications of products with psychoactive properties ............ 49 Kava (Piper methysticum) ......................................................................................... 49 Salvia divinorum ........................................................................................................ 51 Nitrous oxide (N2O) .................................................................................................. 53 DMBA (“Frenzy”) ....................................................................................................... 54 25I-NBOMe ............................................................................................................... 54 The role of marketing and labelling in the classification of psychoactive products ..... 55 Implications for policing and prosecuting in criminal cases ......................................... 57 x Psychoactive substances vs controlled drug analogues ................................................ 59 Conclusions and discussion ........................................................................................... 60 Chapter 5: Issues with monitoring the safety of psychoactive products under a legal regulated market for new psychoactive substances (NPS) (‘legal highs’) in New Zealand .............................................................................................................................. 65 Abstract ......................................................................................................................... 66 Introduction ................................................................................................................... 67 Background: Identifying products to receive interim approvals and developing the safety monitoring system .............................................................................................. 68 Methods ........................................................................................................................ 69 Results ........................................................................................................................... 70 PSA criteria used to select products for interim approval ........................................ 70 Applying the PSA criteria for products in practice .................................................... 70 Perceived safety of interim approved products ........................................................ 71 Quality control of interim products and its unintended consequences ................... 72 Availability of data to monitor the safety of interim approved products ................. 73 Quality of data on adverse events ............................................................................. 74 Consistency of product withdrawal decisions ........................................................... 75 Speed of withdrawing harmful products from the market ....................................... 76 Discussion and Conclusions ........................................................................................... 76 Chapter 6: “Lost in translation”: issues with the establishment of a legal market for ‘low risk’ psychoactive products (‘legal highs’) in New Zealand ....................................... 79 Abstract ......................................................................................................................... 80 Introduction ................................................................................................................... 81 Background: interim retail framework and the role of local communities in the PSA . 82 Methods ........................................................................................................................ 83 Results ........................................................................................................................... 84 Licensing retailers for the interim PSA market .......................................................... 84 Problems with interim licensed outlets ..................................................................... 85 The ‘bottleneck effect’ .............................................................................................. 86 Backlash from local communities .............................................................................. 86 Slowness in implementation of LAPPs ...................................................................... 87 Opposition from local councils .................................................................................. 88 Engagement with the media and public opinion ...................................................... 88 xi Regulatory management and workload during the interim regime ......................... 89 Conclusions and Discussion .......................................................................................... 90 Chapter 7: Legal high industry business and lobbying strategies under a legal market for new psychoactive substances (NPS, ‘legal highs’) in New Zealand ............................. 95 Abstract ......................................................................................................................... 96 Introduction .................................................................................................................. 97 Historical background: the evolution of LHI in New Zealand ....................................... 97 Methods ...................................................................................................................... 100 Results ......................................................................................................................... 102 LHI motivations ....................................................................................................... 102 Keeping a distance from “Big Tobacco” and “Big Alcohol” ..................................... 102 Political advocacy of LHI .......................................................................................... 103 The challenge of industry growth ........................................................................... 103 Benefits and pitfalls of industry professionalization .............................................. 104 Marketing towards youth and low-income customers ........................................... 104 The decline in product prices .................................................................................. 105 Price control as a means to ensure a more responsible client base....................... 105 Brand reputation for product safety ....................................................................... 106 LHI self-regulation and its effectiveness ................................................................. 106 The impact of the global legal high market ............................................................ 107 Discussion and conclusions ......................................................................................... 108 Chapter 8: Are government-approved products containing new psychoactive substances (NPS) perceived to be safer and more socially acceptable than alcohol, tobacco and illegal drugs? Findings from a survey of police arrestees in New Zealand. 113 Abstract ....................................................................................................................... 114 Introduction ................................................................................................................ 115 Methods ...................................................................................................................... 117 Measures ..................................................................................................................... 118 Analysis ....................................................................................................................... 118 Results ......................................................................................................................... 119 Demographics ......................................................................................................... 119 Perceived health risk and social acceptability of approved legal SC and approved legal PP compared to other drugs .......................................................................... 120 Associations between drug use, sociodemographic characteristics and health and social acceptability score ........................................................................................ 121 xii Summary and discussion ............................................................................................. 123 Limitations ............................................................................................................... 125 Conclusions .............................................................................................................. 125 Chapter 9: The challenge of a ban on animal testing for the development of a regulated legal market for new psychoactive substances (NPS) (‘legal highs’) in New Zealand: Issues and options for resolution ..................................................................... 127 Abstract ....................................................................................................................... 128 Introduction ................................................................................................................. 129 Political background: evolution of the animal testing provisions under the new regime .......................................................................................................................... 130 Methods ...................................................................................................................... 131 Results ......................................................................................................................... 132 Scenario 1: Animal testing ban is revoked or modified ........................................... 132 Scenario 2: Wait for scientific progress on non-animal tests .................................. 133 Scenario 3: Applicants use non-validated in vitro test methods ............................. 134 Scenario 4: Unsuccessful applicants challenge rejected applications in court ....... 134 Scenario 5: ‘Creative compliance’ – human trial data is presented without animal test data ................................................................................................................... 135 Scenario 6: Philosophical reconceptualisation of the benefits from recreational psychoactive products ............................................................................................. 136 Discussion and Conclusions ......................................................................................... 137 Chapter 10: Discussion and conclusions ..................................................................... 139 10.1 Synthesis of findings ............................................................................................ 139 10.1.1. Identified challenges with implementing the PSA during the “interim regime” .................................................................................................................... 139 10.1.2. Critique of the PSA policy process ............................................................... 141 10.1.3. Critique of the PSA legislation ..................................................................... 143 10.1.4 Social perceptions of the regulated market approach to NPS ..................... 145 10.2 Research implications .......................................................................................... 147 10.2.1 Comparison of the PSA and cannabis law reforms in Colorado, Washington and Uruguay ............................................................................................................ 147 10.2.2 Lessons for other jurisdictions wanting to establish legal markets for recreational drugs (including cannabis) .................................................................. 153 10.2.3 Recommendations for the future implementation of the PSA in New Zealand .................................................................................................................... 155 10.3 Research strengths and limitations ..................................................................... 161 xiii 10.4 Areas for future research .................................................................................... 162 Bibliography .................................................................................................................... 164 Appendices ...................................................................................................................... 188 Appendix A: Statement of contribution to Doctoral Thesis containing publications . 188 Appendix B: Categorisation of NPS compounds referred to in this thesis ................. 192 Appendix C: Interview protocol .................................................................................. 193 Appendix D: Participant information sheet ................................................................ 197 Appendix E: Participant consent form ........................................................................ 198 Appendix F: Transcript release authority form ........................................................... 199 Appendix G: Letter published in the NZMJ: Did we have the wrong debate about Elixinol™ and medicinal cannabis? ............................................................................. 200 Appendix H: Letter published in Addiction: Thirty-one psychoactive plants exempted from New Zealand's Psychoactive Substances Act 2013 ............................................ 202 Appendix I: Publication for the Polish Drug Information Centre: New Zealand’s pre- market approval regime for ‘low risk’ new psychoactive substances (NPS, ‘legal highs’) - a regulatory alternative to prohibition ..................................................................... 204 Appendix J: Univariate analysis results (preliminary analysis for Chapter 8) ............. 212 Appendix K: Letter published in Addiction: Is the recent ban on animal testing of legal high products a fatal blow to the development of a legal market for ‘low-risk’ psychoactive products in New Zealand? .................................................................... 219 Appendix L: Letter published in Addiction: Recent developments with the New Zealand regulated market approach to ‘low-risk’ psychoactive products. ................ 223 Appendix M: Co-authored book chapter: “Exploring novel policy responses to NPS and ‘legal highs’ in New Zealand, Poland, Republic of Ireland & the United Kingdom” ... 226 xiv List of figures Figure 1: Number of NPS reported to the EU and UN ................................................................... 5 Figure 2: NPS groups categorised by pharmacological effect (data up to 2015), source: UNODC EWA (2017a) .................................................................................................................................. 6 Figure 3: Framework for the review of national responses to NPS ............................................ 11 Figure 4: Framework for the review of national responses to NPS, with examples. .................. 11 Figure 5: SC-related calls received by the National Poisons Centre (October 2010 – February 2016) ............................................................................................................................................ 25 Figure 6: Logic model of the Public Health Law Research (Burris et al., 2010) ........................... 35 Figure 7: Research process flowchart .......................................................................................... 44 Figure 8: Schematic representation of relationships between definitions of psychoactive substance and other products with potential psychoactive properties ..................................... 49 Figure 9: Mean health risk and social acceptability scores for all drugs ................................... 121 Figure 10: Progress in the implementation of the PSA ............................................................. 131 Figure 11: Implementation timeline of “regulated drug market” law reforms in NZ, Colorado, Washington and Uruguay. ......................................................................................................... 148 List of tables Table 1: Support and opposition for the PSB by submitter type................................................. 20 Table 2: Themes identified in the analysis of parliamentary readings on the PSB ..................... 22 Table 3: Interim approved products withdrawn during the interim regime and products which remained on the interim market until PSAA (by active ingredient and declared concentration). Compiled from data archived on PSRA website. ......................................................................... 26 Table 4: Objectives of the PhD and rationales for research papers ............................................ 31 Table 5: Typology of Public Health Law Studies (Burris et al., 2010) and their relevance to this thesis ............................................................................................................................................ 38 Table 6: Categories of products or substances exempted from the PSA regime ........................ 50 Table 7: Psychoactive substances which can potentially sit in multiple regulatory regimes ...... 52 Table 8: Maximum penalties for offences under DSR, FA, MA, PSA and MODA ........................ 57 Table 9: Demographic characteristics of police arrestee sample .............................................. 120 Table 10: Association between drug use and demographic variables and health risk and social acceptability scores ................................................................................................................... 122 Table 11: Association between frequent SC users and other drug user groups and social acceptability scores ................................................................................................................... 123 Table 12. Evaluation of scenarios to overcome the animal test ban impasse .......................... 137 Table 13: Comparison of selected issues in design and implementation of regulatory responses to recreational drugs in NZ, Colorado, Washington and Uruguay ............................................ 149 xv List of acronyms ECJ European Court of Justice EMCDDA European Monitoring Centre for Drugs and Drug Addiction EU European Union EWA Early Warning Advisory (UNODC) EWS Early Warning System (EU) IDMS Illicit Drug Monitoring System (IDMS – NZ) KI Key informant LAPP Local Approved Product Policy (NZ) LH ‘Legal highs’ LHI ‘Legal high’ industry MODA Misuse of Drugs Act (1971 – UK; 1975 – NZ) MOH Ministry of Health NGO Non-governmental organisation NPS New psychoactive substances NZ New Zealand NZ-ADUM New Zealand Arrestee Drug Use Monitoring study NZLC New Zealand Law Commission P Participant PSA Psychoactive Substances Act (2013 – NZ, 2016 – UK) PSAA Psychoactive Substances Amendment Act (2014 - NZ) PSB Psychoactive Substances Bill (i.e. “draft” law, before vote in Parliament - NZ) PSEAC Psychoactive Substances Expert Advisory Committee (NZ) PSRA Psychoactive Substances Regulatory Authority (NZ) RSR Restricted Substances Regime (NZ) SC Synthetic cannabinoids TCDN Temporary Class Drug Notice (NZ) TCDO Temporary Class Drug Order (UK) xvi UN United Nations UNODC United Nations Office on Drugs and Crime UK United Kingdom WHO World Health Organization 1 Chapter 1: Research context 1.1 The challenge of new psychoactive substances (NPS) The international drug control system managed by the United Nations (UN) aims to limit the use of narcotic and psychotropic drugs to medical and scientific purposes, and to prevent their diversion to illicit channels. The system operates by listing drugs and drug preparations in schedules under the 1961 UN Single Convention on Narcotic Drugs and 1971 UN Convention on Psychotropic Substances (Hallam, Bewley-Taylor, & Jelsma, 2014; Krajewski, 1999). Internationally controlled drugs (120 narcotic and 130 psychotropic drugs as of December 2016 (INCB, 2016a, 2016b)) have certain risks, as identified through examination by the World Health Organization (WHO) (Bewley-Taylor, 2003). The 1988 UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances requires that criminal sanctions should apply to illegal supply of internationally scheduled drugs. The UN drug conventions are not self-executing, which means that they are not directly or immediately enforceable; hence states (parties to the Conventions) pass relevant drug laws to enforce prohibitions on supply and possession of drugs. As it is a general principle of criminal law that criminal offences be clearly defined (nullum crimen sine lege certa), controlled drugs need to be named or otherwise clearly specified in national drug control laws. This is done by listing drugs on a substance-by-substance basis in the attachments to national drug laws (i.e. scheduling on a domestic level), and sometimes by tightly defining groups of substances based on their structural similarity to chemical compounds which are already under control (so-called generic definitions) (EMCDDA, 2015c). This long-established mechanism for drug control has been challenged by the emergence and dynamic spread of new psychoactive substances (NPS). NPS, sometimes also known as “legal highs”, are recreational drugs which are not controlled under the international drug control system but which may pose a public health threat (UNODC, 2013a). In the last ten years or so, the number of NPS introduced to the market has risen dramatically and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) currently monitors over 560 different NPS compounds, of which more than 70% have been detected in the last five years (EMCDDA and Europol, 2016b). The number of new drugs overwhelms any attempts to schedule compounds on a substance-by-substance basis. Procedures for international scheduling have been described as “too time-consuming to prevent widespread abuse before bringing a substance under control” (UN, 2014). Scheduling on a domestic level also requires time and financial resources as the substances have to be assessed 2 for harmfulness and prohibition orders need to pass through legislative assemblies. By the time a given compound is prohibited, a new substance will have appeared on the market as new synthetic drugs can be quickly synthesised by introducing slight modifications to chemical structures of existing compounds. This “cat and mouse game” between NPS producers and national authorities is considered a major challenge in designing a comprehensive and effective policy response to the NPS phenomenon (Brandt, King, & Evans-Brown, 2014; Seddon, 2014). 1.1.1 The evolution of NPS phenomenon and definitions The appearance of new substances which are not covered by the international drug control system is not a new phenomenon (Brandt et al., 2014; King & Kicman, 2011), but until early 2000 it was limited to a handful of substances and mostly to traditional illegal drug markets. This section explains how the evolution in the manufacture and distribution of NPS over the last 50 years has influenced changes in the way the NPS phenomenon is defined. It concludes with the definition of NPS used for the purposes of this PhD thesis. The NPS phenomenon can be traced back to the 1960s, when ring-substituted phenethylamines such as STP (2,5-dimethoxy-4-methamphetamine) first appeared on drug markets in the UK (Phillips & Mesley, 1969). In the 1980s, following public health concerns associated with new derivatives of α-prodine and fentanyls (these heroin substitutes were highly potent and the by- product in α-prodine synthesis-induced Parkinson’s disease (King & Kicman, 2011)), the very first definition of “new drugs” was proposed (Henderson, 1988). It defined NPS as “analogues of compounds with proven pharmacological activity manufactured by underground chemists for sale on the street” (Baum, 1985). It was around this time that the question of how to control NPS was first raised (Baum, 1985). In the 1990s, following publication of Alexander and Ann Shulgin’s books PiHKAL (short for “Phenethylamines I Have Known and Loved” (Shulgin & Shulgin, 1991)) and TiHKAL (short for “Tryptamines I Have Known and Loved” (Shulgin & Shulgin, 1997)), the new drugs phenomenon gained new momentum. Despite the short lifespan of most ring-substituted phenethylamines and tryptamines (Brandt et al., 2014; King & Kicman, 2011), their rapid development in illicit drug markets raised public concern. In 1997, in response to these concerns, the European Union (EU) adopted the Joint Action concerning the information exchange, risk assessment, and control of new synthetic drugs. The document contained the first formal definition of “new synthetic drugs” (NSD), i.e. “synthetic drugs which are not scheduled in 1971 UN Convention on 3 Psychotropic Substances, and which cause a comparable serious threat to public health (…) and which have a limited therapeutic value” (Council of the European Union, 1997). Around 2000 a major change in production and distribution of “new drugs” occurred, heralding what is now referred to as “the NPS phenomenon” (Brandt et al., 2014; King & Kicman, 2011). NPS were increasingly being manufactured by legitimate chemical companies located in Asia (King & Kicman, 2011) and shipped to consumer markets where they were openly sold in head shops and online. The change in manufacturing and marketing processes was accompanied by increased diversification of the market into new drug families, including piperazine derivatives (e.g. BZP), cathinone derivatives (e.g. mephedrone), synthetic cannabinoids (e.g. “Spice” brand) and plant products (e.g. salvia divinorum). The UNODC definition of NPS accommodated these changes and it is now accepted that the term NPS covers both synthetic and natural substances which are not scheduled under the UN Conventions and which may pose a public health threat (UNODC, 2013a). It is important to note that some of these substances were synthesised decades ago or have been used by indigenous populations for centuries; hence the word “new” in the term NPS refers to “newly misused” and “newly available”, and not necessarily “newly discovered” (EMCDDA and Europol, 2007; King & Kicman, 2011; UNODC, 2013a). NPS are also referred to as “legal highs”, “research chemicals”, “plant food”, “bath salts”, “party pills”, and “herbal incense” (Brandt et al., 2014; F. Dunne, Jaffar, & Hashmi, 2015), with many of the informal terms invented by distributors to circumvent national laws by suggesting the products are not intended for human consumption and to emphasise their legality (Brandt et al., 2014; Rosenbaum, Carreiro, & Babu, 2012). The term “legal high”, traditionally used to describe herbal psychoactives, has been particularly problematic. Corazza, Demetrovics, van den Brink, and Schifano (2013) suggested that it should not be used in academic debate. However, the term is used in this thesis to distinguish the broad concept of NPS as explained above (i.e. substances not controlled internationally) from substances which are not prohibited under domestic laws, as since the emergence of the NPS phenomenon many countries have implemented legal measures to control NPS compounds or their classes at the national level (these are further discussed in section 1.2). Scheduling of NPS at the international level further adds to the complexity of the phenomenon and its definition. For example, nine substances which were not internationally controlled when this PhD study commenced (i.e. AH-7921, 25B-NBOMe, 25C-NBOMe, 25I-NBOMe, mephedrone, BZP, JWH-018, AM-2201, MDPV, methylone) were subsequently scheduled under the UN conventions (UNODC EWA, 2015). As scheduled drugs, they do not technically fall under the NPS 4 definition anymore, but in practice they are still referred to as NPS (e.g. EMCDDA and Europol (2016b)). As used in this thesis, the term NPS covers any psychoactive substance appearing on the market around or after the year 2000, even if subsequently scheduled under the UN system. 1.1.2 NPS market characteristics In the last ten years or so, the number of NPS identified globally has been on the rise, with over 700 NPS reported to the UNODC since 2008 (UNODC, 2017). The figure now well exceeds the number of illicit drugs and preparations scheduled in the UN Conventions (currently 250 compounds). Reports of new NPS received by the UNODC reporting system more than doubled over the period 2009–2013, with most new substances identified in Europe over the last decade (UNODC, 2014). The EU Early Warning System (EWS) now monitors over 620 NPS (EMCDDA, 2017), and in 2014 the rate of detection in Europe reached two new NPS per week (EMCDDA, 2015b). In 2016, the rate of detection of NPS in Europe dropped to one NPS per week (EMCDDA, 2017). However, the market continues to develop dynamically (UNODC, 2015, 2016, 2017) and the overall number of NPS continues to grow (EMCDDA, 2017) (Figure 1). It is a global phenomenon, with over 100 countries and territories in the world having reported at least one NPS (UNODC EWA, 2017b). 5 Figure 1: Number of NPS reported to the EU and UN Sources used to compile data: UNODC, World Drug Report 2015, 2016, 2017; EMCDDA, European Drug Report 2016, 2017; EMCDDA, Annual Reports on the implementation of Council Decision 2005/387/JHA 2005-2014; EMCDDA & Europol, Drugs Markets Report 2016. The term NPS covers several substance groups and the categorisation of NPS is evolving. The UNODC currently distinguishes nine NPS groups based on chemical structure: (1) synthetic cannabinoids (sold as “legal alternatives” to cannabis); (2) synthetic cathinones (sold as “legal alternatives” to illegal stimulants such as MDMA, amphetamine or cocaine); (3) phenethylamines (e.g. ‘2C series’); (4) piperazines (often include “failed pharmaceuticals”); (5) aminoindanes; (6) tryptamines; (7) ketamine and phencyclidine-type substances; (8) plant- based substances (e.g. Khat, Kratom); and (9) “other NPS” (including synthetic opioids) (UNODC EWA, 2017a). This classification is consistent with academic literature on chemical classes of NPS (Miliano et al., 2016). However, there is no internationally accepted categorisation and the EMCDDA, for example, adopts a more detailed approach, with distinct categories for groups of substances such as arylcyclohexylamines (e.g. methoxetamine) or arylalkylamines (e.g. bromo- dragonfly) (EMCDDA and Europol, 2016a). An increasing number of newly-identified NPS compounds (e.g. fentanyl derivatives and new synthetic sedatives) do not belong to any of the 14 7 15 13 24 41 49 73 81 101 98 66 117 42 41 56 202 66 100 data collection ongoing 739 0 100 200 300 400 500 600 700 800 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 nu m be r o f N PS Number of new NPS reported to the EU (2005-2016) and UN (2008-2016) EU per annum UN per annum EU total UN total "over 620" 6 chemical groups defined in previous years, illustrating the dynamic nature of the NPS market (UNODC, 2016, 2017). Appendix B contains a table of all NPS compounds mentioned in this thesis and their categorisation into chemical groups. An alternative categorisation approach to NPS is by their pharmacological effects. The two most common “effect” groups include synthetic cannabinoid receptor agonists and synthetic stimulants (Figure 2). Figure 2: NPS groups categorised by pharmacological effect (data up to 2015), source: UNODC EWA (2017a) Both global and the EU monitoring systems identify synthetic cannabinoids (SC) as the most frequently reported NPS substance group (EMCDDA, 2015b; UNODC, 2015, 2016). Sold and used as legal alternatives to internationally controlled cannabis and its active ingredient Δ9- tetrahydrocannabinol (THC) (Griffiths, Sedefov, Gallegos, & Lopez, 2010; L. A. King, 2014; Papanti, Orsolini, Francesconi, & Schifano, 2014), SC products have been defined as a case study for analysing new challenges to existing modes of drug control (Griffiths et al., 2010). Indeed, part of the NPS phenomenon, including the appearance of NPS as “legal alternatives” to illicit drugs, has been explained by interplays between traditional prohibitive drug policies and changes in purity and price on the illicit drug markets (Brandt et al., 2014; F. Dunne et al., 2015; Evans-Brown & Sedefov, 2016). The way NPS are manufactured, distributed and marketed is distinct from traditional channels for illegal drugs, with synthetic NPS often manufactured in legitimate chemical companies in Asia and shipped to consumer markets in Europe, the US, Australia and New Zealand, and then sold from so-called head shops and online (King & Kicman, 2011). The marketing and distributional capacity of the Internet has been evidenced in numerous studies (e.g. Bruno, Poesiat, & Matthews, 2013; Corazza et al., 2011; Davies et al., 2010; Kavanagh, Grigoryev, Savchuk, Mikhura, & Formanovsky, 2013; Meyers et al., 2015; Schmidt, Sharma, Schifano, & 35% 35% 18% 3% 2% 2% 5% synthetic cannabinoid receptor agonists stimulants classic hallucinogens dissociatives sedatives/hypnotics opioids not yet assigned 7 Feinmann, 2011; Schneir et al., 2014). This literature presents a distinct picture of NPS markets, where geographical barriers do not constrain trade and legal restrictions in consumer countries have a limited impact on manufacturing processes in source countries (Khey, Stogner, & Miller, 2014). When NPS are not controlled in consumer countries, they may be sold as legal products (hence called “legal highs”) (Griffiths, Evans-Brown, & Sedefov, 2013; Khey et al., 2014; Winstock & Wilkins, 2011). Products containing NPS have been marketed in diverse forms, i.e. as recreational “legal highs” commercialised in bright packages, as “research chemicals” aimed at online communities exploring psychoactive effects (i.e. psychonauts), and as “food supplements” marketed to improve brain function and physical performance (Brandt et al., 2014; EMCDDA, 2015b; Griffiths et al., 2013). In addition to these new presentations of synthetic drugs is the traditional “designer drugs” label, where NPS appear on illicit drug markets either in their own right or as ecstasy/amphetamine. Some NPS first marketed as “legal highs”, and so not controlled under international and national drug control laws (e.g. mephedrone, MDPV), have stayed on the market following imposition of legal controls and became part of the illicit drug market landscape (EMCDDA, 2015a; UNODC, 2016). In terms of prevalence, the latest European data show that 8% of young adults (defined as 15– 24 years old) have tried NPS in their lifetimes. This compares to the 13.3% lifetime prevalence for natural cannabis among young adults (defined as 15–34 years old) in Europe (EMCDDA, 2016a). However, there are limitations in the prevalence data of NPS, including the difficulty in designing survey tools for capturing NPS use, limited knowledge by users about the substances they use, and constant changes in the market which challenge comparisons over time and across countries and regions (EMCDDA and Europol, 2016b; UNODC, 2016). These are some of the reasons why there is no estimate of NPS prevalence at a global level (UNODC, 2016). 1.1.3 Health risks associated with NPS use Knowledge about health effects of NPS use is limited, but the increasing number of case reports and studies on NPS-related adverse health events (including systematic analyses) add to the understanding of their health impacts. The sheer number of different NPS compounds mean variations in psychopharmacological and toxicity profiles (for categorisation of NPS by pharmacological effect see Figure 2 above). Babor, Caulkins, et al. (2010) use a narrow “health frame” in their classification of harms associated with illicit drugs, which is adopted below to review the as yet limited evidence about harms associated with NPS. Five classes of morbidity 8 and mortality outcomes are discussed: (I) overdose; (II) other injuries, e.g. accidents and suicides; (III) non-communicable physical disease; (IV) mental disorders; and (V) infectious disease. The high potency of many synthetic NPS, which may be active at doses lower than traditional drugs, is a major health risk to users as it can increase the risk of overdose (Brandt et al., 2014). For example, fentanyl analogues which appeared on the California drug market as heroin substitutes in the early 1980s were up to 1000 times as potent as heroin, and this contributed to over 110 overdose deaths (Henderson, 1988). In a more recent development, several outbreaks of NPS-related deaths were reported. For example, the EMCDDA reports in the last two years (2014-2016) have identified numerous deaths associated with the use of alpha-PVP (over 100 deaths), acetylfentanyl (32 deaths) (EMCDDA, 2016a), MDMB-CHMICA (28 deaths) (EMCDDA, 2017) and 25I-NBOMe (3 deaths) (EMCDDA, 2014). A recent systematic review of SC- related adverse events identified “at least 26 deaths” associated with SC use (Tait, Caldicott, Mountain, Hill, & Lenton, 2016). Mass poisonings, although rare, have also been reported (EMCDDA and Europol, 2016b). For example, in mid-2015 hospitals in Poland recorded over 200 emergency presentations linked to use of SC products in less than a week (EMCDDA, 2016a). The role of NPS in overdose, however, can be difficult to determine, particularly when NPS are used in combination with other drugs (UNODC, 2016), or when analytical confirmation of NPS use is not available (e.g. EMCDDA, 2014). A British review of criminal casework where NPS were involved found that only 7% of all drug deaths involved NPS as sole factors (Elliott & Evans, 2014). Some death reports refer to suicidal deaths rather than accidental overdoses. For example, Elliott and Evans (2014) found high prevalence of cathinone drugs (41%) in hangings and other mechanical suicides in their analysis of post-mortem cases. Kriikku, Rintatalo, Pihlainen, Hurme, and Ojanperä (2015) also found high suicide rates (24%) among MDPV- positive post-mortem cases in Finland. Consumption of any psychoactive drug may result in adverse health outcomes, even when the toxicity profile appears low risk. The intoxicating effects sought by drug users may lead to accidents (e.g. vehicle accidents) and facilitate assaults (Babor, Caulkins, et al., 2010; Kleiman, 1992). For example, a case study analysis of signs of impairment documented by the police in Germany concluded that “consumption of synthetic phenethylamines can lead to impairments similar to MDMA which can affect driving behaviour” (Maas, Wippich, Madea, & Hess, 2015). However, the contribution of NPS intoxication to driving impairment remains understudied due to the lack of psychomotor studies of specific compounds (Kriikku et al., 2015). For similar 9 reasons, the relationship between the use of NPS and violence is yet to be established. Agitation is one of the symptoms associated with the use of SC (Hermanns-Clausen, Kneisel, Szabo, & Auwärter, 2013; Kronstrand, Roman, Andersson, & Eklund, 2013) and cathinones (Prosser & Nelson, 2012), but the link to violence (Michael et al., 2014) requires further study. The legal or semi-legal status of NPS suggests that the level of systemic violence (i.e. violence associated with aggression in the drug trade (Goldstein, 1985)) will be lower compared to traditional illicit drug markets. The novelty of the NPS phenomenon does not allow for a comprehensive assessment of long- term health effects in relation to the type of drug and mode of administration (Babor, Caulkins, et al., 2010). Outcome studies of long-term use of certain illicit drugs by certain modes of administration (e.g. pulmonary function deterioration due to smoking natural cannabis) may provide some indication about the likely long-term effects of specific NPS (e.g. long term effects of smoking SC). Similarly, the established link between injecting drugs and infectious diseases (Hagan et al., 2001; Pouget, Hagan, & Des Jarlais, 2012; Strathdee et al., 2001; Thorpe et al., 2002) suggests injecting NPS may be associated with an elevated risk of blood-borne diseases such as HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV). However, case-by-case evaluations are needed to assess long-term health effects of using specific compounds. Data about long- term effects and incidence of non-communicable physical diseases are available mostly for herbal NPS, which have long been used by indigenous populations of specific world regions. For example, long-term khat use has been linked with cardiovascular disorders and identified as a risk factor in heart failure (El-Menyar, Mekkodathil, Al-Thani, & Al-Motarreb, 2015). Associations between NPS use and mental disorders may be discussed in terms of psychiatric co-morbidity (e.g. psychosis, anxiety, and depression) and substance dependence itself (Babor, Caulkins, et al., 2010; WHO, 2015). While research on the dependence potential of NPS compounds is limited, emergency departments are a source of information about neuropsychiatric adverse outcomes following NPS consumption. For example, a review by Van Amsterdam, Brunt, and Van Den Brink (2015) concluded that SC may have higher psychosis- inducing potential than natural cannabis, i.e. may cause more frequent and more severe unwanted negative effects. This has been attributed to the high potency of SC and absence of cannabidiol (CBD) which acts as a protective factor against THC. There is also evidence that synthetic cathinones can trigger psychotic episodes, with higher risk among users with concurrent psychiatric disorders (Miotto, Striebel, Cho, & Wang, 2013). 10 Overall, the major risk with NPS use is the unknown psychopharmacological and toxicity profiles of these substances, most of which have never been tested in humans before their appearance on the market (Brandt et al., 2014; Zamengo, Frison, Bettin, & Sciarrone, 2014). Data from national poisons centres, emergency departments and online reports of users’ experiences often provide the first information about adverse effects of specific compounds (Khey et al., 2014; Wood & Dargan, 2012), with some of the common problems including anxiety, paranoia, hallucinations, seizures, hyperthermia and cardiotoxicity (Tait et al., 2016; Zamengo et al., 2014). In addition, the actual active ingredients of NPS products are often unknown, as they may be adulterated and/or mislabelled (Ayres & Bond, 2012; Baron, Elie, & Elie, 2011; Zamengo et al., 2014). 1.2 New policy responses to NPS The number of NPS and uncertainties about their health and social impacts overwhelm any attempts to schedule compounds on a substance-by-substance basis. In recent years, a number of countries have implemented new policy and legislative responses to address the NPS challenge (EMCDDA, 2015c; King, 2013). Understanding the wide range of legislative responses adopted in different countries to address the dynamics of the NPS market has been identified as key in designing and coordinating an effective global response to NPS (UNODC, 2016). The EMCDDA (2015c) has categorised novel responses to NPS adopted in EU countries into three groups, based on the dimension, source of legal provisions: (1) responses that extend existing drug laws and processes (including generic and analogue definitions); (2) responses where other existing laws are applied to NPS, such as consumer safety or medicines legislation; and (3) entirely new NPS-specific laws. For the purpose of reviewing innovative policy responses to NPS adopted globally, I extended this categorisation by adding two new dimensions: (1) the scope of NPS provisions (i.e. whether legal measures aim to impose control over one specific compound, a group of compounds or all NPS, including compounds not yet developed); and (2) the restrictiveness of NPS laws with respect to supply (i.e. whether laws aim to impose controls by prohibition or by regulation of the market). 11 This framework helps illustrate how new policy responses differ from traditional prohibitive drug policy measures (i.e. drug laws controlling individually scheduled compounds by means of prohibition), and how the New Zealand response to NPS stands out from other responses (i.e. NPS law controlling all NPS compounds by means of market regulation). Figure 3 shows how the three dimensions (i.e. source of law, scope of NPS provisions and the restrictiveness of legal control) fit within the spectrum of “innovative” policy responses to NPS: Figure 3: Framework for the review of national responses to NPS In the remaining sections of this chapter the framework will be used to review the major groups of innovative policy responses to NPS: (1) rapid and emergency procedures; (2) generic, analogue and other group definitions; (3) application of other existing laws to prohibit the sale of “legal highs”; and (4) “blanket bans” on NPS supply. Figure 4 illustrates how these policy responses fit into the proposed framework. Figure 4: Framework for the review of national responses to NPS, with examples. 12 1.2.1 Rapid and emergency procedures Under the proposed framework the closest to traditional prohibitive drug law policies are so- called rapid and emergency procedures. These policy responses aim to accelerate the process of bringing specific compounds under state control. “Rapid scheduling” procedures allow for permanent scheduling of NPS in a timeframe shorter than for the standard scheduling of drugs. For example, in Sweden the government can make urgent drug law amendments which enter into force the next day (Hughes & Blidaru, 2009). “Emergency scheduling”, on the other hand, brings NPS under the state’s control for a limited time while their risks are assessed. For example, in 2011 the UK and New Zealand introduced mechanisms for the rapid issuing of so- called Temporary Class Drug Orders (TCDO, in UK) and Temporary Class Drug Notices (TCDN, in NZ). In both countries these controls prohibited supply-related behaviours of “interim scheduled” drugs for a period of 12 months (with a further 12-month extension possible). A similar “emergency scheduling” mechanism was included in the 1961 and 1971 UN Conventions, but has hardly ever been used (UN, 2014). While emergency and rapid procedures significantly speed up the process of bringing substances under state control, they may also accelerate rapid developments in the NPS market thus potentially reinforcing the “cat and mouse game”. Rapid procedures have also been criticised for lacking evidence-based risk assessment of scheduled substances, while emergency procedures have been criticised for their strong presumption that a temporary controlled substance will be banned permanently (Birdwell, Chapman, & Singleton, 2011). Following its introduction in New Zealand, the TCDN mechanism was subsequently assessed as unsustainable as the two-year ban was unlikely to provide sufficient time for risk evaluation (Wilkins et al., 2013), and it was abandoned following passage of the Psychoactive Substances Act (PSA) in 2013. 1.2.2 Generic, analogue and neurochemical definitions In an attempt to impose controls before drugs appear on the market, a number of countries have included broad group definitions in their national drug laws. This includes the so-called generic and analogue definitions, first implemented as early as 1964 (generic controls, UK) and 1986 (analogue controls, US) respectively. While generic definitions cover clusters of substances precisely defined by their similarity in chemical structure to a known illicit drug (Van Amsterdam, Nutt, & Van Den Brink, 2013), analogue definitions address more general aspects of chemical similarity to a known illicit drug (Hughes & Blidaru, 2009). In an attempt to capture groups of 13 compounds, the chemical term “derivative” has also been used in drug legislation. While it rarely causes definitional problems in chemistry, its usage in legal practice has been problematic (King, Ujváry, & Brandt, 2014), with some arguing that a compound can be considered a derivative only if it can be converted into another compound in a single reaction (Phillips, 1973), while others (including the US legal practice) accept several reaction stages (King et al., 2014). In a more recent policy development, ex ante group controls have been imposed by means of the so-called “neurochemical approach”. For example, the US Synthetic Drug Abuse Prevention Act 2012 defines all synthetic cannabinoids as any substance that is a cannabinoid receptor type I (CB1 receptor) agonist (…), and this is further narrowed to five groups of SC generically described by the chemical characteristics of their structural class (UK NPS Review Expert Panel, 2014). While all these solutions efficiently capture large groups of substances by anticipating future modifications of known compounds, they have received criticism on legal and practical grounds, such as: (1) the broad scope of criminal drug controls may hinder development of new medicines and increase administrative burden on the chemical and food industries, as well as academic research; (2) generic definitions are difficult to comprehend and the scope of analogue definitions is difficult to predict, which may violate the principle of legality (the rule that nothing is punishable without clearly defined penalty provisions); and (3) substances with no pharmacological effect whatsoever may be prohibited under these laws (thus drug offences may not be correlated with the harmfulness of the substance), while other harmful substances may remain outside the scope of definitions (King, 2013; King, Nutt, Singleton, & Howard, 2012; Van Amsterdam et al., 2013). 1.2.3 Application of existing administrative laws In another policy response, national authorities have applied existing laws and regulatory regimes to ban supply of NPS products, including medicines and pharmaceutical laws, food safety regulations, consumer protection laws, and import/export laws. Products subject to these regulations need marketing authorisation before being allowed on the legal market (medicines), or need to comply with general product safety requirements (other consumer products). These administrative frameworks have been used to prohibit trade in NPS. For example, BZP (in Spain), mephedrone (in Finland), “Spice” (in the UK) were all first controlled as medicines and their sale prohibited on the grounds of the unlawful sale of “unsafe medicinal products” (Hughes & Winstock, 2012). In Poland, consumer protection legislation was applied to close down over 1,200 legal high outlets in October 2010 (Hughes & Malczewski, 2011). 14 In a review of these innovative policy responses, Hughes and Winstock (2012) concluded that these controls appeared to achieve the objective of curtailing open sale of NPS products across Europe. Nevertheless, they remained concerned about practical challenges, including financial constraints on agencies responsible for enforcement of consumer protection and medicines laws. Other authors have suggested that administrative laws may be circumvented by a disclaimer “not for human consumption” (Birdwell et al., 2011). Sheridan, Atmore, and Russell (2012) also pointed out that the practice brings into question the integrity of the law in falsely labelling NPS as “medicines”, as the substances are used to induce pleasure and not therapeutic effects. Indeed, in its 2014 judgement the Court of Justice of the European Union (ECJ) ruled that recreational products containing synthetic cannabinoids do not fall under the legal term “medicinal product” (European Court of Justice, 2014a). Consequently, their open sale in EU countries can no longer be prosecuted on the grounds of the unlawful sale of unsafe medicinal products (European Court of Justice, 2014b). 1.2.4 “Blanket bans” on NPS supply Most recently, a so-called “blanket ban” approach has attracted considerable international attention. This approach prohibits supply-related activities (and sometimes possession) of any substance with psychoactive properties and hence covers all NPS compounds. Ireland was the first country to implement the solution (July 2010), introducing criminal sanctions on the supply of any “psychoactive substance” (Kavanagh & Power, 2014; Ryall & Butler, 2011). In the same year Poland modified the legal definition of “substitute drug” in its national drug law to cover all NPS, and imposed high administrative fines on suppliers of all substances which are “used instead of illicit drugs or for the same purposes” (Kapka-Skrzypczak et al., 2011). Modelling the Polish approach, Romania criminalised supply of NPS with sanctions including a mandatory minimum prison sentence (Hughes & Griffiths, 2014). In Australia, a blanket ban on importation of NPS has been implemented at the federal level and supply is prohibited in a number of states. In 2016, the UK followed suit by passing the UK Psychoactive Substances Act (UK PSA) 2016. A central criticism of blanket bans is they prohibit sales of any psychoactive product, including where there is no evidence of harm from substance use. This stretches the credibility of the drug control system as a mechanism for protecting public health (Hughes & Winstock, 2012), and raises questions about the acceptability of these laws (Ryall & Butler, 2011). Hughes and Griffiths (2014) agreed that blanket ban approaches remain in a legally “unclear area”. The concept of “psychoactivity” has raised terminological questions when used in legal definitions (Brandt et al., 2014). In the UK, for example, the new definition of “psychoactive substance” included in 15 the UK PSA 2016 has been criticised for being “extraordinarily broad” (Stevens, Fortson, Measham, & Sumnall, 2015) and “conceptually fraught” (Reuter & Pardo, 2017). Reuter and Pardo (2017) went so far as to state that “oparationalising psychoactivity as a usable concept for legal control purposes is extremely difficult, perhaps impossible”. 1.2.5 Summary of issues with prohibiting NPS on national level The innovative policy responses to NPS reviewed in sections 1.2.1–1.2.4 are all prohibitive in nature, i.e. they aim to eliminate or suppress the market for NPS. They all come with some successes, but also significant limitations. Emergency scheduling and temporary bans, although significantly speeding up the process of bringing NPS under state control, have had the unintended consequence of accelerating developments on the NPS market. Generic, analogue and neurochemical definitions included in national drug laws raise other concerns: their application requires expert chemical knowledge and there are uncertainties around the degree of similarity needed to classify specific compounds as analogues. Under these regimes some harmful substances remain outside the legislative framework, while others (less harmful) may be prohibited. The application of other existing civil laws to control the NPS market does not fit their original purpose. This practice was challenged in a 2014 ECJ judgement (joint cases C- 358/13 and C-181/14), which necessitated changes in the practice of prosecuting NPS cases in a number of European countries (EMCDDA and Eurojust, 2016). Finally, while “blanket bans” have proved effective in closing down “legal high” stores in some countries (Hughes & Griffiths, 2014; Hughes & Malczewski, 2011), unintended consequences of this approach, including the impact on the online drug markets or the extent of covert sales, are yet to be explored. These responses also raise concerns of a legal nature in relation to applying the definition of “psychoactivity” in practice. The problematic nature of prohibition-based responses adopted in other countries became the driver for New Zealand’s pre-market approval regime, an alternative legal control approach based on regulation rather than prohibition. 16 17 Chapter 2: New Zealand’s regulated market response to NPS New Zealand’s response to NPS sits in stark contrast to prohibitive policy approaches adopted in other countries. In July 2013, New Zealand’s Parliament passed the Psychoactive Substances Act (PSA), which established the world’s first regulated legal market regime for NPS. Under the PSA product sponsors can gain government approval to legally manufacture and sell their products if they demonstrate through toxicology and clinical trials that the products are “low risk” (New Zealand Parliament, 2013a; Wilkins, 2014a). This new regulated market approach received significant international attention as a “long-term” (UN, 2013), balanced (EMCDDA, 2015e), and “bold and innovative” solution to the NPS phenomenon (UK NPS Review Expert Panel, 2014) which could potentially be adopted in other countries (Seddon, 2014). This chapter outlines the historical background to the PSA and describes how the regulated market is intended to work under the PSA regulatory framework. Section 2.3 contains a summary of issues raised during consultation stage for the Psychoactive Substances Bill (PSB), i.e. the results of content analysis of written submission to the PSB and thematic analysis of parliamentary transcripts completed by me as part of the “formative research” process. The chapter then explains how the law was implemented during the “interim regime” between July 2013 and May 2014. Finally, the existing academic literature on the PSA and its implementation is reviewed, knowledge gaps identified and the research focus of this PhD explained, with specific research objectives outlined in s. 2.7. 2.1 The early emergence of legal highs in New Zealand New Zealand has been at the forefront of the legal high phenomena with a legal high industry (LHI) operating since the early 2000s, when a range of products containing the synthetic stimulants benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP) appeared on the market (Sheridan & Butler, 2007; Wilkins & Sweetsur, 2010). So-called BZP “party pills” were marketed on a commercial scale, with much of the manufacturing happening in India and China, thanks to the then unregulated international status of BZP (Szalavitz, 2015). The party pills varied in strength and quality, and were sold from counter culture stores and increasingly from local convenience stores (Sheridan & Butler, 2007). BZP/TFMPP party pills soon gained popularity among a wide group of users and it is estimated that by 2004 approximately five million legal BZP/TFMPP party pills had been sold on the market, amounting to sales of 24 million New Zealand Dollars (NZD) per year (Wilkins & Sweetsur, 2010). 18 In response to the growing popularity of BZP party pills and uncertainties around potential health impacts, a new regulatory regime was established by an amendment to the Misuse of Drugs Act (MODA). The so-called “Restricted Substances Regime” (RSR, also known as “Schedule D”) allowed controlled sale of substances assessed by the government to be “low risk”, and BZP was immediately included in this new schedule (New Zealand Parliament, 2005). The RSR imposed some restrictions on the newly-regulated market, such as an age limit on sale (i.e. 18 years or older), limits on advertising and a ban on giving away free product samples (Sheridan & Butler, 2010). The legal high industry continued commercial sale of their products under this regulatory regime. More detailed government regulations for the RSR, including product quality standards and maximum dose limits, were anticipated. However, their introduction in late 2008 didn’t impact on the BZP market as it had been brought to an end before these restrictions took effect. In 2008, based on new evidence of BZP-related health harms, including from previously commissioned government research (e.g. I. Thompson et al., 2006), BZP was scheduled as a Class C drug under MODA and thus became a prohibited substance. The “legal highs” industry responded to the ban on BZP by shifting production to non-BZP party pills and SC, which were not controlled by any legislation (Wilkins et al., 2013). Similarly to the early BZP products, SC were increasingly sold from convenience stores without any regulatory restrictions. Again, little was known about their health impacts and the speed of government response was limited due to the slowness of assessment and scheduling processes. Between 2011 and 2013, a number of products were taken off the market by means of Temporary Class Drug Notices which banned 33 compounds (MOH, 2011b). Despite the bans, the Ministry of Health (MOH) estimated in 2013 that approximately 200–300 psychoactive products were being sold from around 3,000–4,000 retail outlets (MOH, 2014f). As part of a review of the Misuse of Drugs Act, the New Zealand Law Commission (NZLC), an independent expert body whose task is to review New Zealand laws, recommended establishment of a new regulated market regime for NPS. In their 2011 report, the NZLC concluded that the government could not keep up with the NPS market by banning individual compounds, as producers could easily circumvent legislative controls by instantly substituting newly scheduled drugs with new uncontrolled compounds (NZLC, 2011). The NZLC recommended the development of a new regime requiring sponsors of NPS products to demonstrate their products are safe before they are permitted to be sold on the legal market (rather than the government having to prove that the products are unsafe in order to remove products from the market). The NZLC recommended regulation of the market by imposing 19 controls on the products approved for sale and retailers of these products. The NZLC report became a guiding document for further work on the PSA regime, including MOH regulatory impact statements and the draft legislation, i.e. the PSB. 2.2 Issues raised during consultation stage for the PSA 2.2.1. Issues raised in public submissions to the Psychoactive Substances Bill The proposed “regulated market regime” outlined in the Psychoactive Substances Bill (PSB) was subject to a public consultation process via written submissions between 9 April 2013 and 1 May 2013. This section contains a summary of postulates raised in written submissions to the PSB. The analytical approach used in the process of analysing submissions to the PSB is explained in Chapter 3 (section 3.2.1.1). The content analysis included 114 written submissions sourced from the official government website, i.e.: 42 submissions (36.8%) from institutions (institutional submissions) and 72 submissions (63.2%) from private citizens (private submissions). Most submitters (n=76; 66.7%) supported the regulatory measures proposed in the PSB (40 institutional submissions and 36 private submitters); 25 submitters (21.9%) clearly opposed the measures (2 institutional submissions and 23 private submitters); and 13 submitters (11.4%) (private submitters only) didn’t express a clear opinion about the proposed regulatory regime. Rather than commenting on the proposed content of the PSB, some of these submitters expressed general concern about the harmfulness of NPS to users and communities (n=3; 2.6%), disapproved of the possibility of testing the safety of prospective products on animals (n=2; 1.8%), proposed decriminalisation of cannabis as an alternative measure (n=1; 0.9%), or expressed support for the Bill under the wrongful understanding that it intended to ban all “legal highs” (n=7; 6.1%). Table 1 contains a summary of support for the PSB by submitter type. 2.2.1.1 Reasons behind support and opposition to regulation of the market Seventy-six supporting submissions praised the proposed regulatory measures as a “modern, comprehensive and rational approach”, stressing the need for regulation of NPS (n=47) and the failure of the traditional drug prohibition measures in the face of the NPS challenge (n=17). Regulation of the market was supported by most submitters from health-related institutions or the health professions (when the individual submitter identified him/herself). The three opposing submitters (PS) from a health background stressed the impossibility of predicting “the full spectrum of long term adverse health effects and social costs” (submission no. 20, hospital 20 scientist) and expressed a preference for “putting the effort into better drug and alcohol rehabilitation and prevention services and programs” (submission no. 90, mental health worker), as well as addressing causes of drug use, such as poverty or poor education (submission no. 56, psychotherapist). The twenty-five opposing submissions largely advocated for a total ban on “legal highs” (n=22), stressing that enough evidence existed that NPS were harmful (n=14), and had negative impacts on local communities (n=12) and youth (n=10). Several submissions (n=3) opposed the proposed measures because they missed the big picture of drug use in NZ. The latter submissions saw the PSA as a “failed opportunity” to modernise drug laws (submission no 45: “This bill is titled: Psychoactive Substances Bill and yet in the opening explanatory notes, it excludes drugs and precursor substances listed in the outdated MODA 1975. Therefore the title is misleading in its intent. Maybe it should be retitled: ‘No change to drug laws’ bill?”), and, in particular, a failed opportunity to regulate cannabis (submission no 80: “Ban all this synthetic stuff, the real stuff is better for you”). Table 1: Support and opposition for the PSB by submitter type Overall (n=114) Institutions (n=42) Private submitters (n=72) Support 67% (n=76) 95% (n=40) 50% (n=36) Oppose 22% (n=25) 5% (n=2) 32%(n=23) 11% (n=13) 0 18% (n=13), including 7 claiming to support under the understanding it’s a ban 2.2.1.2 Recommendations made in public submissions Many submitters called for the provisions of the PSB to be viewed through the lens of harm reduction and recommended that a “public health” focus should be added to the aim of the PSB (in its initial version aim was limited to “regulating the availability of NPS”) (n=22). Many submitters also focused on the need to define the “low risk” threshold (n=24) for approval of 21 products at a level which assures users’ safety and yet is achievable (n=14) (submission no. 2: “The concern is if risk levels are set too high, no products will be allowed; for regulations to work they must be manageable, reasonable and affordable”). The retail and marketing restrictions proposed by submitters were generally similar or stricter than regulations for the tobacco and alcohol industries, and included proposal to introduce plain packaging (n=4), a total ban on any form of advertising (n=8), R20 or R21 purchase age (n=12), and sale from pharmacies only (n=1). The most commonly recommended public health measure related to the restrictions on the place of sale of approved products (n=33), with 20 submitters calling for the introduction of regime-specific retail licenses, and some submitters suggesting that local communities should have a say in placing further restrictions around the place of sale (n=6). A need to implement a post-approval system for monitoring adverse reactions (n=26) and assure public access to information on approved and non-approved products was widely acknowledged (n=15). Many submitters did not agree with the proposal to punish personal possession of an unapproved product (n=17), and claimed that if this was to be an offence, the onus of proof should be on the police to prove the substance to be illegal (e.g. submission no. 42: “Innocent until proven guilty is a pillar of our society and should not be easily dismissed”). Many submitters commented on the broad scope of the proposed definition of “psychoactive substance” (N=13) which “catches almost everything” (submission no. 75) and suggested that the regime should be limited to synthetic compounds only and not cover plant products (n=5). Thirty-one submitters raised the issue of testing prospective products on animals, of which 24 called for a total ban on animal testing (10 supporting submissions; 11 opposing submissions and 2 undefined submissions), with some suggesting there are in vitro and in silico alternatives (n=10) or “plenty of human volunteers” (submission no 75) to test the products (n=3). Finally, the proposal to allow some existing products to stay on the market under “transitionary PSA provisions” was viewed overall as “a sensible approach”. However, some submitters were concerned about the possible duration of temporary measures (n=12), calling for a speeding up of the regulatory process (n=6), while others thought that the sale of products should be discontinued until the full regulatory regime was operational (n=6). 2.2.2 Issues raised in parliamentary debates The three readings of the proposed Psychoactive Substances Bill (PSB) took place in Parliament on 9 April 2013, 2 July 2013 and 11 July 2013. This section contains a summary of key issues raised during the parliamentary debates. Transcripts of debates were sourced from the official 22 government database (parliament.govt.nz). The analytical approach used to analyse transcripts of the parliamentary debates on the PSB is explained in Chapter 3 (section 3.2.3). Overall, the governing National Party and its coalition MPs stressed the prohibitive measures included in the PSB and the need for high safety standards and stringent regulation (exemplary quotes from the government party politicians: “I make no apology for the fact that we will set a deliberately high bar, and that those who want to go through the process will pay an exorbitant fee”; “I hope that for those who are producing the K2s and the synthetic drugs out there, and experimenting on young people, that this sends them out of business”). On the other hand, the opposition largely viewed the PSB as a “missed opportunity for a comprehensive overhaul of MODA” and focused on procedural shortcuts in the process of adopting the law. Table 2 summarises major themes raised by the opposition and the government during parliamentary debates. Table 2: Themes identified in the analysis of parliamentary readings on the PSB Opposing views: Points of agreement: Opposition Government and coalition • Views PSB as a missed opportunity for a comprehensive overhaul of the Misuse of Drugs Act (MODA) • Criticises the government for rushing the procedures, in particular cutting down the standard Select Committee stage from 6 to 2 months; criticises government for not paying enough attention to the animal testing issue • Largely opposes punishing personal possession of unapproved NPS as it has not been proven of benefit to users under MODA and will not be enforceable • Green Party calls for a total ban on animal testing claiming that alternatives exist and are more reliable than animal models • Stress that the PSB is only about NPS and will not be extended to regulate cannabis • Stress prohibitive measures of the PSB, high standards testing regime and possible obstacles for the industry to get a product approved (high fees and safety standards) • Stress that personal possession is punished in order to facilitate health and social intervention, and not to go down the “criminal pathway”. • Rationalise why animal testing is not banned in the PSB: (1) consensus has been reached by allowing animal tests only if there is no alternative; (2) scientific advice that some animal tests are needed in order for the regime to work; (3) testing on animal prevents “testing on people” • Current system of Temporary Class Drug Notices (TCDN) doesn’t work • “Total ban” on these products is not possible due to variety of substances on the market • Agree on the urgency of this law as TCDNs are about to expire • Agree that the law needs to be reviewed after 5 years and further measures need to be considered then, including excise tax 23 2.3 Regulatory mechanisms under the PSA The PSA was passed in July 2013 with nearly unanimous cross-party support in Parliament (119 in favour and 1 vote against the legislation) (New Zealand Parliament, 2013b). It established the world’s first ever regulated legal market for NPS (Wilkins, 2014a). The objective of the PSA, as defined in s. 3 of the Act, is to “regulate the availability of psychoactive substances in New Zealand to protect the health of, and minimise harm to, individuals who use psychoactive substances”. Under the PSA regime, product sponsors can get a government approval to legally import, manufacture and sell psychoactive products containing NPS, provided they prove that the products are “low risk”. The importation, manufacture, supply and possession of any other “unapproved” NPS is prohibited by default (Rychert & Wilkins, 2016b). Requirements for testing the safety of psychoactive products resemble the pre-market approval regime for medicines and are modelled on pharmaceutical standards developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This means that scientific evidence from a series of toxicology and clinical trials is required for each product application, and should cover aspects of the product’s safety such as pharmacology, general toxicity, assessment of pharmacokinetics, metabolism and potential to cause addiction (PSRA, 2014a). The approval is granted for each separate product formulation (not substance), and thus the strength of the product cannot be modified once approval is granted. The Ministry of Health estimated the cost of testing as likely to be 1–2 million NZD per product (MOH, 2012). The product application fee is set at 175,000 NZD per product (MOH, 2014c). While this might seem like a lot of money, returns from the market are likely to compensate the initial expenses (Wilkins, 2014d). The estimated annual retail sale from a regulated SC market during the “interim phase” of the PSA implementation reached 140 million NZD (MOH, 2014f). The retail framework for the regime is modelled on regulations for alcohol and tobacco, with approved products allowed to be legally sold only from specialised licensed retail outlets. No food or alcohol can be sold from the same premises and the PSA explicitly bans the sale of products from supermarkets, petrol stations, local convenience stores or alcohol retail outlets. Retail sales are only allowed to customers 18 years of age and over (which matches the legal drinking age limit in New Zealand). Following postulates raised in the public submissions process, the PSA allows local councils to place further restrictions on location of licensed retailers, including minimum distance from “sensitive sites” such as schools, sports fields or churches. 24 The advertising of approved NPS products is limited to the point-of-sale only (i.e. no advertising in television, radio, or newspapers) and must be limited to objective information about the product, such as active ingredients and the price. The PSA specifically prohibits advertising in a form which conveys a message that an approved product is “safe”. While online sale of products is allowed, it can only be done through websites established specifically for this purpose (but not other internet platforms, including social media websites). Packaging for NPS products must include a list of ingredients, health warnings, contact details of the manufacturer and the telephone number of the National Poisons Centre (New Zealand Parliament, 2013a). The Psychoactive Substances Regulatory Authority (PSRA), a new government agency established within the Ministry of Health (MOH), is tasked with overseeing implementation of the PSA. The PSRA has the ability to revoke any product approval if, after introducing the product to the market, reports about adverse effects emerge and the product is no longer considered to be “low risk”. 2.4 The interim regulated market under the PSA When the PSA was passed in July 2013, much of the regulatory framework to make the new regime workable had not yet been developed, including the required safety testing standards or detailed rules for online sale of approved products. While these regulations were being developed by the PSRA, the “interim regime“ was established, allowing a limited number of “legal high“ products available on the market before the passage of the PSA to continue to be sold subject to new retail and advertising restrictions established under the PSA (Schedule 1 PSA as enacted). This was deemed necessary to avoid the creation of a black market which could have emerged if all “legal high” products had been banned as “unapproved” NPS in the wake of passage of the PSA (New Zealand Parliament, 2013b). The transitional provisions were intended to last until all regulations for the PSA regime were finalised (s. 6 and 9, Schedule 1, PSA as enacted), after which time any product allowed on the market would need to pass the required safety tests to prove its consumption poses no more than a “low risk”to consumers. 2.4.1 Managing products approved on the interim market Forty-seven products received interim approvals under the interim regime, including 40 SC smoking blends (Wilkins, 2014b). The interim approved products did not pass any safety tests but were deemed to be “low risk” as they had been on the market for at least three months before the PSA and there were no significant adverse event notifications against them. The PSRA 25 was tasked with monitoring the safety of interim approved products allowed on the market and had the power to revoke interim approval for any product if information about adverse events emerged. There were three designated sources of data: (i) calls from members of the public to the National Poisons Centre (NPC) and Drug and Alcohol Helpline; (ii) reports sent by medical professionals to the Pharmacovigilance Centre (CARM) and reports made by a subset of hospital emergency units; and (iii) notifications from product manufacturers who were legally obliged to report adverse incidents from their products (MOH, 2013b). Data collected by the National Poisons Centre showed an increased number of SC-related calls from the general public following the establishment of the interim regime. This increase may have been largely due to the requirement for interim approved products to display the NPC telephone number on product packaging. Figure 5: SC-related calls received by the National Poisons Centre (October 2010 – February 2016) Data compiled by Leo Shep, PhD. Source: National Poisons Centre Update March 2016. Eleven interim product approvals were revoked by the PSRA due to harms reported during the interim regime: five in January 2014 (Wilkins, 2014b) and six in May 2014 (MOH, 2014b). Table 3 presents the names and active compounds in the products withdrawn during the interim regime and the composition of products which remained on the regulated legal market until the end of the interim regime. 0 10 20 30 40 50 60 70 O ct ob er Ja