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R E V I E W
Drug and Alcohol Review (November 2014), 33, 678–680 DOI: 10.1111/dar.12203
LETTER TO THE EDITOR
Recent developments with the establishment of a regulated legal market for new psychoactive substances (‘legal highs’) in New Zealand On 17 July 2013, the New Zealand Parliament almost unanimously passed the Psychoactive Substances Act (PSA) (119 ayes to 1 nay), which established the world’s first regulated legal market for ‘low risk’ psychoactive products (‘legal highs’) [1]. This bold policy response to the ongoing problem of new psychoactive substances (NPS) sits in stark contrast to many other countries (including Australia) who are seeking faster and more comprehensive ways to prohibit these products [2–4]. A number of those investigating policy responses to NPS have expressed interest in monitoring the ‘New Zealand NPS experiment’, with the view that if it proves successful, it may serve as a regulatory model for other countries [5,6]. The New Zealand Ministry of Health (MOH) has sought to implement the PSA over the past 10 months, including establishing a transitional interim NPS regulatory regime where 46 existing NPS products were given interim licences and permitted to be legally sold subject to new retail restrictions and licencing requirements [7]. This interim regime was brought to an abrupt end on 8 May 2014 when the Government legislated to ban all remaining interim licenced products [8] following reports of adverse effects (e.g. vomiting, seizures and psychotic episodes), dependency and antisocial behaviour [9–11]. It is important to note that none of the recently banned interim products had been required to undergo the pre-market product testing, which is central to the PSA [1]. The criterion for an interim product licence was merely that the existing product had not received any reports of adverse effects over the three months prior to the passage of the PSA [7,10]. Some of the active compounds in the interim licenced products were particularly potent cannabinoids (as measured by affinity to the cannabinoid receptor type 1 (CB1) receptor in the brain) compared with the tetrahydrocannabinol (THC) found in natural cannabis, and even other previously banned cannabinoid products (e.g. JWH-018) [7]. The rationale for allowing existing NPS products to continue to be sold during the interim period was to avoid the emergence of a large black market if all © 2014 Australasian Professional Society on Alcohol and other Drugs
existing legal products were immediately banned [10]. The prohibition of benzylpiperazine, the principal active ingredient in the ‘legal party pills’ widely sold in New Zealand in the mid-2000s, had not resulted in a large black market for benzylpiperazine [12,13]. Studies of the prohibition of legal highs in other countries also suggest reductions in use following the imposition of greater controls [14–16]. However, continued use of legal highs with effects comparable with illegal drugs has been found in specific populations [17,18]. In addition, the banning of individual legal high products does not address the wider aspects of the NPS problem, such as the continual introduction of (potentially more harmful) replacement compounds, achieving a proportional response and ensuring evidence-based scheduling decisions [6,19–21]. The problems with the interim-licenced products raise the question of why as many as 46 existing products were granted interim licences. The interim licencing of products did reduce the number of products from over 200 to 46 [7]. Yet, it is possible to envision a more cautious approach where only a handful of what were considered to be the safest products on the market were given interim licences. It is also curious that the overwhelming majority of interimlicenced products were smoking products (i.e. 40/46), even though New Zealand has a long-standing smokefree health policy [22]. Although the Psychoactive Substances Regulatory Authority revoked the interim licences of a further 12 products over the course of the interim regime in response to reports of adverse effects, the MOH acknowledged the designated monitoring sources (i.e. the National Poisons Centre emergency telephone service and Centre for Adverse Reactions Monitoring—New Zealand’s pharmacovigiliance centre) sometimes lacked the key details to support a product recall, such as the specific product name [7,10,23]. An effective NPS product monitoring system requires retrospective case studies of NPS adverse cases, including drug confirmation and other toxicological analyses [7,19], and triangulation with other information sources, such as user self-reports and user surveys [24].
Letter to the Editor
The MOH conceded there were important gaps in the understanding of the interim regime, including the prevalence and patterns of use, dependency potential of products and the demographics of the user group [10]. The MOH had assumed the interim market would be similar in value to the legal benzylpiperazine party pill market (i.e. approximately $24 million per year), but sales data revealed it exceeded $140 million per year [10]. In the absence of official data and research, perceptions of the new NPS market were filled by media accounts of extreme adverse cases and social nuisance [25]. There were counter claims that the reported adverse cases related to products that had been banned some time ago [23] and that adverse effects were possibly relate to poor manufacture rather than the products themselves [26]. It also remains unclear what role underlying mental health issues and existing alcohol and other drug use played in the adverse NPS outcomes. Finally, there have been claims that the Psychoactive Substances Regulatory Authority was underresourced, and the interim period was only intended to remain until October 2013 [25]. The banning of all interim-licenced NPS products in May effectively brought an end to the interim NPS regime in New Zealand, but fairly broad cross-party political support for the PSA appears to remain [25]. The MOH is currently developing the requirements for product testing and further retail controls, and these will be available by the end of 2014 [10]. There is likely to be considerable profit and prestige associated with having the first NPS product approved for legal sale (in a currently empty market). Consequently, there is every reason to believe a fully fledged regulated legal market for NPS products will emerge in New Zealand over the next 12–24 months but, as demonstrated to date, there are considerable challenges in designing effective regulation to protect the health of users. Chris Wilkins SHORE & Whariki Research Centre, College of Health, Massey University, Auckland, New Zealand E-mail: [email protected] References [1] New Zealand Parliament. Psychoactive Substances Act 2013. Public Act 2013 No 53. 2013, 17 July. (Archived by WebCite® at http://www.webcitation.org/6MzpzCv3R). Available at: http://www.legislation.govt.nz/act/public/2013/ 0053/20.0/DLM5042921.html. (accessed January 2014). [2] European Monitoring Centre for Drugs and Drug Addiction. Legal Approaches to Controlling New Psychoactive Substances. 2014. (Archived by WebCite® at http:// www.webcitation.org/6Okiup0z3). Available at: http:// www.emcdda.europa.eu/topics/pods/controlling-new -psychoactive-substances (accessed April 2014).
679
[3] Munro G, Wilkins C. New Psychoactive Drugs: No Easy Answer. Melbourne, Australia Drug Foundation, 2014. (PolicyTalk). [4] United Nations Office on Drugs and Crime. Global Synthetic Drugs Assessment: Amphetamine-Type Stimulants and New Psychoactive Substances. Vienna, United Nations Office in Drugs and Crime, 2014. [5] Meacher M. Drug policy reform—the opportunity presented by ‘legal highs. Psychiatrist 2013;37:249–52. [6] All-Party Parliamentary Group for Drug Policy Reform. Towards a Safer Drug Policy: Challenges and Opportunities Arising from ‘Legal Highs’. 2013. (Archived by WebCite® at http://www.webcitation.org/6RSmVaO1O). Available at: http://www.law.qmul.ac.uk/docs/research/90672.pdf (accessed July 2014). [7] Wilkins C. The interim regulated legal market for NPS (‘legal high’) products in New Zealand: the impact of new retail restrictions and product licensing. Drug Test Anal 2014;6:868–75. [8] New Zealand Parliament. Psychoactive Substances Amendment Act 2014, 2014. (Public Act 2014 No 24; Date of assent 7 May). [9] Ministry of Health. Recall Order Issued under Section 88 of the Psychoactive Substances Act 2013. 2014. (Archived by WebCite® at http://www.webcitation.org/6RSmjB1bA) Available at: http://www.health.govt.nz/system/files/ documents/pages/recall-order-v2.pdf (accessed July 2014). [10] Ministry of Health. Regulatory Impact Statement: Amendment to the Psychoactive Substance Act 2013. 2014. (Archived by WebCite® at http://www.webcitation.org/ 6PwNP33OU). Available at: http://www.health.govt.nz/ about-ministry/legislation-and-regulation/regulatoryimpact-statements/amendment-psychoactive-substanceact-2013 (accessed May 2014). [11] Schep L. An Update on Calls Received by the National Poisons Centre on Synthetic Cannabinoids (Oct 2010 to May 2014). Dunedin: New Zealand National Poisons Centre; 2014. [12] Wilkins C, Sweetsur P. The impact of the prohibition of BZP legal highs on the prevalence of BZP, new legal highs and other drug use in New Zealand. Drug Alcohol Depend 2013;127:72–80. [13] Sheridan J, Yang Dong C, Butler R, Barnes J. The impact of New Zealand’s 2008 prohibition of piperazine-based party pills on young people’s substance use: results of a longitudinal, web-based study. Int J Drug Policy 2013;24:412–22. [14] Malczewski A. Psychoactive Substance Use in General Population in 2010: Survey Results. Warsaw, National Bureau for Drug Prevention, 2011. [15] Home Office. Drug Misuse Declared: Findings from the 2011/12 British Crime Survey for England and Wales, 2012. (2nd Edition). [16] Wood D, Greene S, Dargan P. Emergency department presentations in determining the effectiveness of drug control in the United Kingdom: mephedrone (4-methylmethcathinone) control appears to be effective using this model. Emerg Med J 2013;30:70–1. [17] Winstock A, Mitcheson L, Marsden J. Mepedrone: still available and twice the price. Lancet 2010;376:1537. [18] Newcombe R. Mephedrone: the use of mephedrone (M-cat, Meow) in Middlesbrough. Manchester: Lifeline Publications and Research, 2009. [19] Hermanns-Clausen M, Kneisel S, Szabo B, Auwärter V. Acute toxicity due to the confirmed consumption of synthetic cannabinoids. Addiction 2013;108:534–44. © 2014 Australasian Professional Society on Alcohol and other Drugs
680
Letter to the Editor
[20] New Zealand Law Commission. New Psychoactive Substances. Controlling and Regulating Drugs—A Review of the Misuse of Drugs Act 1975. Wellington 2011: 114–48. [21] Birdwell J, Chapman J, Singleton N. Taking drugs seriously: a Demos and UK drug policy commission report on legal highs. London: Demos, 2011. [22] Ministry of Health. Smokefree Law. 2014. (Archived by WebCite® at http://www.webcitation.org/6RSmuE9Y9). Available at: http://www.health.govt.nz/our-work/ preventative-health-wellness/tobacco-control/smokefree -law (accessed July 2014). [23] Noller G. Synthetic Cannabinoid Use in New Zealand: Assessing the Harms. Dunedin, Substance Use and Policy Analysis, 2014. (A report to The STAR Trust). [24] Wood D, Hill S, Thomas S, Dargan P. Using poisons information service data to assess the acute harms associated
© 2014 Australasian Professional Society on Alcohol and other Drugs
with novel psychoactive substances. Drug Test Anal 2014; 6:850–60. [25] New Zealand Parliament. Psychoactive Substances Amendment Bill—First Reading, Second Reading, In Committee, Third Reading. Hansard (debates); 2014. (6 May). Available at: http://www.parliament.nz/en-nz/pb/debates/debates/ 50HansD_20140506_00000936/psychoactive-substances -amendment-bill-—-first-reading (accessed June 2014). [26] Ministry of Health. Code of Manufacturing Practice. 2014. (Archived by WebCite® at http://www.webcitation.org/ 6RSnDKeab). Available at: http://www.health.govt.nz/our -work/regulation-health-and-disability-system/psychoactive -substances-regulation/code-manufacturing-practice (accessed July 2014).
Copyright of Drug & Alcohol Review is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
R E V I E W
Drug and Alcohol Review (November 2014), 33, 678–680 DOI: 10.1111/dar.12203
LETTER TO THE EDITOR
Recent developments with the establishment of a regulated legal market for new psychoactive substances (‘legal highs’) in New Zealand On 17 July 2013, the New Zealand Parliament almost unanimously passed the Psychoactive Substances Act (PSA) (119 ayes to 1 nay), which established the world’s first regulated legal market for ‘low risk’ psychoactive products (‘legal highs’) [1]. This bold policy response to the ongoing problem of new psychoactive substances (NPS) sits in stark contrast to many other countries (including Australia) who are seeking faster and more comprehensive ways to prohibit these products [2–4]. A number of those investigating policy responses to NPS have expressed interest in monitoring the ‘New Zealand NPS experiment’, with the view that if it proves successful, it may serve as a regulatory model for other countries [5,6]. The New Zealand Ministry of Health (MOH) has sought to implement the PSA over the past 10 months, including establishing a transitional interim NPS regulatory regime where 46 existing NPS products were given interim licences and permitted to be legally sold subject to new retail restrictions and licencing requirements [7]. This interim regime was brought to an abrupt end on 8 May 2014 when the Government legislated to ban all remaining interim licenced products [8] following reports of adverse effects (e.g. vomiting, seizures and psychotic episodes), dependency and antisocial behaviour [9–11]. It is important to note that none of the recently banned interim products had been required to undergo the pre-market product testing, which is central to the PSA [1]. The criterion for an interim product licence was merely that the existing product had not received any reports of adverse effects over the three months prior to the passage of the PSA [7,10]. Some of the active compounds in the interim licenced products were particularly potent cannabinoids (as measured by affinity to the cannabinoid receptor type 1 (CB1) receptor in the brain) compared with the tetrahydrocannabinol (THC) found in natural cannabis, and even other previously banned cannabinoid products (e.g. JWH-018) [7]. The rationale for allowing existing NPS products to continue to be sold during the interim period was to avoid the emergence of a large black market if all © 2014 Australasian Professional Society on Alcohol and other Drugs
existing legal products were immediately banned [10]. The prohibition of benzylpiperazine, the principal active ingredient in the ‘legal party pills’ widely sold in New Zealand in the mid-2000s, had not resulted in a large black market for benzylpiperazine [12,13]. Studies of the prohibition of legal highs in other countries also suggest reductions in use following the imposition of greater controls [14–16]. However, continued use of legal highs with effects comparable with illegal drugs has been found in specific populations [17,18]. In addition, the banning of individual legal high products does not address the wider aspects of the NPS problem, such as the continual introduction of (potentially more harmful) replacement compounds, achieving a proportional response and ensuring evidence-based scheduling decisions [6,19–21]. The problems with the interim-licenced products raise the question of why as many as 46 existing products were granted interim licences. The interim licencing of products did reduce the number of products from over 200 to 46 [7]. Yet, it is possible to envision a more cautious approach where only a handful of what were considered to be the safest products on the market were given interim licences. It is also curious that the overwhelming majority of interimlicenced products were smoking products (i.e. 40/46), even though New Zealand has a long-standing smokefree health policy [22]. Although the Psychoactive Substances Regulatory Authority revoked the interim licences of a further 12 products over the course of the interim regime in response to reports of adverse effects, the MOH acknowledged the designated monitoring sources (i.e. the National Poisons Centre emergency telephone service and Centre for Adverse Reactions Monitoring—New Zealand’s pharmacovigiliance centre) sometimes lacked the key details to support a product recall, such as the specific product name [7,10,23]. An effective NPS product monitoring system requires retrospective case studies of NPS adverse cases, including drug confirmation and other toxicological analyses [7,19], and triangulation with other information sources, such as user self-reports and user surveys [24].
Letter to the Editor
The MOH conceded there were important gaps in the understanding of the interim regime, including the prevalence and patterns of use, dependency potential of products and the demographics of the user group [10]. The MOH had assumed the interim market would be similar in value to the legal benzylpiperazine party pill market (i.e. approximately $24 million per year), but sales data revealed it exceeded $140 million per year [10]. In the absence of official data and research, perceptions of the new NPS market were filled by media accounts of extreme adverse cases and social nuisance [25]. There were counter claims that the reported adverse cases related to products that had been banned some time ago [23] and that adverse effects were possibly relate to poor manufacture rather than the products themselves [26]. It also remains unclear what role underlying mental health issues and existing alcohol and other drug use played in the adverse NPS outcomes. Finally, there have been claims that the Psychoactive Substances Regulatory Authority was underresourced, and the interim period was only intended to remain until October 2013 [25]. The banning of all interim-licenced NPS products in May effectively brought an end to the interim NPS regime in New Zealand, but fairly broad cross-party political support for the PSA appears to remain [25]. The MOH is currently developing the requirements for product testing and further retail controls, and these will be available by the end of 2014 [10]. There is likely to be considerable profit and prestige associated with having the first NPS product approved for legal sale (in a currently empty market). Consequently, there is every reason to believe a fully fledged regulated legal market for NPS products will emerge in New Zealand over the next 12–24 months but, as demonstrated to date, there are considerable challenges in designing effective regulation to protect the health of users. Chris Wilkins SHORE & Whariki Research Centre, College of Health, Massey University, Auckland, New Zealand E-mail: [email protected] References [1] New Zealand Parliament. Psychoactive Substances Act 2013. Public Act 2013 No 53. 2013, 17 July. (Archived by WebCite® at http://www.webcitation.org/6MzpzCv3R). Available at: http://www.legislation.govt.nz/act/public/2013/ 0053/20.0/DLM5042921.html. (accessed January 2014). [2] European Monitoring Centre for Drugs and Drug Addiction. Legal Approaches to Controlling New Psychoactive Substances. 2014. (Archived by WebCite® at http:// www.webcitation.org/6Okiup0z3). Available at: http:// www.emcdda.europa.eu/topics/pods/controlling-new -psychoactive-substances (accessed April 2014).
679
[3] Munro G, Wilkins C. New Psychoactive Drugs: No Easy Answer. Melbourne, Australia Drug Foundation, 2014. (PolicyTalk). [4] United Nations Office on Drugs and Crime. Global Synthetic Drugs Assessment: Amphetamine-Type Stimulants and New Psychoactive Substances. Vienna, United Nations Office in Drugs and Crime, 2014. [5] Meacher M. Drug policy reform—the opportunity presented by ‘legal highs. Psychiatrist 2013;37:249–52. [6] All-Party Parliamentary Group for Drug Policy Reform. Towards a Safer Drug Policy: Challenges and Opportunities Arising from ‘Legal Highs’. 2013. (Archived by WebCite® at http://www.webcitation.org/6RSmVaO1O). Available at: http://www.law.qmul.ac.uk/docs/research/90672.pdf (accessed July 2014). [7] Wilkins C. The interim regulated legal market for NPS (‘legal high’) products in New Zealand: the impact of new retail restrictions and product licensing. Drug Test Anal 2014;6:868–75. [8] New Zealand Parliament. Psychoactive Substances Amendment Act 2014, 2014. (Public Act 2014 No 24; Date of assent 7 May). [9] Ministry of Health. Recall Order Issued under Section 88 of the Psychoactive Substances Act 2013. 2014. (Archived by WebCite® at http://www.webcitation.org/6RSmjB1bA) Available at: http://www.health.govt.nz/system/files/ documents/pages/recall-order-v2.pdf (accessed July 2014). [10] Ministry of Health. Regulatory Impact Statement: Amendment to the Psychoactive Substance Act 2013. 2014. (Archived by WebCite® at http://www.webcitation.org/ 6PwNP33OU). Available at: http://www.health.govt.nz/ about-ministry/legislation-and-regulation/regulatoryimpact-statements/amendment-psychoactive-substanceact-2013 (accessed May 2014). [11] Schep L. An Update on Calls Received by the National Poisons Centre on Synthetic Cannabinoids (Oct 2010 to May 2014). Dunedin: New Zealand National Poisons Centre; 2014. [12] Wilkins C, Sweetsur P. The impact of the prohibition of BZP legal highs on the prevalence of BZP, new legal highs and other drug use in New Zealand. Drug Alcohol Depend 2013;127:72–80. [13] Sheridan J, Yang Dong C, Butler R, Barnes J. The impact of New Zealand’s 2008 prohibition of piperazine-based party pills on young people’s substance use: results of a longitudinal, web-based study. Int J Drug Policy 2013;24:412–22. [14] Malczewski A. Psychoactive Substance Use in General Population in 2010: Survey Results. Warsaw, National Bureau for Drug Prevention, 2011. [15] Home Office. Drug Misuse Declared: Findings from the 2011/12 British Crime Survey for England and Wales, 2012. (2nd Edition). [16] Wood D, Greene S, Dargan P. Emergency department presentations in determining the effectiveness of drug control in the United Kingdom: mephedrone (4-methylmethcathinone) control appears to be effective using this model. Emerg Med J 2013;30:70–1. [17] Winstock A, Mitcheson L, Marsden J. Mepedrone: still available and twice the price. Lancet 2010;376:1537. [18] Newcombe R. Mephedrone: the use of mephedrone (M-cat, Meow) in Middlesbrough. Manchester: Lifeline Publications and Research, 2009. [19] Hermanns-Clausen M, Kneisel S, Szabo B, Auwärter V. Acute toxicity due to the confirmed consumption of synthetic cannabinoids. Addiction 2013;108:534–44. © 2014 Australasian Professional Society on Alcohol and other Drugs
680
Letter to the Editor
[20] New Zealand Law Commission. New Psychoactive Substances. Controlling and Regulating Drugs—A Review of the Misuse of Drugs Act 1975. Wellington 2011: 114–48. [21] Birdwell J, Chapman J, Singleton N. Taking drugs seriously: a Demos and UK drug policy commission report on legal highs. London: Demos, 2011. [22] Ministry of Health. Smokefree Law. 2014. (Archived by WebCite® at http://www.webcitation.org/6RSmuE9Y9). Available at: http://www.health.govt.nz/our-work/ preventative-health-wellness/tobacco-control/smokefree -law (accessed July 2014). [23] Noller G. Synthetic Cannabinoid Use in New Zealand: Assessing the Harms. Dunedin, Substance Use and Policy Analysis, 2014. (A report to The STAR Trust). [24] Wood D, Hill S, Thomas S, Dargan P. Using poisons information service data to assess the acute harms associated
© 2014 Australasian Professional Society on Alcohol and other Drugs
with novel psychoactive substances. Drug Test Anal 2014; 6:850–60. [25] New Zealand Parliament. Psychoactive Substances Amendment Bill—First Reading, Second Reading, In Committee, Third Reading. Hansard (debates); 2014. (6 May). Available at: http://www.parliament.nz/en-nz/pb/debates/debates/ 50HansD_20140506_00000936/psychoactive-substances -amendment-bill-—-first-reading (accessed June 2014). [26] Ministry of Health. Code of Manufacturing Practice. 2014. (Archived by WebCite® at http://www.webcitation.org/ 6RSnDKeab). Available at: http://www.health.govt.nz/our -work/regulation-health-and-disability-system/psychoactive -substances-regulation/code-manufacturing-practice (accessed July 2014).
Copyright of Drug & Alcohol Review is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
