title: A critical first assessment of the new pre-market approval regime for new psychoactive substances (NPS) in New Zealand.
abstract: BACKGROUND
  New Zealand has recently attempted to address the underlying drivers of the escalating new psychoactive substances (NPS) ('legal highs') problem by establishing the world's first pre-market approval regulatory regime for NPS. NPS products which can be shown with clinical trial data to pose a 'low risk' of harm will be approved for legal manufacture and sale.
  
  
  OBJECTIVE
  This paper critically assesses the new regime, drawing on experience of the pharmaceutical sector and legal BZP market.
  
  
  RESULTS
  A number of characteristics of the recreational use of NPS may not be well addressed by standard medical clinical trials, including binge use, polydrug use, use by vulnerable groups and high-risk modes of administration. The overt advertising and covert promotion of approved NPS products on the internet may make them fairly visible to young people. The black market for unapproved NPS may be difficult to suppress given that unapproved NPS will be physically identical to approved NPS. If the legal market for NPS encourages the use of NPS, alcohol and other drugs there may be an increase in drug-related harm. Alternatively, if the legal NPS market reduces the use of more harmful drugs, there may be a considerable public health benefit.
  
  
  CONCLUSIONS
  The clinical trials required for NPS products should address the characteristics of recreational NPS use. Enforcement resources and technical solutions are required to clearly distinguish legal NPS products. The impact the new NPS regime has on other drug use is a key issue and demands further study.
authors: Social and Health Outcomes Research and Evaluation (SHORE), SHORE and Whariki Research Centre, School of Public Health, Massey University, Auckland, New Zealand.
authors: Chris
authors: C
authors: Wilkins
mesh_terms: D003132:Commerce; D015198:Designer Drugs / Q000600:supply & distribution*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D009520:New Zealand; D010879:Piperazines; D011619:Psychotropic Drugs / Q000600:supply & distribution*
chemical_list: D015198:Designer Drugs; D010879:Piperazines; D011619:Psychotropic Drugs
keywords: Drug policy; New Zealand; Psychoactive Substances Act 2013; legal drug market; legal highs; new psychoactive substances (NPS)