title: 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.
abstract: BACKGROUND
  In mid-July 2013, New Zealand passed the Psychoactive Substances Act (PSA), which allowed 'low risk' psychoactive products ('legal highs') to be approved for legal sale. In early May 2014, following public protest, the Psychoactive Substances Amendment Act (PSAA) was passed banning animal testing of psychoactive products, potentially making the new regime unworkable.
  
  
  OBJECTIVE
  To investigate strategies to overcome the impasse created by the animal testing ban.
  
  
  METHODS
  Solutions to the impasse were investigated using 'scenario' and 'stakeholder' analysis. Legislation, parliamentary debates, and regulatory statements related to the PSA and animal testing were reviewed. Strategies to resolve the impasse were discussed with stakeholders including the Psychoactive Substances Regulatory Authority (PSRA) officials, health officials, a legal high industry lawyer, and a leading legal highs manufacturer. This process generated six possible scenarios and five decision-making criteria of key importance to major stakeholders. Scenarios were then evaluated based on feedback from the industry and regulators.
  
  
  RESULTS
  The six scenarios were: (1) pragmatic modification of the animal testing ban; (2) waiting until new non-animal test models are internationally accepted; (3) use of non-validated replacement test methods; (4) judicial challenge of the animal testing ban; (5) 'creative compliance' by only presenting human clinical trial results; and (6) philosophical re-conceptualisation of the 'benefits' from psychoactive products. Options 1 and 5 appear to be the most attractive overall solutions. However, both rely on a new political consensus and astute framing of the issues by political communicators. Political decision makers may be happy to accept Scenario 2 which would impose significant delays.
  
  
  CONCLUSIONS
  A 'failed' pharmaceutical product with psychoactive effects may have the test data required to be approved under Scenarios 1 and 5. Ultimately, the pleasurable benefits from psychoactive products may need to be included in the debate.
authors.affiliation: SHORE & Whariki Research Centre, Massey University, PO Box 6137, Wellesley Street, Auckland, New Zealand. Electronic address: m.rychert@massey.ac.nz.
authors.forename: Marta
authors.initials: M
authors.lastname: Rychert
authors.affiliation: SHORE & Whariki Research Centre, Massey University, PO Box 6137, Wellesley Street, Auckland, New Zealand.
authors.forename: Chris
authors.initials: C
authors.lastname: Wilkins
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence*; D003132:Commerce / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D009520:New Zealand; D011050:Policy Making; D011619:Psychotropic Drugs
chemical_list: D011619:Psychotropic Drugs
keywords: Animal testing ban; Legal highs; New psychoactive substances (NPS); Policy impasse; Regulated market