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?

Abstract

In July 2013, New Zealand established the world's first regulated legal market for new psychoactive substances (NPS) (i.e. ‘legal highs’) with the passing of the Psychoactive Substances Act (PSA) 1, 2. This approach has received considerable international attention as a possible solution to the ongoing problems with NPS which could be adopted in other countries 3-8. The UK NPS Expert Panel recently called on the UK Government to monitor the New Zealand regime, including its public health impacts and the mechanisms used to identify ‘low-risk’ psychoactive products 9. Implementation of the PSA has proved to be controversial. The transitory interim regime, which allowed a limited number of existing products continue to be sold subject to new retail restrictions (i.e. R18, no sales from convenience stores, limited advertising) 10, was brought to an abrupt end by the passage of the Psychoactive Substances Amendment Act (PSAA) 11 on 7 May 2014, following reports of adverse effects from products 12. While the ending of the interim regime was viewed widely as a set-back, a potentially more fatal impact of the PSAA was the decision to prohibit the use of animal tests (including tests conducted overseas 13, 14) to demonstrate that products are ‘low-risk’ and thus able to be approved for legal sale 15, 16. The animal testing ban followed public protests against the harming of animals for the purpose of testing products with no therapeutic effect 12, 14. The Psychoactive Substances Regulatory Authority (PSRA) has gone so far as to state that: ‘it is unlikely that a product can be shown to pose no more than a low risk of harm without the use of animal testing’, suggesting that the PSA was now unworkable 13. Other commentators have expressed greater optimism. The legal high industry lobby group predicted recently that there is an ‘over 80% chance’ that an approved psychoactive product will be available for sale by the end of 2015 17. Our reading of the PSAA and engagement with key stakeholders suggests four possible ways forward: (1) modify the animal testing ban (e.g. allow testing on select species); (2) wait until validated non-animal models are available to assess all aspects of product safety crucial to demonstrate low risk; (3) challenge the rejection of product applications in court by questioning whether the animal testing ban is consistent with the stated purpose of the PSA to create a regulated NPS market; and (4) ‘creatively comply’ with the law by providing required evidence of low risk without direct reference to animal tests. This may involve supporting a product application with data from human clinical trials following animal tests (completed overseas) without directly referencing the animal testing, and may entail application for approval of a pharmaceutical product with psychoactive effects which already has extensive safety data (i.e. a ‘failed medicine’). The PSRA has signalled that regulations for the full regime will be finalized by mid-2015, so there is growing urgency for a political, regulatory or judicial solution to the impasse. We are continuing to investigate and assess the feasibility of the above options. What is clear from the short-lived interim regime is that the financial returns of a legal market are considerable (estimated $140 million annual retail sale 12), and this may focus decision-makers’ minds. None.