New psychoactive substances: issues about the new approach from New Zealand government.

Abstract

The regulation of new psychoactive substances (NPS) is a challenge for governments throughout the world. Different approaches have been used to address the problem, although most forbid their use. In July 2013, the New Zealand government proposed a new NPS regime which placed the onus onto manufacturers to prove that their products pose a low risk of harm, prior to receiving approval. One positive aspect of this proposal is that more information will be gathered before the government makes the decision of whether to allow or forbid an NPS. Lack of data on the safety or danger of NPS has led governments to make decisions that are not based on scientific evidence 1. The paper by Wilkins 2 identifies important questions about this new approach, although additional issues were also noted. The first issue is related to whether the manufacturers of NPS will submit their drugs for approval. When considering the high application fee, the huge costs and long time required for clinical trials, and the need to conduct the entire protocol for each final product, the process will probably be extremely expensive and time-consuming. Additionally, in recent decades, NPS manufacturers have attempted to circumvent law and drug regulations. For example, many NPS are created by introducing slight modifications into the chemical structure of controlled substances 3. Is it expected that these same manufacturers will wait years and spend a great deal of money in an attempt to legalize their products? This great difficulty in legalizing a substance may have a similar impact to its restriction. The second issue is whether clinical trials will properly evaluate NPS. As noted by Wilkins, some important aspects, such as high consumption episodes, polydrug use, use by vulnerable populations, high-risk modes of administration and long-term adverse effects, will most probably not be assessed by these studies 2. Moreover, as a therapeutic effect is not the aim, the dosage of the product tested may be the lowest possible in an attempt to mask potential side effects. What will be the sample size of such clinical trials? Small samples are not sufficiently robust to detect even less rare adverse effects. Even so, is it ethical to conduct a clinical trial with a product that has potential harm and no clear benefit? The third issue that is central to this discussion is the purpose of legalizing an NPS with no therapeutic effect. Some argue that such drugs could substitute for more dangerous drugs and reduce their use 4. However, there is no scientific evidence in support of this argument. In New Zealand, from 2005 to 2008, benzylpiperazine (BZP) party-pills were legally available for purchase, although subject to regulations 5. The impact that this ‘legal status’ had on young people was to indicate that it was safe and socially acceptable, suggesting that they could take more pills 5. The argument that prohibition enhances organized crime also does not appear to be very consistent. For example, the ecstasy and marijuana markets have little connection with organized crime 1. However, prohibition reduces the possibility of quality control and assurance of NPS. This is an emerging and complex theme with no simple solution. A longitudinal evaluation of New Zealand's approach to NPS will permit further conclusions about its applicability and usefulness in other countries. None.