Regulatory approaches to new psychoactive substances ( NPS ) in the E uropean U nion

Wilkins' review of New Zealand's approach to the issue of new psychoactive substances (NPS) 1 raises questions relevant to current deliberations within the European Union (EU). Among these are the regulation of the market and the difficulties of assessing, in an appropriate time-frame, the risk profile of NPS. The recent European Commission proposal for a new regulation in this area 2 is based partly on the idea that a significant legitimate market in NPS for commercial and industrial purposes requires protection, and so it is legally based on a Treaty article to improve the functioning of the internal market. It includes a three-level assessment process. Substances judged as ‘low risk’ would not be acted upon at the EU level, while consumer market prohibition would be introduced for ‘moderate-risk’ and drug control measures for ‘high-risk’ substances. Unlike the New Zealand model, the responsibility and costs of assessment do not lie with the producer, and the low-risk category is not intended for limited consumer distribution; it is this shift towards regulation which makes the New Zealand model unique 3. Although EU deliberations are at an early stage, some member states have already raised concerns 4. Since 1997 a mechanism has existed in Europe for identifying and responding quickly to the risks of NPS based on analogy to drugs controlled by the international Conventions. It has three levels: an early-warning system (EWS); risk assessment by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)'s scientific committee of substances identified as potential threats, and political decision at European level enacted through national legislation. This existing mechanism has allowed the EU to be early in recognizing the emergence of the NPS issue, with more than 300 substances now monitored. The phenomenon has, however, become increasingly complex. NPS are sold in shops or through the internet, others appear on the illicit market sold as, or mixed with, controlled substances. Interactions are seen with the market for counterfeit or unlicensed medicinal products 5. Some NPS have, after control, become established on the illicit market 6. NPS have also moved beyond the recreational drug market and use, including injecting, is reported among some groups of chronic problem drug users. Wilkins notes that there are other approaches to NPS control that also merit evaluation. Examples of these can be found within the EU, reflecting the region's relatively long awareness of this issue 7. Independent scientific risk assessment systems exist in some countries, although assessment may not always be in the public domain 8 and recommendations are not always acted upon 9, 10, attracting criticism 11. Several countries have introduced generic or analogue definitions in their drug laws, although the latter can be difficult to enforce 12, and in general new NPS compounds have appeared that fall outside even wide net definitions. Fast-track procedures have also been introduced, allowing the temporary banning of substances under assessment; another approach has been to focus efforts on penalizing distribution but not use 13. While convenient, the credibility 14 and acceptability 15 of laws based simply on the sale of possibly psychoactive products is questionable. As in New Zealand, three European countries (Ireland, Poland, Romania) have chosen to reverse the established control model, using effect-based definitions 13; the supply of any unregulated psychoactive substance that meets certain criteria is banned unless specifically permitted. Ostensibly, two also have ‘pre-market approval regimes’. In Poland, a substance may be risk-assessed by the State Sanitary Inspectorate for up to 18 months, at the cost of the distributor if it is judged to be harmful (and the State if not). Romanian law establishes a detailed pre-authorization risk assessment procedure that would take about 6 months to determine whether a substance may be sold without restriction. We have no data on the use of these regimes. All three countries appear to have some success in stopping open sale 16 and impacting, at least in the short term, upon use, although evidence of a subsequent limited bounce-back also exists. So far this approach has not been legally challenged successfully, but this remains an unclear area. The Autonomous Region of Madeira, for example, recently attempted to introduce an offence to distribute ‘psychoactive substances not regulated by other laws’, which was struck down for vagueness 17. The potential benefits of the New Zealand approach include reducing the introduction of unregulated NPS and that regulated substances compete with and therefore reduce the use of controlled drugs. If this occurs it will be important, but the European experience to date would not encourage optimism. Recent risk assessments have focused upon substances that target the different consumer preferences for all main drugs of abuse, with comparable harms to health. It is hard to imagine that such substances will not continue to appear regardless of the availability, or not, of regulated low-risk products. Similarly, the NPS that have tended to become popular over time in Europe are those that are regarded by users as offering acceptable alternatives to readily available controlled drugs. It will be interesting to see if the NPS industry can compete with products that have both an acceptable safety profile and remain sufficiently interesting to consumers whose preferences are towards the pharmacological action of substances where, to some extent, the health risks are inherent. None.