INTERGOVERNMENTAL COMMITTEE ON DRUGS (IGCD)

FRAMEWORK FOR A NATIONAL RESPONSE

TO NEW PSYCHOACTIVE SUBSTANCES

JULY 2014

Contents

1. Summary of proposed response..............................................................................22. Background..............................................................................................................23. Challenges and Key Considerations........................................................................24. Guiding principles.....................................................................................................25. Elements of a National Response............................................................................2

1. Detection and identification capability..................................................................22. A Drug Monitoring System and associated data collection......................................23. Harms assessments..............................................................................................24. Rapid response laws.............................................................................................25. Uniform treatment of drug analogues...................................................................26. Consumer protection laws....................................................................................27. Other existing laws...............................................................................................28. A Broad Precautionary Psychoactive Substances Control Scheme............................29 Developing agreed terminology............................................................................210 Public awareness and education.......................................................................211 Better coordination between jurisdictions...........................................................212 International Engagement.................................................................................2

Appendix A: Current systems/networks for sharing information on NPS.................2Appendix B: Drug Monitoring System, Issues for consideration..................................2Appendix C – Proposal for a uniform definition of drug analogue................................2Appendix D: NPS Regulatory Options: International Models....................................2

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1. Summary of proposed response

ICGD members agree that:

1. Detection and identification capability

Certified Reference Materials (CRMs) play an important role in identifying NPS, and potentially their metabolites, and need to be kept up-to-date in the face of an evolving drug market.

Improved forensic capability at a national level is essential to enhance agencies’ ability to identify and detect a range of NPS to acceptable scientific standards, including through the provision of physical samples of CRMs.

Given the nature of the NPS market, CRMs may not always be available and jurisdictions should explore other opportunities to enhance existing forensic capabilities to ensure that they can keep pace with the introduction on NPS.

The Illicit Drug Specialist Advisory Group is best placed to explore options to support the identification of suspected NPS where CRMs to support chemical characterisation are not available.

2. A Drug Monitoring System and associated data collection

Timely dissemination and sharing of intelligence will increase the speed and accuracy of responses to NPS and reduce duplication of effort and unnecessary cost.

Jurisdictions should establish standing arrangements to share information between law enforcement, forensic, health and policy agencies and discuss and prioritise the jurisdictional response to NPS.

A comprehensive arrangement to share information relating to NPS between jurisdictions should be developed.

The Commonwealth’s proposed Drug Monitoring System, which will contain relevant unclassified reporting and information relating to the identification of NPS, will usefully complement existing information-sharing systems.

3. Harms assessments

Responses requiring the inclusion, or analysis, of health and/or social risks should be developed by Commonwealth Health and/or jurisdictional health departments with relevant expertise.

A comprehensive national framework for prioritising and sharing information on harms assessments should be developed.

4. Rapid response laws

The ability to carry out emergency or temporary scheduling of NPS where their harm is not known is a key mechanism in protecting the public from potentially harmful substances.

Jurisdictions should ensure that they have enacted appropriate emergency or temporary scheduling provisions. Jurisdictions should aim for national consistency in emergency or temporary scheduling provisions.

Jurisdictions should communicate scheduling actions and proposed actions to each other.

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A comprehensive arrangement to share information between jurisdictions relating to emergency or temporary scheduling decisions should be developed.

5. Uniform treatment of drug analogues

Drug analogue provisions, which expand the coverage of controls on illicit substances to include substances with similar chemical structures, are crucial in ensuring that harmful substances are banned and that controls are not easily circumvented.

Jurisdictions should aim for national consistency in definitions of drug analogues, including considering using the model definition set out in Appendix C.

6. Consumer protection laws

Consumer protection bans are just one of a number of ways to control the sale of NPS.

While these consumer protection laws may offer a rapid response option, NPS are more appropriately controlled through drug legislation administered by health and law enforcement agencies.

Long term consumer product bans based solely on product or “street” names have limited utility

7. Other existing laws

Keeping lists of controlled substances up to date is critical in ensuring that substances known to be harmful are subject to appropriate controls and restrictions.

Where they have not already done so, jurisdictions should consider processes to automatically update controls on substances in line with the Commonwealth Standard for the Uniform Scheduling of Medicines and Poisons.

8. A Broad Precautionary Psychoactive Substances Control Scheme

The development of a national precautionary scheme to control NPS at the border will help to address the problem and respond to emerging drug markets.

To deal with the rapid rate of emergence of NPS, jurisdictions should consider implementing broad precautionary schemes to ban potentially harmful substances without a legitimate use or which are designed to mimic illicit drugs.

Jurisdictions should work together to ensure that their schemes to control NPS are complementary and there are no regulatory gaps.

To assist in building an evidence base about the structure and potential harms of NPS, jurisdictions should consider whether any broad precautionary schemes to control NPS should also include mechanisms to allow law enforcement to seize NPS in the possession of individuals.

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9. Developing agreed terminology

In most instances, the term “new psychoactive substances” should be used in official correspondence and messaging, to ensure consistency with language used by major international sources of information on these drugs. Terminology should be developed to consistently and clearly describe the categories of NPS to support clear policy and technical discussions

10. Public awareness and education

Key public awareness messages about NPS should include the facts that these substances are not legal alternatives to prohibited drugs, they are of unknown composition and purity, the effects can be highly variable between batches and individuals and far from being safe, they can expose people to harms associated with physiological reactions, overdose and erratic behaviour.

Given the variability of the drug market in different states and territories, local public awareness messaging may need to vary to accommodate local circumstances.

11. Better coordination between jurisdictions

The IGCD plays a key role in bringing together officers from Commonwealth, State and Territory Health, law enforcement and justice agencies to discuss how to work together to address issues surrounding NPS, and these networks should continue to be formally and informally used.

The IGCD should continue to draw upon the expertise of agencies outside the IGCD membership when those agencies have an integral role in addressing a particular aspect of the NPS problem.

12. International Engagement

Australia should maintain international engagement on NPS issues.

Agencies should continue to cooperate, both operationally and on policy responses, with overseas partners to respond to NPS.

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2. Background

In recent years, law enforcement and health professionals have seen the emergence of new drugs and chemicals that have pharmacological effects akin to existing controlled drugs. These drugs can be collectively called New Psychoactive Substances (NPS). While the pharmacological effect of these substances is often reportedly similar to existing drugs, the harm and long term-toxicity caused by these substances is usually unknown.

NPS are often marketed as alternatives to internationally controlled drugs. NPS have also been detected mixed with or sold as common internationally controlled drugs. The NPS market remains relatively small but is evolving rapidly, both in scope and in the substances involved, aided by advances in manufacturing and by the distribution and marketing opportunities provided by the internet.

NPS is a transnational and national issue that poses unique challenges for governments. The rate at which new NPS are emerging, and the fact that there are a range of potential health risks poses challenges for identification, monitoring, community education, harms assessment and traditional regulatory and treatment responses.

This paper sets out the IGCD’s Framework for a national response to NPS.

DEFINITION

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) defines a ‘new psychoactive substance’ as ‘a new narcotic or psychotropic drug, in pure form or in preparation, that is not controlled by the 1961 UN Single Convention on Narcotic Drugs or the 1971 UN Convention on Psychotropic Substances, but which may pose a public health threat comparable to that posed by substances listed in these conventions.’

The United Nations Commission on Narcotic Drugs and United Nations Office on Drugs and Crime (UNODC) also use the term ‘new psychoactive substances’ to define such substances.

There are an almost limitless number of possible synthetic drug compounds. International evidence suggests that there are large numbers of these drugs on the market, and hundreds more are believed to be held in reserve by illicit manufacturers to be released progressively to stay ahead of legislative controls. For example, the EMCDDA is monitoring about 300 new substances: 24 were first identified in 2009; 41 in 2010; 49 in 2011 and 73 in 2012. New substances are now emerging at a rate of more than one per week.

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CURRENT CONTROLS

A range of NPS, including several forms of synthetic cannabinoids, 3,4-methyl-methcathinone (mephedrone), 3,4-methylenedioxypyrovalerone (MDPV), other cathinones and phenethylamines, with similar effects to more commonly known internationally controlled drugs such as cannabis and amphetamine type substances (ATS), have already been identified as potential risks to public health and are controlled in Australia. Where controls vary across jurisdictions, this can create inconsistency and uncertainty about whether or not these substances are legal or illegal. In 2013 there has been a move towards greater alignment of Commonwealth and state and territory level controls, and all jurisdictions have aligned their drugs and poisons legislation to cover those substances listed as prohibited under the Commonwealth Poisons Standard. There is still variation in relation to approaches to enforcement.

Commonwealth

At the Commonwealth level, synthetic drugs which have been identified in Australia as posing a risk to public health have been scheduled as Prohibited Substances under the Commonwealth Poisons Standard (the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)), which is administered by the Therapeutic Goods Administration. This has been either by the inclusion of entries for specific substances or broad classes of substances and included a broad generic listing in 2012 capturing all substances which mimic cannabis-like substances.

In addition, a number of new substances are now subject to the Commonwealth serious drug offences framework, the analogue clause has been successfully used, the Prohibited Imports Regulations have been updated to capture a number of these substances as they have emerged. In 2013 interim Product Safety bans have also been used at a national level to support action by states.

Changes have also been made to the serious drug offences framework to better meet the emerging threat. Substances may now be listed quickly and permanently in the Criminal Code Regulations 2002 (Cth) once the relevant criteria, which is harm and evidence based, have been met.

To provide for even quicker response when the full harms are not yet known, substances may also be listed temporarily under an emergency determination made by the responsible Minister. These emergency determinations last for 12 months, extendable to 18 months, so that suitable testing and analysis may take place. Substances listed temporarily are subject to the full range of serious drug offences in the Criminal Code.

States and Territories

States and territories have introduced controls on many NPS. Each State and Territory has its own laws that determine what substances are subject to criminal controls. Some adopt the Commonwealth Poisons Standard schedules by reference. Others replicate certain schedules with amendments.

Jurisdictions have also each independently incorporated certain synthetic cannabinoids and other new substances into their legislation. Further, other approaches, such as extending analogue clauses and using consumer protection laws, have also been adopted in some jurisdictions. Some jurisdictions have introduced broader non-substance-specific controls, such as those prohibiting unregulated substances with psychoactive effect or substances with or purported to have similar pharmacological effect to controlled drugs.

Internationally 6

NPS are not subject to control under the international conventions (the Single Convention on Narcotic Drugs, 1961: the Convention on Psychotropic Substances, 1971; or the Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988). However, many UN member states have put in place measures to address the emergence of these substances. Most notably, Ireland and New Zealand have introduced broad ‘precautionary’ scheme to prohibit or control unregulated NPS and which seek a pre-emptive approach to controlling new psychoactive substances. This is discussed in more detail below.

3. Challenges and Key Considerations

The rate at which new NPS are emerging, and the fact that there is little available evidence of their health risks, poses challenges for identification, harms assessment and traditional regulatory responses.

Lack of a sufficient evidence base on NPS

By definition a substances which has significant psychoactive properties has the capacity to subject the user to the risk of short term harm. Longer term health effects are not known due to the short time many of these substances have been on the market. However there is strong evidence that impacts similar to conventional illicit drugs can arise from use.

Many NPS have been marketed as ‘legal highs’ or ‘safe and legal’, and/or packaged as a product not for human consumption. Until recently they have been available through the legitimate retail environment, in part because of delays at a jurisdictional level in aligning state drug control law to national controls. However, most of these substances have not been subject to scientific testing, largely because NPS are emerging and disappearing so rapidly. When initially detected, these substances require identification, which is a costly and time consuming process, particularly without reference materials. The limited availability of suitably certified reference materials makes it more difficult for authorities to meet the evidentiary burden in court. Other issues contributing to a poor evidence base include:

• Most current drug reporting systems do not collect data on these substances• Self-report data is flawed as users are not always aware of what they are taking• Often products are not accurately labelled• Products have no quality control and ingredients vary significantly from batch to batch• Many substances cannot be positively identified by routine detections technologies• There is little or no toxicological or coronial data• Because most NPS are not controlled, often data is not collected• Evidence is not readily available on best practice treatment responses, where users

experience adverse impacts

Speed of response

There are already hundreds of known NPS, with many more that could be released at any time. Systems used to manage NPS must be able to respond quickly to an anticipated constant stream of substances expected to be released onto the market.

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Legitimate use

Consistent with the approach applied to therapeutic goods, foods and beverages, agricultural, veterinary and industrial chemicals, any decision to control NPS must be balanced against the consequences of banning as yet unknown substances which may have legitimate uses. This unintended consequence will be diminished with legislation that specifically excludes ordinary products and/or enables exemptions.

Using other laws – therapeutic goods, food safety, environmental protection

A number of existing regulatory frameworks may also be relevant when addressing NPS, including regulations that require pharmaceutical, agricultural and veterinary goods or food on sale to be clearly and accurately labelled in relation to their use, laws penalising false or misleading advertising, and placing licensing requirements or age restrictions on the outlets selling these goods.

Drug categories and certainty under criminal law

Many new NPS are slight chemical variants on earlier ones, which presents a challenge in terms of drug control legislation. There is a need for controls and offences according to broader types or categories.

Existing analogue clauses already provide for the ability to capture a wider range of substances than are specifically listed. For example, the Commonwealth serious drug offences apply to substances that have a particular structural modification from a controlled drug. To some extent, analogue clauses such as the one found in the Criminal Code already provide for new and emerging drugs to be quickly captured by the provisions, provided these specified structural modifications are met. There are of course gaps in an approach that only relies on analogue clauses to capture emerging drugs. In particular, gaps are evident in relation to substances that mimic the effects of controlled drugs that are not structurally similar to a listed drug. Temporary scheduling mechanisms could allow for substances that have a similar pharmacological or physical effect to a listed drug to be captured by offence provisions. However, this is reliant on some knowledge of the effects and harm of the substance, which are often difficult and time consuming to establish.

Technical Support

The unprecedented increase in the number of substances of concern will require increased capacity in areas such as chemical analysis, toxicology, harms assessments and drug data for identification. This will be needed for frontline detection, healthcare responses, intelligence, investigation and prosecution purposes. Information sharing will go some way to providing this capacity, but increased resourcing is likely to be needed as well to keep up with the suppliers. This level of technical support will need for example, to enable translation of newly emerging substances into communications about how the substance may present on the street – names, appearance and ease of detection.

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Treatment Capabilities and Harm Minimisation

These new substances cover a broad range of chemicals with a broad range of pharmacological effects. It may be appropriate to use existing treatment modalities for users of some substances, while others may present unique challenges requiring the development of new capabilities. It will be particularly important to have new information as it becomes available to ensure that acute responses to adverse responses to NPS are available.

Displacement of law enforcement and other resources

Depending upon how NPS are controlled, this may have a flow-on effect on the resources of Customs, forensics laboratories, police, prosecutors, courts and correctional services. Monitoring and analysis of harms will also place demands on health services.

Unintended consequences

Like any market, the market for illicit substances responds to changes in supply and demand, competition, user preferences and fashion, profit, or the availability of raw materials. In considering response measures, governments need to consider the likely effects on the market for the substance, as every intervention changes the mix of incentives and risks that shape the behaviour of the particular illicit drug market. It is also important, given continuing confusion over legality, that consumers are not unfairly treated in the transition to new controls, where products previously legal become subject to new laws or regulation.

Risks from non-substance-specific impairment

In certain situations, such as in the workplace or driving, short-term functional impairment from NPS can present unacceptable risks. Substance-specific tests for many NPS are not easily available and impairment-based testing may need to be considered.

Upstream implications – precursor chemicals

Each NPS will have a number of precursor chemicals used in its manufacture. Some of these precursor chemicals may overlap with those used to manufacture controlled drugs, and may already be subject to controls. At present there is no evidence of significant local manufacture of the actual substances. However, additional controls on NPS may require further regulation of precursor chemicals (or even some automatic controls where legislation includes precursor clauses).

Alternate Sentencing

In accordance with the harm minimisation approach of the National Drug Strategy 2010-2015 (NDS), it is important that users of new substances and substances with unknown harms are able to access appropriate options and are not inadvertently subjected to harsher penalties or more limited options than users of established drugs. In particular, if new controls are introduced they should maintain the existing discretion to divert users into alternate sentencing regimes or treatment programs where available. As with other aspects of the NPS strategy, efforts should be made toward nationally consistent eligibility criteria.

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Harm relative to other drugs

While NPS create new challenges, it is important not to overstate their importance in the wider context of drug use in Australia. The NDS makes it clear that the drugs that cause the greatest harm to public health remain alcohol and tobacco. Equally, although individual NPS may be more harmful than some established illicit drugs, the overall harms of NPS – so far at least – remain slight in comparison with those of the established illicit drugs, particularly heroin, cocaine and ATS.

While the harms of many of the NPS are yet to be fully established a wide range of potential harms have been identified. Unless these substances are approved for legitimate use a preventative approach should be adopted to ensure public safety.

There is also a risk that a lack of response may lead to a large demand market becoming established.

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Potential interest to organised crime

Supply of NPS to date has been largely driven through personal and online networks. However, due to the potentially large profits, ease of access and an established user market, there is significant potential for organised crime to become increasingly involved in the supply and trafficking of NPS. Particularly as criminal groups know that the risk of identification is low compared to other drugs and the ambiguity of substances’ legal status can make prosecution challenging. There is already evidence that organised crime is becoming involved in some supply of NPS. There have been multiple large scale detections domestically and at the border.

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4. Guiding principles

Drawing from the issues outlined above, a national response to NPS should be guided by the following seven guiding principles.

1. Protect Australians: Australia’s national response to NPS must protect Australians from the risks posed by untested, unknown and potentially harmful products sold through various sources including shopfronts and the internet.

2. Align with the National Drug Strategy: the response should be based on the principles set out in the NDS, with the objective of minimising harm through a balanced suite of demand reduction, supply reduction and harm reduction measures, including but not limited to legislation.

3. Develop appropriate actions: precautionary, preventive and rapid actions as well as harm minimisation strategies should be used where possible, followed by full harms assessments and long term controls where appropriate.

4. Use existing frameworks and infrastructure: existing frameworks for controlling illicit drugs and other dangerous substances, forensic capability, drug and alcohol research capability, and networks within the drug and alcohol sector provide opportunities for responding in certain circumstances and should be used wherever possible.

5. Develop an evidence base: a commitment to the development of a solid evidence base to inform decisions, backed by technical, information and forensic capabilities is vital. Appropriate monitoring and surveillance processes should be put in place.

6. A commitment to coordination across jurisdictions and sectors: the differing responsibilities and powers of the Commonwealth relating primarily to identification of harmful substances, border control and international engagement, and of states and territories relating to domestic controls, require a cross-jurisdictional commitment to share information, coordinate responses and achieve legislative and broader policy consistency where possible.

7. Promote clear and agreed information: including appropriate information to the community to dispel the myth that NPS are safe or legal.

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5. Elements of a National Response

The national response to NPS is divided into four categories:

establishing a solid evidence base and response capabilities implementing appropriate legislative responses raising public awareness, and increasing national and international coordination.

The following section of this paper deals with each of the four categories and sets out an agreed way forward.

Given that this is an emerging and complex issue it is not likely that any one approach will prove sufficient to guarantee public safety. It is therefore important not to consider the responses canvassed below as competing alternatives to each other, but rather as aspects of a comprehensive national response.

Some of the elements of this comprehensive national response can be actioned immediately. Others will be subject to resourcing, policy and legislative processes that will take longer.

Establishing a solid evidence base and response capabilities

1. Detection and identification capability

The rapid expansion and evolution of the NPS market and the substances it involves continues to challenge the detection capabilities of Australian health and law enforcement agencies and forensic facilities. This is a critical problem which is faced by all jurisdictions.

Detection and analysis equipment used by front-line police and forensic laboratories are dependent on Certified Reference Materials (CRMs). This is a key gap in responding to the NPS challenge.

A recent IGCD Cost Shared Funding Model (CSFM) proposal was developed by the Australian Federal Police (AFP) in consultation with key partners, namely the National Measurement Institute (NMI) and Australian Customs and Border Protection Service (ACBPS), in order to address the NPS gap. The proposal has now been endorsed by the Mental Health, Drug and Alcohol Principal Committee (MHDAPC).

The proposal will facilitate, over a 12 month period, the procurement, certification and distribution of approximately 170 reference materials through the AFP partnership with the NMI, targeted against substances currently appearing across Australian jurisdictions. This will assist operational law enforcement with more timely detection of substances at the border, at domestic street seizures and in the laboratory.

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While this proposal will allow Australia’s law enforcement agencies to ‘catch-up’ to the current wave of NPS, the dynamic nature of the NPS market means that suitable CRMs may not always be accessible in a timely manner, particularly to meet the demands of intelligence and operational investigations, or to support potential early warning systems.

In these circumstances, chemical characterisation of the emerging NPS could be supported through a number of other processes including the use of published peer reviewed data or secondary standards. The Illicit Drug Specialist Advisory Group (ID-SAG), which is a national group of forensic representatives responsible for promoting science excellence, is best placed the explore these options.

There are also a range of initiatives that may assist law enforcement, health and treatment experts to identify NPS and NPS use. For example, a number of law enforcement agencies use drug screening devised for the rapid identification of the presence of a controlled substance. However, current devices have a very limited capability with respect to NPS. This is largely due to the rapid emergence on new substances and the limited availability of CRMs.

ICGD members agree that:

Certified Reference Materials (CRMs) play an important role in identifying NPS, and potentially their metabolites, and need to be kept up-to-date in the face of an evolving drug market.

The IGCD’s Cost Shared Funding Model proposal to be undertaken by the AFP, which will provide forensic laboratories with physical samples of CRMs for a number of known NPS, will enhance agencies’ ability to identify and detect a range of NPS to acceptable scientific standards.

Given the nature of the NPS market, CRMs may not always be available and jurisdictions should explore other opportunities to enhance existing forensic capabilities to ensure that they can keep pace with the introduction on NPS, and to sustain forensic capability at the conclusion of the 12 month IGCD project.

The Illicit Drug Specialist Advisory Group is best placed to explore options to support the identification of suspected NPS where CRMs to support chemical characterisation are not available.

2. A Drug Monitoring System and associated data collection

While there are a number of existing information and data-sharing systems and networks operating at a jurisdictional, national and international level, there is no consistent national coordination and accessibility for information regarding emerging substances. Due to the nature of the NPS market, many substances are initially identified and assessed in other countries before they appear in Australia, and often appear in some Australian jurisdictions before others. Timely dissemination of intelligence from all these sources could increase the speed and accuracy of responses and reduce duplication of effort and unnecessary cost.

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Existing information sharing mechanisms

South Australia, New South Wales and Western Australia have established interagency working groups, consisting of representatives from law enforcement, health, forensics and policy. These groups meet regularly to discuss NPS and provide advice to stakeholders through various means. In addition to these formal information-sharing networks, jurisdictions also have informal networks, both within and across agencies, for disseminating relevant information relating to NPS. For example, Queensland, South Australia and Western Australia provide regular updates on NPS through published newsletters and bulletins.

On a national and international level, data on NPS from various Australian projects is collected and collated to inform a number of reports, including the Australian Crime Commission’s Illicit Drug Data Report and the UNODC’s World Drug Report.

A number of national committees and advisory bodies have been established to progress health and law enforcement issues related illicit drugs and NPS, in support of the pillars of the National Drug Strategy 2010-2015. These include the National Policing Senior Officers Group (NPSOG) and the Standing Council on Police and Emergency Management (SCPEM), but also:

Australian Government Drug Officers Group (AGDOG);

Australian National Council on Drugs (ANCD);

Intergovernmental Committee on Drugs (IGCD);

The majority of these national committees or advisory bodies consist of representatives from Commonwealth, State and Territory law enforcement and/or health agencies. Other advisors, for example technical advisors in the form of forensic experts, may be invited as required.

Informal reporting also takes place through the Illicit Drug Specialist Advisory Group (ID-SAG), as well as the transnational Clandestine Laboratory Investigating Chemists (CLIC) Association and the Scientific Working Group for the Analysis of Seized drugs (SWGDRUG).

Further information on existing systems and networks are set out in Appendix A.

At a minimum, information and data sharing on NPS would be improved if each jurisdiction established a formal interagency working group to facilitate this sharing. The membership would need to include representatives from law enforcement agencies, forensic laboratories, health and policy departments. The role of each working group will be to discuss and prioritise the response to NPS within each jurisdiction. Responses may vary depending on the category or ‘tier’ rating of each NPS, with possible thresholds to be determined based on number of overdoses or identifications (i.e. internet forums, health services, forensic laboratories).

The prioritisation and relevant responses to NPS, identified within each jurisdiction, would feed into discussion at the national level in order to enhance inter-jurisdictional collaboration. A key focus of the national committee should be to coordinate jurisdictional responses and identify avenues for further investigation. The committee will draw upon existing networks, including research institutions, in order to develop an informed national response for consideration by relevant decision makers. This may be in the form of a Joint Report with relevant jurisdictions or research institutions, and should be made available to key stakeholders.

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Drug Monitoring System (DMS)

The Commonwealth will develop an online database, which will contain relevant unclassified reporting and information relating to the identification of NPS. It will make use of existing intelligence sharing networks and information sources from around Australia and internationally where possible, and make intelligence available to relevant agencies. The database would provide a secure source of information regarding new psychoactive substances including such things as their chemical data, formal nomenclature and geographic distribution. Provisions can also be made for appropriate health authorities to upload data on harms. The system would ideally be an automated secure access IT system which would provide an updatable database and alert/message service, and enable stakeholder contributions from all jurisdictions. The DMS should not be viewed as a replacement for existing systems and networks. It should complement and provide an additional avenue for sharing information. The database will be available to key stakeholders via secure log in.

The usefulness of such a system will depend upon the size of the evidence base it is able to draw upon. Agreement will be required regarding terminology, classification and data collection. Engagement with international systems and with border and domestic detections and healthcare presentations will all add value, but may incur costs.

Some of the key considerations in developing the DMS are set out at Appendix B.

IGCD members agree that:

Timely dissemination and sharing of intelligence will increase the speed and accuracy of responses to NPS and reduce duplication of effort and unnecessary cost.

Jurisdictions should establish standing arrangements to share information between law enforcement, forensic, health and policy agencies and discuss and prioritise the jurisdictional response to NPS.

A comprehensive arrangement to share information relating to NPS between jurisdictions should be developed.

The Commonwealth’s proposed Drug Monitoring System, which will contain relevant unclassified reporting and information relating to the identification of NPS, will usefully complement existing information-sharing systems.

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3. Harms assessments

Harms assessments are a vital part of the evidence base for consistent, effective and appropriate controls, and in many cases are required before controls can be introduced for new substances.

While many jurisdictions have existing frameworks in place there is a lack of coordination and communication between these, and opportunities exist to increase efficiencies and responsiveness on a national scale. National cooperation and information sharing would enhance efficiency and the assessments could then provide the basis of nationally consistent decisions on the long-term regulation of a substance if necessary. Once harm assessments have been completed, the drug monitoring system could provide a means for this information sharing, with relevant data contributed by appropriate experts. Other existing frameworks, such as the Therapeutic Goods Administration and the Food Standards, may provide useful models or may be appropriate channels to assess some substances relevant to them.

IGCD members agree that:

Responses requiring the inclusion, or analysis, of health and/or social risks should be developed by Commonwealth Health and/or jurisdictional health department with relevant expertise.

A comprehensive national framework for prioritising and sharing information on harms assessments should be developed.

Legislative responses

4. Rapid response laws

The rate of appearance of new, potentially harmful substances is too rapid for full harms assessment processes and long term legislative responses alone to respond. Rapid response mechanisms are required which can adapt quickly to newly identified NPS which carry a significant risk of harm. Such mechanisms should operate on the principle of precautionary community safety. These mechanisms should operate in parallel with any broader precautionary scheme to ban substances based on their psychoactive effect, and are aimed at criminalising specific substances of significant concern. The drug monitoring and early warning system would provide an important source of evidence for such responses by linking domestic and international jurisdictions.

Some jurisdictions already have mechanisms in place to allow emergency, temporary scheduling to be used where a significant risk of harm from a newly identified substance exists, and some have recently introduced legislation creating such mechanisms. Some jurisdictions list entire classes of compounds which can assist by controlling new variations of substances.

IGCD members agree that:

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The ability to carry out emergency or temporary scheduling of NPS where their long term health effects are not known is a key mechanism in protecting the public from potentially harmful substances.

Jurisdictions should ensure that they have enacted appropriate emergency or temporary scheduling provisions. Jurisdictions should aim for national consistency in emergency or temporary scheduling provisions.

Jurisdictions should communicate scheduling actions and proposed actions to each other.

A comprehensive arrangement to share information between jurisdictions relating to emergency or temporary scheduling decisions should be developed.

5. Uniform treatment of drug analogues

Harmonised definition of ‘drug analogue’

There is no nationally-agreed definition for a ‘drug analogue’. This creates a loophole that is exploited by organised criminal groups and complicates the work of forensic chemists and prosecutors.

The most common criticism of analogue clauses is that they lack clarity and do not provide sufficient certainty as required by criminal law. Both in the US where a broad analogue definition is in use, and in the UK where such a clause was being considered, concerns were raised over the expense of prosecuting, disputes between experts over which substances were controlled and a lack of certainty for defendants over whether an offence had been committed.1

At the 2013 Drug Analogue Workshop, hosted by the AFP and the Australia New Zealand Policing Advisory Agency National Institute of Forensic Science (ANZPAA NIFS), there was general agreement that the analogue clauses in the Commonwealth Criminal Code Act 1995 (section 301.9) provided a good basis to develop a model definition of ‘drug analogue’. The ‘drug analogue’ definition is based on chemical structure and complements other control mechanisms based on similar ‘pharmacological effect’. These clauses provide wide coverage and have been applied successfully for the control of drug analogues seized by the AFP. A uniform definition for ’drug analogue’ was agreed by all IDSAG attendees, who represented each state and territory’s Forensic Science laboratory , and is set out at Appendix C.

In early 2013 Queensland amended its Drugs Misuse Act 1986 to expand the definition of dangerous drug to include substances which have similar chemical structure or pharmacological effect to dangerous drugs, as well as substances intended to have a similar pharmacological effect.2 The Government of Victoria is currently considering a bill to update the State analogue clause along these provisions3.

IGCD members agree that:

1 King, Nutt et al., Analogue Controls: An Imperfect Law, (2012) UK Drug Policy Commission - Briefing Note 2 Drugs Misuse Act 1986 (QLD), S4 .3 Drugs, Poisons and Controlled Substances Amendment Bill 2013 (VIC)

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Drug analogue provisions, which expand the coverage of controls on illicit substances to include substances with similar chemical structures, are crucial in ensuring that harmful substances are banned and that controls are not easily circumvented.

Jurisdictions should aim for national consistency in definitions of drug analogues, including considering using the model definition set out in Appendix C.

6. Consumer protection laws

Under the Competition and Consumer Act, interim bans of up to 90 days may be imposed on consumer products by a state or territory Minister where the goods will or may cause injury to a person. The relevant Commonwealth Minister can impose nationwide interim bans, which can last up to 120 days, or permanent bans.

In June 2013 NSW introduced an interim ban on the sale and supply of 19 synthetic drug products, listed by the trade names under which they were being sold. The NSW actions were in response to growing concerns of the dangers of emerging drugs following the widely reported drug related death of a NSW teenager in June 2013, and a report of the NSW Parliamentary Inquiry into Law Reform Issues Regarding Synthetic Drugs, released on 30 May 2013.

On 16 June 2013, the then Commonwealth Assistant Treasurer announced a national interim ban on the sale of a range of dangerous synthetic drug products and substances, including NBOMe to provide opportunity for states including NSW to update their drugs and poisons legislation to align with the Commonwealth SUSMP to control NPS.

On 7 October 2013 NSW amended its drug laws to automatically control substances listed in Schedule 9 of the Poisons Standard (otherwise known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)), including NBOMe. The Commonwealth national consumer ban gave NSW authorities the scope to act quickly to address the threat posed by harmful NPS while their legislation was updated.

The interim national consumer protection ban expired on 13 October 2013. As it had served its purpose in providing coverage for states and territories to align legislation with the Commonwealth Poisons Standard, the Commonwealth Minister for Small Business decided not to make the ban permanent.

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IGCD members agree that:

Consumer protection bans are just one of a number of ways to control the sale of NPS.

While these consumer protection laws may offer a rapid response option, NPS are more appropriately controlled through drug legislation administered by health and law enforcement agencies.

Long term consumer product bans based solely on product or “street” names have limited utility.

7. Other existing laws.

Existing laws controlling illicit drugs domestically may provide an appropriate response to certain NPS where sufficient evidence of harms exists.

Given the rapid emergence of NPS it is also necessary for legislative approaches to keep the list of controlled substances up to date. In relation to this, it is important that States and Territories reference the recommendations from the SUSMP or else regularly update lists to include particular substances and/or chemical classes of substances (such as the chemical classes of synthetic cannabinoids listed in the SUSMP) which have undergone the rigorous harms assessment process required for substances to be listed in a schedule of the SUSMP.

In addition to laws which specifically control illicit drugs at the border and domestically, there may be other existing laws which could be used to reduce the supply, use and harms of NPS. Other relevant laws could also be used to protect the public, such as laws relating to labelling, marketing and supply.

Where sufficient evidence exists that substances present a relevant risk of harm to the public, or the substance otherwise meets the threshold criteria for listing existing laws controlling illicit drugs should be used.

IGCD members agree that:

Keeping lists of controlled substances up to date is critical in ensuring that substances known to be harmful are subject to appropriate controls and restrictions.

Where they have not already done so, jurisdictions should consider processes to automatically update controls on substances in line with the Commonwealth Standard for the Uniform Scheduling of Medicines and Poisons.

8. A Broad Precautionary Psychoactive Substances Control Scheme

Due to the number and rate of emergence of NPS, controls on specific substances will always lag behind. NPS which have been neither controlled as illicit drugs nor authorised by other regulatory regimes, such as food standards or therapeutic goods, will be present in the community.

The outcome is the rapid expansion of products containing psychoactive substances being sold and supplied to Australian consumers. While being supplied for their psychoactive properties, these products have a potential for harm but have not been subjected to a process demonstrating fitness

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for human consumption. While some products may come with advice that they are not for human consumption, they are marketed as having psychoactive properties.

With so many unknown substances on the market, and more emerging all the time, it is not feasible for lawmakers to specifically prohibit every harmful substance in a timely manner, nor is it possible for law enforcement to recognise, identify or prove that suspect substances are in fact controlled by law.

The responses adopted in Ireland and New Zealand prohibit unknown psychoactive substances unless the seller can prove that they are in fact a substance which is permitted under a law or is otherwise subject to an exception.

The Commonwealth is currently developing a border control scheme to ban the import of NPS without authorisation. Such a scheme would be in addition to existing laws controlling illicit drugs, and would be intended to cover gaps in existing controls. This would not result in the removal of current criminal sanctions. Rather it would provide some measure of community protection against unknown substances which are not otherwise controlled, and where, for lack of evidence and certainty, criminal penalties for possession may not be appropriate.

Ireland

Ireland has introduced the Criminal Justice (Psychoactive Substances) Act 2010 which makes it an offence to sell, import, export or advertise psychoactive substances. This scheme has a focus on community safety and seizure of suspicious substances, and has no possession offences. For community safety, some ability to seize small amounts from users may be required.

Psychoactive substances are defined broadly, along with a list of exceptions for medicines, tobacco, alcoholic beverages, approved food, controlled drugs or other substances specified by Ministerial order. This enables the scheme to distinguish between products such as petrol, which may have a psychoactive property if inhaled but sold/supplied for other purposes, and products which are sold/supplied for the product’s psychoactive properties. Ireland has found that this scheme has reduced shopfront sales of NPS, but online NPS sales remain a problem.

New Zealand

The New Zealand scheme, which came into force in August 2013, is similar but adds a new permit scheme under which a sponsor may pay for a harms assessment for a new psychoactive substance and attempt to prove that the product is safe. If the substance is assessed as having a low risk of harm it will be granted a permit for sale in New Zealand, subject to conditions. This assessment scheme is modelled on existing schemes applied to therapeutic goods. A possible downside of the New Zealand approach is that it may result in substances being approved for sale for no other purpose than recreational psychoactive use. On the other hand, this may reduce the introduction of more harmful drugs onto an uncontrolled black market, and allow point of sale and other controls to be placed on relatively safe substances.

Further information about the schemes in Ireland and New Zealand are set out at Appendix D.

Issues for Australia

Australia’s constitutional arrangements mean that the Commonwealth and the states and territories are responsible for different aspects of controlling NPS. The Commonwealth is primarily responsible

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for regulating the importation of NPS and the assessment and scheduling of prohibited substances on the Commonwealth Poisons Standard by the Health Minister’s delegate. The states and territories are primarily responsible for regulating the manufacture, supply and advertisement of these substances. It is therefore vital that the Commonwealth, states and territories consider complementary legislation to ban the importation, sale, manufacture or advertising of NPS without a legitimate use. Administration of these schemes will require the co-operation of both law enforcement and health agencies, as well as the support of relevant industries.

A broad, non-substance-specific control scheme for psychoactive substances could take a number of different approaches. A key issue is whether there is a preference for the basic safety net approach taken by Ireland, which seeks to ban potentially dangerous products sold for their psychoactive properties once consumed and which are not otherwise controlled by existing laws, or for the New Zealand approach which extends this by introducing a new approval scheme for psychoactive substances which would not otherwise be approved under existing approvals schemes.

Some jurisdictions have already moved to implement broad precautionary schemes.

The Commonwealth is developing options for a precautionary scheme to control NPS at the border. The proposed approach is to ban the importation of substances that have a psychoactive effect and that do not have a legitimate use, in a manner similar to the Irish scheme.

On 7 October 2013, New South Wales implemented legislation that bans the manufacture, supply and advertisement of all substances with a psychoactive effect unless they have a legitimate use, such as a food or therapeutic good. There are penalties of up to two years imprisonment, more than $2,000 in fines or both for the manufacture, supply or advertisement of NPS. In many respects, this legislation is similar to the Irish scheme.

On 25 September 2013, South Australia introduced a Bill to ban the manufacture and promotion of substances with similar pharmacological effects to controlled drugs or which are to be presented as legal alternatives to those drugs. The Bill includes penalties of up to four years imprisonment, $15,000 in fines or both.

Other approaches, such as expanding analogue definitions discussed above, may also extend existing illicit drug controls to a broad range of new substances. Jurisdictions should, however, consider whether the full penalties for illicit drugs should apply to substances whose potential harm is often unknown.

IGCD members agree that:

The development of a national precautionary scheme to control NPS at the border will help to address the problem and respond to emerging drug markets.

To deal with the rapid rate of emergence of NPS, jurisdictions should consider implementing broad precautionary schemes to ban potentially harmful substances without a legitimate use or which are designed to mimic illicit drugs.

Jurisdictions should work together to ensure that their schemes to control NPS are complementary and there are no regulatory gaps.

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To assist in building an evidence base about the structure and potential harms of NPS, jurisdictions should consider whether any broad precautionary schemes to control NPS should also include mechanisms to allow law enforcement to seize NPS in the possession of individuals.

Raising Public Awareness

9 Developing agreed terminology

To avoid confusion in cross-jurisdictional and public discussion, consistent terminology should be used. This paper recommends the use of the term new psychoactive substances (NPS) to refer to the substances at issue, as this is the terminology used in many other countries and the United Nations drug control bodies. This term does not risk the potential ambiguities of other terms such as ‘analogues’ or ‘synthetics’, which, while overlapping with NPS, have different scopes. The term NPS also avoids the misleading message carried by terms such as ‘legal highs’ or ‘party pills’.

Other neutral terminology is in current use to describe this group of substances, including “emerging psychoactive substances”, “novel psychoactive substances” and “research chemicals”. However, given its adaptation by the United Nations Office on Drugs and Crime and the European Monitoring Centre for Drugs and Drug Addiction, the phrase “new psychoactive substances” should be preferred for consistency.

In addition, it is important that wherever possible consistent terminology is used in discussing broad types or categories of NPS. This is essential to support clear policy and technical discussions and to help inform community education, as discussed below.

IGCD members agree that: In most instances, the term “new psychoactive substances” should be used in official

correspondence and messaging, to ensure consistency with language used by major international sources of information on these drugs. Terminology should be developed to consistently and clearly describe the categories of NPS to support clear policy and technical discussions.

10 Public awareness and education

There is a lack of public awareness about the nature and risks of NPS and a number of misunderstandings in the community about NPS, including some public perceptions of NPS as a safe alternative to illicit drugs. In this respect there is a potential role for government and non-government organisations to disseminate information about the health and safety risks from misuse of these substances. However any efforts to raise awareness of NPS need to be balanced against the imperative of doing no harm. In particular public awareness efforts must not inadvertently promote new products or the pathways by which they can be accessed, and must not confound existing confusion about their legality and safety. There is international and Australian evidence that some past attempts to raise awareness of NPS have been counterproductive.

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While prevalence of use appears to remain relatively low, these substances have attracted new drug user groups through their visibility on the internet and availability from sources not traditionally associated with illicit drug supply. Suppliers often mislead the public about the contents, origin, effects and safety of NPS. Most NPS products contain untested, unregulated substances of uncertain origin or composition, but which may be perceived to be safe because of purported legality and claims of natural origin of ingredients.

This is compounded by the dangers associated with the variability of NPS substances. The potency of NPS products in the marketplace may vary from batch to batch, making the effects unpredictable and accurate doses difficult to control. Some NPS have the potential to cause effect in much smaller doses than traditional drugs, heightening the risk of adverse events, including overdose.

Public education strategies must serve to dismantle popular misconceptions that NPS are a legal, safe alternative to existing controlled drugs. It should be reinforced that individuals taking substances which purport to have psychoactive properties can never be confident of what they contain and are always putting their health and safety at risk.

A further challenge remains in communicating information on NPS to the public. In the first instance, governments must resolve to convey agreed messages using clear terminology. Nationally consistent messaging is essential not only for educating individuals but also informing the responses of health professionals, service providers and the wider community. There should also be agreement on ways to avert increasing public interest in NPS through public awareness, including for example, avoidance of terms such as 'legal highs'. Opportunities to cooperate with the media and non-government sector should also be explored to encourage appropriate reporting and to avoid, for example, promoting information on internet pathways through which to access NPS. This level of cooperation, particularly at a jurisdictional or local level will also be important in the event that there is a need to swiftly communicate the dangers of new substances as they emerge, and/or to respond to particular local trends or availability problems.

Efforts to advance appropriate and accurate public awareness of NPS and their risks should build upon existing communication methods targeting illicit drugs, such as the National Drugs Campaign, which is part of the Australian Government’s contribution to the National Drug Strategy. Complementary campaigns at the jurisdictional level can help augment National Drug Campaign messages by responding to local priorities.

Harms assessments, based on available data may be used to inform the development of public awareness and education campaigns.

IGCD members agree that:

Key public awareness messages about NPS should include the facts that these substances are not legal alternatives to prohibited drugs, they are of unknown composition and purity, the effects can be highly variable between batches and individuals and far from being safe, they can expose people to harms associated with physiological reactions, overdose and erratic behaviour.

Given the variability of the drug market in different states and territories, local public awareness messaging may need to vary to accommodate local circumstances.

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Increased national and international coordination

11 Better coordination between jurisdictions

Any inconsistencies between the controls in different jurisdictions can be exploited by suppliers of NPS.

While local factors will mean complete legislative consistency is challenging, coordination and communication are vital tools for authorities. Without timely communication between jurisdictions regarding changes it can be difficult to develop consistent controls and to maintain situational awareness for those involved in education, policy and enforcement.

The IGCD provides a suitable forum for such communication. Other relevant agencies and networks, such as the departments of the state and territory Attorneys-General, should also be involved.

IGCD members agree that:

The IGCD plays a key role in bringing together officers from Commonwealth, State and Territory Health, law enforcement and justice agencies to discuss how to work together to address issues surrounding NPS.

The IGCD should continue to draw upon the expertise of agencies outside the IGCD membership when those agencies have an integral role in addressing a particular aspect of the NPS problem.

12 International Engagement

The international nature of this emerging market presents opportunities for governments to share strategies, information and resources with other countries and international bodies. Most NPS first come to the notice of authorities in one jurisdiction before then spreading to others. Information sharing can increase Australia’s responsiveness and the resources we can draw upon, as well as aiding source and transit countries in applying effective controls. Through engagement with bodies such as the United Nations Commission on Narcotic Drugs, Australia can encourage increased data collection and support measures such as greater controls in source and transit countries.

The Australian Government has been pursuing an active program of action at the international level with organisations such as the United National Office on Drugs and Crime and the Commission on Narcotic Drugs, and with individual countries. This includes information sharing and engagement at operational and policy levels, and in future should provide added information for the drug monitoring system through engagement with similar systems in Europe, the UK and the UN.

ICGD members agree that:

Australia should maintain international engagement on NPS issues.

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Agencies should continue to cooperate, both operationally and on policy responses, with overseas partners to respond to NPS.

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Appendix A: Current systems/networks for sharing information on NPS

Current Systems and Networks - Australia

Agency / Jurisdiction System / Network

Australian Crime Commission (ACC)

Illicit Drug Data Report (IDDR)

Internet Monitoring Initiative

Organised Crime Assessment

Waste Water Initiative

Australian Institute of Criminology (AIC)Drug Use Monitoring in Australia (DUMA)

Waste Water Initiative

Commonwealth Department of Health

National Drug and Alcohol Research Centre (NDARC)

- Drugs and the Internet Project (DNET)- Ecstasy and Related Drugs Reporting System

(EDRS)- Illicit Drug Reporting System (IDRS)- National Illicit Drugs Indicator Project (NIDIP)

National Drug Research Institute (NDRI)

National Centre for Education and Training on Addiction (NCETA)

Australian Government Drug Officials Group (AGDOG)

Commonwealth Poisons Standard (SUSMP)

New South Wales NPS Working Group

Queensland Forensic and Scientific Services Newsletter – The Buzz

South Australia South Australia Drug Early Warning System (SADEWS)

Western Australia Western Australia Emerging Psychoactive Substances Review Group

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Australia

Drug Use Monitoring Australia (DUMA)

DUMA is a project which seeks to measure drug use among those people who have been recently apprehended by police. Data from DUMA is used to examine issues such as the relationship between drugs and property and violent crime, monitor patterns of drug use across time, and help assess the need for drug treatment amongst the offender population. The DUMA program is a partnership between the AIC, State Police Services and local researchers. DUMA is an invaluable aid to community planning, monitoring, and resource allocation and represents an important source of data for state and federal policymakers. Data collected through DUMA sites provides a research and evaluation tool for local analysts, policymakers and practitioners.

Drugs and the Internet (DNET)

This project provides analysis of trends over time in the availability and type of substances sold via the internet to Australia, through the monitoring of both the surface web and deep web (i.e. Silk Road).

Illicit Drug Reporting System (IDRS) and Ecstasy and Related Drug System (EDRS)

The IDRS is a national illicit drug monitoring system intended to serve as a strategic early warning system, identifying emerging trends of local and national concern in illicit drug markets. The IDRS monitors the price, purity, availability and patterns of use of heroin, methamphetamine, cocaine, cannabis and ecstasy and related drugs.

National Illicit Drugs Indicator Project (NIDIP)

The aim of NIDIP is to provide epidemiological data on trends over time in drug-related harms, to complement other Australian monitoring systems such as the IDRS and EDRS, and to improve the understanding of, and systematically track changes in, drug-related harms for both illicit and prescription drugs.

Waste Water Analysis (WWA)

Chemists can now quantify a wide variety of substances in wastewater (i.e. sewage) including those associated with illicit drug consumption. The method has been used to measure drug use in Europe, North America and Australia and to compare drug use across different cities and time periods. Unlike the drug monitoring systems that provide person centric data, WWA is population-based and cannot provide person level information on individuals’ drug consumption, including frequency of use or polydrug use. However, WWA can efficiently provide reliable, objective chemical data on drugs of major concern to the community—in both small and very large population groups (potentially hundreds of thousands of people).

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Current Systems and Networks – International

Agency / Jurisdiction System / Network

European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)

European Drug Report

Risk Assessments

Joint Reports (Europol)

European Information System and Database on New Drugs (EDND)

Global Drug Survey International Reporting

United Kingdom (UK) Forensic Early Warning System (FEWS)

United Nations Office on Drugs and Crime (UNODC)

Early Warning Advisory (EWA) on NPS

World Drug Report

United States (US) Substance Abuse and Mental Health Services Administration (SAMHSA)

Drug Abuse Warning Network (DAWN)

National Survey on Drug Use and Health (NSDUH)

Behavioural Health Services Information System (BHSIS)

European Union (EU)

When EU Member States receive information regarding a NPS, detailed information is forwarded to the European Police Office (Europol) and to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).

If Europol and EMCDDA consider that the information provided by the Member States on a NPS merits further collection and analysis, this information is presented in the form of a Europol-EMCDDA Joint report, which include information regarding the chemical and physical description, associated product names, frequency and patterns of use, how it is manufactured and sold, characteristics of users, health and social risks, current legal status, and whether it is under assessment in other jurisdictions.

After considering the Joint Report, the council may request a risk assessment of the health and social risks, caused by the use of, the manufacture of, and traffic in, a NPS, the involvement of organised crime and possible consequences of control measures.

The EMCDDA also operates a closed online database for information sharing called the EDND (European information system and database on new drugs) to facilitate the process described above.

United Kingdom (UK)

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In 2011, the UK began its Forensic Early Warning System (FEWS).4 FEWS collects samples of NPS from the internet, store fronts, music festivals (using on-site laboratories to test police-seized drugs), other police seizures and customs seizures, and analyses their content in order to determine which NPS are available for use in the UK.

United Nations (UN)

In March 2013, the United Nations Commission on Narcotic Drugs resolved to enhance international cooperation in the identification and reporting of new psychoactive substances.5 Australia was among a large number of countries to sign onto this resolution. Member States are encouraged to take a coordinated approach to detection, analysis and identification of NPS, to collect health harms information, and to take a proactive approach to detection and testing by obtaining products and monitoring emerging trends in their use and harms. The resolution urged international collaboration and coordination of these efforts.

Independent Organisation – Global Drug Survey

The Global Drug Survey (GDS) conducts an annual online questionnaire that monitors alcohol and other drug use, harms and market characteristics. GDS is an independent organisation that does not rely upon external funding. GDS specifically asks about new and emerging psychoactive substances (patterns of use and harm and market characteristics) and use of the internet to purchase drugs. While the sampling methodology means that results cannot be generalised, the GDS has proven useful due to its quick turn-around time of about 4 months from survey to results dissemination, and its capacity to recruit relatively large samples of people who use obscure or new drugs, enabling first assessments of NPS to be conducted.

4 Home Office. (2013). Annual Report on the Home Office Forensic Early Warning System (FEWS). London: Home Office.5 Commission on Narcotic Drugs. (2013). Enhancing international cooperation in the identification

and reporting of new psychoactive substances (No. E/CN.7/2013/L.2/Rev.1): Fifty-sixth session. Vienna, 11-15 March 2013

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Appendix B: Drug Monitoring System, Issues for consideration

Developed by the working group on a proposed Drug Monitoring/Early Warning System

1. Bearing in mind the need to ensure the information contained within the DMS is available to all relevant stakeholders, any decision regarding the progression of the DMS will need to consider the variance in levels of security clearance within and across organisations. In order to overcome this issue, consideration needs to be given to limiting the DMS to unclassified material. Should there be a requirement for classified material; consideration needs be given to scoping the feasibility of developing a closed online database, similar to the EDND maintained by the EMCDDA.

2. Information regarding NPS should complement the information provided to the Commonwealth Department of Health (Health) via a number of sponsored projects, allowing Health to develop appropriate public awareness and education campaigns, where relevant, on this issue.

3. The DMS will enable information sharing for the forensic and law enforcement analysis of NPS. While the system may not initially capture other information around NPS, such as health and trade information, the model could be used as a basis for sharing data on NPS that other portfolios may wish to develop in the future.

4. Responses requiring the inclusion, or analysis, of health and/or social risks should be developed by Commonwealth Health and/or jurisdictional health department with relevant expertise.

5. Where possible, the development of a DMS should make use of existing networks and systems across Australia and internationally, noting the formal systems established in NSW, SA and WA.

6. There needs to be an analytical component to the DMS, whereby the material is collated and assessed, used to inform an understanding of the market and appropriate responses, and identify vulnerabilities and sources of threat.

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Appendix C – Proposal for a uniform definition of drug analogue

The proposal for a uniform definition for the term “drug analogue” is presented along with an explanation of restrictions and issues with the existing analogue clauses of the Commonwealth Criminal Code Act 1995 in the following three sections:

Section 1: Explanation of the existing analogue clauses of the Commonwealth Criminal Code Act 1995 (Sections 314.1(2) and 314.4(2))

Section 2: Potential issues / restrictions with the existing clauses and reasons for making adjustments for the general definition

Section 3: Proposed general definition for ’drug analogue’

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Section 1: Explanation of the existing analogue clauses -Commonwealth Criminal Code Act 1995

Sections 314.1(2) and 314.4(2)

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Section 2: Potential issues / restrictions with the existing clauses(2) A substance is a controlled drug6 if the substance (the drug analogue) is, in relation to a controlled drug listed in subsection (1)7 (or a stereoisomer, a structural isomer (with the same constituent groups) or an alkaloid of such a controlled drug):8

(a) a stereoisomer; or (b) a structural isomer having the same constituent groups; or (c) an alkaloid;9 or (d) a structural modification obtained by the addition10 of one or more of the following groups:

(i) alkoxy, cyclic diether, acyl, acyloxy, mono-amino or dialkylamino groups with up to 6 carbon atoms in any alkyl residue;11

(ii) alkyl, alkenyl or alkynyl groups with up to 6 carbon atoms in the group, where the group is attached to oxygen (for example, an ester or an ether group), nitrogen, sulphur or carbon;12

(iii) halogen, hydroxy, nitro or amino groups;13or14

(e) a structural modification obtained in one or more of the following ways:(i) by the replacement of up to 2 carbocyclic or heterocyclic ring structures with different

carbocyclic or heterocyclic ring structures; (ii) by the addition of hydrogen atoms to one or more unsaturated bonds;(iii) by the replacement of one or more of the groups specified in paragraph (d) with another such

group or groups;(iv) by the conversion of a carboxyl or an ester group into an amide group;15 or

(f) otherwise a homologue,16analogue,17chemical derivative18 or substance substantially similar in chemical structure;19 however obtained, except where the drug analogue is separately listed in subsection (1).

6 The Criminal Code Act 1995 uses the terms “controlled drug” (Section 314.1(2)) or “border controlled drug” (Section 314.4(2)). These terms will need to be adjusted to match the terminology used in the particular State / Territory legislation. For the purposes of the proposed general definition, the term “drug” has been used.

7 This refers to the list of controlled or border controlled drugs. This will need to be adjusted to match the terminology used in the particular State / Territory legislation. For the purposes of the proposed general definition, the term “listed drug” has been used.

8 The text in brackets is redundant – e.g. a stereoisomer of a listed drug is itself a drug analogue under Section 2)a). No need to list stereoisomers of stereoisomers.

9 The term “alkaloid” in this context is ambiguous.10 The term “addition” may cause confusion with an “addition reaction”. Also, addition of any one of these

groups typically requires the replacement of an existing atom or group from the molecule (generally a hydrogen atom). For the purposes of the proposed general definition, this has been reworded to allow the “replacement” of any group for another such group and “hydrogen atom” has been added as one of the listed groups.

11 “carbonyl” and “carboxylic acid” groups have been added to this list in the proposed general definition12 This clause has been moved to apply to all the groups that can be replaced in the proposed general definition.

Also, phosphorus (although and unlikely addition to a drug molecule) has been added to ensure wide coverage.

13 “hydrogen atom” has been added to this list in the proposed general definition14 The use of the word “or” here limits the types of modifications that can be made to either those listed in

subsection d) OR those listed in subsection e). For the purposes of the proposed general definition, this has been changed to “and/or” to allow changes that satisfy one clause or the other as well as changes that require BOTH clauses.

15 Clauses e iii) and iv) are redundant given the changes in the proposed general definition. These types of modifications are now captures in earlier clauses.

16 The term “homologue” has been retained in the proposed general definition17 The term “analogue” in this context is ambiguous and self-referential and has been removed in the proposed

general definition.18 The term “chemical derivative” may be interpreted differently and therefore,to avoid ambiguity, a definition for

chemical derivative has been added to the proposed general definition Section (d).19 The term “substantially similar” is ambiguous and has been removed in the proposed general definition.

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Section 3: Proposed general definition for “drug analogue”

A substance is a drug if the substance (the drug analogue) is, in relation to a listed drug:

(a) a stereoisomer; or

(b) a structural isomer having the same constituent groups; or

(c) a homologue; or

(d) a chemical derivative formed by a chemical process (for example, conversion of a carboxylic acid to an ester or an amine to an amide); or

(e) a structural modification obtained by the replacement of one or more of the following groups with another such group or groups:

(i) alkoxy, cyclic diether, carbonyl, acyl, carboxylic acid, acyloxy, mono-alkylamino or di-alkylamino groups with up to 6 carbon atoms in any alkyl residue;

(ii) alkyl, alkenyl or alkynyl groups with up to 6 carbon atoms in the group;

(iii) hydrogen atom, halogen, hydroxy, nitro or amino groups;

where the group is attached to oxygen, nitrogen, sulphur, phosphorus or carbon; and/or

(f) a structural modification obtained in one or more of the following ways:

(i) by the replacement of up to 2 carbocyclic or heterocyclic ring structures with up to 2 different carbocyclic or heterocyclic ring structures;

(ii) by the addition of hydrogen atoms to one or more unsaturated bonds;

however obtained, except where the drug analogue is separately listed in subsection [Insert relevant reference to drug list].

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Appendix D: NPS Regulatory Options: International Models

New Zealand

The New Zealand Government has implemented a new regulatory regime which will require the supplier or manufacturer of a new psychoactive substance to prove that the substance causes no harm to an individual or the community before Government will grant permission to import, manufacture or sell the substance as a legal product.

The Psychoactive Substances Act20 commenced in July 2013. The scheme bans new psychoactive substances which have not been proven to be safe by their supplier or manufacturer, and regulate those which are shown to be low risk through labelling, content, and retail restrictions. There is currently a transitional period between the Act’s commencement and when Psychoactive Substances Regulations are in place, this is expected to be later in 2013. During the transitional period product owners and businesses had 28 days from when the Act commences to apply for interim product approvals and licences.

Under this scheme a significant administrative fee is expected to be charged for each assessment.21

The Act includes provisions for:

A regulatory authority within the Health Ministry to

o consider and approve or decline psychoactive substances

o issue a manufacturing code of practice

o issue importation, manufacturing and sale licences

o conduct post-marketing monitoring, audit and recall functions

Establish an expert advisory committee to provide the authority with technical advice

Set offences and penalties under the Bill, including up to two years’ imprisonment for some offences, and fines of up to $500,000

Restrict sale of products to those under 18, and place restrictions and prohibitions on places of sale; and

Establish an appeals committee.22

The aim of this scheme is to have a regulated market of legally available low risk psychoactive substances.

20NZ Regulation - Psychoactive Substances 21 See NZ Cabinet Paper and Regulatory Impact Statment (RIS).22 See Annex 1: NZ Health Media Release

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New Zealand has noted that the potential for inconsistencies in the approval of substances between New Zealand and Australia could raise issues due to the Trans-Tasman Mutual Recognition Act 1997 which could require specific exclusions by either nation if desired.23

IrelandIn August 2010, Ireland introduced the Criminal Justice (Psychoactive Substances) Act 2010.24 This Act essentially makes it an offence to sell, import, export or advertise psychoactive substances.

This act uses a broad definition of psychoactive substance combined with a list of exceptions, as follows :

“psychoactive substance” means a substance, product, preparation, plant, fungus or natural organism which has, when consumed by a person, the capacity to—

(a) produce stimulation or depression of the central nervous system of the person, resulting in hallucinations or a significant disturbance in, or significant change to, motor function, thinking, behaviour, perception, awareness or mood, or

(b) cause a state of dependence, including physical or psychological addiction;25

The Act then specifies that it will not apply to medicines, tobacco, alcoholic beverages, approved food, controlled drugs or other substances specified by Ministerial order.26

This approach has had some success in closing down many ‘head shops’ (shopfronts selling tobacco and drug smoking paraphernalia), which had previously been a prominent feature of the Irish NPS market. However, a 2011 review of the Irish situation noted that the online sale of NPS, with postal distribution, remained a problem.27

23 See RIS, p26.24Irish Statute Book 25Criminal Justice (Psychoactive Substances) Act 2010 (Ireland), Section 1 ‘Interpretation’.26Criminal Justice (Psychoactive Substances) Act 2010 (Ireland), Section 2 ‘Exclusions from application of Act’.27 An Overview of New Psyc hoactive Substances and the Outlets Supplying Them, Kellerher et al

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