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Many Member States and the international community, in an effort to protect public health, have explored a wide range of legislative responses to address the dynamics of the NPS market, particularly the rapid emergence and attempts by manufacturers to circumvent legislation; the diversity of the problem; and paucity of data to enable full evaluation of harm.[1] This section provides an overview of the legal situation of NPS at the international level as well as of a wide range of legislative measures and/or regulations that have been adopted so far at the regional and national level to respond to this challenge (see Global SMART Update "Legal responses to NPS: Multiple approaches to a multi-faceted problem".

  

The international drug control system

Since 2015, several NPS have been placed under international control and have been added to the relevant schedules of the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances of 1971. The mechanism provided for in these treaties is as follows:

Initiative

As provided for in the 1961 Convention and the 1971 Convention, whenever a Party or the World Health Organization (WHO) has information relating to a substance not yet under international control, which in its opinion requires that substance to be added to any of the schedules of the Conventions, “it shall notify the Secretary-General and furnish him with the information in support of that notification”, according to article 3(1) of the 1961 Convention and article 2(1) of the 1971 Convention.[2] The notification is subsequently transmitted to the Parties, to the Commission on Narcotic Drugs (CND) and to the World Health Organization (WHO).


Risk assessment

WHO carries out an assessment of the substance under review. The procedure for this medical and scientific evaluation is carried out by the WHO Expert Committee on Drug Dependence (ECDD) and described in detail in the Guidance on the WHO review of psychoactive substances for international control.

Over the years, the ECDD has reviewed a large number of NPS. The review reports of the WHO ECDD are available at:

www.who.int/medicines/areas/quality_safety/reports/en/index.html


Control measures

Based on the results of the assessment and the recommendations on control measures, if any, the Commission may decide that the substance shall be added to, transferred from one schedule to another, or removed from any of the schedules of the respective Convention. The decisions of the Commission are subject to review by the Economic and Social Council upon the request of a Party.

  

Regional responses

The European Union

The European response system to the emergence of new psychoactive substances is the European Early Warning System (EWS) of the European Union (EU). Council Decision 2005/387/JHA [3] allows for the monitoring of NPS, for an assessment of their risks and for the application of existing control measures in the EU Member States for the control of narcotic and psychotropic substances to NPS, if necessary.  

Over twenty new psychoactive substances have already been subject to a risk assessment and many of them were placed under EU control measures following a decision of the Council of the European Union.

On 15 November 2017, the Parliament and the Council of the European Union passed new legislation to speed up the procedure for responding to NPS, and included NPS into the official definition of a "drug" at the European level. The new legislation retains a three-step approach to responding to NPS, i.e. early warning, risk assessment and control measures, while significantly strengthening existing processes by streamlining and accelerating data-collection and assessment procedures.

 

National responses

Several legislative/regulatory approaches have been taken so far to control NPS at the national level. Some countries have adapted their main drug control legislation to ban NPS by introducing some degree of flexibility to the individual listing system, whilst others have used supplementary regulatory frameworks that offer greater flexibility and rapidity, but are also rather limited in scope, focusing primarily on control of the sale of NPS. 

The individual listing system

Most countries use an individual listing system to control narcotic or psychoactive substances. A number of countries have extended drug control legislation beyond the individual list of substances, by introducing analogue and generic legislation.

Amendments to the list of individual substances controlled at the national level typically require a process that encompasses a health risk assessment (based on scientific evidence-based data and data on human experience, which is often scarce in the case of NPS) and a legislative procedure, which may take several months. To account for the rapid emergence of NPS, many countries have introduced alternative ways to speed up their ordinary legislative procedure, through temporary or rapid procedures:

Temporary (emergency) bans: an accelerated procedure to quickly introduce temporary restrictions on NPS for a limited period of time (usually for a year), while the legislative process is completed/or a rigorous assessment of the risks is conducted and a final decision to control the substance is made. If there is no decision to control the substance, the temporary ban expires.

Rapid procedure: an accelerated procedure to place NPS under national control. Unlike the temporary (emergency) procedure, control measures taken under the rapid procedure are permanent, i.e. they do not expire after a certain period of time.

Analogue and generic systems

These systems are used to place NPS under national control. By using these complementary systems, drug control measures foreseen under the individual listing system are extended to other substances (analogue) or a defined group of substances (generic) not explicitly mentioned in the legislation, but which share some similarities with controlled substances in terms of structure, effects, or both without appealing to a legislative reform.

Specific NPS-related legislation 

Austria: The New Psychoactive Substances Act

In 2011, the New Psychoactive Substances Act (Federal Act on the Protection against health hazards in connection with new psychoactive substances) was enacted. The Act defines a ‘new psychoactive substance’ as “a substance or preparation which has, when applied, the capacity to cause a psychoactive effect in the human body…” (Article 1. (1)). Under the Act, the Federal Minister of Health has the authority to specify individual NPS or classes of chemical substances by means of a regulation for the purposes of control, whenever this is needed to prevent their distribution and avoid the health hazards that may arise from them. Two conditions need to be fulfilled for the purpose of this specification: “1. it can be assumed that they will be distributed with a view to being misused by certain groups of individuals for its effect…” and “2. according to the current state of scientific knowledge and experience, they may pose a health hazard to the consumers or such a hazard cannot be ruled out when applied”.[4]   

Ireland: The Criminal Justice (Psychoactive Substances) Act 2010

The Criminal Justice (Psychoactive Substances) Act came into effect on 23 August 2010 to deal with the existence of ‘head shops’. This law makes it an offence to sell, import, export or advertise a psychoactive substance (this is intended to include any such importation or exportation conducted by online means). 

Romania: Law 194/2011 of 10 November 2011

A law to control NPS in Romania was passed in 2011. Under the new legislation, a specific permit is required to sell any product likely to provoke psychoactive effects similar to those caused by substances controlled under drug laws. These effects are defined as those provoking ‘changes in functions and mental processes and behaviour’, or ‘causing dependency’, but no specific reference to ‘harmful’ substances is made. The unauthorized distribution of these substances and their advertisement is punishable by imprisonment, but not the possession for personal use. 

New Zealand: Market Restrictions/Pre-market authorization. The Psychoactive Substances Act 2013

The importation, manufacture, sale, supply, or possession of a psychoactive substance or approved product for the primary purpose of inducing a psychoactive effect in an individual who uses the substance or product is subject to requirements similar to those imposed upon manufactures and suppliers of medications, food or chemicals. This new approach aims to balance the demand for access to such substances with the risk of likely harm to individuals and society. This framework includes a reversed burden of proof whereby manufactures will be required to have their products assessed in order to prove that they are low risk, before they are approved. Additional restrictions on these products will include age restrictions and place-of-sale restrictions on the sale of approved products; advertising, labelling, and packaging restrictions and requirements for approved products; health-warning requirements for approved products; signage, storage, and display restrictions and requirements for approved products; creating offences relating to the sale of approved products by or to persons under the age of 18 years and the possession of psychoactive substances without a licence, authorising the Authority to recall approved products in certain circumstances. 

United Kingdom: The Psychoactive Substances Act 2016

The Psychoactive Substances Act makes it an offence to produce, supply, offer to supply, possess with intent to supply, possess on custodial premises, import or export psychoactive substances; that is, any substance intended for human consumption that is capable of producing a psychoactive effect. The maximum sentence will be 7 years’ imprisonment. It excludes legitimate substances, such as food, alcohol, tobacco, nicotine, caffeine and medical products from the scope of the offence, as well as controlled drugs, which continue to be regulated by the Misuse of Drugs Act 1971. It also exempts healthcare activities and approved scientific research from the offences under the act on the basis that persons engaged in such activities have a legitimate need to use psychoactive substances in their work and includes provision for civil sanctions – prohibition notices, premises notices, prohibition orders and premises orders (breach of the two orders will be a criminal offence) – to enable the police and local authorities to adopt a graded response to the supply of psychoactive substances in appropriate cases. Moreover, it provides powers to stop and search persons, vehicles and vessels, enter and search premises in accordance with a warrant, and to seize and destroy psychoactive substances.


Other regulatory frameworks 

Existing regulatory frameworks that fall outside the main drug control legislation have also been used to control NPS: these include medicine legislation, poison acts and consumer safety regulations. NPS included as medicinal products by national medicine agencies are usually subject to a license for the importation, marketing or distribution of such substances. In Europe, at least eight European countries have used medicine legislation to control NPS, including Austria, Finland and the Netherlands.

Consumer safety regulations directed towards individual substances or psychoactive products in general have been used to control NPS.

  


References

[1] UNODC, "The Challenge of New Psychoactive Substances". Global SMART Programme, 2013.

[2] The wording is identical in both Conventions.

[3] European Monitoring Centre for Drugs and Drug Addiction. Control Measures. Available at: www.emcdda.europa.eu/html.cfm/index16783EN.html.

[4] Neue Psychoaktive Substanzen Gesetz, BGBl. 1 Nr. 146/2011. BGBl. 1 Nr. 48/2013.

mephedrone, 5-IT, 25I-NBOMe, AH-7921, MDPV, methoxetamine, 4,4'-DMAR and MT-45.
importation, manufacture, sale, supply, or possession of a psychoactive substance or approved product
for the primary purpose of inducing a psychoactive effect in an individual who uses the substance or product.

age restrictions and place-of-sale restrictions on the sale of approved products:

(ii)

advertising, labelling, and packaging restrictions and requirements for approved products:

(iii)

health-warning requirements for approved products:

(iv)

signage, storage, and display restrictions and requirements for approved products:

(v)

creating offences relating to the sale of approved products by or to persons under the age of 18 years and the possession of psychoactive substances without a licence:

(vi)

the relationship between this Act and other enactments:

(vii)

authorising the Authority to recall approved products in certain circumstances:

The act applies across the UK and it:
  • makes it an offence to produce, supply, offer to supply, possess with intent to supply, possess on custodial premises, import or export psychoactive substances; that is, any substance intended for human consumption that is capable of producing a psychoactive effect. The maximum sentence will be 7 years’ imprisonment

  • excludes legitimate substances, such as food, alcohol, tobacco, nicotine, caffeine and medical products from the scope of the offence, as well as controlled drugs, which continue to be regulated by the Misuse of Drugs Act 1971

  • exempts healthcare activities and approved scientific research from the offences under the act on the basis that persons engaged in such activities have a legitimate need to use psychoactive substances in their work

  • includes provision for civil sanctions – prohibition notices, premises notices, prohibition orders and premises orders (breach of the two orders will be a criminal offence) – to enable the police and local authorities to adopt a graded response to the supply of psychoactive substances in appropriate cases

  • provides powers to stop and search persons, vehicles and vessels, enter and search premises in accordance with a warrant, and to seize and destroy psychoactive substances