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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. 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.

  

The international drug control system

Not all NPS that have emerged on the global market satisfy the criteria for harm required for international control. So far 10 NPS have been placed under international control being 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.[1] The notification is subsequently transmitted to the Parties, to the Commission on Narcotic Drugs 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 and described in detail in the Guidance on the WHO review of psychoactive substances for international control.

Over the years, the Expert Committee on Drug Dependence has reviewed several NPS, including BZP, ketamine and khat. Previous reports of the WHO Expert Committee on Drug Dependence are available at:

http://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.[2] 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

So far,the only regional 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 [4] of NPS, for an assessment of their risks [5] and for the application of existing control measures [6] in the EU Member States for control of narcotic and psychotropic substances to NPS, if necessary.  

Up to March 2016, eighteen new psychoactive substances [7] have been subject to a risk assessment in the framework of the Council Decision 2005/387/JHA and the Joint Action 97/396/JHA. Sixteen of those were placed under EU control measures following a decision of the Council of the European Union.[8]

 

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; others have used supplementary regulatory frameworks that offer greater flexibility and swiftness, but which are also rather limited in scope, focusing primarily on control of sale of NPS. 

The individual listing system

Most countries in the world use an individual listing system to control narcotic or psychoactive substances. Sometimes control measures extend to a substance’s isomers, esters and ethers, and salts, including the salts of esters, ethers and isomers.[9] A number of countries have extended drug control legislation beyond the individual list of substances by introducing analogue and generic legislation.

Any amendment to the list of individual substances controlled at the national level requires, in most of the cases, a process that encompasses a health risk assessment (based on scientific data and human experience data that in the case of NPS is often scarce) 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. Examples include:

1. Denmark: Consolidated Act no. 748 of 1 July 2008 on Euphoriant Substances (para.1, 2) [10]
2. Singapore: Bill No. 27/2012[11]
3. Hungary: Government Decree 66/2012 [12]
4. New Zealand: Section 4C, Misuse of Drugs Act. United Kingdom: “Temporary Class Drug Orders” were introduced in 2011 as complementary to the Misuse of Drugs Act 1971 (amended by the Police Refor and    Social Responsibility Act 2011, Section 151, Schedule 17) [13]
6. United States: US Controlled Substances Act, 1986, Part B § 811 (h) [14]
7. Other countries: The use of temporary scheduling to control NPS has also been reported from Australia, Croatia, Bahrain, Germany [15], Ghana, Ireland, Italy, Latvia, Netherlands [16], New Zealand [17], Saudi Arabia, Republic of Korea [18], Russian Federation, and Spain [19]. [20]


Rapid procedure: an accelerated procedure to put 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. The following countries have a rapid procedure in place to control new substances:


1. Luxembourg:the rapid procedure is based on the Act of 12 July 1996 on the Reform of the Council of State and lasts between 1-2 months.[21]
2.Sweden:new substances can be added to the individual listing system by a standard or a rapid procedure, using one of two Acts: The Narcotic Drugs (Punishments) Act (SFS 1968:64) or the Act on the Prohibition of Certain Goods Dangerous to Health (SFS 1999:42). The competence to classify new substances is given to Government via Ordinances: the Narcotic Drugs Control Ordinance, SFS 1994:1554 is the statutory instrument to supplement the Narcotic Drugs Control Act. Drugs scheduled by Government decision are listed in an attachment to this Ordinance,[22] and in an attachment to the Ordinance regarding the Prohibition of Certain Goods Dangerous to Health (SFS 1999:58).
3.Other countries that have rapid systems to control NPS in place, include Norway [23], Poland [24], Slovakia [25].

Analogue and generic systems

These have been 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 defined group of substances (generic) [26] 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.

 Examples of analogue control on NPS:[27]

1. Canada: The Controlled Drugs and Substances Act (CDSA) is the main piece of legislation for drug control. It contains eight schedules listing the substances that are subject to the Act. Substances not listed expressly in the schedules may also be subject to the Act, if they are a salt, derivative, isomer, analogue, salt of a derivative, or a similar synthetic preparation of a particular controlled substance. For instance, JWH-018 is considered to be a similar synthetic preparation of cannabis and is therefore considered to be included in Schedule II to the CDSA. The determination on similarity is the result of an assessment of the chemical structure and/or pharmacological activity of the NPS against the controlled substance.

2. United States: Controlled Substances Analogue Enforcement Act (CSA) of 1986: section 802 (32) (A) of the CSA, defines “controlled substance analogue” as a substance (i) whose chemical structure is substantially similar to the structure of a scheduled substance; (ii) whose effects are substantially similar to or greater than the effects of a controlled substance or, (iii) the substance is thought to have such an effect. The use of analogue control operates on a substance by substance basis, and therefore each new substance needs to be assessed individually by a Court who decides whether the substance is or not controlled. Courts in the United States have interpreted the law as meaning that both requirements (similarity in the structure and the effects), must be fulfilled.

 Examples of generic control on NPS: 

Several countries have extended the scope of application of main drug control laws to defined groups of substances: between 2009-2013 this approach has been used to ban synthetic cannabinoids in Cyprus, Italy, Lithuania, Luxembourg and Norway; synthetic cathinones in Cyprus, France, Italy, Lithuania, Norway, United Kingdom; phenethylamines in Cyprus, Lithuania and Norway and tryptamines in Lithuania and Norway.[28]  

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”.[29]   

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 (Expected to come into force on 6 April 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 been also used to control NPS: these include medicine legislation, poison acts [30] and consumer safety regulations.[31]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,[32] Finland and the Netherlands.[33]

Consumer safety regulations directed towards individual substances or psychoactive products in general have been used to control NPS:[34]for instance, Italy used regulations on clear and accurate labelling of foods and goods on sale to confiscate ‘spice’ products containing synthetic cannabinoids that were not labelled in the national language.[35] Poland, amended the ‘Act on State Sanitary Inspection’ in 2011 and granted sanitary inspectors the specific right to withdraw from trade a ‘substitute drug’ for up to 18 months in order to assess its safety, in case of a justified suspicion that it might pose a threat to life or health.

  


References

[1] The wording is identical in both Conventions

[2] Article 3 (3) (iii), (4) Single Convention on Narcotic Drugs 1961; Article 3 (5) Convention on Psychotropic Substances 1971

[3] Council of the European Union, Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances

[4] Monitoring: according to article 4 (1) (2) of the Council Decision 2005/387/JHA, information on the manufacture of, trafficking in, use of, and of preparations containing new psychoactive substances is shared by each EU Member State through its Europol National Unit and its representative in the Reitox Network This information is collected by Europol and the EMCDDA and subsequently shared with all EU Member States, the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA). A ‘Joint Report’ is prepared by Europol and the EMCDDA, if either of them or the Council of the European Union consider that further information on the NPS reported is needed (Article 5 (1) Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances. Council of the European Union). The report contains preliminary information on the description of the substance, manufacture, risks associated to its use, involvement of organized crime in the manufacture and trafficking, user profile, control status of the substance at the national level in EU Member States and on whether or not the substance is under assessment by the United Nations System (Article 5 (2) ibid).This report is then submitted to the Council of the European Union, EMEA and the European Commission. (Reitox is the European information network on drugs and drug addiction created at the same time as the EMCDDA. The abbreviation ‘Reitox’ stands for the French ‘Réseau Européen d ́Information sur les Drogues et les Toxicomanies’:  Reitox Network. European Monitoring Centre on Drugs and Drug Addiction, October 2012 (http://www.emcdda.europa.eu/about/partners/reitox-network))

[5] Assessment of the risks: should the Council of the European Union consider this to be necessary, a ‘Risk Assessment Report’ is prepared by the Scientific Committee of the EMCDDA. This report shall include a complete assessment of the health and social risks caused by the use of, the manufacture of, and trafficking in the new psychoactive substance; information on any control measure in place in EU Member States, and on any assessment of the NPS in the United Nations System; the level of involvement of organized crime; options for control; the possible consequences of control measures; and the chemical precursors used for the manufacture of the substance (Article 6 (4), ibid)

[6] Control measures: it is for the Council of the European Union to decide whether or not to place the NPS under control, acting on an initiative presented by the European Commission on the basis of Article 34(2) (c) of the Treaty on European Union (such initiative shall be presented within six weeks from the date on which the ‘Risk Assessment Report’ is received). Should the European Commission decide not to present such initiative, this may be presented by one or more EU Member States (Article 8 (1) (2) ibid.) If the Council decides in favour of placing the NPS under control, EU Member States shall endeavour to take as soon as possible, but no later than one year from the date of that decision, the necessary measures, in accordance with their national law, to ‘submit’ the NPS to control measures and criminal penalties as provided under their legislation by virtue of their obligations under the international drug control treaties (Article 9 (1) ibid.). The obligations set forth in the Council Decision do not preclude the possibility of individual Member States to maintain or introduce any national control measures on NPS (Article 9 (3) ibid.)

[7] MBDB, 4-MA, 4-MTA (internationally controlled), ketamine, PMMA, 2C-I, 2C-T-2, 2C-T-7, TMA-2, BZP, mephedrone, 5-IT, 25I-NBOMe, AH-7921, MDPV, methoxetamine, 4,4'-DMAR and MT-45. European Monitoring Centre on Drugs and Drug Addiction. Risk assessments (http://www.emcdda.europa.eu/html.cfm/index16776EN.html)

[8] 4-MA, 4-MTA, PMMA, 2C-I, 2C-T-2, 2C-T-7, TMA-2, BZP, mephedrone, 5-IT, 25I-NBOMe, AH-7921, MDPV, methoxetamine, 4,4'-DMAR and MT-45. European Monitoring Centre on Drugs and Drug Addiction. Control Measures, March 2016 (http://www.emcdda.europa.eu/html.cfm/index16783EN.html)

[9] The extension of the listing to a substance’s isomers, esters and ethers, and salts does not apply to all the substances listed in either the Single Convention on Narcotic Drugs, 1961 or the Convention on Psychotropic Substances, 1971, but it changes for each of the Schedules and differs in both Conventions

[10] An Executive Order on Euphoriant Substances amending the list of controlled substances can enter into force in two to three days, from the issuing of the recommendation by the National Board of Health. On 8 of March 2011 the Executive Order No. 187 was issued to control methyl amphetamine and 22 synthetic cannabinoids (in force on 11.03.2011): (3-(1-adamantoyl)-1-pentylindol; AM-694; AM-2201; CP 47,497; CP 55,940; CRA-13; HU-308; 3-(4-hydroxymethylbenzoyl)-1-pentylindol (4-hydroxymethylphenyl- (1-pentylindol-3-yl)methanon); JWH-007; JWH-015; JWH-019; JWH-020; JWH-081; JWH-098; JWH-122; JWH-147; JWH-182; JWH-203; JWH-210; JWH-251; RCS-4; WIN 55,212-2). European Monitoring Centre for Drugs and Drug Addiction, 2011 National Report to the EMCDDA by the Reitox National Focal Point, Denmark, 2011 (http://www.emcdda.europa.eu/attachements.cfm/att_191761_EN_Denmark_2011.pdf )

[11] In 2012, the Misuse of Drugs Act 1973 (MDA) (the main legislation on drug control) was amended by Bill No. 27/2012 (Section 58A, in force since 01.05.2013) to introduce a new fifth schedule that allows temporary control of NPS for a 12 month period, with a possibility for extension for another 12 months. Substances listed in the Fifth schedule (such as several JWH- and AM- compounds) can be seized by law enforcement authorities but the trafficking, manufacture, import, export, possession or consumption does not constitute any offence under the MDA, unless the substance is removed from that schedule and is controlled permanently under the other schedules

[12] in 2012, an emergency procedure allowing the addition of non-therapeutic drugs to the list of controlled substances was enacted, on the basis that they can pose a serious threat to public health as other substances already listed in the drug schedules

[13] the Misuse of Drugs Act 1971, amended by the Police Reform and Social Responsibility Act 2011, Section 151 and Schedule 17, enables the Home Secretary to place a NPS under temporary control by invoking a Temporary Class Drug Order, which will come into immediate effect and last for up to 12 months, subject to Parliament agreeing to it within 40 sitting days of the Home Secretary making the Order. Methoxetamine was controlled under a temporary class drug order in 2012 before being classified as Class B drug under Schedule 2 of the Misuse of Drugs Act 1971; 5-6 APB and NBOMe compounds were placed under temporary control in 2013 (Home Office circulars: 008/2012 and 004/2013)

[14] US Controlled Substances Act, 1986, Part B § 811 (h) allows temporary scheduling of new substances by the Attorney General to avoid imminent hazards to public safety. The scheduling of a substance expires in principle at the end of one year from the date of the issuance of the order scheduling such substance. However, they can be permanently scheduled, if there is an evaluation and recommendation in favour by the Secretary of Health and Human Services; since 2011, several synthetic cannabinoids (JWH-018; JWH-073; JWH-200; CP-47,497; CP-47,497 C8 homologue) and some synthetic cathinones (mephedrone; methylone; and (MDPV)) have been placed under temporary control (Drug Enforcement Administration. ‘21 CFR Part 1308 [Docket No. DEA-345F] Schedules of Controlled Substances: Temporary Placement of Five Synthetic Cannabinoids into Schedule I. Final order’, October, 2012 (http://www.deadiversion.usdoj.gov/fed_regs/rules/2011/fr0301.htm); Drug Enforcement Administration. 21 CFR Part 1308 [Docket No. DEA-357] Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cathinones Into Schedule I(http://www.deadiversion.usdoj.gov/fed_regs/rules/2011/fr1021_3.htm))    

[15] In cases of urgency, new substances can be controlled by means of a regulation issued by the Federal Ministry of Health. The regulation needs to be submitted to either the Council of Ministers or the Bundesrat (upper house of the German parliament) and will be subsequently published in the Federal Law Gazette. This process takes about a week but the regulation expires within a year, if the standard process is not followed (European Monitoring Centre for Drugs and Drug Addiction, ‘2012 Annual report on the state of the drugs problem in Europe’, Lisbon, 2012)

[16] The emergency procedure is based on article 3 of the Opium Act. New substances can be listed by means of Ministerial Regulation within a process that last about a week. Upon the issuance of a regulation, the standard procedure needs to be initiated concomitantly by submitting the regulation to the Council of Ministers for evaluation. If not withdrawn, the regulation remains valid until the corresponding Order in Council takes effect, but for a period not longer than 1 year following its entry into force

[17] The Misuse of Drugs Act was amended in 2011 to introduced temporary class drug notices under Section 4C. At least 31 synthetic cannabinoids have been subject to temporary control. In 2013, temporary notices on at least six NPS were issued or renewed (An updated list on temporary class drug notices in New Zealand can be consulted at: http://www.health.govt.nz/our-work/mental-health-and-addictions/drug-policy/temporary-class-drug-notices

[18] In September 2011, a new ‘temporary scheduling system’ was added to the ‘Act on the Control of Narcotics’. Under the Act, the Korean Food & Drug Administration may temporarily schedule NPS for a year. The synthetic cathinone MDPV (3,4-Methylenedioxypyrovalerone) was the first drug subject to temporary schedule at the end of 2011. However, several NPS had been previously listed as “psychotropic drugs” under the Act on the Control of Narcotics since the mid 2000s; for the definition of psychotropic drugs, see Article 2(4) (a-b) of the Act on the Control of Narcotics. NPS regarded as psychotropic drugs and subject to control include JWH-018 & its analogues, CP-47497 & C6, C8, C9, BZP, 2C-D, 2C-E, MeOPP, HU-210, 4-Acetoxy-DiPT, mCPP, TFMPP, Psilocybin, phencyclidine analogues, etc

[19] Law 17/1967 on Narcotic Drugs and on the Final Stipulations (1) of the Royal Decree 2829/1977 on psychotropic substances. For both, narcotics and psychotropic substances, it corresponds to the Minister for Health and Consumer Affairs to initiate the control procedure by preparing a Ministerial Order that is published in the Spanish Official Journal (with no reference to the Parliament) and enters into force on the following day. The entire procedure requires for an Order to enter into force requires between five and 15 days (Kelleher, C., Christie, R., Lalow, K., Fox, J., Bowden, M., O'Donnell, C. , ‘An Overview of New Psychoactive Substances and the Outlets Supplying Them’, National Advisory Committee on Drugs, Ireland, 2011) (UNODC, 2012. Data from the ‘questionnaire on new psychoactive substances’ submitted by Member States and a network of drug analysis laboratories in 2012)

[20] UNODC, 2012. Data from the ‘questionnaire on new psychoactive substances’ submitted by Member States and a network of drug analysis laboratories in 2012

[21] Following information on the need to include a new substance, the Ministry of Health is entrusted with the drafting of a project of law or a Grand-Ducal Decree that can be directly forwarded to the Parliament for vote. New psychoactive substances that have been added to the list of drugs include 2C-I, 2C-T-2, 2C-T-7, TMA-2 (Grand-Ducal Regulation of 7 October 2004 amending the Grand-ducal regulation of 20 March 1974 on certain psychotropic substances and the Grand Ducal regulation of 6 February 1997 on substances listed in Tables III and IV of the Convention on Psychotropic Substances psychotropic substances 1971)

[22] The Act on Prohibition of Certain Goods allows for the control of new substances at an earlier stage as it applies to goods that, ‘by reason of their innate characteristics, entail a danger to human life or health, or can be used or assumed to be used for the purpose of intoxication or other influence’, and does not punish the use of substances prohibited under the Act. In cases of urgency, the Government amendment to the corresponding Ordinance may enter into force from one day to the next. In 2011, eight substances were controlled as narcotics according to the Act on the Control of Narcotic Drugs (SFS 1992:860) and the Act on Penal Law on Narcotics (SFS 1968:64) and were thereby listed in the amendment to the Ordinance on the Control of Narcotic Substances, (SFS 1992:1554). Several JWH- compounds were previously listed as Goods Dangerous to Health and have been reclassified as narcotics in 2011 (EMCDDA, 2012 National Report to the EMCDDA by the Reitox National Focal Point “Sweden”)

[23] Once the National Medicine’s Agency receives an indication from different sources (i.e. the Police, Customs, media), a consultation letter is sent to relevant authorities, organization and scientific bodies for consultation. After this period, the NMA makes a decision on whether or not to add the substance to the narcotics list. The decision is subsequently published in the official journal. In cases of urgency, this procedure may also be completed in the absence of consultations or with shortened time for comments. The narcotics list is determined by the NMA cf. regulation of 30 June 1978 No. 8 on narcotics etc. section 3. The NMS is empowered to add other substances to the narcotics list if they may have similar damaging effects as substances already included, even though they are not internationally controlled, such as khat

[24] Act 29 July 2005 regulates the standard legislative procedure required for amending any national law, which is estimated to last about nine months. In cases of urgency a rapid procedure that shortens in about one third the time for legislative amendment may take place. It corresponds to the Council of Ministers to initiate the rapid procedure upon initiative of the Ministry of Health. The approval time in the parliamentary chambers is shortened, as well as the signature time given to the president

[25] Act 139/1998 Coll. Of 2 April on narcotic drugs and psychotropic substances establishes the process for controlling new substances. This competence rests with the Parliament. While the standard process to introduce any modification to a parliamentary law takes at least three months, in case of urgency this process can be shortened to about one month 

[26] See the EMCDDA definition for analogue and generic, as shown in

http://www.emcdda.europa.eu/attachements.cfm/att_211257_EN_EMCDDA_POD_2013_Controlling%20new%20psychoactive%20substances.pdf

[27] The meaning of what is understood as an analogue system differs in both legislations

[28] EMCDDA, Perspectives on drugs, controlling new psychoactive substances, 2013

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

[30] Albania, Bahrain, Brunei, Bulgaria, Thailand; UNODC, 2012. Data from the ‘questionnaire on new psychoactive substances’ submitted by Member States and a network of drug analysis laboratories in 2012

[31] Bahrain, Bulgaria, Croatia, Hungary, Israel, Nepal, Portugal, Romania, Russia Federation, United Kingdom and Togo have also reported the use of consumer safety regulations to control NPS. UNODC, 2012. Data from the ‘questionnaire on new psychoactive substances’ submitted by Member States and a network of drug analysis laboratories in 2012

[32] In 2009, Austria controlled the (legal) distribution of ‘spice’ products under non-criminal medicines legislation (The Austrian Medicinal Products Act). United Nations Office on Drugs and Crime, World Drug Report, 2013

[33] Netherlands and Finland applied control measures to mephedrone under their medicines legislation before it was subject to a risk assessment in the framework of the Council Decision on new psychoactive substances. In the Netherlands, mephedrone is classified as a medicine and is therefore controlled under medicinal products legislation. In Finland, mephedrone is classified as a medicine since September 2008 under the Medicines Act (395/87): European Monitoring Centre for Drugs and Drug Addiction, ‘Risk assessment report of a new psychoactive substance: 4-methylmethcathinone (mephedrone)’, 2010

[34] UNODC, 2012. Data from the ‘questionnaire on new psychoactive substances’ submitted by Member States and a network of drug analysis laboratories in 2012

[35] EMCDDA, Perspectives on drugs, controlling new psychoactive substances, 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