Risk assessment of new psychoactive substances - EMCDDA - Europa

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Risk assessment of new psychoactive substances: operating guidelines1.2 ScopeThe scope of the Council Decision is defined in Article 2, which states that theDecision applies to substances not currently listed in any of the schedules to:(a) the 1961 UN Convention, that may pose a comparable threat to public healthas the substances listed in Schedule I or II or IV thereof; and(b) the 1971 UN Convention, that may pose a comparable threat to public healthas the substances listed in Schedule I or II or III or IV thereof.The above implies that substances already listed under the UN conventions areexcluded from the scope of the Council Decision. Important differences withthe Joint Action are the inclusion of narcotic drugs as specified under (a) aboveand psychotropic substances posing a comparable threat as substances listed inSchedules III or IV of the 1971 UN Convention.Although the new psychoactive substances concerned may include human orveterinary medicinal products (point 5 of the recital to the Council Decision), suchproducts are excluded from a risk assessment under Article 7.3 of the CouncilDecision when the new psychoactive substance is used to manufacture a medicinalproduct which has been granted a marketing authorisation or for which anapplication has been made for a marketing authorisation or for which a marketingauthorisation has been suspended by a competent authority.Precursors used for the illicit manufacture of narcotic drugs and psychotropicsubstances are also excluded from the scope of the Council Decision. These aregoverned by different Regulations ( 9 ).1.3 Factors to be considered in a risk assessmentAccording to Article 6.3 of the Council Decision, a risk assessment should take intoaccount all factors which, according to the 1961 UN Convention or the 1971 UNConvention, would warrant placing a substance under international control. The( 9 ) Council Regulation (EEC) No 3677/90 of 13 December 1990 laying downmeasures to be taken to discourage the diversion of certain substances to the illicitmanufacture of narcotic drugs and psychotropic substance (OJ L 357, 20.12.1990);Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11February 2004 on drug precursors (OJ L 47, 18.2.2004).16
factors that would warrant such action are described in Articles 3.3. (iii) and 3.5of the 1961 UN Convention and Article 2.4 of the 1971 UN Convention.Based on the provisions in the UN conventions, the following need to be taken intoaccount:1. Whether a new psychoactive substance is liable to similar abuse ( 10 ) andproduces similar ill effects as the drugs in Schedule I or Schedule II of the 1961UN Convention;2. Whether a new psychoactive substance is convertible into a drug as meantunder point 1;3. Whether a new psychoactive substance is particularly liable to abuse and toproduce ill effects and that such liability is not offset by substantial therapeuticadvantages, which would qualify it for placement under Schedule IV of the1961 UN Convention;4. Whether the new psychoactive substance has the capacity to produce a state ofdependence ( 11 ) and central nervous system stimulation or depression, resultingin hallucinations or disturbances in motor function or thinking or behaviour orperception or mood;5. Whether the new psychoactive substance is liable to similar abuse and similarill effects as a substance listed in Schedules I, II, III or IV of the 1971 UNConvention;( 10 ) The terms ‘abuse’ and ‘use’ are used concomitantly throughout the guidelines.Whenever the text refers to the UN conventions or established terminology such as‘abuse potential’, the term ‘abuse’ is maintained. The EMCDDA preferred term ‘use’appears when, for example, prevalence is discussed.( 11 ) Dependence was defined by the WHO 28 th Expert Committee on Drug Dependenceas: ‘A cluster of physiological, behavioural and cognitive phenomena of variableintensity, in which the use of a psychoactive drug (or drugs) takes on a high priority.The necessary descriptive characteristics are preoccupation with a desire to obtainand take the drug and persistent drug-seeking behaviour. Determinants and theproblematic consequences of drug dependence may be biological, psychologicalor social, and usually interact’ (WHO, 1993, WHO Expert Committee on DrugDependence 28 th Report, World Health Organization, Technical Report Series,Volume 386, Geneva.17
Page 5: ContentsAcknowledgements 5Foreword
Page 13 and 14: IntroductionThese guidelines are a
Page 17: Chapter 1Legal basis and scope1.1 L
Page 23 and 24: Chapter 2General considerations for
Page 25 and 26: 2.6 Quality of dataIn the final eva
Page 29 and 30: Chapter 3A conceptual framework for
Page 31 and 32: (family, neighbourhood and communit
Page 35 and 36: Chapter 4Headings for the Risk Asse
Page 37 and 38: Descriptive elements• Name of the
Page 39 and 40: (c) Social risksSome public health
Page 41 and 42: • Evidence that the same groups o
Page 43: Elements for examining the conseque
Page 47: Chapter 6ConclusionThe Risk Assessm
Page 51 and 52: Annex ITechnical reportThe EMCDDA i
Page 53 and 54: D1.1.D1.2.Animal dataHere, data reg
Page 55 and 56: E6. Possible appeal of the new psyc
Page 59 and 60: Annex IISemi-quantitative assessmen
Page 61 and 62: 8 subgroups. All members give numer
Page 63: Step 4Delphi approach:On the day of
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European Monitoring Centre for Drug
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About the EMCDDAThe European Monito
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