Risk assessment of new psychoactive substances - EMCDDA - Europa

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Risk assessment of new psychoactive substances: operating guidelineswarning system. The assessment showed that the Joint Action had fulfilledits expectations. Nevertheless, the outcome of the assessment made it clearthat the Joint Action was in need of reinforcement and reorientation. Inparticular, its main objective, the clarity of its procedures and definitions,the transparency of its operation, and the relevance of its scope had tobe redefined. The Communication from the Commission to the EuropeanParliament and the Council on the mid-term evaluation of the EU ActionPlan on Drugs (2000-2004) indicated that changes to the legislation wouldbe introduced in order to enhance action against synthetic drugs. Themechanism as established by the Joint Action should therefore be adapted.(4) New psychoactive substances can be harmful to health.(5) The new psychoactive substances covered by this Decision may includemedicinal products as defined in Directive 2001/82/EC of the EuropeanParliament and of the Council of 6 November 2001 on the Community Coderelating to veterinary medicinal products [ 18 ] and in Directive 2001/83/ECof the European Parliament and of the Council of 6 November 2001 on theCommunity Code relating to medicinal products for human use [ 19 ].(6) The information exchange under the early warning system, established underthe Joint Action, has proved to be a valuable asset to the Member States.(7) Nothing in this Decision should prevent Member States from exchanginginformation, within the European Information Network on Drugs and DrugAddiction (hereinafter ‘the Reitox network’), on emerging trends in new usesof existing psychoactive substances which may pose a potential risk to publichealth, as well as information on possible public health related measures, inaccordance with the mandate and procedures of the EMCDDA.(8) No deterioration of either human or veterinary health care as a result of thisDecision will be permitted. Substances of established and acknowledgedmedical value are therefore excluded from control measures based on this( 18 ) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC(OJ L 136, 30.4.2004, p. 58).( 19 ) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive 2004/27/EC(OJ L 136, 30.4.2004, p. 34).76
Decision. Suitable regulatory and public health related measures should betaken for substances of established and acknowledged medical value that arebeing misused.(9) In addition to what is provided for under the pharmacovigilance systems asdefined in Directive 2001/82/EC and in Directive 2001/83/EC, the exchangeof information on abused or misused psychoactive substances needs tobe reinforced and appropriate cooperation with the European MedicinesAgency (hereinafter ‘EMEA’) ensured. The United Nations Commission onNarcotic Drugs (hereinafter ‘CND’) Resolution 46/7 ‘Measures to promote theexchange of information on new patterns of drug use and on psychoactivesubstances consumed’, provides a useful framework for action by the MemberStates.(10) The introduction of deadlines into every phase of the procedure establishedby this Decision should guarantee that the instrument can react swiftly andenhances its ability to provide a quick-response mechanism.(11) The Scientific Committee of the EMCDDA has a central role in the assessmentof the risks associated with a new psychoactive substance, it will for thepurpose of this Decision be extended to include experts from the Commission,Europol and the EMEA, and experts from scientific fields not represented, ornot sufficiently represented, in the Scientific Committee of the EMCDDA.(12) The extended Scientific Committee that assesses the risks associated with newpsychoactive substances should remain a concise technical body of experts,capable of assessing effectively all risks associated with a new psychoactivesubstance. Therefore the extended Scientific Committee should be kept to amanageable size.(13) Since the objectives of the proposed action, namely to bring about anexchange of information, a risk-assessment by a scientific committee and anEU-level procedure for bringing notified substances under control, cannot besufficiently achieved by the Member States and can therefore, by reason ofthe effects of the envisaged action, be better achieved at European Unionlevel, the Union may adopt measures, in accordance with the principle ofsubsidiarity as set out in Article 5 of the Treaty. In accordance with the77
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ContentsAcknowledgements 5Foreword
Page 13 and 14:
IntroductionThese guidelines are a
Page 17 and 18:
Chapter 1Legal basis and scope1.1 L
Page 19 and 20:
factors that would warrant such act
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
Page 66 and 67: Risk assessment of new psychoactive
Page 74: Risk assessment of new psychoactive
Page 90 and 91: European Monitoring Centre for Drug
Page 92: About the EMCDDAThe European Monito
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Risk assessment of new psychoactive substances - EMCDDA - Europa

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