本书从烟草制品监管的基础、烟草产品法规国际指南、监管需求和能力的评估、执行监管前的考虑因素、实施中以及潜在的挑战、新奇、新出的和改进的烟草或相关产品和烟草制品相关信息的测试和披露等多方面进行了深入的阐述。并进行了相关的案例研究。
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目录
前言 1
致谢 3
缩略语表 5
第1章 烟草制品管制基础知识 7
1.1 什么是烟草制品管制？ 7
1.2 影响烟草制品使用及危害的因素是什么？ 10
1.3 烟草制品管制如何促进公众健康？ 14
1.4 现有和新兴的烟草及相关产品管制方法有哪些？ 16
第2章 烟草制品管制国际指南 23
2.1 世界卫生组织对烟草制品管制的指导原则是什么？ 24
2.2 国际贸易法是否限制烟草制品管制？ 26
2.3 在烟草制品管制方面有哪些不同国家的经验？ 30
第3章 监管需求和监管能力评估 33
3.1 现状如何？评估资源和能力 34
3.2 需要什么？确定监管的优先次序 35
案例1 印度——支持现有立法却能力有限的挑战 37
3.3 可能方案？收集和评估证据 39
3.4 该怎么办？做出管制的决定 41
案例2 布基纳法索——在低收入国家发展产品监管和测试的能力 42
第4章 实施监管前的考虑因素 45
4.1 是否收集了相关信息？ 46
案例3 智利——对含薄荷醇产品的禁令被推翻 48
4.2 监管文本中包含哪些内容？ 49
4.3 选择的措施是否实用？ 51
4.4 如何得知管制已经奏效？ 53
案例4 加拿大——烟草行业规避香料禁令的实施 54
第5章 实施与潜在挑战 56
5.1 烟草制品管制的实施是怎样的？ 56
案例5 欧盟——28 个成员国关于烟草制品香料的立法 61
5.2 可能面临的挑战是什么？ 63
案例6 巴西——烟草行业反对者推迟了禁令的实施，但最终还是失败了 65
5.3 实施后的潜在结果是什么？ 66
5.4 如何回应意料之外的结果？ 67
案例7 欧盟——焦油、烟碱和一氧化碳的含量信息 68
第6章 新型和改良烟草制品及相关产品 69
6.1 什么是新型和改良烟草制品及相关产品？ 70
案例8 美国——不同类别产品的授权制度 72
6.2 如何识别市场上的新型和改良烟草制品及相关产品？ 72
6.3 如何评价新型烟草制品及相关产品和“低风险”产品？ 74
6.4 如何对新型和改良烟草制品及相关产品进行管制？ 77
案例9 德国——通过阐明薄荷胶囊增加产品的吸引力来成功禁止薄荷胶囊 81
第7章 测试与披露 82
7.1 什么是烟草制品测试？ 82
7.2 为什么烟草制品测试很重要？ 87
7.3 如何向公众披露产品信息？ 89
7.4 需要什么资源来支持烟草制品测试？ 89
参考文献 91
附录 欧盟烟草制品指令（TPD2）的规定 106
Contents
Preface 113
Acknowledgements 117
Acronyms used in this publication 119
Chapter 1. The Basics of Tobacco Product Regulation 121
1.1 What is tobacco product regulation? 122
1.2 What product factors are determinants of tobacco use and harm? 125
1.3 How can tobacco product regulation improve public health? 130
1.4 What are existing and emerging approaches to regulating TRP? 132
Chapter 2. International Guidance on Tobacco Product Regulation 141
2.1 What is WHO’s guidance on regulating tobacco products? 142
2.2 Does international trade law place limits on tobacco product regulation? 145
2.3 What are different country experiences in regulating tobacco products? 150
Chapter 3. First Steps: Assessing Regulatory Needs and Capacity 154
3.1 Where are you now? Assessing resources and capacity 155
3.2 What do you need? Identifying priorities for regulation 157
Case study 1: India—Challenges to supporting existing legislation due to limited capacity 159
3.3 What is possible? Gathering and evaluating evidence 161
3.4 What should you do? Making the decision to regulate 164
Case study 2: Burkina Faso—Developing capacity for product regulation and testing in a low-income country (LIC) 166
Chapter 4. Regulatory Considerations in Advance of Implementation 169
4.1 Have you gathered the relevant information? 170
Case Study 3: Chile—Ban on menthol products is struck down 174
4.2 What will you include in the regulatory text? 174
4.3 Is the measure you have chosen practical? 178
4.4 How will you know if the regulation has done its job? 179
Case study 4: Canada—Implementation of a ban on flavours circumvented by the tobacco industry 181
Chapter 5. Implementation and Potential Challenges 183
5.1 What does implementation of tobacco product regulation look like? 183
Case study 5: European Union—Legislation on tobacco product flavours for 28 countries 190
5.2 What are the challenges you may face? 192
Case study 6: Brazil—Industry opposition delayed implementation of a ban on flavours but was ultimately unsuccessful 194
5.3 What are potential outcomes following implementation? 196
5.4 How do you respond to unanticipated outcomes? 197
Case study 7: European Union—Information on TNCO-levels 198
Chapter 6. Novel, New and Modified Tobacco or Related Products 200
6.1 What are novel, new or modified TRPs? 201
Case study 8: USA—authorization regimes for different product categories 204
6.2 How do you identify novel, new or modified TRPs in your market? 205
6.3 How do you evaluate novel TRPs and “reduced risk” products? 207
6.4 How do you regulate novel, new and modified TRPs? 210
Case study 9: Germany—Successful ban on menthol capsules by demonstrating that capsules increase product attractiveness 216
Chapter 7. Testing and Disclosure 218
7.1 What is tobacco product testing? 219
7.2 Why is it important to test tobacco products? 224
7.3 How should tobacco product information be reported to the public? 226
7.4 What resources do you need to support tobacco product testing? 227
References 229
Annex 1. Provisions of the EU Tobacco Products Directive (TPD2) 240
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