European Union policy on smokeless tobacco:: a statement in favour of evidence based regulation for public health
European Union policy on smokeless tobacco:: a statement in favour of evidence based regulation for public health
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DOI：
10.1136/tc.12.4.360
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发表时间：
2003-12-01
期刊：
影响因子：
5.2
通讯作者：
Ramström, L
中科院分区：
文献类型：
--
作者：
Bates, C;Fagerström, K;Ramström, L
理由：本声明是同一作者2003年2月发表的声明的更新版本。该声明是为了跟进皇家医师学院（RCP）烟草咨询小组的报告《保护吸烟者，拯救生命：烟草和尼古丁监管机构的案例》（1），该报告主张对无烟烟草和减少危害采取基于证据的监管方法，并提出了监管机构必须解决的一系列与无烟烟草有关的问题。本声明的目的是提供事实和原则论据，以遵循RCP的报告，并概述改变这一领域现有欧洲联盟（欧盟）法规的公共卫生案例。欧盟指令2001/37/EC第11条要求审查与烟草产品（香烟除外）的危害减少和监管有关的监管，（2）这有助于在欧洲公共卫生界就欧盟应根据这一审查采取何种政策达成共识，或在可能完全取消现有法规的持续法律的行动之后。公共卫生案例：我们认为，欧盟对某些形式的无烟烟草实行的部分禁令应该由对所有无烟烟草毒性的规定所取代。我们持有这一观点是出于公共卫生原因：无烟烟草的危害远远小于吸烟，瑞典的证据表明，无烟烟草被用作吸烟和戒烟的替代品。在某种程度上，有一个“门户”，它似乎不会导致吸烟，而是远离吸烟，这是瑞典在欧洲与烟草有关的疾病发病率最低的一个重要原因。我们认为，拒绝其他欧洲人减少风险的选择是错误的，目前的禁令侵犯了吸烟者控制自己风险的权利。对于那些对尼古丁上瘾并且不能或不愿意戒烟的吸烟者来说，重要的是他们可以利用危害小得多的尼古丁和烟草形式-替代方案是“戒烟或死亡”。很多人会死虽然尼古丁替代疗法（NRT）可能在减少危害方面发挥作用，但基于烟草的减少危害选择可能会以不同的市场方式接触到更多的吸烟者。欧盟没有禁止或管制咀嚼烟草，但咀嚼烟草通常具有剧毒，我们的建议可能会使更多产品从市场上消失。监管选择：我们认为欧盟的无烟烟草政策应该适应新的科学知识，欧盟委员会应该提出建议，以新的监管框架修改或取代指令2001/37/EC的第8条。加拿大已经制定了烟草成分的测试方案，这些方案可以随时适应欧洲的情况。欧盟在这方面的政策最迟须于2004年12月进行一次审查，我们认为，委员会应加快审查涉及减少危害和管制香烟以外的烟草产品的部分，以便重新考虑其无烟烟草政策。在瑞典火柴公司提起法律的诉讼挑战欧盟立法之前，我们就持有这种观点，如果它的行动失败，我们将继续持有这些观点。
Rationale: This statement is an updated version of one released by the same authors in February 2003. The statement was produced to follow up the Royal College of Physicians (RCP) Tobacco Advisory Group report "Protecting smokers, saving lives: the case for a tobacco and nicotine regulatory authority",(1) which argued for an evidence based regulatory approach to smokeless tobacco and harm reduction and posed a series of questions that regulators must address in relation to smokeless tobacco. The purpose of this statement is to provide arguments of fact and principle to follow the RCP's report and to outline the public health case for changing existing European Union (EU) regulation in this area. A review of regulation in relation to harm reduction and regulation of tobacco products other than cigarettes is required in Article 11 of EU directive 2001/37/EC,(2) and this is a contribution towards forming a consensus in the European public health community about what policy the EU should adopt in the light of this review, or following ongoing legal action that may potentially strike out the existing regulation altogether.Public health case: We believe that the partial ban applied to some forms of smokeless tobacco in the EU should be replaced by regulation of the toxicity of all smokeless tobacco. We hold this view for public health reasons: smokeless tobacco is substantially less harmful than smoking and evidence from Sweden suggests it is used as a substitute for smoking and for smoking cessation. To the extent there is a "gateway" it appears not to lead to smoking, but away from it and is an important reason why Sweden has the lowest rates of tobacco related disease in Europe. We think it is wrong to deny other Europeans this option for risk reduction and that the current ban violates rights of smokers to control their own risks. For smokers that are addicted to nicotine and cannot or will not stop, it is important that they can take advantage of much less hazardous forms of nicotine and tobacco-the alternative being to "quit or die"... and many die. While nicotine replacement therapies (NRT) may have a role in harm reduction, tobacco based harm reduction options may reach more smokers and in a different, market based, way. Chewing tobacco is not banned or regulated in the EU but is often highly toxic, and our proposal could remove more products from the market than it permitted.Regulatory options: We believe that the EU policy on smokeless tobacco should adapt to new scientific knowledge and that the European Commission should bring forward proposals to amend or replace Article 8 of directive 2001/37/EC with a new regulatory framework. Canada has developed testing regimens for tobacco constituents and these could be readily adapted to the European situation. A review of EU policy in this area is required no later than December 2004, and we believe the Commission should expedite the part of its review that deals with harm reduction and regulation of tobacco products other than cigarettes so as to reconsider its policy on smokeless tobacco. We held this view before Swedish Match brought its legal proceedings to challenge EU legislation and we will continue to hold these views if its action fails.