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欧盟关于无烟烟草的政策:支持基于证据的公共卫生监管的声明。

European Union policy on smokeless tobacco: a statement in favour of evidence based regulation for public health.

作者信息

Bates C, Fagerström K, Jarvis M J, Kunze M, McNeill A, Ramström L

机构信息

Action on Smoking and Health, London, UK.

出版信息

Tob Control. 2003 Dec;12(4):360-7. doi: 10.1136/tc.12.4.360.

DOI:10.1136/tc.12.4.360
PMID:14660767
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1747769/
Abstract

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", 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, 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.

摘要

理由

本声明是同一批作者于2003年2月发布的声明的更新版本。该声明是为跟进皇家内科医师学院(RCP)烟草咨询小组的报告《保护吸烟者,拯救生命:设立烟草和尼古丁监管机构的理由》而撰写的,该报告主张对无烟烟草采取基于证据的监管方法以及减少危害,并提出了监管机构在无烟烟草方面必须解决的一系列问题。本声明的目的是提供事实和原则论据,以跟进RCP的报告,并概述改变欧盟在这一领域现行法规的公共卫生理由。欧盟指令2001/37/EC第11条要求对与减少危害及除卷烟以外的烟草制品监管相关的法规进行审查,这有助于在欧洲公共卫生界就欧盟应根据此次审查或可能完全废除现行法规的正在进行的法律行动采取何种政策形成共识。

公共卫生理由

我们认为,欧盟对某些形式无烟烟草的部分禁令应被对所有无烟烟草毒性的监管所取代。我们持此观点是出于公共卫生原因:无烟烟草的危害远低于吸烟,瑞典的证据表明它被用作吸烟的替代品以及用于戒烟。就存在“入门效应”而言,似乎它不会导致吸烟,而是远离吸烟,这也是瑞典成为欧洲烟草相关疾病发病率最低的国家的一个重要原因。我们认为剥夺其他欧洲人这种降低风险的选择是错误的,而且现行禁令侵犯了吸烟者控制自身风险的权利。对于那些对尼古丁上瘾且无法或不愿戒烟的吸烟者来说,重要的是他们能够利用危害小得多的尼古丁和烟草形式——否则就得“要么戒烟,要么死亡”,而许多人因此死亡。虽然尼古丁替代疗法(NRT)在减少危害方面可能有作用,但基于烟草的减少危害选择可能会惠及更多吸烟者,且方式不同,是基于市场的。嚼烟在欧盟未被禁止或监管,但往往毒性很高,我们的提议可能会使更多产品退出市场而非允许其存在。

监管选择

我们认为欧盟关于无烟烟草的政策应适应新的科学知识,欧盟委员会应提出提案,用新的监管框架修订或取代指令2001/37/EC第8条。加拿大已制定了烟草成分检测方案,这些方案可很容易地适用于欧洲情况。最迟应在2004年12月对欧盟在这一领域的政策进行审查,我们认为委员会应加快其审查中涉及减少危害及除卷烟以外的烟草制品监管的部分,以便重新考虑其对无烟烟草的政策。在瑞典火柴公司提起法律诉讼质疑欧盟立法之前我们就持有此观点,如果其行动失败,我们仍将继续持有这些观点。

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