Councilofthe EuropeanUnion Brussels,9October 2014 (OR.en)

Transcription

1 ConseilUE Councilofthe EuropeanUnion Brussels,9October 2014 (OR.en) 14008/14 LIMITE PUBLIC SAN376 FISC152 UD224 OUTCOMEOFPROCEEDINGS From: To: Subject: GeneralSecretariatoftheCouncil Delegations ConferenceofthePartiestotheWHOFrameworkConventiononTobacco Control(WHOFCTC) Sixthsession, Moscow,RussianFederation,13-18October2014 = Commonapproachesonagendaitems4.3to Atitsmeetingson3and5September and6october2014the WorkingPartyonPublic Health(Atachéslevel)discusedthepreparationfortheaboveconferencewithregardto agendaitems4.3to5.4ofitsdraftagenda(doc.fctc/cop/6/1). 2. TheEUcommonapproachesthatresultedfromthediscusionatthe WorkingPartyhavebeen confirmedbywritenconsultationwithdeadlineon8october2014at13:00andaresetoutin theannex /14 JS/pm 1 DGB4B LIMITE EN

2 ANNEX WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point 4.3 (Article 19 FCTC "Liability") Suggested EU common approach The EU and its Member States thanks the members of the Expert Group for the comprehensive work to fulfil its mandate and welcomes the Report as a good base for the effective implementation of Article 19 FCTC. The EU agrees that it would be useful to facilitate voluntary sharing of information among Parties via a protected website to be facilitated by the Convention Secretariat in collaboration with WHO. This could include access to databases or networks of experts who could provide technical assistance to Parties on request (as outlined in paragraph 32 of the Report). Such a system could be extended to litigation to respond to industry legal challenges against tobacco control measures (as outlined in paragraph 33). The role of the planned "knowledge hub" should be considered in this context. The EU supports such measures on condition they are financed by extra-budgetary resources. The EU takes the view that further guidance on a multilateral basis to implement Article 19 FCTC is not required. Given the divergence of the legal systems of the Parties and the comprehensive nature of the present Report and its accompanying consolidated review, the EU would not be in favour of development of common guidelines, legal principles, model laws or similar instruments /14 JS/pm 2

3 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point Control and prevention of smokeless tobacco products Suggested EU common approach Introduction The EU and its Member States would like to thank the WHO for the report regarding the control and prevention of smokeless tobacco products. General comments Smokeless tobacco (SLT) products are fully covered by the FCTC and its guidelines. It is important to ensure that all FCTC provisions are effectively implemented on SLT products as these products are addictive and have adverse health effects. This includes measures to promote cessation of the use of smokeless tobacco products in line with Article 14 of the FCTC and guidelines. The EU fully supports the guiding principle of the FCTC expressed in Article 4(4) stipulating that comprehensive measures to reduce consumption of all tobacco products are essential. The EU welcomes the efforts of the WHO to update the earlier documents FCTC/COP/4/12 and FCTC/COP/5/12 and to assess the regulatory situation regarding SLT products, best practices on and possible options for prevention and control, evidence from research as well as relevant research needs /14 JS/pm 3

4 The EU acknowledges the complexity of the topic, taking into account inter alia the diversity of existing and of newly emerging products and consumption patterns, as well as the need for further research. Concerning the priority research needs identified (p.14-19), the EU would welcome in particular research and data collection/monitoring on use patterns (e.g. type of products, age of consumer), market developments (including recent introductions of flavoured products), health effects (taking into account the heterogeneity of products), and the role of SLT products for overall tobacco use (attractiveness of products for young people, role of SLT products for initiation and cessation of tobacco consumption (in particular smoking), risk of "dual use", effect of smoking bans on their usage as a (temporary or permanent) alternative to smoking. The EU continues to support regular reports to COP through the Convention Secretariat on smokeless tobacco products via the reporting system of the WHO FCTC as outlined in the report to COP5 (see FCTC/COP/5/12 p 41). EU and smokeless tobacco Smokeless tobacco overall still has a small market share in the EU: ~0.7% in value in Therefore, for smokeless tobacco products, the strengthening of certain provisions in the TPD has been considered sufficient to contain their expansion in the market beyond their traditional use. All smokeless tobacco products sold in the EU have to carry a health warning on the two largest surface areas of the unit packet and any outside packaging (Art 12) and promotional elements on the pack (including reference to taste, smell and flavourings) are now prohibited (Art 13) /14 JS/pm 4

5 While the new EU Directive has overall strengthened the rules for tobacco products on the EU-market, smokeless tobacco products, given their very limited market share, are currently exempted from some of the regulatory measures under the TPD (e.g. the ban of products with characterizing flavours, large pictorial health warnings). The exemption can be lifted in case of a 'substantial change of circumstances'. Tobacco products for oral use (a sub category of smokeless tobacco) have a particular place in the EU regulatory framework and according to the former and current European Tobacco Products Directive, the placing on the market of tobacco products for oral use is prohibited (except within one Member State having an exemption from the ban). This prohibition is in place in order to prevent the introduction in the Union of a product that is addictive and has adverse health effects /14 JS/pm 5

6 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point Electronic nicotine delivery systems Suggested EU common approach Introduction The EU and its Member States would like to thank the WHO for the preparation of a report on electronic nicotine delivery systems for this Conference of the Parties. Having regard to the recently adopted EU Tobacco Products Directive 2014/40/EU, the EU notes that the conclusions reached by the WHO are in line with those identified by the EU during the legislative process. In this light the EU can largely support the general considerations and the specific regulatory options proposed in the WHO. General comments The EU appreciates the work that the WHO has devoted to this area in recent years and the report that was submitted to this COP. In the light of market and product developments, the EU welcomes the efforts and interest of Parties to develop appropriate regulation of electronic nicotine delivery systems (ENDS). The regulatory options proposed are largely compatible with the provisions set out on electronic cigarettes in Article 20 of the newly adopted EU Tobacco Products Directive 2014/40/EU /14 JS/pm 6

7 The EU notes that the product scope of the WHO report is on all electronic nicotine delivery systems (ENDS) and therefore wider than that of the EU regulation, which is on electronic cigarettes only. Comments in detail The EU is of the view that the WHO report addresses the essential questions surrounding ENDS and identifies the key underlying objectives for an effective regulation, in particular in terms of public health. Central issues are the health risks for users and non-users, the efficacy in helping smokers quit (including risks associated with dual use) and the impact on existing tobacco control efforts. The EU wishes to highlight in particular the need for more long-term research (e.g. on health effects) and the interest to protect young people from developing a nicotine dependency. In the context of an emerging market for electronic cigarettes, the EU considers that a robust regulatory regime should be put in place, taking into account a high level of health protection. Regulation should have as an aim that consumers are protected and well-informed, that there is surveillance and monitoring systems in place, and that regulators are enabled to collect evidence of the public health impacts of these products. While a number of areas identified for action in the WHO report are addressed on an EU-wide basis (e.g. regulation of safety and quality requirements, reporting obligations for manufacturers and importers, introduction of mandatory notification obligation, labelling, monitoring and reporting requirements and advertising), others will be regulated at national level (e.g. regulation of flavours, sale to minors, rules on smoke-free environment and possibility to regulate under pharmaceutical legislation). This largely reflects the division of tasks, between the EU level and the Member States. In conclusion, the EU welcomes and supports the report /14 JS/pm 7

8 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point Control and prevention of waterpipe tobacco products Suggested EU common approach Introduction The EU and its Member States would like to thank the WHO for the report prepared regarding the control and prevention of waterpipe tobacco products. General comments Waterpipe (WP) tobacco is fully covered by the FCTC and its guidelines. It is important to ensure that all FCTC provisions are effectively implemented on WP tobacco as it is addictive and has adverse health effects. This includes measures to promote cessation of the use of WP tobacco in line with Article 14 of the FCTC and guidelines. The EU fully supports the guiding principle of the FCTC expressed in Article 4(4) stipulating that comprehensive measures to reduce consumption of all tobacco products are essential. WP tobacco is also increasingly used in the EU, in particular by youth and children. The EU is concerned about the misconception regarding their safety in comparison to other tobacco products and also about the contents and emissions of these products and the associated health risks. WP tobacco poses regulatory challenges stemming from the heterogeneity of products on the market and the context of their consumption (waterpipe often prepared by staff in hospitality sector and not by the consumer) /14 JS/pm 8

9 The EU welcomes the WHO report on WP tobacco summarizing the current knowledge base (including inter alia health effects, product characteristics including contents and emissions, prevalence data). The report also highlights the regulatory challenges and gaps in the knowledge base (e.g. composition and properties of products) and provides some policy recommendations. The EU wishes to highlight that the report in Point 12 should also include a reference to the EU as a party that has developed packaging and labelling rules which include WP tobacco and which are in compliance with Article 11 of the FCTC. The EU would welcome research and data collection/monitoring on prevalence and consumption (e.g. type of products/composition, age and type of consumer), market developments, health effects, and the role of WP tobacco for overall tobacco use (perception and attractiveness of products for young people, role of WP tobacco for initiation and cessation of tobacco consumption (in particular smoking), risk of "dual use"). Regarding health effects, the EU agrees with the need for studies assessing the long-term effects of WP use. Such studies should consider recent changes in the usage and types of products consumed (Maasal) as well as in the population exposed. Background, if needed - EU and waterpipe tobacco According to 2012 Eurobarometer, 16% of EU citizens have tried water pipes (mostly only to try them out once or twice). However, they are particularly popular among young people (ever use among year olds: 32%). WP tobacco is specifically included in the European Tobacco Products Directive (TPD) 2014/40/EU and is considered therein as a tobacco product for smoking (to the extent they contain tobacco) /14 JS/pm 9

10 Under the TPD, water pipes are subject to the same restrictive labelling requirements as cigarettes and RYO tobacco (65% combined health warnings on the top of the front and back, Art 10) and promotional elements on the pack (including reference to taste, smell and flavourings) are prohibited (Art 13). However, the regulatory difficulty remains that exposure of consumers to the packages including health warnings may be limited as waterpipes are often consumed in restaurants, bars and cafés. Furthermore, product composition and cross-border distance sale are now stricter regulated. However, while the new EU Directive has overall strengthened the rules for tobacco products on the EU-market, waterpipe tobacco is currently exempted from some of the regulatory measures regarding ingredients (e.g. the ban of products with characterizing flavours). The exemption can be lifted in case of a 'substantial change of circumstances'. In addition, the EU will monitor the situation and will report by 2021 on market developments and consumer preferences regarding waterpipe tobacco, with a particular focus on its flavours /14 JS/pm 10

11 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian federation, October 2014 Agenda item 4.5. Economically sustainable alternatives to tobacco growing (in relation to Articles 17 and 18 of the WHO FCTC): report by the working group Suggested EU common approach General comments and future process The EU and its Member States would like to thank the FCTC secretariat, the members of the Working Group and Key Facilitators for the work done in drafting and coordinating the report as contained in document FCTC/COP/6/12. In the view of the EU, Articles 17 and 18 of the WHO FCTC are important and necessary elements of a comprehensive tobacco control policy. Therefore, the EU agrees to deal with these two Articles in more detail and to develop guidance for the Parties for their implementation. The EU considers that the latest draft report corresponds much better to the scope of the two Articles and remains within the mandate of the Working Group. However, some of the assessments could be reconsidered during COP6 and regrettably the document remains too long. Therefore, although much progress was made since COP 5, the EU considers that the report requires still some changes to be ready for adoption /14 JS/pm 11

12 The EU strongly supports a consensus of the Parties on a final version of this report at this COP, and would therefore invite all Parties to show the necessary determination and flexibility to agree on a version which is more concentrated on the core of Article 17 and 18, and on the efforts to help farmers to find, where appropriate, economically viable alternatives to tobacco growing. In order to facilitate the adoption of this document, and to ensure a real added value of this work, the EU suggests to assist the COP through an open ended working group during COP6 with interested Parties. If such working group is accepted by the COP, the EU would like to see improvements in particular regarding the following aspects, which are of concern for the EU: o o o o the importance given to the promotion for research and its extension which may appear too broad or too expensive; in any case, the fact that this research is facultative should be more underlined for example by using the expression "where relevant"; many references to the negative effects on environment and health of tobacco production are similar to many other intensive agricultural practices, and not specific to tobacco; this aspect should be more underlined; it should be underlined that the recommendations and policy options should take into account, where appropriate, regional specificities; the interference of the tobacco industry in policy decisions or farmers practices is repeatedly mentioned in the document; to address this concern Principle 5 refers rightly to Article 5.3 of the FCTC, but sometimes the text goes beyond the scope of Article 5.3, particularly regarding the industry liability or when referring to retailers; 14008/14 JS/pm 12

13 o o o o o some considerations are still out of the scope of Articles 17 and 18; for example, in section and in Chapter 5, Article 17 does not aim to reduce tobacco cultivation areas but aims to promote viable alternatives for tobacco growers (who will be impacted by a decline in tobacco demand); in the introduction and in section 6.2, Article 18 does not address concerns on human health and rights as such but on the health of person in relation to tobacco cultivation and manufacture; The recommendation at the end of section 4.4 on public financing and subsidies, the EU suggests to address subsidies directly linked to tobacco growing, as this is more in line with the national or the EU common agricultural policy, which do not make a distinction between products cultivated; It should be also more underlined that professional organisations and stakeholders in agriculture including the tobacco growers could also be consulted in order to provide their knowledge for finding alternatives; The new draft of Chapter 5 seems to be in line with the discussions of the working group and gives the basic lines and tools to monitor and evaluate the issues reflected in chapter 4. However, for the sake of a better comprehension, all the examples detailed in three columns could be described in a new appendix, which will shorten the main text; Regrettably, the document does not contain conclusions or a short summary at the end. Fallback position: If there is no open ended drafting group established by the COP, or such group cannot reach agreement on a text, the EU is in favour of concluding work in this area and taking note of the current report. The EU would not support to continue the work with the same mandate for another time. In any case, further work should be financed by extra-budgetary resources and not from the core budget of the FCTC /14 JS/pm 13

14 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP5), Moscow, Russian Federation, October 2014 Agenda point 4.6 Further development of the partial guidelines on Articles 9 and 10 of the WHO FCTC Suggested EU common approach Introduction The EU and its Member States would like to thank the members of the Working Group (WG) and the Key Facilitators for their work and for the documents prepared for this Conference of the Parties. The EU can support the course of action proposed in the report of the WG and the future work suggested. Background As agreed at COP 4, the guidelines in the area of Article 9 and 10 shall be developed in a step-bystep process. Since COP 4 in 2010, when (partial) guidelines, focussing on attractiveness of ingredients, were adopted, these partial guidelines were complemented further at COP 5 in November 2012 by text on reduced ignition propensity (RIP) cigarettes and additional aspects of disclosure and information to the public. On the basis of the COP decision (FCTC/COP5/6) and in consultation with its Members, the WG has selected the following areas for presentation to this COP, reflecting the discussions that took place at its eighth WG meeting (28-30 January 2014): 14008/14 JS/pm 14

15 1. Examination of draft text for possible inclusion in the partial guidelines in relation to the testing and measuring of contents and emissions using the analytical chemical methods validated by WHO; 2. Analytical chemical methods for the testing and measuring of contents and emissions of cigarettes and other tobacco products for which validation should be extended; 3. Development of a definition of constituents ; 4. Addressing false, misleading or deceptive tobacco product characteristics; 5. Reports from WHO in the areas of dependence liability and toxicology. General comments The EU supports the selection of the topics and the approach proposed by the WG. In this context, the EU wishes to emphasize that: As regards Annex 3, it would be important to agree on a meaningful definition of constituents to complement the already agreed definition on ingredients. As regards Annex 2, point , (iv), it should be noted that the current EU-provisions only foresee a measurement of tar, nicotine and carbon monoxide emissions from cigarettes on the basis of ISO standards (Directive 2014/40/EU, Art 4(1)). While the EU is in favour of assessing and monitoring the suitability of existing methods with a view to their potential improvement and of developing new suitable methods, it is at this point not in favour of recommending in the guidelines the emission measurement via at least two sets of smoking regimens. The EU supports further work and research in the area of product regulation as well as in the area of attractive, misleading or deceptive product characteristics. Furthermore, the EU wishes to thank the WHO for the completed and ongoing work on various relevant aspects such as RIP-cigarettes, novel products, dependence liability and toxicity of tobacco products and encourages further work as outlined in the progress report FCTC/COP/6/ /14 JS/pm 15

16 Future work on Article 9 and 10 The EU believes that progress has been made on Article 9 and 10 and thanks the WG Group for all elements that it has delivered to the COP. The WG-meeting and related activities are very useful for the EU and provide information that can also support the implementation of its Tobacco Product legislation in certain areas (see e.g. Articles 3, 4) as well as the gathering of relevant data needed for the reporting obligations set out in Article 28 of the EU Tobacco Products Directive. The EU supports the approach for the future proposed by the WG, namely to continue its work in relation to the testing and measuring of constituents and emissions of tobacco products, including developing proposals with respect to their disclosure (based on Annexes 1 and 2 proposed), with a view to presenting draft partial guidelines or a progress report to the COP at its seventh session, to continue its work to arrive at a meaningful definition for constituents, to take stock of information received so far from the WHO on dependence liability and toxicology as part of its on-going activities to monitor dependence liability and toxicity and to engage in further work on attractive, misleading and deceptive product characteristics. Furthermore, the EU welcomes the suggestion to invite the WHO to work on the items outlined in point 17 of the progress report, i.e. to 1) prepare a report on specific cigarette characteristics; 2) to finalize the validation of analytical methods and to 3) assess their applicability to other tobacco products. The EU would appreciate if WHO also continued its monitoring of new tobacco products /14 JS/pm 16

17 Additional comment The EU takes note of the recommendation in the WHO-report FCTC/COP/6/14 to tighten the performance standard for RIP-cigarettes to 90%. The EU would like to recall that the current EU-legislation provides for a not-burn-through rate of at least 75%. This fully complies with the approach presented in the FCTC-guidelines on Art 9&10 of 2012 recommending compliance with international practice. The EU would see a merit in exchanging experiences and knowledge on the practical feasibility of the 90% performance standard, in order to further reduce the risk of fires from lit cigarettes in the future /14 JS/pm 17

18 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point 4.7 (Impact Assessment) Suggested EU common approach General remarks The EU and its Member States thank the Secretariat for the report and the proposals for possible actions in this area. We also thank the experts for their input, and the Finnish National Institute for Health for hosting an expert meeting on this topic. The year 2015 will indeed be significant as it will mark the tenth anniversary of this Treaty, which is a very special Treaty for all people working in Public Health. In its decision, COP 5 has "acknowledged a need to examine the impact of the Convention as a tool in promoting public health in general and tobacco prevention in particular; and to conduct an overall assessment and analysis of the long-term trends in prevalence of tobacco use, as well as implementation levels of comprehensive tobacco control legislation, policies and programmes". As regards the EU, we can confirm that the Convention is an important reference point in the development of our own tobacco control legislation. This was demonstrated very recently, when the EU adopted a new Tobacco Products Directive, and mentions compliance with the Convention upfront in its Article 1 as one of the objectives /14 JS/pm 18

19 When discussing this issue, we should bear in mind that (according to the Secretariat paper in point 6 and 7) it cannot be considered international practice to do such a "performance review" of a Treaty, nor is there an established methodology. A very strong added value would need to be demonstrated to deviate from this. The EU would also like to know what the likely use of the impact assessment would be, whether the assessment would also be designed to identify areas where the Convention needs to be amended or where the Secretariat would need to reallocate its resources. In summary, if the COP was to decide in favour of an impact assessment, such assessment should have a clear focus and any overlap with existing tools should be avoided. The projected funds for this exercise seem excessive and the added value remains to be demonstrated. In any case, it is suggested that efforts are made to generate interest the academic world, to use existing tools and to liaise with partner organisations when in carrying out such assessment and research. Detailed remarks The report of the Secretariat usefully brings to light very distinct perspectives and ways to look at the effects of the Convention. It identifies several possible areas for assessment, which are in our view not all equally relevant. We would see the following order within these areas: The areas outlined in points 17 to 22 of the report, relating to health governance, to development co-operation and to non-communicable diseases, could merit an examination in our view, in particular: if and how the Convention has changed global health governance and what that implies e.g. if it could become a model for other areas of public health; whether it has made a difference in development co-operation; and how it is considered in the wider NCD debate /14 JS/pm 19

20 The contribution of the Convention to the adoption and implementation of tobacco control measures (as referred to in point 9), will in most cases become apparent through the Parties reports. No additional assessment seems necessary. On the other hand, assessing the precise role of the Convention in specific legal challenges as proposed in point 10 of the report will be very difficult and perhaps not of a general value. In any case, such aspects could be usefully and systematically observed by the future work with regard to liability and/or industry interference (for example through dedicated knowledge hubs). The impact on tobacco use referred to in points 11 to 13, is certainly a core area, as the ultimate goal of the Convention is to reduce prevalence of use and consumption and consequently the toll of morbidity and mortality on our societies. However, there seem to be already existing indicators and methodologies to examine prevalence and to compare over time and between countries. The added value of a new or different indicator would need to be proven. In any case, assessing the effects on prevalence of use could never be a "one-off" exercise, but needs to be sustainable. Points 14 to 16 of the report refer to the social, economic and environmental impact of the Convention. This is admittedly difficult to assess. However, within this chapter, reference is made to a specific issue, namely the calculation of the economic costs of tobacco consumption. Such data, at global and/or at national level are necessary and useful to argue for tobacco control measures and to justify such measures outside the public health community. It is therefore suggested to prioritise this aspect. It seems that tools exist already that could be used to assess this aspect more broadly /14 JS/pm 20

21 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point 4.8. Implementation of Article 5.3 of WHO FCTC: evolving issues related to the interference of the tobacco industry (item proposed by a Party) Suggested EU common approach Introduction The EU and its Member States would like to thank the Party responsible for proposing this agenda item as well as the Convention Secretariat for the preparation of this document for this Conference of the Parties. Having regard to the WHO FCTC in its entirety, including its Article 5.3, as well as to the COP decision adopting Guidelines on Article 5.3, the EU reconfirms its strong commitment to the implementation of the Convention, including its Article 5.3. The EU takes positive note of the progress reported on the implementation of this Article but notes also the challenges. The EU supports further collaboration, discussion and information-sharing between the Parties to counter the challenges to FCTC implementation currently faced. General comments The EU welcomes the increased monitoring of Parties' efforts regarding the implementation of Article 5.3 within the reporting system, which has allowed for the preparation of this report (point 5 of the report). It also welcomes the increased number of Parties reporting that they have taken steps to prevent industry interference in their tobacco-control policies /14 JS/pm 21

22 Potential areas for further strengthening implementation of Article 5.3 In this context, the EU welcomes recent work by the Secretariat and its partners to assist countries in the implementation of Article 5.3 (points 14, 15 & 16 of the report). The EU supports the continuation and expansion of these efforts. Apart from providing assistance to countries, concerted efforts in other areas will be useful to facilitate implementation of Article 5.3: The EU agrees that enabling exchange of best practice (point 17) is central to this and that existing platforms should be built upon (point 18). The potential of newer platforms, such as social media, should also be explored. Monitoring the tobacco industry and/or further awareness-raising is also of importance (point 17). In this regard, the EU believes that 'existing models and resources should be used' for this, such as the database on tobacco industry monitoring of the WHO Tobacco Free Initiative. Focus should be placed on maximising the potential of such systems. The EU suggests that monitoring of Parties' efforts regarding the implementation of Article 5.3, and consequently the provision of more targeted assistance in this regard, could be further strengthened by including - in the reporting system - questions on perceived obstacles to the full implementation of the Convention and of Article 5.3 in particular, and to potential difficulties surrounding uptake/interpretation of its guidelines. The EU also agrees that utilization of the full set of recommendations, contained in the guidelines should be encouraged, in accordance with national needs and laws, by more targeted advice and examples of good implementation (point 19 of the report). The EU agrees that strengthening assistance to Parties in the form of knowledge, expertise and resources in order to help safeguard their policies against abusive or dilatory legal challenges (point 20 of the report), is an important next step to which the Parties should now look. Whether there is a need to update/bolster the guidelines on Article 5.3 in relation to this subject in the future could only be considered on the basis of a consolidated knowledge base on this subject. We refer also to other agenda points of this COP, which touch upon similar issues (see in particular points 4.3 and 5.4) /14 JS/pm 22

23 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point 5.1. Reporting arrangements under WHO FCTC: Establishment of a mechanism to facilitate review of Parties' reports Suggested EU common approach Introduction The EU and its Member States would like to thank the Convention Secretariat for the preparation of this report for the Conference of the Parties. Having regard to Article 23.5 of the Convention, as well as to the decision on reporting arrangements taken at the last meeting of the COP, the EU takes note of the recommendations drawn up by the Convention Secretariat on the establishment of a mechanism to facilitate review of Parties' reports. The EU agrees that there is a need to enhance review of Parties' reports following the initial years of implementation of the Convention. It is clear that this will involve functions which the Convention Secretariat and the Conference of the Parties' cannot adequately perform alone. The EU would therefore be in favour of the establishment of a dedicated mechanism, in form of an inter-governmental expert group, for the review of reports, provided this mechanism is "light, effective and efficient" as stated by the EU already at COP 5. The added value of such a mechanism, beyond that already provided by the current review process through the Secretariat resulting in the Global Progress Report, must be ensured and should be subject to a further assessment at COP 7. The EU would not be in favour of a mandate for the expert committee to engage in extensive discussions with reporting Parties on any issues identified concerning insufficient implementation or non-compliance. Costs would also have to be justified and limited to the extent possible and a final decision should be taken in the light of the budgetary discussions /14 JS/pm 23

24 General comments The EU and its Member States welcome the report by the Convention Secretariat on the establishment of a mechanism to facilitate review of Parties' reports. It notes the Secretariat's statement that the report is based on input provided by the Parties at the fifth session of the COP, including their wish that such a system not pose an additional burden on the Parties (point 3). The EU notes that the current review of reports undertaken by the Secretariat, and its resulting feedback, is technical in nature and does not include a general assessment of implementation progress or compliance (point 11). Given that the initial years of implementation of the Convention have now been completed, the EU believes that the decision (taken at the last COP) to request the Secretariat to reflect on a mechanism to enhance review of reports was a timely and appropriate one. It also reflects similar steps taken by other international treaties at comparable stages of their implementation (point 14). The EU acknowledges that the establishment of a mechanism to facilitate review of Parties' reports would involve functions which the Convention Secretariat and the Conference of the Parties cannot adequately perform alone (point 15), and that additional resources would therefore be required. On the whole, the EU is favourable towards the proposal to establish such a mechanism and towards many of the recommendations outlined in the report. However, this is provided that the added value of such a mechanism, beyond that already provided by the Secretariat's technical review and the global progress report, could be ensured. The EU would not be in favour of a mandate for the expert committee to engage in extensive discussions with reporting Parties on any issues identified concerning insufficient implementation or non-compliance. If so: - The EU could agree with the proposal that such a mechanism takes the form of an intergovernmental expert committee (point 16) /14 JS/pm 24

25 - Regarding composition, the EU would like to have clarification what "geographical representation" would mean for the European Region. Otherwise, the EU could agree with the first option outlined in point 17, i.e. the nomination of a set number of representatives from each WHO region to the committee. The EU would underline the need, as mentioned in point 18, for balanced representation of expertise, when these selections are being made. - While the EU largely agrees with the proposed mandate of the expert committee (point 20), and the timelines outlined (point 21), some serious concerns exist with regard to the idea of having the expert committee discussing in substance with reporting Parties about insufficient implementation or non-compliance. (Fallback position) If the COP would be in favour of including this point in the mandate, reflection will be needed on the procedure, on what the consequences of a negative report from the expert committee could be and how to handle situations where the review committee and the reporting Party do not come to a shared view on the compliance of certain reported measures. Has the Secretariat considered this case? - As it is in the interest of all Parties to have an accurate projection regarding the costs of such a mechanism (point 24), the EU would like to receive confirmation that the five day face-toface meeting outlined in point 21 is the only aspect for which the Secretariat envisages funding requirements (US$ point 24) and that it does not envisage a need for funds for other aspects of the work plan (e.g. development of a 'protected website' etc.), as the report seems to suggest. The possibilities of modern technology should be used to the largest extent possible /14 JS/pm 25

26 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point 5.2. International cooperation for implementation of the WHO FCTC Suggested EU common approach Introduction The EU and its Member States would like to thank the Convention Secretariat for the preparation of this report for the Conference of the Parties. Having regard to the Convention, as well as to the decisions on international cooperation taken at the last meeting of the COP, the EU welcomes the progress in this area, outlined by the Secretariat, that has taken place since The EU also welcomes the fact that international cooperation, as envisaged in the Convention, has become an important resource available to Parties to meet their implementation needs (point15). It supports the continued development of this. General comments The EU and its Member States welcome the report by the Convention Secretariat on international cooperation for implementation of the WHO FCTC. It welcomes and commends the progress made since the fifth session of the COP in the field of South-South and triangular cooperation (point 3), in particular the three important projects whose implementation has already begun. Regarding the fourth project on prevention of shisha tobacco use (point 11), the EU looks forward with interest to the active phase of its implementation, and is closely following discussions taking place at COP6 on this subject /14 JS/pm 26

27 The EU also welcomes the establishment of knowledge hubs (point 13) as per the work plan of the COP. We are of the view that information-sharing and cooperation, including with development partners, civil society and observer organisations, will be central to the next phases of implementation and to the challenges faced. The knowledge hub agreed in the area of legal challenges to implementation of the Convention (point 14) is of particular relevance, also to ongoing discussions on implementation of Article 5.3. The EU also takes positive note of the progress in cooperation with international organisations, in particularly the conclusion and finalisation of frameworks with devolvement partners (point 18), as well as the continued cooperation with representatives from civil society (point 19). The EU particularly welcomes recent global developments outlined in the report. The reiteration of the commitment to accelerate implementation of the Convention in the outcome document of the High-level Meeting of the UN General Assembly (point 20), the reference to the matrix (point 22), as well as the positive progress regarding the inclusion of full implementation of the Convention as one of the post-2015 Sustainable Development Goals (point 21), are strong reflections of the momentum that has been generated /14 JS/pm 27

28 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point 5.3. Sustainable measures to strengthen the implementation of the WHO FCTC Suggested EU common approach Introduction The EU and its Member States would like to thank the Working Group, its Chair, the Key Facilitators, the WHO and all involved organisations and experts for their work and their contributions leading to this report for the Conference of the Parties. The EU is in favour of acceleration in implementation of the FCTC. Clearly, the comprehensive implementation needs to be next phase in the evolution of the Convention. Given that we will be soon celebrating the 10th anniversary of the Convention, it is very timely to have a closer look at the issues that might be in the way of a successful and sustainable implementation globally and to examine what sort of assistance is best suited to achieve this goal. The EU appreciates the many facts and findings that have been collected to respond to the mandate by the COP and acknowledges that the matters are complex and that not all matters could be addressed during the inter-sessional period. It is in particular positive, that the WHO at headquarter and regional level was involved in the deliberations and that international partners such as UNDP and the World Bank provided their input. If the COP decided to extend the mandate and that mandate was sufficiently focussed, the EU could support a continuation of the work of this Working Group /14 JS/pm 28

29 General comments The EU and its Member States welcome the progress made by the Working Group in addressing the issues which are essential for a successful implementation of the Convention, in particular in low resource settings. Challenges have been identified, but also available resources and successful experiences were identified. It is clear, that many achievements can be reported and several of the actions which the report suggests are already being totally or partially undertaken by Parties or different stakeholders. Still, it is valuable to include them in the report, to raise awareness and to express the expectation that they are further enhanced and targeted towards supporting FCTC implementation. As regards the mandate for future work of the Working Group, should it be extended by the COP, the EU can largely agree to the areas identified, with some comments to be considered: When identifying and mapping the available resources, it would be important to know whether this will entail a regular exercise or one project. In any case, this mapping should result in more than a list or an inventory of potentially available resources. What would be needed is a sort of landscape for FCTC implementation. Such landscape needs to fully respect that the countries are in the driving seat of their tobacco control policies and that the implementation has to happen at country level. It is there that all relevant actors should be coordinated in the framework of One-UN. Developing ideas how to strengthen and build capacity of tobacco control focal points seems an appropriate idea and can be supported. The Intensive Legal Training Programme, which is mentioned in document FCTC/COP/6/20, seems a promising tool in this direction. Also, methods of learning via webinars and other modern technologies should be used as much as possible. The importance of functioning cross-sector co-ordination in line with Article 5 (2) a, is rightly highlighted and guidance and exchange of best practice could be a helpful tool for Parties. The EU would support further work in this area for the benefit of full and global implementation of the FCTC /14 JS/pm 29

30 From the ideas which are included in the report, the EU supports in particular the further development and the use of tools to 1) calculate the impact of tobacco consumption and 2) calculate the costs of implementing the Convention in national/regional and global contexts. Being able to demonstrate the cost effectiveness of tobacco control measures will help "making the case" and convincing of tobacco control measures. Another idea which is potentially interesting is the "co-ordination platform" mentioned in paragraph 8 of the report of the Working Group. It would be important for the EU to understand at which level this is envisaged. Is it at country, regional or global level? What would be the implications? The EU could envisage that the Working Group, if its mandate was extended, worked on developing a concept for such a co-ordination platform, as this is linked to the mapping of resources. A future mandate should be focused on improving the conditions for full implementation of the FCTC, including in low resource countries. A future mandate should also duly take account of COP decisions taken in other areas of the agenda, such as on the Impact Assessment, on industry interference and on international co-operation and overlap should be avoided and synergies gained. A final decision should only be taken in light of the budgetary discussions /14 JS/pm 30

31 WHO FRAMEWORK CONVENTION ON TOBACCO CONTROL (FCTC) Sixth session of the Conference of the Parties (COP6), Moscow, Russian Federation, October 2014 Agenda point 5.4. Trade and investment issues relevant for the implementation of the WHO FCTC Suggested EU common approach Introduction The EU and its Member States would like to thank the Convention Secretariat for the very interesting report on trade and investment issues relevant to implementation of the WHO FCTC. The issue of the relation between trade and health has become increasingly topical in the last years and many exchanges have taken place to the mutual benefit of both trade and health experts. The EU Commission itself has organised such a cross-sector seminar in spring 2014, involving trade and health experts from across all EU Member States. The input to this seminar provided by the Convention Secretariat, the WHO and UNCTAD was much appreciated. The EU believes it is necessary and useful to continue this debate in a factual and constructive manner and supports activities to this end. The EU supports notably the sharing of information between sectors and between Parties and the further dissemination of experiences and best practice on issues linked to trade and tobacco control. The role of the knowledge hub, planned to be operational and available for Parties very soon, will be particularly important. General comments The FCTC obliges all its Parties to take effective tobacco control measures, in order to reduce the consumption of tobacco products and ultimately the disease and premature deaths linked to it. Tobacco control needs efforts at national, regional and international level and tobacco control tools need to be reviewed and updated constantly /14 JS/pm 31

32 At the same time, the main multilateral trade rules as enshrined in WTO and in the agreements based on it have to be complied with. Those are based on the principles of non-discrimination and of necessity and proportionality. It should be underlined that the rules of the FCTC and of the WTO apply in parallel and that no set of rules takes precedent over the other. Thus an effort needs to be made to ensure compliance with both sets of rules. When it comes to tobacco control measures, this means that they must be capable to contribute to the set health objectives and comply with the above mentioned WTO principles of non-discrimination and of necessity and proportionality. This being the case, there is a high degree of discretion for the legislators on tobacco control to come forward with effective measures. A particular aspect in the area of trade and health concerns the investment protection provisions, including investor-state dispute settlement, which are included in nearly all international and bilateral trade agreements. Such rules are important for investment flows and they have worked well. However, the EU believes that the system can be improved. Investment agreements need to guarantee the balance between the right of states to regulate and the need to protect investors. In order to do so, much clearer provisions should be incorporated in investment agreements that will prevent undue interferences with the right of the state to regulate to pursue legitimate public policy, including public health objectives in a non-discriminatory and proportionate way /14 JS/pm 32