Tobacco regulation within the EU : the extent and nature of the EU's ability to regulate tobacco

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Tobacco Regulation within

the EU

The extent and nature of the EU’s ability to regulate tobacco

By

William van Leeuwenkamp

Supervisor: J. Zeitlin

Second Reader A. De Ruijter

June 2017

Masters of Political Science

Specialisation: Political Economy

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I would like to thank my professor and supervisor Mr Zeitlin for his support and depth of knowledge regarding EU legislation. His support has been crucial. In addition I would like to thank the individual I interviewed for taking the time to talk to me. I would also like to thank my friends and family for their support.

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Abstract

This thesis delves into the subject of tobacco regulation and governance within the EU, from the supranational level and the member state level. This is done by looking at the

interaction between member states and the EU when it comes to the creation and

implementation of tobacco regulation, as well as the role international organisations play when it comes to determining the regulatory set up. The importance of EU competencies is illustrated by determining the legal framework off which the EU builds its tobacco

regulations. It is found that the EU has increased its regulation of tobacco since the late 1990s through the use of its internal market competencies, as well through facilitating, indirect support for member states public health policies. The WHO Framework Convention on Tobacco Control (FCTC) is shown, at the EU and member state level, to be influential when it comes to formal tobacco regulation. It is argued in this thesis that the EU acts as an institutional framework for the implementation of elements of the FCTC down to the national level through the use of EU directives. When it comes to the Netherlands as an example of a member state this thesis claims that Dutch tobacco policy is reactive and not proactive and that the EU directives have significant effect when transposed and

implemented within the Netherlands. Overall, when it comes to the governance of tobacco regulation within the EU it is characterised as multilevel and experimentalist in nature, with hierarchical elements still present. Overall the complex nature of EU tobacco regulation has increased over time as the EU has increasingly become involved, along with many NGOs, in governing the regulation of tobacco products.

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Abbreviations

ECJ – European Court of Justice WHO- World Health Organisation

FCTC- Framework Convention on Tobacco Control NMG- New Modes of Governance

TAD1- Tobacco Advertising Directive 1 TAD2- Tobacco Advertising Directive 2 TPD- Tobacco Products Directive SFP- Smoke Free Partnership

FCA- Framework Convention Alliance

DG SANTE- Directorate General for Health and Food Safety COP- Conference of the Parties

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Introduction

On the 19th of May 2014, the European Union’s Tobacco Products Directive was passed, becoming applicable within the member states on the 20th of May 2016 (European Commission, 2017). The passing of this directive has had a widespread impact on the tobacco industry within the EU. Some of the main points within the directive focused on tobacco advertising, health warnings and e-cigarettes (EuropeanCommission, 2017). However, this directive was not the EU’s first foray into the field of tobacco regulation. The success of the Tobacco Products Directive can be contrasted to the EU’s failure in upholding the Tobacco Advertising Directive. This directive (coded as Directive 98/43/EC) was passed into EU law in 1998 and would have effectively banned advertising and sponsorship of tobacco products (Obergfell, 2001: 153). However this directive was brought to the European Court of Justice, with tobacco groups and the Federal Republic of Germany

arguing that it overstepped the EC’s competency, which the ECJ agreed with, thus rendering the directive void (Obergfell, 2001: 153). The logic behind the ECJ’s ruling was that the directive fell outside the bounds of the EU’s authorised competency and legal power as specified under the Treaty establishing the European Community, specifically that it did not satisfy the legal base on which the public health measures of the treaty were built (there was/is no independent authorisation for the EU to act on purely public health grounds) (Obergfell, 2001: 155).

As such it can be shown that the original Tobacco Advertising Directive overstepped the bounds of what the EU can legislate and regulate over versus the member states. An important theme that can be observed when looking at the legislation, directives and court cases surrounding the EU’s attempts to regulate tobacco is that of ‘competency’. For example it was argued by Germany during the ECJ case on the later 2003 Tobacco

Advertising Directive that the EU had overstepped its legal competency to regulate tobacco based on its powers to regulate the internal market (Christopoulou & Lillard, 2015). Thus, when it comes to the regulation of tobacco at the supranational EU level, issues of the division of competencies and the regulatory prerogatives of the member states are crucial. When looking at tobacco itself, the product can be considered a not a normal good in that is consumed by a considerably percentage of the general population within Europe, with 29 percent of adults within the EU being smokers as of 2010 (European Commission, 2009).

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Also the negative health consequences of consuming tobacco, along with its legal status means that it is a public health issue, but at the same time must be regulated like a

consumer good as well. It can be considered similar to alcohol in this regard. The nature of tobacco products helps to explain the complexity of which political entity has competency over its regulation. Tobacco products are economic goods and as such are subject to product regulation, which falls under the EU’s jurisdiction due to the EUs control of the single market. However tobacco, due to its inherent adverse health effects, can be regulated from a social policy and public health perspective. The regulation of social policy and

specifically public health is more nuanced, with there being a level of shared competency between the EU and the member states (European Union, 2012). As such when it comes to tobacco regulation from the angle of public health there is a more grey area between the competencies of the EU and the member states. This mix of competencies when it comes to the regulation of tobacco is evident when the history of regulation and the EU directives regarding tobacco is investigated.

Research Questions

As such this thesis will focus on tobacco regulation within the EU, with a local focus on the Netherlands to explore the application of EU tobacco regulation on a member state. The main research question is,

• How far and in what ways is the EU able to regulate tobacco despite its limited competences in this field?

Sub-questions:

• How has the extent of the EU’s regulatory capacity evolved over time in regards to tobacco?

• How has the WHO Framework Convention on Tobacco Control been incorporated into the EUs regulatory approach towards tobacco?

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• How does the EU influence the regulation of tobacco in the Netherlands?

• How can EU tobacco regulation be characterized in governance-theoretic terms?

Delving into these sub-research questions benefits the overall thesis since they provide a structured deconstruction of the main thesis research question. By approaching each of these sub-questions in isolation (while still taking into account the overall questions of this thesis), it results in a layered and multi-perspectival approach to the question, in addition to a set and clear structure. These sub-questions focus on detailing the nature, both present and in the past, of the EU’s regulatory powers. In doing this limits to the EUs powers will be illustrated which will be further shown by looking at regulation taken by the member states, which in this thesis will take the form of analysing the case of the Netherlands. The WHO Framework Convention on Tobacco Control will also be studied, especially it influence on EU regulation. This will be motivated in the literature review. After this tobacco regulation within the EU shall be characterized in governance-theoretic terms so that it can be contextualised within the broader study of governance and regulation.

Relevance

When looking at the topic of tobacco regulation within the EU the relevance of the topic can be seen from both an academic and social perspective. From the social perspective this study is relevant due to the influential and large position tobacco plays within western societies. While the level of smoking within the EU overall has decreased over time, an average of 29% of EU citizens were considered regular smokers and another 22% were ex-smokers as of 2010 (European Commission, 2009). The prevalence of smoking means that the regulation of it has a wide impact within the EU, with many stakeholders being involved. Furthermore, studying the regulatory approach to tobacco within the EU can be

extrapolated towards other lifestyle issues such as alcohol and unhealthy food. The study of the nature of tobacco regulation within the EU, along with its weaknesses and strengths can potentially be taken into account when formulating regulations on similar lifestyle issues. When it comes to academia, the topic of tobacco regulation is relevant and worthy of study,

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especially in the case of the EU. Due to the complex nature of tobacco and the multiple EU competencies (both for the EU itself and the member states) that are involved, the subject of tobacco regulation puts questions on the limits and division of legal competencies between the EU and member states into a real world context. It has been argued by Alemanno and Garde (2013: 5) that when it comes to the case of tobacco, the EU’s

approach has been a leading example of “federal experimentation”. As a result tobacco is a worthy topic and can act as a lens in which the evolution of governance within the EU can be investigated.

Structure

Firstly previous literature on the topic of public health and tobacco regulation within the EU shall be given. After this the theoretical framework surrounding important concepts

identified shall be unpacked and detailed. After this the methodology and sources of data shall be explained. Next the research questions shall be tackled, with the developmental history and nature of the current EU supranational tobacco regulation being investigated. Within this section the extent of current EU tobacco governance shall be clarified, along with ways in which the EU overcomes limits to its legal regulatory power. The effects of EU policy on the member states will also be looked at from a general point of view. This section and by extension the thesis overall will not tackle the topic of how effective the regulation is. Since this thesis is focus on explaining the current regulatory set up an analysis of effectiveness would broaden this thesis too much and leave it potentially unfocused. Another thesis could study this subject from a quantitative statistical perspective. The following section shall look at the specifically Netherlands as a case study of a member state within the EU, thus showing the national perspective of tobacco regulation and an example of the influence the EU exerts on its member states. The fourth section shall look at the results of researching and studying tobacco regulation within the EU in governance-theoretic terms to see where it fits in within the field of governance. In doing so this it clarifies the ways and extent of the EU’s ability to regulate tobacco from a governance and political perspective. The thesis will then end on a section concluding the findings and points made all the while couched by the central research question, as well as looking at further angles of potential research.

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Literature Review

To get a better understanding of the topic and thus the theoretical framework on which this thesis will be built, the previous literature on tobacco regulation should be studied. There have been other studies delving into the EU’s relationship with tobacco, but these usually are taken together with alcohol. This can be seen in the book Regulating Lifestyle Risks: The EU, Alcohol, Tobacco and Unhealthy Diets by Alemanno and Garde (2013), which focuses on the legality and future of lifestyle regulation, using tobacco, alcohol and unhealthy diets as cases. They find that the issues of EU legal competency versus the member states when it comes to health policy is a complex and tense issue which complicates the ability to effectively regulate (Alemanno & Garde, 2013: 35). As such the issue of competency in the context of the institution of the EU is an important concept that has to be unpacked to better answer the research question. To fully unpack the concept of competency the subject of EU competency, both in the general sense and when applied to the issue of public health, needs to be illustrated and detailed. Limits and ways in which the EU maneuverers around these limits on their ability to effectively regulate will also be an important point of study. Further research papers on tobacco within the EU, such the qualitative paper by McKee, Belcher & Kosinska (2012) and the quantitative paper by Babineau & Clancy (2015) focus on the EU directives that deal with tobacco. They both look at the nature of certain EU

directives and the reason for the specifics of the EU Tobacco Products Directive, specifically the fact that the directive targets elements of tobacco that are seen to appeal to the youth (McKee et al, 2012; Babineau & Clancy 2015). The focus on youth is interesting and it can be argued that the decision to approach tobacco regulation from this angle is a conscious decision by the EU. As a result, studying the governance structure of the EU surrounding tobacco will help explain these reasons. Costa, Gilmore, Peeters, Mckee & Stuckler (2014) also look at the EU Tobacco Products Directive, but from perspective of the influencers of the contents of the legislation. It is argued that the tobacco industry had an impact on the drafting and nature of the legislation, bringing the final result closer to their goals (Costa el al, 2014). As such studying not just the directives the EU passed regarding tobacco

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However an important point when it comes to the literature is that while there are articles and books looking at the EU’s relationship with tobacco, the field is constantly evolving, as new directives are passed and agreements made, leading to previous work which looks at the topic broadly, such as “Measuring activities in tobacco control across the EU” by Thyrian and John (2006), becoming outdated. According to data from Thyrian and John’s paper certain states, such as Germany, had at the time relatively weak tobacco controls, while certain states, such as the UK, had significantly stronger tobacco controls at the time

(Thyrian & John, 2006). This difference in tobacco control levels between the member states of the EU shows the influence member states have on tobacco regulation and asks the question on how much influence the EU can exert. Paulette Kurzer and Francesco Duina also look at the issue of EU public health policy and tobacco. Their article “Smoke in your eyes: the struggle over tobacco control in the European Union” (Kurzer & Duina, 2004) looks at the reason for the failure of the first Tobacco Advertising Directive. They reveal that a combination of factors, including lack of EU competency over certain issues, as well as the political climate at the time, influenced the Tobacco Advertising Directives initial failure (Kurzer & Duina, 2004). The article is important in that it shows the complex and

multifaceted nature of tobacco regulation. Multiple factors play-off one another, especially due to the fact that the EU’s role in the field of public health is ambiguous. As such an explanation of these factors and the influence they have on the level and nature of EU tobacco control is important to get a better understanding of tobacco control and by extension public health overall.

However a holistic study of tobacco regulation at a supranational and national level has to involve non-governmental actors that are involved in the field of health. One of the most prominent of these is the WHO (World Health Organisation), which is involved in a

multitude of public health initiatives and dialogues at the international level. When it comes to tobacco the literature surrounding the WHO is divided into literature from the WHO, such as reports on the negative impacts of tobacco, and literature about the WHO, especially on the influence of the WHO Framework Convention on Tobacco Control. Through the FCTC there is significant literature looking at the impact that the FCTC and by extension the WHO has on tobacco regulation within countries. For example Uang, Hiilamo and Glantz (2016)

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multi-country analysis on the effect of the FCTC on the implementation of smoke-free laws shows the impact that the WHO has on a global level. It is found in the study that the FCTC has a significant impact on nations, accelerating the adoption of smoke-free laws for

workplaces, bars etc, with the greatest effect being found immediately after the ratification of the FCTC (Uang, Hiilamo & Glantz, 2016). This fact, along with the recommendation made in the paper the ratification of the FCTC is key to the creation of smoke-free policies shows the impact that the WHO has on tobacco control at the global level. As such the WHO is an important actor when it comes to tobacco control and a study of tobacco regulation within the EU has to take into account the influence the WHO has through the FCTC, which was signed by all EU members and the EU itself (WHO, 2003). In this respect a study of the evolution and nature of EU tobacco regulation has to be aware of the influence the WHO has had on the development of tobacco controls, both at the supranational EU level and for the member states themselves.

When looking at the nature of the health regulation within the EU certain academic papers delve into the structure and regulatory set up present. In the paper ‘Tobacco control, global health policy and development: towards policy coherence in global governance’ by Collin (2012) it is argued that global health issues are influenced not only by governmental actors, but an array of non-state actors, such as businesses, NGOs and civil society organisations. It is stated that when looking at overall global health governance structures tobacco does not fit the governance structure of other health issues and that the model of tobacco

governance is unique due to the way in which tobacco regulation (through the FCTC) deals with business interests (Collin, 2012). The article details the ways in which tobacco

regulations at a global scale deals with multiple actors and the unique nature of the

governance structure of tobacco, showing that a comprehensive study of tobacco within the EU needs to focus on governance. In another study by Asare, Cairney & Studlar (2009) the formation of tobacco policy in the UK is investigated at multiple government levels (EU, UK nationally and devolved local level). Overall the article finds that while not completely clarifying the nature of UK and EU tobacco control, multilevel governance provides a stronger explanation than the theory of regulatory federalism (Asare, Cairney & Studlar, 2009: 81). The overall reason for this is that according to the article multilevel governance better explains the complexity and variation of the regulatory policies present within the

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supranational EU and the contingencies of the formation and implementation of policy (Asare, Cairney & Studlar, 2009: 98). This is supported by a point made by Bartolini (2011: 4), who argues that one of the reasons why governance theory has increased in importance is that with globalisation regulatory decisions and rule production in certain fields are increasingly being made outside the traditional state orientated power structures. As such both these articles show that the current academic studies of tobacco regulation within the EU needs to take into account governance theory.

By looking at previous literature on the subject of tobacco regulation, it can be seen that a detailed study of tobacco regulation within the EU would be useful, specifically taking into account the latest developments. Furthermore a thesis that synthesises an up-to-date analysis of the supranational regulatory framework with situation and set-up within an individual member state would be important in furthering the understanding of the field. The importance literature places on the role of non-state actors, specifically the WHO shows that the study of tobacco regulation cannot be purely state focused and that analysing the influence of the WHO is important to better understand EU tobacco regulation. Previous studies argue that the EU system of tobacco control is multilevel in nature, motivating a study of governance at multiple levels. Overall there is a gap within the literature for an up-to-date governance-focused thesis on the EU’s relationship with tobacco from the

supranational and national perspective which takes into account the WHO.

Theoretical Framework

Before the research questions can be tackled, the theories and concepts which will be utilised in this thesis have to be clarified. These concepts and theories form the framework on which the analysis will be build. First the concept of governance will be explained, along with two forms of governance, hierarchical/traditional governance and new modes of governance. The concept of governance is important due to the attention that is being paid to regulation. Furthermore, when looking at the regulatory capacity of the EU when it comes to tobacco, the nature of the mode of governance is influential, justifying the need for clear explanation of the different types of governance. In addition, when tobacco regulation is characterised in governance-theoretic terms, these concepts will play an important role in creating the characterisation. The second concept that will be expanded

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on in this section is regulatory capacity. This is because the concept needed to be clarified before it can be used to understand regulation both in the EU and the Netherlands. Finally competency, within the context of the EU, is an important concept on which much of this thesis will be built, thus justifying the need for it to be explained fully.

Governance

When it comes to the concept of governance itself there are certain misconceptions. Readers might assume that governance is synonymous with the state apparatus and those governmental institutions that ‘govern’ a country. However governance itself can be more broadly defined. For example there are other forms of non-governmental governance, such as financial, environmental etc. These non-governmental fields now have levels of

governance theory built into them. As such a proper conceptualisation of governance must be broader than the traditional political/governmental paradigm. This point is identified by Farazmand (2004: 7), who argues that governance as a theory involves not just the

institutions and structures of the state, but also civil society and private entities, with their involvement and relationships with each other constituting the system of governance. When looking at the concept of governance the basic definition by Bartolini (2011: 8) corresponds to Farazmand’s, with governance being characterised as “a system of co-production of norms and public goods where the co-producers are different kinds of

actors”. However looking at the academic discussion surrounding governance it can be seen that there is no one solidified singular conceptualisation of governance and that governance modes can differ. The factors that differ within the governance modes are argued by

Bartolini (2011: 13) to be the identity of the co-producers, level of involvement by public authorities, level of involvement of partners, content of the co-production, ways of achieving co-production, nature and role of sanctions, institutional context and mode of implementation. These dimensions can differ in nature and magnitude, in turn

differentiating dramatically modes of governance, which in turn makes the general concept of governance as a meta-category. This is further acknowledged by Bartolini (2011: 12) who refers to the divide between ‘new’ and ‘old/traditional’ forms of governance. The two different modes of governance are differentiated by certain factors such as new governance

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theories focus on deliberation and elaboration when it comes to forms of co-production of norms as well as the importance of multileveled decisional networks between public and private actors (Bartolini, 2011: 15).

As such the general dichotomy between older/traditional forms of governance and ‘new’ forms of governance need to be elaborated on and the concepts explained so that the method of governance when it comes to tobacco within the EU can be positioned later into governance-theoretic terms.

Hierarchical governance

Hierarchical governance is seen as the ‘traditional’ mode of governance, in that it relies more on top-down power structures. Policy is created by from above, or the centre and followed by actors at the bottom or periphery (Craig & de Burca, 2011: 160). As such the power dynamics are one way and direct between different actors at multiple levels of the governance structure. Another element of hierarchical governance is that the uniform policy when created is set and there is little room for the actors following the policy to adjust, with the requirement to follow binding through legal enforcement (Craig & de Burca, 2011: 160). This power asymmetry between the central actors and the periphery/bottom actors leads to regulation within a hierarchical governance structure being characterised as command-and-control type regulation, with specific uniform regulatory guidelines and requirements being created, which actors must follow (Craig & de Burca, 2011: 160).

When looking at the dynamics and relationship between the actors within a hierarchical governance structure the relationship can be seen as a principal-agent association. The principal, which sets the rules, must also monitor the actions taken by the agent so that they are conforming, with sanctions or rewards being used to incentivise the agent (Sabel & Zeitlin, 2008: 304). However it can be difficult for the principal to ensuring accountability among agents due to volatility and strategic uncertainty (Sabel & Zeitlin, 2008: 304). This is compounded by, in the case of the EU, the multilevel nature and multitude of actors who answer to the principal, a point that can complicate the principal-agent relationship, leading to it possibly breaking down (Sabel & Zeitlin, 2008: 304). This links to the disadvantages of hierarchical governance recognised by Gieseke (2017: 70), who argues that hierarchical

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governance can be overly rigid and this inhibits communication, which results in the weakening and undermining of coordination between the different levels within the structure (Gieseke, 2017: 70). There are certain advantages to hierarchical governance identified however, such as clarity, stability and predictability, due to the chain of responsibility and control being clearly defined and codified in law (Gieseke, 2017: 70).

New modes of governance

Hierarchical governance is traditionally seen as the ‘standard’ system of governance and to many it is seen as the default. However recently there has been a growth of academic study in new modes of governance or NMG, especially in the context of the governance set-up of the EU. When looking at NMG there is a multitude of literature on it in which academics give their perspective on what characterises NMG.

Kohler-Kock and Rittberger see NMG in the context of the EU as a response to gridlock in Community decision making among the European states and is linked to the Open Method of Coordination (Kohler-Kock & Rittberger, 2006: 36). The OMC was created through the Maastricht Treaty in 1992 and it coordinates certain policies related to the economy through recommendations and guidelines (Kohler-Kock & Rittberger, 2006: 36). NMG is characterised by its movement away from Community decision making, in which regulation and directives take precedent, towards a ‘softer’ approach and focuses on voluntary

compliance and does not utilise strong non-compliance sanctions (Kohler-Kock & Rittberger, 2006: 36). Secondly multilevel decision making is conducted between public and private actors, with member states having a level of autonomy when it comes to choosing their effective policy (Kohler-Kock & Rittberger, 2006: 36). Finally Kohler-Kock and Rittberger (2006: 37) argue that participation among all actors within the system is key to NMG. Héritier and Lehmkuhl also discuss NMG (labelled sectoral governance) in their 2008 article by looking at how it is differentiated from traditional territorially bound democratic

government. In the article sectoral government is defined as the policy formation by actors, both private and public, in delimited sectoral areas which operate beyond the traditional political legislative method of decision making (Héritier & Lehmkuhl, 2008: 1). An important element of Héritier and Lehmkuhl (2008: 2) concept of sectoral governance versus

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traditional government is that within sectoral governance there is the ‘shadow of hierarchy’, which is when the legislative body threatens to enact adverse regulatory legislation unless the affected actors change their behaviour to align more with the goals of the legislators. It is found that the shadow of hierarchy is an important element that helps sectoral

governance operate due to the inadequacy of pure monitoring (Héritier & Lehmkuhl, 2008: 7). Along with the shadow of hierarchy studies, such as on European energy markets are used by Héritier & Lehmkuhl (2008: 6) to argue that governance does not mean a retreat of the government from the regulatory system.

Another approach to NMG, especially in the context of the EU, focuses on the

experimentalist architecture present within governance structures. Sabel and Zeitlin look at experimentalist governance as a means in which potential weaknesses of command-and-control regulation, such as strategic uncertainty and issues of legitimacy that exist within the principal-agent model can be resolved (Sabel & Zeitlin, 2012: 175). Sabel and Zeitlin delve into experimentalist governance and identify four key elements that characterise

experimentalist governance architecture.

Firstly broad framework goals and metrics which are jointly formed by actors from multiple levels of the governance structure is one of the important features of experimentalist governance (Sabel & Zeitlin, 2012: 169). The framework goals act as common policy objectives and are more broadly defined, such as ‘good air quality’. The broadness of the goals definition provides the flexibility that is important within experimentalist governance and contrasts it from the rigidity of hierarchical governance. This flexibility allows for easier implementation across multiple different scenarios and situations, which is important especially in the context of the EU, with multiple differentiated member states that similar goals have to be applied to.

Secondly autonomy for the lower-level units within governance structures that actually implements and performs the actions that are linked to the framework goals (Sabel & Zeitlin, 2012: 170). These lower-level actors include private actors such as businesses, but also local government level authorities. The autonomy and flexibility that is provided to the lower lever actors is done with the goal of aiding better implementation and enforcement of elements of governance, such as tobacco regulation, by taking into account local difference

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that could provide difficulties to traditional top-down command-based governance systems. This allows lower-level actors within the multilevel governance structure to pursue

framework goals as they see fit, and as such there are significant levels of political delegation.

However, simply providing autonomy to the local level actors within the governance structure would not be as effective without ensuring that the actions taken work towards achieving the previously agreed broad framework goals (Sabel & Zeitlin, 2012: 170). This is done through continued performance focused peer reviews of the actions taken by the autonomous lower-level actors, with a focus on comparing the actions taken by actors who are working towards the same goal, but are using different methods (Sabel & Zeitlin, 2012: 170). Doing so reveals better practises and successful methods that are being utilised by an actor that could be transposed and shared among other actors.

The fourth element is the periodic revision of goals and methods based on the findings of regular peer reviews (Sabel & Zeitlin, 2012: 170). This revision process leads to

experimentalist governance having the characteristic of recursive learning and as such can be viewed as a fluid system in which the factors within the governance system are

constantly evolving to fit the current situation and new findings. The revision of the goals and methods of the actors is in part influenced by the impact of new participants who enter the governance structure (Sabel & Zeitlin, 2008; p. 274). The theory behind this revision system is that by ensuring the methods used are the most successful, as learned through the peer reviews, then the quality of the governance system and how effective it is will be consistently increasing. Importantly this experimentalist system and process is not

intermittent, but is cyclical and constantly occurring, thus creating the fluidity and evolving nature of experimentalist governance.

When it comes to the scope condition for experimentalist governance one is strategic uncertainty, which is when policy makers within the field are not completely sure of their goals or the best methods to achieve them, thus justifying levels of experimentalism among actors (Sabel & Zeitlin, 2012). The second scope condition is polyarchic of multi-polar distributions of power, which is when one actor within a group cannot enforce their

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preferred solution to a situation onto other actors and must take into account the views and preferences of these other actors (Sabel & Zeitlin, 2012).

When looking at the different conceptualisations of NMG they are not uniquely

distinguished by the non-presence of government or hierarchical forms of governance. Within Héritier and Lehmkuhl conceptualisation the shadow of hierarchy can be seen as the presence of elements of traditional governance within NMG. However, as Bartolini

illustrated, governance can take multiple modes and is not a binary. As such certain modes of governance can be seen as hybrid forms of governance, which possess elements of traditional modes of governance and NMG. When looking at literature on hybrid

governance Aoyama and Parthasarathy (2016: 32) see hybrid governance as not driven by state institutions, but the state is present within the governance structure and its level of power varies. Another definition of hybrid governance is by Trubeck, Cottrell and Nance (2006: 93) who see the hybrid nature of governance coming from the occurrence of hard and soft measures in the same policy domain.

When looking at the tobacco control governance within the EU the nature of the

governance system will be investigated and elements of hierarchical/traditional governance and NMG shall be identified. This way if the governance structure is hybrid in nature it can be acknowledged. When it comes to identifying elements of NMG the experimentalist approach as explained by Sabel and Zeitlin will be utilised, in part due to its EU focus and the detailed attention it plays to the multilevel nature of actors (which fits the multilevel nature of the EU).

Regulatory capacity

With the focus on regulation, specifically tobacco regulation, in this thesis, the concept of regulatory capacity has to be unpacked. The ability to regulate over a certain policy area is determined by a myriad of factors. Firstly, the legal political right to draft and form

regulations over a policy area is an important factor in determining and setting the level of an entity’s regulatory capacity (Thiel, 2008: 63). Secondly, the ability to properly adopt the

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regulation and put it into practise is an important factor that influences entities regulatory capacity (Thiel, 2008: 63).The ability to adopt regulation itself is linked to certain factors, such as having the physical and financial means to enforce regulations. Without the ability to enforce and accurately adopt regulations, the drafting and creation of the regulations itself is useless. As such an entities regulatory capacity is not just based on the presence of a strong legal institutional framework to enforce regulation, but the resources to carry this out and engage in legal action when necessary against non-compliant actors (Vinãls et al, 2010: 14). The need for the enforcement of regulation places an important burden on the ability to supervise the actors who are being regulated so that they are properly and fully following their regulatory requirements.

As such regulatory capacity is linked to the nature of the relationship between supervision and regulation (Vinãls et al, 2010: 15). If the role of supervisor and regulator are separated (due to the two functions being done by two different agencies) then the level of

coordination and cooperation between the two bodies influences the effectiveness of the regulation and thus affects the regulatory capacity (Vinãls et al, 2010: 15). As such it is argued by Vinãls et al (2010: 15) that, in principle, combining the role of regulatory and supervisor is conducive to enhancing the effectiveness of a regulator. The logic behind this is that rolling the monitoring, enforcement and creation of regulation into a single entity means that through supervising, the regulators would get a better understanding of their regulation in practise and inform them better in how to further adjust the regulatory policy (Vinãls et al, 2010: 15). When it comes to regulatory capacity within a real world context, it does not have to be purely at a national level. When it comes to international regulation, the regulatory capacities of multiple actors are linked together and contribute to the overall effectiveness of the regulatory system, with the system being only as strong as its weakest link (Slaughter, 2004). In this respect usually less developed countries (with weak legal systems and political institutions) have a lower regulatory capacity, which leads to cases in which more developed countries assist these countries in developing their institutions and thus strengthen their regulatory capacity (Slaughter, 2004).

Bach and Newman look at regulatory capacity from a specific EU perspective in their 2007 article on the European regulatory state. Within the paper the European regulatory state is explained against the United States as a regulatory state and the influence of the EU at a

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global level is looked at specifically through the lens of data privacy and financial market regulation (Bach & Newman, 2007: 827). Bach and Newman argue that institutional reforms and increasing coordination on the EU level has influenced and increased the EU’s

regulatory capacity (Bach & Newman, 2007: 830). An important aspect which characterises the EU’s regulatory capacity is that it has evolved relatively quickly due to the political harmonisation and growth of the EU itself (Bach & Newman, 2007: 831). The liberalisation and integration have led to the creation of regulatory entities which create the required institutional capacity to translate the considerable market size of the EU (larger than the USA), into international regulatory influence (Bach & Newman, 2007: 831). The increase in EU regulatory capacity is elaborated on two levels as strengthening of regulatory capacity at the member state level and increased institutional coordination on the supranational EU level (Bach & Newman, 2007: 841). Another point that characterises the EU as a regulatory state and its general regulatory capacity is the ability to extend regulatory influence through excluding foreign firms from entering European markets if they do not meet European standards (Bach & Newman, 2007: 841). This characterisation is generalised by Bach and Newman who argue that strong regulatory institutions is important to unlock the power which is vested in large domestic markets (Bach & Newman, 2007: 842). This power can be exerted on a global scale by large polities (EU and USA), meaning that for the EU’s

regulatory capacity is not just a domestic issue but has an influence on many other nations and is an international force.

As a result literature has shown that the institutional set up at the member state and supranational level is important when it comes to evaluating the regulatory capacity of the EU when it comes to tobacco.

Competency

The EU as a supranational institution is an entity in which the member states have agreed on transferring the governance responsibility and legal political power over certain policy areas to a central entity. This is clarified in Article 1 of the Treaty on European Union, that the EU has the ability to work towards set shared objectives among the member states through competences conferred upon the EU (van Zeben, 2014: 6). Articles within Title 1 of

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the Treaty on the Functioning of the European Union delineates what the member states grant as an EU exclusive competency, shared competency and competency for the EU to support the member states actions when it comes to certain policy areas (European Union, 2012). As such policy areas which the EU is conferred exclusive competency over the member states means that the EUs position takes official and legal precedence over the member state, even though the policy position covers the member states (van Zeben, 2014: 6). Similarly in the cases of shared competency, the EU’s actions are influenced by the principle of subsidiarity (van Zeben, 2014: 6). As such with policy areas where the EU has shared competency over the EU can only act if the member states cannot achieve the objectives of the actions that will be taken (European Union, 2007). In this respect

competency determines the power dynamics within a policy area between the EU and the member states and as a result impacts the nature and extent of this policy making power. As such the type and level of the EU’s competency over a policy area heavily impacts the nature of the regulation of that policy area.

When looking at the subject of public health (which incorporates tobacco) it is a case of shared competency between member states and the EU, specifically public health when it is a shared concern among the member states (European Union, 2012). The EU’s influence on public health has built up over time as the EU has developed as an institution. Currently, as stated in Article 168 of the TFEU the EU has shared and complementary competency when it comes to public health, meaning that when previously they had to be aware of public

health, now there is more leeway for them to act, but not at the detriment of the member states (European Union, 2012). As such this is an interesting way in which the EU’s

competency over health has increased formally (by being codified in the TFEU), but not weakening the position of the member states, thereby potentially avoiding a backlash for EU overreach. Working in conjunction with the EU when it comes to public health has been more accepted in part due to certain cross-border health issues, such as salmonella and ‘mad cow disease’, were effective action requires cross-border coordination and solutions, a situation in which the supranational EU can complement the actions of member states (Koivusalo, 2013 : 97). These scenarios in part justify the increase in EU competency when it comes to public health issues.

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The growth of EU competency in public health, specifically resulting from changes made by the Treaty of Amsterdam in 1997, was not the only change when it came to the EU’s regulatory competency. The Treaty of Amsterdam also extended the EU’s powers and thus competency over the area of consumer protection, showing an overall gradual increase in the EU’s powers to regulate as the union has developed. Even when there are limits to their competency the EU is still able to manoeuvre around this. For example when it comes to public health the EU has both shared competency over the field, but also competency to facilitate member state coordination and support their actions with the goal of bettering public health (European Union, 2012). This is an example of what de Ruijter (2015: 87) identified as ‘non-legislative’ actions, ways in which the EU can maneuverer around its formal competency limits. When it comes to non-legislative actions such as facilitating coordination between the member states on issues of health the EU is able to exert indirect influence and as such is an example of non-hierarchical governance (de Ruijter, 2015: 87). In this way, while they do not have strong regulatory powers, the EU Commission, through supporting coordination, can craft and initiate initiatives that promote coordination

(Randall, 2001: 116). This ability, while indirect, can prove to be powerful, since the ability to influence the nature and level of coordination between member states over a policy area is a potent tool in the EU’s arsenal. Furthermore, the Treaty of Amsterdam allowed the EU, in conjunction with member states, to foster international cooperation when it comes to the realm of public health (Randall, 2001: 116). With this the EU was given a level of external powers, along with the member states, to work with third parties such as international NGOs when it comes to public health. As a result, the EU is also able to work around limits on its formal competency with public health by engaging with these international entities to generate programmes and initiatives that support public health within the EU.

The courts, specifically the European Court of Justice have also played a role in determining the EU’s level of competency, especially in the case of public health. For example the cases of Kohl, Decker and Watts and the following rulings have led to healthcare services within EU member states falling under the purview of the internal market and by extension the EU due to their exclusive competency over policy areas related to the internal market

(Koivusalo, 2013: 98). This is an example of where the court system’s ruling can influence the EU’s powers over issues by shifting policy areas into different competency areas and

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thus increase the EU’s ability to govern over them. Regulating through different competency justification is a point recognised by de Ruijter (2015: 28) who explains that the EU utilises policy areas in which the EU’s formal legislative competency is stronger, such as economic policy, to deal with issues of public health (de Ruijter, 2015: 28). The ECJ has also been more explicit in influencing the EU’s powers over specific policy areas. For example when it came to common commercial policy the ECJ ruled that this fell under EU exclusive competence, broadening the scope of the EU’s ability to regulate, a decision which was later codified in amendments made to TFEU in the Treaty of Lisbon (Rosas & Armati, 2012).

It can be argued that the EU is not a static entity bound by strict delineated competency but that it is (at least when it comes to health) a dynamic entity that manoeuvres the limits to its political actions. However it is important to note that the general resistance among member states to greater EU involvement in health issues is due to the important legitimising force national welfare programmes (such as health) have for the nation states and has state building capacity (de Ruijter, 2015: 33). As such the vast differences in the structure and nature of the public health system within the member states of the EU act as a barrier to unified EU health policy and thus explain the importance for coordination facilitation (de Ruijter, 2015: 90). The limits of EU competency to directly act in issues of public health will be important to take note off and will likely heavily influence the ways in which the EU can act and exert regulatory power over the field to tobacco. The usage of non-legislative action and legislating through policy areas in which the EU has formal legislative competency over will be investigated in the specific case of tobacco

Overall while the delineation between the competency of EU and member states over certain policies is clearly defined, the ECJ does plays a role in increasing the EU’s ability to act. Certain policies, such as public health, are shared issues of competency in which the EU can indirectly exert influence through facilitating coordination between member states and international actors. The limits on EU formal competency will be an important issue that will likely structure the nature of EU tobacco regulation and governance.

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Methodology

For this thesis the case of tobacco regulation is intrinsic to the research questions, with the nature of EU health policy and regulation is being investigated through the case of tobacco regulation. Case studies are useful in that they act as phenomena or situations that when analysed and conceptualised have findings that can be generalised to a group of similar phenomena or events (Vennesson, 2008: 226). The type of case study that shall be used is a within-case study, where the factors and features of the case are analysed so as to find causal links between these factors and the results (Vennesson, 2008: 224). The goal of this thesis is not only to find and understand the trajectory of tobacco regulation within the EU, but also to offer an explanation for the nature of the current regulatory set up. When it comes to the within case study, it is argued by Flyvbjerg that generalisations from a single case can be used to help further the understanding of the topic, with there being many examples in history demonstrating this (2011: 305). However this thesis does not only engage in the within case study of tobacco, but also looks at a case within case study, specifically the situation of the Netherlands when it comes to tobacco regulation. The Netherlands was chosen for multiple reasons. Firstly the Netherlands is a founding member of the EU and as such has had influence on and felt the effects of the evolution of tobacco regulation since the EU’s inception. Secondly logistically, due to the nature of the thesis (time period in which to do it) only one country could be analysed in enough depth to get a clear and focused understanding of the regulatory set-up at the national level. Thirdly, when it comes to smoking rates the Netherlands (in 2015) had an average smoking rate of 24.8% according to the WHO which is within a few points of the EU average for 2010 (WHO, 2016a). As such the Netherlands seems as a suitable case within case study to engage in. It is important that points made from interviews conducted that are uniquely characterising of the Netherlands are identified so that they are taken into account when generalising.

When it comes to social science methods process tracing will be utilised. The reason why is that process tracing is a powerful method in establishing causal links in the

development of certain outcomes within a certain case (Vennesson, 2008: 231). In the context of this paper it will be used to investigate the development of EU tobacco policy and as such explaining-outcome process tracing will be used specifically (Beach & Pedersen, 2013; p. 20). Process tracing will help identify the causal mechanisms that explain the

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evolution of EU tobacco policy. As a result it can be argued that the process tracing will be more inductive by nature. Process tracing is a useful and powerful tool due to the

importance placed on the triangulation of data, so as to mitigate bias within sources. This is why multiple interviews will be utilised and multiple types of documents and sources shall be used. This will ensure a stronger level of triangulation in explaining the development of tobacco policy within the EU. Furthermore process tracing has the advantage of focusing on ‘intermediate steps’ between cause and outcome (Checkel , 2006; p. 366).This prevents possible wrong assumptions to be made and helps make sure there is constant checking of the causal links within the case as they are established.

Sources of data

So as to ensure the greatest level of accuracy, depth of information and to reduce bias a multitude of sources will be used. Firstly academic papers from a range of experts will be used. A focus on recent papers will be made, so that the information is as up to date as possible, which is of crucial importance since the field of tobacco regulation is constantly evolving. Papers analysing the politics and legal grounding behind certain tobacco directive passed by the EU shall also be used. Papers on the evolution of Dutch and EU tobacco regulation, as well as health policy in general shall also be utilised. In addition papers and sources on governance, such as Sabel and Zeitlin ‘New Modes of Governance’, shall also be used when the framework of tobacco regulation shall be characterised in governance-theoretic terms.

In combination with papers official EU documentation will be extensively used. This will used to help build the explanation and history of EU tobacco regulation. Furthermore resources from and reports conducted by NGOs such as the World Health Organisation, Framework Convention Alliance and ‘Alliantie Nederland Rookvrij’ (Dutch Smokefree

alliance) shall also be employed in this thesis. News from trusted sources, such as EURACTIV, will also be used to provide information and the media’s reaction to certain elements of tobacco regulation. Finally interviews shall be used. Interviews play an important part in the development of this thesis in that they provide detailed first-hand information from

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identify important points that might not be highlighted in traditional academic texts or documents. Interviews have been conducted with individuals who represent multiple stakeholders at both the EU level and Dutch level, so as to avoid potential bias from one set of stakeholders.

The persons interviewed were:

 Dutch University Professor who focuses on issues of public health

 An individual who works for the Dutch Ministry of Health, Welfare and Sport in Brussels

 A representative from the Smoke Free Partnership

 Sanne Heijndijk (Policy Consultant Alliantie Nederland Rookvrij)

 A senior policy officer at the Dutch Ministry of Health, Sports and Welfare The interviews were chosen both to balance multiple perspectives, but also so that information from one source would not be taken in isolation and can be supported by the points made from another interviewee. This triangulation of sources, as explained with the explanation of process tracing, helps prevent potential individual biases or inaccuracies influencing the thesis. Individuals from civil society organisations, such as the Alliantie Nederland Rookvrij (which is a large umbrella organisation within the Netherlands that represents multiple anti-smoking groups) are interviewed. These interviews provide detailed information regarding the nature of Dutch tobacco regulation, civil societies role, as well as give expert analysis regarding the nature of national and EU regulations on a member state (in this case the Netherlands). Interviews with individuals from the relevant Dutch ministry (Ministry of Health, Sports and Welfare), are also interviewed, both from the local Dutch level, as well from the supranational level through the Permanent Representatives in Brussels.

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How has the extent of the EU’s regulatory capacity evolved over time in regards to tobacco?

History

To understand the EU’s ability and methods of regulating tobacco the historical trajectory of the EU’s regulatory policy has to be examined and evaluated. This will give context and explanation to the current regulatory set up that exists. When looking at the current extent of the EU’s regulatory capacity it is important to highlight the ways in which the EU

overcomes formal limits to its regulatory power. Doing so gives a full understanding of both the EU’s formal and informal regulatory capacity.

The beginning of EU tobacco regulation has to be understood in the context of the constantly evolving nature of the ‘European Project’, from the European Coal and Steel Community to the current European Union. Over 60 years the ‘European Project’ has grown to encompass more and more elements that were previously exclusively part of nation state politics. With the creation of the European Economic Community in 1958 through the Treaty of Rome there was a formal acknowledgement and movement towards economic

harmonisation over the issues of external trade barriers and the removal of internal trade barriers (Ostergren & Le Boss, 2011: 234). Importantly, for the issue of tobacco, there was also the movement towards the free movement of goods, services, capital and people and the start of common integrative policies when it came to certain areas, such as agriculture (Ostergren & Le Boss, 2011: 234). The commitment to the free movement of goods and services by these initial European countries led to common regulation across these nations (necessary if you intend to create a common market). As such product regulation would become a supranational issue. Furthermore the creation of common ‘European’ integrative policies for certain issues, such as agriculture, set the precedent for this to be extended into other policy areas. This also led to harmonised regulation, as well as policies. In this respect the creation of the European Economic Community and the Treaty of Rome set the stage for supranational regulation and policy harmonisation.

After the Treaty of Rome the initial focus of the European Economic Community was economic issues such as agriculture and trade. However the gradual movement towards common policies on non-economic political areas grew significantly with the signing of the

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Single European Act of 1986 and the initiation ‘Europe against Cancer’ programme (in 1986 as well) by the European Commission. The ‘Europe against Cancer’ programme included a 75 point action plan on combatting cancer by looking at early detection, information and health education (Commission of the European Communities, 1995: 26). The Single European Act led to the European Economic Community agreeing to end all barriers to a fully functioning common (or single) market by 1992, as well as giving the EEC formal powers over community policies on education, research and development, the environment, consumer protection and health (Tsoutus, 1993). With these subjects, especially public health, the control and regulation of the policy area was both the EEC and member state responsibility, with the member state able to strengthen and extend

regulatory protections past the minimum the EEC had set, as long as it did not conflict with other elements of the Act (Tsoutus, 1993).

With the Single European Act acknowledging public health (and by extension tobacco) as an element that was intertwined with economic integration the Act can be seen as an

important point off which the supranational regulation of tobacco would be built off (Duina & Kurzer, 2004). As such the EEC acknowledged the potential role they could play when it comes to public health, through the lens of facilitating economic integration. However while the EEC was setting the ground for the future overarching multinational regulation the situation within the member states of the EEC when it comes to tobacco needs to clarified. Among the European states there were differing levels and regulatory structures when it came to tobacco regulation. Traditionally the states of many European countries have had a complex relationship with tobacco. In France, Italy and Spain the state traditionally had a state monopoly over tobacco products (although weakened in the 1970s due to

transnational tobacco companies entering the market) (Chitanondh, 2000: 3). This in turn led to governments having weak tobacco regulations, such as weak or limited enforcement of antismoking laws (Kluger, 1997: 755). Other nations, such as Greece and Germany heavily relied on the large revenues earned from taxes placed on tobacco products, with for some countries (such as Germany) the revenue earned contributing 5 to 6 percent towards total tax revenues earned by the state (Kluger, 1997: 755). This too led to weaker regulation in certain European countries who did not want to overregulate tobacco, likely out of fear that this would lead to diminished tax revenues and by extension put pressure of the

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government budget (Kluger, 1997: 755). When it came to the context of Europe the first strong and comprehensive tobacco regulatory ban on tobacco advertising came about in Norway (who was outside of the EEC) which implemented a total ban on tobacco advertising in all forms (Blanke, 2011: 98). It is argued by Blanke that Norway was the first country in a general trend within Europe to focus on targeting tobacco advertising and limiting it (Blanke, 2011: 98).

Among the members of the EEC from the 1980s there was a movement towards increasing regulation, especially when it comes to advertising. . During the 1980s the increased media attention on the negative health effects of smoking and growing public pressure led to nation, such as France to swing significantly towards being health focused and fighting the tobacco industry (Duina & Kurzer, 2004). After starting to divest itself from the tobacco industry (through privatising the state tobacco industry) France began strengthening tobacco control and regulation within the state under the Mitterrand presidency (Duina & Kurzer, 2004). Health minister Evin proposed a law that would lead to a total ban on direct and indirect tobacco advertising as well as banning smoking in enclosed public spaces, besides designated smoking rooms (Duina & Kurzer, 2004). Although there was a dilution of the law with amendments (due to wide economic and public backlash at the severity of the law) the action taken by the French represented the most stringent tobacco control system within the EEC (Duina & Kurzer, 2004).

As of the passing of the Evin Law in France, the EEC had acted and increased the regulation from the supranational direction. Firstly the ‘Television Without Frontiers’ directive passed by the EEC in 1989 banned tobacco advertising on television through the EEC, with the logic that it harmonised regulation in regards to cross border television services within the internal market, while protecting certain public interests, such as public health (Council Directive 89/552/EEC). This was followed by further supranational regulation taken by the EEC, such as regulations on tobacco product labelling, with the requirement of certain warnings regarding the health implications of tobacco usage, the listing of the contents of cigarettes and, with the 1992 directive, the ban on marketing of certain newer tobacco products (Council Directive 89/622/EEC; Council Directive 92/41/EEC). The 1992 directive used the logic that differences in product packaging impeded the functioning of the internal market, further showing that the EEC used its competency over regulating the internal

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market, along with its ability to take health considerations into account (specifically

mentioning the threat of cancer in the context of the Europe against Cancer programme), to influence and regulate tobacco products (Council Directive 92/41/EEC). Furthermore there were directives which set minimum tax levels for tobacco products, with the later 1995 directive requiring a gradual harmonisation between member states in regards to excise duty on tobacco products in stages (Council Directive 95/59/EC). This directive was passed after the creation of the European Union through the Treaty of Maastricht, which took effective in 1993. While these directives show a growth of tobacco regulation during the early 1990s, it was still limited, with Glantz, Bitton and Neuman arguing that it did not count as a comprehensive supranational tobacco control system and thus was more directed and specific to market harmonisation (Glantz et al, 2002).

For most the 1990s other European nations, such as Germany, the Netherlands, the UK, Greece, Denmark and Austria had been less enthusiastic about anti-tobacco regulation, with Germany being the strongest voice within the EEC/EU in opposition to stronger regulation (Blanke, 2011: 98). The other nations, such as the UK and the Netherlands, while for a time supporting the German position, ended up conceding to the pro regulation side, which consisted of Italy and France (Duina & Kurzer, 2004). The reason for this was a combination of factors. Firstly it is recognised that during the late 1980s and 1990s there was an increase in both information on the damage of tobacco and permeation of this information into the general public and media. Evidence of this comes from multiple sources. Firstly Tulchinsky and Varavikova (2009: 484) point to the fact that in the UK the NHS engaged in large-scale and relatively successful anti-smoking campaigns during the late 1980s and early 1990s, showing an effort on governments’ front to tackle the acknowledged problem of tobacco health issues. There were also media campaigns, as seen in France in the lead up to the Evin Law creation where health academics went straight to the public regarding the issues of smoking and the little action being taken by the government (Duina & Kurzer, 2004). This is compounded by the arguably significant work done by civil society organisation during this time too, with Nardini (2008: 1) stating that the European Respiratory Society (founded in 1990) has greatly increased the level of public awareness regarding the dangers of smoking. These civil society organisations used a three pillar model of educating, science and

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with the European Respiratory Society to create the Smoking Prevention Committee in the latter half of the 1990s, which engaged in public anti-smoking activities (Nardini, 2008: 1). This shows that civil society organisations were ramping up their actions and presence within the political and social discourse around smoking, raising awareness.

This swing of nations from anti to pro stronger tobacco regulations is reinforced by the shifting politics during the middle to late 1990s. Within some of the swing countries, such as the UK and Netherands, the political landscape changed due to the election of left-wing parties, who were more open to supranational tobacco regulation and thus stopped

obstructing it (Duina & Kurzer, 2004). In 1997 when the Labour Party entered government in the UK the official UK policy on tobacco control shifted more in line with France and Italy, with a willingness to accept stronger Commission drafted legislation (Duina & Kurzer, 2004). Within the Netherlands there had been a PvDA (Dutch Labour Party) led coalition since 1994 however it is argued by Duina & Kurzer (2004) that the left wing nature of the Dutch

government, along with the shift that occurred in the UK led to the Netherlands position against stronger supranational regulation shifting. This point is supported by a historical observation from an interview with a Dutch University Professor who focuses on issues of public health and smoking that in the 1970s the Netherlands had relatively strong tobacco control due to the left-wing government that was present at the time, further justifying the link between the political tides of the time and tobacco regulation (interview A). As such it can be argued that civil society activity, increased information on tobacco and the politics within certain member states at the time played a role in the increased ability for the EC to get around member state obstruction and engage in further tobacco regulation. This would be seen with the battle for the Tobacco Advertising Directive.

In the lead up to the official passing of the Tobacco Advertising Directive, it can be seen that not only did the EU influence the member states through the creation of binding directives and the regulation structures that resulted, but that the states themselves had an impact on the trajectory and process of regulation. The internal politics surrounding the creation and passing of stronger regulation was significant in that the previous regulatory set ups of the states and their attitude towards regulation impacted the supranational regulation. As previously mentioned, by the late 1990s both France and Italy had strong regulation and controls on tobacco products, meaning that stronger regulation suggested at the

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supranational level would not have impacted them as much as nations with weaker

regulations, such as Germany. In this case it can be seen that with the process of regulation harmonisation there was a dual effect in that it was dragged behind stronger regulatory states and in turn pulled up states with weaker regulation.

The contention previously mentioned is linked to the first Tobacco Advertising Directive (TAD1). This directive would have banned direct and indirect advertising of tobacco

products as well as sponsorships of events by the tobacco industry (Kurzer, 2010: 268). After years of obstruction it was passed in late 1997 and became law the following year, however there was still opposition to the directive by Germany and Austria, with it passing due to majority of support among the member states, helped in part by the acceptance of Finland and Sweden into the EU and their support for the directive (Kurzer, 2010: 269). However after its passing the German state engaged in a court action at the European Court of Justice to annul the directive. The logic on which the directive was based was again linked to the internal market, specifically Article 95(1) of the EC Treaty which sanctioned a directive if it facilitated the functioning of the internal market through harmonisation (Obergfell, 2001: 156). The argument that differences in advertising would constitute a trade barrier and thus prohibiting all advertising of tobacco was found by the ECJ to be going past the competency of the EU. An argument used against the directive was that not all advertising is cross-border in nature, such as local press, however it was acknowledged by the ECJ that print media could theoretical become cross-border (Obergfell, 2001: 156). Ultimately the ECJ found that the use of internal market competency was weak due to a lack of clear barriers to trade and competition distortions be removed (Obergfell, 2001: 156). As a result the Court ruled that the EU had overstepped its competency and intruded on the competency of the member states. In this regard the ECJ found the directive to be violating the principle of the EU having limited specific authority (Obergfell, 2001: 160). Furthermore there was a criticism of the directive not just from states but from academics and the media, who saw it as a potentially setting a precedent for stronger supranational regulation on advertising for other products such as alcohol and even confections (Obergfell, 2001: 154). The ECJ

overturned the directive in 2000. TAD1 can be seen as a mistake on the part of the Commission due to its over-reach when it came to creating regulatory structures for tobacco, thereby showing the limits of the supranational entity.

Tobacco regulation within the EU : the extent and nature of the EU's ability to regulate tobacco