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Health governance in Europe

The politics, policy and governance of health in the EU

Regulatory policy and crisis politics in contemporary EU health policy

Prior to the economic crisis and the inclusion of health in the EU’s strengthened economic governance framework, the narrative of EU health policy was well-established and its development understood to be shaped by a stable set of dynamics. The judgements of the Court of Justice of the EU (CJEU), the initiative of Council Presidencies and the expansionist strategies of the European Commission each played a part in steering the predominantly regulatory policy process, punctuated periodically by crisis events that would realign and reconfigure health priorities and competences. In the post-crisis era, this piece asks, how relevant is the ‘traditional’ health policy method?

The EU is fundamentally a regulatory state, since it lacks the competence and financial resources necessary to exercise the distributive and redistributive functions of a nation state and so relies on governance-by-regulation (Majone, 1996; Radaelli, 1999; Héritier and Thatcher, 2002). Its exclusive powers over the functioning of the internal market, supported by expansive interpretation by the CJEU and the doctrine of legal supremacy have facilitated rapid regulatory growth (Thatcher, 2006: 312). The same dynamics mean that the majority of EU activity in health is regulatory; it does not act as a service provider but regulates the activity of other health actors (Lamping and Steffen, 2005: 189).

Regulation is broadly defined as state control over activity valued by the community and can be pursued via formal legislative rules as well as informal norms and ‘soft’ regulatory influence (Thatcher, 2006: 312). It has a number of specific characteristics which shape the kind of health policy it produces. Firstly, the regulatory discretion given to the European Commission has enabled it to act as a policy entrepreneur, driving forward the expansion of the EU regulatory state (Majone, 1996). The activism of the Commission, as well as interest groups and the Court, is crucial in the neofunctional model of regulatory growth, whereas by contrast, the intergovernmental model emphasises member states’ decision to delegate and acceptance of EU regulation in areas of environmental, competition and social policy (Thatcher, 2006: 315-316; Rhodes, 1995). Both drivers can be seen in health policy, with member states choosing to delegate power in the wake of crises such as the HIV/AIDS scandal and the Commission pushing forward regulation of pharmaceuticals and medical devices.

Another important feature of regulatory policy is its requirement of expertise. Regulatory policy requires little budget but must be founded on a thorough knowledge of the market and subjects to be regulated (Radaelli, 1999: 6). This is made even more important by the speed at which technology and policy options advance (Majone, 1993: 165). The expansion of the ‘EU regulatory state’ has thus been accompanied by a proliferation of agencies and bodies which advise policy-makers on the technical aspects of policy. In health the European Medicines Agency (EMA), the European Centre for Disease prevention and Control (ECDC), the European Food Safety Agency (EFSA) and various other bodies play a central role in informing and implementing policy, particularly in ‘risk-related sectors’ such as medicines, food safety and disease prevention (Kim, 2014: 2; Versluis et al., 2011). Such policy thus elevates the role of epistemic communities and technocratic governance (Richardson, 2006: 6).

Contemporary EU studies is generally agreed that regulatory policy was the motor behind early integration but that its relevance is now declining (Young, 2015: 132; Wallace and Reh, 2015: 104). This trend is attributed to the rise of Euroscepticism and resistance to further integration, the weakening position of the Commission and the increasing use of alternative policy types, such as redistribution through the European Social Fund (ESF) and voluntary coordination through the open method of coordination (OMC) (Falkner, 2010: 284; Richardson, 2006: 7). As the integration of product standards reaches its limit, the EU has turned to less hierarchical and more decentralised modes of governance to tackle product, services and utilities standards (Wallace and Reh, 2015: 104).

One circumstance where regulatory policy continues to be the default response is that created by a crisis. In health, crisis situations have periodically destabilised the status quo and altered the shape or direction of the policy area. The thalidomide disaster in the 1960s led to the creation of a common regulatory framework for pharmaceuticals and the establishment of the EMA, the HIV/AIDS contamination scandal in the 1980s prompted the introduction of new health powers in the Amsterdam Treaty, the BSE crisis in the early 1990s resulted in the creation of the EFSA, the 2003 SARs pandemic led to the establishment of the ECDC and, most recently, the 2010 PIP breast implant scandal has triggered a revision of the regulatory framework for medical devices. Crisis politics are thus considered by most to be an important driver of the evolution of EU health policy competences (Hervey and McHale, 2004: 78; Lamping, 2005: 23; McKee et al., 2004: 12; Randall, 2002: 9).

The eruption of a crisis opens a window of political opportunity. It increases the political will behind the search for a solution and makes it easier to achieve consensus on a common response, whilst the element of urgency reduces the time made available for debate and obstruction. In health these factors are amplified by the presence of fear – this is easily generated around issues such as communicable disease and has historically proven a powerful tool for shifting both public opinion and political commitment. As a result the introduction of hard law, the creation of new EU competences and the transfer of autonomy are made far easier when undertaken as instances of crisis response. Political commitment to health is not solely witnessed during times of crisis – commitment to addressing key health concerns has been critical in the creation of EU policy on cancer and patient safety, for example, via the Presidency of the Council – but it is a less reliable driver when crisis politics are not in play (Greer et al., 2014: 35).

The power of crisis politics is reflected in the degree of integration and competence transfer experienced in areas such as HIV/AIDS and BSE, as compared to tobacco, alcohol and nutrition policy. Smoking-related disease, alcohol abuse and obesity pose three of the greatest threats to health and health systems but have achieved only marginal centralised policy when compared to communicable disease control and food safety regulation (Lamping and Steffen, 2005: 189). This issue exists, according to Leibfried (2010: 279), because the social policy-making capacities of the EU have not been strengthened nearly as much as the capacities of member states have declined; such a stalemate can only be broken through further crisis.

The economic crisis which has enveloped the EU in recent years presents a different kind of opportunity – it is not a traditional crisis of public safety and is thus unlikely to prompt a revival of regulatory policy, except perhaps in the governance of financial markets (Wallace and Reh, 2015: 104). However, it has manifested in a social and health crisis which has prompted calls for greater social and health policy action at European level. The question is whether policy-makers will respond by recourse to market measures or work to strengthen social policy and integration.

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