Regulating under constraint : the case of EU pharmaceutical policy
This study is concerned with the making of regulatory policy for pharmaceuticals in the European Union. It proposes that an ad hoc development of Community competencies which does not amount to coherent strategy, far less a single medicines market, has resulted in a regulatory framework which favours the interests of industry. This is important on two fronts. First, it appears to run counter to contemporary research into EU regulation, which finds that consumer interests prevail over those of producers generally. Second, this pro-industry leaning seems not to be in keeping with member states' regulatory frameworks at home, which developed primarily as a means of protecting consumers' health (patients) following the Thalidomide tragedy. In providing support for this contention, rather than adopting an economic frame of analysis to assess - quantitatively - how the industry benefits, the study instead proposes a political perspective to understand how policy decisions have been taken. Specifically, the study examines how supranational policy for pharmaceuticals is made with the context of a clash between the European Community's free movement of goods principles and, via the principle of subsidiarity, the right of the member states to decide their national healthcare priorities. The agenda and roles of the European Commission, the member states, consumer interests, and the industry as the sector's four primary stakeholders are scrutinised within this context. The analysis concentrates on policy level interactions, examining how the political considerations at stake over medicines have affected policy outcomes in specific instances. It is shown that the incomplete development of competencies is not just a result of the policy clash, but also because different policy impetuses (and stakeholders) have spurred different aspects of the framework. This involves the development of a multi-faceted theoretical lens in order to capture the complexities of making pharmaceutical policy at EU level. This lens is based on the understanding that EU pharmaceutical policy is made within policy networks consisting of the four stakeholders. To gain a better grasp of the dynamics at play, these networks are tied to a regulatory policy-making framework known as the 'politics of policy'. It is a view which identifies different modes of regulatory politicking on the basis of the perceived costs and benefits the proposed intervention would bring to affected interests. Linked with wider European integration and policy-making theories, including neo-functionalism, intergovernmentalism and multi-level governance, this allows for a more complete perspective on how policy is made for the sector. Via its broader approach, therefore, the study provides insight into the complexities of making supranational policy for medicines, especially with regard to the need to balance conflicting interests within the harmonisation process.