Constitutional asymmetry and pharmaceutical policy-making in the European Union

Abstract

This paper offers a theoretical perspective on pharmaceutical policy-making in the European Union, and shows the lack of a single European market in medicines to be the result of a clash between the supranational free movement rules and national healthcare policy competencies. The paper considers the roles of the European Commission, the member states, the industry and consumer interests (patients) as the main stakeholders, and frames the discussion within an integrated macro- and meso-level approach. Here we draw on Wilson's ‘politics of (regulatory) politics’ typology, tying it to Scharpf's ‘constitutional asymmetry’ perspective on EU policy. This enables the development of a broad sphere of analysis, allowing us to make observations on the EU regulatory arrangement for medicines as a whole. Specifically, the paper shows the extent to which industrial rather than health(care) policy interests have driven the development of regulatory policy in the sector, and seeks to understand the political dynamics shaping the on-going evolution of the regulatory framework.

Keywords:

• Constitutional asymmetry
• European Union
• pharmaceuticals
• policy-making
• regulation
• single market.

Acknowledgements

The authors express their gratitude to two anonymous referees for their helpful comments on an earlier version of this paper.

Notes

1 Directive 65/65/EEC, agreed in the aftermath of the Thalidomide tragedy, was the first piece of Community pharmaceutical legislation, and set guidelines on common authorization requirements for new drugs.

2 Respectively, Regulations 2309/93 and 1768/92, and Directives 92/28/EEC, 92/25/EEC and 92/27/EEC.

3 These three policy inputs involve balancing the provision of safe, efficacious medicines while striving to improve efficiency, quality and equity, and controlling costs. At the same time, many member states are interested in promoting their industry in production and employment terms.

4 An exception is Directive 89/105/EEC on the transparency of national pricing methodologies. But the paper will show that even this had a strong single market influence.

5 Pharmaceuticals are generally regarded as one of the most profitable of industrial sectors (Scherer 1996).

6 This is in part based on Weiler's (1994) distinction between European law as supranational and European policy-making as intergovernmental.

7 For an exploration of the comparative relevance and failings of several theories of European integration and policy-making vis-à-vis EU pharmaceutical policy, see Permanand (2002).

8 The industry can divided into two sectors. The research-based pharmaceutical companies are those that source and develop new drugs, and seek patent protection for their products. Generic manufacturers are companies which produce copies or equivalents, based on an original product once the period of patent protection on that product has expired. Generic products are subject to the same safety, quality and efficacy criteria, but are cheaper.

9 For example, the UK rewards pharmaceutical companies' local capital investment with higher profits. And although not permitted under European law, it is suggested that some other countries implicitly tie reimbursement to a medicine's country of origin in order to promote the domestic industry (Permanand and Altenstetter 2004).

10 Shechter (1998) claims that those Members of the European Parliament who did not appear sympathetic to the industry's stance were not given copies of the report.

11 Also with a large generics industry, the German government's priorities were especially complicated.

12 Most important of which was a transition period for Greece, Portugal and Spain (which had opposed the proposals in the Council of Ministers) allowing them until 1998 to implement the legislation.

13 The agency's recommendations are based solely on the criteria of quality, safety and efficacy from the original 1965 Directive.

14 The US Food and Drug Administration has strict views on what constitutes an innovative advance vis-à-vis drug applications (grounds for ‘priority review’), while the EMEA's innovation criteria are vague and dependent on the ‘opinion’ of the agency.

15 For a detailed discussion of further EMEA criticisms – particularly in terms of the authorization procedures and public health interests – see Abraham and Lewis (2000).

16 These were Directives 75/318/EEC, 75/319/EEC, 83/570/EEC and 87/22/EEC.

17 Cases C-181/82 Roussel Laboratoria BV & Others v. Netherlands (ECR 3849) and C-238/82 Duphar & Others v. Netherlands (ECR 523).