tailieunhanh - Regulatory Europeanization, National Autonomy and Regulatory Effectiveness: Marketing Authorization for Pharmaceuticals

DMOs tend to be part of the local, regional or national government and have political and legislative power as well as the financial means to manage resources rationally and to ensure that all stakeholders can benefit in the long term. Destination management and marketing should act as tools and facilitators to achieve a complex range of strategic objectives, which will ultimately need to satisfy the needs and wants of stakeholders. Four key generic strategic objectives should be addressed by DMOs, as illustrated in Table 2. Figure 1 demonstrates the dynamic wheel of tourism stakeholders. The development and implementation of. | Regulatory Europeanization National Autonomy and Regulatory Effectiveness Marketing Authorization for Pharmaceuticals Jurgen Feick 02 6 Max-Planck-Institut fur Gesellschaftsforschung Paulstrasse 3 50676 Koln Germany Telephone 0221 2767 -0 Fax 0221 2767-555 E-Mail info@ Website MPIfG Discussion Paper 02 6 ISSN 0944-2073 November 2002 2 MPIfG Discussion Paper 02 6 Abstract The EC harmonized market entry regulation for pharmaceuticals from the early sixties on but it achieved neither its goal of uniform national regulatory decisions nor that of automatic mutual recognition. Subsequent attempts to Europeanize the procedures themselves resulted in two alternatives in 1995 a Centralized Procedure for innovative pharmaceutical products implemented at the EU level and a Decentralized Procedure which tries to assure mutual recognition. First the paper analyzes the distinctive modes of Europeanization employed in these regulatory alternatives examining both their impact on the effectiveness of European governing and the balance they strike between European interventionism national participation and national autonomy. Second it tries to assess whether Europeanization furthers the goals of pharmaceutical market entry policy as defined in European regulations - public health protection creation of a single market and the reduction of regulatory costs to industry. There is little evidence that the public s health is less well protected when regulation is Europeanized. Only the Centralized Procedure contributes significantly to the goal of establishing a single market. Regulatory costs in terms of approval time did go down especially for pharmaceutical firms using the Centralized Procedure mainly because of efficiency-enhancing legal provisions and institutionally induced regulatory competition between national authorities. Zusammenfassung Seit Anfang der sechziger Jahre hat die EG das Zulassungsrecht fur Arzneimittel harmo-nisiert ohne