The future of pharmaceutical policy in the European Union until 2025: results of a Delphi survey

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Abstract

Objectives

To examine expectations of and opinions on the development of European Union (EU) and national competencies in pharmaceutical policy until 2025.

Methods

Key issues of pharmaceutical policy (authorisation, pharmacovigilance, classification, distribution, advertising, pricing, dispensing, prescribing, post-licensing evaluation and reimbursement) were selected from published literature. Next a two-round Delphi questionnaire was developed in which 41 selected European experts were asked to rate the level of competence on these issues using a five-point Likert scale (1 = fully national, 5 = fully European).

Key findings

Experts expect that authorisation, pharmacovigilance, classification, distribution, advertising and post-licensing evaluation show a steady and gradual trend towards European regulation. Pricing, dispensing, prescribing and reimbursement remain predominantly national competencies.

Conclusions

Convergence due to the Europeanisation of the pharmaceutical market reinforces opportunities for (and in some cases necessitates) more European collaboration or regulation. National governments are well advised to support such collaborations and to actively participate in the direction of future EU policy instead of resisting it.

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