Examining proposed European Union Pharmaceutical legislation changes: A focus on pharmaceutical industry stakeholders’ perspective of regulatory protection periods for innovation and access

Abstract

There is a high prevalence of unmet medical needs and unequal access to medicines across EU Member States. To address this, there are proposed changes to the European Pharmaceutical legislation which includes changes to regulatory protection periods (data protection, market protection, and market exclusivity). At present, majority of extant literature focuses on the impact previous legislation has had on pharmaceutical research and development (R&D). The existing literature focusing on the impact of regulatory protection periods is limited, especially surrounding the pharmaceutical industry perspective on the proposed changes. This study aims to utilise key pharmaceutical industry stakeholders’ perspective surrounding proposed changes to regulatory protection periods in EU pharmaceutical legislation to develop an understanding of how incentives in legislation impact organisational behaviour in the pharmaceutical industry. This research adopted a qualitative research strategy to understand Swedish pharmaceutical industry stakeholders’ perspective on the proposed changes. Nine participants were recruited using purposive and snowball sampling, and data was collected through semi-structured indepth interviews. The research methodology met the University of Auckland ethics criteria. The results of this research identified four key themes: role and value of regulatory protection periods, regulatory protection and investment in innovation, regulatory protection as an incentive for equal access, regulatory protection and orphan drug development. Regulatory protection is a highly valuable intellectual property asset, however proposed changes are a worsening of protection periods and weaken the intellectual property system. The proposed changes will not lead to equal access or an innovative friendly environment in the EU. The results from this research are useful for both private and public stakeholders as it provides an understanding of the potential future direction of the industry in the EU. The results provide opportunity for constructive dialogue between stakeholders to refine the proposal to better address the legislative objectives.