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.
