Strategic divide management in pharmaceutical alliances: A partner’s strategic evolution as a reason for strategic divide

Strategic alliances are widely used in the pharmaceutical industry and, ideally, they are long-lasting structures that bring many benefits and value to the alliance partners. However, organizations continuously encounter pressures to enhance performance, while the environment in which they operate evolves. Therefore, an alliance partner might be forced to change its strategy, which can lead to the partners’ misaligned priorities and strategic divide. The academic literature acknowledges the impact a partner’s strategic change can have on the value of the alliance, but the phenomenon is not studied further, which is why the purpose of this study is to understand the role that a partner’s strategic evolution plays in strategic alliances within the pharmaceutical industry. The main purpose is further divided into three sub-objectives: 1) Describe reasons behind the strategic direction change of a partner firm, 2) Understand the consequences of partners’ misaligned priorities, and 3) Describe proactive and reactive ways to manage strategic divide between alliance partners. Since the phenomenon is not studied much, the empirical part of the study was conducted as a qualitative analysis using expert interviews to better understand, how the partner’s strategic evolution affects the alliance. The empirical data was organized into themes, according to the researcher’s interpretations on the interviews. The research findings demonstrated, how the partners change their strategies if the external or organizational environments change. The strategic changes, again, cause strategic divides between the alliance partners that are likely to have an impact on the alliance value. The findings revealed that the interviewees consider anticipation of the partner’s strategic change to be really difficult, but, at the same time, it was noted that a proactive strategic divide management could help to prevent and detect some divides. Additionally, the results showed that, after the detection, a reactive approach in a controlled manner was seen to be the most beneficial for the alliance’s future performance. This study proved that a partner’s strategic evolution affects the partners’ priority alignment and alliance value, which is why the strategic divide management is important in organizations that are involved with strategic alliances. In order to understand the role of a partner’s strategic evolution and provide managers with a tool to manage alliances and strategic divides, the study combined the alliance lifecycle as well as the proactive and reactive approaches to strategic divide, and presented a framework for strategic divide management.

Refocusing regulatory exclusivities: Regulatory data protection and marketing exclusivity as forms of pharmaceutical innovation policy

Protection of innovation in the pharmaceutical industry has traditionally been realised through protection of inventions via patents. However, in the European Union regulatory exclusivities restricting market entry of generic products confer tailored, industry specific protection for final, marketable products. This paper retraces the protection conferred by the different forms of exclusivity and assesses them in the light of recent transparency policies of the European Medicines Agency. The purpose of the paper is to argue for rethinking the role of regulatory data as a key tool of innovation policy and for refocusing the attention from patents to the existing regulatory framework. After detailed assessment of the exclusivity regime, the paper identifies key areas of improvement calling for reassessment so as to promote better functioning of the regime as an incentive for accelerated innovation. While economic and public health analysis necessarily provide final answers as to necessity of reform, this paper provides a legal perspective to the issue, appraising the current regulatory framework and identifying areas for further analysis.