Globalization of pharmaceutical R&D Pharmaceutical R&D governance forms in People's Republic of China

Firm's survival and success, which are dependent on its ability to innovate, to create knowledge and to capitalize on inventions and know-how, is in essence directly linked to its R&D process (Dunk and Kilgore 2001). Especially in technology driven industries, such as the pharmaceuticals, there are significant positive returns to R&D investments through introduction of new or improved products and services (McEvily and Chakravarthy 1999). Technological lead and its transformation to innovative products as fruits of corporate R&D can be seen as monopolistic advantage that helps enterprises to compete in today’s market (Lall 1977). This competitive advantage can be derived from corporation's ability to integrate its activities across geographic locations (Porter 1986). According to Boehe (2008) globalization of R&D can executed with different governance forms: R&D internationalization, R&D offshoring or R&D offshore outsourcing. Globalization of R&D is intervened with the changes in global economy of the 21st century. Some studies argue for its influencing factors to be access to vast skilled labor pools and centers of excellence (Bardhan 2006). Other studies indicate the R&D cost differentials between countries to be the major expected benefit (Norwood et al. 2006). Von Zedtwitz and Gassmann (2002) presented benefits as divided to accessing markets and customers or to accessing local science and technology. This study proposes that based on governance form distinct factor derived benefits can be capitalized. To corroborate or refute factors and their relations on R&D globalization governance forms, an empirical study based on expert interviews of pharmaceutical directors was conducted in the People's Republic of China. The market was found to be the major influencing factor. Local requirements and adaptation were corroborated as factors connected with markets. Furthermore, influencing factors, such as labour, centers of excellence, cost, financial incentives were corroborated together with conditional and risk factors. Furthermore this research argues that the globalization of pharmaceutical R&D is dependent on the financial, scientific and operational requirements of the drug discovery stage. And thus establishes the influence of drug discovery's stages continuum on pharmaceutical R&D globalization. Finally, a R&D globalization governance form decision framework is proposed based on the frameworks presented in literature and author's corroborated empirical findings.

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.