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.

The use of future-oriented knowledge in regional innovation processes: Research on knowledge generation, transfer and conversion

The importance of the regional level in research has risen in the last few decades and a vast literature in the fields of, for instance, evolutionary and institutional economics, network theories, innovations and learning systems, as well as sociology, has focused on regional level questions. Recently the policy makers and regional actors have also began to pay increasing attention to the knowledge economy and its needs, in general, and the connectivity and support structures of regional clusters in particular. Nowadays knowledge is generally considered as the most important source of competitive advantage, but even the most specialised forms of knowledge are becoming a short-lived resource for example due to the accelerating pace of technological change. This emphasizes the need of foresight activities in national, regional and organizational levels and the integration of foresight and innovation activities. In regional setting this development sets great challenges especially in those regions having no university and thus usually very limited resources for research activities. Also the research problem of this dissertation is related to the need to better incorporate the information produced by foresight process to facilitate and to be used in regional practice-based innovation processes. This dissertation is a constructive case study the case being Lahti region and a network facilitating innovation policy adopted in that region. Dissertation consists of a summary and five articles and during the research process a construct or a conceptual model for solving this real life problem has been developed. It is also being implemented as part of the network facilitating innovation policy in the Lahti region.

New threats - old routines : bureaucratic adaptability in the security policy environment

Within the framework of state security policy, the focus of this dissertation are the relations between how new security threats are perceived and the policy planning and bureaucratic implementation that are designed to address them. In addition, this thesis explores and studies some of the inertias that might exist in the core of the state apparatus as it addresses new threats and how these could be better managed. The dissertation is built on five thematic and interrelated articles highlighting different aspects of when new significant national security threats are detected by different governments until the threats on the policy planning side translate into protective measures within the society. The timeline differs widely between different countries and some key aspects of this process are also studied. One focus concerns mechanisms for adaptability within the Intelligence Community, another on the policy planning process within the Cabinet Offices/National Security Councils and the third focus is on the planning process and how policy is implemented within the bureaucracy. The issue of policy transfer is also analysed, revealing that there is some imitation of innovation within governmental structures and policies, for example within the field of cyber defence. The main findings of the dissertation are that this context has built-in inertias and bureaucratic seams found in most government bureaucratic machineries. As much of the information and planning measures imply security classification of the transparency and internal debate on these issues, alternative assessments become limited. To remedy this situation, the thesis recommends ways to improve the decision-making system in order to streamline the processes involved in making these decisions. Another special focus of the thesis concerns the role of the public policy think tanks in the United States as an instrument of change in the country’s national security decision-making environment, which is viewed from the perspective as being a possible source of new ideas and innovation. The findings in this part are based on unique interviews data on how think tanks become successful and influence the policy debate in a country such as the United States. It appears clearly that in countries such as the United States think tanks smooth the decision making processes, and that this model with some adaptations also might be transferrable to other democratic countries.

Adaptability, Transformation and Complex Changes in Namibia and Tanzania: Resilience and Innovation System Development in Local Communities

This thesis is a research about the recent complex spatial changes in Namibia and Tanzania and local communities’ capacity to cope with, adapt to and transform the unpredictability engaged to these processes. I scrutinise the concept of resilience and its potential application to explaining the development of local communities in Southern Africa when facing various social, economic and environmental changes. My research is based on three distinct but overlapping research questions: what are the main spatial changes and their impact on the study areas in Namibia and Tanzania? What are the adaptation, transformation and resilience processes of the studied local communities in Namibia and Tanzania? How are innovation systems developed, and what is their impact on the resilience of the studied local communities in Namibia and Tanzania? I use four ethnographic case studies concerning environmental change, global tourism and innovation system development in Namibia and Tanzania, as well as mixed-methodological approaches, to study these issues. The results of my empirical investigation demonstrate that the spatial changes in the localities within Namibia and Tanzania are unique, loose assemblages, a result of the complex, multisided, relational and evolutional development of human and non-human elements that do not necessarily have linear causalities. Several changes co-exist and are interconnected though uncertain and unstructured and, together with the multiple stressors related to poverty, have made communities more vulnerable to different changes. The communities’ adaptation and transformation measures have been mostly reactive, based on contingency and post hoc learning. Despite various anticipation techniques, coping measures, adaptive learning and self-organisation processes occurring in the localities, the local communities are constrained by their uneven power relationships within the larger assemblages. Thus, communities’ own opportunities to increase their resilience are limited without changing the relations in these multiform entities. Therefore, larger cooperation models are needed, like an innovation system, based on the interactions of different actors to foster cooperation, which require collaboration among and input from a diverse set of stakeholders to combine different sources of knowledge, innovation and learning. Accordingly, both Namibia and Tanzania are developing an innovation system as their key policy to foster transformation towards knowledge-based societies. Finally, the development of an innovation system needs novel bottom-up approaches to increase the resilience of local communities and embed it into local communities. Therefore, innovation policies in Namibia have emphasised the role of indigenous knowledge, and Tanzania has established the Living Lab network.