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 indicators and evidence in governance and policy development of science, technology and innovation

This paper was first presented at the 2012 – EU SPRI Conference “Towards Transformative Governance? - Responses to mission-oriented innovation policy paradigms”, Fraunhofer ISI, June 2012, Karlsruhe

Innovation and Globalization Policy in Small Transition Countries ; Case study: Macedonia and Slovenia

Diese Arbeit befasst sich mit der Innovations- und Globalisierungspolitik in kleinen Transformationsländern am Beispiel Mazedoniens; diese wurde mit der Lage in Slowenien verglichen, einem Land von ungefähr gleicher Größe und mit gemeinsamer Vergangenheit als Teilrepublik der Jugoslawischen Föderation, aber mit einem wesentlich höheren ökonomischen Entwicklungsstand. Innovation wird dabei verstanden als „Herstellung, Anpassung und Ausnutzung von Neuerungen“, und sie wird durch das Umfeld, in dem sie stattfindet, beeinflusst. Anpassung und Ausnutzung sind gerade für kleine Transformationsländer von erheblicher Bedeutung, da ihre Fähigkeit zu Herstellung von Neuerungen sehr begrenzt sind. Die Rolle der Innovationspolitik besteht hierbei darin, institutionelle und organisationelle Regulierungen einzuführen, die ein günstiges Umfeld sowohl für Innovationen als auch für die Entwicklung eines nationalen Innovationssystems schaffen. Die Rolle der Politik besteht also nicht in der Innovation als solcher, sondern in der Herstellung der notwendigen Bedingungen für die Industrie und die Forschungseinrichtungen dahingehend zu schaffen, dass sie ihr Wissen, ihre Fertigkeiten und ihre praktischen Erfahrungen für innovative Tätigkeiten einsetzen können. Auf der einen Seite gibt es Institutionen und Organisationen, ohne die die Unternehmen rückständig und wenig leistungsstark wären (etwa das Patentamt oder Institutionen höherer Bildung), und auf der anderen Seite gibt es Institutionen und Organisationen, welche die Unternehmen dabei unterstützen, dass sie ihre Tätigkeit weiter unterstützen (z.B. durch Technologietransfer-Zentren und Netzwerke). Die Leistungen dieser Institutionen und Organisationen sind von großer Bedeutung für die nationalen Innovationssysteme und sollten ihrerseits durch Innovationspolitik unterstützt werden; dies bedeutet jedoch nicht, dass diese Leistungen vom Staat bereitgestellt werden, vielmehr sollte die Wirtschaftspolitik Möglichkeiten für die öffentlich/private oder sogar rein private Bereitstellung solcher Leistungen in Erwägung ziehen; dies würde nicht nur die Kosten für den Staat senken, sondern auch die Effizienz bei der Erstellung dieser Leistungen steigern. Die Arbeit kommt zu dem Schluss, dass das größte Problem der Innovationspolitik in Mazedonien darin besteht, dass es sie gar nicht gibt, und zwar nicht als Folge einer bewussten Entscheidung darüber. Tatsächlich müssen Ressourcen und Zeit für die Schaffung eines nationalen Innovationssystems eingesetzt werden mit Hilfe einer Politik, die sich auf die wesentlichen Umrisse konzentriert, wobei die Nachfrage nach Technologie im Unternehmensbereich gesteigert wird und das Wissen und das Informationsangebot restrukturiert wird. Dieses System muss offen sein, unter beständigem Verbesserungsdruck stehen und fähig sein, sich an Veränderungen anzupassen. Damit eine solche Politik erfolgreich ist, muss es einen Konsens darüber zwischen allen beteiligten Akteuren geben und darüber hinaus auch eine Kohärenz zwischen den verschiedenen politischen Institutionen. Das ist deswegen wichtig, weil der Innovationsprozess komplex ist und verschiedene Politikbereiche berührt. Ziel sollte die Schaffung eines Systems sein, das einerseits auf Autonomie und Kooperation aufbaut, andererseits aber auch Wettbewerb zwischen den beteiligten Institutionen und Organisationen fördert. Eine wichtige Bedingung für ein positives Investitionsklima im Bereich der Innovation ist die Erreichung von makroökonomischer Stabilität. Die gegenwärtige Situation ist gekennzeichnet durch Instabilität des Rechtswesens, durch Korruption und Probleme des Vertragsschutzes, die sowohl ausländische als auch inländische Akteure davon abhält, sich in wirtschaftlichen Aktivitäten in Mazedonien zu engagieren. Bei der Suche nach einem Ausweg aus diesen Problemen ist es wichtig für Mazedonien, von anderen Ländern wie Slowenien zu lernen, die ähnliche Probleme haben, aber auch schon Erfahrungen in der Problemlösung. Man muss dabei beachten, dass der Entwicklungsstand, das wirtschaftliche und das politische Umfeld in beiden Vergleichsländern sich erheblich unterscheiden, so dass die Lektionen, die Mazedonien von Slowenien lernen könnte, nicht direkt übertragen und kopiert werden können, sondern entsprechend angepasst werden müssen. Die vorliegende Arbeit liefert Einsichten in die Probleme der Innovationspolitik in Transformationsländern und liefert daher sowohl einen Anreiz als auch eine Quelle von Informationen für künftige Analysen der wirtschaftlichen Bedingungen und vor allem Innovationspolitik in Transformationsländern.

The world innovation landscape: Asia rising? Bruegel Policy Contribution 2013/02, February 2013

Highlights • Research and development spending has risen rapidly in Asia, particularly in China, which is now the world’s second R&D spender behind the United States.The increase in Korean and Chinese patent applications has been even more rapid, but Chinese patenting for exploitation on the main markets for innovation(the European Union, Japan and the US) is still marginal. • Asia's increased innovation spending is most prominently related to information and communication technologies. Overall, the Chinese and Korean economies are still not specialised in knowledge-intensive goods and services.Furthermore, China in particular is not (so far) capturing much value from its role as a manufacturer and exporter of high-tech goods; China remains mostly an assembler of goods, the value of which is created elsewhere. • It would be wrong to ignore China's innovation potential on the basis of its current performance. Its clear innovation ambitions are likely to drive its future growth. • Europe is struggling much more than the US to retain its place at the global innovation table. The EU should use Asia’s capacity building in innovation as an opportunity for value capture.

Towards a New (European Research) Deal: The Case for Enhanced Fiscal Policy Coordination on Research and Innovation. Bruges European Economic Policy (BEEP) Briefing 20/2008

The paper reviews the evolution of research and innovation in the EU and assesses how current policies and programmes have influenced the development of Europe's research landscape. Based on existing literature, evaluation reports and practice, the paper critically examines the effectiveness of current European research funding instruments in a context of open innovation and in the presence of global spillovers. It therefore develops a subsidiarity test to assess whether current rationales still prove sufficient to justify policy intervention in this area. The paper sheds light on how to improve the effectiveness of EU action by enriching it by the use of coordinated fiscal policy for research funding. This will constitute an incentive to genuine bottom-up research, development and innovation (R&D&I) and a stimulus to local investments in innovation. The paper also assesses the potentials of a reinforced open method of coordination as well as a review of state aid law in the field of research funding in the EU.

Towards better health outcomes - What role for pharmaceutical innovation? EPC Policy Brief, 10 December 2015

From the current refugee crisis to ageing populations, and from rising healthcare prices to patients’ rising expectations: demands on European health systems continue to increase. Delivering health efficiently and ensuring the long-term sustainability of healthcare in the face of reduced public budgets requires new thinking – and there is a role for pharmaceuticals as well. Building on the series of discussions organised under Transformations, this Policy Brief focuses on the specific role of medicines and pharmaceutical innovation in improving health outcomes. It considers the state of play of drug innovation, from the development to the deployment of medicines, and the measures needed to make it deliver more for society and the economy, while ensuring that patients in Europe can have access to innovative and safe solutions.

The European Union’s growing innovation divide. Bruegel Policy Contribution Issue 2016/08 April 2016

There is a significant divide between the European Union countries with the greatest capacity to innovate, and those with the least capacity to innovate. The difficult convergence process has been proceeding only very slowly and unevenly, and more recently seems to have come to a halt. A particular weak spot for the EU is corporate investment in research; in this area, the intra-EU divide is growing. As the business sector is responsible for the persistent R&D intensity gap between the EU and the United States and Asia, the persistent failure of lagging EU countries to catch up in this area provides much of the explanation for the EU’s weak performance compared to other economies. The evidence shows that the deployment of public budgets and the mix of policies employed by EU member states have tended to aggravate the intra-EU divide. The EU needs to better understand its growing internal innovation divide if it is to achieve its ambition of becoming a world innovation leader.

A sociolinguistic approach to applied epistemology: Examining technocratic values in global 'knowledge' policy

This special issue presents an excellent opportunity to study applied epistemology in public policy. This is an important task because the arena of public policy is the social domain in which macro conditions for ‘knowledge work’ and ‘knowledge industries’ are defined and created. We argue that knowledge-related public policy has become overly concerned with creating the politico-economic parameters for the commodification of knowledge. Our policy scope is broader than that of Fuller (1988), who emphasizes the need for a social epistemology of science policy. We extend our focus to a range of policy documents that include communications, science, education and innovation policy (collectively called knowledge-related public policy in acknowledgement of the fact that there is no defined policy silo called ‘knowledge policy’), all of which are central to policy concerned with the ‘knowledge economy’ (Rooney and Mandeville, 1998). However, what we will show here is that, as Fuller (1995) argues, ‘knowledge societies’ are not industrial societies permeated by knowledge, but that knowledge societies are permeated by industrial values. Our analysis is informed by an autopoietic perspective. Methodologically, we approach it from a sociolinguistic position that acknowledges the centrality of language to human societies (Graham, 2000). Here, what we call ‘knowledge’ is posited as a social and cognitive relationship between persons operating on and within multiple social and non-social (or, crudely, ‘physical’) environments. Moreover, knowing, we argue, is a sociolinguistically constituted process. Further, we emphasize that the evaluative dimension of language is most salient for analysing contemporary policy discourses about the commercialization of epistemology (Graham, in press). Finally, we provide a discourse analysis of a sample of exemplary texts drawn from a 1.3 million-word corpus of knowledge-related public policy documents that we compiled from local, state, national and supranational legislatures throughout the industrialized world. Our analysis exemplifies a propensity in policy for resorting to technocratic, instrumentalist and anti-intellectual views of knowledge in policy. We argue that what underpins these patterns is a commodity-based conceptualization of knowledge, which is underpinned by an axiology of narrowly economic imperatives at odds with the very nature of knowledge. The commodity view of knowledge, therefore, is flawed in its ignorance of the social systemic properties of ��knowing’.

Space: Irrealis objects in technology policy and their role in a new political economy

In this article, I show how new spaces are being prefigured for colonization in new economy policy discourses. Drawing on a corpus of 1.3 million words collected from legislatures throughout the world, I show the role of policy language in creating the foundations of an emergent form of political economy: The analysis is informed by principles from critical discourse analysis (CDA), classical political economy and critical media studies. It foregrounds a functional aspect of language called process metaphor to show how aspects of human activity are prefigured for mass commodification by the manipulation of realis and irrealis spaces. I also show how the fundamental element of any new political economy, the property element, is being largely ignored. Current moves to create a privately owned global space, which is as concrete as landed property - namely, the electromagnetic spectrum - has significant ramifications for the future of social relations in any global knowledge economy.

Innovation in Queensland firms: implications for the smart State

The challenges in the business environment are forcing Australian firms to be innovative in all their efforts to serve customers. Reflecting this need there have been several innovation policy statements both at Federal and State government level aimed at encouraging innovation in Australian industry. In particular, the innovation policy statement launched by the Queensland government in the year 2000 primarily intends building a Sman State through innovation. During the last few decades the Australian government policy on innovation has emphasized support for industry R&D. However industry stakeholders demand a more firm-focused policy of innovation. Government efforts in this direction have been hindered by a lack of a consistent body of knowledge on innovation at the firm level. In particular the Australian literature focusing on firm level antecedents of innovation is limited and fragmented. This study examines the role of learning capabilities in innovation and competitive advantage. Based on a survey of manufacturing firms in Queensland the study finds that both technological and non·technological innovations lead to competitive advantage. The findings contribute to the theory competitive advantage and firm level antecedents of innovation. Implications for firm level innovation strategies and behaviour are discussed. In addition, the findings have important implications for Queensland government's current initiatives to build a Smart State through innovation.

Ranking Regional Innovation Policies: DEA-based Benchmarking in an European Setting

Seudullinen innovaatio on monimutkainen ilmiö, joka usein sijaitsee paikallisten toimijoiden keskinäisen vuorovaikutuksen kentässä. Täten sitä on perinteisesti pidetty vaikeasti mitattavana ilmiönä. Työssä sovellettiin Data Envelopment Analysis menetelmää, joka on osoittautunut aiemmin menestyksekkääksi tapauksissa, joissa mitattavien syötteiden ja tuotteiden väliset suhteet eivät ole olleet ilmeisiä. Työssä luotiin konseptuaalinen malli seudullisen innovaation syötteistä ja tuotteista, jonka perusteella valittiin 12 tilastollisen muuttujan mittaristo. Käyttäen Eurostat:ia datalähteenä, lähdedata kahdeksaan muuttujsta saatiin seudullisella tasolla, sekä mittaristoa täydennettiin yhdellä kansallisella muuttujalla. Arviointi suoritettiin lopulta 45 eurooppalaiselle seudulle. Tutkimuksen painopiste oli arvioida DEA-menetelmän soveltuvuutta innovaatiojärjestelmän mittaamiseen, sillä menetelmää ei ole aiemmin sovellettu vastaavassa tapauksessa. Ensimmäiset tulokset osoittivat ylipäätään liiallisen korkeita tehokkuuslukuja. Korjaustoimenpiteitä erottelutarkkuuden parantamiseksi esiteltiin ja sovellettiin, jonka jälkeen saatiin realistisempia tuloksia ja ranking-lista arvioitavista seuduista. DEA-menetelmän todettiin olevan tehokas ja kiinnostava työkalu arviointikäytäntöjen ja innovaatiopolitiikan kehittämiseen, sikäli kun datan saatavuusongelmat saadaan ratkaistua sekä itse mallia tarkennettua.

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.

Influence of Institutional Environment on Companies’ Innovation Activity

At the time of moving towards knowledge-based economy, countries pay much attention to innovations by making them a central issue in countries’ innovation policy development. Innovations are influenced much by the institutional environment, in which they are created. That is why exploration of National Innovation Systems, as an important part of such an environment, became central in works of different researchers all over the world.

Creating possibilities for collective creativity : Brokerage Functions in Practice-Based Innovation

In the network era, creative achievements like innovations are more and more often created in interaction among different actors. The complexity of today‘s problems transcends the individual human mind, requiring not only individual but also collective creativity. In collective creativity, it is impossible to trace the source of new ideas to an individual. Instead, creative activity emerges from the collaboration and contribution of many individuals, thereby blurring the contribution of specific individuals in creating ideas. Collective creativity is often associated with diversity of knowledge, skills, experiences and perspectives. Collaboration between diverse actors thus triggers creativity and gives possibilities for collective creativity. This dissertation investigates collective creativity in the context of practice-based innovation. Practice-based innovation processes are triggered by problem setting in a practical context and conducted in non-linear processes utilising scientific and practical knowledge production and creation in cross-disciplinary innovation networks. In these networks diversity or distances between innovation actors are essential. Innovation potential may be found in exploiting different kinds of distances. This dissertation presents different kinds of distances, such as cognitive, functional and organisational which could be considered as sources of creativity and thus innovation. However, formation and functioning of these kinds of innovation networks can be problematic. Distances between innovating actors may be so great that a special interpretation function is needed – that is, brokerage. This dissertation defines factors that enhance collective creativity in practice-based innovation and especially in the fuzzy front end phase of innovation processes. The first objective of this dissertation is to study individual and collective creativity at the employee level and identify those factors that support individual and collective creativity in the organisation. The second objective is to study how organisations use external knowledge to support collective creativity in their innovation processes in open multi-actor innovation. The third objective is to define how brokerage functions create possibilities for collective creativity especially in the context of practice-based innovation. The research objectives have been studied through five substudies using a case-study strategy. Each substudy highlights various aspects of creativity and collective creativity. The empirical data consist of materials from innovation projects arranged in the Lahti region, Finland, or materials from the development of innovation methods in the Lahti region. The Lahti region has been chosen as the research context because the innovation policy of the region emphasises especially the promotion of practice-based innovations. The results of this dissertation indicate that all possibilities of collective creativity are not utilised in internal operations of organisations. The dissertation introduces several factors that could support collective creativity in organisations. However, creativity as a social construct is understood and experienced differently in different organisations, and these differences should be taken into account when supporting creativity in organisations. The increasing complexity of most potential innovations requires collaborative creative efforts that often exceed the boundaries of the organisation and call for the involvement of external expertise. In practice-based innovation different distances are considered as sources of creativity. This dissertation gives practical implications on how it is possible to exploit different kinds of distances knowingly. It underlines especially the importance of brokerage functions in open, practice-based innovation in order to create possibilities for collective creativity. As a contribution of this dissertation, a model of brokerage functions in practice-based innovation is formulated. According to the model, the results and success of brokerage functions are based on the context of brokerage as well as the roles, tasks, skills and capabilities of brokers. The brokerage functions in practice-based innovation are also possible to divide into social and cognitive brokerage.

The Role of Universities in the Triple Helix model of innovation management within the biotechnology industry, Case example: Turku Science Park Network

Biotechnology has been recognized as the key strategic technology for industrial growth. The industry is heavily dependent on basic research. Finland continues to rank in the top 10 of Europe's most innovative countries in terms of tax-policy, education system, infrastructure and the number of patents issued. Regardless of the excellent statistical results, the output of this innovativeness is below acceptable. Research on the issues hindering the output creation has already been done and the identifiable weaknesses in the Finland's National Innovation system are the non-existent growth of entrepreneurship and the missing internationalization. Finland is proven to have all the enablers of the innovation policy tools, but is lacking the incentives and rewards to push the enablers, such as knowledge and human capital, forward. Science Parks are the biggest operator in research institutes in the Finnish Science and Technology system. They exist with the purpose of speeding up the commercialization process of biotechnology innovations which usually include technological uncertainty, technical inexperience, business inexperience and high technology cost. Innovation management only internally is a rather historic approach, current trend drives towards open innovation model with strong triple helix linkages. The evident problems in the innovation management within the biotechnology industry are examined through a case study approach including analysis of the semi-structured interviews which included biotechnology and business expertise from Turku School of Economics. The results from the interviews supported the theoretical implications as well as conclusions derived from the pilot survey, which focused on the companies inside Turku Science Park network. One major issue that the Finland's National innovation system is struggling with is the fact that it is technology driven, not business pulled. Another problem is the university evaluation scale which focuses more on number of graduates and short-term factors, when it should put more emphasis on the cooperation success in the long-term, such as the triple helix connections with interaction and knowledge distribution. The results of this thesis indicated that there is indeed requirement for some structural changes in the Finland's National innovation system and innovation policy in order to generate successful biotechnology companies and innovation output. There is lack of joint output and scales of success, lack of people with experience, lack of language skills, lack of business knowledge and lack of growth companies.