Shaping the relationship of Academia, State and Industry in Health Policy: Pythagoreans’ Tetraktys application to Triple Helix model of Innovation

Getting deeper and deeper into the “parallel world” of pharmaceuticals and in my effort to locate a solution to the so-called problem of R&D sustainability which represents a great challenge for Health Policy makers, I found myself exploring the nature of capitalism and its political, economic and societal manifestations. What I discovered in the very beginning of my studies is that I cannot address the problem of trade-off between access to health and sustainability of Research and Development (R&D) without putting emphasis on the systemic interaction of this relationship. Demonstrating this relation requires a critical view of the capitalistic forces, commonly presented by notions such as markets, pharmaceutical companies, investors and their institutional reincarnations. The political, economic and societal evolution is bind to coexist with a general profit-oriented mentality and avarice appetite of markets. Nowadays, Health Policy can be located very high in the political agenda of governing parties whose role is limited chieftly by removing barriers to the free market through appropriate property policies, free trade agreements, neutral impact taxation and limited regulation of enterprises which among others raise concerns in terms of economic sustainability, political stability and societal peace. On one hand, it is the undisputable manner in which WTO treat environmental, public health and human rights protection as obstacles to trade that should be eliminated and on the other hand, are new millennia challenges which combine globalization, climate change and an unimaginably increasing ageing population let alone the moral obligations which raise the establishment of profit-oriented values transforming the old citizen into the new consumer. Companies in highly regulated pharmaceutical industry, such as health care immerge in markets characterized by a number of potential market failures such as under-investment for particular diseases, free-riding behavior concerning the use of R&D, and information asymmetry between professionals and clients on various levels. Those reasons explain the extensive regulation of the sector. The attempts to avoid the negative effects of market failures and to pursue public health goals have led to wide-ranging national policy mixes that further influence regulations of pharmaceuticals. These regulations are important to maintain incentives for R&D, to prevent unsafe products from entering the market and to help reduce costs of pharmaceuticals and medical treatment. Health care policy is often seen like navigating “between Scylla and Charybdis”. Attempts to avoid market failure may result in government failure and vice versa. In Homer’s epic poem, The Odyssey, hero Odysseus encounters danger from all manner of man, beast and nature during his decade-long voyage home after the Trojan War. During his trek, Odysseus attempts to travel through a narrow strait guarded on one side by Scylla, a hydra-headed monster, and on the other by Charybdis, a demon who continually inhaled huge quantities of water along with those floating on it. Efforts to avoid one necessarily increased the chance of being attacked by the other. Odysseus’ name means “trouble” in Greek, referring to both the giving and receiving of trouble—as is often the case in his wanderings. What really distinguishes Odysseus is his heroic trait mētis, or "cunning intelligence". Let us now assume that it is Health policy which is navigated through market and government failures. And if we go one step further away? What if humanity is navigated through market and government failure? What would be the solution if not the cunning intelligence. A situation which occurs, involving three institutional spheres- to use to meaningful and significant words to describe a ternary relation between Universitiy, Government and Industry is deemed as the center of this thesis. This relationship, commonly known, as the Triple Helix model of innovation is increasingly presented as the main source of innovation all around the world. Given its broader public health and developmental implications, access to essential medicines has become a central topic at the international policy-making level, not simply as a moral issue, but as a fundamental human rights affair. Despite myriad programs aimed at increasing access to essential medicines in the developing world, the global drug gap persists. In the case of pharmaceutical markets, a plethora of Health Policy solutions are prevented by major political and legal constrains known as Trade-Related Aspects of Intellectual Property Rights (TRIPS). Even though policies exist so as to mitigate the restrictive impact of TRIPS such as greater use of TRIPS flexibilities, advancement of human rights or even an ethical code of distribution of drugs, the cause of calamity is emerging through the current patent system and recent political and societal evolution that takes place the very moment that these lines are written. Democratic capitalism is characterized by a repeated oscillation between private and state capitalism .This perpetual shift from one form of capitalism to the other clearly expose the latter’s fatal vulnerability and as the current crisis deepens it is becoming more apparent that state intervention through increased level of transparency is vehemently needed. The real challenge though, is not merely shift to another form, as in the past but rather go beyond these two central ideologies towards what modern authors present as knowledge Based Era. Research question In my thesis I struggle to gather empirical evidence and further expand the normative framework, one that evolves the current patent system for new medicines following recent trends of innovation policy resulting from an outcome of interactions among Government, University and an internal development within pharmaceutical industry, a relationship adequately described by Triple Helix model of Innovation. While a variety of alternative schemes for patent systems have been offered such as Medical Research and Development Treaty (MRDT) and others1 , virtually all come down to great reliance on government to fund the R&D process of new drugs(DiMasi, Grabowski, 2007). The role of government was always considered as a milestone in shaping Innovation as well as Health financing policy and there is clear empirical evidence for that2. Furthermore, the pharmaceutical sector is a knowledge based manufacturing industry and is deemed as an important part of the health care sector since it is responsible for the production of vital drugs. The role of University is more than critical in shaping policies and is evolving into an institutional sphere with various potential capabilitites. Thus, the research question which occurs answers to whether the Triple Helix model of Innovation is able to improve Health Policy and promote Welfare State”. Objectives The main goal of this thesis is to establish a theoretical framework which promotes a productive social interaction between Governments, Universities and Pharmaceutical Industry. Law, politics and economy are inextricably linked in an unstoppable process of evolution. The Triple Helix of innovation will radically change not only the way we perceive production of drugs but also the general political, economic and societal reality. In this respect, the patent system is also under evolution. This thesis also demonstrates an expanded version of Triple Helix of Innovation that is based on Pythagorean Tetraktys. My work contributes to the ongoing debate of R&D sustainability as well as to the expansion of the application and theory of triple Helix model of innovation in the domain of pharmaceuticals in an effort to promote cooperative treatment of patent system between Universities, Government and Pharmaceutical Industry while simultaneously acknowledges the power of monopoly, political reality and last but not least, the right to heath. Being fully aware of the consequences which raise such a claim I will try to shed some light in the bigger arena within capitalism and its projection to the pharmaceutical sector in the form of patent rights whose purpose is to establish monopolies in order to recoup the investment done during the R&D process and therefore secure the financial sustainability and continuation of development of new drugs. Methodology The dualism between natural science and humaniaties cultures is not new. Positivism and anti-positivism have too long haunted the discussion on the fundamentals of social science and therefore social scientists are divided into camps of support for particular research techniques. On the face of this, few things are ever black and white, especially when it comes to research with an utterly interpretive component. One of the most influential method in Social Research is Grounded Theory which is ideal in generating new theory from data-as opposed to testing existing theory-and one of the most widely used and well-described methodologies in the social sciences. Grounded theory is most often derived from data sources of a qualitative (interpretive) nature. Rather than argue on the best genre of grounded theory (since essential grounded theory methods are multi-faceted) in this thesis I preferred to deploy both postmodernist and constructivist epistemological arguments in an effort to establish a theoretical framework normative in its content so as to promote a productive social interaction of Academia, State and Industry. The Grounded Theory offers a robust research design that combine a methodology which is a set of principles and ideas that inform the design of a research study with methods which are practical procedures that we use to generate and analyze data and finally with the philosophical beliefs since methodology and theoretical/philosophical foundations are inevitably related in any research endeavor. This thesis follows a qualitative analysis based on grounded theory methodology while the method used was an advanced coding and theoretical integration which provides a comprehensive explanation of a process or scheme apparent in relation to particular phenomena. Since for this research methodology data can be everything, in my effort to reach my goals, I had to employ articles whose content range wide from econometric information and political manifestations to law and philosophy in an attempt to cover the area as comprehensively as possible. Grounded theory methodology involves a process of coding. Coding refers to categorization of segments of data with a short name that simultaneously summarizes and accounts for each piece of data. The coding data were collected in relation to the concept of Triple Helix model of innovation, thus Academia, State and Industry are embedded within my hypothesis as concepts and need to be translated into researchable entities. A critical examination of existing research in Pharmaceutical industry, Welfare Stare and University took place relating to the phenomena of interest and of relevant theoretical ideas. Of fundamental importance for the first chapter which introduce the reader into the subject of my thesis were two articles: published by Wolfgang Streeck, “The Crisis in Context: Democratic Capitalism and its Contradictions” as well as “Economic Crisis from a Socialist Perspective, Socialism and Democracy” written by Marxian Economist Rick Wolff who defined and delineated the oscillation of capitalism. I believe that words coming from Sociologists and Marxian economists account for a constructive opposition to what mainstream economists or politics could argue. A variety of articles/documents about TH model of innovation and Knowledge based Economy were cited in an effort to describe adequately both notions with a focus on the original thinkers of the TH model so as to increase the validity of my arguments.