An outsider studying the processes of knowledge production and biomedical and biotechnological innovation in the United States and the European Union. Part 2: a fragmented European health research system

In this blog I am going to post a series of reflections on how a vision from the global south can be useful to improve and democratize biomedical innovation processes in the United States and Europe. In part 2, I present a study on the health research system in the EU
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Beyond the vision that anyone has about the place that the European Union (EU) has in the world, it is undeniable that the EU has a health research system whose mission would consist in principle of translating the advances of scientific knowledge into improvements to the health of the population. Health research in the EU is a complex system made up of a multiplicity of interdependent actors, such as scientists, health personnel, academic institutions, regulatory agencies, national governments, patients, social organizations, industries etc. Despite its complexity, health research in the EU is a limited adaptive system with little capacity to respond and adapt to the social and scientific challenges that arise due to a lack of coherence in the articulation between the different components of the system. In particular, we refer to a lack of policy coherence, which has been defined as "the interaction of all policies that are relevant in the given context with a view to the achievement of overriding development objectives .[1, 2]," but also to a multisectoral and multilevel fragmentation (regional, national, inter-governmental) that prevents achieving an improvement in the health of the population through scientific and technological advances.  There are processes and initiatives, which, although insufficient, point towards a possible reduction in the fragmentation of health research in the EU, such as the recent evolution of research funding priorities by the Framework Programs of the European Commission (FPs) or the initiatives aimed at the institution of a European Health Union (EHU).  However, current efforts are not enough to address the multiple dimensions of the fragmentation or lack of coherence of the region's health research system. Recently, in the context of the COVID-19 pandemic, the creation of an EHU and the establishment of a new pharmaceutical strategy for the EU, at the request of the European Parliament we carried out a detailed analysis of the multiple facets of the fragmentation of of health research, its causes and the policy options that could lead to the construction of a coherent system of health research that responds to the social and economic expectations of European and world society [3]. To carry out the study, we integrated information from various sources, including investment databases and health research expenditures, the description of the projects financed by the PFs contained in the Community Research and Development Information Service (CORDIS), interviews with experts in the operation of the different components of the research system in the EU, and analysis of planning and regulatory documents.

From my collaboration in this study, I identify four dimensions along which the EU health research system is fragmented: temporal fragmentation, geographical fragmentation, translational fragmentation and geopolitical fragmentation. Below I will present these fragmentations and the corresponding policy options that the aforementioned STOA study offers in this regard.

Temporary fragmentation

By temporal fragmentation we refer to a lack of continuity of the European strategies and policies that impact health research. In particular, from the perspective of funding for health research by the Framework Programmes, we can observe an evolution in health research priorities over the years, moving from a predominantly biomedical and clinical-therapeutic research approach to one oriented to the development and management of interventions that impact the social determinants of the disease and the quality of health services (Page 23). Although this evolution of research priorities is a very positive fact in itself, it is important to bear in mind that there is no continuity either in the calls or in the funded projects that constitute the FPs. One might think, for example, of European financing through the PFs of epidemiological studies with multi-national cohorts that require financing and support over several years, if not decades. Temporary fragmentation is also observed in the constant incorporation of new European programs and policies that increase the complexity of the health research system in the region, and without an effective articulation with existing policies.

An increase in the EU budget for long-term collaborative health research would make it possible to finance a set of health research projects that, in addition to requiring the international participation of various academic institutions, require financial support for periods of several years, some beyond seven years. years that the FPs last.

An EU platform that allows national and European agencies to coordinate and optimize the co-funding of long-term collaborative research projects, taking into account the fact that most long-term projects such as cohort studies are funded and led by national entities.

Regional fragmentation

By regional fragmentation we refer, first of all, to the unequal participation in the financing of PFs for health research between the thirteen member states that joined the EU after 2004 (EU13), the majority located in Eastern Europe, and the fifteen states members who joined the Union before that year (EU15). Secondly, we refer to the lower participation in the PFs of the EU countries that were particularly impacted by the global economic crisis of 2008. This inequality in participation among member countries can be observed not only in terms of the amount of health research funding received via FPs (Page 27), but also in terms of connectivity within international collaboration networks (Figure 3). Importantly, note that in terms of connectivity in the collaborative networks of research projects financed by the PFs, it is possible to notice a displacement from the periphery to the center by the countries of the EU15 group that were affected by the 2008 crisis, as are Greece, Ireland, Portugal and Spain in Horizon 2020, but this is not the case in the case of the EU13 countries that remain in the periphery (Pages 28 and 29). These inequalities are aggravated by the migratory processes of scientists and highly trained personnel in the health area towards the EU countries and associated countries with greater socioeconomic development, further reducing the possibilities of reducing the gap in the participation of the affected countries.

A significant increase in the EU budget for collaborative health research, particularly that which requires the participation of EU countries and those associated with a historically lower participation in PFs, would allow balancing regional inequalities while favoring a transfer of technical-scientific capacities among the participating countries.

Restructuring the European Clinical Research Infrastructure Network (ECRIN) as a central EU body with central funding would allow exploiting the potential research capacities that countries with low participation in FPs have considering the infrastructure and population of their national care systems to health.

An EU platform of financing agencies and optimization of co-financing would open opportunities for collaboration for the countries of the group with low participation in the PFs, as there is mutual knowledge among the different participants of the needs, capacities and potential offered by the different possible collaborators.

Translational fragmentation

By translational fragmentation, we refer to the lack of articulation of financing for basic, clinical, and population biomedical research that makes it possible to effectively translate scientific knowledge into pharmaceutical and health interventions that have a positive impact on the health status of the population. Translational fragmentation is related to the so-called European paradox that contrasts the global leadership of the EU in terms of generating scientific knowledge in the biomedical area with its relative inability to translate said knowledge into technological innovations to meet the health needs of the population. To understand this translational fragmentation, it is important to be clear about which entities and how they finance and perform the process of translating biomedical knowledge into health interventions in the EU. In general, basic biomedical research continues to be funded primarily by member state government agencies complemented by ERC funding that supports high-risk, high-reward scientific projects. Clinical research, particularly that oriented to the development and approval of pharmaceutical products, is financed to a great extent with private capital but also with public resources through the national health care systems. In this same sense, the last stage of the translational process consisting of the translation of health interventions (pharmaceutical and non-pharmaceutical) into improvements in the state of health and the quality of life of the population remains fundamentally in charge of the national states, in terms of its implementation and evaluation by national health care systems. Este modelo linear preponderadamente orientado a al desarrollo de productos farmacéuticos genera dos problemas severos. El primero consiste en la concentración de los esfuerzos de investigación y desarrollo farmacéutico en un pequeño conjunto de problemas de salud incrementando las tasas de deserción de proyectos y por lo tanto el desperdicio de recursos económicos. The second problem is that non-commercial clinical research aimed at meeting the health needs of the most vulnerable population and that does not necessarily go through the development of a salable pharmaceutical product in the market do not receive sufficient resources to go through the different stages. of the recognition translation process or to solve the technical requirements demanded by the current regulations.

Increasing health research opportunities in ECDC and Health Emergency Preparedness and Response (HERA) would allow for the strengthening of public funding and for strategic purposes of the last stages of the translational continuum at the EU level, that is, the translation of the efforts of research and development in health in verifiable improvements in the health of the population.

Restructuring ECRIN as a central EU body with central funding would allow the extension and coordination of clinical research efforts, adjusting them to the health needs of the population and accelerating the process of knowledge translation.

A European Health Research Council will allow a group of scientific experts with leadership and global recognition to inform the development of strategies and specific adjustments necessary to connect the supply of scientific and technological knowledge with the health needs of the population and the strategic needs of development of the region.

An even more ambitious option would be the institution of a European Health Institute that would make it possible to connect scientific research in health with the design and implementation of health policies at the regional level.

Geopolitical fragmentation

By geopolitical fragmentation, we mean that in the context of current and future global health challenges such as the COVID-19 pandemic, the emergency or re-emergence of infectious diseases, antimicrobial resistance or the impact on health of climate change, the EU has not been fully capable of offering an articulated response as a supranational community despite its enormous scientific-technological capacities. In this regard, it is important to note that funding for scientific research in general by the 27 current member states of the EU has remained practically stagnant, being surpassed by China since 2014. On the other hand, funding for health research by PFs represents less than 10 percent of public funding for health research when considering the investment of Member States. Despite being among the top three sources of funding for health research, the annual amount of FPs in the field is almost 20 times less than that exercised by the National Institutes of Health of the United States (NIH), although this difference it is reduced when we compare them in terms of scientific publications that report having been supported by one or another source.

Even more important is the lack of a scientific leadership that coordinates, integrates and monitors the financing policies for health research by the PFs. The PFs' health research priorities are defined through a consultation mechanism with experts who represent the different visions and interests of the member states, but they do not have a mechanism that allows for and sustains an integrated vision of what the EU needs in terms of knowledge and health technologies in a challenging global context. If we compare the organizational model of the EU with that of the United States in terms of health research policies, we can see how in the case of the United States, the NIH, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have a scientific leadership instituted in an executive director and a board of directors. The European Medicines Agency (EMA) and the European Center for Disease Prevention and Control (ECDC) have scientific leadership that can establish a horizontal dialogue with their American counterparts, but this is not the case in the case of the PFs health custer.

A European Health Research Council would allow, through a translational and interdisciplinary board of health experts, to have a collective health research strategy to face the present and future challenges of global health such as the current COVID-19 pandemic or the impact on global climate change health.

Both a European Health Institute and a high-level Scientific Adviser for health would allow the EU to have an effective dialogue with international actors inside and outside the EU for the joint design, implementation and evaluation of global strategies aimed at overcoming the great challenges and historical health debts worldwide.

References

1. Ashoff G. Enhancing policy coherence for development: Justification, recognition and approaches to achievement. Studies; 2005.

2. Castro CV. Systems-thinking for environmental policy coherence: Stakeholder knowledge, fuzzy logic, and causal reasoning. Environmental Science & Policy. 2022 Oct 1;136:413-27.

3. European Parliament, Directorate-General for Parliamentary Research Services, Sipido, K., Fajardo-Ortiz, D., Vercruysse, T. et al., Fostering coherence in EU health research – Strengthening EU research for better health, European Parliament, 2022, https://data.europa.eu/doi/10.2861/711150

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