1. Regime of knowledge production in biomedical field : multi-level multi actors policy sector

1. Is biomedical research reshaping health policy ? (case study : Belgium - Wallonia) Catherine FALLON - Université de Liège, BEIPSA Madrid 8 July 2012

2. 1. Regime of knowledge production in biomedical field : multi-level multi actors policy sector • II. The theoretical frame : • - analysing science policy through its instruments • III. Results

3. Funding public research in Wallonia • Public funded basic research is organised in universities (research/training), through : • French Community authority : • the federal state & Regions in areas defined as strategic • European funds are also praised : FP, ERC, Regional Funds • Industrial funds in universities (6.5%) • The Regime of biomedical research = a sector (relatively well defined) where a set of different actors (institutional or not) interfere; where diverse interestsare presented (private / public), characterised by sets of norms and rules which are coordinating the interactions and which the actors consider as legitimate • We consider funding schemes as"instruments of science policy".

4. Funding instruments = instruments of public policy • (Governing by instruments, Lascoumes & LeGales, 2007) • Instruments are technical : they have to fill specific functions, according to policy objectives (eg: funding research) • Instruments are social : they carry a concrete concept of the politics/society relationship, as well as meanings and representations, supporting some behaviors and privileging some actors. An instrument organizes specific social relations • ==> internal procedures for categorisation and hierarchisation (good research / bad research) • ==> identification processes  define institutional boundaries(science / non science) • ==> authority patterns  resource allocations, power relations • (who has the right to decide ?) • ==> legitimating strategy ensuring inscription in society( society giving public funds for a nice meeting in Madrid ?)

5. The construction of instruments of public policy is a translation process: • Instruments are constructed through a series of steps of translation: • coordinating heterogeneous actors (scientists, civil servants, industry) : stabilizing associations by constructing ‘obligatory passage point’, • producing representations, contributing to describe and categorize the social (eg. defining what is “good science”?) •  Conditions of emergence contribute to shape the instrument : an historic approach is necessary (path dependency) • We use tools derived from the sociology of translation (Callon,1986)with a pragmatic approach, to observe the “instruments at work”

6. What are these instruments ? • They are organized by a series of public authorities PCRD ERC E.U. Pôles Pg them IPR Pg Exc PPP Wallonia Eu funds FNRS ARC French Com PAI Federal B Old New

7. Block Grants Univ. funds Instruments are dynamic. P Ex ARC PAI Driventowards application Driven by thematics Academic Driven PPP Thema Poles FNRS PCRD ERC CompetitionBased

8. IPR’s regime : • What is an IPR ? A right (absolute) or a “favor”, whose dimensions are the outcome of a political debate ? • Differentiate the sectors ? Public health <> animal health (Pastor; IPR for pharmaceuticals are quite recent in B)

9. IPR’s regime : • Extending protection : more stress on the historical standards of brevetability (new- resulting from inventive activity – industrial application – use) ; opposition against new IPR contested as “Hunting License” : controlling the monopoly of developing further research in a field (eg. Myriad Genetic BRCA1 Breast Cancer Gene) •  European Directive 98/44/EC encountered opposition from several countries (Belgium only reached a translation in 2005) • Extending privatisation : limiting the publicness of public research outputs – the end of the “Scientific Commnons” • Ex: Bayh Dole Act (USA 1980); • Ex: Wallonia (1998) transferred the IPR to the universities and funded the implementation of “interface” bodies to foster technology transfer between university – industrial partners  a new role is given to the universities with new forms of cooperation between university research groups / biotech firms / industry

10. Coordinating the actors : • Increase of cooperation between university researchers and industry • Increase in the share of “applied research projects” under the pressure of the industrial partners • For researchers, number of patents contributes to “scientific credentials” • Increase in transaction costs between research units • Reinforcing the governing bodies in the universities (strategic management of IP portefolio as a funding scheme) • Increase of cooperation between the universities (organizing the IPR conventions in a coordinated way <> industrial partners) • Increase of competition for “reputation” between universities (<> principle of equivalence) • Limiting the intervention of public administration in the strategic management of research (ex: poles of competitiveness; IPR to universities) : • Logic of “contract” <> logic of institutional long term trust ?

11. New Spaces of coordination : • Macro level : Transversal policy making (fostering the take up of innovation in public health) • Meso level : Spaces of coordination (filled with intermediates bodies : defining the agenda (bottom up approach) and controlling the rules of engagement. In some countries there are numerous spaces (eg NL) • Micro level : translational research : “from bench to bed”. Engaging cooperation between research units and hospitals (a strategic resource); •  At all levels, we observe new forms of engagement with industrial actors and citizens (NGO’s) (eg. Callon et Rabeharisoa for Neuro muscular patients)

12. New issues ? • Political debates on the right level of “publicness” in the area of health research and public health policy • Legitimacy of public science policy when the “market filters the promise of science” in terms of social acceptability and policy efficiency (risks of early lock in when the markets prematurously control emerging networks) • Citizens / NGO’s denounce a double risk of exclusion : • - if a strong “market” frame limits the access to affordable innovation, as extension of IPR showed the risks of extension of proprietary control • - if a too loose regulatory frame increases emergence of risky externalities of the innovation process, also in public health domain •  Where are the instruments regulating those risks ? • eg. In USA a market regime is installed but new patterns of cooperation between researchers and patient associations emerge; • In France : the hospital model is embedded in an universal public health system • In Belgium : pharma companies play a very strong role in the PH system itself

13. Thank you for your attention !

14. Instrumental polyphony : • do we need stronger orchestration ? Each instrument is auto-referential (its own worldview and sensemaking): can gouvernance help confront the increase of fragmentation and manage its consequence ? Eg: fragmented “Science Policy Councils” => no aggregration French speaking Belgium : innovative instruments in the policy mix; a multi-centered polity; emerging strategic patterns Governance is a process : it legitimizes and helps build space for the confrontation of independent sub-systems  to pilot the portfolio. What is the evaluation issue to be addressed ? ? Constructing stable ties and trust Q evaluation is possible (eg. ERC) ?? Are there instruments which support change ? ??? More research on the dynamics of change in coordination modes ?

15. Interactional analysis of instruments : • three types of interaction spaces • “institutionalized markets” : funds <> quality (to be constructed) •  disciplinary boundaries  long term cooperation  Q •  hybrids (interdisciplinary or industry)  how to evaluate Q ? • “Networks” as transient organizations (PAI) • “HEI core funding” : long term funding; little reactivity. • BUT new patterns of cooperation / competition between universities • BUT new patterns of strategic management in universities

16. Tentative Conclusions … • What is governance ? (Simoulin, 2003) A dynamic reality, with • practices of coordination ( euphemizing hierarchy & power relations) • What is changing ? • New tensions in terms of forms of accountability (increase of end-users control and output driven evaluation) under the NPM mantra (agencification, deregulation, delocalisation, more competition, multi level governance) • State is an actor among the others : Private / Public frontiers are disappearing: there is a diversity of forms of cooperation between Private and Public actors • World is complex and ungovernable ==> authorities can only work through concertation and participation • New forms of communication (less hierarchical and less formal)