The Intersection of Science, Law, and Democracy in Knowledge-Based Societies

2. Knowledge-based societies  scientific knowledge as a way to make social life (and its institutions) non-arbitrary • Law is based on, but also regulates, science • Who has the authority to establish valid science for legislation and policy decision-making? • What is the place for science in democratic societies?

3. What is STS • STS (Science & Technology Studies) perspectives  looking at science as “it is” instead of as “it should be”: • Epistemological debate on the historical (Kuhn) and then sociological turn (Bloor) in philosophy of science • Looking at how issues have been historically and concretely framed • Looking at practices, languages, actors involved, place (labs and institutions)

4. Why a STS approach to the law • The STS approach of co-production between science and law knowledge and normativity are interconnected: • Looking at science in the regulatory context (regulatory science) • Looking at the law as a place where knowledge become established

5. Science and public reason(Jasanoff 2012) • T The term public reason as I use it in this volume is not a matter of constructing principled arguments that obey universal rules of democratic deliberation (Rawls 1971). Instead, my objective, grounded in the field of science and technology studies (STS), is to ask what ruling institutions do in practice when they claim to be reasoning in the public interest. • Public reason, for me, is not the result of meeting exogenously defined criteria of logic or argument: rather, it is what emerges when states act so as to appear reasonable. Reasoning comprises the institutional practices, discourses, techniques and instruments through which modern governments claim legitimacy in an era of limitless risks—physical, political and moral. Included here as well is an inquiry into the background conditions that lead citizens of democratic states to accept policy justification as being reasonable.

6. A complete political theory of late modern democracy must include, in my view, alongside classical reflections on representation, participation, and voice, an explicit and sufficient account of the reasoning of state institutions. • Sufficiency, for these purposes, means that we have to account for reason not only theoretically, at the level of claims made on its behalf, but also empirically, as a political practice that connects the communicating state to its attentive citizens.In acting for or on behalf of citizens, governments operate with tacit understandings of what people are like, especially in their capacity to interpret facts and develop arguments. • By uncovering those presumptions, these essays speak to the construction of the political subject as a reasoning agent, not through the sciences of mind, brain and behavior, but through legal and institutional arrangements that presuppose certain ideals of human agency and autonomy.

7. Imagined democracies. Necessary Political Fictions (Ezrahi 2012) • The creative unconscious collective imagination that generates ever-changing visions of legitimate power and authority • If, in the past, political authority was grounded in fictions such as the divine right of kings, the laws of nature, historical determinism, and scientism, today the space of democratic politics is filled with multiple alternative social imaginaries of the desirable political order. • Through science, modernity aimed to establish a politics of reality, the de-theatricality of politics.

8. ...in an evolving landscape… • Opening up the black-box of regulation… • From EC to EU • From scientific certainty to uncertainty • From knowledge to innovation • From legislation to (soft) governance • From ethics to citizens’ rights • …in institutions and institutional visions: from the EEC/EC/EU, from the market to fundamental rights, • …(but also coexistence of) science policy models: science-based model, precautionary model, extended knowledge model, RRI model • …in framing knowledge in relation to the market: from the Knowledge-based society to the Innovation Union  innovation is not just new knowledge; innovators are not neutral experts, but stakeholders • …in knowledge and knowledge production: technoscientific problems not belonging to traditional disciplines; knowledge not only coming from institutional sites; technologies with speculative applications • …in thinking the role of legislation: from hard to soft law, from legislation to committees, in comparative perspective

9. From Xeno to Advanced Therapy Medicinal Products (ATMP) The use of cells,tissues, and organs from one species to another Cell therapy, gene therapy, tissue-engineering products At the forefront of regenerative medicine No direct EC regulatory history, but specific issues (GMOs, clinical experimentation, animal welfare) Direct EC/EU regulatory history through Directive 2004/23/EC and Regulation 2007/1394/EC

10. Xenotransplants

11. Advanced Therapies

12. Scientists Fabricate Rudimentary Human Livers By GINA KOLATA Published: July 3, 2013 Researchers in Japan have used human stem cells to create tiny human livers like those that arise early in fetal life. When the scientists transplanted the rudimentary livers into mice, the little organs grew, made human liver proteins, and metabolized drugs as human livers do. • 03 July 2013 Induced pluripotent stem cells are a type of pluripotent stem cell artificially derived from a non-pluripotent cell - typically an adult somatic cell - by inducing a "forced" expression of specific genes.

13. Xeno, ATMP, and the law Directive 1998/44/EC on the patentability of biotechnological inventions Prominent role of the US science and establishment of the European science European Commission Communication on the Precautionary principle (2000) Competition for the market of tissue-based products Relations between the European Communities and the Council of Europe Directive 86/609/EEC, now 2010/63/EU Competition amongst different policy models (e.g. on precaution) Directive 2001/18/EC on GMOs Action plan for Science and Society (2002) Directive 2001/20/EC on clinical trials Directive 2004/23/EC on donation of human cells and tissues; Regulation 1394/2007/EC Re-emergence of infectious diseases (SARS, H5N5) White Paper on European governance (2001): public consultation and participation TEU (Lisbon Treaty and Charter of fundamental rights of the EU, 2009)

14. Science and law co-production in Xt and ATMP Legal-scientific construction of: • objects and ontologies from animal parts to pharmaceuticals, the boundaries between humans and nonhumans (donors and sources), cell and individual, boundaries between patients/(family)close contacts/public, the US-derived notion of Xt and EU construction of ATMP and the construction of the “xeno” dimension in ATMP • rights and obligations privacy/traceability/confidentiality, lawful detention of the patient, consent to waive fundamental rights, construction of the ethical citizen-donor of tissues • risks and uncertainties reframing of boundaries between known/unknown and manageable/unmanageable, imagination about plausible and implausible potential diseases, individual v. public risk, citizens’ rights/obligations,plausible potential diseases • epistemologies epistemic subsidiarity and soft epistemic harmonization • legitimisation and sovereignty regulation/non-regulation as normalization and capacity of control, EU ethical science in Xt, construction of EC/EU ethics

15. Outline • Today: • The evolution of science policy models • European ethics and science • Regulation as a “learning process” • Monday: • The EU regulatory approach to Xenotransplants • The EU regulatory creation of ATMP • Some ongoing reflections

16. Models of Science & Policy(Funtowicz and Liberatore 2003) Modern model Precautionary model Extended participatory model Responsible research and innovation (EC 2012) Science-based policy Unproblematic scientific facts determine correct policy  “Speaking truth to power” Policy-related science Anticipating the judgment about potentially existing risks Including all relevant knowledge to allow better decision-making Including all interested actors, being “responsive” towards all outcomes Science policy

17. “Risk Assessment in the Federal Government: Managing the Process” Establishing and maintaining clear conceptual separation of risk assessment and risk management as organizational separation between science and policy “The scientific findings and policy judgments embodied in risk assessments should be explicitly distinguished from the political, economic, and technical considerations that influence the design and choice of regulatory strategies. The Red Book (NRC1983)

18. The epistemic statute of not-knowing “We do not respect ignorance enough” (Ian Hacking) The insight leading to Post-Normal Science is that in the sorts of issue-driven science ……typically facts are uncertain, values in dispute, stakes high, and decisions urgent. (Funtowicz and Ravetz ) As knowledge increases, uncertainty increases as well

19. Commission of the European CommunitiesCommunication from the Commission on the precautionary principle Brussels 2.2.2000, COM(2000)1.

20. EEA (2001)Late lessons from early warnings

21. Ethics EU “Ethics” started at the intersection of: -the rise of biotechnology -the political Europe (Maastricht Treaty 1993) Biotechnology attracts considerable public interest and debate, some of it is confused. This is important for industry as such confusion can adversely influence industrial development. The questions arising in public debate will continue to be ill-defined so long as a clear diffentiation is not made

22. Institutionalizing ethics: increasing public acceptance to achieve the single market It is desirable that the Community has an advisory structure on ethics It would enable recognized experts to participate in guiding the legislative process. Addressing the ethical challenges …will improve public understanding, hence facilitating the acceptance of biotech and ensuring a single market

23. Ethics in the EU (advice, soft/hard law) GAEIB/EGE (EC-BEPA) (1991) • incorporate ethics into the decision-making process • to identify and define the ethical issues • keeping public informed • establish European citizenship • (EGE) extending the mandate to cover all areas of the application of science and technology • preparation and implementation of Community legislation or policies. Member States • National Ethics Committees (NEC) (1990s) • Ethics committees (Dir. 2001/20/EC) EC and Member States • FP research ethics (from the Second Framework Programme,1987-1991)

24. EU ethics in biotechnology Expertised • Constructing ethics as “science of ethics” • Disconnecting ethics and citizens (ethics in the modern State was supposed to grant that citizens are “rational subjects”) Outsourcing of values • Given to Committees • As a way to de-politicize political choices Verticality • Ethics managed by Member States and the Commission • Top-down governance of ethics Subsidiarity • Strengthening national sovereignties, legitimising State-based ethics Procedural requirement • In legal documents • To speed up law

25. European Communities, 2002

26. Responsible research and innovation (RRI) (2012)

27. Horizon 2020 “This is a vision of Europe as an economy that is smart, sustainable and inclusive” (EC 2012)

28. Regulation as a “learning process” Common features • Regulation as harmonization and normalization • The rhetoric of the old and new: mantra of “regulation already exists” • Similarities and competition with other approaches (e.g. US) Main differences (more in specific sub-fields) • Biotechnology: mainstream paradigm of legislation, 2+2 Directives (ethics as advice) • Nanotechnology: too diverse to be regulated, legal analogy (REACH), definition, pieces of regulation, nanocode • Synbio: analogy law (Biotechnology), analogy ethics (nanocode?)

29. Links LCT: http://www.youtube.com/watch?v=Hlwv4VwYHQg Xeno: http://www.youtube.com/watch?v=qKJf9SsDZjw Vacanti mouse: http://www.youtube.com/watch?v=PEc7QXAjsL4