1 In relation to administrative decision-making, see Fisher, Elizabeth, Risk Regulation and Administrative Constitutionalism, (Oxford-Portland: Hart 2007)Google ScholarPubMed. On experts’ role in judicial proceedings, see Jasanoff, Sheila, Science at the bar. Law, Science and Technology in America, (Cambridge Mass; London: Harvard University Press, 1995)Google Scholar; Serre, Eric Barbier de la and Sibony, Anne-Lise, “Expert evidence before the EC Courts”, 45 CMLR (2008), pp. 941 et sqq. Google Scholar; Alemanno, Alberto, “The Dialogue Between Judges and Experts in the EU and WTO”, in Fontanelli, Filippo, Martinico, Giuseppe, Carrozza, Paolo (eds), Shaping the Rule of Law through Dialogue. International and Supranational Experiences, (Groningen: Europa Law Publishing, 2009)Google Scholar.

2 See, in similar terms, Elizabeth Fisher, supra note 1, at p. 246: “decision-making [is] a mix of expertise and democracy, science and values, and politics and knowledge. It has not been the case that there has been a stark choice to be made between ‘science’ and ‘democracy’, as all decision-making regimes encompass the two”.

3 Zei, Astrid, Tecnica e diritto, tra pubblico e privato, (Milano: Giuffre, 2008), at p. 6 Google Scholar. On the structural differences running between the legal and the scientific discourse, see Carcaterra, Gaetano, “Certezza, scienza, diritto”, 39 Rivista internazionale di filosofia del diritto (1962), pp. 377 Google Scholar et sqq.

4 Bobbio, Norberto, “La certezza del diritto è un mito?”, 29 Rivista internazionale di filosofia del diritto (1951), at p. 151 Google Scholar et sqq.

5 Nagel, Ernest, The structure of science: problems in the logic of scientific explanation, (New York; Burlingame: Harcourt, Brace & World, 1961)Google Scholar and, critically, Feyerabend, Paul K., Against method: outline of an anarchist theory of knowledge, (London: Verso, 1978)Google Scholar.

6 For an exemplification of some of the features characterising the “ingenuous” attitude of the legal sphere towards science, see Artosi, Alberto, “Reasonableness, Common sense, and Science”, in Bongiovanni, Giorgio, Sartor, Giovanni, Valentini, Chiara (eds), Reasonableness and Law, (Dordrecht: Springer, 2009), pp. 69 et sqq., at pp. 74-78CrossRefGoogle Scholar.

7 Tallacchini, Mariachiara, “Legalising Science”, in 10 Health Care Analysis (2002), pp. 329 et sqq, at p. 329CrossRefGoogle ScholarPubMed. Notable exceptions need to be mentioned as well: among these see in particular Schmitt, Carl, “The age of neutralizations and depoliticizations” (1929), in Schmitt, Carl, The concept of the ‘political’. Expanded edition, (Chicago: The University of Chicago Press, 2007), pp. 80 et sqq Google Scholar, according to whom “technology is always only an instrument and weapon; precisely because it serves all, it is not neutral. No single decision can be derived from the immanence of technology, least of all for neutrality” (at p. 91).

8 See Schepel, Harm, The constitution of private governance: product standards in the regulation of integrating markets, (Oxford: Hart, 2005)Google Scholar.

9 Hence the problems related to if and to what extent to intervene by means of regulation. On the tension between self-organisation and the government of purpose, in relation to science and technology, see Borrás, Susana, “Three tensions in the governance of science and technology”, in Levi-Faur, David (ed.), Oxford handbook of governance, (Oxford: Oxford University Press, 2012), at pp. 431 et sqq Google Scholar. The Author highlights how such an arrangement is currently being put under pressure by the “changing societal expectations about the role of science in society. The traditional ‘social contract for science’ is based on an unveiled positive view of science as an ‘ivory tower’, in the expectation that science produces reliable knowledge and communicates it to society in a one-way fashion. Dissatisfaction with the ‘ivory tower’ means that the old ‘social contract’ is giving way to a new contract, the shape of which is still not clear”. Further tensions are determined by the emergence of new kinds of governmental involvement in science and technology policy and by the issues presented by the ownership (and commodification) of technical and scientific knowledge.

10 Such shift is embodied by the co-production paradigm theorised by Sheila Jasanoff, supra note 1.

11 Elizabeth Fisher, supra note 1, at p. 23.

12 Such issues have alternatively been defined as “trans-scientific”: issues which “can be stated in the language of science but are, in principle, or in practice, unanswerable by science” (Giandomenico Majone, “Foundations of Risk Regulation: Science, Decision-Making, Policy Learning and Institutional Reform”, in 1 European Journal of Risk Regulation (2010), at pp. 5 et sqq, at p. 5.

13 For example, when it comes to identifying the exact threshold above which carcinogenic substances have adverse effects on humans. Uncertainty can also be related to the time factor, as in cases of urgency, when a decision needs to be taken before the relevant data is available, or when it is not yet possible to fully determine the consequences related to the use of a technology (e.g. because it is still being developed).

14 Beck, Ulrich, Risk society: towards a new modernity (1986), (London: Sage, 1992)Google Scholar.

15 As Fisher, Elizabeth, supra note 1, at pp. 9–10 Google Scholar observes, “the state and its conceptual baggage”, although “much maligned, are still the starting points for conceptualising this area of decision-making. In part this has to do with the fact that it is only sovereign states that have the innate power to regulate risk …”.

16 For a typology of risk regulation strategies, see Majone, Giandomenico, supra note 12, at pp. 11 Google Scholar et sqq. Literature on the precautionary principle is extremely rich. For a comparative overview, see Zander, Joakim, The Application of the Precautionary Principle in Practice, (Cambridge: Cambridge University Press, 2010)CrossRefGoogle Scholar; for an influential critique Sunstein, Cass R., Laws of Fear. Beyond the Precautionary Principle, (Cambridge: Cambridge University Press, 2005)CrossRefGoogle Scholar.

17 See for example Everson, Michelle, Vos, Ellen (eds), Uncertain Risks Regulated, (Oxon-New York: Routledge-Cavendish, 2009)Google Scholar and Weimer, Maria, “Risk Regulation and Deliberation in EU Administrative Governance – GMO Regulation and its Reform”, 5 European Law Journal (2015), at pp. 622 CrossRefGoogle Scholar et sqq.

18 Elizabeth Fisher, supra note 1, at pp. 19 et sqq.

19 Veronesi, Paolo, “Le cognizioni scientifiche nella giurisprudenza costituzionale”, 3 Quaderni Costituzionali (2009), at pp. 591 Google Scholar et sqq, at p. 604.

20 Bin, Roberto, “La Corte e la scienza”, in D’Aloia, Antonio (ed.), Bio-tecnologie e valori costituzionali. Il contributo della giurisprudenza costiutioznale, (Torino: Giappichelli, 2005), at pp. 5 Google Scholar et sqq.

21 See decision n. 114/1998 and Salmoni, Fiammetta, Le norme tecniche, (Milano: Giuffre, 2001), at pp. 98 Google Scholar et sqq. All the Constitutional court's judgments quoted are available (in Italian) on the Internet at http://www.cortecostituzionale.it.

22 See for example decisions nn. 103/1957 and 36/1954.

23 See decisions nn. 61/1997 and 21/2010.

24 Decision n. 114/1998. A similar statement can be found also in a more recent decision (n. 342/2006) concerning GMOs, where the Court allowed Parliament “a wide margin of discretion in determining the content which appears to be more appropriate to the achievement of the relevant statutory aims, so that a legislative provision can be found to be unconstitutional only when the level of uncertainty of the scientific evidence on which it is based is so significant to determine the arbitrariness or the irrationality of the provisions under review”.

25 See for example the “Environmental Code” (legislative decree n. 152 of 3 April 2006). On the precautionary principle in the Italian legal system see Butti, Luciano, The precautionary principle in environmental law, (Milano: Guiffre, 2007)Google Scholar.

26 Manfredi, Giuseppe, “Note sull’attuazione del principio di precauzione in diritto pubblico”, < Diritto pubblico (2004), at pp. 1075 Google Scholar et sqq, at p. 1101.

27 Giovanni Di Cosimo, “Corte costituzionale, bilanciamento di interessi e principio di precauzione” (Forum di Quaderni Costituzionali Rassegna, 10 March 2015), <http://www.forumcostituzionale.it/wordpress/wp-content/uploads/2015/03/dicosimo.pdf> accessed 27 January 2016.

28 Cases will not be grouped chronologically but rather following a substantial criteria. It has to be kept in mind that those analysed do not represent the entirety of the cases in which the Constitutional Court has dealt with scientifically controversial issues: for a broader overview, see Ainis, Michele, “Le questioni scientifiche controverse nella giurisprudenza costituzionale”, in D’Aloia, Antonio, supra note 18, at pp. 23 Google Scholar et sqq.

29 For an overview of the Di Bella case see Colucci, Francesco Paolo, Montali, Lorenzo, “Relevance of the Di Bella case in the relationship between people and official medicine”, 3 Epidemiologia e prevenzione (2003), at pp. 180 Google Scholar et sqq.

30 In these terms the claim filed by the Council of State to the Constitutional Court (it would violate art. 32 Const. to deny “la somministrazione gratuita di farmaci di cui siano nota una certa efficacia terapeutica a malati terminali, cui va riconosciuto il diritto a seguire una via terapeutica che ha un margine di possibile efficacia”).

31 See decree n. 23 of 17 February 1998, and law n. 94 of 8 April 1998; all the legislation quoted is available (in Italian) on the Internet at http://www.normattiva.it.

32 See decision n. 185/1995.

33 The law was then amended in order to comply with the Constitutional court's decision (decree n. 186 of 16 June 1998 and law n. 257 of 30 July 1998); having been in turn brought to the Court, the claims were dismissed (decision n. 188/2000).

34 And should therefore be granted in conditions of equality (decision n. 185/1998, at para. 9).

35 Mariachiara Tallacchini, supra note 7, at p. 331.

36 See decision n. 185/1998, at para. 8: “Questa Corte non è chiamata a pronunciarsi, in alcun modo, circa gli effetti e l’efficacia terapeutica di detto trattamento […]. Non è chiamata, né potrebbe esserlo, a sostituire il proprio giudizio alle valutazioni che, secondo legge, devono essere assunte nelle competenti sedi, consapevole com’è del rilievo che, in questa materia, hanno gli organi tecnico-scientifici”.

37 Mariachiara Tallacchini, supra note 7, at p. 332.

38 Law n. 57 of 23 May 2013, converting the decree n. 24 of 25 March 2013, which had temporarily allowed for the continuation of all those treatments which had already begun – for an overview of the “Stamina case” see Antonio Scalera, “Brevi note a margine del ‘caso Stamina’”, 10 Famiglia e diritto (2013), at pp. 939 et sqq; see also D’Amico, Giacomo, “Il volto compassionevole del diritto e la dura scientia ”, 2 Quaderni Costituzionali (2013), at pp. 420 Google Scholar et sqq. The clinical trial was not completed due to the impossibility of even considering the treatment as a therapy. The claim was dismissed by decision n. 274/2014.

39 The treatment was being supplied by the Hospital of Brescia, when an injunction adopted by the Italian Medical Agency (AIFA) prohibited its continuation due to the lack of evidence concerning the treatment's effectiveness.

40 Beyond the national boarders, see the debate on Nature, available on the Internet at http://www.nature.com/news/italian-stem-cell-trial-based-on-flawed-data-1.13329 accessed 27 January 2016.

41 On the reasons that may have brought the Court not to strike down the law see Giacomo D’Amico, “Caso ‘Stamina’: la ‘lotta per la salute’” (Forum di Quaderni Costituzionali Rassegna, 1 February 2015), http://www.forumcostituzionale.it/wordpress/wp-content/uploads/2015/01/nota_274_2014_damico.pdf accessed 27 January 2016; see also Giuliano Sereno, “Il ‘caso Stamina’ all’esame della Corte costituzionale: un esito condivisibile sorretto da una motivazione lacunosa”, (Osservatorio Costituzionale, January 2015) http://www.osservatorioaic.it/il-caso-stamina-all-esame-della-corte-costituzionale-un-esito-condivisibile-sorretto-da-una-motivazione-lacunosa.html accessed 27 January 2016.

42 The same provision was found by the European Court of Human Rights (hereinafter ECtHR) not to be in contrast with the right to health as protected by art. 8 and 14 ECHR in the case Durisotto v. Italy (application n. 62804/13), ECHR 152(2014) 28.05.2014: recalling Hristozov and others v. Bulgaria (nn. 47039/11 and 358/12, ECHR 2012) the ECtHR considered that on the one hand States enjoy a wide margin of appreciation when establishing restrictive criteria for the access to compassionate therapies (see also Evans v. United Kingdom [GC], n. 6339/05, ECHR 2007 I and S.H. and others v. Austria [GC], n. 57813/00, ECHR 2011); on the other hand that it is not for the international jurisdiction to reconsider the competent national authorities’ evaluations (i.e. technical-scientific institutions) concerning the acceptable level of risk for patients in order to have access to therapies undergoing clinical trials.

43 See decision n. 282/2002, concerning regional law (Marche) n. 26 of 13 November 2001 (on which see Elisa Cavasino, “I ‘vincoli’ alla potestà legislativa regionale in materia di “tutela della salute” tra libertà della scienza e disciplina costituzionale dei trattamenti sanitari”, Giurisprudenza Costituzionale (2002), at pp. 3282 et sqq.) and decision n. 338/2003, on regional law (Piemonte) n. 14 of 3 June 2002.

44 See the regional legislative proposal n. 5, 24 July, 2000, available on the Internet at http://www.consigliomarche.it/banche_dati_e_documentazione/iter_degli_atti/pdl/pdf/pdl5.pdf accessed 27 January 2016.

45 Para. 4, decision n. 282/2002.

46 Para. 5, decision n. 282/2002.

47 Para. 8, decision n. 282/2002.

48 Penasa, Simone, “Converging by procedures: Assisted reproductive technology regulation within the European Union”, 3-4 Medical Law International (2012), at pp. 371 Google Scholar et sqq.

49 For an overview of the content of law 40/2004 and of the legal, ethical and medical problems is presented from the outset, see Fineschi, Vittorio, Neri, Margherita, Turillazzi, Emanuela, “The new Italian law on assisted reproduction technology (Law 40/2004)”, 31 Journal of Medical Ethics (2005), at pp. 536 CrossRefGoogle Scholar et sqq, and Boggio, Andrea, “Italy enacts new law on medically assisted reproduction”, 5 Human Reproduction (2005), at pp. 1153 CrossRefGoogle Scholar et sqq.

50 At international level, the blanket-ban on pre-implantation diagnosis was found by the ECtHR to be in contrast with art. 8 ECHR in Costa and Pavan v. Italy (application n. 54270/10). See in particular paras. 68-69, where the ECtHR states that, although the provision has moral and ethical implications, on which States normally enjoy a wide margin of appreciation, what is to be decided is whether it is proportionate, in relation to the legal system as a whole (and thus also in relation to the possibility of therapeutic abortion).

51 On the ban on third-party gamete donations see also the ECtHR decision in S.H. and others v. Austria (application n. 57813/00).

52 Morrone, Andrea, Il bilanciamento nello stato costituzionale. Teoria e prassi delle tecniche di giudizio nei conflitti tra diritti e interessi costituzionali, (Torino: Giappichelli, 2014), at pp. 62 et sqq. Google Scholar

53 Penasa, Simone, “La ‘ragionevolezza scientifica’ delle leggi nella giurisprudenza costituzionale”, 4 Quaderni Costituzionali, (2009), at pp. 817 et sqq Google Scholar.

54 In the Italian constitutional context, the reasonableness principle is rooted in the principle of equality, stated in Art. 3.1 of the Constitution (“All citizens have equal social dignity and are equal before the law, without distinction of sex, race, language, religion, political opinion, personal and social conditions”). However, constitutional interpretation has read this provision so broadly to develop it according to a three-fold dimension: beyond equality and non-discrimination, reasonableness can refer to the rationality/non arbitrariness of the legislative choice or to the reasonable balancing of constitutional interests. Although the merits of the legislative choice remain excluded from the reasonableness review, the Court has not refrained from making an extensive use of the interpretative tools provided by Art 3.1 Const. For an overview of the different dimensions of the reasonableness principle, see Morrone, Andrea, “Constitutional Adjudication and the Principle of Reasonableness”, in Bongiovanni, Giorgio, Sartor, Giovanni, Valentini, Chiara (eds), Reasonableness and Law, (Dordrecht: Springer, 2009), at pp. 215 et sqq Google Scholar. It should therefore be kept in mind that the concept of reasonableness developed by the Italian constitutional court does not fully coincide with the reasonableness test, in its British (Wednesbury test) or Strasbourg (proportionality test) versions.

55 Simone Penasa, supra note 48, at p. 324. For a wider theorization of the concept of scientific reasonableness as a standard for constitutional review of medical-related legislative provisions see Simone Penasa, supra note 53.

56 Such a conclusion is suggested also by the circumstance that each of the three assumptions on which it relies can be found, separately or combined, and perhaps less explicitly formulated, in relation to issues belonging to different branches of the legal system, in particular with regard to the autonomy and importance of technical-scientific institutions. See, for example, decision n. 116/2006.

57 See, in similar terms, also decision n. 342/2006, quoted supra note 23.

58 See above, decision n. 114/1998.

59 Jasanoff, Sheila, The fifth branch. Science advisers as policymakers, (Cambridge Mass; London: Harvard University Press, 1994)Google Scholar.

60 Mariachiara Tallacchini, supra note 7, at p. 330.

61 Simone Penasa, supra note 48, at p. 308. The Author also envisages a third function: “a legitimacy one, as [expertise involvement] guarantees at least a presumption of legitimacy in favour of political decisions when checked in the light of a constitutional framework”.

62 Vos, Ellen, “The European Court of Justice in the face of scientific uncertainty and complexity”, in Dawson, Mark, De Witte, Bruno, Muir, Elise (eds), Judicial Activism at the European Court of Justice, (Cheltenham-Northhampton: Edward Elgar, 2013), at pp. 144 et sqq Google Scholar. The Author points out the changes in the European Courts’ attitude towards technical complexity, from a deferential approach to playing more active role.