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Independent Scientific Advice: Comparing Policies on Conflicts of Interest in the EU and the US

Published online by Cambridge University Press:  20 January 2017

Simone Gabbi
Simone Gabbi*
Affiliation:
European Food Safety Authority
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Abstract

This article highlights the importance of unbiased scientific advice in the European Union's legal system. It then analyses and compares the policies in force throughout the European Food Safety Authority, European Medicines Agency and European Commission's Scientific Committees with the one implemented by the US Food and Drugs Administration. The author argues that at the present time the framework adopted and implemented by the European Food Safety Authority seems to be the most complete and stringent amongst those taken into account in the article and he advances some proposals for further improvement of the policies regulating conflict of interest.

Type
Articles
Information
European Journal of Risk Regulation , Volume 2 , Issue 2 , June 2011 , pp. 213 - 226
Copyright
Copyright © Cambridge University Press 2011

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References

1 Marcia Angell, “Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case” (W.W. Norton amp; Company 1997); Ashford, Nicholas A., “Implementing the Precautionary Principle: Incorporating Science, Technology, Fairness, and Accountability in Environmental, Health, and Safety Decisions”, 5 International Journal of Risk Assessment and Management (2005), pp. 112 et sqq CrossRefGoogle Scholar.

2 See Ronald Bailey, “Scrutinizing Industry-Funded Science: The Crusade Against Conflicts of Interest”, American Council on Science and Health 2008, available on the Internet at <http://www.acsh.org/publications/pubID.1687/pub_detail.asp> (last accessed on 4 April 2011); Elizabeth Williamson, “Farming Critics Fault Industry’s Influence”, Wall Street Journal, 30 April 2008, available on the Internet at <http://online.wsj.com/article/SB120951584294254683.html> (last accessed on 4 April 2011); Center for Science in the Public Interest, “Integrity in Science Watch: Groups Decry Broken Peer Review Process at EPA”, available on the Internet at <http://www.cspinet.org/integrity/watch/200709172.html#1> (last accessed on 4 April 2011); Donald G. McNeil Jr., “Gates Foundation’s Influence Criticized”, New York Times, 16 February 2008, available on the Internet at <http://www.nytimes.com/2008/02/16/science/16malaria.html> (last accessed on 4 April 2011). For an interesting analysis of media coverage on conflicts of interest see McComas, Katherine, Simone, Leah M., “Media Coverage of Conflicts of Interests in Science”, 24(4) Science Communication (2003), pp. 395 et sqq CrossRefGoogle Scholar.

3 Cohen, Deborah, Carter, Philip, “Conflicts of Interest, WHO and the Pandemic Flu ‘Conspiracies’”, BMJ (2010), pp. 340 et sqq. Google Scholar; Fiona Godlee (Editor in Chief), “Conflicts of Interest and Pandemic Flu. WHO Must Act Now to Restore its Credibility, and Europe Should Legislate”, BMJ (2010), p. 340; David Derbyshire, “Government Virus Expert Paid £ 116k by Swine Flu Vaccine Manufacturers”, Daily Mail Online, 27 July 2009, available on the Internet at <http://www.dailymail.co.uk/news/article-1202389/Government-virus-expertpaid-116k-swine-flu-vaccine-manufacturers.html> (last accessed on 4 April 2011).

4 Feldman, Robin, The Role of Science in Law (Oxford: Oxford University Press 2009), at pp. 19 et sqq CrossRefGoogle Scholar.

5 Clearly spelled out in the Commission Communication on Consumer Health and Food Safety, COM(97) 183 and more recently in the “Commission Communication on the collection and use of expertise by the Commission: Principles and Guidelines. Improving the Knowledge for Better Policies”, COM (2002) 713. Of particular relevance also the seminal judgment Case T-13/99, Pfizer Animal Health SA v. Council of the European Union, [2002] ECR Page II-03305, at para. 172. Even more explicitly, Case T-70/99, Alpharma Inc. v. Council of the European Union, [ECR] 2002 II-03495, at para. 211, found that “expert scientific advice meeting the requirements of excellence, independence and transparency is of the utmost importance in risk assessment to ensure that the regulatory measures adopted by the Community institutions have a proper scientific basis and to ensure that the institutions were in a position to examine carefully and impartially all relevant evidence in a particular case”.

6 According to Article 296 of the Treaty of the Functioning of the European Union “In carrying out their missions, the institutions, bodies, offices and agencies of the Union shall have the support of an open, efficient and independent European administration”. From the perspective of the case law of the Court of Justice, see Case C-269/90, Technische Universitaet Muenchen, [ECR] 1991 I-5469, at para. 14 and Case C-326/05P, Industrias Quimicas del Valles/Commission, [ECR] 2007 I-6557, at para. 77.

7 See Cary Coglianese, Richard J. Zeckhauser, Edward Parson, “Seeking Truth for Power: Informational Strategy and Regulatory Policy Making”, 89(2) Minnesota Law Review (December 2004), available on the Internet at <http://www-personal.umich.edu/~parson/website/pdf/parson-minnesota-law-review-1104-seeking-truth-for-power.pdf> (last accessed on 4 April 2011); Antoine Faure-Grimaud, David Martimort, “Regulatory Inertia”, in 34(3) RAND Journal of Economics; Glaeser, Edward, Shleifer, Andrei, “The Rise of the Regulatory State”, 41(2) Journal of Economic Literature (2003), pp. 401 et sqq. CrossRefGoogle Scholar; Dieter Helm, “Regulatory Reform, Capture and the Regulatory Burden”, 22 Oxford Review of Economic Policy (2006), pp. 169 et sqq.; Jean-Jacques Laffont, Jean Tirole, “The Politics of Government Decision-Making: A Theory of Regulatory Capture”, Quarterly Journal of Economics (1991), pp. 106 et sqq.; Mary K. Olson, “Regulatory Agency Discretion Among Competing Industries: Inside the FDA”, Law Econ Organ. (1995), pp. 379 et sqq.

8 The revolving door phenomenon is nothing else than one of the manners in which regulatees seek to influence their regulators, see Dieter Helm, Regulatory Reform, supra note 7, at p. 183. Just to name a concrete case, an “influenza” expert who formerly headed the World Health Organization's (WHO’s) flu program and is now vice president of influenza strategy at Novartis Vaccines and Diagnostics in Cambridge, Robert Roos, “Proposal for Prepandemic Vaccination Sparks Discussion”, available on the Internet at <http://www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/may1310stohr-jw.html> (last accessed on 4 April 2011). Regarding the problematic relationship between Departments of Defense and the defense industries, see Anne Marie Squeo, J. Lynn Lunsford, “Ethics Scandals Show Pentagon-Industry Ties Are Still Problematic”, Wall St. J. Eur., 18 December 2003, at A1; Leslie Wayne, “Pentagon Brass and Military Contractors’ Gold”, New York Times, June 29, 2004, available on the Internet at <http://www.nytimes.com/2004/06/29/business/pentagon-brass-and-military-contractors-gold.html> (last accessed on 4 April 2011); Eric Lipton, “Former Antiterror Officials Find Industry pays better”, Editorial, New York Times, 20 June 2006, available on the Internet at <http://www.nytimes.com/2006/06/18/washington/18lobby.html?_r=1> (last accessed on 4 April 2011); and Joseph Stiglitz, The Roaring Nineties (London: Penguin Books 2003), pp. 258 et sqq. Interestingly, Che, Yeon-Koo, “Revolving Doors and the Optimal Tolerance for Agency Collusion” (1995), 26(3) RAND Journal of Economics, pp. 378 et sqq. CrossRefGoogle Scholar, concludes that the presence of a revolving door between regulator and regulated undertakings can be beneficial to the public interest as regulator's efforts to enhance his industry qualifications may have a complementary effect on his regulatory performance and he may become more aggressive in regulating the market to signal his industry qualifications (thereby increasing his chance of achieving a profitable contract with the regulated entities).

9 Of particular significance is the fact that the complainant pleaded the invalidity of the output on the basis, inter alia, of the alleged breach of that agency's policy on declarations of interest with respect to a single expert of the competent Panel: Case T-74/08, Now Pharm AG v. European Commission, not yet published, at paras. 86–101.

10 This work has been finalised in October 2010.

11 See C. Demmke, M. Bovens, T. Henökl et al., “Regulating Conflicts of Interest for Holders of Public Office in the European Union. A Comparative Study of the Rules and Standards of Professional Ethics for the Holders of Public Office in the EU-27 and EU Institutions”, European Institute of Public Administration in co-operation with the Utrecht School of Governance, the University of Helsinki and the University of Vaasa, available on the Internet at <http://ec.europa.eu/dgs/policy_advisers/publications/docs/hpo_professional_ethics_en.pdf> (last accessed on 4 April 2011), at p. 132 proposes three main categories of systems distinguishing between those countries and institutions who regulate, prohibit and restrict a number of issues, require a detailed number of reporting obligations and have independent control and monitoring mechanisms in place – Model 1: restrictive approach; who regulate, prohibit and restrict a number of issues but leave room for some exceptions and have less strict control mechanisms in place – Model 2: moderate approach; – who are mostly based on voluntary approaches and rely on different forms of self-regulation and self-enforcement – Model 3: soft approach. Nonetheless, it also admits that it is difficult to classify EU institutions in any of the models proposed, see ibidem., at p. 135.

12 On this matter, see ex multis Shamoo, Adil E., Resnik, David B., Responsible Conduct of Research (Oxford-New York: Oxford University Press 2009)CrossRefGoogle Scholar.

13 For a complete and inspiring analysis of policies and rules adopted by international and national actors to guarantee the independence of their civil servants, see Mattarella, Bernardo Giorgio, Le regole dell’onesta. Etica politica, amministrazione (Bologna: Il Mulino 2007), pp. 45–74 and 131–180Google Scholar.

14 See Bekelman, J.E., Li, Y., Gross, C.P., “Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review”, JAMA (2003), pp. 454 et sqq. CrossRefGoogle Scholar; Brockway, Laura M., Furcht, Leo T., “Conflicts of Interest In Biomedical Research – The FASEB [Federation Of American Societies For Experimental Biology] Guidelines”, The FASEB Journal (2006), pp. 243 et sqq. Google ScholarPubMed; Caplan, Aruther, “Halfway There: The Struggle to Manage Conflicts of Interest”, Journal of Clinical Investigation (2007), pp. 509 et sqq. CrossRefGoogle ScholarPubMed; Sylvia Rowe, Nick Alexander, Fergus M Clydesdale et al. for the International Life Sciences Institute North America Working Group on Guiding Principles, “Funding Food Science and Nutrition Research: Financial Conflicts and Scientific Integrity”, Am J Clin Nutr (2009), pp. 1 et sqq.

15 See Conley, Joey G., “Conflict of Interest and the EPA's Science Advisory Board”, Texas Law Review (2007), pp. 165 et sqq. Google Scholar; Donald Elliott, E., “Strengthening Science's Voice at EPA”, Law and Contemporary Problems (2003), pp. 45 et sqq Google Scholar.

16 With the notable exception of the internal rules adopted by several Institutions and agencies, such as the European Central Bank, that however are of internal relevance, see, e.g., Point 4.1 of the ECB Code of conduct for the members of the Governing Council, 2002/C 123/06, according to which conflicts of interests arise where “where the members of the Governing Council have private or personal interests, which may influence or appear to influence the impartial and objective performance of their duties. Private or personal interests of the members of the Governing Council mean any potential advantage for themselves, their families, their other relatives or their circle of friends and acquaintances.”

17 There are of course several alternative definitions of the same concepts, although they do not differ substantially, see Friedman, Paul J., “The Troublesome Semantics of Conflict of Interests”, Ethics and Behaviour (1992), p. 245 et sqq. CrossRefGoogle Scholar; Katherine McComas, Leah M. Simone, “Media Coverage”, supra note 2, at p. 397; Sylvia Rowe et al., supra note 14, at p. 3, and The National Academies, “Policy on Committee Composition and Balance and Conflicts of Interest for Committees Used in the Development of Reports”, 12 May 2003, available on the Internet at <http://www.nationalacademies.org/coi/bi-coi_form-0.pdf> (last accessed on 5 April 2011).

18 Or by a close relative or person belonging to the same household of that person.

19 The definition of Col provided here is rather close to the one endorsed by The National Academies, “Policy on Committee Composition”, supra note 17, at p. 4.

20 A similar conclusion has been reached by The National Academies, “Policy on Committee Composition”, supra note 17, at p. 3.

21 The National Academies, “Policy on Committee Composition”, supra note 17, at p. 3.

22 U.S. Environmental Protection Agency, Science Advisory Board Health Committee, Review of the draft report to Congress “Characterization of date uncertainty and variability in IRIS assessment, pre-pilot vs post-pilot”, Washington DC (2000), available on the Internet at <http://www.epa.gov/sab/pdf/ehcl007.pdf> (last accessed on 5 April 2011).

23 For a comprehensive and comparative analysis of the EU/WTO framework see Alemanno, Alberto, Trade in Food: Regulatory Approaches in EU and WTO (London: Cameron May Publishing 2007)Google Scholar.

24 On the interesting subject of regulatory agencies of the European Union see Chiti, Edoardo, “Decentralised Integration as a New Model of Joint Exercise of Community Functions: A Legal Analysis of European Agencies”, 14(3) ERLP/REDP (2002), pp. 1267 et sqq. Google Scholar; Michelle Everson, Giandomenico Majone, Les Metcalfe et al., The Role of Specialised Agencies in Decentralising EU Governance, Report Presented to the Commission, available on the Internet at <http://ec.europa.eu/governance/areas/group6/contribution_en.pdf> (last accessed on 5 April 2011); Damien Geradin, Nicolas Petit, “The Development of Agencies at EU and National Levels: Conceptual Analysis and Proposals for Reform”, Yearbook of 23 European Law (2004), pp. 137 et sqq.; Majone, Giandomenico, “Delegation of Regulatory Powers in a Mixed Polity”, ELJ (2002), pp. 319 et sqq. CrossRefGoogle Scholar; Majone, Giandomenico, “The New European Agencies: Regulation by Information”, Journal of European Public Policy (1997), pp. 262 et sqq. CrossRefGoogle Scholar; Majone, Giandomenico, Regulating Europe (London: 1996)CrossRefGoogle Scholar; Martin Shapiro, “Independent Agencies, US and EU”, EUI Working Papers, RSC, n. 96/34; Mark Thatcher, “Analysing Independent Regulatory Agencies in Western Europe: Functional Pressures Mediated by Context, Swiss Political Science Review (2002), pp. 103 et sqq.; Vogel, David, The New Politics of Risk Regulation in Europe (London: Centre for Analysis of Risk and Regulation at the London School of Economics and Political Science 2001)Google Scholar, Paper; Xénophon A. Yataganas, “Delegation of Regulatory Authority in the European Union: The Relevance of the American Model of Independent Agencies”, Jean Monnet Working Paper 3/01, 2001, available on the Internet at <http://centers.law.nyu.edu/jeanmonnet/papers/01/010301.html> (last accessed on 5 April 2011).

25 For a detailed analysis of the European Food Safety Authority, see Gabbi, Simone, L’ Autorità europea per la sicurezza alimentare. Genesi, aspetti problematici e prospettive di riforma (Milano: Giuffré 2009)Google Scholar.

26 Scientific Committee on Consumer Safety (SCCS), Scientific Committee on Health and Environmental Risks (SCHER), Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Scientific Committee on Health and Environmental Risks (SCHER).

27 And to several journalists, see articles cited supra note 2 and Paul Benkimoun, “La grande truffa della ‘suina’”, La Stampa, 7/6/2010, available on the Internet at <http://www.lastampa.it/redazione/cmsSezioni/esteri/201006articoli/55702girata.asp> (last accessed on 5 April 2011).

28 The so called ENVI committee of the European Parliament (The Environment, Public Health and Food Safety Committee ) is indeed competent for environmental, public health and food safety matters and therefore also for the policies falling under the remit of EFSA, and EMA, and of the Commission's scientific committees.

29 Article 63 of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136/1, as last amended; Article 14 of the Commission Decision setting up Scientific Committees in the field of consumer safety, public health and the environment (2004/210/ EC), OJ L 66/45, as last amended, and Article 37 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ L 31/1, as last amended.

30 C. Demmke et al., “Regulating Conflicts of Interest”, supra note 11, at p. 115.

31 Hood, Christopher, “Transparency in Historical Perspective”, in Hood, Christopher, Heald, David (eds), Transparency – The Key to Better Governance? (Oxford: Oxford University Press 2006), at p. 3 CrossRefGoogle Scholar.

32 Sylvia Rowe et al., “Funding Food Science and Nutrition Research”, supra note 14, at p. 4.

33 EFSA in particular was established with the objective of creating a scientific body independent from political influence. However, it is far from being the only scientific advisory body created with that primary objective; Dieter Helm, “Regulatory Reform”, supra note 7, at p. 180.

34 See Krugman, Paul, The Return of Depression Economics and the Crisis of 2008 (New York/London: W.W. Norton Company 2009)Google Scholar and George Soros, The Crisis of Global Capitalism: Open Society Endangered (New York: Public Affairs 1998).

35 Along the same lines also IOM (Institute of Medicine), “Environmental Health Sciences Decision Making: Risk Management, Evidence And Ethics”, Workshop Summary (Washington, DC: The National Academies Press 2009), at p. 42. This notwithstanding, some important economists argue in favour of the anticyclic function of an increase in public spending during a phase of recession: Paul Krugman, The Return of Depression Economics, supra note 34.

36 Korn, David, “Conflicts of Interest in Biomedical Research”, JAMA (2000), pp. 2234 et sqq CrossRefGoogle ScholarPubMed.

37 From that stems a different problem, not linked to the subject of the present article, although probably even more important for ensuring an objective assessment of the scientific matters linked to food and feed safety (and to life sciences in general), that is how studies should be designed, by whom they should be financed, and under which conditions. On these problematic matters see Jason Juliano, “Killing Us Sweetly: How to Take Industry Out of the FDA”, Journal of Food Law and Policy, forthcoming, available on the Internet at <http://www.ssrn.com> (last accessed on 5 April 2011) offers a few interesting proposals on how to best make the FDA completely independent.

38 On 13 October 2010, EMA adopted a new Policy on Declarations of Interest, which enters into force in the 2nd quarter 2011. It should be noted that the present article is based on the rules in force in 2010, which are, however, not amended by the new Policy.

39 Article 5 of the EFSA Decision concerning the establishment and operations of the Scientific Committee, Scientific Panels and of their Working Groups, MB 17 12 09 item 7 doc 5a – Rules of procedures of SC, Panels and WG – Adopted, available on the Internet at <http://www.efsa.europa.eu/en/keydocs/docs/paneloperation.pdf> (last accessed on 5 April 2011) and EFSA implementing act to the policy on declaration of interests guidance document on declarations of interest document, pp. 6 and 7, available on the Internet at <http://www.efsa.europa.eu/en/keydocs/docs/doiguidance.pdf> (last accessed on 5 April 2011).

40 Article 14 of the Commission Decision setting up Scientific Committees in the field of consumer safety, public health and the environment (2004/210/EC), OJ L 66/45, 4.3.2004, as last amended, and Article 2 of EFSA Decision concerning the establishment and operations of the Scientific Committee, Scientific Panels and of their Working Groups, supra note 29.

41 Article 1(2) of the EFSA Decision concerning the establishment and operations of the Scientific Committee, Scientific Panels and of their Working Groups, supra note 29.

42 Article 5 of the EFSA Decision concerning the selection of members of the scientific committee, scientific panels and external experts to assist EFSA with its scientific work, available on the Internet at <http://www.efsa.europa.eu/en/keydocs/docs/paneloperation.pdf> (last accessed on 5 April 2011).

43 Differently from the food sector, the risk assessment of medicinal products is carried out in all Member States by bodies or agencies; Cuvillier, Antoine, “The Role of the European Medicines Evaluation Agency in the Harmonisation of Pharmaceutical Legislation”, in Goldberg, Richard and Lonbay, Julian (eds), Pharmaceutical Medicine, Biotechnology and European Law (Cambridge University Press 2001)Google Scholar; Gardener, John S., “The European Agency for the Evaluation of Medicines and European Regulation of Pharmaceuticals”, ELJ (1996), pp. 48 et sqq. CrossRefGoogle Scholar; Gehring, Thomas, Krapohl, Sebastian, “Supranational Regulatory Agencies Between Independence and Control: The EMEA and the Authorization of Pharmaceuticals in the European Single Market”, Journal of European Public Policy (2007), pp. 208 et sqq. CrossRefGoogle Scholar; Koutalakis, Charalambos, Wendler, Frank and Borrás, Susana, “European Agencies and Input Legitimacy: EFSA, EMEA and EPO in the Post-Delegation Phase”, 29(5) Journal of European Integration (2007), pp. 583 et sqq. Google Scholar; Vos, Ellen, Institutional Frameworks of Community Health and Safety Legislation – Committees, Agencies and Private Bodies (Oxford/Portland: Hart Publishing 1999)Google Scholar.

44 Members of its scientific committee and of the scientific panels, Article 37 of Regulation (EC) No 178/2002, supra note 29.

45 Members of EFSA networks, Article 36 of Regulation (EC) No 178/2002, supra note 29.

46 As in the case of the European Medicines Agency, see Article 63(2) of Regulation (EC) No 726/2004, supra note 29.

47 To argue the opposite would be like saying that the European Commission is responsible for the independence of Member States representatives sitting in the comitology committees. On the comitology procedures see Joerges, Christian, Vos, Ellen (eds), EU Committees: Social Regulation, Law and Politics (Oxford/Portland: Hart Publishing 1999)Google Scholar. One of the first analysis on the impact of the Lisbon Treaty on those procedures, with a particular focus on the food sector is provided by Luigi Costato, “Poteri delegati e poteri di esecuzione della Commissione U.E.: Dalla PAC al TFUE”, Rivista di diritto alimentare (Gennaio-Marzo 2010), Anno IV, numero 1.

48 Article 37 of Regulation (EC) No 178/2002, supra note 29.

49 Articles 61 and 63 of Regulation (EC) No 726/2004, supra note 29.

50 Article 15 of Commission Decision 2004/210/EC, supra note 29.

51 Under those provisions, also subjects other than scientific experts are required to submit DoIs, see Article 37 of Regulation (EC) No 178/2002, supra note 29 and Article 63 of Regulation (EC) No 726/2004, supra note 29.

52 EFSA code of conduct on declarations of interests, MB 10.3.2004 – 5.

53 EFSA Guidance on declarations of interests, MB 16.12.2004.

54 EFSA Policy on declarations of interests, MB 11.9.07 –5.2., available on the Internet at <http://www.efsa.europa.eu/en/efsawho/doi.htm> (last accessed on 5 April 2011).

55 See supra para. III.

56 EMA Procedure on the handling of conflicts of interests for EMEA scientific committees members and EMEA experts, EMEA/H/5475/04/ Rev1 Final, London, July 2006, at p. 8, available on the Internet at <http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500005216.pdf> (last accessed on 5 April 2011).

57 See Article 14 of and Rules of Procedure of the Scientific Committees on Consumer Safety, Health and Environmental Risks and Emerging and Newly Identified Health Risks, available on the Internet at <http://ec.europa.eu/health/scientific_committees/docs/rules_procedure_en.pdf> (last accessed on 5 April 2011).

58 The US FDA applies the same threshold, albeit in US dollars; see U.S. Food and Drug Administration, August 2008, Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees, available on the Internet at <http://www/fda/gov/ohrms/dockets>, at p. 8 (last accessed on 5 April 2011).

59 See supra para. III.

60 For a more detailed explanation of the differences and similarities of the two scientific bodies, and of their advisory committees, see Tai, Stephanie, “Comparing Approaches Toward Governing Scientific Bodies on Food Safety in the United States and the European Union”, 2 Wisconsin Law Review (2010), pp. 627–671 Google Scholar.

61 See, e.g., Fox, Dov, “Safety, Efficacy, and Authenticity: The Gap between Ethics and Law in FDA Decision Making”, 4 Michigan State Law Review (2005), pp. 1135 et sqq. Google Scholar; Joseph H. Golec, John A. Vernon, Randall Lutter and Clark Nardinelli, “FDA New Drug Approval Times, Prescription Drug User Fees, and R&D Spending”, AEI-Brookings Joint Center Working Paper No. 06–21 (September 2006); Grossman, Lewis A., Merrill, Richard A., and Hutt, Peter Barton, “FDA Jurisdiction: A Matter of Definitions”, in Hutt, Peter Barton, Merrill, Richard A., and Grossman, Lewis A. (eds), Food and Drug Law: Cases and Materials, 3rd ed. (New York, NY: Foundation Press 2007)Google Scholar.

62 European Parliament, “Report on alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and national courts”, Rapporteur, Manuel Medina Ortega, 1997, available on the Internet at <http://www.europarl.europa.eu/conferences/19981130/bse/a4002097_en.htm> (last accessed on 5 April 2011); Van Zwanenberg, Patrick, Millstone, Erik, “BSE: A Paradigm of Policy Failure”, 74 Political Quarterly (2003), p. 36 CrossRefGoogle Scholar; Vincent, Keith, “Mad Cows’ and Eurocrats – Community Responses to the BSE Crisis”, 10(5) European Law Journal (September 2004), pp. 499 et sqq. CrossRefGoogle Scholar; Vos, Ellen, “EU Food Safety Regulation in the Aftermath of the BSE Crisis”, Journal of Consumer Policy (2000), pp. 227 et sqq CrossRefGoogle Scholar.

63 See U.S. Food and Drug Administration, August 2008, Guidance for the Public, supra note 58.

64 See US Food and Drug Administration, August 2008, Guidance for the Public, supra note 58, at p. 7.

65 Indeed, also Stephanie Tai, “Comparing Approaches”, supra note 60, at p. 40, finds that “exceptions to the conflict of interest provisions undercut any actual impact they might have on removing biased experts”.

66 18 U.S.C. 208(b)(3) and section 712(c)(2) of the Federal Food, Drug, and Cosmetic Act. Section 712 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d-1) was added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), Pub. L. No. 110-85, sec. 701.

67 See U.S. Food and Drug Administration, August 2008, Guidance for the Public, supra note 58, at pp. 9–11.

68 Such as previous hospital employment and use/prescription of medical products for patients for advisory committee matters concerning medical products (5 CFR 2640.203(i)) and certain nonvoting representative members of FDA standing technical advisory committees; see U.S. Food and Drug Administration, August 2008, Guidance for the Public, supra note 58, at p. 15.

69 Lurie, Peter, Almeida, Cristina M., Stine, Nicholas et al., “Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings”, 295(16) JAMA (2006), pp. 1922 et sqq. CrossRefGoogle ScholarPubMed, who found that at least one conflict of interests was declared for at least one advisory committee member or voting consultant in 73% of the meetings taken into account in that study; Katherine A. McComas, Linda A. Sherman, “Conflicts of Interest and FDA Advisory Committee Meetings: A Study of Public Attitudes and Opinions”, available on the Internet at <http://www.fda.gov/oc/advisory/acstudy0904/JIFSANresearch.html> (last accessed on 5 April 2011); Steinbrook, Robert, “Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees”, 353 New England Journal of Medicine (2004), pp. 116–118 CrossRefGoogle Scholar; and Center for Science in the Public Interest, “Twisted Advice: Federal Advisory Committees Are Broken”, 2009, available on the Internet at <http://www.cspinet.org/new/pdf/twisted_advice_final_report.pdf> (last accessed on 5 April 2011); for a stark criticism of the alleged lack of independence of the FDA's advisory committees see Jason Juliano, “Killing Us Sweetly”, supra note 37.

70 See U.S. Food and Drug Administration, August 2008, Guidance for the Public, supra note 58, at p. 6 and Susan F. Wood, Kristen L. Perosino, “Increasing Transparency at the FDA: The Impact of the FDA Amendments Act of 2007”, Public Health Reports (2008), pp. 527 et sqq.

71 Menzel, Donald C., Ethics Management for Public Administrators (New York/London: 2007), at p. 15 Google Scholar.

72 See C. Demmke et al., “Regulating Conflicts of Interest”, supra note 11, at p. 115.

73 Ibid., at p. 142.

74 Although some empirical research allegedly shows that the results of the discussions at advisory committees do not have an impact on the shares of affected companies, as regards horizontal matters, Joseph H. Golec, and John A. Vernon, “What's the ‘Interest’ in FDA Drug Advisory Committee Conflicts of Interest?” (April, 24 2009), NBER Working Paper No. w14932, available on the Internet at <http://www.ssrn.com> (last accessed on 5 April). In our opinion those findings do not come as a surprise, if one considers that undertakings are affected by the opinions issued by advisory committees on regulated products, not on general matters such as guidelines and other opinions not directly linked to products.