Regulatory acceptance and use of 3R models: A multilevel perspective

Altex

Volumn 29, Issue 3, 2012, Pages 287-300

  Schiffelers, Marie Jeanne W A ^a   Blaauboer, Bas J ^b   Hendriksen, Coenraad F M ^c   Bakker, Wieger E ^a  

^a UTRECHT UNIVERSITY   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c UTRECHT UNIVERSITY   (Netherlands)

Author keywords

3R acceptance model; 3R models; Influencing variables; Multilevel perspective; Regulatory acceptance

Indexed keywords

ANIMAL TESTING REDUCTION; ANIMAL TESTING REFINEMENT; ANIMAL TESTING REPLACEMENT; ANIMAL WELFARE; ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; COST CONTROL; EUROPE; HUMAN; LAW SUIT; MODEL; NONHUMAN; PRODUCT SAFETY; RISK MANAGEMENT; RISK REDUCTION; SOCIETY; VALIDITY;

EID: 84864618132     PISSN: 1868596X     EISSN: 18688551     Source Type: Journal    
DOI: 10.14573/altex.2012.3.287     Document Type: Article

References (58)

1. Abraham, J. (1995). Science, Politics and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation. London, UK: Routledge.
2. Anon. (2010). Sixth Report from the Commission to the Council and the European Parliament on the Statistics on the number of animals used for experimental and other scientific purposes in the member states of the European Union COM (2010) 511 final. Brussels, Belgium: EC.
3. Bakker, W. and van Waarden, F. (eds.) (1999). Ruimte rond regels: stijlen van regulering en beleidsuitvoering vergeleken. Amsterdam, The Netherlands: Boom.
4. Bakker, W. (2001). Sturen op de tijstroom: Onderwijs voor werkende jongeren en beleid tussen economie en ontplooiing, 1945-1995. The Netherlands: Thela Thesis.
5. Barrieu, P. and Sinclair-Desgagne, B. (2003). The paradox of precaution, Scientific series, Cirano, Centre interuniversitaire de recherché en analyse des organisations. Montreal, Canada.
6. Beck, U. (1992). The Risk Society, Towards a New Modernity. London, UK: Sage Publications Ltd.
7. Bottini, A., Alepee, A., Phillips, B., et al. (2008). Optimization of the post-validation process, the report and recommendations of ECVAM workshop 67a. ATLA 36, 353-366.
8. Breyer, S. G. (1993). Breaking the Vicious Circle: toward effective risk regulation. London, UK: Harvard University Press.
9. Bruckner, L., Cussler, K., Halder, M., et al. (2003). Three Rs approaches in the quality control of inactivated rabies vaccines. ATLA 31, 429-454.
10. Busfield, J. (2006). Pills, power, people: sociological understanding of the pharmaceutical industry. Sociology 40, 297-314.
11. Carpenter, D. (2010). Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton, USA: Princeton University Press.
12. De Bruijn, H. and Koopmans, M. (2005). Enforcing the law: Strategies used by regulates and enforcement officials. Paper ECPR. http://regulation.upf.edu/ index.php?id=budapest-2005
13. De Leeuw, W. (2004). De ethische toetsing van dierproeven: wat heeft Europa ons te bieden. In J. Swart, J. Wolters, and H. Zwart (eds.), DEC's in Discussie: de Beoordeling van Dierproeven in Nederland. Budel, The Netherlands: Damon.
14. DiMasi, J. A., Hansen, R. W., and Grabowski, H. (2003). The price of innovation: new estimates of drug development costs. J Health Econ 22, 151-185.
15. Dosi, G. (1982). Technological paradigms and technological trajectories, a suggested interpretation of the determinants and directions of technical change. Research Policy 11, 147-162
16. nd Annual Cambridge Conference on regulation, Inspection & Improvement, Cambridge. http://www.cbr.cam.ac.uk/pdf/Dupre-et-al-Paper.pdf
17. ECHA (2010). Evaluation under REACH, Progress Report 2010. ECHA-11-R-001-EN, Helsinki, Finland: European Chemicals Agency.
18. Ellemers, J. E. (1976). Veel kunnen verklaren of iets kunnen veranderen: krachtige versus manipuleerbare variabelen. Beleid en Maatschappij 3, 284.
19. EPAA (2007). Annual Conference of the EPAA. http://www.epaa.eu.com
20. European Commission (2010). Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. http://eurlex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2010:276:0033:0079:EN:PDF
21. Freriks, A., van der Meulen, B., van den Belt, H., et al. (2005). Noodzakelijk kwaad, Evaluatie Wet op de dierproeven. http://www.nvdec.nl/page8/ page1/files/Evaluatie%20WOD.pdf
22. Garthoff, B. (2005). Alternatives to animal experimentation: the regulatory background. Toxicol Appl Pharmacol 207, Suppl 2, 388-392.
23. Geels, F. and Kemp, R. (2000). Transities vanuit sociotechnisch perspectief, report for the study "Transities en Transitiemanagement" of ICIS and MERIT for the Department of Environment for the NMP-4, Okt 2000, UT, Enschede en MERIT, Maastricht. http://kemp.unu-merit.nl/pdf/geelskemp.pdf
24. Geels, F. W. (2002). Technological transitions as evolutionary configuration processes: a multi-level perspective and a case study. Research Policy 31, 1257-1274.
25. Geels, F. W. (2006). Multi-level perspective on system innovation: relevance for industrial transformation. In X. Olshoorn and A. J. Wieczorek (eds.), Understanding Industrial Transformation: Views from Different Disciplines (163-186). The Netherlands: Springer.
26. Giddens, A. (1999). Risk and responsibility. The Modern Law Review 62, 1-10.
27. Heritier, A. (2001). Regulator-regulatee interaction in the Liberalized Utilities: Access and Contract Compliance in the Rail Sector Max-Planck-Projectgruppe, Recht der Gemeinschaftsgüter, Bonn 2001/12. http://www.coll.mpg.de/publications/regulator-regulatee-interaction-liberalized- utilities
28. Hood, C., Rothstein, H., and Baldwin, R. (2001). The Government of Risk: Understanding Risk Regulation Regimes. New York, USA: Oxford University Press.
29. Hood, C. (2002). The risk game and the blame game. Government and Opposition 37, 15-37.
30. Intomart GfK (2004). Publieke opinie over dierproeven in Nederland, a study commissioned by the Dutch Society for the Protection of Animals, Hilversum, The Netherlands.
31. Jaffe, M. E. (1994). Regulation, litigation and innovation in the pharmaceutical industry: An equation for safety. In J. R. Hunziker and T. O. Jones (eds.), Product Liability and Innovation; Managing Risk in an Uncertain Environment (120-128). Washington D.C., USA: The National Academies Press.
32. Kasamatsu, T. and Kohda, K. (2006). Commentary: Balancing risks. Regul Toxicol Pharmacol 46, 100-104.
33. Kemp, R. (2010). The Dutch Energy transition approach. International Economics and Economical Policy 7, 291-316.
34. nd ed). New York, USA: Longman Pub. Group.
35. Krämer, B., Bruckner, L., Daas, A., and Milne, C. (2010). Collaborative study for validation of a serological potency assay for rabies vaccine (inactivated) for veterinary use. Pharmeur Bio Sci Notes, 37-55.
36. Krapohl, S. (2008). Risk Regulation in the Single Market; The Governance of Pharmaceuticals and Foodstuffs in the European Union. Palgrave Studies in European Union Politics, Hampshire, UK: Palgrave Macmillan.
37. Leist, M., Hartung, T., and Nicotera, P. (2008). The dawning of a new age of toxicology, ALTEX 25, 102.
38. Liebsch, M. and Spielmann, H. (2002). Currently available in vitro methods used in the regulatory toxicology. Toxicol Lett 127, 127-134.
39. Light, D. W. and Warburton, R. (2011). Demythologizing the high costs of pharmaceutical research. BioSocieties, doi:10.1057/biosoc.2010.40
40. Majone, G. (2010). Foundations of risk regulation: Science, decision-making, policy learning and institutional reform. EJRR 1, 5-19.
41. Malyshev, N. (2006). Regulatory policy: OECD experience and evidence. Oxf Rev Econ Pol 22, 274-299.
42. MacLachlan, A. (1994). The chemical industry: Risk management in Today's Product liability Environment. In J. R. Hunziker and T. O. Jones, Product Liability and innovation; Managing Risk in an Uncertain Environment. Washington DC, USA: The National Academy Press.
43. Metz, B., Hendriksen, C., Jiskoot, W., and Kersten, G. (2002). Reduction of animal use in human vaccine quality control: opportunities and problems, Vaccine 20, 2411-2430.
44. Nathans, H. (1997). Adviseren als tweede beroep, resultaat bereiken als adviseur, herziene druk. Deventer, The Netherlands: Kluwer bedrijfsinformatie.
45. NIEHS (1997). Validation and regulatory acceptance of toxicological test methods: A Report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods. NIH Publication No. 97-3981, NIEHS, USA.
46. Olson, M. K. (1997). Firm characteristics and the speed of FDA approval. JEMS 6, 377-401.
47. Richmond, J. (2002). Refinement, reduction, and replacement of animal use for regulatory testing: Future improvements and implementation within the regulatory framework. ILAR J V43, Suppl. Regulatory Testing and Animal Welfare. http://dels-old.nas.edu/ilar-n/ilarjournal/43-supp/v43supRichmond.shtml
48. Rip, A. and Kemp, R. (1996). 'Towards a Theory of Socio-Technical Change', mimeo UT, report prepared for Batelle Pacific Northwest Laboratories, Washington, D.C.
49. An edited version has been published as book chapter, 'Technological Change' in S. Rayner and E. L. Malone (eds.) (1998), Human Choice and Climate Change. An International Assessment (327-400, Vol. 2). Washington D.C., USA: Battelle Press.
50. Rudacille, D. (1999). Development of alternatives to animal use for safety testing and hazard assessment. http://www.solutions-site.org/node/84
51. Russel, W. and Burch, R. (1959). The Principles of Humane Experimental Technique. London, UK: Methuen.
52. Schiffelers, M. J. W. A., Hagelstein, G., Harreman, A., and van der Spek, M. (2005). Regulatory animal testing, Report number: P-UB-2005-10, August 2005.
53. Schiffelers, M. J. W. A, Blaauboer, B. J., Fentener van Vlissingen, J. M., et al. (2007). Factors stimulating or obstructing the implementation of the 3Rs in the regulatory process. ALTEX 24, 271-278.
54. Slovic, P., Fischhoff, B., and Lichtenstein, S. (1984). Behavioural decision theory perspectives on risk and safety. Acta Psychol 56, 183-203.
55. Spielmann, H. (2000). Would Sisyphus meet the challenges of validation from test development to global regulatory acceptance, In M. Balls, A. M. van Zeller, and M. Halder (eds.), Progress in the Reduction Refinement and Replacement of Animal Experimentation. New York, USA: Elsevier.
56. Vermeulen, P. (2011). De verankerende organisatie: Een institutioneel perspectief op veranderen en vernieuwen. Den Haag, The Netherlands: Boom Lemma Publishers.
57. Verwer, C. M, van der Ven, L. T. M., van den Bos, R., and Hendriksen, C. F. M. (2007). Effects of housing conditions on experimental outcome in a reproduction toxicity study. Regul Toxicol Pharmacol 48, 184-193.
58. Williams, P. (2002). The competent boundary spanner, Public Administration 80, 103-124.