Shifting priorities at the Health Protection Branch: Challenges to the regulatory process

Canadian Public Administration

Volumn 43, Issue 1, 2000, Pages 1-22

  Wiktorowicz, Mary E ^a  

^a UNIVERSITY OF WESTERN ONTARIO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0041713246     PISSN: 00084840     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1754-7121.2000.tb01558.x     Document Type: Article

References (62)

1. Mary Wiktorowicz, "Regulating Biotechnology: A Rational-Political Model of Policy Development" (Ph.D. diss., University of Toronto, 1995), pp. 13-19.
2. B. Purchase and R. Hirshhorn, Searching for Good Governance (Kingston: School of Policy Studies, Queen's University, 1994).
3. st Century. Carleton Public Policy Series #21 (Don Mills, Ont.: Oxford University Press Canada, 1999);
4. Kathryn McMullen, "Restructuring Government-Human Resource Issues at the Workplace Level," Working Paper (Ottawa: Canadian Policy Research Network, 1998).
5. The streamlining of the regulatory process has resulted in an increased role for external experts in product reviews, largely replacing the former internal review in several national agencies. Tom Reynolds, "European drug agency promises quicker approvals," Journal of the National Cancer Institute 87, no. 14 (19 July 1995), pp. 1050-1051.
6. Philip R. Lee and Jessica Herzstein, "International drug regulation," Annual Review of Public Health 7 (1986), pp. 217-35.
7. Leigh Hancher, Regulating for Competition: Government, Law and the Pharmaceutical Industry in the United Kingdom and France (Oxford: Clarendon Press, 1990).
8. Louis H. Orzack, Kenneth I. Kaitin and Louis Lasagna, "Pharmaceutical regulation in the European community: barriers to single market integration," Journal of Health Politics and Law 17, no. 4 (Winter 1992), pp. 847-68.
9. Canada, Commission of Inquiry on the Pharmaceutical Industry in Canada [Eastman Commission], Report (Ottawa: Supply and Services Canada, 1985).
10. Canada, Department of Health and Welfare, Working in Partnerships, Drug Review for the Future. Chaired by Denis Gagnon (Ottawa: Health and Welfare Canada, 1992).
11. Gilles Paquet and Robert Shepherd, "The Program Review Process: A Deconstruction," in Gene Swimmer, ed., How Ottawa Spends 1996-97. Life Under the Knife. Carleton Public Policy Series #18 (Ottawa: Carleton University Press, 1996), pp. 39-72.
12. Health Canada, "General Information, Roles and Responsibilities," web site 〈http:// www.hc-sc.gc〉
13. Canada, Department of Finance, Federal Budget 1998, Part 3 (Ottawa: Public Works and Government Services Canada, 1998).
14. On why regulation is often negotiation, see also G. Bruce Doern, Margaret M. Hill, Michael J. Prince and Richard J. Schultz, eds., Changing the Rules: Canadian Regulatory Regimes and Institutions (Toronto: University of Toronto Press, 1999), pp. 395-96.
15. A risk-benefit ratio assesses acceptable levels of risk and is determined by summing the number of benefits and adverse effects and by considering 1) the types of measures included; 2) how the effects are defined and quantified; and 3) the number of effects quantified and with what degree of completeness, which will vary depending on the nature of the treatment. See George Torrance, Barbara Markham, David Feeny, David Rosenbloom and Amiram Gafni, Risk-Benefit and Quality of Life Analyses of Prescription Drugs (Ottawa: Health and Welfare Canada, 1990).
16. O.M. Bakke, M. Manoccia, F. de Abjo, K.I. Kaitin and L. Lasagna, "Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: a regulatory perspective," Clinical Pharmacology & Therapeutics 58, no. 1 (July 1995), pp. 108-17;
17. Lee and Herzstein, "International drug regulation," Annual Review of Public Health, p. 219.
18. Torrance et al., Risk-Benefit and Quality of Life Analyses of Prescription Drugs, p. 4.
19. Alvin M. Weinberg, "Science and trans-science," Minerva 10, no. 1 (January 1972), pp. 209-22, at p. 209.
20. Carolyn J. Tuohy, "Regulation and scientific complexity: decision rules and processes in the occupational health area," Osgoode Hall Law Journal 20, no. 4 (December 1982), pp. 562-609, at p. 568.
21. Michael M. Atkinson and William D. Coleman, The State, Business, and Industrial Change in Canada (Toronto: University of Toronto Press, 1989), Chapter 6.
22. Michael M. Atkinson and William D. Coleman, "Corporatism and Industrial Policy," in Alan Cawson, ed., Organized Interests and the State (London: Sage Publications, 1985).
23. Robert M. Campbell and Leslie A. Pal, The Real Worlds of Canadian Politics (Peterborough, Ont.: Broadview Press, 1989);
24. Richard J. Schultz, "Winning and Losing: The Consumers' Association of Canada and the Telecommunications Regulatory System, 1973-1993," in Doem et al., Changing the Rules, pp. 174-200.
25. James Q. Wilson, The Politics of Regulation (New York: Basic Books, 1980).
26. M.J. Trebilcock, L. Waverman and J.R.S. Prichard, "Markets for Regulation," in Ontario Economic Council, ed., Government Regulation: Issues and Alternatives (Toronto: Ontario Economic Council, 1978);
27. Tuohy, "Regulation and scientific complexity," Osgood Hall Law Journal, p. 589;
28. Carolyn J. Tuohy, "Procedural rationality and regulatory decision-making: a decision framework approach," Law and Policy 7, no. 7 (July 1985), pp. 345-72.
29. B.W. Hogwood and L.A. Gunn, Policy Analysis for the Real World (London: Oxford University Press, 1984).
30. Barry M. Mitnick, The Political Economy of Regulation: Creating, Designing, and Removing Regulatory Forms (New York: Columbia University Press, 1980).
31. Donna J. Wood, Strategic Uses of Public Policy (Marshfield, Ma.: Pitman Publishing, 1986).
32. R. Noll and B. Owen, The Political Economy of Deregulation: Interest Groups in the Regulatory Process (Washington, D.C: American Enterprise, 1983).
33. Hancher, Regulating for Competition, p. 371;
34. see also the concept of "precarious pluralism" in Doern et al., Changing the Rules, pp. 398-404.
35. While only five drugs introduced from 1974 through 1983 were discontinued in the U.S., thirteen were discontinued in the U.K. (Bakke et al., "Drug safety discontinuations," Clinical Pharmacology & Therapeutics).
36. In addition, a number of drugs (including ibufenac, indoprofen, practolol, alcofenac and polidexide) that were removed from the market in the U.K. on the basis of safety were never introduced in the U.S. See William C. Bogner and Howard Thomas, "Competitive Positions of European Firms in the U.S. Pharmaceutical Market," in C. Huttin and N. Bosanquet, eds., The Prescription Drug Market (Amsterdam: North Holland, 1992), pp. 203-31.
37. Anne McIlroy, "Safety's tarnished stamp of approval," The Globe and Mail (Toronto) 18 November 1998, p. A1.
38. Peter Baume, A Question of Balance, Report of the Future of Drug Evaluation in Australia (Canberra: Commonwealth of Australia, 1991).
39. In the U.K., the Committee on the Safety of Medicines (CSM) consists of twenty-one experts in fields related to medicine and is supported by three subcommittees. While the Gagnon report recommended establishing a national advisory council on medicines as an independent expert advisory group responsible for approving or rejecting drug products, such a policy has not been implemented (Canada, Department of Health and Welfare, Working in Partnerships, Drug Review for the Future).
40. Nicholas Regush, Safety Last: The Failure of the Consumer Health Protection System in Canada (Toronto: Key Porter Books, 1993);
41. Hancher, Regulating for Competition, p. 147.
42. H.T. Stelfox, G. Chua, K. O'Rourke and A.S. Detsky, "Conflict of interest in the debate over calcium-channel antagonists," New England Journal of Medicine 338, no. 2 (8 January 1998), pp. 101-106.
43. H.T. Stelfox, G. Chua, K. O'Rourke and A.S. Detsky, "New England Journal of Medicine Ibid., p. 106.
44. Canada, Department of Health, Therapeutic Products Programme, Clinical Trial Review and Approval Process. Final Report (Ottawa: Health Canada, 1997).
45. This includes a clinical trial protocol, chemistry and manufacturing information, and prior approval by a Canadian research ethics board of the informed consent form and protocol.
46. Canada, Department of Health, Therapeutic Products Programme, Regulatory Impact Analysis Statement (Ottawa: Health Canada, 2000);
47. Canada, Department of Health, Therapeutic Products Programme, Food and Drug Regulations-Amendment (Schedule No. 1024) Clinical Tri als (22 January 2000) (Ottawa: Health Canada, 2000)
48. Canada, Department of Health, Therapeutic Products Programme, Regulatory Impact Analysis Statement, p. 11.
49. Regulatory Impact Analysis Statement, Ibid., p. 13.
50. Krista Foss, "Proposals cut drug-trial wait periods: in some cases, pharmaceutical companies could begin testing within 48 hours of application," The Globe and Mail (Toronto) 22 January 2000, p. A7.
51. Canada, Department of Health, Bureau of Drug Policy and Coordination, Policy Development in the Therapeutic Products Programme. A Guideline (Ottawa: Health Canada, 1997), pp. 18-19.
52. Steven Kelman, "Cost-benefit analysis: an ethical critique," Regulation (January/February 1981), pp. 33-40.
53. Canada, Department of Health, "General Information, Roles and Responsibilities" [web site].
54. Canada, Department of Health and Welfare, The Drugs Directorate: An Overview 1990 [Cat. H42-2/13-1991] (Ottawa: Health and Welfare Canada, 1991).
55. Given the importance of the timeliness of product reviews to manufacturers, the TPP has made access to product-specific performance information available to companies through modern-based connection. Companies may gain access to information regarding the stage at which a particular therapeutic agent is situated in the product review process, for which company security is ensured.
56. Joel Lexchin, "Secrecy and the health protection branch, Canadian Medical Association Journal 159, no. 5 (September 1998), pp. 481-83.
57. Hancher, Regulating for Competition, p. 389.
58. Henry Mintzberg, "Managing government, governing management," Harvard Business Review 74, no. 3 (May/June 1996), p. 80.
59. R.G. Mathias, "The Krever Commission and public health," Canadian Journal of Public Health 89, no. 1 (January/February 1998), pp. 6-8, 32, 52.
60. Charles Marwick, "FDA funding problems imperil safety of biological products in the United States," Journal of the American Medical Association 279, no. 12 (25 March 1998), pp. 899-901.
61. Paul Slovic, Nancy Kraus, Henner Lappe and Marilyn Major, "Risk perception of prescription drugs: report on a survey in Canada," Canadian Journal of Public Health 82, Supplement (May/ June 1991), pp. S15-S20.
62. Canadian Public Health Association, Benefit, Risk and Cost Management of Drugs: Report of the CPHA National Advisory Panel on Risk/Benefit Management of Drugs (Ottawa: CPHA, 1993), p. 13.