While the pharmaceutical industry arguably has the worst record of serious corporate crime of any industry, international law evasion rather than outright law violation has been the biggest problem in the industry. To understand how these problems can be and are being brought under control, a legal-pluralist analysis is needed that decenters criminal enforcement by the state. Consumer and professional activism and a variety of levels of self-regulation in combination with state, regional, and international regulation are all important to understanding how progress is possible. Creative work within this web of controls can actually transform lowest-common-denominator regulation into highest-common-factor regulation and self-regulation when actors are capable of thinking strategically in world-system terms.
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References
1.
1. John Braithwaite, Corporate Crime in the Pharmaceutical Industry (London: Routledge & Kegan Paul, 1984).
2.
2. Ibid., pp. 14-17.
3.
3. Ibid., pp. 11-50.
4.
4. Ibid., pp. 110-58.
5.
5. Ibid., pp. 159-203.
6.
6. Ibid., pp. 204-44.
7.
7. Ibid., pp. 279-89.
8.
8. Ibid., pp. 51-109.
9.
9. Ibid., p. 285.
10.
10. See David A. Bryan, “Consumer Safety Abroad: Dumping of Dangerous American Products Overseas,”Texas Tech Law Review, 12:435-458 (1981).
11.
11. Braithwaite, Corporate Crime in the Pharmaceutical Industry, p. 266.
12.
12. Rosemary Pierce Wall, “International Trends in New Drug Approval Regulation: The Impact of Pharmaceutical Innovation,”Rutgers Computer and Technology Law Journal, 10:129 (1984).
13.
13. Albert Reiss, Jr., “Detecting, Investigating and Regulating Business Law-Breaking,” in The Future of Regulatory Enforcement in Australia, ed. P. Grabosky and J. Braithwaite (Canberra: Australian Institute of Criminology, 1993).
14.
14. The enforcement-pyramid philosophy I am alluding to here is outlined and defended in much more detail in Ian Ayres and John Braithwaite, Responsive Regulation: Transcending the Deregulation Debate (New York: Oxford University Press, 1992), chap. 2.
15.
15. This book is tentatively titled Passing the Buck: Accountability and the Control of Corporate Crime.
16.
16. Braithwaite, Corporate Crime in the Pharmaceutical Industry, pp. 290-383.
17.
17. Wall, “International Trends in New Drug Approval Regulation,” p. 334.
18.
18. Ibid., p. 335.
19.
19. Ellen N. Cohn, “International Regulation of Pharmaceuticals: The Role of the World Health Organization,”Virginia Journal of Transnational Law, 23:331-361 (1983).
20.
Milton Silverman , Philip R. Lee, and Mia Lydecker, Prescriptions for Death (Berkeley: University of California Press, 1982).
21.
21. Marshall Clinard and Peter Yeager, Corporate Crime (New York: Free Press, 1980), pp. 119-122.
22.
22. Australian Pharmaceutical Manufacturers' Association, Code of Conduct of the Australian Pharmaceutical Manufacturers' Association Inc. (North Sydney: APMA, 1990).
23.
23. See Trade Practices Commission, Report by the Trade Practices Commission on the Self-Regulation of Promotion and Advertising of Therapeutic Goods (Canberra: Trade Practices Commission, 1992).
24.
24. R.F.W. Moulds and L.M.H. Wing, “Drug Advertising,”Medical Journal of Australia, 150:410-411 (1989).
25.
25. The IFPMA introduced a code of pharmaceutical marketing in 1981. IFPMA, IFPMA Code of Pharmaceutical Marketing Practices (Geneva: IFPMA, 1987).
26.
26. Cohn, “International Regulation of Pharmaceuticals,” p. 352.
27.
27. Andrew Chetley, A Healthy Business? World Health and the Pharmaceutical Industry (London: Zed Books, 1990), pp. 133-134.
28.
28. See Olle Hansson, Inside Ciba-Geigy (Penang: International Organization of Consumers' Unions, 1989).
29.
29. An important forum for this discussion is the periodical RAD-AR Report.
30.
30. Chetley, Healthy Business? p. 139.
31.
31. Regulatory culture includes firms, regulators, and public interest groups. I see regulatory culture as a very useful concept; see Errol Meidinger, “Regulatory Culture: A Theoretical Outline,”Law and Policy, 9:355-386 (1986).
32.
32. See Clifford Shearing, “A Constitutive Conception of Regulation,” in Future of Regulatory Enforcement in Australia, ed. Grabosky and Braithwaite.
33.
33. V. A. Wade, P. R. Mansfield, and P. J. McDonald, “Drug Company Evidence to Justify Advertising,”Lancet, Nov. 1989, pp. 1261-1264.
34.
34. Peter R. Mansfield, “Classifying Improvements to Drug Marketing and Justifications for Claims of Efficacy,”International Journal of Risk and Safety in Medicine, 2:171-184 (1991). Of course, with such data one can never be sure that the company would not have changed its marketing practices without the pressure from MLAM.
35.
35. See, for example, Robert I. Chien, Issues in Pharmaceutical Economics (Lexington, MA: Lexington Books, 1979).
36.
36. Michel Foucault, Discipline and Punish: The Birth of the Prison, trans. A. Sheridan (London: Allen Lane, 1977).
37.
37. See the enforcement-pyramid philosophy in Ayres and Braithwaite, Responsive Regulation: Transcending the Deregulation Debate, chap. 2.
38.
38. Braithwaite, Corporate Crime in the Pharmaceutical Industry.
39.
39. Michael Porter, The Competitive Advantage of Nations (London: Macmillan, 1990), p. 585.
40.
40. Ibid., p. 588.
41.
41. Ibid., pp. 648-49.
42.
42. Empirically, it is simply not the case that it is the countries with weak business regulations that are flourishing in the world economy. The toughest environmental or consumer protection legislation in the world on any given hazard will usually be found in the United States, Japan, or Germany. Porter provides an account of some of the reasons why this is the case. Australia's BHP spent a 9-figure sum during the 1980s on new doors to reduce the hazardous emissions from its coke ovens. The doors were bought from Japan. Why? Japan was the leader in tightening regulatory controls over coke oven emissions, and as a consequence it was Japanese steelmakers that developed the control technology and sold it to the rest of the world. The Japanese Energy Conservation Law of 1979 set demanding standards for energy saving in air conditioners, refrigerators, and cars, resulting in a variety of product improvements that have benefited Japan's international position. America more than Japan has historically led the world in the export of pollution-control equipment and services as a result of its tough environmental regulation. However, when certain deregulatory tendencies in the United States allowed Germany, Sweden, and Denmark to move ahead of the United States on some environmental standards, these countries increasingly came to supply world markets for the relevant technologies. Sweden led the world in regulations requiring special access and aids for handicapped persons. Consequently, Swedish companies dominate world markets in technology to aid the disabled.
43.
43. For a sophisticated discussion of the theoretical foundations for a pluralist analysis of market ordering see Shearing, “Constitutive Conception of Regulation.”
