Recent developments in regulating the pharmaceutical business in the EU

European Business Review

Volumn 96, Issue 1, 1996, Pages 17-25

  Earl Slater, Alan ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

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EID: 84986107435     PISSN: 0955534X     EISSN: None     Source Type: Journal    
DOI: 10.1108/09555349610107032     Document Type: Review

References (56)

1. The King of Babylon, Hammurabi, around 2000 BC, penalized physicians for using drugs which damaged patients’ wellbeing. Early and still common concerns relate to the purity of the product.
2. The French pre-market requirements came about as a result of over 100 patient deaths linked allegedly to one drug in the early 1950s. Interesting then that it took a major tragedy, thalidomide, to goad many other member states’ governments to bring into place pre-market regulations even although some of the medical profession had long been calling for such a screening device, e.g. the BMA in 1880 and indeed pharmaceutical industry representative, e.g. the ABPI called, in the mid-1950s, for pre-market screening of drugs for human consumption.
3. Finland was the exception where the licence was granted indefinitely.
4. As defined per List A of annex to Directive 87/22/EEC.
5. As defined in Directive 89/381/EEC.
6. As defined per List B Annex to directive 87/22/EEC.
7. See The Official Journal for European Communities orcrip, various issues, for more detail.
8. Cecchini, P. The European Challenge, Wilwood House, Aldershot, 1988.
9. Gunning, M.I., “European focus: the European Medicines Evaluation Agency”, ESRA News and Views, Vol. 3 No. 3, pp. 8-9.
10. Hancher, L., “Competition and the European pharmaceutical market”, The Antitrust Bulletin, summer, 1992, pp. 387-428.
11. Jones, K. and Jefferys, D., “EMEA”, Health Trends, Vol. 26 No. 1, 1994, pp. 10-3.
12. Redwood, H., Price Regulation and Pharmaceutical Research: The Limits of Co-existence, Oldwicks Press, 1993.
13. Article 49, Chapter 1, Title IV Council Regulation EEC No 2309/93 of 22 July 1993.
14. According to the MCA Future Systems, [15], there is an agreement between member states and the Commission that “as far as possible. the Agency becomes self financing on the basis of industry fees alone”. he pre-1995 EU drug licensing system, administered by the Committee for Proprietary Medicinal Products, CPMP, set up in Directive 75/319/EEC, was financed by the Commission.
15. MCA, Future Systems, Medicines Control Agency, London, 1993.
16. More detail on the two routes is available from the author.
17. Legally it is difficult to see how this route can be valid given the progress towards a single market: a company can refuse to apply for market licences in other member states but then this calls into question EU Competition Law and the Single Market.
18. Artis, M.J. and Lee, N., The Economics of the European Union: Policy and Analysis, Oxford University Press, Oxford, 1994.
19. Bishop, M., Kay, J. and Mayer, C., The Regulatory Challenge, Oxford University Press, Oxford, 1995.
20. Burstall M.L., “Europe after 1992: implications for pharmaceuticals”, Health Affairs, Fall, 1991, pp. 157-71.
21. Dunleavy, P., Democracy, Bureaucracy and Public choice, Harvester Wheatsheaf, Hemel Hempstead, 1991.
22. Taggart, J., The World Pharmaceutical Industry, Routledge, New York, 1993.
23. Gatsios, K. and Seabright, P., “Regulation in the European Community”, Oxford Review of Economic Policy, Vol. 5 No. 2, 1989, pp. 37-60.
24. Helm, D. and Yarrow, G.,”The assessment”, Oxford Review of Economic Policy, Vol. 4 No. 2, 1988, pp. i - xxxi.
25. Joskow, P.L. and Rose, N.L., “The effects of economic regulation”, in Schmalense, R. and Willig R. (Eds), Handbook of Industrial Economics, MIT Press, Cambridge, MA, 1989.
26. Noll, R.G., “Economic perspectives on the politics of regulation”, in Schmalense, R. and Willig R. (Eds), Handbook of Industrial Organisation, MIT Press, Cambridge, MA, 1989.
27. Yarrow, G. (Ed.), Competition and Pricing Behaviour, MacMillan Press, London, 1996.
28. McArthur, D., EEC Pharmaceuticals After 1992: What Will and Won’t Happen, PJB Publications, Richmond Surrey, 1989.
29. Tsoukalis, L., The New European Economics, OUP, Oxford, 1994.
30. Coe, D. and Helpman, E., “International R & D Spillovers”, European Economics Review, Vol. 39 No. 5, 1995, pp. 859-88.
31. Coe, D., Helpman, E. and Hoffmaister, A., “North-South R & D Spillovers”, Centre for Economic Policy Research Discussion Paper No. 1133, February 1995.
32. Makkai, T. and Braithwaite, J., “The limits of the economic analysis of regulation”, Law and Policy, Vol. 15 No. 4, 1993, pp. 271-91.
33. See for instance, “Communication to the Council and Parliament on the outlines of an industrial policy for the pharmaceutical sector in the European Community”, Com. (93) 718 revised version 3, 23 February 1994. See also the 1993 Communication on Public Health.
34. Vickers, J., Concepts in Competition, Oxford University Press, Oxford, 1994.
35. Drummond, M.and Maynard, A., Purchasing and Providing Cost Effective Health Care, Harvester Wheatsheaf, Hemel Hempstead, 1993.
36. Abel-Smith, B.and Mossialos, E., “Cost-containment and health care reform: a study of the European Union”, LSE Health Discussion Paper 1, LSE, London, 1994.
37. Massialos, E., Ranos, C. and Abel-Smith, B., “Cost containment, pricing and financing of pharmaceuticals in the European Union”, London School of Economics, London, LSE Health, 1995.
38. Griffin, J. (Ed.), Medicines: Regulation Research and Risk, 2nd edition, Queens University Press, Belfast, 1992.
39. Walker, S. and Griffin, J.P. (Eds), International Medicines Regulations, Kluwer Academic Publishers, Dordrecht, 1989.
40. Danzon, P.M., “International drug price comparisons: uses and abuses”, draft paper, The Wharton School, University of Pennsylvania, USA, November 1993.
41. Vickers, J. and Yarrow, G., Privatisation: An Economic Analysis, MIT Press, Cambridge, MA, 1989.
42. Hawkins, K. (Ed.), Uses of Discretion, Oxford University Press, Oxford, 1992.
43. Blyth, J.W.D., “New product development in the single market”, European Business and Economic Development, Vol. 1 Part 1, July 1992, pp. 1-5.
44. Bower, D.J. and Whittacker, E., “The golden triangle: strategic trends in pharmaceutical product development”, European Business and Economic Development, Vol. 2 Part 1, July 1993, pp. 20-7.
45. Sugden, R., Industrial Economic Regulation: a Framework and Exploration, Routledge, London, 1993.
46. Irwin, D. and Klenow, P., “Learning-by-doing Spillovers in the Semi-conductor Industry”, Journal of Political Economy, December, 1994.
47. Burns, T. and Stalker, G.N., The Management of Innovation, Oxford University Press, 1994.
48. Bishop, M., Kay, J. and Mayers, Co., The Regulatory Challenge, Oxford University Press, Oxford, 1995.
49. Ogus, A.I., Regulation: Legal Form and Economic Theory, Clarendon Law Series, Clarendon Press, Oxford, 1994.
50. Earl-Slater, A., “Drug licensing: is the past a prologue?”, Oxford Health Economics Discussion Paper, Oxford, No. 44, 1996.
51. Ballance, R., Pogany, J. and Forstner, H., The World's Pharmaceutical Industries: an International Perspective on Innovation, Competition and Policy, Edward Elgar, Vermont, 1993.
52. Earl-Slater, A., “Pharmaceuticals”, in Johnson, P. (Ed.), European Industries, Edward Elgar, Aldershot, UK, 1993.
53. More accurately it is a pan-EU system as the EU does not cover all of Europe even if some would like it to and others think it does.
54. This brings in the question of patents: the EU recently ruled against Italian and British judgments to enable copies of a drug to be made available in Italy or Britain respectively because the product under patent was not“ being sufficiently worked” in Italy or Britain respectively. In the post-1995 era the relevant market for working patents will be at issue.
55. Hutton, J., Borowitz, M., Olesky, I. and Luce, B.R., “Pharmaceutical industry and reform: lessons from Europe”, Health Affairs, Summer, 1994, pp. 98-111.
56. Barr, N. 1994, Economics of the Welfare State, 2nd edition, Weidenfeld and Nicolson, London, 1994.