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An international comparison of medicines regulations

  • M. N. G. Dukes
Chapter
Part of the CMR Workshop Series book series (CMRWS)

Abstract

  1. 1.

    There is very little information on the effectiveness of drag regulation which can be used when devising new and better legislation. The World Health Organization commenced the European Studies of Drug Regulation almost a decade ago in the belief that it is possible to measure the effects of regulation with some degree of objectivity.

     
  2. 2.

    The same assessment of performance should be applied to drug regulation as to any other form of control. A law should have the social effect it was intended to have and it should not have unwanted effects.

     
  3. 3.

    Any drug legislation should meet eight criteria, namely good law and regulation must be general, publicized, understandable, obeyable, stable and implemented as announced. It must not be retroactive or contradictory.

     
  4. 4.

    Drug laws must be integrated, both within themselves and externally, with economic, trade and social regulations.

     
  5. 5.

    If regulation is inadequate, society will find other ways of protecting itself. Balanced, sensible and creative measures are required to ensure that drugs do as much good as possible and as little harm.

     

Keywords

Medicine Regulation Unwanted Effect Drug Regulation Negative Criterion Fourth Sound 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. 1.
    Dukes M N G (1985). The Effects of Drug Regulation. (Lancaster: MTP Press) for WHO (Regional Office for Europe)2.Google Scholar
  2. 2.
    Dukes M N G and Swartz B (1988). Responsibility for Drug-Induced Injury. (New York, Oxford and Amsterdam: Elsevier Science Publishers)Google Scholar
  3. 3.
    Fuller L (1964). The Morality of Law. (New Haven, Conn.: Yale University Press)Google Scholar
  4. 4.
    Dukes M N G and Lunde I (1982). Review of restrictive decisions under the Australian drug regulatory system. Med. J. Austral. 1, 412–55.PubMedGoogle Scholar
  5. 5.
    Public Service Board (1987). Review of Drug Regulatory Procedures. PSB, Canberra, ACTGoogle Scholar
  6. 6.
    World Health Organization, Regional Office for Europe (1985–1988 continuing). Drug Regulation Index (4 vols). Compiled by the WHO Collaborating Centre for Drug Information and Quality Assurance, Budapest.Google Scholar
  7. 7.
    World Health Organization, Regional Office for Europe (1986). Drugs and Money (Fifth Edition). WHO, CopenhagenGoogle Scholar

Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • M. N. G. Dukes

There are no affiliations available

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