Trading risks for markets: the international harmonisation of pharmaceuticals regulation

被引：42

作者：

Abraham, J ^{[1
]}

Reed, T ^{[1
]}

机构：

[1] Univ Sussex, Sch Social Sci, Ctr Res Hlth & Med, Sociol Subject Grp, Brighton BN1 9SN, E Sussex, England

来源：

HEALTH RISK & SOCIETY | 2001年 / 3卷 / 01期

关键词：

drugs; pharmaceutical regulation; safety; harmonisation; drug industry; risk and globalisation;

D O I：

10.1080/713670172

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

Drawing on interviews and documentary research, this paper explores the nature of international hramonisation of pharmaceutical regulation. The relationships between international harmonisation, trade interests in market expansion and the regulatory state are examined. Particular attention is given to the implications of this harmonisation for drug safety, risk assessment and public health. It is argued that this process is lowering regulatory standards regarding drug safety and is making the regulatory state more vulnerable to capture by industrial Interests. This Is accentuated by the misrepresentation of societal and political judgements as technical calculations and a concomitant lack of public accountability.

引用

页码：113 / 128

页数：16

共 51 条

[11] 6 MONTHS BEFORE ICH2 - AN OVERVIEW ON THE HARMONIZATION OF THE GUIDELINES IN TOXICOLOGY [J].

CLAUDE, JR .

COMPARATIVE HAEMATOLOGY INTERNATIONAL, 1993, 3 (03) :174-177

[12]

DAVIS P, 1997, MANAGING MED PUBLIC

[13]

Deboyser P., 1998, P 4 INT C HARM BELF

[14]

Ferris M.J., 1992, MED REGULATION RES R

[15]

FLETCHER P, 1990, ANIMAL TOXICITY STUD

[16]

Garutti R.J., 1994, P 2 INT C HARM BELF

[17]

Giaquinto A., 1998, P 4 INT C HARM BELF

[18]

Gordon A. J., 1994, P 2 INT C HARM BELF

[19]

Guideline IHT, 1994, INT C HARM TECHN REQ

[20] The allocation of resources for R&D in the world's leading pharmaceutical companies [J].

Halliday, RG ;

Drasdo, AL ;

Lumley, CE ;

Walker, SR .

R & D MANAGEMENT, 1997, 27 (01) :63-77

← 1 2 3 4 5 6 →