International Guiding Principles for Ethical Conduct of Clinical Trials: Implications for Generics

Abstract

As a result of intensive international debate, consultations and collaboration, a number of ethical documents and guidelines have been developed by the World Medical Association (Declaration of Helsinki), Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO Guidelines for Good Clinical Practice) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Good Clinical Practice Guideline). From May 2004, all 25 EU member states will be required to implement the legally binding EU Directive on clinical trials. In general, the ethical principles regarding clinical research are consistent in these documents; however, some have been developed more for regulatory purposes whereas others are recommendations and guiding principles. Some documents focus particularly on ethical guidance for clinical trials conducted in developing countries. Taken literally, the Declaration of Helsinki and the CIOMS Guidelines do not indisputably support the ethics of pharmacokinetic studies in which the aim is solely to demonstrate bioequivalence for commercial purposes in non-therapeutic trials. This paper reviews the evolution of ethical guidance in clinical research and discusses how the current international ethical documents advise on drug development research in the generic pharmaceuticals industry.

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References

The World Medical Association (WMA) (2000) Declaration of Helsinki, available at http://www.wma.net.

World Health Organization (WHO) (1995) ‘Guidelines for good clinical practice (GCP) for trials on pharmaceutical products’, WHO Technical Report Series, No. 850, Geneva, pp. 97–137.

Council for International Organizations of Medical Sciences (CIOMS) (2002) ‘International ethical guidelines for biomedical research involving human subjects’, CIOMS, Geneva, Switzerland, available at http://www.cioms.ch.

International Conference on Harmonisation (ICH) (1996) ‘Good clinical practice guideline’, available at http://www.ifpma.org/ich5.

The European Parliament and the Council (2001) Directive 2001/20/EC, available at http://www.europa.eu.int/eur-lex.

Ghangurde

(2001) ‘Indian firms go global with generics’, Scrip Magazine, March, pp. 27–29.

Torbett

(2001) ‘Cipla sets the pace on cut-price AIDS drugs’, Scrip Magazine, June, pp. 46–48.

Peny

J.-M.

(2003) ‘How bright is the future for generics?’, Scrip Magazine, March, pp. 13–17.

Idänpään-Heikkilä

J. E.

(2001) ‘Ethical principles for the guidance of physicians in medical research — the Declaration of Helsinki’, Bulletin of the World Health Organization, Vol. 79, p. 279.

10.

WHO (1996) ‘Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability’, WHO Technical Report Series, No. 863, Annex 9, Geneva, Switzerland.

11.

WHO (1999) ‘Marketing authorization of pharmaceutical products with special reference to multisource (generic) products. A manual for a drug regulatory authority’, Document WHO/DMP/RGS/98.5.

12.

WHO (2000) ‘Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA). Berlin, Germany, April 1999’, WHO and BfArm, Geneva, Switzerland.

13.

Nuremberg Municipal Museum (1996) ‘The Nazi Party rally grounds in Nuremberg. Fascination and terror’, pp. 43–44.

14.

Fluss

(2000) ‘Ethical aspects of the control of human subjects research: A brief overview of the current international configuration’, in Levine

R. J.

Gorowitz

Gallagher

(eds) Biomedical Research Ethics: Updating International Guidelines, CIOMS, Geneva, Switzerland, pp. 248–268.

15.

Levine

R. J.

(2000) ‘Revision of the CIOMS International Ethical Guidelines: A progress report’, in Levine

R. J.

Gorowitz

Gallagher

(eds) Biomedical Research Ethics: Updating International Guidelines, CIOMS, Geneva, Switzerland, pp. 4–15.

16.

Idänpään-Heikkilä

J. E.

Fluss

(2003) ‘Revised CIOMS International Ethical Guidelines for Biomedical Research’, Journal of Commercial Biotechnology, Vol. 10, pp. 140–146.

17.

Joint United Nations Programme on HIV/AIDS (UNAIDS) (2000) Ethical Considerations in HIV Preventive Vaccine Research, UNAIDS, Geneva, Switzerland.

18.

The Council of Europe (2003) ‘Protocol on Biomedical Research, additional protocol to the Council's 1997 Convention on Human Rights and Biomedicine’, available at http://wrww.coe.int.

19.

Nuffield Council on Bioethics (2002) The Ethics of Research Related to Healthcare in Developing Countries, Nuffield Council on Bioethics, London, UK.

20.

Qiu

R.-Z.

(1993) ‘Asian perspectives: Tension between modern values and Chinese culture’, in Bankowski

Levine

R. J.

(eds) Ethics and Research on Human Subjects, CIOMS, Geneva, Switzerland, pp. 188–196.

21.

Osontokun

B. O.

(1993) ‘An African perspective’, in Bankowski

Levine

R. J.

(eds) Ethics and Research on Human Subjects, CIOMS, Geneva, Switzerland, pp. 173–176.

22.

Marshall

P. A.

(2000) ‘Informed consent in international health research’, in Levine

R. J.

Gorowitz

Gallagher

(eds) Biomedical Research Ethics: Updating International Guidelines, CIOMS, Geneva, Switzerland, pp. 100–134.

23.

Hasan

K. Z.

(1993) ‘An Eastern Mediterranean perspective: Islamic and cultural influences’, in Bankowski

Levine

R. J.

(eds) Ethics and Research on Human Subjects, CIOMS, Geneva, Switzerland, pp. 198–200.

24.

Macklin

(2000) ‘Reproductive biology and technology: Ethical issues’, in Levine

R. J.

Gorowitz

Gallagher

(eds) Biomedical Research Ethics: Updating International Guidelines, CIOMS, Geneva, Switzerland, pp. 208–224.