Rotterdam Convention on the Prior Informed Consent Procedure

Rotterdam Convention on the Prior Informed Consent Procedure

Title of the convention

Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade

About the Rotterdam Convention

The Convention creates a legally binding obligation for the implementation of a Prior Informed Consent (PIC) procedure. It replaces an existing voluntary PIC procedure operated by the United Nations Environment Programme (UNEP) and the Food and Agriculture Organisation of the United Nations (FAO) since 1989, and takes into account experience gained during the implementation of the voluntary procedure.

The objectives of the Convention are to:

promote shared responsibility and co-operative efforts among Parties in the international trade of listed hazardous chemicals in order to protect human health and the environment from potential harm; and

contribute to the environmentally sound use of those hazardous chemicals, by facilitating information exchange about their characteristics, by providing for a national decision-making process on their import and export and by disseminating these decisions to Parties.

The Convention was adopted at Rotterdam on 10 September 1998. At this time a resolution was agreed for the provisions of the Convention to operate on an interim basis until the Convention enters into force. UNEP and FAO are jointly performing the Secretariat functions for the Convention during the interim period.

The Convention establishes a “Prior Informed Consent” procedure as a means for formally obtaining and disseminating the decisions of importing countries as to whether they wish to receive future shipments of certain hazardous chemicals and for ensuring compliance with those decisions by exporting countries. The Convention also contains provisions for the exchange of information among Parties about these chemicals. All Parties must designate a national authority to perform the administrative functions.

Initially 22 pesticides and 5 industrial chemicals are subject to the PIC procedure. Many more are expected to be added in the future and Annex 2 of the Convention identifies the criteria for listing additional chemicals. An additional 4 chemicals have recently been added to the interim arrangements as they were deemed to have met the criteria for PIC inclusion. One notification from two specified regions triggers consideration of addition of a chemical to the Convention. The composition of the regions will be determined at the first meeting of the Conference of Parties. Severely hazardous pesticide formulations that present a hazard under conditions of use in developing countries or countries with economies in transition may also be nominated for inclusion.

Once a chemical is included in the PIC procedure, a “decision guidance document” (DGD) containing information concerning the chemical and the regulatory decisions to ban or severely restrict it for health or environmental reasons, is circulated to each Party. Parties are given nine months to prepare a response concerning the future import of a chemical. The response can consist of either a final decision (to allow import of the chemical, not to allow import, or to allow import subject to specified conditions) or an interim response. Decisions by an importing country must be trade neutral.

The Convention establishes a Conference of the Parties to oversee implementation. A subsidiary body, the Chemical Review Committee, is also established to review notifications and nominations from regions and to make recommendations on the inclusion of additional substances in the Convention.

In 2004, 49 countries plus the European Commission have ratified the Rotterdam Convention and a number of others have indicated that they will ratify shortly.

Conclusion

References

See Also

Further Reading

Advisory Committee on Human Radiation Experiments (1995) Final Report. Washington, DC: US Government Printing Office.
Allen, C. , Joly, Y. and Granados Moreno, P. (2013) ‘Data sharing, biobanks and informed consent: a research paradox?’ McGill Journal of Law and Health, 7 (1): 85–120.
Annas, G. J. (1991) ‘Mengele’s birthmark: the Nuremberg Code in United States courts,’ Journal of Contemporary Health Law and Policy, 7: 17–45.
Beauchamp, R. R. and Faden, T. L. (1986) A History and Theory of Informed Consent. New York: Oxford University Press.
Beecher, H. K. (1966) ‘Ethics and clinical research,’ New England Journal of Medicine, 274 (24): 1354–60.
Berg, J. W. , Appelbaum, P. S. , Lidz, C. W. , and Parker, L. S. (2001) Informed Consent: Legal Theory and Clinical Practice. Oxford: Oxford University Press.
Campbell, A. and Glass, K. C. (2001) ‘The legal status of clinical and ethics policies, codes, and guidelines in medical practice and research,’ McGill Law Journal, 46: 473–89.
Caulfield, T. (2007) ‘Biobanks and blanket consent: the proper place of the public good and public perception rationales,’ Kings Law Journal, 18: 209.
Caulfield, T. and Knoppers, B. M. (2010) Consent, Privacy and Research Biobanks, Policy Brief No. 1, viewed 13 March 2014 at: https://www.genomecanada.ca/medias/pdf/en/GPS-Policy-Directions-Brief.pdf.
Caulfield, T. R. , Upshur, R. and Daar, A. (2003) ‘DNA databanks and consent: a suggested policy option involving an authorization model,’ BMC Medical Ethics, 4 (1): pp. E1–E4.
Cohen, C. B. (2002) ‘Public policy and the sale of human organs,’ Kennedy Institute of Ethics Journal, 12 (1): 47–64.
Committee of Inquiry (1988) The Report of the Cervical Cancer Inquiry. Aukland: Government Printing Office.
Deschênes, M. , Cardinal, G. , Knoppers, B. M. , and Glass, K. (2001) ‘Human genetic research, DNA banking and consent: a question of “form”?’ Clinical Genetics, 59 (4): 221–39.
Department of Health and Human Services, Office for Human Research Protections (2013) Letter to the University of Alabama at Birmingham dated 7 March 2013, viewed 13 March 2014 at: https://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf.
Emanuel, E. J. , Currie, X. E. , and Herman, A . (2005) ‘Undue inducement in clinical research in developing countries: Is it a worry?’ Lancet, 366: 336–40.
Faden, R. R. , Beauchamp, T. L. , and Kass, N. E. (2014) ‘Informed consent, comparative effectiveness, and learning health care,’ New England Journal of Medicine, 370: 766–8.
Faden, R. R. , Kass, N. E. , Goodman, S. N. , Pronovost, P. , Tunis, S. , and Beauchamp, T. L. (2013) ‘An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics,’ Hastings Center Report, 43 (1): S16–S27.
Gostin, L. O. , Friedman, E. A. , Buse, K. , Waris, A. , Mulumba, M. , Joel, M. , Dare, L. , Dhai, A. , and Sridhar, D. (2013) ‘Towards a framework convention on global health,’ Bulletin of the World Health Organization, 91: 790–3.
Grubb, A. (1998) ‘Consent to treatment: the competent patient,’ Principles of Medical Law. Oxford: Oxford University Press.
Hadskis, M. (2011) ‘The regulation of human biomedical research in Canada,’ in J. Downie , T. Caulfield and C. M. Flood (eds), Canadian Health Law and Policy. Markham, ON: LexisNexis, pp. 437–500.
Halpern, S. D. , Karlawish, J. H. , Casarett, D. , Berlin, J. A. , and Asch, D. A. (2004) ‘Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials,’ Archives of Internal Medicine, 164 (7): 801–3.
Hawkins, J. S. and Emanuel, E. J. (2005) ‘Clarifying concerns about coercion,’ Hastings Center Report, 35 (5): 16–19.
Health Canada (2010) Requirement for Informed Consent Documents, viewed 26 February 2014 at: https://www.hc-sc.gc.ca/advic-avis/reb-cer/consent/index-eng.php.
Hirtle, M. , Lemmens, T. , and Sprumont, D. (2000) ‘A comparative analysis of research ethics review mechanisms and the ICH good clinical practice guideline,’ European Journal of Health Law, 7 (3): 265–92.
Hudson, K. L. , Guttmacher, A. E. , and Collins, F. S. (2013) ‘In support of SUPPORT – a view from the NIH,’ New England Journal of Medicine, 366 (25): 2349–51.
Katz, J. (1977) ‘Informed consent – a fairy tale? – law’s vision,’ University of Pittsburgh Law Review, 39 (2): 137–74.
Katz, J. (1984) The Silent World of Doctor and Patient. New York: Free Press.
Katz, J. (1992) ‘The consent principle of the Nuremberg Code: its significance then and now,’ in G. J. Annas and M. A. Grodin (eds), The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation. New York: Oxford University Press, pp. 227–39.
Katz, J. (2004) ‘Legal and ethical issues of consent in healthcare,’ in Encyclopedia of Bioethics. New York: Macmillan Reference USA.
Katz, J. , Capron, A. M. and Glass, E. S. (1972) Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process. New York: Russell Sage Foundation.
Kaye, J. (2009) ‘Biobanks networks – what are the governance challenges?’ in J. Kaye and M. Stranger (eds), Principles and Practice in Biobank Governance. Farnham: Ashgate, pp. 201–16.
Kaye, J. , Whitley, E. A. , Kanellopoulou, N.K. , Creese, S. , Hughes, K. J. , and Lund, D. (2011) ‘Dynamic consent – a solution to a perennial problem? (response),’ British Medical Journal, 343 (1 November), p. d6900.
Kim, S. , Ubel, P. , and De Vries, R. (2009) ‘Pruning the regulatory tree,’ Nature, 457: 534–5.
Kouri, R. P. and Philips-Nootens, S. (2011) ‘Civil liability of physicians under Quebec Law,’ in J. Downie , T. Caulfield , and C. M. Flood (eds), Canadian Health Law and Policy. Markham, ON: LexisNexis, pp. 195–252.
Lederer, S. E. (2007) ‘Research without borders: the origins of the Declaration of Helsinki,’ in U. Schmidt and A. Frewer (eds), History and Theory of Human Experimentation: The Declaration of Helsinki and Modern Medical Ethics. Stuttgard: Franz Steiner Verlag.
Lemmens, T. (2014) ‘The Markingson case and the ethics of institutional proceduralism,’ Bioethical Inquiry, 11 (1): 11–16.
Lemmens, T. and Austin, L. (2009) ‘The end of individual control over health information: governing bio-banks and promoting fair information practices,’ in J. Kaye and M. Stranger (eds), Governing Biobanks. Farnham: Ashgate.
Lemmens, T. and Elliott, C. (2001) ‘Justice for the professional guinea pig,’ American Journal of Bioethics, 1 (2): 51–3.
Lemmens, T. , Ban, T. A. , and Charland, L. C. (2013) Final Report of the Independent Committee of Inquiry into the University of Ottawa, the Institute for Mental Health Research, and the Royal Ottawa Hospital.
London, J. A. (2005) ‘Undue inducements and reasonable risks: Will the dismal science lead to dismal research ethics?’ American Journal of Bioethics, 5 (5): 29–32.
McGuire, A. L. and Gibbs, R. A. (2006) ‘No longer de-identified,’ Science, 312: 370–1.
Macklin, R. et al. (2013) ‘The OHRP and SUPPORT – another view (Letter to the Editor),’ New England Journal of Medicine, 369 (2): e3.
Mclean, S. A. (2010) Autonomy, Consent and the Law. London: Routledge-Cavendish.
McLeod, C. and Sherwin, S. (2000) ‘Relational autonomy, self-trust, and health care for patients who are oppressed?’ in C. MacKenzie and N. Stoljar (eds), Relational Autonomy: Feminist Perspectives on Autonomy, Agency and the Social Self. Oxford: Oxford University Press.
Mason, J. and Laurie, G. T. (2006) Mason and McCall Smith’s Law and Medical Ethics, 6th edn. Oxford: Oxford University Press.
Mill, J. S. (2003) ‘On Liberty,’ in D. Bromwich and G. Kateb (eds), Rethinking the Western Tradition. New Haven, CT: Yale University Press.
Modi, N. (2013) ‘How not to reduce uncertainties in care (editorial),’ British Medical Journal, 346: f3786.
Mosby, I. (2013) ‘Administering colonial science: nutrition research and human biomedical experimentation in aboriginal communities and residential schools, 1942–1952,’ Social History, 46 (91): 145–72.
National Bioethics Advisory Commission (1999) Research Involving Human Biological Materials, viewed 13 March 2014 at: https://bioethicsarchive.georgetown.edu/nbac/pubs.html.
National Commission for the Protection of Human Subjects (1979) Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The Belmont Report). Washington, DC: US Department of Health and Human Services.
Nelson, E. and Caulfield, T. (1999) ‘You can’t get there from here: a case comment on Arndt v. Smith,’ University of British Columbia Law Journal, 32: 353.
O’Neil, O. (2002) Autonomy and Trust in Bioethics. Cambridge: Cambridge University Press.
Peppin, P. (2011) ‘Informed consent,’ in Canadian Health Law and Policy, 4th edn. Markham, ON: LexisNexis, pp. 153–94.
Percival, T. (1803) Medical Ethics; or a Code of Institutes and Precepts, Adapted to the Professional Conduct of Physicians and Surgeons. Manchester: S. Russell.
Radin, M. J. (1996) Contested Commodities. Cambridge, MA: Harvard University Press.
Reverby, S. M. (2012) ‘Ethical failures and history lessons: the U.S. public health service research studies in Tuskegee and Guatemala,’ Public Health Reviews, 34 (1): 1–18.
Schmidt, U. (2004) Justice at Nuremberg: Leo Alexander and the Nazi Doctors’ Trial. New York: Palgrave Macmillan.
Sprumont, D. , Girardin, S. and Lemmens, T. (2007) ‘The Helsinki Declaration and the law: an international and comparative analysis,’ in US Andreas Frewer (ed.), History and Theory of Human Experimenation: The Declaration of Helsinki and Modern Medical Ethics. Stuttgart: Franz Steiner Verlag.
SUPPORT Study Group (2010) ‘Target ranges of oxygen saturation in extremely preterm infants,’ New England Journal of Medicine, 362 (21): 1959–69.
Tenenbaum, E. (2012) ‘Revitalizing informed consent and protecting patient autonomy: an appeal to abandon objective causation,’ Oklahoma Law Review, 64: 697–758.
Vollman, J. and Winnau, R. (1996) ‘The Prussian Regulation of 1900: early ethical standards for human experimentation in Germany,’ IRB: Ethics and Human Research, 18 (4): 9–11.
Waring, D. and Lemmens, T. (2004) ‘Integrating values in risk analysis of biomedical research: the case for regulatory and law reform assessment in biomedical research,’ University of Toronto Law Journal, 54: 249–90.
Weir, S. (2004) Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care, 2nd edn. Washington, DC: Georgetown University Press.
Wertheimer, A. (1987) Coercion. Princeton, NJ: Princeton University Press.
Wilfond, B. S. , et al. (2013) ‘The OHRP and SUPPORT (Letter to the Editor),’ New England Journal of Medicine, 368: e36.
Wolfe, S. M. (2013) ‘US study criticized for experimentation with premature infants (editorial),’ British Medical Journal, 347: f4198.

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International Conventions from 1991, Other Environmental conventions, country.


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