Free Prior Informed Consent

1. Free PriorInformed Consent IPinch Conference, Vancouver BC October 1, 2011 Dr. Debra Harry Nicole Schabus, LLM, MBA 1

2. Indigenous Peoples and the Right of FPIC 2 • FPIC is an absolute right closely associated with Indigenous Peoples’ right to self-determination

3. FPIC and Self-Determination 3 • FPIC is a right associated with Indigenous peoples’ right to self-determination, treaties and their rights to lands, territories, and natural resources • procedural & substantive rights (governance element) • UNPFII Report (2005) - FPIC is relevant to “access to natural resources including biological resources, genetic resources and/or traditional knowledge of indigenous peoples, leading to possible exploration, development or use thereof.”

4. Defining FPIC 4 • Freely given without any coercion, manipulation or intimidation or any fear of repercussions • Prior to any action taking place, including planning, implementation, evaluation, and closure; • Informed about the nature, scope, purpose, duration, benefits, impacts, risks, and personnel; accurate and with complete transparency in language the community understands • Consent by the representative body of the Peoples involved, and includes the right to say no. In no case should consent be presumed or implied; new consent must be sought for uses other than that for which the original consent was granted. • FPIC is a process of engagement, not an event.

5. FPIC: An Emerging International Standard for Indigenous Peoples 5 • ILO 169 Convention on Indigenous and Tribal Peoples in Independent Countries refers to consent at the standard to be strived for in the context of IPs development, land and resources • Rotterdam Convention refers to FPIC procedures for hazardous chemicals and pesticides • UN Committee on the Elimination of Racial Discrimination (CERD) has made recommendations calling on States to ensure “no decisions directly related to their rights and interests are taken without their informed consent.” (GRXXIII 51, 1997)

6. FPIC: An Emerging International Standard for Indigenous Peoples p.2 6 • The Convention on Biological Diversity 1992 in its Article 8(j) calls on contracting States, “to respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities………..and promote their wider application with the approval and involvement of the holders of such knowledge, innovation and practices”. • Biosafety Protocol

7. Akwe:Kon Guidelines 7 • for the conduct of cultural, environmental and social impact assessments regarding developments proposed to take place on, or which are likely to impact on, sacred sites and on lands and waters traditionally occupied or used by indigenous and local communities • Canada was the only country opposing an indigenous Prior Informed Consent standard, arguing for “prior informed consultation”: the EU and Latin American countries actively supported indigenous peoples • When Indigenous Peoples from Canada united that managed to back Canada down in plenary

8. Section on prior informed consent of the affected indigenous and local communities 8 53. Where the national legal regime requires prior informed consent of indigenous and local communities, the assessment process should consider whether such prior informed consent has been obtained. Prior informed consent corresponding to various phases of the impact assessment process should consider the rights, knowledge, innovations and practices of indigenous and local communities; the use of appropriate language and process; the allocation of sufficient time and the provision of accurate, factual and legally correct information. Modifications to the initial development proposal will require the additional prior informed consent of the affected indigenous and local communities.

9. ACCESS AND BENEFIT-SHARING 9 • Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization • CBD parties generally agreed to principle of state PIC requirement for access (unless waived) • Debate about indigenous PIC • Clearly shows that public international law principle – where indigenous peoples collectively have independent standing and decision-making power

10. Benefit-Sharing provision 10 • First refers to state PIC and then to Indigenous Peoples in: • Article 5.3 (f): Where applicable, and subject to domestic legislation, set out criteria and/or processes for obtaining prior informed consent or approval and involvement of indigenous and local communities for access to genetic resources;

11. Access provision 11 • Article 6 refers to state PIC and then to indigenous peoples in Article 6.2: • In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that the prior informed consent or approval and involvement of indigenous and local communities is obtained for access to genetic resources where they have the established right to grant access to such resources.

12. Access To Traditional Knowledge AssociatedWith Genetic Resources (Art. 7) 12 • In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that traditional knowledge associated with genetic resources that is held by indigenous and local communities is accessed with the prior and informed consent or approval and involvement of these indigenous and local communities, and that mutually agreed terms have been established.

13. UNDRIP Article 19 13 • States shall consult and cooperate in good faith with the indigenous peoples concerned through their own representative institutions in order to obtain their free, prior and informed consent before adopting and implementing legislative or administrative measures that may affect them.

14. UNDRIP Article 11 14 • Indigenous peoples have the right to practise and revitalize their cultural traditions and customs. This includes the right to maintain, protect and develop the past, present and future manifestations of their cultures, such as archaelogical and historical sites, artefacts, designs, ceremonies, technologies and visual and performing arts and literature. • States shall provide redress through effective mechanisms, which may include restitution, developed in conjunction with indigenous peoples, with respect to their cultural, intellectual, religious and spiritual property taken without their free, prior and informed consent or in violation of their laws, traditions and customs

15. Article 26 15 • Indigenous peoples have the right to the lands, territories and resources which they have traditionally owned, occupied or otherwise used or acquired. • Indigenous peoples have the right to own, use, develop and control the lands, territories and resources that they possess by reason of traditional ownership or other traditional occupation or use, as well as which they have otherwise acquired. • States shall give legal recognition and protection to these lands, territories and resources. Such recognition shall be conducted with due respect to the customs, traditions and land tenure systems of the indigenous peoples concerned.

16. Article 31 16 • Indigenous peoples have the right to maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions, as well as the manifestations of their sciences, technologies and cultures, including human and genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs, sports and traditional games and visual and performing arts. They also have the right to maintain, control, protect and develop their intellectual property over such cultural heritage, traditional knowledge, and traditional cultural expressions. • In conjunction with indigenous peoples, States shall take effective measures to recognize and protect the exercise of their rights.

17. Canada’s vote declaration against UNDRIP 17 • Canadian Ambassador to the United Nations, John McNee, on September 13, 2007, read during the vote: • We have stated publicly that we have significant concerns with respect to the wording of the current text, including the provisions on lands, territories and resources; free, prior and informed consent when used as a veto; self-government without recognition of the importance of negotiations; intellectual property; military issues; and the need to achieve an appropriate balance between the rights and obligations of indigenous peoples, member States and third parties.

18. Informed Consent for Human Subjects (individual right) 18 • Foundation in international human rights law protecting the rights of individuals • International Covenant on Civil and Political Rights (Article 7) • “no one shall be subjected without his free consent to medical or scientific experimentation” • Nuremberg Code - required that doctors obtain the voluntary informed consent of the subject prior to conducting medical experimentation • No coercion, force, fraud, deceit or duress

19. U.S. Law on Informed Consent 19 • In the U.S., informed consent is a legal doctrine that has been developed by the courts over a number of years. • Informed consent protects the research subject or patient by providing him/her with complete information on which to make an informed decision. • US regulations applicable to human subject research conducted, supported or otherwise subject to regulation by any Federal Department or Agency - Code of Federal Regulations (45 CFR sec. 46) • Institutional Review Board (IRB) • Documentation of informed consent

20. U.S. Federal Regulations 20 • “No investigator may involve a human being as a subject in research . . . Unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.” • Information must be in a language understandable to the subject/representative • Required information to be provided includes: • Explanation of the nature, purposes & duration • Foreseeable risks or discomforts • Benefits to subject or others • Participation is voluntary & subject may discontinue participation at any time

21. Other consent standards 21 • In criminal law regarding sexual offences: • Issue of consent – without consent the offence of sexual assault is made out • Clearly what is meant by consent – is the right to say no • Consent has to be unequivocal

22. Risk/Benefit analysis 22 • Benefits must outweigh the risks • Genographic Project • “Who does it benefit and if it doesn’t benefit the Indigenous community, is it ethical to do the research?” Jane Anderson, IPR expert, Australian Institute of Aboriginal and Torres Strait Islander Studies

23. Risk within Genographic Project 23 • GP research protocol states: • “it is possible that some findings that result from this study may contradict an oral, written or other tradition held by you or by members of your group” • National Congress of American Indians resolution: • “findings of human population genetic research . . . May be misused by governments to undermine Indigenous peoples’ rights as the original inhabitants of our territories” • Risks include loss of aboriginal status, loss of land rights, psychological harm, undermining of social institutions, and inter and intra-tribal conflict

24. Vulnerable Populations 24 • “Consent alone cannot justify research on populations that will not be able to benefit from it because such research violates basic principles of social justice & equality. Research subjects can make a gift to researchers or humanity, but the validity of such a gift in the context of studying genetic diversity, especially of isolate populations, is too problematic to provide the sole justification for the research.” • (National Research Council Report on HGDP, 1997)

25. Some questions re: consent 25 • Consultation vs. Consent • Group consent vs. individual consent • Who is the group? • Who can give consent for the group? • How do you operationalize FPIC? • Pressure to consent for economic gain • How should Indigenous peoples’ determine whether or not to participate?

26. Exercising FPIC for Indigenous Peoples 26 • the right to free prior informed consent concerning any access, use, or disposition of our knowledge and resources • the right to deny access to our knowledge and resources • the right to manage our knowledge and resources based on our own customary or codified laws • FPIC includes the right of enforcement

27. Indigenous Peoples Own Processes and Procedures 27 • Exercise their right of self-determination and FPIC • Establish laws, protocols, and procedures that regulate and govern the implementation of FPIC • Exercise Inherent Indigenous Rights and Indigenous Sovereignty • Use Indigenous laws and protocols to address access (public law element) to lands and resources • Sui generis systems for the protection of indigenous knowledge