IPinch Conference,
Vancouver BC
October 1, 2011
Dr. Debra Harry
Nicole Schabus, LLM, MBA
Free
Prior
Informed
Consent
1
2
Indigenous Peoples and the
Right of FPIC

FPIC is an absolute right closely associated with
Indigenous Peoples’ right to self-determination
3
FPIC and Self-Determination
 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





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
 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
 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
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
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.
ACCESS AND BENEFITSHARING
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
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
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 Associated
With Genetic Resources (Art. 7)

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
1.
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
1. 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.
2. 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
1.
2.
3.
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
1. 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.
2. 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


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; selfgovernment 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)
 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
U.S. Law on
Informed Consent

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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
“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
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
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
 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

“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
 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
 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
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
