Prior Informed Consent

Intellectual Property Rights

Prior Informed Consent

Prior Informed Consent

A right or principle of “prior informed consent” (PIC) or sometimes “free, prior and informed consent” (FPIC) is referred to or implied in several international instruments, particularly in the environmental field, such as Article 6(4) of the Basel Convention on the Transboundary Movement of Hazardous Wastes, 1989, and the Convention on Biological Diversity (1992).

In respect to access to genetic resources, the Convention on Biological Diversity (1992) Diversity states in Article 15(5) that it “shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party.

Article 16(1) of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (2010) provides that “[e]ach Party shall take appropriate, effective and proportionate legislative, administrative or policy measures, as appropriate, to provide that traditional knowledge associated with genetic resources utilized within their jurisdiction has been accessed in accordance with prior informed consent or approval and involvement of indigenous and local communities and that mutually agreed terms have been established, as required by domestic access and benefit sharing legislation or regulatory requirements of the other Party where such indigenous and local communities are located.”

The notion was originally derived from medical ethics in which a patient has the right to decide whether or not to undergo a medical treatment after being fully informed about the risks and benefits of that particular treatment.  For instance, the Universal Declaration on the Human Genome and Human Rights of 1997 states in Article 5 that in all cases of research, treatment or diagnosis affecting an individual’s genome the potential risks and benefits should be assessed and “the prior, free and informed consent of the person concerned shall be obtained”.  Article 6 of the UNESCO Declaration on Bioethics and Human Rights of 2005 requires the “prior, free and informed consent of the person concerned” when it comes to “preventive, diagnostic and therapeutic medical intervention” or “scientific research.”

The term flows from the implementation of the general principle of participation of indigenous peoples in decision-making, involvement in the formulation, implementation and evaluation of programs affecting them.

The purpose of the use of the adjective “free” is to ensure that no coercion or manipulation is used in the course of negotiations, while inclusion of “prior” acknowledges the importance of allowing time to indigenous to fully review proposals respecting the time required for achieving consensus.  It also anticipates the reality that decisions, especially those relating to major investments in development, are often taken in advance with indigenous people.  The notion of “informed” consent reflects the growing acceptance that environment and social impact assessment are a pre-requisite for any negotiation process and allow all parties to make balanced decisions.

“Consent” is a process whereby permission is given, based on a relationship of trust.  An informed consent implies that clear explanations are provided, along with contract details, possible benefits, impacts and future uses.  The process should be transparent, and the language fully understood by indigenous peoples.