What is FPIC?

FPIC is an Indigenous right recognized in the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP). The FPIC approach was developed in the context of land and natural resource management to enable Indigenous peoples to negotiate the conditions under which a project is designed, implemented, monitored, and evaluated.¹ As a principle, FPIC allows Indigenous peoples to give or withhold consent to a project that may affect their ancestral lands or territories, natural resources and related properties.^{1 2}

Why is FPIC Relevant to Gene Drive?

Obtaining community consent before the deployment of genetically modified mosquitoes (GMMs) to combat malaria in African countries is crucial to respect local communities’ right of self-determination. While FPIC was originally designed to give or withhold consent to land management projects, some organizations, such as the 2017 and 2018 Conventions on Biological Diversity, have indicated that engaging with local and Indigenous communities in the form of FPIC may also be warranted in the development of gene drives.^{3 4}

Components of FPIC

The Food and Agriculture Organization defines the components of FPIC as:¹

• Free: Consent must be given voluntarily, without manipulation, intimidation, or coercion, as part of a process that is self-directed by the Indigenous group, and upon which external deadlines are not imposed.
• Prior: Consent must be sought in advance of the start of activities.
• Informed: The engagement with Indigenous peoples should be culturally appropriate, and the information provided to individuals should be complete, objective, clear, transparent, and accessible.
• Consent: As a collective decision, consent must be reached by the appropriate rights-holders through the customary decision-making processes of the Indigenous community from which consent is sought.

Challenges of Implementing FPIC Prior to the Release of GMMs

FPIC represents a valuable instrument to ensure Indigenous self-determination. However, this approach was developed in the context of land and natural resource management, which differs from the application of GMMs as a potential public health intervention to combat malaria. Criticisms of FPIC highlight the challenges that could emerge if FPIC is implemented prior to the release of GMMs, including:

• The FPIC model has been criticized for excluding Indigenous groups that are not officially recognized by the state, or non-Indigenous groups that have inhabited a location for generations, from participating in FPIC decision-making processes.⁵ In the gene drive context, this could result in decisions that are seen as illegitimate and exacerbate community disputes.
• The FPIC model views Indigenous governance systems as unified, homogenous and inherently inclusive, when in reality, Indigenous self-governance systems are embedded in complex social, economic and political realities.⁵ FPIC’s reliance on traditional self-governance may exclude the voices of minorities and marginalized members within these communities from participating in decisions related to the deployment of GMMs.
• Because FPIC was developed for the management of land and natural resources, consent processes differ from those required prior to the release of GMMs, which include the need for community authorization or endorsement to be continually confirmed throughout stages of GMM release.⁶
• While FPIC is recognized in international legal agreements, such as UNDRIP, these agreements are non-binding instruments. Different legal interpretations of FPIC, seen in some jurisdictions as simply “a duty to consult” that is not legally enforced, could further complicate its implementation prior to the release of GMMs.

Potential Adaptations

Changes that could enable the adaptation of FPIC to the gene drive space include:

1. Consultation with Indigenous and non-Indigenous individuals on equal terms⁴
2. Development of an engagement model that captures the voices of minorities and marginalized individuals

Incorporation of guidelines that enable communities to continually confirm consent as gene drive projects move forward to successive stages

Gene drive scholars have focused on identifying fair and inclusive models to request community authorization prior to the release of GMMs. However, data is urgently needed to help assess if the implementation of FPIC could result in inclusive, fair, and transparent community authorization processes prior to the deployment of GMMs.

While FPIC, as currently designed, may be unfit for securing community consent in such contexts, it is important to note that the spirit of FPIC is about “shifting power over certain decisions from one set of historically privileged actors to another set of actors, who have typically been marginalized.”⁷

Calls for securing FPIC prior to the release of GMMs often echo calls for effectively addressing such power imbalances when community authorization is sought. The development of community authorization models, whether it be FPIC or others, must prioritize addressing power imbalances between researchers and local populations, as well as recognizing and validating the complex social, economic, and political realities of Indigenous and other marginalized communities.

An overview of FPIC:

• Food and Agriculture Organization of the United Nations. “Free, Prior and Informed Consent: An Indigenous Peoples Right, and a Good Practice for Local Communities.” FAO, 2016. 

An assessment of the potential adaptations of FPIC to the gene drive space:

• George, Dalton R., Todd Kuiken, and Jason A. Delborne. “Articulating ‘Free, Prior and Informed Consent’ (FPIC) for Engineered Gene Drives.” Proceedings of the Royal Society B: Biological Sciences 286, no. 1917 (December 18, 2019): 1–8. 

Guidance framework for testing GMMs:

• World Health Organization, TDR For research on diseases of poverty, and Gene Convene Global Collaborative. “Guidance Framework for Testing of Genetically Modified Mosquitoes, Second Edition,” May 2021.

1. Food and Agriculture Organization of the United Nations. Free, Prior and Informed Consent: an Indigenous peoples right, and a good practice for local communities [Internet]. FAO; 2016. Available from: http://www.fao.org/3/a-i6190e.pdf
2. Convention C169 – Indigenous and Tribal Peoples Convention, 1989 (No. 169) [Internet]. [cited 2020 Apr 28]. Available from: https://www.ilo.org/dyn/normlex/en/f?p=NORMLEXPUB:12100:0::NO::P12100_ILO_CODE:C169
3. Convention on Biological Diversity. Report of the Ad Hoc Technical Expert Group on Synthetic Biology, Montreal, Canada, 5-8 December 2017. Convention on Biological Diversity; 2017 Dec p. 17.
4. George DR, Kuiken T, Delborne JA. Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives. Proceedings of the Royal Society B: Biological Sciences [Internet]. 2019 Dec 18 [cited 2020 Apr 4];286(1917):1–8. Available from: https://royalsocietypublishing.org/doi/full/10.1098/rspb.2019.1484
5. Fontana LB, Grugel J. The Politics of Indigenous Participation Through “Free Prior Informed Consent”: Reflections from the Bolivian Case. World Development [Internet]. 2016 Jan 1 [cited 2020 Apr 17];77:249–61. Available from: http://www.sciencedirect.com/science/article/pii/S0305750X15002041
6. Godfray HCJ, Lindsay SW, Welkhoff PA, Savadogo M, Touré YT, Greenwood B, et al. Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group †. The American Journal of Tropical Medicine and Hygiene [Internet]. 2018 Jun 7 [cited 2018 Jul 11];98(6_Suppl):1–49. Available from: http://www.ajtmh.org/content/journals/10.4269/ajtmh.18-0083
7. Mebratu-Tsegaye T, kazemi leila. Free, Prior and Informed Consent: Addressing Political Realities to Improve Impact. SSRN Journal [Internet]. 2020 [cited 2021 Jun 22]; Available from: https://www.ssrn.com/abstract=3726400