THE LAW MAKING PROCESS OF AN ACCESS AND BENEFIT SHARING REGIME IN KENYA Presented By: Anne N. Angwenyi National Environment Management Authority (Kenya) RELEVANT PRIMARY LAWS The Constitution of Kenya provides that all natural resources and the benefits derived thereof belong to the Government and people of Kenya. All laws on the issue of access to and protection of resources (intellectual property laws) are subject to the provisions of the Constitution. The Environmental Management and Co-ordination Act (No. 8 of 1999) provides for the regulation of biological resources and genetic resources for ensuring sustainable management and protection of such resources. POLICY AND LEGISLATIVE MEASURES ON ACCESS TO GENETIC RESOURCES IN KENYA No specific policy in Kenya on GR Section 53 – NEMA required to issue guidelines and prescribe measures for the sustainable management and utilization of genetic resources in Kenya … … appropriate arrangements for access to GR of Kenya including issue of licence and fees for such access … the sharing of benefits derived from access to GR in Kenya The Environmental Management and Co ordination (Conservation of Biological Diversity and Resources, Access to Genetic Resources and Benefit Sharing) Regulations The Regulations do not apply to: (a) the exchange of genetic resources, their derivative products, or the intangible components associated with them, which are carried out by a local community of Kenya among themselves and for their own consumption; (b) access to genetic resources derived from plant breeders as defined under the relevant laws relating to plant breeding and plant varieties; (c) human genetic resources; and (d) approved research activities intended for educational purposes within recognized Kenyan academic and research institutions which are governed by relevant intellectual property laws. SCOPE • Access’ means obtaining, possessing and using genetic resources, their derived products, and where applicable, intangible components for purposes of research, bio-prospecting, conservation, industrial application or commercial use. • No access without a PIC and MTA RELEVANT DEFINITIONS Commercial use’ means any collection and use of genetic material for profit making; Genetic material’ means any genetic material of plant, animal, microbial or other origin containing functional units of heredity; ‘Germplasm’ means genetic material capable of propagation;‘ Genetic resources’ means genetic material of actual or potential value; ‘Holotype’ means the single specimen chosen for designation of a new species; ‘Intangible components’ means any information held by persons that is associated with or regarding genetic resources within the jurisdiction of Kenya; BENEFIT SHARING Monetary benefits may include but are not limited to: (i) Access fees/fee per sample collected or otherwise acquired; (ii) Up-front payments; (iii) Milestone payments; (iv) Payments of royalties; (v) License fees in case of commercialisation; (vi) Special fees to be paid to trust funds supporting conservation and sustainable use of biodiversity; (vii) Salaries and preferential terms where mutually agreed; (viii) Research funding; (ix) Joint ventures; and (x) Joint ownership of relevant intellectual property rights. Non-Monetary benefits may include, but are not limited to: (i) Sharing of research and development results; (ii) Collaboration, cooperation and contribution in scientific research and development programmes, particularly biotechnological research activities where possible in Kenya; (iii) Participation in product development; (iv) Admittance to ex situ facilities of genetic resources and to databases by participating institutions; (v) Transfer to Kenya of genetic resources of knowledge and technology under fair and most favourable terms, including concessional and preferential terms where agreed, in particular, knowledge and technology that make use of genetic resources, including biotechnology, or that are relevant to the conservation and sustainable utilization of biological diversity; (vi) Strengthening capacities for technology transfer to Kenya; (vii) Institutional capacity building; (viii) Human and material resources to strengthen the capacities for the administration and enforcement of access regulations; (ix) Training related to genetic resources with the full participation of Kenya and where possible in Kenya; (x) Access to scientific information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxanomic studies; (xi) Institutional and professional relationships that can arise from access and benefit sharing agreements and subsequent collaborative activities; and (xii) Joint ownership of relevant intellectual property rights. GAPS • No clear provision of how benefits are to be distributed to local community (what is fair and equitable?) • Who is the local community and TK associated to them? •Do the regulations cover biological resources as well? •No standard form/provisions of the contents of PIC and MTA – this may cause confusion to providers/owners and users as this is a new issue for the country •No distinct lines when research ends and commercialization starts – the dilemma of enforcement. STRENGTHS • Participatory and consultative process that was used to develop regulations •Comprehensive framework to regulate genetic resources and benefit sharing •Harmonized both regional and international (Bonn Guidelines) laws on ABS. •Clear provision for mandatory PIC and MTA to ensure that the providers/owners receive benefits. OVERALL CHALLENGES Different sectors use GR and BR in different ways, adopt a diversity of approaches and tools for ABS associated with resources. Capacity building in provider countries – negotiating skills to reduce inequities between contracting parties. Potential frustration in seeking PIC, negotiating terms and sharing of benefits associated with use of TK is unclear (which local community) Need for legal certainty and clarity of rights to material Problems of genetic identification, capacity constraints and complexity of designing monitoring and tracking system. Continued and effective participation of Kenya in development of an internationally legally binding regime on ABS.