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Legislative, Administrative or Policy Measure (MSR)
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ABSCH-MSR-KE-277535-1   |   PDF   |   Print   |  
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last updated: 06 Mar 2025
General information
Kenya
Environmental Management and Coordination (Access to Biological Resources and Benefit Sharing) Regulations, 2025.
The objectives of these Regulations shall be to— Objectives.
(a) provide mechanisms to protect and prevent exploitation of endangered and threatened plant and animal species;
(b) provide for access to and the fair and equitable sharing of benefits arising from the utilization of biological resources;
(c) provide for the consultation of local communities and other stakeholders in the process of accessing biological resources for research, bio trade, commercial and other
purposes;
(d) safeguard access to biological resources, and biological resources associated with traditional knowledge heldby local communities in conservation of biological resources; and
(e) to domesticate relevant provisions of international conventions and protocols.
4. (1) These Regulations shall apply to— Application.
(a) the conservation of all biological resources in Kenya, whether or not they are found in their natural environment;
(b) access to genetic resources in Kenya and the fair and equitable sharing of benefits derived from their utilization;
(c) approved research and activities that relate to biological resources and biological resources with associated traditional
knowledge;
(d) commercialization and trade in biological resources; and
(e) any digital sequence information relating to Kenya biological resources.
These Regulations shall not apply to—
(a) the exchange of biological resources, their derivative products, or the intangible components associated with them, carried out by members of any local Kenyan
community amongst themselves and for their own consumption and benefits;
(b) access to genetic resources derived from plant breeders in accordance with the Seeds and Plant Varieties Act and the
International Treaty on Plant Genetic Resources for Food and Agriculture; or
Cap. 326.
(c) human genetic resources.
5. The Authority shall be the Competent National Authority and shall be responsible for granting access or as applicable, issuing written evidence that access requirements have been met and be responsible for advising applicants, local communities, other Government agencies and any interested persons on the applicable
procedures and requirements for obtaining prior informed consent and entering into mutually agreed terms.
National / Federal
Legally binding
28 Feb 2025
Regulatory or Administrative Measures
Yes
SCHEDULES First Schedule – Application for Access Permit Second Schedule – Fees per locality Third Schedule – Access Permit Fourth Schedule – Prior Informed Consent (PIC) Fifth Schedule – Mutually Agreed Terms Sixth Schedule – Material Transfer Agreement
Amendments
  • ABSCH-MSR-KE-208067-3 Legislative, Administrative or Policy Measure THE ENVIRONMENTAL MANAGEMENT AND CO-ORDINATION (CONSERVATION OF BIOLOGICAL DIVERSITY AND RESOURCES, ACCESS TO GENETIC RESOURCES AND BENEFIT SHARING) REGULATIONS, 2006
    The regulations were developed to protect biological diversity and resources. These Regulations apply to access to genetic resources or parts of genetic resources, whether naturally occurring or naturalised, including genetic resources bred for or intended for commercial purposes within Kenya or for export, whether in in-situ conditions or ex-situ conditions. They do not apply: to plants listed in the Agriculture Act Cap 318; the exchange of genetic resources where the exchange is done by a local community among themselves and for their own consumption; or where the exchange is certified to be purely for food or other consumptive purposes as prescribed by the relevant laws. Any person who intends to access genetic resources in Kenya needs an Access permit for genetic resources in Kenya with a certificate from National Council for Science and Technology. The process of accessing a permit involves a multi-agency engagement and a Prior Informed Consent as may be applicable.
    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;
    human genetic resources;  and
    approved research activities intended for educational purposes within recognized Kenyan academic and research institutions which are governed by relevant intellectual property laws.

The Environmental Management and Co-ordination (Conservation of Biological Diversity and Resources, Access to Genetic Resources and Benefit Sharing) Regulations, 2006 and the Environmental Management and Co-ordination (Access to Biological Resources and Benefit Sharing) Regulations, 2025 show several key differences reflecting updates to better align with international standards, Nagoya protocol , contemporary biodiversity needs, and regulatory improvements , constitution 2010, EMCA 2015. Below are the main changes between the two:

1. Title and Terminology Changes

  • The 2006 regulations focus on "Conservation of Biological Diversity and Resources" and "Access to Genetic Resources."
  • The 2025 regulations shift to the term "Access to Biological Resources," emphasizing the expanded scope of biological resources rather than genetic resources alone.
2. Objectives (2025 Regulations)

  • 2025 Regulations (Regulation 3) introduce a clear statement of objectives, outlining the purpose of these regulations, which was less explicit in the 2006 regulations.
The objectives of these 2025 Regulations shall be to— Objectives.
(a) provide mechanisms to protect and prevent exploitation of endangered and threatened plant and animal species;
(b) provide for access to and the fair and equitable sharing of benefits arising from the utilization of biological resources;
(c) provide for the consultation of local communities and other stakeholders in the process of accessing biological resources for research, bio trade, commercial and other purposes;
(d) safeguard access to biological resources, and biological resources associated with traditional knowledge held by local communities
in conservation of biological resources; and (e) to domesticate relevant provisions of international conventions and protocols.Competent National Authority (2025 Regulations)
3.2025 Regulations (Regulation 5) introduce the concept of a "Competent National Authority", providing clarity on who is responsible for overseeing the access to biological resources. The 2006 regulations lacked a detailed designation of this role.
4. Indigenous and Local Community Biodiversity Measures (2025 Regulations)2025 Regulations (Regulation 9) introduce a new section dedicated to "Indigenous and Local Community Biodiversity Measures." This reflects the global shift toward recognizing the rights of indigenous peoples and local communities (IPLCs) in biodiversity conservation, ensuring that their knowledge, rights, and participation are respected and incorporated.
5. Access Permit and Prior Informed Consent (2025 Regulations)2025 Regulations (Regulation 11-12) introduce the concept of "Prior Informed Consent (PIC)" and "Mutually Agreed Terms (MAT)." These are aligned with the Nagoya Protocol of the Convention on Biological Diversity, ensuring that access to biological resources respects the rights of countries and IPLCs by requiring consent before accessing resources.
  • The 2006 regulations mention access permits but lack the clarity provided in the 2025 version regarding the need for informed consent and agreed terms.
6. Publication of Access Applications (2025 Regulations)2025 Regulations (Regulation 13) stipulate the publication of access permit applications, increasing transparency in the access process. The 2006 regulations do not mention this requirement.
7. Material Transfer Agreements (2025 Regulations)2025 Regulations (Part IV) introduce a dedicated section on Material Transfer Agreements (MTAs), ensuring that the transfer of biological materials follows legally binding agreements. The 2006 regulations mention these agreements but do not have a dedicated section.
8. Benefit Sharing (2006 vs. 2025)The 2025 regulations (Part V) provide more explicit and detailed guidance on benefit-sharing (Regulation 23) in a manner that integrates modern concepts of equity, including in the form of agreements with IPLCs. The 2006 regulations also discuss benefit sharing but less comprehensively.
9. Monitoring and Reporting (2025 Regulations)2025 Regulations (Regulation 10) introduce monitoring measures for biodiversity resources and access permits. While the 2006 regulations mention monitoring of status of biological diversity , the 2025 regulations emphasize it in greater detail, including the involvement of stakeholders.
10. Dispute Resolution (2025 Regulations)
2025 Regulations (Regulation 26) include a dispute resolution mechanism, which was absent in the 2006 regulations. This can help address conflicts over access permits and benefit-sharing.
11. Penalties and Revocation (2025 Regulations)
Both sets of regulations include penalties and provisions for the suspension or revocation of access permits (Regulations 16-17, 19 in both). However, the 2025 regulations seem more detailed and structured regarding enforcement and penalties.
12. Schedule Additions (2025 Regulations)

  • The 2025 regulations include new Schedules that provide more specific details on the application process, fees, and conditions associated with access permits, including schedules on Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT), reflecting a more comprehensive approach to managing biological resources.
13. Confidentiality (Both Regulations)

  • Both sets of regulations emphasize confidentiality (Regulation 21 in 2006, Regulation 24 in 2025) but the 2025 regulations include more detailed provisions regarding data protection and stakeholder rights.
14. Transition and Revocation

  • The 2025 regulations include more detailed provisions for transition (Regulation 25) and the revocation of previous regulations (Regulation 29), which provides a clearer pathway for phasing in the updated rules.

The key difference between the 2006 and 2025 regulations is the greater emphasis on transparency, indigenous rights, prior informed consent, and monitoring. The 2025 regulations align with international agreements such as the Nagoya Protocol, providing stronger safeguards and clearer frameworks for access to biological resources and benefit-sharing. This reflects a broader, more inclusive approach to biodiversity governance and better management of genetic and biological resources.




EN
Regulatory contact information
- Competent National Authority: | ABSCH-CNA-KE-208058-2
Competent National Authority:
National Environment Management Authority (NEMA) ()
Popo Road,South C, off Mombasa Road P.O.BOX 67839-00200, Nairobi.
Nairobi, Nairobi
00200, Kenya
Phone: +254-020-2101370, 020-2183718, 020-2307281, 020-2103696,
Fax: +(254)-020-6008997,
Email: info@nema.go.ke,
Website: http://www.nema.go.ke/,
ABSCH-CNA-KE-208058-2
Amendments
Relationships
  • ABSCH-MSR-KE-238446-1 Legislative, Administrative or Policy Measure Environmental Management and Co-ordination Act, 1999 (Cap 387)
    The main objective of this Act is the establishment of an appropriate legal and institutional framework for the management of the environment in Kenya. The Act further aims to improve the legal and administrative coordination of the diverse sectoral initiatives in the field of environment so as to enhance the national capacity for its effective management. In addition, the Act seeks to harmonize all the 77 sector specific legislations touching on the environment in a manner designed to ensure greater protection of the environment. This is in line with national objectives and sustainable development goals enunciated in the Agenda 21 of the Earth Summit held in Rio de Janeiro in 1992. The ultimate objective is to provide a framework for integrating environmental considerations into the country’s overall economic and social development.
    SECTION 53: Access to genetic resources of Kenya
    (1)    The Cabinet Secretary shall, on the recommendation of the Authority, issue guidelines and prescribe measures for the sustainable management and utilisation of genetic resources of Kenya for the benefit of the people of Kenya.
    (2)    Without prejudice to the general effect of subsection (1), the guidelines issued or measures prescribed under that subsection shall specify—
    (a)    appropriate arrangements for access to biological resources, genetic resources and ecological services of Kenya by non-citizens, including the issue of licences and fees to be paid for that access;
    (b)    measures for regulating the import or export of germplasm;
    (c)    the sharing of benefits derived from genetic resources of Kenya;
    (d)    biosafety measures necessary to regulate biotechnology;
    (e)    measures necessary to regulate the development, access to and transfer of biotechnology;
    (f)    measures necessary for the recognition, protection and enhancement of indigenous knowledge and associated practices in the conservation of the environment and natural resources;
    (g)    measures necessary for the protection of indigenous knowledge of biodiversity and genetic resources of communities; and
    (h)    any other matter that the Cabinet Secretary considers necessary for the better management of the genetic resources of Kenya.
    [Act No. 5 of 2015, s. 36.]


EMCA is the mother Act
Elements of the measure Collapse All Expand All
  SCOPE OF THE MEASURE
  Genetic Resources
-   All types of genetic resources -   Animals , -   Plants , -   Fungi , -   Microorganism , -   Domesticated species and/or cultivated species , -   Wild species - found in - All areas of access of the genetic resource In-situ Agricultural areas , Dry and sub-humid areas , Forest , Inland waters , Islands , Marine and coastal areas , Mountains , Protected areas , Ex-situ , Soil and/or water samples (Regulation 4)
  Traditional knowledge associated with genetic resources ( Indigenous and Local Community Biodiversity Measures (Regulation 9), Regulation 12,Regulation 21, Regulation 23 )
  Provisions on temporal scope ( Access Permits (Regulation 17-18) )
  Reference to any other relevant articles and sections
-  The regulations apply to both commercial and non-commercial activities (Regulation 11)
-  Competent National Authority (Regulation 5)
-  nvolvement of Indigenous and Local Communities (Regulation 9)
-  The regulations apply to all biological resources within Kenya's jurisdiction, (Regulation 4)
-  Inventory of Biological Resources (Regulation 8)
-  Material Transfer Agreements (MTAs) (Regulation 21)
-  International Obligations and Compliance (Regulation 4)
-  Monitoring and Reporting (Regulation 10)
-  Transition Period (Regulation 25)
-  Benefit Sharing and Monitoring (Regulation 23)
-  Benefit Sharing Conditions in Access Permits (Regulation 23)
  ACCESS
  Access to genetic resources
  For commercial use ( Regulation 11 )
  For non-commercial use ( Regulation 11 )
  Access to traditional knowledge associated with genetic resources, including prior informed consent or approval or involvement
  For commercial use ( Regulation 9 )
  For non-commercial use ( Regulation 9 )
  Provides for the issuance of a permit of its equivalent at the time of access for constituting an internationally recognized certificate of compliance ( Regulation 20 )
  Established rules and procedures for mutually agreed terms ( FIFTH SCHEDULE (regulation 12(4)) )
  BENEFIT-SHARING
  Monetary benefits ( Regulation 23 )
  Non-monetary benefits ( Regulation 23 )
  For commercial use ( Regulation 23 )
  For non-commercial use ( Regulation 23 )
  COMPLIANCE
  Compliance with domestic legislation or regulatory requirements of the other Party (Article 15 and 16) ( Regulation 4: )
  Issues related to monitoring the utilization of genetic resources (Article 17) ( Regulation 20 )
  Compliance with mutually agreed terms (Article 18) ( Regulation 12 (4) )
  RELATIONSHIP WITH OTHER INTERNATIONAL INSTRUMENTS
  Plant genetic resources for food and agriculture exchanged using the standard material transfer agreement of the International Treaty on Plant Genetic Resources for Food and Agriculture ( Regulation 4 )
  OTHER
  Competent national authority/ies ( Regulation 5 )
  Awareness-raising ( Regulation 12, 13 )
  Capacity-building ( Regulation 23 )
Additional Information
Regulation 28. Any person convicted of an offense under these Regulations,
for which no penalty is specified, shall be liable upon conviction, to the
penalty specified in section 144 of the Act.
Penalties.
Regulation 29. The Environmental Management and Co-ordination
(Conservation of Biological Diversity and Resources, Access to
Genetic Resources and Benefit Sharing) Regulations are revoked

Section 144 of the Act - Offenses and Penalties

144. Offenses:
A person who fails to comply with any provision of this Act or any regulation made under this Act commits an offense and is liable, upon conviction, to a fine not exceeding five million shillings (KSh 5,000,000) or to imprisonment for a term not exceeding four years, or both.

If the offence is one which is continuing in nature, the court may, in addition to any fine or imprisonment imposed, order the person to pay a further fine not exceeding one hundred thousand shillings (KSh 100,000) for each day the offence continues after the conviction.

SECOND SCHEDULE
(regulations 11(1), 17(2)(a))
Fees per locality
Non-commercial access
Citizens (Ksh.) Foreigners (Ksh.)
Individual fees 40,000 80,000
Corporate fees 100,000 200,000
Kenyan students fee
(This fee only applies for students researching in Kenyan academic and research
Institutions, for foreign institutions the non-commercial fees apply)
Ksh.
Masters Student Fees 3,000
PhD Candidate fees 10,000
Commercial access
Citizens (Ksh.) Foreigners (Ksh.)
Fee for commercialisation 500,000 1,000,000
Access permit renewal
Citizens (Ksh.) Foreigners (Ksh.)
Individual application 30,000 50,000
Corporate application 50,000 100,000

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