The Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024
These Regulations may be cited as the Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024.
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- The Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024
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access and benefit sharing access permits access to genetic resources agreements application requirements benefit sharing benefit sharing agreement biological diversity border compliance certificate revocation certificate suspension community intellectual property rights compliance compliance recordkeeping consent procedures contract amendment data sharing definitions enforcement environmental governance environmental permitting export clearance genetic resources genetic resources access +16 more
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About this statute
These Regulations may be cited as the Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024. These Regulations apply to access and benefit sharing involving genetic resources, associated traditional knowledge, and naturally occurring or naturalised breeds in Tanzania and beyond Tanzania, subject to listed exceptions. This section defines key terms used in the Regulations. These Regulations aim to set procedures for access to genetic resources, promote sustainable use of biodiversity, support benefit-sharing, increase public awareness, and recognise and protect local communities’ rights over genetic resources and related traditional knowledge. The government holds the right to determine, control, and regulate access to genetic resources and associated traditional knowledge in Tanzania.
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Provisions of The Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024
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AI-assisted research summary: These Regulations may be cited as the Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024.
1. These Regulations may be cited as Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024. Application - 2
AI-assisted research summary: These Regulations apply to access and benefit sharing involving genetic resources, associated traditional knowledge, and naturally occurring or naturalised breeds in Tanzania and beyond Tanzania, subject to listed exceptions.
2.-(1) These Regulations shall apply to access and benefit sharing arise from the use of genetic resources or associated traditional knowledge, naturally occurring or naturalised breeds in in-situ or ex-situ conditions intended for research, commercial or non-commercial purposes within or out of Tanzania. (2) Without prejudice to sub-regulation (1), these Regulations shall not apply to access to genetic resources or associated traditional knowledge which- (a) done by local community among themselves and for their own consumption; (b) certified for food or other consumptive purposes as prescribed by sector specific laws or which do not result from commercial purposes or not for import or export to other countries of not origin; (c) derived from fauna and flora as defined by the existing laws relating to breeding and variety; (d) intended research for approved educational purposes in Tanzania Academic and research 4 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) Institutions recognised and managed by Competent Authority; or the (e) derived from human. Interpretati on - 3 Verify source ↗
Citation
AI-assisted research summary: This section defines key terms used in the Regulations.
3. In these Regulations, unless the context otherwise requires - “Council” shall have the meaning ascribed to it under the Act; “benefit” means any monetary or non-monetary gain or profit or interest or advantage arising from or accruing to or out of commercialisation, non-commercialisation, industrial application or economic use of the biological or genetic resources or associated traditional knowledge used to derive, develop or modify a product or process; “monetary benefit” means payment made or benefit accrued from utilisation of genetic resources or associated traditional knowledge; “intellectual property right” means ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property; “clearing house” means a web-based information sharing platform for facilitating the implementation of Nagoya Protocol; “access permit” means a written document issued by Competent Authority to authorise a person to access genetic resources or associated traditional knowledge; “export clearance certificate” means a written document issued by the National Focal Point to a person intending to export genetic resources be it for commercial or non-commercial; “research permit” means a written document issued by Competent Authority for research to a person who intends to carry out research on genetic resources or associated traditional knowledge; “commercialisation” means utilisation of genetic resources or associated traditional knowledge for financial gains or 5 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) other profit-oriented purposes; “associated traditional knowledge” means the accumulated knowledge for conservation and is vital sustainable use of genetic resources which is of socio- economic value, and which has been developed over the years in local communities; that “Benefit Sharing Agreement” means an agreement entered between applicant and Competent Authority for the purpose of stipulating the benefit framework that accrue from utilisation of genetic resources or associated traditional knowledge; “Data Sharing Agreement” means a formal contract that detail what data may be shared and their appropriate use; “Material Transfer Agreement” means an agreement between the competent authority or its representative and collector, setting out the terms under which genetic resources can be transferred from one party to another; “competent authority” means the government office, ministry, department, regulatory authority, research institution, local government authority or agency responsible for management of any aspect of genetic resources or associated resources; “Mutual Agreed Terms” mean conditions set out in an agreement between providers and collectors for the access to and utilisation of genetic resources or associated traditional knowledge as well as sharing of benefits resulting from their utilisation; “utilisation of genetic resource or associated traditional knowledge” means use of genetic resources or associated traditional knowledge for commercial or non-commercial purposes; “non-commercial utilisation” means utilisation of genetic resources or associated traditional knowledge for academic, research or other non-profit oriented purposes; “benefit sharing” means sharing in fair and equitable manner of monetary and non-monetary benefits accrued to or from the utilisation of genetic resources or associated 6 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) traditional knowledge between collectors and rightful holders; "collector" means a person or agent of that person who obtained a permit to access genetic resources or their derivative products or components or associated traditional knowledge occurring or originating from Tanzania; “National Focal Point” means the Ministry responsible for environment; “applicant” means a person who makes a formal application for the access to genetic resources or associated traditional knowledge; “written prior informed consent” means a consent in a written form given by a respective Competent Authority or local community to a collector to access genetic resource or associated traditional knowledge; “genetic resource” shall have the meaning ascribed to it under the Act; Cap. 191 “Act” means the Environmental Management Act; “access” means obtaining, possessing and using genetic resources resources associated conserved, whether derived products and, where applicable, intangible components, for purposes of research, bio-prospecting, conservation, industrial application or commercial use; traditional or “fair and equitable manner” means the measures taken to ensure that the benefits arising from the utilisation of genetic resources or associated traditional knowledge, subsequent applications and as well as commercialisation, are shared in a fair and equitable way among all those organisations or communities resource identified as having contribution or management, commercialisation; to development research and the “genetic materials” shall have the meaning ascribed to it under the Act; “Minister” means the Minister responsible for environment. 7 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) PART II OBJECTIVES Objectives
Part
PART II
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Objective
AI-assisted research summary: These Regulations aim to set procedures for access to genetic resources, promote sustainable use of biodiversity, support benefit-sharing, increase public awareness, and recognise and protect local communities’ rights over genetic resources and related traditional knowledge.
4. The objectives of these Regulations are to- (a) prescribe procedures and manner for access to genetic resources; (b) promote sustainable management and utilisation of biological diversity; (c) create a framework for sharing of benefits arising the use of such genetic resources or from associated traditional knowledge; (d) enhance education and public awareness on access to genetic resources; and (e) recognise, protect and support the inalienable rights of local communities over genetic resources or associated traditional knowledge found within their area. MANAGEMENT OF GENETIC RESOURCES PART III Ownership over genetic resources
Part
PART III
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AI-assisted research summary: The government holds the right to determine, control, and regulate access to genetic resources and associated traditional knowledge in Tanzania.
5. The right to determine, control and regulate access to genetic resources and its associated traditional knowledge in Tanzania is vested to the government for the benefit of people and shall be exercised in accordance with these Regulations or any other relevant written law. Duty to safeguard national interest - 6 Verify source ↗
Ownership over genetic resources
AI-assisted research summary: A person exercising jurisdiction under these Regulations must uphold Tanzania national interest when making decisions, orders, exercising powers, or performing functions or duties.
6. A person exercising jurisdiction in accordance with these Regulations shall, in making any decision, order, exercise of any power or performance of any function or duty, shall uphold Tanzania national interest. ADMINISTRATION AND INSTITUTIONAL FRAMEWORK PART IV National Focal Point
Part
PART IV
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AI-assisted research summary: The Ministry responsible for environment must be the National Focal Point for the Nagoya Protocol.
7. The Ministry responsible for environment shall be 8 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) the National Focal Point for the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation. Functions of National Focal Point - 8
AI-assisted research summary: The National Focal Point must carry out several functions on access and benefit sharing, including issuing clearance export certificates, coordinating guidance, monitoring implementation, and promoting awareness.
8. The National Focal Point shall- (a) ensure that the United Republic of Tanzania benefits from the genetic resources or associated traditional knowledge accessed; clearance export certificate (b) issue for an transboundary movement of genetic resources; (c) establish contacts and linkages with national, and international agencies and regional institutions; (d) provide and coordinate policy guidance of matters related to access and benefit sharing arising from the utilisation of genetic resources or associated traditional knowledge of the United Republic of Tanzania; (e) collaborate with the office or ministry responsible for environment in the Revolutionary Government of Zanzibar on matters related to access and benefit sharing under Nagoya Protocol; (f) ensure operationalisation of National Clearing House Mechanism of all genetic resources accessed, exported or imported or transit through United Republic of Tanzania (g) facilitate capacity building in collaboration with to the implementation of these Regulations; on matters stakeholders related (h) co-ordinate, monitor the implementation and enforcement of the provisions of these Regulations; assess and (i) monitor and assess the effectiveness of activities being carried out by relevant Competent Authority in order these Regulations; to ensure compliance with (j) promote public participation and awareness on access and benefit sharing of genetic resources and 9 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) associated traditional knowledge; (k) Receive from the Competent Authority inspection reports on authorisation of the country of origin of the genetic resources imported into or exported from or through Tanzania; and (l) perform any other functions necessary for effective implementation of these Regulations. Competent Authority Cap. 226 Functions of Competent Authority - 9
AI-assisted research summary: This provision defines which bodies are called the Competent Authority for compliance and enforcement, and separately names the Tanzania Commission and Technology for Science for research-related matters.
9.-(1) For the purpose of compliance and enforcement of these Regulations, relevant government offices, ministries, departments, agencies, local government authorities and institutions responsible for management over specific genetic resources or associated traditional knowledge shall be known as Competent Authority. (2) Without prejudice to sub-regulation (1), the Tanzania Commission and Technology for Science established by the Tanzania Commission for Science and Technology Act shall be Competent Authority in relation to management, monitoring, promoting and coordinating research on genetic resources or associated traditional knowledge. - 10 Verify source ↗
National Focal Point
AI-assisted research summary: The Competent Authority must carry out listed functions for access to genetic resources and associated traditional knowledge.
10. the Competent Authority shall have the following functions- (a) receive and process application for a permit to access genetic resources or associated traditional knowledge; (b) review the application and recommend to the National Focal Point in writing on the issuance of Export Clearance Certificate of genetic resources or associated traditional knowledge; (c) collaborate with the ministry responsible for local government authority in the process of application resources or associated to access genetic traditional local government or local community; knowledge managed by (d) collaborate with the National Focal Point or other relevant authorities, in monitoring the utilisation 10 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) of genetic resources or associated traditional knowledge; (e) ensure protection of rights of the local community in which genetic resources or associated traditional knowledge are found; (f) establish a depository for representative samples, information, technology or associated traditional knowledge of genetic materials accessed, imported or exported; (g) submit to the National Focal Point annual reports these implementation of the to relating Regulations; (h) to ensure that technology transfer or information exchange in relation to genetic resources or associated traditional knowledge is affected by persons accessing them; (i) facilitate negotiation and conclusion of all Material Transfer Agreement, Data Sharing Agreement and Mutual Agreed Terms include terms and conditions upon which access is to be granted; (j) ensure that all Materials Transfer Agreements, Data Sharing Agreements and Mutual Agreed Terms contain sufficient provisions for the sharing of benefits arising out of use or application of genetic traditional resources or knowledge of Tanzania; associated local community (k) ensure inclusion, involvement and engagement of the process of relevant accession of genetic resources or associated traditional knowledge found within their area, including their prior informed consent; and in (l) perform any other functions necessary effective implementation of these Regulations. for Responsibil ities of local governmen - 11
AI-assisted research summary: Local government authorities managing genetic resources or associated traditional knowledge must help applicants access them and carry out related protection, advice, participation, record-keeping, and community-rights functions.
11. For avoidance of doubt, the local government authorities managing genetic resources or associated traditional knowledge found in their area of jurisdictions shall 11 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) t authorities have responsibilities to- (a) facilitate applicant to access genetic resources or associated traditional knowledge; (b) ensure the right of local communities over genetic resources or associated traditional knowledge is protected; (c) participate in the process of access to genetic resources or associated traditional knowledge; (d) provide advice on issues related to access or use of traditional resources or associated genetic knowledge; (e) protect cultural norms, rights, value or heritage on traditional resources or associated genetic knowledge; and (f) keep records of agreements and written prior informed consent. Duties of local communiti es - 12 Verify source ↗
Responsibilities of local government authority
AI-assisted research summary: Local communities must carry out listed responsibilities for genetic resources and traditional knowledge in their area.
12. Local communities shall have responsibilities to- (a) issue a written prior informed consent on access to genetic traditional knowledge found within their area as prescribed in the First Schedule; resources or associated (b) conserve and manage genetic resources; (c) preserve and protect traditional practices, norms and ethic derived from availability of genetic resources or associated traditional knowledge; (d) use genetic resources or associated traditional knowledge found within their area of jurisdiction in a sustainable manner; and (e) preserve or protect any other traditional knowledge; PART V CONTROL AND MANAGEMENT OF ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES Access to genetic
Part
PART V
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Access to genetic resources
AI-assisted research summary: A person must not access, develop, or use Tanzania’s genetic resources or associated traditional knowledge without a permit from the competent authority.
13. A person shall not access, develop or utilise 12 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) resources genetic resources or associated traditional knowledge of Tanzania without obtaining a permit from appropriate Competent Authority. Application of Access Permit - 14 Verify source ↗
Application of Access Permit
AI-assisted research summary: A person intending to access genetic resources or associated traditional knowledge must apply for an Access Permit from the appropriate Competent Authority.
14. A person who intends to access genetic resources or associated traditional knowledge for commercial or non- commercial purposes, shall apply for Access Permit from the appropriate Competent Authority. Procedures for application of Access Permit - 15 Verify source ↗
Procedures for application for Access Permit
AI-assisted research summary: When deciding Access Permit applications, the Competent Authority must check the listed consent, benefit-sharing, environmental, public-interest, and legal-compliance factors.
15.-(1) Procedures for application of the Access Permit shall be in accordance with the laws governing specific genetic traditional knowledge. resources or associated (2) Without prejudice to sub-regulation (1) and any other written law related to genetic resources or associated traditional knowledge, every Competent Authority shall, when dealing with application for Access Permit to such resources adhere to the following: (a) a written prior informed consent which has been obtained from local community or respective local government authority; (b) a Benefit Sharing Agreement framework which is established in accordance with these Regulations; (c) whether conservation status of a genetic resource is known; (d) whether the impact to the local community is assessed; (e) whether the access will cause genetic erosion or affect any function of the ecosystem; (f) the access may not adversely affect food security; (g) the use of the genetic resource or associated traditional knowledge is not for the purposes contrary to the national interest; (h) the use of the genetic resource or associated traditional knowledge is not for the development of biological or chemical weapons for military or terrorism purposes; (i) the applicant has not committed an offence under 13 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) Responsibil ities of Access Permit holder any other laws applicable in or outside Tanzania; (j) the applicant has not been declared bankrupt or insolvency; (k) the application complies with the requirements of these Regulations or any other written law; and (l) the use of genetic resources or associated traditional knowledge is not contrary to the related international agreements or instruments to which the United Republic of Tanzania is a party. - 16 Verify source ↗
Responsibilities of Access Permit holder
AI-assisted research summary: The Access Permit holder must follow transfer or sharing agreements, report discoveries to the Competent Authority, submit semi-annual and annual status reports, and provide a final report if collection lasts three months or less.
16. The Access Permit holder shall have responsibilities to- (a) adhere to Materials Transfer or Data Sharing Agreements in accordance with these Regulations; (b) inform the Competent Authority of all discoveries made during the validity of the granted Access Permit; (c) provide a semi-annual and annual report on the status of ongoing collection for genetic resources and associated traditional knowledge; (d) In the event that the collection is of a duration of three months or less, provide a final report of collection of genetic resources or associated traditional knowledge; and (e) ensure the benefit arises from genetic resources or associated traditional knowledge are shared in accordance with these Regulations. Restriction for export - 17 Verify source ↗
Restriction for export
AI-assisted research summary: A person must not export genetic resources unless an export clearance certificate prescribed in the Second Schedule is obtained.
17. A person shall not export genetic resources without export clearance certificate prescribed in the Second Schedule. Application for export clearance certificate
Part
Schedule.
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Application for Export Clearance Certificate
AI-assisted research summary: A person intending to export genetic resources must apply to the National Focal Point for an export clearance certificate.
18.-(1) A person who intends to export genetic resources for commercial or non-commercial purposes, shall apply for export clearance certificate to the National Focal Point. (2) An application for export clearance certificate shall be made in a prescribed Form in the Third Schedule. 14 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) Accompan ying documents - 19 Verify source ↗
Accompanying documents
AI-assisted research summary: An application for an export clearance certificate must be submitted with several listed documents and proof of the fee payment, and the National Focal Point may require additional relevant information or documents.
19. An application for export clearance certificate shall be accompanied by- (a) a written prior informed consent from a local resources or community managing genetic associated traditional knowledge; (b) access permit or research permit issued by a Competent Authority; (c) Benefit Sharing Agreement; (d) Mutual Agreed Terms; (e) Material Transfer Agreement; (f) proof of payment of an application fee prescribed in the Fourth Schedule; and (g) any other relevant information or document as may be required by the National Focal Point upon submission of the application. Import or transit clearance - 20 Verify source ↗
Import or transit Clearance
AI-assisted research summary: A person importing or transiting genetic resources through Tanzania must declare them to customs at the border and show proof that they were lawfully acquired from the country of origin.
20. For the purpose of compliance to the Nagoya Protocol, a person imports in or transit genetic resources through Tanzania shall, declare the genetic resources in his possession or under his control to customs at the point of entry or exit, and shall provide evidence of lawful acquisition of such genetic resources from the country of origin. Restriction on transfer of permit - 21 Verify source ↗
Restriction on transfer of permit
AI-assisted research summary: An export clearance certificate or access permit issued under these Regulations cannot be transferred unless the issuing authority authorises it.
21. Export clearance certificate or access permit issued under these Regulations shall not be transferable without authorisation of issuing authority. intellectual property rights local community for - 22 Verify source ↗
Intellectual property rights for local community
AI-assisted research summary: The National Focal Point must help protect community intellectual property rights in local communities.
22.-(1) The National Focal Point shall facilitate protection of the community intellectual property rights as they have enshrined and protected under the norms, practices and customary law found in or within local communities whether such law is written or not. (2) The publication of any written or oral information of a genetic resource, associated traditional knowledge, the presence of genetic resources in a gene bank, any other collection or its local use may not preclude the local intellectual community from exercising its community 15 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) Validity of export clearance certificate Suspension , cancelation or revocation of export clearance certificate property rights in relation to the genetic resources or associated traditional knowledge. - 23 Verify source ↗
Validity of Export Clearance Certificate
AI-assisted research summary: An export clearance certificate is valid for the period stated in it and applies only to the genetic resources or associated traditional knowledge specified in it.
23. Export clearance certificate issued under these Regulations shall be- (a) valid for the period specified in it; and (b) applicable to the genetic resources or associated traditional knowledge specified therein. - 24 Verify source ↗
Suspension, cancelation or revocation of Export Clearance Certificate
AI-assisted research summary: If the certificate holder breaches the certificate’s terms or conditions, the National Focal Point may notify them in writing and start suspension, cancellation, or revocation.
24.-(1) Where the holder of export clearance certificate contravenes any of the terms or conditions imposed, the National Focal Point shall through a written notice, notify the holder on the intention to suspend, cancel or revoke the permit. (2) The holder of export clearance certificate shall be required, within thirty days of receipt of the notice to show course as to why the certificate should not be suspended, cancelled or revoked. (3) Upon receipt of representation, the National Focal Point shall within fourteen working days communicate the decision to the export clearance certificate holder. (4) Where the National Focal Point suspends, cancels or revokes an export clearance certificate, shall publish such decision at least in three newspapers with nationwide circulation. Monitoring of compliance of access permit or export clearance certificate - 25 Verify source ↗
Monitoring of compliance of Access Permit or Export Clearance
AI-assisted research summary: The Competent Authority and the National Focal Point must monitor compliance with the conditions in an access permit and an export clearance certificate.
25.(1) The Competent Authority shall be required to monitor compliance of terms and conditions set out in the access permit in accordance with these Regulations or relevant legislation of such specific genetic resources or associated traditional knowledge. (2) The National Focal Point shall monitor compliance of the terms and conditions set out in the export clearance certificate. 16 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) PART VI BENEFIT SHARING MECHANISMS Benefit Sharing
Part
PART VI
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AI-assisted research summary: Benefit from genetic resources and associated traditional knowledge must be shared, and certain holders or collectors must facilitate or pay fees in specific cases.
26.-(1) The benefit accrued from collection, modification and utilization of the genetic resources or associated in accordance with the principles of fairness and equitable and Mutually Agreed Terms. traditional knowledge shall be shared (2) The export clearance certificate holder shall facilitate both monetary and non-monetary sharing of benefit arising from the use of genetic resources or associated traditional knowledge. (3) For the purpose of this regulation- (a) monetary benefit may include- (i) (ii) access fee and fee per sample collected or acquired; fee for analysis of collected or acquired sample; upfront payments; (viii) (ix) (iii) (iv) milestone payments; (v) payment of loyalties; (vi) research funding; (vii) joint ownership of relevant intellectual property rights; joint ventures; license fee in case of the genetic resource or its associated knowledge is to be utilised for commercial purposes; fees to be paid to trust fund supporting conservation and sustainable use of biodiversity; export acquired; and salaries and professional mutually agreed; (b) non-monetary benefit may include- fee per sample collected or fee where (xii) (xi) (x) (i) collaboration, cooperation and contribution in scientific research and development 17 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) (v) (ii) (iii) (iv) to use genetic research and development programmes; sharing of results; participation in product development; permission resource facilities including laboratory and database of the collaborating parties; transfer of knowledge and related to genetic resources; capacity building; permission to use scientific information relevant to conservation and sustainable use of biological resources; permission to collect sample; equipment and infrastructure support; or community development support. (4) Where genetic resources or associated traditional knowledge is collected in a protected area, the collector shall pay entry fee and other applicable fee to the respective Competent Authority. (viii) (ix) (x) technology (vi) (vii) (6) Dividend of profit derived from the use of genetic resources or associated traditional knowledge shall be shared in accordance with these Regulations and the Mutual Agreed Terms. Categories for benefit sharing - 27 Verify source ↗
28. Written Prior Informed Consent
AI-assisted research summary: Benefit Sharing Agreements must depend on the specific purpose of access to genetic resources or associated traditional knowledge.
27. Benefit Sharing Agreements shall depend on the specific purpose of access to genetic resources or associated traditional knowledge which may include commercial or non- commercial purposes. Written prior informed consent - 28 Verify source ↗
Written Prior Informed Consent
AI-assisted research summary: A collector must not access Tanzania’s genetic resources or associated traditional knowledge without written prior informed consent from the relevant Competent Authority.
28. (1) A collector shall not access genetic resources or associated traditional knowledge of Tanzania without a written prior informed consent from relevant Competent Authority. (2) Without prejudice to sub-regulation (1), a written prior informed consent shall be granted in accordance with manner prescribed in the relevant written law governing traditional specific genetic resources or associated 18 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) knowledge. Access and Benefit Sharing Agreement - 29
AI-assisted research summary: Before accessing or using genetic resources or associated traditional knowledge, the applicant and the relevant Competent Authority must negotiate and sign a Benefit Sharing Agreement.
29.-(1) Before access or utilisation genetic resources or associated traditional knowledge the applicant and relevant Competent Authority shall negotiated and entered into a Benefit Sharing Agreement. (2) The Benefit Sharing Agreement shall to contain the following: (a) full details of the parties to the agreement which include- (i) (ii) (iii) (iv) (v) names; identification; address; registration number and business address for a business person; and any other related information which may be required by a Competent Authority; (b) information and description of intended genetic resources to be accessed, which may include- the (i) (ii) (iii) (iv) (v) name of the genetic resource or associated traditional knowledge to be accessed; type of genetic resources; quantity of genetic collected; geographical or ecological area where the genetic resource is to be collected; and any other related information which may be required by a Competent Authority; resources to be (c) description of time intended to be spent in access and other stages of utilization of genetic resources or associated traditional knowledge; (d) description on purpose of access of genetic resources or associated traditional knowledge; (e) intended use of the genetic resources or associated traditional knowledge; (f) modality and type of benefit sharing; (g) rights and responsibilities of parties providing or 19 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) accessing the genetic resources or associated traditional knowledge and Benefit Sharing Agreement; (h) ownership and management of data and research findings; (i) reason for suspension or termination of agreement; (j) procedure for termination of access permit; (k) consequences of the breach of conditions of Mutual Agreed Terms; terms and (l) conditions in relation to intellectual property rights associated with genetic resources or associated traditional knowledge; (m) limitations if any on the possible use of the genetic resources or associated traditional knowledge; (n) strategy relating to biodiversity conservation; (o) right and obligation of parties; (p) settlement of disputes; (q) amendments; (r) description on force majure; and (s) such other relevant information as may be required facilitation Benefit Sharing for necessary Agreement. Copies of agreement these - 30
AI-assisted research summary: Agreements made under these Regulations must be prepared in six original copies and distributed to the listed recipients.
30.-(1) Any agreement concluded under Regulations shall be in six original copies to be distributed to- (a) applicant or collector; (b) Competent Authority; (c) National Focal Point; (d) manager or authorised representative of genetic resources or associated traditional knowledge; (e) local government authority where the genetic resources or associated traditional knowledge is found; and (f) local community in case the genetic resources or associated traditional knowledge managed by a person. 20 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) Review of Benefit Sharing Agreement - 31 Verify source ↗
Benefit Sharing Agreement
AI-assisted research summary: The benefit sharing agreement’s terms must be reviewed within the time agreed in the agreement, and signed provisions may be amended after consultation and approval by the parties.
31.-(1) Terms and conditions in the Benefit Sharing Agreement shall be reviewed within the time agreed and provided in the agreement between the parties. (2) Any provision of the signed Benefit Sharing Agreement may be amended after consultation and approval of the parties to the agreement. RIGHTS OVER ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES PART VII Rights of local community
Part
PART VII
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AI-assisted research summary: Local communities have rights to access, be consulted, participate, and share benefits in relation to genetic resources or associated traditional knowledge in their area, when those resources or knowledge are found within their jurisdiction.
32. Local communities shall, where the genetic resources or associated traditional knowledge are found within their areas of jurisdiction, have right to- (a) access of genetic resources or associated traditional knowledge for consumption; (b) be consulted for issuance of a written prior informed consent on access to genetic resources or associated traditional knowledge; (c) participate in scientific research and other activities involving genetic resources or associated traditional knowledge collected from their area of jurisdiction; and (d) share monetary or non-monetary benefits arising from utilisation of genetic resources or associated traditional knowledge found within their area of jurisdiction. - 33 Verify source ↗
Rights of local community
AI-assisted research summary: A holder of an access permit or export clearance certificate has rights to access genetic resources or associated traditional knowledge, use them sustainably, share in benefits, and seek renewal or extension of the permit, subject to the permit and applicable regulations.
33. Access permit or export clearance certificate holder shall have right to- (a) access to genetic resources or associated traditional knowledge as per the granted access permit; (b) sustainable use as per the terms and condition set out in the access permit or export clearance certificate; (c) fair and equitable sharing of benefit arising from the utilisation of such genetic resources or 21 Rights of access permit or export clearance certificate holder Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) associated traditional knowledge in accordance with these Regulations; and (d) renew or extend access permit in accordance with specific legislations governing the Competent Authority issued the permit. specific PART VIII GENERAL PROVISIONS Offences and penalties
Part
PART VIII
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AI-assisted research summary: A person must not access genetic resources or associated traditional knowledge without written approval from the Competent Authority, and violations can lead to fines, imprisonment, or both.
34. -(1) A person who- (a) access genetic resources or associated traditional knowledge without a written approval issued by Competent Authority; (b) breach any terms and conditions attached to the permit granted under these Regulations or any other relevant laws; (c) fails to furnish information related or connected to resources or associated these access traditional knowledge Regulations or relevant laws; required under to genetic (d) provide false, misleading or deceptive information in order to secure an approval; and commits an offence and shall, on conviction be liable to a fine of not less than fifty thousand shillings but not exceeding one billion shillings or to imprisonment for a term of not less than three months but not exceeding seven years or to both. (2) A person shall, on conviction of an offence under subregulation (1), be prohibited from accessing genetic resources or associated traditional knowledge of Tanzania. Transitiona l period - 35
AI-assisted research summary: Existing access permit holders must comply with these Regulations within 12 months from commencement.
35.-(1) Access permit holder engaged in access to genetic resources or associated traditional knowledge before coming into force of these Regulations, shall be required to comply with the requirements of these Regulations within twelve months from the date commencement. (2) Without prejudice the provision of subregulation (1), any payment payable for access to genetic resources or associated traditional knowledge in accordance to 22 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) Duty to give feedback Record keeping Appeals with these Regulations or any other written law shall be paid during the transitional period. - 36
AI-assisted research summary: The holder of an access permit or export clearance certificate must give feedback on results, developments, or naturalized breeds connected to the accessed genetic resources or associated traditional knowledge.
36. The access permit or export clearance certificate holder granted under these Regulations or any other relevant laws, shall be required to give feedback of any result, development or naturalized breeds connected to the genetic resources or associated traditional knowledge accessed. - 37
AI-assisted research summary: An access permit holder or export clearance certificate holder must keep transaction information, documents, and records connected to accessed genetic traditional knowledge.
37. The access permit holder or export clearance certificate holder, shall be required to keep information, documents and records of transactions connected to the genetic traditional knowledge accessed. resources or associated - 38
AI-assisted research summary: A person aggrieved may appeal to the Minister, usually within 30 days, and the Minister must decide within 14 days of receipt and tell the appellant the decision and reasons within 7 days.
38.-(1) A person aggrieved by the decision made under these Regulations, in accordance with the provision of the Act. (2) Where an appeal under subregulation (1) lies to the Minister, it shall be made, within thirty days from the date of decision and shall be by way of a letter stating the grounds of these appeal attached with Regulations and any necessary documents as the Minister may require. the decision made under (3) The Minister shall make decision on the appeal within fourteen days from the date of receipt of an appeal. (4) The Minister shall within seven days from the date of his decision, communicate his decision and the reasons for the decision to the appellant Powers to issue policy guidelines or directives - 39 Verify source ↗
Offences and Penalties
AI-assisted research summary: The Minister may issue policy guidelines or directives to help implement these Regulations.
39. The Minister may issue policy guidelines or directives to facilitate effective implementation of these Regulations. 23 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) ___________ FIRST SCHEDULE ____________ (Made under regulation 12(a)) PRIOR INFORMED CONSENT FORM FOR ACCESS TO GENETIC RESOURCES OR ASSOCIATED TRADITIONAL KNOWLEDGE I/We ................................................................................................................................................... ..... being the manager/custodian of the following genetic resources or associated traditional knowledge: ................................................................................................................................................... ..... ................................................................................................................................................... ..... (State the type of genetic resources or associated traditional knowledge) Provide location Information Village/street: ………………………………………………………………. Ward:………………………………………………………………………… District/Town/Municipal/City:…………………………………………….. Region:……………………………………………………………………… hereby consent that ............................................................................................................... (Name and address of applicant for prior informed consent) may apply to the Competent Authority for consideration to access the above stated genetic resources or associated traditional knowledge found in my/our management/custody. This consent is granted subject to the following conditions- (1) ..................................................................................... (2) ..................................................................................... (3) ..................................................................................... (4) ..................................................................................... This of…………………….20………….. consent is granted this………………………… day …………………………………………… Signature/Seal of the Managing Authority 24 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) _______________ SECOND SCHEDULE ________________ (Made under regulation 17) THE UNITED REPUBLIC OF TANZANIA THE ENVIRONMENTAL MANAGEMENT (ACCESS AND BENEFIT SHARING OF GENETIC RESOURCES) REGULATIONS, __________ EXPORT CLEARENCE CERTIFICATE This is to certify that Certificate No...................……. granted ………………..................................……of P. O. Box………....……………… clearance has from resources been ...................................................................…….(name country of origin of the genetic resources) to..............................................................................................(name transit (if any) and country) ……………………………………………………………………………………… destination genetic export to List by name, type and size of genetic resources knowledge collected and intended to be exported …………………………………………………………………………………………………… …………………………………………………………………………………………………… …………………………………………………………………………………………………… …… This certificate is to acknowledge that the above-mentioned collector, obtained an Access Permit as a requirement for an approval to export the above-mentioned genetic resources of Tanzania origin. The certificate is to approve that, the permit holder be allowed on transit and accepted in the country of destination with such genetic resources. This certificate shall not be valid for any subsequent export. Terms and conditions for this certificate are set out overleaf. Name…………………………….…………………...…. Signature ……………….……………………………... Date……………………….……………………………… 25 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) Minister responsible for Environment ____________ THIRD SCHEDULE ____________ (Made under regulation 18(2)) ____________ APPLICATION FOR EXPORT CLEARANCE CERTIFICATE To*: ...........................................................(address of the National Focal Point) ................................................................... ............................................................ ….. ……………………………………………. I/We*..............................................................of apply for.............................................................................................................................................. ................... .................................................... here by The Export Clearance Certificate is being applied in respect of the following genetic resources (attach the Access Permit) issued by the relevant Competent Authority. ................................................................................................................................................... ..... ................................................................................................................................................... ..... I/We* hereby further declare that to the best of my/our knowledge that, the information given in this application is correct and true. __________________________ ______________________________ Date of Applicant Signature FOR OFFICIAL USE ONLY Application received and worked by ................................................................................ (name of the officer) This………………………..day ………………………………………..20………………… *Delete whichever is not applicable of 26 Environment Management (Access and Benefit Sharing of Genetic Resources) Regulations GN. No. 368 (Contd) _____________ FOURTH SCHEDULE ____________ (Made under regulations 19(f)) FEES FOR EXPORT CLEARANCE CERTIFICATE PURPOSE NON-CITIZEN PRESCRIBED FEES NON COMMERCIAL Application for Export Clearance Certificate of genetic resources Individual: USD 150 Corporate: USD 300 FOR COMMERCIAL Application for Export Clearance Certificate of genetic resources Pharmaceutical’s: USD 1,000 Other product: USD 1,500 NON COMMERCIAL CITIZEN Application for Export Clearance Certificate of genetic resources Individual: Tzs 50,000/= Corporate: Tzs 150,000/= FOR COMMERCIAL Application for Export Clearance Certificate of gnetic esources Pharmaceutical: Tzs 200,000/= Other products: Tzs 1,000,000/= SELEMAN SAID JAFO Dodoma, ……………….., 2024 Minister of State- Vice President’s Office Union and Environment 27
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The Environmental Management (Access and Benefit Sharing of Genetic Resources) Regulations, 2024
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