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Interim National Reports on the Implementation of the Nagoya Protocol
(NR)
published: 01 Nov 2017
last updated: 09 Jul 2018
No country selected.
Interim national report on the implementation of the Nagoya Protocol
CHM-NFP-ZA-209342-2
ABS National Focal Point
Mr. Stanley Tshitwamulomoni
This document has been updated. This is not the latest published version.
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Yes
Yes
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) (NEMBA) is the framework legislation which includes in Chapter 6 regulatory provisions on Bioprospecting, Access and Benefit Sharing.
Chapter 6 of NEMBA was given effect by the Regulations on Bioprospecting, Access and Benefit Sharing (BABS Regulations) which entered into force on 1 April 2008. These Regulations have since been amended and came into force on 19 May 2015.
The amended Regulations prescribe the notification process for the discovery phase of bioprospecting involving any indigenous genetic and biological resources contemplated in section 81A (2) of the Act and further prescribe the permit system set out in Chapter 7 of the Act insofar as that system applies to bioprospecting involving any indigenous genetic and biological resources or export from the Republic of any indigenous genetic and biological resources for the purpose of bioprospecting or any other kind of research. In addition, the amended Regulations set out the form and content of, and requirements and criteria for benefit-sharing and material transfer agreements and the administration process of the Bioprospecting Trust Fund.
Yes
The National Department of Environmental Affairs is a National Focal Point
Yes
The National Department of Environmental Affairs is the Competent National Authority
No selection made
Yes
Insufficient human resource capacity.
• South Africa has issued 56 permits since 2008 when the ABS law came into force.
• Copies of these permits are not available in the ABS Clearing House, because they are treated as Confidential Information in terms of the South African ABS law.
Not applicable, since no access requirements are in place
Yes
South Africa has published 9 IRCC
Yes
South Africa has the following check points which are operational but not yet formalised through the ABS Clearing House.
• Patent office,
• Ports of Entry & Exit,
• Provincial Permit Issuing Authorities, and
• National Department of Environmental Affairs
No additional information provided
Insufficient human resource capacity.
Yes
Yes
The BABS Regulations provides for fair and non-arbitrary rules for people that want to access indigenous biological resources for bioprospecting in South Africa. The procedure and rules are the same to all persons. However, the Regulations provides that a permit application may only be submitted by;
(a) a natural person registered in terms of South African law;
(b) a natural person, who is a South African citizen or permanent resident of South Africa; or
(c) a juristic person that is not registered in terms of South African law or a natural person who is not a South African citizen or permananet resident of South Africa, if that juristic person or foreign national applies jointly with juristic or natural person reffred to in paragraph (a) or (b) above
Yes
The BABS Regulations provides for clear information on how to apply for PIC as provided in Article 6.3(c). Section 82 of the Act states that the applicant must disclosed all material information relating to the bioprospecting to the relevant stakeholders and on the basis of that disclosure, has obtained prior consent of the stakeholder to use any of the stakeholder’s knowledge of or discoveries about the indigenous biological resources for the proposed bioprospecting. Further, the applicant and stakeholder involved must negotiate and conclude material transfer agreement and benefit sharing agreement.
Yes
Yes
South Africa’s legislative framework provides for the issuance of permit for access and utilisation of the indigenous biological resources for bioprospecting. Section 81 of the Act, provides for permit requirements when one is engaged in comercilsisation phase of bioprospecting involving any indigenous biological resources for the purpose of bioprospecting or any other kind of research.
0
Copies of these permits are not available in the ABS Clearing House, because they are treated as Confidential Information in terms of the South African ABS law
Yes
The Act and Regulations require the establishment of MAT in the form of material transfer agreement and benefit sharing agreement. Section 82, 83, 84 of the Act and regulations 38 & 39 of the Regulations states that benefit sharing agreement which provides for the sharing of the benefits derived from bioprospecting involving the indigenous biological resources or associated traditional knowledge must be concluded by the applicant and the stakeholder.
Yes
Yes
Monetary benefits: More than two million rands has been paid to the stakeholders providing access to Genetic Resources.
Yes
Non-monetary benefits: various community development projects implemented.
Yes
Yes
Monetary benefits: More than four million rands has been paid to the stakeholders providing access to traditional knowledge associated with genetic resources.
Yes
Non-monetary benefits: various community development projects implemented
No additional information provided
Yes
The Act as well as the associated BABS Regulations provides for everyone in the value chain involved in the bioprospecting activities to obtain bioprospecting permit. As part of the permit application process, the application must be submitted together with material transfer agreement and benefit sharing agreement concluded with Traditional Knowledge holders as well as stakeholders providing access to the genetic resources. This is to ensure that benefits arising from the commercialisation and the subsequent user/application are shared with the provider country through stakeholders involved.
Yes
Section 82 of the Act requires the issuing authority considering the application for permit to protect any interests of the following stakeholders may have in the proposed bioprospecting project. Stakeholders in this regards refers to:
a) A person, including organ of state or community providing or giving access to the indigenous biological resource
Further, the applicant and the stakeholders have to enter into benefit sharing agreement and material transfer agreement that provides for sharing by stakeholders in any future benefits that may be derived from the relavant bioprospecting in accordance with section 82(2).
Yes
Section 82 of the Act requires the issuing authority considering the application for permit in accordance with this section protect any interests any of the following stakeholders may have in the proposed bioprospecting project. Stakeholders in this regards refers to:
indigenous community-
i) whose traditional uses of the indigenous biological resources to which the application relates have initiated/or will contribute to or form part of the proposed bioprospecting.
ii) whose knowledge of or discoveries about indigenous biological resource to which application relates are to be used for proposed bioporpscting.
Further, the applicant and the stakeholders have to enter into benefit sharing agreement and material transfer agreement that provides for sharing by stakeholders in any future benefits that may be derived from the relavant bioprospecting in accordance with section 82(3).
The benefit sharing agreement requirements provide for two categories of benefits sharing with the indigenous and local communities namely;
1. For access to the indigenous biological resources utilised for bioprospecting; and
2. For access to traditional knowledge whose uses on the indigenous biological resources have initiated or contributed to or form part of the proposed bioprosceting.
No additional information provided
No
No selection made
No selection made
The Act is currently undergoing amendment process to include legislative measures to ensure that genetic resources utilised with jurisdiction have been accessed in accordance with PIC and that MAT have been established in accordance with Article 15.1 of the Nagoya Protocol.
However, if the issuing authority comes across a situation where a South African based Institution want to utilise genetic resources accessed from other Countries within South African jurisdiction- they always request for documentation to confirm compliance with the provider countryis regulatory requirements. Further, the National Focal Point on ABS of the provider country is notified by the South African National Focal Point on ABS.
No
No selection made
No selection made
The Act is currently undergoing amendment process to include legislative measures to ensure that traditional knowledge associated with genetic resources utilised with jurisdiction have been accessed in accordance with PIC and that MAT have been established in accordance with Article 16.1 of the Nagoya Protocol.
However, if the issuing authority comes across a situation where a South African based Institution want to utilise traditional knowledge associated with genetic resources accessed from other Countries within South African jurisdiction- they always request for documentation to confirm compliance with the provider country is regulatory requirements. Further, the National Focal Point on ABS of the provider country is notified by the South African National Focal Point on ABS.
Yes
When indigenous biological resources is exported to other countries, the user should provide permit as proof of compliance to the provider country. i.e at Port of entry and Port of exit.
Yes
If the user does not provide proof of compliance with the regulatory requirements of the provider country, the National Focal point alerts the National Focal Point of the provider country about the resources that are being imported into South Africa for them to take the necessary action.
Further, the Patents Amendment Act of 2015, has been amended to include section “(3A) Every applicant who lodges an application for a patent accompanied by a complete specification shall, before acceptance of the application, lodge with the registrar a statement in the prescribed manner stating whether or not the invention for which protection is claimed is based on or derived from an indigenous biological resource, genetic resource, or traditional knowledge or use. (3B) The registrar shall call upon the applicant to furnish proof in the prescribed manner as to his or her title or authority to make use of the indigenous biological resource, genetic resource, or of the traditional knowledge or use if an applicant lodges a statement that acknowledges that the invention for which protection is claimed is based on or derived from an indigenous biological resource, genetic resource, or traditional knowledge or use.”
Yes
No
No
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) and related BABS Regulations were promulgated before the coming into force of the Nagoya Protocol; however; the legislation is currently going through amendment, which would also result in the amendment of the Regulations and the provision to encourage users and providers to include provisions in MAT to share information on the implementation of such terms as provided under Article 17.1 (b) would be included.
No
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) and related BABS Regulations were promulgated before the coming into force of the Nagoya Protocol; however; the legislation is currently going through amendment, which would also result in the amendment of the Regulations and the provision to encourage the use of cost-effetive communication tools and systems as provided under Article 17.1 (c would be included.
No additional information provided
Not applicable, since no access requirements are in place
No
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) and related BABS Regulations were promulgated before the coming into force of the Nagoya Protocol; however; the legislation is currently going through amendment, which would also result in the amendment of the Regulations and the provision to cover dispute resolution as provided under Article 18.1 would be included.
Yes
The scope of offences provided in the BABS Regulations includes disputes arising from MAT as provided in Article 18.2. However, a more effective legal systems is under development through the current amendment of the National Environmental Management: Biodiversity Act, 2004 ( Act No.10 of 2004) and its BABS Regulations.
Yes
The scope of offences provided in the BABS Regulations includes disputes arising from MAT as provided in Article 18.2 which is also supported by access to justice at national level. However, a more effective legal systems is under development through the current amendment of the National Environmental Management: Biodiversity Act, 2004 ( Act No.10 of 2004) and its BABS Regulations to deal with issues of access to justice in a foreign country.
No
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) and related BABS Regulations were promulgated before the coming into force of the Nagoya Protocol; however; the legislation is currently going through amendment, which would also result in the amendment of the Regulations and the provision to provide for the utilization of mechanism regarding mutual recognition and enforcement of foreign judgements and arbitral awards.
No additional information provided
Yes
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) and related BABS Regulations includes provisions for simplified measures on access for non-commercial research purposes.
No
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) and related BABS Regulations were promulgated before the coming into force of the Nagoya Protocol; however; the legislation is currently going through amendment, which would also result in the amendment of the Regulations and includes provision to cover cases of present or imminent emergencies would be included.
No
The National Environmental Management:Biodiversity Act, 2004 (Act No. 10 of 2004) and related BABS Regulations were promulgated before the coming into force of the Nagoya Protocol; however; the legislation is currently going through amendment, which would also result in the amendment of the Regulations and includes provisions for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits.
Yes
The national strategic documents have already considered the importance of genetic resources for food and agriculture and their special role for food security.
No additional information provided
Yes
Yes
The National Environmental Management: Biodiversity Act of 2004 provides for the following:
Section 82. (1) states that “Before a permit referred to in section 81(1)(a) or (b) is issued, the issuing authority considering the application for the permit must in accordance with this section protect any interests any of the following stakeholders may have in the proposed bioprospecting project:
(a) A person, including any organ of state or community, providing or giving access to the indigenous biological resources to which the application relates; and
(b) an indigenous community—
(i) whose traditional uses of the indigenous biological resources to which the application relates have initiated or will contribute to or form part of the proposed bioprospecting; or
(ii) whose knowledge of or discoveries about the indigenous biological resources to which the application relates are to be used for the proposed bioprospecting.
Bioprospecting, Access and Benefit Sharing Amendment Regulations of 2015 provides for the following:
Section 38. (1) states that “Parties to a material transfer agreement are the applicant and the stakeholder or stakeholders contemplated in section 82(1) (a) of the Act for the provision of access to the indigenous genetic and biological resources to which the application for any of the permits relates.”
Yes
Section 82 (2) of NEMBA states that “If a stakeholder has an interest as set out in subsection (1)(a), an issuing authority may issue a permit only if—
(a) the applicant has disclosed all material information relating to the relevant bioprospecting to the stakeholder and on the basis of that disclosure has obtained the prior consent of the stakeholder for the provision of or access to such resources;
Section 38 (4) of the BABS Amendment Regulations states that “If the stakeholder, that is party to the material transfer agreement, is a community, a community resolution authorizing a representative to enter into material transfer agreement, must be in the prescribed format set out in Annexure 13 to the Regulations.
Yes
The process is provided for in NEMBA and the BABS Regulations. The Regulations further set criteria for involving the indigenous communities. A Material Transfer Agreement is concluded for access to the material and if the party giving access to the material is a commununity, a Community Resoulution as prescribed in the Regulations is required.
Yes
Section 82. (1) of NEMBA states that “Before a permit referred to in section 81(1)(a) or (b) is issued, the issuing authority considering the application for the permit must in accordance with this section protect any interests any of the following stakeholders may have in the proposed bioprospecting project:
(b) an indigenous community—
(i) whose traditional uses of the indigenous biological resources to which the application relates have initiated or will contribute to or form part of the proposed bioprospecting; or
(ii) whose knowledge of or discoveries about the indigenous biological resources to which the application relates are to be used for the proposed bioprospecting.
Yes
As already indicated above, the representatives of local and indigenous communities cannot act on behalf of them without getting approval from the entire communities.
In addition, when engaging with indigenous and local communities, the point of entry will be through the Traditional Councils which comprises of the elders and Chief of the the community. South Africa through the Department of Environmental Affairs (DEA) also encourages the communities that do not have formal structures as yet to organise themselves. Other Departments like Science and Technology (DST) and Cooperative Governance and Traditional Affairs (COGTA) are also very involved in terms of ensuring that community protocols and customary laws are taken into consideration.
Yes
The NEMBA and the associated BABS Regulations are very clear in terms of the utilisation of traditional knowledge associated with the use of indigenous genetic and biological resources. The permitting system that has been put into place to further implement ABS in South Africa, sets out the critea to be followed by potential users of traditional knowledge associated with the the genetic resources.
As a result, no ABS permit can be issued without a Benefit Sharing Agreement concluded with the traditional knowledge holders. If the traditional knowledge holders are not yet identified, the DEA usually include a condition on the permit that should the relevant traditional knowledge holders be identified, the permit holder will have to conclude a Benefit Sharing Agreement with that community.
No selection made
Yes
The DEA provides support for the development of community protocols through awareness raising workshops, one on one engagements with communities when required.
Yes
Minimum requirements for mutually agreed terms
The minimum requirements for mutually agreed terms is set out in the BABS Regulations. The Benefit Sharing Agreement format outlines the minimum terms that should be agreed upon by parties entering into an agreement. This requirements includes the following key areas amongst others:
• Sharing of benefits and the types of benefits to be shared
• Payments of benefits (When, where, how and if monetary how much will be paid)
• Review of the Benefit Sharing Agreement
• Third party transfer
• Breach and termination
• All parties outlined in the agreement, should agree to the terms of the agreement by signing.
Yes
The development of Model contractual clauses was taken into consideration during the development of the formats for permit applicatiopn forms, benefit sharing agreement and material transfer agreements and it is still being taken into consideration as the Country continue to learn through its previous experinces, best practices and challenges faced.
The clauses in agreements mentioned above, are mostly generic but flexible and can be adapted to different kinds of users and providers. For example, the Benefit Sharing Agreement can either be concluded for access to the genetic material and this is mostly in instances where a company to company transaction is invloved or where there is no traditional knowldge associated with the genetic resources. In instances where the is traditional knowledge, then the section of the agreement that deals with traditional knowledge will be completed.
In addition, with regards to the Material Transfer Agreement, the format provides for different access providers like the ones cultivating their own material, farming, breeding and also the format in which the genetic resources will be received whether extracts, leaves, stems, seeds, oil, crystals etc. Although the model contractual clauses used in all the forms can be adapted to suit different types of users and providers, they cannot be changed or any other model cannot be used except for the prescribed ones.
Yes
The DEA regulate the utilisation of indigenous genetic and biological resources for the purpose of research and commercial purposes and the utilisation of traditional knowledge associated with the use of the indigenous genetic and biological resources. The customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities is not restricted.
No selection made
No additional information provided.
South Africa’s trajectory in protecting, developing and promoting indigenous knowledge commenced with the adoption of the historic White Paper on Conservation and Sustainable Use of South Africa’s Biological Diversity and the Indigenous Knowledge Systems Policy, followed by the enactment of key pieces of legislation affirming the importance of indigenous knowledge. These include the Traditional Health Practitioners Act, Traditional Leadership Governance Framework, Access and Benefit Sharing Regulations, and amendments to Intellectual Property Laws to accommodate indigenous knowledge, amongst others.
The above measures that have been put into place to date with regards to the utlilisation of traditional knowledge associated with the genetic resources have played a big role in the implementation of ABS in South Africa. Although, as a country, we are still not at the level where we want to in terms of issues relating to traditional knowledge, but so far there is good progress.
A sue generis legislation on the protection, promotion, development and management of indigenous knowledge system is under development. In addition, there is an ongoing initiative on documenting indigenous knowledge system through the National Recordal System.
Challenges:
• The different industries are interested in complying with the law but there are those users in the industries that still have resistance in terms of concluding benefit sharing agreements with traditional knowledge holders.
• There is also a human resource capacity issue because there is still so much to be done but the officials are not enough.
Yes
The BABS Regulations provides that the monetary benefits derived from such benefit sharing agreement may be utilised to support the following:
a) Conservation of the indigenous genetic and biological resources;
b) Support for further research on indigenous genetic and biological resources and traditional knowledge;
c) Enhancement of the scientific knowledge and technical capacity to conserve, use and develop the indigenous genetic and biological resources;
d) Any other activity to promote conservation, sustainable use and development of indigenous biological resources for the benefit of South Africa; or
e) Improve livelihoods of the communities and enhancement of technical capacity of the communities or individuals involved.
No answer provided
• A national species management plan for Pelargonium species was developed
• A resource assessment for Aloe ferox species was undertaken
• A number of species utilised for ABS are being cultivated in order to reduce pressure on the wild population
No additional information provided.
The current amendment of the National Environmental Management: Biodiversity Act, 2004 ( Act No. 10 of 2004) and its BABS Regulations will provide mandatory provisions to direct a portion of the benefits arising from the utilization of genetic resources towards the conservation of biological diversity and sustainable use of its components
Yes
The current amendment of the National Environmental Management: Biodiversity Act, 2004 ( Act No. 10 of 2004) and its BABS Regulations will provide mechanism to ensure transboundary cooperation, in accordance with existing regional and subregional structures.
Not applicable, since there are no indigenous and local communities in my country
Yes
The current amendment of the National Environmental Management: Biodiversity Act, 2004 ( Act No. 10 of 2004) and its BABS Regulations will provide mechanism to ensure transboundary cooperation, in accordance with existing regional and subregional structures.
No additional information provided
Yes
The current amendment of the National Environmental Management: Biodiversity Act, 2004 (Act No. 10 of 2004) and its BABS Regulations also focuses on updating the model contractual clauses for MAT.
Yes
The current amendment of the National Environmental Management: Biodiversity Act, 2004 (Act No. 10 of 2004) and its BABS Regulations also focuses on encouraging the development and use of sector specific best practices.
No additional information provided
Yes
Yes
Several workshops and stakeholder engagement on raising awareness about ABS and how South Africa is implementing ABS and the Nagoya Protocol nationally have been conducted.
Below is a summary of awareness raising initiatives:
• Biodiversity awareness workshops with Muthi traders and traditional healers
• Indigenous Knowledge System (IKS) Bioprospecting and Product Development Platform
• Compliance awareness campaign undertaken jointly between DEA and the Traditional Healers Organisation.
• BABS workshops with various Industry Associations
• BABS workshop with various academic and research instutions
• Biennial Indigenous Knowledge System Expo
• Biennial Biodiversity Economy Indaba
• Bioprospecting Forum
Yes
Yes
South Africa is very keen in developing capacity and strengthening of human resources to effectively implement the Protocol. Officials are often exposed to workshop and seminars that strengthen their ability to implement the Protocol.
Below are some of the workshops that South African official participated in:
• Regional Training Capacity-Building Workshop for the African Region on Community Protocols, Indicators on Traditional Knowledge and Customary Sustainable Use of Biodiversity
• ABS Dialogues at various International meetings
• Capacity-building workshop on the negotiation of Mutually Agreed Terms for access to genetic resources, to support effective implementation of CBD and the Nagoya Protocol on Access and Benefit Sharing
• IDLO Capacity Building Training on establishing measures to implement the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity
Yes
The Country has received funding from the Global Environment Facility (GEF) for implementation of ABS projects
Yes
South Africa has delivered ABS Presentation at various platforms aimed at building and developing capacity for the implementation of the Nagoya Protocol both at regional, subregional and international levels.
No additional information provided
The main challenge to this is the issue of funding. Some of the activities are not implemented in time because of lack of funding.
Yes
Issues of technical and scientific research and development are the national agenda not only for the Department but for the country. The South African policies and programs support technology transfer as well as collabration and cooperation.
The BABS Regulations support and encourage the applicants for bioprospecting activities to share and transfer scientific and technological knowledge developed in the bioprospecting purposes with the skakeholders involved i.e communities providing access to indigneous genetic and bilogical resources as well as those providing traditional knowledge associated with indigenous genetic and biological resources.
Futher, the BABS Regulations require that Benefit Sharing Agreement required in terms of section 82(1)(a) and (b) of the Act to support further research on indigenous genetic and biological resources and traditional knowledge associated with indigenous genetic and biological resources; ensure enhancement of the scientific knowledge and technical capacity to conserve, use and develop indigenous genetic and biological resources.
In addition, the Department of Science and Technology has programs such as;
• Bioprospecting Platform- focuses on African Traditional Medicines, Nutraceuticals and Cosmeceuticals through the development and manufacturing of high-end products.
• Technology Innnovation Agency – is a national public entity that serves as the key institutional intervention to bridge the innovation chasm between research and development from higher education institutions, science councils, public entities, and private sector, and commercialisation.
These program also encouragre collaboration and cooperation between the applicant and the indigenous knowledge holders; also coordinate and support research and high-end skills development in strategic and emerging areas.
No additional information provided
Yes
South Africa has a well established unit within the Department of Environmental Affairs with budget allocation by the State.
No selection made
None
None
Yes
Less than 5
None
None