Biological Resources – Access and Benefit Sharing

The Way Forward

© Steve Bloom Images/Alamy

Agenda

CONVENTION ON NAGOYA EXAMPLES OF SABAH &

BIOLOGICAL PROTOCOL BENEFIT SHARING SARAWAK LAWS
DIVERSITY

FEDERAL LAW & WAY FORWARD

NATIONAL POLICY
 One of the 12 Megadiverse
Countries in the World

Tropical forests amongst the

Malaysia’s most biologically diverse

Rich
Biodiversity Over 15,000 species of Vascular
Plants

Over 152,000 species of Animal

Life
 What is Access &
Benefit Sharing about?

• It refers to the way in which genetic

resources may be accessed
• And how the benefits that result from
their use are shared between the
people or countries using the
resources (users) and the people or
countries that provide them
(providers)
• How users and providers reach
agreement on the sharing of benefits
that may result from their use
Source: https://www.cbd.int/abs/infokit/brochure-en.pdf
Difference between Biological and Genetic Resources

The genetic resources, organisms, microorganisms,

derivatives and parts of the genetic resources,
organisms, microorganisms or derivatives
Biological Resources The populations and any other biotic component
of an ecosystem with actual or potential use or
value for humanity (CBD)

Any material of plant, animal, microorganism, fungi

or other origin that contains functional units of
Genetic Resources heredity and that has actual or potential value for
humanity
International Agreement
on ABS
• Access & benefit-sharing (ABS)
is laid down in the Convention
on Biological Diversity (‘CBD’)
in the 3rd Objective of the
Treaty principles
• Elaborated in the Bonn
Guidelines (2002)
• Nagoya Protocol (2010)
supports the implementation
of the 3rd Objective
• Nationally implemented
through Access to Biological
Resources and Benefit Sharing
Act 2017.
• First international agreement to
address all aspects of biological
diversity: species, ecosystems and
genetic resources
• Signed by Malaysia at the Earth
Summit, 65th country to do so.
• Ratified 24 June 1994
• Entered into force 22 September 1994
3 Objectives
• Conservation of Biological Diversity
• Sustainable use of its components
• The fair and equitable sharing of the
benefits arising out of the utilization
of genetic resources, including by
appropriate:-
• Access to genetic resources
• Transfer of relevant
technologies
• Funding
 Nagoya Protocol
Supplementary Agreement to the CBD
Provides legal framework to
implement the 3rd objective of the
CBD: the fair and equitable sharing of
benefits arising out of the utilization
of genetic resource
Ratified on 5th November 2018
Creates greater legal certainty and
transparency for both providers and
users of genetic resources by:
Establishing more predictable
conditions for access to genetic
resources.
Helping to ensure benefit-sharing
when genetic resources leave the
country providing the genetic
resources.
Key Elements of the Nagoya Protocol
The ABC of ABS (three pillars of the Protocol):

• Access
Decision to exercise sovereign rights by requiring Prior Informed Consent for access
to genetic resources over which you have those rights
• Benefit-sharing
in a private law contract, parties agree to the type of utilization, sharing of benefits
(monetary/non-monetary) and other clauses including eg settlement of disputes
and reporting
• Compliance
obligation for Parties to the Protocol to monitor the use of genetic resources in
their jurisdiction

Other key terms include:

• Utilization
• User
• Provider
• Prior Informed Consent (PIC)
• Mutually Agreed Terms (MAT)
 Prior Informed Consent
&
Mutually Agreed Terms
• Prior informed consent (PIC) and mutually agreed terms
(MAT) are the cornerstones of any access to genetic
resources for utilization.
• Ensures a fair and equitable relationship between
provider and user of genetic resources and associated
traditional knowledge.
 Prior Informed Consent
• Stated in Article 15 of the CBD
Article 15 (5) Access to Genetic Resources
5. Access to genetic resources shall be subject to prior informed consent of the
Contracting Party providing such resources, unless otherwise determined by that
Party.

• Permission given prior to accessing genetic resources, in

line with an appropriate national legal and institutional
framework.
 Concept of Prior Informed Consent
• Based on the principle that prior to potential users
getting access to genetic resources, those affected and
those authorized to make decisions should be informed
about the potential uses in order to be able to make a
fully educated decision.
• In the context of ABS, PIC requires that:
• the provider who makes the genetic resources available gives
his/her consent through an affirmative act;
• this decision (affirmative act/consent) is based on information
provided by the potential user of the genetic resources; and
• the information is provided prior to the actual decision
(affirmative act/consent) that grants access.
 Incorporating PIC in our law
• The exact manner, extent, and procedure in which PIC
should be obtained are governed by national access
legislation OR respective state laws.
• it is important to note that Article 15(5) of the CBD refers to
“unless otherwise determined by that Party”.
• This implies that in exercising their sovereign rights over
genetic resources, Parties may decide to require or not to
require PIC for access to their genetic resources.
• Also supported by Article 15(1) of the CBD, which states
that “the authority to determine access to genetic
resources rests with national governments and is subject to
national legislation”.
 Mutually Agreed Terms (MAT)
• Where access is granted, it is conditional upon reaching
mutually agreed terms (MAT) between the Party providing
the genetic resources and the potential user
• Given their "mutually agreed" nature, MAT are contractual
arrangements and will normally be set out in private law
contracts.
• Term used in Article 15 of the CBD and establishes that
specific benefit sharing conditions must be "mutually
agreed" between providers and users of genetic resources.
• The term is also used in the Nagoya Protocol and elaborated
in the Bonn Guidelines.
The Bonn Guidelines
Bonn guidelines are relevant for institutions
and individuals involved in the negotiation of
ABS agreements.

The Guidelines outline principles and basic

requirements to be considered in the
development of mutually agreed terms,
including:
• Legal certainty and clarity
• Facilitating the transaction through clear
information and formal procedures
• Reasonable periods of time for
negotiations
• Terms set out in a written agreement
 Basic requirements for MAT
The following principles or basic requirements could be considered for
the development of mutually agreed terms:
(a) Legal certainty and clarity;
(b) Minimization of transaction costs,
(c) Inclusion of provisions on user and provider obligations;
(d) Development of different contractual arrangements for different
resources and for different uses and development of model agreements;
(e) Different uses may include, inter alia, taxonomy, collection, research,
commercialization;
(f) Mutually agreed terms should be negotiated efficiently and within a
reasonable period of time;
(g) Mutually agreed terms should be set out in a written agreement.
Did you
know? 75% of modern medicine
are based on leads
Anesthesia originated
from plant-based poison
provided by the based on traditional
traditional knowledge of knowledge of South
indigenous peoples and American indigenous
local communities. people.
Examples of Benefit
Sharing
San people of the Kalahari Desert and the Hoodia Plant
 San people from Kalahari Bitter flesh of the Hoodia
Desert, South Africa – used to suppress appetite
one of World’s oldest and give energy for
communities hunting and gathering.

Background
1930s – shared
to the San people shared
traditional knowledge in
traditional knowledge
with Dutch
Hoodia exchange for small gifts. anthropologist who
published findings.

Plant
1960s – South African
Council for Scientific and
Industrial Research
(CSIR) took interest
 Towards Benefit-Sharing

CSIR undertook significant R&D After overcoming initial

program
Recognized potential properties of
Hoodia for commercialization
1996 – CISA patented hoodia
compound (P57)
disagreements with the san people
CSIR recognized their traditional
knowledge
Negotiated one of the world’s first
benefit sharing agreements
Giving the San People a share of
royalties derived from the sale of
products containing P57.
 A Benefit Sharing Agreement shall be
entered into between the resource
provider and an applicant for permit for
ABR for commercial or potential
commercial purposes (“Applicant”).

Benefit Terms of the agreement shall be

mutually agreed between parties hence
Sharing it is important to ensure that the agreed
terms are fair and have equitable

Agreement benefit sharing.

An Applicant may be compelled by the

Competent Authority, if not the resource
provider, to pay a percentage of any
monetary benefits derived under the
benefit sharing agreement to a fund as
may be established by the Federal or
State Government.
 Benefit Sharing Agreements and
Mutually Agreed Terms
Section 22 (2)
A benefit sharing agreement has
to be based on mutually agreed
terms and provide for fair and
equitable benefit sharing.
The following principles are basic
requirements to consider in
developing mutually agreed
terms:
• Legal Certainty and Clarity
• Minimization of transaction costs
• Inclusion of provisions on user and
provider obligations
• Different contractual arrangements for
different resources
 The elements below should be considered:
• Regulating the use of resources for the
purpose of ethical concerns of the local
communities and indigenous people
Guiding involved
• A provision to ensure the continued
Parameters customary use of genetic resources and
related knowledge
in Benefit- • A provision for the use of intellectual
Sharing property rights include joint research,
obligation to implement rights on
Agreements inventions obtained and to provide
licences by common consent
• Possibility of joint ownership of
intellectual property rights according to
degree of contribution
 Listed in the Bonn Guidelines

Benefits under a Benefit Sharing

agreement are Monetary and
What are Non-Monetary

these
Benefits?
Sharing of research
Examples of Non- and development
results
Monetary Benefits: Institutional Capacity
Building

Up-front payments
Milestone Payments
Examples of Royalties
Monetary Benefits: Joint ownership of
intellectual property
rights
Litsea Cubeba Plant and the Natives of Sarawak
 LitSara® Project
 Litsea cubeba was long utilized for its culinary and
healing properties.
 Sarawak Biodiversity Centre (SBC) partnered with
indigenous communities to study and develop
innovative products
 Involved indigenous communities of the Bidayuh
of Kampung Kiding, Lun Bawang in Long Semadoh
(Long Telingan and Long Kerebangan) and the
Kelabit of Bario (Pa’Ukat and Pa’Lungan).
 Research and development on LitSara® is the
pioneering project that provides for benefit sharing
with the communities.

Source: www.litsara.com
 Traditional Knowledge
Documentation in
Sarawak
Main Objective
• To facilitate the local indigenous communities in
the State in preserving their Traditional Knowledge
through proper recording or documenting
techniques.

Carried Out through:

• Capacity building workshops on documentation
techniques, propagation, and management of
useful indigenous plants.
 LitSara® project demonstrates the good
spirit of ABS
 Utilises Prior Informed Consent (PIC)
from participating communities
 Communities actively involved in the in-
situ conservation of the Litsea
cubeba plant’s natural habitat through
sustainable harvesting using Good Wild
Craft Practice.
 The project ensures that the valuable
traditional knowledge is recognised and
benefits, both in monetary and non-
monetary way, are appropriately shared.

Source: litsara.com
 Enables the community To be the keeper in
to make decision on the managing the biological

Why do we proposed project. resources in the village.

need PIC?

Community can understand the The community will be

proposed project especially the
potential and effects to the
able to negotiate for
village. benefit sharing.
 • Sabah Biodiversity Enactment 2000 and
Laws in amendment of 2017
Sabah & • Sarawak Biodiversity Centre Ordinance of
1997 and amendment of 2014
Sarawak • The Sarawak Biodiversity Regulations 2004
 Sabah Biodiversity
Centre (SBC)

Plays secretarial role

Focal point in the
and monitors
matter of access.
compliance

ABS in SBC is responsible for:

Granting access and
advising on the
Requirement for
obtaining PIC and

Sabah negotiating process entering into MAT

Assist local
Monitoring and Implementation / communities in
evaluation of ABS enforcement of ABS developing access
agreements; agreements protocol to their
Traditional Knowledge
Sabah Biodiversity Sabah Biodiversity
Director
Centre Council

Biodiversity Corporate Affairs Biotechnology

Management Management Research
Division Division Promotion Division

Conservation Administration
Research Centre
Management Unit Unit

Information
Finance Unit
Management Unit

Access Regulatory
Unit
 Adopted principles based on the Nagoya
Protocol

Sabah Establishes Sabah Biodiversity Council

Biodiversity Mandatory for commercial users to share

Enactment benefits from utilisation

2000 with Enactment covers benefits in S.24

amendment
of 2017 Section 24A – Benefit Sharing Agreement

Section 24B – Requires PIC and MAT

Section 24A - Benefit sharing agreement

(1) An applicant for a licence for access to a biological resource or

associated relevant knowledge, for commercial or potential
commercial purposes shall enter into a benefit-sharing agreement
with the resource provider.
(2) A benefit-sharing agreement shall be based upon mutually agreed
terms and provide for fair and equitable benefit sharing.
(3) Any such monetary benefits shall be deposited into a fund
established by the State Government.
(4) The Council shall use any payment or any part thereof received
under this section towards the conservation of biological diversity
and the sustainable use of its components and for such other
incidental expenses.
Section 24B - Requirement for prior informed consent and
mutually agreed terms
(1) The prior informed consent of the relevant native or local community shall be obtained for any access to:
(a) a biological resource on land to which such native and local community have a right as established by
law; and
(b) associated relevant knowledge that is held by such native and local community.
(2) The prior informed consent of native and local community shall be obtained in accordance with customary laws
and practices, protocols and procedures, of native and local community, as the case may be.
(3) Any person who intends to access the biological resource or associated relevant knowledge in subsection (1) for
commercial or potential commercial purposes shall enter into a benefit sharing agreement under section 24A with
the relevant native and local community.
(4) Any prior informed consent shall be obtained from and benefit sharing agreement entered into with;
(a) the representative, organisation or body identified in accordance the customary laws and
practices, protocols and procedure of the native and local community; or
(b) where no such representative or organisation of the associated relevant knowledge can be
identified –
(i) with the holders of the associated relevant knowledge within the native and local
community; or
(ii) with the State Government, if the holders of the associated relevant knowledge
cannot be identified.
 Where does the money from a
benefit sharing agreement go?
• To the local/indigenous community

• Where the community cannot be identified.

Section 24B (5)

Any monetary benefit obtained from the benefit sharing agreement entered under
paragraph 4(b)(ii) shall be deposited into a fund as may be established by the State
Government and any benefit, including where applicable non-monetary benefit, shall be
applied for the interest of native and local community.
 Where multiple communities hold
the traditional knowledge
• The organisation of the holders of the associated traditional
knowledge will enter the benefit sharing agreement.

• If impractical, applicant may ascertain duly identified

representatives or organisation
Section 24B (6)
Where the same associated relevant knowledge is shared by more than one native or local
community –
(a) the applicant shall obtain the prior informed consent of and enter into benefit sharing
agreement with the duly identified representative or organization of all the holders of the
associated relevant knowledge; or
(b) where it is not practicable in all the circumstances of the case to ascertain all such holders, and
this is proven to the satisfaction of the Council, the applicant shall obtain the prior informed
consent of, and enter into the benefit sharing agreement with the duly identified
representatives or organisation of such of the holders as the applicant may ascertain.
Sabah Biodiversity Strategy 2012-2022
• 10-year strategy that charts Sabah’s commitment and
contributions to fulfil the pledge made by Malaysia to implement
the CBD.
• Closely follows the CBD Strategic Plan 2011-2020,
• Action Plan devised for implementing the 20 Aichi Biodiversity
Targets in the Sabah context.
• Target 18 deals specifically with indigenous people:
“By 2020, the traditional knowledge, innovations and practices of indigenous
and local communities relevant for the conservation and sustainable use of
biodiversity, and their customary use of biological resources, are respected,
subject to national legislation and relevant international obligations, and
fully integrated and reflected in the implementation of the Convention with
the full and effective participation of indigenous and local communities, at
all relevant levels”
 Section 3 - Establishes Sarawak Biodiversity
Council

Sarawak
Biodiversity Section 5 – Empowers Council to establish,
manage and maintain the Sarawak Biodiversity
Centre Cenre

Ordinance
of 1997 and Section 22A – Ordinance does not relieve persons
from compliance with other relevant laws.
amendment
of 2014 Section 35 (1)(d) - Empowers Majlis Mesyuarat
Kerajaan Negeri to make regulations for the terms
and conditions for access to and use of biological
resources
Organisation Chart
SBC Council
(Competent Authority)

Chief Executive Officer

SBC Research & SBC Product

SBC Corporate Affairs
Development Development

Chief Operating Officer Chief Scientist

Administration,
Finance and Human Analytical Chemistry
Resource

Regulatory Function,
Planning &
Plant Tissue Culture
Development &
Quality Assurance

Corporate
Molecular Biology
Communication

Traditional Knowledge
Sample Extraction &
Documentation &
Biochemistry
Biodiversity Garden

Microbiology
 Provides for terms and conditions regarding Access and
Benefit Sharing Agreements

Section 3 - Imposes requirement of Permit for Access to

Sarawak Biological Resources

Biodiversity Section 5 (2) (b) - Permit requires Prior Informed Consent

when involving traditional knowledge
Regulations
2016 Section 14 – Requires Benefit Sharing Agreement based on
mutually agreed terms to be entered between Sarawak
Biodiversity Council, if involved traditional knowledge,
natives shall also be a party

Section 24 – Prior Informed Consent is decided by

Community
  Federal Constitution
National  National Policy on Biological Diversity
Laws and 2016-2025
 Access to Biological Resources and
Policies Benefit Sharing (ABS) Act 2017
 Federal Constitution
• Sabah and Sarawak have a different
constitutional status vis-à-vis the Federal
Government
• Part VI - Rel
• Constitutional dichotomy raises the issue of
legislative competence over genetic resources.
• Sabah and Sarawak are excluded from national
plans for land use, local government and
development.
• Complicates issue of rights to access (to genetic
resources) within Malaysia
• State governments govern land and natural
resources
• Federal Government has authority to enter
international agreement
 National Policy on Biological
Diversity 2016-2025
Target 14
• By 2025, Malaysian has an operational ABS framework that
is consistent with the Nagoya Protocol
Key Indicators
14.1 – By 2017, national legislation and regulations on access
to biological resources and benefit sharing (ABS) are in place
14.2 – By 2025, the level of public awareness on ABS has
doubled compared to the 2016 level
14.3 – By 2025, a registry of traditional ecological knowledge
has been established.
Actions
14.1 – Develop and enforce legislation on ABS
14.2 – Enhance capacity and awareness on ABS
14.3 – Protect and Document the traditional knowledge,
innovations and practices of indigenous people and local
communities.
 ABS Act 2017
Section 3 - Act to be read with other laws
(1) This Act shall be read together with any other written laws relating to access to
biological resources and benefit sharing arising from the utilization of the biological
resource.

(2) The provisions of this Act shall be in addition to, and not in derogation o, the provisions
of any other law for the time being in force, relating to forests, wildlife, animals, fishery
and international trade in endangered species, except for matters that fall within the
provisions of this Act.

(3) Nothing in this Act shall be interpreted as restricting the right of a State to take
action relating to access to biological resources and benefit sharing arising from their
utilization, provided that such action is consistent with the objective and provisions of
this Act.
 • The main features of the Act addresses
the following matters:
• Scope of Resources - (s. 2 and s. 4)
• Competent National Authority - Part
II
Key • Lists out Competent Authorities in
each state
Features • Prior Informed Consent - s.23
• Mutually Agreed Terms - s.23
• Benefit Sharing - s. 22
• Traditional Knowledge – s. 21
Organisation Charts - Hierarchy

National
Competent
Authority

State
Advisory
Competent
Committee
Authorities

Advisory Body
 • Legal status and ownership of genetic
resources in Malaysia?
• How do you ascertain who owns the
traditional knowledge when shared among
various indigenous communities?
Constitutional situation
• Prevents legal implementation of all-
Issues encompassing Act governing all sectors of
genetic resources.
• Difficult for nationally administered scheme
to cover all of Malaysia’s biodiversity.
• Federal Government can only legislate to (1)
fulfil obligations under international treaties,
and (2) to promote uniformity of the laws of
two or more states