Draft Access and Benefit Sharing (ABS) Law for Pakistan
Transcript of Draft Access and Benefit Sharing (ABS) Law for Pakistan
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ISLAMABAD, [date]
PART I
Acts, Ordinances, Presidents Orders and Regulations
SENATE SECRETARIAT
Islamabad, [date]
No. [insert text]
Act No. [number] of 2012
An Act to provide for facilitating access to genetic resources and their derivatives for
environmentally sound uses, protecting traditional knowledge associated with them, equitably
sharing benefits derived from them, and promoting technology transfer and building scientificknowledge and technological capacity associated with them;
WHEREAS it is necessary to recognize the historical contribution that communities
throughout Pakistan have made to the conservation, development and sustainable utilization
of biological resources of the country;
AND WHEREAS, Pakistan is a Party to the United Nations Convention on Biological
Diversity (CBD) and to the International Treaty on Plant Genetic Resources for Food and
Agriculture (ITPGRFA) whose implementation requires, among other things, the enactment
of legislation governing access to genetic resources and equitable sharing of the benefits
resulting from their use;
AND WHEREAS, it is necessary to protect and encourage the customary use of genetic
resources by communities throughout Pakistan, and protect against their misuse, in order to
ensure the in-situand ex-situconservation and sustainable use of biological resources;
AND WHEREAS, it is necessary to recognize and protect the traditional knowledge
generated and accumulated by custodians and communities with respect to the conservation
and utilization of genetic resources and promote the wider application of such knowledge
with the involvement and approval of such custodians and communities and the equitable
sharing with such custodians and communities of any benefits resulting from the use of their
traditional knowledge;
AND WHEREAS, in order to realize these objectives, it is necessary to determine by law the
manner of access to genetic resources and traditional knowledge associated with them, and
to provide for the rights of custodians and communities to equitably share in benefits
resulting from the use of their traditional knowledge, and of genetic resources of which they
are the owners;
It is hereby enacted as under:-
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Chapter 1
(Preliminary)
1. Short title, extent and commencement.-
(1) This Act shall be called the Pakistan Access to Genetic Resources and
Benefit-sharing Act, 2012.
(2) It shall extend to the whole of Pakistan.
(3) It shall come into force at once.
2. Definitions.-
In this Act, unless there is anything repugnant in the subject or context,
(1) Access means obtaining, from any source, and using, genetic resources
or their derivatives and any associated traditional knowledge for purposes
of conservation, research, or commercialization.
(2) Access agreement means the agreement entered into between the ownerof the biological resource or the custodian of the traditional knowledge (asthe case may be) and the Applicant.
(3) Access permit means the permit issued by the permitting authority underSection 11(19) of this Act.
(4) Applicant means a person seeking access to genetic resources and their
derivatives and any associated traditional knowledge.
(5) Benefit sharing means the equitable distribution of the results of access to
genetic resources and their derivatives and any associated traditional
knowledge and includes both monetary and non-monetary benefits.
(6) Biodiversity or biological diversity means the variability among living
organisms from all sources including, among other things, terrestrial,
marine and other aquatic ecosystems and the ecological complexes of
which they are a part; this includes diversity within species, between
species and of ecosystems.
(7) Biological resources includes genetic resources, organisms or parts
thereof, populations, or any other biotic component of ecosystems with
actual or potential use or value for humanity, excluding human genetic
resources.
(8) Biotechnology means any technological application that uses biological
systems, living organisms, or derivatives thereof, to make, or modify
products or processes for any specific use.
(9) Certificate of compliance means the access permit which certifies that a
genetic resource or derivative and any associated traditional knowledge
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have been accessed in accordance with prior informed consent and that
mutually agreed terms have been established.
(10) Community means a human population that defines itself, and whose
members are dependent on each other and share physical space whether
living in a distinct geographical area or moving seasonally from place to
place.
(11) Confidential Information means all know-how, financial information and
other commercially valuable or sensitive information in whatever form,
which a party marks as confidential or proprietary and discloses to the
other party. The following are exceptions to such information:
a. information which is lawfully in the public domain prior to itsdisclosure to a party by another party;
b. information which enters the public domain otherwise than as aresult of an unauthorised disclosure;
c. information which is or becomes lawfully available to the recipient
party from a third party who has the lawful power to disclose suchinformation to the recipient party on a non-confidential basis; and
d. information which is rightfully known by the recipient party (asshown by its written record) prior to the date of disclosure.
(12) Court means any Courts established by or under any laws of the Islamic
Republic of Pakistan.
(13) Custodian means the person or community that holds traditional
knowledge.
(14) Derivative means a naturally occurring biochemical compound resulting
from the genetic expression or metabolism of biological or genetic
resources, even if it does not contain functional units of heredity.
(15) Ecosystem means a dynamic complex of plant, animal and micro-
organism communities and their non-living environment interacting as
functional unit.
(16) Environmental impact assessment means an environmental study
comprising collection of data, prediction of qualitative and quantitative
impacts, comparison of alternatives, evaluation of preventive, mitigatoryand compensatory measures, formulation of environmental management
and training plans and monitoring arrangements and framing of
recommendations and such other components as may be prescribed.
(17) Ex-situconservation of genetic resources means the conservation of
genetic resources outside the natural habitats of the biological resources
of which they are a part or the surroundings where they have developed
their distinctive properties.
(18) Ex-situfacility means gene banks, seed banks, sperm banks, and othertypes of storage services for genetic resources including those that may
be maintained by the private sector, universities, zoos, botanical gardens,
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herbaria and other similar national institutions, and international
organizations.
(19) Field research means preliminary investigation in in-situconditions into
biological resources and any associated traditional knowledge.
(20) Genetic resources means any material derived from plants, animals, fungior microorganisms which contains functional units of heredity and which
has actual or potential value for humanity.
(21) Government means the person or persons authorized by law to administer
executive Government in Pakistan, or in any part thereof.
(22) In-situconservation of genetic resources means conservation of the
biological resources of which they are a part, in the natural habitats of the
biological resources, and, in the case of domesticated or cultivated
species, in the surroundings where they have developed their distinctiveproperties. In-situconservation of plant genetic resources means
conserving the plants where they grow naturally. In-situconservation of
animal genetic resources means conserving the animals in their natural
habitats.
(23) Initial environmental examination means a preliminary environmental
review of the reasonably foreseeable qualitative and quantitative impacts
on the environment of a proposed project to determine whether it is likely
to cause an adverse environmental effect, requiring preparation of an
environmental impact assessment.
(24) Intellectual property rights means rights established by any statute or
customary law over any property created through intelligent activity of the
human mind, in the form of patents, trademarks, design, protection of plant
varieties and animal breeds, copyrights, and traditional knowledge.
(25) IPO means the Intellectual Property Organization of Pakistan organized
and existing under the Intellectual Property Organization of Pakistan
Ordinance, 2005 or any modifications thereof.
(26) Material transfer agreement means the agreement used to exchange
genetic resources and derivatives between two ex-situfacilities.
(27) Mutually agreed terms means the conditions for access to genetic
resources and any associated traditional knowledge and the way in which
monetary and non-monetary benefits from their use will be shared, as
freely decided between an Applicant, the owner of a biological resource,
the custodian of any associated traditional knowledge, and the permitting
authority.
(28) No Objection Certificate means a document issued by the permitting
authority pursuant to Chapter 3 Section 11(4) of this Act.
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(29) Permit holder means the person to whom an access permit is issued and
the person who receives genetic resources or derivatives as a party to a
material transfer agreement.
(30) Permitting Authority means the governmental authority responsible for
granting access to genetic resources and regulating matters associatedtherewith under this Act.
(31) Person means a natural or juridical person.
(32) Plant genetic resources for food and agriculture means any genetic
material of plant origin of actual or potential value for food and agriculture.
(33) Prior informed consent means the basis on which the owner, the custodian
and the permitting authority, properly supplied with all the required
information, agree to permit access to biological resources, anyderivatives of genetic resources, and any associated traditional
knowledge.
(34) Protected area means a geographically defined area which is designated
or regulated and managed to achieve specific conservation objectives.
(35) Traditional knowledge means knowledge, practices, innovations or
technologies created, developed and held by a custodian thereof and
handed down through generations by long standing traditions, oral or
written transmission.
3.Scope of Application.-
(1) This Act shall apply to access to genetic resources found in in-situ or ex-situ
conditions and traditional knowledge associated therewith and to the equitable
sharing of benefits resulting from their use.
(2) Notwithstanding the provision of Sub-section (1) of this Section, provisions of this
law shall not apply to:
(a) the customary use and exchange of genetic resources and traditional
knowledge by and among communities;
(b) the customary or commercial exchange of biological resources for
processing or direct consumption, that does not involve the use of the
genetic resources thereof;
(c) human genetic resources; and
(d) genetic resources governed by the International Treaty on Plant Genetic
Resources for Food and Agriculture (ITPGRFA).
4. Ownership.-
(1) Ownership of genetic resources shall be vested in owners of the biological
resources from which the genetic resources are derived, subject to title of
ownership being established under the applicable laws. Where no such title exists
or where the biological resources are owned by the State, ownership of genetic
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resources shall be vested in the people of Pakistan and be administered by the
Government in trust for the people of Pakistan.
(2) The ownership of traditional knowledge shall be vested in the custodian thereof.
Chapter 2(Community Rights)
5. Principle.-
Communities shall have the following rights over the traditional knowledge of which they
are custodians:
(1) the inalienable right to use their traditional knowledge in their customary ways;
(2) the right to regulate the access to their traditional knowledge;
(3) the right to share the benefits arising out of the utilization of their traditional
knowledge.
6. Use right.-
Communities shall have an inalienable right to use and exchange among themselves
genetic resources and any associated traditional knowledge in the course of sustaining their
livelihoods in accordance with the applicable laws.
7. Right to regulate access to traditional knowledge.-
(1) The right of communities to regulate access to their traditional knowledge shall
include the following:
(a) the right to give or withhold their prior informed consent for access to their
traditional knowledge;(b) the right to withdraw or restrict any prior informed consent they have
given for access to their traditional knowledge where they find that such
consent is likely to be detrimental to their socio-economic life or their
natural or cultural heritage;
(c) the right to demand the suspension or revocation of their prior informed
consent as expressed in the access permit.
(2) The conditions and the procedure in accordance with which an Applicant may
approach communities to secure prior informed consent for access to their
traditional knowledge shall be specified by rules and regulations made under this
Act.
8. Right to share benefits.-
Communities shall have the right to share in all benefits arising out of the utilization of
traditional knowledge that they hold as custodians and any such benefits shall be equitably
shared among all members of the concerned communities.
9. Protection of community rights.-
(1) The rights of communities over biological resources of which they are the owners
and any associated traditional knowledge of which they are the custodians shall
be protected.
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(2) Traditional knowledge shall have the like protection of undisclosed information
and secret under Section 67 of the Trade Marks Ordinance 2001, and any
modification thereof.
(3) Any use of traditional knowledge that is not explicitly authorized by the custodian
shall constitute an act of unfair trade practice cognizable under the Trade Marks
Ordinance 2001, any modification thereof, or any other applicable laws.
(4) The publication or oral description of traditional knowledge associated with any
given genetic resource, or the existence of documentation of traditional
knowledge associated with any genetic resource held in an ex-situ facility, shall
not affect its protection under Sub-sections (1), (2) and (3) of this Section.
Chapter 3
(Permits and Procedures)
10. Consent and permit required.-
(1) Access to genetic resources shall be subject to the prior informed consent of
the owner of the biological resource and to mutually agreed terms set out in an access
agreement, which is attached as Schedule I of this Act.
(2) Access to traditional knowledge shall be subject to the prior informed consent
of the custodian and to mutually agreed terms set out in an access agreement.
(3) No person may commence field research related to access to genetic
resources and traditional knowledge unless in possession of a No Objection Certificate(NOC) from the permitting authority and no person may access biological resources in in-situ
conditions and any associated traditional knowledge unless in possession of an access
permit issued by the permitting authority.
(4) Public and private national universities and research institutions that are not
associated with a non-national Applicant may be eligible for an expedited permitting
procedure, which may be set out in the Regulations to this Act.
(5) No person shall be eligible to export genetic resources out of Pakistan unless
in possession of:
(a) an access permit issued by the permitting authority;
(b) a duly executed material transfer agreement, for transfers between ex-
situfacilities of genetic material not governed by the ITPGRFA, which
is attached as Schedule II of this Act; or
(c) a duly executed standard material transfer agreement as required
under the ITPGRFA.
(6) No person shall import into Pakistan genetic resources that are not
accompanied by a certificate of compliance from the country of origin, or a material transfer
agreement as specified in Section 13.
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(7) All permit applications shall be made in prescribed form and shall be subject
to non-refundable fees. Renewals of permits may be subject to a reduced fee. Applicable
fees shall be notified from time to time by the permitting authority.
(8) In addition to the fees prescribed in sub-Section 7, all costs of the procedures
prescribed in this Act are the responsibility of the Applicant.
(9) A non-national Applicant must submit proof of its formal association with a
national public or private entity with capacities or activities in fields related to access to
genetic resources.
(10) A non-national Applicant must be accompanied in all activities carried out
under an access permit by a representative of the national entity with which it is associated
for the purposes of this Act.
11. Procedure for access to genetic resources from in-situconditions
(1) An Applicant shall submit to the permitting authority a formal expression ofintent to carry out field research related to access to genetic resources and traditional
knowledge.
(2) On receipt of such expression of intent, the permitting authority shall inform
the authorities of the province or provinces involved.
(3) The authorities of the province or provinces involved shall cause public notice
of the expression of intent to be disseminated, in particular using media that are accessible
to the community or communities that may be involved.
(4) If there is no objection to the research activity described in the formal
expression of intent, the permitting authority shall issue the NOC.
(5) In the event that there is an objection, the permitting authority shall conduct a
public hearing, giving all parties involved an opportunity to be heard, and based on the
material and records presented, shall make a just order either by issuing the NOC or by
denying such issuance and shall communicate the reasons to all parties in writing. Following
a rejection, an Applicant may submit a new expression of intent which reflects and addresses
the reasons for the rejection.
(6) Any NOC issued for the purposes of this Act shall be final and binding on all
concerned government authorities.
(7) When, on the basis of the results of field research conducted under a valid
NOC, an Applicant determines that it wants to enter into an access agreement or
agreements with owners of biological resources and custodians, it shall notify the permitting
authority, which shall notify the provincial authorities concerned, and proceed to negotiate
the access agreement.
(8) An access agreement shall use one of the formats which are attached as
Schedules I-A, I-B, and I-C to this Act, as appropriate.
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(9) An access agreement may be entered into between the Applicant and:
(a) a person who is both the owner of the biological resource and the
custodian of the associated traditional knowledge;
(b) the owner of biological resource and the custodian of the associated
traditional knowledge; or
(c) a custodian only.
(10) A community that wants to enter into an access agreement with an Applicant
may be represented by a community based organization, whether incorporated or not, which
is empowered to bind its members for the performance of their obligations and enjoyment of
the rights under any such agreements.
(11) A community custodian or an individual custodian that wants to enter into an
access agreement with an Applicant may be assisted by a duly registered non-governmental
organization. Such support shall be arranged by the permitting authority and shall be
provided at the expense of the Applicant. The permitting authority shall, by notification,
stipulate the conditions for supporting individual custodians in negotiating an accessagreement with an Applicant.
(12) The provincial government or governments concerned must review and endorse
all access agreements, in consultation with the community or communities involved, in order
to ensure that community concerns and demands are safeguarded.
(13) An access agreement is not an access permit and is only valid when it is
annexed to a permit issued by the permitting authority.
(14) Once an access agreement has been concluded, an Applicant may submit tothe permitting authority an application for an access permit, in the form which is attached as
Schedule III to this Act.
(15) On receipt of an application, the permitting authority shall inform the
authorities of the province or provinces involved, taking into account any request from the
Applicant not to disclose confidential information made under Section 12.
(16) On receipt of information from the permitting authority under sub-Section 15 of
this Section, the authorities of the province or provinces involved shall cause public notice of
the application to be disseminated, using a mode of public communications that is readily
accessible by the concerned community or communities.
(17) On receipt of an application for an access permit, the permitting authority, in
consultation with the provincial authorities and, where applicable, the communities
concerned, shall determine:
(a) Whether the activities involved in the access applied for require an
initial environmental examination or environmental impact assessment
and, if so, direct the Applicant to fulfill such requirements prior to
proceeding with the access permit application process;
(b) Whether the application requests access to biological resources that
are protected under any Pakistani law and, in particular, under any law
or regulations implementing Pakistans obligations under the
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Convention on International Trade in Endangered Species of Fauna
and Flora (CITES);
(c) Whether the application requests access to biological resources that
are found in a protected area;
(d) Whether the activities involved in the access applied for may cause
adverse impact on the environment in general and biodiversity in
particular, including but not limited to ecosystem degradation; and(e) Whether the activities involved in the access applied for may have
adverse effects upon human health and the livelihoods of the
concerned community or communities.
(18) If the permitting authority determines that there is an issue arising under sub-
Sections (b), (c), (d), or (e) of sub-Section 17 of this Section, the permitting authority shall
request the Applicant to submit in writing further information demonstrating measures it will
take to avoid or mitigate such impacts.
(19) On receipt of all required information, the permitting authority shall:(a) issue the access permit, in the form which is attached as Schedule IV
to this Act; or
(b) reject the application and provide written justification for such rejection
to the Applicant. Justification for rejecting an application may include,
but is not limited to, a finding by the permitting authority that the
additional information requested under Section 18 of this Section does
not resolve an issue arising under sub-Sections (b), (c), (d), or (e) of
sub-Section 17 of this Section.
(20) The permitting authority shall cause public notice of the permit to bedisseminated, taking into account any request from the Applicant not to disclose confidential
information under Section 12, and send a copy of the permit to the concerned provincial
authorities, resource owners, and custodians.
(21) The permitting authority shall cause public notice of rejection of an application,
the justification for the rejection, and the invalidation of any access agreement entered into
for the purposes of the application, to be disseminated and shall communicate the same
information to the concerned provincial authorities, resource owners, and custodians.
(22) Any access permit issues for the purposes of this Act shall be final and
binding on all concerned government authorities.
(23) The access permit shall serve as the international certificate of compliance.
(24) Where a permit holder is in full compliance with all terms and conditions, an
access permit may be renewed at the discretion of the permitting authority.
(25) Detailed procedures for applications and renewals, including timelines for
responses by the permitting authority, shall be notified by the permitting authority.
12. Confidential information
No information shall be disclosed to the public which relates to:
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(f) Profit-sharing in case of commercialization;
(g) Special fees to be paid to trust funds supporting conservation and
sustainable use of biodiversity;
(h) Salaries and preferential terms where mutually agreed;
(i) Research funding;
(j) Joint ventures;
(k) Establishment of a venture capital fund to support in-country researchand development.
(4) Non-monetary benefits may include, but shall not be limited to:
(a) Sharing of research and development results;
(b) Collaboration, cooperation and contribution to scientific research and
development programmes, particularly biotechnological research
activities, where possible in the province or district providing genetic
resources;
(c) Participation in product development;
(d) Collaboration, cooperation and contribution in education and training;
(e) Access to international ex-situ facilities and databases;(f) Transfer to the provider of the genetic resources of knowledge and
technology under fair and most favourable terms, including on
concessional and preferential terms where agreed, in particular,
knowledge and technology that make use of genetic resources,
including biotechnology, or that are relevant to the conservation and
sustainable utilization of biological diversity;
(g) Strengthening capacities for technology transfer;
(h) Institutional capacity-building including, but not limited to, donation of
research equipment;
(i) Human and material resources to strengthen the capacities for theadministration and enforcement of this Act, and any Rules and
Regulations thereunder;
(j) Training related to genetic resources with the full participation of the
provinces and communities countries providing genetic resources, and
where possible, in such provinces and communities;
(k) Access to scientific information related to the genetic resources
accessed and also to information relevant to conservation and
sustainable use of biological diversity, including biological inventories
and taxonomic studies;
(l) Contributions to the local economy, including locating research and
production facilities in the province or district where genetic resources
or traditional knowledge are accessed, where appropriate;
(m) Research directed towards priority needs, such as health and food
security, taking into account domestic uses of genetic resources by the
community providing genetic resources;
(n) Institutional and professional relationships that can arise from an
access and benefit-sharing agreement and subsequent collaborative
activities;
(o) Food and livelihood security benefits;
(p) Social recognition;
(q) Joint ownership of intellectual property rights.
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15. Benefit sharing.-
(1) In cases in which there is an access agreement for access to genetic
resources in-situ and associated traditional knowledge and the custodian of
the traditional knowledge is also the owner of the biological resources:
(a) not less than sixty (60) per cent of any monetary benefits shall be
distributed to the custodians for use of their traditional knowledge as
set out in the access agreement;(b) not less than twenty-five (25) per cent of any monetary benefits arising
from use of genetic resources shall be allocated in equal shares to the
province or provinces in which the biological resources were accessed,
and shall be allocated by that province or those provinces for
conservation of biodiversity and traditional knowledge and the social
welfare of the communities involved;
(c) up to fifteen (15) per cent of any monetary benefits shall be allocated
to the permitting authority for the operation of the permitting and
monitoring system for access to genetic resources and benefit sharing.
(2) In cases in which there is access to genetic resources in-situand associated
traditional knowledge and the custodian of the traditional knowledge and the
owner of the biological resources are different persons:
(a) not less than forty (40) per cent of any monetary benefits shall be
distributed to the custodians for use of their traditional knowledge as
set out in the access agreement;
(b) not less than twenty-five (25) per cent of any monetary benefits shall
be allocated to the owner of the biological resources;
(c) Not less than twenty (20) per cent of any monetary benefits arising
from use of genetic resources shall be allocated in equal shares to theprovince or provinces in which the biological resources were accessed,
and shall be allocated by that province or those provinces for
conservation of biodiversity and traditional knowledge and the social
welfare of the communities involved;
(d) up to fifteen (15) per cent of any monetary benefits shall be allocated
to the permitting authority for the operation of the permitting and
monitoring system.
(3) In cases in which there is access to genetic resources in-situand no access to
traditional knowledge:
(a) not less than sixty (60) per cent of any monetary benefits shall be
allocated to the owner of the biological resources;
(b) not less than twenty-five (25) per cent of any monetary benefits arising
from use of genetic resources shall be allocated in equal shares to the
province or provinces in which the biological resources were accessed,
and shall be allocated by that province or those provinces for
conservation of biodiversity and traditional knowledge and the social
welfare of the communities involved;
(c) up to fifteen (15) per cent of any monetary benefits shall be allocated
to the permitting authority for the operation of the permitting and
monitoring system.
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(4) In cases in which there is access to genetic resources ex-situand access to
associated traditional knowledge:
(a) not less than sixty (60) per cent of any monetary benefits shall be
distributed to custodians for use of their traditional knowledge as set
out in the access agreement;
(b) not less than twenty-five (25) per cent of any monetary benefits shall
be allocated to the ex-situ facility;(c) up to fifteen (15) per cent of any monetary benefits shall be allocated
to the permitting authority in the jurisdiction where the ex-situfacility is
located.
(5) The non-monetary benefits arising from access to genetic resources and
associated traditional knowledge shall be determined:
(a) by the parties to an access agreement; and
(b) by the permitting authority and set out in the access permit.
16. Benefit distribution.-(1) The permit holder shall transfer benefits directly to custodians, resource
owners, provincial governments and the federal government, as stipulated in the access
permit.
(2) The permit holder shall distribute monetary benefits in the shares stipulated in
Section 15 and shall, on the date of transfer of the funds, provide to each beneficiary a
written account of the allocation and distribution thereof.
(3) Non-monetary benefits shall be shared and distributed as stipulated in the
access agreement and access permit.
17. Amendment, suspension or revocation of permit.-
(1) The permitting authority may at any time amend, suspend or revoke any
permit on the following grounds:
(a) Evidence of incomplete or false information in the original application;
(b) Non-compliance with or violation of any of the conditions of the access
permit or material transfer agreement;
(c) Refusal to allow inspection;
(d) Suspension or revocation of an import license or export license for
genetic material;
(e) Suspension or revocation of any license for research and for engaging
in any type of commercial or industrial activity related to genetic
resources and traditional knowledge;
(f) Conviction of the permit-holder for a violation of this Act or other
applicable legislation;
(g) Demand by a community to revoke its prior informed consent as
expressed in the access agreement;
(h) Availability of new information indicating that the activities involved in
access may create risks to livelihoods and the environment, including
but not limited to genetic erosion and degradation and depletion of the
resource which cannot be feasibly averted; and
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(i) Any other grounds as may be notified by the permitting authority from
time to time.
(2) Where the permitting authority decides to amend, suspend or revoke an
access permit, it shall communicate same to the concerned provincial authorities, resource
owners, and custodians, where applicable.
Chapter 4
(Compliance Monitoring)
18. Inspection and reporting.-
(1) The permitting authority shall monitor compliance with access permits and
material transfer agreements through the following mechanisms:
(a) inspection;
(b) periodic progress and status reports by permit holders;
(c) a report or complaint by any other person; and
(d) any other mechanism deemed appropriate.
(2) The permit holder shall submit to the permitting authority periodic reports on
the activities specified in the access permit or material transfer agreement, the progress of
any research, and the findings therefrom, and the distribution of benefits during the reporting
periods, and shall, no later than thirty (30) days from the date of publication, submit to the
permitting authority paper and electronic copies of any publications resulting from the
activities being carried out under the permit.
(3) In the case of a non-national permit holder associated with a national
institution, the permit holder and the associated national institution shall jointly submit thereport required in sub-Section 2, specifying the activities and results produced by each.
(4) The permitting authority shall transmit the reports required under this Section,
and copies of any publications, to the concerned provincial authorities, which shall be
responsible for appropriately disseminating to the concerned resource owners and
custodians in their respective provinces the information contained in the reports and
publications.
19. Community policing.-
(1) The permitting authority shall be responsible for coordinating with provincial
authorities and other enforcement authorities to ensure that community policing is
appropriately incorporated into mechanisms for monitoring compliance with this Act and with
the terms of access agreements and access permits.
(2) Community policing in the context of access to genetic resources includes, but
is not limited to, establishing a basis for:
(a) guaranteeing the conservation of biological resources and the
sustainability of their use;
(b) protecting traditional knowledge and its custodians; and
(c) collaborating between governmental enforcement authorities and the
community to ensure that the provisions of this Act are not violated.
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Chapter 5
(Information, Awareness, Public Participation, and Capacity Building)
20. Communication with Clearing-house Mechanism.-
The permitting authority shall be responsible for communicating to the national focal
point of the CBD Clearing-house Mechanism all information concerning the implementationof this Act as required by the CBD Clearing-house Mechanism.
21. Public education, awareness, and participation.-
(1) The permitting authority shall collaborate with the appropriate federal and
provincial authorities to ensure that issues related to access to genetic resources and benefit
sharing are appropriately integrated into the curricula of primary, secondary, and university-
level education in Pakistan.
(2) The permitting authority shall be responsible for coordinating with the
appropriate federal and provincial authorities to promote public awareness of access togenetic resources and associated traditional knowledge and benefit sharing in Pakistan.
(3) The permitting authority shall be responsible for ensuring public participation
in the decision making processes concerning access to genetic resources, traditional
knowledge and benefit sharing.
22. Professional capacity building.-
The permitting authority shall be responsible for:
(1) coordinating with the appropriate federal and provincial authorities to create
opportunities in the country for professional capacity building in fields related to access to
genetic resources, traditional knowledge and benefit sharing;
(2) ensuring that non-monetary benefits supporting professional capacity building,
in-country and abroad, in fields related to access to genetic resources, traditional knowledge
and benefit sharing are included in access permits.
Chapter 6
(Research and Technology Transfer)
23. Research.-(1) The Government shall promote the creation of domestic research and
development capacity in the field of genetic resources and shall promote domestic research
in support of the preservation of traditional knowledge and shall prepare regulations to
govern conduct of research and development involving genetic resources in Pakistan.
(2) The permitting authority shall:
(a) in cooperation with all appropriate federal and provincial authorities,
promote national research programmes which contribute to the conservation and
sustainable use of biological resources;
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(b) coordinate cooperation in international programmes to conduct
research and develop methods for conserving and sustainably using biological
resources and for conserving and protecting traditional knowledge;
(c) coordinate with the Higher Education Commission, national research
institutions, and other appropriate federal and provincial institutions, to ensure the
creation of research programmes that are relevant to the objectives of this Act;
(d) ensure that provisions for non-monetary benefits that facilitate and
support the creation of domestic research and development capacity in the field of
genetic resources and their derivatives are included in access permits.
24. Technology transfer.-The permitting authority shall:
(1) coordinate with the appropriate federal and provincial authorities to createeconomic and fiscal opportunities in the country that facilitate the transfer of biotechnology
and other technologies, and technical information, to support the development of domestic
capacity for research and development in fields related to genetic resources and their
derivatives;
(2) ensure that non-monetary benefits facilitating and supporting transfer of
biotechnology and other technologies in fields related to genetic resources and their
derivatives are included in access permits.
Chapter 7
(Administration of Access)
25. Powers and functions of the permitting authority.-
(1) Without prejudice to the powers delegated to it in other provisions of this Act,
the permitting authority shall have the powers to:
(a) initiate inquiries and investigations into issues arising from access to
biological resources, genetic resources, and derivatives, at its own
discretion or on complaint from any person;
(b) require any person to furnish any information or data relevant to its
functions;
(c) establish panels comprising of technical experts, of which at least halfof the members shall be drawn from scientific, academic, legal, andnon-governmental organization sectors, to analyze and advise asneeded, on issues arising from the implementation of this Act;
(d) initiate, with the approval of the Federal Government, requests for
foreign assistance in support of the purposes of this Act and enter into
arrangements with foreign agencies and organizations for the
exchange of material or information;
(e) initiate, with the approval of the Federal Government, requests for
repatriation of information related to genetic resources of which
Pakistan is the country of origin;
(f) initiate legal action against persons who have committed violations of
this Act; and
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(g) any other power that may be delegated to it by the Federal
Government.
(2) Without prejudice to the functions assigned to it in other provisions of this Act,
the permitting authority shall have the functions to:
(a) administer and implement the provisions of this Act and the rules and
regulations made thereunder;(b) assist local and provincial authorities in carrying out the functions
assigned to them under this Act;
(c) collect, analyze and as necessary appropriately disseminate
information on all issues matters arising under this Act;
(d) recommend to the Federal Government the adoption of financial and
fiscal programmes, schemes or measures for achieving the purposes
of this Act, including but not limited to:
(i) incentives, prizes awards, subsidies, tax exemptions, rebates
and depreciation allowances; and
(ii) taxes, duties, cesses and other levies; and(e) any other function that may be assigned within the scope of this Act.
Chapter 8
(Appeals, Offences and Penalties)
26. Appeals.-
Any person aggrieved by any order or direction of the permitting authority under any
provision of this Act and its rules and regulations may, within thirty (30) days of the date of
communication of the impugned order or direction to such person, prefer an appeal before
the court having jurisdiction.
27. Offences and penalties.-
(1) Any person who:
(a) accesses genetic resources or traditional knowledge without obtaining
an access permit from the permitting authority;
(b) provides false information in the access permit application or in the
course of subsequent monitoring of an access permit or material
transfer agreement;
(c) breaches in any respect the terms and conditions of the access permit,
including the access agreement;
shall, without prejudice to the confiscation of the biological resource accessed
and any materials and equipment used in the commission of the offense, the
cancellation of the access permit, and the civil liability arising therefrom, be
punished, depending on the gravity of the circumstance, with rigorous
imprisonment of not more than three (3) years and a fine of not more than
three hundred thousand rupees (Rs. 300,000./-).
(2) Where the offence committed involves biological resources endemic to
Pakistan or which are protected under any national law or listed pursuant to any
international agreement, the punishment shall be, depending on the circumstance,
rigorous imprisonment of not more twelve (12) years and a fine of not more than four
hundred thousand rupees (Rs. 400,000./-).
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Chapter 9
(Miscellaneous Provisions)
28. Import and export.-
No customs officer shall:
(1) accept a permit for export of genetic resources, or biological resources to be
used for the purpose of accessing genetic resources, that is not accompanied by an accesspermit issued by the permitting authority; and
(2) allow the import into Pakistan of genetic resources that are not accompanied
by an international certificate of compliance.
29. Power to make rules.-
The Federal Government may, by notification in the official Gazette, make rules for
carrying out the purposes of this Act.
30. Power to make regulations.-For carrying out the purposes of this Act, the permitting authority may, by notification
in the official Gazette and with the approval of the Federal Government, make regulations not
inconsistent with the provisions of this Act or the rules made thereunder.
31. Power to amend the Schedules.-
The permitting authority may, by notification in the official Gazette, amend the
Schedules to this Act so as to add any entry thereto or modify or omit any entry therein.
32. Duty to Cooperate.-
(1) Every person shall have the duty to cooperate with the permitting authority, all
concerned provincial authorities, communities, custodians and biological resource owners in
the implementation of this Act and all permits, Rules, Regulations and notifications issued
hereunder.
(2) The permitting authority is responsible for coordinating cooperation on access
to genetic resources with the appropriate authorities of other countries, particularly those that
are countries of origin of biological resources for which Pakistan is also a country of origin.
33. Inapplicable laws.-
The provisions of this Act shall have effect notwithstanding anything inconsistent
therewith contained in any other law, regulation, directive or practice with respect to matters
provided for by this Act.
Asif Ali Zardari,
President
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SCHEDULE I-A
ACCESS AGREEMENTTo be used when the custodian of traditional knowledge and owner of biological resources
are the same person (Article 11(9)(a)
THIS AGREEMENT is made on the _____________ day of _____________, the year______
BETWEEN______________________________, hereinafter referred to as the Owner/Custodian ofbiological resources and associated traditional knowledge which term shall be deemed toinclude, as the case may be, his respective community, successors, officers, employees,contractors, agents and assigns, located at ______________________________,
REPRESENTED BY
______________________________, [insert legal name of organization representing theCustodian/Owner] hereinafter referred to as the Representative of the Custod ian/Owner,which term shall be deemed to include its respective successors, officers, employees,contractors, agents and assigns, having its office at ______________________________,and whose designated representative is ______________________________, [insert title ofthe designated representative of the organization representing the Custodian/Owner]
AND__________________________________, hereinafter referred to as the Applicant whichterm shall be deemed to include the Applicants successors, officers, employees,contractors, agents and assigns, located at ______________________________.
RECITALS:
Whereas the Custodian/Owner is in the possession and ownership of a biological resourceor biological resources and traditional knowledge associated therewith, as detailed inclauses 3.1 and 3.2, respectively, of this Agreement, and seeks to facilitate access to thesaid biological resources and associated traditional knowledge for gainful and beneficialpurposes keeping in mind the conservation of biodiversity, the sustainable use of itscomponents, and equitable sharing of benefits derived from its use; and
Whereas the Custodian/Owner is willing to give the Applicant access to the said biologicalresources and traditional knowledge associated therewith; and
Whereas the Applicant is interested in gaining access to the said biological resource(s) andthe traditional knowledge associated therewith;
This Agreement sets out the terms that the parties agree to apply to the taking and use ofthe biological resources and associated traditional knowledge.
Now this Agreement witnesseth as under:-
1. DEFINITIONS & INTERPRETATION1.1 Definitions
(1) ABS Act means the Pakistan Access to Genetic Resources and Benefit-sharing Act,2012.
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(2) Biological resources includes genetic resources, organisms or parts thereof,populations, or any other biotic component of ecosystems with actual or potential useor value for humanity, excluding human genetic resources.
(3) Commencement date means the date of the access permit to which this AccessAgreement is annexed.
(4) Confidential information means all know-how, financial information and othercommercially valuable or sensitive information in whatever form, which a party marksas confidential or proprietary and discloses to the other party. The following areexceptions to such information:(a) information which is lawfully in the public domain prior to its disclosure to a party
by another party;(b) information which enters the public domain otherwise than as a result of an
unauthorised disclosure;(c) information which is or becomes lawfully available to the recipient party from a
third party who has the lawful power to disclose such information to the recipientparty on a non-confidential basis; and(d) information which is rightfully known by the recipient party (as shown by its
written record) prior to the date of disclosure.
(5) Custodian means the person or community that holds traditional knowledge.
(6) Derivative means a naturally occurring biochemical compound resulting from thegenetic expression or metabolism of biological or genetic resources, even if it doesnot contain functional units of heredity.
(7) Intellectual property rights means rights established by any statute or customary law
over any property created through intelligent activity of the human mind, in the formof patents, trademarks, design, protection of plant varieties and animal breeds,copyrights, and traditional knowledge.
(8) Mutually agreed terms means the conditions for access to genetic resources and anyassociated traditional knowledge and the way in which monetary and non-monetarybenefits from their use will be shared, as freely decided between an Applicant, theowner of a biological resource, the custodian of any associated traditionalknowledge, and the permitting authority.
(9) Results means all information and tangible objects arising from the Applicants use ofbiological resources and associated traditional knowledge and any derivatives,including information published in accordance with clause 3.11 of this Agreement.
(10) Traditional knowledge means knowledge, practices, innovations ortechnologies created, developed and held by a custodian.
1.2 Interpretation(1) Headings are for convenience only and do not affect interpretation.
(2) The singular includes the plural and conversely, and a gender includes all genders.
(3) Where the Owner/Custodian or the Applicant is comprised of more than one personthe Owner/Custodians and the Applicants obligations apply to each person jointlyand severally.
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(4) A reference to any legislation or to any provision of any legislation includes anymodification or re-enactment of it, any legislative provision substituted for it and allregulations and statutory instruments issued under it.
2. COMMENCEMENT OF AGREEMENTThis Agreement commences on the date of issue of the access permit to which this AccessAgreement is annexed and shall remain valid for one (1) year unless terminated earlier orrenewed by the Permitting Authority prior to the expiration date.
3. MUTUALLY AGREED TERMS
3.1 Resources to be accessed
If more than one biological resource is to be accessed, add rows to the table below and
provide the specified information for each biological resource.
Biological resource
(a) Scientific classification:(b) Local language name(s):
(c) English language name:
(d) Characteristics for which the resource issought:
3.2 Traditional knowledge to be accessed
Insert a comprehensive description of the traditional knowledge associated with each
biological resource for which access is sought. If more than one biological resource is to be
accessed, add rows to the table below and provide the specified information for each
biological resource and the associated traditional knowledge.
Biological resource Associated traditional knowledge
3.3 Site(s) where access will be carried out
If access activities will be carried out in more than one site, add rows to the table below and
provide the specified information for each site.
Site
(a) Village/community:
(b) District:
(c) Province:
(d) Geographic location (longitude and latitude):
(e) GIS coordinates:
(f) Attach map
3.4 Activities to be carried out
Insert a comprehensive description of the activities to be carried out. If more than one
activity will be carried out for collection of biological resources and/or compilation of
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traditional knowledge, add rows to the table below and provide the specified description for
each activity.
Activity
Collection of biological resources:
Compilation of traditional knowledge:
3.5 Intended use and foreseen results
Insert a comprehensive description of the intended use of the biological resources and
associated traditional knowledge and of the foreseen results.
Intended use:
Foreseen results:
3.6 Custody, transfer and storage
(1) The Applicant must not, without the prior written permission of the
Owner/Custodian:
(a) use the biological resources and the associated traditional knowledge or the
results for any purpose other than the intended use and foreseen results
described in clause 3.5 of this Agreement;
(b) sell, loan, or otherwise provide the biological resources and the associated
traditional knowledge or the results to any third party; or
(c) use or store the biological resources and the associated traditional knowledge
in any location where they are not under the direct supervision of the
Applicant or the Applicants legally-designated representative.
(2) The Owner/Custodian acknowledges that the biological resources accessed
under this Agreement will be of limited quantity and may be exhausted during the
intended use.
3.7 Compensation and benefit-sharing
(1) The Applicant undertakes to bear all costs, expenses, fees, levies and taxes
incurred by the Owner/Custodian in entering into this Agreement.
(2) The Applicant undertakes to bear all costs, expenses, fees, levies and taxesincurred in accessing the biological resources and associated traditional
knowledge specified in this Agreement, including:
(a) Salaries and other costs of persons hired to assist with the activities to be
carried out as specified in clause 3.4 of this Agreement (specify amounts of
salaries and of each other cost):
(b) Costs incurred by the Representative (specify each cost):
(3) The Applicant undertakes to provide the following benefits, regardless of
commercialization of any results:
(select one or more, provide specifics related to this particular accessagreement, delete the options that are not used)
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(a) Up-front payment (specify or delete):
(b) Milestone payments (specify or delete):
(c) Contributions to local livelihood security and the local economy (specify or
delete):
(d) Contributions to health and food security in the community or communities
where access activities are carried out, taking into account domestic uses ofbiological resources by the community or communities providing the
resources (specify or delete):
(e) Public recognition of the contribution of the Owner/Custodian and of the
members of the community or communities where access activities are
carried out (specify or delete):
(f) Donation of tools and equipment (specify or delete):
(g) Sharing information gathered during the access activities described in clause
3.4 of this Agreement, in a language and format that is accessible to and
usable by the Owner/Custodian and members of the community or
communities where access activities are carried out (specify or delete):(h) Training to enable the Owner/Custodian and members of the community or
communities where access activities are carried out to participate in the
activities described in clause 3.4 of this Agreement (specify or delete):
(i) Funding for educational opportunities in-country and abroad for the
Owner/Custodian and members of the community or communities where
access activities are carried out, particularly in fields relevant to conservation
and sustainable use of biological diversity, including biological inventories and
taxonomic studies, biotechnology, and maintenance of traditional knowledge
(specify or delete):
(j) Training and funding for educational opportunities to enable theOwner/Custodian and members of the community or communities where
access activities are carried out to participate in research and development of
products using biological resources and associated traditional knowledge
(specify or delete):
(k) Any other benefit (specify or delete):
(4) In the event of commercialization of any results, the Applicant undertakes to
provide the following benefits to the Owner/Custodian:
(select one or more, provide specifics, and delete the options that are not
used)(l) Payment of royalties (specify or delete):
(m) License fees (specify or delete):
(n) Profit-sharing (specify or delete):
(o) Establishment of a trust fund to support conservation and sustainable use of
biological resources at the access site(s) (specify or delete):
(p) Funding to enable the Owner/Custodian and/or other members of the
communities at the access sites to participate in research (specify or
delete):
(q) Joint venture (specify or delete):
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3.8 Ownership and licensing of the biological resources and associated traditional
knowledge
(1) All property rights in and in relation to the biological resources and the associated
traditional knowledge are vested in the Owner/Custodian.
(2) The Owner/Custodian gives no warranty that any use of the biological resourcesand the associated traditional knowledge will not infringe the intellectual property
rights or other rights of any third party.
(3) The Owner/Custodian hereby grants the Applicant a non-exclusive license to use
the biological resources and associated traditional knowledge only as described
in clause 3.5 of this Agreement.
(4) Nothing in this Agreement shall give the Applicant any rights whatsoever in and in
relation to the biological resources and the associated traditional knowledge that
are the subject of this Agreement.
3.9 Ownership of intellectual property rights in results
(1) Nothing in this Agreement shall give the Applicant any intellectual property rights
in results arising directly or indirectly from the intended use of the biological
resources and the associated traditional knowledge described in clause 3.5 of
this Agreement.
(2) The Applicant must immediately notify the Owner/Custodian of any unforeseen
use of the biological resources and the associated traditional knowledge and of
any unforeseen results not described in clause 3.5 of this Agreement.
(3) Where the Applicant wishes to commercialise any results or apply for intellectual
property rights arising from the intended or unforeseen use of the biological
resources and the associated traditional knowledge and any intended and
unforeseen results, it must first enter into an appropriate agreement with the
Owner/Custodian who agrees to negotiate non-exclusively in good faith with a
view to concluding such an agreement on terms acceptable to the parties.
3.10 Confidentiality
For sub-clause (1), choose one and delete the one not selected
(1) The Owner/Custodian stipulates that the traditional knowledge described in
clause 3.2 of this Agreement must be protected as confidential information.
or
(1) The Owner/Custodian does not require protection as confidential information
for the traditional knowledge described in clause 3.2 of this Agreement.
(2) The Applicant must restrict access to the biological resources and the associated
traditional knowledge, the results, and all unpublished reports required under the
conditions of the access permit, to those persons who are legally designated by the
Applicant and placed under an obligation to observe the terms of this Agreement.
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(3) Each party must respect the confidentiality of all information designated as
confidential by the other party under the ABS Act and this Agreement, and must not
to disclose any such confidential information to any third person without prior
approval in writing from the other party.
(4) The obligations of the parties under this clause shall not be taken to have beenbreached where such confidential information is legally required to be disclosed.
(5) The obligations of the parties under clauses 3.10(1) and 3.10(3) shall survive the
expiration or termination of this Agreement.
(6) The obligations of the parties under clause 3.10(2) shall continue in effect for a
period of three (3) years after the date of expiration or termination of this Agreement.
3.11 Publication(1) The Applicant must not publish or publicly disclose details of traditional
knowledge that the Owner/Custodian has stipulated as confidential in clause
3.10(1) of this Agreement.
(2) The Applicant must transmit to the Owner/Custodian electronic and paper copies
of any publication arising out of the Applicants use of the biological resources
and the associated traditional knowledge that are the subjects of this Agreement.
(3) In any publication arising out of the Applicants use of the biological resources
and the associated traditional knowledge that are the subjects of this Agreement,the Applicant must identify Pakistan as the country of origin and must
acknowledge:
(a) that the biological resources and the associated traditional knowledge were
obtained in accordance the laws of Pakistan;
(b) the role of Pakistani scientists; and,
(c) any contribution or co-authorship of a Pakistani scientist or scientists.
(4) The Applicant shall immediately notify the Owner/Custodian of any inquiries
received from any third party regarding rights in, or the use, copying, or
distribution of information concerning results published or publicly disclosed in
accordance with this Agreement.
3.12 General provisions
(1) The Applicant may access the biological resources and the associated traditional
knowledge only at the site or sites identified in clause 3.3 of this Agreement.
(2) The Applicant agrees to use the biological resources, associated traditional
knowledge and results:
(a) as specified in this Agreement and in the access permit; and
(b) in accordance with the laws of Pakistan and of the country where the
Applicant is domiciled.
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(3) The Applicant must notify the Owner/Custodian immediately of any change in its
address or designated representative as specified in this Agreement
(4) Any notice under this Agreement may be served by hand delivery or by being
forwarded by registered post, or first class courier, to the address of the party or
to such other address as may be notified in writing by the party from time to timeand in the case of service by post is deemed to have been received upon receipt.
(5) This Agreement contains the entire understanding of the parties with respect to
its subject matter. It sets out the only conduct relied on by the parties and
supersedes all earlier agreements, oral or written, by the parties with respect to
its subject matter.
(6) This Agreement may be varied only by written agreement signed by the parties.
(7) No waiver by the Owner/Custodian of any right, remedy or power and noamendment to this Agreement, shall be effective unless it is in writing signed by
the Owner/Custodian and any such waiver shall be effective only in the specific
instance and for the specific purpose for which it is given.
(8) No failure or delay by the Owner/Custodian to exercise any right, remedy or
power under this Agreement or to insist on strict compliance by the Applicant with
any obligation under this Agreement, and no custom or practice of the parties at
variance with the terms of this Agreement, shall constitute a waiver of the right of
the Owner/Custodian to demand full compliance with this Agreement.
(9) If any provision of this Agreement is unenforceable or invalid for any reason, the
relevant provision shall be deemed to be modified to the extent necessary to
remedy such unenforceability or invalidity or, if this is not possible, then such
provision shall be severed from this Agreement, without affecting the
enforceability or validity of any other provision of this Agreement.
(10) This Agreement is governed by the laws of Pakistan without regard to
conflicts of laws principles, and the parties submit to the non-exclusive jurisdiction
of the courts of Pakistan.
(11) Each signatory to this Agreement warrants that he has authority to bind to this
Agreement the party that he is stated to represent.
IN WITNESS WHEREOF the parties have set their respective hands and signatures on the
day and the year written above.
Owner/Custodian Representative
____________________________________
_
____________________________________
_
Name: Name:
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Title: Title:
Witness Witness
____________________________________
_
____________________________________
_
Name: Name:
Date: Date:
Applicant Affiliated national institution (if applicable)
____________________________________
_
____________________________________
_
Name: Name:
Title: Title:
Witness Witness
____________________________________
_
____________________________________
_
Name: Name:
Date: Date:
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SCHEDULE I-B
ACCESS AGREEMENTTo be used when the custodian of traditional knowledge and owner of biological resources
are NOT the same person (Article 11(9)(b)
THIS AGREEMENT is made on the _____________ day of _____________, the year______
BETWEEN
_________________________hereinafter referred to as the Owner of biological resourceswhich term shall be deemed to include, as the case may be, his respective community,successors, officers, employees, contractors, agents and assigns, located at______________________________,
AND
______________________________, hereinafter referred to as the Custodian oftraditional knowledge, which term shall be deemed to include, as the case may be, hisrespective community, successors, officers, employees, contractors, agents and assigns,located at ______________________________,
REPRESENTED BY______________________________, [insert legal name of organization representing theCustodian] hereinafter referred to as the Representative of the Custodian, which term shallbe deemed to include, as the case may be, its respective successors, officers, employees,contractors, agents and assigns, having its office at ______________________________,
AND__________________________________, hereinafter referred to as the Applicant whichterm will be deemed to include his successors, officers, employees, contractors, agents andassigns, located at ______________________________.
RECITALS:
Whereas the Owner is in the possession and ownership of a biological resource or biologicalresources, as detailed in clause 3.1 of this Agreement, and seeks to facilitate access to thesaid biological resource(s) for gainful and beneficial purposes keeping in mind theconservation of biodiversity, the sustainable use of its components, and equitable sharing of
benefits derived from its use; and
Whereas the Custodian is in possession and ownership of traditional knowledge associatedwith the biological resources of the Owner, as detailed in clause 3.2 of this Agreement, andseeks to facilitate access to the said traditional knowledge for gainful and beneficialpurposes keeping in mind the conservation of biodiversity, the sustainable use of itscomponents, and equitable sharing of benefits derived from its use; and
Whereas the Owner is willing to give the Applicant access to the said biological resource andthe Custodian is willing to give the Applicant access to the traditional knowledge associatedtherewith; and
Whereas the Applicant is interested in gaining access to the said biological resource and thetraditional knowledge associated therewith;
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This Agreement sets out the terms that the parties agree to apply to the taking and use ofthe biological resources and associated traditional knowledge.
Now this Agreement witnesseth as under:-
1. DEFINITIONS & INTERPRETATION1.1 Definitions
(1) ABS Act means the Pakistan Access to Genetic Resources and Benefit-sharingAct, 2012.
(2) Biological resources includes genetic resources, organisms or parts thereof,populations, or any other biotic component of ecosystems with actual or potentialuse or value for humanity, excluding human genetic resources.
(3) Commencement date means the date of the access permit to which this AccessAgreement is annexed.
(4) Confidential information means all know-how, financial information and othercommercially valuable or sensitive information in whatever form, which a partymarks as confidential or proprietary and discloses to the other party. Thefollowing are exceptions to such information:
a. information which is lawfully in the public domain prior to its disclosure toa party by another party;
b. information which enters the public domain otherwise than as a result ofan unauthorised disclosure;
c. information which is or becomes lawfully available to the recipient partyfrom a third party who has the lawful power to disclose such information tothe recipient party on a non-confidential basis; and
d. information which is rightfully known by the recipient party (as shown byits written record) prior to the date of disclosure.
(5) Custodian means the person or community that holds traditional knowledge.
(6) Derivative means a naturally occurring biochemical compound resulting from thegenetic expression or metabolism of biological or genetic resources, even if itdoes not contain functional units of heredity.
(7) Intellectual property rights means rights established by any statute or customarylaw over any property created through intelligent activity of the human mind, inthe form of patents, trademarks, design, protection of plant varieties and animalbreeds, copyrights, and traditional knowledge.
(8) Mutually agreed terms means the conditions for access to genetic resources andany associated traditional knowledge and the way in which monetary and non-monetary benefits from their use will be shared, as freely decided between anApplicant, the owner of a biological resource, the custodian of any associatedtraditional knowledge, and the permitting authority.
(9) Results means all information and tangible objects arising from the Applicantsuse of biological resources and traditional knowledge and any derivatives,including information published in accordance with clause 3.11 of this Agreement.
(10) Traditional knowledge means knowledge, practices, innovations ortechnologies created, developed and held by a custodian.
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1.2 Interpretation(1) Headings are for convenience only and do not affect interpretation.
(2) The singular includes the plural and conversely, and a gender includes allgenders.
(3) Where the Owner, Custodian or Applicant is comprised of more than one personthe Owners, Custodians and Applicants obligations apply to each person jointlyand severally.
(4) A reference to any legislation or to any provision of any legislation includes anymodification or re-enactment of it, any legislative provision substituted for it andall regulations and statutory instruments issued under it.
2. COMMENCEMENT OF AGREEMENTThis Agreement commences on the date of issue of the access permit to which this AccessAgreement is annexed and shall remain valid for one (1) year unless terminated earlier or
renewed by the Permitting Authority prior to the expiration date.
3. MUTUALLY AGREED TERMS
3.1 Resources to be accessed
If more than one biological resource is to be accessed, add rows to the table below and
provide the specified information for each biological resource.
Biological resource
(a) Scientific classification:
(b) Local language name(s):
(c) English language name:
(d) Characteristics for which the resource issought:
3.2 Traditional knowledge to be accessed
Insert a comprehensive description of the traditional knowledge associated with each
biological resource for which access is sought. If more than one biological resource is to be
accessed, add rows to the table below and provide the specified information for each
biological resource and the associated traditional knowledge.
Biological resource Associated traditional knowledge
3.3 Site(s) where access will be carried out
If access activities will be carried out in more than one site, add rows to the table below and
provide the specified information for each site.
Site
(a) Village/community:
(b) District:(c) Province:
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(d) Geographic location (longitude and latitude):
(e) GIS coordinates:
(f) Attach map
3.4 Activities to be carried out
Insert a comprehensive description of the activities to be carried out. If more than oneactivity will be carried out for collection of biological resources and/or compilation of
traditional knowledge, add rows to the table below and provide the specified description for
each activity.
Activity
Collection of biological resources:
Compilation of traditional knowledge:
3.5 Intended use and foreseen results
Insert a comprehensive description of the intended use of the biological resources andassociated traditional knowledge and of the foreseen results.
Intended use:
Foreseen results:
3.6 Custody, transfer and storage
(1) The Applicant must not, without the prior written permission of the Owner and the
Custodian:
(a) use the biological resources and the associated traditional knowledge or theresults for any purpose other than the intended use and foreseen results
described in clause 3.5 of this Agreement;
(b) sell, loan, or otherwise provide the biological resources and the associated
traditional knowledge or the results to any third party; or
(c) use or store the biological resources and the associated traditional knowledge
in any location where they are not under the direct supervision of the
Applicant or the Applicants legally-designated representative.
(2) The Owner acknowledges that the biological resources accessed under this
Agreement will be of limited quantity and may be exhausted during the intended
use.
3.7 Compensation and benefit-sharing
(1) The Applicant undertakes to bear all costs, expenses, fees, levies and taxes
incurred by the Custodian in entering into this Agreement.
(2) The Applicant undertakes to bear all costs, expenses, fees, levies and taxes
incurred in accessing the biological resources, genetic resources, derivatives and
associated traditional knowledge specified in this Agreement, including:
(a) Salaries and other costs of persons hired to assist with the activities to be
carried out as specified in clause 3.4 of this Agreement (specify amounts
of salaries and of each other cost):
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(b) Costs incurred by the Representative (specify each cost):
(3) The Applicant undertakes to provide the following benefits, regardless of
commercialization of any results: (select one or more, provide specifics
related to this particular access agreement, delete the options that are not
used)(a) Up-front payment (specify or delete):
(b) Milestone payments (specify or delete):
(c) Contributions to local livelihood security and the local economy (specify or
delete):
(d) Contributions to health and food security in the community or communities
where access activities are carried out, taking into account domestic uses of
biological resources by the community or communities providing the
resources (specify or delete):
(e) Public recognition of the contribution of the Owner and the Custodian and of
the members of the community or communities where access activities arecarried out (specify or delete):
(f) Donation of tools and equipment (specify or delete):
(g) Sharing information gathered during the access activities described in clause
3.4 of this Agreement, in a language and format that is accessible to and
usable by the Owner, Custodian and members of the community or
communities where access activities are carried out (specify or delete):
(h) Training to enable the Owner, the Custodian and members of the community
or communities where access activities are carried out to participate in the
activities described in clause 3.4 of this Agreement (specify or delete):
(i) Funding for educational opportunities in-country and abroad for the Owner,the Custodian and members of the community or communities where access
activities are carried out, particularly in fields relevant to conservation and
sustainable use of biological diversity, including biological inventories and
taxonomic studies, biotechnology, and maintenance of traditional knowledge
(specify or delete):
(j) Training and funding for educational opportunities to enable the Owner, the
Custodian and members of the community or communities where access
activities are carried out to participate in research and development of
products using biological resources and associated traditional knowledge
(specify or delete):
(k) Any other benefit (specify or delete):
(4) In the event of commercialization of any results, the Applicant undertakes to
provide the following benefits to the Owner and the Custodian to be shared as
stipulated in the ABS Act: (select one or more, provide specifics, and delete
the options that are not used)
(a) Payment of royalties (specify or delete):
(b) License fees (specify or delete):
(c) Profit-sharing (specify or delete):
(d) Establishment of a trust fund to support conservation and sustainable use ofbiological resources at the access site(s) (specify or delete):
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(e) Funding to enable the Owner, the Custodian and/or other members of the
communities at the access sites to participate in research (specify or
delete):
(f) Joint venture (specify or delete):
3.8 Ownership and licensing of the biological resources and associated traditionalknowledge
(1) All property rights in and in relation to the biological resources are vested in the
Owner. All property rights in and in relation to the associated traditional
knowledge are vested in the Custodian.
(2) The Owner and Custodian give no warranty that any use of the biological
resources and the associated traditional knowledge will not infringe the
intellectual property rights or other rights of any third party.
(3) The Owner and Custodian hereby grant the Applicant a non-exclusive license touse the biological resources and associated traditional knowledge only as
described in clause 3.5 of this Agreement.
(4) Nothing in this Agreement shall give the Applicant any rights whatsoever in and in
relation to the biological resources and the associated traditional knowledge that
are the subject of this Agreement.
3.9 Ownership of intellectual property rights in results
(1) Nothing in this Agreement shall give the Applicant any intellectual property rights
in results arising directly or indirectly from the intended use of the biologicalresources and the associated traditional knowledge described in clause 3.5 of
this Agreement.
(2) The Applicant must immediately notify the Owner and the Custodian of any
unforeseen use of the biological resources and the associated traditional
knowledge and of any unforeseen results not described in clause 3.5 of this
Agreement.
(3) Where the Applicant wishes to commercialise any results or apply for intellectual
property rights arising from the intended or unforeseen use of the biological
resources and the associated traditional knowledge and any intended and
unforeseen results, it must first enter into an appropriate agreement with the
Owner and Custodian who agree to negotiate non-exclusively in good faith with a
view to concluding such an agreement on terms acceptable to the parties.
3.10 Confidentiality
For sub-clause (1), choose one and delete the one not selecte