Draft Access and Benefit Sharing (ABS) Law For Pakistan

ABS DRAFT ACT v12 26 July 2012
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 scientific knowledge 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-situ and ex-situ conservation 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:-
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) (3) It shall extend to the whole of Pakistan. 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. Access agreement means the agreement entered into between the owner of the biological resource or the custodian of the traditional knowledge (as the case may be) and the Applicant. Access permit means the permit issued by the permitting authority under Section 11(19) of this Act. Applicant means a person seeking access to genetic resources and their derivatives and any associated traditional knowledge. 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. 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. 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. 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. Certificate of compliance means the access permit which certifies that a genetic resource or derivative and any associated traditional knowledge 2
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
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. 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 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 recipient party 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. Court means any Courts established by or under any laws of the Islamic Republic of Pakistan. Custodian means the person or community that holds traditional knowledge. 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. Ecosystem means a dynamic complex of plant, animal and microorganism communities and their non-living environment interacting as functional unit. Environmental impact assessment means an environmental study comprising collection of data, prediction of qualitative and quantitative impacts, comparison of alternatives, evaluation of preventive, mitigatory and compensatory measures, formulation of environmental management and training plans and monitoring arrangements and framing of recommendations and such other components as may be prescribed. Ex-situ conservation 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. Ex-situ facility means gene banks, seed banks, sperm banks, and other types of storage services for genetic resources including those that may be maintained by the private sector, universities, zoos, botanical gardens, 3
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
herbaria and other similar national institutions, and international organizations. (19) Field research means preliminary investigation in in-situ conditions into biological resources and any associated traditional knowledge. Genetic resources means any material derived from plants, animals, fungi or microorganisms which contains functional units of heredity and which has actual or potential value for humanity. Government means the person or persons authorized by law to administer executive Government in Pakistan, or in any part thereof. In-situ conservation 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 distinctive properties. In-situ conservation of plant genetic resources means conserving the plants where they grow naturally. In-situ conservation of animal genetic resources means conserving the animals in their natural habitats. 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. 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. IPO means the Intellectual Property Organization of Pakistan organized and existing under the Intellectual Property Organization of Pakistan Ordinance, 2005 or any modifications thereof. Material transfer agreement means the agreement used to exchange genetic resources and derivatives between two ex-situ facilities. 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. No Objection Certificate means a document issued by the permitting authority pursuant to Chapter 3 Section 11(4) of this Act. 4
(20)
(21)
(22)
(23)
(24)
(25)
(26)
(27)
(28)
(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. Permitting Authority means the governmental authority responsible for granting access to genetic resources and regulating matters associated therewith under this Act. Person means a natural or juridical person. Plant genetic resources for food and agriculture means any genetic material of plant origin of actual or potential value for food and agriculture. 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, any derivatives of genetic resources, and any associated traditional knowledge. Protected area means a geographically defined area which is designated or regulated and managed to achieve specific conservation objectives. 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.
(30)
(31) (32)
(33)
(34)
(35)
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 5
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.
(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. 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. 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.
(3)
(4)
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 exsitu facilities 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.
(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-situ conditions (1) An Applicant shall submit to the permitting authority a formal expression of intent 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.
(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 access agreement 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 to the 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 9
(c) (d)
(e)
Convention on International Trade in Endangered Species of Fauna and Flora (CITES); Whether the application requests access to biological resources that are found in a protected area; 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 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 subSections (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 be disseminated, 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: 10
(1) trade, manufacturing, or business activities, processes or techniques of a proprietary nature or financial, commercial, scientific or technical matters which the Applicant has requested should remain confidential, unless for reasons to be recorded in writing the permitting authority is of the opinion that the request for confidentiality is not well-founded or the public interest in the disclosure outweighs the possible prejudice to the competitive position of the Applicant; or (2) international relations, national security, or maintenance of law and order except with the consent of the federal government; or (3) matters covered by legal professional privilege.
13. Procedure for access to genetic resources in ex-situ conditions.(1) No person shall access genetic resources from an ex-situ facility in Pakistan, unless in possession of a duly executed material transfer agreement, in the form attached as Schedule II to this Act. The material transfer agreement to be used to access genetic resources governed by the ITPGRFA shall be in the format prescribed by the treaty. (2) Where there is access to genetic resources from an ex-situ facility and also access to traditional knowledge associated with those genetic resources, the Applicant must enter into an access agreement with the custodian or custodians of the traditional knowledge and obtain an access permit according to the procedure specified in Section 11, in addition to executing the material transfer agreement. In such a case, the material transfer agreement shall not be valid without the access permit. The date of issue of the access permit and the date of execution of the material transfer agreement must be the same. (3) An ex-situ facility in Pakistan must submit to the permitting authority a copy of each material transfer agreement it executes. (4) On receipt of a material transfer agreement, the permitting authority shall cause public notice of the material transfer agreement to be disseminated, taking into account any request from the Applicant not to disclose confidential information under Section 12. 14. Types of benefits.(1) Benefits shall be: (a) agreed between an Applicant, biological resource owner and custodian and shall be set out in an access agreement; and (b) stipulated by the permitting authority and set out in the access permit. Such benefits may include monetary benefits and non-monetary benefits. Monetary benefits may include, but shall not be limited to: (a) Access fees/fee per sample collected or otherwise acquired; (b) Up-front payments, which may include a percentage of the total research budget; (c) Milestone payments; (d) Payment of royalties; (e) License fees in case of commercialization; 11
(2) (3)
(f) (g)
(4)
Profit-sharing in case of commercialization; 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 research and development. 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 the administration 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-situ and 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 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; (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. In cases in which there is access to genetic resources in-situ and 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.
(3)
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(4)
In cases in which there is access to genetic resources ex-situ and 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-situ facility is located. 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.
(5)
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 14
(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 the report 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 implementation of 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 universitylevel 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 to genetic 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 create economic 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 half of the members shall be drawn from scientific, academic, legal, and non-governmental organization sectors, to analyze and advise as needed, 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 17
(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./-). 18
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 access permit 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
19
Schedule 1-A Access Agreement
SCHEDULE I-A ACCESS AGREEMENT To 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 of biological resources and associated traditional knowledge which term shall be deemed to include, 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 the Custodian/Owner] hereinafter referred to as the Representative of the Custodian/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 of the designated representative of the organization representing the Custodian/Owner] AND __________________________________, hereinafter referred to as the Applicant which term 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 resource or biological resources and traditional knowledge associated therewith, as detailed in clauses 3.1 and 3.2, respectively, of this Agreement, and seeks to facilitate access to the said biological resources and associated traditional knowledge for gainful and beneficial purposes keeping in mind the conservation of biodiversity, the sustainable use of its components, and equitable sharing of benefits derived from its use; and Whereas the Custodian/Owner is willing to give the Applicant access to the said biological resources and traditional knowledge associated therewith; and Whereas the Applicant is interested in gaining access to the said biological resource(s) and the traditional knowledge associated therewith; This Agreement sets out the terms that the parties agree to apply to the taking and use of the biological resources and associated traditional knowledge. Now this Agreement witnesseth as under:1. DEFINITIONS & INTERPRETATION 1.1 Definitions (1) ABS Act means the Pakistan Access to Genetic Resources and Benefit-sharing Act, 2012. 20
(2) 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. (3) Commencement date means the date of the access permit to which this Access Agreement is annexed. (4) 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 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 recipient party 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 the genetic expression or metabolism of biological or genetic resources, even if it does not 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 form of 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 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. (9) Results means all information and tangible objects arising from the Applicants use of biological 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, technologies created, developed and held by a custodian. innovations or
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 person the Owner/Custodians and the Applicants obligations apply to each person jointly and severally. 21
(4) A reference to any legislation or to any provision of any legislation includes any modification or re-enactment of it, any legislative provision substituted for it and all regulations and statutory instruments issued under it. 2. COMMENCEMENT OF AGREEMENT This Agreement commences on the date of issue of the access permit to which this Access Agreement 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 is sought:
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
22
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 taxes incurred 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 access agreement, delete the options that are not used) 23
(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/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 the Owner/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):
24
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 resources and 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.
25
(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 been breached 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.
26
(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 time and 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 no amendment 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 ____________________________________ _ Name: Representative ____________________________________ _ Name: 27
Title: Witness ____________________________________ _ Name: Date:
Title: Witness ____________________________________ _ Name: Date:
Applicant ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:
Affiliated national institution (if applicable) ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:
28
Schedule 1-B Access Agreement
SCHEDULE I-B ACCESS AGREEMENT To 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 resources which 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 of traditional knowledge, which term shall be deemed to include, 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 the Custodian] hereinafter referred to as the Representative of the Custodian, which term shall be 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 which term will be deemed to include his successors, officers, employees, contractors, agents and assigns, located at ______________________________.
RECITALS: Whereas the Owner is in the possession and ownership of a biological resource or biological resources, as detailed in clause 3.1 of this Agreement, and seeks to facilitate access to the said biological resource(s) for gainful and beneficial purposes keeping in mind the conservation 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 associated with the biological resources of the Owner, as detailed in clause 3.2 of this Agreement, and seeks to facilitate access to the said traditional knowledge for gainful and beneficial purposes keeping in mind the conservation of biodiversity, the sustainable use of its components, 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 and the Custodian is willing to give the Applicant access to the traditional knowledge associated therewith; and Whereas the Applicant is interested in gaining access to the said biological resource and the traditional knowledge associated therewith; 29
This Agreement sets out the terms that the parties agree to apply to the taking and use of the biological resources and associated traditional knowledge. Now this Agreement witnesseth as under:1. DEFINITIONS & INTERPRETATION 1.1 Definitions (1) ABS Act means the Pakistan Access to Genetic Resources and Benefit-sharing Act, 2012. (2) 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. (3) Commencement date means the date of the access permit to which this Access Agreement is annexed. (4) 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 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 recipient party 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 the genetic expression or metabolism of biological or genetic resources, even if it does not 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 form of 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 any associated traditional knowledge and the way in which monetary and nonmonetary 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. (9) Results means all information and tangible objects arising from the Applicants use 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 or technologies created, developed and held by a custodian. 30
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 Applicant is comprised of more than one person the Owners, Custodians and Applicants obligations apply to each person jointly and severally. (4) A reference to any legislation or to any provision of any legislation includes any modification or re-enactment of it, any legislative provision substituted for it and all regulations and statutory instruments issued under it. 2. COMMENCEMENT OF AGREEMENT This Agreement commences on the date of issue of the access permit to which this Access Agreement 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 is sought: 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: 31
(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 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 and the 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 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): 32
(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 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, 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 of biological resources at the access site(s) (specify or delete): 33
(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 traditional knowledge (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 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 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 selected (1) The Custodian stipulates that the traditional knowledge described in clause 3.2 of this Agreement must be protected as confidential information. or (1) The Custodian does not require protection as confidential information for the traditional knowledge described in clause 3.2 of this Agreement. 34
(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. (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 parties. (4) The obligations of the parties under this clause shall not be taken to have been breached where such confidential information is legally required to be disclosed. (5) The obligations of the parties under sub-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 Custodian has stipulated as confidential under clause 3.10(1) of this Agreement. (2) The Applicant must transmit to the Owner and 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 and 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. 35
(2) The Applicant agrees to use the biological resources, associated traditional knowledge and results: (c) as specified in this Agreement and in the access permit; and (d) in accordance with the laws of Pakistan and of the country where the Applicant is domiciled. (3) The Applicant must notify the Owner and 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 time and 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 or Custodian of any right, remedy or power and no amendment to this Agreement, shall be effective unless it is in writing signed by the Owner and 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 or 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 or 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.
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IN WITNESS WHEREOF the parties have set their respective hands and signatures on the day and the year written above. Custodian ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date: Representative ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:
Owner ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:
Applicant ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:
Affiliated national institution (if applicable) _____________________________________ Name: Title: Witness _____________________________________ Name: Date:
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Schedule 1-C Access Agreement
SCHEDULE I-C ACCESS AGREEMENT To be used when the access agreement is with the custodian of traditional knowledge only (Article 11(9)(c) THIS AGREEMENT is made on the _____________ day of _____________, the year ______
BETWEEN ______________________________, hereinafter referred to as the Custodian of traditional knowledge associated with a biological resource, which term shall be deemed to include, 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 the Custodian] hereinafter referred to as the Representative of the Custodian which term shall be deemed to include its respective successors, officers, employees, contractors, agents and assigns, having its office at ______________________________, AND __________________________________, hereinafter referred to as the Applicant which term shall be deemed to include his successors, officers, employees, contractors, agents and assigns, located at ______________________________. Whereas the Custodian is in the possession and ownership of traditional knowledge, as detailed in clause 3.2 of this Agreement, associated with a biological resource as detailed in clause 3.1 of this Agreement, and seeks to facilitate access to the said traditional knowledge for gainful and beneficial purposes keeping in mind the conservation of biodiversity, the sustainable use of its components, and equitable sharing of benefits derived from its use; and Whereas the Custodian is willing to give the Applicant access to the said traditional knowledge; and Whereas the Applicant is interested in gaining access to the said traditional knowledge; This Agreement sets out the terms that the parties agree to apply to the taking and use of the traditional knowledge. Now this agreement witnesseth as under:1. DEFINITIONS & INTERPRETATION 1.1 Definitions (1) ABS Act means the Pakistan Access to Genetic Resources and Benefit-sharing Act, 2012. (2) 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.
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(3) Commencement date means the date of the access permit to which this Access Agreement is annexed. (4) 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 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 recipient party 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 the genetic expression or metabolism of biological or genetic resources, even if it does not 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 form of 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 any associated traditional knowledge and the way in which monetary and nonmonetary 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. (9) Results means all information and tangible objects arising from the Applicants use of biological resources and traditional knowledge and any derivatives, including information published in accordance with clause 3.11. (10) Traditional knowledge means knowledge, practices, innovations or technologies 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 Custodian or the Applicant is comprised of more than one person, the Custodians and the Applicants obligations apply to each person jointly and severally. (4) A reference to any legislation or to any provision of any legislation includes any modification or re-enactment of it, any legislative provision substituted for it and all regulations and statutory instruments issued under it. 39
2. COMMENCEMENT OF AGREEMENT This Agreement commences on the date of issue of the access permit to which this Access Agreement 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 is sought: 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 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: 40
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 The Applicant must not, without the prior written permission of the Custodian: (1) use the traditional knowledge or the results for any purpose other than the intended use and foreseen results described in clause 3.5 of this Agreement; (2) sell, loan, or otherwise provide the traditional knowledge or the results to any third party; or (3) use or store the documentation of the traditional knowledge in any location where they are not under the direct supervision of the Applicant or the Applicants legally-designated representative.
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): (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 Custodian and of the members of the community or communities where access activities are carried out (specify or delete): 41
(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 Custodian and members of the community or communities where access activities are carried out (specify or delete): (h) Training to enable 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 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 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 Custodian: (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 of biological resources at the access site(s) (specify or delete): (e) Funding to enable 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 traditional knowledge (1) All property rights in and in relation to the traditional knowledge are vested in the Custodian. (2) The Custodian gives no warranty that any use of the traditional knowledge will not infringe the intellectual property rights or other rights of any third party. (3) The Custodian hereby grants the Applicant a non-exclusive license to use the 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 traditional knowledge that is the subject of this Agreement. 3.9 Ownership of intellectual property rights in results 42
(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 traditional knowledge described in clause 3.5 of this Agreement. (2) The Applicant must immediately notify the Custodian of any unforeseen use of the 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 traditional knowledge and any intended and unforeseen results, it must first enter into an appropriate agreement with the Custodian who agrees to negotiate nonexclusively 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 Custodian stipulates that the traditional knowledge described in clause 3.2 of this Agreement must be protected as confidential information. or (1) The 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 traditional knowledge, the results, and all unpublished reports required under the conditions of the access permit, to those persons who legally designated by the Applicant and placed under an obligation to observe the terms of this Agreement. (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 been breached 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 Custodian has stipulated as confidential in clause 3.10(1) of this Agreement.
43
(2) The Applicant must transmit to the Custodian electronic and paper copies of any publication arising out of the Applicants use of the traditional knowledge that are the subjects of this Agreement. (3) In any publication arising out of the Applicants use of the traditional knowledge that is the subject of this Agreement, the Applicant must identify Pakistan as the country of origin and must acknowledge: (d) that the traditional knowledge was obtained in accordance the laws of Pakistan; (e) the role of Pakistani scientists; and, (f) any contribution or co-authorship of a Pakistani scientist or scientists. (4) The Applicant shall immediately notify the 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 traditional knowledge only at the site or sites identified in clause 3.3 of this Agreement. (2) The Applicant agrees to use the traditional knowledge and results: (e) as specified in this Agreement and in the access permit; and (f) in accordance with the laws of Pakistan and of the country where the Applicant is domiciled. (3) The Applicant must notify the 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 time and 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 Custodian of any right, remedy or power and no amendment to this Agreement, shall be effective unless it is in writing signed by the 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 Custodian to exercise any right, remedy or power under this Agreement or to insist on strict compliance by the Applicant with any 44
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 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. Custodian _______________________ _ Name: Title: Witness _______________________ _ Name: Date: Representative _______________________ _ Name: Title: Witness _______________________ _ Name: Date: Applicant _______________________ _ Name: Title: Witness _______________________ _ Name: Date:
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Schedule II Non-Commercial Material Transfer Agreement
SCHEDULE II NON-COMMERCIAL MATERIAL TRANSFER AGREEMENT [INSERT NAME OF EX-SITU FACILITY] is committed to the letter and spirit of the Convention on Biological Diversity (CBD) the Nagoya Protocol and expects its partners to act in a manner consistent with these multilateral environmental agreements and with the Pakistan Access to Genetic Resources and Benefit-sharing Act, 2012. This Material Transfer Agreement (MTA) is designed to promote scientific research and exchange, while recognising the terms on which [INSERT NAME OF EX-SITU FACILITY] acquired the animal, plant or fungal material or microorganism and the important role played by ex-situ collections in the implementation of the CBD and the Nagoya Protocol. [INSERT NAME OF EX-SITU FACILITY] reserves the right not to supply any animal, plant or fungal material or microorganism if such supply would be contrary to any terms attached to the material or to the CBD, the Nagoya Protocol, or the Pakistan Access to Genetic Resources and Benefit-sharing Act, 2012. [INSERT NAME OF EX-SITU FACILITY] will supply the animal, plant or fungal material or microorganism listed in the Schedule to this agreement (Material) subject to the following terms and conditions: 1. The Applicant may only use the Material, its progeny or derivatives for the common good in scientific research, education, conservation and the development of ex-situ conservation facilities; 2. The Applicant shall not sell, distribute or use for profit or any other commercial application1 the Material, its progeny or derivatives; 3. The Applicant shall share fairly and equitably the benefits arising from its use of the Material, its progeny or derivatives in accordance with the CBD, the Nagoya Protocol, and the Pakistan Access to Genetic Resources and Benefit-sharing Act, 2012, as amended from time to time. 4. The Applicant shall acknowledge Pakistan as the country of origin of the Material and [INSERT NAME OF EX-SITU FACILITY] as supplier, in all written or electronic reports and publications resulting from its use of the Material, its progeny and derivatives and shall lodge a copy of all such publications and reports with the Permitting Authority and with [INSERT NAME OF EX-SITU FACILITY]; 5. The Applicant shall take all appropriate and necessary measures to import the Material in accordance with relevant laws and regulations and to contain the Material, its progeny or derivatives so as to prevent the release of invasive alien species; 6. The Applicant may only transfer the Material, its progeny or derivatives to a bona fide third party ex-situ conservation facility such as a botanic garden, university or scientific institution for non-commercial use in the areas of scientific research, education, conservation and the development of botanic gardens. All transfers shall be subject to the terms and conditions of this agreement. The Applicant shall notify the Permitting Authority] and [INSERT NAME OF
1
For the purposes of this agreement, commercial application shall mean: applying for, obtaining or transferring intellectual property rights or other tangible or intangible rights by sale or licence or in any other manner; commencement of product development; conducting market research; seeking pre-market approval; and/or the sale of any resulting product.
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Schedule II Non-Commercial Material Transfer Agreement
EX-SITU FACILITY] of all such transfers and, on request, shall provide the Permitting Authority and [INSERT NAME OF EX-SITU FACILITY] with copies of the relevant material transfer agreement; 7. The Applicant shall maintain retrievable records linking the Material to these terms of acquisition and to any accompanying data provided by [INSERT NAME OF EX-SITU FACILITY] and any Pakistani national experts; 8. Unless otherwise indicated, copyright in all information or data (Data) supplied with the Material is owned by [INSERT NAME OF EX-SITU FACILITY] or [INSERT NAME OF EXSITU FACILITY]s licensors. The Applicant may use these Data on condition that they are used solely for scholarly, education or research purposes; that they are not used for commercial purposes; and that the Applicant always acknowledges the source of the Data with the words With the permission of the Permitting Authority and [INSERT NAME OF EXSITU FACILITY]; 9. [INSERT NAME OF EX-SITU FACILITY] makes no representation or warranty of any kind, either express or implied, as to the identity, safety, merchantability or fitness for any particular purpose of the Material, its progeny or derivatives, or as to the accuracy or reliability of any Data supplied. The Applicant will indemnify [INSERT NAME OF EX-SITU FACILITY] from any and all liability arising from the Material, its progeny or derivatives and/or the Data and from their use or transfer, including any ecological damage. This agreement is governed by and shall be construed in accordance with Pakistani law; 10. The Applicant shall contact [INSERT NAME OF EX-SITU FACILITY] to request prior permission from [INSERT NAME OF EX-SITU FACILITY] or, where appropriate, from the provider of the Material to [INSERT NAME OF EX-SITU FACILITY], for any activities not covered under the terms of this agreement. I agree to comply with the conditions stipulated above: Signed: Date: (dd/mm/yyyy) Name and Position: Organisation and Department: Address: E-mail: Tel. Number: Please return a signed copy to: ..., [INSERT NAME OF EX-SITU FACILITY] [INSERT POSTAL ADDRESS OF EX-SITU FACILITY] [INSERT NAME OF EX-SITU FACILITY] Authorized Signature: Name: Position: Date: (dd/mm/yyyy) SCHEDULE LIST OF MATERIAL SUPPLIED
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Schedule III Application for Permit to Access Genetic Resources and Associated Traditional Knowledge
SCHEDULE III
[logo of permitting authority]
APPLICATION FOR PERMIT TO ACCESS GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE [Permitting Authority full name and address] The undersigned hereby applies for a permit authorizing access to [biological resources] [genetic resources] [derivatives] and any associated traditional knowledge as specified below. (Please type/write in BLOCK LETTERS) 1.a. Name: Complete address: Telephone No.: Email: CNIC No.: Attach photocopy [business license number or other registration number] Attach photocopy 1.b. Name: Name and title of authorized representative: Complete address: Telephone No.: Email: CNIC No.: [business license number or other registration number] The Applicant must notify the [Permitting Authority] immediately of any change in the information provided in sections 1.a and/or 1.b. 2. Tick box Access applied for: For non-national Applicants, the affiliated national institution is: Applicant
In-situ: Biological resource: (provide a complete description of the biological resource, including its scientific and local language names Traditional knowledge: Ex-situ: Biological resource (provide a complete description of the biological resource, including its 48
scientific and local language names Genetic resource: (provide a complete description of the genes and genetic characteristics that are sought from each biological resource) Derivative: (specify the derivative sought)
3. Tick box
Purpose of access:
Research with no commercial application: (describe in detail the proposed research) Research with planned or potential commercial application: (describe in detail the planned or potential commercial application) Add rows if required. 4.a. If the application is for access to biological resources, genetic resources and associated traditional knowledge in-situ, provide a comprehensive description and justification for the activities to be carried out, including the [geographic location] [geographic locations] in which the Applicant proposes to carry out activities. Specify each activity, the location in which it will be carried out, and who will carry it out. Provide maps and GIS coordinates. Activity and justification Location (coordinates, maps, Who will carry out the GIS coordinates) activity
Add rows if required. 4.b. If the application is for access to biological resources, genetic resources and associated traditional knowledge in-situ, provide a comprehensive description of the proposed arrangements for participation of local communities and indigenous people in the proposed activities.
Add rows if required. 5. If the application is for access to biological resources, genetic resources and derivatives from an ex-situ facility, provide the following information on the ex-situ facility:
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Add rows if required. 6. Provide a comprehensive description of the proposed arrangements for participation of national researchers in all activities, including collection and identification of biological resources and traditional knowledge in-situ as well as research and development.
Add rows if required. 7. Provide a comprehensive description of the Applicants preliminary proposal for benefitsharing arrangements, including monetary and non-monetary benefits.
Add rows if required. 8. Provide a comprehensive description of proposed arrangements for technology transfer, including among other things, training for national students and researchers, transfer of equipment, and transfer of information.
Add rows if required. 9. Provide a comprehensive description of any transfer to third parties intended at the time of the application.
Add rows if required. 50
Signature of authorized representative of the Applicant: ______________________________________________________________________________ Name: (in block letters) Title:_________________________________________________________________________ Place :_______________________________________________________________________
Date :________________________________________________________________________
Signature of authorized representative of the affiliated national institution: ______________________________________________________________________________ Name: (in block letters) Title:__________________________________________________________________________ Place :________________________________________________________________________
Date:_________________________________________________________________________
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Schedule IV Permit to Access Genetic Resources and Associated Traditional Knowledge
SCHEDULE IV [logo of permitting authority] PERMIT TO ACCESS GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE [Permitting Authority complete name and address] [Permit number and date of issue] The [Permitting Authority] hereby grants to [insert name of Applicant/permit holder] this permit No. [insert permit number] authorizing access to genetic resources and any associated traditional knowledge on the terms and conditions specified below. 1.a. Name: Complete address: Telephone No.: Email: CNIC No.: [business license number or other registration number] 1.b. Name: Name and title of authorized representative: Complete address: Telephone No.: Email: CNIC No.: [business license number or other registration number] The permit holder must notify the [Permitting Authority] immediately of any change in the information provided in sections 1.a and/or 1.b. 2. Name: Name and title of authorized representative: Complete address: Telephone No.: Email: CNIC No.: [business license number or other registration number] The owner of the [biological resources] [genetic resources] [derivatives] is: For non-national permit holders, the affiliated national institution is: The permit holder is:
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If more than one provider of the biological resources, the information above must be given for each provider. 3.a. The [custodian] [custodians] of traditional knowledge associated with the [biological resources] [genetic resources] [derivatives] [is] [are]: Name: Name and title of authorized representative: Complete address: Telephone No.: Email: CNIC No.: 3.b. The organization representing the [custodian] [custodians] of the traditional knowledge is: Name: Name and title of authorized representative: Complete address: Telephone No.: Email: CNIC No.: Registration number: If more than one custodian/provider of traditional knowledge, the information above must be given for each custodian/provider. Add rows if required. 4. The [biological resource(s)] [genetic resource(s)] [derivative(s)] provided [is] [are]:
Insert a complete description of the biological resources, genetic resources, and/or derivatives that are covered by this permit, including but not limited to the scientific and local language names of the biological resources, the characteristics for which the genetic resource is sought, and the characteristics of the derivative and the process by which it was produced. Add rows if required. 5. The traditional knowledge associated with the [biological resource(s)] [genetic resource(s)] [derivative(s)] provided is:
Insert a complete description of the traditional knowledge associated with the biological resources, genetic resources or derivatives being provided. Add rows if required. 53
6. The [geographic location] [geographic locations] from which it is permitted to access biological resources in-situ and any associated traditional knowledge [is] [are]:
Insert a complete description of the sites in which access activities are permitted, including the names of the village or community, district, and province, geographic location (longitude and latitude), maps, and GIS coordinates. Add rows if required. 7. The [activity] [activities] that are permitted in order to access biological resources and any associated traditional knowledge [is] [are]:
Insert a complete description of the activities that are permitted, including, but not limited to the activities required to collect biological resources and to compile information on traditional knowledge. Add rows if required. 8. The mutually agreed terms with the providers of the [biological resources] [genetic resources] [derivatives] and any associated traditional knowledge and the approved uses thereof are set out in the Access Agreement attached as Annex 1 to this permit. All providers named in items 2 and 3 of this permit have signed the Access Agreement, confirming that they were involved in the negotiation of it, understand it, and consent to all of its provisions and the terms and conditions contained in it. Without prejudice to the terms and conditions of the Access Agreement, the terms and conditions of this permit are: a. Access is limited to the biological resources, genetic resources and/or derivatives specified in this permit. b. Access is limited to the geographic locations specified in this permit. c. The permit holder shall deposit, with a designated national ex-situ facility, duplicate samples of all biological resources collected, noting the existence of any associated traditional knowledge and the custodians of that traditional knowledge. d. Authorization to use the biological resources, genetic resources, and/or derivatives and any associated traditional knowledge is limited to the uses specified in the access agreement. e. Restrictions on use are: [list and explain any restrictions. If there are no restrictions, specify There are no restrictions on the intended use specified in the access agreement.] f. Transfer to third parties of any biological resources, genetic resources, and/or derivatives and any associated traditional knowledge covered by this permit is not permitted without prior written authorization from the [Permitting Authority], Owner, and Custodian. g. There shall be no export of the biological resources, genetic resources, and/or derivatives and any associated traditional knowledge covered by this permit without a separate export permit. h. The permit holder must inform the [Permitting Authority], Owner, and Custodian, as applicable, of potential commercial developments not foreseen in this permit and 54
enter into further written agreement with the [Permitting Authority], Owner, and Custodian, as applicable, on the unforeseen uses prior to proceeding to develop them. i. The permit holder must inform the [Permitting Authority], Owner, Custodian of all research and use of genetic resources and derivatives and any traditional knowledge accessed. j. Confidential information: [insert restrictions on confidential information, if any] k. The permit holder shall submit to the [Permitting Authority] [specify how often reports are to be submitted monthly, annually, other frequency] reports on the activities specified in this permit and shall submit to the [Permitting Authority] paper and electronic copies of any publications resulting from the activities carried out under this permit. The [Permitting Authority] is responsible for immediately transmitting the reports to the Owner and Custodian. l. The permit holder shall fully cooperate with inspections and any other mechanisms used by the [Permitting Authority] to monitor compliance with the terms and conditions of this permit. m. In the event of any grievance concerning the activities carried out under this permit, the permit holder shall fully cooperate with the [Permitting Authority] to address and resolve it. [Conditions that the Permitting Authority may impose on a case-by-case basis include: Human and material resources to strengthen the capacities for the administration and enforcement of this Act, and any Rules and Regulations thereunder A performance bond/indemnification for environmental harm The possibility of exclusive or concessionary rights for the permit holder Establishment of a venture capital fund to support in-country research and development Any other conditions that the Permitting Authority deems necessary.]
9. This permit is valid for a period of [insert the period of validity of the permit] and shall expire on [insert the date of expiry] unless renewed by the [Permitting Authority] prior to that date. Authorized representative of the [Permitting Authority] Signature:_________________________________________________________________ Name:____________________________________________________________________ Title:_____________________________________________________________________ [Seal of the Permitting Authority]
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Draft Access and Benefit Sharing (ABS) Law For Pakistan

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Draft Access and Benefit Sharing (ABS) Law For Pakistan

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ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

ABS DRAFT ACT v12 26 July 2012

Technology transfer.The permitting authority shall:

ABS DRAFT ACT v12 26 July 2012

any other power that may be delegated to it by the Federal Government.

ABS DRAFT ACT v12 26 July 2012

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Schedule 1-A Access Agreement

Title: Witness ____________________________________ _ Name: Date:

Title: Witness ____________________________________ _ Name: Date:

Applicant ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Schedule 1-B Access Agreement

Owner ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:

Applicant ____________________________________ _ Name: Title: Witness ____________________________________ _ Name: Date:

Schedule 1-C Access Agreement

Schedule 1-C Access Agreement

Schedule 1-C Access Agreement

Schedule 1-C Access Agreement

Schedule 1-C Access Agreement

Schedule 1-C Access Agreement

Schedule 1-C Access Agreement

Schedule 1-C Access Agreement

Schedule II Non-Commercial Material Transfer Agreement

Schedule II Non-Commercial Material Transfer Agreement

[logo of permitting authority]

Add rows if required. 50

Schedule IV Permit to Access Genetic Resources and Associated Traditional Knowledge

Schedule IV Permit to Access Genetic Resources and Associated Traditional Knowledge

Schedule IV Permit to Access Genetic Resources and Associated Traditional Knowledge

Schedule IV Permit to Access Genetic Resources and Associated Traditional Knowledge

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