Application for permit for commercial or potential commercial purpose
(1) Any person who intends to access a biological resource or traditional knowledge associated with a biological resource including through an authorized intermediary for commercial or potential commercial purposes shall apply for a permit to the relevant Competent Authority in the form and manner as may be prescribed and which shall be accompanied by payment of the prescribed fee.
(2) The Competent Authority may, after receiving the application under subsection (1), approve the application, if the following matters have been satisfied:
(a) a benefit sharing agreement has been established in accordance with section 22;
(b) in the case of access to a biological resource or traditional knowledge associated with a biological resource, as the case may be, the applicant has obtained the prior informed consent in accordance with section 23;
(c) the application is not for any threatened taxa;
(d) the application is not for any endemic species, rare species or any species protected under any Federal or State law;
(e) the access is not likely to result in adverse effects on the livelihood or cultural practices including religious, ceremonial or other traditional or customary practices of indigenous community and local community;
(f) in the case of access to human genetic resource, its use is not for the purposes contrary to ethical values or the public interest;
(g) the access may not result in adverse environmental impact which may be difficult to control and mitigate;
(h) the access may not cause genetic erosion or affect any function of the ecosystem;
(i) the access may not adversely affect food security;
(j) the use of the biological resource is not for the purposes contrary to the national or State interest;
(k) the use of the biological resource is not for the development of biological or chemical weapons, or for military or terrorist purposes;
(l) the use of the biological resource is not for the purposes associated with genetic use restriction technology;
(m) the applicant has not committed an offence under this Act;
(n) the applicant has not been adjudicated a bankrupt or, in the case of a company, has not been wound up;
(o) the application complies with the requirements of this Act or any other written law; and
(p) the use of the biological resources is not contrary to the related international agreements or instruments to which Malaysia is a party.
(3) The Competent Authority shall refuse the application if—
(a) any of the grounds specified in subsection (2) is not fulfilled; or
(b) after consultation with the National Competent Authority, the applicant is from, or otherwise based or operating in, jurisdictions which do not provide for adequate and effective measures that requires biological resources utilized within its jurisdiction to be accessed in accordance with prior informed consent and that mutually agreed terms to be established as provided under this Act.
(4) Notwithstanding subsection (3), the Competent Authority may issue a permit relating to paragraphs (2)(c) and (d) if the Competent Authority is satisfied that the application for permit does not undermine the conservation and sustainable use of biodiversity.
(5) After giving due consideration to the application under subsections (1) and (2), the Competent Authority may—
(a) approve the application, with or without condition, and issue a permit to the applicant; or
(b) refuse the application, stating the grounds for refusal.
(6) Any person who accesses a biological resource or traditional knowledge associated with a biological resource without a permit under subsection (1) or contravenes any condition imposed on the permit under subsection (5) commits an offence and shall, on conviction, be liable—
(a) where such person is an individual, to a fine not exceeding five hundred thousand ringgit or to imprisonment for a term not exceeding ten years or to both; or
(b) where such person is a body corporate, to a fine not exceeding five million ringgit.
Issue of permit for commercial or potential commercial purpose
(1) The Competent Authority shall issue a permit for commercial or potential commercial purpose which contains particulars as may be determined by the National Competent Authority in consultation with the Competent Authority.
(2) Upon issuance of the permit under subsection (1), there shall be no change of use in relation to the biological resource as specified in the permit except upon a fresh application being made and a permit issued under this section.
(3) The Competent Authority may at any time after issuing a permit under subsection (1)—
(a) impose any additional condition on the permit as it thinks necessary or expedient; or
(b) amend or revoke any condition imposed on the permit.
(4) Where the Competent Authority invokes subsection (3), the Competent Authority shall give the permit holder a written notice of its intention to do so and opportunity to make written representations within the period specified in the notice.
(5) After the expiry of the period specified in the notice, and after considering any representation made by the permit holder, the Competent Authority shall decide whether to impose, vary or revoke any condition under subsection (3).
(6) The Competent Authority shall give the permit holder a written notice of its decision under subsection (5) as soon as practicable and the decision shall take effect on a date specified in the written notice.
(7) Any person who contravenes subsection (2) or any condition imposed on the permit under subsection (3) commits an offence and shall, on conviction, be liable—
(a) where such person is an individual, to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding ten years or to both; or
(b) where such person is a body corporate, to a fine not exceeding five hundred thousand ringgit.
Permit for commercial or potential commercial purpose not transferable
(1) A holder of a permit shall not transfer the permit or assign any right, duty, liability or obligation under the permit to any other person.
(2) Any person who contravenes subsection (1) commits an offence and shall, on conviction, be liable—
(a) where such person is an individual, to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding ten years or to both; or
(b) where such person is a body corporate, to a fine not exceeding five hundred thousand ringgit.
Application for permit for non-commercial purpose
(1) Any person who intends to access a biological resource or traditional knowledge associated with a biological resource, including through an authorized intermediary for non-commercial purpose shall apply for a permit to the relevant Competent Authority in the form and manner as may be prescribed and shall be accompanied with a copy of a statutory declaration duly completed as specified in the Second Schedule and payment of the prescribed fee.
(2) Any activity undertaken under subsection (1) shall be in collaboration with a public higher education institution, public research institution or Government agency, unless the relevant Competent Authority is satisfied that—
(a) the applicant is a non-profit organization based or registered in Malaysia;
(b) local researchers are involved in the activity; and
(c) a program for capacity building is included in the activity.
(3) The Competent Authority may, after receiving the application under subsection (1), approve the application, if the following matters have been satisfied:
(a) the application is not for commercial or potential commercial purpose;
(b) in the case of access to a biological resource or traditional knowledge associated with a biological resource, as the case may be, the applicant has obtained the prior informed consent in accordance with section 23;
(c) the application is not for any threatened taxa;
(d) the application is not for any endemic species, rare species or any species protected under any Federal or State law;
(e) the access is not likely to result in adverse effects on the livelihood or cultural practices including religious, ceremonial or other traditional or customary practices of indigenous community and local community;
(f) in the case of access to human genetic resource, its use is not for the purposes contrary to ethical values or the public interest;
(g) the access may not result in adverse environmental impact which may be difficult to control and mitigate;
(h) the access may not cause genetic erosion or affect any function of the ecosystem;
(i) the access may not adversely affect food security;
(j) the use of the biological resource is not for the purposes contrary to the national or State interest;
(k) the use of the biological resource is not for the development of biological or chemical weapons, or for military or terrorist purposes;
(l) the use of the biological resource is not for the purposes associated with genetic use restriction technology;
(m) the applicant has not committed an offence under this Act;
(n) the applicant has not been adjudicated a bankrupt or, in the case of a company, has not been wound up;
(o) the application complies with the requirements of this Act or any other written law; and
(p) the use of the biological resources is not contrary to related international agreements or instruments to which Malaysia is a party.
(4) The Competent Authority shall refuse the application if—
(a) any of the grounds specified in subsection (3) is not fulfilled; or
(b) after consultation with the National Competent Authority, the applicant is from, or otherwise based or operating in, jurisdictions which do not provide for adequate and effective measures that requires biological resources utilized within its jurisdiction to be accessed in accordance with prior informed consent and that mutually agreed terms to be established as provided under this Act.
(5) Notwithstanding subsection (4), the Competent Authority may issue a permit relating to paragraphs (3)(c) and (d) if the Competent Authority is satisfied that the application for permit does not undermine the conservation and sustainable use of biodiversity.
(6) After giving due consideration to the application under subsections (1) and (3), the Competent Authority may—
(a) approve the application, with or without condition, and issue a permit to the applicant; or
(b) refuse the application, stating the grounds for refusal.
(7) Any person who accesses a biological resource or traditional knowledge associated with a biological resource without a permit under subsection (1) or contravenes any condition imposed on the permit under subsection (6) commits an offence and shall, on conviction, be liable—
(a) where such person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding seven years or to both; or
(b) where such person is a body corporate, to a fine not exceeding one million ringgit.
Issue of permit for non-commercial purpose
(1) The Competent Authority shall issue a permit for non-commercial purpose which contains particulars as may be determined by the National Competent Authority in consultation with the Competent Authority.
(2) Upon issuance of the permit under subsection (1), there shall be no change of use in relation to the biological resource as specified in the permit except upon a fresh application being made and a permit issued under this section.
(3) The Competent Authority may at any time after issuing a permit under subsection (1)—
(a) impose any additional condition on the permit as it thinks necessary or expedient; or
(b) amend or revoke any condition imposed on the permit.
(4) Where the Competent Authority invokes subsection (3), the Comptetent Authority shall give the permit holder a written notice of its intention to do so and opportunity to make written representations within the period specified in the notice.
(5) After the expiry of the period specified in the notice, and after considering any representation made by the permit holder, the Competent Authority shall decide whether to impose, vary or revoke any condition under subsection (3).
(6) The Competent Authority shall give the permit holder a written notice of its decision under subsection (5) as soon as practicable and the decision shall take effect on a date specified in the written notice.
(7) Any person who contravenes subsection (2) or any condition imposed on the permit under subsection (3) commits an offence and shall, on conviction, be liable—
(a) where such person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding seven years or to both; or
(b) where such person is a body corporate, to a fine not exceeding five hundred thousand ringgit.
Decision to be informed
The Competent Authority shall inform its decision in writing to the applicant and notify the National Competent Authority as soon as practicable of the outcome of any application relating to permits made under this Act.
Circumstances where permit is not required
No permit is required—
(a) by any person employed or studying and carrying out research for non-commercial purpose in or under the authority of, a public higher education institution, public research institution or Government agency within Malaysia, subject to such conditions as may be prescribed and subject to prior informed consent of the relevant indigenous community and local community has been obtained for any access to a biological resource and traditional knowledge associated with a biological resource referred to in subsection 23(1);
(b) for the exchange of biological resources between persons within a public higher education institution, public research institution or Government agency within Malaysia or between such institutions or agencies within Malaysia for non-commercial purpose, unless otherwise required by a Competent Authority and subject to such conditions as may be prescribed; or
(c) by any person or institution in or outside Malaysia who accesses a biological resource from a permit holder under subsection 15(1) or the person or institution under paragraph (a), at the request of such permit holder or the person or institution, for the purpose of carrying out or continuing any research for non-commercial purpose.
Transfer of biological resource or results of research in relation to biological resource
(1) No person or institution referred to in paragraphs 18(a) and
(b) shall transfer any biological resource or traditional knowledge associated with a biological resource or results of research in relation to a biological resource or traditional knowledge to a person or institution other than that referred to in paragraphs 18(a) and (b) without the prior approval of the Competent Authority.
(2) Where the approval is given by the Competent Authority for the transfer, such transfer shall be subject to such conditions as may be prescribed and the transferee shall be required to apply for a permit under this Act, unless otherwise decided by the Competent Authority.
(3) A permit holder or the person or institution referred to in paragraphs 18(a) and (b) shall notify the Competent Authority of the access and such access may be subject to such terms and conditions as may be imposed by the Competent Authority.
Permit for non-commercial purpose not to be used for commercial purpose
No person issued with a permit for non-commercial purpose, and no person or institution referred to in paragraphs 18(a) and
(b) and the transferee referred to in subsection 19(2) shall carry out, or allow others to carry out, research and development for commercial purposes on any biological resource or traditional knowledge associated with the biological resource, unless the person obtains a permit for commercial or potential commercial purpose under section 13 and a benefit sharing agreement has been entered into in accordance with section 22.
Possession, etc., of biological resource and traditional knowledge associated with biological resource
(1) Any person who is not an authorized intermediary and who has in his possession or under his control a biological resource or traditional knowledge associated with a biological resource and—
(a) supplies, sells, offers or advertises for sale; or
(b) offers for profit, gain or benefit,
such biological resource or traditional knowledge associated with a biological resource to a person who requires a permit under this Act commits an offence.
(2) Any person who commits an offence under subsection (1) shall, on conviction, be liable—
(a) where such person is an individual, to a fine not exceeding five hundred thousand ringgit, or to imprisonment for a term not exceeding ten years or to both; or
(b) where such person is a body corporate, to a fine not exceeding five million ringgit.
Benefit sharing agreement
(1) An applicant for a permit for access to a biological resource or traditional knowledge associated with a biological resource, for commercial or potential commercial purposes shall enter into a benefit-sharing agreement with the resource provider.
(2) A benefit sharing agreement shall be based upon mutually agreed terms and provide for fair and equitable benefit sharing.
(3) Where the Federal Government or State Authority is not the resource provider under subsection (1), it may require the applicant to pay a percentage of any monetary benefits derived under the benefit sharing agreement as it may determine.
(4) Any such monetary benefits shall be deposited into a fund as may be established by the Federal Government or State Government.
(5) The Competent Authority shall use any payment or any part of the payment received under this Part towards the conservation of biodiversity and the sustainable use of its components and for such other incidental expenses.
Requirement for prior informed consent and mutually agreed terms, etc.
(1) The prior informed consent of the relevant indigenous community and local community shall be obtained for any access to—
(a) a biological resource on land to which such indigenous community and local community have a right as established by law; and
(b) traditional knowledge associated with a biological resource that is held by such indigenous community and local community.
(2) The prior informed consent of indigenous community and local community shall be obtained in accordance with customary laws and practices, protocols and procedures of indigenous community and local community, as the case may be.
(3) Any person who intends to access the biological resource or traditional knowledge in subsection (1) for commercial or potential commercial purposes under subsection 12(1) shall enter into a benefit sharing agreement with the relevant indigenous community and local community.
(4) Any prior informed consent shall be obtained from and benefit sharing agreement entered into with—
(a) the representative, organisation or body identified in accordance with the customary laws and practices, protocols and procedures of the said indigenous community and local community; or
(b) where no such representative or organisation of the traditional knowledge associated with a biological resource can be identified—
(i) with the holders of the traditional knowledge associated with a biological resource within the indigenous community and local community; or
(ii) with the Federal Government or State Authority, as the case may be, if the holders of the traditional knowledge associated with a biological resource cannot be identified.
(5) Any monetary benefit obtained from the benefit sharing agreement entered under subparagraph (4)(b)(ii) shall be deposited into a fund as may be established by the Federal or the State Government and any benefit, including where applicable non-monetary benefit, shall be applied for the interest of indigenous community and local community taking into account the advice of the advisory body established under subsection 9(2).
(6) Where the same traditional knowledge associated with a biological resource is shared by more than one indigenous or local community—
(a) the applicant shall obtain the prior informed consent of and enter into benefit sharing agreement with the duly identified representative or organization of all the holders of the traditional knowledge associated with the biological resource; or
(b) where it is not practicable in all the circumstances of the case to ascertain all such holders, and this is proven to the satisfaction of the Competent Authority, the applicant shall obtain the prior informed consent of, and enter into the benefit sharing agreement with the duly identified representatives or organisation of such of the holders as the applicant may ascertain.
(7) In the event that there is a claim by any indigenous community and local community that it is the rightful holder of the traditional knowledge associated with a biological resource after the application is approved, the Competent Authority shall—
(a) determine the said claim in consultation with the indigenous community and local community whose prior informed consent has been obtained and benefit sharing agreement entered into;
(b) if the claim is proven to the satisfaction of the Competent Authority, declare that the said indigenous community and local community is entitled to share the benefits due to the indigenous community and local community under the benefit sharing agreement; and
(c) determine the quantum or nature of benefits to which the indigenous community and local community is entitled under paragraph (b), in consultation with all the indigenous community and local community concerned.
Source: Laws of Malaysia, Attorney General's Chambers of Malaysia (lom.agc.gov.my). Not a copy of the Gazette printed by the Government Printer (Interpretation Acts 1948 and 1967, s 61).
