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I am Drafter: Access and Benefit Sharing Law in Malaysia





Malaysia is in the process of drafting Access and Benefit Sharing Law. The objective of this Bill to implement the objectives under the Convention on Biological Diversity specifically on access to biological resources and the sharing of benefits arising from their utilization.

For the purpose of this Bill, the author seeks to propose certain features to include in this Bill. These features are taken from the several countries which already enacted this law under their jurisdiction such as Australia, Costa Rica, Kenya, Bhutan and so on.






 Title
        This Act shall be called the Access Benefit Sharing Act of Malaysia, 2012 and it shall apply throughout Malaysia

Purpose and objectives
        This Act shall have the following purposes and objectives: a) to ensure national sovereignty of Malaysia over genetic resources in accordance with relevant National and International Law; b) to ensure the conservation and sustainable use of the biological and genetic resources; c) to promote the equitable sharing of benefits derived from the use of genetic resources; d) to promote technology transfer and capacity building at the national and local levels, including the building of scientific and technological capacity relevant to the conservation and sustainable use of biological diversity; e) to recognize and protect Traditional Knowledge, innovation and practices of local communities associated with biodiversity; f) to regulate and facilitate the process by which collectors may legally obtain genetic resources; g) to prevent illegal access to genetic and biological resources and associated Traditional Knowledge.
 
Justification:-
         One of the purposes of this Act is to ensure national sovereignty of Malaysia over genetic resources. This had been affirmed in the Articles 3 and Article 15 of the Convention on Biological Diversity which affirms countries’ national sovereignty over their resources. For an example, the Australian system is only applied to species naturally found in Australia. Species from other countries are not covered. Australia does not seek to take advantage of its possession, accidental or otherwise, of foreign species. This accord with the spirit of Article 3 of the CBD. 
       Besides that, this Act also promotes conservation and sustainable use of biological diversity. The Australian law also promotes the three objectives of the Convention on Biological Diversity as it states under Environment Protection Biodiversity Conservation Regulations 2000 under regulation 8A.0. In addition, there is an article which gives useful tips to make an ABS law whereby in this article, it has encourages to promote conservation and sustainable use in the ABS law.
          The important thing is this Act may seek to protect traditional knowledge. Traditional knowledge has not been defined in the CBD and the Bonn Guidelines. Nevertheless, the CBD speaks of “knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and the sustainable use of biological diversity“ (Art. 8j). The concept of TK is not limited to ancient wisdom, but also includes innovative knowledge acquired because of traditional methods. Besides that, the protection of traditional knowledge mentions under Article 7 of the Nagoya Protocol whereby the scope states explicitly that the Protocol applies to traditional knowledge associated to genetic resources within the scope of the CBD and to benefits arising from the utilization of such knowledge.



Scope
        This Act shall apply to all the genetic and biological resources including wild, domesticated and cultivated species of flora and fauna, both in-situ and ex-situ conditions found within the territory of Malaysia. In addition, the procedure and conditions provided by this Act shall apply even if the genetic resources for which access is sought are located in protected areas or government reserved forests. Next, the provision of this Act shall apply to the Traditional Knowledge, innovation and practices associated with biodiversity.
 
Justification:-
           We propose that this Act shall apply to all genetic and biological resources in-situ and ex-situ within the territory of Malaysia because it is consistent with both Articles 8 and 9 of the CBD which promotes in-situ conservation and ex-situ conservation. Besides that, Costa Rica in their Biodiversity Law 1998 also applies to the ex-situ and in-situ of all genetic and biological resources.
           Moreover, this Act shall apply to traditional knowledge because of Article 8(j) of the CBD focuses on the relationship between biological diversity and indigenous and local communities. Further, parties providing the resource are obliged to take measures with the aim that traditional knowledge associated with the resource is accessed with the approval or involvement of indigenous and local communities as sets up under Article 7 of the Nagoya Protocol. For instance, traditional knowledge is a particularly important aspect for New Zealand, due to the vital relationship between Maori and New Zealand’s indigenous flora and fauna. ‘Matauranga Maori’ is the term often used to refer to knowledge originating from Maori communities - the relationship with their physical and spiritual environment. Thus, it same goes to Malaysia because in all, the indigenous peoples of Malaysia represent around 12% of the 28.6 million people in Malaysia.



 Exemptions
        This Act shall not apply: a) where the biological material is used as a commodity for the purpose of direct use or consumption as determined by the Competent Authority; b) to access, use and exchange of biological and genetic resources among local communities resulting from their traditional and customary practices; c) to access of human genetic resources; d) to varieties for which patent protection is available; e) To the prevention of the commercial exploitation, which is necessary to protect public order or morality including prejudice to the environment, the general interest or traditional rights of farmers.
 
Justification:-
            Commodities and direct consumption are not within the ambit of Nagoya Protocol and CBD. The Protocol only deals with acquisition for the purpose of its 'utilization'. This has a special meaning under the Protocol which is to conduct research and development on the genetic or biochemical composition of genetic resources. Commodities for direct use as commodities including for consumption or for non-breeding purposes are not accessed for research and development. They clearly are not covered by the Protocol. It follows that if the resource is accessed from wherever for research and development purpose, then the Protocol would require that the PIC and MAT of the provider be obtained. Some developing countries expressly provide for the exclusion of commodities from their ABS law. Some others reserve the power to exclude biological resources 'normally traded as commodities', for instance, India Biological Diversity Act 2002, section 40.
        Besides that, according to Article 9(4) of the Nagoya Protocol states that parties shall not restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities. It means that Parties are required not to restrict the customary use and exchange of genetic resources and associated TK within and amongst ILCs. This is ‘as far as possible’ and in accordance with the objectives of the CBD.  
        Another thing is, in this draft ABS law promotes patent protection. In the case of Hoodia gordonii and the San People of Africa, this case study illustrates how an indigenous plant (i.e., Hoodia gordonii) used by an indigenous community (the San), was patented by a government research body in South Africa and in turn licensed to a large pharmaceutical company, without any consultation with the San community. Apparently, because they were believed to be extinct. With the help of their lawyer, the San embarked on an intensive campaign to be acknowledged as the legitimate holders of the indigenous knowledge on which the patent was based. After months of negotiation, they eventually successfully entered into a benefit-sharing agreement with the research institute. The negotiations between the San and the Council for Scientific and Industrial Research (CSIR) went on for seven months (June 2001 to January 2002) before they signed a memorandum of understanding on February 1, 2002. Thereafter, the parties negotiated for another year, March 2002 to March 2003, until they signed a benefit-sharing agreement on March 24, 2003.
        The COP of CBD has interpreted the ABS provision in such a way to exclude human genetic resources. According to the Guideline 9 of the Bonn Guidelines states that All genetic resources and associated traditional knowledge, innovations and practices covered by the Convention on Biological Diversity and benefits arising from the commercial and other utilization of such resources should be covered by the guidelines with the exclusion of human genetic resources. During the COP 9, the conference interprets the scope of the international regime extends to biological resources, genetic resources and their derivatives and associated traditional knowledge. It excludes, among others, human genetic resources.
          It is important to note that there are three basic sources for impetus to develop an ABS law or policy. Typical cross-cutting conceptual elements to be considered when defining the purpose of the legislation include promoting equity in natural resources exploitation.



Requirements of access
            Access covered by this Act shall be subject to the prior informed consent and research agreement of the Competent Authority of Malaysia. If the research and collection of biological and genetic resources is intended, directly or indirectly, for commercial purposes, the agreement must be a Commercial Research Agreement. If the prospecting of biological and genetic materials is intended primarily for academic purposes, the agreement shall be an Academic Research Agreement. In cases where an academic research agreement detects the possibility of marketing results of research, the applicant must apply for a commercial research agreement. If the access is beyond or outside the agreed term in the PIC or research agreement, the applicant shall make a fresh application.

Application for access permit
            To enable the Competent Authority to arrive at a decision to grant or refuse a permit, the applicant shall include the following information, when submitting an application for access to genetic and/or biological resources covered by this Act:
a. Provide a description of the applicant including their legal status, place of residence and a list of all entities and individuals, which will be involved in the access activities and their respective responsibilities; b)Describe the applicant’s technical and financial capability to conduct the access activity and previous biological resource collection activities within Malaysia and elsewhere; c) Identify the kind of genetic and biological resources it is seeking.

Justification:-
            Prior Informed Consent is now also prescribed by the Convention on Biological Diversity for the utilization and research of genetic resources which is states under Article 15(5) of the Convention on Biological Diversity: The competent national authority of the providing country must be informed of the planned research as part of the application process. The researcher seeking access needs to provide all of the relevant information and ensure that the government or other responsible authority obtains this information. The informed consent of the competent agency is a prerequisite for access to biological resources. Under national legislation, it may also be necessary to include stakeholders involved on various intermediary levels in the Prior Informed Consent.
            It is recommended that stakeholders who are entitled to give their Prior Informed Consent to your project or access be informed about the following elements (Bonn Guidelines 36) such as legal entity and affiliation of the applicant and/or collector; contact person if the applicant is an institute, project organization, possibly budget and treatment of confidential information. For example, all countries require that prior informed consent (PIC) is gained and that mutually agreed terms (MAT) are reached before accessing the genetic or biological resource. In Costa Rica, Uganda, India and Brazil, PIC is required from the Competent National Authority. The Competent National Authority is then responsible for consulting with the access provider, be it local communities, private landowners, or government departments. In Australia, The Philippines, Norway, the USA, South Africa and Kenya, PIC is required directly from the access provider. In the Bonn Guidelines 26 also mention the basic principles of a prior informed consent system should include a legal certainty and clarity, access to genetic resources should be facilitated at minimum cost and etc.



The Minimum terms of the Commercial Research Agreement and Academic Research Agreement
            The applicant must fulfilled all the terms under the research agreement which are a) state the potential use and anticipated benefits of the accessed material and how the results will be shared; b) identify the nature of the legal rights the applicant may seek over the collected resources, derivatives of the collected resources, and innovations that are derived from those resources, including any intellectual property rights; c) indicate agreement to abide by the conditions set out by the Competent Authority for collection activities. This includes appropriate arrangements with the Competent Authority to facilitate the collection mission, including establishing provisional routes, estimated timing, types of material collected and quantities and identification of methods of collection (sampling, harvest and storage methods); d) the identification of the national institution or institutions, which will participate in the research; i) indicate agreement to bear all costs involved in collection; j) Provide information about existing or proposed contracts between the applicant and any third party relating to the use of any information and products resulting from the access activity; l) Provide information on the arrangements made within Malaysia to facilitate the collection mission; m) Indicate plans, if any, for cooperation with national institutions, scholars, scientists, students, farmers and farmer groups in Malaysia in the field mission and/or its follow-up activities; n) Demonstrate that the collection/access activity will have no negative environmental impact; o) Provide information on the prior informed consent of the relevant stakeholders when necessary; p) The economic, social, technical, scientific, environmental or any other benefits that are intended or may be likely to be accrued to the country and an indication of the types of short, medium and long term benefits to be shared with Malaysia and other relevant stakeholders as well as the proposed mechanisms and arrangements for benefit sharing; q) An application shall be affixed with an affidavit.

Justification:-
          An academic research agreement that deals with prospecting biological and genetic resources for academic purposes and only duly recognized Malaysian universities and academic institutions, domestic governmental and intergovernmental entities can apply for this kind of agreement. On the other hand, commercial research agreement deal with research and collection activities intended, whether directly or indirectly for commercial purposes and thus encompass all agreements stipulated with private persons, corporations and foreign or international entities. Clearly, this law assumes that all agreements other than those undertaken with domestic research institutions and domestic governmental entities have economic ends.
           According to Article 15(4) of the CBD, the contracting parties need to negotiate and agree on the terms of the access agreement, sometimes called the 'material transfer agreement' or 'academic/commercial research agreement' that authorizes access to genetic resources, controls subsequent use and establishes the type of benefits to be returned. If the provider country claims ownership over genetic resources, then it is up to the state to negotiate the mutually agreed terms and enter into the agreement. 



 Issuance of Permit
            The Competent Authority may, after considering the application issue or refuse to issue a permit.The Competent Authority shall refuse to issue a permit, if it satisfied that (a) a benefit sharing agreement has not been established in accordance with Act; (b) in the case of access to biological resource or traditional knowledge associated with biological resource, as appropriate, the applicant has not obtained the prior informed consent in accordance with this Act; (c) the access is likely to result in adverse effects on the livelihood or cultural including religious, ceremonial or other traditional or customary practices of indigenous and local communities; (d) in the case of access to human genetic resource, its use is for purposes contrary to ethical values; (e) the access may result in adverse environmental impact which may be difficult to control and mitigate; (f) the access may cause genetic erosion or affect the ecosystem function; (g) the use of the biological resource is for purposes contrary to the national or State interest; (h) the application does not comply with the requirements of this Act or any other written law. Besides that, the Competent Authority shall inform the applicant of its decision in writing.

Justification:-
            An obligation to issue a permit or equivalent at the time of the access. Such a permit or equivalent is evidence of the decision of a country to grant PIC and of the establishment of MAT (Article 6.3(e) and Article 14.2(c)). The permit or equivalent also forms the basis of an internationally recognized certificate of compliance. Once the permit is made available to the ABS Clearing House, it automatically acquires the status of such an international certificate (Article 17.2). As there is a mandatory requirement to notify the issuance of the national permit to the Clearing House (Article 6.3(e)), all national permits issued and notified would thus convert to the status of internationally recognized certificates. It is restated that such a certificate shall serve as evidence that the genetic resource, which it covers, has been accessed in accordance with PIC and that MAT has been established as required by the legal requirements of the Party providing the resource (Article 17.3).





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