The Access to Biological Resources and Benefit Sharing Act 2017 ('the Act') came into operation on 18 December 2020.
The Act, among others, seeks to implement the Convention on Biological Diversity to which Malaysia has been a signatory since 1992 and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilisation, regulate the use of biological resources, curb biopiracy and ensure that benefits are shared equitably. To read our article, Guardians of the (Bio-Resources) Galaxy, that provides a summary of the main features of the Act, please click here.
The Access to Biological Resources and Benefit Sharing Regulations 2020 ('the Regulations') were gazetted on 17 December 2020 and came into operation on 18 December 2020.
In summary the Regulations, among others, provide for the
- The composition and procedures of the Advisory Committee established under section 11 of the Act;
- The composition and procedures of the Advisory Body established under section 9 of the Act. It is interesting to note that the Competent Authority is required under regulation 3 of the Regulations to appoint representatives of the indigenous community and local community nominated by the respective communities to be members of the Advisory Body;
- Provisions that set out the procedures and forms to be used for an application for a permit for commercial or potential commercial purpose under section 12 of the Act or for non-commercial purpose under section 15 of the Act, the fees payable, and the conditions that may be imposed on a permit. A mandatory condition which is to be imposed on every permit is a prohibition against placing the biological resource accessed at any international repository, including any data bank, without the prior written consent of the Competent Authority;
- Terms that have to be included in a benefit sharing agreement under section 22 of the Act, including, among others, the requirement for the agreement to be in writing, the details of the parties, the timing and frequency of entry to the place of access, the description of the biological resource to be accessed, the quantity of the biological resource that can be removed from the place of access, the purpose of the access (whether for commercial or potential commercial purpose), the use of the biological resource or traditional knowledge associated with the biological resource ('associated knowledge'), the ownership of the data and results of any research in relation to the biological resource or its associated knowledge, information on the monetary and non-monetary benefits, the conditions relating to intellectual property rights, the particulars of source of the associated knowledge and of the resource provider of the associated knowledge;
- The obligation on the part of an applicant to ensure that prior informed consent of the indigenous community and local community under section 23 of the Act is obtained prior to commencement of access activity, without coercion, undue pressure or inducement and that all relevant information in relation to the access to the biological resource or associated knowledge is disclosed to the indigenous community and local community;
- Procedures for claims by other communities claiming to be the rightful holder of the associated knowledge under section 23 of the Act; and
- The duty imposed on a public higher education institution, public research institution or Government agency within Malaysia undertaking research involving the use of biological resources or associated knowledge under section 18 of the Act to maintain a register containing the information prescribed in the Regulations, and on any researcher carrying out any research for non-commercial purpose to record all particulars of his research in the register of the institution or agency.
The Act has finally come into force three years after it was gazetted. The Regulations are most certainly welcome as they provide many essential details required for the operation of the Act. It is now time to regulate the use of our biological resources and to fight bio-piracy. The Guardians of the (Bio-Resources) Galaxy must now come to the fore!
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