On 17 October 2017, the Access to Biological Resources and Benefit Sharing Act 2017 (the “Act
”) was gazetted. We previously wrote about the main features of the Act in our article, Guardians of the (Bio-Resources) Galaxy
, which can be read here
. As a quick recap, the Act 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, to protect Malaysia’s rich biodiversity and to combat biopiracy.
Now, three years later, the Act has finally come into operation on 18 December 2020
. With it comes its subsidiary legislation, the Access to Biological Resources and Benefit Sharing Regulations 2020 (the “Regulations
”), which were gazetted on 17 December 2020 and came into operation on 18 December 2020
KEY PROVISIONS OF THE REGULATIONS
Procedures for a Permit Application
One of the main thrusts of the Regulations is the setting out of the procedures for an application for a permit, which is described in the flowchart which can be accessed here
Potential requirements for access
In some circumstances, the prior informed consent of an indigenous or local community must be obtained, without coercion, undue pressure or inducement, before a person may have access to a bio-resource or associated traditional knowledge. For this purpose, all relevant information in relation to the access must be disclosed to the indigenous or local community (Section 23 of the Act and Regulation 10 of the Regulations).
Where the access to bio-resources or associated traditional knowledge is for commercial or potential commercial purposes, the applicant must enter into a benefit sharing agreement (“BSA
”) with the resource provider (Section 22 of the Act) which is to take affect after the issuance of a permit (Regulation 9(3) of the Regulations).
Change of purpose
A holder of a permit for a non-commercial purpose may not access a bio-resource for commercial purposes unless he obtains a permit for commercial or potential commercial purpose under Section 13 of the Act and has entered into a BSA with the resource provider (Section 20 of the Act).
Information required in a BSA
Regulation 9(1) of the Regulations stipulates that a BSA must be in writing and provides a list of particulars that must be contained therein including, among others
, the purpose of the access, the particulars of monetary and non-monetary benefits, the description of the bio-resource, and an obligation that the parties enter into a new agreement or to renegotiate the existing one if there is any change of use in relation to the bio-resource.
The wording of the provision suggests that the inclusion of the particulars is mandatory. Further guidance from the National Competent Authority by means of a template BSA will be most welcomed by stakeholders.
The Regulations introduce provisions which allow a permit applicant to apply for confidential treatment of any information furnished to the Competent Authority for the purposes of an application (Regulation 7(1) of the Regulations). The Competent Authority will consider the factors set out in Regulation 7(3) of the Regulations in determining whether confidentiality is to be granted. Permit applicants should, where appropriate, make use of this and apply to protect their confidential information.
Measures for preventing unauthorised use
The Regulations state that random checks will be conducted on any product which has been commercialised to determine whether the product is produced from the use of any biological resource or traditional knowledge associated with a biological resource (Regulation 14(1)(a) of the Regulations). The Competent Authority may, for this purpose, require the user to produce any document or record in relation to the use of the biological resource or associated traditional knowledge (Regulation 14(3) of the Regulations).
EFFECT ON PATENTS
As covered in our earlier article, Guardians of the (Bio-Resources) Galaxy
, the Act contains a number of provisions which impact patents specifically. The Regulations now supplement those provisions and clarify the regulatory requirements imposed on patent applicants.
The Regulations have now made it clear that the Malaysian Intellectual Property Corporation of Malaysia (“MyIPO
”) and the National Pharmaceutical Regulatory Agency are designated as checkpoints at which permits and any relevant information relating to the use of a bio-resource or traditional knowledge must be produced as a means to monitor and track bio-resources and traditional knowledge (Regulation 12(1) of the Regulations).
Further, the Regulations specify that the notification to the National Competent Authority of an application for a patent as required under Section 31(1) of the Act must be given in Form 3 of the First Schedule of the Regulations (Regulation 13 of the Regulations).
The question arises as to whether these requirements may be additional steps required in the patent filing process and whether an application will be rejected by MyIPO if such requirements are not complied with.
POSSIBLE EXEMPTIONS UNDER THE ACT?
The obligation to obtain a permit likely falls on the first person who accesses the bio-resource, and not any subsequent users who purchase the said bio-resource from the first person. For example, if a manufacturer were to purchase a bio-resource from a supplier who collected the bio-resource, it would appear that only the supplier is required to obtain a permit, not the manufacturer. This is likely to be the position, but confirmation on this from the authorities will be most welcome.
Section 5(2) of the Act contains a list of activities which do not amount to accessing a bio-resource, namely:
As permits are required under the Act by a person intending to have access to a bio-resource or associated traditional knowledge (Sections 5(2) and 12(1) of the Act), it would appear that the aforesaid activities will not require a permit as they are not regarded under the Act as an access to a bio-resource or associated traditional knowledge.
The Regulations are welcome as they provide some much-needed clarification on matters pertaining to the procedures stipulated under the Act and a framework for how the Act is meant to be implemented. As certain aspects of the Act require additional clarification, it is believed that the authorities will be issuing guidelines to assist in the interpretation of the Act and the Regulations.
Equipped with the Act and the Regulations, the Guardians of the Malaysian (Bio-Resources) Galaxy can now begin the fight against biopiracy.
Article written by Charmayne Ong (Partner), Gooi Yang Shuh (Associate) and Cheam Tat Sean (Associate) of the Intellectual Property Division of Skrine.