16 September 2020

Biodiscovery and Traditional Knowledge

Noting the Queensland Parliament's Innovation, Tourism Development and Environment Committee report on the Biodiscovery and Other Legislation Amendment Bill 2019 (Qld) passed last month. 

The reports states 

 The primary objective of the Bill is to amend the Biodiscovery Act 2004 (the Act) to ensure that it is contemporary, effective and equitable, by reflecting international standards which include providing an obligation for the use of traditional knowledge. This will help Queensland’s biodiscovery industry to remain globally competitive and ensure that the benefits of biodiscovery are shared equitably throughout Queensland, including with First Nations peoples. 

Specifically, the Bill:

1. recognises and protects traditional knowledge used for biodiscovery by providing for consent to be provided, and benefit sharing on mutually agreed terms, to be negotiated with traditional knowledge custodians prior to commencing biodiscovery activities, where traditional knowledge is to be used in the biodiscovery 

2. simplifies approvals under the Act by removing the requirement for a biodiscovery entity to apply for and obtain an approved biodiscovery plan, on the basis that information contained in the biodiscovery plan is provided in the application for a collection authority, or in the negotiation of a benefit sharing agreement with the State 

3. clarifies the relationship between the Act and relevant international protocols by: 

a.recognising that the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol) (adopted in 2010 and signed by Australia in 2012) is the relevant international agreement under the Convention on Biological Diversity (CBD) to which the Act gives effect, to the extent it concerns native biological material and traditional knowledge in Queensland 

b. clarifying that plants listed under Annex 1 of the CBD and subject to the Food and Agriculture Organisation of the United Nations International Treaty on Plant and Genetic Resources for Food and Agriculture (FAO Treaty) are exempt from the Act under certain circumstances.

... Stakeholders and the Government agreed that the Act should be amended to recognise and protect traditional knowledge used for biodiscovery. Members of the Traditional Knowledge Stakeholder Roundtable agreed that the inclusion of traditional knowledge in legislation for biodiscovery is essential to First Nations peoples, to enable them to decide how their traditional knowledge is to be used, to maintain a connection to country, and to be able to negotiate a fair and equitable share of the benefits arising from the use of their traditional knowledge. 

Stakeholders agreed that closer alignment with the Nagoya Protocol will benefit Queensland long-term, and reflects a general trend toward improved research practices by biodiscovery entities. Biodiscovery entities agreed that closer alignment with the Nagoya Protocol is essential to enable international collaboration and commercialisation, and supported amendments that simplify approval processes such as the removal of a requirement for a biodiscovery entity to apply for and obtain an approved biodiscovery plan. Biodiscovery entities consistently cite a desire to avoid over-regulation in order to encourage industry development and maintain academic freedoms. 

Biodiscovery entities – most notably QAAFI – strongly supported the provision for an exemption from the Act for plant species listed under the CBD and subject to the FAO Treaty. QAAFI consulted extensively with the department to develop a solution.

In discussing issues raised during the committee’s examination of the Bill the report states 

Background 

What is biodiscovery Biodiscovery is the take and use of minimal quantities of native biological material from state land or waters for molecular, biochemical or genetic analysis for commercial purposes, such as pharmaceuticals, foods and bioplastics. 

Policy framework 

In Queensland, biodiscovery is regulated under the Act. The Act establishes an access and benefit sharing framework for use of the State’s native biological material and was established in part to meet the requirements of Article 15 of the CBD, which deals with access to genetic resources.   

The Act aims to ensure biodiscovery activities in Queensland are undertaken in a sustainable manner, while returning a fair and equitable benefit to the community. This is achieved through approvals and agreements administered by department, including: • a collection authority • a biodiscovery plan • a benefit sharing agreement.   

The biodiscovery industry has evolved since the introduction of the Act and the international regulatory context for access and benefit sharing has changed, particularly with the introduction of a supplementary agreement to the CBD, the Nagoya Protocol in 2014. The Nagoya Protocol provides a framework for the fair and equitable sharing of benefits arising from the utilisation of genetic resources and including the use of traditional knowledge associated with genetic resources. Access and benefit sharing in accordance with the Nagoya Protocol acknowledges and involves the contributions of Indigenous peoples and local communities. 

Australia signed the Nagoya Protocol in 2012, and while Australia has yet to ratify, over 120 countries have, including many of Queensland’s trading and scientific partners. These partners often require demonstrated compliance with the Nagoya Protocol before negotiating research or commercialisation partnerships.   

The Act cannot align with the Nagoya Protocol without providing for First Nations peoples to consent to and negotiate benefit sharing for the use of their traditional knowledge. Therefore, biodiscovery entities in Queensland are unable to demonstrate Nagoya level compliance and are at risk of being denied international collaborations and access to the global market. Furthermore, without formal recognition and legal protection, First Nations peoples can do little to prevent further use of traditional knowledge or resources without consent. 

The department advised that, as at January 2020, there are nine benefit-sharing agreements signed in Queensland and a further eight under negotiation. 

The department provided some examples to the committee of potential biodiscovery projects in Queensland:

We have examples in areas in which biodiscovery would be applied. An example of a medical discovery would be the venom collected from dangerous marine species, like stonefish and box jellyfish, in the Great Barrier Reef which are used to develop life-saving venins, for example. In industry we have nanofibres from spinifex grass in North-West Queensland that have been used to develop extremely strong rubber reinforcement for a range of latex products and as a road base additive for strengthening bitumen. It is also being explored as a toughening agent in a wide range of building materials. 

In the industrial area we have water repellent and flame resistant biodegradable plastics being created using the fibres from the nesting material of native honey bees in South-East Queensland. In agriculture we have some work going on on the characteristics of resilient or wild agricultural crops to make our standard food crops such as rice more productive and more resistant to drought, climate change and so on.

Griffith University described some of the benefits and economic potential of the biodiscovery industry to Queensland at the public hearing to the Bill:

It has a really high potential. Traditionally the pharmaceutical industry looked for these compounds. Right now, with agriculture you cannot get a product in Europe on the field if it is not a natural product. The US is going the same way. In cosmetics, people want natural products. With food additives it is the same thing. We talked to two of the four largest food companies about NatureBank. There is immense potential, but it is hard to get there. In each field, only one out of several thousand makes it. It is a high-risk activity, but the key is that the more it is used, the more success we have and the more success is coming back to Queensland, to university, to our Indigenous partners, to traditional knowledge holders. It is really about enabling easy, clear deal flow in a certain sense. The more that is happening and the more results that are used, the more benefits there are.

Other jurisdictions 

Queensland was the first State or Territory in Australia to implement an access and benefit sharing (ABS) framework for biodiscovery with the introduction of the Act, providing Queensland’s emerging biotechnology industry with greater certainty and giving effect (in part) to Article 15 (about access to genetic resources) of the CBD. Since 2004, other jurisdictions both nationally and internationally have adopted access and benefit sharing legislation and policies, such that the Act in its current form is now inconsistent because it does not include provisions for the use of traditional knowledge. 

Commonwealth legislation, specifically the Environment Protection and Biodiversity Conservation Act 1999 regulations, establish a process for ABS on Commonwealth land where traditional knowledge is used. Commonwealth regulations require that a benefit sharing agreement contains:

  • a statement regarding any use of Indigenous people’s knowledge, including details of the source of the knowledge, such as, for example, whether the knowledge was obtained from scientific or other public documents, from the access provider or from another group of Indigenous persons 

  • a statement regarding benefits to be provided or any agreed commitments given in return for the use of the Indigenous people’s knowledge 

  • if any Indigenous people’s knowledge of the access provider, or other group of Indigenous persons, is to be used, a copy of the agreement regarding use of the knowledge (if there is a written document), or the terms of any oral agreement, regarding the use of the knowledge. 

The Northern Territory’s Biological Resources Act 2006 requires similar information, however in the form of details of the benefits the access provider will receive in return for the taking of resources. This may be more limited than the Commonwealth’s approach as it focusses on access providers only. 

The Australian Capital Territory’s Nature Conservation Act 2014 also includes provisions for benefit sharing when accessing biological resources, similar to the Northern Territory approach. When entering into a benefit sharing agreement with an access provider, the agreement must provide for reasonable benefit sharing arrangements, including protection for, recognition of and valuing of any Aboriginal or Torres Strait Islander people’s knowledge to be used. As with the Northern Territory Act, the legislation is focused on benefit sharing with access providers (for traditional knowledge, this may mean those with an exclusive possession Native Title claim granted) and is thus narrower in scope than the Commonwealth regulations. 

The Bill is intended to advance the protection of traditional knowledge in biodiscovery beyond the frameworks in other States as requirements for prior informed consent and benefit sharing apply State-wide and irrespective of whether a traditional custodian has an access right over given land. In this way, the traditional knowledge protections provided by this Bill are significantly more robust and broader in scope than other laws in Australia and are reflective of an evolving understanding and appreciation of traditional knowledge, and the rights of First Nations peoples to self-determination. 

The Bill Hon Leanne Enoch MP, the Minister for Environment and the Great Barrier Reef, Minister for Science and Minister for the Arts, stated in her introduction speech that the Bill’s purpose is to amend the Act and the Right to Information Act 2009 to ‘ensure the use of traditional knowledge in biodiscovery is protected and to support economic opportunities for First Nations communities in Queensland’. 

Minister Enoch further stated that the Bill will help to meet Queensland’s:

... international obligations, fulfil the government's commitment to support the commercialisation of new bioproducts and improve the business environment for biodiscovery in Queensland. 

Amendment of Biodiscovery Act 2004 

Purpose of the Act 

Clause 5 amends the purposes of the Act (section 3) to include a new purpose to encourage biodiscovery entities to only use traditional knowledge for biodiscovery with the agreement of the custodians of that traditional knowledge, where the custodians are the Aboriginal or Torres Strait Islanders to whom the traditional knowledge relates. 

This is a new purpose and achieved by imposing requirements on persons accessing or using traditional knowledge for biodiscovery including a new obligation on a person who chooses to use traditional knowledge for biodiscovery, to do so only with the agreement of the custodians of that knowledge (section 3). The objective of amending the Act in this way is to ensure Queensland’s regulatory framework is contemporary, effective and equitable, and suitably reflects international standards, namely the Nagoya Protocol. The Act cannot align with the Nagoya Protocol without recognising and protecting traditional knowledge. 

Using traditional knowledge for biodiscovery 

Clause 10 provides for a new Part (Part 2A) in the Act and additional legislative provisions to recognise and protect traditional knowledge used for biodiscovery. It also aligns the Act more closely to international standards for ABS by establishing an obligation on persons using traditional knowledge for biodiscovery. 

Failing to comply with the obligation will trigger a new penalty provision of up to 5,000 penalty units and be considered an executive liability provision similar to existing offences under the Act. A penalty of this size is consistent with other serious offences in the Act, such as using native biological material sourced from State lands or Queensland waters for biodiscovery without a benefit sharing agreement.

Traditional knowledge Code of Practice 

The Bill proposes that a person is not limited in how they comply with the traditional knowledge obligation, however to ensure people can satisfy this obligation and are fully aware of how to do so, a traditional knowledge Code of Practice (the Code) will be developed in consultation with stakeholders. The Code will define when the traditional knowledge obligation applies; processes for identifying the custodians of traditional knowledge; and the reasonable and practical steps that a person must follow. Compliance with the Code will fulfil the obligation. 

Providing a pathway for compliance through the Code in Division 3 ensures that industry and First Nations peoples are clear about what is required to satisfy the obligation. The Code would detail the minimum steps required, including that free and prior informed consent of the custodians of the traditional knowledge must be obtained before traditional knowledge is used for biodiscovery. This means that consent is given willingly without coercion, and based on having a clear understanding of the project details such as its design, duration, likely benefits and impacts. The Code will also detail that benefit sharing must be negotiated on mutually agreed terms, between the custodian of traditional knowledge and the person who accesses the traditional knowledge. The State would not be a party to these agreements. 

The Code will also detail 

  • under what circumstances the traditional knowledge obligation applies 

  • how to identify the appropriate/authorised custodian of the traditional knowledge 

  • definitions for free and prior informed consent, benefit sharing and mutually agreed terms 

  • minimum requirements to fulfil the traditional knowledge obligation under different circumstances, such as when biodiscovery activity is undertaken on non-State land and/or when ex-situ collections of native biological material are accessed. 

The Code can only be prepared in consultation with First Nations peoples and the biodiscovery industry. The department advised that guidelines to ‘facilitate compliance’ with the traditional knowledge obligation and Code will also be produced to further support industry engagement with First Nations peoples, such as identifying culturally appropriate ways to negotiate free and prior informed consent and mutually agreed benefits arising from a biodiscovery project. 

The Code and supporting guidelines will enable biodiscovery entities and First Nations peoples to collaborate more easily by, for example, identifying culturally appropriate ways to negotiate free and prior informed consent and benefit sharing.  The department informed the committee that the Code will be set out in subordination legislation, while the guidelines will not. 

On the issue of conflict resolution, and concerns held by the committee as to possible delays due to conflicting interests among traditional owners, the department advised the Code would address this issue ... 

Jurisdiction 

During consultation, stakeholders shared that because of past government policies that resulted in, for example, the Stolen Generation, some traditional knowledge may not always be connected to a given parcel of land, or the land from which the native biological resource was collected. In order to properly recognise and protect all traditional knowledge about native biological material used for biodiscovery, the obligation would apply state-wide. 

Collection authority requirements 

Clause 11 relates to Part 3 Collection Authorities in the Act and amends procedural requirements for application for a collection authority. References to the Environmental Protection Agency (a legacy of machinery of government changes) and biodiscovery plans have been removed. Approvals under the Act have been simplified by removing the requirement for biodiscovery entities to apply for and obtain an approved biodiscovery plan, on the basis that information contained in the biodiscovery plan is provided in the application for a collection authority, or in the negotiation of a benefit sharing agreement with the State. 

Clause 12 proposes to amend section 12 of the Act relating to the contents of a collection authority, to include a description of the proposed commercial use of material proposed to be taken under the collection authority. 

Clause 13 would provide consistency with other provisions by omitting references to the Environmental Protection Agency and biodiscovery plans as per clause 11. 

Clause 14 proposes to amend current legislative provisions for public access to the collection authority register in section 28 of the Act, to omit references reflecting government changes. 

Consequential minor amendments 

The Bill proposes a number of consequential amendments to the Act, as outlined below: 

Clause 15 provides for a minor amendment to section 29 of the Act, which incorrectly makes a direct reference to a penalty. 

Clause 16 proposes to amend current legislative requirements for the Minister to enter into a benefit sharing agreement. This amendment would establish that the Minister must not enter into a benefit sharing agreement with a biodiscovery entity unless satisfied that a biodiscovery entity does not have a traditional knowledge obligation (because it has not or will not use traditional knowledge) or that the entity has met and will continue to meet their traditional knowledge obligation. This can be outlined in the benefit sharing agreement (see clause 17). 

Clause 17 outlines that for consistency, the new provision for a traditional knowledge obligation would mean that future benefit sharing agreements will be negotiated and agreed on the basis that a biodiscovery entity has discharged and will continue to discharge its obligation regarding the use of traditional knowledge, where the obligation applies (i.e. they have or may use traditional knowledge). 

Clause 18 outlines that for consistency, the removal of biodiscovery plans from the approvals process means that benefit sharing agreements will no longer be conditioned to include only the activities detailed in an approved biodiscovery plan, and therefore only one statutory condition applies to benefit sharing agreements relative to the biodiscovery entity’s relationship with other entities. 

Clause 19 outlines that for consistency, the provisions for the approval of biodiscovery plans as per part 5 Division 2 of the Act will be repealed. 

Clause 20 provides consistency with other provisions to remove unnecessary reference to ‘State native biological resources’. 

Clause 21-26 proposes to remove historical references to Queensland Government departments and/or references to departments that no longer have responsibility for administering the Act or references to past processes that are now redundant.   Clause 26 adds a new reference to the Code, as a stated document, to be made under the Act. It also removes any reference to a biodiscovery plan for consistency purposes. 

Clause 27 provides consistency by including the traditional knowledge obligation in the list of executive liability provisions similarly to other serious offences of equivalent and/or lower penalty under the Act. 

Clause 28 provides consistency by removing reference to a biodiscovery plan. 

Clause 29 notes that in reference to the Public Service Act 2008 and provision for the protection of civil liability in relation to State employees in section 26C, a similar provision may be provided for the Minister in other Queensland legislation as required. 

Clause 30 provides a minor amendment to section 120 of the Act to omit reference to ‘an official’ in favour of ‘the Minister or chief executive’.  

Clause 31 omits the provision for review of the Act as it is no longer required on the basis the Act has been in operation for longer than 5 years and reviewed twice during its operation. 

Clause 32 provides consistency with other provisions by omitting references that are a legacy of machinery of government changes. 

Repeal and transitional provisions 

Clauses 33 – 34 of the Bill provide for consequential changes to Part 13 of the Act (Transitional provisions) in order to repeal Part 15 of the Act. Clause 13 inserts a new division (Division 3) in Part 13 to allow for the transitional provisions that would arise from the introduction of this Bill. In regard to compliance, the explanatory notes state:

These provisions acknowledge that a person cannot be prosecuted for not complying with the traditional knowledge obligation until the first traditional knowledge code of practice (the Code) is approved by regulation, given that the Code outlines how a person is able to discharge the traditional knowledge obligation. However, a person is not prevented from complying with the traditional knowledge obligation before the Code is made.40

Clause 35 would allow for the approval process to continue under the current provisions of the Act. The explanatory notes advise that ‘prosecution is not warranted for a person who has engaged in or are continuing to engage in biodiscovery activities approved prior to the Act commencing, provided that what is contemplated or undertaken is in line with what has been approved. However, this does not prevent a person from complying with the new traditional knowledge obligation in these circumstances’. 

For the purposes of developing the Code, the explanatory notes state: The Minister is required to consult with First Nations Peoples and biodiscovery entities in the making of the Code and the consultation undertaken in the making of the first Code satisfies this obligation.

In addressing Traditional knowledge provisions the report states

The submission of the Chuulangun Aboriginal Corporation, BioCultural Consulting and Leslie Shirreffs supported the proposed amendments at clause 10 (new section 9B), which require a person to take all reasonable and practical measures to ensure the person does not use traditional knowledge for biodiscovery other than under agreement with the custodians of the knowledge. Their submission suggested the clause should include reference to ‘custodian’s customary obligations’, to be more ‘accurate’,  and the addition of the term ‘apical families’, to refer to ‘the rights of the speakers, knowledge holders and usufructuary rights-based peoples who exercise activities with native biological material’. 

The department noted these suggestions, and stated: 

DES views that recognition of custodians' customary obligations is best contained within the Code, because the Code will contain steps to help people meaningfully engage with, and understand, the specific customary obligations of a First Nations person or community. The concept of customary obligations will need to be defined and this is can be done by developing the Code in consultation with First Nations people.

The department further stated:

The existing definition of custodians was selected to align closely with existing or similar terms used in other Queensland legislation, on the basis that these terms already function effectively and are clear. 

DES envisages that the suggested definition will form a part of the Code, with respect to identifying the custodians of traditional knowledge. 

 Griffith University expressed concern that clause 10 was worded in a way that ‘may have broader consequences, as it seems to extend the traditional knowledge obligation to the use of digital sequence information and other information used separately from the physical materials’.  Accordingly, this may render the provision unworkable. 

For an example, Griffith University submitted:

... a company, which accesses digital genetic sequence data, may have unintended access to Traditional Knowledge from Queensland, as almost all sequence data are heavily annotated, and such annotation may include information gained from Traditional Knowledge from Queensland that may be in the public domain (e.g. originating from a scientific publication).

At the public hearing Dr Fran Humphries elaborated on Griffith University’s concerns:

In Queensland I think we need to be cautious in terms of the way the bill is drafted so that it does not necessarily bring in using digital sequence information or the intangible aspects of the genetic material separately from the physical material, having that connected with the traditional knowledge if in the act the traditional knowledge is not connected with the physical material in terms of it being the transaction. Is that fairly clear? If you have a benefit-sharing agreement for the physical materials and a benefit-sharing agreement for the traditional knowledge, and if the traditional knowledge does not relate to the physical materials seen in Queensland, I guess in terms of the definition of biodiscovery it imports aspects of information.

In response to Griffith University on this matter, the department clarified: 

Digital sequence information about native biological material is already included within the scope of the Biodiscovery Act. The traditional knowledge obligation only applies to digital sequence information that is utilised as a direct result of traditional knowledge.

Jocelyn Bosse and David Jefferson of the UQ School of Law, noted the wording of clause 35 of the Bill, which proposes to insert new section 139(2)(b) to provide an exception if a person ‘engages in other biodiscovery contemplated by the existing biodiscovery’. Their submission suggested the term contemplated was ‘overly subjective’ and suggested the use of the words ‘directly linked to the existing biodiscovery’ instead.   

The department stated that it considered the suggested wording changes to the Bill, ‘but is of the view that the existing drafting is clear’. 

The submission of the Chuulangun Aboriginal Corporation, BioCultural Consulting and Leslie Shirreffs called for specific provisions to be added to the legislation concerning the making of guidelines to ‘further support’ the use of traditional knowledge. 

The department responded by stating that this suggestion was considered, but that the guidelines are not a statutory instrument. The department further stated: ‘DES will develop the guidelines in consultation with First Nations people and biodiscovery entities to ensure they are fit for purpose’