6. Building a Comprehensive Bioprospecting Framework for New Zealand
The previous sections have outlined why the government is looking at the development of a comprehensive bioprospecting policy in New Zealand, what needs to be considered, and what can be learned from examining frameworks that already exist internationally. This section introduces a framework for considering how bioprospecting policy might best meet New Zealand's needs.
6.1 Vision and principles to guide New Zealand's bioprospecting policy
The following vision and principles are proposed to guide the development of bioprospecting policy in New Zealand.
The proposed vision for a bioprospecting policy in New Zealand is:
that access to New Zealand's biological resources for bioprospecting is facilitated in a way that ensures the benefits derived are captured and shared, that social, cultural and environmental values are respected, and Mäori traditional knowledge of biological resources is recognised and, where appropriate, protected.
To achieve this vision on a domestic level, New Zealand needs to ensure that a bioprospecting policy framework:
- is ecologically sustainable;
- takes appropriate account of the Treaty of Waitangi and Treaty settlements;
- ensures acknowledgement and respect of Mäori traditional knowledge, and the need to seek permission from holders of the traditional knowledge for its use in bioprospecting;
- ensures the equitable sharing of benefits;
- ensures that applications to bioprospect are treated fairly, with all applications judged against transparent criteria and according to law;
- encourages the timely processing of applications related to bioprospecting, with applicants' transaction costs kept to an optimum level;
- does not unduly inhibit non-commercial scientific and academic research;
- is integrated with New Zealand's Biotechnology Strategy, and encourages national and international investment in biotechnology research and development in New Zealand; and
- ensures the implementation of the government's desired policy option, and its associated institutional and administrative arrangements, occur in a cost-effective manner.
To achieve this vision on an international level, New Zealand needs to ensure that a bioprospecting policy framework:
- gives effect to New Zealand's obligations under the Convention on Biological Diversity (CBD) to endeavour to create conditions that facilitate access to biological resources in return for a fair and equitable share of benefits from their use;
- is consistent with the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilisation, which are voluntary and were developed under the auspices of the CBD;
- is consistent with New Zealand's interests and responsibilities arising from other international agreements and New Zealand's strategic interests; and
- only includes terms and conditions that New Zealand would support in other countries' frameworks.
6.2 Bioprospecting policy scope: what's in and what's out?
The design of a comprehensive bioprospecting framework in New Zealand will depend heavily on what activities and resources will be managed under the policy.
This section explores the current working definition of "bioprospecting" and discusses whether the current scope is adequate.
6.2.1 The current definition of "bioprospecting"
Our working definition of bioprospecting for this discussion paper is:
Bioprospecting is the collection of biological material and the analysis of its material properties, or its molecular, biochemical or genetic content, for the purpose of developing a commercial product. Bioprospecting policy excludes the later steps in the chain of product development.
What is currently in scope and currently out of scope of a comprehensive bioprospecting framework is shown in Figure 2.
Figure 2: What's in and what's out currently
| |
Commercial bioprospecting activities |
Non-commercial bioprospecting activities |
| Central government access providers to indigenous biological resources |
in scope |
currently out of scope |
| Local government access providers |
currently out of scope |
| Private access providers |
| Ex situ collections |
| Non-indigenous biological resources |
What is "in scope"?
The following are currently in scope:
- naturally occurring (wild-type) biological resources;
- commercial bioprospecting activities;
- the exploratory stages of commercial biodiscovery activities;
- commercial activities that arise originally from non-commercial research activities. If biological material is originally collected for non-commercial purposes and this material then becomes the subject of commercial research and development, these activities would become in scope of a comprehensive bioprospecting policy; and
- establishing mechanisms to facilitate and better capture the potential benefits arising from activities that occur after the collection of biological samples.
What is "out of scope"?
The following are currently not included and are therefore "out of scope":
- genetically modified organisms and other man-made varieties;
- non-commercial biological research activities. The benefits of non-commercial research, for example, taxonomy and ecological research, are generally not appropriated by the researcher or any particular individual or organisation;
- the taking and collecting of biological samples for purposes other than research and analysis. Examples of such "out of scope" activities include seed collection for sale to the nursery trade, or collection of biological material for food or as firewood. In these cases, the material is valued for its immediate physical properties rather than the information that can be derived from analysing its properties and constituents;
- those processes that are already regulated by such Acts as the Hazardous Substances and New Organisms Act 1996, the Patents Act 1953 and the Plant Varieties Act 1987; and
- the collection and use of biological material of human origin. This is firmly excluded from the CBD's Bonn Guidelines.34
6.2.2 Should non-commercial activities be included?
Of the activities currently not captured by the current working definition of "bioprospecting", the desirability of including non-commercial activities is one that warrants some discussion because:
- it is often hard to draw the line between commercial and non-commercial activities. This apparently "simple" question has been the cause of legal dispute;
- non-commercial activities on biological samples can become, quite unexpectedly, commercial activities. This change in "status" can occur over a long timeframe as well as between completely unconnected research groups. An example of this would be one research group publishing their findings about an interesting biological activity in a plant. A few years later, another research group may use this information to develop a commercial product; and
- non-commercial research that involves the use of mätauranga Mäori should be managed in the interests of knowledge holders.
Potential advantages of inclusion
Comprehensive information about all activities involving the collection and analysis of biological material can be gathered and monitored on a nationwide basis, with the advantages that:
- it would be possible to track samples either held here and/or taken overseas in case the research results were later commercialised;
- if a biological sample collected for non-commercial activities is then used for commercial activities, documentation would be available to confirm this chain of events; and
- potential cases of biopiracy could be detected.
The transformation of domestic non-commercial activities into commercial activities could be facilitated and supported.
Potential disadvantages of inclusion
Depending on the design of the framework, there could be an associated increase in the costs to various stakeholders, for example:
- to the government. This could occur through, for example, raised running and monitoring costs caused by a larger number of applications; and
- to non-commercial biological researchers. This could occur as a result of introducing aspects, such as additional procedures and processes, before and during a research project. This could be perceived as delaying project progress and raising compliance costs.
Some activities could be unintentionally considered bioprospecting, for example, biological samples collected from the natural environment that are used for teaching purposes in a laboratory. Specific exclusions to a broader definition of bioprospecting would have to be carefully considered in order not to influence such activities.
In summary, there may be potential benefit in including non-commercial research "in scope" as long as compliance costs are minimal.
6.2.3 Which biological resources should be accessed for bioprospecting?
This section explores which resources should be accessed for bioprospecting activities. As outlined in section 4.2, government access systems that cover bioprospecting activities are already presumed to be included.
Local government access providers to biological material
Local government manages access to significant areas of New Zealand as well as the biological resources associated with it. Although the potential environmental impacts of accessing biological resources are currently managed for the most part through the Resource Management Act 1991 (RMA), not all bioprospecting activities may be subject to these processes. In addition, there are no procedures in place to facilitate the capture of potential benefits arising from bioprospecting activities.
Private access providers to biological material
Private access providers are generally private owners who can control access to biological resources found, for example, on privately-owned land or in ex situ collections.
Some stakeholders may view the current situation, whereby a private access provider to biological material can negotiate an access agreement and receive benefits in return, as inappropriate because the private access provider, for example, may not be in the position to negotiate a reasonable level of benefit (that related to the true value of the resource to bioprospectors).
Including private access providers within the scope of a comprehensive bioprospecting policy would provide a mechanism to protect against the inappropriate use of traditional knowledge or mätauranga Mäori associated with the sampled biological material.
On the other hand, placing additional processes on the use of biological material provided by private access providers may be viewed as an infringement of existing property rights, and would have associated administrative, compliance and monitoring costs.
Biological resources in ex situ collections
Ex situ collections are collections of biological material located outside their natural environment. They include zoos, aquariums, botanical gardens, nurseries, herbaria and repositories of extracts and frozen biological material, for example, micro-organisms. These collections hold a large variety of indigenous biological material. Collections of material held for research purposes generally have a database to support them. These databases may record information about the appearance, location and habitat of the material collected.
Ex situ collections in New Zealand
Ex situ collections are significant sources of biological material for bioprospectors. Many of New Zealand's research organisations maintain collections and databases of native flora and fauna, some of which are internationally significant. Collections include the Allan Research Herbarium, the Cawthron Micro-algae Collection and the International Collection of Micro-organisms from Plants. These collections are made available to bona fide researchers, but charges are levied where appropriate. New Zealand has an interest in having collections of species, as they often form the basis of research for environmental and economic outcomes that benefit New Zealand. These benefits usually come from research activities other than bioprospecting. These organisations are tasked with maintaining collections through funding arrangements with the Foundation for Research, Science and Technology.
The CBD's Bonn Guidelines state that consent to use biological material in ex situ collections "should be obtained from the competent national authority(ies) and/or the body governing the ex situ collection concerned as appropriate".35
Non-indigenous biological material
In New Zealand, there may never be much interest in bioprospecting based on non-indigenous resources because of the relatively narrow genetic base of introduced biological material. If a national framework covered indigenous biological material only, there would need to be some guidance on how it would apply in cases where it was difficult to determine whether or not a species is indigenous.
The access articles of the CBD36 apply to resources that occur in situ. The Convention defines "in situ conditions" as "conditions where genetic [biological] resources exist within ecosystems and natural habitats, and, in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties". This definition could include both indigenous and non-indigenous species.
Some countries, such as Colombia, Ecuador, Chile, Costa Rica, the Philippines and Thailand, have included both indigenous and non-indigenous biological resources. Others, for example South Africa, Australia and Mexico, cover only indigenous biological resources.
6.3 Designing a comprehensive bioprospecting framework: what do we have to consider?
Although there are important domestic drivers for a comprehensive bioprospecting policy framework, it is useful to first take a look at the international guidelines used to design bioprospecting frameworks.
6.3.1 International considerations
In considering the design of a comprehensive bioprospecting framework, it is worth looking at the international context. The CBD's Bonn Guidelines are particularly relevant because they are intended to aid the development of national bioprospecting frameworks (section 3.4.1). The suggested "National Focal Point" and "Competent National Authority" building blocks have been implemented in some countries that have developed bioprospecting frameworks according to the CBD's guidelines. Federal and State/Territorial regimes developed in Australia see these aspects as core to effective management of bioprospecting activity.
Another interesting set of international guidelines has been developed by the Biotechnology Industry Organization. However, these guidelines concern a voluntary code of conduct for bioprospectors.
Biotechnology Industry Organization guidelines
The Biotechnology Industry Organization is an international organisation that has developed educational guidelines for members engaged in bioprospecting. A significant purpose of these guidelines is to represent "best practices" that can be followed by companies that engage in these activities. These practices are consistent with emerging international norms, notably the CBD. They cover topics such as how a bioprospector should go about obtaining prior consent to take biological material, the sharing of benefits and research results, measures to protect the rights of indigenous communities, and environmental protection.
Sources: Cover Memo for Bioprospecting Guidelines [link to BIO.org website]; Guidelines for BIO Members Engaging in Bioprospecting [link to BIO.org website]
6.3.2 The Mäori dimension
Section 3 discussed a number of issues that are important on a national level, some of which are of particular importance to Mäori. In designing a comprehensive bioprospecting framework, it is important to bear these issues in mind, in particular those related to the interface between bioprospecting and traditional knowledge.
Traditional knowledge considerations
The protection and use of traditional knowledge, in particular mätauranga Mäori, is an issue much broader than bioprospecting policy. Traditional knowledge extends beyond the use of biological resources and includes elements such as house building, fishing methods and ethics. With respect to bioprospecting, unless there is greater clarity on how to access and use mätauranga Mäori, then commercial interest in New Zealand for bioprospecting may be limited due to the perceived risk relating to intellectual property issues. The following approaches are suggested as options to stimulate thought on this important matter, though each belongs to broader on-going discussions. Some possible approaches could be to:
- establish a voluntary register of traditional knowledge;
- ensure the existence of legally registered and fully mandated governance entities; and
- establish a code of "best practice" for the use of traditional knowledge by bioprospectors.
A voluntary register?
A voluntary register (part of which could be confidential) could help to protect mätauranga Mäori. If an interested party, for example, a bioprospector, wished to know whether mätauranga Mäori exists in relation to a particular subject, they could apply to the appropriate body. This body could check against the mätauranga Mäori register for information about the appropriate knowledge holders. Then, if the interested party wished to use this information, they would negotiate terms with the registered knowledge holders.
If mätauranga Mäori of relevance to the interested party's enquiry was not registered, the interested party could go ahead to develop their product, on the assumption that their potential intellectual property could not reasonably be challenged because of pre-existing knowledge.
Ensuring legally registered and fully mandated governance entities?
There is currently a complex mix of governance bodies representing Mäori for settlement or land holding (or other) purposes. While some of these entities may already have the mandate and resources to encourage activities through the ability to offer secure contracts and any associated use of mätauranga Mäori, others may not have sufficient resources, or their mandate to negotiate contracts may not be sufficiently strong to facilitate activities in their rohe (area). Some strengthening of governance entities might be desirable to achieve maximum benefits from bioprospecting for Mäori.
Code of "best practice" for bioprospectors?
Similar to the concept developed by the Biotechnology Industry Organization, an approach to provide clarity and guidance around bioprospectors' use of mätauranga Mäori could be to develop a code of "best practice". This code would need to balance measures to prevent the misappropriation and misuse of mätauranga Mäori with the benefits Mäori and others might stand to gain from a system that:
- does not give rise to numerous legal disputes (between Mäori groups, or between Mäori and bioprospectors); and
- does not make compliance so difficult that almost no bioprospectors use mätauranga Mäori, and therefore no benefits are made available in return for its use.
Such a code would not apply if a bioprospector did not use mätauranga Mäori. However, in line with international practice, a bioprospector could not seek intellectual property protection for a product or use that was not novel (that is, it already existed in the form of prior knowledge).37
A further option could be to consider the establishment of an advisory council to assist a Competent National Authority with facilitating the negotiation of benefit sharing upon usage of mätauranga Mäori (and traditional knowledge more broadly, if appropriate). It might also be appropriate for such an advisory body to develop guidelines for the use of mätauranga Mäori, and assist with identifying the most appropriate knowledge holders to negotiate terms with.
A framework for mätauranga Mäori would provide greater certainty for mätauranga Mäori holders and bioprospectors – firstly, that knowledge holder interests are respected and acknowledged; secondly, that the bioprospector's need for certainty is addressed so that investment into any one product or activity can proceed. The potential benefit to Mäori, and to New Zealanders generally, could therefore be greatly enhanced.
6.4 The building blocks of a comprehensive bioprospecting framework: what do we have to work with?
There are a number of building blocks that can be considered in designing a comprehensive bioprospecting policy framework. In fitting these building blocks together, it is important to think about our domestic considerations, what we know about international guidelines and what has been learned from them.
A National Focal Point
The Bonn Guidelines recommend a National Focal Point to act as a link between New Zealand and the CBD and to be an initial point of contact with bioprospectors. On an operational level, a National Focal Point could be, for example, a website or 0800 number.
A Competent National Authority
The Bonn Guidelines recommend a Competent National Authority as a centrally co-ordinating and policy implementing body that also acts as a second point of contact with bioprospectors to provide in-depth information and individual assistance. Under these guidelines, there is a range of roles and responsibilities that this body could fulfil. In the New Zealand context, a Competent National Authority could, for example, have one or more of the following functions:
- direct the bioprospector to the appropriate access provider;
- gather and store information about all bioprospecting activities in New Zealand – establish a database and facilitate the formation of linkages between bioprospectors, research facilities and access providers;
- monitor a code of best practice as suggested above and inform bioprospectors about the use of mätauranga Mäori;
- on request, assist bioprospectors and access providers in the negotiation of access and benefit sharing agreements;
- act as a final permit issuing authority for all access providers. For example, the issuing of permits could be conditional on the negotiated use of mätauranga Mäori being suitable and conducted with the appropriate holders of that knowledge and/or the general adequacy and legitimacy of benefit sharing between bioprospectors and the respective resource providers; and
- conduct the entire bioprospecting process from beginning to end, including negotiating access/benefit sharing agreements with bioprospectors and issuing permits upon approval.
Central government access providers
Other building blocks to consider are the existing central government access systems. A large proportion of New Zealand's biological resources are already managed through various access systems by government agencies or government-funded organisations (section 4.2).
Making use of these existing systems and adapting them to align with a comprehensive bioprospecting policy framework should be an efficient use of public resources. For instance:
- Department of Conservation: this department already has systems in place to deal with bioprospecting applications. However, this access system would need to align, in particular, with comprehensive policy developed for benefit capture;
- Ministry of Fisheries: bioprospecting is already taking place under both the special permit and fishing permit systems. However, further work will be needed in developing a bioprospecting policy to identify whether any changes are necessary, for example, in relation to providing for some aspects of benefit sharing;
- Ministry of Foreign Affairs and Trade: this Ministry is responsible for approving requests for foreign-flagged vessels to undertake marine scientific research in New Zealand's territorial waters and exclusive economic zone as well as on its continental shelf. The distinction between marine scientific research and bioprospecting is often blurred, however, and the relationship between these two activities has not yet been clearly defined. If bioprospecting activities were considered to be marine scientific research for the purposes of the United Nations Convention on the Law of the Sea, such activities would be subject to the international legal regime for marine scientific research established under that Convention; and
- Land Information New Zealand: to date, there are no specific systems in place to deal with bioprospecting activities. However, a framework may be able to be developed to accommodate this activity if it complies with relevant statutes38 and can take into account the difficulties surrounding the roles of third parties such as lessees, licensees and potential beneficial owners of Land Information New Zealand administered land.
Local government access providers
Another building block for consideration is the inclusion of the resources accessed through local government. Not all bioprospecting activities may currently be subject to RMA processes. This aspect of local government planning, as well as the associated capture of potential benefits, will need further consideration.
Private access providers
If private resources were to be included (section 6.2.3) under a comprehensive bioprospecting framework, they would thereby become another building block in the bioprospecting framework. It could be desirable for private access providers to be represented in some form, for example, by the Competent National Authority (if established). This organisation could oversee bioprospecting activities and offer a number of services to private access providers, for example, to:
- assist with the negotiation of benefit sharing arrangements upon access to biological material by offering model contracts and advice;
- monitor compliance and enforcement of those agreements;
- provide certainty that the bioprospector has complied with all requirements developed, for example, a code of best practice on the use of mätauranga Mäori; and
- issue permits on the private owner's behalf.
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