Bioprospecting sharing the benefits for Tasmania

Position Paper for public consultation - January 2009

Department of Primary Industries and Water DISCLAIMER The information presented in this publication is provided by the Tasmanian Government as an information source only. The State of Tasmania (Department of Primary Industries and Water) makes no statements, representations or warranties about the accuracy or completeness of the information contained in this publication. The Tasmanian Government disclaims all responsibility and liability (including without limitation, liability in negligence) for all expenses, losses, damages and costs you might incur as a result of the information being inaccurate or incomplete in any way, and for any reason.

Published by Department of Primary Industries and Water GPO Box 44 Hobart, Tasmania, 7001 Australia www.dpiw.tas.gov.au

© Government of Tasmania 2009

ISBN 10: 0-7246-6772-5 ISBN 13: 978-0-7246-6772-7 CONTENTS

FOREWORD ...... 1

1.
INTRODUCTION ...... 2

2.
BACKGROUND ...... 3

2.1
THE INTERNATIONAL CONTEXT ...... 3
2.2
BIOPROSPECTING IN AUSTRALIA ...... 4
2.3
BIOPROSPECTING IN TASMANIA ...... 5
3.1
PROPOSED POLICY FRAMEWORK ...... 8
3.1.1
KEY OBJECTIVES ...... 8
3.1.2
KEY OUTCOMES ...... 9
3.1.3
GUIDING PRINCIPLES ...... 9
3.1.4
PROVISIONAL ARRANGEMENTS ...... 10
3.1.5
POLICY REVIEW ...... 11
4.
REGULATORY FRAMEWORK FOR BIOPROSPECTING ...... 11

4.1
INTRODUCTION ...... 11
4.2
LEGISLATIVE OPTIONS ...... 11
HOW TO HAVE YOUR SAY ...... 15

QUESTIONS FOR FEEDBACK...... 15
WHERE TO FROM HERE? ...... 15
GLOSSARY OF TERMS ...... 16

SUBMISSION FORM: ...... 17

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 FOREWORD

Tasmania is rich and diverse in natural biological resources. Many plant and animal species are endemic to Tasmania and our biological resources are of global significance.

Tasmania’s diversity of native plants, animals and other organisms has led to an increase in interest from around the world by companies and research groups investigating possible commercial applications of genetic and biochemical material from these resources.

The information gained from bioprospecting can be used to create valuable products such as pharmaceuticals, nutraceuticals, agrochemicals and bioremediation materials.

The Tasmanian Government recognises that whilst bioprospecting has the potential for significant environmental, economic and social benefits for all Tasmanians, our native biological resources are a key asset to the State and need to be managed in a sustainable manner.

The Australian and all State and Territory Governments have agreed to develop terms of access to resources that position Australia to obtain the maximum economic, social and environmental benefits from the ecologically sustainable use of our genetic and biochemical resources, whilst protecting our biodiversity and natural capital.

Introducing a clear, consistent, fair and equitable policy for managing access to our biological resources will ensure the sustainable use of our resources whilst attracting more investment in Tasmania’s biotechnology capacity. Requirements for benefit sharing will also capture monetary and non-monetary benefits that arise from research and commercialisation of products.

This position paper has been developed to explain how bioprospecting in Tasmania is currently managed and to generate discussion on a suitable policy environment to encourage bioprospecting in our State in a sustainable and ethical framework.

Thank you for taking the time to read this paper. I encourage all those interested in the future of bioprospecting in Tasmania to provide feedback on the issues raised.

David Llewellyn MP MINISTER FOR PRIMARY INDUSTRIES AND WATER

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 1 1. INTRODUCTION

Biological resources are all around us, in plants, animals, fungi, microorganisms and viruses on the land, in freshwater and in the sea. The term ‘biological resources’ refers to genetic resources, organisms or parts thereof, populations or any other biotic component of ecosystems with actual or potential use or value for humanity.1

There is an increasing interest worldwide in conducting research into the genetic and biochemical makeup of natural biological resources with the view of developing commercial products. The term ‘bioprospecting’ refers to the collection of biological materials and the analysis of its material properties, or its molecular, biochemical or genetic content for the purpose of developing a commercial product.

Until 1993 when the Convention on Biological Diversity (CBD) entered into force, biological resources were widely considered ‘the common heritage of mankind’. As such, plant and animal genetic resources were removed from many environments around the globe in the hope of making new discoveries and products. Benefits rarely flowed to the communities or countries from where the resources were obtained.

The Australian Government and States and Territories have recognised the need for a stable and transparent system to facilitate sustainable access to biological resources while ensuring appropriate returns to those who granted permission to use the resources. This recognition became formal when the 2002 “Nationally consistent approach for access to and the utilisation of Australia’s native genetic and biochemical resources” (Nationally Consistent Approach) was signed by all State and Territory Governments and by the Australian Government. The Nationally Consistent Approach (NCA) sets out general principles underpinning development or review of legislative, administrative or policy frameworks for access to biological resources.

A number of companies have received permission from the Tasmanian Government to extract biological resources for medicines, health products and essential oils. As will be explained in the following chapter, such permission has been obtained under existing laws that allow access to native biological resources for scientific or collection purposes.

Without strong policies and regulation biological resources may be taken from Tasmania without permission and/or without an obligation to share the benefits. A policy and regulatory framework also provides certainty to legitimate organisations seeking to invest in Australia’s research and development capabilities.

1 Article 2 of the Convention on Biological Diversity.

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 2 2. BACKGROUND

2.1 The International Context

The Convention on Biological Diversity The Convention on Biological Diversity (CBD) was signed and ratified by the Australian Government on 5 June 1992. In 1993 the CBD entered into force. Article 2 of the CBD defines biological diversity as the variability among living organisms from all sources including, amongst other things, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems.

The CBD has been ratified by 155 other nations, meaning that they have officially agreed to implement the Convention in domestic laws.

The CBD affirms a nation’s sovereign right over its natural biological resources and, in so doing, has three primary goals:

1. The conservation of biological diversity; 2. The sustainable use of its components; and 3. The fair and equitable sharing of the benefits arising from the use of genetic resources.

Article 15 of the CBD states that parties should “…endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other contracting parties. Access should be through the prior informed consent of the sovereign state and on mutually agreed terms.”

Further information on the CBD can be found at: http://www.cbd.int/convention/about.shtml

The Bonn Guidelines The Bonn Guidelines are voluntary guidelines adopted by the parties to the CBD to assist Governments and other stakeholders in developing access and benefit-sharing strategies, including policy and legislation. The guidelines are also meant to assist when negotiating contractual arrangements for access to biological resources and sharing benefits from their commercialisation.

The core objectives of the Bonn Guidelines are conservation and sustainable use of biodiversity consistent with the Convention, as well as clarifying the roles and responsibilities of access providers and access seekers.

The Bonn Guidelines can be found at: http://www.cbd.int/abs/bonn.shtml

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 3 2.2 Bioprospecting in Australia

Nationally Consistent Approach (NCA) To satisfy Australia’s international obligations under the CBD and Bonn Guidelines, the Australian Government developed the NCA. The NCA was signed by all Australian jurisdictions in October 2002.

A copy of the NCA can be found at: http://www.environment.gov.au/biodiversity/publications/access/nca/index.html

The NCA sets out general principles for legislative, administrative or policy frameworks in Australian jurisdictions for access to genetic and biological resources. These include:

 consistency with national and international obligations;  facilitation of ecologically sustainable access to and the use of biological resources;  fair and equitable sharing of benefits;  enhancement of biodiversity conservation; and  fair and transparent access approval processes.

So far the Australian Government and the Governments of Queensland and the Northern Territory have implemented policies and legislation for managing access to biological resources. 2

In Commonwealth areas and for Commonwealth regulated species3, access to native genetic, biological and biochemical resources is managed by a permit system established under the Environment Protection and Biodiversity Conservation Act 1999 (Cth). The Australian Government regulations relate only to the taking of biological resources of native species for research and development on any genetic resources, or biochemical compounds, comprising or contained in the biological resource.

The Queensland Biodiscovery Act 2004 sets out a framework regulating biodiscovery with the purpose of assisting sustainable access to the State’s biodiversity and ensuring the fair and equitable sharing of any benefits developed from that biodiscovery. The purpose of the Act is achieved through a benefit sharing regime using Benefit Sharing Agreements and an access permit system.

The Northern Territory Biological Resources Act 2006 regulates bioprospecting for biological resources belonging to the Northern Territory and its people. The Northern Territory’s regulatory framework requires the use of Access and Benefit Sharing Agreements and allows for the issue of Certificates of Provenance for samples.

2 Other States have yet to introduce specific policies or legislation for bioprospecting. 3 Commonwealth areas are those lands and waters owned or managed by the Australian Government and those not managed by State and Territory governments, for example military training areas and light stations. Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 4 2.3 Bioprospecting in Tasmania

Tasmania is rich in biodiversity. Many plant and animal species are endemic to Tasmania. Increasing awareness of the unique nature of Tasmania’s native biological resources has elevated interest from around the world by companies and research groups investigating possible commercial applications.

Whilst bioprospecting has the potential to produce significant environmental, economic and social outcomes, our biological resources are a key asset to the State and access to them needs to be managed in a sustainable manner to ensure our natural environment is protected now and for the future.

Tasmania’s national obligations As a signatory to the NCA, Tasmania has agreed to develop terms of access to biological resources that encourage local, national and international investment in Australia’s biotechnology research and development capabilities.

Current bioprospecting activities in Tasmania There are a number of research bodies and companies that have conducted or are currently in the process of conducting known bioprospecting activities in Tasmania. These are the bodies that have applied for and received relevant collection permits for native plants or animals. Bioprospecting activities in Tasmania are known to have included the collection of:  Plant material;  Bioactive compounds from marine plants;  Fungi and lichens;  Micro-organisms; and  Aquatic organisms.

Some of these collections are approved as bioprospecting activities. Others may be permitted for other purposes and in such cases bioprospecting activities could be occurring unknown to authorities.

Bioprospecting – the challenge and the benefits for Tasmania BioVision Tasmania 2007-2015 Tasmania’s Biotechnology Strategy establishes a challenge for the Tasmanian Government to attract bioprospecting activity to the State while ensuring sustainable use of our biodiversity.

For a copy of BioVision go to: http://www.development.tas.gov.au/publications/BioVision%20Tasmania%202007- 2015.pdf

To meet this challenge the Tasmanian Government has undertaken to work closely with both local and Australian Government policy development agencies to ensure a nationally consistent policy for access to genetic resources and benefit sharing arrangements for commercial bioprospecting activity in Tasmania.

BioVision Tasmania 2007 - 2015 recognises Tasmania’s potential for a thriving biotechnology industry. This is due in part to our geographic, climatic and demographic advantages as an island with pure air and water, comparative pest and disease free status and relatively stable and contained population.

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 5 Tasmania also has niche biotechnology research and development capabilities with world-class research institutes and companies operating in agricultural, environmental, forestry, aquaculture, marine, and human health areas. In addition to research capabilities, Tasmania has a number of companies, small and large, involved in extracting biological resources for medicines, health products and essential oils. Other companies are involved in processing products for food and cosmetics.

Introducing a clear, consistent, fair and equitable policy for access to our biological resources will ensure the sustainable and ethical use of our resources whilst attracting more investment in Tasmania’s biotechnology capacity. Requirements for benefit sharing will also capture monetary and non-monetary benefits that arise from research and commercialisation of products. These potential benefits can include, but are not limited to:

Non-monetary:  Sharing of the results of research and development;  Collaborative and cooperative partnerships in scientific research and development and/or product development;  Collaborative and cooperative partnerships in education and training, including training communities to better manage native biological resources;  Access to ex situ collections and/or databases;  Technology transfers;  Capacity building in research institutions and the like;  Social recognition; and  Joint ownership of relevant intellectual property.

Monetary benefits could include:  Up-front payments;  Regular milestone payments;  Royalties;  Research funding;  Licence fees;  Joint ventures;  Joint ownership of intellectual property.

Current regulation of access to biological resources in Tasmania At present in Tasmania, access to genetic and biological resources is regulated under general provisions of existing legislation for nature conservation, reserves, inland fisheries, living marine resources, and crown lands. Therefore regulation is on the basis of tenure or resource. Gaps in the management of resources mean that some bioprospecting activity can occur without the Government’s knowledge.

The legislation that has been, and could be, applied to regulate bioprospecting activities in Tasmania includes:

 Forestry Act 1920;  Forest Practices Act 1985 & Forest Practices Regulations 2007  Inland Fisheries Act 1995;  Living Marine Resources Management Act 1995;  Nature Conservation Act 2002 & Wildlife Regulations 1999;  National Parks and Reserves Management Act 2002 & Crown Land Regulations 2001;

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 6  Threatened Species Protection Act 1995 & Threatened Species Protection Regulations 2006;  Wellington Park Act 1993 & Wellington Park Regulations 1999; and  Whales Protection Act 1988

Table 1 details how this legislation relates to access to resources for bioprospecting.

Table 1: Tasmanian legislation that is relevant to bioprospecting Legislation Responsible Aspects of Permit Authority(ies) Application Forestry Act 1920 Forestry Corporation Applies to collections from state forests Forest Practices Act 1985 Forest Practices Authority Forest practices on all & land must be in Forest Practices accordance with a certified Regulations 2007 Forest Practices Plan Inland Fisheries Act 1995 Director of Inland Fisheries A commercial freshwater fishing licence is required for bioprospecting activities Living Marine Resources Department of Primary Able to issue specific Management Act 1995 Industries and Water permit or licence for bio- prospecting activities Nature Conservation Act Department of Primary Applies to the taking or 2002 Industries and Water possession of specified & wildlife, specified products Wildlife Regulations 1999 of specified wildlife or specified protected plants or soils National Parks and Department of Environment, Applies to the taking of Reserves Management Act Parks, Heritage and the Arts wildlife or products of 2002 & wildlife, plants, soils and & Department of Primary rocks from reserved land Crown Lands Regulations Industries and Water managed by the Parks 2001 and Wildlife Services Threatened Species Act Department of Primary A Permit is needed in 1995 Industries and Water order for listed species to & be taken. Threatened Species Applies to any listed taxon Protection Regulations 2006 of flora or fauna (listed in the Schedules of the Act) Wellington Park Act 1993 Department of Environment, The Regulations prohibit & Parks, Heritage and the Arts the taking and/or Wellington Park Regulations possession of flora and 1999 fauna from Wellington Park without a permit. Whales Protection Act 1998 Department of Primary Applies to the taking of a Industries and Water whale or product of a whale for scientific or educational purposes

Tasmanian legislation can be found at http://www.thelaw.tas.gov.au/index.w3p

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 7 3. BIOPROSPECTING POLICY The preceding chapters of the position paper establish that: 1. Bioprospecting is happening now, in Tasmania. In the absence of specific provisions for benefit sharing, Tasmania’s resources are vulnerable to biological resources being taken without an obligation to share the benefits. A strong policy framework also provides certainty to legitimate organisations seeking to invest in Australia’s research and development capabilities;

2. Tasmania has an obligation to implement the Nationally Consistent Approach for Access to and the Utilisation of Australia’s Native Genetic and Biochemical Resources;

3. Tasmania has set a challenge in BioVision Tasmania 2007-2015 to attract biodiscovery activity to the State while ensuring sustainable use of our biodiversity; and

4. Access to our biological resources is currently regulated under many pieces of legislation with no central government coordination to ensure consistency.

The Tasmanian Government intends to respond to these issues by introducing a policy framework for bioprospecting in Tasmania. That policy framework will include provisional arrangements for access and benefit sharing.

The policy framework will be reviewed within four years and the effectiveness of the provisional arrangements examined.

The remainder of this paper sets out the proposed policy framework and outlines a legislative model that could be used to give effect to that policy in the future.

3.1 Proposed policy framework

The Tasmanian Government supports terms of access to Tasmanian biological resources that encourage local, national and international investment for the benefit of Tasmanians. The objectives, outcomes and principles that follow are designed to ensure that access to our biological resources occurs within a sustainable and ethical framework that ensures benefit sharing and recognition of traditional knowledge.

3.1.1 Key objectives

Consistent with the NCA the key objectives of the policy will be to: 1. Realise the benefits to the State’s economy and environment that come from managed access to, and benefit sharing from, those resources;

2. Simplify access and benefit sharing arrangements as much as possible;

3. Encourage investment in bioprospecting research in Tasmania; and 4. Ensure that activities are conducted in a manner that does not negatively impact on the sustainability of Tasmania’s diverse biological resources.

Question 1: Do you have any comments on these key policy objectives? What other objectives should the policy aim to meet?

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 8 3.1.2 Key outcomes

The key outcomes sought by the Tasmanian Government from the bioprospecting policy are:

1. A clear framework for the management of bioprospecting in Tasmania.

2. Regulation of the bioprospecting activities in a manner consistent with national and international agreements.

3. Increased national and international business investment in the Tasmanian bioprospecting industry.

4. Enhanced biodiversity conservation in those areas where resources have been accessed for bioprospecting.

5. The traditional knowledge of the Aboriginal community is recognised and benefits flow to the community from the use of such knowledge.

6. The Tasmanian community is confident that bioprospecting in Tasmania is managed in a sustainable and controlled manner that provides benefits to the State and community.

Question 2: Do you agree with these key outcomes? Are there any other outcomes that the policy should aim to achieve?

3.1.3 Guiding Principles

The following principles will guide the Government’s policy approach to managing bioprospecting in Tasmania.

Facilitation  Research into Tasmanian biological resources is encouraged.  Bioprospecting is managed in such a way that the growth and development of Tasmania is fostered.

Recognition  Bioprospecting in Tasmania is undertaken with respect to the property rights of the owners of the land from which the resources are accessed.  Access to biological resources on Aboriginal land remains subject to the operation of the Aboriginal Lands Act 1995, Aboriginal Lands (Settlement Point Cemetery) Regulations 1999, Aboriginal Lands Amendment Act (No. 2) 2005, and the Aboriginal Lands Regulations 1998.  Bioprospecting that involves the use of traditional knowledge that is not currently in the public domain must only be undertaken with the cooperation and approval of the holders of that knowledge, include prior informed consent of the custodians of that knowledge and be on mutually agreed terms.

Clarity  Bioprospecting of Tasmania’s native biological resources is not permitted unless access to the resource has been granted and benefit sharing arrangements agreed.

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 9 Efficiency • Administration and transaction costs will be kept to a minimum to ensure the policy framework does not create unnecessary barriers to trade.

Sustainability  Access to native biological resources for bioprospecting is to be subject to conditions that ensure minimal impact on, or damage to, the habitats and surrounding ecosystems of the resource.  Where possible the benefits derived from access to and use of biological resources from publicly owned or managed areas will be used for biodiversity conservation in the areas from which the resources were taken.

Fairness  Access to native biological resources should not be granted unless appropriate benefit sharing arrangements are in place.  Benefit sharing arrangements must be based on mutually agreed terms.  Benefit sharing arrangements will only come into effect if access is granted.

Question 3: Do you agree with these guiding principles? Are there any other principles that should guide the policy approach to bioprospecting in Tasmania?

3.1.4 Provisional Arrangements

Until specific bioprospecting legislation can be developed, the Tasmanian Government’s policy position on bioprospecting will be effected through provisional arrangements. Access to/the taking of native biological resources in Tasmania will be governed by the guiding principles. A key feature of the provisional approach will be the requirement for Access and Benefit Sharing Agreements. ABSAs are legally binding contracts between the provider of access to native biological material and the person, institution or company seeking that access. The Agreements aim to share bioprospecting benefits with the access provider on mutually agreed terms. Those benefits can be monetary (for example: royalties, commissions) and/or non-monetary (for example: research outcomes). The Tasmanian Government will develop model ABSAs for private land and public land which can be used as a basis for negotiating mutually agreed terms. When specific legislation can be developed it will give effect to ABSAs entered into during the provisional arrangements.

For access to native resources that are regulated by the Crown, the Tasmanian Government may require voucher specimens to be kept of the organisms from which material is derived and all resources that have been obtained through bioprospecting. (Voucher specimens are samples of biological material that are stored for future reference.)

All enquiries regarding, and applications for ABSAs will flow through a central issuing authority within government, or ‘one-stop shop’. Using a central coordinating

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 10 authority will allow for seamless administration and ease of access for industry, government and private individuals alike.

During the provisional arrangements the Tasmanian Government will remain active in national forums relevant to bioprospecting to ensure that international and national developments continue to inform our policy and regulatory approach.

3.1.5 Policy Review

The final policy will set a time for review, no later than four years from the date of commencement. That review will take into account relevant national and international developments in relation to access to, and utilisation of, native genetic and biochemical resources and the effectiveness of the provisional arrangements, particularly with regard to benefit sharing agreements. The review will recommend an appropriate regulatory approach for bioprospecting in Tasmania.

4. REGULATORY FRAMEWORK FOR BIOPROSPECTING

4.1 Introduction

The remaining sections of this paper explore what a regulatory regime for bioprospecting could involve.

As discussed in section 2 of this paper, access to Tasmania’s native biological resources is currently regulated under a number of pieces of legislation. Each piece of legislation has slightly different assessment criteria to be established before access can be granted and there are no specific provisions for benefit sharing agreements.

Administratively, there is no central coordination point within government for the regulation of bioprospecting, with responsibilities falling across several agencies.

The provisional arrangements will apply until specific legislation can be developed.

The Tasmanian Government has not decided on a specific legislative or regulatory model for bioprospecting, as public comment and further consideration of the implications for Tasmania are required. However, any regulation will be in keeping with the NCA and the bioprospecting policy.

4.2 Legislative Options

Several legislative options are possible. These include:

1. Introducing specific bioprospecting legislation for both access and benefit sharing – the ‘specific purpose legislation’ option;

2. Amending each existing Act to achieve consistency in assessment and inserting specific requirements for access and benefit sharing agreements to be entered into – the ‘amendment’ option; and

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 11 3. Introducing legislation to provide comprehensive cover for access and benefit sharing arrangements that will work in conjunction with existing laws that regulate access. This is the ‘complementary legislation’ option.

The review of the provisional arrangements will include analysis of the most appropriate legislative option for bioprospecting in Tasmania. Key features that future legislation could include are discussed below.

Objective The primary objective of bioprospecting legislation should be to facilitate and manage the ecologically sustainable access to, and use of, native biological resources for the purpose of bioprospecting.

Other objectives would be in accordance with the bioprospecting policy.

Scope Bioprospecting legislation should apply to taking samples of native biological resources either ex situ or in situ to identify novel natural products.

It is important to note that Tasmanian bioprospecting legislation would not apply to, amongst many other things, human biological resources, commercial or recreational fishing, extraction of essential oils (other than for bioprospecting) or taking native animals or plants for food or commercial forestry. Human biological resources are not included in either the CBD or the NCA. Industries such as commercial and recreational fishing, forestry and essential oils, worth hundreds of millions of dollars to the Tasmanian economy annually, are already subject to regulation. Subjecting these industries to further regulation may create economic inefficiencies greater than any likely benefit that would come from benefit sharing agreements, thus potentially defeating their purpose.

Application and administration Bioprospecting legislation would apply in Tasmania and to native Tasmanian biological resources. Some native biological resources are held in ex situ collections outside of Tasmania. The legislation would need to recognise this situation and allow ABSAs to be made in respect of such collections.

An “Issuing Authority” may need to be formed with objectives to:

 Assess any application for a permit to collect biological resources where the purpose is for research into a commercial or industrial application.  Provide recommendations to the relevant Departmental Secretary or General Manager, in which the relevant legislation to be used to grant the permit is administered, for granting of collection permits for access to native biological resources for the purpose of undertaking research into a commercial or industrial application.  Assist the Tasmanian Government in negotiations with the applicant to determine an appropriate benefit sharing agreement where the Government is part of a benefit sharing agreement.  Review performance reports of applicants and report annually to an appropriate Departmental Secretary.

The Issuing Authority would develop operating guidelines and consist of representatives from the key Government agencies directly related to access to

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 12 biological resources in Tasmania and who have some level of responsibility for Tasmanian biological resources.

Where deemed necessary, the Issuing Authority would have the ability to seek independent and professional advice.

Access Bioprospecting can occur on private land or public land. Access arrangements for private land will be subject to ABSAs as well as any permit required by the Government in relation to the biological resource being collected.

Access to native biological resources on public land will be subject to existing laws for crown land (including reserved land, forestry land and marine areas), as well as any permit required for taking the biological resource.

Permits would need to specify an appropriately broad classification level to allow a range of specimens to be taken in cases of taxonomic uncertainty.

The Government may only grant a bioprospecting permit when an ABSA has been entered into (see below).

Assessment of applications for bioprospecting permits will involve consultation with relevant Agencies and stakeholders.

Benefit Sharing Any new legislation would create a legal requirement for an ABSA to be entered into between the access provider and the person or persons seeking access to biological resources. As stated previously, ABSAs entered into under provisional arrangements would need to be legally recognised under any new legislation.

Monetary benefits would normally only accrue when a commercial product is created from the biological resource. Where an ABSA is between a bioprospector and a private person it is up to those parties to agree on the benefits. An example of a model ABSA between private parties and a model ABSA between a bioprospector and Government can be located at: http://www.environment.gov.au/biodiversity/science/access/model- agreements/index.html

Traditional Knowledge The NCA requires legislative, administrative or policy frameworks in Australian jurisdictions for access to and utilisation of Australia’s native genetic and biochemical resources to recognise the need to ensure the use of traditional knowledge is undertaken with the cooperation and approval of the holders of that knowledge and on mutually agreed terms.

The Aboriginal community will be engaged in the development of the bioprospecting policy, to identify methods to address and respect traditional knowledge of Tasmanian biological resources where such knowledge may be used for bioprospecting.

Question 4: Do you agree that benefit-sharing agreements should be required by law? If not, why?

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 13 Compliance and Enforcement To ensure legislation is effective, consideration needs to be given to how to ensure compliance.

Legislation may require that voucher specimens are kept by industry. It is usual practice for voucher specimens to be kept by researchers and in some jurisdictions it is required by law. Where the law requires voucher specimens, it may also specify where the specimens are to be kept to ensure reputable collecting and storing protocols.

Certain information relating to bioprospecting permits will be in a public register, maintained by the Government. This may, for example, include the names of permit holders and the species for which the permit has been given. Commercial in- confidence information is unlikely to be included on a public register.

Legislation would establish offences and penalties for non-compliance.

Question 5: What other mechanisms for compliance and enforcement may be appropriate and should be considered?

Question 6: Do you have any other comments to make about this Position Paper?

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 14 How to have your say

Questions for feedback Particular issues that we want feedback on have been identified throughout this document. With this document you will find a form that contains each of these questions and space for you to write your comments.

If any individuals or groups would like to discuss the position paper, information sessions may be organised by contacting the Executive Officer at the address below.

Submissions are due by close of business Friday 20 March 2009. A response can be sent either electronically by e-mail, by filling in the submission form (attached to this document or available online from www.dpiw.tas.gov.au), or by post to:

Postal address:

Access to Biological Resources Project Executive Officer Department of Primary Industries and Water GPO Box 44 HOBART TAS 7001

E-mail address: [email protected]

Where to from here? Following receipt of submissions, the Minister will consider all the information and recommend to the Government the policy that should be adopted. For information and updates on progress, go to DPIW website at www.dpiw.tas.gov.au

The Freedom of Information Act 1991 and confidentiality: Please note that submissions will be treated as public documents. By law, information provided to the Government may be provided to an applicant under the provisions of the Freedom of Information Act 1991.

When making your submission, please detail any reasons why you consider the information that you have provided is confidential or should not be publicly released. Your reasons will be taken into account in determining whether or not to release the information.

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 15 GLOSSARY OF TERMS “ABSA” – Access and Benefit Sharing Agreement. A legally binding contract between the provider(s) of access to native biological material and the person, institution or company seeking that access.

“Biodiscovery” – The examination phase of a bioprospecting activity.

“Biological resources” – Includes genetic resources, organisms, parts of organisms, populations and any other biotic component of an ecosystem with actual or potential use or value for humanity.

“Biological Diversity” – Means the natural diversity of biological resources, together with the environmental conditions necessary for their survival, and includes the diversity of: (a) the landforms, soils and water of a region, and the functional relationships that affect environmental conditions within ecosystems (called "regional diversity"); and (b) the different types of communities formed by living organisms and the relations between them (called "ecosystem diversity"); and (c) species (called "species diversity"); and (d) genes within each species (called "genetic diversity").

“Bioprospecting” – The collection of biological materials and the analysis of its material properties, or its molecular, biochemical or genetic content, for the purpose of developing a commercial product.

“Biotechnology” – A group of technologies based on the application of biological processes.

"ecosystem" – Means a dynamic complex of plant, animal and micro-organism communities and their non-living environment interacting as a functional unit;

“Ex situ” – outside its original place.

“Genetic Resources” – Means any material of plant, animal, microbial or other origin that contains functional units of heredity and has actual or potential value for humanity.

“In situ” – In its original place.

“NCA” – Nationally Consistent Approach.

“Voucher Specimens” – are samples of original biological material that are stored for future reference. Voucher specimens provide a permanent record of the biological material that has been collected and can be used for both identification and compliance purposes.

Bioprospecting: sharing the benefits for Tasmania Position Paper for public consultation – January 2009 Page 16 Submission form:

Bioprospecting – Sharing the benefits for Tasmania

Submission from (name): Address (optional): E-mail (optional):

Instructions: Please write your comments in the boxes.

Question 1: Do you agree with these key policy objectives? What other objectives should the policy aim to meet?

Question 2: Do you agree with these key outcomes? Are there any other outcomes that the policy should aim to achieve?

Question 3: Do you agree with these guiding principles? Are there any other principles that should guide the policy approach to bioprospecting in Tasmania? Question 4: Do you agree that benefit-sharing agreements should be required by law? If not, why?

Question 5: What other mechanisms for compliance and enforcement may be appropriate and should be considered?

Question 6: Do you have any other comments to make about this Position Paper?

Thank you for completing this submission form. Submissions are due by close of business Friday 20 March 2009. Please send your completed form to:

Postal address: Access to Biological Resources Project Executive Officer Department of Primary Industries and Water GPO Box 44 HOBART TAS 7001

E-mail address: [email protected] CONTACT DETAILS

Strategic Policy Division Department of Primary Industries and Water Telephone: (03) 6233 4031 [email protected]