access and benefi t sharing Biopiracy in A broken record that needs repair

Given that repeated calls for reform of access and benefi t sharing laws have produced minimal success, perhaps it is time for to stop playing a broken record and look for solutions outside of legislation and bureaucracy.

Jocelyn Bosse

ustralia is a megadiverse country, Aso the protection of its biological resources is a signifi cant priority. Fol- lowing its ratifi cation of the Conven- tion on Biological Diversity (CBD) in 1993, the Commonwealth Government enacted the Environment Protection and Biodiversity Conservation Act 1999 (Cth) (EPBCA) to protect areas of “national environmental signifi cance”. In ac- cordance with the federal distribution of legislative powers, State Govern- ments in Australia have also enacted laws for the protection of biodiversity.1

Biodiscovery to biopiracy Genetic or biochemical analysis of naturally-occurring material is frequently used in scientifi c research to produce commercial products, espe- cially pharmaceuticals. However, the practice—called biodiscovery—raises rials and their associated traditional spermum) from was two important concerns. knowledge have been used and, in investigated in the 1980s and patented First, the unrestrained use of na- some cases, patented without the in- as a medication for HIV by the United tive biological resources for scientifi c formed consent or appropriate benefi t States (US) National Cancer Institute or commercial purposes can cause sharing with the indigenous commu- in 1993.2 Although the healing proper- environmental harm and threaten nity—termed biopiracy. For example, ties of smokebush were known to local biodiversity. Secondly, living mate- the smokebush plant (genus Cono- Aboriginal communities for genera-

Trade Insight Vol. 12, No. 2, 2016 35 access and benefi t sharing

tions, the State Government awarded It sets out guidelines for biodiversity creates no substantive obligations. The the Institute an exclusive licence to conservation and protection of Indig- other States have not yet implemented conduct research into the smokebush, enous ecological knowledge. Principle biodiscovery laws.6 with no fi nancial returns for the 7 of the NCA obliges governments Out of all the ABS legislations in traditional custodians from whom the to “recognise the need to ensure that Australia, Queensland’s is the most knowledge was obtained.3 the use of traditional knowledge is likely to see any signifi cant change Acts of biopiracy, similar to the undertaken with the cooperation and soon. The Biodiscovery Act is reviewed smokebush patents, gave rise to approval of the holders of that knowl- every fi ve years; the most recent Article 8(j) of the CBD, which requires edge and on mutually agreed terms.” fi ndings were published in the 2009 that parties “respect, preserve and Nevertheless, the legislative response Report7 and the next report is due for maintain knowledge, innovations from the State Governments has been publication this year. Depending on and practices of indigenous and deeply fragmented; in most cases, no the fi ndings and government re- local communities… and encourage legislation was produced at all. sponse, the Act may be amended for the equitable sharing of the benefi ts Queensland was the fi rst State to greater consistency with other laws. arising from the utilization of such enact an ABS law: the Biodiscovery Act As it currently stands, the Act knowledge, innovations and practic- 2004. It was followed by the compre- establishes a permit system, whereby a es.” The objectives of Article 8(j) were hensive Biological Resources Act 2006 in person can apply to the State Gov- furthered in the 2010 Nagoya Protocol the . Like the Com- ernment for a biodiscovery collection on Access to Genetic Resources and the monwealth laws, and in accordance authority (BCA) in order to take small Fair and Equitable Sharing of Benefi ts with the NCA, the Northern Territo- amounts of native biological mate- Arising from their Utilization. ry’s ABS scheme covers the traditional rial for biodiscovery research. The Article 8(j) was recognised in Aus- knowledge of Aboriginal and Torres BCA application process attracts no tralia under section 3(g) of the EPBCA. Strait Islander communities, as well as fees, but the person must enter into Substantive provisions for access and biological resources accessed on State a benefi t sharing agreement with the benefi t sharing (ABS) with Aboriginal land.4 Under the Act, the biodiscovery State Government within a year of and Torres Strait Islander communi- entity must obtain prior informed approval. The agreement limits which ties were subsequently included in the consent from the community. Any commercialization activities can be Environment Protection and Biodiversity benefi t sharing agreements must be on undertaken, and stipulates the share of Conservation Regulations 2000 (Cth). mutually-agreed terms. benefi ts—fi nancial or non-fi nancial— However, attempts to harmonize Western Australia recently enacted to be given to the State.8 legislation in Australia have, in fact, the Biodiversity Conservation Act 2016. The Queensland Government produced a cacophony. The Council Although the regulation of biopros- administers over 26 million hectares of Australian Governments collec- pecting was debated,5 ABS rules were of State land covered by the Act. The tively drafted a Nationally Consistent ultimately discarded. Section 256(3) subtropical State has high biodiversity Approach for Access to and the Utilisa- of the Act allows scope for future and strong research institutions— tion of Australia’s Native Genetic and regulations on ABS in the context of two factors of signifi cant interest for Biochemical Resources (NCA) in 2002. a government licencing scheme, but biodiscovery activities, and therefore BCA applications. But, the Biodiscov- ery Register tells a different story. Figure The last decade saw the grant of Number of BCAs issued in Queensland (2005-2016) only nine BCAs (Figure). These num- bers are surprisingly low. In contrast, at least 45 benefi t sharing agreements 2.0 were registered in the fi rst three years of the Northern Territory legislation.9 Although it is bizarre that so few BCAs have been issued, two main 1.0 limitations of the statute may explain it. Number of BCAs ‘State land’ limitation: The coverage 0.0 of the Biodiscovery Act is limited to bi- 2005 2006 2007 2008 2010 2011 2012 2013 2014 2015 2016 ological resources obtained from State land, such as parks and reserves. This is narrower than the Northern Territo- ry law, which applies to private land Source: Biodiscovery Register (as of 31/05/2016) for collection authorities administered by the Queensland Gov- ernment Department of Environment and Heritage Protection (EHP) as well and, notably, native title land

36 Trade Insight Vol. 12, No. 2, 2016 under exclusive possession by Aborig- Box inal communities. Though inconsistent with the NCA, Recommendation 3.1 of Queensland ABS case study the 2009 Review suggested that the ex- clusion of private land be maintained The traditional knowledge of the Chuulangun Aboriginal community in in Queensland. The Review also northern Queensland includes a number of medicinal plant products, par- suggested that Indigenous Land Use ticularly from oils and resins of native woody plants. In 2003, the Chuulan- Agreements (ILUAs) were the most gun Aboriginal Corporation (CAC) initiated a project with scientists from appropriate means of gaining access to the University of (UniSA), with two objectives: native title land for biodiscovery. i) To investigate the novel pharmacological actions and chemical com- Negotiation of access and benefi t pounds of plant species used as traditional medicines; and sharing: When the Queensland legis- ii) To facilitate the preservation and transfer of cultural knowledge about lation was enacted, the protection of these plants. traditional knowledge had been the UniSA entered into a Collaborative Research Agreement with CAC, subject of international discussion for which acknowledges the contributions of intellectual property from the nearly two decades. Nevertheless, community, namely the traditional knowledge about medicinal plant the Queensland legislation does not products and their properties. The agreement includes the equal sharing of establish any mechanism for access commercial benefi ts and ensures that CAC are partners in commercializa- 14 and equitable sharing of benefi ts with tion decisions. The joint activities are not regulated by any ABS laws; they Indigenous communities; the Act sole- are solely governed by contract. ly regulates ABS with the State. The research, led by Dr. Susan Semple from UniSA’s Quality Use of The only mention of traditional Medicines and Pharmacy Research Centre, and David Claudie from CAC, knowledge and biopiracy is found in has primarily focused on treatments for infl ammatory skin conditions. The Article 10 of the Code of Ethical Practice plant Dodonaea polyandra, known as ‘Uncha’, has been traditionally used by for Biotechnology in Queensland, which the Chuulangun community as a treatment for mouth pain, infection of the 15 stipulates that “Where in the course oral cavity and infl ammation. of biodiscovery we obtain and use tra- As well as being recognized as joint authors in several scientifi c publi- 16 ditional knowledge from Indigenous cations about Uncha, David Claudie and George Moreton from CAC were 17 persons, we will negotiate reasonable named as joint inventors on a patent application in 2010. While the phar- benefi t sharing arrangements with maceutical development continues, CAC has taken the lead with on-coun- these persons or communities…” and try aspects of the research into collection of plant materials, examination of “We will not commit acts of biopiracy plant distribution, and analysis of the effects of plant harvesting. As part and will not assist a third party to of the commercialization process, the researchers have sought to adhere to commit such acts.” Although Rec- Indigenous ecological practices. The benefi t sharing agreement ensures em- ommendation 3.6 of the 2009 Review ployment opportunities by having members of the Chuulangun community suggested that similar provisions harvest the plants, rather than using Western ‘controlled cultivation’ meth- be added to the Compliance Code for ods. This is especially important in the context of Chuulangun spirituality Taking Native Biological Material under and law, which dictates that only authorized members of the community a Collection Authority, it did not occur. may harvest Uncha, or it will lose its medicinal effect. In contrast, the Northern Territory and Commonwealth laws provide scope for fair and equitable benefi t sharing agreements with Indigenous people. diana), which is part of the traditional private returns for Indigenous com- Despite the inconsistencies be- knowledge of the Mirarr people in munities and governments, as well as tween jurisdictions, Recommendation Northern Territory.11 It appears that biodiversity conservation.13 Thus, ABS 7.1 of the 2009 Review suggested that the inconsistent Commonwealth legislation might be viewed as more Queensland should not harmonize laws meant that Mary Kay was able bureaucratic red tape that researchers with other schemes until after the to remove samples of the plum from should seek to avoid—avoidance of conclusion of the Nagoya Protocol. the country without negotiating with which is evidenced by the negligible However, a broader question remains: the Mirarr community. Nonetheless, engagement with the Biodiscovery Act. would that actually benefi t traditional opposition from Indigenous groups Broadly speaking, two options knowledge holders in Australia? probably led to the withdrawal of the seem to be available. The fi rst is full US cosmetic company, Mary Kay, Australian patent application in 2011.12 compliance with the Nagoya Proto- was granted a US patent in 2007 for a The unclear ABS schemes have, col. Amendments to the Queensland skin cream made from the extract of to a large extent, been unsuccessful legislation which mirror the laws in the Kakadu plum (Terminalia ferdinan- in meeting their objectives: ensuring the Northern Territory, if coupled

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with harmonization across Australia, Tailor-made contracts biodiversity and Indigenous knowledge”. could have positive implications for Indigenous Law Bulletin 7(14): 11. can have more equi- 5 Aboriginal communities and would Western Australia. 2015. Parliamentary table outcomes than Debates. Legislative Assembly, 312- reduce confusion for biodiscovery ‘ticking boxes’ under 348. February 18. entities. This, however, would increase 6 The other States are , the regulatory burden on biodiscovery an inadequate legis- , and South Australia. entities. lative scheme. 7 DLA Phillips Fox. 2009. Statutory Re- The second option is that Aus- view of the Biodiscovery Act 2004 (Qld) tralian governments could abandon Report No RPB01 / 0475042. 8 legislative schemes for ABS in the Biodiscovery Act 2004 (Qld) ss 10, 33-34. 9 context of biopiracy and replace them Holcombe, S., and Janke, T. 2012. regulation’. Nevertheless, it is expect- “Patenting the Kakadu Plum and the with ‘soft’ codes and stronger educa- ed that the upcoming Biodiscovery Act Marjarla Tree”. In Intellectual property tion for Indigenous communities and review will recommend compliance and Emerging Technologies editors biodiscovery entities. The removal of Matthew Rimmer and Alison McLennan, with the Nagoya Protocol, as foreshad- 293, 296. Edward Elgar. bureaucratic ABS laws could allow for 18 owed by the 2009 Review. 10 individualized arrangements which Bull, J. and Shaw, T. 2014. “Implications Like any framework, the Nagoya of Nagoya Protocol implementation in suit the needs of particular traditional Protocol does not perfectly meet the Australia”. Australasian Biotechnology knowledge holders, as well as the 24(3): 59. needs of Indigenous communities, nature of the biological research in 11 regardless of how consistent the laws Holcombe, S., and Janke, T. 2012. Note question. In a similar vein, the 2009 9. are. Although there is little chance of Review did not support additional 12 Australian Patent Application uniform implementation of the Nagoya regulation, but instead recommended 2007205838 “Compositions comprising Protocol internationally, it is doubtful kakadu plum extract or acai berry ex- improvements to the online informa- that the federal and State Govern- tract” fi led 19 January 2007; withdrawn tion about Indigenous knowledge 12 October 2011. ments will think laterally about the holders (Recommendation 3.3), an 13 Lawson, C. ‘Patents and Access and ABS issue. To that extent, the question education process about ILUAs and Benefi t-sharing Contracts: Conservation for Australia is no longer “Should or Just More Red Tape?’ (2011) 30(2) inclusion of a notifi cation system Nagoya-compliant ABS legislation be Biotechnology Law Report 197. about indigenous occupants under the implemented?” but “In what form?” „ 14 IP Australia. 2016. Chuulangun Aborigi- Compliance Code. As the Queensland The author is student, TC Beirne School of nal Corporation and University of South law currently stands, ABS agreements Australia. https://www.ipaustralia.gov. Law, University of Queensland, undertaking with indigenous communities can au/about-us/public-consultations/indige- dual bachelors of law and plant biology. nous-knowledge-consultation/chuulan- only occur outside of the legislative gun-aboriginal-corporation. Accessed: framework, commonly in the form of October 1. contracts or ILUAs. The extra-regula- Notes 15 Simpson, B. S. et al. 2013. “Learning tory method could reduce transaction from Both Sides: Experiences and costs and yield more benefi ts for Opportunities in the Investigation of 1 Relevant State legislation includes: En- Australian Aboriginal Medicinal Plants”. Indigenous communities; a successful vironmental Protection Act 1994 (Qld); Journal of Pharmacy and Pharmaceuti- example is set out below. Environmental Protection Act 1970 cal Science 16(2):259, 264. (Vic); Environment Protection Act 1993 16 Simpson, B. S. et al. 2012. “Rare, Red tape versus contract (SA); Protection of the Environment Op- seven-membered cyclic ether labdane erations Act 1997 (NSW); Environmen- In some respects, successful examples diterpenoid from Dodonaea polyandra”. tal Management and Pollution Control Phytochemistry 141: 84; Simpson, B. S. of ABS agreements with Indigenous Act 1994 (Tas). et al. 2014. “Polyandric Acid A, a Cler- communities like the UniSA-CAC 2 Kerr, P. 2010. “Bioprospecting in Aus- odane Diterpenoid from the Australian collaboration (see Box on page 37) il- tralia – Sound Biopractice or Biodiver- Medicinal Plant Dodonaea polyandra, sity?” 29(3) Social Alternatives 44, 45. Attenuates Pro-infl ammatory Cytokine lustrate that tailor-made contracts can Patent US5672607 “Antiviral naphtho- Secretion in Vitro and in Vivo”. Journal have more equitable outcomes than quinone compounds, compositions and of Natural Products 77: 85. ‘ticking boxes’ under an inadequate uses thereof”. 17 Australian Patent Application legislative scheme. The low engage- 3 Biber-Klemm, S., Cottier, T., Cullet, P., 2010317657 “Anti-infl ammatory com- ment with bureaucratic frameworks and Berglas, D. S. “The Current Law of pounds”; PCT PCT/AU2010/001502; Plant Genetic Resources and Traditional WIPO WO 2011/057332 A1. Inventors: suggests a reticence to invoke red tape Knowledge”. In Rights to Plant Genetic Susan Jean Semple, Bradley Scott where a personalised contract would Resources and Traditional Knowledge: Simpson, and Jacobus Petrus Gerber suffi ce. As such, one could argue that Basic Issues and Perspectives editors (University of South Australia), Ross education and awareness about ABS Susette Biber-Klemm and Thomas Allan McKinnon (Flinders University), Cottier, 98. Centre for Agriculture and David Claudie and George Moreton would have better outcomes for tra- Biosciences International. 2006. (Chuulangun Aboriginal Corporation), ditional knowledge holders than the 4 Collings, N., and Heidi Evans, H. 2009. and Jiping Wang (Monash University). same old song of ‘more government “Access and benefi t sharing: protecting 18 DLA Phillips Fox. 2009. Note 7.

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