Updated: Feb 9
DNA analysis is still a niche market — or rather, a collection of niches: people with diseases who need answers, genealogy buffs and the curious. In the United States, only about 10 million people have had their genomes analysed so far. However, new models have now been developed which treat DNA data much like other personal digital information. If collected in bulk, anonymised, and aggregated, that pool of data can be mined. Just like Facebook.
In 2015, the drug company Genentech agreed to pay 23andMe as much as $60 million for access to its genetics data. 23andMe also has research arrangements with Pfizer and other pharmaceutical companies, and its in-house research team is combing through the data for insights into cancer, skin disease, heart disease, and other conditions.
It is often assumed that donors of genetic material used in research act altruistically and are therefore not entitled to property rights or direct benefit-sharing in the outcome of that research. However, given the relatively recent history of access and benefit-sharing agreements, this approach may be changing.
The Traditional Access and Benefit-Sharing Model
As genetic research has become more sophisticated, so has our capacity to use plant and animal DNA to modify crops and develop new drugs. When research groups attempted to search for biological resources (bioresources) in a legal and respectful manner, it was called bioprospecting. When researchers collect biological resources without permission, it was called biopiracy.
Access and benefit-sharing agreements evolved largely out of a recognition that developing nations were too often exposed to biopiracy. Unique biological resources being patented by foreign entities without fair and equitable compensation for those resources. For example, Indian products such as the neem tree, tamarind, turmeric, and Darjeeling tea.
The Law & Bioresources
Article 15 of the United Nations Convention of Biological Diversity (‘the Convention’) recognizes the right of Contracting Parties (signatory nations) over bioresources found within their borders. This includes taking legislative measures with the aim of sharing, in a fair and equitable way, the results of research and development arising from commercial utilisation of bioresources. Section 3A(a) of the EPBC Act states that decision-making processes should integrate both long-term and short-term economic, social and equitable considerations through (e) pricing and incentive mechanisms. This is achieved through section 301(1), which provides for control of access to bioresources in Commonwealth areas (defined in s 525). Control of access regulations are outlined in the Environmental Protection and Biodiversity Conservation Regulations 2000 (Cth), with 8A.06 requiring anyone accessing bioresources on Commonwealth land to have a permit from an access provider.
There is a specific carve out for Indigenous Peoples (as access providers), which ensures the possibility for both financial and non-financial arrangements regarding bioresources found on Native Title land. The content of these benefit-sharing agreements (contained in Reg 8A.08) include provision for recognition, protection and valuing of any Indigenous Peoples’ knowledge that will be used as part of access. Some claim that the aim here is to acknowledge that Indigenous knowledge shapes or preserves aspects of the biological environment, and/or may lead bioprospectors to useful qualities of plant life.
However, there is no prohibition against private landowners also entering into benefit-sharing agreements for any bioresources found on their land. The Convention is designed to ensure that physical access to bioresources is facilitated and the benefits obtained from their use are shared equitably to providers.
The Modern Benefit-Sharing Model and People
What makes the above model interesting for the purposes of this article is whether the approach to bioresources in plants and animals can (legally or conceptually) be applied to human donors of genetic material. If so, then it is at least arguable that human donors of genetic material used in research might be entitled to a limited form of benefit-sharing.
Human Tissue Donation & Property Rights
One objection to donors of genetic material being granted access and provider rights is that plants and animals are defined as property. As described in Yanner v Eaton, property is the legal relationship with a thing. It refers to the degree of power that is recognised in law as power permissibly exercised over that thing. One of the key features of property is that it is alienable (able to be transferred to new ownership).
Human tissue, unlike plant and animal tissue, is not generally considered property and therefore not alienable. PQ v Australian Red Cross Society held blood products were goods under the Trade Practices Act 1974 and R v Kelly and Lindsay upheld the conviction of theft of body parts. However, in both these cases the tissue itself was not considered property. It is only when a person applies lawful skill to a human body, or part thereof – and it acquires usefulness which distinguishes it from that tissue – that that person therefore acquires a right to retain possession of it.
As exemplified by Moore v Regents of University of California, defendant researchers will not be liable for conversion of property if human tissue is used to subsequently create highly profitable cell lines. A broadly similar line of reasoning is also applied in the patenting of human DNA. For example, the High Court unanimously found in D’Arcy v Myriad Genetics that isolated DNA in itself is not an invention, and thus cannot be patented.
Aside from the legal context, there are also policy justifications for not allowing access and benefit-sharing agreements for donors of genetic material. For example, there are concerns about the exploitation of vulnerable people and that allowing compensation for human tissue and DNA would stifle research.
The Trustee/Beneficiary Model
While the property framework is persuasive, it is not determinative. The following are examples of, essentially, a form of trustee-beneficiary relationship. Specifically, biobanks – such as those listed below – collect donor samples from specific populations and become, in effect, a type of trustee of that populations’ genetic data. In this scenario, the biobank is the access provider to human bioresources, which have become valuable due to the volume and organization of data collected by that biobank. The beneficiaries in this scenario are the sample populations from whom these samples are taken.
The Human Genome Organization (HUGO) adopted a statement on access and benefit-sharing agreements regarding genetic research. Broadly, this statement argued that: there is an emerging position at international law that groups participating in research should, at minimum, receive some benefit, which could be financial.
The Human Genome Diversity Project (HGDP) provides a good example of this type of model. If commercial products are developed as a result of HGDP’s collection its guidelines require that “a fair share of the financial rewards shall be returned to sample populations”. PXE International provides proof of concept. PXE International collected blood samples and DNA from more than 2,000 people with Pseudoxanthoma Elasticum. It then provided researchers access to these samples under the condition that terms be agreed to regarding subsequent intellectual property and profits made using those samples. Inclusion of such terms did not appear to deter researchers, as more than 17 laboratories agreed to PXE International’s terms.
A more recent example might include DNAsimple, a startup that – while not doing any sequencing itself – works as a matchmaker between volunteers and researchers. DNAsimple provides anonymity for participants and useful information to scientists. DNAsimple then shares a portion of its fee among each of its volunteers.
It could turn out that financially compensating volunteers isn’t necessary. For example, DNA.Land asks people who have already gotten DNA readouts from 23andMe, Family Tree DNA, or Ancestry.com to donate their genetic data. More than 6,000 people have joined, answering questions about who in their family has had breast cancer, and what the result has been — making it possible to find new connections between genes and this cancer.
Such projects are not counting on generosity alone to pull people in. The DNA.Land team runs an additional analysis on the volunteers’ data to give them new information about ancestry, link up relatives who have been sequenced by different companies, and let people see how traits like their actual height or intelligence compare to what the genetic analysis predicts. The type of access and benefit-sharing agreement could vary beyond this as well. For example, perhaps a requirement that a portion of profits gained from patenting a highly profitable cell line – developed using a biobank’s data – be used to fund less profitable, but equally as valuable lines of research.
The access and benefit-sharing agreement model for human donors of genetic material – already occurring in a limited commercial context – appears legally justifiable. The shift toward benefit-sharing (whether direct financial or direct informational services) presents a wider acknowledgement of the value of bioresources. Ideally, these models might continue to evolve and become more common and socially responsive, able to ensure relevant identifiable communities are benefited in a more structured and organised manner.
REFERENCES & FURTHER READING
Gary Marchant ‘Property Rights and Benefit-Sharing for DNA Donors?’ (2005) 45(2) Jurimetrics Journal of Law, Science and Technology, 153.
Jane Carpenter and Christine Clarke, ‘Biobanking sustainability-experiences of the Australian breast cancer tissue bank (ABCTB)’ (2014) 12(6) Biopreservation and Biobanking 395.
Janna Rose, ‘Biopiracy: when indigenous knowledge is patented for profit’, The Conversation (online), 18 March 2016 < https://theconversation.com/biopiracy-when-indigenous-knowledge-is-patented-for-profit-55589>.
Tae Kim, ‘Goldman Sachs asks in biotech research report: ‘Is curing patients a sustainable business model?’, CNBC (online), 17 April 2018 < https://www.cnbc.com/2018/04/11/goldman-asks-is-curing-patients-a-sustainable-business-model.html>.
K McGowan, ‘Get paid for your DNA’, Neo.Life (online), 20 April 2018 <https://medium.com/neodotlife/dna-wants-to-be-free-d2dd205667f9>.
Jubliee Purkayastha (ed), Bioprospecting of Indigenous Bioresources of North-East India (Springer, 2016)
PQ v Australian Red Cross Society and Others  1 VR 19.
R v Kelly and Lindsay  3 All ER 741.
Moore v Regents of the University of California 51 Cal. 3d 120.
D’Arcy v Myriad Genetics  HCA 35.
Environmental Protection and Biodiversity Conservation Act 1990 (Cth)
Environmental Protection and Biodiversity Conservation Regulations 2000 (Cth)
United Nations Convention of Biological Diversity
Image: Mario Tama