Challenges in regulating biotechnology

Genevieve Butler, Law and Bills Digest

Key issue 
Rapid developments in biotechnology pose challenges for legislators and courts internationally, as legal systems struggle to keep pace with scientific advances. Key issues include ownership of genes and genetically modified crops, equity of access to treatments, bioprospecting, biopiracy and biosafety.

Biotechnology—the use of biological knowledge and materials for human benefit—has been used for thousands of years in agriculture and medicine. However, recent decades have witnessed revolutionary scientific advances in fields such as genetic modification, use of human biomaterial, and biopharmaceuticals.

Ownership and equitable access

Fundamental to many of the new technologies is the question of ownership of biomaterial. Multinational companies providing seed, agricultural chemicals, food-processing and pharmaceuticals play a major role in biotechnology research, and are keen to see a return on their investments. However, the patent system, which protects ownership rights to new biotechnologies, can also serve to block access for many who could benefit, especially in developing countries.

Genetically modified (GM) seed commercialisation practices have come into conflict with farmers’ customary practices of saving, reusing, sharing and developing plant varieties. The US biotechnology corporation Monsanto aggressively defends its patents, requiring some users of GM canola seeds to purchase new seed every year, with a licensing fee to use the patent rights.

Gene patents have also been at the forefront of public debate, with contentious litigation both domestically and internationally. The key difficulty is the distinction between a ‘product of nature’, an altered product of nature (modified by human inventiveness) and a method of using a product of nature.

The landmark decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics on 13 June 2013 overturned three decades of gene patent awards. The Court ruled that a naturally-occurring DNA segment is a product of nature and cannot be patented simply because it has been isolated. Myriad had originally obtained the patents after discovering the location and sequence of the BRCA1 and BRCA2 genes, mutations of which can increase the risk of breast and ovarian cancer. This enabled Myriad to develop and patent tests for cancer risk, which cost up to US$4,000, precluding many from access.

In a similar lawsuit brought by Cancer Voices Australia in February 2013, Australia’s Federal Court provided the opposite view: that the two genes extracted from natural cells obtained from the human body could be patented. The decision is currently on appeal before the Full Court of the Federal Court.

Bioprospecting and biopiracy

Bioprospecting is the process of finding and commercialising new products, such as medicines and agrichemicals, based on biological resources.

Bioprospecting is particularly significant in Australia due to the country’s diverse biological resources. In 2001, the House of Representatives Standing Committee on Primary Industries and Regional Services inquired into the contribution that bioprospecting may make to the development of new industries, especially in regional Australia.

Part 8A of the Environment Protection and Biodiversity Conservation Regulations 2000 provides a legislative framework for biodiscovery, establishing a legal basis for biological discoveries and providing security for investments in research and development. The regulations apply to biological resources of native species in Commonwealth areas taken for research and development of any genetic resources or biochemical compounds.

Bioprospecting is often based on indigenous knowledge of uses and characteristics of plants and animals. Biopiracy occurs when corporations use traditional knowledge of nature for profit, without acknowledging indigenous intellectual property rights or compensating indigenous peoples. Many patents operate to deny economic compensation to indigenous groups or prevent them from using specific plant materials.

International laws in place to regulate bioprospecting and prevent biopiracy include the Convention on Biological Diversity (1992), to which Australia is a party, and the Nagoya Protocol (2010).

Indigenous communities in Australia have a unique understanding of native plants and their potential uses for medicine, cosmetics and nutrition. The Jarlmadangah Burru Community in the Kimberley has used the bark from the Marjala plant - said to be more powerful than morphine – as a traditional painkiller for generations. When Community Chairman John Watson lost his finger while crocodile hunting and used the Marjala plant for pain relief, the community was prompted to consider the commercial potential of the treatment. They formed a research partnership with Griffith University, resulting in a successful joint patent application.

Biosafety

Biosafety refers to the prevention of large-scale loss of biological integrity, particularly in health, agriculture and ecology. Biosafety in agriculture involves reducing the risks of disease outbreaks, quarantine breaches, genetic engineering and food contamination, while in medicine, biosafety procedures ensure the integrity and suitability of organs or tissues.

In Australia, under the Gene Technology Act 2000, the Office of the Gene Technology Regulator (within the Department of Health) has a mandate to protect people’s health and safety, and the environment, by identifying risks posed by gene technology, and by managing those risks through regulating dealings with genetically modified organisms (GMOs).

GM crops produced in Australia include canola and cotton, but experimental trials of other crops are underway. GM produce can be imported into Australia, provided it meets the usual food safety guidelines. GM crops are banned in Tasmania and South Australia until 2014, when the bans will be reviewed. States that allow GM crops require buffer zones of five to 20 metres, but some critics suggest that buffers need to be at least two to three kilometres.

A case expected to set a national precedent over GM seed contamination in Australia will come before the Western Australian Supreme Court in early 2014. Stephen Marsh, a farmer near Kojonup, south-east of Perth, is suing neighbouring farmer Michael Baxter for loss of income and compensatory damages after harvested seed heads of GM canola allegedly blew onto Marsh’s organic farm in 2010. As a result, Marsh lost his organic certification with the National Association for Sustainable Agriculture Australia, along with export contracts for organic oats and local deals for organic wheat, spelt, seeds and lamb. Monsanto says that while it supports its client, Baxter, it will not join as a party to the court case.

Further reading

R Beckmann and S Scully, Patent Amendment (Human Genes and Biological Materials) Bill 2010 [No.2], Bills digest, 107, 2010–11, Parliamentary Library, Canberra, 2011.

S Harris Rimmer and R Polya, Gene Technology Amendment Bill 2007, Bills digest, 131, 2006–07, Parliamentary Library, Canberra, 2007.

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