Science & Biotechnology Law & Lawyers

Science & Biotechnology Law & Lawyers News

News, updates and further information - Science, Biotechnology & Gene Technology Law & Lawyers

Throughout 1999 and 2000 the State, Territory and Australian governments worked together with interested parties to develop the Gene Technology Act 2000.

The Act was passed by the Australian Government in December 2000 and took effect on 21 June 2001. It is the Australian Government's component of a national scheme for the regulation of genetically modified organisms (GMOs). It includes legislation in every Australian State and Territory.

The objective of the Act is to protect the health and safety of people and to protect the environment by identifying risks posed by or as a result of gene technology and by managing those risks. It does this by creating laws for certain dealings (or activities) with GMOs.

While most GM products are regulated by agencies such as the Therapeutic Goods Administration (TGA), Food Standards Australia New Zealand (FSANZ) and the Australian Pesticides and Veterinary Medicines Authority (APVMA), GM products which were not already covered by an exisiting national regulation scheme are now regulated by the Gene Technology Regulator under the legislation.

Details about the regulatory framework for gene technology in Australia, including information on the Act, Regulations and the Gene Technology Ministerial Council, which oversees the operation of the national regulatory scheme for gene technology, can be found at the Office of the Gene Technology Regulator (OGTR).

A scientific, ethical and precautionary approach. The Act establishes three key advisory groups to provide advice, on request, to the Gene Technology Regulator and the Gene Technology Ministerial Council:

•the Gene Technology Technical Advisory Committee (GTTAC) provides advice on scientific and technical matters
•the Gene Technology Ethics Committee (GTEC) provides advice on ethical matters
•the Gene Technology Community Consultative Committee (GTCCC) provides advice on community issues regarding gene technology.
More information on the roles and memberships of these committees can be found at:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/committees-index-1
Section 4 requires that the object of the Act is to be achieved through a regulatory framework which:

(aa) provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation

(a) provides an efficient and effective system for the application of gene technologies

(b) operates in conjunction with other Commonwealth and State regulatory schemes.

Section 4(aa) outlines a ‘precautionary approach’. This means that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation. However, the legislation also requires that the object of the Act is achieved by balancing a precautionary approach with the other two, equally important, provisions of efficiency/effectiveness and co-regulation.

A precautionary principle is, therefore, one of three 'pillars' in a regulatory framework for gene technology that seeks to protect human health and safety and the environment.

International arrangements

Working in international forums is one way Australia can encourage other countries to take up comprehensive arrangements to ensure the protection of people and the environment in the development of gene technology.

We need to ensure Australians and other nations act responsibly when exporting or transporting genetic material internationally. Likewise, we need to ensure that people importing or transporting genetic material across Australian boundaries act appropriately.

Convention on Biological Diversity

Australia is signatory to the Convention on Biological Diversity (CBD) and a member of the Intergovernmental Committee on the Cartagena Protocol on Biosafety (see http://www.dfat/gov.au/environment/bsp). In response to the CBD, an international biosafety protocol was negotiated and came into force on 11 September 2003. The protocol governs the ‘transboundary movement’ (i.e. movement across international borders) of living modified organisms resulting from modern biotechnology, which may have an adverse effect on the conservation and sustainable use of biodiversity.

You can find evidence about the safety of genetically modified products by examining the different regulatory arrangements around the world and the outcomes of other countries' research. While many countries are developing or have just established arrangements for regulating GMOs, some countries rely on self-regulation by industry and scientists. The Australian arrangements under the Gene Technology Act 2000 set an international benchmark for managing the risks associated with GMOs.

Further resources - Science & Biotechnology Law

Biotechnology
Bioethics Portal
This site has been established to increase the awareness of bioethics and improve the Australian public's access to information about bioethics. It acts as an information portal to bioethics and biotechnology-related information in all State and Territory Governments and the Australian Government.
http://www.bioethics.gov.au/

Biotechnology Online
The Biotechnology Online Secondary School Resource provides balanced and factual information about biotechnology. It has been designed to fit with Australian State and Territory Science curriculums, with cross-over into Studies of Society and the Environment to allow for broader discussion of issues.
http://www.biotechnologyonline.gov.au/

CSIRO Gene Technology
Gene technology is a powerful tool that sits within the broader area of biotechnology - the use of living things to make or change products.
http://www.csiro.au/science/Biotechnology.html

Ethics of biotechnology

Ethics are the rules or standards that govern the way people behave and their decisions on the 'right' thing to do. It asks basic questions about what is right and wrong, how we should act towards others and what we should do in specific situations.

It is important to note that ethics relating to biotechnology and its applications are not fundamentally different from other situations. Ethics are practiced by everyone, every day.

One common feature of ethics is that different people with different values often disagree on the ‘right thing’ for individuals and society. One reason for this disagreement is that one thing may benefit some people but not others.

An example is embryonic stem cell research. Some people see this as having great potential to develop cures for diseases. But, others object because it involves the destruction of human embryos that have the potential to become a human being.

There is no clear right or wrong position in ethics. A person’s individual experience and view of the world often guides the way they make ethical choices.

For instance, someone who has a strong environmental outlook might see the use of genetically modified (GM) crops as unnatural. But, someone who has a strong scientific-based view of the world might see the use of GM crops as a natural extension of traditional crop breeding technologies.

Commercial outcomes and ethics

Many new technologies raise ethical concerns that might not be part of the world view held by those who develop the technologies in the first place.

When it comes to developing products for commercial use, the goal is usually to increase sales and increase profits for shareholders. The decision for developing products can be seen as good for industry development, but perhaps not as good for individuals who do not have products developed to suit their needs when there is not enough company profit to be made.

Also, in some areas of biotechnology development, the money needed to fund research projects is out of the range of individuals or small groups; it can only be undertaken by multinational or overseas companies. Some perceive this as acceptable, because it helps local researchers form links with wealthy larger companies. But others do not think it is not acceptable, because local research and development leave the community and are then controlled by international corporations.

Many people believe that biotechnology products and applications should respond to and fulfil community needs. For example, some products may be of obvious social benefit (such as a drug that treats cancer), while others may be created by a business for attractive advertising and skilful marketing (for example, unusual-coloured flowers for the floral industry, or fluorescent fish for the pet industry).

In a world with decreasing resources, where many people go hungry, is spending research dollars on developing a fluorescent fish acceptable or not? Your answer will differ depending on your world view. The ‘right thing’ for one person may not be right for others. It can be very difficult to balance these conflicting views.

There are particular ethical positions that are commonly shared. One of these is the view that all biotechnology products must be safe for humans and the environment. This is why Australia has developed a sound regulatory system. But, other ethical positions are diverse, such as an individual’s rights to do what they want with their body.

Legislation
Australia
Gene Technology Act 2000 (CTH)
An Act to regulate activities involving gene technology.

Prohibition of Human Cloning Act 2002 (CTH)
An Act to prohibit human cloning and other unacceptable practices associated with reproductive technology.

Research Involving Human Embryos Act 2002 (CTH)
An Act to regulate certain activities involving the use of human embryos.

Commonwealth
Gene Technology Regulations 2001 (Cth)
Regulations relating to genetically modified organisms

Plant Breeder's Rights Act 1994
An Act to provide for the granting of proprietary rights to breeders of certain new varieties of plants and fungi, to repeal the Plant Variety Rights Act 1987, and for related purposes.

Plant Breeder's Rights Regulations 1994
Regulations to provide for the granting of proprietary rights to breeders of certain new varieties of plants and fungi, to repeal the Plant Variety Rights Act 1987, and for related purposes.

Research Involving Human Embryos Regulations 2003 (Cth)
Regulations made under the Research Involving Human Embryos Act 2002 (Cth).

Australian Capital Territory
Gene Technology Act 2003 (ACT)
An Act to regulate activities involving gene technology, and for related purposes.

Gene Technology Regulations 2004 (ACT)
Regulations relating to genetically modified organisms, made under the Gene Technology Act 2003.

Human Cloning and Embryo Research Act 2004 (ACT)
An Act to prohibit human cloning and other unacceptable practices associated with reproductive technology and to regulate certain activities involving the use of human embryos.

New South Wales
Gene Technology (GM Crop Moratorium) Act 2003 (NSW)
An Act to enable a moratorium to be imposed on the cultivation of certain genetically modified plants.

Gene Technology (New South Wales) Act 2003 (NSW)
An Act to apply the Gene Technology Act 2000 and the Gene Technology (Licence Charges) Act 2000 of the Commonwealth as a law of this State.

Human Cloning and Other Prohibited Practices Act 2003 (NSW)
An Act to adopt in this State a uniform Australian approach to the prohibition of human cloning and certain other practices associated with reproductive technology.

Research Involving Human Embryos (New South Wales) Act 2003 (NSW)
An Act to apply the Research Involving Human Embryos Act 2002 of the Commonwealth as a law of this State.

Queensland
Gene Technology Act 2001 (Qld)
An Act to provide for regulating activities involving gene technology.

Gene Technology Regulation 2002 (Qld)
Regulation made under the Gene Technology Act 2001.

Research Involving Human Embryos and Prohibition of Human Cloning Act 2003 (Qld)
An Act to regulate certain activities involving the use of human embryos, to prohibit human cloning and other unacceptable practices associated with reproductive technology, and for related purposes.

Research Involving Human Embryos and Prohibition of Human Cloning Regulation 2003 (Qld)
A regulation made under the Research Involving Human Embryos and Prohibition of Human Cloning Act 2003.

South Australia
Gene Technology Act 2001 (SA)
An Act to regulate activities involving gene technology; to make a related amendment to the Agricultural and Veterinary Chemicals (South Australia) Act 1994.

Gene Technology Regulations 2002 (SA)
Regulations made under the Gene Technology Act 2001

Genetically Modified Crops Management (Designation of Areas) Regulations 2004 (SA)
Regulations made under the Genetically Modified Crops Management Act 2004 (SA).

Genetically Modified Crops Management Act 2004 (SA)
An Act to provide for the designation of areas of the State for the purposes of preserving for marketing purposes the identity of certain food crops according to whether they are genetically modified crops or non-genetically modified crops; to provide for the segregation of ...

Prohibition of Human Cloning Act 2003 (SA)
An Act to prohibit human cloning and other unacceptable practices associated with reproductive technology and for other purposes.

Prohibition of Human Cloning Regulations 2003 (SA)
Regulations made under the Prohibition of Human Cloning Act 2003, specifically in relation to applications for warrants, and compensation for damage.

Research Involving Human Embryos Act 2003 (SA)
An Act to regulate certain activities involving the use of human embryos and other related activities; to amend the Reproductive Technology Act 1988; and for other purposes.

Research Involving Human Embryos Regulations 2003 (SA)
Regulations made under the Research Involving Human Embryos Act 2003, and specifically in relation to: prohibited and regulated practices, applications for warrants, compensation for damage, collection and provision of information, and provision of research protocols.

Tasmania
Gene Technology Act 2001 (TAS)
The purpose of this Act is to regulate activities involving gene technology. The object of this Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks ...

Gene Technology Regulations 2003 (TAS)
Regulations made under the Gene Technology Act 2001.

Human Cloning and Other Prohibited Practices Act 2003 (TAS)
The object of this Act is to adopt in Tasmania a uniform Australian approach to the prohibition of human cloning and certain other practices associated with reproductive technology.

Victoria
Control of Genetically Modified Crops Act 2004 (VIC)
The purposes of this Act are (a) to provide for the making of orders that designate areas of the State for the purpose of preserving the identity of GM crops or non-GM crops for marketing purposes; and (ii) prohibit or restrict the cultivation of GM crops, or other dealings ...

Gene Technology Act 2001 (Vic)
An Act to regulate activities involving gene technology.

Gene Technology Regulations 2001 (Vic)
Regulations to prescribe those matters that are required, permitted, necessary or convenient to be prescribed for the implementation of the Gene Technology Act 2001

Western Australia
Genetically Modified Crops Free Areas Act 2003 (WA)
An Act to prohibit the cultivation of certain genetically modified crops in designated areas of the State and to provide for their destruction in certain cases.

Organisations
Australia
Multi-jurisdictional
Centre for Law & Genetics
The aim of the Centre is to provide excellence in research into the legal and ethical issues associated with developments in genetic technology. The Centre is based at the Schools of Law at the Universities of Melbourne and Tasmania.

Organisations - Government
Australia
Plant Breeder's Rights Office
The official Australian site for Plant Breeder's Rights (PBR).Varieties protected by PBR may only be produced for sale, sold, imported, exported or conditioned with the authority of the owner. Site has a PBR Database search and access to the Plant Varieties Journal.

Commonwealth
Biotechnology Australia
Biotechnology Australia is a collaboration of five Commonwealth Government departments. It was created to assist in co-ordinating the Government's approach to biotechnology. This organisation seeks to provide balanced and factual information on biotechnology to the ...

Office of the Gene Technology Regulator
The Office of the Gene Technology Regulator has been established within the Commonwealth Department of Health and Ageing to provide administrative support to the Gene Technology Regulator in the performance of her functions under the Gene Technology Act 2000.

Publications
Australia
Commonwealth
Essentially Yours: The Protection of Human Genetic Information in Australia (ALRC 96)
This ALRC Report represents the culmination of a major, two-year inquiry by the Australian Law Reform Commission (ALRC) and the Australian Health Ethics Committee (AHEC) of the National Health and Medical Research Council (NHMRC). It covers an extensive range of activities ...

Handbook on the Regulation of Gene Technology in Australia
The Handbook on the Regulation of Gene Technology in Australia has been developed as a resource for organisations that conduct work with GMOs. It will assist organisations to understand and comply with the requirements of the new regulatory system for GMOs. It includes ...

Human Cloning: Scientific, Ethical and Regulatory Aspects of Human Cloning and Stem Cell Research.
The Australian House of Representatives Legal and Constitutional Affairs Committee was asked in 1999 to review the report of the Australian Health Ethics Committee on Human Cloning. This report examines the complex issues surrounding human cloning and stem cell research. The ...

Intellectual Property Rights over Genetic Materials and Genetic and Related Technologies
The Terms of Reference for this Issue Paper, require the ALRC to examine the impact of patent laws and practices, as they relate to genes and genetic and related technologies. The examination of this impact will be done in three contexts: the conduct of research and its ...

Liability Issues Associated with GM Crops in Australia
This paper is a scoping paper on the potential legal risks associated with the commercial release of genetically modified (GM) crops in Australia and possible risk minimisation strategies. The paper focuses on liability for economic loss arising from the unintended presence ...

Multi-jurisdictional
Biotech Bulletin
A regular bulletin on current biotechnology law issues. There is a link to the pdf version of the latest issue of the Bulletin on this webpage.

Biotech News
AAR Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.There is a link to the html version of the latest issues on this webpage.

European Union
European Directive on the Legal Protection of Biotechnological Inventions: Scope, Status and Controversies in a Nutshell
This article examines the extent to which the objections levelled at the European Union Council's 1998 Directive on the 'legal protection of biotechnological inventions' can be justified. The author first describes what the main provisions and goals of the Directive are, and ...

International
Access to Biological Resources: Domestic and International Developments and Issues
The author of this article follows the controversy which began on 14 February 1998 when two Australian agricultural agencies were alleged to have committed biopiracy. The agencies had apparently applied for Plant Breeder's Rights under the Australian Plant Breeder's Rights ...

Intellectual property & Biotechnology: A Training Handbook
This handbook is designed to provide a practical introduction to the nature and management of intellectual property rights in relation to biotechnology. It is intended to contribute material for use in training courses, to assist in raising awareness of some of the complex ...

Treaties and Conventions
International
Convention on Biological Diversity
The objectives of this Convention are, the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources ...

If you need legal advice regarding Science, Biotechnology & Gene Technology Law, then please complete your free legal enquiry form on the right, and we will put you in touch with a Science, Biotechnology & Gene Technology Law lawyer nearest you, who can help you with Science, Biotechnology & Gene Technology Law.

Our free legal enquiry service for Science, Biotechnology & Gene Technology Law extends to all suburbs throughout Australia.

These news come from