Feature
Queensland's biotechnology Code - a legal and regulatory 'bible'?
The Queensland Government has taken positive steps to increase public awareness of biotechnology and the standards expected of organisations operating in this industry in Queensland by introducing the Code of Ethical Practice for Biotechnology in Queensland (the Code) effective 1 September this year.
Registration under the Code has both mandatory and voluntary components. It is hoped that widespread registration of organisations within the industry will enhance public confidence in the regulation of biotechnology as registration requires organisations to comply with a wide range of legal, safety and ethical undertakings. It is proposed that the Code will be redrafted every 3 years to take into account any changes made to the regulatory landscape, and to accommodate for changes in public opinion and concerns.
A first for Australia
To date no similar comprehensive Code or Guideline for the biotech industry has been introduced in any other State or Territory. The Code represents a fresh and innovative alternative to mandatory legislation and guidelines imposed by Government. Obligations undertaken by organisations subscribing to the Code include the provision of information and annual reporting to Government with a view to opening the industry up to public scrutiny and encouraging the participation of organisations in ongoing development of biotechnology within the State. If the Code is successful in these respects it is likely that other States will introduce comparable initiatives to assist their State (and Australia as a whole) in improving the biotech industry en masse and attracting foreign investment and activity.
To whom does the Code apply?
Automatically-registered Queensland Biotechnology Organisations include Queensland Government Agencies and organisations funded by the State which undertake or conduct biotechnology activities and co-operative research centres (CRCs) funded by the State or which have the State as a participating member. These organisations are listed in a publicly available Register alongside the voluntarily-registered Subscribing Biotechnology Organisations. The Queensland Government expects all organisations undertaking biotechnology activities in Queensland to register under the Code as a gesture of goodwill and a vote of confidence in the Code as a "best practice" model.
Breaches of the Code
The Queensland Government has made it clear that the primary means of enforcing the Code's principles will be through application of existing and forthcoming legislation in specialist areas including gene technology, human cloning, food safety and biological resources. In many cases the legislation will establish heavy penalties for non-compliance. Additionally, for Queensland Biotechnology Organisations, including interstate or federal organisations or CRCs, a failure to comply with the Code will result in the Queensland Government reviewing its funding and/or participation in the activity undertaken.
As the Code is not "law", its aim is not to provide the State with additional regulatory powers but to increase awareness of both the major day-to-day issues relevant to biotechnology practices and the more discreet issues to which those working in the industry may not have been aware or to which they might not otherwise have turned their minds.
Aspects of the Code
The Code has three main aspects:
- Scope;
- Principles; and
- Specific Industries - Medical Research & Healthcare, Agriculture, Food, and the Environment.
There is no doubt that the Code is intended to apply to all aspects of biotechnology. The Scope seeks to reconcile the traditional areas of biotechnology with the new and emerging technologies such as gene mapping, DNA sequencing, diagnostics, genetic modification and cloning. The Code recognises that these new technologies provide [a] greater understanding of, and potentially more control over, living processes at the level of individual cells and genes. These new techniques offer a range of new and practical applications...[however] they are raising important issues of safety and ethics which are the subject of this Code.
The Principles outlined in the Code are both general and specific. The General Principles describe the fundamental values which it is hoped organisations currently have or aim to adopt. Included in these principles are new ideals such as recognition of community interests and transparency in decision-making. Specific Principles cover issues ranging from commercial considerations such as IP management, risk assessment and access to the State's biodiverse resources, to the care and protection of staff and animals, research into GMOs and international obligations.
Issues relevant to Specific Industries are also considered. For example, Medical Research & Healthcare deals with topical ethical issues such as patient confidentiality, genetic testing, cloning and xenotransplantation. On the other hand, Agriculture, Food and the Environment covers issues such as biodiversity and sustainable agriculture, genetic modification in animals and the labelling of GM foods. Further amendments to the Code will no doubt expand on these areas.
For further information please contact Alex Feltham on +61 7 3334 3327.