Proven Approaches to Accelerate Pharma Drug Development
Both within Australia and internationally, concerns exist about the potential risks that gene technology may pose people and/or the environment. Consequently, there is a risk-based approach taken by legislators regarding the use of gene technology. Although genetically modified plants, seeds and animals are more commonly thought of when GMOs are mentioned, the technology is increasingly being applied to therapeutics.
What is gene technology?
Gene technology, as defined by the Gene Technology Act 2000 (GT Act), is any technique for the modification of genes or other genetic material and embraces a wide range of potential applications including medical and vaccine research, diagnosis and treatment of disease, environmental remediation, and the modification of plants and animals to incorporate new growth and compositional characteristics.
How is gene technology regulated in Australia?
In Australia, the Gene Technology Regulator (GTR) is responsible for protecting the health and safety of people and the environment by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs) consistent with the object of GT Act.
The GTR is an independent statutory office holder who, with the support of the Office of the Gene Technology Regulator (OGTR), is responsible for administering the GT Act and corresponding state and territory laws. All Australian jurisdictions contributed to developing the regulatory scheme and legislation to ensure national consistency.
A GMO (as defined by the GT Act) is:
- An organism that has been modified by gene technology; or
- An organism that has inherited traits from an organism, where the traits occurred in the initial organism because of gene technology.
Activities undertaken with GMOs are known in the gene technology legislation as ‘dealings’. Dealings with GMOs include conducting experiments with, making, developing, producing, breeding, propagating, growing, importing, transporting or disposing of GMOs. All dealings with GMOs are prohibited unless explicitly authorised under the GT Act.
The GTR accredits organisations to conduct work with GMOs, certifies containment facilities used for dealings conducted under the Act, and conducts monitoring and compliance activities and maintains a publicly accessible record of all dealings in Australia that involve GMOs (the GMO Record).
Who can apply for a licence to deal with GMOs?
The GT Act does not restrict who can apply for a licence, however in considering licence applications the Regulator must consider applicant suitability. Licence holders assume certain responsibilities and legal obligations as set out by the GT Act and the Regulator. Licences are usually issued to organisations operating in Australia, such as universities, hospitals or companies. Generally, licence conditions also require the licence holder to be accredited under the GT Act. If an organisation is not already accredited, it is possible to submit an application for accreditation at the same time as an application for a GMO licence.
What are GMO Medicines?
Medicines produced by genetic manipulation can be divided into two broad categories:
• Medicines derived or produced from GMOs (biological medicines).
• GMOs that are intended for use as medicinal agents (GMO medicines)
GMO medicines may include:
• live attenuated vaccines (viral or bacterial)
• viral vectors
• modified somatic cells
Sponsors that are intending to submit applications to the TGA for a GMO as a medicine or biological medicine (including use in a clinical trial) need to consult the OGTR to determine any obligations under the GT act. For medicines that contain or consist of GMOs or are manufactured in Australia and are derived from GMOs an approval/licence from the OGTR is required before the medicine can be used.
Genetically Modified Organisms vs Genetically Modified Products
Genetically modified (GM) products are products that are derived or produced from a GMO but which are not alive. Provided the therapeutic product does not contain viable GMOs, it is considered a GM product and is not covered by the GT Act. For example, a purified protein derived from a genetically modified bacteria is a GM Product and not covered by the GT Act, however, the bacteria responsible for producing the protein would be subject to the gene technology legislation for dealings undertaken in Australia.
The GTR does not directly regulate the use of GM products in Australia because the use of these products is usually overseen by other regulatory agencies in a number of situations. For example, while the Therapeutic Goods Administration oversees the use of GM products as human therapeutics. This arrangement avoids duplication of regulatory oversight.
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