Gene therapy permitted for diseases when the cause is a defect in a single pair of genes or in cancers, and when there is clear evidence that therapy may improve clinical outcomes. Gene therapy regulated under the Medicines Act and every gene therapy must be approved by the Gene Technology Advisory Committee (GTAC).
Products/Research
- Parkinson’s disease: US Food and Drug Administration approved the world’s first clinical trial using a gene therapy approach for Parkinson’s Disease, run by researchers at the University of Auckland.
- Epilepsy: Gene therapy approaches currently being developed by researchers at the University of Auckland.
Regulatory Timeline
2018: The Research Ethics Guidelines define acceptable gene therapy programs for clinical and research use that allows gene therapy for diseases when the cause is a defect in a single pair of genes or in cancers, and when there is clear evidence that therapy may improve clinical outcomes.
2017: Royal Society of New Zealand releases Gene Editing in a Healthcare Context, which considers the social, cultural, legal and economic implications of gene-editing technologies for New Zealand and summarizes the current regulations for human gene editing.
2001: Royal Commission on Genetic Modification established, and issues a report detailing strict regulation of all gene therapies.
1996: The Environmental Protection Authority releases the Hazardous Substances and New Organisms (HSNO) Act 1996, establishing regulations for the creation and release of non-native (including genetically modified) organisms into New Zealand. The Royal Commission on Genetic Modification decided that research involving genetic modification of human cells is also covered by this Act.
1981: The Medicines Act, which regulates all drugs administered to humans, finalized.
NGO Reaction
None
Additional Resources
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of New Zealand’s gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- The Australia New Zealand Clinical Trials Registry includes a list of all clinical trials undertaken in New Zealand.
- Royal Society of New Zealand: Gene Editing: Legal and Regulatory Implications
