A Public Resource Compiled by the

New Zealand: Therapeutic / Stem Cell

Print Friendly, PDF & Email
New Zealand Flag

Highly Regulated

Gene therapies for certain diseases permitted in New Zealand, but highly regulated.

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

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which human / health products and processes are approved or in development and their regulatory status.

European Union

Brazil

New Zealand

United States

Australia

Canada

China

United Kingdom

Israel

Argentina

Japan

Mexico

Russia

Chile

Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Central America

Colombia

Norway

Ecuador

Human / Health Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Gene and stem cell therapies regulated with minimal restrictions and requirements.
*Determined: No Unique Regulations: Gene and stem cell therapies regulated as phamaceuticals with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene and stem cell therapies that would not require unique regulations beyond current restrictions on pharmaceuticals.

Therapeutic:
Gene editing of adult human cells, including gene therapy and stem cell therapy, that is used to treat and cure disease. Recent breakthroughs include CAR T-cell therapy, which uses patients’ own immune cells to treat their cancer.
Germline:
Gene editing of the human embryo or germline that results in genetic changes that are passed down to the next generation. This type of gene editing is the most controversial because changes are inherited and because it could theoretically be used to create “designer babies”. A Chinese scientist announced in 2018 that he had successfully edited twins that were brought to term. International backlash from the announcement has resulted in China and other countries working to clarify regulations on germline gene editing.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionTherapeuticGermlineHuman Rating
Japan888
Brazil402
Canada402
Russia1057.5
Argentina513
Israel825
Australia402
China846
US402
Chile412.5
New Zealand402
Ukraine1057.5
Central America111
Paraguay111
Uruguay111
India402
UK444
Mexico804
EU402
Share via

Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

Send this to a friend