Gene editing and genetic engineering techniques

Continuing our series on biotechnology for #Bio2018, this post looks at the development of new gene editing and genetic engineering techniques – a key trend shaping the biotechnology industry.  

New genome editing techniques, such as CRISPR/Cas9, have made editing genomic material cheap, efficient and accessible.  These new techniques have opened up a plethora of opportunities for scientific progress previously considered decades away.  For governments around the world, however, novel genome editing techniques present a regulatory challenge – governments must consider whether frameworks designed for traditional genetic engineering techniques remain suited to address newer techniques like CRISPR/Cas9, zinc finger nucleases (ZFNs) and transcription activator-like effector nucleases (TALENs).

Australia’s current regulatory system for gene technology comprises a patchwork of organisations administering an assortment of national regulations, guidelines and principles.  As shown in the diagram below, this system provides mixed coverage depending on the end-use of the genetically modified material and the development stage of the application. Questions remain however and the application of laws regulating genetically modified organisms (GMOs) and genetically modified foods (GM foods) produced by, or involving, genome editing are uncertain.  For example, are organisms modified by CRISPR/Cas9 ‘genetically modified organisms’ within the meaning of the legislation?  This arguably depends on whether the edit to an organism’s genome introduces new genetic material or simply involves the deletion of a mutation.

The Australian Government is proactively considering these uncertainties and the suitability of existing regulatory systems as they relate to new genome editing techniques.  In particular:

  • Australia’s chief gene technology regulator, the Office of the Gene Technology Regulator (OGTR), has initiated a technical review of genome editing techniques. Submissions on proposed amendments to the Gene Technology Regulations closed in February 2018 and the OGTR is now considering the issues raised in submissions and formulating draft amendments.  More information on the reforms, as well as an exposure draft of the proposed amendments, can be found here.
  • Food Standards Australia New Zealand (FSANZ), the statutory authority responsible for developing food standards in Australia, is evaluating the suitability of the Food Standards Code to appropriately regulate foods derived from new breeding techniques. FSANZ released a consultation paper in February 2018 and a preliminary report will be published in July 2018.  For more on these reforms, you can read about them here.

We will be watching developments in these areas with interest!

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About the Author

James EllsmoreJames is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.View all posts by James Ellsmore