Promoting biotechnology innovation in New Zealand

Having just returned from two conferences in New Zealand during March, I could not help but be caught up in the optimism in New Zealand surrounding the proposed reforms to the country’s genetic modification (GM) and genetic engineering (GE) regulations. This is long overdue.

In contrast to Australia, New Zealand was one of the few countries in the world where genome-edited crops and meat products are regulated as genetically modified organisms (GMOs). Genetic modification is governed by The Hazardous Substances and New Organisms (HSNO) Act 1996 which regulates research into and release of all living things that do not already exist in New Zealand, including those that are genetically modified. Therefore, in New Zealand you cannot import, develop, field test, or release a genetically modified organism without approval from the Environmental Risk Management Authority (ERMA).

Even though New Zealand relies heavily on agriculture, the practical effect of the HSNO Act is that no genetically modified crops are grown commercially in New Zealand, including fruit, vegetables as well as meat.

The current regulatory framework has also impacted the biotechnology industry in New Zealand. New Zealand’s current rigid regulatory framework has stifled innovation in research and commercialization domestically. Although gene technology has been used in laboratories in New Zealand for many years, the ‘restrictive rules which were put in place in 2003 have made research outside of the laboratory all but impossible’ (to quote Minister Judith Collins). This has resulted in companies such as Lanzatech (which utilizes a unique microbial gas fermentation process to produce chemicals) needing to relocate offshore to be able to exploit their research.

Fortunately, the recently elected New Zealand government proposes to overhaul current restrictions on the use of genetic technologies in New Zealand and establish a dedicated regulator within the Ministry of Business, Innovation and Employment. The ‘Harnessing Biotech Plan’ proposes to:

• End the effective ban on gene editing (GE) and genetic modification in New Zealand

• Create a dedicated regulator to ensure safe and ethical use of biotechnology

• Streamline approvals for trials and use of non-GE/GM biotech in line with other OECD countries.

The regulator is yet to be appointed and the mechanics of how it will work in practice is yet to be worked out. This change, which is expected to come into effect in 2025, should stimulate research and development into GM and GE biotechnology in New Zealand.

Gene therapy in New Zealand

New Zealand does not permit patentability of an invention which relates to a method of treatment of human beings by surgery or therapy. Although genetically modified human germ line cells are not patentable, genetically modified somatic cells are patentable as are gene therapy methods when the claims are presented in the so-called Swiss-style second medical use format (e.g. Use of X in the manufacture of a medicament for treating disease Y).

With respect to regulation of this technology, gene therapy is 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 is regulated under the Medicines Act and every gene therapy must be approved by the Gene Technology Advisory Committee (GTAC).

Examples of gene therapy research being conducted in New Zealand include:

• A first in human clinical trial of CRISPR-Cas9 gene editing therapy in hereditary angioedema patients, stemming from research at the University of Auckland; and

• A phase I clinical trial of autologous CAR-T therapy resulting in safer and superior treatment outcomes in patients with CD19 expressing lymphomas, stemming from research led by the Malaghan Institute.

The freedom to exploit gene therapy without fetter in New Zealand will be viewed as a welcome development by the biotechnology industry in New Zealand.