Biotechnology Research Roadmap - Science and Innovation

4.2 The biotechnology regulatory environment
The way that biotechnology is regulated in New
Zealand also provides important strategic context.
New Zealand’s biotechnology regulatory system is
generally considered well harmonised with other
leading countries’ processes, particularly in relation
to the regulation of medicines, foods and agricultural
compounds. New Zealand is distinctive, however,
in how it regulates new organisms (which includes
genetically modified organisms), in particular, the
Hazardous Substances and New Organisms
(HSNO) Act.
The HSNO Act does not exclude from formal
approval any types of developments involving
genetically modified organisms (GMOs). Some
countries have exemptions or notification processes
for research involving certain specified types of “low
risk” genetically modified organisms. In addition, the
HSNO Act requires consideration of “cultural, ethical
and spiritual effects” in the risk assessment process. 58
Since the HSNO Act came into force (in 1998), there
have been a range of changes (both legislative and
operational) to improve the efficiency and effectiveness
of the application processes. These include adding a
new type of release approval, removing duplications
in processes between different regulatory processes,
and reducing costs and information requirements
for some types of “low risk” applications. There are,
however, still concerns expressed by some researchers
and biotechnology companies, as well as others, about
the time and costs associated with regulation of new
organisms in New Zealand. Work to address these, and
any other biotechnology regulatory issues, forms the
basis of the Biotechnology Strategy’s regulation work
stream and fall outside of the scope of this Roadmap.
4.3 Primary industry strategy and research priorities
The government’s outcome-focused research
investments relating to existing parts of the economy
are largely driven by research priorities determined by
large industry end-users. In the case of biotechnology
research the end-users are mostly primary industry
bodies. Many of the primary industry sectors invest
in industry-good research through levies collected
through the Commodity Levies Act.
An analysis of primary industry research priority and
strategy documents 59 shows a number of shared
research priorities and relatively clear indications
of which different “player” industries see the
responsibility for research investment lying with (that
is, government R&D investment, public-private coinvestment
or private sector R&D investment).
These end-users can be segmented into the following
indicative industry groupings: the pastoral sector (dairy,
meat and wool, deer); arable; horticultural (includes
fruit and vegetables); forestry; marine; and the food
and beverage industry.
58
A study of the biotechnology regulatory system, commissioned by MoRST, describes some of the strengths and weaknesses of New Zealand’s biotechnology regulatory
system: Biotechnology Regulatory System Baseline Study - http://www.morst.govt.nz/publications/a-z/biotechnology-regulatory-system-baseline-study/
59
Primary sector research strategies prepared for the Foundation for Research, Science and Technology in 2004 were used in this analysis. These are not exhaustive but
give a useful representation of broad primary industry research priorities.
Roadmaps for Science : biotechnology research
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