This report is not intended as a comprehensive review of biopharming per se.  Rather it
emphasises those aspects addressed by the Constructive Conversations / Kōrero
Whakaaetanga approach, and it specifically addresses the implications of biopharming in
and for New Zealand contexts.
The Constructive Conversations / Kōrero Whakaaetanga research on biopharming
addressed what we see as three common deficiencies in the process of assessing
technologies. First, the projected benefits of developing  or applying a technology are
rarely given the same scrutiny as its potential harms.  Second, there is insufficient
recognition of the importance of context to evaluating the implications of developing and
deploying a technology.  Third, insufficient attention is paid to the kind of detailed
knowledge of context necessary to evaluate  this interaction. This knowledge is often
more experiential than formalised. 
The Constructive Conversations / Kōrero Whakaaetanga approach thus involved
identifying those with experiential expertise  in relevant contexts  and eliciting relevant
knowledge from them.  People who are unfamiliar with the technology in question may
nonetheless have knowledge of context that is highly relevant to assessing that
technology. Such people are rarely part of formal risk assessment processes. The
Constructive Conversations / Kōrero Whakaaetanga approach also involves conversations
among those with diverse formal expertise.  Pathways to harm or benefits are often
“hybrid” in nature; that is, they entail interactions of biophysical and social events.  
Those who see biopharming as beneficial for New Zealand have emphasised returns to
farmers, the composition of exports, and a related transformation of the New Zealand
economy. These benefits depend on the commercial success of biopharming as a drugproduction process, which in turn hinges on whether it will significantly lower the costs
of drug production. Unresolved issues in  relation to cost include: difficulty of
comparison, purification costs, costs of negotiating the “patent thicket”, developments in
competing platforms, and regulatory issues, particularly regarding biosimilars.  
Whether or not farmers will benefit from biopharming depends on a number of factors,
including ownership and management arrangements and relative market power.  With
regard to animal biopharming, our research suggests that the most likely arrangement
would be a self-contained commercial research enterprise producing the transgenic
animals, farming them, and extracting the product.  It is likely that such an enterprise
would require some degree of foreign ownership and unlikely that it would offer
significant benefits to New Zealand farmers.  With regard to plant biopharming, the most
likely arrangement may be local seed producers contracting with a multinational
biotechnology company.  Because the market power of the contracting biotechnology or
pharmaceutical companies is much greater than that of the potential biopharm-crop
growers, benefits to growers  are likely to be limited.  We  have not identified a likely
scenario for biopharming in aquaculture because practitioners were almost unanimously of the opinion that containment was impossible and contamination would seriously
threaten their industry.
Other issues impacting on potential returns to New Zealand include: involvement of lowcost competitors in biopharming, use of  New Zealand-sourced animals in overseas
biopharming enterprises, the current expectations regarding CRI commercialisation of
products, and the challenges of establishing the necessary commercial partnerships. 
Biopharmed drugs avoid some risks of human-derived drugs but entail other risks. These
are related to infection, allergenic responses, immunogenic responses, and autoimmune
reactions.  Risk issues include viral pathogens and prions, unanticipated changes resulting
from transgenesis, and impacts of differences in glycosylation processes. 
Unlike other forms of drug production, biopharming poses the risk of contamination of
the food supply chain.  The potential pathways to food contamination are many and
complex, including both biophysical and social  components.  We review pathways for
plant and animal biopharming, in connection with impacts on human, animal and
ecosystem health.  We also review the potential for economic harm, including damage to
trade and tourism, additional costs to non-biopharm producers, and opportunity costs.
The risk of social and cultural harms is difficult to assess.  Social and cultural impacts
extend beyond economic returns or employment opportunities to include such things as
ability to engage in a valued way of life, community relations, the distribution of harms
and benefits, and the socio-cultural implications of the intensified instrumentalisation of
life forms. Exploring such harms was not the primary focus of much of our research;
however, socio-cultural issues emerged strongly within the research on Māori
assessments of biopharming in aquaculture.  Key issues included: the wider social and
cultural implications of damage to ecosystems, the impacts on cultural practices around
mana moana and kaimoana, and implications of this for self-determination.
Our research findings have implications for  various groups in the governance arena. 
With regard to ERMA, our research raises  questions about whether it is practical to
assume that mandated controls will be consistently implemented.  Relevant elements of
context include: economic (dis)incentives, attitudes of practitioners toward risk, labour
conditions, and the unavoidability of human error.  
Our research on Māori assessments of biopharming in  aquaculture, which led to wider
discussion of Māori involvement in aquaculture more generally, has raised a number of
issues regarding iwi governance as well as national legislation and policy. Despite
policies and legislation that promote Māori involvement in the aquaculture industry, it is
questionable whether hāpū and iwi are able to participate in ways that fulfill their
cultural, environmental, and development aspirations.  The legislative parameters that iwi
operate within, the relationships between iwi and hāpū, and the lived realities of whānau
make Māori involvement in aquaculture development and biopharming fraught.  Of
particular concern is the  potential use of biotechnologies to advance aquaculture
development and the impact (both positive and negative) that such technology may have on hāpū and iwi rights as mana whenua/mana moana to practice and fulfill kaitiakitanga
obligations. 
Biopharming is also of significance for private governance systems, including quality
assurance regimes such as GLOBAL-GAP,  which are important regulators of New
Zealand producers’ access to premium markets. Biopharmed products have the potential
to raise three issues around the emerging necessity to preserve market access for
exporters: biopharmed products themselves will  be required to meet strict standards of
safety and risk management in order to achieve market access;  non-biopharmed products
produced by the same company will face increased scrutiny and risk, and will have to
maintain strict protocols of containment; and most significantly, other companies
exporting products will have to implement measures to ensure that there is no crosscontamination of products in the same ecosystem. If introduced into the arable sector,
biopharming would require reform of the current SCID system. In its current voluntary,
self-regulatory form, the SCID system cannot be relied upon to provide the kind of highquality information that would be needed in order to assess the contamination potential of
a biopharm crop in any particular location.
Biopharming raises issues in connection with the Resource Management Act.  It is
essential that reforms of the RMA not undermine the ability to harness local knowledge
when assessing risks of biopharming operations.  Further, it is important that the question
of whether or not the RMA would protect residents from any potential negative impacts
of a neighbouring biopharm facility be publicly clarified.