Animal biopharming in New Zealand: drivers, scenarios and practical implications

Abstract

The research presented here is premised on the assumption that in order to evaluate the risks and benefits, the desirability and ethics of a technology, we must know how it is likely to interact with its context. The research aims to identify the contexts relevant to the implementation of biopharming in New Zealand and to investigate whether and how the associated risks can be managed. It does this by eliciting relevant knowledge from people with experience and expertise in the identified contexts. Animal biopharming is defined here as the farming of transgenic animals genetically modified to produce pharmaceutical compounds for use in humans. Plant biopharming is also under development. Biopharming is one of several methods that can be used to produce the class of drugs known as biopharmaceuticals. Animal biopharming research and development have focused primarily on dairy species. The major drivers internationally for the development of animal biopharming are its potential to lower the costs of drug production, the greater ease of upscaling and downscaling production, an anticipated shortage of manufacturing capacity using other production methods, the potential to address some of the limitations of other production methods, and the desire to strengthen or evade patent restrictions. In New Zealand, major drivers include New Zealand’s animal-health status, the strength of its dairy research and farm management, and a desire to use biopharming as a tool to move the economy away from commodity production and to enhance economic competitiveness. Biopharming research and development in New Zealand is currently focused on dairy cows. Significant uncertainties remain regarding the potential benefits and hazards of biopharming. These include: cost-effectiveness in relation to competing platforms, unresolved technical problems, patent and regulatory issues, potential risks to human health, issues of gene spread, and animal-welfare concerns. Factors to be considered when assessing the prospects, including the risks and benefits, of biopharming in New Zealand should include the nature of the biopharming enterprise (e.g., animals used, activities encompassed, and operational and ownership structure) as well as the risk management measures likely to be applied. Four scenarios have been developed for assessment based on these factors. Factors relevant to risk assessment and management of biopharming emerging from the research encompass implications of the farm context for risk management as well as impacts of risk management on farm practice. The former include: impact of ownership structure, social and economic influences on implementation of controls, labour market, and the role of human error. The latter include: grazing practices, disposal of carcasses and waste, farm location, movements on and off the farm, and future land use. Application of the research findings to the scenarios suggests that there are substantial obstacles in the way of animal biopharming being taken up by dairy farmers in New Zealand. Specialist integrated biopharm operations may not face the same obstacles, but may also not offer the prospective benefits that have driven research on biopharming in New Zealand. Application of the findings to risk assessment and risk management points to a need to include a wider range of knowledge in risk-assessment processes and to consider a wider range of factors in assessing risks and benefits and in developing risk management protocols.