How Political Interference is Jeopardizing Agriculture Research in Developing Countries
In Canada, the regulatory approval of all new crop varieties is done using science as a basis of comparison. New varieties have to be at least as good as existing varieties in terms of yield, disease resistance, and other agronomic factors. This means that a new variety has to be as good as, or better, to be approved for farmers to plant. Over the past five years, there has been a growing international pressure to move away from a science-based regulatory system to one that includes a host of socio-economic issues as part of the variety approval process.
Biotechnology offers several innovative technologies for developing new plant varieties. In Canada and the United States, it takes 20-30 months for federal regulators to review the information provided by the company or university that submitted the variety registration package. The concern about moving to include socio-economic issues such as consumer acceptance, labelling, ethics and intellectual property rights, for example, is that there are no benchmarks to be compared with. Each such assessment would be subjective, lacking any ability to determine if the situation would be unchanged, better or worse, by approving the new variety.
A 2011 study on the cost and time to secure regulatory approval for a new biotechnology developed crop variety revealed that it takes an average of 268 months (just over 12 years) to receive variety approval at a cost of US$136 million. This is what it would cost a large technology development firm. When these firms consider the investment of $136 million to develop a new variety, on average, they would expect a return on investment (ROI) of 100%. This means that if the firm invested $136 million in developing a new variety, it would expect to receive $136 million in revenue from the sale of variety.
Universities and federal agriculture research centers are no different when it comes to a return on investment. While the ROI percentage that would be expected to be received would be lower, a public research institution still requires an ROI to be able to continue to fund new variety development programs. A 20% ROI would be considered to be an average return for a university of agricultural research center.
Many environmental groups and opponents of agricultural innovations are advocating for the inclusion of socio-economic considerations to be part of the regulatory approval process for new crop varieties. The lack of benchmarks will result in additional time and cost to receive approval for new plant varieties. The concern from this is that in developing countries where national agricultural research centers and universities do most of the research on new plant varieties, this additional cost may be so high that it reduces the ROI below zero, providing no financial return, thus ending the ability to fund further variety development research.
In new research that I will be presenting this week at the Agricultural Bioscience International Conference 2015 in Melbourne, Australia, a two-year delay in regulatory approvals could be enough to end research into the development of new plant varieties in most developing countries. This places an incredible burden on the ability to improve food security in these countries and will have a negative impact on the development of all plant varieties.