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The two main barriers to plant biotechnology are: 1. Regulatory Approval 2. Patent Protection!
Despite the phenomenal scientific progress that has underscored the development of the first generation of plant biotechnology products, significant and serious challenges remain which could delay or even prevent their successful introduction and acceptance in the marketplace.
1. Regulatory Approval:
Field testing and commercial introduction of genetically engineered products come under the statutory jurisdiction of three federal agencies in the USA: the United States Department of Agriculture (USDA), the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA).
In Europe, regulation is based on individual country guidelines, but efforts are progressing to develop a policy on field release to cover the entire European Union (formerly the European Community).
The field testing of genetically engineered crops has proceeded remarkably smoothly; since 1987 there have been thousands of tests of engineered crops in diverse locations across the USA and Europe. These field tests, along with thousands of laboratory experiments, have produced a remarkable degree of consensus internationally that engineered crops present virtually no risk to the environment or to human or animal health. The regulatory emphasis has now shifted from laboratory and field testing to commercialisation approval.
In the USA, progress has been made to develop a coordinated framework between USDA, FDA and EPA for oversight of the commercialisation of engineered crops and food products. Timing is particularly critical since the defining of regulatory approval requirements sets both projected regulatory costs and commercialisation timelines for new products; this is a significant issue for the universities, institutes and companies currently in the process of developing improved genetically engineered crops for introduction in the mid-1990s.
It is essential that regulatory requirements for transgenic plants continue to be based on scientific principles that protect the safety of consumers and the food supply, and recognise the inherent low risk of gene transfer technology and the benefits afforded by genetically engineered crops to growers, food processors and consumers.
International harmonisation of regulatory approval standards is necessary to prevent development of non-tariff trade barriers between countries that could ban shipments of genetically engineered seeds or food products without sound scientific basis. Other imposed political barriers could include labeling and inspection “requirements” that would effectively limit access and distribution of these products.
2. Patent Protection:
Patent protection for genetically-engineered plants is essential to offset the cost of developing crops with significant new traits, and to encourage more overall investment and research in this field. Patent protection provides a broader proprietary right than is currently provided under either the International Convention for the Protection of New Varieties of Plants (UPOV) or the Plant Variety Protection Acts (PVPA) in the USA.
While few dispute that companies that have invested heavily in R&D to isolate, test and commercialise genes are entitled to protection for their inventions, there is considerable debate within the seed industry concerning how much protection is deserved and how patents will impact the cooperative nature of the seed industry itself. Much of this concern results from confusion surrounding the restrictions imposed by patent rights versus the incentive they provide for competitive research and product development which stimulates innovation.
Many of the conciliatory proposals, including patenting of genes (but not plants) as well as compulsory licensing in the event that plant patenting is permitted, if implemented, could significantly reduce the incentive for private industry funding.
Lack of proprietary protection for genetically engineered plants in many countries outside the USA remains a very serious limitation; plant and animal varieties are largely excluded from patent protection by the European countries that signed the 1973 European Patent Convention.
The availability, scope and enforceability of plant patents in other countries, including Japan, China and Eastern European countries, remains questionable; perhaps more than any other issue, proprietary rights protection may limit plant biotechnology R&D and commercialisation in these regions.
In today’s era of global communications, radical groups opposed to technological creativity have demonstrated an increasing ability to influence public and political opinion. As opposed to the more mainstream public interest groups with whom dialogue is possible, these groups exploit the public’s lack of understanding of biotechnology and interweave political, societal and emotional issues (population control, animal rights, religion, concerns over the environment, etc.) for purposes of gaining visibility, credibility, membership, financial support and political presence.
These critics represent various positions across a spectrum of thought; in most cases, they rarely attack science and technology directly, but instead focus on peripheral, but more vulnerable issues, such as food safety, proprietary rights, religious views, etc.
Popular strategies involve reducing the commercial incentive for R&D through actions which delay product introduction and increase commercialisation costs. For example, proposals for mandatory licensing of patented plants are often supported because this would reduce the incentive for companies to invest in the development of proprietary new crops.
By attempting to block critical and needed components of plant biotechnology such as the use of marker genes in plants through political, non-science-based regulation, some of these groups hope to effectively delay commercialisation or create opportunities for eventual trade sanctions.
Similarly, by falsely raising concerns over food safety, they hope to increase regulatory testing costs to prohibitive levels. Others are demanding labeling of foods to discourage consumer purchase and also to facilitate subsequent boycotting activities against particular brands or companies who introduce, distribute or sell these products.
These groups represent a serious threat; they are just as motivated, and often as well-funded, as the companies and organisations who are trying to commercialise plant biotechnology products. Their misrepresentations of issues and concerns are dangerously effective at further confusing a skeptical public and undermining the science-based regulation that is in place to protect the food system.