Home > Topics > Freedom to Operate and Risk Management > Managing Liability Associated with Genetically Modified Crops > Editor's Summary, Implications and Best Practices

The other chapters in this section on freedom to operate (FTO) and risk management dealt with the legal liabilities of infringing other people’s intellectual property. But liability goes beyond intellectual property and this is the subject of this chapter based on the example of the development of a genetically modified organism (GMOs).

The legal framework for thinking about liability relies upon the borders of the nation-state, but GMOs and crops have the potential to cross such borders. This has led to intense debate about whether or not a liability regime specific to such organisms and crops should be created. Providing an overview of current common law and statutory theories of liability, this chapter considers the liability issues facing public-sector efforts to develop and disseminate agricultural biotechnologies.

Common law applies to countries that were once British territories or colonies. The common law theory of liability encompasses negligence, trespass, nuisance, and strict liability. Statutory law shares a concern with strict liability, but also includes infringement provisions, both of which are crucial for understanding the current global IP system. The adequacy of these legal frameworks for GMOs, however, has been called into question by the European Union among others, which contends that special legal liability regimes are required for GMOs. Germany and Austria have already taken steps in this direction, but some fear that these laws are too extreme and will steer investment away from these technologies. Those who believe that these new technologies have an important part to play in alleviating hunger and suffering in the developing world are concerned that the effect of such special legal liability regimes will be to reduce already limited investments in much-needed innovation.

There are several ways that the production and use of GMOs can raise liability issues. A farmer who damages a neighboring farmer’s crop by failing to take appropriate precautions to contain his transgenic crops may face negligence claims, or else claims of trespass. A claim based on strict liability might be pursued, though the requirement of showing that growing GM crops is “abnormally dangerous” would be very difficult to meet in most countries. Surprisingly, liability issues may also flow the other way. Monsanto, for example, has successfully brought suit against a farmer who replanted seeds contaminated with genetic material from a neighboring farmer growing Monsanto’s Roundup-resistant plants.

While debate rages about liability and redress issues within the Cartagena Protocol on Biosafety, developing countries need to think carefully about how to manage liability today. Referencing the African Agricultural Technology Foundation (AATF), this chapter provides several liability-management tools that can be of great value:

• ensuring compliance with intellectual property, license, and regulatory requirements
• including indemnification provisions in technology transfer agreements
• using warranty disclaimers
• obtaining letters of nonassertion
• adhering to appropriate technology stewardship best practices

The legal, health, and environmental risks of using GMOs should be reduced as far as possible because failing to do so may be extremely costly in terms of lost time and money.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Implement policies and promote legislation that address liability issues related to genetically modified organisms (GMOs) in a rational and objective manner. Of course, risks should be ascertained and managed, but benefits should not be overlooked. In balance, the promise of progress should not be paralyzed by undue, and unfounded, liability claims.

For Senior Management (university president, R&D manager, etc)

• Institutional wide awareness of liability related to genetically modified organisms (GMOs) should be implemented through policies and training sessions. Any investments made up front will be well worthwhile, in that they will help the institution to avoid potentially complex downstream liability issues.

For Scientists

• Attend any training sessions offered on genetically modified organisms (GMOs) and liability.
• Whenever working with GMOs, consult with your technology transfer office so as to fully understand and comply with your institution’s policies and guidelines concerning proper handling and disposal of GMOs and related materials.

For Technology Transfer Officers

• Develop a broad understanding of the theories of liability associated with genetically modified organisms (GMOs), such as negligence, trespass, nuisance, strict liability and infringement of IP rights.
• Carefully, and thoughtfully, work with counsel to develop and implement liability management tools and approaches. These may include, among others, indemnification provisions and warranty disclaimers.
• Conduct regular training sessions for faculty and staff on liability issues related to GMOs, and how these are to systematically managed according to institutional policy and guidelines.