Workshop Summary for Maintaining Innovation and Security in Biotechnology: Lessons Learned from Nuclear, Chemical, and Informational Technologies
In the fast-paced field of biotechnology where innovation has such far-reaching impacts on human health and the environment, dealing with the implications of possible illicit activities, accidents or unintended research consequences with potential detrimental societal impacts tends to remain in the background. While controls may be inevitable for the biotech industry, workshop attendees agreed that the way in which controls are implemented will play a major role in the agility and innovation of the biotechnology industry. There is little desire to slow down the pace of the gains while dealing with the security issues that arise. As was seen from the brief examinations of the Nuclear, Chemical, and Information Technology sectors explored in this workshop, establishing a regulatory regime needs to be a partnership between the public, corporate interests, scientists, and the government. Regulation is often written to combat perceived risk rather than actual risk—the public’s perceptions (occasionally even fictional portrayals) can spur regulatory efforts. This leads to the need for a thorough and continuing assessment of the risks posed by modern biotechnology. Inadequate or minimal risk assessment might expedite development in the short term but has potential negative long-term security and economic consequences. Industry and the technical community also often have a large role in setting regulatory policy, especially when well-crafted incentives are incorporated into the regulations. Such incentives might actually lead to enhanced innovation while poorly designed incentives can actually reduce safety and security. Any regulations should be as agile and flexible as the technology they regulate and when applied to biotechnologies they will need a new framework for thinking and implementing. The new framework should consider biotechnology as a technology and not simply a science since it is an extremely complex and adaptive system. This suggests the need to invest in social and political systems, rather than exclusively in technology, as a part of maintaining not only robust, but agile regulation. Modeling and simulations to illustrate how the biotech ecosystem might respond to new policies may be a promising approach to crafting regulations.