Prospects for Transatlantic Cooperation in Biotech Policy—A US Perspective
There are multiple opportunities to advance solutions to major societal challenges by fostering transatlantic cooperation in biotech policy. But developing and applying them will require a return to science-based regulation that advances safety while enabling, not deterring innovation.
Mutual self-interest provides a strong basis for transatlantic cooperation in biotechnology based on shared recognition of its vast potential to provide solutions to some of civilization’s most pressing problems. Thanks to explosive advances in our understanding of the many ways in which promiscuous nature has been manipulating DNA and RNA for the past billion years, it is widely anticipated that the 21st century will belong to biology. We are now at the point where our ability to innovate is constrained less by technical capability than by the limits of our imaginations. Multiple laboratories and companies on both sides of the Atlantic (and throughout the world) are pursuing promising applications, and experience confirms progress would be accelerated by cooperative approaches. But there are some considerable challenges, especially in agricultural and industrial contexts.
The most important rate-limiting factor in our ability to harness biological innovations to the challenges of feeding the world, sustaining human and environmental health, and addressing climate change, is the burden imposed by ill-considered regulations. Unless this bottleneck can be unblocked, the enormous potential for transatlantic scientific cooperation will not yield the necessary fruits.
Existing policies, legislation, and regulations do little or nothing to advance human or environmental safety. Born out of understandable caution at the dawn of recombinant DNA technologies, today their most obvious impact is to obstruct and discourage research, development, and deployment of innovative solutions to various challenges. This is so despite an abundant record of production and consumption of new biotech products with enviable records of improved safety, superior sustainability, and widespread beneficial economic impacts. The benefits are so substantial that a pattern has emerged of farmers breaking the law to acquire and plant improved seeds in countries where governments have lagged in allowing access.
It is one thing to implement policies and regulations ostensibly designed to ensure safety; it is quite another to ignore vast data and decades of experience around the world to maintain obsolete policies and regulations that add nothing to safety or sustainability, but only impede our ability to use the most innovative, precise, and safest tools to address our gravest challenges.
In terms of regulatory policy and openness to biological innovations, the width of the Atlantic might be measured better in light years than miles or kilometers. As imperfect as regulations for the products of biotechnology are in North America, they are simply indefensible in Europe.
The United States decided in 1986, after years of study and consultation, that no new laws were required to ensure the safety of crops and foods improved through biotechnology. This was based on the finding that they present no novel hazards, and foreseeable risks of their development and use fall into categories with which humans have considerable experience from millennia of conventional plant and animal breeding. The United States therefore decided to regulate these novel products under existing authorities administered by the Department of Agriculture, the Food and Drug Administration, and Environmental Protection Agency. While implementation of this policy, the “Coordinated Framework,” has been far from perfect, it has been sufficiently predictable and science-based to enable an explosion of innovation, new product development, and commercial activity. Consequently, the United States has led the world to the present day wherein crops improved through biotechnology are now the global standard for quality seeds, delivering improved yields, safety, sustainability, and economic productivity around the world, with the lion’s share of benefits accruing on behalf of small farmers in developing countries. Europe took a different approach.
It is one thing to implement policies and regulations ostensibly designed to ensure safety; it is quite another to ignore vast data and decades of experience around the world to maintain obsolete policies and regulations that add nothing to safety or sustainability.
The European Union decided to regulate seeds improved through biotechnology as a novel class governed under new regulations specifically focused on an arbitrary category known as “GMOs” (for “genetically modified organisms”). The conceit was that because they represented gene combinations produced by mechanisms supposedly “not found in nature” (but actually ubiquitous) they must present novel hazards, even though none has ever been identified. These putatively novel hazards, despite the lack of any concrete manifestations, allegedly required dedicated, specific, “precautionary” regulations. The resulting regulatory regime proved so burdensome it led to the general collapse of agricultural biotechnology in Europe, which had played a leading role in its discovery and invention. Permissions for field trials proved almost impossible to obtain, products could not be developed and brought to market, academic labs abandoned the field, and the industry relocated most of its assets and activities to the Americas. And Europe became the world’s largest importer of commodity foods improved through biotechnology, only recently surpassed by China.
Many scientists in the EU (and around the world) knew from the beginning that this was the wrong approach, yet the EU pushed its model internationally, with aggressive diplomacy, leading to emulation by many countries in the developing world, with equally unhappy results to those seen in Europe. But a growing number of scientists, policymakers, and even “green” NGOs that had originally opposed GMOs, now recognize the counterproductive results of this approach and are working to avoid repeating the same mistakes with gene editing. This shines a spotlight on the most important and potentially fruitful opportunity for transatlantic cooperation in biotechnology: the revival of science-based regulatory regimes in which the degree of regulatory oversight is proportional to the hazards involved, and regulation that enables, rather than discourages the safe development of innovative products. A return to and reaffirmation of these first principles would provide fertile ground for cooperation and coordination globally. Regulatory reform (everywhere, not just in the EU and its emulators, though the need is greatest there) provides fertile ground for transatlantic cooperation and coordination. We have robust models of proven approaches. Without such cooperation, other progress in developing and deploying innovative solutions through biotechnology will be impeded or foregone.
As to national security risks, just as with other risks, novelty attributable to biotechnology is elusive. One can do very nasty things with conventional bioweapons, and they are easily magnified with recombinant DNA techniques. At the same time, defensive capacities are also buttressed by biotechnology, as demonstrated by the rapid development of mRNA vaccines against SARS-CoV-2. There has been some good work done in this area, but this topic is worth exploring at greater depth. The OECD has a track record of thoughtful analyses with such topics. One possibility would be to build on that foundation by establishing a joint OECD/NATO working group to serve as a forum.
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This publication was made possible in part by a grant from the U.S. Air Force to the Center for a New American Security (CNAS). It is based on a presentation delivered at a Hybrid Workshop on Transatlantic Cooperation in Biotechnology Policy organized and convened by CNAS on February 8, 2022, in Palo Alto, California. The statements made and views expressed are solely the responsibility of the author.
About the Author
L. Val Giddings () is a senior fellow at ITIF. He has over three decades of experience in science and regulatory policy relating to biotechnology innovations in agriculture and biomedicine. His work at ITIF focuses on constraints inhibiting innovations in these areas, and remedies to those constraints. Giddings is also president and CEO of PrometheusAB, Inc., a consultancy focusing on regulatory compliance, media, and strategic planning for governments, multilateral organizations, and industry.
The Information Technology and Innovation Foundation (ITIF) is an independent, nonprofit, nonpartisan research and educational institute focusing on the intersection of technological innovation and public policy. Recognized by its peers in the think tank community as the global center of excellence for science and technology policy, ITIF’s mission is to formulate and promote policy solutions that accelerate innovation and boost productivity to spur growth, opportunity, and progress.
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