Regulatory review of new product innovation: Conceptual clarity and future research directions

The unwarranted interference of some environmental non-governmental organisations (ENGOs) in decision-making over genetically modified (GM) crops has prompted calls for politics to be removed from the regulatory governance of these products. However, regulatory systems are inevitably political because their purpose is to decide whether the use of particular products will help or hinder the delivery of public policy objectives. ENGOs are most able to interfere in regulatory decision-making when policy objectives and decision-making criteria are vague, making the process vulnerable to disruption by organisations that have a distinct agenda. Making regulatory decision-making about GM crops and other green biotechnology more resistant to interference therefore requires better politics not the removal of politics. Better politics begins with political leadership making a case for green biotechnology in achieving food security and other sustainable development goals. Such a policy must involve making political choices and cannot be outsourced to science. Other aspects of better politics include regulatory reform to set policy aims and decision-making criteria that encourage innovation as well as control risk, and engagement with civil society that discusses the values behind attitudes to the application of green biotechnology. In short, green biotechnology for sustainable development needs better politics to counter well-organised opposition, to encourage innovation, and to build the trust of civil society for these policies. Removing politics from regulatory governance would be a gift to ENGOs that are opposed to the use of biotechnology.

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Improving the politics of biotechnological innovations in food security and other sustainable development goals.

Biotechnology has great potential to contribute to sustainable development. Over the past 18 months, it has enabled rapid deployment of methods to detect, treat and protect people against infection by SARS-CoV-2 (Baek et al., 2020; Beigel et al., 2020; Voysey et al., 2021). In addition, gene editing is promising to revolutionize medicine, public health, agriculture and manufacturing through, among other things, the treatment of hereditary diseases, the control of agricultural pests and vectors of dangerous human pathogens, the breeding of crops for healthier diets and livestock for greater animal welfare, and the production of organisms for industrial biotechnology that produce raw materials that may replace fossil fuels in the manufacture of numerous products (Barrangou and Doudna, 2016; Collins, 2018; Ricroch, 2019; Clarke and Kitney, 2020).

Nevertheless, application of biotechnology could cause severe harm if the associated risks are not well managed. Gain-of-function research may increase our knowledge of pathogen evolution; however, it may also cause catastrophic effects if laboratory containment fails or if the new knowledge is used to develop biological weapons (Duprex et al., 2015). Treatment of disease using gene editing, particularly through heritable modifications, raises numerous questions about the bearing of inter-generational risks and the possible exacerbation of health inequalities (Vasiliou et al., 2016). And the use of biotechnology in agriculture remains controversial over 25 years after genetically modified (GM) crops were first grown commercially. Supporters point to reduced pesticide use, greater carbon sequestration and increased yield and profitability for farmers who grow GM crops (Brookes and Barfoot, 2018). By contrast, critics claim that the use of GM crops perpetuates harmful environmental and social consequences of industrial agriculture (Wilson et al., 2021).

To realize the potential of biotechnology, society must envisage biosafety and biosecurity as more than simply containment of organisms that have been bioengineered. Biosafety and biosecurity should seek to enable continuous improvement in policy- and decision-making to optimize the balance between opportunity and risk in using biotechnology to find sustainable solutions to societal problems. I discuss three new frontiers that must be opened to achieve this aim: political leadership in making and justifying choices about the use of biotechnology for sustainable development; regulations that encourage innovation; and responsible innovation by businesses and responsible engagement by civil society.

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Daniel Barlow

Papers

Responsible innovation: Its role in an era of technological and regulatory transformation