Gene Drive Regulations to Evolve as the Technology Advances -Experts

Gene drive is a rapidly emerging technology with promising benefits that can help mitigate animal plagues and vector-borne diseases, but it is a challenge for regulatory bodies around the world to keep up with it. While existing regulations are helpful and can be adopted to tailor fit this new technology, experts say that there are plenty of opportunities to develop sustainable regulations for gene drives.

ISAAA's latest webinar on July 22, 2021, entitled Regulatory and Governance Considerations for Gene Drive Research caps off the Gene Drive Webinar Series co-organized by the Biotechnology Information Centers and the Outreach Network for Gene Drive Research. The webinar featured three experts who explained the existing biosafety regulations and regulatory bodies that implement them, how these can help regulate gene drives, and how the stakeholders and public can participate in the regulatory process.

Dr. Flerida Carino of the Department of Science and Technology Biosafety Committee of the Philippines presented the gene drive global governance and cited that governance works in three levels – institutional, national, and global. She detailed the different regulations implemented by their respective organizations and bodies but noted that there is not one single framework that specifically oversees gene drives. Rather, the provisions from different existing regulations are being followed to regulate it. She ended her presentation by posing the question of whether there should be specific governance to regulate gene drives, which may be lead to unique governance strategies for each new technology that emerges and may be strenuous for some countries to implement.

The second speaker was Dr. Andy Sheppard of the Commonwealth Scientific and Industrial Research Organisation Health and Biosecurity Program who talked about the guidelines for responsible research that is currently available and being implemented. Similar to Carino, Sheppard cited some regulatory bodies that have successfully implemented their own regulations. However, his presentation included insights about what the ideal regulations for gene drives can be based on the biosafety regulations that are being implemented. "Majority of relevant government agencies, reputable research and development providers and many NGOs have signed up to these collectively agreed guidelines for undertaking open and transparent research supported by national academies and regulators, making sure we're working with the regulators as the research is undertaken in order to address the governance issue head-on. We'll need to recognize that these technologies are still at the very early stage of research without field-ready systems. We've got plenty of time to develop this in a sustainable way," he said. "There is plenty of available guidance for responsible research," he concluded.

Finally, Ms. Naima Sykes of Target Malaria discussed the importance of stakeholder engagement and public consultation in regulating gene drives. She emphasized that both are very important and that these are the fundamental aspects of responsible and ethical gene drive research. She also said that deploying a gene drive product involves a whole community, hence community engagement is very important. According to Sykes, the best practices available can help guide gene drive research while continuous research will fill in the gaps of the gene drive technology.

The webinar was opened by Dr. Rhodora Romero-Aldemita, Director of the ISAAA SEAsiaCenter, and closed by Dr. Mahaletchumy Arujanan, ISAAA Global Coordinator. It was moderated by Dr. Vibha Ahuja, the Chief General Manager of the Biotech Consortium India Ltd.

Catch all four sessions of the Gene Drive Webinar Series in the ISAAA.org YouTube Channel. To learn more about gene drives, subscribe to the Outreach Network for Gene Drive Research Newsletter.