By Madhav Chandavarkar, Anirudh Kanisetti, Ajay Patri, and Shambhavi Naik
Gene editing offers many benefits. They range from basic research that can enhance the scientific understanding of gene functions to practical applications like improved healthcare and agricultural production. At the same time, like other developing technologies, gene editing is not without its limitations and problems.
Guided by a few core principles, this discussion document develops a framework to analyse gene editing technologies. The paper explores three broad categories, corresponding to the stage of development of the technology: Fundamental R&D, Commercial R&D and Commercialisation. Each of these groups requires a different governance principle. This idea is used to develop a three-level framework, as set out below.
- “Laboratory” Stage (Fundamental R&D) – Compliance with Standards.
Research organisations free to conduct lab experiments as long as they adhere to scientific standards and protocols for different technologies. Government to set standards in collaboration with research and industry groups.
- “Trial” Stage (Commercial R&D) – Subject to Approval.
Clinical/open field trials on a demonstrated product cannot be carried out without prior approval. The approval will be granted by an agency based on standards set by the government in collaboration with research and industry groups.
- “Public Release” Stage (Commercialisation) – Verification of Safety.
Product can be sold on the market only after government has independently verified that the product meets safety and disclosure standards.
A vital feature of this framework is that there is no absolute moratorium on any technology. Instead, it provides for safety checks at each stage which become increasingly rigorous as the technology/application gets closer to being released to the public. Its primary goal is to ensure that the regulatory environment is conducive to scientific progress. As such, the framework would allow India to harness the benefits of gene editing while keeping risks in check.
The implementation of such a framework, which separately regulates laboratories, trials and public releases of gene editing technologies could take many forms. One such form would be the creation of independent accreditation firms that would implement safety standards at the Laboratory Stage and approve the trials of gene editing research. These safety standards as well as the parameters on which approvals are granted would implement standards set by a Gene Editing Authority. This authority would also be in charge of setting safety protocols for laboratories and regulating the public release of gene edited products. This framework allows timely approvals while still keeping risks in check. However, a detailed discussion of implementation pathways is left for future work.
Tagged: Ajay Patri, Animal Trials, Anirudh Kanisetti, CRISPR Cas9, Designer Babies, Framework, Gene Editing, Gene Editing Authority, Genetic Modification, genomics, GMO, Human Trials, Madhav Chandavarkar, Moratorium, Regulation, Scientific Progress, Shambhavi Naik, Takshashila Discussion Document, The Takshashila Institution