Gene editing technologies like CRISPR-Cas9 are evolving and can therefore be better governed by guidelines rather than laws. © Barun Chatterjee
The global scientific community has been outraged by a Chinese scientist He Jiankui’s claim of creating the world’s first genetically modified baby using the gene editing technique CRISPR-Cas9. The scientist claims that baby Lulu – who differs from previous recipients of gene therapies like Layla Richards1 – was born with a genetic modification and will pass it on to any child she may have in future.
On ethical and safety grounds, scientists worldwide have abstained till now2 from genetically-modified embryo experiments. However, the Chinese case hints that some researchers may be secretly competing to outbid their peers in creating gene-editing based solutions. There have also been instances of biohackers crafting DIY CRISPR kits3, affording buyers with elements that could be used in home experiments.
The technology itself is still in its infancy and will require significant research and trials before application. Extensive conversations about the ethics and scientific risks of its applications are needed. USA has recently approved4 its first clinical trial in adults for use of CRISPR-Cas9 in the remediation of ß-thalassemia. China on the other hand has been experimenting with gene editing in adults for a couple of years, albeit not with as much ethical rigour as USA and Europe5.
Early days in India
India has maintained consensus with the international community on managing emerging technologies. Research geared towards application of gene editing techniques to provide affordable healthcare solutions is just picking up steam in India and, therefore, this is the right time to assess the potential of these new age tools.
India stands to benefit by creating gene editing guidelines now as research in this area is just picking up. Credit: Soundhar Ramsay
India needs policies that can foster innovation in healthcare but a law, with all the rigidity of the legal system, may not be able to keep pace with the rapid development of such evolving technologies. Instead, these technologies can be governed better through flexible guidelines – a moral code instead of legally enforceable rules. Instead of recommending prohibitions, it may be better to prescribe standards around application of gene editing technologies.
Currently, gene editing policies in India are limited to certain sections of the Stem Cell Guidelines 20176 that guide the use of gene editing in embryos and stem cells. The lack of policies leaves India vulnerable to unscrupulous entities, such as those seen mushrooming for stem cell therapies, which in the first place warranted the stem cell guidelines7.
Global standards
To create a more inclusive policy framework, a team at the Takshashila Institution in Bengaluru studied international policies and conversations at major scientific conferences to understand national and scientific perspectives of gene editing in somatic and germline cells. The foundation of these frameworks lies in the principles that scientific progress should not be inhibited and that technology should be viewed differently from its applications.
When it comes to governance, regulation is better than outright prohibition. Policy making must be scientific and inclusive. In the field of emerging technologies India needs to balance its alignment with global powers with her own national interest.
Guided by these principles, the Takshashila framework outlines the various uses of the gene editing technology based on ethical considerations and any unintended consequences (Figure 1). The proposed guidelines draw from interdisciplinary discussions with academic and industry scientists, lawyers, ethicists, patient group representatives and governmental agencies8.
Figure 1: A proposed analytical framework for assessing gene editing applications
This framework suggests that fundamental research, when done under pre-determined standards, should be allowed to progress with minimal restrictions (Figure 2). Governance and compliance should be increased gradually as technological application advances to the level of clinical use9.
Figure 2: A proposed regulatory structure for various gene editing applications
To make compliance effective, a governance structure helmed by national and institutional committees (similar to the national stem cell committees) would be necessary. Forming application-based expert working groups to provide detailed technical directives would also be essential. For instance, a working group consisting of thalassemia doctors, scientists, patient group representatives and lawyers should formulate the guidelines for gene editing applications for thalassemia.
These directives will need to set out the thresholds of acceptability, standard practices and ethical guidelines. Such working groups will allow debates on individual applications and help to account for the cost to benefit ratio of all applications – from that of remedying well-studied genetic diseases to the more controversial isolated incidents of gene enhancement.
Transparency and a happy balance between scientific and societal requirements are central to introduction of any new technology that directly impacts human lives. A streamlined regulatory environment around gene-editing technologies would ensure that more scientists are attracted to experiment with these new-age solutions that hold the potential to revolutionise healthcare.
[Shambhavi Naik is a technology and policy research fellow at the Bengaluru-based think tank Takshashila Institution.]
