India needs to discuss the ethics of gene editing

Universities and institutions need to create the required framework for ethically responsible research

With recent news that doctors in California edited the genes of a patient with Hunters syndrome in what was described as the world’s first experimental attempt at changing faulty genetic material in a human, genome editing is fast moving from the labs to clinics and companies.

India too is readying for genome editing – a technique in which scientists use ‘molecular scissors’ to snip a faulty gene and repair it or replace it with a correct one. This opens up possibilities in plant and animal breeding; medicine, public health, and development biology at the practical level; and designer babies and lean or even micro pigs as pets at the exotic. Private companies have entered the fray for its commercial potential to treat inherited genetic disorders, cancers and neurodegenerative diseases.

But scientists worldwide have also begun to grapple with emerging ethics, regulation and biosecurity implications of the technology; and are struggling to draw the fine line between not impeding research and defining what are societally-acceptable applications. The co-creator of gene editing, Jennifer Doudna from University of Berkeley, told a recent conference of science journalists in the US that she did not anticipate the rapidity with which it would spread. Then she had a nightmare – that Hitler wanted to use it – which is when she started looking at the thorny ethical and regulatory issues.

It is unclear whether and how much Indian science policy analysts and academies are addressing the grey areas of technical and socio-political implications of gene editing technologies. Discussions, if any, seem confined to closed scientific circles, and are yet to spill into public discourse. Indian research institutions also need to create the required framework for ethically responsible research.

Most geneticists see it as an extension of previous genetic modification technologies — and posing, at most, issues of technology. The department of biotechnology’s (DBT) 1989 guidelines foresaw genome editing as part of a range of genetic modification technologies. That said, India’s track record in allaying fears over GM crops is not exemplary, nor are its science academies proactive on policy issues. Despite its claims that regulation was in place when GM cotton was first approved for release in India in 2002, GM cotton was reportedly illegally sown in Gujarat even before its approval. India’s own GM mustard may have its merits, but some biotechnologists’ arguments that it should be released because that Indians are, anyway, consuming imported oil from GM canola and rapeseed does not pass muster.

Indian regulators also need to address the capacity of the Indian regulatory system, given the concerns that genome editing could misfire, impacting unintended organisms, or altering the genome of bona-fide targets in unintended ways. There is also potential for misuse by private companies with access to genetic data. There are worries too that citizen scientists and DIY (do it yourself) groups may tinker with the technology.

There are thorny ethical issues – while most support its use in non-reproductive cells (so that changes are limited to one specific organism), there is disagreement over its use in human embryos, and on germline cells which means changes can be passed on to generations.

A 2016 US National Intelligence report described it as a potential ‘dual use technology’ that could be misused by some groups in biowarfare. The report did not specify how or why it is a national security threat, but subsequent reports by other agencies described how gene editing could be misused to manipulate human pathogens, make vaccines ineffective, create neurotoxins or release drug-resistant microbes as part of bio warfare.

Of particular concern are ‘gene drives’ or selection of genes for specific traits, which changes the dynamics of inheritance by favouring one set of genes, and alters ecological balances.

Even as Indian biotechnologists embark on the research, it would be wise to learn from the GM cotton experience and initiate a broader dialogue and foster public trust and understanding. As with all emerging technologies that interface science with society, there is no need to throw the baby out with the bathwater.

OF PARTICULAR CONCERN ARE ‘GENE DRIVES’ OR SELECTION OF GENES FOR SPECIFIC TRAITS, WHICH CHANGES THE DYNAMICS OF INHERITANCE BY FAVOURING ONE SET OF GENES, AND ALTERS ECOLOGICAL BALANCES