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CRISPR: a challenge for policy makers and regulators

​Genetic modification has never been far from controversy and as much as the power and ease of use of CPISPR technology is a boon to research and development, there is a corresponding increased risk and concern that such technology may be abused and misused.

GMOs

There is currently a lacuna in the regulation of genetically modified products, with existing policies and regulation designed with older GM technology in mind.  This older generation of technology relied on the incorporation of viral or bacterial DNA into the genome of the modified organism.  The existing regulation largely focuses on whether there has been use and incorporation of such foreign genetic material and accordingly fails to address the new landscape of ZFN, TALENs and CRISPR edited products, which do not necessarily require the incorporation of viral or bacterial DNA.

For example, in April 2016, the US Department of Agriculture (USDA) decided that a CRISPR-edited mushroom engineered to resist browning fell outside of its regulatory oversight (see here) – the first such decision made in relation to a CRISPR-edited GMO.  At the same time, plants modified using ZFN or TALENs technology are also escaping USDA GMO scrutiny (see here). However, the relative ease and lower cost of CRISPR modification (especially compared to ZFNs and TALENs) is such that, in light of the USDA’s decision, it seems inevitable that further CRISPR-modified products will follow.  How policy makers and regulators respond will be instrumental in determining the continued use of CRISPR in the food/agricultural industry.

Germ line modifications

Meanwhile, the biggest concern expressed in the research community (including by leading lights such as Jennifer Doudna) is the potential for CRISPR to be used in eugenics and to make inheritable modifications to the germ line of organisms. This would result in the preferential expression of the engineered genotype in a population – i.e. gene edits not to the somatic, adult cells of an organism (which will only affect that organism), but to the reproductive cells, such that those modifications will be passed down to offspring of the organism (and potentially their offspring, and so on down the line).  

A particularly powerful yet dangerous variant of such germline modification is “gene drive” technology, where the edit made encodes for the CRISPR gene editing machinery required to actively propagate the edit and so the inheritance of a particular trait is “driven” throughout the population over a number of generations.  A single escaped organism with such a gene drive edit could irrevocably change or exterminate an entire population in the space of several generations (which for some organisms may not be very long at all). However, such “gene drive” technology also holds significant potential for positive use – one proposal that has captured the imagination is the potential eradication of malaria and/or Zika virus carrying mosquitos in Florida and Africa. 

One of the pioneers of gene drive technology, Kevin Estvelt, warned in late 2017 that the invasiveness and penetration of simple gene drives in a population was far more aggressive than previous projections, and advised that gene drive field trials are too risky.  This comes despite the formation of consensus guidelines to implement gene drive standards, both in terms of containment protocol as well as ethics.  More sophisticated gene drive models which rely on the inheritance of multiple components to form a functioning drive (such as the “Daisy drive” system studied by Estvelt) are being explored but are not yet mature enough to be used in practice.

On another front, some licensors such as the Broad have taken to stipulating in licensing agreements that licensees are not to use the technology for gene drive research.  Government is also concerned about the potential of gene drives as a threat to biosafety, with the US Defence Advanced Research Projects Agency (DARPA) committing $65 million in research funding to various CRISPR-related projects (including several in respect of gene drive and anti-CRISPR technology) under its “Safe Genes” program.

It remains for governments, policy makers and regulatory bodies to implement policies to regulate CRISPR mediated genetic modification, which balance the need to encourage free and open research but, at the same time, protect humans and the environment from reckless or dangerous use of the technology.  The signs are that administrations around the world recognise this imperative, with the US Senate Committee on Health Education Labor & Pensions holding a hearing on gene editing technology on 14 November 2017 and the UK House of Commons’ Science and Technology Committee holding an inquiry into genomics and genome-editing which published its report on 1 May 2017.

For more detail on the regulatory regime that would govern a CRISPR-based human therapeutic product in Europe, see our feature article here.



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