Is International CRISPR Regulation a Pipe Dream?

Written by Shawn Xiong
Edited by Manisha Talukdar
Header image courtesy of Marie Ann Liebert

At the dawn of recombinant DNA technology in the early 1970s, two conferences took place in Asilomar state beach in California, led by Stanford biochemist Paul Berg. From an outright prohibition during the first meeting in 1973 to tight regulation in 1975, Berg single handedly shaped the biotechnology revolution. The conferences set an exemplar for the extent to which scientists and science should self-regulate. In fact, in CRISPR pioneers Jennifer Doudna and Samuel Sternberg’s new book “A Crack in Creation”, they emphasize the necessity of having a similar Asilomar project for CRISPR technology. Doudna herself even called for an international moratorium on CRISPR based human genome editing at the 2015 International Summit on Human Genome Editing, but is it going to work this time?

Most of the participants at the Asilomar conferences were American, partially owing to its invite-only status. In addition, only countries with a gross GDP surplus could advance such luxurious research. As a result, many similar-minded and agreeable people worked together to strike an “international protocol”, while the excluded countries could only begrudgingly swallow the forced-upon regulations. However, in today’s political, economic, and scientific landscape, this kind of imperial monopoly is not going to work. Emerging economic powerhouses in many developing countries can now afford and are willing to spend billions of dollars on scientific research. More importantly, many countries are realizing that the key to catching up to their developed counterparts is to play the game of invention and innovation. Countries like China, India, and Brazil have placed a high priority on research in their national policies. They are, as a result, becoming stronger and more aggressive when participating in international science and technology exchange. In the case of CRISPR, China and South Korea, uninvited to the previous Asilomar conferences, are playing major roles in the development of this biotechnology. South Korean scientists were among the first to demonstrate the translatability of the bacterial defense system CRISPR to eukaryotic gene editing. Whereas Chinese scientists were the first to use CRISPR gene editing technology in various animals including non-human primates, nonviable human embryos, and even human patients. An international agreement on CRISPR regulation in the 21st century would need to be inclusive of all people and countries, many with differing values and priorities. This would make international consensus on a framework for CRISPR regulation an insurmountable challenge.

If we are to consider applying the Asilomar protocol to CRISPR regulation, then we also need to subjectively evaluate the success of the meetings. The guidelines established at the Asilomar conferences loosened rapidly; from an initial ban on DNA recombinant technology in 1973, to regulated-allowance in 1975, to today’s almost ubiquitous and restriction-free use of recombinant DNA technology. The only relic from the conference that is still in place, albeit in an updated form, is the four-level categorization scheme for biohazards. Does this mean the concerns from the 1970s are no longer relevant? Not at all. The fact that anybody can purchase DNA, restriction enzymes, and the equipment involved in recombinant DNA technology for any wild experiment they want is still a concern today. This type of ineffectual reinforcement seems to permeate throughout all international agreements, most notably in the Kyoto Protocol and Paris Climate Accords.  Many of these agreements were established based on mutual compromises rather than mutual benefits. Even with noble intentions, many members of the international community involved with creating these deals ultimately fell off the wagon.

An international agreement on CRISPR regulation in the 21st century would need to be inclusive of all people and countries…

What’s unique and interesting in the case of CRISPR is that the pioneering academic scientists who are advocating fervently for regulations are also the first to secure venture capital to start up their own CRISPR-based biotech companies. It is very possible that these existing companies would be exempt from regulation. If this occurs, then the regulations can be viewed as a measure to prevent other researchers from following suit. Again, this strategy would not be new. The international Treaty on the Non-Proliferation of Nuclear Weapons is perhaps the best illustration of a small contingency of nations with nuclear arms preventing anyone else from having them. Multiple countries have as a result disregarded the treaty and amassed nuclear weapons. Even nations that currently do not have nuclear weapons possess the necessary parts to assemble them at short notice. This is, of course, not a justification for nuclear proliferation, but instead highlights how ineffectual international regulatory frameworks are in controlling global safety threats. These treaties are like scarecrows, menacing on a superficial level but possessing little substantial threat.

Dr. Herbert Boyer at the Asilomar Conference, 1979. Image courtesy of the National Library of Medicine.

While the Asilomar meetings did little to regulate the use of recombinant DNA technology in the long term, it did have a real consequence of impeding academic research. Researchers increasingly moved into industry because of the restrictions and academic research fell behind as a result. Just as the Asilomar regulations reached a fever pitch, Genentech was established in the early 1970s for the sole reason that Herbert Boyer (UCSF professor) became frustrated by the regulations. Boyer teamed with a venture capitalist, Robert Swanson, to create a company which uses DNA technology to produce large amounts of commercial proteins for therapeutic use. Similarly, many CRISPR pioneers have started their own companies, leading one to consider the motive behind their push for regulation –is it really out of concern for public safety, or to further monopolize the CRISPR biotech-field?

I am not here to argue that precision gene editing shouldn’t be regulated. Regulation would be a much more effective and civilized approach than an outright prohibition. However, the effectiveness of reinforcing such a regulation is my real concern. If such regulations indeed materialized, they should be applied equally to industry and labs supported by industry instead of targeting vulnerable academic labs trying to potentiate “boring and useless” basic science. After all, this very same boring and useless science led to the discovery of CRISPR in the first place.

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