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5.
Regulatory responses to emerging technologies can be understood as developing in a

gradual and iterative fashion, where sequential cyclical activities are connected
by anticipatory and consequential linkages. In addition, regulatory responses to
emerging technologies are exposed to the source, effect, and response uncertainty,
which affect the expectations that individuals hold toward future technological and
regulatory developments. The regulatory response to emerging technologies is also
affected by existing regulatory institutions, which help account for different
trajectories of regulatory development across countries.
eories of regulatory development, therefore, should include the possibility that

policy‐makers remain passive toward the rise of emerging technologies while they
“wait and see” the effects of the application of existing regulatory institutions.
The empirical part of the study also throws some light onto the regulatory
responses to CRISPR gene editing technologies in the US and the EU, in particular.
In the US, the Update to the Coordinated Framework and subsequent adaptation in the
conduct of the federal regulatory agencies resulted in a relatively tolerant and
permissive regime toward CRISPR products.
In the EU, instead, the ECJ ruling and following enforcement actions of the
Commission resulted in a relatively restrictive regime toward CRISPR applications.
Critiques from the scientific community and the industry suggest, however, that the
regulatory responses in both the US and the EU are unfinished business
March 2021 - The UK government has an opportunity to create a new system for
regulating gene editing in food and agriculture that is scientifically sound. It
must do so in a way that respects the independence of the regulatory process,
because, among other things, that will be key to bringing the public with it.
May 2019 - China is poised to introduce a new regulation on gene editing in humans.
A draft of the country’s new civil code lists human genes and embryos in a section
on personality rights to be protected. Experiments on genes in adults or embryos
that endanger human health or violate ethical norms can accordingly be seen as a
violation of a person’s fundamental rights.
The United States is reevaluating the way it regulates products created through
genetic engineering, collectively are known as the Coordinated Framework for
Regulation of Biotechnology. In its decision in April 2016 to approve its first
CRISPR edited food, a non-browning mushroom, USDA wrote. “APHIS does not consider
CRISPR/Cas9-edited white button mushrooms as described in your October 30, 2015
letter to be regulated,” the agency wrote in a 13 April letter to the developing
scientist. It also chose not to regulate a strain of his-yield way corn created
using CRISPR by DuPont Pioneer.
Future products, depending on the individual circumstances, could still be handled

by a patchwork regulatory net involving the Environmental Protection Agency, Food
and Drug Administration and the Department of Agriculture. The problem is that the
U.S. is trying to do this with laws written in the 1950s and re-interpreted in the
1980s that were not designed to deal with modern genetic modification. Essentially,
they only cover crops engineered with Agrobacterium tumefaciens, a bacterium used
to insert DNA into plant genomes.
That has created challenges for regulators when it comes to examining crops made
through newer technologies.
23 April 2019
Updated regulations allow scientists to use some genome-editing techniques in

plants and animals without government approval.
reviously, the use of such technologies, including CRISPR–Cas9, for research was
restricted in practice because the techniques were governed by the same rules as
conventional genetic modifications, which require approval from a biosafety
committee accredited by the Office of the Gene Technology Regulator (OGTR).
The amended rules remove that requirement for the use of tools in which proteins
cut DNA at a specific target site — as long as the tools allow the host cell to
repair the break naturally, rather than using a template containing genetic
material to direct the repair process.
In March 2018, the US Department of Agriculture excluded genome-edited plants from

regulatory oversight altogether. By contrast, the Court of Justice of the European
Union ruled in July last year that it would treat gene-edited crops as genetically
modified organisms, subject to stringent regulation.
The Australian regulator says that genetic edits made without templates are no
different from changes that occur in nature, and therefore do not pose an
additional risk to the environment and human health. Gene-editing technologies that
do use a template, or that insert other genetic material into the cell, will
continue to be regulated by the OGTR.
6.
A punishment is justified insofar as it stays true the established constitution and

relevant laws set in place as an objective basis and a verdict is reached by fairly
considering ethical and rational considerations pertaining to the case .Justice,
therefore, has to start with a theoretical basis out of which there are practical
considerations. If we operate in the reverse, justice dissolves into subjective
pragmatism where the end can easily justify the means.
From this definition of Justice, where are the grounds for justifying He Jiankui's
actions? Are you also operating in the reverse, using the ends or euphemized
"potential good" to justify the means?
He was firstly charged with practicing medicine without a license and therefore
were unqualified to conduct their study from the on-set. This was a direct
contravention of the law. This act highlighted He Jiankui's disingenuinity by
following through with his research and his pride in thinking that his
inventiveness afforded him the right to perform his study for the sake of science.
He made the claim that he had altered the genes of a human embryo. The researcher
worked with seven volunteered couples, where each couple had one partner who has
HIV positive. The aim was to ensure that HIV was not transmitted to the child. He
used CRISPR Cas0 techonology to disable a gene CCR9 which allows HIV to infect the
cells, then used in-vitro fertilisation to implant the edited embryos. Since this
used germe line technology, these changes were inheritable.
This was irresponsible, as disabling the CCR5 gene could potentially lead to known
permanent negative impacts, one of which is heightened susceptibility to the flu.
It is important to note that the results of this study would implicate the genome
of the descendants of the subjects since the change was permanent. There could be
many more risks that are unknown so he, as a researcher took an unnessary risk that
could potentially not only implicate the babies but all of their descendents. One
may argue that there are inherent risks to any study, but we must understand that
He Jiankui was guilty even before the study started by operating without a medical
license. The risky procedure only serves to compound the severity of his
unjustified actions.
Some may say that his actions were necessary for the development of science.
However, this is not an objective claim. Science does not tell us how we should
develop it and not all developments no matter how "progressive" they sound should
be sought after. Conservatism in science is not sacrilegious and your preference to
pursue a certain scientific development does not somehow give you magical white
coat impunity.
To conclude, He Jiankui's actions may have been innovative but they directly
contravened the law, were not reasonable. He was presumptuous not only in this
regard, but in pursuing such a significant procedure on an ethically controversial
issue. His punishment was justified.

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5.

Regulatory responses to emerging technologies can be understood as developing in a

eories of regulatory development, therefore, should include the possibility that

Future products, depending on the individual circumstances, could still be handled

Updated regulations allow scientists to use some genome-editing techniques in

In March 2018, the US Department of Agriculture excluded genome-edited plants from

A punishment is justified insofar as it stays true the established constitution and

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