Abstract

The new gene editing technologies, including gene line editing embryos, are extensively used and drive the development of a new military and health sector. However, these new technologies are uncertain, creating uncertainty in how their application for health uses will be regulated. A comparison between North America and EU in regard of gene editing moves the needle much when the legal approach, the patenting of the CRISPB and the possibilities of industrial use is evaluated. The Court of Justice of the EU argued that gene editing is a challenge that signals ethical thoughts posed by this new tool as relating to different applications. The ex-ante regulation and ex-post liability framework gives always the possibility to economic implications of different options being addressed. Meanwhile, the comparison between legal frameworks that regulate the genomics global market gives helps on finding out the hidden barriers in this market. The results show that under current conditions, some options are more expensive than others are. The least costly option encompasses regulating new gene editing protocols similar to those used in ‘conventional’ genetic protocol.

Key words

#Regulatory #Affairs #Food #EFSA #FAO #COURTOFJUSTICE #EU #CHINA

Introduction

The market of Genome editing is estimated by 2019 at $3.5 Billion (Rohan 2016)[1] and is a terrific novel business opportunity for every country on global market to excel in. We can use
the Triade in one piece: the Whole Genome Sequencing, Synthetic Genomics and Genome Editing, even for non-coding DNA segments of the protected intellectual property of Fracto Gene to compute Fractal Defects, the synthetic genomics to manufacture with low cost an edited replacement-sequence, and the Genome editing itself. According to Foreign Affairs research, General James Clapper, appeared before USA Congress in early January 2016, admitting,

“Research in genome editing conducted by countries with different regulatory or ethical standards than those of Western
countries probably increases the risk of the creation of potentially harmful
biological agents (Regalado, 2016) or products”

However, this speech got resonance with two principal events. At first place, it tickled the collective remembrance of 1960, of the allegations that the US used germs and insects as
combat weapons during the Korean War (Endicott, 1979) (Powell, 2019). (During post-Korean War confidentiality [4], including McCarthyism, trials, uninterrupted bowdlerisation, and programmed failure to recall, these allegation have grown into an historical profoundly shaping event for the today world). Second, the general affirmation highlighted the Chinese government $9 billion and 15-year effort on turning China into a global leader in connecting
computing and AI technologies for interpreting genetic and health data[5]. This investment was far more important than a similar precision medicine initiative by the Obama administration, which started with a $215 million investment inthe President’s 2016 Budget.

The empirical evidence

The key to separating supply side effects from demand-side effects is to examine the interaction between the price of genomic protocol and the quantity of gene editing analysis produced, since demand-side price increases suggest concomitant increases in the volume
of gene editing units produced, whereas supply side increases suggest just the opposite (POCHAT-COTTILLOUX, 2019). Although this approach appears on the surface to disentangle the dynamics of a containment policy price effect, few studies have employed gene editing quantity variables in their investigations (Davidson, Roei, and Yariv Tsfati, 2019). One explanation for the neglect of genomic market supply in military industry or health industry containment studies is the over-reliance on hedonic techniques (Carlson, 2019). The hedonic
model is a useful tool for understanding the contribution of various gene-editing services and population attributes to the price of the services, but the model offers little insight into the relationship between price movements and the output decisions of genomic industry producers. This is not a weakness of the technique per se, but merely a statement that the model cannot answer to the questions the market makes today. The intergovernmental framework of genomic edition containment policy implementation has been studied using the
data of the Official Journal of European Union, The Diário Oficial da União, Iran Data Portal, the USA federal register as well as each western Balkan country juridical publication. The focus of the research was making a comparison on the legal framework of the gene editing and after that evaluate economically the implication of the policy in the market, utilizing a variety
of information sources to gather technical, social, political, and economic data related to gene editing in different countries. Sources included databases such as Web of Science, Hoovers, Bloomberg, Dow Jones Factiva, Mergent Online Horizon, Compustat, SDC Platinium We also sought information through search engines, websites, and social media platforms.

Results

Nowadays, there are no internationally agreement upon gene editing legal regulation and national current regulations that reflect the research conducted by each country, as well
as the applications and products related to this biological tool. The human
germ line editing approach reflects usually the military industry interest as
well as the government, religion authority and the community pressure. In EU, in 2019, the Gene-editing technology was put on the table, by European Commission, as a

“pressing challenge that would
benefit from further reflection, signalling
the ethical challenges posed by gene
editing as relating to various potential applications”

Before that, following the decision of Court of Justice, at the European Commission, expressed its opinion concerning the cell types used for the HPRT and XPRT tests[3] should have a demonstrated sensitivity to chemical mutagens, a high cloning efficiency, a stable karyotype,and a stable spontaneous mutant frequency (Cox, Julie A., et al. “,2019). The use of other cell lines should be justified and validated [4]. In addition, under Article 4(4) of Regulation No 258/97, the Commission is to publish recommendations concerning scientific aspects of GMO food (Martini, Daniela, Cristian Del Bo, and Alessia Cavaliere. “, 2019) (Rasmussen, Kirsten, et al. , 2019). Based on that provision, the Commission adopted Recommendation 97/618, the following passages of which are of importance in the present case:

“In the terminology of the OECD, the
concept of substantial equivalence embodies the idea that existing organisms
used as foods or as food sources can serve as a basis for comparison when
assessing the safety of human consumption of a food or food component that has
been modified or is new…… If a NF (novel food) has not been found to be
equivalent to an existing food or food component, this does not imply that it
is unsafe. It just indicates that such a NF should be evaluated on the basis of
its unique composition and properties.”

(EUR-Lex – 31997H0618 – EN – EUR-Lex, 2018)

For the same topic, INSA reported that Iranian researchers used Hemophilia mouse models that went on display as the first cases of using CRISPR-Cas9 technology (Zarei, Ali, et al.
, 2019) in gene editing in the country. Another group of Iranian scientist reported later they induced apoptosis and inhibits cell proliferation in Leukemic Cell Lines, HL60 And KG1 [6].
But there are not only roses in the room. The gene editing innovative technology caused a catastrophe in Brazil in 2019. As previously and wildly referred, a British-American gene-editing company has released millions of genetically modified mosquitoes containing a dominant lethal gene, each week for two years in a row, in the Bahia, Brazil region in a test to see if the gene-edited mosquitoes would mate with local mosquitoes carrying Zika, malaria or other mosquito-borne diseases[7]. The scientists note that, “Genetic sampling from the target population six, 12, and 27–30 months after releases commenced provides clear evidence that
portions of the transgenic strain genome have been incorporated into the target population. Evidently, rare viable hybrid offspring between the release strain and the Jacobina population are sufficiently robust to be able to reproduce in nature…” They continue, “Thus, Jacobina Ae. aegypti are now a mix of three populations. It is unclear how this may affect disease transmission or affect other efforts to control these dangerous vectors.”[8] In WB6, there is no legal framework that regulates the human cell market, as well as the biotechnological modifications or any intervention on germline, that may raise up in the genomic enterprise, transforming these countries in hidden market paradise in the middle of Europe. They are almost human 1792 fertility centres in WB6, organised in private hospitals and small clinics, in this unregulated market, when the patients have no idea and rights on their germ cells.

But which are the policy implication of gene editing in global scale?

When it comes to the USA, China, and technology, AI tends to grab most of the attention. Fortunately, though, shared concerns about China’s role in biotechnology also provide a rare chance for meaningful and productive engagement in shaping the rules of a new world from the policymakers. But in the room various linked issues to gene editing technology are to deal with, like genetic counselling, patenting of gene editing technologies, gene editing impact on genetically modified foods, or genome testing, germ line editing in embryos, and potential diverse uses in adult human applications just to mention few.

The European Council noted that any intervention on germline also contains the risk of reducing genetic diversity and may produce drastic effects on the species involved. This issue is off the table of the EU, although there is no binding international act, which would restrict human genome editing. In the last 5 years, the inexpensive gene editing techniques changed drastically the tissue of the biomedical research, creating a new-born classification of security threats from using genetic information to persecute populations, on developing sophisticated bioweapons[9].There is no clear and crisp legal framework, or legal definition on bio warfare and bioterrorism, nor regionally, or globally. As James Giordano affirms,

“ Although instances of bio warfare and bioterrorism have been rare in the 21st century, somewhat inconspicuous, but rapidly advancing bioscience and technology that are capable of being weaponized are becoming ever more difficult to surveille, regulate, and govern”.

The scope of existing competencies—and the challenges/ opportunities on development and/or exploitation of such techniques—in public safety and health need a global discussion, a very scrupulous and visionary reassessment of current perceptions and characteristics of weaponizable biology. The defence ministries and agencies of different countries deals the growing viability of developing bioweaponizable agents and use international regulations for safety controls. We have distinguished different critical areas for the national securities, as synthetic prions, aerosolized transmissibility, gain of function (GOF), increased knowledge of genomics and proteomics, cross-species transmissibility, interactions with other pathogens and the non-kinetic weaponization of prions”.

There is no firm scope in the Global genomics enterprise, as well as there is no achieved goal: the destruction of the opposing regime, because there is no such thing. This is a wonderful chaos under development. However, the chances of creation a quasi-absolute economic hegemony – and power – in these markets and perhaps on the world stage are very high.

Conclusion

Whenever we discussed, in every civilisation the cloning process, we somehow knew we were shaping the future with no idea of the consequences, following the stories of the monotheist religions where putting into life and transforming the life was not magic but Gods miracle. Among billions of failures and success with cell and DNA transformation, we developed our ethical schools, the political approach, a fatalistic orientation as well as the military industry. The genetic game theory is somehow in between probability and possibility of meeting our future and our end but this does not change the urgent need to evaluate all the policy
implication of this military industry in our world.