Clustered Regularly Interspaced Short Palindromic Repeat Technology

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Table of Contents

Introduction
Premarket Approval and Regulatory Agencies
Tort Law and Deterrence
Patents and Ethical Licenses
Conclusion
References

Introduction

Clustered regularly interspaced short palindromic repeat (CRISPR), a gene editing technology, has recently received much attention. CRISPR allows more accurate and effective genetic alterations than conventional genetic engineering techniques. Tiny strands of RNA are used to direct a CRISPR-associated protein, such as a Cas protein, to a particular location on an organism’s DNA to make the modifications (Vidyasagar & Lanese, 2022). The Cas protein then precisely cuts the DNA, allowing the insertion of a modified gene or the alteration of the nucleotide sequence at that site.

These characteristics have generated a lot of excitement and raised many questions about the potential effects of CRISPR-related research on the economy, bioethics, and biosafety. The US National Academies of Science has conducted several local and international conferences and published reports on the possible benefits and drawbacks of gene editing (Vidyasagar & Lanese, 2022). Given the US’s scientific and governmental interest in CRISPR, no published research has examined how gene editing technologies evolve inside and across distinct national contexts. Such issues are critical to comprehend since gene editing technologies are being developed and applied in various national and transnational contexts. Furthermore, each with its own set of historical, social, economic, scientific, and political factors can influence the adoption and use of these technologies.

Many critics have emphasized the possibility of CRISPR leading to a worsening of health disparities and a diminution of human dignity in the absence of enhanced oversight of the technology. To that aim, a significant amount of CRISPR-related bioethics studies has argued for a resurgence of the precautionary principle (Sherkow, 2019). These calls imply that, whatever rules now exist to control CRISPR, the technology is so radically disruptive that the state cannot appropriately police it.

Premarket Approval and Regulatory Agencies

One of the main criticisms of CRISPR in bioethics is that it reinforces technological determinism: if a technical application is theoretically viable, it will be adopted. As applied to CRISPR, this raises the possibility of employing the technology in unethical or harmful ways merely because they are feasible. He Jiankui’s recent trials on human embryos, which resulted in the birth of two infants in China with CRISPR-mediated genetic changes, serve as arguably the greatest warning about the perils of such an approach (Sherkow, 2019). To combat such an implacable torrent of technological advancement, several bioethicists have proposed reinvigorating the precautionary principle, particularly when employing CRISPR for therapeutic reasons (Guttinger, 2018). This has included a special request from some of the most renowned CRISPR experts for a temporary global ban on human germline editing.

The motivating concept underpinning proposals for more rigorous precautionary methods is that present rules and regulations are insufficient to review the safety of novel CRISPR applications before they become common in the marketplace. Given CRISPR’s worldwide reach, there are fears that even if sufficient domestic laws forbid such work, the globe will descend into a technology race, with certain governments encouraging work that others deem ethically questionable (Sherkow, 2019). In reality, such evaluations are the responsibility of the several overlapping regulatory authorities that now supervise various components of CRISPR. Of course, for human therapeutics, the Food and Drug Administration (FDA) and its foreign counterparts, such as the European Medicines Agency, oversee the commercialization of practically all new medications and biological products (Sherkow, 2019). Given the range of the FDA’s statutory jurisdiction, the agency’s authority in this area is extensive and, when rigorously implemented, highly potent.

Ultimately, these authorities are precautionary in nature and their mode of operation. CRISPR therapy developers are barred from publicly launching their medicines until they have been tested for safety and efficacy in the human setting. Many applications for novel biological products fail, despite believing that such approvals are unavoidable. This includes technologies like CRISPR, which have piqued the interest of both scientists and the general public. The FDA had routinely rejected non-CRISPR-based gene treatments for decades, despite their enormous promise in treating genetic illness (Guttinger, 2018). Considering the public’s decades-long enthusiasm for stem-cell therapies, the FDA has consistently rejected applications. After receiving the Nobel Prize in Physiology and Medicine in 2006, the FDA recently authorized the first RNA interference (RNAi) treatment (Sherkow, 2019). The FDA is the legal expression of the precautionary principle if such a thing exists.

Tort Law and Deterrence

Tort law—usually the civil, monetary remedy of injuries caused by the carelessness of others—exists in addition to regulatory bodies. This covers situations involving faulty products or insufficient services that cause bodily or economic injury to its consumers. In the case of CRISPR, this implies that people harmed by the technology’s careless usage might sue for restitution, at least in the United States.

At first glance, the tort regime appears to run counter to the precautionary principle. Tort restitution seems to be reactive rather than proactive. Many bioethicists have highlighted concerns regarding the nature of CRISPR as a technology. Since CRISPR is inexpensive, simple, and widely available, its dangers are not adequately contained in the same way that risks from bigger, more institutional initiatives are (Sherkow, 2019). Mitigating problems following the widespread adoption of new technology is notoriously inefficient.

However, tort law is based on deterrents rather than distribution. Tort responsibility, when done correctly, should instill dread in the minds of technology users, ensuring that the technology is utilized safely, ethically, and responsibly. In that sense, a well-oiled tort regime is ideally matched with the precautionary principle: it aims to dissuade harmful applications of technology in the absence of adequate measures.

Patents and Ethical Licenses

Patents, like tort judgments, can ideally be used to drive the precautionary principle as well. Patents are the right to exclude, that is, to restrict others from applying the claimed technology without prior authorization. One of the reasons for the viral interest in CRISPR patents is that the power can be highly economically strong. Due to their potential economic rewards, the University of California and the Broad Institute famously battled for the foundational parts of the CRISPR-Cas9 patents (Sherkow, 2019). The winner, whose identity is still unknown, will have enormous legal and economic authority to prevent others from using the technology.

Those wishing to utilize protected technology must first get permission from the patent owners; this is known as a license. Although licenses are permissive, they can be used to constrain others in restricted ways, such as doing unethical research. Furthermore, licenses, particularly in biotechnology, are frequently in scope worldwide. This is precisely what the Broad Institute does with its CRISPR patents. It forbids licensees from utilizing its technology in immoral ways, such as conducting human germline editing trials or conducting tobacco research. While such licenses are only valid for the duration of the patent, this “ethical licensing” method is ultimately a version of the precautionary principle.

Conclusion

Since the widespread use of CRISPR is a foregone conclusion, it is not subject to meaningful ethics studies that adhere to the precautionary principle. However, if certain safeguards are not taken, a complex and extensive fabric of legal regimes, largely local but some international, can hinder, and in some cases block, the implementation of CRISPR technology. Bioethicists and politicians interested in undertaking ethical evaluations of CRISPR “before it’s too late” should think about these in greater depth. This is not to imply that such systems are without risk—far from it. Even if they only inadequately reflect ethical concerns about technology adoption, they go a great way toward policing some of the more problematic “rogue” applications.

References

Guttinger, S. (2018). Trus in science: CRISPR–Cas9 and the ban on human germline editing.Science and Engineering Ethics, 24(4), 1077-1096.

Sherkow, J. S. (2019). Controlling CRISPR through law: legal regimes as precautionary principles.The Clustered Regularly Interspaced Short Palindromic Repeats journal, 2(5), 299-303.

Vidyasagar, A., & Lanese, N. (2022). What is CRISPR? LiveScience.

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