Context

Globally, there has been rapid growth in the field of biotechnology that has the potential to impact various aspects of people’s lives. At the same time, however, these technologies present unique regulatory and bioethical conundrums.

Background

• During the course of technological maturity, various technologies often challenge existing ethical and regulatory norms, primarily due to their novelty. Biotechnology is one of them.
• It is difficult to regulate the technology at this stage because their broader implications on health, the environment, and national security are yet to be fully understood.
• Regulatory apparatuses however will eventually have to catch up and a new equilibrium is to be established. In this regard, we will delve into details of various ethical conundrums surrounding biotechnology.

We shall examine two of the most promising advances in the field of biotechnology: the CRISPR/Cas9 gene-editing system, and artificial gene synthesis technology.

Analysis

CRISPR/Cas9 Gene Editing Technology

• The CRISPR is an acronym for Clustered Regularly Interspaced Short Palindromic Repeats.
• It is a less than a decade-old gene-editing technology that has revolutionized the field of medical research and biotechnology owing to its efficiency, simplicity, and cost-effectiveness.
• Working of the CRISPR/Cas9: It finds the target DNA sequence in the cell and performs desired edits to the gene sequence, all by itself.

Concerns regarding CRISPR:

• Germline Editing concerns: Germline Editing involves making genetic modifications to human embryos and reproductive cells (sperms/ egg cells). The changes made in the germline are passed on to the subsequent generation. Thus, the use of CRISPR technology in the process raises Ethical concerns like should the unborn child not have a say in decision making of how they want their future to look like.
• Biosafety Concerns: CRISPR, in the wrong hands, could bring in new dangers. It can be used to make dangerous pathogens more potent. An accidental or deliberate release of genetically engineered microorganisms or viruses into the environment is also a cause of major concern.
• Ecological dis-equilibrium: As genetically engineered or modified organisms are introduced, they can reduce the genetic diversity of the targeted population. As this organism can spread to other populations through cross-breeding, it can also affect the genetic diversity of these populations. Eg. BT Cotton can crossbreed with other varieties of Cotton and change their genetic composition.
• Regulatory Bypass: CRISPR has brought into the market a new way to produce genetically engineered crops. Using CRISPR technology, there is no need to insert foreign DNA in a plant to make the required changes. Hence, the plant would not be classified as transgenic. This will help in bypassing regulations controlling the use of GM crops.

Ethical issues involved:

• Safety: It becomes a primary concern due to the possibility of
  • off-target effects (edits in the wrong place) and
  • mosaicism (when some cells carry the edit but others do not)
• Informed Consent: As the long-term impact of germline therapy remains unknown, obtaining truly informed consent from prospective parents is not possible. It has also been argued that the person directly affected, ie. the child (embryo), has no way of providing consent.
• Justice and Equity: Genome editing, like many other new technologies, is accessible mainly to rich people in society. This has the potential to increase existing disparities in access to healthcare and other interventions.
  

Challenges and Opportunities with CRISPR/Cas9

Artificial Gene Synthesis (AGS) Technology

• Artificial gene synthesis is the chemical synthesis of a DNA sequence that represents one or more genes.
• The technology broadens the scope of biological experiments by providing a method to efficiently produce long stretches of natural and non-natural nucleic acid sequences.
• This technology provides several advantages during the research and development process. Gene synthesis is used to make custom plasmid optimize gene expression, produce recombinant antibodies, study mutant genes, and even design and synthesize DNA vaccines

Difference between Synthetic Biology and Genome Editing Synthetic biology, to an extent, is similar to genome editing because both involve changing an organism's genetic code. However, there is a distinction between these two approaches based on how that change is made. In synthetic biology, scientists typically stitch together long stretches of DNA and insert them into an organism's genome. These synthesized pieces of DNA could be genes that are found in other organisms or they could be entirely new. But in genome editing, scientists typically use tools to make smaller changes to the organism's DNA. Genome editing tools can be used to delete or add small stretches of DNA in the genome.

• Ethical issues involved:
  • Playing God!: AGS will enable humans to create life from non-living, inorganic matter. Indeed a role played by God till now. The concern is that humans fail to recognize their limitations, for example, by overestimating their ability to control complex ecosystems. Introducing structurally deep chemistry changes in DNA within living systems could generate unpredictable and possibly lethal outcomes by allowing natural selection to proceed through a competition between current life forms and new ones using modified genetic codes.
  • Organisms or machines?: A unique ethical concern about synthetic biology is that it may result in the creation of entities that fall somewhere between living things and machines.
  • Misuse of knowledge: The accessibility and advantages of this technology make it a potentially attractive instrument, for example, for bioterrorism.
  • If there’s human error, then who will be liable?: For example, concerns have been made that the SARS CoV2 virus which has brought the COVID pandemic was a result of an accidental leak of a genetically edited virus from a laboratory.

Way Forward - Balancing Alarmism and Regulation

• Ethical standards for research and development (R&D) activities are usually enforced through legislation or guidelines issued by national governments.
• So, the challenge before government policymakers is to develop regulations that do not stifle innovation and protect scientific freedom, while ensuring enough checks and balances to minimize risks posed by the misuse.
• For example:
  • Both technologies have been at the forefront of tackling the Covid-19 pandemic. mRNA vaccines have used both these technologies. This shows the usefulness of these technologies.
  • Extremely restrictive regulations would have added more months to the vaccine development process—something that the world could not afford.
• The scientific community also bears a special responsibility to:
  • uphold the highest standards of biosafety and ethical probity
  • minimize incidents of misuse and negligence as they can negatively affect public perception and hamper growth prospects of the emerging technology

Conclusion

Policymakers should take an approach that involves regular deliberations between scientists, civil society, and the private sector. This can be more beneficial than resorting to ad-hoc regulatory arrangements.

Scientists and researchers must always keep in mind Gandhi’s one of the seven sins, i.e, Science without humanity is a sin. Without humanity, science has the potential to cause great harm.  Humanity at the heart of science will make the world a better place.