Synthetic Biology

In Context

A draft foresight paper on synthetic biology released by the Department of Biotechnology.

Major Points

The document looks at the global policies and protocols that have to be kept in mind while developing such a policy.
It also attempts to define synthetic biology and how intellectual property rights will be applicable to resulting processes and products.
It will later help in creating a national policy.

What is Synthetic Biology?

Synthetic biology refers to the science of using genetic sequencing, editing, and modification to create unnatural organisms or organic molecules that can function in living systems.
Synthetic biology enables scientists to design and synthesise new sequences of DNA from scratch.
First usage:
- The term ‘synthetic biology’ was first used by Barbara Hobomin in 1980, to describe bacteria that had been genetically engineered using recombinant DNA technology.
- Synthetic biology was initially synonymous with ‘bioengineering’.
- In 2000, the term ‘synthetic biology’ was again introduced by Eric Kool and other speakers at the annual meeting of the American Chemical Society in San Francisco.

Applications

Synthetic biology has applications in various fields from developing synthetic organisms for vaccination to creating natural products in a lab such as vanillin, the organic compound extracted from vanilla seeds, which can now be grown in yeasts with additional plant genomes.
In the pharmaceutical industry, synthetic biology can be used to make natural compounds such as artemisinin used for the treatment of malaria and Car T cell therapy for cancer treatment.
It is starting to be used in the fashion industry as well; some companies are exploring the possibility of dyeing jeans without producing hazardous waste.
Then there are companies using it to deliver fixed nitrogen to plants instead of using fertilisers, engineering microbes to create food additives or brewing proteins.
Other applications to therapeutics include engineered networks and organisms for disease-mechanism elucidation, drug-target identification, drug-discovery platforms, therapeutic treatment, therapeutic delivery, and drug production and access.

Risk and Challenges

The great challenge of synthetic biology is that the biological systems are complex, and the operating principles are still not fully elucidated.
The intentional or accidental release of genetically engineered organisms into the environment could have significant negative impacts on both human and environmental health.
- Misuse of these technologies and a failure to account for unintended consequences could cause irreversible environmental damage.

Regulating the use of easily accessible and low-cost technologies like CRISPR will likely be a challenge for authorities.
- There is also growing concern that the technology could be misused by extremist groups.

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.
- It is not difficult to see why some products of synthetic biology might fail to fit comfortably into our intuitive dichotomy between the living and the non-living.

Way Forward

Under the precautionary principle, stringent risk assessment and the inclusion of diverse stakeholder perspectives should be applied in the development and handling of innovative synthetic biology applications and products.
It is time for India to consolidate its stand on the science of synthetic biology and communicate its interests and aspirations in relevant international fora with clarity and should avoid conflicting stands on science on one hand and policy on the other.
It is time to create a policy for synthetic biology now more than ever as it is rapidly evolving with new discoveries happening every year.
- Soon we will start to see some products and we need to be ready with the regulatory framework.
  - There is also a need to look at the benefits of the products and the risk it poses to biodiversity.

International treaties and organisations related to synthetic biology

Various international treaties and organisations are currently examining the impacts of synthetic biology and engineered gene drive systems on their respective agreements.
- India is a party to all the International governance bodies discussed below.

Convention on Biological Diversity (CBD):
- Synthetic biology falls within the scope of biotechnology, as defined by the Convention on Biological Diversity.
  - Signed by 150 government leaders at the 1992 Rio Earth Summit, the Convention on Biological Diversity is dedicated to promoting sustainable development.
  - Conceived as a practical tool for translating the principles of Agenda 21 into reality, the Convention recognizes that biological diversity is about more than plants, animals and microorganisms and their ecosystems – it is about people and our need for food security, medicines, fresh air and water, shelter, and a clean and healthy environment in which to live

Food and Agricultural Organization (FAO):
- The FAO International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) , a report commissioned in 2017 examined the impacts of synthetic biology and digital sequence information (DSI) on the Plant Treaty.

Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES):
- It has been engaged in discussion on the question of synthetic products that are indistinguishable from products from listed specimens and the status of modified organisms and products under the Convention.
- The seventieth meeting of the CITES Standing Committee in October 2018 adopted a report on the “Specimens Produced from Synthetic and Cultured DNA.

International Union for the Conservation of Nature (IUCN):
- IUCN Members adopted a Resolution titled “Development of IUCN policy on biodiversity conservation and synthetic biology” to map the impacts on conservation and sustainable use of biodiversity.
- In early 2018, an IUCN Synthetic Biology and Biodiversity Conservation Task Force was created to oversee the implementation of the Resolution and to develop policy recommendations before the 2020 World Conservation Congress.

Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS):
- The focus under TRIPS, on issues related to synthetic biology, pertains to the intellectual property rights issues.
- In accordance with TRIPS, patents should be available under the national law of WTO members (other than LDCs) for innovative products/ processes in the field of synthetic biology, provided that they constitute inventions that comply with the general patentability standards.

UN Convention on the Law of the Sea (UNCLOS):
- UNCLOS includes activities and resources beyond national jurisdiction.
- In relation to a new treaty under negotiation that includes marine genetic resources in areas beyond national jurisdiction (ABNJ), including sharing of benefits synthetic biology and its impact on ocean governance is being discussed.

Source: IE

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