Team:IBB Pune/BIOETHICS

As scientists and citizens, we must address questions and controversies surrounding the use of biotechnology and make choices that will best serve humanity. We should be committed to the socially responsible use of biotechnology in health care, food and agriculture, industry and the environment. As biotechnology reaches toward such benefits as treatments for intractable diseases such as cancer, Alzheimer’s and Parkinson’s; abundant, nutritious food; industrial sustainability; and a cleaner world, we encourage public discussion of the ethical, legal and social implications of biotechnology research. Responsible and ethical testing of new technologies and believes that decisions regarding whether and how to use medical products and technologies always must be made with profound respect for the rights of patients. In our view, appropriate regulation of biotechnology is solidly rooted in values such as autonomy, privacy, beneficence, social justice and intellectual freedom.

Synthetic biology is broadly defined as the area of intersection of biology and engineering, that is focused on: The design and fabrication of biological components and systems that do not already exist in the natural world and the redesign and fabrication of existing biological systems. A primary objective of this nascent research area is to create a programmable microorganism from scratch, as opposed to modifying components of living cells to achieve desired functionality. This distinguishes it from current genetic techniques that result in genetically modified organisms at the cellular level. How can we compare synthetic biology to other areas of biotechnology? Transgenic mice, bio-engineered plasmids, and other living forms are regularly created in the process of biomedical research. What would be the difference between these modified life forms and life forms created using a synthetic biology approach? In order to address these questions, the primary differentiators between synthetic biology and other techniques are outlined below. Synthetic biology systems would exhibit one or more of these attributes (first two are mandatory): Raw materials: Synthetic elements would be constructed from basic elements (synthetic or purified oligonucleotides in the case of synthetic DNA) in the lab (and not as part of a natural cellular process). *''No natural counterpart:'' Synthetic elements or networks would not have an identical copy in natural cells. The caveat would be synthetically created whole genomes of existing organisms – although a minimal genome (critical genes for survival) organism would be more likely. *'' Programmable:'' Synthetic regulatory elements and networks engineered in cells would be controllable with external stimulus in a deterministic fashion. *''Synthetic whole genome:'' Starting with synthetic oligonucleotides as raw materials, the end product would be an artificially assembled genome or “minimal genome”. In order to distinguish between synthetic biological creations and other approaches like transgenic organisms, the key difference to be noted is that transgenic organisms are the result of introducing naturally occurring foreign or mutated DNA (genes) into the organism. *''Risks involved in synthetic biology practices'' Some of the risks posed by products of synthetic biology are outlined below. As we move up the classification hierarchy of synthetic biology products, and thus on to higher levels of integration, the risks increase. *''Risk of negative environmental impact:'' This includes scenarios in which a synthetically created micro-organism designed for a particular task (e.g.: Environmental cleanup) could have a side effect of interacting with another environmental substance and impact the overall environment negatively. *'' Risk of natural genome pool contamination:'' Any genetic exchange between a synthetic biological entity and a naturally occurring biological entity would result in natural genome contamination. This is similar to the problem of “gene-flow” in the context of transgenic plants. *''Run-off risk (“Grey-goo” problem):'' This is similar to the problem often discussed in the context of nanotechnology. Synthetic biology products released into the environment to accomplish a specific task should have a controlled lifespan outside the lab. If this in not the case, one can envision unintended consequences of a system run amuck. *''Risk of creation of deadly pathogens for the purposes of bio-terrorism:'' The creation of the complete genome of Polio virus in the lab shows the potential of synthetic biology to engineer harmful pathogens. This technology, in rogue hands, could be used to engineer the genomes of deadly pathogens. The fact that the synthetic Polio virus was proven to be infectious shows the deadly potential of this technology.

For over 200 years, intellectual property laws have been the driving force for innovation and progress. The biotechnology industry as we know it did not exist prior to the landmark US Supreme Court decision of Diamond v. Chakrabarty of 1980. The court held that anything made by the hand of man was eligible for patenting. Since this decision, the biotechnology industry has flourished and continues to grow. The patent system fosters the development of new biotechnology products and discoveries, new uses for old products and employment opportunities for millions of Americans. Nowhere is this more apparent than in the biotechnology arena. Patents add value to laboratory discoveries, providing incentives for private sector investment into biotechnology development of new medicines and diagnostics for treatment and monitoring of intractable diseases, and agricultural and environmental products, to meet global needs. Patents facilitate academic research, because the release of information to the public is critical to the advancement of knowledge. The fact that an inventor can obtain patent protection on an invention encourages inventors not to withhold beneficial information from the public. In fact, the patent system provides strong incentive for sharing information. Not only can researchers use the information in a patent, but also by disclosing cutting-edge scientific information, the patent system helps prevent expensive duplication of efforts.