From a technical perspective, synthetic biology is more akin to a new engineering discipline, in which new cells or organisms are synthesized according to the design of human cells. Previous reports have described the function of synthetic cells as "like a machine", and some synthetic biologists even refer to their products as “genetically engineered machines”. The findings of synthetic biologists may present many beneficial applications, but also gives rise to concerns issues relating to ethics, security and safety. Therefore, the development of scienceand technology must be navigated in accordance withethical standards. The debate surrounding syntheticbiology has raised several issues, such as bioethics, bio-security, bio-safety, involvement of stakeholders and intellectual property rights which has launched more than 10 years ofheated discussion within the scientific community.
Bio-ethics Issues
Ethical Issues The creation of artificial organisms that are not found in nature leads to ethical questions about the role and responsibility of human beings in creating novel life forms. Statements to the effect that the next 50 years of DNA evolution will take place “not in nature but in the laboratory and clinic”. clearly challenge our understanding of the natural world and our place within it. With innovations such as cell-free approaches, synthetic biology raises difficult questions about where the line should be drawn between what is ‘natural’ and what is not, and whether it is helpful to attempt to draw such a line at all. From a deontological perspective, these arguments are a continuation of longstanding debates, such as "Whether people should play God?", "If people have the right to intervene with the characteristics of future humans", "Whether people should interfere with natural development?" and so on. The emergence of artificial life has once again sparked much criticism and the opposition between conservative Catholic and radical Darwinism viewpoints has been particularly intense, in which points of contention revolve around whether that only God (or nature) has the ability to create life, all things in nature evolve after long-term evolution, and only behaviour conforming to natural development is correct. Thus, these groups cannot accept the opposing directions of synthetic biology and nature.
Bio-Security Issues
Bio-security issues mainly include misuse through loss, theft, diversion or intentional release of pathogens, toxins and other biological materials. For example, some worry that terrorist attacks and biological warfare with synthetic biological products will become much easier, especially considering that techniques to produce deadly pathogens are relatively very easy to obtain. One should recognize that any new biotechnology will bring similar risks, and synthetic biology is no exception. But, for the moment, at least, the construction of laboratories to conduct synthetic biological experimentation is beyond the range of most terrorist organizations, thereby rendering the use of these products against society unlikely. Furthermore, it must be mentioned that synthetic biology research has the potential to benefit all of humanity, thus we cannot limit the development of synthetic biology because of perceived or hypothetical terrorist attacks. Hence, cautious analysis of events that may occur should be addressed to minimize risks and maximize benefits offered by this technology.
Bio-safaty Issues
Bio-safety issues mainly include unintentional exposure to pathogens, toxins and otherwise harmful or potentially harmful biological materials, or their accidental release. The concern of bio-safety issues associated with biotechnology is indeed worthy of attention. But as long as effective security measures are enforced, for example the use of Escherichia coli strains that only survived below 36°C in gene engineering experiments, we can eliminate the possibility of propagation and spread of experimental bacteria to humans. In addition, with the continued improvements in rigorous experimental rules, security measures and new methods of risk assessment to decide whether a new synthetic biology technique or application is sufficiently safe, breaches of biological safety will probability become ever more scarce.
Intellectual property issues
Since synthetic biology is a new field, the intellectual property issues are still in flux. Intellectual property law works on the basis of precedent, and attempts to draw parallels with already existing technologies. This is problematic in the case of synthetic biology, because it sits at the intersection of biotechnology, software and electronics. Some commentators have expressed the view that the main objective should be to develop some form of protection of intellectual property in synthetic biology “without stifling the openness that is so necessary to progress”. But patents already exist that could inhibit the progress of research in the field. Some of these are very broad patents relating to foundational technologies - such as methods of producing synthetic DNA. Other patents are narrower, eg patents on the biological functions encoded by bioparts. Others relate to software and computer simulations. Perhaps the most famous synthetic biology patent application is Craig Venter’s application, filed in May 2007, for his Mycoplasma laboratorium genome, the smallest genome needed for a living organism. The patent also claims any method of hydrogen or ethanol production that uses the minimal genome as a chassis. It has received a great deal of media attention, because it can be interpreted as a patent on the ‘essence of life’ itself. However, analysts think it is unlikely to be granted on the grounds of lack of enablement. The company Scarab Genomics has a patent on a minimised E coli genome, which, some argue, may prove to be more important. Synthetic biology encompasses more than just bioparts. There has been discussion about whether there should be different ownership regimes for different levels of a synthetic entity, such as parts, devices and systems. Some argue that since any systems and organisms produced by synthetic biology will be the result of a great deal of work, they should be subject to more stringent forms of intellectual property protection than bioparts. This approach raises the question of whether it is possible to separate different levels of synthetic entity. In summary, emerging the creation of overly broad patents that may foster monopolies, hamper collaboration, and stifle innovation by other researchers; and, conversely, the creation of unduly narrow patents that can impede subsequent applications because of the complexity of licensing arrangements required to deal with multiple holders. The multidisciplinary nature of synthetic biology, which requires that patent expertise be drawn from several different fields, may serve to exacerbate these problems. Or it may not; an alternative view holds that the discrete and separate entities that go to make up synthetic biology are relatively well suited to commoditization. Either way, EASAC advises patent offices to take care when asked to grant broad patents.
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