<p>In the context of conversations on modern biotechnology in the country, the ethics need to be reiterated much more. One view in fact is that if the ethical considerations were centrestage, then the many controversies associated with the application of this technology would not have been there. <br /><br />Much of the debates on this subject have revolved around the proposed legislation - the Biotechnology Regulatory Authority of India (BRAI) Bill, and its many versions from 2008 to the latest one of 2013. The BRAI Bill, 2013 is now before a Parliamentary Standing Committee. <br /><br />As per the bill the intended administration of this law-in-the-making hinges largely on the national-level authority. It shall be the duty of the authority to regulate the research, transport, import, manufacture and use of specified organisms and products of modern biotechnology so as to ensure the safety to human health, animal health and the environment.<br /><br />From an ethical standpoint the bill is based on the presumption that it is alright to invent living modified organisms (LMOs) using tools of modern biotechnology. In fact the bill settles the question without the legislature having discussed the possible answers to that with specificity to an Indian ethos. It de facto forestalls the asking of that question. A reading of the bill also indicates that it does not encourage debate on another ethical aspect, i.e. if and how the new technology empowers or disempowers peoples. <br /><br />Strategic advice<br /><br />The bill provides that the Central Government shall, by notification, constitute a Biotechnology Advisory Council (BAC) to render strategic advice to the authority on the matters relating to developments in modern biotechnology and their implications in India. This sixteen-member council is to have the chairperson of the Biotechnology Regulatory Authority as its presiding officer. <br /><br />Scientists, 'from public or private sector' as stated in the text, are to be part of BAC. It is also to have a representative of a farmer organisation and a legal expert. But what is most relevant to the context here is that bill requires the said BAC to also have one ethicist as its member. This is the only place in the bill that ethics has a mention. <br /><br />However, this is a lone guard post for a nation's conscience on biosafety. And it may get to be a very lonely position for the incumbent too. An ethicist is someone whose judgment of what is right and wrong is trusted by the larger community. She is not simply to consider what would set good moral example, but how best to deal with practical issues. <br /><br />For instance, outside the process of the BRAI law-making, actual experiences with approvals for genetically engineered crops have not been able to instill public faith in the existing regulatory system on LMOs. The ongoing public interest petition before the Supreme Court of India and the committee reports it has propelled point to 'pervasive conflict of interest' embedded in existing biosafety regulatory bodies. Can these instances be plugged by a singular ethicist placed under a Chair who is otherwise tasked to promote biotechnology?</p>.<p>Law and ethics don't automatically co-exist. Law in general has to reflect and encourage ethical practice. In a situation of glaring gaps from an ethical standpoint in both the implementation of existing rules on biosafety and proposed pro-GM Bill, there is risk of both law and law-making suffering a further trust deficit by people. <br /><br />The bill might well be the acid test of how India will deal with ethical questions with regard to new and emerging technologies. Unfortunately, the country's latest Science, Technology and Innovation Policy 2013 announced earlier this year does not help. In fact it makes no mention of ethics whatsoever. A decade ago, India's Science and Technology Policy had expressly stated that scientific and technological developments today also have deep ethical, legal and social implications. <br /><br />The BRAI Bill and those debating it can't simply be approaching it from the concerns of biosafety, a new bioethics – that which can not be 'engineered' for narrow political and economic interests, has to be honestly developed. The cacophonous back and forth on the provisions of the BRAI Bill can not be quieted by the lone ethicist. The basic reasoning of why something is good or bad ought to be in the letter and spirit of the law. </p>
<p>In the context of conversations on modern biotechnology in the country, the ethics need to be reiterated much more. One view in fact is that if the ethical considerations were centrestage, then the many controversies associated with the application of this technology would not have been there. <br /><br />Much of the debates on this subject have revolved around the proposed legislation - the Biotechnology Regulatory Authority of India (BRAI) Bill, and its many versions from 2008 to the latest one of 2013. The BRAI Bill, 2013 is now before a Parliamentary Standing Committee. <br /><br />As per the bill the intended administration of this law-in-the-making hinges largely on the national-level authority. It shall be the duty of the authority to regulate the research, transport, import, manufacture and use of specified organisms and products of modern biotechnology so as to ensure the safety to human health, animal health and the environment.<br /><br />From an ethical standpoint the bill is based on the presumption that it is alright to invent living modified organisms (LMOs) using tools of modern biotechnology. In fact the bill settles the question without the legislature having discussed the possible answers to that with specificity to an Indian ethos. It de facto forestalls the asking of that question. A reading of the bill also indicates that it does not encourage debate on another ethical aspect, i.e. if and how the new technology empowers or disempowers peoples. <br /><br />Strategic advice<br /><br />The bill provides that the Central Government shall, by notification, constitute a Biotechnology Advisory Council (BAC) to render strategic advice to the authority on the matters relating to developments in modern biotechnology and their implications in India. This sixteen-member council is to have the chairperson of the Biotechnology Regulatory Authority as its presiding officer. <br /><br />Scientists, 'from public or private sector' as stated in the text, are to be part of BAC. It is also to have a representative of a farmer organisation and a legal expert. But what is most relevant to the context here is that bill requires the said BAC to also have one ethicist as its member. This is the only place in the bill that ethics has a mention. <br /><br />However, this is a lone guard post for a nation's conscience on biosafety. And it may get to be a very lonely position for the incumbent too. An ethicist is someone whose judgment of what is right and wrong is trusted by the larger community. She is not simply to consider what would set good moral example, but how best to deal with practical issues. <br /><br />For instance, outside the process of the BRAI law-making, actual experiences with approvals for genetically engineered crops have not been able to instill public faith in the existing regulatory system on LMOs. The ongoing public interest petition before the Supreme Court of India and the committee reports it has propelled point to 'pervasive conflict of interest' embedded in existing biosafety regulatory bodies. Can these instances be plugged by a singular ethicist placed under a Chair who is otherwise tasked to promote biotechnology?</p>.<p>Law and ethics don't automatically co-exist. Law in general has to reflect and encourage ethical practice. In a situation of glaring gaps from an ethical standpoint in both the implementation of existing rules on biosafety and proposed pro-GM Bill, there is risk of both law and law-making suffering a further trust deficit by people. <br /><br />The bill might well be the acid test of how India will deal with ethical questions with regard to new and emerging technologies. Unfortunately, the country's latest Science, Technology and Innovation Policy 2013 announced earlier this year does not help. In fact it makes no mention of ethics whatsoever. A decade ago, India's Science and Technology Policy had expressly stated that scientific and technological developments today also have deep ethical, legal and social implications. <br /><br />The BRAI Bill and those debating it can't simply be approaching it from the concerns of biosafety, a new bioethics – that which can not be 'engineered' for narrow political and economic interests, has to be honestly developed. The cacophonous back and forth on the provisions of the BRAI Bill can not be quieted by the lone ethicist. The basic reasoning of why something is good or bad ought to be in the letter and spirit of the law. </p>
