By: Fred Jankilevich
Lawyer – Consultant
November 18th 2017
A recent panel this week at Harvard University presented new methodologies in the field of synthetic biology. This compelling and challenging field of biology empowers scientists with the faculty to “evolve” life. Nonetheless, to what extent is there a legal and ethical framework to make this research ethically and legally compliant?
The notion of protection in terms of bio-security can be traced back to the Nineteenth Century, as Shattuck L. in his “Report of a General Plan for the Promotion of Public Health” affirms (ca. 1850: Pp. 304): Each individual in society has a right to be protected by the enjoyment of his life…(…) it is the duty of the State to extend over the people its guardian care, that those who cannot or will not protect themselves, may nevertheless be protected; and that those who can and desire to do it, may have the means of doing so more easily.” It can be assumed, as an inference, therefore, that life and physical integrity as fundamental freedoms constitute the starting point in the foundation of the framework.
As a consequence of the above stated, its possible to surmise as well that, before regulating a new field such as synthetic biology further, its important to complete more research to understand the nature, effects, and distribution regarding the potential threats to our health as well as the available potential interventions to protect us.
In this sense, the new methods proposed by synthetic biology are still in its diapers as the local Massachusets experiments reflect. Therefore, while some regulation exists in the Commonwealth pertaining new methods of synthesis, the Academic Research Bodies at Harvard and its Bioethics Committee are mostly concerned with the global, mid-term and long-term implications of new cell synthesis technologies.
As can be inferred from the above stated, the field of research is fairly recent, but the U.S. Supreme Court has made clear its stance with regards to DNA patenting in the sense that “isolated D.N.A. is not patent eligible.” (Association of Molecular Pathology v. Myriad. 133 S. Ct. 2107. 2013). Australia follows a similar ruling in a Full Federal Court decision of the High Court whereby “when trying to patent isolated genetic material, the crux or substance of the invention is the genetic information encoded in the D.N.A.” The ruling affirms, following the cited text that “information, however, is naturally occurring, which means it is not “made” by human action and is not a “manner of manufacture” and therefore is not patentable under Australian patent law.” (2014: FCAFC. 115. Austl.). As a result, pharms and biotech companies, are discouraged from protecting investments by using patents from isolated D.N.A.
In relation to bio-security, therefore, there is a persistent neglect that to the present prevails as overwhelmingly refuted by scientific evidence. In this regard, its estimated that “70-80 percent of the crops in the United States destined for consumption contain ingredients that have been genetically modified.” (Lowe R.: 2009: Online)