Time for ELSI to Take its Proper Place from Lab to Market

By Dr. Ilise L Feitshans JD and ScM and DIR

Former Guest Researcher at NCRWE Copenhagen

Legal Advisor for the Greek National Platform on Nanomedicine

Post Doctoral Fellow in SaferNano Law and Design

Executive Director The Work Health and Survival Project

Swiss 0041 79 836 3965  USA  917 239 9960     forecastingnanolaw@gmail.com

Author, Council of Europe Handbook for Parliamentarians on the

Ratification of the Convention Preventing Medicrime

(English and french versions available on the web coe.int)

MS-JD  Writer in residence on international Law



Award Recipient MS-JD SUPERWOMEN- JD conference 2016

Expert on Nanotechnology for the Parliamentary Assembly of the Council of Europe


“Human Security and Health: Time for ELSI to Take its Proper Place from Lab to Market”

The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being“.  Constitution, WHO 1948


Rights are not mere gifts or favors motivated by love or pity for which gratitude is the sole fitting response. A right is something that can be demanded or insisted upon without embarrassment or shame[1]


Law and science have partnered together in the recent past, to solve major public health issues, using “global health diplomacy”. The global health package embraces nanotechnology: new economic frontiers with wide horizons, promising new medicines, strong packaging to protect goods from contamination, cheaper consumer products and new commerce from their trade. Nanotechnology involves manipulating known chemicals at the molecular and atomic level in order to create smaller, faster, stronger, lighter, reliable products.


Opinion leaders in science, law and health policy herald nanotechnology as a “revolution”, bringing to civil society unprecedented developments and economic growth. Trillions of dollars will be spent on research and development funding for the application of nanotechnology in global commerce. Touching the economy globally, nanotechnology spans across almost every industry: food processing Nanotechnology products and the local, national and international laws that may govern them touch the lives of everybody. “It is expected that nanotechnology will play the role electronics played in the 20th century and metallurgy played in the 19th….Manufactured nanomaterials are expected to yield significant innovation…a new competitive edge to European industry and strong benefits… from medicine to agriculture, from biology to electronics”[2]


The promised the vision of nanotechnology’s new world, and how  nanotechnology can be regulated under law in order to incubate new commerce while promoting the realization of health protections may be nanotechnology’s greatest challenge. But nanotechnology is here— Not only is it true that « you can’t put the toothpaste back into the tube », but the toothpaste you use reflecting the latest nanotechnology is already here;  a quiet but important example of the daily application of nanotechnology to consumer products in retail markets, cosmetics, paintings and coatings, agriculture, equipment and packaging.


Everything on earth is made up of nanoparticles. Some nanoparticles have been engineered or manufactured by humans, others occur naturally, and yet another, mysterious group of nanoparticles seem to be generated as a bi-product of events or industrial process. The interaction of the nanoparticles that have been deliberately created with biological systems raises many questions, and opens the door to discussion of the role of naturally occurring nanoparticles and accidental nanoparticles in shaping events in daily life. Thus, bringing together law and science for a decisions about the future of nanotechnology in commerce, health and every aspect of  civil society raises profound scientific questions about the role of  humans in controlling life.


Nanotechnology’s “revolution” provides the perfect vehicle to pose difficult, unresolved health policy questions in civil society and then fix them.  The sound of freedom that resonates from civil and political rights rings hollow to a newborn who has low birth weight, because the baby’s mother had no access to a clean workplace, good nutrition or adequate prenatal care.  And, what good are political and civil rights to a different baby, who has lost a parent due to an occupational accident, or whose parents are debilitated by occupational disease, or to the baby who may suffer personal injury due to the effects of a parent’s workplace exposure to mutagens or unchecked but foreseeable harms caused by unregulated applications of nanotechnology, at home or in their parents’ workplace? Healthy workers are needed to perform work. Unrecognized and underfunded, women’s occupational health is  the linchpin that holds together civil society. No society survives without work or Moms who bear and raise children, even when people are paid to be surrogates the work must be done.   Protecting women’s  occupational health is therefore key to opening the doors of a healthy posterity.


Law and science have partnered together in the recent past, to solve major public health issues, but to do so requires breaking the traditional silos that separate disciplines and compartmentalize knowledge into realms of expertise that ignore the importance of parallel science and policy structures. Heritage from the human genome project of funded projects about  Ethical, Legal and Social Impact (ELSI) research regarding nanotechnology for  two decades ago, drawing in part upon the Human Genome Initiative ELSI projects and remarkable legislative drafting for genentic privacy  HIV AIDS teaches us that addressing such concerns with forethought is not an add-on or an abstract alternate reality  but instead an efficient method of forecasting problems so that there is enough time to solve those problems as they emerge in civil society.   Together,  law and science have created and implemented policies that serve the greater social good ranging from preventing the threat of bankruptcy in the asbestos industry to averting the threat of nuclear holocaust. Historically, this partnership between law and science enables policymakers to write regulatory programs that incubate new industries and advance human development using new technologies,  in face of  unknown  but great risks. Partnership between law and science is particularly significant for nanotechnology,  which has been heralded as a revolution[1] for industry and commerce. Known dangers of many of the substances whose molecular structure are changed using nanotechnology has caused alarm among scientists and policymakers who fear that unfettered use of such new technologies can unleash a public health crisis.  Lessons learned from the late twentieth century initiatives that funded “Big Science” teach us that governments  can use regulatory programs to supervise and  promote risky new technologies, without creating a new race of genetically -engineered monsters or blowing up the whole world.

Despite its cross cutting importance for the funding, development of materials and products and ultimate control of protection for end-users , there has been little or no recognition of existing nanotechnology research addressing  ELSI, the ethical  legal social and policy implications of nanotechnology in commerce, to date. It is difficult to imagine how responsible development of nanotechnology can proceeed without adequate attention to these parameters,  and there is reason to believe that ELSI matters in actual corporate practice despite the dearth of literature regarding these subjects. Beond the issues fof funding that so often have a small percentage set aside for ethical. Known dangers of many of the substances whose molecular structure are changed using nanotechnology has caused fear that unfettered use of such new technologies can unleash a public health crisis. Wise people will try to foresee inevitable but presently unknown nanotechnology risks. Then they will try to address anticipated risks with best practices, codes of conduct and scientific principles to prevent harm,  using the rule of law to harness nanotechnology.

Nanotechnology: Balancing Benefits and Risks to Public Health: A Preliminary Survey of  Possible Legislative Approaches to  Nanotechnology for the Council of Europe Preliminary Draft report .Rapporteur:  Mme Ilise Feitshans  May  29 2012 Based on AS/ENA (2011) 35   22 September 2011Aena11_35  “Nanotechnologies, a new danger to the environment ? ».

Council of Europe, Strasbourg France Report to Committee on the Environment, Agriculture and Local and Regional Affairs Commission de l’environnement, de l’agriculture et des questions territoriales

[1]Henry Shue, BASIC RIGHTS: Subsistence, Affluence and US Foreign Policy p 58-59 citing Feinberg, who was citing Wesley Hohfeld, FUNDAMENTAL LEGAL CONCEPTIONS New Haven, Yale University Press 1923. It is useful to recall too that when this text was first published, women in the USA had obtained suffrage only four years before. It is easy to imagine some very dignified strident women demanding their right to vote in Hohfeld’s then-recent experiences.

[2] Nicolas Segebarth and Georgios Kagarianakis Foreword, IN:  Michael Riediker  and Georgios Kagarianakis, Editors, NanoSafety Cluster “Compendium of Projects In the European Nanosafety Cluster 2011 Edition”. Brussels Belgium

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