Prepared for the Conference “20 YEARS AFTER:
THE OVIEDO CONVENTION ON HUMAN RIGHTS & BIOMEDICINE”
Dr. Ilise L Feitshans JD and ScM and DIR
Fellow in Nanotechnology Law for the European Scientific Institute, France
Legal Advisor for the Greek National Platform on Nanomedicine
Executive Director The Work Health and Survival Project USA AND SWITZERLAND
Swiss 0041 79 836 3965 USA 917 239 9960 email@example.com
MS-JD Writer in residence on international Law
Award Recipient MS-JD SUPERWOMEN- JD conference 2016
Expert on Nanotechnology, Nanomedicine and the Prevention of Medicrime for the Parliamentary Assembly of the Council of Europe
Co-author Cagri Zeybek Unsal, PhD(c)
NEW BOOK!! GLOBAL HEALTH IMPACTS OF NANOTECHNOLOGY LAW
ABSTRACT 298 words
Protecting human rights concerning genetically related aspects of biomedicine has been effectively addressed by the Oviedo Convention. Marvelous achievements nonetheless require ancillary legislation to promote coherent Pan European policies for implementation by national governments and locally. Given the achievements of this Convention, it is important to sustain these achievements in the near future. But, scientific realities, not envisioned at the time of its writing turn bioethics upside down: Frozen eggs and remarkably accurate in vitro harvesting impact choices and decisions about human reproduction, including the spectrum of embryos that will be considered viable for new parents to raise. Nanotechnology plays a major role in this sweeping social change, bringing new approaches to physical properties of matter, new uses of human stem cells from oneself and ultimately new definitions of key legal terms. Nanotechnology and nano-enabled treatments are being developed for synthetic organs, grown from the patient’s own stem cells. This may reduce significantly trafficking in human organ transplants, once the price of grow-your-own organs becomes commercially marketable, but without attention to bioethical concerns about prolonging life, and who decides. It is also not difficult to imagine that people will be able to use their own stem cells to create eggs or sperm, and thus have only one parent for a newborn child, who will be completely of their choosing if not design, with their genetic imprint plus a few alterations via gene therapies or fetal surgery in an artificial womb. Therefore it is unclear whether Convention will apply or place limits on genetic tinkering made possible using nanotechnology. This article offers a retrospective summary relating to the Convention’s achievements regarding genetics and biomedicine, suggests future challenges to sustaining the impact of those achievements and offers a glimpse of the potential synthesis of existing law as applied to new developments.##
Control and scrutiny of medicines and treatments that touch genetically relevant aspects of human biomedicine have been effectively addressed by only one international instrument: the Council of Europe Oviedo Convention on Human Rights and Biomedicine, created in 1997. Nanotechnology plays a major role in this sweeping social change, bringing new approaches to physical properties of matter, new uses of human stem cells from oneself and ultimately new definitions of key legal terms. When the Convention was drafted and debated, scientists were still mapping the human genome and bioethicists were worried about what society would do with information revealed at the chromosomal level. In 1993, The Human Genome Project had revealed the information on functions of genes and proteins which paved the way for next generation sequencing techniques and gene editing. This led to a paradigm shift and provide the opportunity to tailor therapeutics for every person individually due to their genes and DNA segments. It became possible to do genetic modifications and use genetic information of each person to manage their own health care. However, these new developments have the potential to enhance human traits. Article 13 attempted to address this problem and arrest development of eugenic changes to the human species or the creation of a new sub-human species by stating: “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants”. Since it can be argued that any changes are ultimately designed to influence destiny, civil society faces the multibillion dollar question:. Are these changes ok -Or- in violation of the convention -Or not covered by it at all? Scientific realities, not envisioned at the time of its writing therefore turn the Convention’s vision of bioethics upside down: Frozen eggs and remarkably accurate in vitro harvesting impact choices and decisions about human reproduction, including the spectrum of embryos that will be considered viable for new parents to raise.
Impacts of Nanotechnology on Human Genome
Nanotechnology offers new tools for genetic testing and gene therapies. Manipulating particles at the nanoscale is smaller than D N A. Therefore nanotechnology and nano-enabled devices are now used in genetic engineering, gene therapies and a variety of new approaches to reproduction in humans and other species. Nanotechnology can be used to alter nanoparticles within DNA and RNA which is a subset of a subset at the chromosomal level, thereby enabling geneticists to alter or create new proteins by manipulating DNA or the protein corona that surrounds a cell. Some people will be unaware of these larger implications, or may underestimate its importance for ongoing genetic testing, gene editing and the development of replacement organs from an individual’s own stem cells, or other aspects of personalized medicine. The natural question is whether application of nanotechnologies are juridically viewed as “an introduction of modifications in the genome”. In the alternative, it could be argued that such developments in science is excluded from the provision of the Convention, because there is no mention of nanotechnologies in the text itself. This raises the possibility that thanks to scientific progress, researchers, commercial entities and prospective customers who wish to be parents can circumvent the constraints of the Convention.
Although anyone who studies this Convention is charged with the mission to think carefully about whether amendment is needed, the key outcome determinative variable about its applicability to new sciences is the context in which the new technology is applied. When discussing genetic manipulation of the human genome or related species, some people might have the mistaken impression that Nanotechnology and genetics are distinct disciplines, but nanotechnology actually offers a new tool for addressing the Convention’s concerns. A classic question of whether plain meaning of the text limits or overtakes the implementation of purposes and principles, unless saving clauses can be applied to a reasonable interpretation.. The impact of nanotechnologies on the scope and vibrant application of the Convention will depend very much upon HOW nanotechnologies are applied in the genetics context. And if they are ok under the convention’s plain meaning but violate its principles, is it the text or the principles that must change? Or not covered by plain meaning and violate its principles what shall we do? Amend.. Ignore… Write a different convention??
Cancer drug delivery presents a deceptively easy example. There is likely to be wide popular consensus that society agrees to alter the genetics of cancer in order to kill cancer cells. Some people, including bioethicists, may not even care if exterminating cancer cells also has a long term genetic impact on a terminal patient who enjoys an extended survival curve because that comparatively small damage means they still have years more to live. A person who is not expected to reproduce cannot, by definition, face an impact on the human genome even if there would be alteration or damage to their individual genetic material. Thus, altering the genome of cancer cells is a desirable outcome even though it might at first reading run afoul of the terms of the Oviedo Convention.
Fighting Against Organ Trafficking with Nanotechnology That Creates Replacement Organs
Another context in which embracing nanotechnology would advance the convention’s purposes involves those instances when nanomedicine and nano-enabled medical devices are used for developing synthetic organs for use in humans, grown from the patient’s own stem cells. Such applications of nanotechnology can be very effective in implementing some of the biomedical concerns addressed by the Council of Europe convention because, synthetic organs may reduce significantly trafficking in human organ transplants, once the price of grow-your-own organs becomes commercially marketable. Even so the commercialization of new products to replace transplants may require attention to bioethical concerns about prolonging life which are also implicit in the convention. Additionally, equal access to the benefits of those technologies is another concern of bioethics that should be addressed. Efforts must be made to assess keystone questons about bioethics that have not yet been explored in this new nanotechnology context. Is the economic gap between developing and developed countries cause developed countries to benefit more from nanotechnology? How will commercialization of new products affect society? How will the organ allocation policies be affected after availability of commercially marketable organs?
It is also not difficult to imagine that people will be able to use their own stem cells to create eggs or sperm, and thus have only one parent for a newborn child, who will be completely of their choosing if not design, with their genetic imprint plus a few alterations via gene therapies or fetal surgery in an artificial womb. Thus, interpreting nanotechnology as acceptable under the terms of the convention has many advantages. We like that when it is a targeted drug delivery assaulting a cancer cell or ending trafficking of human organs for sale. But perhaps some other types of manipulation run afoul of the convention? But perhaps some other types of manipulation run afoul of the convention because the alteration of the human genome, ostensibly designed to avoid a terrible disease or genetic condition, also makes an irretrievable change in the human genome. In this regard, the difference between enhancement and treatment needs to be considered since enhancement does more than restoring existing human functions in comparison to treatment. (Erik Parens, Shaping Our Selves: On Technology, Flourishing and a Habit of Thinking, p. 20)
New Developments Beyond the Purposes of the Oviedo Convention:
Revisiting the Oviedo Convention in regard to Applications of Nanotechnology
Since no legislature has authorized a list of forbidden genes, and no popular vote has been taken to determine which diseases and genetic conditions are by majority of political will forbidden or undesirable, avoiding discussion of whether the biomedicine convention applies to nanotechnologies that did not exist at the time of its writing runs the risk of defeating the purposes of the convention. Thanks to scientific progress, individual researchers, potential parents or government authorities imposing the conditions for an acceptable fetus may be able to circumvent the constraints of the provision. At present, new nano-enabled technologies such as “three parent” manipulation of genetic material in the maternal mitochondria fly in the face of its provisions that ban “and only if its aim is not to introduce any modification in the genome of any descendants”. This unexpected outcome undermines the purposes and intention of the convention, leaving it equally vulnerable to new questions not clearly covered by its text, and without criteria to differentiate between acceptable genetic alteration in contrast to genetic impacts that are unacceptable. Or impacts that constitute a major trade off for someone who is very sick but not considered terminal and therefore might live struggling with problems such as Parkinson’s or Alzheimer’s or broken bones without nanomedicine? Another blank spot in the blanket interpretation of the convention is equally disconcerting: What about human volunteers in nanotechnology experiments (which exist in some European countries). Are such experiments exempted because the Convention does not discuss “Nanotechnology”? These open questions are so numerous and important that it is reasonable to ask whether the Council of Europe should amend or modify the Council of Europe Convention on Biomedicine and Human Rights, but in reality integrating expert information about state of the art nanotechnology would avert such and expensive and destructive path. Amendment inevitably the process requires rethinking the entire document.
By contrast, a working group could be empowered to examine these issues with a view to creating interpretive guidance documents. There is a credible argument to support an opinion that application of nanotechnologies can be considered “an introduction of modifications in the genome”, but there is no text referring to nanotechnologies that offers jurisdiction over nanotechnologies in order to scrutinize them. It is a matter first of interpretation and seconds of legislative judgment or examination by a court to determine whether unanticipated nanotechnologies are excluded from the provision of the Convention. Therefore it is unclear whether Convention will apply or place limits on genetic tinkering made possible using nanotechnology. These developments are, however, the first of many more in a sea change of nano-enabled alterations of evolution, suggesting additional future challenges to sustaining the impact of those achievements. If experts anticipate these issues then civil society can effectively address them without writing new law.
Author of GLOBAL HEALTH IMPACTS OF NANTOTECHNOLOGY LAW
Dr ilise L Feitshans devoted her Masters of Science thesis to exploring decisionmaking concerning genetic testing during pregnancy for Johns Hopkins University School of Public Health. As a student, she had the honor and good luck to be part of one of the very first Ethical Legal and Social Implications (ELSI) working groups: a multidisciplinary group of legal scholars geneticists bench researchers ethicists economists sociologists and medical anthropologists. Ilise was tasked to examine the right to know the right not to know and to refuse treatment or testing (for example in the case of individuals whose family members have Huntington’s Disease, the working group included Dr Nancy Wexler who discovered the Huntington’s gene and proved that the disease occurs in women as well as men); genetic privacy ; legal questions about who owns genetic information and also to draft the necessary legislation proposed to prevent genetic discrimination. Her thesis was based on work for the US government National Institutes of Health (NIH) for the Human Genome Project while teaching Legislation and Legislative Development of the Law at Columbia University School of Law in the City of New York and predicted surprisingly accurately the gaps that needed attention in the legal framework regulating genetic research experimentation on humans and commercializaction. Many of the issues that she predicted would be important for legislation (such as preventing genetic discrimination) became the subject of new law such as GINA the Genetic Information Non Discrimination Act under USA federal law in 2008. Ilise’s most recent research and legislative work for the Council of Europe and elsewhere has focused on Nanotechnology which is the newest tool for genetic manipulation and biomedicine. Her report to PACE, Council of Europe, Report to the Parliamentary Assembly, Accepted April 26 2013, “Nanotechnology: Balancing benefits and risks to public health and the environment” http://assembly coe .int/ASP/NewManager/EMB_NewsManagerView.asp?ID=8693&L=2 foll International lawyer and former international civil servant at the United Nations, Geneva, Switzerland, Dr ilise Feitshans obtained her master of science in public health from Johns Hopkins University, Baltimore, USA, and doctorate in international relations from Geneva School of Diplomacy, Switzerland, in 2014. She is Fellow in Law of Nanotechnology at the European Scientific Institute, Archamps, France (affiliated with CERN and the University of Grenoble), and executive director of the Work Health and Survival Project. She is also a member of the US Supreme Court bar and was acting director of the Legislative Drafting Research Fund, Columbia University School of Law, New York, USA. Her pro bono activities include serving as legal advisor to the Greek National Platform on Nanomedicine, University of Aristotle, Thessaloniki, Greece, since 2015.
Dr. Feitshans served as coordinatrice for the ILO Encyclopedia of Occupational Health and Safety in Geneva, Switzerland. A graduate cum laude of Barnard College of Columbia University, New York, USA, she was also visiting scientist at the Institute for Work and Health, University of Lausanne, Switzerland (2011–2014). She was honored among “100 Women Making a Difference in Safety, Health and Environment Professions” by the American Society of Safety Engineers in 2011 and received the Ms-JD.org Superwomen award in 2016. Her doctorate in international relations also won the best research prize in social medicine and prevention at the University of Lausanne in 2014.