20 Years after the Oviedo Convention

Looking Backward to Look Forward:  Sustaining Oviedo Convention achievements in the Era of Genetic Engineering and Nanotechnologies

 

Prepared for the Conference

“20 YEARS AFTER:
THE OVIEDO CONVENTION ON HUMAN RIGHTS & BIOMEDICINE”.

 

You´ll find the lecture here as a pdf

And here you´ll find the powerpoint version

 

Dr. Ilise L  Feitshans  JD and ScM and DIR

Former Guest Researcher at NCRWE Copenhagen

Legal Advisor for the Greek National Platform on Nanomedicine

CITIZEN OF GREECE

Executive Director The Work Health and Survival Project USA AND SWITZERLAND

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 PACE (Parliamentary Assembly of the Council of Europe)

Author of several books and hundreds of published articles about health, technology, nanotechnology, education, disability, assistive technology for people with disabilities

NEW BOOK!! GLOBAL HEALTH IMPACTS OF NANOTECHNOLOGY LAW

 

 

Looking Backward to Look Forward:  Sustaining the Achievements of the Oviedo Convention  in an Era of Genetic Manipulation Applying Nanotechnologies

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 législation to promote coherent Paneuropean 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 traffiking 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 presentation 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.

 

I  put the phrase genetic manipulation in the title because people in the audience might have the mistaken impression that Nanotechnology and genetics are distinct disciplines.

 

Nanotechnology is a new tool for genetics. Manipulating particles at the nanoscale is smaller than D N A . therefore Nanotechnology and nanoenabled devices are now used in genetic engineering g gene therapies

Nanotechnology can alter nanoparticles within DNA and RNA which is a subset of a subset at the chromosomal level. We can change or create new proteins by altering their DNA and even change the protein corona that surrounds a cell..

 

When the Convention was written scientists were still mapping the human genome and bioethicists were worried about what society would do with information revealed at the chromosomal level Concrete examples, what do you think or article 13:

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.

Some people will be unaware of the larger implications of nanotechnology, or mistakenly underestimate its importance for ongoing genetic testing, gene editing and the development of replacement organs from an individual’s own stem cells,, or oterh aspects of persobnalized medicine.  The natural question is whether application of nanotechnologies considered “an introduction of modifications in the genome” or could it be argued that it is excluded from the provision of the Convention? In other words, thanks to scientific progress can we circumvent the constraints of the provision?

 

 

It is true that civil society has before us the multibillion dollar question…

Are these changes ok

Or

In violation of the convention

Or not covered by it at all?

 

And if they are ok under the convention’s plain meaning but violate its principles

Or not covered by plain meaning and violate its principles what shall we do?

Amend.. Ignore… Write a different convention??

 

While I reserve the right to think very carefully about your questions  for the next few years,

 

The short answer to your question is that the impact of nanotechnologies on the scope and vibrant application of the Convention will depend very much on context

HOW nanotechnologies are applied in the genetics context.

 

Let’s consider cancer drug delivery because it is a comparatively easy example.

We like altering the genetics of cancer if we can kill the cells

We may not even care if it 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.

I actually discuss this in my book

 

We like that when it is a targeted drug delivery assaulting a cancer cell

But perhaps some other types of manipulation run afoul of the convention?

 

Or perhaps involve something not clearly covered by the Convention at all?

 

I believe that if we anticipate these issues we can effectively address them without writing new law.  END

 

nanomedicine

is an evolving concept it’s based on

using the manipulation of nanoparticles

a unit of analysis the

tiniest 53 molecules 60 molecules

depending on what you’re looking at it’s

an evolving concept of using what we’ve

out nanotechnology to cure

health problems to prevent health

problems and to develop cheaper and much

more efficient drug delivery systems

 

mean by a drug delivery system well if you have an aspirin you have an

active agent you have a bunch of stuff

surrounding that aspirin so that it’s

digestible and  so that it doesn’t spoil in

shipping

 

what if you could just reduce that

particles that you shoot

through a laser think of how much money, space for shipping and storage

and time you could save and possibly

life saving time that you could save if

you just had a few well targeted

particles that went right to the problem

nanoparticles are so

small that they can fit between cell

walls and enter cells and try to

kill for example a cancer tumor

 

But..

What about genetic impacts we don’t like?

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 alzheimers or  broken bones without nanomedicine?

 

What about human volunteers in Nanotechnology experiments (which exist in some

European countries). Are the experiments exempted because the Convention does not use the word Nanotechnology?

 

Everyone who studies this Convention is charged with the mission to  think carefully about whether amendment is needed but I believe the key is the context in which the new technology is applied

 

Personally, I am not a fan of amendment because inevitably the process requires rethinking the entire document

I like saving clauses applied to a reasonable interpretation…

 

Perhaps a working group could be empowered to examine these issues with a view to creating interpretive guidance documents

 

A classic question of whether plain meaning of the text limits or overtakes the implementation of purposes and principles

 

such as the one mentioned with targeted drug delivery assaulting a cancer cell would be more effective.

 

Would you suggest amending the said provision and eliminating the phrase: “and only if its aim is not to introduce any modification in the genome of any descendants”. In other words, would you be satisfied if it were formulated “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes”. Would the scope of nanotechnogies be covered in such a formulation?

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.

In your opinion, is the application of nanotechnologies considered “an introduction of modifications in the genome” or could it be argued that it is excluded from the provision of the Convention? In other words, thanks to scientific progress can we circumvent the constraints of the provision?

Would you suggest amending the said provision and eliminating the phrase: “and only if its aim is not to introduce any modification in the genome of any descendants”. In other words, would you be satisfied if it were formulated “An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes”. Would the scope of nanotechnogies be covered in such a formulation?

Nanotechnology can alter nanoparticles within DNA and RNA which is a subset of a subset at the chromosomal level. We can change or create new proteins by altering their DNA and even change the protein corona that surrounds a cell..

 

We like that when it is a targeted drug delivery assaulting a cancer cell

But perhaps some other types of manipulation run afoul of the convention?

 

Or perhaps involve something not clearly covered by the Convention at all?

 

I believe that if we anticipate these issues we can effectively address them without writing new law.

 

 

 

++++++Bio sketch

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