1. Introduction
1. In October 2010, Mr Marquet (Monaco, ALDE) and other
parliamentarians – amongst them your rapporteur – tabled a motion
for a resolution on “Nanotechnologies, a new danger to the environment?”
(
Doc. 12372), with a view to recommending that the Council of Europe’s
member States take measures aimed at harmonising the use of nanotechnologies
in order to guarantee in particular health security and ensure environmental
protection.
2. This motion was referred to the (then) Committee on Environment,
Agriculture and Local and Regional Affairs for report and to the
(then) Social, Health and Family Affairs Committee for opinion.
I was appointed rapporteur for the lead committee in February 2011,
with Mr Paul Flynn (United Kingdom, SOC) being appointed rapporteur
for opinion. Both committees immediately started work on the subject,
leading to an exchange of views with an expert consultant, Ms Ilise
Feitshans, in the Social Committee in September 2011 and a discussion
on a preliminary draft report in the Environment Committee in October
2011.
3. In January 2012, the two committees were merged with the Committee
on Economic Affairs and Development to become the new Committee
on Social Affairs, Health and Sustainable Development. At the end
of May 2012, Ms Feitshans delivered an expert paper on which the
rapporteur has based this report, which she kindly updated with
a chapter on nanotechnology and bioethics at the end of September
2012. The rapporteur has chosen to reproduce this expert paper as
a committee information document and to summarise its findings in
this explanatory memorandum – but the conclusions and recommendations
are the rapporteur’s own.
2. Definition
and potential of nanotechnology
4. Nanotechnology is the manipulation of matter on an
atomic and molecular scale. Nanomaterials involve structures having
dimensions of nanometres (nm), that is one billionth (or 10-9)
of a metre, typically between 1 and 100 nanometres in size. At such
dimensions, materials can show significantly different physical,
biological and/or chemical properties from materials at bigger dimensions,
which opens up a range of new possibilities for technology.
5. Nanotechnology already has myriad applications and the potential
for more: since materials behave so differently at nanoscale, structures
and devices can be engineered that would have been unthinkable a
few decades ago. Some nanomaterials are already being mass-produced
and incorporated into consumer products, ranging from titanium dioxide
and zinc oxide in sunscreens and cosmetics, over silver in food packaging,
clothing, disinfectants and household appliances to carbon nanotubes,
for example in tennis rackets. However, the developing field of
“nanomedicine”, which uses both the scale of nanomaterials (able
to penetrate, for example, the skin barrier or even the brain barrier,
which bigger molecules cannot) and/or their different properties
at nanoscale, holds the promise of enormous benefits in both detection
and treatment of some of the greatest contemporary killers of mankind,
including cancer and heart disease.
6. As with most emerging technologies, nanotechnology also carries
the risk of serious harm, both to human health and to eco-systems
in the environment. Many of these risks are as yet poorly understood. However,
studies have already demonstrated that nano-silver applied to textiles
does wash out. The anti-bacterial properties of nano-silver considered
beneficial in hospital sheets (and, more frivolously, in tennis socks)
can wreck havoc when washed away in the waste water stream, as they
have the capacity to destroy bacteria which are critical components
of natural eco-systems, farms and waste-treatment processes. Even more
worryingly, some carbon nanotubes seem to have the capacity of provoking
similar tissue damage in the lungs as asbestos, and it appears that
nanoscale titanium dioxide (used, for example, in sunscreens) can create
oxidative stress in cells. Ms Feitshans cites the special report
of the German Advisory Council on the Environment (SRU) in this
respect: “The possible consequences of this use have not been sufficiently
studied. There is a danger of a widening gap between the technological
development and the knowledge about risks …”
3. Nanotechnology
and bioethics
7. In the eyes of the expert consultant, Ms Feitshans,
“[n]anotechnology poses the greatest bioethical issue of informed
consent for the 21st century, for Europe and for the rest of the
world”.
The reason for this assertion is
that in her view the state of the art is such that there are more
questions than answers at this stage when it comes to risk assessment
(and thus also risk disclosure).
8. Informed consent is a crucial concept in bioethics. A whole
chapter is devoted to the issue of free and informed consent in
the 1997 Council of Europe Convention for the Protection of Human
Rights and Dignity of the Human Being with regard to the Application
of Biology and Medicine: Convention on Human Rights and Biomedicine
(ETS No. 164, “Oviedo Convention”). It is the linchpin of consumer
protection (in the area of biomedicine/nanomedicine–patient protection),
and also of corporate liability.
9. Both of the key facets of informed consent – disclosure of
risks to inform the consumer and acceptance of risks, or consent
to conditions despite stated known risks – cannot be addressed in
the field of nanotechnology given the present state of the art,
due to the dearth of information about unknown and unquantified
risks, in particular from cumulative exposures. Traditional labelling
requirements are thus not workable in this context, unless set against
the background of a solid (European, if not international) regulatory framework
that will facilitate examining nanotechnology applications from
the standpoint of their functionality in the context of their use,
so that risk can be managed in light of their expected benefits
and potential harm.
4. Balancing potential
risks and benefits
10. Regulations have indeed struggled to keep up with
the pace of scientific innovation in the field of nanotechnology.
For the time being, most jurisdictions are either using existing
regulations (which, of course, leave wide gaps, due to the extremely
small scale and/or the specific nature of nanomaterials), or “adding
on” to them in an effort to close these gaps. Thus, in the European
Union, for example, a multitude of regulations apply to nanotechnology.
Efforts are currently being made by many to devise more novel, comprehensive
and consistent nanotechnology regulations, from nation States (United
States, China, South Africa, India) to international organisations
(Organisation for Economic Cooperation and Development (OECD), World
Health Organisation (WHO)), associations (International Standards
Organisation (ISO)) and non-governmental organisations (NGOs).
11. Unfortunately, there seems to be far too little communication
between the different stakeholders and even less effort at harmonisation.
The result is a cacophony, and a current legislative environment
which either tends to stifle innovation or is short on risk control.
It is my impression that most jurisdictions are currently not erring
on the side of caution, in an attempt to stimulate technological
development and reap economic rewards in the process. The resultant
lack of application of the precautionary principle may yet prove
to be dangerously short-sighted, as it has the potential to cause
enormous harm both to human health and to the environment.
12. It is thus clear that there is a need to create a common standard
to properly balance potential risks and benefits of nanotechnology
by harmonising the legislative base with the precautionary principle
in mind. What is also needed is not just communication and debate
between the different stakeholders in achieving this goal, but also
an informed public debate, including consumer and patient information
and education (including labelling requirements taking into account
informed consent imperatives). The Council of Europe, with its unique
human rights mandate and convention-based standard setting, as well
as its expertise in the bioethics field, may be able to achieve
such transparent harmonisation where other stakeholders with a narrower mandate
have so far failed.
5. Conclusions
and recommendations
13. The expert consultant, Ms Feitshans, offered her
own conclusions and recommendations, based on the idea that laws
can foster and incubate new industries while monitoring the situation
through funding and incentive systems, to control emerging risks.
I agree with her on this (and most other) point(s): there is an important
role for the Council of Europe to play at this stage of the development
of embryonic laws and regulations governing nanotechnology.
14. This is because the Committee of Ministers and the Parliamentary
Assembly agree that it is necessary to advocate “a culture of precaution
incorporating the precautionary principle into scientific research
processes, with due regard for freedom of research and innovation”.
In
this context, the Committee of Ministers recalled in 2008 the undertakings
given by the Heads of State and Government of the Council of Europe
in the Final Declaration of the 3rd Summit of the Council of Europe
to “ensure security for our citizens in the full respect of human
rights and fundamental freedoms” and to meet, in this context, “the
challenges attendant on scientific and technical progress”.
15. In the context of the current knowledge (and lack of it) on
the potential hazard nanotechnologies present both to human health
and the environment, it thus seems evident to me that the precautionary
principle needs to be applied in this field. Unfortunately, it appears
that the nanotechnology industry is developing at a pace at which
regulatory development and application is not keeping up. The massive
use – already today – in everyday consumer products, as described
by Ms Feitshans, of certain nanoparticles with known toxicity (for example
nano-silver in everything from clothing to food packaging) or with
a potential – as yet poorly understood – for considerable harm to
human health (such as nano-sized titanium oxide in sunscreens) may turn
out in hindsight to have been a poor application of the precautionary
principle. Obviously, researchers and workers in the nanotech industry
are in the front line here. But end-consumers may also suffer. Do
we really need another asbestos,
a prime example of
poor (or lacking) application of the precautionary principle?
16. I believe that the Council of Europe, as the only pan-European
body with a human rights protection mandate, is well placed to work
out guidelines on nanotechnology based on the precautionary principle
which will protect 800 million Europeans from risk of serious harm,
but which will not hinder the technology’s potential beneficial
use. These guidelines could first take the form of recommendations
(such as a Committee of Ministers recommendation), but could also
be transformed into a binding legal instrument if the majority of member
States so wish, for example in the form of an additional protocol
to the Oviedo Convention. The Council of Europe’s Committee on Bioethics
(DH-BIO) could be the body to be entrusted with a feasibility study on
the elaboration of possible standards in this area as a first step
in the start of negotiations on the topic with a multiple stakeholder
approach.
17. The guidelines should be designed with a view to obtaining
a clear and consistent text applicable across borders, across the
origins of nanomaterials (synthetic, natural, accidental, manufactured,
engineered) and across the functional uses and biological fate of
the nanomaterials under regulation. The guidelines should seek to
harmonise regulatory frameworks, including of risk assessment and
risk management methods, protection of researchers and workers in
the nanotech industry, consumer protection and education (including labelling
requirements where appropriate), as well as of reporting and registration
requirements, in order to lay down a common standard.
18. The process of negotiation of these guidelines should be as
open and transparent as possible, involving multiple stakeholders
(national governments, national parliaments, international organisations,
the Parliamentary Assembly, civil society, experts and scientists)
in the framework of a dialogue transcending the Council of Europe
area, leading to the creation of an international interdisciplinary
centre to be the world’s knowledge base in the field of nanosafety
in the near future. I believe that such regional guidelines would
have the potential of imposing themselves as the regulatory standard
worldwide, thus protecting the human rights of every person to health
and to a healthy environment.