Swedish National Council on Medical Ethics
Date: 2010-10-12
Abstract
The Swedish National Council on Medical Ethics is an advisory body to the Government and the Riksdag with the primary task of drawing attention to medical ethics issues from a general societal perspective. Against the backdrop of rapid developments in the field, the Council is to assess the consequences of medical research, diagnostics and treatment for human dignity and integrity. This area of interest includes developments in nanotechnology, which are expected to have a major impact on medicine and other fields.
Since the autumn of 2004, the Council has been actively following nanomedical developments. In October 2010, it submitted its communication entitled ‘Ethical aspects of nanotechnology’ to the Government. It aimed to attract attention to the ethical issues raised by new nanosciences and nanotechnologies (N&N) research, and to emphasise the importance of considering ethical aspects when designing future government initiatives for research and development. The communication came in response to reports by VINNOVA (the Swedish innovation agency) and the Swedish Chemicals Agency, which were published in the spring of 2010.
In 2009, these agencies were tasked by the Government with:
– formulating a strategy for how the opportunities and risks that can be associated with the use of nanotechnologies can be utilised and considered in light of the rapid developments in the area;
and
– analysing the need for regulation or other measures within the EU and at national level, to achieve a good assessment of the environmental and health risks of nanomaterials.
In the view of the Council, the two reports provide a valuable foundation and also highlight the risks associated with the new technologies. However, in contrast to many reports and strategies on nanotechnology from other countries they pay limited attention to the ethical problems that must be considered in future research and development of nanotechnologies.
In its statement, the Council highlights the following areas:
• EU regulations and commitments with regard to nanotechnology and ethics
• Ethics in national nanostrategies (Finland, Norway, Germany, the Netherlands, the UK and the United States)
• Statements by national bioethics councils (France, Austria, Canada)
• Ethical aspects of nanotechnology
With regard to the ethical aspects of nanotechnology and nanomedicine, the following problem areas in particular are highlighted:
• Safety and risks
• Research ethics and informed consent
• Transparency and public debate
• Equity issues
Safety and risks
Since there are major gaps in knowledge concerning the risks in the area of nanotechnology, reports and statements primarily highlight questions to do with the health and environmental risks of nanomaterials. To clarify the risks associated with different nanomaterials, risk assessment methodology and reliable testing and measurement methods that are adapted to nanomaterials must be developed as soon as possible. Different kinds of nanomaterials may also have different effects, and therefore different risks, meaning that they must be studied individually in order to produce reliable results. This kind of risk research is largely lacking at present. This is particularly worrying when it has been established that nanoparticulates can pass through biological barriers such as the blood-brain barrier. The Council considers that research into the health and environmental risks is an area that must be prioritised, and therefore welcomes the Swedish Chemicals Agency’s proposal that Sweden should work to ensure that the EU and Swedish research funders set aside more funds for this purpose. Like the European Group on Ethics in Science and New Technologies (EGE), the Council also considers that substantial resources should be used to investigate the ethical, legal and social implications (ELSI). The Council also wants to stress that the need for additional research is urgent, as nanotech products are already on the market.
The possibility of verifying the safety of a product and ensuring that it is not hazardous before it is released onto the market must be a basic principle. Nanotech products should also be labelled with consumer information on the nanomaterial content; this is stressed by the European Parliament in its resolution.
Assessing and actively considering the risks that new technologies and research can involve by taking various measures is a prerequisite in order for new technologies and research to be able to develop in a responsible and sensible way. The precautionary principle is a basic premise in managing risks. UNESCO offers the following definition of this principle: “When human activities may lead to morally unacceptable harm that is scientifically plausible but uncertain, actions shall be taken to avoid or diminish that harm.” Precautionary measures that are proportionate to preventing potential damage should be taken. However, this does not necessarily mean creating ‘zero-risk’ scenarios, but rather defining what is an ‘acceptable risk’ depending on the values at stake. In this respect it is important that the assessment process is reported openly so that it is clear what values were used, what the underlying principles were, who made the assessment and when.
Regardless of whether the precautionary principle is used for research and development of nanomedicine and nanotechnology, the risks associated with a specific nanomaterial/nanotech application must be assessed and actively dealt with if we want to achieve sensible and responsible development. Since there is a major lack of knowledge concerning the effect of nanomaterials on health and the environment, the measures needed to make methods ethically acceptable must, as far as possible, be taken.
Research ethics and informed consent
Scrutiny of research ethics is of crucial importance to nanoresearch. The knowledge gaps in research into the risks associated with nanoparticulates mean that it is difficult to carry out clinical research and obtain informed consent from participating patients. It is important that decisions are taken in the best interests of the individual. The question is whether the existing regulations in this area for research on human beings provide enough protection for the individual.
It is extremely important that the research community itself has knowledge of, and continuously discusses, the ethical implications that research findings and applications may have on individuals and also on society as a whole. To achieve responsible development of nanotechnology, the ethical discussion must be an integral part of the entire innovation process. However, it may be difficult to ask the relevant questions in a research context governed by political and commercial interests. Basic questions for the responsible and ethical researcher to reflect on are: Why and for what purpose is the research being undertaken? Who will benefit from it? What further implications and applications might the research findings lead to? Ethics training is crucial for researchers in all research areas, and should be included at an early stage of their education. It is of central importance that an ethical evaluation of a new nanotech method is carried out by researchers with appropriate expertise. A comprehensive assessment requires knowledge of the nanotech method to be evaluated, an ethical perspective and assessment of the potential effects on society.
Finally, it is extremely important that nanotechnology is also critically evaluated outside research and business spheres, and that ELSI is an important part of the background data before a new nanotech application or method is introduced. In its Opinion, the EGE proposes that a research network on the philosophical, ethical and anthropological issues surrounding the development of nanomedicine be established and funded by the European Commission.
Transparency and public debate
National bioethics councils in the EU hold continuous discussions on the various possibilities of involving society and citizens in the debate on bioethical issues, with the aim of creating broadly supported, legitimate decisions. The importance of public debate on nanotechnology has been emphasised by several bodies in the EU. In its recommendation, the European Commission states that the Member States should strengthen public debate on benefits, risks and uncertainties related to nanotechnology. In its resolution, the European Parliament also urges the Commission to begin an EU-wide public debate on nanotechnology and nanomaterials. Interest in this area is also clear from the Commission’s 2010 report entitled ‘Understanding public debate on nanotechnologies’ and from research projects funded by EU Framework Programmes, such as Deepening Ethical Engagement and Participation with Emerging Nanotechnologies (DEEPEN) and the NanoMed Round Table.
Creating communication with the public is highlighted as an important element in the Swedish Agency for Innovation Systems’ proposed Swedish strategy on nanotechnology. However, the ethical issues are not discussed in that context. T
o bring about responsible development in nanotechnology and N&N research, the Council considers that openness and transparency with regard to the ethical issues are required at all stages of development. If a broad discussion of the risk issues fails to materialise at an early stage, there is a danger that research will simply be stigmatised, which was, to some extent, the case in the development of genetically modified organisms (GMOs).
The ethical issues should have a prominent role in dialogue and communication with the public. It is important that identification and evaluation of the risks and uncertainties and discussion of which research areas should be prioritised takes place openly between different actors and in dialogue with the public.
Equity issues
There are ethical implications in deciding what type of research projects are to be given priority. What research should be prioritised is generally debatable, as is how the profits from nanotech research should be distributed. One question that is often asked is whether rich countries have a moral duty to develop and share advanced technology that could benefit poor countries. Nanotechnology has the potential, for example, to create more effective filtration systems for water purification. One major misgiving that has been expressed is that the majority of the resources invested in nanotech research are used to develop products and applications for the Western market with the richest consumers. The risk is that the development of nanotechnology thereby benefits those who already possess the greater part of the world’s resources and power, to the detriment of the rest of the world. This also applies to nanomedicine. Which diseases will be given priority and who will benefit from nanomedical progress?
The Council, like the EGE, believes that the objectives of nanomedical research should be considered against the backdrop of the desire for an equitable distribution of health and medical care resources and the aim of achieving better global health.
Other ethical issues
There are also other ethical issues in the area of nanomedicine. How do we protect the privacy of the individual when more and more data, both medical and non-medical, is collected? What happens if the information obtained via refined nanomedical diagnostic tests is used by a third party, e.g. insurance companies and employers? How do we ensure that patents on nanomedical technologies do not limit the availability of treatment on financial grounds? A further medical-ethical implication is whether nanotech diagnostic techniques should be made available and offered in cases where there is no appropriate treatment available for the condition in question. Ethical issues also arise surrounding the opportunities offered by nanomedicine to optimise and improve human capacities over and above what is typical or statistically normal. These are issues to do with our understanding of what it is to be human, society’s view of performance and disability, the right to care and our view of responsibility and autonomy.
The Council considers open discussion of these issues, in dialogue with the public, to be of fundamental importance for the responsible development of nanotechnology.
Summary
Despite the fact that many nanotech methods, products and materials have already been introduced onto the market, there are major knowledge gaps with regard to the risks to people and the environment associated with nanoparticulates. This is a result of a partial lack of reliable test methods to investigate the health and environmental hazards of various nanomaterials. The possibility of verifying the safety of a nanotech product and ensuring that it is not hazardous before it is released onto the market must be a basic principle. Otherwise, we risk harming people and the environment for many generations to come.
In light of this, the Swedish National Council on Medical Ethics would like to particularly highlight the following points:
• Research to determine the health and environmental risks associated with nanomaterials is urgently needed.
• Risk analysis and ethical evaluation of research and new technologies are ongoing processes that must accompany and be integrated into all stages of innovation processes. Ongoing research and the pace at which knowledge changes mean that analyses must be constantly reappraised. The lack of knowledge in the nanotech area has direct significance for ethical discussions of how to proceed with research and various applications.
• To ensure responsible development of nanotechnology, an ethical analysis must be integrated into a future Swedish strategy on nanotechnology. It is crucially important that the ethical aspects are continuously taken into account at research and political level and in dialogue with the public.
• It is important that ethical competence is included in the delegation on nanotechnology proposed by VINNOVA. Ethical aspects must be taken into account in future considerations concerning nanotechnology and highlighted in research funding.