Political and Legal Influences regarding Nanotechnology in Medicine
Nanotechnology can be described as the making of functional objects, systems and devices by controlling matter on the length scale of the nanometer and using new trends and properties on the length scale (Basavaraj, 2012). Nanotechnology has gained use in different medical areas like cardiovascular medicine and oncology, due to the need for the growth of new medicines, using the innate nanoscale roles of the biological elements of living cells (Basavaraj, 2012). However, use of nanotechnology in medicine faces many legal and political issues, which forms the theme of discussion, in this study.
What are some Legal and Political Issues regarding Nanotechnology in Medicine?
Fiedler & Reynolds (1994), in their summary of legal issues emerging from nanotechnology, reveal that classification, which the government uses for regulatory functions, might face solemn challenges with the establishment of nanotechnology in the medical area. According to governments’ classification, drug and device become distinguished by the chemical and mechanical processes. Nevertheless, as suggested by Fiedler & Reynolds (1994), the impending utilization of nanotechnology in medicine distorts this difference. This is because it is hard to discriminate the forces at work on an atomic scale, thus, making it hard to isolate chemical from mechanical, or effects of electricity.
Fiedler & Reynolds (1994) discuss the latent function of nanorobots operating to eliminate the atherosclerotic plaque, present in coronary arteries. Existing techniques for the elimination of this plaque entail the use of a range of comparatively small devices, such as, balloons, lasers and drills. In the prospect, it may be predicted that doctors could utilize nanodevices for the recurrent elimination of this plaque. The devices would function through finding plaque deposits and eliminating them each molecule at a time, metabolically. However, this process leaves the question as to whether the elimination will occur mechanically, or chemically unanswered. On the other hand, if the act of the nanorobots gets perceived to be acting as a solvent rather than scratching the plaque from the arterial walls, the nanorobots can be regarded as drugs, obtaining energy from the host cells and metabolizing the plaque (Fiedler & Reynolds, 1994; Tsai, 2012). Whereas it may not matter if the process of such nanorobots gets considered as chemical or mechanical, in a practical, or even an educational set up, it is extremely significant in a regulatory and legal perspective. Hence, establishing ways to handle these matters is essential as new products start to penetrate markets. The phase during which new technologies start to penetrate the marketplace, mostly, coincides with an unprepared legal system.
Fiedler & Reynolds (1994) argue that for evolving nanotechnology, there is a possibility of a window phase, wherein the old regulations will remain at the rear of the new technology. In case the existing language of the laws, relating to drugs and devices do not succeed to contain nanotechnology, Fiedler & Reynolds (1994) recommend preemptive modifications to the phrasing of such laws to aid in alleviating some potential for mismanagement.
Fiedler & Reynolds (1994) propose a functional loom to regulation, in relation to a classificatory structure depending on how technology functions. Functions can be separated into three classes including replacement, repair and enhancement or expansion. According to Fiedler & Reynolds (1994), all the three functions are related to current medical practices and can, therefore, be contained within the legal and medical organizations, easily. Moreover, each one of these three functions can be regulated separately, with repair necessitating loose regulation and augmentation necessitating utmost oversight. However, the legal issues associated with the use of nanotechnology are not restricted to regulation and classification (Fiedler & Reynolds, 1994). Extra effort will be essential to decide, for instance, whether or not nanotechnology ought to be patented like soft ware or hardware, the way insurance firms should handle nanotechnology in medicine, threats to ideas of confidentiality and fortification of regulatory competence.
Kai (2011) highlights several legal issues regarding nanotechnology, in Japanese law. The first issue entails danger that nanotechnology can pose to the human body and health. For instance, some medical tools, for drugs, with nanotechnology may be extremely risky for both patients and staff. The second issue is that use of nanotechnology causes a high risk to the environment. Lastly, use of nanotechnology can compromise privacy and security of personal information (Kai, 2011).
Besides, lack of appropriate regulation of nanotechnology is a concern in the application of nanotechnology in medicine (Tsai, 2012). Currently, regulation of nanotechnology is almost fictional. According to Tsai (2012), present legislation does not address nanomaterials or nanoparticles, particularly, and there are alarms regarding nomenclature, the suitability of the present, test methods and describing nanomaterials as new materials under chemicals convention. Nevertheless, the scientific alarms have ignited interest from several regulatory groups. For instance, the Environmental Protection Agency (EPA) has articulated toxicological alarm for possible health consequences of carbon nanotubes (CNTs) (Tsai, 2012). This expression is based on resemblance of CNTs to irresolvable, scantily, soluble particles and other carbon substances. Hence, EPA demonstrates concern upon exposure to CNTs through both dermal and inhalation routes (Tsai, 2012).
Presently, there exists no agency accountable for regulation, supervision and research of nanotechnology use, growth and implications. The federal administration instituted the National Nanotechnology Initiative (NNI), in 2000, which is accountable for the synchronization of the national nanotechnology research and development (Tsai, 2012). The NNI comprises various groups, which are responsible for aiding partnership around non-governmental societies, academia, worldwide governance units, industry and the public at large. Since, NNI program does not finance research its subsidy comes from the summation of nanotechnology, linked funding that gets allotted by each of the implicated agencies. Besides, the NNI notifies and controls the Federal budget and planning actions, via its affiliate agencies.
Besides, the Food and Drug Administration (FDA) has shown interest in the enhancement and regulation of nanotechnology (Tsai, 2012). Nanotechnology, which is relevant to the FDA, may include research and technology development that both satisfy the NNI meaning and relates to a commodity controlled by the FDA, such as, drugs that may utilize or contain nanomaterials (Tsai, 2012). The FDA announced the configuration of an internal FDA Nanotechnology Task Force, in 2006, given responsibility of determining the approach to be taken in regulation which would allow progressive development of creative, innovative, safe, and efficient products that use nanoscale materials and are FDA regulated.
The EPA has the authority to control nanotechnologies through the Toxic Substance Control Act (TSCA), which is rather broad and enables the EPA to standardize almost all chemical matters (Tsai, 2012). The EPA, in 2008, established that it regarded carbon nanotubes as new chemical materials under TSCA. Tsai (2012) reveals that, in 2009, the EPA suggested significant new use rules (SNURs) for single-walled and multiwalled carbon nanotubes, although, they became reserved on technical grounds, after an attorney filed opposition to them in support of anonymous clients. These regulations would have necessitated that importers, processors and producers of certain substances inform EPA at least 90 days before commencing any action that EPA has chosen as significant for new use. These regulations, though, would have applied only to the explicit CNTs that were the focus of approval orders between the EPA and a certain manufacturer of CNTs (Swan).
Kelty (2006) explains that the European Union, together with US have established regulatory systems through which danger and exposure risks of nanotechnology might be assessed. Besides, the European Commission has already published a prelude report on the potential method by which these risks can be tackled. In addition, the new Registration, Evaluation and Authorisation of Chemicals (REACH) regulation in the EU will have far-reaching effects on the chemical industry with anonymous penalty for manufacturers of nanoparticles.
The US Environmental Protection Agency (US EPA), the Food and Drug Administration, the Occupational Safety and Health Administration, and the National Institute of Occupational Safety and Health have also begun to query into the need to change, on hand processes, to hava roomm for nanotechnology (Kelty, 2006). Specifically, the United States EPA is analyzing its first pre-manufacturing notice from a company that wants approval for carbon nanotubes. In count to the regulatory consent of this organization, several are moreover supporting intramural or extramural research projects, which seek to understand the danger and exposure hazard posed by engineered nanomaterials.
Lately, the UK Royal Society has published a report, which proposes a two to five year window within which corporations and universities are expected to examine and value the toxicity and design processes for managing it, before the government can take on any new regulation in nanotechnology. Further, the mind set of politicians and citizens towards risk and regulation poses a political constituent to the whole problem (Kelty, 2006). This is because globalization has made the efficiency of safety assurance and public regulation more political.
Bochon (2011) reveals that conformity with current regulations demonstrates that the existing plan for regulating the nanotech production, in the EU, is conservative. The situation of nanotechnologies is symbolic of the discursive twirl, in the EU, from administration to governance. Since control of nanotechnology, in the EU, is deliberative, the governmental and political bodies of the EU reduce their decision-making power in an intricate structure of nongovernmental and official institutions, integrating experts with councils of consumer associations or trade unions (Bochon, 2011). Flexible regulation appears, afterward, as a new means to boost citizen and industrial zeal with the integration of views, remarks and other reports sent during conferences, seminars and workshops.
According to Bochon (2011), the prospect of a code of ethical conduct for the legally responsible expansion and use of nanotechnology has been examined at a global level, although, there has not been common, universal agreement on the Commission’s suggestions. Following years of efforts to adopt a global code of conduct, the Commission, lastly, decided to go on and suggest its own code. The Commission declared its plan to set up a code of ethical conduct restricted to Member States of the European Union. The goal of this code was to encourage responsible and safe research on nanotechnology and create room for its safe and responsible use and application (Bochon, 2011). Thus, the Code of Conduct serves two functions. First, the code acts as a general reference for the entire organizations and people, who are interested or concerned in nanotechnologies or nanosciences. Second, the code acts as a European foundation for discourse with third nations and global societies.
This final role demonstrates the hesitant character of the code. On one side, it is a group of principles and regulations, not lawfully binding all the members it may regard, but whose target is, nonetheless, to control softly an industrial and scientific field of the domestic, European market. Conversely, the guidelines and standards articulated in the code symbolize the center of the political agreement amid the Member nations and are, thus, a tool not only sketched for regulatory functions but also for the discussions in which the EU is playing as a sole, political player. The Code of Conduct unlocks the doors for an international discussion that could initiate global regulation of nanosciences beneath the management of the United Nations Environmental Program, since article 211 accepts the member nations and the Union to collaborate with global organizations (Bochon, 2011).
In conclusion, there exist many legal and political issues regarding use of nanotechnology in medicine. First, nanotechnology can pose a danger to the human body and health. For instance, some medical tools, for drugs, with nanotechnology may be extremely risky for both patients and staff. Second, nanotechnology causes a high risk to the environment. Again, use of nanotechnology can compromise privacy and security of personal information. Further, the mind set of politicians and citizens towards risk and regulation poses a political constituent to the whole problem, because globalization has made the efficiency of safety assurance and public regulation more political. Hence, nations need to put more efforts towards adopting a global code of conduct regarding use of nanotechnology in medicine.
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Bochon, A. (2011).Evaluation of the European Commission recommendation for a code of conduct for responsible nanosciences and nanotechnology research. Nanotechnology Law & Business 117(8), 117-143.
Fiedler, F.A. & Reynolds, G.H. (1994). Legal problems of nanotechnology: an overview. Southern Cali fornia Interdisciplinary Law Journal, 3, 593-629.
Kai, K. (2011).Nanotechnology and medical robotics: legal and ethical responsibility. Waseda Bulletin of Comparative Law, 30, 1-6.
Kelty, C.M. (2006). The ethics and politics of nanotechnology. Paris: United Nations Educational, Scientific and Cultural Organization.
Tsai, C. (2012). The nanotechnology revolution: ushering in a new wave of toxic torts? Intellectual Property & Technology Law Journal, 24(3), 20-23.
