Nanotechnology: Crossing the legal horizon

Dr. Md. Ershadul Karim is a Senior Lecturer at the Faculty of Law, University of Malaya in Malaysia, and holds a PhD from the same institution for his thesis on “Human Health and Environmental Implications of Nanotechnology”. Emraan Azad from Law Desk talks to him on the following issues:

Law Desk (LD): We have come to know that the researchers from the Imperial College of London, who are pioneer in introducing robotic surgical instruments using nanotechnology, are developing device that can be applied to more efficient delivery of cancer drugs and better target cancer cells with chemotherapy drugs. Would you please briefly explain about 'nanotechnology'? How is it different from other technologies? 
Md. Ershadul Karim (MEK): Nanotechnology is hailed as the 'next wonder of modern science after the internet'. The prefix 'nano' means billionth. So, if we say 'one nanometer', it means one billionth a meter i.e. one part if you can divide one meter into one billion parts. It is not easy to comprehend and that's why different examples are used to describe it. For example, a strand of human hair is roughly 75,000 nm across and a six-foot tall man is two billion nanometer.
Scholars are divided in using 'nanotechnologies' instead of 'nanotechnology'. Attributing different prospects, nanotechnology is described as generic, emerging, disruptive, game-changing, general purpose, enabling or key technology. All these features make it different from traditional technologies.

LD: What are the utilities of nanotechnology in our daily life? 
MEK: Theoretically, when you can control atom, you are able to do anything. Nanotechnology is the art and science of manipulating things at the atomic level. So, it has the potential to develop and enhance any product of your own will and thus, you can coin it as the practical version of 'Aladin's Magic Lamp'!
Though the regulators are yet to endorse, many scientific literature, based on laboratory studies and published in high impact journals, have already indicated that some nanomaterials have the tendency and ability to adversely affect human health and different environmental components. Therefore, the regulators put emphasis on conducting more and more research. 

LD: Does the functioning of this technology have any legal and human rights challenge?
MEK: During the life cycle of nanomaterials, the regulators will be facing challenges to implement legal provisions relating to intellectual property, occupational health and safety, environment, trans-boundary pollution, product safety, tort etc. Human rights challenges will include, inter alia, right to life, information and expression, privacy, environment etc. 
Already Europeans have assessed the adequacy of their municipal law provisions to handle different aspects of nanotechnology. More or less, they reached to similar conclusion that the existing legal framework seems to be sufficient based on the present state of knowledge. However, since nanomaterials pose some unique challenges, extensive scientific research must be continued and that may compel to introduce significant changes in the legal system in near future. 

LD: As patent is generally granted on the basis of novelty and usefulness of any innovation, does nanotechnology fall into this?  
MEK: The United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) have already introduced a new Class 977 and new tags “Y01N”, respectively for nanotechnology. Nanomaterial is nanoscale chemical and chemicals are normally patented. However, the main challenge is that at the nanoscale the chemicals exhibit some unique features totally different from the bulk chemical. Here comes the debate whether nanomaterial is 'new' chemical or 'existing' chemical. Hence, we foresee a patent war in this regard soon.

LD: Is there any legal instrument that deals with nanotechnology?
MEK: Unfortunately, there is no single comprehensive legal instrument so far in this field. The USA and South Korea enacted laws on nanotechnology, containing provisions for setting up relevant administrations without any substantive provision e.g. on liabilities arising out of 'engineered nanomaterials' (ENMs).
In the Europe, the regulators introduced some changes in the community laws on chemicals, biocides, cosmetics and food. In relation to cosmetics and food, it is now mandatory to label with the word 'nano', if nanomaterials are used in the products.
Nano-enabled products are one of the serious concerns by many including UNESCO. Due to strict regulation in developed countries and in the absence of an international instrument, it may happen that manufacturers from those countries may move to or target developing countries for all kind of experiments and dumping.

LD: Is the introduction of compulsory registration of nanomaterials necessary? 
MEK: Yes, it can be seen as the first formal move to regulate nanotechnology. Having an official list of nanomaterials through registration will enable regulators to assess the risks of nanomaterials. Threshold registration system is included in the European REACH Regulation. But there are some inherent limitations in the REACH Regulation; that's why countries like France, Belgium, Denmark, Canada, and Sweden have introduced mandatory registration. 

LD: What roles can the members of legal community play in this emerging field of nanotechnology? 
MEK: Given the limitless potential of nanotechnology, we should welcome more development of this, but at the same time human health and environmental degradation must not be compromised. In developed countries unlike developing ones, the regulators remain very active. Hence, the legal community should understand the life cycle of nanomaterials, see the adequacy of existing legal provisions, raise their voice and assist the government toward its safe, sustainable and responsible development. As I previously wrote in The Daily Star, I again like to say that the next big thing is nanotechnology and the members of the legal community have great roles to play to this end.

LD: Is there any possibility that Bangladesh will be facing legal challenges concerning nanotechnology?
MEK: Without making any comprehensive assessment, it will not be wise to comment on this. The Europeans are very active in regulating nanotechnology as they experienced the genetically modified food issue. Among the South Asian countries, India is the forerunner and one of the key global players. Pakistan is also doing well. But surprisingly, Sri Lanka seems to realise the importance of this technology and has taken many pragmatic steps. 

LD: Thank you, sir for addressing the queries. 
MEK: It was my pleasure to talk to you.