By Michael Becker
Small Times Correspondent
July 30, 2001 — As nanotechnology moves from the realm of science fiction to the real world of commercial application, legislation and regulation are going to have to play catch-up.
Legal experts say the lag between technology and
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| The respirocyte would be a spherical nanorobot, approximately 1 micron in size. Just a 5cc dose should do the work of all red blood cells in the blood stream. But what laws would govern its use? These bacterium-sized gadgets would likely to force a debate over existing regulations. |
Biotechnology has led to a closer examination of patent law and what is patentable. Stem cell research is having a similar impact — witness a recent bill that emerged from the judiciary committee of the U.S. House of Representatives in late July that seeks to outlaw not just the cloning of humans, but also the use of cloning technology to create stem cells to treat diseases.
Nanotechnology will be no different. But the range and scope of laws and regulations could be much broader: everything from international trade law, to treaties banning chemical and biological weapons, to regulations governing medicine and the environment.
A good example of a nanotechnology application that would likely to force a debate over existing regulations is the respirocyte. Theoretically, it would be a spherical nanorobot, approximately 1 micron in size — about as big as a bacterium.
Respirocytes would consist of a tiny, pressurized tank and pumps carrying oxygen and carbon dioxide in the blood stream. They would augment or even replace red blood cells — just a 5cc dose should the work of all the red blood cells in the blood stream.
While it may take 10 to 20 years to build and perfect respirocytes, the question is whether it would qualify as a medical device, as a drug or as something completely different.
Robert Freitas, a research scientist at Zyvex Corp. in Richardson, Texas, who also holds a law degree, notes that other potential nanorobots designed to eat bacteria, repair individual cells and deliver precise drug doses to precise locations will force regulators to take a long, hard look at how to test, monitor and approve such technologies.
“With greater potential for danger,” he said, “comes greater need for regulation.”
Much of the existing body of law, however, will probably need only minor tinkering.
“Whenever you see a new technology, there is always a temptation to say, ‘We need all new laws to deal with it,'” noted Glenn Reynolds, a law professor at the University of Tennessee who has written about the legal implications of nanotechnology.
This kind of reaction, he said, usually turns out to be wrong. “Old laws often work out surprisingly well,” he said, adding that when legislators do try to craft new bodies of law to deal with new technologies, “the results are either pointless or disastrous.”
That is not to say that government should take a hands-off approach. T.S. Twibell, an associate with the Kansas City, Mo., law firm Kurlbaum Stoll Seaman Mustoe & McCrummen, who has also written about nanotechnology’s legal implications, says government involvement will help lawmakers and regulators.
“Government needs to have a hand in, to know what people are developing and be able to react to it,” Twibell said.
But the biggest area of concern is likely to be copyright and patent law. While some may question whether a company can patent an atomic structure, most legal experts agree that there are enough precedents involving biotechnology and genetic material to cover nanotechnology. Rather, the problem will more likely be protecting the intellectual property from illegal copies and piracy.
Reynolds offers a hypothetical situation in which “disassemblers” are created that can examine something atom by atom, keeping track of the object’s overall structure and making perfect copies of it.
In such a case, it would be nearly impossible to determine if a copy of something was obtained legally or not. Zyvex’s Freitas, when asked how the law might seek to resolve this, laughed, “that’s a good question. I think as we get closer to it, the answer will emerge.” But, he added, “it won’t be painless, there will be economic adjustments.”
Freitas, Reynolds and Twibell all agree that in this kind of situation, the real value will reside not in the physical object, but in its design. Consumers would download the design of an object and replicate it themselves, rather than go out and buy it.
Patent issues will also emerge with self-replicating nanotechnologies, especially if those technologies are designed to adapt to new surroundings. “If evolution occurred in a, say, patent grain,” he said, “if the patent grain evolves over time, where does the patent stop?”
This has led some researchers to argue that an “open source” approach to nanotechnology is more feasible. Similar to the software design community of the same name, developers and researchers would collaborate on designs without any one person or company holding a patent or copyright on it.
“There are a lot of good reasons for an open source approach,” Reynolds said. “It tends to be more robust, less ‘buggy.'”
And, if it is so easy to copy things, he added, open source may be the only viable commercial approach. Freitas, on the other hand, argues that while open source, “in some selected areas might have some utility” — such as in developing kernels for nanotechnology tools — he doesn’t believe it can provide enough incentive to lead to major new developments in nanotechnology.
Some of the other big legal headaches are likely to emerge when scientists perfect replicating, or self-replicating, nanotechnology.
The U.S. Department of Defense is spending prolifically on such nanotechnology research, which could be used to disrupt enemy communications or disable weapons systems and equipment. The fear is that defense researchers will develop and release a self-replicating nanorobot without knowing how to shut it down, devouring matter to recreate itself in a formless mass of nanoparticles sometimes referred to as “gray goo.”
Existing international regimes designed to prevent the use of chemical and biological weapons may have to be re-examined and rewritten to ban the development or use of such technology.
A more benign application of replicating nanotechnology would allow manufacturers to build things atom by atom, rather than the present method of taking hunks of metal or wood and reducing them to the proper size and form.
Such manufacturing technologies would be extremely clean, with little or no environmental pollution. As a result, as such technology becomes cheaper and more prevalent, “(environmental) laws could actually even tighten up,” Freitas said.
And while such a “ground up” approach to manufacturing should lower production costs, the development costs to get there could be huge, effectively leaving developing countries left with legacy industries that can’t compete. Twibell believes such a prospect means nanotechnology will affect trade law, “definitely at the global level.”
But Reynolds is a bit more sanguine. “It’s something to worry about, I suppose, but it’s not assured,” he said. He argues that development could actually go the other way, and cites India’s emergence as a center for call centers and software development as an example of how technologies created in developed countries can be embraced by developing ones, with positive economic results. “If you can get the technology to them,” he said, “people will do better, not worse.”
Given the pace of development occurring within nanotechnology, it is expected that the law will find itself at odds with these new technologies sooner than some may think. “That’s going to affect all of us in our lifetime, certainly in our professional lifetime,” Freitas said.
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