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Why do cutting-edge products scare regulators?

Companies developing innovative products may also unwittingly generate a difficult-to-understand hysteria. It appeared first with genetically modified foods. Fringe groups convinced the main-stream media that GM foods were unsafe, and all without evidence. Arizona State University professor of life sciences Gary Marchant has looked into the fear of innovation in Lessons for new technologies, published by think tank Mercatus Center at George Mason University (http://tinyurl.com/7oe2ds).

Marchant thinks there are too many regulatory burdens foisted on emerging technologies. There is a growing consensus, he says, that regulators are biased against almost anything new. Even 25 years ago, law professor Peter Huber said that regulatory programs tend to disproportionately target innovative products even though the versions they replace were often riskier.

He claims the problem of regulatory discrimination has gotten worse. “It is currently wreaking havoc on emerging technologies that could address many of the 21st century's most pressing problems,” he says. Nanotechnology and irradiated foods are other high-tech ideas hit with irrational regulation. Nanotech has most application to medical devices, so let's deal with that one.

The news section of this magazine frequently reports on how nano-sized particles improve products. Examples include more effective anticancer agents, techniques that inhibit tooth decay, and more comfortable and secure hip implants. A recent review of nanomaterial toxicity concluded that although it's possible engineered nanomaterials may create toxic effects, there are no conclusive data to indicate these effects will become a problem.

Progress will not cease and easily frightened people will find lots to be frightened about. Those scared by nanotech may conjure up a dark side of synthetic biology (new life forms), animal cloning (Jurassic Park), artificial intelligence (things smarter than they are), RFID and new telecommunication technologies (which will let Big Brother track them), robotics, and more.

To show how things do get out of hand, Marchant cites Magic Nano, a German-made glass and tile sealant. Soon after its release, dozens of consumers began complaining of “inhalation injuries.” Several were hospitalized. Front-page headlines warned about the dangers of nanotechnology. “Some organizations called for an immediate moratorium on all nanotechnology goods,” he says. “But a few days later, the German government announced that Magic Nano in fact contained no nanotechnology. Curiously, attention and concern about the case immediately vanished.”

Marchant suggests a two-step solution for this nuttiness: Reject the precautionary principle and establish a principle of nondiscrimination. “The first and easiest step in leveling the regulatory playing field for emerging technologies is to reject incorporation of the precautionary principle — also known as “better safe than sorry” — into local, state, national, and international regulations. It assumes that if something is new, it is unsafe. The principle manifests itself in governments requiring proponents of new technology to prove they are safe before they can be marketed.

The principle of non-discrimination would prohibit laws against products based on how they are made without clear evidence the method significantly increases the likelihood of risk or danger. Regulations would be based on a product's individual risk, not on the technology used to make it.

Marchant makes good points, but would it not make more sense to teach students to think logically and expose them to more math and science? The idea is to clobber fear with solid science wielded by a better informed public. It's too easy for the lunatic fringe to convince ignorant populations that something new is unsafe. Failing that, perhaps we should apply the same precautions to new regulations. Rule writers should have to prove new regulations will have no negative effect before their proposals become law.

How would you protect new technology against irrational regulation? Post your ideas on the Fear of Innovations forum on medicaldesign.com.

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© 2012 Penton Media Inc.


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