The Legal Minefield of Emerging Health Care Technologies

VIDEO (coming soon)

The U.S. health care system is on the verge of being transformed by a series of rapidly developing and converging emerging technologies including pharmacogenomics, nanomedicine, stem cells, synthetic biology, regenerative medicine, and "smart" medical systems.  Yet, the implementation of these potentially break-through technologies may be impeded by a series of legal, policy, and ethical challenges relating to regulatory approval, reimbursement, intellectual property, liability, ethical objections, and public anxiety.  This presentation will identify some common legal, policy and ethical challenges facing emerging medical technologies, and suggest potential approaches for addressing those concerns.

Attorney Gary Marchant, executive director of the Arizona State University Center for Law, Science and Innovation, speaking at the University of Miami’s Global Business Forum, held Jan. 12–14, 2011, made the case that the law isn’t prepared for the current and coming pace of scientific innovation.

Gary Marchant, Executive Director of the Arizona   State University Center for Law, Science and   Innovation

“It’s going to be an extraordinary ride. The law is going to play an increasingly important role in how we employ these new technologies,” he told the audience during the session titled “Emerging Technologies and Health Care: A Conversation with Gary Marchant.”

He pointed to discoveries in genetic testing that can help doctors identify who will likely benefit from drug treatments and who might suffer complications. “More than 100,000 people die every year from complications of drugs taken properly. Genetic tests could prevent many of those deaths,” he said.

But when are doctors legally obligated to use those tests? Studies have found that very few do so, even at top-rated facilities like the Mayo Clinic, which has a computer program that reminds doctors about such tests when they write certain prescriptions. Historically, one of the key tests of legal liability in medical malpractice is whether a particular practice is the norm for most physicians. But with the speed of innovation today, doctors are being forced to evaluate new potentially life-saving therapies and tests ever faster.

“There’s a legal danger in being too slow to adopt and in being too fast to adopt,” Marchant said.

Doctors are also on shaky legal ground when they practice telemedicine, even as they try to save the lives of people who are unable to travel to see experts. Malpractice laws differ by state, and insurance policies may not cover a doctor in one state who is effectively practicing in another.

New scientific research poses more legal uncertainty. For example, consider a doctor’s dilemma as to when and how to treat breast cancer. Doctors already know that many women with breast cancer will never develop an aggressive form of the disease and don’t need treatment. But they don’t know how to determine which women fall into which category. As the science advances though, new tests will offer insights, and might help some patients avoid unnecessary treatments, Marchant said. But, once those tests exist, doctors who recommend aggressive treatment without doing them may find themselves in legal jeopardy.

The question of safety looms large when even scientists are unsure of technological advances. The reality is that the legal system is rarely able to keep up with innovation. That leads to its own host of uncertainties. When laws and regulations fall behind innovation, cases get decided in court. And they often make their way through justice system very slowly.

Consider the issues raised by genomics. A 1980 U.S. Supreme Court ruling opened the door for patenting human genes in their purified form — meaning the genes in your body can’t be patented, but the purified form of them required for genetic testing can be. The companies that control those patents can charge significant fees for potentially life-saving tests. The American Civil Liberties Union has sued the company that controls a test for a breast cancer gene in a case Marchant predicted will end up in the Supreme Court. The decision has the potential to reverse more than 30 years of legal precedent.

Other technologies may also wind down the same road. Consider nanotechnology. Some of the carbon nanotubes used in nanotechnology can provoke similar reactions to the carcinogen asbestos in the human body. Some don’t. “We think some of these things might be dangerous. They probably are. But they’re not all dangerous,” Marchant said. 

Nanoparticles are already being used in hundreds of products. Nanotechnology’s potential benefits range from curing cancer to brewing up clean energy. But it is not regulated because legislators and government agencies haven’t come up with a framework for doing so. Certainly, there have been calls to regulate nanotech, but science hasn’t even settled on the basics. “We don’t have a legal definition that says this is nanotech and this is not,” Marchant said.

Nanotech regulations may come down as early as next year. But in general, regulatory bodies tend to move slowly, and the legal process can take years. Technology, however, doesn’t wait. Marchant noted that the antitrust case against Microsoft was heard on appeal long after the technology at its center was obsolete. “We’re going to be constantly behind if we’re regulating last year’s technology,” he said.