ITC Abuse Presents a Serious Problem for Public Health

COMMENTARY

On Aug. 16, President Biden signed the Inflation Reduction Act into law, a sweeping bill that ticked some major items off the president’s health care agenda. The Biden administration has made reforming and improving health care in the U.S. a top priority, and has poured hundreds of millions of dollars into medical research.

However, President Biden and Congress also need to address the International Trade Commission and the misuse of its power threatening to undermine public health.

The ITC is an executive agency that was originally created to advise Congress and the president on international trade, and the commission has the authority to exclude products from being imported into the United States.

Until recently, the ITC was considered a rarely used forum that protected U.S. companies’ patents and intellectual property from foreign firms that did not play by the rules. Now, it’s common for firms looking to make a quick buck or to gain leverage in business negotiations to file their lawsuits with the ITC.

When the ITC reviews cases, the organization is supposed to account for whether excluding a product from the U.S. could adversely affect the public good. However, in its over 100-year history, the ITC has only issued three decisions to overturn an exclusion order based on public interest.

Now, one ongoing ITC case filed by a technology company called AliveCor against Apple could potentially bar the Apple Watch from being imported into the U.S and could hamstring U.S. research into atrial fibrillation, a heart condition that affects over 6.1 million Americans and results in 158,000 deaths every year.

The Apple Watch features a wearable electrocardiogram heart monitor, and it includes features that allow people to quickly and easily send health information to their doctors. Americans living with atrial fibrillation often use the Apple Watch as an accessible, straightforward way to monitor their heart rates and collect data regarding their health.

Additionally, even for those who use the Apple Watch’s health features as a perk rather than a health management tool, the device can alert users to undetected heart conditions, and you can find dozens of stories of the technology discovering previously unknown life-threatening conditions. 

Conversely, in the suit currently before the ITC, AliveCor, despite alleging patent infringement, does not offer a comparable wearable ECG product. The product AliveCor uses as its example of patent infringement was discontinued in 2019, and AliveCor has not announced plans to introduce a comparable product to U.S. markets.

That means an ITC ruling excluding the Apple Watch would take away a product millions of Americans use to improve their health.

The ITC has not established any real credibility when it comes to using public health as a factor in its decision-making, but this is a particularly meaningful case because of how this particular technology works. The features in the Apple Watch help Americans manage life-threatening health conditions. They also can detect and alert the user to unknown problems.

This technology is offering a public good to every user. These features provide critically important information to research institutions and universities conducting cutting-edge research that is changing the way we treat and think about conditions like atrial fibrillation.

The National Institutes of Health, an institution President Biden has worked hard to adequately fund, hospitals like the Mayo Clinic, research universities like Stanford and organizations like the American Heart Association have used the Apple Watch to develop novel treatments for heart conditions like atrial fibrillation.

More needs to be done to ensure the ITC takes its “public good” mandate more seriously, not only to prevent this looming public health crisis, but also to safeguard against future ITC cases that could negatively impact Americans’ health.

Leaders in Washington like Sens. Ron Wyden, D-Ore., and Mike Crapo, R-Idaho, as well as Reps. Kevin Brady, R-Texas, and Richard Neal, D-Mass., who lead committees with oversight over the ITC, can issue orders to rein in the commission, and Congress can take action to pass legislation like the Advancing America’s Interests Act to reform the ITC.

Actions like these, while not the entire solution, would make serious progress in protecting public health in the U.S. We need Congress to act now — before it’s too late.

Susanna Kmiecik is an anesthesiologist at Georgetown University Medical Center and an assistant professor in the department of anesthesiology at Georgetown University. You can reach her on LinkedIn.