Over the last seven months, Americans have endured economic pain, mass unrest, a spike in unemployment and surging coronavirus cases. The good news is that with each passing day, news reports highlight the breakneck speed at which medical innovators are working to develop a coronavirus vaccine. Once we get the vaccine, life will get closer back to normal.
Aside from a potential vaccine, medical innovators, including in the medical device industry, are investing unprecedented levels of manpower and resources to help contain this pandemic. From rapid-result coronavirus tests to novel decontamination systems for personal protective equipment, these innovations are a critical pillar of support for providers and health care workers on the frontlines of this fight.
Despite trials and tribulations, America still leads the world in innovation, and we will lead the way out of the coronavirus pandemic abyss. Innovators give us confidence that we will get through this. New technologies already on the market and coming in the future to combat the pandemic. Unfortunately, while innovators are working around-the-clock to deliver life-saving solutions to patients and health care providers, some opportunistic businesses are trying to use the power of government to seize the intellectual property of these innovators for their own commercial interests.
This is government overreach at its worst and will hurt American innovation across the board.
Indeed, since the onset of the public health emergency, unregulated third-party medical device servicing companies have cravenly pursued access to trade secrets and other proprietary information developed by the original equipment manufacturers (OEMs) of medical devices. While these businesses claim that OEMs restrict access to information needed to properly service many devices, the real story is a bit more complicated.
Unlike third-party servicing businesses, original equipment manufacturers are held to rigorous FDA regulations and quality standards. Key mechanisms ensure that medical devices in the U.S. are properly designed, manufactured, installed and serviced. This stands in contrast to third-party servicing businesses, which operate in a regulatory “Wild West” and are not held to any quality or safety standards by the FDA.
Protecting the intellectual property of innovators is a critical pillar of America’s health care system, yet some politicians are trying to use the power of the federal government to change the rules on the field to benefit medical device servicing companies. Once they wrestle away business, the servicing will fall to largely unregulated companies working to service complex medical devices that detect cancers and other critical illnesses where there is no accountability.
And yet, despite a gaping lack of federal oversight or accountability, third-party servicing businesses and their cabal of Beltway lobbyists have successfully pressured federal policymakers to introduce legislation that would force medical device manufacturers to cede their intellectual property to unregulated third-party service companies.
The legislation, the Critical Medical Infrastructure Right-to-Repair Act of 2020, would grant independent service organizations (ISO) unfettered access to tools, manuals, schematics, software keys and other proprietary information for the duration of the coronavirus public health emergency. The bill guts intellectual property rights and would set a dangerous precedent for a post-coronavirus world.
Intellectual property for medical technology can only be developed through heavy investment, countless man hours and extensive research. Technology for capital equipment such as medical imaging machines takes even more resources for research and development. The legislation undervalues these investments by stripping away copyright protections from the original manufactures of the equipment and allows competitors access to proprietary information that can then be published online. Ultimately, other servicers that aren’t held accountable by the FDA can access the information and use it even though they did not produce this intellectual property.
Medical innovators will see that during times of crisis, the government will engage in tactics that wrestle away intellectual property. This will lead to a reluctance to invest resources to fight the next pandemic. Third-party servicers using the power of government to get free access to the intellectual property of others without developing it on their own is not fair. The United States has a long history of protecting private-property rights, including intellectual property.
The legislation is also flawed in that it increases certain cybersecurity vulnerabilities for hospitals and other providers by allowing for the uncontrolled distribution of an original equipment manufacturer’s proprietary information. This could lead to cyber-attacks and privacy breaches that put patients and their providers at risk.
Congress should be promoting innovation not socializing access to intellectual property. The proposed legislation to wrestle away intellectual property from original equipment manufacturers should be rejected because it violates that idea that private-property rights are sacrosanct — even during times of crisis.
• Brian Darling is former counsel and senior communications director for Sen. Rand Paul, Kentucky Republican.