Proposed US Copyright Exemptions Introduce Unnecessary Risk, Says National Association of Manufacturers

While the “right to repair” movement aims to empower consumers to utilize their devices longer and reduce electronic waste, in some cases it can present significant risks to both manufacturers and consumers that get overlooked.

The National Association of Manufacturers (NAM) recently expressed their concerns about the risks to their members from exemptions to copyright law that can limit right to repair, as highlighted in their testimony before the U.S. Copyright Office. Namely, manufacturers who invest significantly in research and development to create innovative products, are at risk.

Charles Crain, NAM Vice President of Domestic Policy, argued that this movement “hinges on the false notion that owners do not have the ability to repair their own equipment.” Instead exemptions being considered by the Copyright Office will only serve to potentially expose proprietary technologies and trade secrets, thereby diminishing manufacturers’ incentives to innovate. He stated, “These exemptions would undermine manufacturers’ IP rights in service of right-to-repair—and the record does not support their adoption.”

It’s clear why business is wary of expanded repair. We could be headed to a world with limited technological innovation among manufacturers’ designs in favor of standardization. But there are also consumers we need to consider in this discussion.

Last year, the American Consumer Institute (ACI) submitted a comment (INCLUDE LINK) to the U.S. Copyright Office as they considered exemptions under Section 1201 of the Digital Millennium Copyright Act (DMCA).  We laid out how a potential copyright exemption could “undermine the maintenance and repair standards laid out by the FDA for the equipment employed in patient care.” 

Medical devices are regulated by the FDA because they require precision and expert training to conduct necessary repairs. The FDA requires specific technical requirements, specifications and expertise when manufacturing these regulated products.

However, independent servicers (ISOs) are neither regulated nor monitored, and not required to adhere to the FDA’s Quality System Regulations or report adverse repair events. We have strong federal regulations on the manufacturers in this market, but none related to third-party servicers. This gap puts patients at serious risk.

If your loved one needed an emergency diagnostic evaluation, you certainly would want that equipment to be maintained by a licensed professional with the same knowledge and training required by the FDA. Patients deserve better.

It is crucial decisionmakers recognize the importance of excluding medical devices from these types of policy decisions and rulemakings. Clearly many different camps are sounding the alarm of the detrimental impacts associated with the exemptions and opening up right to repair broadly. Manufacturers adhere to rigorous safety standards during production and carrying out authorized repairs; unrestricted access increases the risk of substandard maintenance that does not meet these critical safety benchmarks.

Patients deserve the assurance that the medical devices they rely on for their care are repaired by professionals who are federally regulated by the FDA, ensuring their safety and efficacy. Hence why as Crain stated, “right-to-repair is a solution in search of a problem.”