Social Technologies
Author: Dr Opeyemi Kolawole (Post-doctoral Researcher, PatentInHuman Project)
Medical devices are integral to healthcare service delivery. Patients and healthcare service providers utilise these devices to diagnose, prevent, monitor, alleviate, and restore impaired body functions. Depending on the complexities of these devices and how they are deployed, they can become integrated with the patient’s body, and the patient’s healthy functioning and life may become dependent on the device (for example, an insulin pump or a pacemaker). Yet, like every other device, medical devices are susceptible to wear and tear: embedded software in the device may become obsolete over time, and physical elements may become deficient, making a device unsuitable for the patient’s needs. What options are available to the patient or health service provider in such instances? Should they, or a trusted repairer, be allowed to repair these devices? Patients and hospitals confronted this question at the height of the COVID-19 pandemic.
The average consumer may answer the question in the affirmative. Since many medical devices are integral to the patient’s health outcomes, some patients may feel they should be allowed to repair and improve their devices at will and when necessary. Yet, in the general device context (which also includes medical devices) many manufacturers adopt strategies to make self, or third-party repair out of reach. For instance, some manufacturers restrict access to tools, spare parts, technical notes and manuals; some install software that “bricks” the device if tampered with. Intellectual property issues are also relevant in this context: It is reported that some manufacturers use “microscopic trademarks” on their spare parts to prevent third-party importation. Patent infringement claims and the threat of litigation are also deployed to dissuade third-party repairers. In some cases, manufacturers opt not to sell repair parts or mandate consumers to use their authorised repair services, which are often too expensive. For software-embedded devices, manufacturers may embed digital locks on the device, which can make the device unusable if repair is attempted. In such cases, attempts to repair may also violate copyright law or be subject to other legal sanctions such as criminal liability. If repair is not available, the result is that device holders may need to replace defective devices with new ones, which may also often align with manufacturers’ interests. Manufacturers justify these strategies on several economic and proprietary interests grounds. A critical question arises: how do we balance some patients’ desire to repair and customise medical devices with broader considerations in such contexts, including manufacturers’ interests? This general question of the extent to which users can repair devices is at the heart of the right-to-repair movement.
The right-to-repair movement started in the United States, particularly among farmers constrained in their ability to repair their tractors. Other stakeholders in the movement include technology enthusiasts, consumer rights advocates andindependent repair trade unions. The impact of this replacement-focused corporate strategy on the environment has also made it an essential issue for sustainability and environmental protection advocates. The movement has extended to other jurisdictions, including the European Union, Canada, France and Australia. Many right-to-repair advocates aim to create and sustain a legal framework that allows third-party repairers or device users to fix their devices and equipment. A key focus of the right-to-repair movement is around control and freedom of consumers (and other device users): it is “about who owns our devices and who controls what we can do with them.”
Policy and regulatory responses to this movement have been slow and narrow. Most legislations adopted in response, in the United States and other jurisdictions, including the EU, which has focused on automobiles, smartphones, tablets, washing machines, televisions and other household devices and machines. The focus on these products is likely due to their “high turnover rates” and their downstream effect on waste and sustainability. Thus, more than anything, regulatory responses, particularly in the EU, are driven by environmental concerns. These laws and regulations (and the proposed laws) often mandate manufacturers to provide spare parts, manuals and other training materials to third-party repairers.
While the regulatory responses are laudable, medical devices are conspicuously exempted from the emerging legal framework on the right to repair. Yet, patients and hospitals also confront repair restrictions. Indeed, some scholars have argued that the lack of a right-to-repair in the medical devices context has dangerous implications for healthcare service delivery. The problem, in the medical devices context, was particularly evident in the COVID-19 pandemic, where hospitals and patients struggled to access necessary spare parts and repair services for their devices and equipment. Issues also arise in other contexts. For example, patients and users of mobility devices and machines have also been significantly impacted by the lack of the right to repair, especially those living in remote places. Patients dependent on these devices may become more vulnerable. This suggests an urgent need for greater consideration of the right-to-repair in the context of medical devices.
Expectedly, there is significant pushback from some medical device manufacturers. Some argue that a right-to-repair for medical devices could compromise patient safety. AdvaMed, an association of medical device manufacturers, note that the right-to-repair poses concerns in the medical device context because “unauthorised third-party servicers are not required to follow FDA regulations or report adverse events.” Citing a 2018 study, they highlight studies showing a significant number of adverse health outcomes arising from improper repairs. Their point is that medical devices are not like every other consumer good: they are heavily regulated, and how they function is integral to a patient’s well-being. Consequently, extending the right-to-repair to these delicate devices would be “a terrible mistake”. Manufacturers also cite commercial reasons, including their interest in protecting their intellectual property portfolio and trade secrets and the need to prevent reverse engineering of their devices. Some argue that the right-to-repair medical devices “would erode the incentive for innovation and endanger patients”.
Consequently, the role of the right-to-repair in the medical device context requires deeper investigation as several vital questions arise in this context. The arguments discussed above that are put forward by medical device manufacturing sector actors raise important issues. Medical devices are heavily regulated for safety reasons and undergo stringent certification requirements before making them available to the public. Could an extension of the right-to-repair to medical devices jeopardise the safety of some devices or the sanctity of this certification process? If we proceed to design a law on this issue, what should this law look like? What type(s) of medical devices should this law cover? At the same time, the arguments from consumers and patients are important. Access to affordable and quick repair options is critical for many patients. In sum, there is a need to consider whether the right to repair should be extended to medical devices, and in what contexts. This is one of the questions we are currently exploring on the PatentsInHumans project, led by Prof. Aisling McMahon, focusing particularly on how the right to repair may operate in this context and the interactions between this and relevant intellectual property rights that may apply to such devices. Nonetheless, it is clear that a delicate balance, which considers issues of repair, access and patient safety, is likely needed in any emerging legal framework.
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Funded by the European Union (ERC, PatentsInHumans, Project No.101042147). Views and opinions expressed are however those of the authors only and do not necessarily reflect those of the European Union or the European Research Council Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.