Discussion

Through the research and the discussions presented in this book, my colleagues and I have argued and shown that free innovation is very generally valuable for individual innovators, for producers' profits, and for social welfare. Solidifying legal, regulatory, and social support for free innovation will require an increase in general awareness of free innovation and of the benefits it provides. In our 2015 paper, Torrance and I suggest that a term that may be useful in that regard: "innovation wetlands.” Just as Boyle (1997) did with respect to popularizing the value of the intellectual commons, we draw an analogy to successful efforts made in recent decades to create general awareness of the great public benefits that environmental wetlands provide.

Consider that until the 1970s marshy ecosystems were generally regarded as, at best, resources ripe for conversion to more beneficial uses. At worst, they were considered noxious sources of pestilence and disease, as exemplified by the disparaging phrase "malarial swamp.” Accordingly, for many decades governments promoted the filling or the draining of wetlands through a variety of legislative and policy instruments. For example, the Watershed Protection and Flood Prevention Act (1954) directly and indirectly increased the drainage of wetlands near flood-control projects. Tile drainage and open-ditch drainage were considered conservation practices under the Agriculture Conservation Program. These and other policies caused losses of wetlands averaging 550,000 acres a year from the mid 1950s to the mid 1970s (Dahl and Allord 1997).

Beginning in the 1950s, a paradigm shift in scientific understanding of wetland ecology drove the recognition that, far from being dangerous or waste areas, wetlands are actually among the most productive and diverse of ecosystems, providing such benefits as habitats for diverse species, flood control, and water purification. Diffusion of information about these benefits changed society's perception of wetlands, and the posture of governments also changed. "Noxious swamps” increasingly came to be viewed as "valuable wetlands.” Changes in regulatory approaches resulted in in a new emphasis on protection, preservation, and even rehabilitation of degraded wetlands both nationally and internationally (Clean Water Act 1972; Ramsar Convention 1971). Where governments had once targeted wetlands for destruction, many now focus on preserving them.

Torrance and I define the " innovation wetlands” as the rights and conditions that enable free innovation by individuals to flourish. Just as is true of environmental wetlands, the nature and the extent of innovation wetlands must be understood, and the value of the innovation activity that takes place within them must be better appreciated.

A more enlightened understanding of the benefits of free innovation can create a climate within which regulators and firms will be able to work with free innovation rather than against it. As illustration, consider again the very interesting example of medical patients' freedom to innovate relative to highly regulated medical producers. In line with the general case discussed in chapter 6, free innovator pioneering may turn out to be a very good thing for rapid medical progress and for medical producer firms—especially if public understanding enables intelligent support from producers and regulators and legislators rather than resistance. As we saw, free innovators have the right to innovate to help themselves, and are clearly impatient to do so. The motto of the Nightscout free innovator group that develops medical devices for diabetics (discussed in chapter 1) is "#WeAreNotWaiting” (Owen 2015; Nightscout project 2016). By this, the Nightscout group is saying that it rejects the common pattern of producer and FDA instructions to wait for promised commercial solutions to their urgent medical needs— commercial solutions that always seem to be five years away. And, indeed, why should patients wait for commercial solutions when they can instead effectively innovate to help themselves?

Medical self-experimentation clearly has dangers to the individuals who, nonetheless, have a right to risk danger in order to help themselves. There will clearly be instances of failure and injury or even death from such experimentation. But there will also predictably be great progress, including life-saving help for many. A climate of understanding and support for the overall value of the enterprise will enable legislators and regulators to resist "clamping down” in response to specific unfortunate failures. Instead, they will be able to offer intelligent support to enable free innovators to innovate more safely, and to better assess the actual safety and efficiency of the innovations they develop.

As an example, consider that today the US Food and Drug Administration, along with governmental agencies of similar function around the world, supports a "gold standard” system of clinical trials. This system has evolved over time, and today has become so expensive that it is viable only for drug and device innovations that offer the potential for very high profits. Many very important and also commonplace medical innovations have no chance of getting evaluations via clinical trials under this system. For example, a new device or method for assisting getting out of bed in the morning may be very valuable to many disabled or elderly individuals—but it would not be cost-effective to test its efficacy and safety via clinical trials of the type mandated by the FDA.

Rather than attempting to suppress the development, personal use, or diffusion of free innovators' medical innovations, public awareness of the value of that activity could support more positive responses. For example, public and producer support could help to develop user-friendly, affordable clinical trial methods that enable free innovator communities to quickly evaluate the efficacy and safety of free innovations. The practicality of patient-run clinical trials has been demonstrated, for example, in a clinical trial of possible ALS therapies (Wicks, Vaughan, Massagli, and Heywood 2011; see also DoubleBlinded

2016). At least initially, of course, the methodologies of these community-based trials will not be at the level of the FDA gold standard. But the FDA gold standard also was not built in a day. With public understanding, the FDA, producers, and legislators would be enabled to support the development of a grass-roots complement to the FDA system that will steadily improve over time.

Without public support, in contrast, FDA regulators might be motivated or even forced to attempt to suppress free innovation even in the face of Commerce Clause restrictions. Citing, for example, the possibility that malevolent individuals might "hack” medical devices, the FDA could try to make free innovation more costly. It could, for example, compel producers of medical devices—firms that are under the purview of the FDA—to make the devices they sell more difficult for medical patients to reverse engineer, extract personal data from, and otherwise improve for their own use. (For example, the NightScout innovators described in chapter 1 did require access to the personal medical measurements generated by commercial medical devices as inputs to their free and very useful designs.) The net result would, in my view, produce damage very similar to that caused by the overbroad legislative response to digital piracy via the DMCA discussed previously. Alternative responses that prevent malevolent hacking but at the same time grant "owner override” to owners and users who wish to modify their own devices and systems are both possible and, in my view, clearly preferable (Schoen 2003).

Prominent legal scholars both support and urge such a transition in public thinking. Pamela Samuelson (2015, 1) explains the importance of "freedom to tinker” in well-protected innovation wetlands, noting that "people tinker with technologies and other human-made artifacts for a variety of reasons: to have fun, to be playful, to learn how things work, to discern their flaws or vulnerabilities, to build their skills, to become more actualized, to repair or make improvements to the artifacts, to adapt them to new purposes, and occasionally, to be destructive.” She urges efforts to preserve and legally protect the freedom to tinker. William W. Fisher III (2010) similarly argues that creative tinkering is fundamentally important to "human flourishing” and summarizes psychological and philosophical research to argue that user innovation is an important pathway to self-fulfillment, the richly lived life, and human happiness.

In net, Torrance and I conclude that free innovation is important to both human happiness and inventive progress. We find that fundamental legal protections afforded to free innovators are robust. At the same time we argue, along with colleagues, that better stewardship of the innovation wetlands can be created by greater public and governmental understanding of the beneficial effects free innovation brings to individuals, to social welfare, and to national economies.

 
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