The term biohacking, as well as the concept of biology “do it yourself”, were known as early as 1988. As biohacking has become more frequent and public, academics, ethicists and regulators have expressed concern about the absence or inadequacy of government oversight to address the risks that these activities may pose. In fact, biohackers sometimes work in private, while traditional research is carried out in teams supervised by institutions. Biohackers generally don't get an ethical review of their work, unlike traditional biological research. In addition, biohackers tend to finance themselves and are therefore not usually accountable to private or agency funders, unlike their traditional professional counterparts.
From intermittent fasting and meal replacement drinks to nootropics, “biohacking” has won the favor of the world's smartest people. For example, calls for a ban on biohacking, such as those from a consumer protection organization in Australia, go too far. Beyond patents, people injured by genetic biohacking materials could file civil liability lawsuits against computer biopirats and component suppliers to seek compensation for their injuries. Unlike some European countries, the United States does not prohibit genome editing done outside authorized laboratories, although it is not unlikely that such a ban will be proposed if it is discovered (as was the case with He) that some genetic biohackers have crossed the generally observed lines of ethics or safety.
The Food and Drug Administration (FDA), for example, has broad powers to regulate the public health impacts of genetic biohacking, with a jurisdiction that goes beyond what many biohackers believe. The democratization of genetic biohacking aggravates these public health risks, since many experiments use easy-to-obtain materials and equipment purchased from companies that are dedicated to the DIY market or that are provided free of charge by other biohackers. Thanks to all this, I learned that biohacking is more than doing science outside traditional environments. It's curious that they're called Biohackerspaces, considering that most of those who venture there don't like the term Biohacker.
Even without a valid license, patent holders can enforce restrictions by threatening to initiate patent infringement litigation against any recalcitrant biohacker or manufacturer of biohacking products. These collaborations could also promote transparency between biohackers affiliated with community laboratories and those outside the niche of community laboratories. Biohacking has created a participatory feedback cycle that will ensure that one day their numbers will be much greater than that of traditional scientists. One of the loudest voices on the scene is Geoffrey Woo, CEO and co-founder of HVMN, a start-up company specializing in biohacking.
The tools for public and private regulators to manage the public health risks of biohacking are now largely available. Under many circumstances, products used by genetic biohackers, such as biological raw materials, traditional drugs and homemade CRISPR kits, are, by law, drugs regulated by the FDA. Given the continuing confusion of some biohackers about the FDA's authority over their work, the agency could begin by clarifying the limits of its jurisdiction, in simple terms and in sufficient detail to cover the various biohacking activities, and at the same time seek the opinion of biohacking communities on how best to exercise their authority in this area. .
