INTRODUCTION
The advent of technological innovation has proven to be advantageous and practical but also dangerous at the same time. Similarly, innovation in medicine and biology has also introduced new and fascinating experiments yielding results which have never been seen before. Biohacking is an umbrella term used for all those experiments that are executed outside the purview of governments and academic institutions[1].There are also called “do-it-yourself” or DIY experiments because they are done by people in their homes with the objective to achieve some unconventional result like modifying genes of plants, animals and even humans. Through this process, one can modify their appearance, health and performance. Additionally, it has also been used to produce cheap drugs and experiment with new forms of treatment[2].
ISSUES PRODUCED BY CONTEMPORARY INNOVATIONS
While these innovations might sound riveting, they are mostly driven by the self-interests of hackers and hence lack ethical inspection and due care. This means that they are extremely dangerous and have the potential of disrupting the health of the person engaging in it and also society in general. There are so many regulations that scientific products and experiments are subjected to that act as safeguards against any unwanted result. For example, the approval of a vaccine is put under so much scrutiny and it is only after many trials that the vaccine gets approved. However, there is no such provision for products created by biohacking because it employs unverified methods to create modifications. Moreover, a culture resistant to critical evaluation and regulation exists in the biohacking community[3].
SCOPE OF LAW IN THE AREA OF BIOHACKING
Issues such as these raise legal considerations. The existence of such powerful scientific and biological mechanisms needs to be regulated by laws that address the societal and ethical challenges that are brought forward by these mechanisms. This area is an intersection of human rights, intellectual property laws, medical regulation etc. In the area of human rights, it is necessary to uphold the privacy and the physical autonomy of an individual but at the same time ensure that there is no abuse of someone’s physical and mental well-being. It is essential because genetic modifications can disrupt the same. Experiments in Transhumanism collect and store data of the person on whom the experiment is done along with their biometric information and this means that a potential threat of privacy breach is expected. Biohackers and Transhumanists should ensure that data is collected and handled properly. Additionally, appropriate consent and robust security to avoid unauthorised data access are also of utmost importance. The person’s anonymity, along with other factors, must also be maintained and respected. Individuals should have control over their own data and the power to decide whether and how much data can be disclosed. Another legal aspect in the world of biohacking is the intellectual property of the innovators. Since these are original innovations, patents and copyrights might incentivise innovators to share their knowledge in a way that ensures that it is critically evaluated and regulated. Since transhumanism comes within the scope of medicine and biotechnology, it needs to be regulated by medical laws. It is essential that every innovation goes through clinical trials to assess its risk level and safety rate to check whether it is sustainable for public use. There are some forms of biohacking which also intersect criminal laws. For example, if a person engages in illegal genetic modification, or in activities that would categorise under bioterrorism, with an objective to cause harm to another individual or community, it would come under criminal law. Moreover, it could have greater legal implications if the crime is concerned with national security and public safety.
EXISTING LAWS AND FDA REGULATIONS
In terms of actual laws that currently exist, there is a grey area when it comes to biohacking. Although it is disapproved of by regulations such as the FDA, it is not completely to administer gene therapy. The first law targeting Biohacking was passed in California in the United States of America in 2019[4]. In 2020, it was made illegal to sell CRISPR therapy kits without warning labels which instructed that they were not safe for self-administration[5]. There are arguments both for and against the restrictive regulation of the CRISPR gene kits. Some people argue that restricting them would lead to restricting of human enhancement and abilities and would hinder the process of achieving innovative medical techniques. They also believe that putting restrictions would not stop these processes but drive them underground[6]. However, those in support of the regulations argue that the regulations are necessary in order to safeguard the health and well-being of people. Agencies like the Food and Drugs Administration (FDA) has also warned against these types of modifications[7]. Since the jurisdiction of the FDA is majorly concerned with protecting the safety of the public against harmful drugs, biological products and medical devices[8], it is its duty to ensure that a balance is struck between innovation and safety. By requiring surveilling the approval process and the post-market effects, it aims to minimise the risk that is involved in mechanisms such as biohacking. In the future, there is a scope of the cases of biohacking coming under the purview of FDA. There is also a possibility that just like in California, more legislation related to biohacking is implemented.
CONCLUSION
Biotechnology and Transhumanism are without any doubt rapidly growing fields which by the day continue to spread across different sectors. For example, genetic modification is majorly done by individuals seeking to enhance their appearance and abilities but now companies and firms have also started using biotechnology to increase the productivity of their employees[9]. As this new arena of biotechnology advances, legal systems must adapt to address the issues that come with it. The practice of Biohacking can contribute to progress in the medical field but individuals must learn how to navigate the legal landscape related to its practice. The many areas of law that can contribute to the field of biohacking are human rights, intellectual property law, medical law and privacy laws. Biohacking and Transhumanism should be carried out in such a way that ensures compliance, human research ethics, and fosters innovation at the same time. The notable development in these fields in recent years has given us the hope that the legal grey area that surrounds these topics will slowly but steadily vanish. The first law targeting Biohacking passed in California is a relevant example of the same. Institutions and governments will continue to regulate new innovations as we move towards the future of biotechnology and the branches of the executive such as the FDA will definitely play a huge role in the regulation. It will be a challenge for lawmakers but moving forward, it will benefit everybody.
Author(s) Name: Devleena Sharma
Reference(s):
[1] Teodora Lalova-Spinks, ‘Burning Down the House: Talking (Bio)Hackers’ (KU Leuven, 4 August 2020) <https://www.law.kuleuven.be/citip/blog/burning-down-the-house-talking-biohackers/> accessed 20 June 2023
[2] Ibid
[3] ‘Biohacking is a response to societal problems, but is not the answer’ (Pharmaceutical Technology, 23 February 2023) <https://www.pharmaceutical-technology.com/comment/biohacking-response-flawed/> accessed 20 June 2023
[4] Avalyne Diotte, ‘The First US Law Targeting Biohacking’ (Policy Horizons Canada, 11 February 2020) <https://horizons.gc.ca/en/2020/02/11/the-first-us-law-targeting-biohacking/> accessed 21 June 2023
[5] Ibid
[6] Sigal Samuel, ‘Is it time to regulate biohacking? California thinks so.’ (Vox, 13 August 2019) <https://www.vox.com/future-perfect/2019/8/13/20802059/california-crispr-biohacking-illegal-josiah-zayner> accessed 21 June 2023
[7] Ibid
[8] ‘What We Do’ (U.S. Food & Drugs Administration, 28 March 2018) <https://www.fda.gov/about-fda/what-we-do#:~:text=The%20Food%20and%20Drug%20Administration,and%20products%20that%20emit%20radiation.> accessed 21 June 2023
[9] Sakshi Bhatt, ‘How companies are using Biohacking to increase employee productivity (Economic Times, 14 October 2021) <https://hr.economictimes.indiatimes.com/news/workplace-4-0/how-companies-are-using-biohacking-to-increase-employee-productivity/87010619> accessed 06 July 2023
