This student article is written by Bassam Al-Balushi, Law Student at Sultan Qaboos University College of Law, under the supervision of Dr Saleh Al-Barashdi. This article is part of a series of student articles published on Decree in collaboration with Sultan Qaboos University College of Law to showcase the legal academic writing of Omani law students.
Biotechnology has been defined by many researchers in different ways, but the most common definition is applying technology to living organisms.[1] This field is a wide sea with lots of interesting caves, some of which we have already explored while others are yet to be discovered. Although biotechnology is filled with fertile soil for opportunities, it most of the time ends up in a two-case scenario: either a financial loss or an ethical dilemma.
If we examine the issue from a legal perspective, we would find that biotechnology has a lot to offer but requires some patience and a lot of delicate work to not cross the limits, e.g., procedures of cell line companies require some supervision and agreements made with trial patients to conduct empirical research must be overseen. A lack of supervision in the abovementioned examples can cause some serious incidents, sometimes even leading to biohazardous consequences.
This article will examine a number of issues viewed from a legal perspective, some are related to the ethics of biotechnology, while others raise a financial question regarding the field; hence, we will be covering human cloning, biological weapons, genetically modified organisms’ relationship with infectious diseases, exploiting trial patients, tension between a patentee and an industry partner, and finally the dispute of distributing cell profit.
Bassam Al-Balushi
Law Student
College of Law
Sultan Qaboos University
Ethical Issues
Over the years, the field of biotechnology has encountered some of the most interesting ethical issues as science has developed. We start the first part of the article by introducing some of those ethical concerns.
Human Cloning
As one of the most ubiquitous ethical issues out there, human cloning remains far from achieving reality, or is it?[2] The reproduction of human genetics has more to it than meets the eye and is most certainly a different path from the case of Dolly the sheep,[3] which was the only successful experiment out of 277.[4] However, the Academy of Sciences located in Shanghai, China, achieved a successful experiment in 2018 regarding the cloning of monkeys Hua Hua and Zhong Zhong, hence leaving the world with many questions.[5]
It is undeniable that research papers on human cloning create new paths in science; however, the consequences of conducting factual experiments based on those papers would beg to differ. From a medical aspect, for instance, cloning can stimulate diseases to develop and change their Pathogenesis;[6] therefore, human cloning is considered dangerous and can cause unpredictable harm.[7] As for possible legal outcomes, police might have a tough time verifying their suspects since similar physical traits would be detected during the investigation. Cloning could also make fingerprints useless. Moreover, cloning could possibly disturb the process of proving kinship.
Clones tend to live in the shadows of their originals,[8] making them an easy target for psychological disorders and therefore a victim of emotional disruption.
As the temptation to carry out more experiments on human cloning increases, the United Kingdom has decided to ban it as a precautionary measure due to the high risks involved.[9] Other instruments banning human cloning would be the Universal Declaration on the Human Genome and Human Rights (1997) and the United Nations Declaration on Human Cloning (2005).[10]
Biological Weapons
As one of the many ethical challenges of biotechnology, we are confronted with the weaponization of biological agents and the use of biohazardous weapons. As it is internationally known, there is a famous convention regarding the regulation of biological weapons called the Biological Weapons Convention (BWC),[11] also known as as the Biological and Toxin Weapons Convention (BTWC). This multilateral treaty defines biological weapons and forbids their use as a tool for solving international disputes.[12]
Parties are encouraged by the BWC to enforce their domestic laws in accordance with the treaty and its obligations,[13] but does not request any formal verification of their compliance.[14]
The BWC began its phase of accepting signatures in 1972, and while it came into force in 1975,[15] Oman ratified its adoption of the treaty in 1992 by Royal Decree 17/92.[16]
That being said, with no required evidence or proof of the necessity of compliance, cell line companies and other research establishments with access to any essential tools for developing biological weapons supposedly would not get in trouble and be held accountable;[17] however, that is not true, as it was cleared in the final declaration of the 1996 conference that reviewed the treaty.[18]
Moreover, BWC’s prohibition included numerous conducts, but it most certainly did not limit the resort to the argument of doing it for “research purposes”, as long as it fell under the meaning of peace that the treaty has mentioned in Article 1.[19] In other words, a formal educational clearance or a research license would serve just fine as an exemption. This is one way of breaching the treaty’s firewall and getting beyond its obligations.
Biological Weapons are Unethical
Biological weapons have the ability to create chaos in a way that no weapon can, harm the environment, and develop diseases.[20] Consequently, after the well-known outbreak of the COVID-19 pandemic and its contagious phase, the United Nations Secretary General opened up suspiciously about the necessity to improve BWC so it can protect the world significantly more against weaponizing diseases.[21]
Moreover, in the current Russian-Ukrainian war, allegations of the intention to use biological weapons have increased.[22] UN denied any knowledge of the subject when confronted by the Security Council.[23]
Genetically Modified Organisms (GMOs) are Future Biological Weapons
The international community undeniably stands by its statement regarding the hazards of biological weapons; however, it has yet to discover what genetic manipulation[24] can cause. GMOs are clearly at an intersection with infectious diseases. However, their promising environmental benefits[25] and noticeable financial outcomes, including high-profit margins, satisfy the majority.[26] Therefore, international regulations Like the International Health Regulations (IHR) 2005 are struggling to rein in GMO production.[27]
As for Oman, it does not encourage growing GMOs within its borders but rather urges for proper labelling to continue the importation.[28]
Exploiting the Right to Privacy of Trial Patients
One form of exploitation towards trial patients is breaching their right to privacy by sharing private medical records. As we know, experiments are crucial for any research, especially in a field where new variables appear every now and then. However, the private information gathered through experimenting with human tissue and genetics should be preserved and guarded, as it is not meant for sharing unless given consent.[29]
While artificial intelligence is becoming the new face of science, entrusting it with private information does not sound like the best of ideas. AI is meant to exceed human capabilities, with machine learning (ML) not preserving data.[30] As a result, doors would be open freely to cybercrimes and data infringements.[31] Noteworthy, the biggest cyberattack in 2018 targeted AccuDoc Solutions, with a total of 2.7 million people affected.[32]
Another form of exploiting trial patients is taking advantage of them in clinical trials with no recognition for their participation whatsoever.[33] This incident occurs for those who do not acquire health insurance due to poverty.[34]
Financial Issues
As we have encountered, as legally as possible, some of the most interesting ethical issues regarding the field of biotechnology, we will now move on to explain some interesting financial incidents that may occur within the field.
Tension Between a Patentee and an Industry Partner
A patentee is someone to whom the law has given the right to grant permission over their work;[35] therefore, without the patentee’s authorization, no investor can lay hands on their research paper.[36]
Now imagine going back and forth to negotiate over groundbreaking research, spending extensively, yet still being required to wait a long time for any capital returns, let along peaking some proper profit.[37]
Although the aforementioned scenario seems factual, it is not reality, as there are legal protective methods available to prevent such financial tension.[38] International legal instruments such as the World Intellectual Property Organization (WIPO) and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) treaty guarantee the consistency of funding during the fostering period, let alone the marketing Exclusivity they urge parties to provide.[39]
Noteworthy, Oman joined WIPO by Royal Decree 74/96; hence, Oman is required to offer the above-mentioned rights to its researchers in any field, not just biotechnology.[40]
Donor’s Eligibility of Gaining Profit After Cell Donation
Research establishments conducting empirical experiments rush for a patent request once a profit-making opportunity is apparent.[41] In this case, are those who donate cells eligible to gain some of the profit?[42]
To answer the previous question, we must first seek the provisions regarding the act of donation in law. For instance, Oman’s Civil Transactions Law (promulgated by Royal Decree 29/2013) stated in Article 465(1) that if a donee performed any conduct insinuating a transfer of ownership, the donor would be prohibited from recovering his donation.[43] As a result, the donor of a cell would not be eligible for any profit if the research establishment put a patent on it, as it is an act of requesting ownership.[44] Moreover, If there was an agreement beforehand to distribute the cell’s profit, then we apply the principle of pacta sunt servanda.[45]
Conclusion
There is neither a law nor certain regulations that can possibly cover all the legal outcomes in all the various subjects of biotechnology.[46] As it is a moving train, with every valid research conclusion a new legal implication is awakened; therefore, many ethical and financial issues take advantage of the presented legal gaps.[47]
Findings
-Cloning is not ethical due to the implications it may have on the clone’s well-being, let alone all the ethics left behind.
-BWC has great potential against those who want to obtain a shelf of biological weapons; however, it has some vulnerable gaps.
-GMOs are future biological weapons unless their process is monitored and supervised.
-Oman does not grow GMOs but allows for their import.
-Data on trial patients is not shareable; hence, it must be protected from cybercrimes targeting analytical AI systems.
-International legal instruments keep the tension down between the patentee and investors.
-An agreement concluded beforehand would protect the donor’s right to ask for cell profit.
Recommendations
-We recommend enhancing the supervision of human cloning experiments.
-We advise filling the vulnerable gaps in the BW convention.
-We recommend adding more supervision to the GMO sector.
-For more security in trial patients’ files, an electronic personal key is advised to be kept solely with the patient.
Notes
[1] For further information see Yashon, R., Cummings, M. “Biotechnology” (2019), Momentum Press, New York, p.1.
[2] Klotzko, A. “The Cloning Sourcebook” (2003), Oxford University Press, pp.23-24; for further information see Macintosh, K. “Human Cloning: Four Fallacies and Their Legal Consequences” (2013), Cambridge University Press, p. 195.
[3] Ibid, p. 196.
[4] Ibid, p.195.
[5] Kaya, I. “Genetically Modified Organisms and Regulations Concerning Biotechnological Products” (2020), Cambridge Scholars Publishing, Newcastle upon Tyne, UK, p.83.
[6] Klotzko, supra note 2.
[7] Vöneky, S., Wolfrum, R. “Human Dignity and Human Cloning” (2004), Leiden: Brill | Nijhoff, p.126.
[8] Klotzko, supra note 2 at 204-205.
[9] Mayor, S. “UK government confirms ban on human reproductive cloning” (1999) British Medical Journal vol 319,7201.
[10] For further information see Kaya, supra note 5 at 88-92.
[11] The Nuclear Threat Initiative, “Biological Weapons Convention (BWC)” (2023), available at: https://www.nti.org/education-center/treaties-and-regimes/convention-prohibition-development-production-and-stockpiling-bacteriological-biological-and-toxin-weapons-btwc/. accessed 25 July 2023.
[12] Ibid
[13] Ibid
[14] Ibid
[15] Ibid
[16] Royal Decree 17/1992 Approving the Accession of the Sultanate to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (issued 24 February 1992, published 1 March 1992) Official Gazette 474.
[17] The Nuclear Threat Initiative, supra note 11.
[18] Ibid
[19] Ibid
[20] Tychinin, D., Kosterin, P. “Contribution of Biotechnology to Chemical-Weapons Destruction”, (2002), available at: https://doi-org.squ.idm.oclc.org/10.1007/BF02987492. accessed 2nd July 2023, p.218.
[21] The Nuclear Threat Initiative, supra note 11.
[22] Ibid
[23] Ibid
[24] For further information see Kaya, supra note 5, at 1.
[25] Pool, R., National Research Council, Division on Earth and Life Studies, Board on Life Sciences, “Environmental Contamination, Biotechnology, and the Law: The Impact of Emerging Genomic Information: Summary of a Forum” (2001), National Academies Press, Washington, p.23; for further information see Kaya, supra note 5, at 11-15.
[26] Mariani, M. “The Intersection of International Law, Agricultural Biotechnology, and Infectious Disease” (2007), Leiden: Brill | Nijhoff, p.215; for further information see Kaya, supra note 5, at 8-10.
[27] Kaya, supra note 5, at 213.
[28] Al-Sadqi, N., Alansari, A. “Detection of Unlabeled Genetically Modified Soybean in the Omani Market” (2016), SQU Journal for Science vol 21(1), pp. 1-6, p.2.
[29] Khalid, N., Qayyum, A., Bilal, M., Al-Fuqaha, A., Qadir, J. “Privacy-preserving artificial intelligence in healthcare: Techniques and applications” (2023) Computers in Biology and Medicine Journal vol 163, pp. 1 – 21, p.3; for further information see Taylor, M. “Genetic Data and the Law: A Critical Perspective on Privacy Protection” (2012), Cambridge University Press, p.186.
[30] Khalid, supra note 29.
[31] Ibid, pp.4-7; for further information see Rathee, A. “Data Breaches in Healthcare: A Case Study” (2020), CYBERNOMICS vol 2(2), pp. 25-2, p.25.
[32] Khalid, supra note 29, at 4.
[33] Dal‐Ré, R., Rid, A., Emanuel, E., Wendler, D. “The potential exploitation of research participants in high income countries who lack access to health care” (2016) British Journal of Clinical Pharmacology vol 81, pp. 857 – 864.
[34] Ibid
[35] Marsoof, A., Kariyawasam, K., Talagala, C. “Reframing Intellectual Property Law in Sri Lanka: Lessons from the Developing World and Beyond” (2022), Springer Singapore, 1st ed, p.34.
[36] Gersten, D. “The quest for market exclusivity in biotechnology: Navigating the patent minefield”, (2005), available at: https://doi-org.squ.idm.oclc.org/10.1602/neurorx.2.4.572. accessed 2nd July 2023, p.573.
[37] The University of Tasmania, “We need to think about the legal implications of futuristic biotech” (2018), available at: https://www.utas.edu.au/about/news-and-stories/articles/2018/760-we-need-to-think-about-the-legal-implications-of-futuristic-biotech. accessed 25 July 2023.
[38] Abdel-Maguid, M. “Protection of Intellectual Property Rights for Biotechnology Products” (2007) Agricultural Investment Journal vol 5, pp. 45 – 49, p.45.
[39] Ibid, p.46; for further information see Gersten, supra note 36, p.573.
[40] Al-Wahaiby, J. “Intellectual Property System in the Sultanate of Oman”, WIPO Introductory Seminar on Intellectual Property (2004), Muscat, the World Intellectual Property Organization (WIPO), p.6.
[41] Hodgson, C. “Social and Legal Issues of Biotechnology” (1987) The Ohio Journal of Science vol 87, pp. 148 -153, p.152.
[42] Ibid
[43] The Civil Transactions Law 2013, Royal Decree 29/2013 (issued 6 May 2013, published 12 May 2013) Official Gazette 1012.
[44] Gersten, supra note 39.
[45] Kunz, J. “The Meaning and the Range of the Norm Pacta Sunt Servanda” (1945), American Journal of International Law vol 39(2), pp. 180-197.
[46] Morrison, A. “Biotechnology Law: A Primer for Scientists” (2019), Columbia University Press, New York, p.1; for further information see Novikova, R. “Legal regulation in the field of genetically modified organisms (GMO) turnover in Russia and foreign countries” (2021) RUDN Journal of Law vol 25, pp. 32 – 66, p.33.
[47] Pool, R., National Research Council, Division on Earth and Life Studies, Board on Life Sciences, “Environmental Contamination, Biotechnology, and the Law: The Impact of Emerging Genomic Information: Summary of a Forum” (2001), National Academies Press, Washington, pp.13-21.