05.09.2024

The continuing need to limit biomedical research through the law

Defined as an interdisciplinary field, based on the transfer of theoretical and methodological principles between biology and medicine^[1], biomedicine^[2] has contributed to spectacular changes in human life^[3], while at the same time having a narrower view of the human being, which is viewed strictly from its biological perspective^[4].

After the Second World War, biomedicine emerged as an expression of innovative, experimental medicine, a scientific research in areas less explored until then. The prominence acquired by this term between 1945 and 1975 coincided with the emergence of a new system of medical innovation in terms of health policy and biology, without a homogeneous system^[5].

Although they have been the subject of lengthy ethical, philosophical and legal debates, the implications of biomedical discoveries, particularly in the last 60 years, for human rights, even if they are sometimes the subject of internationally binding legal instruments, remain open to any possible regulation in most countries of the world. States that have agreed to ratify such international legal instruments are generally states whose development does not allow them to be actors on the world stage and where the national economy is little, if at all, affected by the limitations and prohibitions of international treaties. The causes are many, but the most important stem from the main features of biomedicine: the lack of transparency - natural, since we are talking about the commercial secrecy of discoveries, the multiplicity of players in the field - both public research institutions and private, the direct interest of the broad masses in using the results of discoveries^[6].

6] This gives rise to the limitations of the law, which is called upon to organize the newly created issues: the difficulty of limiting discoveries that have not yet been made but which are somewhat predictable, the impossibility of controlling what happens in the privacy of all the laboratories around the world, the difficulty of preventing the general public from exerting pressure to make use of a useful discovery.

However, since "human rights are values in themselves proclaiming the primacy of the human being over social and collective interests, research is free only if these rights are respected"^[7].

Biomedicine is an area where the conflicting interests of research, law, medicine, religion and, ultimately, politics intersect.

The combination of these conflicting interests will inevitably lead to conflict, and the risk that international human rights law will be rendered ineffective or even obsolete by the extreme dynamics of research is immense. It is therefore necessary to update concepts, to use existing legal instruments for innovative purposes and even to create new regulatory instruments specific to the field.

For a better understanding of these conflicts, it is necessary to explain the terms to which we will refer. For example, bioethics, which is the study of what is right or wrong in new discoveries or techniques in biology^[8], such as genetic engineering and organ transplants, analyzes - albeit from a different perspective than law - the same issues. From a different perspective, the definition of bioethics should start from the etymology of the term, which essentially means ethics in the particular context of biology, and by ethics is meant the identification, study and resolution of the conflict between competing values and goals^[9]. In principle, all definitions of bioethics note that it is the study of the ethical issues raised by biological research and its applications^[10].

The range of issues that fall under the umbrella of bioethics varies according to the strictness of the definition. In principle, bioethics focuses on issues intrinsically related to human beings and their well-being in a biological sense, but may also include ethical issues related to the non-human biological environment (e.g. debates on the possibility of recognizing animal rights or issues raised by biotechnologies).

The impossibility of exhaustively defining the legal framework applicable to future medical research, stemming from the unpredictability of biomedical methods and progress, leads to the effort to try to regulate post-factum, with all the disadvantages that this entails, by far the most important of which is the emergence of biomedical applications or results of medical research that test the limits of the law existing at the time.

An example of this is xenotransplantation, i.e. the use in humans of tissues, cells or organs from animals or even plants. At first sight, not only does it not violate any bioethical principle - of the classic, hitherto known and generally accepted ones - but it also supports respect for these principles, in particular the principle of non-injury, because the aim of xenotransplantation is to improve the patient's state of health or to make life easier for him or her, when there is no other medical option. But the law intervenes by applying the same 'slippery slope' method, and creates a virtual danger by assuming that genetically engineered mixing of human and animal DNA, even with the aim of the good of the human being, may have a long-term destructive effect on human dignity, understood as ensuring the genetic specificity of homo sapiens in relation to other species. In other words, what would do individual good could create collective harm.

In the era of pandemics and genetic engineering, health problems have become global, no longer necessarily specific to one region or country, and bioethics must follow this trend. To address bioethical issues at a global level, they need to be translated and addressed in a global language, amenable to a global approach. This global language needs a universal foundation, and such a foundation belongs to human rights as the lingua franca of bioethics^[11].

An article by Veronica Dobozi (vdobozi@stoica-asociatii.ro), Partner, STOICA & ASOCIAȚII.

[1] Web source tensor.ro, captured on 12.05.2019.

[2] The meaning of biomedicine has been profoundly influenced by the different scientific and national cultures that have shaped Western medicine since the 19th century. In the UK, the term "biomedicine" first appeared in 1923 in the Dorland's Medical Dictionary and meant "clinical medicine based on the principles of physiology and biochemistry". In the French context, the term 'biomedicine' did not appear until the 1960s, when it was mainly used by science policy makers and state authorities. Paradoxically, the term was not used by the biologists involved in the post-war development of state-funded research agencies (the National Center for Scientific Research (CNRS), or the National Institute of Body Hygiene (INH), later the National Institute for Health and Medical Research (INSERM). On the contrary, they advocated a "de-medicalization" of disciplines such as bacteriology, immunology and virology, whose expansion was hampered, in their view, by the influence of "medical mandarins", and whose disciplinary agenda led them to reject the very idea of "biomedicine" (Viviane Quirke, Jean-Paul Gaudilliere, The Era of Biomedicine: Science, Medicine and Public Health in Britain and France after the second World War, Medical History, October 2008, 52 (4), p. 442).

[3] The Merriam-Webster Dictionary New Edition, 2016.

[4] Cathy Lloyd, What is biomedicine?, Health Studies, 27.02.2012, The Open University, available at http://www.open.edu/openlearn/body-mind/health/health-studies/what-biomedicine, retrieved 18.03.2019.

[5] Viviane Quirke, Jean-Paul Gaudilliere, The Era of Biomedicine: Science, Medicine and Public Health in Britain and France after the second World War, Medical History, October 2008, 52 (4), p. 442.

[6] Gheorghe Scripcaru, Aurora Ciuca, Vasile Astărăstoae, Călin Scripcaru, Introducere în biodrept, de la bioetica la biodrept. Lumina Lex Publishing House, Bucharest, 2003, pp. 13-14.

[7] Gh. Scripcaru, op. cit., p. 19.

[8] See www.dictionary.cambridge.org, captured on 12.02.2018.

[9] See www.bioethics.msu.edu, captured on 20.09.2018.

[10] See www.collinsdictionary.com, capture from 20.09.2018. According to others, bioethics is a branch of applied ethics, which studies the philosophical, social and legal issues arising in medicine and the life sciences(www.britannica.com) or consists in the study of the moral issues raised by biological, medical or genetic research and some of their applications(www.larousse.fr).

[11] Elizabeth Fenton, John D. Arras, Bioethics and Human Rights: Curb Your Enthusiasm, in Bioethics and human rights: Access to health-related goods, Hasting Center Report, 2009, vol. 39, pp. 27-28.