Toward A Theory of Biomedical Law

Biojurisprudence: Toward a Theory of Biomedical Law

Biomedical Law, also known as Biolaw, has long been envisaged as the legal extension of applied Bioethics, for the realm of translational medicine and biomedical research. This field division seems to reflect a classical division in Jurisprudence, that of Law and Morality. Biolaw sits at the crux of this tension, since medical practice is bound by strong substantive ethical principles, dating back to the Hippocratic Code [1]. At international level, biolegal norms are mostly composed of “soft law,” in the form of recommendations, and non-binding international instruments [2]. Hard law, in this context, seems to be relegated to a reactive role, an ultima ratio that safeguards the effective implementation of such principles, through some of its deterring principles, anchored in national legislations. Consequently, biojuridical literature confronts the application of the Law (Biolaw, in this very instance) to its social and political consequences i.e., healthcare qua policy. Law provides the coerciveness that such ethical principles require to become and remain enforceable. Yet one is to ask, however, if legal provisions do only exist for the sake of enforceability, or if the legal facet of Bioethics acts as a normative instance of its own right, alongside the ethical principles guiding biomedical practice. Is Law a mere instrument of such bioethical principles, or does it bring more to Bioethics, especially as pertains to medical decision-making, policymaking and the protection of patients’ rights? This question assuredly deserves a theoretical inquiry, to overcome the Bioethics-Biolaw divide [3] and assemble legal reasoning with ethical choices in the biomedical realm. In this brief post, I will attempt to explore the possible avenues which could sketch the scaffolding of a theoretical framework for Biomedical Law.

1. Biolaw’s Conventional Epistemological Framework

The emergence of a discipline seems hard to locate in time; it is a challenge that numerous critical epistemologists have pointed out. Usually, a new scientific discipline appears after the overcoming of a given “paradigm,” as explained at length by Thomas Kuhn in his Structure of Scientific Revolutions [4]. Kuhn’s account of paradigm shifts is useful to describe how a discipline crystallizes once its methodology and instruments converge into a stable epistemological delineation. Take the example of DNA: approaches of George Gamow or Erwin Schrödinger envisaged the human genome as crystal, a mineral, before other researchers claimed its biological nature. Rosalind Franklin used crystallography to take the first “Picture 51” which served as James Watson’s “aha moment” and determined the helicoidal conformation of DNA. Molecular biology became a field of its own right when both the methodology and the instruments converged into such a stable delineation [5]. Yet Kuhn’s framework primarily describes how disciplines emerge through rupture; it does not, on its own, account for why the knowledge produced within a given paradigm may harbor blind spots or sustain questionable practices. For this, one must turn to Gaston Bachelard’s notion of the obstacle épistémologique [6]: the idea that scientific consensus itself can function as a barrier to genuine understanding, perpetuating errors beneath the appearance of established knowledge. This Bachelardian insight will prove essential to the critique of legal instrumentalism developed below.

When it comes to soft sciences (humanities), things get more complicated. Law, especially, has been grappling and still grapples with the contours of its own legitimacy as a science, its scientificity (Wissenschaftlichkeit, in the Humboldtian tradition). As jurists, we know that Kelsen’s project of a “pure theory of law” exemplifies an ideal of scientificity, mirroring that of hard sciences, and especially a will to emancipate legal scholarship from values, hidden inside the everlasting mystery lying behind the Grundnorm [7]. Kelsen’s contribution, however, is not to be discarded wholesale. His hierarchical model of normativity (the Stufenbau, whereby legal norms derive their validity from higher-order norms) remains a foundational insight that later critical theorists, including Kaarlo Tuori, have sought to surpass rather than replace. What proves untenable for Biolaw is not the idea of normative stratification itself, but the aspiration to purity: the claim that legal science can and should be purged of values. Biolaw is precisely about values extended as human rights, research governance and medical practice alike.

“Biolaw” comes from another place: it is a compound word merging legal scholarship with its very object i.e., medical care (including bench to bedside protocols) applied to human biology. Biolaw, emanating from the French concept of Biodroit — attributed to Christian Byk — has a wider scope than that of “biomedical law” [8], encompassing medical and healthcare law. Erick Valdès has recently delved into the question of a “consistent epistemology of biolaw” [9], aiming at deconstructing “the history of biolaw and its oblique epistemologies.” In his view, the history of biolaw needs to be deconstructed. I tend to think that, on the contrary, the history of biolaw unravels its core rationale: the prohibition of eugenics practices, epitomized by the protection of human dignity as a legally protected value and human right. Ultimately, what transpires from numerous accounts about the epistemological delineation of biolaw is that it necessarily works as an open system where values (emanating from deliberative processes, such as Bioethics committees, legislative norm-making, soft law instruments such as recommendations, etc.) and scientific progress are an intricate part of the field. No “pure theory of biolaw” is possible nor advisable, in my view, since it is created upon other normative instances than legal stricto sensu. Bioethics is the intersubjective forum where values attributed to medical practice and the human condition [10] are deliberated upon; Biolaw is their legal skeleton. Therefore, it is usual for biojurists to segue from Bioethics to Biolaw, without necessarily assessing the normative enmeshment such a dyad implies.

2. “Biojurisprudence” as a First Theoretical Delineation

The term was first coined by Polish Law Professor Roman Tokarczyk in a book published in 2008, titled Biojurisprudence: The Foundations of Law for the Twenty-First Century. Tokarczyk’s contribution provides a finer delineation of a theoretical approach to Biolaw yet somewhat overlooked in subsequent scholarship: Biojusgenesis (law of unborn forms of life), Biojusthanatology (law framing end of life), and Biojustherapy (law framing medical care). Tokarczyk sets life (understood as the protection of life) as the prenorm, hence a value-laden kernel. In such a setting, Kelsen’s recursive Grundnorm, stipulated as a mere theoretical basis, does not fit a Biojurisprudential approach. Tokarczyk emphasizes the axiological facet of this new field and its strong moral embedment. He insists on multiple objectives, and mainly to tackle the challenges of biotechnological development, including those incurred by the progress of genetics. In my view, the book does not sufficiently address the core architecture of this discipline at the normative level, which is the role of Jurisprudence and its specific declinations.

The scaffolding of a discipline necessitates more than the aggregation of thetic views; one must answer: what truly constitutes a biolegal norm? And there lies the major challenge of Biolaw: it is a disparate aggregation of norms stemming from fields other than Law itself. Law comes as a formal validation of norms pertaining to medical practice and biomedical research. As explained earlier, Biolaw covers areas such as public healthcare legislations (statutes concerning hospitals, or pandemic preparedness), but also human and fundamental rights (“right to life” of the ECHR) and the protection of research subjects (for instance, the Biomedicine Convention at regional level). The science-ladenness of biolegal norms is tied to their object and objectives: healing the human body. Thus, one is to ask what is properly legal about biolegal norms?

Legal validity, as evoked earlier, is the seal that allows the enforcement of medical norms into the social and political sphere. Evidently, it is a cumulative requirement: medical practice must conform to professional ethics, which are legally enshrined. I would venture to say that the most legal-norms-per-se of the biolegal field are those emanating from Criminal Law, framing what we find in liminal cases: poisoning, murder, manslaughter, corporal damages, breach of trust, quackery. These legal qualifications correspond to extreme malpractice cases where the intention of the professional is no longer curative or in extreme cases of professional recklessness. Yet criminal qualifications do not exhaust the properly juridical dimension of Biolaw. The rights of patients (informed consent, the right to refuse treatment, the protection of bodily integrity) are genuine subjective rights, not mere transpositions of ethical principles. They emanate from the natural law tradition and European religious culture: the respect for patients’ human dignity is typically a culturally loaded concept, but it is also a juridically operative one, bearing its own normative weight within constitutional and human rights frameworks. Therefore, what truly constitutes a biolegal norm is its specific object – healing patients, sometimes via experimental research – but the sources may vary greatly. A biolegal norm is generally hybrid, in that it emanates from medical ethics and benefits from formal validity, Law sealing their existence as enforceable norms.

3. Towards Critical Biojurisprudence

At this stage, I have only described a first layer of complexity surrounding biolegal norms: the admixture of medical normativism and formal validity. Biojurisprudence is undeniably conceived of as a highly axiological discipline, yet science-laden norms are far from anodyne. The risk of circumscribing Biojurisprudence to its ethical kernel is to shun the hermeneutical complexities that science-laden norms raise, both at legislative and adjudicative levels. The main risk, from a jurist’s perspective, is to interpret scientific norms (as inferred from scientific knowledge) as a given that may not be called into question. The jurist is generally concerned with the social implication of new medical practices and projects the application of a legislation onto social life, in terms of risks, reforms and healthcare policies; such an approach corresponds to a pragmatist conception of Law. But one must not forget that science is not neutral and scientific knowledge changes through time. Here, Bachelard’s insight returns with full force: sometimes, scientific consensualism itself functions as an epistemological obstacle, maintaining nefarious practices or dangerous drugs on the medical market. It takes huge scandals for hazardous products to be removed from the market (e.g., thalidomide in the 1960s, the opioid crisis since the 1990s), or for patients to be compensated for massive damages incurred by a product or a medical practice. Consequently, one might perceive biolegal norms as mere funnels of science-laden norms. The latter interpretation is called “legal instrumentalism” which, I contend, is not an adequate view for laws framing science.

One of Law’s main concerns is the fulfillment of legal certainty i.e., the crafting of legislations perennial through time. More specifically, obligatory healthcare policies constitute a highly polarizing area, especially when it involves newly stamped drugs. Such policies generally compel citizen-patients [11] to acquiesce to preventive treatments, thus yielding heated debates [12]. While public deliberation remains important to the process of legitimation of a new healthcare legislation (one, for instance, authorizing research in polarizing areas, such as human genetics), jurists cannot remain mere participants of the Habermasian option. This does not mean discarding Habermas’s substantive insights: his critique of liberal eugenics and the commodification of human nature [10] is, in fact, consonant with Biolaw’s core rationale — the prohibition of eugenic practices and the protection of human dignity. What I question is rather the sufficiency of discursive proceduralism as a framework for biolegal interpretation. Law in practice is, above all, a question of interpretation, otherwise known as hermeneutics. Science as a source of Law is thus, in my view, another core issue of Biojurisprudence: interpreting biolegal norms entails both mastery in legal technique and scientific knowledge.

The epistemology of Biolaw, and therefore Biojurisprudence, thus entails the recognition that science is a genuine source of Law influencing biolegal interpretation. Biojurisprudence is to define biolegal normativism as a separate corpus of the legal sphere, hybrid to their core, but sometimes problematic. Both science and law are instances of political legitimation: they act as a social technique of a specific kind, that shall not overshadow the protection of patients’ rights.

In this perspective, Kaarlo Tuori’s Critical Legal Positivism provides a productive angle of analysis, one that, crucially, does not abandon Kelsen’s insight into normative stratification but surpasses it by reintroducing the axiological and cultural dimensions that Kelsen’s purity principle sought to exclude. Tuori analyzes law through a threefold system: the surface level of statutes and treaties, which in the biolegal context transpose science-laden norms into enforceable rules governing medical and research practices; the middle level of legal culture and ethical traditions, which provides the interpretive resources through which jurists make sense of those norms, not as a mere reception of scientific data, but as a properly hermeneutical operation; and the deep structure of foundational principles, which protects patient autonomy and human dignity as non-negotiable limits, functioning as constitutional bulwarks against both scientific overreach and legislative short-termism. Such a framework, complemented with an interdisciplinary analysis of scientific normativism within the legal realm, would provide the balance required for Biolaw, and Biojurisprudence, to secure its ethical integrity while responding to scientific changeability.

Conclusion: Biojurisprudence’s Theoretical Legitimacy

What we are witnessing today is a clear pattern: biolegal norms are often relegated to a reactive role, remaining the followers of scientific progress. In such a paradigm, the theoretical work surrounding the consistency and legitimacy of Biojurisprudence cannot be overstated: the rise of germline gene editing especially yields ethical responsibilities for future generations. Biolaw shall therefore become more anticipatory of scientific changes, not only in terms of critique or epistemological inquiry, but also in terms of vision: biojurists need to secure the production of legal categories and principles capacious enough to frame future biotechnological development. The precautionary principle offers a telling example of such anticipatory normativity: it allows legal action in the face of scientific uncertainty, thereby reversing the default reactive posture of biolegal regulation. It demonstrates that Law need not wait for scientific certainty to intervene, a possibility that further undermines the instrumentalist view. Biojurisprudence, as a field of its own right, shall exist to fill a theoretical gap, that of the existence of medical norms transformed into legal norms as an objective of both normative and critical inquiry.

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[1] Baltussen, Han. “‘Hippocratic’ Oaths: A Cross-Cultural Exploration of Medical Ethics in the Ancient World.” In The Frontiers of Ancient Science: Papers in Honor of Heinrich von Staden, edited by Brooke Holmes and Klaus-Dietrich Fischer, 47–66. Berlin: De Gruyter, 2015. https://doi.org/10.1515/9783110336337-005.

[2] Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (Oviedo Convention). ETS No. 164. Oviedo, April 4, 1997.

[3] UNESCO. Universal Declaration on the Human Genome and Human Rights. Paris, November 11, 1997.

[4] Kuhn, Thomas S. The Structure of Scientific Revolutions. Chicago: University of Chicago Press, 1962.

[5] This corresponds to a Bachelardian conception of science, whereby the formation of a scientific discipline requires the overcoming of prior epistemological frameworks. See Bachelard, Gaston. Le nouvel esprit scientifique. Paris: Alcan, 1934.

[6] Bachelard, Gaston. La formation de l’esprit scientifique. Paris: Vrin, 1938.

[7] Kelsen, Hans. Reine Rechtslehre. Leipzig and Vienna: Franz Deuticke, 1934. English translation: Pure Theory of Law, trans. Max Knight. Berkeley: University of California Press, 1967.

[8] Lecaros, Juan Alberto. “Biolaw and Bioethics: Convergences and Divergences.” In Biolaw and Policy in the Twenty-First Century, edited by E. Valdés and J. A. Lecaros, 79–108. International Library of Ethics, Law, and the New Medicine 78. Cham: Springer Nature Switzerland, 2019. https://doi.org/10.1007/978-3-030-05903-3_7.

[9] Valdès, Erick. This claim raises eyebrows, I know. To dig deeper, please refer to: [reference to be completed].

[10] Habermas, Jürgen. The Future of Human Nature. Translated by Hella Beister, Max Pensky, and William Rehg. Cambridge: Polity Press, 2003.

[11] Weiner, Dora B. The Citizen-Patient in Revolutionary and Imperial Paris. Baltimore: Johns Hopkins University Press, 1993.

[12] Vaccine hesitancy can be viewed as an illustrative example. See, for instance: MacDonald, Noni E. et al. “A Systematic Literature Review to Clarify the Concept of Vaccine Hesitancy.” Nature Human Behaviour 6 (2022): 1634–48.

Disclaimer

The opinions and views expressed here are solely my own and do not reflect the official policy or position of the University of Helsinki, its Faculty of Law, or any affiliated institution. This blog is a personal space for intellectual reflection and does not constitute legal advice or professional recommendation. All content is non-binding and subject to constant revisions and corrections. Biolaw can be a polarizing field: before sharing or commenting publicly and to avoid any confusion, please refer to the legal notice.