TEST BioLaw Journal - Rivista di BioDiritto
BioLaw Journal - Rivista di BioDiritto (e-ISSN 2284-4503) is a peer-reviewed, online law journal focusing on the relationships between law and life sciences in a comparative perspective. According to its interdisciplinary nature, the Journal hosts contributions in the fields of law, life sciences, bioethics and artificial intelligence.
Does ChatGPT Have Law Sense? Reflections on an Experimental Study of Argument Mining in Judicial Decisions of the Italian Court of Cassation
This article examines the potential and limits of Large Language Models in judicial practice, taking as its test case the reconstruction of legal argumentation within judicial reasoning. Through an argument mining experiment on decisions of the Italian Supreme Court of Cassation, conducted with GPT-4o and interpreted through Philip Bobbitt’s theory, the paper asks whether an LLM can grasp not only the textual dimension of a judicial decision, but also its rhetorical form. The results show a concrete usefulness in preliminary tasks of segmentation and textual organ-ization, but also a structural limitation in recognizing ethical argumentation and, more broadly, the law sense required by legal judgment.
Artificial Intelligence and Law - Perspectives
Copyright (c) 2026 https://creativecommons.org/licenses/by-nc-nd/4.0
From the Enhanced Subject to the Digital Subject: New Damages of Difficult Quantification
This paper investigates the hermeneutic challenges posed by technological acceleration, analyzing the evolution from the physical person to the “enhanced subject” and “digital subject”. By examining human enhancement practices and digital twins, the study highlights the crisis of traditional dogmatic and constitutional categories, including biodiversity protection under Art. 9 of the Constitution. Particular attention is paid to the complex quantification of damages resulting from the injury to “supra-normal” capacities, proposing the analogical application of differential damage. Finally, the article advocates for a “new legal humanism” capable of governing man-machine hybridization, balancing self-determination, progress, and human dignity.
Towards Ethical Governance of Digital Innovation: Reflections on Tuscany Regional Law No. 57 of 2024
In line with European legislation, Regional Law No. 57 of 9 December 2024, entitled “Regulation of Digital Innovation in the Regional Territory and Protection of Digital Citizenship Rights”, introduces an organic regulatory framework aimed at governing the use of digital technologies while also promoting a balanced relationship between technological innovation and the protection of fundamental rights. This contribution focuses on governance models based on the ethical principles outlined in the regional legislation and on the regulation of artificial intelligence.
Risk Criteria and Liability Rules in the Deployment of Artificial Intelligence
ABSTRACT: The impact of artificial intelligence systems has renewed reflection on civil liability, prompting jurists to identify approaches capable of securing fair and effective remedies. The paper reconstructs possible criteria for attributing harm, ranging from product liability to the rules laid down by Art. 2050 of the Italian Civil Code, and foregrounds risk as a parameter for calibrating remedial responses. The general clause in Art. 2043 of the Civil Code remains the minimum framework of protection. Alongside this, the paper considers whether no-fault compensation schemes might be introduced to manage the cost of AI-related harm.
Emerging Technologies and Vulnerabilities: From a Risk-Based Approach to a Rights-Promotion Paradigm
This paper explores the relationship between emerging technologies and vulnerabilities through the analytical distinction between the European paradigm of risk protection and an emerging national paradigm oriented toward the promotion of fundamental rights. EU digital regulation largely adopts a precautionary and risk-management approach aimed at safeguarding the internal market and ensuring minimum standards of rights protection. Within this framework, national constitutional systems may develop complementary strategies focused on the active promotion of rights. The Italian case illustrates how digital technologies can operate as enabling infrastructures for dignity, autonomy, and participation, particularly in relation to vulnerable individuals and contexts.
Regulating Single-Use Plastic Under Directive (EU) 2019/904 and Beyond: Lessons from Italy and Spain
In the last years, the European Union has vigorously sought to curb the ever-spreading production and use of single-use plastic, underpinned by persistent concerns over its adverse environmental and health impacts. The instruments employed include Directive (EU) 2019/904 and, more recently, Regulation (EU) 2025/40 on plastic packaging. The former has not only triggered acute debate, but has also unveiled divergent approaches and standpoints across Member States. This paper hence illustrates its regulatory cornerstones and explores its transposition, as well as the regulation of plastic more broadly, in both Italy and Spain, with a particular focus on extended producer responsibility as a pivotal mechanism of circular economy.
Environmental Collective Memory: Decolonizing the Environment Through Deanthropocentrization
This paper aims at proposing a critical framework addressed at the environmental justice movement: a deanthropocentrization of the subject – through the recognition of the intrinsic worth of nature, and its procedural shades – may lead to the decolonization of the environment itself. Through examples such as the Ecuadorian recognition of Pachamama, and the acknowledgement of Maori lands as right-bearing entities in New Zealand, the framework builds on the adaptation of collective memories theories, intended as environmental collective memories, to operationalize Eric Yamamoto’s “4Rs” approach, based on Recognition, Responsibility, Reconstruction, and Reparation, in a nature-related context.
Medical Cannabis in the Context of the European Convention on Human Rights: Balancing Personal Autonomy and the Interests of Society
The article analyses the problem of medical cannabis within the framework of human rights and the jurisprudence of the European Court of Human Rights. The authors point to the tension between the individual’s right to autonomy and relief from suffering and the State’s obligation to protect public health. An analysis of the case law of the European Court of Human Rights shows that although the choice of treatment falls within the scope of the right to private life, States are granted a wide margin of appreciation – justified by the lack of a European consensus and the need to protect against risky therapies. In this context, the question arises as to whether, with the increasing liberalisation of regulations and growing social acceptance of medical cannabis, the Court, when adjudicating cases concerning access to medical cannabis, will lean more towards individual autonomy or towards the wide margin of appreciation of Member States in ensuring the protection of the public interest.
The Protection of Genomic Data in Italy in the Specific Case of Forensic DNA Phenotyping: Regulatory Prospects
The paper explores the use of Forensic DNA Phenotyping (FDP) in Italy and the EU, an investigative technique that infers physical characteristics from biological traces. It highlights how FDP raises significant concerns regarding the protection of genetic data and the risk of discrimination. The relevant legislation is examined to underline the potential violation of privacy and the lack of a specific regulatory framework governing its use and providing adequate safeguards. The paper also assesses the impact of artificial intelligence in support of FDP, warning of an amplification of the associated risks. Suggestions are put forward to balance public security with the right to personal data protection.
The Regulatory Vacuum of Research Biobanks: Between Grey Areas and Future Developments in Health Data
Research biobanks, fundamental engines for scientific progress, managing vast quantities of biological samples and associated data. Despite their importance, they suffer from a significant regulatory vacuum, lacking a specific and organic discipline. Currently, their regulation is fragmented between national healthcare standards and the complex technicalities of personal data protection. This paper analyzes the existing legal framework and the current gaps, focusing on recent regulatory evolutions. If correctly interpreted, these innovations could disruptively influence the operations of biobanks, offering crucial perspectives to fill existing legal uncertainties while enhancing modern scientific research.
Genetic Data Sharing in the European Health Data Space: An Urgent Call for Coordinated Action by the Member States
In the European Health Data Space, there are still loose ends to be tied up. Regarding the secondary use of genetic data, the failure of Member States to reach a consensus during the EHDS negotiations led to a regulatory exception. Once again, in application of Article 9(4) GDPR, Member States may introduce additional safeguards for the secondary processing of genetic data in the EHDS. This paper analyses the risks of this exception for genetic research and personalised medicine, while proposing policy alternatives that would allow Member States to enhance institutional control over the genetic data lifecycle and boost individual autonomy and trustworthiness.
Copyright (c) 2026 Guillermo Lazcoz, Giovanni Comandé https://creativecommons.org/licenses/by-nc-nd/4.0
Ethical and Legal Problems of Direct-to-Consumer Genetic Testing: Can Legal Boundaries Be Set for a Borderless Medicine?
Advances in genetics, particularly in their practical application to health care, have created new possibilities in the fight against disease, especially in relation to early and predictive diagnosis. These developments offer significant benefits, but they also generate new ethical and legal dilemmas and conflicts. Among the most salient are those raised by so-called direct-to-consumer genetic tests, which appear to promote greater citizen empowerment through increased access to personal health information. However, this purported empowerment may conceal decisions that are not truly autonomous, due to the lack of reliable information about the clinical validity and utility of such tests. That context, however, may be changing with the growing use of polygenic studies.
The Underrepresentation of Older Adults in Clinical Trials: Toward Solutions for a Persistent Issue
The persistent underrepresentation of older adults in clinical trials constitutes a structural paradox in contemporary pharmaceutical research: those who are the primary recipients of medicinal products are often excluded from the evidentiary processes underlying their authorization. While widely documented in biomedical literature, its legal implications remain comparatively underexplored. This paper examines the issue from a legal and regulatory perspective, situating age-based exclusion at the intersection of scientific methodology, regulatory design, and fundamental rights protection. It reviews the main causes and consequences of underrepresentation and assesses current regulatory responses, including international soft law, U.S. policies, and the EU framework under Regulation (EU) No 536/2014, highlighting persistent gaps between formal commitments to representativeness and their practical implementation.
Copyright (c) 2026 Rosa Signorella https://creativecommons.org/licenses/by-nc-nd/4.0
The Use of Artificial Intelligence in Contemporary Armed Conflicts: Essential Notes
Summary: 1. Some Key Distinctions – 2. Rules Applicable to AI in Armed Conflict – 3. The Question of Empathy and Human Emotions in Target Selection and Attack – 4. The Question of Liability for the Use of AI in Armed Conflict – 5. Concluding Remarks.
Copyright (c) 2026 Marco Pertile https://creativecommons.org/licenses/by-nc-nd/4.0
The Construction of the Fundamental Right to a Dignified Death by the Colombian Constitutional Court in the Face of Legislative Silence
This study analyses the more than quarter-century case-law journey on the “fundamental right to a dignified death” of the Colombian Constitutional Court. It opens with the exam of the birth of the right in 1997 and then explores how, over more than two decades, the Constitutional Court has progressively defined its nature and scope. Finally, it examines the first extension of the clinical cases that qualify for medically assisted death, as well as the definitive elimination of an incomprehensible inconsistency: how the decriminalisation of euthanasia under certain conditions has coexisted with the absolute prohibition of assisted suicide for 25 years.
Copyright (c) 2026 Gonzalo Arruego https://creativecommons.org/licenses/by-nc-nd/4.0
Identity as Number: Reflections on Quantification, Gender, and Body
This paper offers a critical examination of the dynamics of quantification that underpin identity classification processes in relation to gender, with a specific focus on the regulatory mechanisms governing the hormonal monitoring of professional trans and intersex athletes. These mechanisms illustrate how quantification translates complex social and biological phenomena into parameters that appear objective, yet simultaneously produce normative and performative effects. The apparent neutrality of such standards conceals, in fact, deeply political and value-laden choices that shape not only what the law recognizes as gender, but also the bodily characteristics deemed necessary to embody it.
Copyright (c) 2026 Maria Vittoria Izzi https://creativecommons.org/licenses/by-nc-nd/4.0
Medically Assisted Suicide and the National Health Service, Between Institutional Complexity and Crisis: A Bioethical Analysis of the Italian Context
This paper investigates the intersection between medically assisted suicide (MAS) and the structural crisis of Italy’s National Health Service (SSN). Triggered by Constitutional Court rulings no. 66/2025 and no. 132/2025, both of which confirm strict eligibility criteria and stress the importance of procedural safeguards within the SSN, the analysis explores how systemic deficiencies – staff shortages, organizational inefficiencies, and limited access to care – impair the practical realization of MAS. These shortcomings, the paper argues, point to a broader erosion of biomedical ethics, increasingly replaced by market-oriented logics within both public and private healthcare. In the absence of national legislation on MAS, this ethical and institutional gap highlights the urgency of reform to ensure equitable end-of-life care and uphold patient self-determination.
Copyright (c) 2026 Lorena Forni https://creativecommons.org/licenses/by-nc-nd/4.0
Gender, Populism and Democratic Regression: The Politicization of the Istanbul Convention in Central and Eastern Europe
The article examines the emblematic case of the Istanbul Convention – a Council of Europe treaty aimed at preventing and combating violence against women – which in all Central and Eastern European (CEE) countries has been the subject of deliberate distortion campaigns carried out by illiberal and populist actors. These actors have presented it as part of an alleged project by Western European elites to enforce “gender ideology”, promote LGBTQ+ rights, and undermine state sovereignty. This narrative, constructed through the strategic use of moral, cultural, and legal categories, has transformed an instrument designed to protect human rights into a symbol of “Western interference”, thereby contributing to the delegitimization of both international cooperation on gender equality and the authority of European institutions themselves.
Copyright (c) 2026 Susanna Mancini https://creativecommons.org/licenses/by-nc-nd/4.0
Science Advice to Parliaments: The Office of Technology Assessment at the German Bundestag
Technology assessment (TA) emerged over 50 years ago as a scientific approach for analyzing and evaluating the consequences of technology. The main reason for this was the increasing awareness of negative consequences of technology. Parliamentary TA originated in the US Congress. Since the 1980s, it has been established in many European parliaments. This article describes the work of the Office of Technology Assessment at the German Bundestag. It reflects on the experiences gained in over 30 years of existence. A clear distinction between scientific and political mandates has proven to be central to the well-functioning of parliamentary policy advice.
Oficina C: Towards a Collective Intelligence to Meet the Challenges of Parliamentary Work in Spain
The integration of scientific knowledge into parliamentary work is increasingly recognised as a cornerstone of democratic resilience in the twenty-first century. Confronted with global challenges such as climate change, digital transformation, demographic ageing, and political polarisation, parliaments must enhance their ability to deliberate on complex and uncertain issues. In Spain, the creation of Oficina C, the Science and Technology Office of the Congress of Deputies, represents a decisive step towards institutionalising science advice for democratic governance and strengthening trust between citizens and political institutions.
The Evolution and Functioning of the EU Science for Policy Ecosystem
Scientific advice to policymaking plays a central role in modern techno-scientific societies, both informing and legitimizing policymaking. Yet a fundamental tension exists between its appeal to scientific authority and the need for policy relevance and democratic accountability. These concerns are particularly prominent in the context of European Union (EU) policymaking, in which scientific expertise and advice play a central role due to the technical nature of many EU policies. This paper traces the historical development of scientific advice in EU policymaking from the late 1990s to the most recent developments, zooming in on the functioning of the European Commission’s Scientific Advice Mechanism (SAM).
The concept of a “science for policy ecosystem” is increasingly being used at the European Commission’s Joint Research Centre, and has been operationalized in a series of reports on several European countries, published in 2021-2022. Using an original methodology developed in one of these reports, this paper describes the French science for policy ecosystem, focusing on the scientific advisory bodies for environmental and public health matters. Beyond this specific case study, the paper reflects on the theoretical and methodological implications of the concept, in the light of the literature in Science and Technology Studies (STS) and in policy sciences.
The Parliamentary Office of Science and Technology: Connecting the UK Parliament with Research Evidence
The Parliamentary Office of Science and Technology (POST) has connected the UK Parliament with impartial research evidence for over 35 years. This article outlines POST’s structure, methodology, and services – including briefings, expert access, and confidential enquiries – that support evidence-informed policymaking. It highlights POST’s role in overcoming barriers to research use in parliament, its collaboration with academia, and its impact on parliamentary work, especially committee scrutiny. The paper also explores future developments, including rapid evidence synthesis and AI tools, aimed at enhancing responsiveness and efficiency in meeting growing parliamentary demand for trusted research.
The Fragmentation of Science for Policy and the Denied Rights: The Italian Cases of Thalidomide and XLH
In the face of uncertainties in science policy, in recent years the European legislator has combined reflections coming from post-normal science and from the idea of co-production between science and policy to build more open and transparent public decisions. But the science for policy is still often fragmented between the European and national levels, where opaque policy choices are legitimized by presumed scientific objectivity and certainty. The Italian stories of a teratogenic drug, thalidomide, and a rare genetic disease with a very expensive therapy, XLH, reflect and exemplify such fragmentation and opacity.
Techniques in Science Advice: Modelling for Policy and the Politics of Models
Computational models have become indispensable in policy-making across many domains, from environmental regulation, to trade policies and public health. Yet their role as techniques in science advice remains underexplored. This article discusses models through three interrelated analytical dimensions: as boundary objects coordinating different social spheres; as sites where authority is enacted, negotiated, and contested; and as performative devices that actively constitute policy realities. Drawing on social science scholarship and empirical cases, the article demonstrates how models entangle epistemic, technical, social, and political dimensions within advisory assemblages. It concludes with a discussion of responsible modelling, emphasizing inclusion, transparency, and communication.
Speaking Science to Law Toward a Multidimensional and Actor-Centric Framework
The picture sketched here rests upon a deep and wide-ranging transformation in both the methods and paradigms that structure the exercise of power. It also constitutes an invitation to interdisciplinary communities of scholars and practitioners to engage in empirically grounded and forward-looking discussions about the sources of legitimacy upon which democratic institutions should rely when adopting laws, which are paradigmatic and foundational acts of authority and power.
Science Advice to Parliament in the Italian Ecosystem for Science Advice
The article examines the conditions for a potential reintroduction in Italy of a Parliamentary Technological Assessment Body. Like most democratic legislative assemblies, the Italian Chambers have established bodies and procedures dedicated to processing the knowledge necessary for political decision-making. The article examines how the establishment of a parliamentary body dedicated to technical and scientific issues might fit into this context. To be successful, the establishment of the new body would need to carefully identify an appropriate combination of political input and technical expertise, as well as a positive integration into Parliament’s factfinding procedures.
La consulenza scientifica e tecnica per le istituzioni in Europa: una ricerca interdisciplinare
Scientific Advice to Governments: A Comparative Perspective Based on the Italian Experience During the Covid-19
Scientific advice to governments is an ancient practice, yet it is only in the second half of the twentieth century that we observe the gradual institutionalisation and proliferation of bodies established for this purpose. This development has been driven by the increasingly technical nature of the issues on which public decision-makers must act, including energy policy, genetically modified organisms (GMOs), bioethics, climate change and artificial intelligence. The Covid-19 pandemic placed scientific advisory bodies at the centre of government decision-making to an unprecedented degree, exposing both their structural strengths and limitations. Against this backdrop, this article takes a comparative approach, drawing on the Italian experience in particular, to analyse how scientific advice operates in times of crisis. This exploration provides a critical perspective through which to reconsider the institutional design, legitimacy, and operation of scientific advice in contemporary democracies, and to reflect on the evolving relationship between science and political decision-making.