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.
PFAS in the Agri-Food Chain: The Precautionary Principle in the Age of “Forever Chemicals”
In recent years, scientific and institutional attention to the per- and polyfluoroalkyl substances (PFAS) has brought to the forefront of legal debate the risks arising from the contamination of environmental matrices and the food chain. This contribution explores the operational scope of the precautionary principle in the light of the pervasiveness, ubiquity, and toxicity of so-called “forever chemicals”. From this perspective, the concept of “essential use” and the emerging model of “cognitive-normative anticipation” in the field of chemical substances are critically scrutinized to assess their suitability to redefine the relationship between the production, regulation, and dissemination of knowledge, in the interest of a high level of food safety protection.
Copyright (c) 2026 Luca Leone https://creativecommons.org/licenses/by-nc-nd/4.0
From Anthropocentrism to Ecocentrism: Emerging Paradigms in EU Environmental Law in the Light of the Mar Menor Case
The European legal tradition has historically conceived nature as an object of instrumental protection, recognising its value exclusively as a resource functional to human activity. However, the progressive deterioration of global ecological balances has imposed a profound rethinking of this anthropocentric approach. The Mar Menor case in Spain constitutes a turning point, as, for the first time, a legal system of an EU Member State attributes rights and autonomous legal personality to an ecosystem. This study reconstructs the main stages of this evolution, analysing European and non-European experiences that have led the EU towards an ecocentric model of environmental protection.
Copyright (c) 2026 Denis Cianconi https://creativecommons.org/licenses/by-nc-nd/4.0
Physician-Assisted Suicide: The Applicant’s Position Between Individual Rights and Legitimate Interests
Starting from an analysis of the Constitutional Court’s rulings on end-of-life-matters, this article examines whether a “right to suicide” can be recognized within the current legal framework, characterized by the persistent absence of specific national legislation. After analysing the impact of supranational sources, the study focuses on the legal framework governing assisted suicide, evaluating the patient’s legal position and the related forms of protection.
Copyright (c) 2026 Emanuele Talarico https://creativecommons.org/licenses/by-nc-nd/4.0
Open Reflections Starting From the New Regulation on Surrogacy (Law No. 169/2024)
Law No. 169/2024 converts Italy’s domestic prohibition on surrogacy into an extraterritorial offence, extending criminal liability to Italian citizens who resort to gestational surrogacy abroad. The provision constitutes a decisive passage against the economic exploitation of women in conditions of vulnerability and the commodification of the child. This paper analyses the profiles of the new discipline considering Articles 2, 3, 30 and 31 of the Italian Constitution, demonstrating its full compatibility with the protection of human dignity. Through a philosophical and bioethical examination of the most slippery issues it shows how the legislative choice strengthens a constitutional anthropology that places the person before the contract.
Copyright (c) 2026 Gabriele Pio Prosperi https://creativecommons.org/licenses/by-nc-nd/4.0
Egg Freezing: A New Flight Route for the Stork?
The demographic crisis poses an important threat to Italy’s future and, in order to be properly tackled, requires the adoption of various measures. The oocyte cryopreservation – egg freezing – has some challenges but, in this complex scenario, it should be part of a mix of policies designed by lawmakers with the aim of relaunching the fertility rate. Some entities, such as the Puglia Region, have already acted in this direction; however, without the involvement of the central State, it is difficult to experience a significant increase in the adoption of this medical method.
Copyright (c) 2026 Matteo Bursi, Veronica Palladini https://creativecommons.org/licenses/by-nc-nd/4.0
The Possibility for Same-Sex Couples and Single Individuals to Access Medically Assisted Reproduction: Towards What Concept of Family?
This paper aims at considering the evolution of medical assistance procedures dealing with same sex couples and singles. The present works takes into account the legislative reforms and the jurisprudential decisions taken by the Italian Constitutional Court and the European Court of Human Rights. Thanks to a comparative perspective and after social changes we could underline both the importance of Parliament’s action and of constitutional justices’ support. These comprehensive innovative tools are vital to define a new notion of family, in a modern and transformed legal system.
Copyright (c) 2026 Giulia Sulpizi https://creativecommons.org/licenses/by-nc-nd/4.0
Ageism, Autonomy, and Justice in Healthcare and Clinical Research: A Structured Narrative Review of Bioethical and Legal-Governance Implications Beyond Chronological Age
Ageism in healthcare and clinical research becomes a bioethical and legal-governance problem when chronological age is used as a proxy for clinically relevant heterogeneity. This structured narrative review integrates empirical, review-level and normative literature to distinguish legitimate age-sensitive reasoning, grounded in individualised assessment, from age-as-proxy shortcutting, where age substitutes for frailty, function, cognition, multimorbidity, treatment burden, communication needs and patient goals. The review examines effects on care pathways, autonomy, informed consent, rehabilitation, research inclusion and accountability, and argues for safeguards including multidimensional assessment, autonomy-preserving communication, supported decision-making, pathway audit and inclusive research governance.
Copyright (c) 2026 Paolo Bailo, Marilyn Cennamo, Tommaso Spasari, Giovanna Ricci https://creativecommons.org/licenses/by-nc-nd/4.0
Territorial Inequalities in Access to Healthcare and Their Effects on Women’s Labour: A Constitutional Perspective From the Italian and Spanish Cases
The article offers a comparative analysis of the right to health in light of Article 32 of the Italian Constitution and Article 43 of the Spanish Constitution, highlighting how healthcare decentralisation has generated persistent territorial inequalities in access to healthcare services, albeit through different mechanisms in the two legal systems. The analysis shows that these asymmetries have a particularly significant impact on women's employment, as healthcare mobility and the fragmentation of services turn the “logistics of care” into an employment-related variable, with cumulative effects on income, job continuity, and professional opportunities. Finally, the article examines corporate welfare as a possible compensatory response, while also highlighting its potential and its systemic limitations.
Copyright (c) 2026 Anastasia Granato https://creativecommons.org/licenses/by-nc-nd/4.0
The European Citizens’ Initiative “My Voice, My Choice: For Safe and Accessible Abortion”. Brief Reflections on Reproductive Rights and Women’s Self-Determination in a Time of Revisionist Backlash
This article examines the European Citizens’ Initiative My Voice, My Choice: For Safe and Accessible Abortion, focusing on the position adopted by the European Union institutions regarding sexual and reproductive rights. After reconstructing the content of the initiative and the support expressed by the European Parliament, the paper analyses the division of competences between the European Union and Member States in the field of health protection, as well as the European Commission’s decision to include the financing of access to safe abortion within the framework of the European Social Fund Plus. The analysis also considers the practice of international human rights monitoring bodies, with particular attention to the case law of the European Court of Human Rights. The article argues that, in a context marked by increasing backlash against reproductive rights and the rise of anti-gender movements, the Initiative constitutes an important step towards recognising access to safe abortion as an essential component of women’s right to health and self-determination.
Copyright (c) 2026 Adele Del Guercio https://creativecommons.org/licenses/by-nc-nd/4.0
Neurodata and European Law: On the Structural Incapacity of the Current Regulatory Framework to Protect the Cognitive Sphere
This paper argues that the current European regulatory framework (GDPR, AI Act, and Medical Devices Regulation) is structurally inadequate to address the challenges posed by commercial neurotechnologies. The focus is specifically on inferential neurodata processed in non-therapeutic consumer contexts. This ineffectiveness is not merely an interpretive gap, but a systemic failure rooted in the absence of a unified conception of the cognitive sphere as an autonomous legally protected interest. The analysis demonstrates how the uncoordinated overlap of these regulations creates a severe protection vacuum regarding algorithmic neural inferences. Finally, the paper identifies the minimum conditions for an adequate European framework.
Copyright (c) 2026 Salvatore Tirrito https://creativecommons.org/licenses/by-nc-nd/4.0
Digital Data Sovereignty: Law and Democracy in the Algorithmic Age
This contribution addresses the crisis of democratic legitimacy induced by algorithmic governance, proposing a reconceptualisation of digital data sovereignty as an emerging form of infrastructural power exceeding data protection paradigms. Through three converging axes, namely sovereignty as a protective office serving the citizen, datafication as a structural reorganisation of the informational environment, and the application of FAIR principles as FAIR by design, the paper develops a conceptual architecture seeking to align technological innovation with democratic imperatives. The HAIMLA methodology is proposed as a procedural device for intelligibility and accountability of automated decisions, framing digital constitutionalism as a systemic response to the asymmetries of informational power.
Copyright (c) 2026 Elisa Sorrentino https://creativecommons.org/licenses/by-nc-nd/4.0
The Impact of Surveillance Biometric Technologies on Fundamental Human Rights: A Comparative Study of China and Canada
The article examines the use of biometric surveillance as a concerning technology that affects several fundamental human rights in both China and Canada. Specifically, it explores the differing interpretations of human rights between the two countries through case studies, including Canada’s border surveillance system and the securitisation of its borders. In the case of China, the article delves into human rights violations in Xinjiang and the extensive implementation of the Social Credit System (SCS).
Copyright (c) 2026 Antonella Benedetto https://creativecommons.org/licenses/by-nc-nd/4.0
Do the EHDS, GDPR and AI Act Protect Against the Risk of Discrimination in DQUL-Based Health Technology Assessment?
This article examines whether the European Health Data Space (EHDS), the General Data Protection Regulation (GDPR), and the Artificial Intelligence Act adequately prevent discriminatory outcomes in DQUL-based health technology assessment. Focusing on the Data Quality and Utility Label (DQUL) and its interaction with Quality-Adjusted Life Year (QALY) cost-effectiveness models, the article argues that regulatory compliance does not eliminate the risk of structural disadvantage. It introduces the concept of numerical discrimination to describe inequality arising from threshold-based evaluative architectures that systematically undervalue underrepresented populations. Through doctrinal analysis of EU equality, data protection, and AI governance law, the article demonstrates that current frameworks struggle to capture distributive harms arising from hierarchical data governance and proposes reforms that integrate distributive impact assessment and population representativeness into health data architecture.
Copyright (c) 2026 Sabire Sanem Yılmaz, Andrea Parziale https://creativecommons.org/licenses/by-nc-nd/4.0
AI Companions for Mental Health: Regulatory Qualification Between Intended Use and Functional Reality. Comparative Remarks Between the EU and the US
This article examines the regulatory landscape concerning AI Companions between the EU and the US. It concludes that in both legal systems the intended use of a product or service expressed by the manufacturer is used as a decisive element whenever it is dubious as to where a device is or not a medical device. It is argued that, in many cases, the prevalence of the manufacturer’s intended use in dubious cases is used to market products as “simple” consumer products whereas, instead, they would need a clinical validation under the medical devices regulations of the two legal systems. This becomes more evident with AI Companions, LLM-based (for now) services which offer companionship to users that are generally not categorized as a medical device. The growing cases of suicide, self-harm, depression, and addiction by young people highlight the limits of the primacy of the manufacturer’s intended use when defining or not an object as a medical device. As authors, we argue in favour of a functional qualification of the intended use, as both the current EU and US regulatory landscape do not ensure a sufficiently high level of care and protection of consumers and patients alike.
Copyright (c) 2026 Francesca Gennari, Sofia Palmieri https://creativecommons.org/licenses/by-nc-nd/4.0
Artificial Intelligence and the Public Sector: Outstanding Issues
This paper builds on a report on artificial intelligence and public administration produced as part of an Astrid research project and examines a number of specific issues concerning, in particular, internal governance, administrative planning, transparency and access to algorithms, the assessment of environmental costs, and the exchange of best practices among public administrations. It concludes by high-lighting both the strengths and the shortcomings of the current phase of experimentation with and deployment of artificial intelligence by public authorities.
Artifical Intelligence and Law - Focus on
Copyright (c) 2026 Barbara Marchetti, Nicoletta Rangone https://creativecommons.org/licenses/by-nc-nd/4.0
Artificial Intelligence in the Public Sector: The Perspective of Italian Administrations, Between Digital Sovereignty and Environmental Sustainability
The paper examines the adoption of artificial intelligence in Italian public administrations through a qualitative and quantitative study conducted between February 2025 and April 2026, involving 21 administrations – including central government bodies, regions, independent authorities and agencies – via questionnaires and focus groups. The analysis presents the research findings, organizing them by thematic area and, in particular, referring to use cases, procurement strategies, data management, internal governance and the environmental impact of AI. Based on the diverse picture that has emerged – which highlights a clear distinction between ‘pioneering’ administrations and bodies still in the exploratory phase, as well as unresolved tensions between digital sovereignty, regulatory compliance and sustainability – the study concludes with operational recommendations for Italian public administrations.
Copyright (c) 2026 Giulia Fantoni, Marina Rallo https://creativecommons.org/licenses/by-nc-nd/4.0
Research Biobanks and Consent Models: Regulatory Challenges and Opportunities in the Era of the European Health Data Space
Research biobanks are essential infrastructures for biomedical innovation, yet they raise complex legal questions relating to consent and data processing. The entry into force of the European Health Data Space (EHDS) Regulation redefines the role of biobanks within the European health data ecosystem. This contribution identifies the main challenges and opportunities arising from integrating biobanks into the EHDS. To this end, the article examines the evolution of the regulatory framework from the GDPR to the EHDS, the data access procedures, the roles of key actors, and the opt-out mechanisms designed to protect data subjects. Special attention is devoted to the Italian context, analysing biobank integration within the Electronic Health Record 2.0 architecture and the national health data ecosystem, including under Law no. 132/2025 on artificial intelligence.
Copyright (c) 2026 Andrea Parziale https://creativecommons.org/licenses/by-nc-nd/4.0
From Primary Tissues to Induced Pluripotent Stem Cells and Organoids: Legal Profiles
This article examines the legal status of induced pluripotent stem cells (iPSCs) and organoids through a three-dimensional framework encompassing material, informational, and ethical dimensions. These entities challenge the traditional dichotomy between person and property, as biological materials become increasingly transformed and integrated into research and economic circuits while retaining a connection to personal identity. Particular attention is devoted to the evolving role of consent. While its function as a legal basis for data processing is progressively relativized, consent re-emerges in an ethical sense as a dynamic regulatory device, capable of governing the lifecycle of biological materials and data in contexts of scientific uncertainty and reuse.
Copyright (c) 2026 Matteo Mancilotti https://creativecommons.org/licenses/by-nc-nd/4.0
Body Donation and Data Protection: Comparative Issues
The text undertakes an analysis of the application of EU data protection law within the framework of procedures governing the donation of the human body for purposes of scientific research and training. Beyond the integrity of anatomical components, such donation entails the transfer of the individual’s associated informational patrimony, construed as an expression of their biological identity. The requirements prescribed for the valid expression of the donor’s will, together with the anonymity thereby ensured – albeit within the diversity of national legal systems – does not preclude construing the transfer of data effected through body donation as a specific expression of the “data altruism”.
Copyright (c) 2026 Roberto D’Orazio https://creativecommons.org/licenses/by-nc-nd/4.0
“Access Costs” and the Governance of Post-Mortem Tissues
From a law and economics perspective, legislation governing the donation and post mortem use of human tissues for research can be understood as a governance system that structures access to a scarce resource. Against this background, this paper aims to capture the economics of the legal mechanisms that enable, hinder or condition access to human biological material after death. To do so, it adopts the category of “resource access costs” to trace the costs embedded in governance schemes across European legal systems. Finally, the paper applies this framework to assess whether allowing the donors to limit or condition their consent could improve the overall allocative performance of the Italian law.
Copyright (c) 2026 Andrea Gorini https://creativecommons.org/licenses/by-nc-nd/4.0
Consent in Body Donation for Scientific Research Between Self-Determination and Solidarity
This article examines the role of consent in body donation for scientific research as a tool for balancing individual self-determination and collective interest. Drawing on a comparative study (England, France, Germany, the Netherlands) and a review of Italian Law no. 10/2020, it argues that consent performs a constitutive function in creating resources for scientific research, and identifies the shortcomings in the Advanced Healthcare Directives model, proposing more flexible and relational alternatives. The effectiveness of the system also depends on the capacity of institutions to build an environment of trust and transparency, as well as a widespread culture of donation.
Copyright (c) 2026 Viola Cappelli, Maria Elena Lippi https://creativecommons.org/licenses/by-nc-nd/4.0
The “Gift of the Body to Science” After Law no. 10/2020: Towards a Legal Framework for Brain Tissue Research
This essay examines Italian Law No. 10/2020 on the post-mortem disposition of the human body and tissues for study, training and scientific research, five years after its enactment, from the standpoint of biomedical research on brain tissues. The first part traces the genealogy of the law, from the nineteenth-century dirigiste model based on the appropriation of unclaimed bodies to the contemporary paradigm of informed consent, and highlights its structural shortcomings: a rigid, quasi-proprietary conception of individual autonomy, modelled on the scheme of advance directives, and a scope of application confined to anatomical training, which neglects the needs of neuroscientific research. With specific reference to brain tissues, it is argued that the clinical setting and shared care planning provide the most favourable ground for the formation of an informed willingness to donate. The second part identifies, within the framework defined by European comparative law, EU and Council of Europe law, and Law No. 10/2020 itself, two courses of action de iure condito: “freeing” for research the biological materials overlooked by the law, through regional legislation grounded in Articles 9 and 32 of the Italian Constitution, Article 22 of the Oviedo Convention and Article 14 of Recommendation CM/Rec(2016)6; and the development, through clinical-scientific self-regulation, of collaboration agreements between reference centres and research institutions and of informed consent protocols specifically designed to promote brain tissue donation.
Copyright (c) 2026 Valentina Calderai, Erica Palmerini https://creativecommons.org/licenses/by-nc-nd/4.0
Introduction to the Focus on - Proceedings section of BioLaw Journal 2/2026, entitled Il dono del corpo alla scienza (Donating One’s Body to Science).
New “Geographies” of Family Life: Migration and the Legal Boundaries of the Family
This article critically examines how law and its implementation practices contribute to shaping the family models emerging from migration processes, situating the issue within a broader reflection on new forms of family life. Starting from the demographic significance of migration in contemporary societies, the article shows how migrant families are often exposed to processes of legal fragmentation, precarisation and invisibilisation, thereby representing a crucial test for the coherence of some core concepts of contemporary constitutionalism. The analysis focuses on a number of particularly significant issues: birth registration and family status, the possible criminalisation of care-related conduct, the removal of foreign parents, and the shortcomings of family reunification procedures. Through an engagement with the case law of national and European courts, the article highlights the uneven role played by the right to family life and the best interests of the child. What emerges is a tension between the abstract recognition of the family as a space of care, relational continuity and identity formation, and its concrete subordination to administrative, security-based and border-control logics.
Copyright (c) 2026 Marta Tomasi https://creativecommons.org/licenses/by-nc-nd/4.0
Post-Mortem Procreation: Between Legislative Shortcomings and Jurisprudential Substitution
The essay analyzes post-mortem procreation in Italy, highlighting the deep conflict between the prohibitions of Law no. 40/2004 and the protection of procreative self-determination. Through the study of jurisprudential evolution, the text critically evaluates the prohibition based on the requirement of both partners being alive at the same time, shedding light on how praetorian practice distinguishes the lawful implantation of cryopreserved embryos from the controversial fertilization of gametes after death. Guided by the case law of the Supreme Court of Cassation, the investigation stresses the centrality of informed consent as the foundation of the status filiationis. Finally, the paper proposes a comparison with the Spanish regulatory model to overcome the current aporias of the domestic legal system.
Copyright (c) 2026 Franca Meola https://creativecommons.org/licenses/by-nc-nd/4.0
The Fate of Cryopreserved Embryos between Itineraries Case Law and de Iure Condendo Perspectives
The paper examines the complex issue of embryo cryopreservation in light of the most recent legislative and case law developments, which have led to a significant reconsideration of the legal framework. Although the need to protect the embryo has become a well-established tenet in both scholarly debate and case law, significant unresolved issues remain concerning the disposition of supernumerary embryos and the limits of cryopreservation practices. Against this background, the study explores the delicate balance between embryo protection, scientific freedom, and public health considerations, with the aim of identifying interpretative approaches consistent with constitutional and supranational principles.
Copyright (c) 2026 Raffaele Picaro https://creativecommons.org/licenses/by-nc-nd/4.0
Who Is a Parent? Reflections on Plural Models of Filiation between Legislative Silence and Constitutional Court Intervention
The article investigates the constitutional transformation of parenthood in the Italian legal system, taking as its interpretive key the growing dissociation between biological fact, legal status, and family model. Its central thesis is that judgments nos. 68 and 69 of 2025 of the Constitutional Court do not reflect a fluctuating line of case law, but rather articulate two distinct standards of review: full, ex post protection of the status and rights of the child already born; and, ex ante, deference to legislative discretion in access to medically assisted reproduction. What emerges is a Court that remedies constitutionally intolerable asymmetries without replacing the legislature, whose persistent silence remains the true systemic critical issue.
Copyright (c) 2026 Andrea Patroni Griffi https://creativecommons.org/licenses/by-nc-nd/4.0
The Limitations of Fundamental Rights and Respect for Their Essential Content in the Affective Relationships of Transgender People
This paper aims to address the issue of the limitations of fundamental rights and the respect for their essential content in the context of the affective relationships of transgender people. Drawing on Italian constitutional case law on the subject, it seeks to identify the irreducible core of rights that are subject to limitations. The analysis of this constitutional clause is carried out from a comparative perspective, examining the Spanish constitutional experience and the case law of the Court of Justice of the European Union.
Copyright (c) 2026 Luigi Ferraro https://creativecommons.org/licenses/by-nc-nd/4.0
Gender Affirmation and the Transformation of Family Structures
The essay analyses the interaction between gender identity and the transformation of family models, from the perspective of promoting the principle of personal self-determination and the pluralism enshrined in the Constitution. By examining how this relationship has evolved at the individual level, within couple relationships, and in parent-child relationships, the study aims to highlight the tensions arising between changing social demands and traditional legal categories. The most recent developments in constitutional case law on gender affirmation, in particular, highlight certain regulatory gaps or the need to update the legislative framework in order to respond effectively to changing social sensibilities, whilst ensuring legal certainty.
Copyright (c) 2026 Lucia Busatta https://creativecommons.org/licenses/by-nc-nd/4.0
Adoption by Single Individuals in Italy: Historical Development, Legal Evolution, and Comparative Perspectives with the Spanish Legal System
This article examines the historical and systematic evolution of adoption law in the Italian legal system, with particular reference to single individuals, from the Civil Code of 1865 to Constitutional Court judgment no. 33 of 2025. It explores the gradual overcoming of the paradigm of the heterosexual married couple as the exclusive model of adoptive parenthood, through an analysis of legislative reforms (Law no. 431/1967, Law no. 184/1983, Law no. 149/2001, Law no. 476/1998, Law no. 173/2015) as well as constitutional and European case law. The article also offers a comparative perspective on the Spanish legal system, which has long allowed adoption by single individuals and has further expanded access through the reforms of 2005 and 2015. It highlights the remaining inconsistencies within the Italian framework – particularly the discrepancy between domestic and international adoption, as well as the exclusion of same-sex couples and unmarried partners – and advances proposals de iure condendo aimed at strengthening the centrality of the child’s best interests.
Copyright (c) 2026 Stella Nacca https://creativecommons.org/licenses/by-nc-nd/4.0