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Collaboration in Healthcare: Implications of Data Sharing for Secondary Use in the European Union European Journal of Health Law (IF 0.6) Pub Date : 2024-08-23 Fanni Kertesz
The European healthcare sector is transforming toward patient-centred and value-based healthcare delivery. The European Health Data Space (EHDS) Regulation aims to unlock the potential of health data by establishing a single market for its primary and secondary use. This paper examines the legal challenges associated with the secondary use of health data within the EHDS and offers recommendations for
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European Health Data Space, Use of Data and Data Subjects’ Control over Their Own Health Data: Can an Opt-Out Restore the Balance? European Journal of Health Law (IF 0.6) Pub Date : 2024-06-21 Tomislav Sokol
The creation of the European Health Data Space is a milestone. It establishes something new and makes it possible to have faster and more efficient health treatment, but also to untap the potential of unused data for policy-making and development of new technologies. However, for the EHDS to be functional, it is imperative that a balance it struck between the aim of having useful data to achieve important
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Uterus Transplantation: A Future Issue for the French Legislator? European Journal of Health Law (IF 0.6) Pub Date : 2024-06-19 Antoine Bérar, Laetitia Marcucci, Renaud Bouvet
Uterus transplantation (UT) is a surgical procedure that seeks to correct absolute uterine infertility. As such, it is coupled with assisted reproductive technologies (ART). Currently performed as an investigational procedure in France, this technique could be subject to a legal framework in the future. Given its specificities, the French legislator will need to state their position on several matters
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Anonymous Gamete Donation: a Case for Balancing Under Article 8 ECHR European Journal of Health Law (IF 0.6) Pub Date : 2024-05-22 Jakub Valc
Anonymous gamete donation creates a specific conflict between human rights and public interests under Article 8 of the ECHR. This was first assessed in the ECtHR’s landmark decision in Gauvin-Fournis and Silliau v. France of 7 September 2023. This article critically analyses this judgment, taking into account the European legal framework for anonymous gamete donation, the recommendations of the competent
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Can EU Law Be Used to Challenge Better Regulation Practices That Do Not Lead to Better Health? European Journal of Health Law (IF 0.6) Pub Date : 2024-05-13 Ollie Bartlett
Legislation produced under the EU Commission’s Better Regulation Agenda sometimes fails to achieve the Treaty obligation to ensure a high level of health protection in all EU policies and activities. Public health advocates have raised the question of whether EU law can be employed to challenge this apparent breach of Treaty obligations at the proposal preparation stage, compelling the Commission to
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Promoting Individual Health Responsibility in the Welfare State: Debating Regulations De Lege Lata and De Lege Ferenda on the Example of Germany’s Public Health Insurance European Journal of Health Law (IF 0.6) Pub Date : 2024-05-03 Nicole Friedlein
The public health insurance in Germany will face huge economic challenges in the upcoming years. New diagnostic and therapeutic methods as well as the demographic change contribute to constantly rising expenditure. Although incentives for health-promoting behaviour or financial sanctions for an unhealthy lifestyle have been already discussed in the past, there has been a general reluctance to legally
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The Compatibility of Mandatory Vaccination with the European Convention on Human Rights: Implications for a National Vaccination Policy European Journal of Health Law (IF 0.6) Pub Date : 2024-04-30 Rogier C. Simons, M. Corrette Ploem, Johan Legemaate
This contribution examines the compatibility of mandatory vaccination with the European Convention on Human Rights (ECHR) through an analysis of the relevant ECHR rights and related case law of the European Court of Human Rights (ECtHR). By focusing on Article 8 (Right to Private Life), Article 2 (Right to Life) and Article 9 (Freedom of Thought, Conscience and Religion) ECHR, we formulate conditions
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Mental Health Acts — Perspectives from Mental Health and Law in Ireland and in Portugal European Journal of Health Law (IF 0.6) Pub Date : 2024-04-22 Ana Lúcia R. Moreira, Darius Whelan, Máximo F. Colón, Ana Caldeira Fouto
Mental health legislation is a cornerstone to ensure that individuals with severe mental illness access proper care and treatment. Each country establishes their own legislation. We aimed to compare the Portuguese and Irish Mental Health Acts (MHAs). We reviewed the respective MHA and the literature. While the definition of mental disorder is similar in general, who, where, when and how one can be
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EHDS and Free Movement of Patients: What EU Intervention is Needed? European Journal of Health Law (IF 0.6) Pub Date : 2024-04-12 Johan van de Gronden, Marc Veenbrink
The European Commission issued a proposal for a Regulation on the European Health and Data Space to improve patient mobility. This EHDS Regulation lays down rules for the exchange of digital health data for primary use (treatment) and for secondary use (i.e. research, policymaking). This proposal has far-reaching implications for national healthcare systems. The question arises whether, with this draft
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Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe European Journal of Health Law (IF 0.6) Pub Date : 2024-03-13 Miquel Díaz Hernández, Waltter Roslin, Juli Mansnérus
Off-label use of pharmaceuticals involves a wide array of aspects ranging from legal and regulatory ones to clinical to safety considerations. Access to off-label therapies is particularly relevant question for patients in areas of unmet medical need. Simultaneously, off-label use also triggers wider considerations relating to social and economic sustainability of health care systems and access to
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Give Due Consideration …: Some Thoughts on Member States’ Obligations Under Article 13 of the HTA Regulation European Journal of Health Law (IF 0.6) Pub Date : 2024-03-13 Gisela Ernst, Karl Stöger
The new EU Regulation on health technology assessment (HTAR) provides for joint clinical assessments (JCA) of health technologies at EU level. When Member States carry out health technology assessments (HTA) at the national level, they shall give due consideration to the results of a JCA and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for
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What are the Changes in 2023 for Access to Advanced Therapy Medicinal Products (ATMPs) in France? European Journal of Health Law (IF 0.6) Pub Date : 2024-01-29 Blanka Bartos
ATMPs are the most expensive innovative treatments, thus they require special regulation. Past regulatory measures in France, such as limiting the growth of drug expenditures, the creation of a fund to finance pharmaceutical innovation, the use of performance-based contracts and greater emphasis on medico-economic evaluations in pricing have been contributing to having both universal access to innovative
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Bringing Climate Change to Strasbourg. The Convention and Healthy Environment Claims European Journal of Health Law (IF 0.6) Pub Date : 2024-01-24 André den Exter
Climate change profoundly impacts all aspects of human life, including health. International fora and nation States recognise the importance of urgently cutting greenhouse gas emissions as a primary cause of global warming. States’ commitment to alter climate change has resulted in several treaty documents referring explicitly to human rights obligations. But what exactly are States’ obligations under
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Critically-Ill Children and the International Human Rights System: Assessing the Status and Role of the UNCRPD in the Case of Archie Battersbee European Journal of Health Law (IF 0.6) Pub Date : 2024-01-10 Conrad Nyamutata
Over the past few years, some parents and clinicians in the UK have argued about decisions on the fate of critically-ill children, with the cases ending in protracted and emotionally-sapping legal disputes. The long-running legal conflicts have played out in the public eye, eliciting conflicting opinions. At the core of the disputes is whether parents or clinicians should determine the appropriate
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The Proposal for a Directive on Defective Products: A Game Changer for Innovative Medicinal Products European Journal of Health Law (IF 0.6) Pub Date : 2024-01-10 Mathieu Guerriaud, Valérie Siranyan
At the end of 2022, the European Commission published a proposal for a directive to revise the strict liability regime introduced in 1985. Although the main goal of this new proposal is to adapt the regulations to information technologies such as artificial intelligence, it has multiple impacts on other economic sectors, including the pharmaceutical market. Therefore, this proposal could change the
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Concept of Due Care in Medical Law in a Comparative Perspective European Journal of Health Law (IF 0.6) Pub Date : 2023-12-11 Witold Borysiak
In many European legal systems, the provisions of medical legislative acts impose directly on healthcare professionals an obligation to act with due care. This imperative may be considered a basic principle of practising all medical professions, and even a generally accepted principle of medical law. Due care is the manner of conduct by medical professionals that meets the requirements contained in
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Moral Dilemmas of Surrogate Motherhood European Journal of Health Law (IF 0.6) Pub Date : 2023-10-10 Milena Kavarić, Rajka Djoković
In the sphere of new modalities of creating offspring, one of the most controversial issues is related to surrogacy because it opens the space to unforeseeable ethical, legal, sociological and psychological world of dilemmas. Surrogacy is the process whereby a woman carries and gives birth to a baby for a couple who cannot conceive naturally and it has become increasingly popular worldwide. This reproductive
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What Healthcare Services Temporary Protection Entitles to Have? Navigating the European Social Charter European Journal of Health Law (IF 0.6) Pub Date : 2023-09-29 Yana Litins’ka
Due to the war against Ukraine, the European Union Temporary Protection Directive, establishing a new migration status of temporary protection, was activated for the first time. The substance of the minimum requirement for providing healthcare services in the Directive appears unclear but is supposed to correspond to human rights standards. This article analyses the standards established in the European
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Exploring Regulatory Interplay in the Health Internet of Everything: Digital Health Technologies, Data Protection and Cybersecurity European Journal of Health Law (IF 0.6) Pub Date : 2023-07-25 Aiste Gerybaite
Against the backdrop of interconnected devices, people, and processes in the Internet of Everything (IoE) an examination of the MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE), data protection
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What Kind of Death? The Ethics of Determining One's Own Death, written by Govert den Hartogh. European Journal of Health Law (IF 0.6) Pub Date : 2023-06-30 Paul Schotsmans
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Obstetric Violence: Sterilisation without Consent. The Case of Y.P. v. Russian Federation European Journal of Health Law (IF 0.6) Pub Date : 2023-06-02 André den Exter
On 20 September 2022, the European Court of Human Rights (ECtHR) delivered its judgment in a remarkable case on sterilisation without the patient’s consent, Y.P. v Russian Federation (ECtHR, application no. 43399/13, 20 September 2022). According to the Court, there is no inhuman and degrading treatment, but it was a justified medical procedure. However, the Court did conclude a violation of the right
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‘Software as Medical Device’ Regulation: What the US Can Teach to the EU for a Fairer Balance Towards Its Digital Sovereignty? European Journal of Health Law (IF 0.6) Pub Date : 2023-05-26 Anna Fiorentini
The AI presence in healthcare (e.g., telemedicine platforms and Software as Medical Devices) is uncontroversial by now. Beyond the Big Tech already for some time large investors in this field, the States, repeatedly accused to be unable keeping pace with the exponential technological development, are growingly called upon to deal with it. Taking the distance from those who perceive the US as a regulatory
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COVID-19 Vaccination and the Role of Informed Consent: England as a Case Study European Journal of Health Law (IF 0.6) Pub Date : 2023-05-22 Caterina Milo
Informed consent (IC), following the Supreme Court judgment in Montgomery v Lanarkshire Health Board, [2015] UKSC 11, constitutes a key patients’ right. There is a vast literature exploring the significance of this right, while an analysis of the role that this has played in England during the COVID-19 vaccine distribution has been under-explored. Using England as a case study, this paper argues that
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Case Mortier V. Belgium: The Balance Between the Right to Life and the Right to Respect for Private Life in the Light of Euthanasia European Journal of Health Law (IF 0.6) Pub Date : 2023-05-19 Paulien Walraet
The case Mortier v. Belgium is the first case where the Court comments on the figure of euthanasia. The area of euthanasia in particular raises the issue of finding a balance between the protection of the patients’ right to life in Article 2 of the Convention and that of the right to respect for his or her private life and personal autonomy in Article 8 of the Convention. The Court confirmed the States
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A Blanket That Leaves the Feet Cold: Exploring the AI Act Safety Framework for Medical AI European Journal of Health Law (IF 0.6) Pub Date : 2023-02-07 Sofia Palmieri, Tom Goffin
The AI Act is based on, and at the same time aims to protect fundamental rights, implying their protection, while fulfilling the safety requirement prescribed by the AI Act within the whole lifecycle of AI systems. Based on a risk classification, the AI Act provides a set of requirements that each risk class must meet in order for AI to be legitimately offered on the EU market and be considered safe
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Administrative Liability for Vaccination with an Age-Inappropriate SARS-CoV-2 Vaccine: Latvian Experience European Journal of Health Law (IF 0.6) Pub Date : 2022-11-09 Laura Šāberte, Karina Palkova
The duty of ensuring epidemiological safety, including the duty to ensure vaccination against SARS-CoV-2 to people, is included in the framework of the national constitutional rights. The healthcare institutions providing vaccination and medical practitioners performing vaccination are one of the key assets of the national health care system, to whom the duty in the field of public health and protection
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Maintaining Compliance While Healing at a Distance: Telehealth Services within the Frame of Turkish Data Protection Regime European Journal of Health Law (IF 0.6) Pub Date : 2022-10-28 Elif Küzeci, Oğuzhan Yeşiltuna
Telehealth enables equal, high-quality, and efficient provision of health services, but it also poses serious risks in the absence of a legal basis. Despite its increasing use and promising potential, there has been no specific legal framework for telehealth in Turkey until recently. A new by-law governing the procedures and principles of telehealth services has been introduced by the Ministry of Health
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Compromises and Asymmetries in the European Health Data Space European Journal of Health Law (IF 0.6) Pub Date : 2022-10-27 Petros Terzis
In the post-pandemic world, the ability of researchers to reuse, for the purposes of scientific research, data that had been collected by others and for different purposes has rightfully become a policy priority. At the same time, new technologies with tremendous capacity in data aggregation and computation open new horizons and possibilities for scientific research. It is in this context that the
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HIV and Access to Private Insurance in Spain European Journal of Health Law (IF 0.6) Pub Date : 2022-10-27 Miguel Ángel Ramiro Avilés, María del Val Bolívar Oñoro
In 2018, the Spanish Insurance Contract Act was amended to guarantee that people living with HIV could access to private insurance, such as, health, life, and burial insurances. The number of inquiries received at the HIV Legal Clinic of the University of Alcalá from 1 January 2019 to 31 December 2021 shows that the legal reform is not being effective because insurance companies continue to practice
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Information Privacy in Healthcare — The Vital Role of Informed Consent European Journal of Health Law (IF 0.6) Pub Date : 2022-10-27 Roy McClelland, Colin M. Harper
The use and disclosure of patient information is subject to multiple legal and ethical obligations. Within European human rights law the differences relating to consent are reflected in the separate requirements of data protection law, the common law, and professional ethics. The GDPR requires explicit consent. This contrasts with the ethical and common law availability of reliance on implied consent
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Tobacco Control and The Council of Europe: the Potential and Limits of the Collective Complaints Procedure of the European Social Charter European Journal of Health Law (IF 0.6) Pub Date : 2022-10-27 Giulia Bosi
The role of the Council of Europe (CoE) in tobacco control remains largely unexplored. This paper aims to fill this gap, focusing on the CoE’s European Social Charter. Article 11 of the Charter protects the right to health, and adequate tobacco control measures are necessary to respect this article. This paper examines the potential and limits of the Collective Complaints procedure, one of the two
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Comparing the Decriminalisation of Assisted Dying in Europe European Journal of Health Law (IF 0.6) Pub Date : 2022-10-26 Jessica Maureen Krüger
Assisted dying is subject to markedly different laws in different European countries, and the legislation is rapidly changing in many of them. This article seeks to enhance our understanding of how public and health-care professionals’ opinions shape assisted dying legislation in Europe. To that end, data on the attitudes of the general public as well as health-care professionals was systematically
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Health Care Complaints and Professional Legal Responsibility — A Cross-Country Comparative Review European Journal of Health Law (IF 0.6) Pub Date : 2022-10-26 Søren Fryd Birkeland
One approach to stimulating patient safety and health care quality is through holding health care professionals legally responsible for their performance. Law and health care variation across countries, however, makes it difficult to get an overview and make comparisons of the personal legal responsibility of health care providers. This article describes health care professional liability and complaint
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Assessment of the Dutch Rules on Health Data in the Light of the GDPR European Journal of Health Law (IF 0.6) Pub Date : 2022-10-19 Irith Kist
In 2021, the European Commission published its Assessment of the EU Member States’ rules on health data in the light of General Data Protection Regulation. The Commission concluded that the GDPR has been interpreted in many ways in the EU as regards health research, and national implementation legislation has resulted in a fragmented legal landscape. Several lawful bases are used as a legitimation
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Secondary Use of Personal Health Data: When Is It “Further Processing” Under the GDPR, and What Are the Implications for Data Controllers? European Journal of Health Law (IF 0.6) Pub Date : 2022-08-01 Regina Becker, Davit Chokoshvili, Giovanni Comandé, Edward S. Dove, Alison Hall, Colin Mitchell, Fruzsina Molnár-Gábor, Pilar Nicolàs, Sini Tervo, Adrian Thorogood
Contemporary biomedical research heavily relies on secondary use of personal health data that were obtained in a different clinical or research setting. Under the European Union’s General Data Protection Regulation (GDPR), data controllers processing personal data must comply with the principle of purpose limitation, which restricts further processing of personal data beyond the purpose for which the
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On the Administrative Powers of the WHO: A Lesson from the Pandemic European Journal of Health Law (IF 0.6) Pub Date : 2022-07-27 Donato Vese
The WHO’s management of the pandemic has drawn sharp criticism. It has been suggested that there is an urgent need for a reform providing more intrusive administrative powers. By contrast, this paper argues that the WHO needs sharing powers rather than intrusive powers. Given that the main international norms have arguably designated the WHO as a “non-authoritarian” authority aiming at the highest
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Telemedical and Self-Managed Abortion: A Human Rights Imperative? European Journal of Health Law (IF 0.6) Pub Date : 2022-07-13 Zoe L. Tongue
Early into the COVID-19 pandemic, abortion rights advocates highlighted the importance of maintaining access to abortion through telemedicine. It was argued that telemedical and self-managed abortion was, in the pandemic context, a human rights imperative. This article argues that providing for telemedical and self-managed abortion remains a human rights imperative beyond the duration of the pandemic
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COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland European Journal of Health Law (IF 0.6) Pub Date : 2022-07-08 Mary-Elizabeth Tumelty, Mary Donnelly, Anne-Maree Farrell, Clayton Ó Néill
Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of
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Expansion of Smoke-Free Policies: Stepping Up FCTC’s Game European Journal of Health Law (IF 0.6) Pub Date : 2022-07-08 Aikaterini Tsampi, Jasper V. Been, Michelle Bruijn, Brigit Toebes
The Framework Convention for Tobacco Control (FCTC) is undoubtedly the most efficient international instrument for tobacco control. Article 8 FCTC shapes many smoke-free policies worldwide and in doing so it is usually associated with smoke-free regulation in enclosed public spaces. Our paper highlights that the FCTC contains a sound foundation for smoke-free policies that stretch beyond enclosed public
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The Evolution of Whistleblowing Protection in Healthcare on a European Level European Journal of Health Law (IF 0.6) Pub Date : 2022-07-01 Paulien Walraet, Sofia Palmieri, Tom Goffin
The protection of whistleblowers in healthcare is necessary to ensure quality of care by raising concerns about suspected breaches of human rights and Union law. This protection has evolved over the years through initiatives from the European Council, which were also taken into account in two rulings of the European Court of Human Rights, and the European Parliament. However, these initiatives implement
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The Problematic Path of Fundamental Rights in the European Union: Continuing the Journey on the Regulation on Clinical Trials European Journal of Health Law (IF 0.6) Pub Date : 2022-06-14 Caterina Di Costanzo
In this paper I have tried to identify and analyse some critical points that Regulation No. 526 of 2014 on clinical trials still presents. I have seen that in the face of a long gestation, the criticisms that have been made of the regulation have been various. If we think of the first criticism identified in the regulation, the so-called law shopping, we must affirm that the subject of experimentation
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Legal Challenges to Restrictions on Assistance in Suicide in Italy, Germany and Austria: An Ethico-Legal Analysis European Journal of Health Law (IF 0.6) Pub Date : 2022-05-20 David Albert Jones, Laura Palazzani, Franz-Josef Bormann, Stefan Hofmann
This paper deals with a series of legal cases in Italy, Germany, and Austria, between September 2019 and December 2020, which ruled that laws prohibiting or restricting assistance in suicide were unconstitutional. There are similarities between these three cases, all of which are influenced by the practice of assisted suicide in Switzerland, but also differences, not least because of the antecedent
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The Conceptual Legal Structure of The Patient’s Right to Informed Consent European Journal of Health Law (IF 0.6) Pub Date : 2022-05-20 Noelia Martínez-Doallo
Informed consent has been inconsistently conceptualised as a right, an immunity or even a power in the hands of the patient, which leaves its legal definition as partially indefinite. From the norms of the CHRB, a legal theory stance and the proposals of celebrated authors — namely, W.N. Hohfeld, H. Kelsen and R. Alexy, I will provide a steady conceptual structure for the subjective legal positions
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Women's Birthing Bodies and the Law: Unauthorised Intimate Examinations, Power and Vulnerability, edited by Camilla Pickles and John Herring. European Journal of Health Law (IF 0.6) Pub Date : 2022-05-06 Emma Milne
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The European Court of Human Rights and the Emergence of Human Germline Genome Editing European Journal of Health Law (IF 0.6) Pub Date : 2022-04-21 Merel M. Spaander
The field of human germline genome editing (HGGE) offers a promising reproductive potential to prevent inheritance of genetic diseases, yet also opens the door to undesirable eugenics. This stirred the debate about the acceptability of HGGE in light of human rights, particularly human dignity. The European Convention of Human Rights (ECHR) and the European Court of Human Rights (ECtHR) use human dignity
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Transformation of Medical Care through Gene Therapy and Human Rights to Life and Health – Balancing Risks and Benefits European Journal of Health Law (IF 0.6) Pub Date : 2022-04-21 Anne Kjersti Befring
This article is about how somatic gene therapy can be legally regulated and risk assessed as medical treatment when taking the following international human rights conventions into consideration: the right to life in Article 2 of the ECHR and the right to health in Article 12 of ICESCR. The right to life can involve both protection against risky genetic methods and access to necessary health care.
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Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Santa Slokenberga,Timo Minssen,Ana Nordberg
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Addressing Cognitive Vulnerabilities through Genome and Epigenome Editing: Techno-Legal Adaptations for Persons with Intellectual Disabilities European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Pin Lean Lau
The key aim of this paper is to highlight the oft-under-represented narrative of how persons with disabilities (specifically, those with intellectual disabilities) may access the benefits that genome editing may offer. Firstly, this paper reflects on the critical need for a paradigm shift in how we view intellectual disabilities, and centering the rights of persons with disabilities to allow them to
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The Application of EU Competition Law to the Exploitation of Human Genome Editing Technology European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Vladimir Bastidas Venegas
This paper explores the application of EU Competition Law to the exploitation of human genome editing technology. Holders of key patents in the sector have applied different methods for disseminating the technology, such as different forms of licensing agreement and patent pools. It is found that that the competition rules are ill-suited to assess some of the licensing arrangements applied, which give
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Balancing Innovation, ‘Ordre Public’ and Morality in Human Germline Editing: A Call for More Nuanced Approaches in Patent Law European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Duncan Matthews, Timo Minssen, Ana Nordberg
This article analyses the role that ‘ordre public’ and morality exceptions can play in the granting of patents on inventions in the field of human germline editing and the consequences of this policy option. In order to provide the context for such an analysis, the article will, first, provide an overview of the current patent landscape for relevant genome editing technologies, drawing attention to
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Genetics and Justice, Non-Ideal Theory and the Role of Patents: The Case of CRISPR-Cas9 European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Oliver Feeney
There are ongoing concerns of social justice regarding inequalities in the distribution of access to potential genome editing technologies. Working within non-ideal theory, Colin Farrelly advances a justification for the use of patents to speed up the arrival of safe and effective interventions for all, including the socially disadvantaged. This paper argues that such success is less assured when one
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Genome Editing: Learning from Its Past and Envisioning Its Future European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Judit Sandor
With the technical possibility of genome editing, we have reached a new phase of transforming human beings and even altering our genetic legacy. Genome editing constitutes new responsibilities in many fields. Science and society have never been as dependent on each other as they are today. We must also learn from the past episodes of eugenics and we need to investigate fraudulent practices and cases
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The Object-Based and Process-Based Regulation of Genome Editing European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Michal Koščík, Eliška Vladíková
The article explores whether the broader regulatory framework applicable to the member states of the EU contains suitable tools to react to the rapid advances in science, especially as to the question of germline editing technologies. From the perspective of EU member states, the regulatory framework is fragmented between norms of international law, secondary EU law and national legislation. The rules
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Regulating Heritable Human Genome Editing: Drawing the Line between Legitimate and Controversial Use European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Noemi Conditi
In general, to modify the human germline is prohibited. However, regulating the use of HHGE might be a more efficient method than the actual ban. Indeed, when genome editing is safe for introduction in clinical practices, it is frequently proposed that the prohibition is lifted solely for therapeutic purposes, i.e., to eliminate serious genetic diseases. Definitions of the concepts of health and disease
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A Room with a View (and with a Gene Therapy Drug): Gene Therapy Medicinal Products and Genetic Tourism in Europe European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Vera Lúcia Raposo
In contrast to the extreme caution that has been imposed on genetic medical procedures, in European law genetic drugs, or medications, have found a legal loophole that allows flexible (perhaps too flexible) access to these drugs. In Europe, Gene Therapy Medicinal Products are a form of Advanced Therapy Medicinal Products and as such submitted to the marketing authorization procedure. However, there
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Somatic Genome Editing with the Use of AI: Big Promises but Doubled Legal Issues European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Anastasiya Kiseleva
Both Artificial Intelligence (‘AI’) and genome editing are technologies that on their own promise to revolutionise healthcare. But their common application can facilitate progress in the field even more. Multiplied benefits go along with increased risks. In this article, I identify and analyse legal challenges associated with applying AI facilities in medicinal products based on somatic genome editing
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What Would It Take to Enable Germline Editing in Europe for Medical Purposes? European Journal of Health Law (IF 0.6) Pub Date : 2022-04-08 Santa Slokenberga
Commonly, the regulation on germline editing in Europe is described through the two prohibitions: the prohibition set out in Article 13 of the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine and the prohibition that is set out in the EU Clinical Trials Regulation. These prohibitions
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German State Aid for Covid-19 Medicinal Products: A Risk for Solidarity in the European Union European Journal of Health Law (IF 0.6) Pub Date : 2022-03-09 Kristine Plank
To respond to the need for a vaccine against and a treatment for Covid-19, the German Federal Government (German government) used various economic incentives to promote pharmaceutical and biotechnological (biotech) research and development (R&D) as well as manufacturing. More specifically, it decided to subsidise several German companies working in this field. Such domestic measures might, however
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The Multilevel Dimension of Rules-Based Disease Surveillance beyond the State European Journal of Health Law (IF 0.6) Pub Date : 2022-03-09 Pedro A. Villarreal
The timely availability of accurate information on disease outbreaks with a potential for cross-border spread is a global public good, allowing for a more effective preparedness and response. An ensuing question for national public health authorities is how such information is attained when it is gathered in territories beyond their jurisdiction. International and regional law norms emerge as an option
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The Fragmented Nature of Pandemic Decision-making: A Comparative and Multilevel Legal Analysis. European Journal of Health Law (IF 0.6) Pub Date : 2022-03-04 Irene Domenici,Pedro A Villarreal