35 results
Search Results
2. Tobacco Control and The Council of Europe: the Potential and Limits of the Collective Complaints Procedure of the European Social Charter.
- Author
-
Bosi, Giulia
- Subjects
- *
TOBACCO , *CHARTERS - Abstract
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 monitoring mechanisms of the Charter, as a means to evaluate the compliance of national tobacco control measures with Article 11. It demonstrates that, so far, this mechanism has never been used in this way. However, although the Collective Complaints procedure presents several drawbacks, it should not be underestimated. Indeed, it possesses certain features, such as the collective nature of the complaint and the lack of the requirement of the exhaustion of domestic remedies, which might make it a particularly suitable tool for the abovementioned purpose. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
3. Give Due Consideration ...: Some Thoughts on Member States' Obligations Under Article 13 of the HTA Regulation.
- Author
-
Ernst, Gisela and Stöger, Karl
- Subjects
- *
TECHNOLOGY assessment , *MEDICAL technology , *SOFT law - Abstract
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 the Member States and whether JCA results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as 'national HTA' and which requirements need to be fulfilled to trigger the obligations under Article 13 HTAR are discussed in more detail in this paper. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
4. On the Administrative Powers of the WHO: A Lesson from the Pandemic.
- Author
-
Vese, Donato
- Subjects
- *
PANDEMICS , *NON-state actors (International relations) , *DECISION making - Abstract
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 possible level of health for individuals, the paper suggests that sharing of administrative powers should be incentivised by involving all the relevant actors in the decision-making process, namely through the participation in proceedings of all actors involved in the decision-making, namely governments, national health authorities, and other non-state actors. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
5. What Healthcare Services Temporary Protection Entitles to Have? Navigating the European Social Charter.
- Author
-
Litins'ka, Yana
- Subjects
- *
TEMPORARY protection of refugees , *PRIVATE security services , *CHARTERS , *SOCIAL & economic rights , *HUMAN rights , *EMIGRATION & immigration - Abstract
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 Social Charter (revised), recognising several health-related rights. The paper clarifies the material scope of health-related rights and analyses to what extent the Charter applies to persons enjoying temporary protection. The application of health-related rights in the Charter varies depending on citizenship, whether refugee status was additionally sought, and whether a person is seen as a resident or regular worker. The study indicates ambiguity in the position of this group and how the European Social Rights Committee may include it in the scope of protection. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
6. Critically-Ill Children and the International Human Rights System: Assessing the Status and Role of the UNCRPD in the Case of Archie Battersbee.
- Author
-
Nyamutata, Conrad
- Subjects
- *
HUMAN rights , *CIVIL rights of people with disabilities , *INTERNATIONAL law , *INTERNATIONAL obligations ,CONVENTION on the Rights of Persons with Disabilities - Abstract
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 course of action. In the event of the disagreements, the domestic court intervenes guided by the 'best interests' principle. A corpus of scholarship, falling on either side of the debate, has captured the contradictions. Until recently, the discourse had focused on the common recourses to domestic courts and the European Court of Human Rights. However, in the recent case of incapacitated 12-year-old Archie Battersbee, his parents sought redress from the international human rights system through the Committee on the Rights of People with Disabilities to stop termination of his life support. The courts barred the involvement of the Committee on the basis that the UK had not incorporated the treaty which birthed the Committee. The case brought into sharp focus the relationship between international law and domestic law. First, this paper asserts that the weight (not) given to international law by the domestic courts was inconsistent with its treatment of international obligations in other cases. Secondly, the position that unincorporated treaties do not have legal effect in domestic proceedings is ambiguous. Finally, the treaty body appeared ill-suited to handle a case of a critically-ill child in the face of the impatient demands of local justice. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
7. Addressing Cognitive Vulnerabilities through Genome and Epigenome Editing: Techno-Legal Adaptations for Persons with Intellectual Disabilities.
- Author
-
Lau, Pin Lean
- Subjects
- *
SOCIAL model of disability , *INTELLECTUAL disabilities , *GENOME editing , *DISABILITY laws , *PEOPLE with disabilities , *LEGAL documents , *HUMAN rights - Abstract
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 access the broad scope of their right to health under various international law instruments (including the complementary right to habilitation under Article 26 of the CRPD). Secondly, the paper evaluates the legal provisions in the CRPD and other international instruments relating to the rights of persons with intellectual disabilities, and their access to genome editing technologies. This analysis intends to demonstrate that human rights in disability discourse be complemented with emancipatory, participatory, and transformative research. Finally, the paper argues for a reinvigorated line of thinking that expands on the social model of disability: to align with inclusive, contemporary disability discourse that embodies greater responsibility and innovation in perpetuating better access to genome editing technologies for persons with intellectual disabilities. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
8. COVID-19 Vaccination and the Role of Informed Consent: England as a Case Study.
- Author
-
Milo, Caterina
- Subjects
- *
COVID-19 vaccines , *COVID-19 pandemic , *PATIENTS' rights , *PATIENT autonomy , *LEGAL judgments - Abstract
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 IC has received limited protection in the COVID-19 vaccination context of the adult population, upholding at its best only a minimalistic approach where mere 'consent' has been safeguarded. It suggests that new approaches should be brainstormed so as to more properly safeguard IC in a Montgomery-compliant-approach , namely in a way that enhances patients' autonomy and medical partnership, and also to better prepare and respond to future pandemics. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
9. A Blanket That Leaves the Feet Cold: Exploring the AI Act Safety Framework for Medical AI.
- Author
-
Palmieri, Sofia and Goffin, Tom
- Subjects
- *
ARTIFICIAL intelligence , *CIVIL rights , *BLANKETS - Abstract
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. However, despite their classification, some minimal risk AI systems may still be prone to cause risks to fundamental rights and user safety, and therefore require attention. In this paper we explore the assumption that despite the fact that the AI Act can find broad ex litteris coverage, the significance of this applicability is limited. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
10. COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland.
- Author
-
Tumelty, Mary-Elizabeth, Donnelly, Mary, Farrell, Anne-Maree, and Ó Néill, Clayton
- Abstract
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 the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
11. Compromises and Asymmetries in the European Health Data Space.
- Author
-
Terzis, Petros
- Subjects
- *
ADMINISTRATIVE efficiency , *DATA protection , *HIGH technology industries - Abstract
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 European Commission published in May 2022 its proposal for a sector-specific regulation aiming at establishing the legal landscape and governance mechanisms for the secondary use of health data within the European Union. The ambitious project is centred on administrative efficiency and aspires to unleash the potential of new technologies. However, the quest for efficiency usually comes with privacy compromises and power asymmetries and the case of the European Health Data Space Regulation is no different. This paper draws attention to some of these compromises and suggests specific amendments. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
12. The Problematic Path of Fundamental Rights in the European Union: Continuing the Journey on the Regulation on Clinical Trials.
- Author
-
Di Costanzo, Caterina
- Subjects
- *
CIVIL rights , *CLINICAL trials , *PATIENTS' rights , *RISK perception , *DAMAGES (Law) - Abstract
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 is a very delicate matter since it has a direct and frontal impact on the guarantee of the right to health of European citizens and the use of law shopping does not provide adequate guarantees for the protection of the rights of those participating in a trial. Secondly, the marginalisation of the Ethics Committees whose role is decided at the level of the single national legal system does not ensure that components of independence and representation of the point of view of patients and their associations are guaranteed. This aspect is undoubtedly an important criticism of the regulation as the importance of the role played by the Ethics Committees in the assessment procedures for authorisation applications is not taken into fully consideration. Also, in this case, the economic need for simplification and speed of the evaluation procedure seem to prevail over the need to ensure a thorough and independent scientific and ethical review of authorisation applications. We believe that in the case of Regulation No. 536 of 2014, greater awareness of risks and opportunities will be achieved only by verifying in practice the possible distortions to which this legislation can lead. Only through serious monitoring and reporting of the effects of the regulation on the protection of patients' rights will it be possible to identify and indicate targeted changes to the rules contained therein and, of course, to adopt the consequent measures to reduce possible damages. In this sense, also on the basis of a possible and foreseeable future phase of gestation of Regulation No. 534 of 2014, we believe that in the European area, in the field of clinical trials but not exclusively, that trend, developed above all in the French context, of the "experimentation of laws" should be further cultivated. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
13. Legal Challenges to Restrictions on Assistance in Suicide in Italy, Germany and Austria: An Ethico-Legal Analysis.
- Author
-
Jones, David Albert, Palazzani, Laura, Bormann, Franz-Josef, and Hofmann, Stefan
- Subjects
- *
ASSISTED suicide , *SUICIDE , *PATIENT refusal of treatment , *ACTIONS & defenses (Law) , *SUICIDE victims - Abstract
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 legal contexts. Each case is based on flawed reasoning. They have in common an exaggerated account of autonomy or self-determination, insufficiently qualified by the duty to protect human life or by other ethical constraints. The Italian and Austrian Courts also appeal to the principle of equality and to a supposed analogy with refusal of life-sustaining treatments, both of which raise concerns in relation to further expansion of the provisions. In responding to these flawed judgements, legislators should favour proposals that prevent the normalisation of assisted and non-assisted suicide. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
14. The Application of EU Competition Law to the Exploitation of Human Genome Editing Technology.
- Author
-
Bastidas Venegas, Vladimir
- Subjects
- *
GENOME editing , *HUMAN genome , *EXPLOITATION of humans , *ANTITRUST law , *EUROPEAN Union law - Abstract
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 rise to legal uncertainty. Accordingly, holders of patents on human genome editing technology may be discouraged to apply efficient methods for disseminating the technology. This may delay or obstruct some of the benefits the technology is supposed to deliver to the market, maker actors and consumers. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
15. Genetics and Justice, Non-Ideal Theory and the Role of Patents: The Case of CRISPR-Cas9.
- Author
-
Feeney, Oliver
- Subjects
- *
JUSTICE , *CRISPRS , *PATENTS , *SOCIAL marginality , *GENOME editing - Abstract
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 considers the actual functioning of patents and the practical implications of the patent system in the context of biotechnological innovations. I suggest that non-ideal theoretical approaches risk reverting back to a form of ideal theory if they simply refer to such real-world constraints — e.g. patents — but do not critically assess and fully examine how such constraints manifest themselves in practice. I highlight some considerations that would be important in order to develop and foster a more robust non-ideal approach to justice in biotechnological developments. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
16. Genome Editing: Learning from Its Past and Envisioning Its Future.
- Author
-
Sandor, Judit
- Subjects
- *
GENOME editing , *GENE therapy , *SOCIAL impact , *GENETIC engineering , *NATURAL history - Abstract
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 of failure in scientific research that have often occurred due to merciless scientific competition, profit-seeking commercial interests, or individual pride. Genome editing raises numerous legal questions, such as: Would it be possible to make a legal difference between specific versions of gene editing? Who decides on what is considered a disease or an anomaly, a condition, or a variation? Which diseases are worth being corrected or treated and which ones are not? What kinds of social implications will gene editing bring about when it becomes widely available? Some normative distinctions have already been made in the case of gene therapy: separating somatic from germline interventions. But this distinction has not yet been analyzed in the light of the most recent editing practices. Genome editing also realigns the structure of ethical debates. It makes us rethink the concept of discrimination and scrutinize its cases in the field of assisted reproductive procedures. It revolutionizes the concept of medical treatment. It may increase or reduce inequalities based on health conditions. It may lead to numerous new rights in the field of genetics. Good genome editing practice can only be achieved through the close cooperation between the natural and social sciences. The present paper will endeavor to examine this new form of dialogue. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
17. Somatic Genome Editing with the Use of AI: Big Promises but Doubled Legal Issues.
- Author
-
Kiseleva, Anastasiya
- Subjects
- *
GENOME editing , *ARTIFICIAL intelligence , *QUALITY control , *PRODUCT quality - Abstract
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. These challenges are caused by several factors. First, the two technologies share the characteristics that create and facilitate common risks. Second, each of the technologies is subject to very complex regulatory frameworks. These frameworks are not substantially connected to control the safety and quality of the common product. The main argument of this paper is that the management of common risks is only possible through common procedures. I discover the gaps in the current legislation that prevent from establishing these common procedures and provide recommendations to fill them in. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
18. Expansion of Smoke-Free Policies: Stepping Up FCTC's Game.
- Author
-
Tsampi, Aikaterini, Been, Jasper V., Bruijn, Michelle, and Toebes, Brigit
- Abstract
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 places, such as open public spaces and (quasi-)private spaces. We demonstrate, in particular, that such wide smoke-free regulation, which is gaining momentum around the globe, is versatile and compatible with human rights standards. As such, these expanded smoke-free policies contribute to a wider culture of smoking denormalisation that scales up FCTC's aspiration for tobacco control and subsequently to a smoke-free global society. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
19. Azerbaijan's Healthcare Legislation: Major Developments Amid the COVID-19 Pandemic.
- Author
-
Jafarova, Lala A., Mammadov, Vugar G., Mammadov, Leyli E., and Mammadova, Leyli E
- Subjects
- *
COVID-19 pandemic , *TRANSPLANTATION of organs, tissues, etc. , *HEALTH insurance laws , *HEALTH insurance , *COVID-19 , *MEDICAL care - Abstract
Significant changes in the field of Azerbaijan's healthcare legislation came just at the time when the coronavirus (COVID-19) pandemic broke out in the world. The end of 2019 was supposed to lay the groundwork for the introduction of the country's long-awaited health insurance - a landmark change in terms of national healthcare transformation; although the Law 'On health insurance' was adopted in the 1990s, its implementation was per se frozen for many years due to various reasons. Therefore, the pandemic complicated the process even more. It also coincided with significant updates of the Law 'On human organs and tissues donation and transplantation', which comes into force in 2022, and legislation related to disability. Thus, this paper focuses on recent changes in healthcare legislation; analyses system of health insurance, updated transplantation and disability laws. It gives an overview of the developments that accompany the process of legislation transformation. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
20. On the Administrative Powers of the WHO: A Lesson from the Pandemic
- Author
-
DONATO VESE
- Subjects
Health Policy ,Law - Abstract
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 possible level of health for individuals, the paper suggests that sharing of administrative powers should be incentivised by involving all the relevant actors in the decision-making process, namely through the participation in proceedings of all actors involved in the decision-making, namely governments, national health authorities, and other non-state actors.
- Published
- 2022
21. Addressing Cognitive Vulnerabilities through Genome and Epigenome Editing: Techno-Legal Adaptations for Persons with Intellectual Disabilities
- Author
-
Pin Lean Lau
- Subjects
right of habilitation ,techno-legal adaptations ,right to health ,disability discourse ,Health Policy ,health innovation ,genome editing ,ComputingMilieux_LEGALASPECTSOFCOMPUTING ,intellectual disabilities ,non-discrimination ,Law - Abstract
Special Issue: Gene Editing, Health Innovation, Regulation. Copyright © 2022 The Author. 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 access the broad scope of their right to health under various international law instruments (including the complementary right to habilitation under Article 26 of the CRPD). Secondly, the paper evaluates the legal provisions in the CRPD and other international instruments relating to the rights of persons with intellectual disabilities, and their access to genome editing technologies. This analysis intends to demonstrate that human rights in disability discourse be complemented with emancipatory, participatory, and transformative research. Finally, the paper argues for a reinvigorated line of thinking that expands on the social model of disability: to align with inclusive, contemporary disability discourse that embodies greater responsibility and innovation in perpetuating better access to genome editing technologies for persons with intellectual disabilities.
- Published
- 2022
22. COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland
- Author
-
Mary-Elizabeth Tumelty, Mary Donnelly, Anne-Maree Farrell, and Clayton Ó Néill
- Subjects
COVID-19 Vaccines ,SARS-CoV-2 ,Health Policy ,Vaccination ,COVID-19 ,vaccines ,humanities ,SDG 3 - Good Health and Well-being ,redress ,legal preparedness ,parasitic diseases ,Communicable Disease Control ,Humans ,consent ,Ireland ,Law ,health care economics and organizations ,Aged - Abstract
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 the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks.
- Published
- 2022
23. COVID-19 Vaccination and the Role of Informed Consent: England as a Case Study
- Author
-
Caterina Milo, Milo, Caterina [0000-0002-5669-2785], and Apollo - University of Cambridge Repository
- Subjects
Vaccine Related ,4807 Public Law ,50 Philosophy and Religious Studies ,Health Policy ,Immunization ,3 Good Health and Well Being ,Patient Safety ,Generic health relevance ,Law ,48 Law and Legal Studies - Abstract
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 IC has received limited protection in the COVID-19 vaccination context of the adult population, upholding at its best only a minimalistic approach where mere ‘consent’ has been safeguarded. It suggests that new approaches should be brainstormed so as to more properly safeguard IC in a Montgomery-compliant-approach, namely in a way that enhances patients’ autonomy and medical partnership, and also to better prepare and respond to future pandemics.
- Published
- 2023
24. A Blanket That Leaves the Feet Cold: Exploring the AI Act Safety Framework for Medical AI
- Author
-
Sofia Palmieri and Tom Goffin
- Subjects
Health Policy ,Law - Abstract
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. However, despite their classification, some minimal risk AI systems may still be prone to cause risks to fundamental rights and user safety, and therefore require attention. In this paper we explore the assumption that despite the fact that the AI Act can find broad ex litteris coverage, the significance of this applicability is limited.
- Published
- 2023
25. Compromises and Asymmetries in the European Health Data Space
- Author
-
Petros Terzis
- Subjects
Health Policy ,Law - Abstract
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 European Commission published in May 2022 its proposal for a sector-specific regulation aiming at establishing the legal landscape and governance mechanisms for the secondary use of health data within the European Union. The ambitious project is centred on administrative efficiency and aspires to unleash the potential of new technologies. However, the quest for efficiency usually comes with privacy compromises and power asymmetries and the case of the European Health Data Space Regulation is no different. This paper draws attention to some of these compromises and suggests specific amendments.
- Published
- 2022
26. The Problematic Path of Fundamental Rights in the European Union: Continuing the Journey on the Regulation on Clinical Trials
- Author
-
Caterina Di Costanzo
- Subjects
Health Policy ,Law - Abstract
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 is a very delicate matter since it has a direct and frontal impact on the guarantee of the right to health of European citizens and the use of law shopping does not provide adequate guarantees for the protection of the rights of those participating in a trial. Secondly, the marginalisation of the Ethics Committees whose role is decided at the level of the single national legal system does not ensure that components of independence and representation of the point of view of patients and their associations are guaranteed. This aspect is undoubtedly an important criticism of the regulation as the importance of the role played by the Ethics Committees in the assessment procedures for authorisation applications is not taken into fully consideration. Also, in this case, the economic need for simplification and speed of the evaluation procedure seem to prevail over the need to ensure a thorough and independent scientific and ethical review of authorisation applications. We believe that in the case of Regulation No. 536 of 2014, greater awareness of risks and opportunities will be achieved only by verifying in practice the possible distortions to which this legislation can lead. Only through serious monitoring and reporting of the effects of the regulation on the protection of patients’ rights will it be possible to identify and indicate targeted changes to the rules contained therein and, of course, to adopt the consequent measures to reduce possible damages. In this sense, also on the basis of a possible and foreseeable future phase of gestation of Regulation No. 534 of 2014, we believe that in the European area, in the field of clinical trials but not exclusively, that trend, developed above all in the French context, of the “experimentation of laws” should be further cultivated.
- Published
- 2022
27. Genome Editing: Learning from Its Past and Envisioning Its Future
- Author
-
Judit Sandor
- Subjects
Health Policy ,Law - Abstract
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 of failure in scientific research that have often occurred due to merciless scientific competition, profit-seeking commercial interests, or individual pride. Genome editing raises numerous legal questions, such as: Would it be possible to make a legal difference between specific versions of gene editing? Who decides on what is considered a disease or an anomaly, a condition, or a variation? Which diseases are worth being corrected or treated and which ones are not? What kinds of social implications will gene editing bring about when it becomes widely available? Some normative distinctions have already been made in the case of gene therapy: separating somatic from germline interventions. But this distinction has not yet been analyzed in the light of the most recent editing practices. Genome editing also realigns the structure of ethical debates. It makes us rethink the concept of discrimination and scrutinize its cases in the field of assisted reproductive procedures. It revolutionizes the concept of medical treatment. It may increase or reduce inequalities based on health conditions. It may lead to numerous new rights in the field of genetics. Good genome editing practice can only be achieved through the close cooperation between the natural and social sciences. The present paper will endeavor to examine this new form of dialogue.
- Published
- 2022
28. Somatic Genome Editing with the Use of AI: Big Promises but Doubled Legal Issues
- Author
-
Anastasiya Kiseleva
- Subjects
Health Policy ,Law - Abstract
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. These challenges are caused by several factors. First, the two technologies share the characteristics that create and facilitate common risks. Second, each of the technologies is subject to very complex regulatory frameworks. These frameworks are not substantially connected to control the safety and quality of the common product. The main argument of this paper is that the management of common risks is only possible through common procedures. I discover the gaps in the current legislation that prevent from establishing these common procedures and provide recommendations to fill them in.
- Published
- 2022
29. Genetics and Justice, Non-Ideal Theory and the Role of Patents: The Case of CRISPR-Cas9
- Author
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Oliver Feeney
- Subjects
Health Policy ,Law - Abstract
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 considers the actual functioning of patents and the practical implications of the patent system in the context of biotechnological innovations. I suggest that non-ideal theoretical approaches risk reverting back to a form of ideal theory if they simply refer to such real-world constraints — e.g. patents — but do not critically assess and fully examine how such constraints manifest themselves in practice. I highlight some considerations that would be important in order to develop and foster a more robust non-ideal approach to justice in biotechnological developments.
- Published
- 2022
30. Azerbaijan’s Healthcare Legislation: Major Developments Amid the COVID-19 Pandemic
- Author
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Vugar Mammadov, Leyli E Mammadova, and Lala Jafarova
- Subjects
Economic growth ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Health Policy ,Legislation ,Transplantation ,Donation ,Political science ,Health care ,Pandemic ,Health insurance ,Health law ,business ,Law - Abstract
Significant changes in the field of Azerbaijan’s healthcare legislation came just at the time when the coronavirus (COVID-19) pandemic broke out in the world. The end of 2019 was supposed to lay the groundwork for the introduction of the country’s long-awaited health insurance – a landmark change in terms of national healthcare transformation; although the Law ‘On health insurance’ was adopted in the 1990s, its implementation was per se frozen for many years due to various reasons. Therefore, the pandemic complicated the process even more. It also coincided with significant updates of the Law ‘On human organs and tissues donation and transplantation’, which comes into force in 2022, and legislation related to disability. Thus, this paper focuses on recent changes in healthcare legislation; analyses system of health insurance, updated transplantation and disability laws. It gives an overview of the developments that accompany the process of legislation transformation.
- Published
- 2021
31. Legal Challenges to Restrictions on Assistance in Suicide in Italy, Germany and Austria: An Ethico-Legal Analysis
- Author
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David Albert Jones, Laura Palazzani, Franz-Josef Bormann, and Stefan Hofmann
- Subjects
Health Policy ,Law - Abstract
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 legal contexts. Each case is based on flawed reasoning. They have in common an exaggerated account of autonomy or self-determination, insufficiently qualified by the duty to protect human life or by other ethical constraints. The Italian and Austrian Courts also appeal to the principle of equality and to a supposed analogy with refusal of life-sustaining treatments, both of which raise concerns in relation to further expansion of the provisions. In responding to these flawed judgements, legislators should favour proposals that prevent the normalisation of assisted and non-assisted suicide.
- Published
- 2022
32. What Healthcare Services Temporary Protection Entitles to Have? Navigating the European Social Charter.
- Author
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Litins'ka Y
- Subjects
- Humans, European Union, Ukraine, Citizenship, Human Rights, Right to Health
- Abstract
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 Social Charter (revised), recognising several health-related rights. The paper clarifies the material scope of health-related rights and analyses to what extent the Charter applies to persons enjoying temporary protection. The application of health-related rights in the Charter varies depending on citizenship, whether refugee status was additionally sought, and whether a person is seen as a resident or regular worker. The study indicates ambiguity in the position of this group and how the European Social Rights Committee may include it in the scope of protection.
- Published
- 2023
- Full Text
- View/download PDF
33. Tobacco Control and The Council of Europe: the Potential and Limits of the Collective Complaints Procedure of the European Social Charter.
- Author
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Bosi G
- Subjects
- Humans, Europe, Tobacco Control
- Abstract
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 monitoring mechanisms of the Charter, as a means to evaluate the compliance of national tobacco control measures with Article 11. It demonstrates that, so far, this mechanism has never been used in this way. However, although the Collective Complaints procedure presents several drawbacks, it should not be underestimated. Indeed, it possesses certain features, such as the collective nature of the complaint and the lack of the requirement of the exhaustion of domestic remedies, which might make it a particularly suitable tool for the abovementioned purpose.
- Published
- 2022
- Full Text
- View/download PDF
34. Compromises and Asymmetries in the European Health Data Space.
- Author
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Terzis P
- Subjects
- Humans, European Union, Privacy
- Abstract
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 European Commission published in May 2022 its proposal for a sector-specific regulation aiming at establishing the legal landscape and governance mechanisms for the secondary use of health data within the European Union. The ambitious project is centred on administrative efficiency and aspires to unleash the potential of new technologies. However, the quest for efficiency usually comes with privacy compromises and power asymmetries and the case of the European Health Data Space Regulation is no different. This paper draws attention to some of these compromises and suggests specific amendments.
- Published
- 2022
- Full Text
- View/download PDF
35. Legal Challenges to Restrictions on Assistance in Suicide in Italy, Germany and Austria: An Ethico-Legal Analysis.
- Author
-
Jones DA, Palazzani L, Bormann FJ, and Hofmann S
- Abstract
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 legal contexts. Each case is based on flawed reasoning. They have in common an exaggerated account of autonomy or self-determination, insufficiently qualified by the duty to protect human life or by other ethical constraints. The Italian and Austrian Courts also appeal to the principle of equality and to a supposed analogy with refusal of life-sustaining treatments, both of which raise concerns in relation to further expansion of the provisions. In responding to these flawed judgements, legislators should favour proposals that prevent the normalisation of assisted and non-assisted suicide.
- Published
- 2022
- Full Text
- View/download PDF
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