Pub Date : 2024-05-22DOI: 10.1163/15718093-bja10130
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 authorities and the previous case law of the ECtHR on the right to know one's biological origin as an integral part of one's identity that is protected under the right to private and family life.
{"title":"Anonymous Gamete Donation: a Case for Balancing Under Article 8 ECHR.","authors":"Jakub Valc","doi":"10.1163/15718093-bja10130","DOIUrl":"10.1163/15718093-bja10130","url":null,"abstract":"<p><p>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 authorities and the previous case law of the ECtHR on the right to know one's biological origin as an integral part of one's identity that is protected under the right to private and family life.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"411-432"},"PeriodicalIF":0.6,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141089235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-13DOI: 10.1163/15718093-bja10129
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 amend prospective EU legislation so that it better protects health. This article will demonstrate that unfortunately this is not possible due to the justiciability of both Article 168 TFEU and the Better Regulation Agenda. However, this awareness can help public health advocates to re-focus their efforts on strategies that will likely have a greater impact in swaying the direction of EU health policy.
{"title":"Can EU Law Be Used to Challenge Better Regulation Practices That Do Not Lead to Better Health?","authors":"Ollie Bartlett","doi":"10.1163/15718093-bja10129","DOIUrl":"10.1163/15718093-bja10129","url":null,"abstract":"<p><p>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 amend prospective EU legislation so that it better protects health. This article will demonstrate that unfortunately this is not possible due to the justiciability of both Article 168 TFEU and the Better Regulation Agenda. However, this awareness can help public health advocates to re-focus their efforts on strategies that will likely have a greater impact in swaying the direction of EU health policy.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"389-410"},"PeriodicalIF":0.6,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140923631","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-04DOI: 10.1163/15718093-bja10128
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 establish corresponding mechanisms for fear of eroding solidarity and increasing state control. In the course of the Coronavirus pandemic however, a stronger awareness rose to the fact that personal health-related life choices can have a huge impact on the stability of the healthcare system including public health insurance. Not only in Germany but throughout much of Europe, the pandemic led to a new and more fundamental debate about the relationship between individual responsibility for personal health and the wider responsibility for public health assumed by the community of solidarity.
{"title":"Promoting Individual Health Responsibility in the Welfare State","authors":"Nicole Friedlein","doi":"10.1163/15718093-bja10128","DOIUrl":"https://doi.org/10.1163/15718093-bja10128","url":null,"abstract":"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 establish corresponding mechanisms for fear of eroding solidarity and increasing state control. In the course of the Coronavirus pandemic however, a stronger awareness rose to the fact that personal health-related life choices can have a huge impact on the stability of the healthcare system including public health insurance. Not only in Germany but throughout much of Europe, the pandemic led to a new and more fundamental debate about the relationship between individual responsibility for personal health and the wider responsibility for public health assumed by the community of solidarity.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"99 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140827403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-04DOI: 10.1163/15718093-bja10127
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 under which mandatory vaccination legislation is justified. With that, this analysis aims to provide national legislators with guidance on responsible legislative policy. Additionally, this article discusses the legal framework underlying the Dutch vaccination policy, including developments therein since COVID-19. Furthermore, the role of the European Union in the context of vaccination is briefly discussed. The importance of an extensive societal and parliamentary debate before implementing a mandatory vaccination policy is stressed, as is the need for proportionality in enforcement.
{"title":"The Compatibility of Mandatory Vaccination with the European Convention on Human Rights: Implications for a National Vaccination Policy","authors":"Rogier C. Simons, M. Corrette Ploem, Johan Legemaate","doi":"10.1163/15718093-bja10127","DOIUrl":"https://doi.org/10.1163/15718093-bja10127","url":null,"abstract":"This contribution examines the compatibility of mandatory vaccination with the European Convention on Human Rights (<jats:sc>ECHR</jats:sc>) through an analysis of the relevant <jats:sc>ECHR</jats:sc> 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) <jats:sc>ECHR</jats:sc>, we formulate conditions under which mandatory vaccination legislation is justified. With that, this analysis aims to provide national legislators with guidance on responsible legislative policy. Additionally, this article discusses the legal framework underlying the Dutch vaccination policy, including developments therein since <jats:sc>COVID</jats:sc>-19. Furthermore, the role of the European Union in the context of vaccination is briefly discussed. The importance of an extensive societal and parliamentary debate before implementing a mandatory vaccination policy is stressed, as is the need for proportionality in enforcement.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"107 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140827315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-13DOI: 10.1163/15718093-bja10125
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, the Commission in fact proposes to overstep the powers of the European Union, as the delivery and organization of healthcare belongs to the competences of the Member States. Furthermore, the (lack of) exchange of digital health data is not the only hinderance for the free movement of patients. The current set-up of the Patient Directive and the Social Security Coordination Regulation also discourages patients from seeking treatment abroad. Therefore, a more integrated approach in the form of a new Patient Regulation is, in our view, needed.
{"title":"EHDS and Free Movement of Patients: What EU Intervention is Needed?","authors":"Johan van de Gronden, Marc Veenbrink","doi":"10.1163/15718093-bja10125","DOIUrl":"https://doi.org/10.1163/15718093-bja10125","url":null,"abstract":"The European Commission issued a proposal for a Regulation on the European Health and Data Space to improve patient mobility. This <jats:sc>EHDS</jats:sc> 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, the Commission in fact proposes to overstep the powers of the European Union, as the delivery and organization of healthcare belongs to the competences of the Member States. Furthermore, the (lack of) exchange of digital health data is not the only hinderance for the free movement of patients. The current set-up of the Patient Directive and the Social Security Coordination Regulation also discourages patients from seeking treatment abroad. Therefore, a more integrated approach in the form of a new Patient Regulation is, in our view, needed.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"51 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140596310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-01DOI: 10.1163/15718093-12423563
Herman Nys
{"title":"European Court of Justice.","authors":"Herman Nys","doi":"10.1163/15718093-12423563","DOIUrl":"10.1163/15718093-12423563","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"349-355"},"PeriodicalIF":0.6,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-22DOI: 10.1163/15718093-bja10126
Joseph Dute, Tom Goffin
{"title":"European Court of Human Rights.","authors":"Joseph Dute, Tom Goffin","doi":"10.1163/15718093-bja10126","DOIUrl":"https://doi.org/10.1163/15718093-bja10126","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"31 2","pages":"234-246"},"PeriodicalIF":0.8,"publicationDate":"2024-03-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140859067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-13DOI: 10.1163/15718093-bja10123
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 health. National authorities have adapted different regulatory approaches to off-label use of pharmaceuticals, ranging from (1) “regulatory silence”; to (2) allowing off-label use at the discretion of the treating physician; and to (3) a more stringent approach in which off-label use is subject to third party approval. This article provides a brief overview of these different regulatory approaches from a helicopter perspective, and it discusses benefits and shortcomings these approaches. Finally, it presents ideas for preconditions for sustainable and responsible off-label use of pharmaceutical products to ensure patient safety whilst ensuring their timely access to health.
{"title":"Paving the Path for Sustainable and Responsible Off-Label Use of Pharmaceutical Products in Europe","authors":"Miquel Díaz Hernández, Waltter Roslin, Juli Mansnérus","doi":"10.1163/15718093-bja10123","DOIUrl":"https://doi.org/10.1163/15718093-bja10123","url":null,"abstract":"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 health. National authorities have adapted different regulatory approaches to off-label use of pharmaceuticals, ranging from (1) “regulatory silence”; to (2) allowing off-label use at the discretion of the treating physician; and to (3) a more stringent approach in which off-label use is subject to third party approval. This article provides a brief overview of these different regulatory approaches from a helicopter perspective, and it discusses benefits and shortcomings these approaches. Finally, it presents ideas for preconditions for sustainable and responsible off-label use of pharmaceutical products to ensure patient safety whilst ensuring their timely access to health.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"22 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140151786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-13DOI: 10.1163/15718093-bja10122
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 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.
{"title":"Give Due Consideration …: Some Thoughts on Member States’ Obligations Under Article 13 of the HTA Regulation","authors":"Gisela Ernst, Karl Stöger","doi":"10.1163/15718093-bja10122","DOIUrl":"https://doi.org/10.1163/15718093-bja10122","url":null,"abstract":"<p>The new EU Regulation on health technology assessment (<span style=\"font-variant: small-caps;\">HTAR</span>) provides for joint clinical assessments (<span style=\"font-variant: small-caps;\">JCA</span>) of health technologies at EU level. When Member States carry out health technology assessments (<span style=\"font-variant: small-caps;\">HTA</span>) at the national level, they shall give due consideration to the results of a <span style=\"font-variant: small-caps;\">JCA</span> and comply with other obligations of the Regulation. This article aims to clarify what these obligations mean for the Member States and whether <span style=\"font-variant: small-caps;\">JCA</span> results have to be considered outside a national health technology assessment as well. In this context, the question of which processes qualify as ‘national <span style=\"font-variant: small-caps;\">HTA</span>’ and which requirements need to be fulfilled to trigger the obligations under Article 13 <span style=\"font-variant: small-caps;\">HTAR</span> are discussed in more detail in this paper.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"115 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140106117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-06DOI: 10.1163/15718093-bja10120
Joseph Dute, Tom Goffin
{"title":"European Court of Human Rights.","authors":"Joseph Dute, Tom Goffin","doi":"10.1163/15718093-bja10120","DOIUrl":"10.1163/15718093-bja10120","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"31 1","pages":"122-127"},"PeriodicalIF":0.8,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139913679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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