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  • 1.
    Bastidas Venegas, Vladimir
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    The Application of EU Competition Law to the Exploitation of Human Genome Editing Technology2022In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 29, no 3-5, p. 589-619Article in journal (Refereed)
    Abstract [en]

    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 licens- ing 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. 

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  • 2. Litins’ka, Yana
    et al.
    Karpenko, Oleksandra
    Advocate; Founder, Attorney Office Karpenko Oleksandry Ukraine.
    Does Self-isolation Violate the Right to Liberty? An Analysis of the European Court of Human Rights’ Practice in Light of the Ukrainian Experience2020In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 27, no 4, p. 368-385Article in journal (Refereed)
    Abstract [en]

    COVID-19 became a stress-test for many legal systems because it required that a balance be found between rapid action to prevent the spread of the disease, and continued respect for human rights. Many states in Europe, including Ukraine, chose to enforce an obligation to self-isolate. In this article we review what the obligation to self-isolate entails in the case of Ukraine. We also analyse whether such an obligation should be viewed as a deprivation or a mere restriction of liberty, and if it is permissible under the European Convention for the Protection of Human Rights and Fundamental Freedoms.

  • 3.
    Paskalia, Vicki
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Cross-border Healthcare in the EU: And What if Something Goes Wrong?2017In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 24, no 5, p. 507-522Article in journal (Refereed)
    Abstract [en]

    In March 2011, a new Directive was adopted by the European Parliament and the Council of the European Union: Directive 2011/24, on the application of patients' rights in cross-border healthcare, the primary purpose of which has been to facilitate access to healthcare across national borders. Healthcare safety and the availability of legal remedies in cases of harm are important parameters of quality healthcare and important patients' rights in modern healthcare systems, and they are therefore important issues in a context of cross-border patient mobility. The aim of this article is to shed some light on the provisions of the Healthcare Directive in relation to the issue of legal remedies in cases of harm. It is argued that the current legal state should be considered unsatisfactory, problematic and in need of more clarity and even harmonisation.

  • 4.
    Rynning, Elisabeth
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    The ageing populations of Europe--implications for health systems and patients' rights.2008In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 15, no 3, p. 297-306Article in journal (Refereed)
    Abstract [en]

    Europe is facing a trend of demographic and social change that is likely to have a significant impact on our health systems in the coming decades. The primary concerns are related to the double challenge of population ageing and population decline. These changes will result in a shrinking workforce to handle the steadily increasing healthcare needs of the very old, who will constitute the fastest growing segment of the population. A number of strategies to meet this challenge are suggested and implemented, not least at the EU level. Adaptation of European health systems to the new situation also makes it necessary to revisit familiar medico-legal issues, in order to clarify and consolidate a number of already established patients' rights.

  • 5.
    Rynning, Elisabeth
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Arnardottir, Oddný Mjöll
    Reykjavík University School of Law.
    Hartlev, Mette
    University of Copenhagen.
    Aasen, Henriette Sinding
    University of Bergen.
    Soini, Sirpa
    University of Helsinki.
    Recent developments in Nordic health law2010In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 17, no 3, p. 279-294Article in journal (Refereed)
    Abstract [en]

    The five Nordic countries — Denmark, Finland, Iceland, Norway and Sweden — share a considerable part of their cultural and historical heritage. They have collaborated closely in their development of legislation during most of the 20th century and are also all traditional welfare states, but nevertheless demonstrate a surprising degree of variety in the area of health law. The Nordic Network for Research in Biomedical Law was founded in 2006, with the aim to promote intra-disciplinary collaboration and stimulate comparative Nordic research in this field of law. Exchange of information on recent legal developments has been a recurrent point on the agenda at the Network meetings.

  • 6.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Lund Univ, Fac Law, Lund, Sweden; Riga Stradins Univ, Fac Law, Riga, Latvia.
    Biobanking between the EU and Third Countries - Can Data Sharing Be Facilitated via Soft Regulatory Tools?2018In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 25, no 5, p. 517-536Article in journal (Refereed)
    Abstract [en]

    In biobanking, collaboration and data sharing contribute to building genomic research capacity, and have the potential to further scientific advances that ultimately can result in advances in clinical care. However, in the absence of common applicable legal frameworks that enable collaboration, capacity building is hindered. With the applicability of the General Data Protection Regulation, the obstacles to data sharing which involve export of data from European Union Member States to third countries are expected to grow, rendering the collaboration between the EU and third countries even more challenging. This article examines how, if at all, data sharing in biobank research between the EU and third countries could be facilitated via the use of soft regulatory tools. It argues that although the existing soft tools might not in itself be suitable for meeting all the GDPR requirements, they could be the basis on which to raise the area-specific data protection bar globally.

  • 7.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Book review - T.K. Hervey, C.A. Young and L.E. Bishop (eds.) Research Handbook on EU Health Law and Policy (Cheltenham: Edward Elgar Publishing, 2017), ISBN 978-1785364716, 592 pp.2018In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 25, no 3, p. 355-360Article, book review (Other academic)
  • 8.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Case C-243/19, A v Veselibas ministrija, Judgement of the Court (Second Chamber) of 29 October 2020, EU:C:2020:8722021In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 28, no 3, p. 285-306Article in journal (Other academic)
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  • 9.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Direct-to-consumer Genetic Testing: Changes in the EU Regulatory Landscape2015In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 22, p. 463-480Article in journal (Refereed)
    Abstract [en]

    Rapid advances in genomics and technology have rendered genetic testing services easily accessible to consumers over the Internet in the form of direct-to-consumer genetic testing. In the EU, the IVD Directive has been animadverted for its inability to tackle the challenges direct-to-consumer genetic testing has posed. Currently, the EU legislation is in a transition state. It is thus, timely to assess, to what extent the proposed IVD Regulation is intended to address the performance requirements and utility of direct-to-consumer genetic tests, which are made available to consumers within the EU over the Internet, and discuss the developments vis-à-vis the IVD Directive. To compare with the IVD Directive, the IVD Regulation presents a major shift in how direct-to-consumer genetic testing is treated in the EU. It remains unclear, whether and how the EU requirements can be applied beyond the EU market.

  • 10.
    Slokenberga, Santa
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    What Would It Take to Enable Germline Editing in Europe for Medical Purposes?2022In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 29, no 3-5, p. 521-542Article in journal (Refereed)
    Abstract [en]

    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 reflect the European regional position regarding the ethical and legal questions raised by the technology, and an unwillingness to enable such interventions in Europe. Simultaneously, these prohibitions have been shaped prior to the recent breakthroughs in the field, such as the discovery of the CRISPR-Cas technology, which has initiated a new era in the field. This contribution examines what it would take to enable human germline gene editing in Europe for medical purposes. It scrutinises in detail the content and context of the existing bans, as well as mechanisms to lift them. It argues that the bans that are prescribed by each of the European regional legal orders are embedded in strong structures, composed of values and principles. For the human germline gene editing to be enabled in Europe for health-related purposes, the approach to these values and principles needs to change. Only then can the machinery to lift the bans lead to a change.

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  • 11.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law, Department of Law.
    Minssen, Timo
    Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Copenhagen, Denmark .
    Nordberg, Ana
    Faculty of Law, Lund University, Lund, Sweden .
    Governing, Protecting, and Regulating the Future of Genome Editing: The Significance of ELSPI Perspectives2022In: European Journal of Health Law, ISSN 0929-0273, E-ISSN 1571-8093, Vol. 29, no 3-5, p. 327-340Article in journal (Refereed)
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