EUROPEAN JOURNAL OF HEALTH LAW最新文献

This article seeks to discuss informed consent in English law. The attitudes on informed consent have shifted to a more patient-centred approach following Montgomery v Lanarkshire Health Board [2015] UKSC 11, [2015] AC 1430, as opposed to the long-standing Bolam decision where clinical judgment was more widely accepted. Thus, following on from the decision in Montgomery a patient is required to know about material risks regarding the proposed treatment and not what the doctor thinks would be the best practice as has been the long-standing consensus since Bolam was decided back in 1957 with subsequent cases following suit. The Montgomery principle has allowed more transparency in the patient-doctor relationship, allowing for a discussion between the doctor and the patient to be the central focus. The outcome of Montgomery was a much needed change in healthcare because prior to this it could be seen that patients were having decisions made on their behalf, and if they had been informed accordingly regarding the risks involved may have decided not to go ahead with the procedure. In the case of Diamond v Royal Devon & Exeter NHS Foundation Trust [2019] EWCA Civ 585 the case highlights the issue of causation in medical negligence action if a doctor does not warn of risks and advise treatment alternatives this would not result in a claim for damages because the patient in this case as was held would have gone ahead with the mesh repair in any case, and thus failing to establish causation could result in no remedy as it did in Diamond. Furthermore, the recent case of McCulloch and others v Forth Valley Health Board [2023] UKSC 26 adds a bit of salt to the wounds of those who had thought or believed that Montgomery had already clarified the position regarding disclosure of alternative treatments to a patient, and to our dismay to learn of that once again English courts have ruled in favour of 'Bolam'.

The COVID-19 pandemic has hit national healthcare systems on an unprecedented scale. At the same time, European societies are witnessing an ongoing war, growing migration and climate crisis. In order to respond to the global challenges facing national healthcare systems, the European Union (EU) is stepping up its actions to promote resilience of national healthcare systems. This is to ensure adequate availability of healthcare services in times of health crises through numerous actions. Despite limited powers in health, the EU legal system creates a multidimensional order for protection of various health-related interests which touch upon the organisation of the Member States' healthcare systems. This paper navigates the ongoing trends with regard to the EU's health policy and presents the perspective on 'standardisation' of the Member States' healthcare systems.

This article explores the legal problems regarding reimbursing drugs used to treat muscular atrophy. The article highlights the importance of insurance coverage for patients with muscular atrophy and the need for more uniform policies. In the Slovak Republic, the state health insurance company refused to reimburse the medicine several times, although it made an exception for other children in the past. The patient asked the civil court to order an urgent measure. The court granted this proposal and ordered the insurance company to pay for the drug Zolgensma. The article analyzes the legal nature of this case considering fundamental human rights.

Considering the difficult procedure of obtaining consent, consent-free health data reuse is believed to be one major contributor towards the creation of thriving health innovation ecosystem. While classic researchers are supported by the GDPR to reuse health data without consent, the innovator's situation remains unclear, and this uncertainty continues to exist upon the introduction of the EHDS. To shed light on grey areas, positions of GDPR and EHDS on the ability of innovators for consent-free health data reuse were assessed. The study concludes that, while academicians are able to reuse health data without consent, a private company's ability has been impeded by individual member states' deviations from Article 9(2) GDPR. Furthermore, in contracts to EHDS (2022) which appeared in favour of innovators through the elimination of consent mechanism, EHDS (2024) with the inclusion of opt-out mechanism, and exclusion of private sector bodies from the Article 35(f), has negatively affected private companies.

The current legal test for capacity under the common law is a functional test. It determines whether a person can make a particular decision at a particular time; it focuses on retained abilities rather than on presumed deficits - in order to promote patient autonomy in decision-making. International evidence suggests however that the test is not well understood and consequently not being correctly applied in practice by a range of medical professionals. Donnelly has argued that gaining a better understanding of how capacity assessments are actually employed is essential to improving the quality of assessments. To date, there is little data on how doctors in particular make their assessments in practice. Using a socio-legal methodology, this quantitative study aims to assess understanding of capacity among a group of general practitioners/family medicine doctors in Ireland, and to determine how they assess capacity in clinical practice. Our study found that notwithstanding a lack of confidence in their ability to assess decision-making capacity, that respondents in fact demonstrated a high level of understanding and of ability to correctly apply the functional test in practice.