Background: This article provides an overview of direct-to-consumer (DTC) genomic services that are currently available in Greece and the legal framework within which they operate. Methods: Here, we describe the landscape of the DTC genomic testing companies and laboratories by conducting a systematic Ιnternet search for relevant websites. We examine the existing legal framework regarding genetic testing in Greece by a review of present regulation. Although Greece does not have explicit legal provisions for DTC genomics, several other laws, including soft law mechanisms, create the broader legal framework within which DTC genomic services may exist. Results/Conclusions: While the current legal framework creates a flexible environment that is conducive to DTC genomic operations, it is also ambiguous about the legality of some specific services. Given the growing DTC activity in Greece, we argue that it is important to both enforce compliance with existing law and clarify legal ambiguities that may risk limiting the power of legal protections that ought to be afforded to consumers.
The paper examines the ethical and legal challenges of making decisions for previously competent patients and the role of advance directives and legal representatives in light of the Oviedo Convention. The paper identifies gaps in the Convention that result in conflicting instructions in cases of a disagreement between the expressed prior wishes of a patient, and the legal representative. The authors also examine the legal and moral status of informally expressed prior wishes of patients unable to consent. The authors argue that positivist legal reasoning is insufficient for a consistent interpretation of the relevant provisions of the Convention and argue that ethical argumentation is needed to provide guidance in such cases. Based on the ethical arguments, the authors propose a way of reconciling the apparent inconsistencies in the Oviedo Convention. They advance a culturally sensitive approach to the application of the Convention at the national level. This approach understands autonomy as a broader, relational consent and emphasizes the social and cultural embeddedness of the individual. Based on their approach, the authors argue that there exists a moral obligation to respect the prior wishes of the patient even in countries without advance directives. Yet it should be left to the national legislations to determine the extent of this obligation and its concrete forms.
Background End-of-life decisions for neonates with adverse prognosis are controversial and raise ethical and legal issues. In Greece, data on physicians’ profiles, motivation, values and attitudes underlying such decisions and the correlation with their background are scarce. The aim was to investigate neonatologists' attitudes in Neonatal Intensive Care Units and correlate them with self-reported practices of end-of-life decisions and with their background data. Methods A structured questionnaire was distributed to all 28 Neonatal Intensive Care Units in Greece. One hundred and sixty two out of 260 eligible physicians answered anonymously the questionnaire (response rate 66%). Demographic and professional characteristics, self-reported practices and opinions were included in the questionnaire, along with a questionnaire of 12 items measuring physicians’ attitude and views ranging from value of life to quality of life approach (scale 1–5). Results Continuation of treatment in neonates with adverse prognosis without adding further therapeutic interventions was the most commonly reported EoL practice, when compared to withdrawal of mechanical ventilation. Physicians with a high attitude score (indicative of value of quality-of-life) were more likely to limit, while those with a low score (indicative of value of sanctity-of-life) were more likely for continuation of intensive care. Physicians’ educational level (p:0.097), involvement in research (p:0.093), religion (p:0.024) and position on the existing legal framework (p < 0.001) were factors that affected the attitude score. Conclusions Physicians presented with varying end-of-life practices. Limiting interventions in neonates with poor prognosis was strongly related to their attitudes. The most important predictors for physicians' attitudes were religiousness and belief for Greek legal system reform.
The Greek legal framework on healthcare is characterized by the complexity of an immense number of laws and regulatory acts, particularly regarding the national health system. In the face front of that problem, the Directive stands as an effort (and an opportunity) to achieve a regulatory rationalization. The Law 3918/2011 established the National Organisation for Healthcare (EOPYY). EOPYY is the unique national contact point in the country for the purposes of the Directive, having a responsibility to ensure that the services provided by its affiliated healthcare providers meet certain quality and safety standards. Furthermore, the Greek legal system encompasses an integrated body of legislation on informed consent, privacy, and data protection, as well as an explicit reference to the 'quality, safety and efficiency' of medical services, and provisions related to reimbursement issues that need further regulatory specification.
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