“HTA is a multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused, and seek to achieve best value” (EUnetHTA 2007). Even though the assessment of ethical aspects of a health technology is listed as one of the objectives of a HTA process, in practice, the integration (...) of these dimensions into reports remains limited. The article is focused on four points: 1. the HTA concept; 2. the difficult HTA-ethics relationship; 3. the ethical issues in HTA; 4. the methods for integrating ethical analysis into HTA. (shrink)

In the field of health technology assessment, there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues in HTA in the field of complex health interventions. Complex health interventions have been the focus of methodological attention in HTA. However, the (...) potential methodological challenges for ethical analysis are as yet unknown.Six of the most frequently described and applied ethical approaches in HTA were critically assessed against a set of five characteristics of complex health interventions: multiple and changing perspectives, indeterminate phenomena, uncertain causality, unpredictable outcomes, and ethical complexity. The assessments are based on literature and the authors’ experiences of developing, applying and assessing the approaches.The Interactive, participatory HTA approach is by its nature and flexibility, applicable across most complexity characteristics. Wide Reflective Equilibrium is also flexible and its openness to different perspectives makes it better suited for complex health interventions than more rigid conventional approaches, such as Principlism and Casuistry. Approaches developed for HTA purposes are fairly applicable for complex health interventions, which one could expect because they include various ethical perspectives, such as the HTA Core Model® and the Socratic approach.This study shows how the applicability for addressing ethical issues in HTA of complex health interventions differs between the selected ethical approaches. Knowledge about these differences may be helpful when choosing and applying an approach for ethical analyses in HTA. We believe that the study contributes to increasing awareness and interest of the ethical aspects of complex health interventions in general. (shrink)

This contribution deals with the issue of the professional autonomy ofthe medical doctor. Worldwide, the physician's autonomy is guaranteedand limited, first of all, by Codes of Medical Ethics. InItaly, the latest version of the national Code of MedicalEthics (Code 1998) was published in 1998 by the Federation ofprovincial Medical Associations (FnomCeO). The Code 1998acknowledges the physician's autonomy regarding the scheduling, thechoice and application of diagnostic and therapeutic means, within theprinciples of professional responsibility. This responsibility has tomake reference to the following (...) fundamental ethical principles:(1) the protection of human life; (2) the protection of thephysical and psychological health of the human being; (3) therelief from pain; (4) the respect for the freedom and the dignityof the human person, without discrimination; (5) an up-to-datescientific qualification (Art. 5). The authors underline that autonomyis an anthropological – and consequently ethical –characteristic of the human person. Different positions on autonomy inbioethics (individualistic, evolutionistic, utilitarian andpersonalistic models) are explained. The relation between theprofessional autonomy of the physician and the autonomy of the patientand of colleagues is discussed. In fact, the medical doctor isobliged: (1) to respect the fundamental rights of the person,first of all his/her life; (2) to ensure the continuity of thecare, even if he can only relieve the patient's suffering; (3) tomaintain, except under certain circumstances, professional secrecy andconfidentiality regarding patients and their medical records. Moreover,the physician cannot deny the patient correct and appropriateinformation. He/she should not perform any diagnostic or therapeuticactivity without the informed consent of the patient and the medicaldoctor must give up medical treatment in case of documented refusal ofthe individual. Furthermore, the medical doctor has the right to raiseconscientious objections if he/she is requested to perform medicalactions that are contrary to his/her conscience or medical opinion,unless this attitude would seriously and immediately harm the patient.Regarding the relationships with colleagues, the physician is obliged tosolidarity, mutual respect, and care of sick colleagues. Finally, theauthors discuss the Italian legislation affecting the physician'sprofessional autonomy: (1) the SSN health care Acts; (2) theso-called Charter for Public Health Care Services; (3) the Acts onprivacy; (4) Good Clinical Practice. (shrink)

El artículo analiza cómo la revista Medicina e Morale ha afrontado en su historia el tema de la ética en la experimentación clínica, que representa una parte muy amplia y compleja de la bioética y también de la deontología médica. Los aspectos que esta temática comprende son ya numerosos y la literatura producida ingentísima. La ética de la experimentación ha recibido particular impulso y atención a continuación de diversas experimentaciones no éticas que han turbado profundamente la opinión pública y hecho (...) necesario una fuerte reconsideración en el ámbito de la investigación clínica. En general, de los años 60's a los años 80's del siglo XX, ha prevalecido en la literatura un intenso empeño e interés en la elaboración de los principios de referencia y en la reflexión teórica relativa a varias cuestiones . De los años 90 en adelante se ha en cambio intensificado -probablemente por las exigencias nacidas en seno de los Comités de ética que precisamente en aquel período han iniciado a difundirse masivamentela elaboración de códigos, reglamentos, líneas-guía que han orientado el desarrollo de la disciplina más en sentido de procedimiento y con un acercamiento ético-deontológico. En particular, Medicina e Morale, ha estado siempre en estas temáticas, desde los inicios de su historia, constituyendo una voz original en el debate, además que un instrumento de difusión de documentos nacionales y sobre todo internacionales. La Revista ha representado, sobre todo en los últimos treinta años, un verdadero punto de referencia a nivel nacional y en algunos casos también internacional, proponiendo a veces orientaciones originales, que han sido luego acogidas en el ámbito de líneas-guía y de normativas.The article deals with how the journal Medicina e Morale has faced ethics in clinical trials, which represents a very large and complex bioethical issue, but also deontological one. This area comprises many questions and the literature is huge. It has risen after unethical clinical trials that have shocked the public and have produced a big rethinking about it. In general, from the '60s to the '80s of the XXth century, an intense commitment and interest have prevailed on the elaboration of the reference principies and on theoretical reflection on various issues, such as informed consent, the ethical significance of clinical research, the protection of vulnerable people, the risk acceptability). Since the '90s onwards the development of codes, regulations, guidelines -that have guided the development of the discipline in a procedural and also deontological sense- has increased, probably due to the large diffusion of ethics committees. Particularly, the journal "Medicina e Morale" has always been present on these issues, since the beginning of its history, creating an original voice in the debate, as well as a dissemination tool of national and especially international documentabon. The journal has been, especially in the last thirty years, a real national, and sometimes international, be nchmark, offering original suggestions which are then accepted in guidelines and regulations. (shrink)

The contribution describes a case report addressed in 2011 by the clinical ethics consultation service team of the Institute of Bioethics and Medical Humanities at the “Agostino Gemelli” School of Medicine of the Università Cattolica del Sacro Cuore, Rome. The clinical case regards ethical dilemmas about the patient’s prospects for receiving an orthotopic liver transplant, because she was a non-resident and lacked a caregiver to assist her during the follow-up period, as well as a place to stay after liver transplant (...) surgery. DOI: 10.5294/pebi.2016.20.1.7. (shrink)