Suchergebnisse

Auch mit seinem aktuellen Buch tritt Carlo Petrini, Vater und Leitikone der Slow-Food-Bewegung, für seine Überzeugung ein: Wir müssen unserer Nahrung und ihren Produzenten ihren wahren Wert zurückgeben. Er macht deutlich, dass unsere Bedürfnisse nur im Einklang mit der Umwelt zu befriedigen sind und soziale Gerechtigkeit nur durch Nachhaltigkeit und ein neues Bewusstsein möglich ist. Terra Madre ist ein leidenschaftliches wie eindrucksvolles Plädoyer gegen den Konsumismus unserer Zeit und seine Folgen und für ein neues Gleichgewicht zwischen Mensch und Erde. Nicht umsonst zählt The Guardian Petrini zu den 50 Personen, die die Welt retten könnten

The Law of 3 January 2018 established in Italy the "National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use" and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy's compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies. Unfortunately, certain organizational and structural conditions do not bode well for the success of the National Centre.

A review of the European Union (EU) regulations concerning blood, tissues, and cells of human origin is under way in the EU. From the ethical point of view, the non-remuneration of donations and the ban on deriving gain from human biological materials are of particular significance. While the basic ethical principles involved in the procurement, preservation, and use of these materials are the same, their practical application should be adapted to the specific context of each material. In the case of donation and use of blood, in particular, the issue of legitimate reimbursements to donors and for transfusion centers has to be managed in accordance with the principle of non-commercialization. There is also a need for strict rules to avoid possible commercial spillover effects from blood-derived products. The author proposes ethical criteria regarding reimbursements to donors, costs associated with processing, and the development (and possible marketing) of products.

Carlo Petrini Bioethics Unit, Office of the President, National Institute of Health, Rome, Italy Abstract: A review of the European Union (EU) regulations concerning blood, tissues, and cells of human origin is under way in the EU. From the ethical point of view, the non-remuneration of donations and the ban on deriving gain from human biological materials are of particular significance. While the basic ethical principles involved in the procurement, preservation, and use of these materials are the same, their practical application should be adapted to the specific context of each material. In the case of donation and use of blood, in particular, the issue of legitimate reimbursements to donors and for transfusion centers has to be managed in accordance with the principle of non-commercialization. There is also a need for strict rules to avoid possible commercial spillover effects from blood-derived products. The author proposes ethical criteria regarding reimbursements to donors, costs associated with processing, and the development (and possible marketing) of products. Keywords: bioethics, blood, legislation, Europe, transfusion

Italy has recently introduced regulations that profoundly change the arrangement of ethics committees. Specifically, their numbers have been reduced from more than 200 to a few dozen.The decree defining the criteria for their composition and functioning includes regulations intended to improve efficiency and efficacy. The present article provides a brief overview of the new provisions and identifies some critical aspects.

For the 28 member states of the European Union, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC, represents a substantial innovation in the procedures for authorising clinical trials and for handling all the subsequent stages. It introduces a single authorisation that will be valid for all EU member states, as well as a single portal through which all data concerning all clinical trials performed throughout the EU will pass. The present article offers an over-view of the general aspects of the new procedures. It does not address the specific issues involved, each of which merits separate examination.

Carlo PetriniItalian National Institute of Health, Rome, ItalyAbstract: This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.Keywords: bioethics, biological specimen banks, cord-blood stem cell transplantation, ethics, informed consent, legislationCorrigendum for this paper has been published