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| Pontifical Academy for Life Prospects for xenotransplantation IntraText CT - Text |
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21. With respect to the specific fields of health-related policies and legislation on matters of xenotransplantation, it is our heartfelt hope that the considerations offered in the present document will provide a useful point of reference for all those who - at an international, national, regional and local level - are responsible for leading society. Many countries(74) have already developed guidelines to regulate this complex sector, offering helpful operational directives. On our part, we do not believe that this document should enter into procedural political-legislative matters. We therefore limit ourselves to emphasizing the importance and desirability that a substantial convergence of international legislation in this area should be achieved as soon as possible, by means of a genuine coordination at the different levels. On the one hand such legislation must provide rules for the continuation of scientific research, guaranteeing its validity and safety; on the other hand it must watch over the health of the citizens involved and the potential risks (especially infective) connected with xenotransplantation. Furthermore it must offer criteria for organizing the necessary information campaigns aimed at the entire population. We conclude this document with the sincere hope that the effort made on this study by those who have participated in it - scientists, jurists, theologians and bioethicists - will represent a concrete contribution to the development of the discussion on the important theme of xenotransplantation. May it also be seen as a further expression of the close attention which the Catholic Church pays on problems related to human disease and suffering. Juan DE DIOS VIAL CORREA Elio SGRECCIA * As is the custom, this document of the Pontifical Academy for Life is published under the editorship of the President and Vice-President. In drafting its contents, the Academy received input from an international work group with specific expertise in the various disciplines connected with xenotransplantation; this work group met many times in the Vatican earlier this year. Members
of the work group are the following: for
the scientific section: -Prof.
Fulvio Calise - Prof.
Felix Cantarovich - Prof.
Emanuele Cozzi - Prof.
Marialuisa Lavitrano - Prof.
Ignazio Marino - Prof.
Eraldo Seren - Prof.
Angelo Serra, S.J. - Prof.
Jonathan P. Stoye for the ethical-anthropological section: - The
Rev. Maurizio Calipari - Msgr.
Ignacio Carrasco De Paula - Prof.
Maurizio P. Faggioni, O.F.M. - Msgr.
Nunzio Galantino - Prof.
Bonifacio Honings, O.C.D. - Msgr.
Osvaldo Neves de Almeida - Prof.
Renzo Pegoraro - Msgr.
Angel Rodriguez Luo - Prof.
Antonio G. Spagnolo - Justice
C.G. Weeramantry Representatives
of the Holy See - Dr.
Maria Isabel Telleria Tapia
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74) To give a few examples of some important organizations that have drafted guidelines in this area, we list the following: the Council of Europe, the Health Council of the Netherlands, the Swedish Committee on Xenotransplantation, the Spanish Xenotransplantation Sub-committee, the Argentine National Commission on Xenotransplantation, the U.S. Department of Health and Human Services Committee on Xenotransplantation, the United Kingdom Xenotransplantation Interim Regulatory Authority, and the Italian Xenotransplantation Commission. In France, the ethical aspects are currently being examined by the French National Ethics Committee and applications for clinical trials will need the approval of the newly formed Agency for the Security of Health Products and of the Ministry of Health. In Germany, the German Medical Council has established a committee to prepare guidelines on xenotransplantation. In Canada "Health Canada' has the authority to regulate xenotransplantation as a new technology. |
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