Marina Casini

Health Technology Assessment of pathogen reduction technologies applied to plasma for clinical use.

Although existing clinical evidence shows that the transfusion of blood components is becoming increasingly safe, the risk of transmission of known and unknown pathogens, new pathogens or re-emerging pathogens still persists. Pathogen reduction technologies may offer a new approach to increase blood safety. The study is the output of collaboration between the Italian National Blood Centre and the Post-Graduate School of Health Economics and Management, Catholic University of the Sacred Heart, Rome, Italy. A large, multidisciplinary team was created and divided into six groups, each of which addressed one or more HTA domains.Plasma treated with amotosalen + UV light, riboflavin + UV light, methylene blue or a solvent/detergent process was compared to fresh-frozen plasma with regards to current use, technical features, effectiveness, safety, economic and organisational impact, and ethical, social and legal implications. The available evidence is not sufficient to state which of the techniques compared is superior in terms of efficacy, safety and cost-effectiveness. Evidence on efficacy is only available for the solvent/detergent method, which proved to be non-inferior to untreated fresh-frozen plasma in the treatment of a wide range of congenital and acquired bleeding disorders. With regards to safety, the solvent/detergent technique apparently has the most favourable risk-benefit profile. Further research is needed to provide a comprehensive overview of the cost-effectiveness profile of the different pathogen-reduction techniques. The wide heterogeneity of results and the lack of comparative evidence are reasons why more comparative studies need to be performed.

Electronic Medical Diary (EMD): Ethical Analysis in a HTA Process

Ethical analysis within Health Technology Assessment (HTA) – a comprehensive form of health policy research that examines the short- and long- term consequences of the application or use of technologies (in a broad meaning) – aims at analysing the moral questions raised by the technology itself and by the consequences of implementing or not a health technology as well as ethical issues that are inherent in the HTA process. The work intends to assess, within a HTA process, the ethical consequences of implementing the Electronic Medical Diary (EMD) in health care systems. The EMD is a device for supporting the daily registration and collection of clinical events related to a certain patient. The storage of these patient-specific clinical data constitutes the patient database (PDB) that may be connected with the many online tools which can improve the flow of information within the hospital information system. Such devices should be able to replace the traditional paper record.

I diritti umani alla vita e alla coscienza e la risoluzione dei conflitti dei diritti umani / The human rights to life and conscience and resolving conflicts of human rights

Gli autori affrontano la questione del criterio da seguire per risolvere le situazioni in cui i diritti umani legalmente riconosciuti entrano in conflitto tra loro. La questione e aggravata dalla mancanza di consenso per quanto riguarda le priorita tra i diritti umani. Tuttavia, gli autori ritengono che quando e in gioco il diritto alla vita, questo – sia dal punto di vista etico che giuridico – dovrebbe prevalere sulle rivendicazioni di altri diritti, quanto meno nella sua formulazione negativa (non cagionare la morte). Si tratta infatti, logicamente e cronologicamente del piu fondamentale dei diritti. Gli autori ritengono che vi sia una forte logica a stabilire una priorita tra le tre generazioni di diritti umani andando dal piu al meno importante. E comunque un utile esercizio quello di esaminare – nella dimensione del conflitto tra diritti – la questione del diritto al rispetto della coscienza nell’ambito sanitario, cercando di stabilire l’ordine delle priorita. Gli autori approvano la posizione assunta da legislazioni e decisioni giudiziarie che generalmente assicurano il riconoscimento del diritto al rispetto della coscienza per gli operatori sanitari. ---------- The authors raise the question of what should be done when legally recognized human rights come into conflict. This serious problem is further complicated by a lack of consensus concerning prioritization among human rights. Nevertheless, the authors believe that a solid legal and ethical case can be made that the right to life should trump other human rights claims, particularly in its negative version. It is in fact, logically and chronologically the most basic human right. The authors believe that there is a strong logic to prioritizing the three generations of human rights as generally more important to less so. Viewing the problem of conscience rights in healthcare settings through the prism of conflicting rights and attempting to determine which rights should prevail is also a helpful exercise. The authors concur with the generally high position that the human right of conscience of healthcare professionals has been granted in most legislation and court decisions on the issue.

The Regulation of the Medically Assisted Reproduction (MAR) in Croatia and the European legislative context

Le nuove acquisizioni tecnologiche nel campo delle tecnologie riproduttive e le loro svariate applicazioni si sono imposte dapprima nella prassi, spesso consolidata da normative di carattere non legislativo, successivamente all’attenzione del Parlamento con l’esigenza di una regolamentazione legislativa. Gli Autori mostrano come la Croazia, una delle ex Repubbliche socialiste dell’est europeo, non ha fatto eccezione a questa tendenza e ha iniziato a fronte alla mancanza di una legge sulla “procreazione medicalmente assistita” (PMA) con sei disposizioni contenute in una legge dal contenuto molto piu ampio: Act Concerning Medical Measures for Exercising the Right to Free Decision about Giving Birth to Children, risalente a trent’anni fa. L’articolo, poi, prosegue richiamando il mutamento dello scenario politico-istituzionale che, unitamente all’evoluzione biotecnologica, ha portato alla nel 2009 alla prima legge organica sulla materia. Sebbene non esente da criticita e per certi versi “permissiva” (per quanto riguarda la fecondazione eterologa, non seguita per altro da un chiaro diritto a conoscere le proprie origini da parte dei nati con questa modalita procreativa), la legge del 2009 si caratterizzava per le istanze di tutela dell’embrione umano in particolare mediante il divieto di produzione soprannumeraria di embrioni. Per questo motivo la legge e stata giudicata dal nuovo Governo formatosi dopo le elezioni del 2011 “antiquata” e conservatrice”. In reazione a queste valutazioni ritenute ingiuste, gran parte dei cittadini croati ha aderito all’iniziativa “Anche io sono stato un embrione”. Il dibattito, intenso e vivace, ha comunque portato alla legge del 2012, considerata una delle piu permissive nel panorama europeo. Gli Autori esaminano dunque quest’ultimo testo legislativo mettendo in evidenza le differenze rispetto alla legge precedente e tenendo presente il contesto normativo europeo nel quale si registrano evoluzioni e revisioni delle varie leggi. Nonostante l’evoluzione legislativa croata sulla PMA abbia imboccato la strada dell’affermazione dei c.d. “nuovi diritti civili” i cui titolari sono gli aspiranti genitori e gli operatori del settore (medici, scienziati), e presente in Croazia – concludono gli Autori – una cultura alternativa a quella che rivendica il “figlio a tutti i costi” e la distruzione di embrioni umani come “advancemento scientifico”. La campagna “Anche io sono stato un embrione” e la piena adesione all’iniziativa dei cittadini europei “Uno di noi” sono espressione di questa cultura secondo la quale solo a partire dal rispetto dei diritti dei piu piccoli tra gli esseri umani e possibile comprendere il vero significato della genitorialita e del progresso scientifico. ---------- Technology advancements in the MAR domain and its different applications that first engaged themselves in the medical practice, often were reinforced with the non-legislative normative, and further with the Government attention with a need for legislative regulation. The Authors show how Croatia as one of the ex-Socialistic Republics was no exception in this tendency and stated “Medical Assisted Reproduction” regulation in front of the lack of a law. At that time, it consisted only of six dispositions contained in the 1978 law entitled Act Concerning Medical Measures for Exercising the Right to the Free Decision about Giving Birth to Children, dating 30 years ago. The article then continues mentioning the turn of the political institutional setting that, with the biotechnological evolution, brought, in 2009, to the first systematic law regarding MAR. Although, without some criticism and, in some ways “permissive” law of 2009 (regarding heterologous fertilization, not followed by a clear right to know ones own origins by those born with this procreation way), it was characterized by instances of protection of the embryo in particular by prohibiting production of surplus embryos. By this reason, the law was evaluated by the new Government formed after the elections 2011, as “antiquated and conservative”. As reactions to these unjustifiable evaluations emerged, the great number of Croatian citizens joined the initiative “I was an embryo too”. The following intensive and lively debate had brought to the 2012 law, which was considered as one of the most permissive laws in the European context. Therefore, the authors investigated this last legislative text, enhancing the differences between this and the former law also keeping in mind, the normative European context in which the legislative revolutions and revisions of different laws emerged. Even though the Croatian legislative evolution on MAR has paved the way of spreading “new civil rights” in which the holders are the parents to-be and the different professionals (medical, scientists), presently in Croatia -conclude the authors- there is an alternative culture to the one seeking the “child at all costs” and the destruction of the human embryos as a “scientific advancement”. The initiative “I was an embryo too” and the European Citizens’ Initiative called “One of Us” shared the same expressions of this culture, from which the rights of the smallest ones among human beings stem; therefore, it is possible to understand the true meaning of parenthood and that of the scientific advancement.

Diritto di proprietà vs diritto alla vita? Una nuova questione dinanzi alla Corte europea dei diritti dell’uomo

Il recente ricorso alla Corte europea dei diritti dell’uomo (n. n. 46470/11) nasce dalla pretesa di usare gli embrioni umani per la ricerca scientifica sul presupposto che si tratti di “cose”. Infatti, la ricorrente invoca il suo diritto di proprieta sugli embrioni appellandosi all’art. 1 del Protocollo n. 1 addizionale alla Convenzione Europea per la salvaguardia dei diritti e delle liberta fondamentali. L’attacco e diretto contro la legge italiana sulla procreazione medicalmente assistita (Legge 40 del 19 febbraio 2004) il cui art. 13/1 vieta “qualsiasi sperimentazione su ciascun embrione umano”. Gli Autori, ritengono che sia infondata scientificamente e giuridicamente la pretesa di considerare l’embrione umano una cosa; mostrano come il riconoscimento del il concepito soggetto titolare di diritti (art.1), sia supportato da un importante complesso normativo; contestano la pretesa contraddizione tra la Legge 40 del 2004 con la legge 194 del 1978; sostengono la ragionevolezza scientifica, etica e giuridica di orientare la scienza verso la ricerca sulle staminali adulte, anziche su quelle embrionali. L’indagine viene condotta passando in rassegna numerose disposizioni a partire dall’art. 18 della Convenzione di Oviedo. Ampio spazio e dato alla giurisprudenza della Corte europea dei diritti dell’uomo in materia di bioetica in relazione alla dottrina del margine di apprezzamento che dovrebbe essere applicata anche in senso favorevole all’Italia nel caso in esame. Il contributo auspica che i giudici tengano conto di quanto scritto nell’articolo 2 del Trattato di Oviedo che sotto il titolo “Primato dell’essere umano”, dichiara “l’interesse ed il bene dell’essere umano devono prevalere sul solo interesse della societa e della scienza”. ---------- The recent appeal to the European Court of Human Rights (Application n. 46470/11) originates from the demand to use human embryos for scientific research on the ground that they are “things”. Indeed the appellant claims her right to property of the embryos pleading to the art. 1 of the Additional Protocol n. 1 of the European Convention for the Protection of Human Rights and Fundamental Freedoms. The attack is directed against the Italian Law on medically assisted procreation (Law n. 40 of 19 February 2004) which bans any experimentation on human embryo. The Authors argue that the demanded evaluation of the human embryo as a “thing” is scientifically and legally baseless. They also show how the Italian Law n. 40/2004, which recognizes the embryo as a subject holder of rights (art.1), is backed by an important normative complex. In this article the thesis on the inconsistency between Law n. 40/2004 and Law n. 194/178 is rejected and it is claimed the scientific, ethical and legal reasonableness to lead the science to adult stem cells instead embryonic stem cells. The analysis is conducted reviewing numerous dispositions from art. 18 of the Oviedo Convention on Human Rights and Biomedicine. In this article a wide space is allowed to the Bioethics case-law of the European Court of Human Rights as for the doctrine of the margin of appreciation which should be applied also to defend Italy in the examined case. The article hope that the Court set great store by what is written in art. 2 (“Primacy of the Human Being”): “The interests and welfare of the human being shall prevail over the sole interest of society or science”.The recent appeal to the European Court of Human Rights (Application n. 46470/11) originates from the demand to use human embryos for scientific research on the ground that they are “things”. Indeed the appellant claims her right to property of the embryos pleading to the art. 1 of the Additional Protocol n. 1 of the European Convention for the Protection of Human Rights and Fundamental Freedoms. The attack is directed against the Italian Law on medically assisted procreation (Law n. 40 of 19 February 2004) which bans any experimentation on human embryo. The Authors argue that the demanded evaluation of the human embryo as a “thing” is scientifically and legally baseless. They also show how the Italian Law n. 40/2004, which recognizes the embryo as a subject holder of rights (art.1), is backed by an important normative complex. In this article the thesis on the inconsistency between Law n. 40/2004 and Law n. 194/178 is rejected and it is claimed the scientific, ethical and legal reasonableness to lead the science to adult stem cells instead embryonic stem cells. The analysis is conducted reviewing numerous dispositions from art. 18 of the Oviedo Convention on Human Rights and Biomedicine. In this article a wide space is allowed to the Bioethics case-law of the European Court of Human Rights as for the doctrine of the margin of appreciation which should be applied also to defend Italy in the examined case. The article hope that the Court set great store by what is written in art. 2 (“Primacy of the Human Being”): “The interests and welfare of the human being shall prevail over the sole interest of society or science”.