02.-Don-dorganes / Organ donation — CHURCH OF FRANCE / États généraux de la bioéthique — States General on Bioethics

http://eglise.catholique.fr/sengager-dans-la-societe/eglise-et-bioethique/comprendre-les-enjeux/

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Scientific and legal elements :

Organ trans­plant prac­tices have devel­oped con­sid­er­ably since the 1950s, thanks to dis­cov­er­ies made it pos­si­ble to rem­e­dy the phe­nom­e­non of trans­plant rejec­tion. Accord­ing to the Bio­med­i­cine Agency, 5891 organ trans­plants were per­formed in 2016, of which 4937 are kid­ney or liv­er trans­plants. From 2012 to 2016, the num­ber of trans­plants increased by 17%. The vast major­i­ty of trans­plants are per­formed postmortem[1].

The law reg­u­lates the prac­tice of organ removal. On the trans­plant recip­i­en­t’s side, the oper­a­tion must have a seri­ous chance of suc­cess, not involve dis­pro­por­tion­ate risks and rep­re­sent a real pro­lon­ga­tion of life for the recipient[2]. On the donor’s side, the donor may be alive or deceased.

As regards organ dona­tion between liv­ing per­sons, bioethics laws have con­stant­ly extend­ed the cir­cle of poten­tial donors who, in all cas­es, must have the legal capac­i­ty to con­sent, in par­tic­u­lar be of legal age. In 1994, the cir­cle was lim­it­ed to the nuclear fam­i­ly: par­ents, chil­dren, sib­lings, pos­si­bly spouse. In 2004, cousins and allies joined this cir­cle, as did “any per­son pro­vid­ing proof of at least two years of liv­ing togeth­er with the recip­i­ent”. The law of 7 July 2011 went even fur­ther by includ­ing “any per­son who can prove a close and sta­ble emo­tion­al link with the recip­i­ent for at least two years”. It also autho­rized “cross-dona­tion” of organs between two donor/recipient pairs, each meet­ing the rela­tion­al con­di­tions of organ dona­tion and trans­plan­ta­tion but not compatible.

For sam­pling from a deceased per­son, the first require­ment is to ensure that the per­son is dead. The Pub­lic Health Code gen­er­al­ly requires three checks to estab­lish that a per­son with “per­sis­tent car­diac and res­pi­ra­to­ry arrest” is dead: total absence of con­scious­ness and spon­ta­neous move­ment; abo­li­tion of all brain­stem reflex­es; total absence of spon­ta­neous breathing[3]. If the per­son is on ven­ti­la­to­ry sup­port and blood flow con­tin­ues to a cer­tain degree, fur­ther tests are need­ed to ensure that the entire brain is irre­versibly destroyed[4]. How­ev­er, since a decree of August 2, 2005 (n°2005–949), the removal of a kid­ney or a liv­er can be car­ried out on per­sons rec­og­nized dead sim­ply fol­low­ing “a per­sis­tent car­diac and res­pi­ra­to­ry arrest[5]”. Since 2014, cer­tain hos­pi­tals based on the 2005 law have been per­form­ing organ removal from a deceased per­son fol­low­ing a deci­sion to lim­it or stop treatment.

Since the Health Act of 26 Jan­u­ary 2016, it is suf­fi­cient that the deceased per­son has not reg­is­tered on the Nation­al Reg­is­ter of Refusals to indi­cate his oppo­si­tion to organ removal, or that he has not explic­it­ly expressed his refusal in anoth­er form, for removal to be pos­si­ble (this is referred to as “deemed con­sent”). The doc­tor must sim­ply “inform” the rel­a­tives of the nature and pur­pose of the planned sample.

Despite the increase in trans­plants, not all requests are met. Hence the ques­tion of relax­ing the rules reg­u­lat­ing the prac­tice of organ har­vest­ing and trans­plan­ta­tion, in par­tic­u­lar the prin­ci­ples of anonymi­ty, free dona­tion and con­sent to donation[6].

Anthropological and Ethical Issues

Organ dona­tion always involves painful human sit­u­a­tions. Faced with these sit­u­a­tions of suf­fer­ing, we must fos­ter a cul­ture of giv­ing in our soci­ety. Adult cit­i­zens should also be encour­aged to explic­it­ly declare their pos­si­ble con­sent to a dona­tion and to pre­pare their fam­i­lies for it. How­ev­er, a pure­ly quan­ti­ta­tive rea­son­ing on organ needs to jus­ti­fy the exten­sion of trans­plant pos­si­bil­i­ties is too nar­row in rela­tion to the per­son­al and fam­i­ly issues involved.

The cur­rent “deemed con­sent” regime, which gov­erns organ dona­tion from a deceased per­son, is atyp­i­cal in law. It is con­trary to the Hos­pi­tal­ized Patient Char­ter, which, for ther­a­peu­tic acts, requires a pri­ori “free and informed” con­sent on the basis of “acces­si­ble and fair” infor­ma­tion. On 26 June 2014, the Euro­pean Court of Human Rights rul­ing “Petro­va v. Latvia” stat­ed: “Nation­al leg­is­la­tion which by lack of clar­i­ty makes it pos­si­ble to remove an organ from a pub­lic hos­pi­tal with­out the con­sent of the fam­i­ly vio­lates Arti­cle 8 of the Euro­pean Con­ven­tion on Human Rights on respect for pri­vate and fam­i­ly life.

Such an atyp­i­cal rule requires strength­ened safe­guards to ensure that con­sent does not become “imposed” from “pre­sumed”. In this con­text, the col­lec­tion of infor­ma­tion from fam­i­lies should be a rule, the fam­i­ly unit being the first cir­cle of sol­i­dar­i­ty. The law giv­ing the right to pub­lic med­i­cine to remove organs on the basis of pre­sumed con­sent only, with­out con­sul­ta­tion with the fam­i­ly, tends to nation­alise the body, in fla­grant con­tra­dic­tion with the patien­t’s free­dom, and with­out there being any real expres­sion of sol­i­dar­i­ty. Rather, a true dona­tion eth­ic should be encouraged[7].

Fur­ther­more, the removal of organs from a deceased per­son can be done not only for ther­a­peu­tic pur­pos­es but also for sci­en­tif­ic (research) purposes[8]. It is not respect­ful of the cit­i­zen that these dis­tinct and spe­cif­ic pur­pos­es are sub­ject to the same pro­ce­dure. If spe­cial sol­i­dar­i­ty is required from the cit­i­zen to help oth­er peo­ple, each cit­i­zen is free to refuse such or such research (as pro­vid­ed for in the Hos­pi­tal­ized Patient Char­ter for research on liv­ing patients).

Should we then ask our­selves whether we should return to the explic­it con­sent regime? At a min­i­mum, in the “deemed con­sent” regime, fam­i­ly noti­fi­ca­tion is essen­tial to ensure con­sent. Although med­ical teams are still try­ing to obtain this opin­ion, it is regret­table that the 2016 law no longer requires them to do so.

Final­ly, among liv­ing donors, the suc­ces­sive enlarge­ment of poten­tial donors could encour­age a cer­tain form of organ traf­fick­ing. On the one hand, the notion of “close and sta­ble emo­tion­al bond” is vague and dif­fi­cult to arbi­trate by the courts, a pas­sage required by law for organ trans­plant autho­riza­tion. On the oth­er hand, the pos­si­bil­i­ty of inte­grat­ing indi­vid­u­als into the “cross-dona­tion” cir­cuit risks encour­ag­ing finan­cial motivation[9]. The risk of such a drift would increase if the prin­ci­ple of free dona­tion were called into question.

Is the non-expres­sion of a refusal suf­fi­cient to char­ac­ter­ize a “gift”? To encour­age organ dona­tion, infor­ma­tion cam­paigns should be pro­mot­ed that pro­mote reg­is­tra­tion in a reg­is­ter where every­one could clear­ly express their con­sent to or oppo­si­tion to the removal of some of their organs in the event of death, in the spir­it of the “advance direc­tives” (see fact sheet on the end of life).

Feb­ru­ary 1, 2018

[1] https://www.agence-biomedecine.fr/IMG/pdf/cp_activite-greffes-organes-2016_agence-biomedecine.pdf
[2] cf. Code de la San­té Publique (CSP), arti­cle L1211‑6.
[3] CSP, arti­cle R. 1232–1.
[4] CSP, arti­cle R. 1232–2.
[5] Cf. CSP, arti­cle R. 1232–4‑1.
[6] Cf. CCNE, Dossier de presse, « Les thèmes des États généraux », fiche n°2, 18 jan­vi­er 2018.
[7] Cf. dis­cours de Benoit XVI sur le don d’organes du 7 novem­bre 2008.
[8] CSP, L1232‑1.
[9] Cf. J.-R. BINET, La réforme de la loi bioéthique. Com­men­taire et analyse de la loi du 7 juil­let 2011, Lex­is­Nex­is « Actu­al­ité », 2012. Voir aus­si J.-R. BINET, Droit de la bioéthique, LGDJ, 2017, pp. 212–235.