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Presumed Consent for Organ Donation: Is Romania Prepared for It?
Presumed Consent for Organ Donation: Is Romania Prepared for It? I. Grigoras, C. Condac, C. Cartes, M. Blaj, and G. Florin ABSTRACT Introduction. In November 2007, a legislative initiative regarding the presumed consent for organ donation was proposed for parliamentary debate in Romania and was followed by public debate. The study aimed to asses public opinions expressed in the Romanian media. Materials and Methods. An Internet search was made. The pro and con reasons, the affiliation of parts involved in the debate and suggested future direction of action were identified. Results. The Internet search had 8572 results. The parts involved in the pro and con debate consisted of governmental structures, physicians, ethicists, politicians, media, religious authorities, nongovernmental associations, and lay persons. The main pros were the low rate of organ donation and the long waiting lists, enhancement of organ procurement, avoidance of wasting valuable organs, avoiding responsibility, and the stress imposed to the family in giving the donation consent, humanitarian purposes (saving lives), going along with the scientific progress, and less bureaucracy. The main cons were an unethical issue, violation of human rights, denial of brain death, unethical advantage of public ignorance, unethical use of underprivileged people, little results in terms of organ procurement, but huge negative effects on public opinion, public mistrust in transplant programs and impossibility of refusal identification due to particularities of the Romanian medical system. Conclusion. The con opinions prevailed. For the moment, Romania seems to be unprepared to accept presumed consent. A future change in public perception regarding organ transplantation may modify the terms of a public debate. RESUMED CONSENT is a hot topic around the world. The ethical and legal aspects are a matter of intense debate involving large parts of the society. At present, 21 of 27 countries in the European Union included in their legislation the presumed consent. In November 2007, a legislative initiative regarding the presumed consent for organ donation was proposed for parliamentary debate in Romania and was followed by public debate. The study aimed to asses public opinions expressed in the Romanian media.
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MATERIALS AND METHODS An Internet search was made with the search keywords: presumed consent, informed consent, legislation, legislative amendment, organ harvesting, organ transplantation, Romanian Transplant Agency, Romanian College of Physicians, and brain death. The pro and con reasons, the affiliation of parts involved in the debate, and suggested future direction of action were identified. 0041-1345/10/$–see front matter doi:10.1016/j.transproceed.2009.12.006 144
RESULTS AND DISCUSSION
In November 2007, 7 members of the Romanian Parliament had a legislative initiative regarding the modification and the completion of the Law no.95/2006 concerning the Healthcare System reform.1,2 According to that law, family consent is a mandatory condition for organ donation from brain-dead patients. The proposed amendment intended to replace the informed consent by the presumed consent for organ donation. So any person, who during life time never From the University of Medicine and Pharmacy (I.G., M.B., G.F.), School of Medicine, the University Emergency Hospital “Sf. Spiridon” (I.G., C.Co., C.Ca., M.B.), Anesthesia and Intensive Care Department, the 3rd Surgery Department (G.F.), Iasi, Romania. Address reprint requests to Ioana Grigoras, Bdul Independentei, no. 1, 700111, Iasi, Romania. E-mail: [email protected] © 2010 Published by Elsevier Inc. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 42, 144 –146 (2010)
PRESUMED CONSENT FOR DONATION
expressed the refusal to donate organs after death, implicitly agrees with organ donation. The legislative amendment was adopted in February 2008 by the Senate Chamber of Parliament3–5 and was sent for further debate to the Deputy Chamber. In May 2008, the Romanian government expressed an official point of view6,7 in favor of informed consent, recommending a wider documentation, consultation of the civil society and the introduction of a National Donor Registry. A public debate followed and the Romanian media reflected and fuelled it. The internet search (8572 results) investigated the opinions reflected by the Romanian media. The parts involved in the pro and con debate were The National Transplant Agency, The Romanian College of Physicians, directors of transplant accredited hospitals, physicians, ethicists, politicians, media, religious authorities, nongovernmental associations, and lay persons.8 The main pros were the low rate of organ donation and the long waiting lists, enhancement of organ procurement, avoidance of wasting valuable organs, avoiding the responsibility, and the stress imposed to the family in giving the donation consent, humanitarian purposes (saving lives), going along with the scientific progress, and less bureaucracy. The overall pro opinions were expressed mainly by physicians. “Family consent is an additional stress that, perhaps, the family should not endure” said Irinel Popescu, professor of surgery, pioneer of liver transplant in Romania.”9 “I believe that, we are not far from cloning human bodies and organs. In our laboratories we already have stem cell, kits for the modification of the human cell. If only ten people see in the future and are able to understand the mysteries of science, they have the obligation to explain to others ten million people, who do not understand,” explained Virgil Pa˘unescu, head of Physiology and Immunology Clinic at the University of Medicine and Pharmacy “Victor Babes¸”, Timis¸oara.10 The main cons were an unethical issue, violation of human rights, denial of brain death, unethical advantage of public ignorance, unethical use of underprivileged people, little results in terms of organ procurement, but huge negative effects on public opinion, public mistrust in transplant programs, and the impossibility of refusal identification due to particularities of the Romanian medical system. The overall con opinions were expressed by ethicists, religious authorities, nongovernmental organizations, and lay persons. “Even if it may lead to a relative increase in the number of organs and tissues harvested from deceased donors, the introduction of presumed consent is a lack of respect towards human beings, it is a way of satisfying professional egos, will bring new problems and may open the door to abuses” said Vasile Astarastoaie, president of the Romanian College of Physicians and professor of Medical Ethics.11 He also said: “You should take into consideration that the legislative amendment has a major impact not only in the medical field. It changes a way of thinking and a whole culture. It is about the respect we pay for a person also after his death. Only the person himself
145
may dispose during life or after death of his own organs, own body and his own image. If, during your life time, you didn’t call your public notary or your GP to notice in your file or you didn’t call the National Transplant Agency your organs not to be harvested, than after your death you will be treated as an object, the state property, and anyone can harvest your organs for transplantation.”12,13 Constantin Stoica, the spokesman of the Romanian Patriarchy said, “The Holy Synod favors the maintenance of the actual transplant law in its current form. The introduction of the presumed consent system might lead to abuses. The Orthodox Church encourages people to voluntarily donate their organs after they die, and also militates for the introduction of the donor card, but cannot agree with the presumed consent proposal.”14,15 “Silence does not mean consent” was the opinion of Larisa Iftime, the president of The Romanian Family Alliance, a nongovernmental association.16 –18 People should be prepared for understanding and accepting the presumed consent. It is possible that in countries with the presumed consent law, the population already has strong believes in organ donation. In other words, it may be a country’s attitude toward donation that is causing presumed consent to be present in legislation. By simply changing legislation from informed consent to presumed consent will not result in a significant increase of donation rate. A country’s preexisting attitude toward donation is the main factor influencing the donation rate and not legislation. The media debate emerged in ideas for future directions of action in order to promote enhancement of organ donation: the introduction of the donor card, the National Donor Registry, educational programs, computerized medical system around the country, the National Refusal Registry. In conclusion, to date, the entire evolution of attitudes towards organ and tissue transplant and of the Romanian legislation in this area focuses on respect for individual autonomy, either donor or recipient. For the moment, Romania seems to be unprepared to accept presumed consent. A future change in public perception regarding organ transplantation may modify the terms of a public debate. REFERENCES 1. Ifrim M: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii 7 nov 2008. Comisia de Sanatate si Familie PL-x nr. 404/2008. Available: http://www.cdep.ro/proiecte/2008/400/00/4/in1034.pdf. Accessed July 2, 2009 2. Expunerea de motive: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. PL-x nr. 404/2008. Available: http://www.cdep.ro/proiecte/ 2008/400/00/4/em404.pdf. Accessed July 2, 2009 3. Dadacus Mirela. Lege: ne vor pe toti donatori de organe” Adevarul. July 31, 2008. Available: www.adevarul.ro/.../lege-ne-vorpe-toti-donatori-de-organe.html. Accessed July 2, 2009 4. Vacaroiu N: Adresa Senatului: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul
146 sa˘na˘ta˘¸tii. PL-x nr. 404/2008. June 17, 2008. Available: http://www. cdep.ro/proiecte/2008/400/00/4/as404.pdf. Accessed July 2, 2009 5. Vacaroiu N: Forma adopatata de Senat: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. PL-x nr. 404/2008. May 12, 2008. Available: http://www.cdep.ro/proiecte/2008/400/00/4/se404.pdf. Accessed July 7, 2009 6. Parvu Luminita: Romanii ar putea dona organe dupa moarte in baza unui acord prezumat. HotNews Agency. May 12, 2008. Available: http://www.hotnews.ro. Accessed July 10, 2009 7. Popescu-Tariceanu C: Punctul de vedere al Guvernului: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. PL-x nr. 404/2008. May 9, 2008. Available: http://www.cdep.ro/proiecte/2008/400/00/4/pvg404. pdf. Accessed July 2, 2009 8. Popescu Carmen. Mortul decide donarea organelor. Ziua. March 6, 2007. Available: http://www.ziua.ro. Accessed July 10, 2009 9. Voica Steluta, Ion Raluca: Se pierd organe. Cotidianul. May 15, 2008. Available: http://www.cotidianul.ro/acordul_prezumat45947.html. Accessed July 7, 2009 10. Cezara: Dezbatere pe tema prelevarii organelor. Portal medic.ro. April 24, 2009. Available: http://www.i-medic.ro/stiri/ dezbatere-pe-tema-prelevarii-organelor. Accessed July 7, 2009 11. Lazarescu D: Consimtamantul prezumat: intre utilitate si etica medicala. Viata medicala. 2007;17:903. Available: http:// www.vmr.ro/z17-07.htm. Accessed July 9, 2009
GRIGORAS, CONDAC, CARTES ET AL 12. Astarastoaie V: Consimtamantul prezumat: intre utilitate si etica medical. May 29, 2007. Available: http://www.medicalnet.ro/ content/view/115/32/. Accessed July 9, 2009 13. Astarastoaie V. Dezbatere despre consimt¸˘amântul prezumat. Available: http://www.medicalnet.ro/blog/astarastoae/articol/ 221. Accessed July 9, 2009 14. Romanian Orthodox Church Against Introducing Presumed Consent In Transplant Law. Mediafax. March 3, 2008. Available: http://www.mediafax.ro. Accessed July 9, 2009 15. Nota referitoare la: PL-x nr. 404/2008 - Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. Provita. February 10, 2009. Available: http:// provitabucuresti.ro/docs/acord.prezumat.FOPV.pdf. Accessed July 10, 2009 16. Nota referitoare la: PL-x nr. 404/2008 - Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privindreforma în domeniul sa˘na˘ta˘¸tii. Provita. February 10, 2009. Available: http:// provitabucuresti.ro/docs/acord.prezumat.scrisoareCD.pdf. Accessed July 10, 2009 17. Protest fat¸˘a de introducerea “acordului prezumat” la donarea de organe. Provita. February 17, 2009. Available: http:// provitabucuresti.ro/docs/presa/2009/cdp.PV.acord.prezumat.pdf. Accessed July 10, 2009 18. Mateciuc B. Nota. Aliant¸a Familiilor din România. Available: http://www.provitabucuresti.ro/docs/acord.prezumat.scrisoareCD. pdf. Accessed July 10, 2009
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MATERIALS AND METHODS An Internet search was made with the search keywords: presumed consent, informed consent, legislation, legislative amendment, organ harvesting, organ transplantation, Romanian Transplant Agency, Romanian College of Physicians, and brain death. The pro and con reasons, the affiliation of parts involved in the debate, and suggested future direction of action were identified. 0041-1345/10/$–see front matter doi:10.1016/j.transproceed.2009.12.006 144
RESULTS AND DISCUSSION
In November 2007, 7 members of the Romanian Parliament had a legislative initiative regarding the modification and the completion of the Law no.95/2006 concerning the Healthcare System reform.1,2 According to that law, family consent is a mandatory condition for organ donation from brain-dead patients. The proposed amendment intended to replace the informed consent by the presumed consent for organ donation. So any person, who during life time never From the University of Medicine and Pharmacy (I.G., M.B., G.F.), School of Medicine, the University Emergency Hospital “Sf. Spiridon” (I.G., C.Co., C.Ca., M.B.), Anesthesia and Intensive Care Department, the 3rd Surgery Department (G.F.), Iasi, Romania. Address reprint requests to Ioana Grigoras, Bdul Independentei, no. 1, 700111, Iasi, Romania. E-mail: [email protected] © 2010 Published by Elsevier Inc. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 42, 144 –146 (2010)
PRESUMED CONSENT FOR DONATION
expressed the refusal to donate organs after death, implicitly agrees with organ donation. The legislative amendment was adopted in February 2008 by the Senate Chamber of Parliament3–5 and was sent for further debate to the Deputy Chamber. In May 2008, the Romanian government expressed an official point of view6,7 in favor of informed consent, recommending a wider documentation, consultation of the civil society and the introduction of a National Donor Registry. A public debate followed and the Romanian media reflected and fuelled it. The internet search (8572 results) investigated the opinions reflected by the Romanian media. The parts involved in the pro and con debate were The National Transplant Agency, The Romanian College of Physicians, directors of transplant accredited hospitals, physicians, ethicists, politicians, media, religious authorities, nongovernmental associations, and lay persons.8 The main pros were the low rate of organ donation and the long waiting lists, enhancement of organ procurement, avoidance of wasting valuable organs, avoiding the responsibility, and the stress imposed to the family in giving the donation consent, humanitarian purposes (saving lives), going along with the scientific progress, and less bureaucracy. The overall pro opinions were expressed mainly by physicians. “Family consent is an additional stress that, perhaps, the family should not endure” said Irinel Popescu, professor of surgery, pioneer of liver transplant in Romania.”9 “I believe that, we are not far from cloning human bodies and organs. In our laboratories we already have stem cell, kits for the modification of the human cell. If only ten people see in the future and are able to understand the mysteries of science, they have the obligation to explain to others ten million people, who do not understand,” explained Virgil Pa˘unescu, head of Physiology and Immunology Clinic at the University of Medicine and Pharmacy “Victor Babes¸”, Timis¸oara.10 The main cons were an unethical issue, violation of human rights, denial of brain death, unethical advantage of public ignorance, unethical use of underprivileged people, little results in terms of organ procurement, but huge negative effects on public opinion, public mistrust in transplant programs, and the impossibility of refusal identification due to particularities of the Romanian medical system. The overall con opinions were expressed by ethicists, religious authorities, nongovernmental organizations, and lay persons. “Even if it may lead to a relative increase in the number of organs and tissues harvested from deceased donors, the introduction of presumed consent is a lack of respect towards human beings, it is a way of satisfying professional egos, will bring new problems and may open the door to abuses” said Vasile Astarastoaie, president of the Romanian College of Physicians and professor of Medical Ethics.11 He also said: “You should take into consideration that the legislative amendment has a major impact not only in the medical field. It changes a way of thinking and a whole culture. It is about the respect we pay for a person also after his death. Only the person himself
145
may dispose during life or after death of his own organs, own body and his own image. If, during your life time, you didn’t call your public notary or your GP to notice in your file or you didn’t call the National Transplant Agency your organs not to be harvested, than after your death you will be treated as an object, the state property, and anyone can harvest your organs for transplantation.”12,13 Constantin Stoica, the spokesman of the Romanian Patriarchy said, “The Holy Synod favors the maintenance of the actual transplant law in its current form. The introduction of the presumed consent system might lead to abuses. The Orthodox Church encourages people to voluntarily donate their organs after they die, and also militates for the introduction of the donor card, but cannot agree with the presumed consent proposal.”14,15 “Silence does not mean consent” was the opinion of Larisa Iftime, the president of The Romanian Family Alliance, a nongovernmental association.16 –18 People should be prepared for understanding and accepting the presumed consent. It is possible that in countries with the presumed consent law, the population already has strong believes in organ donation. In other words, it may be a country’s attitude toward donation that is causing presumed consent to be present in legislation. By simply changing legislation from informed consent to presumed consent will not result in a significant increase of donation rate. A country’s preexisting attitude toward donation is the main factor influencing the donation rate and not legislation. The media debate emerged in ideas for future directions of action in order to promote enhancement of organ donation: the introduction of the donor card, the National Donor Registry, educational programs, computerized medical system around the country, the National Refusal Registry. In conclusion, to date, the entire evolution of attitudes towards organ and tissue transplant and of the Romanian legislation in this area focuses on respect for individual autonomy, either donor or recipient. For the moment, Romania seems to be unprepared to accept presumed consent. A future change in public perception regarding organ transplantation may modify the terms of a public debate. REFERENCES 1. Ifrim M: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii 7 nov 2008. Comisia de Sanatate si Familie PL-x nr. 404/2008. Available: http://www.cdep.ro/proiecte/2008/400/00/4/in1034.pdf. Accessed July 2, 2009 2. Expunerea de motive: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. PL-x nr. 404/2008. Available: http://www.cdep.ro/proiecte/ 2008/400/00/4/em404.pdf. Accessed July 2, 2009 3. Dadacus Mirela. Lege: ne vor pe toti donatori de organe” Adevarul. July 31, 2008. Available: www.adevarul.ro/.../lege-ne-vorpe-toti-donatori-de-organe.html. Accessed July 2, 2009 4. Vacaroiu N: Adresa Senatului: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul
146 sa˘na˘ta˘¸tii. PL-x nr. 404/2008. June 17, 2008. Available: http://www. cdep.ro/proiecte/2008/400/00/4/as404.pdf. Accessed July 2, 2009 5. Vacaroiu N: Forma adopatata de Senat: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. PL-x nr. 404/2008. May 12, 2008. Available: http://www.cdep.ro/proiecte/2008/400/00/4/se404.pdf. Accessed July 7, 2009 6. Parvu Luminita: Romanii ar putea dona organe dupa moarte in baza unui acord prezumat. HotNews Agency. May 12, 2008. Available: http://www.hotnews.ro. Accessed July 10, 2009 7. Popescu-Tariceanu C: Punctul de vedere al Guvernului: Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. PL-x nr. 404/2008. May 9, 2008. Available: http://www.cdep.ro/proiecte/2008/400/00/4/pvg404. pdf. Accessed July 2, 2009 8. Popescu Carmen. Mortul decide donarea organelor. Ziua. March 6, 2007. Available: http://www.ziua.ro. Accessed July 10, 2009 9. Voica Steluta, Ion Raluca: Se pierd organe. Cotidianul. May 15, 2008. Available: http://www.cotidianul.ro/acordul_prezumat45947.html. Accessed July 7, 2009 10. Cezara: Dezbatere pe tema prelevarii organelor. Portal medic.ro. April 24, 2009. Available: http://www.i-medic.ro/stiri/ dezbatere-pe-tema-prelevarii-organelor. Accessed July 7, 2009 11. Lazarescu D: Consimtamantul prezumat: intre utilitate si etica medicala. Viata medicala. 2007;17:903. Available: http:// www.vmr.ro/z17-07.htm. Accessed July 9, 2009
GRIGORAS, CONDAC, CARTES ET AL 12. Astarastoaie V: Consimtamantul prezumat: intre utilitate si etica medical. May 29, 2007. Available: http://www.medicalnet.ro/ content/view/115/32/. Accessed July 9, 2009 13. Astarastoaie V. Dezbatere despre consimt¸˘amântul prezumat. Available: http://www.medicalnet.ro/blog/astarastoae/articol/ 221. Accessed July 9, 2009 14. Romanian Orthodox Church Against Introducing Presumed Consent In Transplant Law. Mediafax. March 3, 2008. Available: http://www.mediafax.ro. Accessed July 9, 2009 15. Nota referitoare la: PL-x nr. 404/2008 - Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privind reforma în domeniul sa˘na˘ta˘¸tii. Provita. February 10, 2009. Available: http:// provitabucuresti.ro/docs/acord.prezumat.FOPV.pdf. Accessed July 10, 2009 16. Nota referitoare la: PL-x nr. 404/2008 - Proiect de Lege pentru modificarea ¸si completarea Legii nr.95/2006 privindreforma în domeniul sa˘na˘ta˘¸tii. Provita. February 10, 2009. Available: http:// provitabucuresti.ro/docs/acord.prezumat.scrisoareCD.pdf. Accessed July 10, 2009 17. Protest fat¸˘a de introducerea “acordului prezumat” la donarea de organe. Provita. February 17, 2009. Available: http:// provitabucuresti.ro/docs/presa/2009/cdp.PV.acord.prezumat.pdf. Accessed July 10, 2009 18. Mateciuc B. Nota. Aliant¸a Familiilor din România. Available: http://www.provitabucuresti.ro/docs/acord.prezumat.scrisoareCD. pdf. Accessed July 10, 2009