Abstract
Organ procurement and transplantation have grown steadily, and the need for organs will only rise in the future. Increasing the number of potential donors is therefore paramount. However, transplant coordination teams face refusals that can be linked to the contexts of the deaths, especially when they involve legal issues. In France, deaths involving legal proceedings are not uncommon (7–10%). In these cases, the prosecutor is immediately contacted, and makes the decision of whether to remove the involved organs. Refusals of this type represent 4% (approximately 30 cases per year) of obstacles to organ removals, and are governed by specific legislation. Thus, the prosecutor must arrange contact with a forensic pathologist and with the organ transplant teams to assemble all of the necessary elements for him to take the decision. To assist prosecutors in their decision making and to ensure them scientific rigour, the French Society of Forensic Medicine sought to develop a national recommendation to harmonise practices; it emerged in early 2013. The guideline makes practical recommendations, including among others: nominating local referents; writing regional protocols between judicial authorities, forensic pathologists and transplant teams; establishing terms for the forensic pathologist’s intervention on the donor’s body before and after a procurement. This recommendation by the French Society of Forensic Medicine aimed to combine two interests: addressing the shortage of organs, and fulfilling the requisites of a criminal investigation by standardising practices and encouraging communication.
Keywords
Introduction
Organ procurement and transplantation has increased steadily since the second half of the 20th century. Research continues to progress in this direction, forecasting yet another increase in the near future. Meanwhile, advances in modern revival techniques have been so effective that many situations that would once have been flagged with an almost systematic lethality can at present be managed. These treatable diseases do not lead to new organ donor candidates but paradoxically create additional demand. These patients do survive with serious morbidities, conditions that could necessitate transplants owing to organ failure. This, of course, is a happy development for the victims and should be encouraged. However, it is, in conjunction with an ageing population, causing a growing need for organs. Therefore, increasing the number of potential donors is paramount.
Recently, the European Community adopted a directive on standards of quality and safety of human organs intended for transplantation. This directive, dated 7 July 2010, which came into force on 6 August 2010, promotes the exchange of organs between member states. It therefore increases opportunities for transplantations that follow uniform regulations to ensure the best preservation of the removed organs under strict health rules. 1 In the last major bioethical reform, the French legislature attempted to endorse increasing donation opportunities. In addition to the organs harvested from brain-dead donors, transplantation from living donors has increased, following a very organised legal procedure, whether through informed consent or in the strict definition of the links between the donor–recipient pair that allow these procedures. Thus, the last bioethics law, dated 7 July 2011, licensed cross-organ donation and expanded the circle of potential living donors, which mostly comprised close family, to people related by a ‘stable and close emotional bond’ for more than two years. 2 Another possibility for increasing donations was adopted in France in 2005 concerning deceased donors with persistent cardiac and respiratory arrest, so-called non-heart-beating donors. A decree dated 2 August 2005 defined the criteria for this type of organ harvesting, which initially focused on kidney and liver transplantation in pilot centres. 3
These increased harvesting opportunities are, however, not sufficient to bridge the gap between organ resources and needs. In 2012, there were 17,627 people registered in France on the national transplant waiting list. Only 1589 donors were harvested, for 5023 transplants performed. 4 Note that if only 1589 donors were collected, 3301 donors were identified. Thus, there is a significant disparity between harvested and identified donors. This disproportion is multifactorial: there are sometimes medical obstacles to the removal (donor medical history, discovered pathologies, ill organs), but more often, transplant coordination teams face refusals. These refusals may on the one hand be related to the will of the donor himself or his family, but on the other hand, they can be linked to the contexts of the deaths, especially when they involve legal issues.
Barriers to organ procurement in France
Refusals
Consent to organ donation in France since the first existing legislation in this area is commonly known as ‘presumed consent’. 5 It implies the possibility of organ removal in cases in which the donor did not clearly express opposition to it during his lifetime. The Caillavet Act 1976 6 introduced this principle, which was subsequently confirmed by the 1994 bioethics law in Article L 671-7 of the Code of Public Health. 7 This article provided two modes of refusal validation: registering on a national computerised registry or a family’s clear expression of opposition while the donor is alive. The bioethics law of 6 August 2004 endorsed the principle in Article L 1232-1 of the Code of Public Health, 8 and the new bioethics law of 2011 2 did not change these provisions.
Registration on the national register of refusals accounts for approximately 5% of obstacles to organ removal. Refusals expressed via relatives represent approximately 30% of these obstacles (these figures have been stable for a number of years).
Contexts of death
Aside from refusals and medical obstacles regarding organ health, if the context of the death requires a judicial procedure and a removal is considered, the prosecutor is immediately contacted and makes the decision of whether to remove the specified organs alone.
Deaths involving legal proceedings are not uncommon (7–10% in France), 9 and according to the European R99-3 recommendation to the member states’ Committee of Ministers 10 on the harmonisation of rules concerning forensic autopsy, the death certificate must include notification of a suspension of funeral operations (which is a forensic obstacle to burial and therefore implies legal procedures) in suicides, accidents, sudden deaths, homicides, fatal accidents at work, unidentified bodies, deaths in custody and other examples.
These medical and contextual situations, which frequently involve revival, may also prompt removal and harvesting, especially because they often involve young subjects, who are ‘good’ potential donors. However, if a removal is proposed for such a donor, certain laws and practices must be followed, and it is ultimately the lead prosecutor in the criminal investigation and preservation of evidence who will validate the procurement or not. The prosecutor may in these cases oppose the organ procurement in order to preserve evidence, a legal obstacle to organ harvesting that currently represents, in France, approximately 4% of obstacles to organ removals. 4 These obstacles are governed by specific legislation.
Harvesting and forensic deaths
Legal and practical arrangements in France
The decree of 27 February 1998 approving the rules of good practice concerning organ removal from the deceased for therapeutic purposes is the relevant text for these particular situations. 11 The text indicates that the prosecutor must immediately be contacted for any death with unknown or suspicious cause, under the terms of Article 74 of the Code of Criminal Procedure.
The magistrate must, according to this text, arrange contact with a forensic pathologist and with the organ transplant teams to assemble all of the necessary elements for him to decide whether to pursue the organ procurement.
To inform the magistrate from the technical point of view, the forensic pathologist is required to examine the donor’s body before harvesting it in the intensive care unit (ICU) where the procedure will take place. The purpose of the forensic examination is to make a record of all the important clinical forensic evidence, but also to establish an exhaustive list of ongoing care (intubation, intravenous lines, probing, etc.). These elements of paramount importance are documented in order to prevent potential interpretation bias if a secondary autopsy is ordered after the organ procurement; in addition to surgical harvesting procedures that require skin incisions, clamping, ligatures and sutures, many stigmas associated with ICU care (intubation, cardiac massage, surveys) may interfere with the designated medical examiner’s interpretation of the autopsy if he has no knowledge of them.12–14 Examination of the donor’s body by the pathologist before the organ procurement procedure is therefore crucial for preserving evidence and ensuring the proper conduct of a potential subsequent autopsy.
After this legal and forensic consultation, and to ensure the judges’ scientific and legal guarantees regarding preserving forensic evidence, the decree of 27 February 1998 provides that the organ procurement may only be carried out under strict conditions:
11
Photographing the donor’s body before the procurement; Collecting blood and urine samples prior to procurement; Writing postoperative medical reports after surgery that will accompany the body during transport for autopsy; Absolute prohibition of skin procurement to allow the medical examiner to identify possible skin lesions at autopsy; No removal from an unidentified person; Only therapeutic procurements are allowed; Organs not used for transplant must be returned to the pathologist performing the autopsy.
The legislature thus sought to regulate these situations better to encourage organ harvesting despite the legal contexts. The Keeper of the Seals (Minister of Justice), because of the difficulties encountered in these procedures, wrote a letter of recommendation dated 12 March 2004 entitled ‘Organ Removal and Medico-Legal Acts’ for judges, reminding them of the provisions of the decree of 27 February 1998 that allow for preserving evidence and stating that opposition to a judicial organ harvesting must be justified by serious medico-legal reasons. However, even if all of these provisions ensure scientific rigour in order to preserve forensic evidence, the judge is free to oppose an organ procurement procedure. There are in France a significant number of annual cases in which the judge opposes organ removal: 28 cases in 2008, 28 in 2009, 36 in 2010, 44 in 2011 and 34 in 2012. These figures cannot be neglected in view of the shortage of organs currently encountered in our country: each year in France, just over 400 people die directly from this shortage. However, if one considers that one organ donor can potentially benefit approximately three to four receivers (dispatching organs to different receivers), 100 organs suitable for transplant are lost annually because of legal contexts. Improvement of these practices is therefore essential.
Creation of a scientific protocol by the French Society of Forensic Medicine
In a previous study conducted at our institution between 2003 and 2011, 15 we noted that the main reasons given by judges for opposing organ removal in legal situations were lack of information on the circumstances of death (17%), the criminal nature of the death (28%) and, most importantly, the need for an autopsy (38%). This last and most-often expressed reason for opposition to judicial organ harvesting suggests that judges consider that autopsy findings may be hampered by the organ removal because of the required surgical procedures. Preservation of evidence would be compromised and, worse, procurement procedures could create biased interpretation, which could in turn distort forensic conclusions. 16 However, it seems simple to argue that organs harvested must by definition be healthy and cannot contain evidence of trauma. Traumatised bodies that could constitute evidence are not taken because they have no therapeutic value. Our study also showed, as have many works published in the literature,17–21 that if strict rules are observed and if a pathologist can examine the donor’s body, there should be little or no doubt about any forensic conclusions: of the 27 autopsies performed after organ procurement that were analysed in this study 15 (eight criminal, eight suicidal, nine accidental, two medical malpractice), none showed interpretation bias related to surgical procedures, if procedural and scientific rigour in this process was followed to ensure judges the preservation of evidence.
Judicial and scientific strictness require actions based on evidence. It is for this reason that the French Society of Forensic Medicine sought to develop a national recommendation to harmonise practices. The recommendation emerged in early 2013
22
and is available online on our society’s website.
23
It recalls the provisions of the decree of 27 February 1998 and makes practical recommendations:
Establishment of early contact between transplant coordination teams and pathologists in case of procurements in a judicial context; Terms of the forensic pathologist’s intervention on the donor’s body:
○ Examination of the body prior to procurement in the ICU to identify forensic semiotic elements, record the planned resuscitation and surgical procedures (type of incision, organs to be harvested, etc.); ○ Assistance with procurement in the operating room – not systematic in regard to organisational difficulty but on an ad hoc emergency basis to offer a transient observation if necessary; ○ The autopsy after transplant should preferably be performed by the pathologist who examined the donor before harvesting and otherwise by a pathologist who has the forensic report. The autopsy report should include a note as to whether missing organ(s) could interfere with the forensic pathologists’ findings or whether it did not affect these findings. Nomination of local referents (forensic pathologists and hospital doctors responsible for transplant coordination) in order to not disperse information between an excessive number of intermediaries but also to impose constraints on transplant teams’ participation in the judicial inquiry: taking photographs of the donor before, during and after surgery, writing operative reports early for the pathologists who will perform the autopsy, and so on; Writing regional protocols between judicial authorities, forensic pathologists and transplant teams that consider local conditions and specific operators or situations.
Conclusion
This recommendation by the French Society of Forensic Medicine 22 sought to combine two interests: addressing the organ shortage, and fulfilling the requisites of a criminal investigation by standardising practices and encouraging communication. It is often, as observed in the literature, a lack of communication between judicial actors, forensic pathologists and transplant teams that is at the origin of many oppositions.17,21,24
Efforts leading to procurements despite legal contexts should be encouraged in order to reach a judicial policy of ‘zero refusal’. 20 To accomplish this, scientific and procedural rigour are necessary, in order to attain greater reciprocity between forensic and medical care teams.
Footnotes
Declaration of conflicting interest
The authors declare that there is no conflict of interest.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Acknowledgements
Sincere appreciation is expressed to Maxime Lemoine and American Journal Expert for their assistance in the preparation of this manuscript.