Bulgaria is conducting surgical debate on the law of human organ transplants. Although such operations are performed frequently in Bulgaria, the legal basis for them has been inadequate. But now time is running out for the law to be clarified, as Bulgaria comes under pressure to harmonise its legislation with European Union law. IVAN VATAHOV probes the issue.
In 1967 the world became newly aware of its medico-surgical obligations when South African surgeon Chris Barnard performed the first human heart transplant.
Later, new developments in immuno-suppression (the use of drugs to prevent organ rejection) have advanced the field of transplantation enormously. Kidneys, livers, and even lungs have been transplanted to prove that humankind is overcoming one of its major medical problems.
In most countries, the law on organ transplants is poorly defined, because legislation has not kept up with advances in surgery. The existing legal framework relating to physical intervention and care of the dead has no provision for organ transplantation.
It is customary to ask the permission of the relatives, but, because organ removal must take place immediately after death, it may be impossible to reach the relatives in time. It has been suggested that there should be a widespread campaign to encourage persons to provide in their wills that their organs be used for transplantation. An alternative is to provide by law that permission is assumed unless removal has been forbidden by the individual in his lifetime.
Compulsory post-mortem examination, a far more extensive procedure than organ removal for grafting, is required in most countries after unexpected death, and this compulsion is not a matter of public concern and debate.
There would seem to be no reason why organ removal for transplantation purposes should not also be acceptable to public opinion, provided there is a mechanism by which individuals in their lifetime can refuse this permission.
This, of course, requires an efficient register of those who indicate their refusal; the register would be consulted before any organs would be removed. It is important that there be public reassurance that considerations of transplantation would not impair normal resuscitative efforts of the potential donor.
Last week saw, for the first time in Bulgaria, serious discussion on the legal, ethical and even technical aspects of organ transplantation. The reason for the discussion was the Transplantation Bill that was approved on first reading by the National Assembly in mid-May. Given that MPs did not seem to be aware of what they had approved, the medical experts were the ones expected to explain the issues to the public.
Human organs, tissues and cells cannot be traded under the Transplantation Bill that was passed in May. It regulates the conditions and procedure for transplantations and for providing and storing transplants for use in human medicine.
The bill does not apply to blood donation, transfusion of blood and blood products and the transplantation of reproductive organs and tissues, nor to the supply, use and storage of embryos, ova and semen, or to auto-transplantation and implantation of artificial organs.
Under the bill, everyone will have a chance to declare in writing their refusal to have their organs, tissues and cells used as transplants after their death. This shall be stated in the person’s medical insurance book and after the death of this person no tissues or organs can be taken for transplantation.
The transplantation of animal organs and tissues into people will be regulated by a Health Ministry ordinance.
The bill also provides for the establishment of an Executive Agency for Transplantation with the Health Ministry, which will manage, coordinate and control transplantations in Bulgaria. There are also plans to set up a commission on ethics, also with the Health Ministry, to authorise the use of organs and tissues for transplantation in the cases provided for by the law.
Medical establishments will sign contracts for financing transplantations with the Medical Insurance Fund, with other insurance funds and profit and non-profit organisations. The contract will have to be approved by the Executive Agency for Transplantations.
Bulgaria needs capacity for some 100 to 120 liver transplantations and at least 1,000 kidney transplantations, Health Minister Bozhidar Finkov said last Tuesday following a discussion on the Transplantation Bill.
Apart from the Health Minister, other participants in the discussion were MPs of the parliamentary medical committee, the executive director of the transplantation management centre Bultransplan Yanko Nachkov, the national consultant on transplantations Professor Milan Milanov, Associate Professor Sashka Popova of the Department of Public Health with the Medical Academy and other experts in the field of transplantations.
Everybody agreed that the bill is good as a whole and meets the European standards. There was a debate on the provisions about the declaration of non-consent for organ donorship: whether the general practitioners should put down in the medical book of a patient his non-consent to be a donor after his death and whether the consent of brain-dead people’s relatives should be asked. One position at the discussion was that, legally, the relatives could not express the will of a dead person.
The participants in the discussion will probably propose to have a provision in the law saying that the family should only be informed rather than asked for consent, or another option is to require from them proof that the person has changed his or her mind in the meantime, said Atanas Shterev, chairman of Parliament’s health committee.
Milanov suggested that a person should declare his decision not to act as a donor to the civil service rather than to his doctor because it is a civil and not a medical matter. Then the declarations will be forwarded to the Executive Agency for Transplantation that will be set up under the new law.
According to Milanov, the national medical insurance fund cannot finance transplantations because it does not currently have the capacity. There need to be clear rules to say whether the money for transplantations will come from a special fund with the Health Ministry or will go to an ethics commission to manage it, or directly to the Agency for Transplantations.
There was a suggestion at the discussion that free donorship should be reconsidered because few people are willing to donate organs if they are not related to the patient in need of a transplant. The participants also agreed that special attention should be paid to the funding of wards supporting the life of brain-dead people, because it is a very expensive procedure.
The experts were unanimous that it is important for Bulgarians to overcome the psychological barrier that exists with regard to the organ donorship and they should start perceiving donorship as their supreme duty.
However, during the discussion one very important aspect of human transplantation was missed. When it comes to the tragic issue of illegal human organs trafficking, silence of the lambs becomes common. And Bulgaria has had frequent encounters with this problem, with the most recent example this past April when the country was involved in a cross-border scandal involving alleged human organ trafficking.
Media reports in Germany in April said that a Bulgarian was involved in human organ trafficking in Germany. The news was reported by Bulgarian media but the only reaction from Bulgarian authorities was that they promised to cooperate with their German colleagues.
Major General Vassil Vassilev, Director of the National Police Service, wrote to police liaison officer Uwe Schiller, offering coordination and interaction with the Bavarian police.
DPA agency reported in April that a Bulgarian had been arrested on suspicion of trafficking in human organs. The German newspapers wrote that prosecutors in Munich would charge the man with a violation of the transplantation law, which carries up to five years’ imprisonment.
A year ago the Bulgarian, whose company is not registered as required by German law, reportedly started sending letters to transplantation centres and consulates around the world, saying: “We sell people in excellent health”. In other words, the case was a typical example of how such a dirty job could be performed without any action taken against the perpetrators.
And there are sources, which claim the organ trafficking in Bulgaria is becoming a serious problem like it is in many third world countries. Authorities still fail to recognise organ trafficking as one of the reasons for many child abductions in Bulgaria, although media reports very often indicate such a connection.
When Yanaki Stoilov, MP from the Bulgarian Socialist Party stood up to protest in Parliament against some of the provisions in the new bill, saying that it would get Bulgaria involved in the human organs trade and will make it a part of the world trade in human organs, there appeared to be no response.
MPs decided it was enough to state in the bill that international exchange of transplants will be authorised by the Health Minister and it will be possible only with countries with which Bulgaria has signed an agreement.
Regardless of the ongoing discussion and the many problems posed, the Transplantation Bill should become a law as soon as possible. It is one of the requirements on Bulgaria’s path to the European Union.
In 1967 the world became newly aware of its medico-surgical obligations when South African surgeon Chris Barnard performed the first human heart transplant.
Later, new developments in immuno-suppression (the use of drugs to prevent organ rejection) have advanced the field of transplantation enormously. Kidneys, livers, and even lungs have been transplanted to prove that humankind is overcoming one of its major medical problems.
In most countries, the law on organ transplants is poorly defined, because legislation has not kept up with advances in surgery. The existing legal framework relating to physical intervention and care of the dead has no provision for organ transplantation.
It is customary to ask the permission of the relatives, but, because organ removal must take place immediately after death, it may be impossible to reach the relatives in time. It has been suggested that there should be a widespread campaign to encourage persons to provide in their wills that their organs be used for transplantation. An alternative is to provide by law that permission is assumed unless removal has been forbidden by the individual in his lifetime.
Compulsory post-mortem examination, a far more extensive procedure than organ removal for grafting, is required in most countries after unexpected death, and this compulsion is not a matter of public concern and debate.
There would seem to be no reason why organ removal for transplantation purposes should not also be acceptable to public opinion, provided there is a mechanism by which individuals in their lifetime can refuse this permission.
This, of course, requires an efficient register of those who indicate their refusal; the register would be consulted before any organs would be removed. It is important that there be public reassurance that considerations of transplantation would not impair normal resuscitative efforts of the potential donor.
Last week saw, for the first time in Bulgaria, serious discussion on the legal, ethical and even technical aspects of organ transplantation. The reason for the discussion was the Transplantation Bill that was approved on first reading by the National Assembly in mid-May. Given that MPs did not seem to be aware of what they had approved, the medical experts were the ones expected to explain the issues to the public.
Human organs, tissues and cells cannot be traded under the Transplantation Bill that was passed in May. It regulates the conditions and procedure for transplantations and for providing and storing transplants for use in human medicine.
The bill does not apply to blood donation, transfusion of blood and blood products and the transplantation of reproductive organs and tissues, nor to the supply, use and storage of embryos, ova and semen, or to auto-transplantation and implantation of artificial organs.
Under the bill, everyone will have a chance to declare in writing their refusal to have their organs, tissues and cells used as transplants after their death. This shall be stated in the person’s medical insurance book and after the death of this person no tissues or organs can be taken for transplantation.
The transplantation of animal organs and tissues into people will be regulated by a Health Ministry ordinance.
The bill also provides for the establishment of an Executive Agency for Transplantation with the Health Ministry, which will manage, coordinate and control transplantations in Bulgaria. There are also plans to set up a commission on ethics, also with the Health Ministry, to authorise the use of organs and tissues for transplantation in the cases provided for by the law.
Medical establishments will sign contracts for financing transplantations with the Medical Insurance Fund, with other insurance funds and profit and non-profit organisations. The contract will have to be approved by the Executive Agency for Transplantations.
Bulgaria needs capacity for some 100 to 120 liver transplantations and at least 1,000 kidney transplantations, Health Minister Bozhidar Finkov said last Tuesday following a discussion on the Transplantation Bill.
Apart from the Health Minister, other participants in the discussion were MPs of the parliamentary medical committee, the executive director of the transplantation management centre Bultransplan Yanko Nachkov, the national consultant on transplantations Professor Milan Milanov, Associate Professor Sashka Popova of the Department of Public Health with the Medical Academy and other experts in the field of transplantations.
Everybody agreed that the bill is good as a whole and meets the European standards. There was a debate on the provisions about the declaration of non-consent for organ donorship: whether the general practitioners should put down in the medical book of a patient his non-consent to be a donor after his death and whether the consent of brain-dead people’s relatives should be asked. One position at the discussion was that, legally, the relatives could not express the will of a dead person.
The participants in the discussion will probably propose to have a provision in the law saying that the family should only be informed rather than asked for consent, or another option is to require from them proof that the person has changed his or her mind in the meantime, said Atanas Shterev, chairman of Parliament’s health committee.
Milanov suggested that a person should declare his decision not to act as a donor to the civil service rather than to his doctor because it is a civil and not a medical matter. Then the declarations will be forwarded to the Executive Agency for Transplantation that will be set up under the new law.
According to Milanov, the national medical insurance fund cannot finance transplantations because it does not currently have the capacity. There need to be clear rules to say whether the money for transplantations will come from a special fund with the Health Ministry or will go to an ethics commission to manage it, or directly to the Agency for Transplantations.
There was a suggestion at the discussion that free donorship should be reconsidered because few people are willing to donate organs if they are not related to the patient in need of a transplant. The participants also agreed that special attention should be paid to the funding of wards supporting the life of brain-dead people, because it is a very expensive procedure.
The experts were unanimous that it is important for Bulgarians to overcome the psychological barrier that exists with regard to the organ donorship and they should start perceiving donorship as their supreme duty.
However, during the discussion one very important aspect of human transplantation was missed. When it comes to the tragic issue of illegal human organs trafficking, silence of the lambs becomes common. And Bulgaria has had frequent encounters with this problem, with the most recent example this past April when the country was involved in a cross-border scandal involving alleged human organ trafficking.
Media reports in Germany in April said that a Bulgarian was involved in human organ trafficking in Germany. The news was reported by Bulgarian media but the only reaction from Bulgarian authorities was that they promised to cooperate with their German colleagues.
Major General Vassil Vassilev, Director of the National Police Service, wrote to police liaison officer Uwe Schiller, offering coordination and interaction with the Bavarian police.
DPA agency reported in April that a Bulgarian had been arrested on suspicion of trafficking in human organs. The German newspapers wrote that prosecutors in Munich would charge the man with a violation of the transplantation law, which carries up to five years’ imprisonment.
A year ago the Bulgarian, whose company is not registered as required by German law, reportedly started sending letters to transplantation centres and consulates around the world, saying: “We sell people in excellent health”. In other words, the case was a typical example of how such a dirty job could be performed without any action taken against the perpetrators.
And there are sources, which claim the organ trafficking in Bulgaria is becoming a serious problem like it is in many third world countries. Authorities still fail to recognise organ trafficking as one of the reasons for many child abductions in Bulgaria, although media reports very often indicate such a connection.
When Yanaki Stoilov, MP from the Bulgarian Socialist Party stood up to protest in Parliament against some of the provisions in the new bill, saying that it would get Bulgaria involved in the human organs trade and will make it a part of the world trade in human organs, there appeared to be no response.
MPs decided it was enough to state in the bill that international exchange of transplants will be authorised by the Health Minister and it will be possible only with countries with which Bulgaria has signed an agreement.
Regardless of the ongoing discussion and the many problems posed, the Transplantation Bill should become a law as soon as possible. It is one of the requirements on Bulgaria’s path to the European Union.
