BY Dr. H.T.D.W. Ariyarathna
Organ transplantation is an integral part of the medical practice and the harvesting of necessary tissues is carried out during life and upon death. However, professionals need to be aware of what is happening right now within Sri Lanka – a severe shortage of tissues and organs is prevailing in the country, as well as around the world.
Being sensitive and knowledgeable may help a great deal to overcome this barrier, according to E.H. De Silva, M.H.P. Godakandage, W.A.N.N. Peries, L.P. Dilrukshi, T.D.S. Gunasekera, A.R.S. Fernando, P. Herath, M.N. Danansuriya, A. Jasinghe, and R. Dissanayake’s “Deceased Donor Organ Donation in a Developing Country; An Early Experience in a Tertiary Care Centre in Sri Lanka (2017)”. However, the whole process should comply with the law of the country.
The legal aspect
The transplantation of human tissues and organs is governed mainly by two legal provisions. In addition to that, there may be certain working guidelines or protocols adopted by health personnel according to the requirements without contravening the law of the country.
The first provision is the Transplantation of Human Tissues Act, No. 48 of 1987. Section 17 of the said Act provides legal mandates “for the donation of human bodies for therapeutic, scientific, and research purposes, for the removal of such tissues and the use on living persons, for the preservation of such tissues and also matters connected therewith or incidental thereto”.
The second provision is the Code of Criminal Procedure Act, No. 15 of 1979. Based on the above legislations, a circular was issued in 2010, namely General Circular Number 01–37/2010. Another to be mentioned is the General Circular No. 01-09/2015 that was issued by the Ministry of Health, as per the National Transplant Programme (Health Circulars – Ministry of Health).
The Transplantation of Human Tissues Act has clearly mentioned many aspects though certain deficiencies have also been identified. This article only discusses a few aspects that are warranted for a general understanding.
At what age can a donor consent to organ donation?
According to the Act, the accepted age is 21 years. In 2016, it was declared that new driving license holders would also be allowed to donate organs if they happened to face a fatal accident resulting in brain death even if they still had not reached the age of 21 as stipulated by the Act. The age limit to possess a valid driving license in Sri Lanka is 18 years and the Cabinet of Ministers’ approval has been received for a donation of organs below the stipulated age of 21 years, since there is a higher potential to prevent the wastage of organs. With this approval, not only individuals above 21 years of age, but also individuals above 18 years of age have also been provided with an opportunity to provide their consent for future organ retrieval if they succumb to brain death during an accident.
Live donation as per the Act (Section 8)
There are two types of tissues that have been identified according to the Act – tissues with regenerative capacity and tissues without regenerative capacity. Live organ donation from minors, whether the organ is regenerative or not, poses serious ethical and legal issues.
Donation of regenerative tissues by children
The Act only allows donations by children only for another member of the family of the child. But there should be proper consent obtained by both the parents, and in the absence of one parent, consent should be given by the remaining parent. In the absence of both parents, the guardian of such a child may file their consent in writing to the Director General of Health Services (DGHS), seeking approval for donation during life, by the child. According to the Act, there is no provision to obtain non-regenerative organs from children.
Donation of regenerative tissues in adults
For an adult aged more than 21 years, if they wish to donate regenerative tissues, a request is still required to be forwarded to the DGHS. But such stipulations are not being essentially practised to date, such as in the cases of blood donation and bone marrow donation.
Donation of non-regenerative tissues by adults
Obviously, children are strictly not allowed to donate non-regenerative organs. But adults are allowed according to the Act when the adult has reached 21 years of age, through a request to the DGHS.
Organ donation from deceased
There are two broader categories in terms of organ donation from the deceased. The first category is where the deceased had provided explicit consent during life, and at the same time, this should not have been revoked. However, if the deceased has not provided consent during life, it does not prevent donation, since the next of kin is allowed to provide consent on behalf of the deceased.
Is it legal to provide consent always by a next of kin for organ donation from the deceased? The answer is no. It is only legal to obtain organs from such an individual as long as the deceased had not specifically indicated not to donate his body or organs (Section 5).
If the deceased had specifically mentioned their wishes as to how their organs are to be utilised, medical professionals should comply with such indications, and the organs should not be used for any other purposes contravening these wishes.
Unclaimed corpses and organ donation
As per the Act, it is clearly mentioned that if a corpse is unclaimed for seven days, a postmortem examination is to be performed, and then it is legal to utilise the tissues and organs by prescribed institutions for any anatomical research (Section 12). But this is not practised at present, since it is not ethically sound.
Organ retrieval from a prisoner
According to Section 11, when a prisoner dies inside a prison, it is illegal to harvest their organs unless the prisoner had specifically expressed their consent.
Is it legal to sell, buy, or dispose of any body parts or dead bodies?
It is illegal to perform such activities and also to deal directly or indirectly with valuables (converting into monetary value), even for the instances which are mentioned in the Act as being “for the donation of human bodies for therapeutic, scientific, and research purposes, for the removal of such tissues and the use on living persons, for the preservation of such tissues and also matters connected therewith or incidental thereto”.
Offences under the Act
If a person is unable to adhere to the legislation, they shall be guilty of an offence. If convicted before a Magistrate, the person is liable to imprisonment not exceeding two years or to a fine not exceeding Rs. 1,500 or for both.
Contribution from a non-Governmental organisation
The Sri Lanka Eye Donation Society is a non-Governmental organisation involved in harvesting and donating human eyes and tissues for transplantation, not only in Sri Lanka but around the world. One of the key aspects of this society is its capacity of obtaining postmortem samples with consent.
The extraction and harvesting is feasible for up to 12 hours upon death. The Sri Lanka Eye Donation Society maintains the Sri Lanka International Eye Bank and Sri Lanka Model Human Tissue Bank, which is one of the largest in the world. If the deceased and/or the next of kin have no objections, the society is informed to obtain samples from the cadaver.
It is not limited to the cornea, but also the amnion (a membrane forming a fluid filled cavity or the amniotic sac that encloses the embryo), skin, bones, and soft tissues, including tendons (connects muscles to the bones), ligaments (bands of tough elastic tissue around the joints that connect bone to bone), pericardium (a fibrous sac that encloses the heart and the great vessels), fascia lata (the deep fascia of the thigh which encloses the thigh muscles and forms the outer limit of the fascial compartments of the thigh), and dura mater (one of the layers of connective tissue that make up the brain’s meninges, the three layers of membranes that cover and protect the brain and spinal cord), are also retrieved.
Some Government hospitals utilise such tissues, including the National Hospital in Colombo. The society has over 450 branches in Sri Lanka, with manpower of over 15,000 trained volunteers who are ready to remove donor eyes on demand.
Contribution from private hospitals
Private hospitals also conduct organ transplantation, and this is mostly limited to kidney transplants and bone marrow transplants. Still, such hospitals are also required to adhere to the mentioned Act, and prior permission from the DGHS should be obtained along with an Ethical Review Committee’s approval.
In 2016, there had been a scam regarding kidney transplantation for foreign nationals within Sri Lanka. There had been an organised organ harvesting racket involving patients and donors from India. Until the matter was investigated, a temporary ban on kidney transplant operations for foreigners had been imposed for the private hospitals in Sri Lanka.
A brief history of organ transplantation in Sri Lanka
Organ transplantation in Sri Lanka dates back to 1985, when a kidney transplant was conducted by Prof. A.H. Sheriffdeen. Liver transplantation had been commenced in 2010 by Prof. Mandika Wijeratne. Since then, many transplants have and are being performed including limbs, the pancreas and liver, according to J. Arudchelvam’s “Transplantation in Sri Lanka”.
At present, an en’ bloc (instead of transplanting a single organ, both organs from the same donor are transplanted into a single recipient) transplant of kidneys, liver, and heart were successfully conducted in Sri Lanka, according to the “Transplant Policy 2020 Draft”.
Recent developments
A national transplant programme for deceased donor organ transplantation had been initiated in our country, which was streamlined via a circular issued in 2015. This paved the way for more efficient programmes in the form of establishing a National Transplant Co-ordination Centre and a transplant team at the National Hospitals, the appointment of institutional Transplant Co-ordinators, the allocation of surgical theaters for organ harvesting from deceased donors, the arranging of efficient transport facilities, and then the allocation of theatres for an organ transplant that is already harvested.
The duties of the institutional Transplant Co-ordinators were also stipulated through this circular. Maintaining a National Transplant Management Information System was also mentioned in said circular.
According to the Ministry of Health, nine hospitals are able to perform transplant surgeries, including the National Hospitals of Colombo and Kandy. The required training for the specialists in the disciplines of medicine and surgery and facilities have been provided.
Very recently, a national donor card was introduced by the Sri Jayewardenepura General Hospital in 2021. Since this card is issued on request with explicit consent during a patient’s lifetime, it will definitely be helpful to solve many of the legal and ethical issues that may arise upon brain death.
Conclusion
Organ transplant and tissue transplant are achieved with the noble thought of donation. From the deceased who suffer cardiac death (ward or home death), a variety of tissues are harvested by the Sri Lanka Eye Donation Society, and those organs and tissues are subsequently donated free of charge to recipients both locally and internationally.
Both live donations and deceased donations are being successfully performed in Sri Lanka. Tissues that are harvested from the deceased are secured in human tissue banks under optimal conditions after retrieval until the transplantation is performed. In any case, certain deceased donations and subsequent transplantation are to be carried out without any gap in order to achieve success. Organs that have been successfully transplanted from deceased organs are the kidneys, pancreas, liver, and lower limbs.
However, it has been identified that there is a severe shortage of organs, since the demand is very high. The point to be emphasised is that there is significant wastage of potentially transplantable deceased organs. As professionals, we all can contribute to developing those programmes by being aware of this prevailing situation.
The Ministry of Health and the staff members who are already engaging in these activities should be commended. The programmes that have already been initiated need support, and we all can extend our support to upgrade these projects wholeheartedly. The very gift of life for a chronically ill or injured person will be possible if all of us are a bit concerned and vigilant.
Recommendations
- To make all health care personnel more aware as to how they can help to increase the options for organ donation while engaging in ordinary duties as a “community service” (but a health worker should not promote such to individuals while they are on duty, as it is not ethically accepted).
- To include at least one lecture with well-organised learning outcomes (and in turn assessments) in the medical curriculum in order to provide an overview of organ transplantation in our country and around the world.
- To make all students in a suitable grade aware about organ transplantation, the relevant knowhow and what to know by introducing a chapter in a textbook.