Revision of Organ and tissue transplantation in Azerbaijan: all we need to know, and more. Narmin Mamedova. from 09.10.20 - 12:35

Organ and tissue transplantation in Azerbaijan: all we need to know, and more

Narmin Mamedova, lawyer at MGC, nmamedova@mgc.az

Introduction

On October 6, 2020 the Parliament of the Republic of Azerbaijan discussed the bill "On donation and transplantation of human organs and tissues" in the second reading. In this regard, we would like to introduce readers to the existing legislation in the area of transplantations, as well as to the development of its legal regulation. This article does not intend to cover relations regulating donation of blood or any reproductive organs or tissues.

Briefly into the history of organ and tissues transplantation

Alexis Carrel, French surgeon and biologist, opened way to what is known as the organ transplantation by inventing first perfusion pump. In 1912, he was awarded the Nobel Prize for pioneering vascular suturing techniques. Despite the revolutionary invention of Dr.Carrel, the founding father of modern transplantation is considered to be Dr. Thomas E. Starzl, who advanced organ transplantation from a risky complicated procedure to an accessible surgery for the patients in the most critical conditions. In 1954 the first successful kidney transplant between identical twin brothers in Massachusetts was performed.

Meanwhile, scientific studies and breakthroughs in the area developed rapidly in the USSR, which included Azerbaijan at the time. Throughout 1920s there were performed a number of successful skin grafting surgeries, followed by kidney transplant from corpse in 1933, as well as many famous experiments with transplantation from dog organs. No wonder the Soviet doctors could develop their knowledge in the field of transplantation without any particular difficulties: the resolution of the Council of People's Comissars of September 15, 1937 "On the procedure for conducting medical operations", which was in force right up to 1992, literally stated the freedom of use for educational purposes of the corpses unclaimed by relatives of people who died in medical institutions.

Due to the deep concern over commercial trade in organs, the need for global standards for transplantation in respect of ethics and human rights, in 1991 the World Health Organization approved Guiding Principles on Human Cell, Tissue and Organ Transplantation. A year after, the above mentioned resolution of the Soviets was withdrawn, and Law “On transplantation of human organs and (or) tissue” of the Russian Federation was adopted.

The history of transplantation in our country dates to 1971, when Dr.Mirmammad Javadzadeh performed first ever kidney transplant not only in Azerbaijan, but the whole Near East. However, for unknown reasons, the program closed the year after and no transplant surgery was performed thereafter in the Soviet Azerbaijan. As of today, more than a thousand transplant surgeries are carried out in modern Azerbaijan.

Legal framework

The main legal document regulating relations in the field of transplantation is the Law “On transplantation of human organs and (or) tissues” adopted on October 28, 1999. Together with various decisions of the Cabinet of Ministers, Criminal Code of Azerbaijan and international treaties, it forms the basis of legal sources for studying the regulation of this area from different aspects.

Under the legislation of Azerbaijan, the replacement of a non-existent or damaged organ/tissue can only be performed in order to save human life or restore health, in case other medical methods are  not efficient. This is important to note that not all the organs are allowed to be objects of the transplantation.  The objects are limited to the list approved by the Cabinet of Ministers on September 13, 2020, which includes: heart, lung (heart-lung complex), liver, kidneys, the pancreas and segments, pancreatic vertebrae with 12 finger intestines, spleen, bone marrow, and the cornea of the eye. It has to be noted that purchase or sale of above mentioned objects is criminalized and leads to sanctions stipulated under article 137 of the Criminal Code of Azerbaijan (sanctions vary depending on the circumstances of the crime).

Another regulatory restriction applies to the institutions where such surgery can be carried out. The list of specialized state medical institutions together with the respective type of transplantation is approved by the decision of the Cabinet of Ministers on November 17, 2011.

Given that transplantation is not just a regular medical intervention, local legislation regulates every single step of the surgery with particular responsibility. The decision of necessity of transplantation shall only be given by the special commission created in the medical institution and approved by the institution’s chief. Hospitalization of donor and recipient shall also be carried out upon the commission’s special review. The precise guidelines of the whole procedure, together with steps to be taken before and after the surgery is carried out are prescribed in the above mentioned decision of Cabinet of Ministers. 

Among all the regulatory provisions, Azerbaijani legislation highlights the importance of full consent of the parties. Both the donor and the recipient (or in case s/he is under 18, his/her legal representative) shall give their written consent for the transplantation. The only exception applies to the cases when the recipient is under life threat. Speaking of the consent, this is also illegal to spread any information regarding transplantation without permission of the donor and the recipient. Simultaneously, both parties shall be informed in details about all the possible complications regarding transplantation.

Legal status of a donor

Donor is a person who voluntarily donates his/her organs/tissues to transplant to patients. Under the local legislation, it is allowed to transplant organs/tissues from the donor, in case it is not possible to save human life or restore health through cadaveric organ transplant or any other medical method.

“Primum non nocere”, or “first, do not harm” is one of the fundamental principles of medicine. Hence, aiming to not to harm the donor, who motivated by pure intensions sometimes risks his/her own health, the Azerbaijani legislation sets various norms mandatory for donors. These legal norms span different aspects of life, including donor’s age, status, health and etc., and below we will analyze each of them.

First of all, one can be a donor exclusively on a volunteer basis, under no external influence or pressure. To ensure this, the legislation prohibits anyone who is under physical, moral, material dependence from the recipient to become the donor.  Prisoners, war captives and mentally disabled persons cannot be donors either.

Only those who have reached the age of majority can donate organs and tissues. People under 18 can only become bone marrow donors.

Finally, the most important aspect of the legal status of donors is  their health. As it was mentioned before, the donor shall be precisely informed of any possible complications of the procedure. To start, a detailed medical assessment procedure shall be conducted on the potential donor, after which specialized doctors shall give their review. Except for the bone marrow transplantation, the genetic compatibility between the donor and the recipient must be examined. The transplantation of organ or a tissue can only be held in the scale which won’t negatively affect health of the donor. After the transplantation is carried out, the donor shall be provided with treatment, rehabilitation and all the needed medicines on free basis. In case the transplantation results in health limitations or disabilities for the donor, s/he shall have the right to get disability pension.

The donor shall provide doctors with precise information on all the bad habits s/he has and all the illnesses s/he is acknowledged of, because in case the potential donor has a disease which can harm recipient’s health, transplantation of his/her organ or tissue is legally prohibited.

International experience and the need to pass the new Bill

Despite presence of various legal norms protecting rights of donors, it is clearly impossible to guarantee no further deterioration in health of donor. Hence, the World Health Organization's Secretariat gives “preference to dead donors”, or cadaveric organ transplant. However, the disputes arise when it becomes complicated to agree on what to be considered the death. Interestingly, depending on ethics, history and legal system, majority of developed countries have their own approach to determination and fixation of death. Whilst some of them accept the brain-stem death, the irreversible absence of all brain activity, others recognize cardiac death only.  

In accordance with the Azerbaijani legislation, cadaveric organ transplant is only acceptable upon permission of the chief physician of the medical institution, given after indisputable fact of biological and brain death provided by the board of doctors. Important to note, the presence of transplant surgeon or specialist during confirmation of death certificate of the donor is forbidden.

When it comes to the permission for the cadaveric organ transplant, it can be given by the donor himself before his death (he can change his mind after giving the consent) or by his/her close relatives after the death. However, in case the donor gave written prohibition on the transplant, his/her organs cannot be used in this regard.

Conclusion

Despite presence of the Law on transplantation of organs and/or tissues, there are still big gaps in the legislation in terms of their application mechanisms and sanctions for disobedience. We believe that not only this gap creates ambiguity in the legal regulation of the transplantation, it is also follows by serious legal consequences and misconceptions. Despite presence of cadaveric organ transplant in the domestic legislation, there has not been performed any transplantation from a dead body in more than 20 years after the Law was adopted and more than a thousand surgeries have been performed, and, in accordance with the statemnets of the members of the Parliament, represented in the committee of healthcare of the Parliament, the lack of proper implementation mechanism is its core reason. Similar gaps can be examined in terms of possibility of  foreigners and people without citizenship to become donors, notably, not only in regard of organ or tissue transplant, as described in the article, but also in the field of reproductive health, which is of big demand. Hence, we believe updating the legislation in the field and adopting new law will make a big step forward to modernization and accessibility to the subjects of donation and transplantation.

October 2020