| Abstract|| |
The Organ Transplantation Act issued by the Government of India 1994 has undergone major and minor changes in the form of addition of rules and amendments in order to improve the Act to make it much acceptable legally. Over a period of time, with an increase in cadaver organ donations, the rules and policies with regard to the same have been defined and redefined over the years. In this article, the Act, the rules, the amendments, the quick essentials of approach, and the forms are reviewed.
|How to cite this article:|
Yadla M. Legal policies of organ transplantation in India: Basics and beyond. Saudi J Kidney Dis Transpl 2019;30:943-52
| Introduction|| |
Over the past three decades, the Government of India has brought in various guidelines to be followed across the country for the uniformity of organ transplantation in order to maintain the ethical and legal values of the system.
Available guidelines are in the form of Act, amendments, and rules.
| Definitions|| |
Act: Act is a law passed by the legislature. Amendments: A minor change or addition designed to improve a piece of legislation. Rules: As most laws are not complete code in themselves and certain provisions are deliberately left by the legislature, wherein rules can be laid to help govern the law.
| The Acts, Rules, and Amendments|| |
Over the past 30 years, the organ transplantation Act was published for the first time in 1994. Following this, many rules and amendments were made to the existing Act in order to make it much stronger ethically and legally.
The timeline of evolution of the Human Organs and Tissues Act is given in [Table 1].
Transplantation of Human Organs Act, 1994
An Act to provide for the regulation, removal, storage, and transplantation of human organs for therapeutic purpose and for prevention of commercial dealings in human organs in human organs was passed. This Act is called Transplantation of Human Organs Act (THOA), 1994.
There are 26 sections in the Act. Each section deals with different aspects involved in donation, retrieval, and legal procedures [Table 2].
|Table 2: Sections and subsections of Transplantation of Human Organs Act 1994.|
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In the year 1995, certain rules were added to THOA 1994. Addition of these rules further defined duties of the medical practitioner and introduced specific tests in immunology to establish the relationship. In addition, the prerequisites for grant of permission or renewal of permission were further defined. Salient points of THOA Rules in 1995 are depicted in [Table 3].
Although the Act and rules were introduced in 1994 and 1995, respectively, the states of Andhra Pradesh and Jammu Kashmir had their own legislation passed. After a gap of 13 years, in 2008, notification was issued mentioning the rules, now on called, Transplantation of Human Organs (Amendment) Rules 2008 [Table 4].
Following this, certain amendments were made to the Act, 1994 in the year 2011. As the utility of tissues was increasing, the Act was made as Tissue and Organ Act, 2011. Introduction of swap transplantation, increase in the quantum of punishment, and definition of near relative were included in the Act, 2011, as shown in [Table 5].
THOA (Amendment) 2011 clearly defined the regulation, storage, and transplantation of human organs and tissues for therapeutic purposes. This redefined a donor as a person who voluntarily authorizes the removal of his/her human organs and tissues or both for therapeutic purposes. In addition, a hospital is identified as Human Organ Retrieval Centre, provided it has adequate facilities for treating seriously ill patients who can be potential donors of organs in the event of death, and more importantly, such a hospital should have been registered under the Act with the appropriate authority.
With the inclusion of the above features, it was called Transplantation of Human Organs and Tissues (Amendments) Act (THOTA), 2011, which was approved the Parliament and had the assent of the then President of India.
Three years later, with an increase in number of deceased donor organ transplantations and an increase in number of centers performing organ transplant, rules were published which are THOTA Rules, 2014. In these rules, there are further definition of certain terminologies and introduction of 21 forms, which are mandatory for live/deceased donor submission to authorization committee. Procedure for near relatives and for other than near relatives, qualifications for transplant coordinator, details and process of establishment, and maintenance of organ registry has been defined in these rules. Scope of the regulatory bodies such as appropriate authority and advisory committee has also been defined [Table 6].
Regulation and registration of hospitals
According to the Act, registration of a hospital which shall commence activity in organ transplantation for therapeutic purpose has to be done with the appropriate authority in a prescribed form and manner along with the due payment of fees. Appropriate authority which is appointed by the state government shall grant/renew/suspend/cancel registration to enforce the standards. Appropriate authority shall be satisfied with the infrastructure, workforce, facilities, equipment, and availability of an eligible transplant co-ordinator and maintain the standards thereby. No hospital is registered unless the appropriate authority is satisfied. Eligibility criteria of a transplant coordinator were defined in THOTA Rules 2014. Apart from this, registration of tissue bank was also emphasized, whose application shall be made to appropriate authority in such a form and manner prescribed. Appropriate authority shall issue a certificate of registration to the respective hospital “tissue bank” which can be renewed in such a manner and on payment of fees. In case of lack of meeting up to the requirements, appropriate authority can cancel/ suspend the registration of hospital/tissue bank with notice or even without notice in case of issue of public interest. A provision for appeal by the aggrieved group is available within 30 days of receipt of the order (Chapter v of the Act, section 14, 14A, 15, 16, 17).
An application for registration to appropriate authority may be made in Form 12/Form 13/ Form 14/Form 15 with a prescribed fee in the form of bank draft payable at appropriate authority.
Organ/Tissue/Cornea Transplant Center: 10,000 INR (Ten thousand only).
Tissue/Eye Bank: 10,000 INR (Ten thousand only).
Nontransplant retrieval center: Nil.
Certificate of registration is Form 16. Renewal may be done three months before the expiry of registration, accompanied by the prescribed fee payable at appropriate authority. Organ/Tissue/Cornea Transplant Center: 5000 INR (Five thousand only) Tissue/Eye Bank: 5000 INR (Five thousand only).
Nontransplant retrieval center: Nil. Certificate of renewal of registration is Form 17 which is valid for up to five years. However, the following requirements need to be met with, for grant of registration (Rule 26, THOTA 2014):
24-hour availability of: medical, surgical, nursing staff, ICU units with equipment, staff, blood bank, laboratory services, operation theater, experts of specialty, HLA lab, communication systems.
Expertise in each organ transplant has been clearly defined with the required experience in the respective department of specialization. A mention was made about maintenance of minimum standards of hospital as per the Clinical Establishment Act 2010.
Registration of retrieval center also requires ICU facilities along with prescribed expertise and should be attached to the nearest government hospital designated for postmortem, for retrieval in medico-legal cases.
Who can become a transplant co-ordinator: (Rule 29, THOTA 2014) Shall be an employee of the registered hospital having qualification of degree in recognized field of medicine/nurse/bachelor’s/master’s degree in social work, psychiatry, sociology, social science, and public health.
Authorization committee (Rules 11, 12, 13, 14, THOTA 2014)
One state-level authorization committee should be constituted in each state. Hospital-based or institution-based authorization committees would be available if each hospital does more than 25 transplants in a year. No transplantation team of the institution would be a member of respective authorization committees. Compositions of hospital-based, state-level authorization committee have been clearly defined. If transplantation is between near relatives, then authority for permission is competent authority. If transplantation is between other than near relatives or foreigner donor/recipient, then the authority of permission is authorization committee [Figure 1].
|Figure 1: Schema showing the approach for permission in case of living donor.|
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Role of competent authority in case of near relatives is to verify the evidence of relationship between donor and recipient with relevant certificates (Aadhar card, ration card, voter card, marriage certificate, PAN card, driving license, and birth certificate). If not convinced about the relationship, further tests like DNA test may be done at NABL accredited labs.
In case of other than near relatives, authorization committee needs to evaluate regarding proof of link between donor and recipient, commercial transaction, reasons of donation, circumstances leading to donation, and old photographs of donor and recipient together. In case of married couple, establishment of factum and duration of marriage need to be done. In case of foreigners, Form 21 from embassy of that particular country needs to be submitted, which is a proof of relation between the donor and recipient.
In brain death declaration, duty of registered medical practitioner has been defined, who with the help of transplant co-ordinator is expected to do the needful. For brain death certification, appropriate authority may appoint a panel of experts in accordance with the Act. Form 7 is for pledging the organs before death.
Form 8 is for declaration by the near relative or either of the parents (in case of minors), and Form 10 is for brain death certification whereas Form 9 applies for consent in case of unclaimed bodies. Brain stem death certificate format for the first and second examination, supposed to be done 6 h apart, has been defined in THOTA 2014. Brain stem death certification would be made by RMP in charge of the hospital, RMP nominated by appropriate authority, neurologist/neurosurgeon of the hospital (anesthetist/physician/surgeon in case neurologist/neurosurgeon is not available), and RMP in charge of the treatment. The concerned authorities/consent to be obtained in case of organ retrieval from deceased donor is as shown in [Figure 2].
|Figure 2: The authorities concerned/consent for removal of organs in case of deceased donor.|
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The differences between the Act 1994, amendments made in the Act, 2011, and the rules added 2014 are shown in [Table 7]. The forms that need to be followed during workup of organ transplantation are mentioned in [Table 8].
|Table 7: What are the differences between Transplantation of Human Organs Act 1994, Transplantation of Human Organs Act 2011, and THOTA 2014?|
THOA: Transplantation of Human Organs Act, THOTA: Transplantation of Human Organs and Tissues Act.
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| What are the Other Guidelines and Policies at International Level Regarding Organ Transplantation?|| |
Declaration of Istanbul
The Declaration of Istanbul (DOI) expresses the determination of donation and transplant professionals and their colleagues in related fields that the benefits of transplantation should be maximized and shared equitably with those in need, without reliance on unethical and exploitative practices that have harmed poor and powerless persons around the world.
It aims to provide ethical guidance for professionals and policymakers who share this goal. The declaration thus complements efforts by professional societies, national health authorities, and intergovernmental organization to support the development of ethical programs for organ donation and transplantation and to prevent organ trafficking and transplant tourism. These efforts have contributed to the considerable progress made in countries around the world since 2008. The Declaration of Istanbul Custodian Group has further defined certain activities such as:
- Organ trafficking
- Trafficking in persons for purpose of organ removal
- Definition of resident and nonresident with respect to organ transplantation tourism
- Travel for transplantation
- Self-sufficiency in organ transplantation and donation
- Financial neutrality in organ donation.
ISOT is one of the organizations endorsing DOI. For further details please check website: www.declarationofistanbul.org. Latest edition of 2018 is available in English, Hindi, and Urdu.
| Is There a Legal Definition of Death? Is There a Difference between Death and Brain Stem Death?|| |
Section 2 (b) of the Registration of Births and Deaths Act, 1969 defines “death” as the “permanent disappearance of all evidence of life at any time after live birth has taken place.” The term is also defined under section 46 of the IPC as “the death of a human being, unless the contrary appears from the context.” Yes, death is cardiac death. Hence, brain stem death is different from the term death. [Figure 1] shows the competent authorities in the committee to authorize transplants depending on the type of donor. The various forms that are required to be submitted for different types of donors are given in [Table 9].
|Table 9: The forms required in live and deceased donor transplantation are THOTA 2014.|
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- In case of interstate organ transplants, where should be the NOC obtained from?
- In case of interstate organ transplants, NOC should be obtained from the state of domicile and approval should be obtained from the authorization committee of the state where transplant is intended to be done.
Rule 6b of Transplantation Organ Rules 2008,
Rule 14 – THOTA 2014: Form 20
- Is the donor card legal?
No, no provisions were made in the Act regarding the legal validity of such donor cards. Hence, permission needs to be obtained according to the Act and rules from the near relative.
- Are there definitive documents which needed to be verified by the authorization committee during the interview?
Yes, under rule 7 (3) of THOTA Rules 2014:
- “Evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person;
- Prepare an explanation of the link between them and the circumstances which led to the offer being made;
- Examine the reasons why the donor wishes to donate;
- Examine the documentary evidence of the link, e.g., proof that they have lived together, etc.;
- Examine old photographs showing the donor and the recipient together;
- Evaluate that there is no middleman or tout involved; evaluate that financial status of the donor and the recipient by asking them to give appropriate evidence of their vocation and income for the previous three financial years and any gross disparity between the status of the two must be evaluated in the backdrop of the objective of preventing commercial dealing;
- To give appropriate evidence of their vocation and income for the previous three financial years and any gross disparity between the status of the two must be evaluated in the backdrop of the objective of preventing commercial dealing;
- Ensure that the donor is not a drug addict;
- Ensure that the near relative or if near relative is not available, any adult person related to donor by blood or marriage of the proposed unrelated donor is interviewed regarding awareness about his or her intention to donate an organ or tissue, the authenticity of the link between the donor and the recipient, and the reasons for donation, and any strong views or disagreement or objection of such kin shall also be recorded and taken note of.”
Guides and References
THOA Rules, 1995
THOA Rules, 2008
THOA Amendments, 2011
Department of Nephrology, Gandhi Medical College, Hyderabad, Telangana
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]