The Transplantation of Human Organs and Tissues Act, 1994

Introduction:

Transplantation of Human Organs Act, 1994 was enacted by the Indian parliament and was introduced by the Ministry of Health and Family Welfare. This act was initiated on request of Goa, Maharashtra, Himachal Pradesh.

 In 2009 Goa, West Bengal, Himachal Pradesh proposed amendment to overcome the inadequacies this was passed in 2011 which widens the scope of donation in 2014 new rules came. This is not the only initiative of government to encourage organs or tissue donations.

It applies upon Goa, Himachal Pradesh and Maharashtra and to all the Union territories and it shall also apply to such other State which adopts this act because some states have their own act dealing with this issue like Andhra Pradesh has its own legislation for human organ transplantation. This act for the first time in India recognized the brain stem death.

This act has 6 chapters in total. There are various penalties mentioned if there is a violation of this act.

This act deals with regulation, storage, and transplantation of human organs for therapeutic purposes.

Objectives

This act also governs the procedure of organ donation and transplant it even prevents commercial dealing of organs in India which is growing day by day.

This act even provides with who can or cannot donate their organs and who can receive them.

Authority for Removal of Organ or Tissue or Both

 Chapter II of this act provides ways through which removal of organs or tissues or both can take place.

In case of the removal of organ or tissue from the dead person, it is important that he should give consent either in written or verbally before 2 witnesses and one of them has to be near relative of the dead person. The given consent by the dead person can be revoked by the relative in near future.

Section 3 even provides for the provision of removal of organ or tissue from brain-stem death person. Clause 6 of this section states that before any such removal it is important to obtain a death certificate. In case of brain-stem death of a minor, it is important to have the consent of the guardian.

In the case where a dead body remains unclaimed for 48 hours, the authority to remove organs or tissue may be given under section 5.

Under section 6 Authority for removal of human organs or tissues from bodies sent for post-mortem examination for medico-legal or pathological purposes can be given by the appropriate authority if the dead person before his death never objected.

Section 7 says that It is important that after removal of organ or tissue they are preserved properly.

Section 9 of this act states when an organ or tissue can be removed and in which cases it can be transplanted to a near relative recipient or unknown individual.

Regulations of Hospitals

Chapter III talks about regulations of hospitals for the removal of organs or tissues.

Section 10 of the act states that no hospital is to perform any transplantation or removal of any organ or tissue until and unless they are registered under this act.

Section 11 mentions that no organ or tissue can be removed for any other purpose other than the therapeutic purpose. It even mentions that no person or donor has an authority to give consent for a removal for any other purpose.

Section 12 states that no authorized hospital can perform the act until they explain the effects, possible complications or any hazard connected to the transplantation. The effects are to be explained to both donor and recipient.

 Appropriate Authority

Section 13 of the act states that the Central or State government shall appoint an Appropriate Authority.

Clause 3 of section 13 provides functions of Appropriate Authority –

1. Under section15 Appropriate Authority after inquiry shall issue a certificate of registration for the time as it may be prescribed
2. The authority has the power to reject an application if it feels that the applicant didn’t comply with the regulations of this act. Rejection can only be done after giving the applicant opportunity to be heard.
3. Under section 16 the appropriate authority has the power to reject or suspend the registration. The applicant ( hospital or tissue bank) should be given an opportunity to be heard, the authority has to inquire and have to be sure that there has been a breach of this act. It may suspend the registration as it may deem fit or it may cancel it’s registration altogether.
4. The authority has to inspect Tissue Bank periodically
5. It has to inspect the hospital periodically for checking the quality of transplantation.
6. It has to investigate any complaint regarding a breach of this act.
7. It has to enforce standards.

Section 13B talks about powers of Appropriate Authority – the authority under this act shall have all the powers of a Civil Court for trying a suit under Civil Procedure Code 1908 –

1. Can summon any person who has any information regarding the violation of this act
2. Discover or production of any material fact
3. Can issue a search warrant for any place suspected to hold unauthorized removal
4. Any other thing which is prescribed.

Penalties and Offences

Chapter 6 of this act talks about various punishments for offences.

1. (Section 18) Punishment for removal of human organ– Any person who renders help to a hospital or any other institute which removes or transplants organs and isn’t authorized to do so. Shall be punishable with imprisonment which can be extended till 10years with a fine which shall not exceed 20 lakhs.

If a medical practitioner helps in removal of an organ the authority shall notify the state medical council same and the practitioner name shall be removed from practice for 3 years for 1^st-time offence and permanently of continued to do the offence.

Any person if renders help or associates with the removal of human tissue shall be punished with imprisonment which may extend to 3 years with fine which may extend to 5 lakhs.

2. (Section 19) Punishment for commercial dealings in human organs– It states various ways through which commercial dealings of human organs can take place and provides punishment for not less than 5 years which may extend till 10 years with fine which shall not be less than 20 lakhs but cannot exceed 1 crore.

3. (Section 19A) Punishment for illegal dealings with human tissues– It is same as section 19 but differs in terms of punishment. Under this section, a person shall be punished for not less than 1 year which can extend till 3years with fine which shall not be less than 5 lakhs and shall not exceed 25 lakhs.

4. (Section 21) Offence by Company– Company shall be punishable for its offence committed under this act, every person who had knowledge about the offence or was in charge shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished. If the person had no knowledge about the act and proves the same or shows that he performed his duty without any negligence he shall not be punished.

Any offence committed by the company has been proved that it is done by consent or negligence of Director, Secretary, Manager or any other officer shall be deemed to be guilty and shall be punished accordingly.

Expenses

Cost of organ or tissue removal or transportation or preservation isn’t to be paid by the donors family. The expenses of the donor are paid by recipient or government or institution or NGOs.

Reasons

One of the main reason for introducing this acts was to create awareness amongst the people about organ donation because many people die due to lack of awareness statistics show that people in lakhs die and only thousand of transplants take place. Another reason was to stop commercial dealing with organs and tissues which still takes place.

Reasons for Low Rate of Transplantation

Various acts have been enacted by the Parliament of India to encourage the donation of organs but still, the rate is very low and demand is high.

Experts believe that the act which brought new rules in 2014 has not been implemented properly. As or the act the states are required to appoint appropriate authority but many states have not appointed them yet.

Another reason could be that many physicians don’t approach families of deceased for organ donation. Doctors play an important role in sensitizing and creating awareness

Many hospitals are not abiding by the major rules of the act.

People have superstition regarding donation of their organs.

There are lack of organ transplant and retrieval centers in India.

Conclusion

Over the decades the transplantation act has been improved. India as of 2017 had 301 hospitals which dealt with organs transplantation. Various other acts and provisions have been developed by the government to create awareness and to stop illegal trade of organs but the implementation is not strong enough to deter people. Many people who follow the act or regulations die waiting for their turn so the people who can afford transplantation through illegal means pursue that way. Difference between demand and supply of organs is very high.

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References:

• Legislative.gov.in > AI 1994-42
• India’s organ transplant law requires better implementation by Saptarshi Dutta link- https://sites-ndtv-com.cdn.ampproject.org/v/s/sites.ndtv.com/moretogive/indias-organ-transplant-law-requires-better-implementation-as-some-recommendations-remain-unimplemented-2177/amp/?amp_js_v=a6&amp_gsa=1&usqp=mq331AQFKAGwASA%3D#aoh=16043879818327&amp_ct=1604390762069&referrer=https%3A%2F%2Fwww.google.com&amp_tf=From%20%251%24s&ampshare=https%3A%2F%2Fsites.ndtv.com%2Fmoretogive%2Findias-organ-transplant-law-requires-better-implementation-as-some-recommendations-remain-unimplemented-2177