Thursday, 3 April 2014

MAIN FEATURES OF TRANSPLANTATION OF HUMAN ORGANS AND TISSUES RULES, 2014

Organ donation and transplantation provides a second chance at life for thousands of people each year. The growing disparity between the rich and poor, demand for human organs and availability of technology in the country makes the trading of organs a quick means to riches for some and a relief for others. Invariably Organ trade leads to exploitation of the poverty-stricken people by tempting them with financial gains to meet their immediate short-term financial needs.

Making organs a commodity is fraught with erosion of social, moral, and ethical values and is not an alternative that can be acceptable to meet organ requirements in a civilized society. The World Health Organization (WHO) in its statement on the sale of organs clearly states that it violates the Universal Declaration of Human Rights as well as its own constitution: “The human body and its parts cannot be the subject of commercial transactions. Accordingly, giving or receiving payment… for organs should be prohibited.”
Each year hundreds of Indians die while waiting for an organ transplant. The reason: there is acute imbalance between the number of organs donated and the number of people waiting for a transplant. While 2.1 lakh Indians require kidney transplantation annually, but only 3000 – 4000 kidney transplants are done. The situation is not very different in relation to heart transplants. While annually around 4,000–5,000 patients in India require a heart transplant, so far only 100 heart transplants have been conducted across the country. According to the National Programme for Control of Blindness (NPCB) 2012-13 report, only 4,417 corneas were available in 2012-13 against a whopping requirement of 80,000-1, 00,000 per year.  There are currently over 120 transplant centres   in India performing approximately 3,500 to 4,000 kidney transplants annually. Out of these four centres undertake approximately 150 to 200 liver transplants annually while some do an occasional heart transplant.

 Finding a donor is the main issue in the country. Lack of awareness and improper infrastructure facilities are the main reasons behind the existing scenario. Administrative hurdles and conservative mindset further affect organ transplantation scenario in India.  There are a lot of myths associated with organ donation which needs to be addressed to solve this problem. Most Indians generally believe that it is against the nature and religion that body parts are mutilated. Some are suspicious that the hospital staff may not work hard to save their lives if they want organs. Others believe that there might be a temptation to declare them dead before they are actually dead. Lack of a centralised registry for organ donation, acts as another major hurdle for the people to donate organs or get data about donors. Also, there is a problem of certifying brain deaths; if people are not aware of brain deaths, it becomes difficult to convince the relatives of the patients for organ donation. 






Kidney transplants in India first started in the 1970s and since then India has been a leading country in this field on the Asian sub-continent. The evolutionary history of transplants in the last four decades has witnessed commerce in organ donation becoming an integral part of the program. The Government passed the Transplantation of Human Organ Act (THO) in 1994 which made unrelated transplants illegal and deceased donation a legal option with the acceptance of brain death. Overcoming organ shortage by tapping into the pool of brain-dead patients was expected to curb the unrelated transplant activity. But, despite the THO Act, neither has the commerce stopped nor have the number of deceased donors increased to take care of organ shortage. The concept of brain death has never been promoted or widely publicized. Most unrelated transplants currently are being done with the approval from an Authorization committee.
Government of India enacted the ‘Transplantation of Human Organs (Amendment) Act in 2011 which made provisions for simplifying the procedure for human organ donation. The provisions included retrieval centres and their registration for retrieval of organs from deceased donors, swap donation and a mandatory inquiry by the registered medical practitioner of a hospital in consultation with transplant coordinator (if available) from the near relative(s) of potential donor admitted in Intensive Care Unit and informing them about the option to donate and if they consent to donate, inform the retrieval centre for retrieval of organs.
In India, the potential for deceased donation is huge due to the high number of fatal road traffic accidents and this pool is yet to be tapped. At any given time, every major city would have 8 – 10 brain deaths in various ICUs. Some 4 – 6% of all hospital deaths are due to brain death. In India, road accidents account for around 1.4 lakh deaths annually. Out of these, almost 65% sustain severe head injuries as per an AIIMS, Delhi, study. This means there are almost 90,000 patients who may be brain dead.
It is not that people don’t want to donate, but that there are no mechanisms in hospitals to identify and certify brain deaths. Plus, no one empowers the relatives of a brain-dead person to save lives by donating his organs. Anyone from a child to an elderly person can be a donor. Organ donation from the brain dead – also referred to a cadaveric donation is still very low in India. While Spain has 35 organ donors per million people, Britain has 27 donors, US 26 and Australia 11, India’s count stands at a mere 0.16 per million people.

Signing a donor card is the first step in making your wishes about donation known. A donor card is not a legal document but an expression of one’s willingness to donate. While signing a donor card demonstrates one’s desire to donate organ after death, letting the family or friends know about the decision is very important. That is because family members will be asked to give consent for the donation. The decision will be considered final when they give consent. Vital organs such as heart, liver, lungs, kidneys, pancreas and intestines, and tissues such as corneas, heart valves, skin, bones, ligaments, tendons, veins, etc. can be donated in case of brain death.

The proposed Transplantation of Human Organs and Tissues Rules, 2013 has many provisions to remove the impediments to organ donation while curbing misuse/misinterpretation of the rules. To mention a few;

·         When the donor is unrelated and if donor and/or recipient belong to a State/ Union Territory, other than the State/Union Territory where the transplantation is proposed to be undertaken, “No Objection Certificate” from the State/Union Territory of domicile of donor and/ or recipient is required. “No Objection Certificate” will not be required for near relatives and Swap donation cases.
·         The quorum of the Authorisation Committee should be minimum four and is not complete without the participation of the Chairman, Secretary (Health) or nominee and Director of Health Services or nominee.
·         Every authorised transplantation centre must have its own website. The Authorisation Committee is required to take final decision within twenty four hours of holding the meeting for grant of permission or rejection for transplant and the decision of the Authorisation Committee should be displayed on the notice board of the hospital and the website within twenty four hours of taking the decision. The website of transplantation centre shall be linked to State/Regional/National Networks through online system for organ procurement, sharing and transplantation.
·         There would be an apex national networking organization at the centre. There would also be regional and State level networking organizations where large of number of transplantation of organ(s) or tissue (s) are performed. The State units would be linked to hospitals, Organ/Tissue matching Labs and Tissue Banks within their area and also to regional and national networking organisations. Such networks shall coordinate procurement, storage, transportation, matching, allocation and transplantation of organs/tissues and shall develop norms and standard operating procedures.
·         A National Registry on Donors and recipients of Human Organ and Tissue accessible on-line through dedicated website having National, Regional and State level specificities will come into force. National/Regional registry shall be compiled based on similar registries at State level. The identity of the people in the database shall not be in public domain.

 Accordingly, the Government is going to set up an online network under the National Organ and Tissue Transplant Organisation (NOTTO). The online service will be able to connect people directly to the donor. OTTO, an autonomous body under the Health ministry, would be the nodal agency coordinating all organ transplants in the country. All hospitals in the country, whether private, public or district-level health centres, will be part of the network. Apart from NOTTO, four regional centres would also be set up across the country.

To conclude, the emerging field of regenerative medicine may allow scientists and engineers to create organs to be re-grown from the patient's own cells (stem cells, or cells extracted from the failing organs).This would not only improve the availability of compatible organs but also would address the socio-ethical issues attached with it.

(PIB Features.)
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*Director (M&C), Press Information Bureau, Kolkata.
SS-60/SF-60/02-08-2013
RTS/HSN

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