Lok Sabha Question No. 336 (STARRED), answered on 2017-03-24
Subject: Organ Transplantation
Ministry: HEALTH AND FAMILY WELFARE
Asked by: JYOTIRADITYA MADHAVRAO SCINDIA, KAMAL NATH

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO. 336 TO BE ANSWERED ON THE 24 TH MARCH, 2017

## ORGAN TRANSPLANTATIO N

## *336.SHRI JYOTIRADITYA M. SCINDIA: SHRI KAMAL NATH:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a)  whether  there  exists  a  mismatch between  demand  and  supply  of  various human organs and tissues and if so, the details thereof;
- (b) the details of existing guidelines, protocols for organ transplantation;
- (c)  whether  the  Government  has  decided to  come  out  with  new  rules, regulations and protocols for facilitating organ donation and transplantation in the country and if so, the details thereof;
- (d) whether the views of eminent doctors, health experts and other stakeholders have  been/are  being  considered before  bringing  new  rules,  regulations  and protocols for facilitating organ donation, etc. and if so, the details thereof; and
- (e) the rules that exist in developed countries in this regard?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE ( SHRI JAGAT PRAKASH NADDA )

- (a) to (e) : A Statement is laid on the table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 336* FOR 24 TH MARCH, 2017

(a)    The demand for organs for transplantation is far more than the ava of organs.

(b)  and (c)  The Transplantation of Human Organs in India is regulated as pe the Transplantation of Human Organs and Tissues Act, 1994 (as amended i 2011) and rules made thereunder. Further, the following guidelines/regulatio have been issued in recent past for facilitating organ donation and transplantation in the country :

- (i) Highlights  of  National  Organ  and  Tissue  Transplant  Programme  and operational Guideli nes for its implementation, in 2015.
- (ii) Allocation  Criteria  for  Kidney,  Liver,  Heart,  Lung,  Heart - Lung and Cornea in 2016
- (iii) Draft Standard Operating Procedures (SOPs)/protocols for management of brain stem dead donors and retrieval of different Organs.

These are  available  in  public  domain  on  the  website  of  National  Organ Tissue Transplant Organization (NOTTO) namely www.notto.gov.in:

(d)   It is a standard practice to obtain expert advice of eminent doct rs, health experts  and  other  stakeholders before finalizing  any  rules,  guidelines  or protocols.  The  Allocation  Criteria  in  respect  of  Kidney,  Liver,  Heart, Heart - Lung  and  Cornea  has  been  prepared  after  taking  the  views  of  emine doctors, health experts and other stakeholders into account.

(e)    T he  details  of  the  law  governing  organ  donation  in  world  as  diffe countries of the world accessed on 22.03.2017 at 5:00 PM from website l https://dash.harvard.edu/bitstream/handle/1/8963882/Arthur%20Chern%20%20 Food%20%20Drug%20Law%20Final%20Paper%20%20Regulation%20of%20 Organ%20Transplants.pdf?sequence=1 are annexed .

******

## TABLE 2: ORGAN DONATION LAWS IN 34 COUNTRIES

| Country         | Informed Consent Law                                            | Presumed Consent Law                                          |
|-----------------|-----------------------------------------------------------------|---------------------------------------------------------------|
| Australia       | Law of 1982                                                     |                                                               |
| Austria         |                                                                 | Law of 1982                                                   |
| Belgium         |                                                                 | Law of 1986 (Families could object)                           |
| Bulgaria        |                                                                 | Law of 1996 (In practice consent is from the next - of - kin) |
| Canada          | Law of 1980                                                     |                                                               |
| Croatia         |                                                                 | Law of 2000 (In practice consent is from the next - of - kin) |
| Cyprus          |                                                                 | Law of 1987                                                   |
| Czech Republic  |                                                                 | Law of 1984                                                   |
| Denmark         | Current Law of 1990                                             | (Previous Law of 1967)                                        |
| Finland         |                                                                 | Law of 1985                                                   |
| France          |                                                                 | Law of 1976 (In practice consent is from the next - of - kin) |
| Germany         | Law of 1997                                                     |                                                               |
| Greece          |                                                                 | Law of 1999                                                   |
| Hungary         |                                                                 | Law of 1972                                                   |
| Ireland         | No law, follows UK guidelines                                   |                                                               |
| Israel          |                                                                 | Law of 1953                                                   |
| Italy           |                                                                 | Law of 1967                                                   |
| Japan           | Law of 1997 (Before 1997, brain death not accepted) (Family can | veto)                                                         |
| Luxemburg       |                                                                 | Law of 1982                                                   |
| The Netherlands | Law of 1996                                                     |                                                               |
| New Zealand     | Law of 1964                                                     |                                                               |
| Norway          |                                                                 | Law of 1973 (Family consulted and potentially object)         |
| Poland          |                                                                 | Law of 1990                                                   |
| Portugal        |                                                                 | Law of 1993                                                   |
| Romania         | Law of 1998                                                     |                                                               |
| Singapore       |                                                                 | Law of 1987 (Only Asian country with presumed consent law)    |
| Slovak Republic |                                                                 | Law of 1994                                                   |
| Slovenia        |                                                                 | Law of 2000                                                   |
| Spain           |                                                                 | Law of 1979 (In practice consent is from the next - of - kin) |
| Sweden          |                                                                 | Law of 1996 (Family can potentially                           |
| Switzerland     | Law of 1996                                                     |                                                               |

## ANNEXURE - 1

| Turkey         |                                                                                      | Law of 1979 (Only Muslim - dominated country with a presumed consent law; in practice is soughtfrom the next - of - kin)   |
|----------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| United Kingdom | Laws of 1961 and 1989                                                                |                                                                                                                            |
| United States  | Uniform Anatomical Gift Act 1968, revised in 1987 National Organ Transplant Act 1984 | of of                                                                                                                      |

Source: Alberto Abadie and Sebastien Gay (June 2004). The Impact of Presumed Consent Legislation on Cadaveric Organ Donation: A Cross Country Study. Kennedy School of Government Working Paper No. RWP04 - 024.