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LEGISLATION
• Legislation (or "statutory law") is law which has been promulgated
(or "enacted") by a legislature or other governing body or the
process of making it.
• Legislation can have many purposes: to regulate, to authorize, to
outlaw, to provide (funds), to sanction, to grant, to declare or to
restrict.
• Legislation is usually proposed by a member of the legislature (e.g.
a member of Congress or Parliament), or by the executive, where
upon it is debated by members of the legislature and is often
amended before passage.
• Legislation is regarded as one of the three main functions of
government, which are often distinguished under the doctrine of the
separation of powers.
• Those who have the formal power to create legislation are known as
legislators
• A judicial branch of government will have the formal power to
interpret legislation (statutory interpretation)
THE 4 BASIC TYPES OF LEGISLATION
• There are four basic types of legislation that are handled by Congress.
They include bills, simple resolutions, joint resolutions and concurrent
resolutions.
Bill
• A bill is the most common type of legislation and can be either
permanent or temporary.
• It may also be general or special in nature; public or private.
• Bills can originate in either the Senate or the House of Representatives
• General appropriation bills typically originate in the House of
Representatives by tradition.
• A public bill affects the public in general while a private bill is one
that affects a private party or specified individual.
Joint Resolutions
• A joint resolution may originate in either the Senate or the House of
Representatives, even though it is often assumed that this type of
legislation originates in both houses.
• There is actually not much difference between a joint resolution and a
bill, but one difference is that a joint resolution can include a preamble
that precedes the resolving clause
Concurrent Resolutions
• A matter that affects the operations of both chambers of Congress is
typically initiated through a concurrent resolution.
• They are often used for expressing opinion, principles, facts and
purposes of the two houses of Congress.
Simple Resolutions
• A matter that concerns the rules, opinion or operation of either House
alone is begun with a simple resolution.
• A simple resolution will be considered only the House in which it is
introduced.
ACTS
• A bill which has passed through the various legislative steps required
for it and which has become law.
• They are passed by the government, to let people know the rules and
regulations about specific situations.
• Some of the acts are PNDT act, Organ Transplantation act, Consumer
Protection act etc
PRE-CONCEPTION AND PRE-NATAL
DIAGNOSTIC TECHNIQUES ACT, 1994
• Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act,
1994 is an Act of the Parliament of India enacted to stop female
foeticides and arrest the declining sex ratio in India.
• The act banned prenatal sex determination.
• An Act to provide for the prohibition of sex selection, before or after
conception, and for regulation of prenatal diagnostic techniques for the
purposes of detecting genetic abnormalities or metabolic disorders or
chromosomal abnormalities or certain congenital malformations or
sex-linked disorders and for the prevention of their misuse for sex
determination leading to female foeticide; and, for matters connected
therewith or incidental thereto.
Citation Act No. 57 of 1994
Enacted by Parliament of India
Assented to 20 September 1994
Commenced 1 January 1996
Amended by: The Pre-Conception and Pre-Natal Diagnostic
Techniques (Prohibition of Sex Selection) Act. 2003
The main purpose of enacting the act is to ban the use of sex selection
techniques after conception and prevent the misuse of prenatal
diagnostic technique for sex selective abortions.
Salient features
Offences under this act include conducting or helping in the conduct of
prenatal diagnostic technique in the unregistered units, sex selection on
a man or woman, conducting PND test for any purpose other than the
one mentioned in the act, sale, distribution, supply, renting etc. of any
ultra sound machine or any other equipment capable of detecting sex of
the foetus.
Main provisions in the act are:-
• The Act provides for the prohibition of sex selection, before or after
conception.
• It regulates the use of pre-natal diagnostic techniques, like ultrasound
and amniocentesis by allowing them their use only to detect :
• Genetic abnormalities
• Metabolic disorders
• Chromosomal abnormalities
• Certain congenital Sex linked disorders. Malformations
• Haemoglobinopathies
• No laboratory or centre or clinic will conduct any test including
ultrasonography for the purpose of determining the sex of the foetus.
• No person, including the one who is conducting the procedure as per
the law, will communicate the sex of the foetus to the pregnant woman
or her relatives by words, signs or any other method.
• Any person who puts an advertisement for pre-natal and pre-
conception sex determination facilities in the form of a notice, circular,
label, wrapper or any document, or advertises through interior or other
media in electronic or print form or engages in any visible
representation made by means of hoarding, wall painting, signal, light,
sound, smoke or gas, can be imprisoned for up to three years and fined
Rs. 10,000.
• no pre-natal diagnostic techniques shall be used or conducted unless
the person qualified to do so is satisfied for reasons to be recorded in
writing that any of the following conditions are fulfilled, namely:
(i) age of the pregnant woman is above thirty-five years;
(ii) the pregnant woman has undergone of two or more spontaneous
abortions or foetal loss;
(iii) the pregnant woman had been exposed to potentially teratogenic
agents such as drugs, radiation, infection or chemicals;
(iv) the pregnant woman or her spouse has a family history of mental
retardation or physical deformities such as, spasticity or any other
genetic disease;
(v) any other condition as may be specified by the Central Supervisory
Board;
Compulsory registration
• The Act mandates compulsory registration of all diagnostic
laboratories, all genetic counselling centres, genetic laboratories,
genetic clinics and ultrasound clinics.
Amendment in 2003
Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse)
Act, 1994 (PNDT), was amended in 2003 to The Pre-Conception and
Pre-Natal Diagnostic Techniques (Prohibition Of Sex Selection) Act
(PCPNDT Act) to improve the regulation of the technology used in sex
selection.
Implications of the amendment are:-
• Amendment of the act mainly covered bringing the technique of pre
conception sex selection within the ambit of the act
• Bringing ultrasound within its ambit
• Empowering the central supervisory board, constitution of state level
supervisory board
• Provision for more stringent punishments
• Empowering appropriate authorities with the power of civil court for
search, seizure and sealing the machines and equipments of the
violators
• Regulating the sale of the ultrasound machines only to registered
bodies.
OFFENCES AND PENALTIES
• No person, organization, Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic, including clinic, laboratory or centre
having ultrasound machine or imaging machine or scanner or any
other technology capable of undertaking determination of sex of foetus
or sex selection shall issue, publish, distribute, communicate or cause
to be issued, published, distributed or communicated any
advertisement, in any form, including internet, regarding facilities of
pre-natal determination of sex or sex selection before conception
available at such centre, laboratory, clinic or at any other place.
• Any person who contravenes shall be punishable with imprisonment
for a term which may extend to three years and with fine which may
extend to ten thousand rupees.
MISCELLANEOUS
• Maintenance of records.
• Power to search and seize records, etc.
• Protection of action taken in good faith.- Removal of difficulties
• Power to make rules.
• Power to make regulations.
• Rules and regulations to be laid before Parliament.
CONSUMER PROTECTION ACT, 1986
• The Consumer Protection Act, 1986 (COPRA) is an Act of the
Parliament of India enacted in 1986 to protect the interests of
consumers in India.
• It is replaced by the consumer protection act 2019 it is made for the
establishment of consumer councils and other authorities for the
settlement of consumer's grievances and for matters connected there
with it.
• The act was passed in Assembly in October 1986 and came into force
on December 25, 1986.
Citation Act No. 68 of 1986
Enacted by Parliament of India
Commenced 24 December 1986
Significance of the statute
This statute is regarded as the 'Magna Carta' in the field of consumer
protection for checking unfair trade practices, ‘defects in goods’ and
‘deficiencies in services’ as far as India is concerned.
Consumer Protection Council
Consumer Protection Councils are established at the national, state and
district level to increase consumer awareness.
Various Consumer Organizations
• To increase the awareness of consumers, there are many consumer
organizations and NGOs that have been established.
• Consumer guidance society of India (cgsi) was the first consumer
organization established in India in 1966.
It was followed by many others such as
1. Consumer Education and Research Centre (Gujarat)
2. Bureau of Indian Standards
3. Federation of Consumer Organisation In Tamil Nadu
4. Mumbai Grahak Panchayat
5. Consumer Voice (New Delhi)
6. Legal Aid Society (Kolkata)
7. Akhil Bhartiya Grahak Panchayat
8. The Consumers Eye India.
9. United India Consumer's Association
Consumer Disputes Redressal Agencies
• District Consumer Disputes Redressal Forum (DCDRF): Also known
as the "District Forum" established by the State Government in each
district of the State.
• The State Governments may establish more than one District Forum in
a district.
• It is a district level court that deals with cases valuing up to ₹2 million
(US$28,000).
• State Consumer Disputes Redressal Commission (SCDRC): Also known
as the "State Commission" established by the State Government in the
State. It is a state level court that takes up cases valuing less than ₹10
million (US$140,000)
• National Consumer Disputes Redressal Commission (NCDRC):
Established by the Central Government. It deals with matters of more
than 10 million.
OBJECTIVES
Objectives of Central Council
The objectives of the Central Council is to promote and to protect the rights
of the consumers such as:-
• The right to be protected against the marketing of goods and services which
are hazardous to life and property.
• The right to be informed about the quality, quantity, potency, purity,
standard and price of goods or services, as the case may be so as to protect
the consumer against unfair trade practices;
• The right to be assured, wherever possible, access to a variety of goods and
services at competitive prices
• The right to be heard and to be assured that consumer's interest will receive
due consideration at appropriate forums
• The right to seek redressal against unfair trade practices or restrictive trade
practices or unscrupulous exploitation of consumers
• The right to consumer education.
Jurisdiction/Three Tier System of Council Courts
Jurisdiction of District Forum
Subject to the other provisions of this Act, the District Forum shall have
jurisdiction to entertain complaints where the value of the goods or services
and the compensation, if any, claimed does not exceed rupees twenty lakhs.
Jurisdiction of State Commission
• Complaints where the value of the goods or services and compensation, if
any, claimed exceeds rupees twenty lakhs but does not exceed rupees one
crore (R10 million); and
• Appeals against the orders of any District Forum within the State; and
Jurisdiction of National Commission
• Complaints where the value of the goods or services and
compensation, if any, claimed exceeds rupees one crore; and
• Appeals against the orders of any State mayor; and
NATIONAL ORGAN TRANSPLANT ACT OF 1984
• An Act to provide for the regulation of removal, storage and
transplantation of human organs for therapeutic purposes and for the
prevention of commercial dealings in human organs and for matters
connected therewith or incidental thereto.
• The National Organ Transplant Act (1984 Pub.L. 98–507), approved
October 19, 1984, and amended in 1988 and 1990
HISTORY
• Before NOTA was put in place, there was no clear jurisdiction on what
property rights were for a human corpse. Instead, America applied a
"quasi-right" to a corpse. This meant that the relatives of a deceased
person had a possessory right long enough to decide how to bury or
dispose of the corpse. This does not mean a property right which
means they do not have a right to transfer, devise, possess, and lease
the human organs and tissues.
• Due to a shortage in organs but a growing demand for transplantations,
people began to use other means to purchase organs outside of a
hospital setting. The organ market began to become a commercial
market. H. Barry Jacobs, the head of a Virginia company, announced
in 1983 a new plan to buy and sell human organs on the market.
• This plan put healthy, human kidneys in the price range of up to
$10,000 plus a $2,000 to $5,000 commission fee for Jacobs. This
brought the issue out into the open. NOTA was a response to this
proposal making it criminal to transfer human organs for valuable
consideration for the purposes of a human transplantation.
Title I - Task Force on Organ Procurement and Transplantation
• Title I states the Secretary of Health and Human Services will establish a
Task Force on Organ Procurement and Transplantation to regulate how
deceased donor organs are handled and who receives transplantations and
the process one must go through in regards to a deceased donor organ
transplantation along with other lines of duty. This Task Force is composed
of 25 members.
Duties of the Task Force include:
• Handling all medical, legal, ethical, economic, and social issues that may
rise from obtaining deceased human organs and the transplantation of them.
• Assessing immunosuppressive medication used to prevent organ rejection in
transplant patients, including safety, effectiveness, costs, insurance
reimbursements, and making sure those who need these drugs can receive
them
• Prepare a report including assessments of public and private efforts to
obtain deceased human organs, problems in obtaining these organs,
recommendations for education and training of health professionals
and for education of the general public
• Assessment of the effectiveness and of establishing a national registry
of deceased human organ donors
Title II - Organ Procurement Activities
• Title II established the Organ Procurement Organizations (OPO) for
deceased organ transplants. These OPO's are designed to increase the
number of registered deceased organ donors and when those donors
become available, they coordinate the donation process from donor to
patient.
• NOTA also established the Organ Procurement and Transplantation
Network (OPTN), a membership organization transplant-related
individuals and organizations, primarily transplant centers.
• The Act also introduced a scientific Federal Registry of all the
recipients of organ transplants. This registry includes patient
information and transplant procedures.
Their duties include:
• "facilitating the deceased organ matching and placement process through
the use of the computer system and a fully staffed Organ Center operating
24 hours a day"
• "developing consensus based policies and procedures for deceased organ
recovery, distribution (allocation), and transportation"
• "collecting and managing scientific data about organ donation and
transplantation"
• "providing data to the government, the public, students, researchers, and the
Scientific Registry of Transplant Recipients for use in the ongoing quest for
improvement in the field of solid organ allocation and transplantation"
• "developing and maintaining a secure Web-based computer system, which
maintains the nation's deceased organ transplant waiting list and
recipient/donor organ characteristics"; and,
• "Providing professional and public education about donation and
transplantation, the activities of the OPTN and the critical need for
donation."
Title III - Prohibition of Organ Purchases
• NOTA specifically states "it shall be unlawful for any person to
knowingly acquire, receive, or otherwise transfer any human organ for
valuable consideration for use in human transplantation if the transfer
affects interstate commerce." The penalty of breaking this law is a fine
of $50,000 or up to five years in prison, or both.
Title IV - Miscellaneous
• NOTA created a "national registry of voluntary bone marrow donors."
Donors on this list have given informed consent and their names are
kept confidential. This registry is upheld by the Secretary of Health
and Human Services.
Amendments
• 1988:- The 1988 Amendment of NOTA introduced the Organ
Procurement Organizations and Organ Procurement and
Transplantation Network explained in detail in Title II of NOTA.
• 1990:-The 1990 Amendment of NOTA introduced the Federal
Registry.
ETHICS
• Some believe that if organ transplantation is a commercial process,
incentives for the disfranchised and poor would be created to
manipulate them into being more willing to donate.
• The issue of putting a purchase price on a body part resembles slavery
and treats a class of people as subhuman. These critics believe that this
dehumanization is intolerable. Also, the buying and selling of organs
for transplantation as a business arrangement would lead to
misrepresentation of a person's medical information if the donor was
in poor financial shape.
THANK YOU

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Legislation

  • 1. LEGISLATION • Legislation (or "statutory law") is law which has been promulgated (or "enacted") by a legislature or other governing body or the process of making it. • Legislation can have many purposes: to regulate, to authorize, to outlaw, to provide (funds), to sanction, to grant, to declare or to restrict. • Legislation is usually proposed by a member of the legislature (e.g. a member of Congress or Parliament), or by the executive, where upon it is debated by members of the legislature and is often amended before passage.
  • 2. • Legislation is regarded as one of the three main functions of government, which are often distinguished under the doctrine of the separation of powers. • Those who have the formal power to create legislation are known as legislators • A judicial branch of government will have the formal power to interpret legislation (statutory interpretation)
  • 3. THE 4 BASIC TYPES OF LEGISLATION • There are four basic types of legislation that are handled by Congress. They include bills, simple resolutions, joint resolutions and concurrent resolutions. Bill • A bill is the most common type of legislation and can be either permanent or temporary. • It may also be general or special in nature; public or private. • Bills can originate in either the Senate or the House of Representatives
  • 4. • General appropriation bills typically originate in the House of Representatives by tradition. • A public bill affects the public in general while a private bill is one that affects a private party or specified individual. Joint Resolutions • A joint resolution may originate in either the Senate or the House of Representatives, even though it is often assumed that this type of legislation originates in both houses. • There is actually not much difference between a joint resolution and a bill, but one difference is that a joint resolution can include a preamble that precedes the resolving clause
  • 5. Concurrent Resolutions • A matter that affects the operations of both chambers of Congress is typically initiated through a concurrent resolution. • They are often used for expressing opinion, principles, facts and purposes of the two houses of Congress. Simple Resolutions • A matter that concerns the rules, opinion or operation of either House alone is begun with a simple resolution. • A simple resolution will be considered only the House in which it is introduced.
  • 6. ACTS • A bill which has passed through the various legislative steps required for it and which has become law. • They are passed by the government, to let people know the rules and regulations about specific situations. • Some of the acts are PNDT act, Organ Transplantation act, Consumer Protection act etc
  • 7. PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC TECHNIQUES ACT, 1994 • Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994 is an Act of the Parliament of India enacted to stop female foeticides and arrest the declining sex ratio in India. • The act banned prenatal sex determination. • An Act to provide for the prohibition of sex selection, before or after conception, and for regulation of prenatal diagnostic techniques for the purposes of detecting genetic abnormalities or metabolic disorders or chromosomal abnormalities or certain congenital malformations or sex-linked disorders and for the prevention of their misuse for sex determination leading to female foeticide; and, for matters connected therewith or incidental thereto.
  • 8. Citation Act No. 57 of 1994 Enacted by Parliament of India Assented to 20 September 1994 Commenced 1 January 1996 Amended by: The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act. 2003
  • 9. The main purpose of enacting the act is to ban the use of sex selection techniques after conception and prevent the misuse of prenatal diagnostic technique for sex selective abortions. Salient features Offences under this act include conducting or helping in the conduct of prenatal diagnostic technique in the unregistered units, sex selection on a man or woman, conducting PND test for any purpose other than the one mentioned in the act, sale, distribution, supply, renting etc. of any ultra sound machine or any other equipment capable of detecting sex of the foetus. Main provisions in the act are:- • The Act provides for the prohibition of sex selection, before or after conception. • It regulates the use of pre-natal diagnostic techniques, like ultrasound and amniocentesis by allowing them their use only to detect :
  • 10. • Genetic abnormalities • Metabolic disorders • Chromosomal abnormalities • Certain congenital Sex linked disorders. Malformations • Haemoglobinopathies
  • 11. • No laboratory or centre or clinic will conduct any test including ultrasonography for the purpose of determining the sex of the foetus. • No person, including the one who is conducting the procedure as per the law, will communicate the sex of the foetus to the pregnant woman or her relatives by words, signs or any other method. • Any person who puts an advertisement for pre-natal and pre- conception sex determination facilities in the form of a notice, circular, label, wrapper or any document, or advertises through interior or other media in electronic or print form or engages in any visible representation made by means of hoarding, wall painting, signal, light, sound, smoke or gas, can be imprisoned for up to three years and fined Rs. 10,000.
  • 12. • no pre-natal diagnostic techniques shall be used or conducted unless the person qualified to do so is satisfied for reasons to be recorded in writing that any of the following conditions are fulfilled, namely: (i) age of the pregnant woman is above thirty-five years; (ii) the pregnant woman has undergone of two or more spontaneous abortions or foetal loss; (iii) the pregnant woman had been exposed to potentially teratogenic agents such as drugs, radiation, infection or chemicals; (iv) the pregnant woman or her spouse has a family history of mental retardation or physical deformities such as, spasticity or any other genetic disease; (v) any other condition as may be specified by the Central Supervisory Board;
  • 13. Compulsory registration • The Act mandates compulsory registration of all diagnostic laboratories, all genetic counselling centres, genetic laboratories, genetic clinics and ultrasound clinics. Amendment in 2003 Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 (PNDT), was amended in 2003 to The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition Of Sex Selection) Act (PCPNDT Act) to improve the regulation of the technology used in sex selection.
  • 14. Implications of the amendment are:- • Amendment of the act mainly covered bringing the technique of pre conception sex selection within the ambit of the act • Bringing ultrasound within its ambit • Empowering the central supervisory board, constitution of state level supervisory board • Provision for more stringent punishments • Empowering appropriate authorities with the power of civil court for search, seizure and sealing the machines and equipments of the violators • Regulating the sale of the ultrasound machines only to registered bodies.
  • 15. OFFENCES AND PENALTIES • No person, organization, Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, including clinic, laboratory or centre having ultrasound machine or imaging machine or scanner or any other technology capable of undertaking determination of sex of foetus or sex selection shall issue, publish, distribute, communicate or cause to be issued, published, distributed or communicated any advertisement, in any form, including internet, regarding facilities of pre-natal determination of sex or sex selection before conception available at such centre, laboratory, clinic or at any other place. • Any person who contravenes shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to ten thousand rupees.
  • 16. MISCELLANEOUS • Maintenance of records. • Power to search and seize records, etc. • Protection of action taken in good faith.- Removal of difficulties • Power to make rules. • Power to make regulations. • Rules and regulations to be laid before Parliament.
  • 17. CONSUMER PROTECTION ACT, 1986 • The Consumer Protection Act, 1986 (COPRA) is an Act of the Parliament of India enacted in 1986 to protect the interests of consumers in India. • It is replaced by the consumer protection act 2019 it is made for the establishment of consumer councils and other authorities for the settlement of consumer's grievances and for matters connected there with it. • The act was passed in Assembly in October 1986 and came into force on December 25, 1986.
  • 18. Citation Act No. 68 of 1986 Enacted by Parliament of India Commenced 24 December 1986 Significance of the statute This statute is regarded as the 'Magna Carta' in the field of consumer protection for checking unfair trade practices, ‘defects in goods’ and ‘deficiencies in services’ as far as India is concerned. Consumer Protection Council Consumer Protection Councils are established at the national, state and district level to increase consumer awareness.
  • 19. Various Consumer Organizations • To increase the awareness of consumers, there are many consumer organizations and NGOs that have been established. • Consumer guidance society of India (cgsi) was the first consumer organization established in India in 1966. It was followed by many others such as 1. Consumer Education and Research Centre (Gujarat) 2. Bureau of Indian Standards 3. Federation of Consumer Organisation In Tamil Nadu 4. Mumbai Grahak Panchayat
  • 20. 5. Consumer Voice (New Delhi) 6. Legal Aid Society (Kolkata) 7. Akhil Bhartiya Grahak Panchayat 8. The Consumers Eye India. 9. United India Consumer's Association Consumer Disputes Redressal Agencies • District Consumer Disputes Redressal Forum (DCDRF): Also known as the "District Forum" established by the State Government in each district of the State. • The State Governments may establish more than one District Forum in a district.
  • 21. • It is a district level court that deals with cases valuing up to ₹2 million (US$28,000). • State Consumer Disputes Redressal Commission (SCDRC): Also known as the "State Commission" established by the State Government in the State. It is a state level court that takes up cases valuing less than ₹10 million (US$140,000) • National Consumer Disputes Redressal Commission (NCDRC): Established by the Central Government. It deals with matters of more than 10 million.
  • 22. OBJECTIVES Objectives of Central Council The objectives of the Central Council is to promote and to protect the rights of the consumers such as:- • The right to be protected against the marketing of goods and services which are hazardous to life and property. • The right to be informed about the quality, quantity, potency, purity, standard and price of goods or services, as the case may be so as to protect the consumer against unfair trade practices; • The right to be assured, wherever possible, access to a variety of goods and services at competitive prices • The right to be heard and to be assured that consumer's interest will receive due consideration at appropriate forums • The right to seek redressal against unfair trade practices or restrictive trade practices or unscrupulous exploitation of consumers • The right to consumer education.
  • 23. Jurisdiction/Three Tier System of Council Courts Jurisdiction of District Forum Subject to the other provisions of this Act, the District Forum shall have jurisdiction to entertain complaints where the value of the goods or services and the compensation, if any, claimed does not exceed rupees twenty lakhs. Jurisdiction of State Commission • Complaints where the value of the goods or services and compensation, if any, claimed exceeds rupees twenty lakhs but does not exceed rupees one crore (R10 million); and • Appeals against the orders of any District Forum within the State; and
  • 24. Jurisdiction of National Commission • Complaints where the value of the goods or services and compensation, if any, claimed exceeds rupees one crore; and • Appeals against the orders of any State mayor; and
  • 25. NATIONAL ORGAN TRANSPLANT ACT OF 1984 • An Act to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto. • The National Organ Transplant Act (1984 Pub.L. 98–507), approved October 19, 1984, and amended in 1988 and 1990
  • 26. HISTORY • Before NOTA was put in place, there was no clear jurisdiction on what property rights were for a human corpse. Instead, America applied a "quasi-right" to a corpse. This meant that the relatives of a deceased person had a possessory right long enough to decide how to bury or dispose of the corpse. This does not mean a property right which means they do not have a right to transfer, devise, possess, and lease the human organs and tissues. • Due to a shortage in organs but a growing demand for transplantations, people began to use other means to purchase organs outside of a hospital setting. The organ market began to become a commercial market. H. Barry Jacobs, the head of a Virginia company, announced in 1983 a new plan to buy and sell human organs on the market.
  • 27. • This plan put healthy, human kidneys in the price range of up to $10,000 plus a $2,000 to $5,000 commission fee for Jacobs. This brought the issue out into the open. NOTA was a response to this proposal making it criminal to transfer human organs for valuable consideration for the purposes of a human transplantation.
  • 28. Title I - Task Force on Organ Procurement and Transplantation • Title I states the Secretary of Health and Human Services will establish a Task Force on Organ Procurement and Transplantation to regulate how deceased donor organs are handled and who receives transplantations and the process one must go through in regards to a deceased donor organ transplantation along with other lines of duty. This Task Force is composed of 25 members. Duties of the Task Force include: • Handling all medical, legal, ethical, economic, and social issues that may rise from obtaining deceased human organs and the transplantation of them. • Assessing immunosuppressive medication used to prevent organ rejection in transplant patients, including safety, effectiveness, costs, insurance reimbursements, and making sure those who need these drugs can receive them
  • 29. • Prepare a report including assessments of public and private efforts to obtain deceased human organs, problems in obtaining these organs, recommendations for education and training of health professionals and for education of the general public • Assessment of the effectiveness and of establishing a national registry of deceased human organ donors
  • 30. Title II - Organ Procurement Activities • Title II established the Organ Procurement Organizations (OPO) for deceased organ transplants. These OPO's are designed to increase the number of registered deceased organ donors and when those donors become available, they coordinate the donation process from donor to patient. • NOTA also established the Organ Procurement and Transplantation Network (OPTN), a membership organization transplant-related individuals and organizations, primarily transplant centers. • The Act also introduced a scientific Federal Registry of all the recipients of organ transplants. This registry includes patient information and transplant procedures.
  • 31. Their duties include: • "facilitating the deceased organ matching and placement process through the use of the computer system and a fully staffed Organ Center operating 24 hours a day" • "developing consensus based policies and procedures for deceased organ recovery, distribution (allocation), and transportation" • "collecting and managing scientific data about organ donation and transplantation" • "providing data to the government, the public, students, researchers, and the Scientific Registry of Transplant Recipients for use in the ongoing quest for improvement in the field of solid organ allocation and transplantation" • "developing and maintaining a secure Web-based computer system, which maintains the nation's deceased organ transplant waiting list and recipient/donor organ characteristics"; and, • "Providing professional and public education about donation and transplantation, the activities of the OPTN and the critical need for donation."
  • 32. Title III - Prohibition of Organ Purchases • NOTA specifically states "it shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce." The penalty of breaking this law is a fine of $50,000 or up to five years in prison, or both.
  • 33. Title IV - Miscellaneous • NOTA created a "national registry of voluntary bone marrow donors." Donors on this list have given informed consent and their names are kept confidential. This registry is upheld by the Secretary of Health and Human Services. Amendments • 1988:- The 1988 Amendment of NOTA introduced the Organ Procurement Organizations and Organ Procurement and Transplantation Network explained in detail in Title II of NOTA. • 1990:-The 1990 Amendment of NOTA introduced the Federal Registry.
  • 34. ETHICS • Some believe that if organ transplantation is a commercial process, incentives for the disfranchised and poor would be created to manipulate them into being more willing to donate. • The issue of putting a purchase price on a body part resembles slavery and treats a class of people as subhuman. These critics believe that this dehumanization is intolerable. Also, the buying and selling of organs for transplantation as a business arrangement would lead to misrepresentation of a person's medical information if the donor was in poor financial shape.