AI, surrogacy, assisted reproductive techniques - medico legal and ethical issues, and related Bills and Acts.

1. Reproductive medicine-
medico legal importance
DR M BALAJI SINGH
COURTESY : SLIDE SHARE, DR SUNIL DUCHANIA , DR GAUTHAM BISWAS

2. Topics covered….
 Methods of assisted reproduction
 Artificial insemination
 surrogacy
 ICSI
 Medico legal importance

3. Assisted reproductive technology (ART
)
 Definition: Any fertility treatment in which the gametes (sperms and eggs) are
manipulated outside of the body. The gametes or embryos are replaced back into the
body to establish pregnancy.
 Surgical removal of eggs is known as egg retrieval.
 In vitro fertilization is the most common ART procedure.

4. Various Methods of assisted reproduction
 Artificial insemination ( A I )
 Conventional in- vitro fertilization and embryo transfer (IVF-ET,
TEST TUBE BABES)
 Surrogate motherhood, Embryo donation ( surrogacy)
 Gamete intra fallopian tube transfer (G I F T )
 Zygote intra fallopian tube transfer( Z I F T )
 Intracytoplasmic sperm injection ( I C S I )
 Micromanipulation techniques include zona drilling and partial zona
drilling. (Assisted insemination by drilling of zona pellucida of ovum is
one of the microsurgical techniques widely used to facilitate sperm
penetration )

5. Types of Micro manipulation techniques
ZD – zona drilling
Z P – zona pellucida
ZD – zona drilling

7. I V F and
Embryo Transfer

8. IVF &
E T

9. I C S I
ovum

10.  Gamete intra fallopian transfer (GIFT): fallopian tube is a paradise of the
gametes.
GIFT is similar to IVF. It is used when a woman has at least one normal fallopian tube. Egg is
placed in this tube along with sperm to fertilize there.
GIFT

11.  Zygote intra fallopian transfer (ZIFT): ZIFT is tubal embryo transfer in
which a woman’s egg is taken from her ovaries, fertilized in the laboratory,
and put back in the fallopian tubes rather than the uterus
ZIFT

12.  Assisted fertilization techniques when not enough sperm are
available or sperm quality is not sufficient to fertilize include the
 Partial zona dissection ( P Z D )
 Sub zonal sperm injection ( SUZI )
 Intracytoplasmic sperm injection ( I C S I )
 Embryo cryopreservation and E T. (frozen fertilized egg )

13. I C S I
 Stands for intracytoplasmic sperm injection. This process is used
to inject a single sperm cell into each egg in the well organized micro
environment , before the fertilized eggs are put back into the woman's
body. The procedure may be used if the male has a low sperm count.
ovum
Holding
pipette
Sperm
injection

14. intercourse

15. Artificial insemination (AI )
Mechanical placement of semen containing viable spermatozoa into the
female reproductive tract.

16. AI technique

17. AI - Three Types based on semen collection
 Artificial insemination homologous (AIH)
The insertion of sperm from the husband into the uterus by means other than by intercourse. –
done in case of cervical barriers like anti sperm antibodies or thick mucus plug in the cervix
 Artificial insemination donor (AID)
Artificial insemination of a woman with sperm from an anonymous donor. The procedure
is generally done in cases in which the husband is sterile.
 Artificial insemination homologous and donor (AIHD)
Artificial insemination of a woman with pooled sperm from an anonymous donor and her
husband . The procedure is generally done in cases in which the husband is suffering with
oligospermia or any sperm insufficiency.

18. indications
 AIH- male factors
1. Impotency
2. Quality of the sperm is not up to the mark, or
oligozoospermia
3. gross physical anomaly of penis
4. posthumous period ( after death of the husband)

19. Indications……female factors
 PID - sterility ( pelvic inflammatory disease ).
 wife is isoimmune to husband’s sperm, anti sperm anti bodies in cervical mucus plug
("isoimmune," also "alloimmune," refers to the development of antibodies in an
individual against antigens from another individual in the same species ). Isoimmune
infertility can be caused also by sperm antibodies, which are able to stop in vitro and in
vivo sperm progressive penetration needed for fertility.
 HIV or Hepatitis B infection,
 lesbian couples,

20. Precautions for AI
 Consent of semen donor and his wife,
 Consent of the recipient and her spouse
 Donor Couple should be psychologically fit and emotionally stable.
 At most confidentiality about donor
 Proper records should be maintained, necessary details can be given to the couple to
avoid marriage between children born to the same donor ( to avoid incest)
 Birth certificate should contain couples name only, should not mention the donors
name.

22. Medico-legal Aspects
i. Danger of litigation: The doctor may be sued following the birth of a
defective child. To avoid this, the donor must be screened for any genetic
defects.
ii. Nullity of marriage and divorce: It is not a ground for divorce, if AI is
done for sterility. If AI is due to impotence, it is a ground. If AID is done without
the consent of the husband, then he can file for divorce and sue the doctor
(regarded as an act of cruelty for the purpose of divorce).
iii. Legitimacy: The artificiality of the process would make no difference in
legitimacy in case of AIH, and the child would be legitimate child. Since, the
husband is not the actual father of the child in AID, child is illegitimate and
cannot inherit property, but for all practical purpose, the husband is accepted as
father of the child and treated as legitimate and can inherit property.

23. iv. Adultery: Recipient cannot be held guilty of adultery because there is no
physical union by coitus. Moreover, the Indian law specifically provides that the woman
cannot be punished for adultery in any case.
v. Incest: Risk of incestuous relationship between the offspring born by AID and
children of same donor is possible
vi. Natural birth: Status remains legitimate, but that of AID remains illegitimate.
vii. Unmarried women or widow: There is no legal bar on an unmarried woman /
widow going for AID.
A child born to a single woman through AID would be deemed to be legitimate.
However, AID should be performed only on a married woman with the written consent of
of her husband. A child born through AIH with the stored sperms of her deceased husband is
considered to be legitimate, despite the existing law of presumptions under the Indian
Evidence Act

24. viii. Psychosocial aspect: If it is known that the husband
consented to AID and the husband was not capable of
consummating the marriage, difficulties may arise. The identity of
donor is kept secret; nevertheless, it is not uncommon for such
secrets to be leaked out with adverse consequences.
The artificial insemination with donor’s semen has not been
in India, and should only be undertaken at infertility centers after
appropriate counseling and explanation of its implications to both
partners.

25. MLI of AI
 Adultery
 Legitimacy
 Paternity ,motherhood, parentage
 Affiliation case
 Question of citizen ship , nationality,, and rights of the child.
 baby with congenital abnormalities
 Inheritance of property
 Breech of confidentiality
 Children born to the same donor – possibility of incest

26. Ethical issues
 Bypassing the natural method of conception.
 Fertilization of more embryos than will be needed – multiple pregnancy
 Unnatural environment for embryos.
 Not affordable for many – not a cost effective procedure
 Exposure of gametes and embryos to unnatural chemical substances.
 Potential to create embryos for medical purposes.
 Potential to modify embryos.
 Financial rewards for IVF doctors dissuade them from recommending other methods to couples.
 Infertility is treated as a disease and not as a symptom of underlying medical problems.
 Chances of more commercialization of human reproduction.

27. Medico legal importance of ART
 Adultery
 Legitimacy , Inheritance of property
 Paternity
 Affiliation case
 Question of citizen ship
 baby with congenital abnormalities
 Breech of confidentiality
 Children born to the same donor – possibility of incest
 Multiple pregnancy
 Pregnancy related complications, compensations
 unmarried woman opting for A I D

28.  Passed to regulate of donation, sales and supply of human semen and
ovum
 Main provisions
 All semen banks in Delhi would have to be duly registered.
 Renewal of registration every year.
 Certification by DHS ,Govt. of NCT Delhi.
 Running without registration –fine of 5000 and for subsequent offences
fine of 5000 or 3 months imprisonment

30. precautions
(Duties of qualified medical practitioner (s.14) )
 Keep complete record of bio data of donor and recipient couple
 Informed and Written consent
 No segregation of XX and XY chromosomes – no sex selection of baby
 Maintain secrecy about the identity of donor and recipient – complete
confidentiality.
 Test for HIV 1,2 and any other blood born diseases , inheritable diseases
Before donation

31. surrogacy

32.  “surrogacy" means a practice whereby one woman bears and
gives birth to a child for an intending couple with the intention of
handing over such child to the intending couple after the birth.
 “surrogacy clinic" means surrogacy clinic or centre or
laboratory, conducting assisted reproductive technology services,
invitro fertilisation services, genetic counselling centre, genetic
laboratory, Assisted Reproductive Technology Banks conducting
surrogacy procedure or any clinical establishment, by whatsoever
name called conducting surrogacy procedures in any form.

33. Types of Surrogacy on the Nature of Process
1.Traditional or Partial Surrogacy
2.Gestational Surrogacy or Total Surrogacy
And basing on money paid to surrogate mother
1. Altruistic or Emotional Surrogacy
2. commercial surrogacy

34. Traditional or Partial Surrogacy
In the traditional case, the surrogate mother will be artificially inseminated
with the sperm of the intended father or the sperm from a donor when the sperm
count is low.
Here the mother would be genetically related with the baby because in either
case the surrogate’s own egg will be used.
Due to this reason the two parties’ i.e. infertile couple and surrogate mother enter into a
contract where surrogate mother is artificially inseminated with the sperm of male partner of
that couple..
◦

35. Gestational Surrogacy or Total
Surrogacy
 Surrogate mother merely allows her womb to be used for carrying further the
reproductive process.
 Eggs are extracted from the intended mother or egg donor and mixed with
sperm from the intended father or sperm donor in vitro.
 In case of total surrogacy an embryo created by the process of In-Vitro
fertilitsation is implanted into the surrogate’s uterus.
 Mother is not genetically related to the child.
 The gestational surrogacy comes under the ambit of assisted reproductive
technologies. Gestational surrogacy can be described as “Womb leasing
Process”.

36. Altruistic or Emotional Surrogacy
surrogate mother does not receive any financial reward
for the pregnancy or for baring discomfort and pain related to the delivery or
for the handing over of the child to the commissioning parents.
all expenses such as reimbursement of medical and other expenses related
to the pregnancy and birth would be paid to surrogate mother by intended
parents.
no fees, remuneration or monetary incentive of whatever nature, except the medical
expenses incurred on surrogate mother and the insurance coverage for the surrogate mother,
are given to the surrogate mother or her dependents or her representative.

37. commercial surrogacy
It means commercialization of surrogacy services
or its component services
or selling or buying of human embryo
or purchase of human embryo or gametes
or selling or buying or trading the services of surrogate motherhood
by way of giving payment, reward, benefit, fees, remuneration or
monetary incentive in cash or kind, to the surrogate mother or her
dependents or her representative,
except the medical expenses incurred on the surrogate mother and the
insurance coverage for the surrogate mother;

38. Bills and Acts on surrogacy in India
 In 2013, surrogacy by foreign homosexual couples and single parents was
banned.
 In 2015, the government banned commercial surrogacy in India and permitted
entry of embryos only for research purposes.[
 In 2016, a Surrogacy (Regulation) Bill was introduced and passed by Lok Sabha, proposing to permit
only heterosexual Indian couples married for at least five years with infertility problems to access
altruistic surrogacy.
 The 2016 bill lapsed owing to the adjournment sine die of the parliament session. The bill was
reintroduced and passed by the Lok Sabha in 2019.
 The bill would require to be passed by the Rajya Sabha, upper house of the Indian parliament and
presidential assent before it becomes an act and thereby a law.
-Wikipedia

39. Bills and Acts on surrogacy in India
 Before commercial surrogacy was banned in 2015, India was a
popular destination for surrogacy.
 The economic scale of surrogacy in India is in July 2012
estimated the business at more than $400 million a year, with
over 3,000 fertility clinics across India.
-Wikipedia

40. Indian Council for Medical Research guidelines on surrogacy
The following observations had been made by the Law Commission:
Surrogacy arrangement will continue to be governed by contract amongst parties, which will
all the
terms requiring consent of surrogate mother to bear child, agreement
agreement of her husband and other family members for the same,
medical procedures of artificial insemination, reimbursement of all reasonable expenses for carrying child to
full term, willingness to hand over the child born to the commissioning parent(s), etc.
But such an arrangement should not be for commercial purposes.
Should provide financial support for surrogate child in the event of death
death of the commissioning couple before delivery of the child, or divorce
between the intended parents and subsequent willingness of none to take
of the child.

41. Surrogate mother can be known, unknown or a relative of the couple. In the
case of a relative, she should belong to the same generation ( age) as the
woman desiring the surrogate.
„ proper indication Surrogacy should normally be
considered only for parents for whom it would be physically or medically
impossible or undesirable to carry a baby to term.
„ The genetic (biological) parents must adopt a child born through
surrogacy.
„ The payment provided to the surrogate mother must include all
expenses related to the pregnancy which must be documented through an
agreement between the two.
„ The ART clinic cannot advertise to find a surrogate mother or be a party
to any commercial dealing in gestational surrogacy. The responsibility of
finding a surrogate mother rests completely with the intending couple.

42. The surrogate mother should be < 45 years of age.
It is the responsibility of the ART clinic management to ensure that the
candidate chosen for surrogacy passes all treatable criteria to
ensure full-term pregnancy.
„ Any surrogate mother should Not more than thrice in a lifetime.
„ Since there are no laws to protect the couples seeking surrogacy,
the ART clinic is responsible for guiding the couples through the processes
of egg and embryo donation, and surrogacy.

43. ICMR guidelines………
A surrogacy contract should necessarily take care of life insurance cover for surrogate mother.
One of the intended parents should be a donor - bond of love and affection with a child primarily
improves biological relationship and minimize child-abuse.
in case the intended parent is single, he or she should be a donor to be able to have a
child.
Otherwise, adoption is the way to have a child which is resorted to if biological (natural) parents and
adoptive parents are different.
surrogate child to be the legitimate child of the commissioning parent(s) without there being any
need for adoption or even declaration of guardian.
The birth certificate should contain the name(s) of the commissioning parent(s) only.
Right to privacy of donor as well as surrogate mother should be protected.
Sex-selective surrogacy should be prohibited.
Cases of abortion should be governed by the Medical Termination of Pregnancy Act 1971 only.

44. THE SURROGACY (REGULATION) BILL, 2020
ARRANGEMENT OF CLAUSES

45. SURROGACY BILL 2020……….
It allows any “willing” woman to be a surrogate mother and proposes
that widows and divorced women can also benefit from its provisions,
besides infertile Indian couples.
The bill proposes - establishing National Surrogacy Board and, State
Surrogacy Boards .
The proposed insurance cover for surrogate mother has now been
increased to 36 months from 16 months provided in the earlier version.
Ethical surrogacy will be allowed on fulfilment of certain
lndian married couples, Indian-origin married couples and Indian single
woman (only widow or divorcee between the age of 35 and 45 years).

46. Conflicting Interest and Rights of
Parties of Surrogacy
◦ Interests and Rights of Surrogate Child
◦ Interests and Rights of Surrogate Mother
◦ Interests and Rights of Commissioning Parents

47. surrogacy
 Surrogacy in India and Indian surrogates became increasingly
popular amongst intended parents in industrialized nations
because of the relatively low costs and easy access offered by
Indian surrogacy agencies.
 Before commercial surrogacy was banned in 2015, India
was a popular destination for surrogacy.
 The economic scale of surrogacy in India is unknown, but
study backed by the United Nations in July 2012 estimated the
business at more than $400 million a year, with over 3,000
fertility clinics across India.

48. Features of the Surrogacy Bill, 2016
1. Surrogacy will not be allowed for –
◦ Homosexual couples
◦ Single parent
◦ Couples in live-in relationships( not married legally)
◦ Foreigners
◦ Couples with children
◦ Attempts at commercial surrogacy

49. Features of the Surrogacy Bill, 2016……
2. Couple must be married for at least 5 years.
3. Either one of couple must have proven infertility.
4. Only Indian citizens are eligible; NRIs are not included.
5. Age of couple: 23-50 for females and 26-55 for males.
6. Women can be surrogates only once and a married couple can only have
one surrogate child.
7. The couple should employ an “altruistic relative”, i.e. the surrogate mother
should be a relative who is sympathetic to the situation.
8. Egg donation is banned for any commercial surrogacy

50. Surrogacy (Regulation) bill 2020:

51. surrogacy

52. Surrogacy Bill
 The Surrogacy Bill was introduced by Union health minister Harsh
Vardhan.
 The Surrogacy (Regulation) Bill, 2019, was passed by the Lok Sabha on
August 5, 2019.
 The Rajya Sabha, in its meeting held on November 21, 2019, adopted a
motion to refer the bill to a Select Committee.
 The Cabinet incorporated all the recommendations of the Rajya Sabha
Select Committee before approving the Bill on 26 February 2020.

53. The Surrogacy (Regulation) Bill, 2020 aims at
 banning commercial surrogacy and allowing altruistic surrogacy.
 Prohibiting the sale and purchase of human embryos and gametes
 Allows ethical surrogacy to Indian married couples and Indian single woman.
 Bill allows a willing woman and not exactly the close
relatives of the intended couple to be a surrogate mother; this
includes even widows and divorced women besides infertile Indian couples.
 age of 23-50 years for females and 26-55 years for males.
 Bill- recommended removing the definition of “infertility” as ‘the inability to conceive
after five years of unprotected intercourse’ as it is a very long period for any couple to
wish for a child of their own.
 The bill has also increased the insurance cover for a surrogate mother from 16
months to 36 months.

54.  The surrogacy bill makes it mandatory
 for the couple - certificate of essentiality as well as a certificate of
eligibility for process of surrogacy.
 Intending couples should not abandon the child.
 It advocates for all rights and privileges to the newborn that is available to
a natural child.
 The bill also specifically restricts sex determination -by surrogacy.

55.  The bill demands the constitution of surrogacy boards at the national as
well as state levels to ensure effective regulation.
 It stresses on the regulation of the functioning of surrogacy clinics which
includes the registration of clinics by the appropriate authority.
 There are multiple reasons which include hundreds of heart-wrenching stories
of exploitation and malpractices carried out in the industry, which led to the
development of the Surrogacy (Regulation) 2020 Bill.
 presence of unregistered third party agents behind the scene whose actions
were under no regulatory surveillance, made the situation even worse.

56. Thanking you………and time to
relax