MEDICO LEGAL ISSUES In Infertility & IVF DR. SHARDA JAIN Dr. Jyoti Agarwal Dr. Jyoti Bhaskar HISTORY of IVF THE WORLD FIRST IVF BABY..LOUISE BROWN 25/7/1978 WORLD 2nd but INDIA,s first undocumented IVF BABY..KANUPRIYA [DURGA]…was born 67 days later on 3/10/1978 through effort of DR SUBHAS MUKHERJEE****Mainly went unnoticed BABY HARSHA 6/8/1986 … BOMBAY KEM HOSPITAL + ICMR Effort.

1. DR. SHARDA JAIN
Dr. Jyoti Agarwal
Dr. Jyoti Bhaskar
Senior Consultant Gynaecologists
Infertility and Reproductive Medicine EXPERT
MEDICO LEGAL ISSUES
In Infertility & IVF

2. HISTORY of IVF
THE WORLD FIRST IVF BABY..LOUISE BROWN 25/7/1978
• WORLD 2nd but INDIA,s first undocumented IVF
BABY..KANUPRIYA [DURGA]…was born
67 days later on 3/10/1978 through effort of
DR SUBHAS MUKHERJEE****Mainly went unnoticed
• BABY HARSHA 6/8/1986 …
BOMBAY KEM HOSPITAL + ICMR Effort.

3. MEDICO LEGAL ISSUES
Tailor-made - G.O.I. Guidelines
Assisted reproduction has now touched
the lives of 5.5 million of couples with
I.V.F. Births already and now more and
more INDIAN couples are coming
forward to take the help of various ART
procedures [IUI/IVF]for realizing their
dream of having a child.

4. But inour ART practice we often face situations
whereour clinicalknowledge of Infertilityis not
enough to manage INFERTILITY…IVFCENTRES
The doctor is no more on pedestal any more.
Court cases are on the rise.
Violenceagainst doctors is also seen.
This PPT is an effort bridge this gap.

6. A.R.T.[Regulation]Guidelines…..
2010
In India, until recently there is only
*MOHFW/ICMR guidelines for practice of A.R.T.
A new legislation is about to be implemented for
the ethical practice of A.R.T in India .
*****
GOI, ICMR & National academy medical sciences
(NAMS), appointed 19 members as expert group
committee.
Final Draft is awaiting approval of the parliament.

7. A.R.T. THREE TIER SYSTEM
• The guidelines have elaborated ‘’three-
tier’’ system of infertility management
centres.
• Level 1
• Level 2
• Level 3
• patient can attend the specific level of
infertility care unit…depending on what is
needed

8. Classification of Infertility
Clinics/Expertise/ACCREDITATION
*Level 1 infertility care units– with PG qualification
not doing IUI ..thus NO sperm manipulation for the
purpose of IUI ***NO accreditation under the guidelines.
*Level 2 infertility care units-- involved in IUI & thus sperm
manipulation have postgraduate degree ** need
GOI accreditation.
*Level III—IVF-ICSI
* PGD /PGS …require further permission

9. Physical Requirements
for an ART clinic

10. Guidelines for A.R.T
Physical Requirements for an ART clinic
A well-designed ART clinic of lever II or level III
should have A* nonsterile and B*a strictly sterile
areas .
Some of the spaces could be combined as long as
such a step does not compromise the quality of
service.. The space provision for the sterile area
cannot be combined with those of nonsterile area
and vice versa.

11. The Nonsterile Area
• A reception and waiting
room
• A Consulting room with
privacy
• A general- purpose clinical
laboratory
• Store room
• Record room
• Autoclave room
• Semen collection room
• Andrology room-
• Semen processing
• IUI room

12. The Sterile Area
• The Operation theatre
• The Embryology Laboratory complex- with all
the necessary equipment.
• Room for intrauterine transfer of embryos
Entry to the sterile area must be strictly
controlled by an ante-room for changing
footwear, area for changing into sterile garments
and a scrub station.

13. THE STERILE AREA
*The sterile area must be air-conditioned where fresh
air filtered through an approved and appropriate
filter system is circulated at an ambient temperature
of 20-25 degrees centigrade.
*In the guidelines maintenance of the laboratories,
quality of consumable and media have all been laid
out.
*It is imperative that a 24 hrs. power backup in the
form of UPS system and /or a captive power
generation system is available in
all ART centres.

14. The Personnel's of ART Clinic

15. The Personnel's:
Essential qualifications of ART Team
The staff requirements would be
mandatory for level II and level III clinics.
*GYNAECOLOGIST with postgraduate
diploma or degree in gynaecology.
*ANDROLOGIST

16. The Personnel's:
Essential qualifications of ART Team
CLINICAL EMBRYOLOGIST-he or she must be
either a medical graduate or have postgraduate
degree or a doctorate in an appropriate area of
life sciences.
A person with B Sc or B V Sc with at least 5 years
of hands –on experience of the techniques of ART
is acceptable in case of clinic in existence for at
least 1 year before the promulgation of these
guidelines.

17. The Personnel's:
Essential qualifications of ART Team
*COUNSELLORS: A person with degree in
social sciences, psychology, life sciences or
medicine with good knowledge of all aspects
of INFERTILITY.
**PROGRAM COORDINATOR/DIRECTOR-
should have a postgraduate degree in an
appropriate medical or biological science and
must have reasonable experience in ART.

18. The Personnel: Essential qualifications
of ART Team
In the case of small level II and level III
clinics, the services of Andrologist,
clinical embryologist and counsellors can
be shared.
Strict guidelines have been laid out for
quality control and quality assurance in
ART laboratory with good audit from
third party

19. CODE OF PRACTICE

20. REGARDING CODE OF PRACTICE
• Any information about clients and donors
must be kept CONFIDENTIAL .
• No information about the treatment of
couple provided may be disclosed except
with the consent of the person (S) to whom
the information relates .
• No treatment should be given without the
written consent of the couple .

21. REGARDING THE USE OF GAMETES
AND EMBRYOS
• not more than three embryos con be placed in a
women uterus in any one cycle , regardless of
the procedure /s used , excepting under
exceptional circumstances such as
• Elderly women (>37 years)
• Poor implantation (>3 previous failures)
• Advanced endometriosis or
• poor embryo quality
Which should be recorded .

22. REGARDING THE USE OF GAMETES
AND EMBRYOS
• no woman should be be treated with
gametes or with embryos derived from
the gamets of more than one man or
woman during any one treatment cycle.

23. REGARDING STORAGE AND HANDLING OF
GAMETES/ EMBRYOS
• The “highest possible standard” in
the storage and handling of gametes
and embryos in respect of their
security , and regard to their
recording and identification should
be followed .

24. REGARDING CODE OF PRACTICE
• Specific consent must be obtained from
couple who have their gametes or embryos
frozen in regard to what should be done with
them if he /she dies .
• Couple shoud receive PROPER COUNSELING
about various implications of the treatment
to be given and the cost .

25. REGARDING …. GAMETES/ EMBRYOS
• Research on embryos shall be restricted to the
first 14 days only and shall be conducted only
with the permission of the owner of the
embryos.
• No commercial transaction will be allowed for
the used of embryos for research
• The human fertilization and embryology Act,
UK(1990) allows a 5 years storage period which
India also follows.

26. REGARDING …. GAMETES/ EMBRYOS
• For research purposes, no human
embryo may be placed in a non –human
animal and all research projects must be
approved by the institutional ethics
committee before submission to the
accreditation authority.

27. GAMETE DONORS

28. REGARDING GAMETE DONORS
• Gametes produced by a person under
the age of 21 years shall not be used .
• The accepted age for a SPERM DONOR
shall be between 21 years and 45 years
• For OVUM donor .. woman should be
between 18 years and 35 years.

29. Who Can be Sperm donor ?
Use of sperm donated by a relative or a
known friend of either the wife or
husband shall Not be permitted.
*It will be the responsibility of the ART
clinic to obtain sperms from appropriate
banks.
Neither the clinic nor the couple shall
have the right to known the donor
identity and address.

30. Sperm donor
ART clinic & couple, both shall have the fullest
possible information from the semen bank of the
donor such as height, weight, skin colour, blood
group, education qualification, profession, family
background, freedom from any known diseases or
carrier status, medical or genetic diseases, ethnic
origin, and the DNA fingerprint .
********
The identity of the donor shall not be revealed
.Only adult child has the right to know.

31. SEMEN BANK

32. Requirements for Semen bank
The bank must be run professionally and must
have facilities for cryopreservation of semen,
following internationally accepted protocols &
Guidelines.
The bank will ensure that suitable records of all
donors is kept for 10 years, after which, or if the
bank is wound up during this period, the records
should be transferred to an ICMR repository.

33. Requirements for Semen Bank
Semen samples must be cryopreserved for at
least 6 months before first use, at which time
the semen donor must be tested for HIV and
hepatitis B and C.
A bank may advertise for semen donors who
may be appropriately compensated
financially.
All semen banks will require accreditation.

34. Sperm Donor
• The semen bank shall not supply
semen
of one donor for more than ten
successful pregnancies.

35. Guidelines/Regulations on
Controversial issues in ART

36. •Donor should be healthy women in the age
group of 18-35 years. She should be married
and having at least one child.
•Oocytes can be obtained from willing donor
on ‘’hired’’ basis.
•Following blood tests should be carried out:
Blood group, HIV, hepatitis, Syphilis.
Oocyte Donation or
Embryo Donation

37. Oocyte Sharing
• Oocyte sharing can be
encouraged for economically
poor couple to share with a
wealthy donor for a monetary
compensation that would take
care of expenses of
an ART procedures.

38. AIH or ART in HIV- Positive
Women
This is not permissible in our country as per
the decision of the Supreme Court in thee
case of CVS.
Hospital 2 (1998) and section 269.

39. Embryo Reduction and Sex
Selection
Embryo reduction is allowed in principle and by
law due to benefit to the continuing foetuses
and welfare of the mother but is restricted to
case having more than 2 LIVE FOETUSES
only.
Gender selection is legally banned except for
medical indications, for example, sex-linked
medical disorders.

40. Preservation, Utilization & Destruction
of Embryos
Couples must give specific consent to storage
and use of their embryos by other couples
or for research.
* No commercial transaction will be allowed
for the use of embryos for research.

41. Ethical and Moral Responsibilities
of ART clinics

42. at any age can become pregnant, but are
we justified in offering to an age couple
without realizing the economic, social and
psychological impact on the offspring born
at that advanced age.
MENOPAUSAL WOMEN

43. CLONING
Therapeutic and REPRODUCTIVE CLONING
which is now possible has raised new moral,
ethical, social and legal conflicts.
• How does an ART clinic response as apart of
society to such situations??

44. LEGAL RIGHTS OF
THIRD PARTIES
IN ART
• The moral, and ethical responsibilities and
the legal rights of third parties in ART, such as
donors, oocyte and embryo donors and
surrogate mothers, are already a cause of
concern to our society.

45. ETHICS COMMITTEE
Each ART clinic must have its own ethics
committee as per ICMR guidelines or
should take the help of accreditation
authority in forming an ethics committee
to decide on what is morally and ethically
right.

46. Advertisements
Through hoardings and paper advertisements
shall be Banned.
An honest display at appropriate placates or
publicity of statistics, fee structure, quality of
services provided, should be encouraged.

47. Registration of IVF Centre
No new ART clinic may start operating unless it has
obtained a temporary registration to do so.
• Permanent registration from the Centre or State’s
appropriate accreditation authority within two years of
obtaining the temporary registration.
• The registration must be renewed every seven years.

48. Information and Counselling to be
given to COUPLE in Every IVF
Centre
Basis, limitations and possible
outcome
of the treatment side-effects and
the risks of treatment to the
women and the child.

49. Information and Counselling to be
given to Patients
Techniques involved in ART,
Possible deterioration of gametes or embryos
associated with storage,
And
possible pain /discomfort ,cost right up to the
child born through ART .

50. Code of Practice
Deals with all aspects of the treatment provided and the
research done at registered clinics.
• Staff- Sufficiently qualified, using proper equipment and
keeping & disposing off the genetic material properly.
Failure to comply with the mandatory code of practice
can lead to his/her removal or suspension of the Clinic’s
registration.

51. Code of Practice
• Facilities-Proper systems for monitoring and
assessing practise and procedures are
required to be in place in order to optimize
to outcome of ART.

52. Code of Practice
• Storage and handling of gametes and embryos-The ‘highest
possible standards’ in respect of their security, and their
recording & identification, should be followed.
• Research-Accreditation authority must approve all research
that involves embryos created in vitro. A separate registration
should be issued for each research project. Additionally: No
human embryo may be placed in a non-human animal. All
research projects must be approved by the institutional Ethics
Committee.
• Complaints-All registered ART clinics should have procedures
for acknowledging and investigating complaints, and
nominate a person to deal with such complaints.

53. Possible misuse of ART
Without appropriate national guidelines and
controlling authority, there is a possibility of sale or
transfer or human embryos or any part thereof, or
gametes in any form and in any way.
This should be prohibited and such embryos or
gametes could be available to benefit researchers only
as gift, with all the parties having no commercial
transaction or interest or intent.

54. National Database for ART
There is an urgent need to bring in
with appropriate law in bringing
all the ART providers to document
their work in national database
that would cover all aspects of
infertility.

55. SURROGACY
guidelines 2016
Now under review by standing
committee of Rajya sabha

56. References
• ICMR Guidelines 2010
• Brinsden PR, In Vitro Fertilization and Assisted
Reproduction, 3rd edition,2005.
• BN Chakra arty and Rita Modi, Regulation,
Licencing, and Accreditation of ART laboratories
in India; Practical manual of in Vitro Fertilization;
619-630. Springer, 2013.

57. References
• BN Chakravorty et al. National Guidelines for
Accreditation, Supervision and Regulation of ART
Clinics in India. Indian Council of Medical
Research, National Academy of Medical
Sciences,2005.
• The Assisted Reproductive Technologies
(Regulation) Rules, Ministry of Health and Family
Welfare, Govt of India, Indian Council of Medical
Research, 2010.

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