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ART BILL 2013 and Dos and Donts for Surrogacy/ Third Party ART in India

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  • 1. Indian Philosophy
  • 2. Why we want children? • Different culture, societies and religions answers this question differently based on their belief and practises. • Ancient Indians had explained the instinct of motherhood very well long before the down of the western civilization. • According to ancient Indian philosophy the biological purpose of life is to propagate once own traits (genes) and all living creatures are here on a transition phase to pass their own traits (genes) to the next generation.
  • 3. Nature has given a provision to all creatures to ensure the immortality of its species through a process called “reproduction” Sex ImportantReproductive Tactic Continuity of Life Indian Vedic Literature Artha (Money)Dharma (Duty) Moksa (Salvation)Kama (Sex) For a good happy life
  • 4. Reproductive Health and Infertility
  • 5. Estimated Magnitude of Infertility in India India‟s projected population (2009) 1166 Million Male 604 Million Female 562 Million Married Female (15-49 yrs) 216 Million (38.5%) Age Group Rural Urban Total 15-49 3.38 Million 4.82 Million 8.2 Million Prevalence of Infertility (3.8%) Source – Registrar General of India, 2005 Sample Registration System, 2009 ICMR Study, 2011
  • 6. 1 Austria 8.4 2 United Arab Emirates 7.9 3 Switzerland 7.8 4 Israel 7.8 5 Hong Kong, SAR 7.1 6 Libya 6.4 7 Denmark 5.6 8 Finland 5.4 9 Singapore 5.2 10 Norway 4.9 11 New Zealand 4.4 Source – Population Reference Bureau, 2011 Countries with around 8.2 Million Population Figure in Millions
  • 7. Assisted Reproductive Technologies (ART) New hopes to infertile couples
  • 8. New Scientific Development Raises several issues • Ethical issues • Technical issues • Moral issues • Social issues
  • 9. National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India 2005 Edited by Dr R S Sharma Dr P M Bhargava Dr Nomita Chandiok Shri N C Saxena http://www.icmr.nic.in/art/art_clinics.htm
  • 10. Drafting Committee Dr. Pushpa M Bhargava, Hyderabad - Chairman Dr. Rajeev Dhavan , Sr. Advocate Supreme Court of India, New Delhi Dr. Kamini Rao, Bangalore Dr. Jayant G. Mehta, Chennai/Bangalore Dr. Manish Banker, Ahmedabad Dr. Gautam Allahabadia, Mumabi Sh. Bhairav Acharya, Ms. Aparna Ray Advocate Supreme Court of India, New Delhi Dr. M. S. Jayalakshmi, MOHFW, Govt of India, New Delhi Dr. Keerti Malaviya, MOHFW, Govt. of India, New Delhi Mr. J.K. Trikha, MOHFW, Govt of India, New Delhi Dr. R. S. Sharma, ICMR, New Delhi – Member Secretary National Advisory Committee on Assisted Reproduction
  • 11. I ART (Regulation) Bill – 2013
  • 12. The Assisted Reproductive Technology (Regulation) Bill - 2013 Describes procedures for: • Accreditation and supervision of Assisted Reproductive Technology Clinics & Banks, • ensuring that services provided by the Assisted Reproductive Technology Clinics and Banks are ethical and • that the medical, social and legal rights of all those concerned are protected with maximum benefit to the infertile couples or individuals within a recognized framework of ethics and good medical practice.
  • 13. Authorities to Regulate ART Clinics and Banks Registration Authority State Board (within 6 months) National Board DHR, MOHFW (within 3 months) Advisory Committee National Registry of ART Clinics and Banks in India (ICMR) Established (within 3 months)
  • 14. All ART Clinics a. Involve in infertility treatment – including IUI, AIH, AID b. Infertility treatment involving the use and creation of embryos outside the human body c. Processing or storage of gametes and embryos d. Research on embryos. CHAPTER – III PROCEDURES FOR REGISTRATION AND COMPLAINTS
  • 15. Steps for Registration under National Registry of Assisted Reproductive Technology (ART) Clinics and Banks in India • Confirmation of contact No. and details of ART Clinics/Banks. • Obtaining the information regarding available infrastructure facilities, trained manpower and different ART procedure being followed at your ART Clinic/Bank through prescribed Performa. • Verification of the information provided by the respective ART Clinic/Bank through a sight visit to be conducted by the competent experts in the field at the respective ART Clinic/Bank. • On receipt of satisfactory report of the Site Visit Committee, the Unique Registration Number will be issued.
  • 16. Application for Registration under State Board (i) Unique Registration Number Certificate from the National Registry of Assisted Reproductive Technology (ART) Clinics and Banks in India of the ICMR. (ii) Bio-data of all the faculty members of the clinic or bank including Director or in-charge of the clinic or bank. (iii) Copies of the degrees and certificates of all the faculty members of the clinic or bank including Director or in-chare of the clinic or bank. (iv) Such other information and documents as may be prescribed.
  • 17. Dr. R. S. Sharma, FNAMS Sr. Deputy Director General, Scientist-G & Member Secretary, Drafting Committee, ART (Regulation) Bill Indian Council of Medical Research, Ansari Nagar, New Delhi -110 029 (India) Third Party Reproduction: Do‟s and Don'ts
  • 18. Surrogacy
  • 19. Lord Balrama Lord Krishna Mrs. Deviki & Mr. Vasudeva Mrs. Rohini Embryo transfer to Hindu Mythology “Mahabharatha”
  • 20. Indications for surrogacy Surrogacy by ART should be considered only for patients for whom it would be physically or medically impossible/undesirable to carry a baby to term.
  • 21. Notifications from Govt. of India Ministry of Home Affairs (Foreigners Division) The appropriate visa category will be a medical visa for foreign nationals who are coming to India for commissioning surrogacy. Such a visa may only be granted if the following conditions are fulfilled: I. The foreign man and woman are duly married and the marriage should have sustained at least for two years. (I) No.25022/74/2011-F.I dated 9th July, 2012 (II) No.25022/74/2011-F.I dated 7th March, 2013 (III) No.25022/74/2011-F.I dated 16th July, 2013 (IV) No.25022/74/2011-F.I dated 14th October, 2013
  • 22. II. A letter from the Embassy of the foreign country in India or the Foreign Ministry of the Country should be enclosed with the Visa application stating clearly that a) the country recognizes surrogacy and b) the child/children to be born to the commissioning couple through the Indian surrogate mother will be permitted entry into their country as a biological child/children of the couple commissioning surrogacy. iii. The couple will furnish an undertaking that they would take care of the child/children born through surrogacy. iv. The treatment should be done only at one of the registered ART Clinics recognized by ICMR. v. The couple should produce a duly notarized agreement between the applicant couple and the prospective Indian surrogate mother.
  • 23. Other Conditions • Before the grant of visa, the foreign couple need to be told that before leaving India for their return journey, „exit‟ permission from FRRO/FRO would be required. • Before granting „exit‟, the FRRO/FRO will see whether the foreign couple is carrying a certificate from the ART Clinic concerned regarding the fact that the child/children have been duly taken custody by the foreigner and that the liabilities towards the Indian surrogate mother have been fully discharged as per the agreement. • A copy of the birth certificate(s) of the surrogate child/children will be retained by the FRRO/FRO along with photocopies of the passport and visa of the foreign parents. • The foreign couple can be permitted to visit Indian on a Tourist Visa for signing agreement between the applicant couple and the prospective Indian Surrogate mother.
  • 24. Notification from Govt. of India Ministry of Commerce and Industry, Deptt. of Commerce No.52 (RE-2013)/2009-2014 dated 2nd Dec., 2013 Policy for import of human embryos Human embryo is classified under ITC (HS) Code 0511 99 99 of Chapter 5 of ITC (HS) 2012, Schedule 1 (Import Policy). Import of Human Embryo will be „free‟ subject to a „No Objection Certificate‟ from Indian Council of Medical Research (ICMR).
  • 25. No Objection Certificate (NOC) from ICMR 1. Request for NOC should be submitted only by the Director/In- Charge of the ART Clinic on the Letter Head whose name has been registered with National Registry of ART Clinics and Banks in India of ICMR as Director/In-Charge of the ART Clinic. 2. Also mention the Enrolment Number of the Clinic issued by the National Registry of ART Clinics and Banks in India of ICMR, in the application for NOC. 3. All the certificates / agreements should be in compliance with the notification F.No. 25022/74/2011-F.I dated 9th July 2012 issued by the Ministry of Home Affair in this matter.
  • 26. The following certificates and documents should be submitted to the National Registry of ART Clinics and Banks in India (NRACBI) of ICMR. Certificates I. A certificate from the authorized/registered Foreign ART Clinic. II. Certificate from the infertile foreign couple. III. A certificate from the enrolled ART Clinic in India. Documents I. Authorized identification proof of both husband and wife. II. Marriage certificate of the infertile couple. III. Copy of the registration certificate of the ART Clinic from foreign Country where the treatment of the infertile couple is undergoing. If the embryos have been generated at some other ART clinic, then please provide the copy of registration certificate of that clinic also.
  • 27. 60. Rights and duties in relation to surrogacy 60.(1) Both the couple or individual seeking surrogacy through the use of assisted reproductive technology, and the surrogate, shall enter into a surrogacy agreement which shall be binding on the parties. (2) All expenses, including those related to insurance if available, of the surrogate related to a pregnancy achieved in furtherance of assisted reproductive technology shall, during the period of pregnancy and after delivery as per medical advice, and till the child is ready to be delivered as per medical advice, to the biological parent or parents, shall be borne by the couple or individual seeking surrogacy. (3) Notwithstanding anything contained in sub-section (2) and subject to the surrogacy agreement, the surrogate may also receive monetary compensation from the couple or individual, as the case may be, for agreeing to act as surrogate.
  • 28. (4) A surrogate mother shall relinquish all parental rights over the child. (5) No woman under twenty one years of age and over thirty five years of age shall be eligible to act as a surrogate mother under this Act. Provided that no woman shall act as a surrogate for more than three successful live births in her life including her own children and with not less than two years interval between two deliveries. (6) Any woman seeking or agreeing to act as a surrogate shall be medically tested for such diseases, sexually transmitted or otherwise, as may be prescribed, and all other communicable diseases which may endanger the health of the child or children, and must declare in writing that she has not received a blood transfusion or a blood product in the last six months.
  • 29. (7) The individuals or couples may obtain the service of a surrogate through an assisted reproductive technology bank, which may advertise to seek surrogacy. Provided that no such advertisement shall contain any details relating to the caste, ethnic identity or descent of any of the parties involved in such surrogacy and no assisted reproductive technology clinic shall advertise to seek: surrogacy for its clients. (8) A surrogate shall, in respect of all medical treatments or procedures in relation to the concerned child or children, register at the hospital or such medical facility in her own name, clearly declare herself to be a surrogate and provide the name or names and addresses of the person or persons, as the case may be, for whom she is acting as a surrogate, along with a copy of the agreement referred to in sub-section (1) and the copy of the certificate referred to in sub-section (16).
  • 30. (9) If the first embryo transfer has failed in a surrogate, she may, if she wishes, decide to accept on mutually agreed financial terms, at most two more successful embryo transfers for the same couple that had engaged her services in the first instance and no surrogate shall undergo embryo transfer more than three times for the same couple. (10) The birth certificate issued in respect of a baby born through surrogacy shall bear the name of individual or individuals who commissioned the surrogacy, as parents. (11) The person or persons including foreigners who have availed of the services of a surrogate shall be legally bound to accept the custody of the child or children irrespective of any abnormality that the child or children may have.
  • 31. (12) Subject to the provisions of this Act, all information about the surrogate shall be kept confidential and information about the surrogacy shall not be disclosed to anyone other than the National Registry of Assisted Reproductive Technology Clinics and Banks in India of the Indian Council of Medical Research except by an order of a court of competent jurisdiction. (13) A surrogate shall not act as an oocyte donor for the couple or individual, as the case may be, seeking surrogacy. (14) No assisted reproductive technology clinic and assisted reproductive technology bank shall provide information on or about surrogate or potential surrogate to any person. (15) In the event that the woman intending to be a surrogate is married, the consent of her spouse shall be required before she may act as surrogate.
  • 32. (16) A surrogate shall be given a certificate by the person or persons who have availed of her services, stating unambiguously that she has acted as a surrogate for them. (17)(a) A foreigner or foreign couple not resident in India, or a non-resident Indian individual or couple, seeking surrogacy in India shall – (i) appoint a local guardian who shall be legally responsible for taking care of the surrogate during and after the pregnancy, till the child or children are delivered to the foreigner or foreign couple or the local guardian; (ii) insure the child or children born through the surrogacy, at the time of signing the agreement, till the age of twenty one years or till the time of custody of the child or children is taken, whichever is earlier, for wellbeing and maintenance of the child or children;
  • 33. (iii) use at least one gamete of their own in creation of the embryos; (b) The party seeking the surrogacy must ensure and establish to the assisted reproductive technology clinic through proper documentation (a letter from either the embassy of the Country in India or from the foreign ministry of the Country), stating that the child or children born through surrogacy in India, shall be permitted entry in the Country as a biological child or children of the commissioning couple or individual that the party shall be able to take the child or children born through surrogacy, including where the embryo was a consequence of donation of an oocyte or sperm, outside of India to the country of the party's origin or residence, as the case may be; (c) (i) If the foreign party seeking surrogacy fails to take delivery of the child or children born to the surrogate commissioned by the foreign party, the local guardian shall be legally obliged to take delivery of the child or children and be free to hand the child or children over to an adoption agency, if the commissioned party or their legal representative fails to claim the child within one month of the birth of the child or children:
  • 34. Provided that during the transition period, the local guardian shall be responsible for the well-being of the child or children. (ii) If the child or children are being given adoption to an adoption agency, the child or children shall be allowed to claim the provisions of Indian Citizenship Act, 1955 in respect of matters relating to Indian citizenship. (18) couple or an individual shall not have the service of more than one surrogate at any given time. (19) A couple shall not have simultaneous transfer of embryos in the woman and in a surrogate. (20) Only Indian citizens shall have a right to act as a surrogate, and no assisted reproductive technology bank or assisted reproductive technology clinic shall receive or send an Indian woman for surrogacy abroad.
  • 35. (21) Any woman agreeing to act as a surrogate shall be duty- bound not to engage in any act that may harm the foetus during pregnancy and the child after birth, until the time the child or children is handed over to the designated person(s). (22) The commissioning parent(s) shall ensure that the surrogate and the child or children she deliver are appropriately insured until the time the child or children is handed over to the commissioning parent(s) or any other person as per the agreement and till the surrogate is free of ail health complications arising out of surrogacy.
  • 36. ART Clinic should “DO” & “DON‟TS” 1. Surrogacy by ART should be considered only for patients for whom it would be physically or medically impossible/undesirable to carry a baby to term. 2. Surrogacy shall be available to all Indian persons including single persons and married couples. 3. All provisions of the Surrogacy listed under the ART (Regulation) Bill should be followed. 4. No woman under twenty one years of age and over thirty five years of age shall be eligible to act as a surrogate mother under this Act. 5. Provided that no woman shall act as a surrogate for more than three successful live births in her life including her own children and with not less than two years interval between two deliveries.
  • 37. For Foreign Nationals 1. Surrogacy shall be available to only married foreign nationals whose marriage should have sustained at least for two years. 2. Only those ART Clinics who are enrolled/registered under the National Registry of ART Clinics and Banks in India (NRACBI) of ICMR shall be permitted to provide surrogacy services for foreign married couple. 3. All the provisions of the notification issued by Ministry of Home Affairs should be strictly followed. 4. The foreign married couple shall have to physically come to India for signing Agreement between the surrogate mother and married couple, on Tourist visa, but no samples may be given to any Clinic during such preliminary visit. 5. However, the foreign married couple has to come to India on Medical Visa to take the custody of the child/children born through surrogacy.
  • 38. 6. OCI/PIO Card holders coming to India for commissioning surrogacy will not require a separate medical visa. However, on arrival to India and before commissioning surrogacy they will have to obtain a special permission from the FRRO/FRO concern. 7. The FRRO/FRO concern may grant the permission subject to all the conditions mentioned in the MHA notification dated 9th July, 2012. 8. The ART clinic should send a copy of the agreement to the concerned FRRO/FRO and to the National Registry of ICMR along with photocopies of the passport and the visa of the foreign couple. 9. For import of embryos, the Director/In-Charge of the Enrolled ART Clinic shall apply to the NRACBI of ICMR for NOC along with all mandatory certificates and documents. 10. In such case also, the married foreign couple shall have to come to India signing the Agreement if the embryos are to be transferred into the surrogate womb.
  • 39. Conclusion Indian society considered surrogate mother as an amalgam of religion, culture and science and is a social act of highest level of services which is scientific and brims with goodwill. The proposed draft Assisted Reproductive Technology (Regulation) Bill proposes to ensuring that services provided by them are ethical and that the medical, social and legal rights of all those concerned are protected with maximum benefit to the infertile couples or individuals within a recognized framework of ethics and good medical practice.
  • 40. Thanks

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