Case of mix up or switching of gametes, embryos – Glaring Omission under ART Bill, India.

Pub. Info- Case of Mix-up or Switching of Gametes, Embryos – Glaring Omission Under ART Bill, India, Indian Journal of Clinical Practice, monthly journal,  Vol. 27, No. 10, March 2017, Pg No 929 – 932. ISSN 0971-0876 Full text online: http://ebook.ijcpgroup.com/ijcp/

Key words – Biomedical ethical safeguards, IVF mix up, Surrogacy law, regulations India, Switching gametes or embryos.

Abstract –

Infertility has been recognized as an alarming public health issue worldwide with estimated 48.5 million infertile globally and over 20 million infertile couples in India” [1]. In the background of rising infertility couples around the world to resorting to assisted reproductive technologies (ART) including in vitro fertilization, surrogacy to attainment of parenthood ensuring child either genetically related with either or both couples or otherwise, However in many cases there has been gross errors in handling gametes, embryos by clinics or banks, leading to breach of medical ethics, violation of right to privacy, family formation of couples of patients, legal complexities.

The objective of this paper is to identify such grave medical malpractices by the fertility clinics or banks, to emphasize on the unregulated, unmonitored functioning of clinics away in the absence of law, to demonstrate implicit bio medical legal issues through case studies.

As a proposed conclusion to suggest for formulation of progressive, effective bio medical ethical standards to be complied by the clinics, banks for providing better reproductive health care and to suggest inclusion of the same in the proposed law. For the same, there is use of comparative legal perspectives, descriptive or analytical research methods following literature survey, relying on primary and secondary sources of data collection. There is use of comparative legal perspectives, descriptive research methods following literature survey, secondary data sources.

Introduction – Understanding the cases of IVF mix up or switching of gametes or embryos or  misdirection of gametes are identified as “medical errors” which may occur or take place during the course of practice of ART reproductive technology which essentially/ inherently involves handling of human biological materials or gametes or embryos through the retrieval, processing, transfer, and storage of human gametes and embryos , where in these medical errors may include use of wrong sperm for insemination,  or  mistakenly switched gametes or embryos resulting in fertilization, or any other manipulation  during embryo transfer, implantation or use of the gametes or embryos in implantation not those originally intended for use in the patient undergoing treatment, potentially leading to the birth of a child with a different genetic parentage than intended, or an unplanned genetic parentage causing negative consequences  or harm for patients. These medical errors are subsequently discovered through DNA tests during the course of civil, legal formalities when the couple or the patient is seeking to apply for citizenship, passport, or birth registration for the concerned surrogate child.

While the Assisted Reproductive Technologies (ART) Bill 2014[2] is awaiting to be enacted, given effect, there are glairing commissions and unresolved issues under the proposed ART Bill 2014.  A major lacuna under the Bill is the absence of provisions to address cases of mix up or switching of gametes. Though under the relevant provisions of the Bill there is statutory duties imposed on ART Banks “to follow highest possible standards for storage and handling of gametes and human embryos” [3]. But there is no legal recourse or remedial measure under Bill in case of failure to perform such duty by ART Banks. There have been series of such case of mix up or switching of gametes both at nationally, internationally while gametes are stored with the ART Bank for various reasons including deferred use,  these occurrences impair  cardinal human rights established under constitution as well as human rights conventions including right to privacy, family formation , right to procreative or reproductive health there by constituting breach of right to life which are couples and leave the couples legally vulnerable without any legal remedy under such circumstances. Some of these case may be reiterated as below:

  1. Canadian Intending couple mix up of gametes at ART Bank in India, 2005 yr.[4]-

A Toronto based couple commissioned surrogacy in India in 2005 by availing the gestational services of an Indian surrogate mother who was carrying a foetus conceived of eggs from anonymous egg donor  and intending father’s sperm resulting in birth of surrogate twins boy and surrogate girl in March 2006. the couple applied for citizenship to the Canadian High Commission in New Delhi by adducing proof  of genetic connection between the couple and the surrogate child using DNA Test that showed the boy was not genetically related, only girl child was genetically connected , this indicated an error or mix up or switch or swapping of gametes in the Indian fertility lab. The Canadian government permitted citizenship only for the genetically related twins but refused to issue citizenship to the other twin, leaving the couple stranded in India. The couple made an application on humanitarian and compassionate grounds for their non-biological child to be granted citizenship, the Canadian Government issued a citizenship card and travel papers to the other twin only in the year 2012 almost six years after the couple commissioned surrogacy in India.

2.Dr.K.K.Gopinathan vs Anitha Jayadevan [5]- Kerala couple mix up of gametes at Clinic in Kerala, 2012 yr.-

A Kerala based couple named Mr.& Mrs Anita Jayadevan underwent intra cytoplasmic sperm injection (ICSI) treatment using their own gametes, the sperm of her husband, her own ovum respectively. Following a DNA test, it was found that there was no genetic connection with the intending mother and the foetus. The hospital authorities admitted a donor ovum was used for artificial insemination. The couple has filed a law suit in the high court of Kerala against the Hospital authorities for Rs 20, 01,000 as damages. Ms Anitha has written a book titled as “Malicious medicine my experience with fraud and falsehood in infertility clinics” (Malayalam language) on her testimony and recounting similar cases of mix up and switching of gametes by infertility clinics among other misuse and malpractice of technology by clinics.

3. Baby X – New Zealand – mix up, swapping of child post birth, 2015 yr. [6]–

A New Zealand couple, Mr and Mrs Y, commissioned surrogacy in Chiang Mai Thailand using intending father’s sperm, egg donor from a family member and a local Thai woman to act as surrogate mother to carrying the same resulting in birth of baby X in Thailand. The couple applied for issue of travel documents for the surrogate child in compliance with the rules New Zealand Immigration rules a  DNA test, was conducted that showed that the surrogate child had no genetic connection with the father, or the relative who donated the egg or to the surrogate. This indicated embryos were mixed up during IVF or the baby was swapped after birth. New Zealand Family Court Judge held that “Baby X was not the child the concerned intended parents, this is another child altogether.” The couples were directed by the authorities to leave the Baby x surrogate child in a Thai orphanage. The Baby X was born with no genetic records, no identity even termed as “scrap of humanity”, Investigation into the identification of the genetic parents of Baby X, showed nil records with the hospital authorities on the same. However, the couple sought to adopt the baby X following the foreign adoption orders. This case manifest the legal, human crisis underlying such issues, gross violation of right to life of child.

4. A White couple had black twins following mix up of gametes, UK, 2001yr. [7]- UK based the white couple, named Mr and Mrs A , had black twins following a IVF mix-up at the ART Clinic owing to confusion over sperm, eggs or embryos belonging to a black couple with those from a white couple.

Findings & Inferences –

Progressive regulations on handling of gametes, embryos – A comparative foreign legal perspective:

In the light of these cases, it is imperative to consider comparative foreign laws, regulations on the same.

The UK Human fertilisation and embryology authority (HFEA)[8] provides for code of practice for effective monitoring system of to ensure security, storing, handling of gametes and embryos. The UK HEFA Guidance Note issued to all clinics centres with the main purpose to minimise, check use of wrong gametes or IVF mix up cases, wrong infertility treatments. The UK HEFA recommends to the clinics, centres to ensure, maintain highest possible standards including effective monitoring for storage and handling of gametes and embryos. These guidelines are laid down as below [9]:

  • All clinics handling, using of stored or donated gametes or biological materials are to be licensed by the Human Fertilisation & Embryology Authority.
  • Periodic inspection by the Clinical and scientific inspectors of gametes, embryos or biological materials kept at the clinic. The UK HEFA Authority also regularly inspects and monitors the same.
  • Procedures to ´cross-identification´ or double-check the identification of gametes embryos at three crucial stages namely the individuals undergoing treatment, the sperm and eggs at the time of insemination, the embryos and the patient at the time of embryo transfer.
  • Double-check identification of the individuals undergoing treatment, the sperm and eggs at the time of insemination, and the embryos and the patient at the time of embryo transferred. Confirmation by nurse, embryologist and gynaecologist establishing patient’s identity.
  • The source of gametes and embryos should be accurately recorded and labelled in a manner that is not susceptible to unauthorised or undetectable alteration.
  • The location of gametes and embryos in such a manner to minimise unnecessary handlings, interventions in retrieving the same.
  • Labelling with unique identification of an individual’s all biological material including gametes, embryos at all stages of treatment. Writing the names of the patients on both the lid and the bottom of the dish
  • Restricted Permissible access to such gametes, embryos only to such concerned or named Person in the centre, for whom it is essential to their work. No Permission for any other person to access to gametes and embryos.
  • Maintenance of records on the location of gametes and embryos along with each occasion of handling of gametes or embryos, source of gametes and embryos, the various procedures or recourse on embryo, egg or sperm sample collected kept from the date of collection.

The European Society of Human Reproduction and Embryology (ESHRE) – Handling & Identification of patients and their gametes and embryos [10]–

  • Training of all the laboratory staff on handling of gametes, embryos is made mandatory.
  • Development of written procedures describing the various phases or stages of handling of IVF techniques.
  • All biological materials including gametes, embryos obtained from the patients should bear unique identification of the treated couple.
  • Organization of Incubators in such manner to facilitate better identification of gametes and embryos.
  • Double checks of patients and their gametes and embryos must be maintained, recorded at these stages insemination of oocytes, replacement of embryos, embryo freezing and thawing respectively
  • Verification of patient’s identity should be performed at crucial stages steps as ovum retrieval, at semen recovery and embryo transfer procedures.

 

American Society for Reproductive Medicine (ASRM)[11]- Ethical Committee on Disclosure of medical errors involving gametes and embryos:

  • The ASRM imposes stringent ethical obligation on the Clinics to disclose errors at the earliest as soon as discovered without any further delay.
  • To respect patient autonomy and practice fairness in treatment, delivery of services to patients.
  • To uphold and recognise that the patient’s right to know is compelling in case of such misdirection or medical error of mix up or switching of gametes or embryos physicians are obligated to disclose to patients any error as soon as discovered that could lead to a child being born with an unintended paternity or maternity.
  • Clinics are obliged to ensure availability necessary written policies and procedures for making disclosure of errors to patients in such cases without nay exception.

 

 

Preventive safeguards for the couples [12]- to detect genetic connection of the child with the intended parents with the child during pregnancy

Preimplantation Genetics Diagnosis (PGD) – This genetic test intended for identifying genetic defects in embryos, this test carried out before implantation ensures a couple that the embryo shares the genetic match with the intended couples.

Amniocentesis – This is another pre-natal test using amniotic fluid around the foetus for detection of chromosomal and genetic birth defects and identifies genetic match with the intended couples.

Such early identification or determination allows the couples in consultation with clinic to decide on the continuation or termination of pregnancy or foetal reduction or otherwise. Thus safely prevents any further IVF mix up or birth of child with unintended genetic parentage.

Issues for consideration –

These case raise a range of issues as enumerated, first and foremost these cases evince the largescale malpractice, abuse of this technology by ART Clinics, Banks. These clinics, Banks as well as unregulated, unmonitored practice of these clinics, banks which are largely unregistered, lack infrastructure, expertise and function for vested or commercial gains flouting the Indian council of medical research (ICMR) guidelines as these are non-binding. Similar concerns are expressed by the Indian Council of Medical Research (ICMR) which have reported that there are some 1,200 assisted reproductive technology (ART) clinics in India. Only 177 of these, have enrolled with the ICMR. “While some have top-class facilities, others are really bad in terms of infrastructure and technical expertise.” Under these circumstances, with no effective law any accountability, control or check on the functioning of these clinics is challenging.

In addition to this, there are other pertinent concerns associated with the same which are briefly mentioned as follows:

  • There is need for inclusion of biomedical ethical principles, safeguards coupled with protocols, best practices to prevent ensure maximum safety, minimize any tampering , manipulation  and check or control of such acts
  • There must be identification of onus of proof, legal presumption establishing the liability for such acts commission or omissions or any foul play on the part of ART Bank, clinic.
  • Legal recourse or remedial measure may be provided to redress such cases including complaint forum, procedural mechanism for the same.
  • To specifically enlist the acts of mix up switching, swapping of gametes, embryos as punishable act with imprisonment, fine under the list of offences as ART Bill 2014.

 

Conclusion –

These issue gain alarming significance in the absence of a binding legislation in India. These unresolved issues are submitted for consideration of law and policy makers formulating the ART Bill 2014. A list of select provisions taken after the regulations, best practices of international medical regulatory bodies for safe, desirable practice of ART Technology is suggested that may be incorporate under the ART Bill as there is omission to address the same in the face of rising number of such irregularities and legal complexities. There should be inclusion of mandatory principles of bio medical ethics in the Bill seeking compliance from all banks, clinics towards ensuring safe practice of ART technology in the best interest of couples as well as towards greater good of society.

 

References –

1.VIDYA VENKAT , “There are 20 million infertile couples in India” the Hindu, Septmeber28, 2014 , available at http://www.thehindu.com/sunday-anchor/pushpa-m-bhargava-there-are-20-million-infertile-couples-in-india/article6453374.ece   (Last visited March 1,  2016). See also, Ashok Agarwal, et others / al , A unique view on male infertility around the globe, Journal ListReprod Biol Endocrinolv.13; 2015PMC4424520, 2015 Apr 26. US National Library of Medicine National Institutes of Health,   available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4424520/ (Last visited March 1, 2016).

2.Government of India, Ministry o f Health and Family Welfare, ( Department of Health Research) ART Bill 2014 , 30th September 2015, available at http://www.prsindia.org/uploads/media/draft/Draft%20Assisted%20Reproductive%20Technology%20(Regulation)%20Bill,%202014.pdf  (Last visited March 1,  2016).

  1. ART Bill 2014 Sec. 53. (1) The highest possible standards should be followed in the storage and handling of gametes and human embryos in respect of their security, and with regard to their recording and identification.
  2. 4. Raveena Aulakh, Couple fights federal surrogacy policy to bring their boy back to Canada

The satr, ,  Aug 20 2011 available at http://www.thestar.com/news/gta/2011/08/20/couple_fights_federal_surrogacy_policy_to_bring_their_boy_back_to_canada.html

(Last visited March 1, 2016).

5.OP(C).No. 2084 of 2012 (O),

OS.12/2004 of SUB COURT, TIRUR, available at http://indiankanoon.org/doc/57268181/(Last visited March 1,  2016). See also, Tehelka, The invisible baby makers, tehelka

Issue 50 volume 11,  2014- 12 -13,

available at http://www.tehelka.com/2014/12/the-invisible-baby-makers/(Last visited March 1,  2016).

  1. Catherine Woulfe, The untold story of NZ’s surrogate babies, Newzealand Listner

Current Affairs, Science available at http://www.listener.co.nz/current-affairs/the-untold-story-of-nzs-surrogate-babies/ (Last visited March 1, 2016).

See also Paula Penfold, Breakthrough in surrogacy mix-up case, newshub 30 Nov 2015, available at http://www.newshub.co.nz/tvshows/3d/breakthrough-in-surrogacy-mix-up-case-2015113017#ixzz44HpYYOiD (Last visited March 1, 2016).

  1. Steven Morris, Clinics urged to tighten checks after embryo mix-up theguardian, 9 July 2002,

available at http://www.theguardian.com/uk/2002/jul/09/health.healthandwellbeing ART Bill 2014

  1. UK .Gov, Human Fertilization Embryology Authority, available at http://www.hfea.gov.uk/25.html ( Last visited March 1, 2016).
  2. UK .Gov, Human Fertilization Embryology Authority , UK HEFA, Code of Practice , Guidance notes No. 17 , Use of gametes and embryos Storage of gametes and embryos available at http://www.hfea.gov.uk/505.html (Last visited March 1, 2016). See also,

UK .Gov, Human Fertilization Embryology Authority, UK HEFA, Press releases archive 2002, HFEA statement on the systems currently in place to prevent use of the ‘wrong’ infertility treatment, 11 September 2002, available at http://www.hfea.gov.uk/925.html (Last visited March 1,  2016).

10.Luca Gianaroli et al and Committee of the Special Interest Group on Embryology, ESHRE guidelines for good practice in IVF laboratories, Oxford Journals Medicine & Health Human Reproduction Volume 15, Issue , 10Pp. 2241-2246. June 26, 2000, available at http://humrep.oxfordjournals.org/content/15/10/2241.full (Last visited March 1,  2016).

  1. American Society for Reproductive Medicine, American Society for Reproductive Medicine (ASRM) , Disclosure of medical errors involving gametes and embryos: an Ethics Committee opinion, Elsevier Inc., 2015 , https://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf
  2. Katherine, IVF Mistakes: Making Sure the Baby Is Yours

March 26, 2007, FoxNews.com, http://www.foxnews.com/story/2007/03/26/ivf-mistakes-making-sure-baby-is-yours.html

 

 

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