Family balancing, ART Techniques & Sex selective Surrogacy – National international legal perspectives

Pub. Info. –Family Balancing, ART & Sex Selective Surrogacy – National, International, Legal Perspectives,  May 9, 2016 indiamedicaltimes http://www.indiamedicaltimes.com/2016/05/09/opinion-family-balancing-art-sex-selective-surrogacy-national-international-legal-perspectives/

Legalization of ART, Surrogacy in India-

India has no law to regulate Assisted Reproductive technologies including In Vitro Fertilization (IVF), Surrogacy. However the practice of ART gained momentum with the first ever formulation of National Guidelines for Accreditation, Supervision and Regulation of ART Clinics by Indian Council of Medical Research (ICMR) under the aegis of Ministry of Health & family welfare Government of India in the year 2005 providing for conduct of ART including IVF, surrogacy in India [1]. This guidelines  though nor enforceable as law but this guidelines paved way for In vitro fertilization, gestational, commercial surrogacy among other ART techniques. The Supreme Court of India in the landmark case of Baby Manaji Yamanda vs. Union of India [2], formally legalized surrogacy in commercial form in the year 2008 The supreme court directed enactment of a statutory law on the same. This led to formulation draft legislation titled as Assisted Reproductive Technologies (Regulation) Bill 2008 [3]. The ART Bill for the first time defined the ART including IVF, surrogacy among other techniques. This ART Bill is awaiting enactment. This bill is so far revised thrice, in the year 2010 [4] then in the year 2013, [5] subsequently in the year 2014 [6] respectively. Presently, there is ART Bill 2014 awaiting enactment, yet there is no effective, binding statutory law on the same.

Proliferation & medical malpractices by ART or Fertility Clinics –

Taking advantage of such unregulated, unmonitored regime on ART, surrogacy a large number of ART or fertility clinics have come up. A rough estimates states that there are around 3000 IVF clinics in the country but this has not received official approval [7]. There is no official records on the number, sex of the surrogate born annually in India same as evinced through RTI petitions with concerned government bodies, Ministries commissions at national and regional level [8]. There is no mandatory biding on the clinics to declare if a baby is born through surrogacy or not, in their records.[9] This lack of data on in itself is a major void in controlling use of ART techniques for sex selection or sex selective surrogacy.

These ART or infertility clinics are functioning or operating with neither registration, nor licensing of equipment, there is dearth of lacking qualified medical experts along with no regulatory compliances. Most of these clinics are neither registered with the directorate of medical services under the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, neither these follow the ICMR Guidelines nor the draft ART Bill nor the existing PCPNDT Act [10]

In the absence of statutory legislation, these ART or fertility clinics indulge in host of illicit acts or medical malpractices one of such is family balancing sex or selective surrogacy or in other words child of the desired sex using ART techniques or sex selective surrogacy as pre genetic diagnosis (PGD), foetal reduction in the name of family balancing for commercially vested interests [11]. These clinics cause widespread advertisements offering sperm sorting on the internet for the same. In a case before the Manchester, Salford Magistrates’ Court involving an Indian doctor had been issued legal notice for alleged “conspiracy to procure poison for inducing sex selective abortion of the unborn baby  under UK Offences Against the Person Act 1861 [12].

Conceptualization of Family Balancing as sex selection –

Family Balancing is popular and socially conducive terminology for gender selection done for the purposes of achieving a more balanced representation of both genders in a family [13]. In another words family balancing involves conduct of sex selection or detection tests accordingly sex selective abortion which may also include aborting female fetuses, embryos for nonmedical reasons at the instance of couple as a facet of personal procreative choice of couples with regard to family formation [14]. The UK government regulatory authority on ART namely the Human Fertilization and Embryology Authority (HFEA), 2002, surrogacy uses the term, “family balancers” to refer to “such couples who already have children predominantly of one sex and would like a child of the other sex to complement their existing family” [15].

These issues of family balancing hold particular significance in India considering gender imbalance, skewed sex ratio, as a result of alarmingly high rate or incidence of female foeticide [16], the female foeticide has caused  demographic crisis in few states namely Punjab, Haryana, Himachal Pradesh, Gujarat and Maharashtra others[17].

Sex Selection via ART –

The Assisted reproductive technology provides for sex selection at two strategic stages firstly before the implantation of embryo through sperm sorting and after implantation through PGD. Clinics conduct sperm sorting to select sperm based on the whether they carry male or female chromosomes and use the one carrying the preferential chromosomes. Secondly, after implantation PGD is used with IVF to identify medical defects, disease including detection of genetic, sex-linked disorders  by screening for carriers of X-linked, Y linked  genetic diseases [18], for instance namely Duchenne muscular dystrophy, Hemophilia, is a X linked genetic disease indicating the female sex child where as Y linked genetic disease includes  infertility, reproductive disability indicating male child accordingly the sex of the foetus is detected and  sex selective surrogacy may be facilitated.

Many demographers, social workers, NGO in their research reports have clearly indicated the role of ART in sex selection, National Institute of Public Cooperation and Child Development, in a Socio-cultural Study stated  that  Assisted Reproductive  Technologies (ARTs)  permits the choice to intending couples to “choose” the sex of a child at the time of conception through in vitro fertilization (IVF) [19]. This is supported by UN Women, UNFPA in their report titled ‘Implementation of the PCPNDT Act in India: Perspectives and Challenges’ April 2010, this report identifies three new medically advanced techniques namely vitro fertilization (IVF), Ericsson‘s technique of semen separation, pre-implantation genetic diagnosis (PIGD) as contemporary trend of easy, effective means of sex determination and selection used by gynecologist [20].

National Laws Ban on Sex selection –PCPNDT Act, ART Bill

The Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) (PC & PNDT Act) 1994 amended as the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act 2003 [21] includes within itself the emerging pre conception sex selection techniques used by infertility clinics under its regulatory purview. PC & PNDT Act gives state’s health department the power to conduct inspections of fertility and assisted reproductive technology centers and close them down in case of absence of registration certificates. In consonance with these,  in Voluntary Health Association of Punjab Vs. Union of India & Others [22] , the supreme court has brought all the infertility clinics under the ambit of PCPNDT and the court directed the infertility Clinics, using  pre-conception   and   pre-natal diagnostic techniques to maintain all  records  and exhibit the same to the concerned  District Authorities.  Similarly, the ART Bill carries forward the mandate of PCPNDT Act.

 

ART Bill 2014 provisions –

The ART Bill 2014 provides for prohibition of advertisement relating to pre-natal determination of sex and punishment for contravention [23 ] Section 63 (1) ART Bill 2014  and the Bill provides for punishment for conducting pre-natal

diagnostic techniques in consonance with the Pre-natal Diagnostic Techniques

(Regulation and Prevention of Misuse) Act, [24] but untill the Bill becomes the statutory law these provision remains only in paper.

 

Gaps in ART Bill & Scope for Sex Selection, Family balancing –

The ART Bill is riddled with inadequacies gaps. The ART Bill provides for conduct of Pre Implantation Genetic Diagnosis (PGD) [25] along with foetal reduction to reduce the number of fetuses in the case of multiple pregnancies after counseling with the clients or the couples [26]. These provisions may be misused for abortion of the female foetus after screening, detection through PGD for female sex of the child. Another issue which faces omission in the ART Bill is the specification regarding any limitation on the number of times a couple may use this technology to have a child, coupled with this there is no background assessment of couple and their family the number and sex of their existing children as done in the case of adoption, in the absence of these clear specification couples may seek sex selective surrogacy on the ground of family balancing.

National Cases on family balancing, ART techniques, surrogacy:

There has been a host of cases at national level on the issue of sex selection, surrogacy under  the garb of family balancing. Some of these may be reiterated here,

In Malpani Infertility Clinic Pvt vs Appropriate Authority, PNDT Act[27], the Mumbai HC reinforced the direction issued by the supreme court [ direction] in the PIL Public Interest Petition bearing Writ Petition (Civil) No. 301 of 2001 prohibited, penalized seeking strict implementation of the PCPNDT Act against a leading infertility clinic of Mumbai for  cancellation and suspension of registration of the infertility clinic for five years in  public interest, for carrying prohibited activity of “sex determination test” under the guise of “family balancing. The court rejected the permissibility of family balancing and emphasized on strict implementation of the PCPNDT Act for promote greater social interest.

Amy Antoinette Mcgregor &Anr Vs Directorate of Family Welfare [28] wherein an Australian couple sought  direction from the Delhi High court to issue them a no-objection certificate for commissioning sex selective surrogacy for reasons of family balancing using the pre-natal diagnostic techniques to “balance their family”. The court rejected the same. The Delhi High Court held that “the rules of the Pre-Conception and Pre-Natal Diagnostic Techniques Act (Prohibition of Sex Selection) (PCPNDT) Act, 1994, strictly prohibits child sex determination, this law equally applies to both Indian and foreign nationals seeking to conceive a child in the country in order prevent misuse of pre-natal diagnosis for sex determination. The Delhi HC held that any relaxation would be detrimental of the government’s endeavor and would reverse the trend of the declining female child sex ratio.

In Varsha Laxman Deshpande vs The Municipal Commissioner[29]wherein a women right NGO based in Mumbai filed a complaint at the magistrate court against a popular hindi film actor for conducting sex selection test using the genetic testing techniques (PGD) on the surrogate foetus to ensure birth of male surrogate child thus violation of the PCPNDT Act, pursuant to this Mumbai HC issued a legal notice against the actor for the same and the court directed the civic body for necessary investigation in the same.

International cases on family balancing ART Techniques, Surrogacy –

It is important to consider the comparative foreign legal, judicial developments on family balancing using ART techniques, surrogacy. The UK Human Fertilization and Embryology (HEFA) Act states that sex selection for all nonmedical reasons is illegal [30].  In Masterton case [31] an intending couple who had already four sons and sought to use PGD to have sex selection for family balancing reason in order to have a daughter for fulfilling a complete family this was refused by UK HFEA. Another UK case, Olsson v. Sweden [32] held sex selection for medical reasons is legal , permissible but sex selection for non-medical reasons is contentious and disproportionate and banned or prohibited.

In Canada under the Canada Assisted Human Reproduction Act, use of PGD for sex selection for the purpose of detection of particular gender is both prohibited and punishable as a criminal act with a penalty of imprisonment up to ten years in jail and fine amounting to $500,000 [33].

Few of the European nations namely, Spain under Human assisted reproduction techniques Act [34] prohibit sex selection for non-medical or family balancing reasons and permits sex selection only for medical reasons. In a Spanish case,  ‘Sentencia de Mataró’ case [35], the intending mother who had  already existing sons sought to commission sex selective surrogacy using the ART Techniques including PGD  or such others to choose the sex of the baby but the court denied the same and the court held sex selection is only allowed for medical  reasons.

Contest & Counterbalancing of Personal Rights Vs Public interest , policy –

The practice, permissibility of family balancing under ART technology has brought forth issues of legitimacy, restraint or regulation of reproductive or procreative choices, reproductive autonomy of couples. The concerned stakeholders including couples espouse for family balancing as a facet of right to privacy, choice of family formation emanating from basic human right to privacy, procreation or family formation as enshrined under the international human right conventions namely Universal declaration of human rights (UDHR) [36], International convention on civil political rights (ICCPR)[37], European convention on  human rights (ECHR)[38], International Conference on Population and Development ICPD[39].

But this is pitted against larger public interest which entails preservation, balance in sex ratio and right to life among other legal issues. The right to reproductive freedom is not an absolute right including decision making related to pre decide, pre determine the sex of the unborn child [40]. This right is subject to competing larger public or social interest, public policy promoting or protecting sex ratio or gender balance, ensuring gender balance or sex ratio and controlling female feticide [41] protection and preservation of right to life. Thus restrictions on the reproductive freedom may be justified.

There are significant judicial pronouncements on these contesting issues of imposing restriction on reproductive freedom of couples, these are briefly reiterated here, in a leading European case, S.H. And Others v Austria [42], the European Court of human right (ECHR) held that the right of a couple to make use of medically assisted procreation for the purpose of procreation, family formation is not an absolute right but rather subject to intervention by public authority for reasons related to  national security, public safety for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.

On similar lines, The California Court opined that “the biological parents have no such authority to take decision on the sex of the child and that the parents should put the child’s best interest ahead of their own fears and concerns” [43].  Thus it the court takes away from the parents right to pre determine or alter sex of the unborn child for non-medical reasons.

 

Ending notes –

In the light of these misuse and unethical practice of this technology, it is suggested that the early enactment of ART Bill is the need of hour to control and curb these practices. With the Bill coming into effect, the government appointed regulatory authorities will conduct the necessary supervision monitoring on the conduct of the clinic. The ART Clinics must be directed to maintain records on the number, sex of the surrogate child must be appropriately maintained and periodically furnished to the concerned authorities. Though a progressive initiative of ART registry is initiated by the Indian Council of Medical Research (ICMR) in the year 2013 which has set up the National Registry of ART Clinics and Banks in India (NRACBI) in India for creating an central database on the number of ART clinics in the country [44].

Keeping in mind, the Indian position on sex ratio, menace of female foeticide, it may be rightfully said that  sex selection through any other nomenclature means or techniques must be strictly, prohibited penalized as there ought to be counter balancing of the individual rights towards larger social, legal objectives, social welfare. The relevant provisions of the ART Bill on sex selection in consonance with the provisions of PC PNDT Act must be mandatorily or strictly enforced to eliminate any scope for family balancing or any other form of sex selection in disguise.

References –

[1] ICMR National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India, 2005, available at http://icmr.nic.in/art/art_clinics.htm (Last visited May 2, 2016).

[2] (2008) 13 S.C.C. 518.

[3] Indian Council of Medical Research. The Assisted Reproductive Technology (Regulation) Bill– 2008(Draft) Ministry of Health and Family Welfare, Government of India, available at http://icmr.nic.in/art/Draft%20ART%20(Regulation)%20Bill%20&%20Rules%20-%202008-1.PDF(Last visited May 2, 2016).

[4] The Assisted Reproductive Technologies (Regulation) Bill – 2010 (Draft), Ministry of Health & Family Welfare Govt. Of India, New Delhi & Indian Council of Medical Research New Delhi, available at

 http://icmr.nic.in/guide/ART%20REGULATION%20Draft%20Bill1.pdf (Last visited May 2, 2016).

[5] Assisted Reproductive Technology (Regulations) Bill 2013, (Tentative Draft) Date Jun. 27, 2013, Legislative Department, Ministry of Law & Justice, Government of India  For supporting documents, see also, Kounteya Sinha, Bill Aims To Weed Out Rent-A-Womb Clinics, TNN, Jul. 13, 2012, available at http://timesofindia.indiatimes.com/india/Bill-aims-to-weed-out-rent-a-womb-clinics/articleshow/14858687.cms?referral=PM (Last visited May 2, 2016).

[6] 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 May 2, 2016).

[7] Nita BhallaMansi Thapliyal, Inside a ‘baby-making factory’: How the rent-a-womb industry became India’s latest booming industry,dailymail.co.uk, 30 September 2013,
available at http://www.dailymail.co.uk/news/article-2439297/How-IVF-treatment-Indias-latest-booming-industry.html/(Last visited May 2, 2016).

[8] “No Record of Surrogate Mother and Child at Regional and National Levels”  by Sonali Kusum,  Mainstream, Vol LII, No 15, April 5, 2014 , available at http://www.mainstreamweekly.net/article4838.html (Last visited May 2, 2016).

[9]Gayatri Jayaraman , Suhani Singh and Sonali Acharjee , The New Baby Bloom India today, July 12, 2013

available at http://indiatoday.intoday.in/story/surrogacy-abram-shah-rukh-khan-gauri-khan-surrogate-child/1/291019.html/(Last visited May 2, 2016).

[10] Express News Service  IVF centres get three months to register, indian express,  Mumbai, May 8, 2014, available at http://indianexpress.com/article/cities/mumbai/ivf-centres-get-three-months-to-register/ (Last visited May 2, 2016).

[11] Malpani, Modi D, Preimplantation sex selection for family balancing in India, Hum Reprod. 2002 Jan;17(1):11-2, PMID: 11756354  available at http://www.ncbi.nlm.nih.gov/pubmed/11756354 (Last visited May 2, 2016).

[12] John Bingham, Doctor to appear in court in UK’s first gender abortion prosecution ,telegraph.co.uk

09 Nov 2014, available at http://www.telegraph.co.uk/news/uknews/law-and-order/11217504/Doctor-to-appear-in-court-in-UKs-first-gender-abortion-prosecution.html (Last visited May 2, 2016).

[13] Dr. Harvey Stern , Family Balancing & gender Selection , Genetics & IVF Institute, available at www.givf.com/familybalancing/

(Last visited May 2, 2016).

[14] Claude Sureau, Gender selection: a crime against humanity or the exercise of a fundamental right? Oxford Journals Medicine & Health, Human Reproduction, Volume 14, Issue 4Pp. 867-868, available at http://humrep.oxfordjournals.org/content/14/4/867.full(Last visited Feb. 15, 2015).

[15] UK Human Fertilization and Embryology Act 2008, (c 22), available at http://www.legislation.gov.uk/ukpga/2008/22/introduction/ (Last visited May 2, 2016),  see also ,

Stephen Wilkinson,  Sexism, sex selection and ‘family balancing’,, UK.,Medical Law Review (Impact Factor: 0.73). 07/2008; 16(3):369-89. DOI: 10.1093/medlaw/fwn013 available at http://www.researchgate.net/publication/51403261_Sexism_sex_selection_and_’family_balancing (Last visited May 2, 2016).

[16] Palash Ghosh ,Selective Abortion Of Female Fetuses In India Creating Gender Imbalance Crisis, IBT US, 09/19/12 available at http://www.ibtimes.com/selective-abortion-female-fetuses-india-creating-gender-imbalance-crisis-793298 (Last visited May 2, 2016).

[17]Indiaonlinepages, India Guide Population of India Sex Ratio in India 2016, Sex Ratio in India, available at http://www.indiaonlinepages.com/population/sex-ratio-of-india.html (Last visited May 2, 2016).

[18] Caroline Mackie Ogilvie and Paul N. Scriven ,Preimplantation Genetic Diagnosis for Sex-linked Diseases and Sex-Selection for Non-Medical Reasons , available at http://www.pgd.org.uk/resources/tests/pgd-sexing.pdf(Last visited May 2, 2016).

[19] National Institute of Public Cooperation and Child Development, A Socio-cultural Study of the Declining Sex Ratio in Delhi and Haryana,  New Delhi,2008, available at http://nipccd.nic.in/reports/esratio.pdf(Last visited May 2, 2016). see also , UN Women, UNFPA , Sex Ratios and  Gender Biased Sex Selection History, Debates and Future Directions 2014 UN Women available at http://asiapacific.unfpa.org/webdav/site/asiapacific/shared/Publications/2014/Sex-Ratios-and-Gender-Biased-Sex-Selection.pdf (Last visited May 2, 2016).

[20] Public Health Foundation , IMPLEMENTATION OF THE PCPNDT ACT IN INDIA – Perspectives and Challenges- April 2010,  available at http://countryoffice.unfpa.org/india/drive/IMPLEMENTATIONOFTHEPCPNDTACTININDIAPerspectivesandChallenges.pdf (Last visited May 2, 2016).

[21] THE PRE-NATAL DIAGNOSTIC TECHNIQUES (PROHIBITION OF SEX-SECTION) ACT, 1994, ACT NO. 57 OF 1994, 20th September, 1994,section 2 (o) available at http://www.rajswasthya.nic.in/PCPNDT%2005.12.08/PCPNDT%20Act%20(2).pdf(Last visited May 2, 2016).

[22] Writ Petition (Civil) No. 349 Of 2006.

[23] Section 63 (1) ART Bill 2014.

[24] Section 65 ART Bill 2014.

[25]Section 50(1) ART Bill 2014.

[26]Section 49 (5) ART Bill 2014.

[27] AIR 2005 Bom 26, 2005 (1) BomCR 595, (2005) 107 BOMLR 737, 2004 (4) MhLj 1058.

[28] W.P.(C)6332/2013.

[29] W.P.4164.2013.

[30] UK Human Fertilization and Embryology Act 2008, (c 22), available at http://www.legislation.gov.uk/ukpga/2008/22/introduction/(Last visited May 2, 2016).

[31]Wilkinson, S, ‘Sexism, Sex Selection and “Family Balancing”’, 2008, Medical Law Review, Vol.16,

Issue.3, page 371. available at https://pol285.blog.gustavus.edu/files/2009/08/Wilkinson-Sexism-Sex-Selection-and-Family-Balancing.pdf(Last visited May 2, 2016).

[32]App no 10465/83, A/130, [1988] ECHR 2, (1989) 11 EHRR 259, IHRL 75 (ECHR 1988).

[33] Government of Canada , Ministry of Law & justice, Canada, Assisted Human Reproduction Act,  § 5, 60, S.C. 2004, c. 2 , Assented  on 2004-03-29 , available at http://laws-lois.justice.gc.ca/eng/acts/A-13.4/page-1.html, (Last visited May 2, 2016).

[34] INMACULADA DE MELO-MARTI´N, Assisted Reproductive Technology in Spain:Considering Women’s Interests, Cambridge Quarterly of Healthcare Ethics,  (2009), 228–235. available at

http://www.academia.edu/3993851/Assisted_reproductive_technology_in_Spain_considering_womens_interests(Last visited May 2, 2016).

[35] Tribunal constitucional de Espana , SENTENCIA SOBRE PARTICIPACIONES PREFERENTES. 5 DE FEBRERO DE 2012, MATARÓ,  SENTENCIA 236/1992, de 14 de diciembre de 1992, available at http://vabogados.com/wp-content/uploads/2015/04/Resumen-Sentencia-Matar%C3%B3-doc_14HY.pdf (Last visited May 2, 2016).

[36] UN General Assembly, Universal Declaration of Human Rights, 10 December 1948, 217 A (III), available at http://www.refworld.org/docid/3ae6b3712c.html (Last visited May 2, 2016).

[37] UN General Assembly, International Covenant on Civil and Political Rights, 16 December 1966, United Nations, Treaty Series, vol. 999, p. 171, available at: http://www.refworld.org/docid/3ae6b3aa0.html (Last visited May 2, 2016).

[38]Council of Europe, European Convention for the Protection of Human Rights and Fundamental Freedoms, as amended by Protocols Nos. 11 and 14, 4 November 1950, ETS 5, available at: http://www.refworld.org/docid/3ae6b3b04.html(Last visited May 2, 2016).

[39] International Conference on Population and Development, Cairo, 5-13 September 1994 , United Nations Distr. General A/CONF.171/13, 18 October 1994, available at http://www.un.org/popin/icpd/conference/offeng/poa.html(Last visited May 2, 2016).

[40] American Society for Reproductive Medicine, SEX SELECTION OR GENDER SELECTION AND PREIMPLANTATION GENETIC DIAGNOSIS: Fertility and Sterility, The Official Journal of the American Society of Reproductive Medicine , Volume 82, Issue (Supplement 1), Pages 245-248 (September 2004) available at http://www.academia.edu/14399711/Choosing_Genes_for_Future_Children_Chapter_5_-_Law_and_Regulation (Last visited May 2, 2016).

[41] Katherinei Seligman Chasing Chromosomes: Selecting for Sex
San Francisco Chronicle Sunday Magazine
July 23rd, 2006, available at  http://www.geneticsandsociety.org/article.php?id=1907(Last visited May 2, 2016).

[42] Application no. 57813/00, (ECtHR, 3 November 2011).

[43] Intersex society of North America, Colombia’s Highest Court Restricts Surgery on Intersex Children, SU-337/99, 12 May 1999 and T-551/99, 2 August 1999, available at  http://www.isna.org/colombia/(Last visited May 2, 2016).

[44] Ramesh Shankar, ICMR gets good response for its National Registry of ART clinics pharmabiz.com, June 19, 2012 available at http://pharmabiz.com/NewsDetails.aspx?aid=69639&sid=1(Last visited May 2, 2016).

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