Tag Archives: ART

Three Parent IVF / Three Parent Baby

three parents baby

Britain on 3 Feb 2014 became the first country in the world to allow ‘Three Parent – In Vitro Fertilisation (TP-IVF)’ or ‘Three Parent Babies’. This technique will help couples with mitochondrial diseases, an incurable conditions passed down the maternal line that affect around one in 6,500 children worldwide. But critics say the technique will lead to the creation of genetically modified ‘designer babies’.

The treatment is known as TP-IVF because the babies, born from genetically modified embryos, would have DNA from a mother, a father and from a female donor. Under current UK law, genetically altered embryos cannot be implanted into a woman. But in this case fertility clinics will be given license for TP-IVF.

What is the benefit of TP-IVF?

A small number of children each year are born with faults in their mitochondrial DNA which can cause diseases. Mitochondria are small structures present inside cells and provide energy. They have their own set of 37 genes which are separate from the 25,000 genes present in nucleus and does not affect human characteristics such as hair or eye colour, appearance or personality traits.

How do the faulty mitochondria affect people?

The parts of the body that need most energy are worst affected: the brain, muscles, heart and liver. Faulty mitochondria have also been linked to more common medical problems, including Parkinson’s, deafness, failing eyesight, epilepsy and diabetes. There are no cures for mitochondrial disorders.

How are mitochondrial disorders passed on?

Only mothers pass mitochandria on to their children. Because egg cells contribute nucleus as well as rest other cellular component including mitochondria whereas sperms contribute only nucleus during fertilization process.

How TP-IVF could prevent the mitochondrial diseases?

Scientists have developed two techniques to stop mitochondrial diseases being passed from mother to child.

The first is called mitochondrial spindle transfer (MST). In this, doctors use standard IVF procedures to collect eggs from the mother. They take the nucleus from one of the eggs and drop it into a healthy donor egg that has had its own nucleus removed. The reconstituted egg contains all the normal genes from the mother, but her faulty mitochondria are replaced by those from the healthy donor. The egg is then fertilised with the father’s sperm. The resulting embryo has the usual 23 pairs of chromosomes that hold the mother and father’s DNA, but the 37 mitochondrial genes, about 0.2% of the total, come from a third person, the donor.

TP-IVF

The second procedure is called pronuclear transfer. It is similar to MST, but both the mother’s and donor’s eggs are fertilised first with the father’s sperm. Before the eggs divide into early stage embryos, the parents’ chromosomes are removed from the mother’s fertilised egg and placed into the donor egg, which has had its own chromosomes removed.

Is mitochondrial transfer safe and effective?

Both procedures have been tested in animals and resulted in healthy offspring. Good results have also been seen in human cells, but treated embryos have not been implanted into a woman to achieve a pregnancy. A review of work on mitochondrial transfer by independent scientific panel concluded there was no evidence the procedures were unsafe.

What objections do people have to the TP-IVF procedure?

Mitochondrial transfer passes on genetic changes from one generation to another. That raises ethical concerns because any unexpected problems caused by the procedure could affect people who are not yet born. Mitochondria are not completely understood, and the DNA they hold might affect people’s traits in unknown ways. The Catholic church opposes because a fertilised egg from the mother is destroyed in pronuclear transfer process and mitochondrial transfer dilutes parenthood.

Is ‘three-parent’ babies a good description of children born to the procedure?

Three-parent baby is misnomer. Women who donate their mitochondria would remain anonymous and have no legal rights over the child. On a genetic level the donor only contributes mDNA, less than 0.2% of the total genetic material.

Will this change in law allow ‘designer’ babies?

Designer baby is a concept of modifying human characteristics such as eye, skin and hair colour and other defining traits by altering nuclear DNA or gene. The procedure of TP-IVF does not change this nuclear DNA. The ban on altering nuclear DNA remains in place.

Ending Discrimination in Surrogacy laws

surrogacy

Recent meetings on March 6 and 7 of departments and ministries of the Government of India, to discuss and review divergent views on the draft Assisted Reproductive Technology (Regulation) Bill, 2013 (ART Bill), have resulted in a proposal to revise the Bill with significant changes. The most crucial proposal is to restrict surrogacy in India to “infertile Indian married couples” only. Non-resident Indians (NRIs), Persons of Indian Origin (PIOs) and Overseas Citizens of India (OCIs) would be eligible but foreigners, unless they’re married to Indian citizens, will not. The purpose of this is to prevent exploitation of Indian women who may be tempted to take the risk of surrogacy in the face of financial hardships.

Existing Policy

The Indian Council of Medical Research (ICMR), working under the Ministry of Health and Family Welfare (MoHFW) finalised the National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India in 2005 after extensive public debate across the country involving all stake holders. Under these guidelines, there was no legal bar for the use of Assisted Reproductive Technology (ART) by a single or an unmarried woman, and the child born would have legal rights on the woman or man concerned.

Thereafter, the draft ART Bills of 2008, 2010 and 2013, stated to be revised based on the recommendations of the Ministry of Law and Justice, have consistently proposed that ART in India would be available to all persons including single persons and foreign couples. The draft Bill 2013, an exhaustive document containing 100 sections addressing various issues relating to ART, is stated to now be ‘Top Secret,’ being a part of the Cabinet note as per the requirement and procedure of the handbook of the Cabinet Secretariat on Cabinet writing notes. The draft Bills and Rules of 2008 and 2010 were extensively circulated for public opinion, besides being sent to State governments, institutions, statutory bodies, NGOs, medical professionals and other stakeholders, but the 2013 Bill was not circulated or placed in the public domain.

The Supreme Court judgment in Baby Manji Yamada vs Union Of India case in 2008 took due notice that in cases of “commercial surrogacy,” an intended parent may be a single male. The Court had the occasion to consider the petition of a Japanese grandmother wanting issuance of a travel document for her Japanese divorced son’s daughter.

In another matter decided by the Gujarat High Court in Jan Balaz vs. Union of India, 2009, the decision of the High Court holding — that babies born in India to gestational surrogates are Indian citizens and are entitled to Indian passports — has been stayed by the Supreme Court. However, the twin German children in the case were permitted to leave India upon the directions of the apex Court. The main issue of nationality and citizenship, being of grave importance, is still undecided.

The Ministry of Home Affairs (MHA), according to the guidelines of July 9, 2012, restricted surrogacy to foreign nationals; i.e. a man and a woman married for at least two years would be required to take a medical visa for surrogacy in India. As of now, even though surrogacy is an administrative concern and in the domain of the MoHFW, it has been decided that till the enactment of a law on the ART Bill, 2013, the guidelines issued by the MHA will prevail till then. Hence, foreign single parent surrogacy is barren.

Restricting surrogacy to infertile Indian married couples only, and debarring all foreigners other than OCIs, PIOs and NRI married couples, is a turnaround in the thought process. The suggestion barring foreigners from commissioning surrogacy in India is stated to be subject to there being no conflict with other Indian laws applicable to foreigners, such as those for adoption. The most important contradiction and inconsistency seems to be that arising from the Guidelines Governing the Adoption of Children, 2011, for inter-country adoptions, which now have statutory sanction by virtue of them having being enacted under the Juvenile Justice (Care and Protection of Children) Act, 2000. The Juvenile Justice Act clearly provides that a court may allow a child to be given in adoption to an individual, irrespective of his or her marital status.

Moreover, the Guardian and Wards Act, 1890 and The Hindu Minority and Guardianship Act, 1956 permit a guardian to be declared or appointed where the Court is satisfied that it is for the welfare of a minor. Barring single parents to adopt is not statutory but can be a restraint in a particular case upon examination by a competent court. Therefore, debarring single persons and foreign nationals from being parents will amount to rewriting laws in existence which have been enacted by Parliament.

Recent Decisions

The Supreme Court in Stephanie Joan Becker vs State in 2013 permitted a single 53-year-old lady to adopt a female orphan child aged 10 by relaxing the rigour of the guidelines of the Central Adoption Resource Authority (CARA). It said the proposed adoption would be beneficial to the child as experts were of the view that the adoption process would end in successful blending of the child in the U.S. Likewise, in Shabnam Hashmi vs. Union of India, 2014, the Court upheld the recognition of the right to adopt and to be adopted as a fundamental right. It held that every person, irrespective of the religion he/she professes, is entitled to adopt. The latest verdict of the Supreme Court recognising transgenders as the third gender says “discrimination on the basis of sexual orientation or gender identity includes any discrimination, exclusion, restriction or preference, which has the effect of nullifying or transposing equality by the law or the equal protection of laws guaranteed under our Constitution.” Clearly, legal recognition means that they would be entitled to rights of adoption, succession, inheritance and other privileges under law.

The sum and substance is not to shut the door to surrogacy which is an accepted societal practice in India and grown slowly over almost two decades. Medical technology, advancement of science permitting free export of frozen embryos and other scientific methods have offered hopes to childless people. The more pragmatic approach would be to make a law hedged with safeguards, checks and balances. The appropriate and desirable method would be to create a mechanism to judge the suitability of proposed surrogate parents rather than to debar all single and foreign persons. This would also avoid any conflict with existing laws of adoption wherein foreign persons including single parents are allowed to adopt through a strict and rigorous mechanism provided by CARA.

Simply trying to shut out surrogacy for foreign nationals and single persons may not be the ideal way to stamp out the hopes of persons wishing to be a parent. Whether Indians or foreign nationals, law treats persons as individual parents when required. A restrictive meaning to the word “person” cannot qualify or change the definition by restricting it to an Indian national. The celebrated view of the apex court in widening the horizons to prevent discrimination on grounds of sex or gender identity is a new thought process based on international covenants of human rights. We cannot permit our thinking to be retrograde simply because of the problems accompanying surrogacy. Administrators cannot usurp law making functions to be a law unto themselves.

Published in The Hindu, May 3, 2014; by Anil Malhotra

No visa for PIOs coming for Surrogacy

kids

Union Home Ministry issued an order on 6 March 2014 saying that an Overseas Citizens of India (OCIs) and Persons of Indian Origin (PIOs) can visit India without a medical visa for commissioning surrogacy. This facility will be applicable for those couples who are married for at least two years and will only require permission only from the Foreigners’ Regional Registration Office (FRRO) or the Foreigners’ Registration Office (FRO).

They must, however, carry a letter from their country, issued by the Foreign Ministry or the Embassy here, saying it recognised surrogacy and that the child born thus would be permitted entry as the couple’s biological offspring.

The couple should furnish an undertaking that they would take care of the child. Treatment should be done only at registered assisted reproductive technology clinics recognised by the Indian Council of Medical Research. The couple will have to produce a notarised agreement between them and the prospective surrogate mother.

Before granting the child exit, the FRRO/FRO will confirm that the couple had taken the required permission and certificates for commissioning surrogacy, and liabilities due to the surrogate mother have been settled. The office will retain a copy of the birth certificate.

The wife of a foreign national or an OCI/PIO cardholder who is not involved in the treatment may not require a specific medical visa.

OCI & PIO Cardholders

The OCI card is issued to foreign nationals who were eligible to become citizens of India on January 26, 1950, or were Indian citizens on or after that date with eligibility based on lineage. The PIO card is issued to a person of Indian origin who is a citizen of any country other than Pakistan, Bangladesh, Sri Lanka, Bhutan, Afghanistan, China or Nepal or who has held an Indian passport at any time or is the spouse of an Indian citizen or a Person of Indian Origin.

[Credit – The Hindu]