U.K. Parliament approves controversial three-parent mitochondrial gene therapy

ScienceMag.org By Gretchen Vogel Erik Stokstad – February 3, 2015

The United Kingdom’s House of Commons voted overwhelmingly today to allow British researchers to pursue a new fertility treatment that could prevent certain kinds of genetic diseases. The technique, called mitochondrial DNA replacement therapy, could allow women who carry disease-causing mutations in their mitochondrial genes to give birth to genetically related children free of mitochondrial disease.

The measure, which passed 382 to 128, has been controversial, especially because it would alter the DNA of an embryo in a way that could be passed on to future generations. Some scientists and nongovernmental organizations have argued that not enough is known about possible side effects of the technique to go forward in human patients. “We believe the House of Commons has made a serious mistake, which we hope does not have dire consequences,” said Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, California, in a statement.

Proponents of the measure quickly began to celebrate. “I am delighted that [members of Parliament] have voted to allow the introduction of mitochondrial transfer techniques into the clinic,” said John Tooke, president of the Academy of Medical Sciences in London, in a statement. Robert Meadowcroft, head of the Muscular Dystrophy Campaign in London, added: “We have finally reached a milestone in giving women an invaluable choice, the choice to become a mother without fear of passing on a lifetime under the shadow of mitochondrial disease to their child.”

Mitochondria are the energy-producing engines of a cell. These organelles contain their own set of genes, called mtDNA. When mitochondria don’t work properly, a variety of symptoms can result, which can make mitochondrial diseases difficult to recognize and diagnose. Some babies born with defective mitochondria die within months. Other people don’t show any symptoms until much later in life.

Researchers have developed ways to transfer the genetic material from an egg cell that carries faulty mitochondria into a donor egg that has healthy mitochondria. The resulting embryo carries nuclear DNA from the mother and father and mitochondrial DNA from the egg donor.

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How mitochondrial donation involved in three parent babies works

TheTelegraph.co.uk – by The Agency, February 3, 2015

MPs will tomorrow decide whether mitochondrial donation allowing IVF babies to be born with DNA from three different people should be made legal.

The technique involves replacing DNA in an egg in order to prevent devastating inherited mitochondrial diseases.

What are mitochondria?

Mitochondria are tiny rod-like structures in cells which act as power houses, generating the energy that allows our bodies to function. Unusually, they have their own DNA, distinct from the genetic material within the cell nucleus. Mitochondrial DNA (mDNA) makes up about 0.1% of a cell’s total DNA and does not affect individual characteristics such as appearance and personality.

What causes mitochondria disease?

Harmful mutations in mitochondrial DNA can prevent the mitochondria working properly, resulting in a number of diseases some of which can be serious and life threatening. They may affect major organs and cause conditions ranging from poor vision to diabetes and muscle wasting.

How are mitochondria diseases passed on?

Children may inherit mitochondrial DNA defects from their mothers, but not their fathers. People with faulty mDNA can develop symptoms or be carriers of the condition without experiencing ill-effects themselves.

What is mitochondria donation?

Defective mDNA from a mother’s egg can be replaced with healthy mDNA from a donor. This will then prevent the harmful mutations being inherited and passed onto future generations.

What are the techniques involved?

There are two different procedures, one carried out before fertilisation and the other after.

Maternal Spindle Transfer (MST) involves first removing the nuclear DNA from a donor egg whose mitochondria are healthy. The “spindle” of chromosomes containing the mother’s nuclear DNA is then taken from her egg and inserted into the donor egg. As a result, the donor egg is left with nuclear DNA from the mother and mDNA from the donor. This healthy egg is then fertilised and implanted into the mother’s womb.

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European Court of Human Rights Decision Re: Italian Couple’s Surrogacy Arrangement

January 27, 2015 – From the Press release of the European Court of Human Rights Re: Paradiso and Campanelli v. Italy

In today’s Chamber judgment1 in the case of Paradiso and Campanelli v. Italy (application no. 25358/12) the European Court of Human Rights held, by a majority, that there had been:

a violation of Article 8 (right to respect for private and family life) of the European Convention on Human Rights.

The case concerned the placement in social-service care of a nine-month-old child who had been born in Russia following a gestational surrogacy contract entered into by a couple; it subsequently transpired that they had no biological relationship with the child.

The Court found in particular that the public-policy considerations underlying Italian authorities’ decisions – finding that the applicants had attempted to circumvent the prohibition in Italy on using surrogacy arrangements and the rules governing international adoption – could not take precedence over the best interests of the child, in spite of the absence of any biological relationship and the short period during which the applicants had cared for him. Reiterating that the removal of a child from the family setting was an extreme measure that could be justified only in the event of immediate danger to that child, the Court considered that, in the present case, the conditions justifying a removal had not been met.

However, the Court’s conclusions were not to be understood as obliging the Italian State to return the child to the applicants, as he had undoubtedly developed emotional ties with the foster family with whom he had been living since 2013.

Principal facts

The applicants, Ms Donatina Paradiso and Mr Giovanni Campanelli, are Italian nationals who were born in 1967 and 1955 respectively and live in Colletorto (Italy). They are husband and wife.

After unsuccessfully attempting to use in vitro fertilisation Ms Paradiso and Mr Campanelli opted for a gestational surrogacy arrangement to become parents. For that purpose they entered into an agreement with the company Rosjurconsulting in Russia. A surrogate mother was found and given in vitro fertilisation and a baby was born on 27 February 2011 in Moscow. In accordance with Russian law, Ms Paradiso and Mr Campanelli were registered as the baby’s parents, without any indication that the child had been born through a surrogacy arrangement.

In April 2011 the Italian Consulate in Moscow delivered documents allowing the child to leave for Italy. A few days after their arrival in Italy, Mr Campanelli unsuccessfully asked the municipal authority of Colletorto to register the birth. The Italian Consulate in Moscow informed the Campobasso Minors Court, the Ministry of Foreign Affairs and the Collerorto municipality that the file on the child’s birth contained false information.

On 5 May 2011 Ms Paradiso and Mr Campanelli were charged with “misrepresentation of civil status”, and violation of the adoption legislation, in that they had brought the child to Italy in breach of Italian and international law and without complying with the authorisation to adoption obtained by them in December 2006, which ruled out the adoption of such a young child. On the same date the public prosecutor at the Campobasso Minors Court requested the opening of proceedings to free the child for adoption, since, for the purposes of Italian law, he had been abandoned.

In August 2011 a DNA test revealed that Mr Campanelli was not the child’s biological father. Gametes from other sources must have been used in the course of the fertilisation procedure. In consequence, the minors court decided on 20 October 2011 that the child should be removed immediately from the applicants and placed under guardianship, on the ground that there was no biological relationship between them and that there existed doubts as to the applicants’ child-raising and emotional capacities, the conduct of Ms Paradiso and Mr Campanelli having been contrary to the law. The baby was placed in a children’s home, without Ms Paradiso and Mr Campanelli being informed of his location or allowed any contact, then in January 2013 the baby was entrusted to foster parents. In addition, he was left without a formal identity.

In April 2013 the refusal to register the Russian birth certificate was confirmed on the ground that its registration would be contrary to public policy, given that the certificate was inaccurate, there being no biological relationship between the child and the applicants. The latter unsuccessfully submitted that they had acted in good faith, and claimed to have been unaware that Mr Campanelli’s seminal fluid had not been used in the Russian clinic.

In April 2013 the child received a new identity, and it was indicated in the new birth certificate that he had been born to unknown parents. On 5 June 2013 the minors court declared that the applicants no longer had the capacity to act in the adoption procedure initiated by them, given that they were neither the parents nor relatives of the child.

Complaints, procedure and composition of the Court

Relying on Article 8 (right to respect for private and family life), the applicants complained, in particular, about the child’s removal from them, and about the refusal to acknowledge the parent- child relationship established abroad by registering the child’s birth certificate in Italy.

The application was lodged with the European Court of Human Rights on 27 April 2012. Judgment was given by a Chamber of seven judges, composed as follows:

Işıl Karakaş (Turkey), President, Guido Raimondi (Italy), András Sajó (Hungary), Nebojša Vučinić (Montenegro), Helen Keller (Switzerland), Egidijus Kūris (Lithuania), Robert Spano (Iceland), and also Stanley Naismith, Section Registrar. Decision of the Court

Article 8

The Court dismissed at the outset the applicants’ complaint submitted in the child’s name, finding that they did not have standing to act on his behalf. It also dismissed, for failure to exhaust domestic remedies, the complaint submitted by Ms Paradiso and Mr Campanelli alleging that it was impossible to have the child’s birth certificate registered in Italy, as the applicants had not appealed on points of law.

With regard to the complaint concerning the child’s removal and placement under guardianship, the Court, noting the existence of a de facto family life between the couple and the child, held that Article 8 was applicable in this case and declared this complaint admissible. Although Ms Paradiso and Mr Campanelli had spent only six months with the baby, that period had covered important stages in his young life and they had behaved as parents towards him during that period.

As to the merits of the case, the Court considered, firstly, that the measures to remove the child and place him under guardianship amounted to interference in the applicants’ private life and had been in accordance with the law. Indeed, the domestic courts’ application of Italian law in concluding that the child had been abandoned had not been arbitrary, and the measures taken had been based on provisions of domestic law. In addition, the contested measures pursued the legitimate aim of “prevention of disorder”, in so far as the applicants’ conduct had been contrary to the law.

Secondly, in assessing the necessity of this interference in a democratic society, the Court was required to examine whether the application of the national law had struck a fair balance between the public interest and the applicants’ private interests, namely respect for their private and family life. In so doing, it had to have regard to the essential principle according to which, whenever the situation of a child was in issue, the best interests of that child were paramount.

On the issue of whether these interests had been taken into account by the Italian authorities, the Court noted that they had decided to remove the child in order to put an end to an unlawful situation. They had considered that by contacting a Russian agency and then bringing back to Italy a child whom they passed off as their son Ms Paradiso and Mr Campanelli had attempted to circumvent the prohibition in Italy on using surrogacy arrangements and the rules governing international adoption. According to the Italian authorities, that situation resulted from a narcissistic desire or from a wish to resolve problems in their relationship, which cast doubt on their child- raising and emotional capacities.

However, the reference to public order could not be considered as giving carte blanche for any measure, as the State had to take into consideration the best interests of the child, irrespective of the parental relationship, genetic or otherwise. The Court reiterated that the removal of a child from the family setting was an extreme measure, which could be justified only in the event of immediate danger to the child. The threshold set in its case-law in this respect was very high2.

Admittedly, the minors court had taken into account the undoubted harm in removing the child, but had considered, given the short period spent with the applicants and his young age, that he would bounce back from this difficulty. For its part, the Court considered that, although the situation before the Italian courts was a sensitive one, the conditions justifying removal had not been met. The argument that, with time, the child would have developed closer ties with his intended parents, making a possible subsequent separation even more problematic, was not sufficient to justify his removal. Moreover, Ms Paradiso and Mr Campanelli, who had been assessed as fit to adopt in December 2006, when they received the authorisation to adopt, were then held to be incapable of bringing up and loving the child on the sole ground that they had circumvented the adoption legislation, without any expert report being ordered by the courts. In addition, the child had not received his new identity until April 2013, which meant that he had had no official existence for more than two years. Yet it was necessary to ensure that a child was not disadvantaged on account

of the fact that he or she was born to a surrogate mother, beginning with citizenship or identity, which were of crucial importance3.

In consequence, the Court was not persuaded that the authorities had relied on appropriate evidence in deciding to place the child in the care of the social services. Thus, they had failed to strike a fair balance between the interests at stake, in violation of Article 8. This finding of a violation was not to be understood as obliging the Italian State to return the child to the applicants, given that he had undoubtedly developed emotional ties with the foster family with whom he had been living since 2013.

Just satisfaction (Article 41)

The Court held that Italy was to pay the applicants 20,000 euros (EUR) in respect of non-pecuniary damage and EUR 10,000 in respect of costs and expenses.

Separate opinion

Judges Raimondi and Spano expressed a joint partly dissenting opinion, which is annexed to the judgment.

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Colin Farrell Suggest Gay Couples Make Better Parents

January 21, 2015 – ontopmag.com

Hollywood actor Colin Farrell has suggested that gay and lesbian couples make better parents than their heterosexual counterparts.

Farrell appeared via satellite from Los Angeles on RTE’s Claire Byrne Live to discuss an upcoming referendum on marriage equality in his home country of Ireland.

The 38-year-old actor spoke of the bullying his brother Eamon faced growing up in Ireland and his “incredibly successful” marriage.

“He went to Vancouver and they got married and they’ve been happily married for six years, maybe seven years. They have an incredibly successful marriage,” Farrell said. “And to think they had to leave their own country to do that is sad and disappointing and just grossly unfair, I feel.”

When host Claire Byrne noted that opponents claim that allowing gay couples to marry hurts children, Farrell said it was the other way around, that the children of gay couples suffer when their parents cannot legally marry.

“Without same-sex marriage being legalized … it’s the children that are going to be left in the dark, if there’s a separation. It’s the children who won’t have the equal rights as the children of straight couples who are married. So, the children are actually going to suffer.”

“Guess what? There’s a hell of a lot of unsuccessful marriages between men and women. There’s a hell of a lot of children who have to experience day to day the arguments, the bickering, the domestic violence between their parents.”

“This is a demographic of society – gay, lesbian, transgender – who have been pilloried and who have been ostracized, who have been polarized, excluded for so long that when they get the chance to experience marriage or … parenthood, it has been kept [from] them for so long, and it is a God-given human right, and it’s too easy for heterosexuals to be parents, if you want the truth.”

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The Hidden Costs of International Surrogacy

By Darlena Cunha – The Atlantic – December 23, 2014

When Rhyannon Morrigan and her husband Drew used an egg donor and surrogate to have their child at a clinic in Delhi, India, they knew the road would be long, but had no idea how rough. Their kids, John and Maizy Morrigan, were born at 32 weeks in India. Stuck in the paperwork limbo of international surrogacy, the Morrigans not only missed the birth but they had to wait nearly two weeks, receiving word of their infants’ health from across the globe.

John died at ten days due to a lack of oxygen. Morrigan heard of his death just as she was on her way to the airport in Seattle, ecstatic to finally be meeting her twins. Days later, she wrote on Facebook: “My son died. The fact that I have a daughter does not change this.”

When Morrigan finally met her surrogate—Mrs. S—the meeting was strained and awkward, full of unspoken emotion.

“The doctors kept beaming at us, almost desperately,” Morrigan said. “’Congratulations on your beautiful daughter’, they said. But my surrogate and I felt anything but celebratory.”

Morrigan said the birth of her children was supposed to be the end of her story, but it has actually forced her to look at surrogacy and all its complexities more carefully. She wanted a story with a happy ending in an industry which has been recently marred by scandals and fraud. Instead, she’s left worrying whether her financial contribution to her surrogate will be enough.

“I left feeling very concerned for her because I get to come home to the U.S., and we have counseling services and a lot of privilege, and while I know that her economic life will be better, I’m not sure she’ll be able to handle this emotionally by herself. She was devastated. She is my son’s mother, too.”

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Germany High Court Paves the Way for Surrogacy

By  Richard B. Vaughn, Esq. – December 20, 2014

Chair, ABA Family Law Section A.R.T. Committee

In a landmark ruling released yesterday, Germanys highest court essentially has paved the way for German intended parents via surrogacy to have their children recognized.

 

In summary:  The decision of the highest court in Germany (Bundesgerichtshof) is a milestone. Mainly it says that both intended parents – also the non-genetic parent – can be recognised as legal parents of the child in Germany. Until now Germany had a very restrictive policy about surrogacy. In some cases even the genetic parent was not recognised as legal parent. The decision marks an important and positive shift.

 

Here is a short breakdown of the ruling:

 

  1. Applicant-appellant in this case was a same sex couple and their child born by a surrogate in California. ‎The Superior Court in Place County had issued a decision holding that appellants were the parents of the child. They petitioned the authorities in Berlin to issue a birth certificate for the child listing appellants as the parents. The officer at the birth register denied that request because the California surrogate was the child’s mother for all purposes under German law.

 

  1. Appellants sought judicial review of this decision but the Berlin courts upheld‎ the officer’s refusal to register appellants as parents. In its decision the Berlin appellate court held that a foreign court order recognizing a surrogacy agreement was null and void in Germany as it was against public policy (ordre public). Accordingly, German law applied and under the Civil Code only the woman giving birth may be registered as the child’s mother.

 

  1. On further appeal, the Federal Supreme Court vacated the Berlin court’s decision and issued a mandate that appellants be registered as legal parents.

 

  1. The Federal Court held that the decision by the California court commands comity and German courts may not, as a rule, second-guess a foreign court’s decision (prohibition against a so-called revision au fond).

 

  1. The presumption of validity under the comity principle may only be overcome if a recognition of the foreign decision led to a result that was entirely irreconcilable with basic principles of German law, especially the bill of rights or basic human rights.

 

  1. Even though Germany prohibits surrogacy, the child born to a surrogate is entitled to have legal parents. The court observed that the child could not influence the circumstances of its birth and a surrogacy background could therefore not be grounds to deny it its legal parents.

 

  1. If the intended parents could not be recognized as legal parents in Germany, the child’s human rights would be infringed. It would have a mother (the surrogate) who is not recognized as the mother in her jurisdiction and who is not prepared to take responsibility for the child.

 

  1. Adoption was not a viable alternative.

 

If anyone is interested in getting the court ruling (which I only have in German), I will be happy to send it to you under separate cover.

 

International Fertility Law Group Inc.

http://www.iflg.net/blog

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UK proposes rules for embryos made from 3 people

By Maria Checng – December 17, 2014

LONDON (AP) — New rules proposed in Britain would make it the first country to allow embryos to be made from the DNA of three people in order to prevent mothers from passing on potentially fatal genetic diseases to their babies.

In a statement issued on Wednesday, the department of health said it had taken “extensive advice” on the safety and efficacy of the proposed techniques from the scientific community.

“(This) will give women who carry severe mitochondrial disease the opportunity to have children without passing on devastating genetic disorders,” Dr. Sally Davies, the U.K.’s chief medical officer, said in a statement.

Experts say that if approved by parliament, these new methods would likely be used in about a dozen British women every year who are known to have faulty mitochondria — the energy-producing structures outside a cell’s nucleus. Defects in the mitochondria’s genetic code can result in diseases such as muscular dystrophy, heart problems and mental retardation.

The techniques involve removing the nucleus DNA from the egg of a prospective mother and inserting it into a donor egg, where the nucleus DNA has been removed. That can be done either before or after fertilization.

The resulting embryo would end up with the nucleus DNA from its parents but the mitochondrial DNA from the donor. Scientists say the DNA from the donor egg amounts to less than 1 percent of the resulting embryo’s genes. But the change will be passed onto future generations, a major genetic modification that many ethicists have been reluctant to endorse.

Critics say the new techniques are unnecessary and that women who have mitochondrial disorders could use other alternatives, such as egg donation, to have children.

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India to have new surrogacy law soon

November 16, 2014 – FirstPost.com

New Delhi, Nov 16 (IANS) Much in the news for all the wrong reasons, surrogacy in India will soon be a regulated sector with the government bringing in a law to govern all aspects of the process like compensation, age and consent of the surrogate mother.

“The final draft bill is now lying with the law ministry and, after being cleared, will be presented before the cabinet for approval,” V.M. Katoch, secretary, department of health research under the health ministry, told IANS.

Surrogacy is a method of reproduction where a woman – the surrogate – agrees to carry a pregnancy to term for a fee.

A study backed by the United Nations in July 2012 estimated that surrogacy is a more than $400 million business a year in India, with over 3,000 fertility clinics across the country.

India now has only the guidelines the Indian Council for Medical Research (ICMR) released in 2002.

In Oct 2008, the Supreme Court ruled that “commercial surrogacy is legal and an industry in India”, making it a legally protected and viable option for international couples.

Named the Assisted Reproductive Technology (Regulation) Bill, 2013, it seeks to address issues like how many pregnancies can be allowed for a surrogate mother, the age of the mother and due compensation to be paid to her.

“The issues addressed in the bill are compensation, informed consent and health of the women involved,” Katoch said.

He said that the bill might also provide a punishment framework for violators.

It has been cleared after rounds of discussions with various ministries and could be passed as early as the winter session of parliament in November-December, said Katoch, who is also the ICMR chief.

The bill will also provide a framework for letting foreigners use Indian surrogate mothers.

Surrogacy in India has always been a controversial subject with activists blaming foreigners for exploiting poor women.

In 2012, an Australian couple left behind one of the twins born to an Indian surrogate mother because they could not afford to bring up two children back home.

Earlier in 2010, a German couple, Jan Balaz and Susan Lohle, had to wait for two years before they could take their twin babies home.

Their twin sons, Nikolas and Leonard, were trapped in a citizenship limbo ever since an Indian surrogate mother gave birth to them in February 2008.

The boys were refused passports by their parents’ homeland because German nationality is determined by the birth mother. The issue was finally settled after a prolonged court battle.

Centre for Social Research Director Ranjana Kumari told IANS: “Surrogate motherhood has grown exponentially in India to become part of a thriving globalized industry.

However, it raises difficult ethical, philosophical and social issues”.

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Colombia court allows lesbian adoption

AFP.com, AUgust 29, 2014

Colombia’s Constitutional Court ruled Thursday that a lesbian woman could adopt her long-time partner’s daughter, though the ruling does not apply to gay adoption in all circumstances.

Ana Leiderman appealed to the court to let her partner, Veronica Botero, adopt her biological daughter after the Colombian Family Well-being Institute rejected Botero’s adoption application.

With six votes for and three abstentions, the court ruled that Leiderman, who underwent artificial insemination to conceive her daughter and raised her together with Botero, had the right to request an adoption by her partner regardless of sex.

“The court considered that the discriminatory criterion the administrative authority had used to deny the adoption procedure… was unacceptable in this case, which involves a consensual adoption in which the biological father or mother consents to an adoption by his or her permanent partner,” said chief justice Luis Ernesto Vargas Silva.

The ruling sets a precedent for all similar cases in the South American country, but will not apply to gay couples seeking to adopt if neither person is the child’s biological parent.

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In Thailand’s Surrogacy Industry, Profit and a Moral Quagmire

New York Times – August 26, 2014 by Thomas Fuller

PAK OK, Thailand — Soon after the first surrogate mother from this remote village gave birth, neighbors noticed her new car and conspicuous home renovations, sending ripples of envy through the wooden houses beside rice paddies and tamarind groves.

“There was a lot of excitement, and many people were jealous,” said Thongchan Inchan, 50, a shopkeeper here.

In the two years since, carrying babies for foreigners, mainly couples from wealthier Asian nations, quickly became a lucrative cottage industry in the farming communities around Pak Ok, a six-hour drive from Bangkok. Officials say at least 24 women out of a population of about 13,000 people have since become paid surrogate mothers.

“If I weren’t this old, maybe I would have done it myself,” Ms. Thongchan said. “This is a poor village. We make money by day and it’s gone by evening.”

The baby boomlet here was just one of several bizarre and often ethically charged iterations of Thailand’s freewheeling venture into what detractors call the womb rental business, an unguided experiment that the country’s military government now says it is planning to end.

Commercial surrogacy has been available for at least a decade in Thailand, one of only a handful of countries where it is allowed, and one of only two in Asia, making it a prime destination for couples in the region from countries where the practice is banned.

Officials estimate that there are several hundred surrogate births here each year, a number that does not include foreign surrogates, including many hired by Chinese couples, who come to Thailand for the embryo implantation then return home to carry out the pregnancy.

But a pair of recent scandals have focused scrutiny on the largely unregulated industry, raising ethical questions and prompting the government’s crackdown.

In late July, the Thai news media reported that an Australian couple who had paid a woman to carry twins returned home with only one of their children, leaving behind the other, who had Down syndrome. Pleas for assistance by the surrogate mother helped produce a sustained national outcry that was further stoked by comments by the boy’s biological father that were deemed insensitive at best.

The father, David John Farnell, told an Australian television program that he would have preferred that the pregnancy had been terminated. “I don’t think any parent wants a son with a disability,” he said.

He also said that he and his wife had told the agency in Bangkok that served as an intermediary to “give us back our money.”

The Australian news media raised questions about his fitness as a father after finding court records showing that he was convicted and imprisoned for 22 counts of child sex abuse in the 1990s.

Click here to read more.

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