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Law creates artificial relationships between non-related people and entities. It even gives person-hood to non-biological beings such as companies and partnerships (although not yet to non-human species). Genetics describe the underlying relationship of all biological beings. For centuries, law and genetic science developed in parallel with very little overlap. But as genetic discoveries ride the crest of the technological revolution, law finds itself on the back foot. Legal instruments, such as property law and the law of obligations between non-related individuals were crafted in feudal times with the aim of protecting property beyond the death of the owner. With genetic discoveries, we face a myriad of questions, from ownership of gene editing techniques to the dangers of discrimination based on genetic predisposition for disease.
The entanglement of law and ethics is always perilous when it involves the threat of prohibition. When Shenzhen scientists announced two years ago that they had edited the genes of twin human babies whilst still in vitro, voices of disapproval reverberated around the globe. Whilst it seems that gene modification of potential human life fills us with fear and loathing nothing has stood in the way of the race to refine this technology. Efforts to predict and restrict genetic engineering seem quaint and outmoded, from the UNESCO 1997 Declaration on the Human Genome and Human Rights, to the Council of Europe’s Convention in the same year to restrict the modification of the genome to therapeutic purposes only. These agreements, as well as the 2015 call by UNESCO for a moratorium on germline modification, are well past their sell by dates.
ABC v Thomson Medical Pte Ltd and others, Singapore Civil Court of Appeal [2017] SGCA 20 – read judgment
It is a trite reflection that law should change with the times but every so often we see the hair-pin bends in law’s pursuit of modern technology. This case from Singapore about reproductive rights and negligence in an IVF clinic is just such an example. As the judge said at the outset, the need for the law to adjust itself to the changing circumstances of life is clearest in the area of medical science,
where scientific advancement has made it possible for us to do things today which would previously have been unimaginable a few decades ago. This has brought untold prosperity to many, and hope to those who previously had none; but it has also given us greater capacity for harm.
Background facts
The Appellant, a Chinese Singaporean, and her husband, a German of Caucasian descent, sought to conceive a child through in-vitro fertilisation . The Appellant underwent IVF treatment and delivered a daughter, referred to in the judgment as “Baby P”. After the birth of Baby P, it was discovered that a serious mistake had been made: the Appellant’s ovum had been fertilised using sperm from an unknown Indian third party instead of sperm from the Appellant’s husband. It turned out that the clinic had processed two semen specimens inside one laminar hood at the same time and failed to discard the disposable pipettes that had been used after each step of the IVF process. This had resulted in a baby being born on 1 October 2010, whose DNA did not match her father’s. Continue reading →
ABC v St George’s Healthcare NHS Trust and Others [2017] EWCA Civ 336 – read judgment
All the advocates in this case are from 1 Crown Office Row. Elizabeth-Anne Gumbel QC, Henry Witcomb QC and Jim Duffy for the Appellant, and Philip Havers QC and Hannah Noyce for the Respondents. None of them were involved in the writing of this post.
In a fascinating twist to the drama of futuristic diagnosis, the Court of Appeal has allowed an argument that doctors treating a Huntington’s patient should have imparted information about his diagnosis to his pregnant daughter to go to trial.
The background to this case is outlined in my earlier post on Nicol J’s ruling in the court below. A patient with an inherited fatal disease asked his doctors not to disclose information to his daughter. The daughter came upon this information accidentally, shortly after the birth of her child, and found, after a genetic test, that she suffered from this condition as well, which has a 50% chance of appearing in the next generation. Had she known this, she would have sought a termination of the pregnancy. She claimed that the doctors were liable to her in damages for the direct effect on her health and welfare.
A claim for “wrongful birth” is well established in law; no claim was made on behalf of the child, who was too young to be tested for the condition. The twist is the duty of secrecy between doctor and patient, which has held very well for the past two centuries. Short of confessions pertaining to homicide or information regarding contagious diseases, the dialogue behind the consulting door should end there.
The problem is that the typical medical relationship only pertains to the pathology of the individual patient. Now that tests are available that make every single one of us a walking diagnosis not only for our own offspring but those of our siblings and their offspring, the one-to-one scenario collapses, along with the limited class of people to whom a doctor owes a duty of care. The pregnant daughter who came across the information about her father’s condition was not the defendant doctor’s patient. In pre-genetic days, that meant there was no duty of care relationship between her father’s doctors and her. But the certainty of hereditability brings her into that circle. Continue reading →
I have posted about genetic discrimination here and here. In the US some of these problems have been foreseen and legislated against: GINA prohibits discrimination against healthy individuals for employment decisions or health insurance purposes on the basis of genetic information alone; it also prevents employers and insurance providers from demanding or using information from genetic tests.
The law does include limited exemptions, however. Forensic laboratories can ask workers for their DNA to check that employees’ genetic material does not contaminate the genetic samples that they analyse. Continue reading →
I have blogged before on the Pandora’s box of ethical problems and dilemmas emerging out of our increasing understanding of genetic disorders (see here, here and here), and here is a case that encompasses some of the most difficult of them. Continue reading →
M.R. and D.R.(suing by their father and next friend O.R.) & ors -v- An t-Ard-Chláraitheoir & ors [2014] IESC 60 (7 November 2014) – read judgment
The definition of a mother, whether she is “genetic” or “gestational” for the purpose of registration laws was a matter for parliament, not the courts, the Irish Supreme Court has ruled.
At the core of the case was the question whether a mother whose donated ova had resulted in twin children born by a surrogacy arrangement should be registered as their parent, as opposed to the gestational mother who had borne the twins.
The genetic mother and father sought her registration as “mother” under the Civil Registration Act, 2004, along with a declaration that she was entitled to have the particulars of her maternity entered on the Certificate of Birth, and that the twins were entitled to have their relationship to the fourth named respondent recorded on their Certificates of Birth. Continue reading →
D’Arcy v Myriad Genetics Inc [2014] FCAFC 115 (5 September 2014) – read judgment The recent ruling from the Full Federal Court of Australia allowing the breast cancer gene isolated in the laboratory to be patented contrasts sharply with the ruling by the US Supreme Court last year that a naturally occurring DNA segment is a “product of nature” and therefore not patent eligible merely because it has been isolated. The implications of this ruling for gene testing and patenting of biological products have been eloquently discussed elsewhere and I will not attempt to cover the same ground – see for example the excellent discussion posted by the Enhanced Genetic Services Project. All I want to point up in this post – apart from the obvious need for intellectual property law to encompass the development of science and technology – is the Australian court’s focus on how easily misled one may be by semantics in this sort of dispute. This ruling upholds an earlier decision that gene patenting is permissible under Australian law, declaring that “the boundaries of the conception of patentability are not dictated only by deductive logic from the linguistic premises formulated in the scientific knowledge of a particular age”. The concept of patentability has been broadening since the first quarter of the 17th century, and there is no reason why it should reach an artificial wall erected by unfathomable and unexplained “laws of nature” (a premise much relied upon by the US Supreme Court). I posted last year on the decision of the US Supreme Court in Association for Molecular Pathology v Myriad Genetics Inc. It will be remembered that that Court held that a sequence of DNA mimicking the BRCA breast cancer mutation could not be patented because DNA’s information sequences and all the other processes that allow the information to manufacture bodily tissues occur naturally within human cells. Continue reading →
Association for Molecular Pathology et al v Myriad Genetics Inc, et al, United States Supreme Court 13 June 2013 – read judgment.The headlines are misleading. Myriad Genetics has lost some, but not all of its patent protection as a result of this final ruling in the long running litigation concerning the company’s BRCA 1 and BRCA 2 breast cancer gene patents. According to the American Council on Science and Health, the Court’s decision is
a groundbreaking moment in the history of biotechnology, and a case that will surely rank among the most noteworthy biomedical decisions of our time.
I have posted here, here and here on previous stages in the Myriad patent case, in the United States and Australia, so will not set out the facts again (although for anyone who is interested, the Supreme Court judgment provides a superbly clear explanation of the molecular biology underlying the issues). Continue reading →
Waller v James [2013] NSWSC 497 (6 May 2013) – read judgment
So-called “wrongful birth” cases – where parents claim for the costs of bringing up a child that has been born as a result of the hospital’s alleged negligence – have long been the subject of heated debate.
Since 1999 (MacFarlane v Tayside Health Board) such damages have been refused on grounds of public policy – for the birth of a healthy baby, that is. As far as disabled children are concerned, parents can the additional costs attributable to the disability (Parkinson v St James and Seacroft NHS Trust). Now that so much more can be predicted with a high level of certainty from pre-birth, even pre-conception genetic tests, where do we stand on public policy in wrongful birth cases where the negligence not so much in failure to treat (failed vasectomies etc) but failure to inform? This Australian case gives some indication of the way the courts may approach such questions.
Background facts
Keeden Waller was conceived by IVF using the Wallers’ own gametes. There was a fifty percent chance that he would inherit from his father a blood disorder called antithrombin deficiency (ATD), a condition that affects the body’s normal blood clotting ability and leads to an increased risk of thrombosis. Keeden suffered a stroke a few days after his birth resulting in severe disabilities, which his parents, Lawrence and Deborah Waller, alleged was the result of ATD. They brought a claim in damages against their doctor for the care of their disabled son and psychological harm to themselves. Continue reading →
Y and Z (Children), 25 April 2013 [2013] EWHC 953 (Fam) – read judgment
Having children is a lottery. No judge or court in the land would sanction the regulation of childbearing, however feckless the parents, unsuitable the conditions for childrearing, or unpromising the genetic inheritance.
Adoption on the other hand is stringently regulated, set about with obstacles for prospective parents, and strictly scrutinised by an army of authorities backed up by specialist family courts and a battery of laws, statutory instruments and guidance papers. Usually the filtering is in one direction only: the suitability of the parents to the child or children up for adoption. But sometimes it goes the other way, and this case raises the fascinating and somewhat futuristic question of whether children’s chance of finding a suitable home might be increased by genetic testing.
The circumstances were somewhat exceptional here, since the local authority had ascertained from the biological father of the two young boys in question that they might have a chance of inheriting a rare genetic disorder of the central nervous system. Huntington’s Chorea is caused by a single gene mutation on chromosome IV and causes damage of the nerve cells and areas of the brain which in due course leads to severe physical, mental and emotional deterioration. Anyone whose parent has the disease is born with a fifty per cent chance of inheriting the gene. Anyone who inherits the gene will, at some stage, develop the disease. Continue reading →
is what the technology giant Myriad calls the US First Amendment and other human rights arguments raised by their opponents in the litigation concerning Myriad’s patents over cancer gene sequences BRCA1 and BRCA2.
We’ve been here before, in this previous post and in this, and next week the US Supreme Court starts hearing arguments in the latest round of this battle. The only reason for mentioning the issue now is to draw attention to a fascinating article by US science historian Daniel Kevles in a recent edition of the New York Review of Books.
The author provides a dispassionate view of patent law, from its roots in the philosophy of the American revolution, which gave birth to the “Progress Clause” in the American Constitution. Clause 8 authorises Congress
to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries. Continue reading →
Cancer Voices Australia v Myriad Inc 13 February 2013 – read judgment
Another battle in the war against gene patenting has been lost, this time in Australia.
The US litigation is still ongoing, with the US Court of Appeals for the Federal Circuit upholding Myriad’s patents on DNA sequenced in the laboratory: see my post on that judgment. On 30 November 2012, the US Supreme Court announced that it would hear an appeal in the Myriad case. The US law in relation to the patentability is therefore not likely to be settled until the Supreme Court reaches it own decision on the issue.
This Federal Court ruling in Australia has now endorsed the government’s rejection of calls for an outright ban on the patenting of genes by ruling that isolated nucleic acid (including isolated DNA and RNA) is patentable. Continue reading →
A newsflash on the eve of the May 2010 elections was instantly eclipsed by the news of the coalition-bartering in the days that followed. But it concerned one of the most important scientific discoveries of the year, if not the century.
Evolutionary biologists at the Max Planck Institute for Evolutionary Anthropology in Germany had finished sequencing the Neanderthal genome. In the publication of their results the team pointed up the similarity between the four billion pairs of Neanderthal DNA and stretches of the human genome, suggesting that humans and their ancient hominid cousins must have interbred some time after modern Homo Sapiens left Africa, meaning that elements of Neanderthal genome is present in non-African modern humans. The study found that 2.5 percent of the genome of an average human living outside Africa today is made up of Neanderthal DNA. Continue reading →
Meiklejohn v St George’s Healthcare Trust [2013] EWHC 469 (QB) – read judgment
Richard Booth of 1 Crown Office Row acted for the claimant in this case. He is not the author of this post.
There is no doubt that medical diagnosis and therapy are struggling to keep pace with the genetic information pouring out of the laboratories and sequencing centres. And the issue of medical liability is being stretched on the rack between conventional treatment and the potential for personalised therapy. Treatment of disease often turns out to be different, depending on which gene mutation has triggered the disorder. However fine tuned the diagnosis, it may turn out to be profoundly wrong in the light of subsequent discoveries.
This is perhaps an oversimplified characterisation of what happened in this case, but it exemplifies the difficulties facing clinicians and the courts where things go wrong, against the backdrop of this fast-moving field of scientific endeavour. Continue reading →
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A newsflash on the eve of the May 2010 elections was instantly eclipsed by the news of the coalition-bartering in the days that followed. But it concerned one of the most important scientific discoveries of the year, if not the century.
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