DNA
20 March 2017 by Isabel McArdle
A clinic in Newcastle upon Tyne has been granted the UK’s first licence to carry out a trial of “three person IVF” (Mitochondrial Replacement Therapy, or MRT). The fertility technique is intended to be used by couples who want to prevent genetic diseases being passed on to their children, due to faulty mitochondrial DNA. The process uses genetic material from the mother, father and a female donor, and replaces faulty genetic material in the mother’s DNA with the female donor’s genetic material.
There have already been a small number of three parent IVF pregnancies elsewhere in the world, resulting in reportedly healthy babies.
However the technique is not without its controversies and critics.
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20 April 2016 by Rosalind English
Spencer v Anderson (Paternity Testing) [2016] EWHC 851 (Fam) – read judgment
A fascinating case in the Family Division throws up a number of facts that some may find surprising. One is that this is the first time the courts in this country have been asked to direct post-mortem scientific testing to establish paternity. The other is that DNA is not covered by the Human Tissue Act, because genetic material does not contain human cells. One might wonder why the statute doesn’t, given that DNA is the instruction manual that makes the human tissue that it covers – but maybe updating the 2004 law to cover genetic material would create more difficulties than it was designed to resolve.
The facts can be briefly stated. The applicant had been made aware of his possible relationship to S, who had died of bowel cancer some years before. When S had presented with the disease, it turned out that there was a family history of such cancer. The hospital treating him therefore took a blood sample and extracted DNA from it to test for high-risk genes. If the applicant was the son of the deceased he would have a 50% risk of inherited predisposition to bowel cancer. This risk would be mitigated by biannual colonoscopies.
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30 June 2015 by Rosalind English
Jack Lowe and Dennis Reynolds, Plaintiffs v Atlas Logistics Group Retail Services
The first prosecution under the 2008 US Genetic Information Nondiscrimination Act (GINA) has won $2.25 million jury damages for the individuals involved .
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.
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11 February 2015 by Guest Contributor
X & Anor v Z (Children) & Anor [2015] EWCA Civ 34 – read judgment
The Court of Appeal has ruled that it would not be lawful for DNA originally collected by the police to be used by a local authority for the purposes of a paternity test.
Factual and legal background
X’s wife had been found murdered. The police took DNA from the crime scene. Some of the DNA belonged to X’s wife and some was found to be X’s. X was tried and convicted of his wife’s murder.
X’s wife had young children and they were taken into the care of the local authority. During the care proceedings X asserted that he was the biological father of the children and said he wanted to have contact with them. He refused to take a DNA test to prove his alleged paternity. The local authority asked the police to make the DNA from the crime scene available so that it could be used in a paternity test. The police, with the support of the Home Secretary, refused on the grounds that they did not believe that it would be lawful to do so.
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20 November 2014 by Rosalind English
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.
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7 October 2014 by Rosalind English
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.
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13 November 2013 by Rosalind English
There’s a crisis in South Africa’s mortuaries – in the investigation of death.
This is due to a number of problems – incompetent staff who fail to gather forensic evidence, creaking and inadequate facilities, and the sheer number of dead bodies waiting to be processed. In a gripping but bleak documentary about Salt River Mortuary, which is responsible for processing cadavers in the Western Cape, the figures will make you gasp and stretch your eyes:
For the Western Cape alone, 3,000 bodies are handled by this Mortuary each year. Of this number, 65% are unnatural deaths (accidents, suicides, homicides). Of that number (approx 2,000) a staggering 80% are homicides – in other words, Salt River is responsible for providing the forensic evidence for reconstructing the crime scenes leading to 1,600 murders a year.
Watch the ten minute film here.
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13 June 2013 by Rosalind English
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).
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20 March 2013 by Rosalind English
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.
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11 March 2013 by Rosalind English
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.
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12 December 2012 by Rosalind English
This week David Cameron announced plans to introduce whole genome mapping for cancer patients and those with rare diseases within the NHS.
Single gene testing is already available across the NHS ranging from diagnosing cancers to assessing patients’ risk of suffering side effects from treatment, but this initiative will mean that the UK will be the first country in the world to introduce the technology within a mainstream health system, with up to 100,000 patients over three to five years having their whole genome – their personal DNA code –sequenced. According to Chief Medical Officer Professor Dame Sally Davies
The genome profile will give doctors a new, advanced understanding of a patient’s genetic make-up, condition and treatment needs, ensuring they have access to the right drugs and personalised care far quicker than ever before.
What will this mean for medical confidentiality? The official announcement ends with the following declaration:
1. Genome sequencing is entirely voluntary. Patients will be able to opt out of having their genome sequenced without affecting their NHS care.
2. Whole genome sequence data will be completely anonymised apart from when it is used for an individuals own care.
3. A number of ways to store this data will be investigated. The privacy and confidentiality of NHS patients will be paramount in this decision.
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3 December 2012 by Rosalind English
I posted previously on the decision by the US Court of Appeals for the Federal Circuit to uphold the patents on the genetics company Myriad’s gene sequences for breast cancer research and therapy. In September 2012 the American Civil Liberties Union once again petitioned for Supreme Court review. The Court should decide today whether to review the case.
The whole question of proprietary claims over genetic information is not limited to patents and is very much open to debate. In my piece on the US Bioethics Commission’s report to the Obama administration I discussed the challenge faced by lawmakers in regulating the increasing flow of genomic information so as to protect people’s privacy without shutting down the flow of data vital to biomedical research. Whilst it is true that the availability of patent protection creates vital incentives for such research, genetic testing companies like Myriad can extend their exclusivity beyond their patented products by creating limiting access to private databases containing information vital to interpreting the clinical significance of human genetic variations. There is concern that this threatens to impede the clinical interpretation of genomic medicine. The Genomics Law Report Journal reports that
National health systems and insurers, regulators, researchers, providers and patients all have a strong interest in ensuring broad access to information about the clinical significance of variants discovered through genetic testing.
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18 October 2012 by Rosalind English
I have posted previously on the logistical difficulties in legislating against genetic discrimination.
The prospect that genetic information not only affects insurance and employment opportunities is alarming enough. But it has many other implications: it could be used to deny financial backing or loan approval, educational opportunities, sports eligibility, military accession, or adoption eligibility. At the moment, the number of documented cases of discrimination on the basis of genetic test results is small. This is probably due to the relatively few conditions for which there are currently definitive genetic tests, coupled with the expense and difficulty of conducting these tests. But genetic discrimination is a time bomb waiting to be triggered and the implications of whole genome sequencing (WGS) are considered in a very interesting and readable report by the US Presidential Commission for the Study of Bioethical Issues Privacy and Progress in Whole Genome Sequencing.
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20 September 2012 by Rosalind English
Yes, says the US Court of Appeals for the Federal Circuit, upholding the validity of human gene patents related to breast and ovarian cancer (Association for Molecular Pathology and others v the Patent Office and Myriad Genetics – read judgment) UPDATED
The three judge panel ruled in a 2-1 decision that the biotechnology company Myriad was entitled to its patents on the molecules because each of them represented “a non-naturally occurring composition of matter”. The court also upheld Myriad’s patent on a technique for identifying potential cancer therapies by monitoring effects on cell growth, but denied their claim on assessing cancer risk by comparing DNA sequences because the method is based on “abstract, mental steps” of logic that are not “transformative”.
This fascinating judgment is a model of clarity and fluency in this difficult area. But what does this intellectual property tussle have to do with human rights? Well, there is nothing unfamiliar to human rights lawyers in litigation over the availability of life-saving treatment (patient B, the Herceptin case and the antiretroviral litigation in South Africa are three examples that spring to mind). And much of it begins in the laboratory, with the critical allocation of exclusivity rights.
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9 May 2012 by Rosalind English
The late US law Professor Paul Miller reflected recently that Beethoven, Stephen Hawking and Elton John were examples of individuals whom, if they had been tested for serious genetic conditions at the start of their careers, may have been denied employment in the fields in which they later came to excel.
Earlier this month the Association of British Insurers announced the latest extension on the moratorium on the use of genetic test results for insurance purposes. But is this “Concordat” sufficient protection? Genetic technologies are becoming increasingly available and profound questions are arising in relation to life and health insurance and employability as genetic screening becomes cheaper and widespread.
According to the Human Genetics Commission (HGC)
The advent of cheap whole-genome sequencing, and greatly reduced costs for genetic tests in general, will provide the platform for genetic testing to be used for novel and unpredicted purposes. (Report on The Concept of Genetic Discrimination, Aril 2011)
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