In South Africa, the not-so-quick and the dead.

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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. Continue reading

Human genes may not be patented, but synthesised ones can, rules US Supreme Court

298x232-dna_genetic_test-298x232_dna_genetic_testAssociation 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

The Patentability of Human Genes: more developments

Breast Cancer in DNA StrandsCancer 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

Would resurrected Neanderthals have human rights?

mm75890804271827A 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

From base pairs to the bedside: medical confidentiality in a changing world

DNA database impact on human rightsThis 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. Continue reading

Should any genetic information be a trade secret?

dna_infograph1I 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. Continue reading

Can we keep our genomes quiet? Some suggestions from the US

DNA database impact on human rights

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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Can an individual claim ownership of “life’s instructions” – a human gene?

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. Continue reading

Should we outlaw genetic discrimination?

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) Continue reading

Big Brother or crime fighting? DNA evidence under the microscope

DNA database impact on human rightsA proposal to retain DNA samples taken from people who have been arrested but not charged with a crime for up to five years has come under criticism from the Joint Committee on Human Rights.

The committee has been reviewing the Protection of Freedoms Bill for its compatibility with human rights (see our post: Protections of freedom bill under scrutiny and the Committee’s conclusions). The retention of DNA has long been a hot topic.

On the one hand, many people feel strongly that retention of something as personal as someone’s genetic code should never be done when the person has not been convicted of a crime. As DNA analysis gets more advanced, it can reveal increasingly large amounts of information about a person.

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DNA case analysis: The mystery of the missing purpose

We reported last week the Supreme Court ruling in R (on the application of GC) (FC) (Appellants) v The Commissioner of Police of the Metropolis (Respondent) in which the majority found that they could interpret the DNA retention provision in the Police and Criminal Evidence Act (PACE) in such a way that it would be compatible with article 8 of the ECHR.

Not only that; the Court concluded that such a reading could still promote the statutory purposes: ” Those purposes can be achieved by a proportionate scheme.”
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Courts entitled to ignore European DNA and fingerprints ruling… for now

R (C) v Commissioner of the Police of the Metropolis [2010] WLR (D) 193 – Read judgment

Last month, Matt Hill posted on a case relating to the retention of DNA profiles and fingerprints by the police, for which the full judgment is finally available. Permission has been granted for an appeal directly to the Supreme Court, and the outcome of that appeal may have interesting implications for the status of European Court of Human Rights decisions in domestic law.

It is worth revisiting the decision in order to extract some of the principles, as although not novel, they do highlight the difficulties for claimants who have taken a case to the European Court of Human Rights and won, but who are still waiting for their decision to be implemented by the UK government.

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DNA, home testing and fuzzy human rights

DNA database impact on human rightsThe Human Genetics Commission have today published new guidance for direct-to-consumer genetic tests, including a recommendation that children should not be genetically tested by their parents unless the test is clinically indicated. The guidelines highlight that the ethical issues surrounding home-testing are still fuzzy and provide an interesting challenge from a perspective of human rights.

Home DNA testing kits are a fast-growing trend. They have already been on sale direct to consumers for three years by companies such as 23andMe and deCODEme, which advertise home-testing as a means of “taking charge of your health” and “filling in your family tree”. DNA paternity testing has been available for years, but it is the health aspects of home testing which have huge and potentially troubling implications in respect of basic rights.

Continue reading