We use cookies to enhance your browsing experience. If you continue to use our website we will take this to mean that you agree to our use of cookies. If you want to find out more, please view our cookie policy. Accept and Hide [x]
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 →
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 →
Hundreds of people have died; others have been starved, dehydrated and left in appalling conditions of indignity, witnessed by their loved ones. Surely this is what Chris Grayling, Justice Secretary, had in mind when he recently cautioned to need to “concentrate on real human rights”?
As Mr Francis makes clear, what happened at Staffordshire Hospital was a breach of basic rights to dignity and respect, and what is needed now are stronger lines of accountability and culture change which places patients at the heart of healthcare. Human rights speak to the fundamental standards that the Report says are needed to achieve this transformation in care.
The Mid Staffordshire NHS Foundation Trust Public Inquiry report has been published. Robert Francis QC was tasked to investigate the role of the commissioning, supervisory and regulatory bodies in the monitoring of Mid Staffordshire Foundation NHS Trust.
The report built on the work of Francis’s earlier independent inquiry into the care provided the hospital between January 2005 and March 2009. A number of 1 Crown Office Row barristers, including me, represented various participants at the Inquiry. They were:
Sally Smith QC and Christopher Mellor for the Strategic Health Authority;
David Hart QC for the CQC
Owain Thomas for the NHSLA;
Jeremy Hyam and Kate Beattie for a number of the families;
Shaheen Rahman and Peter Skelton for AVMA and the Patients Association;
An NHS Trust v SR [2012] EWHC 3842 (Fam) – read judgment
The highly publicised case about a seven year old boy whose estranged parents could not agree about the necessary treatment following surgery for his brain tumour was resolved by a firm ruling in favour of orthodox medicine by Bodey J, four days before Christmas.
The facts of the case are well known, but it may be instructive to lay out some of the details of the procedure that follows in a situation like this, and to point up the approach of the courts to a matter where orthodox science lies flat against the claims of complementary medicine. Where the life of a child is at stake, there is no polite equivocation between the two.
Background
Briefly, the mother would not agree to the recommended post-operative course of chemo- and radiotherapy (carrying an 80% chance of success), believing instead that her son would fare better with alternative forms of treatment and would avoid or reduce the undoubtedly detrimental long-term side effects of the treatment package being proposed. In a serious matter such as this, where the parents cannot agree, an application has to be made to the court for a declaration that the procedure in question is lawful. That involves a decision as to the child’s best interests, being the court’s paramount consideration. Hence it was incumbent on the NHS Trust concerned to apply to the High Court to determine the issue of N’s treatment following on from his brain surgery two months previously. Continue reading →
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. Continue reading →
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. Continue reading →
Debate about whether the Human Rights Act (HRA) might be replaced by a new UK Bill of Rights often dwells on the potential loss, or at least weakening, of the legal route to accountability and redress for victims of human rights violations. An event next month in Liverpool reminds us how much more might be lost if the HRA were to be scrapped or watered down. In particular, it highlights the significance of section 6 of the Act, which requires all public authorities to act in a way which is compatible with European Convention rights unless primary legislation requires them to act otherwise.
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.
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 →
The Queen(on the application of Tony Nicklinson) v Ministry of Justice [2012] EWHC 2381 (Admin) – read judgment
Lord Justice Toulson, sitting with Mrs Justice Royce and Mrs Justice Macur, has handed down judgment in the case of Tony Nicklinson and that of another “locked-in” syndrome sufferer, “Martin”. On all the issues, they have deferred to parliament to take the necessary steps to address the problems created by the current law of murder and assisted suicide.
Philip Havers QC of 1 Crown Office represented Martin in this case.
Tony Nicklinson sought a declaration of immunity from prosecution for a doctor who would give him a fatal dose of painkillers to end his life in Britain. He also sought a declaration that the current law is incompatible with his right to respect for private life under article 8, contrary to s1 and 6 of the Human Rights Act 1998, in so far as it criminalises voluntary active euthanasia and/or assisted suicide.
Martin’s claim was slightly different as his wife does not want to do anything which will hasten his death. He therefore asked for permission for volunteers to be able to help him get to the Dignitas clinic in Switzerland (under recent guidelines from the Director of Public Prosecutions only family members or close friends who are motivated by compassion are unlikely to be prosecuted for assisting a suicide). In the alternative he sought a declaration that section 2 of the Suicide Act is incompatible with the right to autonomy and private life under Article 8 of the European Convention. Continue reading →
Eleven Winterbourne View staff have pleaded guilty to 38 charges of ill-treatment and neglect of a mental health patient under s127 Mental Health Act 1983 (MHA). In this post I want to consider why we need ‘special’ offences like s127 MHA and also s44 Mental Capacity Act 2005 (MCA), rather than prosecuting crimes in care settings using more ‘mainstream’ offences.
The UN Convention on the Rights of Persons with Disabilities (CRPD), with articles emphasising access to justice (Article 13) and equal recognition before the law (Article 12) encourages us to think about how we can ensure disabled people have effective access to the law that protects us all before we develop parallel ‘special’ systems of rights protection (see, for example, Inclusion Europe, European Disability Forum). So my question is: why are we using ‘special’ offences of ill-treatment and neglect to prosecute crimes that occur in care, rather than the ordinary ‘offences against the person’ those outside of care rely upon?
Updated | As has been widely reported, a regional German court has ruled that a Muslim boy’s religious circumcision was a crime and that it violated his basic constitutional rights to bodily integrity. This ruling has no direct effect on other European states, but will buoy the campaign against male circumcision.
Thanks to an admirably swift response from the Cologne Regional Court to my request, I have uploaded the appeal decision (the important one), the original decision which was under appeal and the court’s press release. All are in German. I have also uploaded a version of the appeal judgment in English (updated – I have been sent a much better English translation).
Lee Carter, Hollis Johnson, Dr. William Shoichet, The British Columbia Civil Liberties Association and Gloria Taylor v Attorney General of Canada (2012 BCSC 886) 15 June 2012 – read judgment
Interest in the “locked-in syndrome” cases currently before the High Court runs high. We posted here on the permission granted to locked-in sufferer Tony Nicklinson to seek an advance order from the court that would allow doctors to assist him to die under the common law defence of necessity.
He is also arguing that the current law criminalising assisted suicide is incompatible with his Article 8 rights of autonomy and dignity. The other case before the three judge court involves another stroke victim who is unable to move, is able to communicate only by moving his eyes, requires constant care and is entirely dependent on others for every aspect of his life. (Philip Havers QC of 1 Crown Office Row is acting for him)
Re E (Medical treatment: Anorexia) [2012] EWHC 1639 (COP) – Read judgment
Update | In an earlier version of this post a question was raised by the author concerning the implications of funding restrictions within the department of the Official Solicitor for cases similar to E’s. The author is happy to make clear that no criticism is made of the actions of the OS in this or indeed any other case in the judgment of Peter Jackson J or in this post.
Mr Justice Jackson has ruled that it would be lawful and in the best interests of a 32 year old woman (referred to in the judgment as “E”) for her to be fed, using physical force or chemical sedation as necessary, for a period of “not less than a year”.
The judgment has sparked considerable press attention, and is also reported to have drawn criticism from Rochdale Lib Dem MEP Chris Davies. Against that background, this post intends to offer a modicum of analysis as to what was decided, why and what lessons the case holds for the future.
This blog is maintained for information purposes only. It is not intended to be a source of legal advice and must not be relied upon as such. Blog posts reflect the views and opinions of their individual authors, not of chambers as a whole.
Our privacy policy can be found on our ‘subscribe’ page or by clicking here.
Cancer Voices Australia v Myriad Inc 13 February 2013 – read judgment
The Mid Staffordshire NHS Foundation Trust Public Inquiry report 
An NHS Trust v SR [2012] EWHC 3842 (Fam) – 
Debate about whether the 
Eleven Winterbourne View staff have 
Re E (Medical treatment: Anorexia) [2012] EWHC 1639 (COP) – 
This blog is run by
Recent comments