Fostering public engagement in the ethical and social implications of genetic technologies

Care.data and exercising our right to democracy

We have until March to opt out of the care.data initiative. The "theoretical risk" that we might be reidentified from our personal data once it is made available to third parties is a compelling reason to opt out. However, this is not the only reason. Care.data is part of a major legislative programme that includes the Clinical Practice Research Datalink (CPRD) and the 100,000 genome project – through which whole-sequenced genomes will be put to commercial use. These major infrastructural developments have been accompanied by radical changes to privacy law that have resulted in a cultural shift in the governance of information. These sweeping changes in privacy law were introduced without consultation, and the risks they entail will be borne by those whose medical records may be accessed without their consent. How did we get to this point? Fourteen years ago, written evidence by SmithKline Beecham to the Select Committee on Health, House of Commons, advanced…
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Standing in the way of Google-backed, 23andMe, will only delay the revolution medicine needs

Genetic testing is a powerful tool. Two years ago, with the help of my colleagues, it was this tool that helped us identify a new disease. The disease, called Ogden Syndrome, caused the death of a four-month old child named Max. But the rules and regulations for genetic testing in the US, laid down in the CLIA (Clinical Laboratory Improvement Amendments), meant I could not share the results of the family’s genetic tests with them. Since that time, I have advocated performing all genetic testing involving humans such that results can be returned to research participants. This I believe should extend beyond research, and some private companies, like 23andMe, are helping to do just that. For as little as US$99, people around the world can send a sample of their saliva to 23andMe to get their DNA sequenced. Their Personal Genome Service (PGS) analyses parts of a person’s genome. This data is then compared with…
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'A Shift in Privacy law, and the Attendant Risks'

EthicsandGenetics has published ‘A Shift in Privacy Law, and the Attendant Risks'. Coverage of the report by the Guardian can be found here. In this report, we identify and explore the risks associated with the government’s plans to establish a national genetic database and commercialise personal genetic information. Furthermore, we assess changes to privacy law and practice - in particular, the recent information governance review, and demonstrate that the new privacy framework fails to adequately safeguard highly sensitive information.  Our report, reveals that the government are set to commercialise personal genetic information collected from the population, and stored on a national genetic database. As well as this, EthicsandGenetics can reveal that now, by default, NHS-users can be contacted to take part in clinical trials with private companies, without having expressed an interest in taking part in research of any kind - let alone clinical trials.  Furthermore, the report offers a critical account of a…
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Privacy, the CRPD and the Commercialisation of Personal Medical and Genomic Information

Medicine and healthcare appear to be in the midst of previously unimaginable changes. These changes might result in an improvement in our understanding of the nature of disease and, in time, assist us in predicting how a patient might respond to treatment. However, the fact remains, sweeping changes have been made to the way medical information is shared and accessed, and the cornerstones of medical law are being eroded for a science still in its infancy. The coming together of genomics, genetics and society in entirely novel ways, brings with it risks that are difficult to quantify, and must be the object of open and sustained public discussion. Genetics, genomics and advanced biotechnology are not business as usual. The public must,  therefore, be given a central role in decision-making when it comes to substantive decisions in these areas. Indeed, a national genetic database and the commercialisation of genomic data was…
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Moratorium on Insurers' use of Genetic Tests

The Moratorium on insurers’ use of predictive tests was recently extended and the UK Government has launched a consultation on how it is working in practice. The Moratorium is exclusively concerned with tests used to predict future illness. While EthicsandGenetics applauds these developments, as the Concordat is merely an agreement, the question remains: how long will it last for, and most importantly, the Government will eventually have to regulate this new terrain by way of legislation, when we arrive at this point, what kind of legislative measures can we expect? Can we assume that future legislation will broadly reflect the current Concordat? Let us firstly consider its substance.     In brief: The Association of British Insurers (ABI) and the Government have agreed to the following measures: A. To abide by a policy framework that ensures that insurers’ use of genetic information is transparent, fair and subject to regular reviews. B. Remain…
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A centralised genomic database and the risks it carries for privacy

In a recently published report for the Government, the Human Genomics Strategy Group called for the development of a national central genomic data storage facility. This would mean that genetic data collected from the population will be linked to electronic medical records. ‘Connecting for Health’ was rolled-out on opt-out basis – can we expect the same with a national genetic database? In response to a Freedom of Information request by EthicsandGenetics, Danny Lamond, Ministerial Correspondence and Public Enquiries for the Department of Health confirmed that a “central repository for storing genomic and genetic data and relevant phenotypic data from patients” will be set-up. Lamond goes on to say that “The report (by the Human Genomics Strategy Group) has been welcomed by the Secretary of State for Health and the Minister for Universities and Science, who have asked for the recommendations to be implemented through a shared strategic framework.” While this…
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Privacy, the database state and the genomic era

In anticipation of a supposed shift in healthcare based upon genetics, New Labour, under the direction of the UK pharmaceutical sector, set about implementing a considerable legislative programme in order to gain a competitive edge in the global market for personalised medicine. This new model of healthcare requires access to massive data sets, and thus, the NHS National IT Programme, which included, ‘Connecting for Health’ – a national, set of interconnected databases, containing electronic medical records – was set up. Moreover, the Secondary Uses Service, a mechanism by which personal medical information can be shared and accessed, and makes patient-identifiable data available without individual consent, was also introduced. Lastly, Section 251 of the 2006 NHS Act circumvents the common law of confidentiality, Article 8 of the Human Rights Act 1998, as well as the Data Protection Act 1998 – and permits access to personal medical information without the need for…
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The merits of 'Personalised genetic tests'

Medicine and healthcare are in the midst of previously unfathomable changes. It is clear that we are moving towards an era of ‘proactive genomics.’ As the costs of sequencing a human genome fall, more and more private clinics and companies will offer ‘personalised medicine.’ From the standpoint of developing ever more sophisticated methods in healthcare, personalised medicine is an exciting prospect. Thus far, however, we are seeing unsubstantiated promises about a science that is still in its infancy. Genomic sequencing enables physicians to identify an individual’s predisposition to disease and potentially predict how a given patient might respond to a particular drug. It may also go some way in eliminating unnecessary treatments and reduce the possibility of adverse reactions to drugs and thus increase the efficacy of treatments. The continual development of new, faster and cheaper DNA sequencing technologies such as ‘next generation DNA sequencing’ is making it easier for more…
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The Ethics of Enhancement

“Genetic enhancements will not merely be permissible, but may be morally required. We face the dawn of biological liberation.” These are the words of Julien Savulescu, a philosopher at Oxford, and prominent member of the Oxford Uehiro Centre for Practical Ethics. What are genetic enhancements, why would they be morally required – and what on earth does Savulescu mean by the “dawn of biological liberation?” While genetic enhancements are not currently available for humans, some interesting and rather odd examples of the kind of enhancements that may become available in the future, can be found in GM mice. Genetic enhancements operate on the individuals’ genome, and very roughly, allow changes to be made, new genes to be added, faulty genes to be replaced by functional ones, and better genes in place of unwanted genes. There are two kinds: firstly, germ-line engineering, and then there is somatic gene therapy. The latter…
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Ethicsand @Ethicsand report on genetic privacy and the commercialisation of genetic data - covered by the Guardian guardian.co.uk/politics/2013/… … …

Friday, 05 July 2013 via web • 3 retweets

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Ethicsand Caldicott2 was not an independent review of privacy. Privacy laws have been redefined by the commercialization of personal data @Ethicsand

Friday, 05 July 2013 via web • 1 retweet

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Ethicsand All #NHS users can now, by default, have their medical records accessed by pharma companies, to take part in clinical trials. Happy 65th!

Friday, 05 July 2013 via web • 6 retweets

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