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

Privacy, the CRPD and the Commercialisation of Personal Medical and Genomic Information

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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 certainly was a big decision; we will soon have a national genetic database that has been a decade in the making. Throughout this period, the public, reassured by promises of anonymity and misled from the beginning, have been excluded from playing any part in what amounts to no less than a cultural shift. Let me explain.  

In anticipation of a supposed paradigm shift in healthcare based upon genetics, New Labour, under the direction of the UK pharmaceutical sector, set about implementing a major legislative programme in order to gain a competitive edge in the development of proactive genomics. It began with NHS National IT Programme, which included, ‘Connecting for Health’ – a set of interconnected databases, containing electronic medical records. The Secondary Uses Service soon followed, a mechanism by which personal medical information can be shared and accessed. Shortly after, the piece of legislation that facilitated all of this was introduced: Section 251 of the 2006 NHS Act. Section 251 is granted by the Secretary of State for Health and provides relief to the common law of confidentiality, Article 8 of the Human Rights Act 1998, as well as the Data Protection Act 1998. It permits access to patient-identifiable medical information without the need for consent. The only thing that is missing is a national genomic database; the last piece in this grand design.

Remember, the premise of ‘Connecting for Health’ and Summary Care Records was that they were ‘essential to treating patients in an emergency or out-of-hours with faster access to key clinical information.’ EthicsandGenetics has long argued that ‘Connecting for Health’ was in fact specifically designed so that electronic medical records would ultimately be linked to personal genetic data.

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 established. 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.’

A national genomic database is a major development which that has far-reaching implications for confidentiality and privacy. With regards to this, the report by the Human Genomics Strategy Group recognises that ‘an individual’s genetic information is sensitive personal data, and a whole genome cannot be truly anonymised.’ Furthermore, ‘there is a risk of the information being misused.’

In September, a further and crucially important development took place: The Clinical Practice Research Datalink (CPRD) was launched. It streamlines medical research by connecting patient information from GPs and hospitals to other records, such as the national genomic storage facility; making the data accessible to both the public and private sectors at a cost. Under the new system, anyone who uses the NHS will automatically become a research subject, unless they chose to opt -out. On the CPRD website, it is claimed that ‘researchers never get access to names, addresses, post codes or dates of birth.’ Moreover, Dame Sally Davies, Chief Medical Officer and Chief Scientist at the Department of Health said: ‘protecting the confidentiality of patients remains a priority, so all data is anonymised and people can opt out.’

When these proposals were initially announced, David Cameron claimed that ‘this does not threaten privacy, it doesn’t mean anyone can look at your health records but it does mean using anonymous data to make new medical breakthroughs and that is something that we should want to see happen right here in our country.’ Shortly afterwards Andrew Lansley claimed that ‘it is not about sharing individual records in a way that can identify who those people are.’ Within the context of medical research, anonymised information is not of that much use. I could not help but feel sceptical. A further FoI disclosure to EthicsandGenetics by the Department of Health revealed that ‘information may be made accessible where it has been effectively anonymised or where there is appropriate legal authority to make it accessible. Whilst most researchers will only want access to effectively anonymised data, legal authority to access identifiable information may be provided through the consent of the citizens concerned or through legislation, such as Section 251 of the NHS Act 2006 can be used to authorise access for specific purposes.’ In a further Freedom of Information request by EthicsandGenetics, the Department of Health was asked if patient-identifiable information will be made accessible to private organisations:

“In most cases, the Department would expect consent to be obtained for disclosures of identifiable data. However, projects may apply to the Ethics and Confidentiality Committee for Section 251 approval where consent cannot be obtained. There are circumstances where it is very difficult to contact patients to seek their consent, or where it is vital that the data are identifiable, for example, to link data with a separate data set.”  

When we turn to the number of times Section 251 is secured, a separate FoI request by EthicsandGenetics to the Department of Health revealed that Section 251 of the NHS Act 2006 was been granted 42 times in 2008-09, 36 in 2009-10 and 54 times in 2010-11. This is at the rate of once a week and is often for very large studies. Moreover, this is before the launch of the Clinical Practice Research Datalink. The picture that emerges is that that identifiable personal medical information is being made available, through the CRPD, to private organisations without the consent of the individual. This is in complete contradiction to the official line given by the Conservatives as well as what is stated on the CRPD website.

After a series of FoI requests by EthicsandGenetics to the Department of Health, however, the Department confirmed that patient-identifiable data - which will soon be followed by genetic data - is being made available to private organisations without the consent of the indivdual.  After a series of exchanges between the Department and the EthicsandGenetics, the ‘for the public’ section on the CRPD website, which covers privacy and confidentiality, was finally brought a little closer to the reality of current practice. When the website was first set-up, it stated that all information shared through the CRPD is strictly anonymised and consent is alwayys sought. By the end of September, it was changed to the following: 

“CPRD Researchers never* get access to names, addresses, post codes or dates of birth. They also work under strict rules covered by legal agreements about what they can do with the data and what they must never do. CPRD is based around a service that has been operating for many years and we can state we are not aware of any breaches of our security policy.”

“*There are studies undertaken where patients give consent that some forms of identifiers can be accessed.” 

While this may be closer to the truth, it is impossible to reconcile it to the FoI disclosure by the Department of Health, which clearly states that identifiable information is made available through the CRPD without individual consent. Surely, given that it is our data,  a modicum of transparency would be the least we could expect. 

Let us reflect upon these developments. I am enthusiastic about the prospects of personalised medicine and proactive genomics. However, it is truly objectionable that promises of anonymity do not reflect the reality of current practice or the considerable changes that have taken place over the last decade. Whilst these changed have occured incrumentally, they amount to a cultural shift which has redefined the status of personal medical data and the legal framework that governs it. Given the salience of these developments, and our democratic credentials, the public must be afforded a more central role.

The impending scenario of personal medical information moving between public and private sectors puts the individual at risk of being targeted by aggressive marketing strategies based upon tenuous claims about genetic predisposition to illness. Pharmaceutical companies will create new 'needs' for products, the medical and scientific basis of which may be little more than conjecture. The commercialisation of personal medical data and the relaxation of the medical research framework, opens up the possibility that genomic information could be used for purposes far beyond the public good. Many now believe that the future of marketing lies in genetics; it doesn't take too long to make the right connections and appreciate that it could be imprudent to hand over our genomic information without serious consideration of the consequences.

At EthicsandGenetics, we believe that big decisions about new forms of biotechnology and  genomics ought to be democratised. Indeed, people should decide for themselves if there is a clear medical advantage, individual benefit or public good, to be found in handing over our entire genome for purposes far beyond our knowledge. In order to do this, more transparency, more public engagement, is vital.    

For more information, please refer to the EthicsandGenetics Report, 'Privacy, The CPRD and the Commercialisation of Personal Medical Information,' in the 'research' section of this website. For more background information and commentary, please refer to GeneWatchUK, 'A DNA database in the NHS.' 

 

Edward Hockings

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A centralised genomic database and the risks it carries for privacy

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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 is a considerable development, what will it mean for confidentiality, privacy and the autonomy we ought to have over our own personal genetic and phenotypic information? The report by the Human Genomics Strategy Group recognises that “an individual’s genetic information is sensitive personal data, and a whole genome cannot be truly anonymised.” Adding that, “there is a risk of the information being misused.” Despite this, the report advocates a generic form of consent: which means that although consent to use tissue or genetic data must be secured in the first instance, it will be used in future research studies, the nature and purposes of which will be unknown.

EthicsandGenetics has long argued that ‘Connecting for Health’ was specifically designed so that electronic medical records would ultimately be linked personal genetic data (which will be collected and stored) to medical data (medical history). 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 consent. In short, these are the ideal legal and infrastructural conditions for the advancement of personalised medicine. The only thing that is missing is a national genomic database; the last piece in this grand design.

Should we sanction a practice where genetic information, linked to our medical records, moves between the public and private sphere - and is used for purposes beyond our knowledge? Genetic discrimination is increasingly prevalent in America; people are losing their jobs due to a mere predisposition to cancer. An examination of current practice suggests that, notwithstanding substantial changes, especially to Government transparency, and indeed, the need for far greater levels of public engagement in these matters - a national genomic database is a step too far. Let me explain.

Only recently, the Conservatives announced that they plan to open up medical data to private organisations. Andrew Lansley pledged that personal data will be made available in a strictly anonymised fashion. A Freedom of Information disclosure by the Department of Health to EthicsandGenetics reveals that the public were misled regarding these proposals. Both Andrew Lansley MP and David Cameron PM explicitly stated that any data shared under these proposals would be ‘anonymised.’

"Now let me be clear, this does not threaten privacy, it doesn’t mean anyone can look at your health records but it does mean using anonymous data to make new medical breakthroughs and that is something that we should want to see happen right here in our country."

David Cameron at the FT Global Pharmaceutical and Biotechnology Conference

In reference to the proposals Andrew Lansley, the Secretary of State for Health, explicitly stated that “it is not about sharing individual records in a way that can identify who those people are.”

However - in a Freedom of Information disclosure to EthicsandGenetics, the Department of Health stated that:

“Any release of data must be lawful and with appropriate permissions data could be released in anonymised, pseudonymised or identifiable form.”

These are the three different ways of classifying personal medical data:

Anonymised data: it is impossible to connect it with an identifiable individual

Pseudonymised data: is stored separately from identifiable information, but the link is still maintained and so the data can be attributed to an identifiable individual by anyone who has access to the linking codes. Moreover, pseudonymised data is such that in most cases the individual’s name and address are merely replaced by their data of birth and postcode. Identifying a person, if you so desire, is not difficult.

Patient-identifiable data: contains key identifiable information includes: patient’s name, address, full post code, date of birth; pictures, photographs, videos, audio-tapes or other images of patients; NHS number and local patient identifiable codes; Anything else that may be used to identify a patient directly.

While the Freedom of Information disclosure by the Department of Health goes on to say that “private companies operating on a commercial, for-profit basis will only ever receive fully anonymised data” - it is clear that the public were misinformed about the nature of these proposals and the type of information that would be shared with third-parties. It is also clear that the Government do not have a consistent position.

The Department of Health, in their initial response to a Freedom of Information request by EthicsandGenetics about what kind of information would be shared under these proposals, stated that all data would be strictly anonymised. It was only when pushed on the matter and asked to specifically define anonymised data; and confirm whether any data shared under these proposals would, in fact, be pseudonymised and patient-identifiable - that the Department of Health changed their position and confirmed that data would not always be anonymised.

As we have seen, ‘lawfulness’ – within the context of UK data protection law and practice – fails to provide us with the necessary safeguards. Moreover, the ‘appropriate permission’ undoubtedly refers to the powers given to the secretary of state of under section 251 of the 2006 NHS Act; which means that data could be shared without individual consent. Lastly, while Andrew Lansley pledged that the data would be ‘strictly anonymised’, the Department of Heath makes it clear that it could be ‘pseudonymised’ or made available in a ‘patient-identifiable’ form. These are categorically different propositions and is indicative of a staggering lack of coherence in their overall position.

Given these inconsistencies, lack of meaningful legal protection and the dramatically new model of consent that genomic research requires - a national genomic database is not something that we should take lightly. 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. The premise of 'Connecting for Health' was to advance personalised medicine. This is not objectionable in and of itself. It is the manner by which it was implemented, the gross lack of transparency and, most importantly, the far-reaching changes to privacy law that is objectionable. It is the fact that it was driven by the Labour Party and the highest eshelons of the UK pharmaceutical sector in a way which sought to deceive the public that is indescent. The Conservatives pledged to curtail both 'Connecting for Health' and other similarly unappetising databases, yet they have followed in Labour's footsteps.

Some feel that we are inevitably moving towards a culture where personal genomic information moves between the public and private sector to the great medical benefit of the community. The question we must ask at this stage is whether all this is being done for the ultimate good of the public or are we dealing with a science that is in its infancy and some impatient members of GlaxoSmithKline that simply cannot wait to get ahead in the global market for personalised medicine? The latter is the more compelling explanation. Many argue that in the genomic era the classic model of consent is no longer appropriate and nor is it desirable. Ultimately, we would be wise to hold on to some control over our personal genetic information. Certainly, without meaningful public discussion, we should not relinquish tried and trusted principles overnight and nor should we let the genetic basis of human nature become a mere commodity. 

 

Edward Hockings

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