Sign in. It’s quick, free and it’s up to you.
An account is an optional way to support the work we do. Find out more.
A PRIVATE COMPANY called Genomics Medicine Ireland (GMI) has an ambitious plan to collect the genetic code of a significant portion of the Irish public.
To start with, let’s deal with the science bit. As I’m not a scientist, let’s hear what Orla Hardiman, professor of neurology at Trinity College and David McConnell, a fellow emeritus in genetics, had to say about this in an opinion piece for the Irish Times last year.
Clinicians are being contracted and asked to obtain consent from their patients to transfer clinical information to GMI, along with a tissue sample for WGS. We understand GMI will pay for the additional hospital clinical costs required for the project. It will obtain the full genetic code for each patient (WGS), and it will analyse all the data. For the most part (with notable exceptions in some paediatric cases) there is minimal tangible benefit to the patient who participates in this programme.
The State has pumped approximately €73.5 million into GMI, as a commercial investment via the Irish Strategic Investment Fund (ISIF). This investment was made alongside Google’s Venture capital fund.
The beneficial ownership of the company is obscure but it has acknowledged it is a subsidiary of WuXi NEXTcode, part of the Chinese WuXi pharma group.
But the business plan is clear. Collect up 400,000-ish Irish genomes. Hold it as the private asset of the company. Take payment to let other companies access it.
This is a bad idea.
It is not just a bad implementation of a good intention.
It is the wrong policy altogether.
It will be an irreparable error to allow GMI to collect up this genetic data and hold it as a corporate, private asset, selling access to it for profit. If there is to be a research benefit from genetic data, it is critical that we do not allow the privatisation of the critical private data of individuals.
Senator Alice Mary Higgins was less convinced by the benefits of GMI when she said last summer that “some very concerning issues arose in regard to GMI in that it has been asking questions about where biobanks might be stored, indicating that the genetic data it is collecting would be shared first with pharmaceutical companies”.
No national framework
In the UK, the NHS established a special vehicle to collect and secure genomic data for the public good.
Our Government has simply abdicated its duty to set a national framework genomic policy. As Dr Ciara Staunton wrote recently “this investment has serious legal and ethical concerns that are likely to negatively impact genomic research in Ireland”.
So let’s look at some of those legal concerns.
To do that, we need to understand the personal experience of a patient who is asked to give consent to their genetic data to be given to GMI.
The issue of consent
We can do this pretty clearly because Digital Rights Ireland (DRI), whom I act for, obtained the paperwork submitted to Galway University Hospital’s Ethics Board to allow for data sharing with GMI. This included the information leaflet proposed to be given to patients to obtain a consent.
And, reassuringly, there was a special section in that information leaflet headed, in all caps ‘ARE THERE ANY RISKS INVOLVED IN PARTICIPATING’. Less reassuringly, the likelihood of re-identification is neither addressed nor referred to under this risk register section at all.
This is despite that Dan Crowley, while Acting CEO of GMI, confirmed that:
All participants are made aware in the Patient Information Leaflet (PIL) that we can never fully eliminate the risk of re-identification… In the case of rare disorders, we have specifically stated in the Patient Information Leaflet that, if a participant has unusual clinical symptoms, it could result in their identification.
Last May, our office wrote on behalf of DRI to the Clinical Research Ethics Committee pointing out the Patient Information leaflet they had approved did not have any specific statement highlighting the specific rare disorders risk, or what the consequence of re-identification could be (or the consequence for their family members).
Without these risks of participation detailed to patients, we did not believe that any consent gathered for sharing genetic data with GMI would meet the standard to demonstrate valid and informed consent under Article 7.1 of the GDPR.
We also highlighted that the leaflet did not inform patients of the identity of the data controller(s) in respect of their sensitive personal data, distractingly discussing the legally irrelevant question of ‘access’.
In a document endorsed by all of the EU’s data regulators (the Article 29 Working Party) it was confirmed “at least the following information is required for obtaining valid consent: (i) the controller’s identity”.
Similarly Recital 42 of the GDPR says “for consent to be informed the data subject should be aware at least of the identity of the controller”.
The proposed information leaflet didn’t even meet the ‘least’ requirement to allow for informed consent.
An irreversible error
Despite this, at the start of July, the Clinical Research Ethics Committee replied that it was not their responsibility “to ensure and monitor compliance with any relevant legislation in the country where the study is due to take place” and that “study sponsors Genomic Medicine Ireland state they are in compliance with the GDPR”. They said they saw “no reason to change our opinion on the study”.
Digital Rights Ireland was sufficiently concerned with this approach from the Galway University Hospital that our office was instructed to forward all of the documents and the correspondence to the Data Protection Commission last August, raising an official concern.
In early November, the Irish Data Protection Commission confirmed that it had commenced what it termed a “widespread compliance and supervision exercise into the processing of personal data by Genomics Medicine Ireland and its clinical research partners”.
This is just one project. There are many others where GMI have been urgently pressing the Department of Health to declare they don’t have to rely on valid consent.
Some policy errors are reversible. Some mistakes can be fixed later.
Letting the genetic code of a sizeable chunk of the Irish population fall into private hands to be used for profit, forever, isn’t one of the fixable kinds of mistakes.
Simon McGarr is a solicitor with litigation firm McGarr Solicitors and the Director of Data Compliance Europe.
SELLING OUR GENES Investigation
Do you want to know if the Government should be funding a private company to collect 400,000 Irish people’s DNA?
The Noteworthy team want to do an in-depth investigation into why a private rather than public initiative was funded to sequence Irish genomes and find out what is being done to protect Irish genomes and data privacy in terms of genetic material.
Here’s how to help support this proposal>
To embed this post, copy the code below on your site
Fabulous, if not dystopian piece Simon. I have to say, the increasing grip private corporations have on everything from our newsfeeds, to our diets, to our medical data is truly frightening. What’s even more frightening though is people’s lack of interest; I give you Alexa, Google Home etc.
@Diarmaid Twomey: Corporations control governments when it’s supposed to be the other way around. Ireland was probably targeted for its light touch regulation.
I mean in the U.S. the corporations literally author the vast majority of bills passed in Washington and the people voting on them have little clue about their contents and it takes a couple of business days to get the 10,000 page document into law.
Welcome to late stage capitalism ladies and gentlemen.
We should all be concerned at such a proposal, your DNA is unique to you , why should a private company acquire your genetic code and use it for profit or God knows what purpose in the future. Be careful if you are asked to sign any documents in this regard and if you are not comfortable with this, just say no.
@Honeybee: Ní féidir sclábhaíocht ar Éire. But, yes, read and say Nó if you don’t comprehend..
Let the government make it illegal, is it not already??
@Mick McGuinness: “. . . The State has pumped approximately €73.5 million into GMI . . .”
@Mick McGuinness: I’d like to know whether the Taoiseach, Tánaiste, any Minister, or any other office-holder has a beneficial interest. Why else would the State be pumping money into a secretive private concern?
@Fachtna Roe: look it up. Not that difficult.
Whats the point of GDPR if things like this are happening???
@Lydia McLoughlin: GDPR is a smokescreen to prevent you finding out these things are happening. Data Protection is worthwhile, but GDPR seems to be used to tilt the scales in such way as to balance Freedom of Information.
@Fachtna Roe: this is a complex area of data protection , your ill informed comment about GDPR does not help as it is completely inaccurate and just plain wrong. GDPR is no smokescreen , it is a large global regulation that required a lot of work and is designed to deter organisations from misusing data collected with some very heavy financial penalties (eg 4% of global turnover is a lot of money just for abusing somebody email data ) – it is not a ‘smokescreen’ – as for the GMI issue in the piece – the author makes a very good case as to why we should not allow privatisation of our genetic data – I would go a step further and point out the risks that this genetic data can be used by private companies in the future ( especially insurance companies ) if they remain unregulated – to risk profile and refuse health cover and life cover or else more likely ‘charge more’ money for individuals they claim are riskier to cover due to their ‘genetic history’ – that level of data abuse really will need the governments to legislate and protect citizens from.
@Dave Hammond: Waffle. Plus, GDPR is an EU regulation.
Neither the author nor his employer are medical professionals. This is a medical project and yet the legal profession feel emboldened to make judgements in the collection of anonymous data that may prove beneficial for future medical research.
This is an ongoing issue, where the pursuit of narrow legal interests out ways the public good. This occurs regularly in medical negligence cases where impossible legal standards are imposed on imperfect medical practices and the outcome deemed negligent and therefore cash generating.
Not all areas of life should be subject to the whims of lawyers, their legal arguments or the interests that employ them to do so.
This incessant creep of legal interference in areas they are not qualified to make judgements in does a disservice to us all.
Any possible leak of data, possibly trivial, from this study should not be considered important enough to interfere with initiatives which may have beneficial outcomes for public health.
Not all data is created equal, and the current fetishisation of the protection of innocuous information is pointless and almost certainly negative for future research.
@Gerard Carthy: Well done for missing the entire point Gerard. In case you forgot the legal profession exist to protect citizens through the use of laws. Just cause you’re a medic doesn’t give you a licence to obtain and process people’s most private data because you say it will be of use for private ends.
@Diarmaid Twomey: Exactly right.
@Diarmaid Twomey: I feel so protected every time I have to answer stupid data protection questions to pay my own bills. Or try to interact with a bank. Or move electricity supplier. Or prove I’m the same person to my own bank. Or hear that the legal profession are going to make swings hazardous implements that need supervision at al times from now on in the pursuit of a narrow and depressingly idiotic argument.
And you thin I’m missing the point and should be grateful to be treated like a child?
@Diarmaid Twomey: it’s the state that exists to protect citizens, not the legal profession per se.
@Gerard Carthy: Gerard if you feel private corporations being made tell you when and if they are processing your information is akin to you being treated like a child, fair enough. That’s your prerogative. However, don’t insinuate that a legal professional, or anyone else for that matter, who expresses concern about private corporations profiting from the processing of private medical data is being pedantic or some sort of pain in the *asre! Feel free to join MAGA rallies and eat chlorinated chicken, if the medical professional (who obviously are above us all) tell you to, but I’ll stick to wanting my data and rights protected and vindicated, thanks very much.
@Gerard Carthy: You absolutely do not have a clue.
@Gerard Carthy: ‘the protection of innocuous information is pointless’ – hmm this is very valuable data ( not innocuous information ) – one example is the risk profiling that a private company will be able to use this data to ‘monetise’ such as health insurance – life assurance – corporations and big pharma will be able to target profiles that are more vulnerable based on genetic data – the author is correct to point out the slippery slope that ‘privatising’ this field is going down – I think you are quite incorrect and missing the point to lump this in as potential innocuous data – it is not about a possible leak or the consequences of such a leak that it the concern – it is that the unique genetic data of individuals can be monetized by private companies – that is the risk that the author correctly identifies as very real and very wrong. There is nothing innocuous about the motivations of large private companies wanting to access important private data.
@Dave Hammond: The database in question has no personal identifiers, is accessible on a read only basis and the amount of information that can be accessed at a time is limited. It would be impossible for an insurance company for example to make any commercial use of it. Since we have a community rated private insurance and pre existing conditions are non exclusionary it’s not even an issue.
It amazes me how often access to fairly useless insurance is a reason why data projects should be cancelled. Weird.
@Gerard Carthy: Excellent comment. I would add that in this whole zone of research, a tremendous new vista is opening. The most popular gift now given in some countries, is an ancestry DNA test, which shows those participating, really interesting information on where one came from back the millennia. What it could also show is the presence of problem recessives. A simple App will then allow prospective parents to do a pre check. This will inform them of the chance of their potential offspring exhibiting some life effecting syndrome, hemophilia, CF or the like. This information will allow them to go for I.V. and pre implantation selection, thus leaving the horror story behind. Who could say no to that, but meddling lawyers could greatly obstruct it.
@Nicholas Grubb: That reads like an advert, or a paid comment.
Informative article
Like any economic or military advantage, genetic engeering is unstoppable. Sadly.
If we (the West) ban it others will get an advantage – and like how we destroyed aborigines in the Americas, Australia and Asia with more advanced technology – they will do unto us.
Humanity didn’t decide to move from hunting to farming 10,000 years ago; it had no choice.
Frightening
Isn’t this the second time in a couple of weeks this article (or a slightly different version of it) has been posted on the Journal?
@This Guy: Were you hoping it would be kept a secret?
I have a problem understanding this whole thing. I can understand How a company can profit from this, by selling the information or an old man I.e. me. A sixty year old man, three major health issues identify unknown but how does it affect me with regard to data protection
@Alan Dignam: A situation might arise where health insurance companies would be able to pick and choose who to insure based on risks associated with your genetic makeup. Not a good situation, essentially removing risk for them.
@Alan Dignam: Your DNA is the most unique and valuable thing you received from your parents, and the most unique and valuable thing you give to your children.
It is also the most complicated thing most of us know of, and printed would be a stack of paper 130m high.
You get that complexity free, and pass it on free for the natural purpose.
A corporation is legally a person, but non-living. Think “Corpse” and “Oration”. This is the type of entity that may end up ‘owning’ the code for living people.
The effect on our planet of these dead-people-speaking is hardly positive. Why trust them with the codes for life?
In that corporations are themselves non-living, but require us living people to survive and propagate, they are functionally the same as a virus.
They can sell mine their defective lol
@Aaron92utd: evidently!
@Aaron92utd: so you can pay higher health insurance premiums, or maybe be deprived of obtaining life insurance for that mortgage you applied for? And you won’t know why unless you pay for the results….
If think we should get a % every time our data is sold whether dna or online usage. We should have the right to have it deleted and to block further sales.
It’s our data about us we should have complete control, but also if someone is profiting from the sale of our data we show also profit.
@Davis Payne: Your DNA also contains information about your relatives, and theirs about you; that’s worth a lot more than the few cent you’d be lucky to get from a corporation.
Data is the new oil……
Very interesting series of documentaries about the oil industry.
Part 3 is called “Data is the new oil”
A fairly comprehensive explanation of how data has become a commodity.
have your say