It’s 2020, and we’re not yet flying around in hovercars. Yet the world is a fundamentally different place to what it was 20 years ago.
Back then, mobile phones were becoming increasingly common, but the smart device revolution was still several years away. Facebook wouldn’t appear before 2005. Google existed, but was many years removed from the all-conquering behemoth we know now.
Nowadays, in a world of smartphone ubiquity and endless online information, the marketing of data has become commonplace. While such information is valuable, the whole oblique nature of the process renders it, for good or ill, of little everyday interest to most.
The health and wellbeing sphere has been far from immune to the encroachment of big data.
Google routinely monitors the exercise its users take, where they cycle to, where they’ve walked.
Popular apps such as FitBit, acquired last year by Google, or Apple Health, collect data on individual users’ fitness and wellbeing statistics as a matter of course, though the volunteering of said information is voluntary.
Closer to home the recent launch of the Covid Tracker app was a poster-child for responsible data processing in the case of a civic-minded app, one which people who would ordinarily have little appetite for interacting with the data giants such as Google would be more inclined to download.
However, the app has not been without its problems, most of which have stemmed from the Google/Android side of things and have been fired by that company’s need to acquire data to feed its behavioural marketing models.
Asked at the launch about the appropriateness or otherwise of relying so heavily on private entities Apple and Google for an application aimed at curing a societal ill, Health Minister Stephen Donnelly compared the tech giants' status to that of a national utility.
“I think it is probably a facet of modern life. They are the technology platforms. We’re largely dependent on the ESB to keep the country running, but that’s ok. We are largely dependent on these private-sector companies to keep the internet running, to keep broadband running, to do an awful lot of things,” he said.
“It just is what it is.”
However, there is other data relating to our collective health — physical information that is of huge value. And the sheer scope of what it means is something the Irish State, let alone its people, has yet to get a handle on.
We’re talking about genetic data, and the market value of the individual human genome — the DNA files which double as the building blocks for humankind.
The focus of this market is not necessarily research. The value lies in what may seem a far more banal avenue, mainly the predictability of susceptibility to disease. But if you think that means the potential for enormous profit does not exist, you are very much mistaken.
Last month, Blackstone Group, a giant American private-equity multinational, acquired about 75% of Ancestry.com in a deal worth the guts of €4bn.
Ancestry is an American genealogy company set up in 1996, the largest for-profit entity of its kind on the planet, with its European headquarters in Dublin.
Its fundamental premise is the sale to consumers of DNA kits with which they can map their genetic ancestry. This basically translates to an estimate of ethnicity, together with the inference of family relationships between its 18m users. In practice, the service is used by customers to trace unknown biological relations. Analysis of its kit samples is performed by the American corporation Quest Diagnostics, one of the largest clinical laboratory companies in the world. Irish people will be familiar with it as one of the laboratories, used to process Cervical Check samples, which became household names after a number of Irish women took lawsuits over incorrect smear-test results.
Blackstone’s recent track record has been one of investment in growth industries and companies likely to benefit from dramatic shifts in consumer behaviour. It is far from inconceivable that the move towards marketable genomes is a classic example of such a shift.
What may come as a surprise is that a valuation can indeed be placed on an individual’s genetic sequence.
“For $99 they’ll tell you what percent Viking you are, and how susceptible you are to cancer,” says Simon McGarr, a privacy solicitor.
“It’s amazing that they get you to pay them. You don’t get much of anything in return really. But they’ve got the genome, and the genome is valuable.”
A recent presentation by pharmaceutical research company Open Orphan put the price per sample at anything between $450 and $3,000. A compromise figure of $1,500 is often accepted as the current going rate.
Apply that rate to a full population and you begin to see that genomics is big business, with large-scale pharma multinationals on the lookout for areas where they can access swathes of genetic data, ostensibly for pharmaceutical research, most especially in the field of rare disease drugs.
Individual citizens owning the rights to their own genetic data is far from usual, but that cannot alter the fact that the acquisition of such data is big business in 2020.
So, what if there were a determined grab for the genetic data of the Irish people?
That’s an easy question to answer because it has to all intents and purposes already happened.
In late June of this year a private entity known as Genomics Medicine Ireland (GMI), established in 2015, quietly rebranded its American, Icelandic, and Irish operations as Genuity Science, while acquiring a new chief executive.
GMI had made any number of headlines in recent years, with its goal of sequencing the genomes of 450,000 people — a tenth of the Irish population, and a large enough cohort to enable the effective profiling of the entire citizenry, given the interrelated ancestry of Ireland’s people.
The company has been partnering with individual hospitals to acquire large tracts of genetic data.
Earlier this year it found itself embroiled in a controversy of sorts after a joint venture between itself and Beaumont Hospital in Dublin, aimed at harvesting the genetic data of 9,000 brain-tumour patients of the hospital, was broadcast publicly via a series of newspaper advertorials. The catch is that participation in the project is on an opt-out basis, rather than opt-in, and many of the participants are already dead.
The study itself had initially been blocked by the State’s Health Research Consent Declaration Committee, established under the Data Protection Act 2018, which gave effect to GDPR in Irish law. That decision was overturned on appeal, with a caveat that the study must be publicly advertised.
Eventually the company and Beaumont bowed to public pressure and extended the deadline for opting out of the study by three months until the middle of this month, to mitigate the effects the Covid-19 pandemic would have had on the visibility of the public information announcements. This week the deadline was extended once more until the end of this year, following a flurry of criticism from the likes of Social Democrats co-leader Roisin Shortall.
Why the name change?
Despite its name, Genomics Medicine Ireland was in fact a subsidiary of an international genetics company, WuXi NextCode, which acquired it in 2018.
Officially, Genuity has said the rebrand was necessitated by it having to “overhaul its structure after China introduced new national security regulations which make it harder for foreign genetic research companies to share data”. The move saw Wuxi NextCode split from its Chinese operations as part of the corporate restructuring.
However, the company’s prior association with China, given the political climate in the Asian country, had led to criticism from some quarters, with Wuxi NextCode last year rebuffing accusations of ties to China, emanating from the American Senate, and reiterating its status as a multinational headquartered in the US.
“Where does GMI stand? They’ve kept stating that they’re not Chinese, so that would suggest it was damaging the study,” said one industry source, speaking on condition of anonymity.
“This restructuring allows us to sharpen the short-term strategic focus of our business to better catalyse the biopharma industry’s ability to effectively and efficiently integrate genomic data and insights into their drug development endeavors,” said Rob Brainin, incoming CEO of the new entity. “Our long-term vision and commitment to improving the lives of patients by accelerating the pace of precision health remains the same.”
Where Genuity stands out is that in it the Government has opted for the genomic profiling of the Irish nation via a private entity, one backed by roughly €70m in taxpayers' money via the Irish Strategic Investment Fund.
Meanwhile, a Wuxi NextCode executive went on LinkedIn in August 2019 to announce that GMI had “12,000 whole genome sequenced MS patients” and was “actively looking for a pharma partner to explore the underlying genetic and biological drivers”. The post was removed shortly thereafter. The executive no longer works for Wuxi.
This is not to say that Genuity’s data-acquisition practices have escaped regulatory scrutiny. In November 2019, months prior to the Beaumont Hospital public announcement, the Data Protection Commission informed privacy advocacy grouping, Digital Rights Ireland, that it had commenced a “widespread compliance and supervision” investigation regarding how the company processes the genetic data of Irish citizens. No update on the matter has yet been released, although it is understood the possibility of a full inquiry into the company’s data-acquisition practices has been mooted and may yet materialise.
The overriding question regarding Genuity’s endeavours with the Irish public’s genetic data is why the Government hasn’t become involved in orchestrating a publicly-funded genomics project — one which would cost a fraction of the price of the private project, and which would see the collated data returned to the public domain.
“What these private projects are doing is collating genome banks and then charging big pharmaceutical companies to access them,” says McGarr. “You could use that genetic information to profile who might be susceptible to the coronavirus, for example.” The then-GMI had made just under $13m in revenue through “making available certain genomic data to be used in extensive research” per its most recently-filed accounts as at the end of 2018.
“It comes down to this: What do people know and what do they expect? DNA is abstract; someone could consent to selling it, but would they want it sold on to the big pharma companies?” says McGarr.
In theory, the sale of genetic data does not have to be a one-off either, but something that can be repeated, with the same windfall on each occasion. Taking the 450,000 cohort which Genuity has aimed for, at a price of $1,500 per sample, you’re left with a databank with a value of $675m with the possibility of resales.
“The fact that Ireland hasn’t considered the ethical problems involved in the collation of this data is an abomination,” says the industry source.
“For €10m we could have a national genome project which benefits those taking part. Private industry, its responsibility is to make profits via therapeutic products. You have to presume that such concerns make decisions which will be beneficial to them,” they say.
So why wouldn’t the Government get involved in a publicly-funded genome project, of which there are multiple examples already in existence across Europe? Why instead sign on with private industry?
“My feeling is that there has been a tendency to worship at the altar of foreign direct investment in Ireland at a cost of letting foreign companies dictate the terms of engagement,” says the industry source.
“These companies are not questioned in terms of risk-benefit ratios. That is fine in terms of reputational risk, but your genome is another ball game. It’s like a naked picture of you. If you knew someone was taking one you wouldn’t let them. In Ireland we’ve chosen the most exploitative model possible.”
“This private project should be countered by a public one. Look for diseases in the Irish population and benefit a huge amount of people for the least amount of investment possible.”