The future of tens of thousands of Irish DNA samples, some collected under controversial donation and consent mechanisms, isn’t any clearer now than it was two years ago when US biotechnology company HiberCell acquired DNA analysis company Genuity Science Ireland.
Genuity might be better recognised under its original name, GMI (Genomics Medicine Ireland), which received a €5 million investment of taxpayer money in 2016 from the State’s Irish Strategic Investment Fund (ISIF). GMI was then acquired by Chinese-backed WuXi NextCode in 2018 in a €350 million deal that saw ISIF stick in €66 million more.
As many genomics and DNA experts have pointed out, this was an extraordinary amount to place into a commercial company handling sensitive Irish DNA data, especially when the State lacked – and still doesn’t have – an established national genomics centre, the expected priority for taxpayer money. Ireland does not have national research, ethics and security standards for genomic data, despite the growing importance of genomic research and treatments.
For a time, GMI/Genuity flagged itself as the solution for this gap. In line with such a role, the company aimed to obtain DNA from 400,000 Irish people, at the time a tenth of the national population. Scientists estimate that the entire population of a country can be genetically profiled from the DNA of just 2 per cent of its citizens – with many potential privacy and security implications that would extend beyond Ireland, given the significant numbers of Irish immigrants whose DNA features in populations abroad, particularly in Britain, the United States, Canada and Australia.
GMI/Genuity’s acquisition of Irish DNA included collaboration deals with Irish hospitals, in some cases utilising DNA from tissue or other samples obtained originally for healthcare purposes, not for a commercial database.
In the case of DNA taken from brain tumour samples of current and past patients at Beaumont Hospital, GMI’s consent process came under scrutiny for requiring individuals or their families to formally opt out of having DNA included in a data set, rather than the international gold standard of having donors or their families opt in for inclusion.
A similarly questionable approach was taken for obtaining modified consent for DNA from people with Alzheimer's.
During the pandemic, Genuity began to struggle. It was acquired in August 2021 by HiberCell, another company in the portfolio of its Arch Venture Partners, Genuity’s largest venture capital investor. HiberCell said at the time that the Irish genome databases would remain in its Irish-based Genuity Science operations.
However, in March Genuity’s directors noted that poor trading and financial losses meant the company had “material uncertainty” that it would continue to receive funding from parent HiberCell. If Genuity were to be sold again, or fold, those valuable Irish genomes could move elsewhere, or disappear.
So much for all the past government and company hype over the genomic benefits Irish people would receive from the company. Perhaps GMI’s changeovers have focused government and ISIF minds on the volatility of funding high-risk private companies to manage Irish genomes, rather than pouring that €71 million into creating a stable national project.
Public genomics infrastructure
Whatever the impetus, the Government has finally begun to invest in a long overdue public genomics infrastructure. Earlier this year, Genomics Data Infrastructure (GDI) Ireland was launched, aimed at creating secure national infrastructure for Irish DNA and clinical data. It is part of the European Union’s €40 million European 1+ Million Genomes initiative. Alongside this, the Health Service Executive plans to create an office to oversee a national strategy around genomic medicine.
There is scant detail so far on the Irish projects but any serious move to bring Ireland up to even basic international standards on managing these sensitive national resources would be welcome, even if woefully belated.
The Irish Council for Civil Liberties (ICCL) has expressed concern about GMI/WuXi/Genuity for years. Olga Cronin, ICCL’s surveillance and human rights senior policy officer, notes: “It’s a crushing loss for the people of Ireland that a private company, on receipt of €66 million in State funding, built a database of Irish people’s genetic data by collecting the same via publicly-funded Irish entities.”
She believes the Department of Health “must take urgent steps to find a mechanism for the DNA samples and data to be returned to the Irish people” while also finally addressing the “social, ethical and legal implications” of genetic and genomic research.
One obvious step would be for the State to acquire the Genuity Irish genomes for GDI – or for HiberCell to donate them. Irish donors and families were always united in wanting their genomic donations to benefit Irish and global research, and ultimately, other people through new treatments and medicines.
Given that questions have remained about whether some GMI/Genuity consent mechanisms met international standards or requirements for informed consent, it’s hard to see how these genomes would or should be bound in perpetuity to Genuity or HiberCell. After all, families and donors likely did not imagine their genomes would already have been passed to new entities beyond GMI, after two corporate acquisitions. It’s time for them to come home.
