Selling Our Genes: Government inaction allowing private sector to take control of our DNA

Hospitals and universities across Ireland are collaborating with Genuity Science due to, experts say, lack of a public project or strategy.

By Maria Delaney

“I KIND OF feel like a pawn and a commodity in the research being planned by Genuity Science.”

Cancer patient advocate Eileen O’Sullivan is concerned about how consent, access to data as well as patient rights are handled when it comes to research involving private firms including Genuity Science, formerly known as Genomics Medicine Ireland (GMI), who collect DNA from Irish patients.

“As a country, we need to ask ourselves, because this is Irish patients’ data being used, what specific value is going to accrue to Irish patients,” explained O’Sullivan, who was diagnosed with breast cancer in 2013 and sits on the Irish Cancer Society Research Advisory Committee and a HIQA Advisory Group.

Genuity Science has been in the national news in recent years due to consent controversies, testy exchanges with the Government and cutting ties with its Chinese operations

Photo 1 Eileen O’Sullivan says that once trust is broken, it could potentially damage patient-doctor relationships.
Source: Eileen O’Sullivan

“The trust has been broken,” according to O’Sullivan who was one of a number of people who voiced concerns on RTÉ Radio’s Liveline about a study that Genuity are running with Beaumont Hospital where they intend to collect genetic data on over 9,000 brain tumour patients, without explicit patient consent. Noteworthy first publicised concerns by researchers about the timing of an opt-out process for this study last April.

This potential breakdown in trust was a great concern to many researchers that Noteworthy spoke to, including professor Cathal Seoighe of NUI Galway, director of the Science Foundation Ireland (SFI) Centre for Research Training in Genomics Data Science. Genuity Science is a partner and part-funding the research centre.

There is a concern around access to patient data. Seoighe told Noteworthy:

“We have not had adequate and sufficiently clear regulation [in this area]. That is very disappointing to see, as genomics has enormous potential benefits for Ireland if it is managed correctly.”

In order to get to the root of the issue, Noteworthy teamed up with the Business Post. Over the past few months, we trawled publicly available information and submitted numerous freedom of information (FOI) and press requests. We can now reveal:

  • Genuity Science, the main company involved in DNA sequencing in Ireland, has at least 25 links to facilities around Ireland. These include funding and collaborations with major hospitals, universities, research facilities and charities.
  • A collaboration agreement signed between Genuity Science and UCD is “restrictive”, according to an academic expert, though Genuity Science Ireland disagree with this assessment. We have the full details in this breakout article.
  • Hospital clinicians have become “agents of a company” due to the nature of agreements in place, according to experts.
  • Researchers are making “the best of the situation” in Ireland by working with the private sector but most would prefer a public system due to data access concerns.
  • Lack of Government policy and adequate regulation means that private companies have no limit on how long they have exclusive access to the data they collect from Irish patients.
  • Researchers and patient representatives are concerned about a potential erosion of trust in genetics research in Ireland.

In addition, in their article, also out today, our colleagues on the Business Post investigation team, delve more into:

  • The “engagements” the Data Protection Commissioner with Genuity Science following concerns brought to it about consent for research studies.
  • Genuity Science as a company, including their development, shareholders and what their rebranding from Genomics Medicine Ireland entails.

DNA collection projects across public system

Our investigation focused on Genuity Science, formerly GMI, as they are the main company involved in for-profit genomics research in Ireland. It recently announced a major corporate restructure, splitting from its Chinese operations and rebranding as Genuity Science.

This restructure is detailed in correspondence to SFI – obtained through FOI – which states it was a “process which began in mid-2019 in response to changes in China’s Human Genetic Resources Regulation”.

The company’s well-publicised goal is to collect genetic data from as many as 400,000 Irish people over the next couple of years. They have already made nearly $13 million from selling access to its Irish genetic data banks since founded, according to its most recently filed accounts. As part of this investigation, our colleagues at the Business Post have gone into more detail on the finances of Genuity Science, which you can read here.

Genuity Science Ireland insist that “all data that is generated and assembled during collaborations is done so in compliance with the GDPR and the HRR [Health Research Regulations] and following strict privacy controls and protections”. A spokesperson added:

“Our commitment to the lives and quality of life of patients and their families, remains at our core. We seek to better understand the role of genomics in disease to enable pharma and biotech clients to develop new and more targeted therapies for the treatment of life-limiting conditions.”

The investigation team found that they have links with 13 hospitals, six universities, six research facilities, one health research network and two charities around Ireland.

It has been confirmed through press requests or other documentation that the company has provided funding to ten of these facilities, though many hospitals and universities did not answer queries about funding links, with some citing it as “commercially sensitive information”.

Beaumont Hospital, which is running the controversial brain tumour study with Genuity Science, received a piece of equipment valued at €250,000, in relation to this project. The company paid for staff to conduct the research Tallaght Hospital is doing in partnership with Genuity Science at a cost of €520,000. It also funded all the study costs including research nurses for nine projects that St Vincent’s University Hospital (SVUH) are conducting with the company on patients who have conditions including Alzheimer’s disease, cancer and asthma.

UCD, which has signed a collaboration agreement with Genuity, did not respond to our query regarding funding but from searching the university’s website, we found a number of grants had been given to academic staff at UCD, including one for over €430,000 for asthma research. We obtained a copy of this agreement through FOI and an analysis of this can be read here.
https://public.flourish.studio/visualisation/3833445/

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We’ve created a searchable table showing a detailed breakdown of our findings. This lists each facility we found with links to Genuity Science, the projects they are involved in, funding received and other details such as consent, ethical approval and parliamentary question responses.

We divided the facilities such as hospitals and universities into documented association (mentioned in public documents such as press releases), confirmed collaboration (in a statement to us or an official document e.g. parliamentary response) and confirmed funding (in a statement to us or on an official site). View this table here >>

When we put our research to Genuity Science Ireland, a spokesperson said that “all research studies undertaken by Genuity Science and its collaborators are reviewed and approved by independent research ethics committees prior to commencement”.

Ethics are approved by the local hospital committees relevant to the study in question, they added. “All our research studies are subject to a formal contract between the hospital, Genuity Science, and, where relevant, the affiliated University.”

The company’s links with public hospitals and universities are set to grow as its focus for this year and next, according to an email from Genuity Science to SFI released to the investigation team under FOI, is to “double the disease areas of study”.

We asked the Department of Health if there are any new regulations and policies in development to enhance protection in terms of people’s genomes. A spokesperson cited articles five, six and nine of GDPR and also the Health Research Regulations 2018 and said that “there is already in place in Ireland a rigorous and statutory data protection structure for the protection of personal data processed for health research purposes”.

In addition, a department spokesperson said that a HSE genetics and genomics programme is planned.

Lack of response and conflicting information

Some universities and hospitals refused to provide any information to Noteworthy or the Business Post, even when we provided them with a list of publicly available information on projects they were participating in. Maynooth University was once such institution:

Maynooth University cannot release any information pertaining to ongoing research projects with industry partners as it could damage the overall integrity of the research outputs and the confidential nature of the partnership.

NUI Galway press office initially responded to our queries by stating that it was “unable to reveal the nature of agreements with industry partners as they are bound by confidentiality agreements”. After further inquiries, they subsequently provided some detail on their research links.

When asked about this response, Seoighe, who works in the university and reached out to Noteworthy, said that “companies and universities can be anxious about communicating with journalists on sensitive issues such as this, due to negative past experiences, but regardless of any risk of misrepresentation, I am in favour of maximum transparency about research partnerships between companies and universities”.

He disclosed that Genuity Science is part-funding the SFI Centre for Research Training in Genomics Data Science led by NUI Galway in collaboration with a number of other university and industry partners, by funding one to two PhD scholarships at a cost of approximately €120,000 each.

Seoighe explained that these scholarships have not been funded yet, but could involve the potential student spending some time at Genuity Science and an IP relationship would be drawn up in line with national IP policy.

“Genomics Medicine Ireland / Genuity Science is an industry collaborator on several SFI funded research awards. Irrespective of whether there are specific national strategies in certain areas, as with all such industry/academic collaborations, these collaborations are carried out under a formal IP agreement between the company and the host Higher Education Institution, in line with the National IP Protocol,” according to a spokesperson from the Department of Further and Higher Education, Research, Innovation and Science.

Others stated that they were not involved in any projects with Genuity Science in spite of press coverage to the contrary.

Cork University Hospital said it “has no record of any projects in association with Genomics Medicine Ireland” and Mercy Hospital Cork stated it “can confirm that it is not working with GMI” when the investigation team asked if they were working on projects with GMI, now rebranded as Genuity Science.

It was announced in 2018 that both hospitals were participating in an inflammatory bowel disease (IBD) nationwide study with Genuity Science. A spokesperson for the hospital said that “there is no official statement/information from MUH/CUH” in an article on the announcement provided to the hospital by Noteworthy.

In a statement to Noteworthy, Genuity Science Ireland said:

Ethics approval has been granted for the Mercy University Hospital study, but this study has not commenced. Genuity Science has an active agreement between CUH, UCC, and Genuity for an MS study led by Dr Brian Sweeney.

Children’s Health Ireland (CHI) were also queried by the investigation team about a conflicting statement in a recent HSE response to a parliamentary question by Róisín Shortall, joint leader of the Social Democrats, about hospitals association with Genuity Science. The hospital group stated that it has “not provided genomic data” to GMI, now Genuity Science.

However, CHI at Crumlin, previously known as Our Lady’s Children’s Hospital, was the subject of an internal investigation in 2019 after it emerged that genetic samples of roughly 1,500 patients were shared with GMI/Genuity without the required consent.

An FOI released to the Business Post from July stated that the hospital and the National Children’s Research Centre (NCRC) which is based there “provided pseudonymised samples to GMI in 2016 for whole genome sequencing in connection with a longstanding genetics research study” and “the provision of pseudonymised samples to GMI is the subject of ongoing inquiries”.

A spokesperson told Noteworthy and the Business Post that CHI has “not provided genomic data” to GMI/Genuity Science for their use. They added:

CHI at Crumlin and the NCRC provided pseudonymised samples to GMI in 2016 for whole genome sequencing in connection with a longstanding genetics research study that the NCRC and Crumlin were undertaking. No patient information or other personal details were shared with GMI.

The spokesperson said that CHI were advised by GMI that these samples were not analysed and none of the samples were ever used in a GMI research study. “As part of the internal review process in 2019, the samples were retrieved from GMI by CHI and NCRC, which was completed in accordance with best practices in data management.”

Genomics in the public health system 

Shortall told the investigation team that “the relationship between Genuity and the public health system would appear to be insidious and devoid of public benefit”. 

A spokesperson for Genuity Science Ireland disagreed with this comment and said: “Aside from covering all study costs and additionally returning genomics data to PIs [principal investigators], Genuity Science also has multiple give-backs including supporting diagnosis for children with rare diseases (gratis), offering gratis sequencing for Covid studies, participating in multiple research grants, etc.”

Shortall raised concerns in relation to genomics research in the Dáil in June and has submitted a number of parliamentary questions since.

Some of these questions were redirected to the HSE and remain unanswered. The ones the Minister for Health did respond to show either a complete lack of understanding, or an unwillingness to engage in the myriad issues associated with handing over Irish citizens DNA to a private company.

The Health Minister at the time of response of most of these parliamentary questions was Simon Harris, now Minister for Further and Higher Education, Research, Innovation and Science. We asked Harris for an interview on the topic of genomics research in Ireland but he did not take up this opportunity.

We also asked Minister Harris whether in the absence of a public genomic research initiative, if it was appropriate that a private company has such an influential stake in Irish genomics research, but he declined to comment.

Shortall was speaking in the Dáil about a Brain Tumour Information System (BTIS) study planned by Beaumont Hospital in conjunction with Genuity Science. This study was started in 2016 but suspended in 2018 after the introduction of Health Research Regulations which meant the researchers had to get approval from the Health Research Consent Declaration Committee (HRCDC).

Concerns have been raised by researchers and patient advocates about this study since it went before the HRCDC last year. The researchers applied to the HRCDC to be exempt from having to seek informed consent from brain tumour patients, before sequencing their DNA from archived tissue samples.

Why can’t they obtain consent? It says on their research website that “trying to obtain consent but not knowing whether a patient is alive or deceased is extraordinarily challenging, with great potential for causing patient and family distress, as has been shown with previous re-consent attempts in Ireland”.

This is an excuse, according to European consent expert Dr Deborah Mascalzoni. Difficulty in recontacting patients is “the narrative that I’m hearing over and over again” over the past almost 20 years, said the senior researcher at the Centre for Research Ethics and Bioethics, Uppsala University in Sweden.

“You can’t say that ‘patients don’t want to know’,” said patient advocate O’Sullivan, who added “that’s not good enough”.

The BTIS project began in 2016, according to a spokesperson from Beaumont Hospital. They said that “it was suspended in 2018, following introduction of Irish health research regulations and pending receipt of a declaration from the HRCDC”.

Research at CHI at Temple Street, previously Temple Street Children’s Hospital, was also put on hold for a period of time following the introduction of these regulations, as well as GDPR. The project on rare diseases started in 2016 but was suspended for a number of months in 2019 to update an agreement between the hospital and GMI, according to a CHI spokesperson.

The HRCDC initially rejected the BTIS research application stating “a ‘for-profit’ organisation processing personal data introduces a higher risk that data subjects may have a deeper concern for their privacy rights”.

However, the researchers were granted permission to conduct the study on appeal with the condition of a “publicity campaign”. Concerns were raised and reported by Noteworthy about the timing of the publicity campaign which consisted of notices in national newspapers in March, on the day the schools closed due to the pandemic, and again in April. In June, Genuity Science told Noteworthy that “further advertisements on the research will be placed in national media in the coming weeks”.

If people do not contact the research team by the end of December, “it will not be possible to request to opt-out from the study”, according to the research website. Last month, the Business Post reported that 200 patients had requested to be excluded from the study at that time. 

In addition to the brain tumour study, it also appears that Genuity Science will be conducting its own research using the Beaumont data.

In an FOI released to the investigation team, Genuity Science told SFI in June that “GMI will support this project by generating the sequence data that will be used by Beaumont Hospital to build the BTIS”. It also stated that “in parallel, GMI may conduct its own study into the genomic basis of brain tumours with our commercial partners to develop new drug therapies in this complex therapy area”.

When the investigation team enquired if Genuity Science needed an additional declaration from the HRCDC for this research, a spokesperson for Genuity Science Ireland said that it was in compliance with the GDPR and the Health Research Regulations.

Following the issue being raised in the Dáil in June, the original deadline was extended from that month to September. At the time, after Shortall raised the issue, then Health Minister Simon Harris called on researchers at Beaumont Hospital to extend the opt-out deadline. It was extended again last month after it made national airwaves on Liveline.

notice-4 Part of the notice that appeared in national newspapers on 25 April.

Shortall welcomes the extension to this study but said: “It doesn’t resolve the overarching issue, why is the State facilitating the handing over of citizens personal data to a commercial entity?”

Researchers are also wary of what this extra time will achieve. Dr Ciara Staunton, senior lecturer in law at Middlesex University in London, said without a requirement to engage further with patients and families, “all it’s doing is kicking the can down the road as it previously did”.

She, along with a number of academics we spoke to, also had concerns over the appeal process which overturned the original HRCDC decision. She said that there are times when informed consent is important, but acknowledge that “it does provide for waivers”. However, she doesn’t think “enough was done” in this case.

The independent appeal panel made the consent declaration with conditions, one of which is that the publicity campaign would be carried out. The appeal panel overturned the decision of the HRCDC who have no role in the appeals process.

The investigation team asked the Department of Health if there were any plans to review or change the appeal process. A spokesperson said that “appeals are decided by an independent appeals panel appointed by the Minister for Health and no member of the HRCDC sits on an appeal panel”.

They outlined the role of the HRCDC in applications “for a consent declaration which means that the consent of the individual is not required”. The HRCDC is an independent and representative committee that carefully considers such applications from “a range of perspectives”, they added.

Academic, Mascalzoni was a co-author on a research study published last month which found that participants were most willing to donate DNA or health information for research when the recipient was specified as a medical doctor and least willing to donate when the recipient was a for-profit researcher. “Trust is consistently associated with the willingness to donate,” according to the researchers.

This can be changed with good oversight mechanisms where people have control over their data and are informed about projects, explained Mascalzoni.

Building a system where people know what is happening – so they don’t learn from the newspapers that their data is somewhere in a private company – but they have the feeling, if something like this is going to happen: ‘I will be informed, I will have the chance to control it’.

Issues with informed consent

There have also been other issues with consent and Genuity Science which were referred to the Data Protection Commissioner (DPC) last year. A spokesperson for the DPC said that “the DPC is well progressed in its engagements with GMI in relation to a number of issues”.

Solicitor Simon McGarr, who represents Digital Rights Ireland, sent a letter in August 2019 to the DPC about what they felt were consent issues with a patient information leaflet (PIL) from Galway University Hospital for a study in partnership with Genuity Science.

This letter stated that the PIL was missing information required by GDPR including the name of the data controller. It also said there was no mention of additional risks in terms of re-identification for patients with unusual clinical symptoms.

Source: (Photo) Leah Farrell via Rollingnews.ie

“It’s a very serious matter,” according to McGarr, “because it’s sensitive personal data”. He added that “the volume is such that it’s not just one person, but it’s a whole cohort of people across the country and across a number of different organizations, different hospitals”.

A spokesperson for Genuity Science Ireland disagreed with the letter’s assessment of their compliance with GDPR. When asked if they did anything to rectify this, they stated: 

The Galway Clinical Research Ethics committee reviewed this letter, agreed it was incorrect, and continued with the study.

DNA also has significance beyond the individual, explained McGarr. “My DNA will also tell you an awful lot about my children and my father, my uncle, and so on. I’m also disclosing a great deal of information about other members of my family when I disclose information about myself.” This makes it a tricky area of data protection law, according to the solicitor, who added that DNA is in a special category of data that gets extra protections under GDPR.

Professor Orla Hardiman, consultant neurologist at Beaumont Hospital, described to Noteworthy that your DNA is your fingerprint. “You can say you’re de-identified but you’re always identifiable with your DNA.”

In a statement to the investigation team, Shortall said that “by right the Government should put an immediate end to Genuity’s current access to personal data from Irish hospitals” until data protection issues are addressed further.

At the very least, no further data should be collected or processed until the Data Protection Commissioner’s probe into Genuity’s handling of genetic data is complete.

A spokesperson for Genuity Science Ireland said that it has a primary goal, to improve patient lives. “Our commitment to the lives and quality of life of patients and their families, remains at our core. We seek to better understand the role of genomics in disease to enable pharma and biotech clients to develop new and more targeted therapies for the treatment of life-limiting conditions.”

Our colleagues on the investigation team, the Business Post, have delved into the engagement with the DPC and its potential findings in more detail. You can read their article here.

It is not just politicians that have concerns over the privatisation of genetic research here. Associate professor in public health biostatistics at UCD, Dr Ricardo Segurado, said that “commercialisation does erode confidence in genomic research and is counterproductive”.

Lack of public funding was also mentioned by numerous researchers as a reason that there are so many Irish publicly-funded researchers collaborating with the private sector. “How else are researchers going to get the funding?” asked law academic Staunton.

The Government needs to see the importance of public genomics research, according to Dr Ciara Staunton.
Source: Dr Ciara Staunton

‘Restrictive’ agreement with UCD

UCD has a research collaboration agreement, signed in March last year, with Genuity Science, then GMI, and Noteworthy obtained the full text of this, which you can view here, through an FOI request to the university.

The agreement details the obligations, duties, intellectual property and other rights for both the company and university for research that they undertake. An expert familiar with such agreements had concerns about a number of sections in the agreement and told the investigation team that it was quite “restrictive”.

Genuity Science Ireland disagreed with the points made by this expert about the agreement, according to a spokesperson.

UCD stated that “a number of our investigators choose to collaborate with Genuity Science where they see in the collaboration the opportunity to deliver benefits to research and to patients”. The spokesperson said that the agreement “provides a framework that governs such collaborations, balancing the needs and obligations of all parties”.

We felt this was worth a separate analysis and you can read our article on this now >>

Change of relationship between doctors and patients

Hospital clinicians have become “agents of a company” due to the nature of agreements in place, according to data protection expert McGarr. He said this is the case when companies such as Genuity Science are the data controller, as the hospital becomes the data processor, which is “fully controlled” and “the responsibility of the controller”.

You’re met with clinicians with whom they have a pre-existing and parallel doctor-patient relationship, a clinical relationship. And then suddenly that doctor is working as an agent for a commercial entity. That’s very difficult if you’re a patient, that suddenly the doctor has changed hats.

Genuity Science is the data controller in a number of research studies they are undertaking with Irish hospitals. In the patient information leaflets – which you can view here – provided to Noteworthy by Tallaght University Hospital (TUH), for one such study on Alzheimer’s disease, GMI is listed as the data controller.

“The focus of the study is to research how our genes, environment and lifestyle influence disease risk, disease subtype, progression and drug response”, according to a spokesperson for this hospital. “All GMI studies are approved by the Joint Research & Ethics Committee [and] all TUH based studies have been approved on the clear condition that patient consent is sought.”

No Government policy on exclusive access to DNA

Companies must comply with GDPR which deems that personal data can be kept for “no longer than is necessary for the purpose for which the personal data are processed”.

However, one major issue with this type of research that many researchers are concerned about is the lack of regulation or policy in Ireland around the length of time a private company can exclusively keep genetic data it collects from studies with public universities and hospitals, before it gives access to other researchers.

This results in Irish researchers not getting access to data on Irish patients. Access to data is mentioned in the UCD agreement but no “exclusivity period” is defined. Instead, this will be done on a “case by case basis”. See our full article on this agreement for more on this.

The appeal panel for the brain tumour study also raised this issue when they stated that “the public benefit in the research would be significantly enhanced if the anonymised genetic data from the GMI study was to be made available to other researchers”.

They found difficulty in this as “public policy has yet to be formulated on when genomic data might be made available to qualified researchers” so one of their conditions was that the research from this particular study be made publicly available in “a recognised genomic data repository once public policy in this area has been formulated”.

When asked about access issues to data on Irish people collected by Genuity Science and similar companies, NUI Galway’s Seoighe said that he is “lobbying to make sure that Genuity has good policies in place to release data for research”. He added that this was “a key issue in the debate that needs to happen about how private companies engage in genome sequencing”.

The data belongs to the participants who have contributed samples. This is both morally and legally the case under European data protection laws.

Seoighe cited the partnership between the UK Biobank and Regeneron as a good example of a public-private partnership in genome sequencing and said “a key issue is the timeframes within which data are made more widely available for research towards the public good”.

The UK Biobank collaborated with pharmaceutical companies GSK and Regeneron to undertake genetic sequencing of samples and granted them exclusive access to the data generated for nine months before making it available to other researchers.

Irish DNA behind a paywall

“We want to integrate into the Irish healthcare system,” Dr Anne Jones, then chief executive of GMI and current chief operating officer of Genuity Science, told Mariane Finucane as a guest on her radio show last year. “In order to do that we absolutely have to open up the database”, she added.

We do plan to have a Data Access Program similar to the UK. There just has to be a time delay because [of] the cost as we have to get a return.

The investigation team asked Genuity Science Ireland if it had any policy in place around time periods for when it has exclusive access to data generated by or in conjunction with Irish hospitals and universities. A spokesperson for the company stated: “We actively share the data (including the genomic data) that is generated in our research programmes with the research groups for their own research purposes.”

They used the planned Brain Tumour information System (BTIS) study in conjunction with Beaumont Hospital as an example: “Through this study, Genuity Science, working with Beaumont researchers, will establish a revolutionary database that will improve clinicians’ overall understanding of adult brain tumour biology to help improve the accuracy of diagnoses and treatment options for adult patients with brain tumours.”

When asked if Irish researchers will ever be able to get access to the entire Irish genomic dataset that Genuity Science is collecting in order to research it in its entirely, a spokesperson for the company said “yes”, but had “no further comment” when asked when this would happen.

One of the conditions attached to the appeal decision on the Beaumont Hospital / Genuity Science brain tumour study is that the genomic data collected is made publicly available, but it is unclear when this will occur.

It all comes down to lack of public funding, according to UCD’s Segurdo. He cites the Beaumont study as an example of this as “if the state provided the funding for that project, the sequencing could have still been done by a private company, but the company wouldn’t have retained the data”. Instead, he added, “the public would retain the data”.

Patient advocate O’Sullivan said that the result of Irish patient data being behind such a paywall is a “huge opportunity lost for research and patients”. With such a large database of patients owned by a private company she felt that “is unlikely that another database will be compiled using public funding and unlikely that patients would contribute their data again”.

The “problem of exclusivity” is one of professor Orla Hardiman’s main problems with the current private-led system in Ireland. The clinician said that for research of this kind, the doctor’s experience of both the disease area and the patients involved, “which is worth a lot of money, funded by the taxpayer”, is also being provided to the company, along with the DNA sample, and then “held exclusively with the company”. 

The consultant neurologist at Beaumont Hospital and professor of neurology at TCD said this is “not for the good of society” and at a “society level, it’s pretty bad value for money”.

A spokesperson for Genuity Science Ireland disagreed with this assessment of their partnerships with Irish universities and hospitals. 

She is involved in an international philanthropically-supported collaboration which is sequencing DNA samples of at least 15,000 people with motor neuron disease. This model does not have an exclusivity clause and the data remains in the public domain.

If somebody wants to access the genomic material, as long as the question is scientifically valid, we will allow people to interrogate the data. It’s completely different from the GMI model.

O’Sullivan has a similar line of thinking as she felt that Genuity is getting “decades of effort that went into gathering clinical data”.

That’s a huge database of information being put on a plate for them.

Even if Genuity Science or other private companies share some of their data with public researchers, Hardiman felt that it is “still a bad deal because, ultimately, the overall Irish dataset is still in its entirety, essentially locked, and commercially very valuable”.

In a statement to the investigation team, the Department of Health said that the aim of a planned HSE network – the National Genetics and Genomics Medicine Network – is to “build effective governance arrangements that recognise the interdependence between corporate, financial and clinical governance across the service”. For more on the progress of this, read our article on how researchers are calling for a public genome project.

Private, not public, funding

The reason that funding is such an issue of contention with genetics researchers in Ireland is that they have been campaigning for a public genome project, to gather DNA sequences of the Irish population and make them available to researchers, well before private companies like Genuity Science entered the Irish market.

A fully-public or private-public partnership model to create such genome projects have been in place for a number of years by countries around the world. Examples include the 100,000 Genomes Project in the UK, the 1+ Million Genomes initiative in the EU and the All of Us Research Program in the US.

In Ireland, despite campaigning from researchers for a public project, the Ireland Strategic Investment Fund (ISIF), which is managed by Government agency the National Treasury Management Agency (NTMA), invested in Genuity Science – GMI at the time – initially in 2016 and it made a further investment in 2018.

A spokesperson told the investigation team that “the amount invested by ISIF is €66 million”. ISIF is a minority shareholder in Genuity Science and was a minority shareholder in GMI, they added. As part of this investigation, our colleagues at the Business Post go into detail about the company structure and shareholders of Genuity Science. You can read this part of the investigation here.

genomics-medicine-ireland Then Taoiseach Leo Varadkar with (L-R) Dr Anne Jones of Genuity Science (then GMI), Paul Saunders of ISIF and Rob Brainin of WuXi NextCODE at the announcement of the 2018 ISIF investment
Source: MKC Communications

The investigation team invited both Minister Stephen Donnelly and Jones of Genuity Science – or a representative – for an interview but these requests were declined.

We put this Genuity Science investment to the Department of Health and asked it why the Government is prioritising commercial genomics over public initiatives. A spokesperson responded: “The Department of Health does not have an agreement to procure services and does not provide any funding to the named company (or any other company).” They acknowledged that Genuity Science has received commercial investment via other state bodies and added:

“The situation now is that the government has invested in a privately funded venture through ISIF,” said Seoighe. “One of my concerns is that if that investment goes badly, it will leave the Government with little appetite to invest further public funds in genomics and Ireland will not benefit from advances in this area.”

The director of the SFI Centre for Research Training in Genomics Data Science added that “it is important to make the best of the situation we are in”.

If I was given the option to go back five years and if the decision was left to me, I would opt for a public genome project. I think there are great advantages to that. But that is not the route we went and it is not possible to change the past.

Because the Government invested this money in Genuity Science, Staunton said that it saw “a public benefit to giving money” and “the importance of it”. However, she felt “it was just done the wrong way”.

Going forward, because Genuity are now in Ireland, Staunton felt that the company needs to be involved in the conversation. Outlining the need for a Government framework, she concluded that Genuity Science is “a symptom of the problem but not the actual problem”.

Genuity Science Ireland thinks there should be a public genome project, according to a spokesperson, who added that the company “does not wish nor proclaim to be the national genomics project”. 

The overwhelming consensus amongst people the investigation team spoke to was that a public genome project and strategy was needed in Ireland. We have explored why this may be a better solution in more detail in this article which you can read now >>

An erosion of public trust

A lack of structure to deal with private companies – means it’s “a bit of a wild west here”, according to Beaumont’s Hardiman.

Professor John Greally, director of the Center for Epigenomics at Albert Einstein College of Medicine in New York City said that “the lack of a public, national genome project and the legislative and regulatory protections that should precede engaging such a commercial enterprise makes the Irish situation an outlier compared with other countries”.

There are ways that the Government is doing what they should, according to Dr Avril Kennan, chief executive of the Health Research Charities Ireland. “By bringing in the Health Research Regulations, though they have caused many challenges for research, they’re also very strong on the protection of health data.” These regulations were introduced in 2018 and govern the processing of personal data for health research, including issues around consent. 

Many experts are concerned about the damage being done to the research community by the failure of the Government to act.

“We don’t want to be in a position where, because of certain things that are happening in terms of genomics research, that the public loses faith that their data will be protected,” said Kennan. “That’s potentially damaging far beyond genomics research [but to] all of health research.”

A spokesperson for Genuity Science Ireland stated: “We actively welcome patient input into our research programmes. We have two patient advocates on our Strategic Advisory Board. These two groups complement and inform the Genuity Science Ireland Board of Directors.”

“There needs to be a really strong role for a regulator to make sure that private companies cannot generate genomics data and keep it indefinitely,” argued Seoighe, who said that the Government need to develop policies in this area.

A spokesperson said that the Department of Health “is aware of the significant potential opportunities and benefits afforded by genetic and genomic research”. They continued:

It also recognises the not insignificant challenges and system-wide change that is necessary for effective integration into a healthcare delivery context. Officials are actively examining initiatives and approaches taken in other countries with a view to developing a national genomic policy framework in order to provide a consistent national and strategic view for integrating genomics into our healthcare system.

A HSE genetics and genomics programme is planned, according to the Department’s spokesperson. This “will ensure the sustainable development of clinical and laboratory genetics and genomics services in Ireland”. More information on this is included in our article on how experts are calling for a public, not private, genome project.

For some patients, trust has already been eroded. O’Sullivan said that she is “a passionate supporter of research and advocate for cancer research through a number of channels” but added that her “trust in the research ecosystem has been seriously damaged by those making the decisions around patient data with respect to Genuity Science”.

***

Read our additional articles which explore more deeply an agreement that UCD signed with Genuity Science and why experts are calling for the Government to fund a public genome project.

Our Business Post colleagues on the investigation team also published an article today which delves more deeply into issues with Genuity Science which you can read now.

This investigation was carried out by Maria Delaney of Noteworthy in collaboration with Killian Woods and Barry Whyte of the Business Post. The Noteworthy costs were funded by you, our readers.

Noteworthy is the community-led investigative journalism platform from TheJournal.ie. You can support our work by helping to fund one of our other investigation proposals or submitting an idea for a story. Click here to find out more.

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