Official Report: Minutes of Evidence

The Chairperson (Ms Maeve McLaughlin): You are very welcome. We have Amy Jayne McKnight, who is the director of the Rare Disease Partnership; Dr Anna Gavin, director of the Cancer Registry; and Mr Dale Ashford, who is the interim Chief Fire Officer of the Fire and Rescue Service. I invite you to make your opening presentation, and we will then open it up to comments or questions.

Dr Anna Gavin (Northern Ireland Cancer Registry): Is there a particular order that you would like us to go in?

The Chairperson (Ms Maeve McLaughlin): Not at all. You decide.

Dr Gavin: I will start. First of all, thank you very much for the opportunity to present to the Committee. I will talk about cancer, but my comments could easily reflect other diseases. You are probably all aware that cancer is quite a burden in our community. We have 3,500 cancer deaths a year, and, in 1994, the then Department of Health invested in and had the foresight to set up the Cancer Registry. We know not just what is the tip of the iceberg but what is below the waterline. We know that about 12,000 cases of cancer are diagnosed each year. We know their survival. We know how many people are living with cancer, how their treatment has changed and how it has improved.

I want to take a fictional patient and follow them through so that you can see in practice how the Bill would affect them and how it would work. This is what happens currently. If a lady in her 50s discovers a lump, she has a biopsy, then surgery, then radiotherapy, and she might have chemotherapy. So, she interacts with health service about 20 times in the period of that one cancer. You might say, "We can use that data. We do use that data, but why could we not do that anonymously?" The problem is that, if we did it anonymously, we would not know whether that was 20 individual women coming in contact with the service or one woman coming 20 times. In addition, we would not be able to link it back to the screening service to see whether she had a mammogram and whether that failed or to see the quality of the mammography service or whatever screening service she was in. We would not be able to link that with the deaths to see how long she survived. Without her postcode, we would not be able to know whether she lived in a deprived area or an affluent area, whether the rate of disease was higher or lower in that area, or whether her chance of survival was higher or lower depending on whether she was affluent or deprived.

There would maybe be an energetic MLA who thinks that there is a cancer cluster in their area. If we did not have the postcode, we would not be able to answer those questions. If we did not have information on all the cancers that are diagnosed, we also would not be able to answer those questions. So, the Cancer Registry and other disease registries need identifiable data for the reasons that I have outlined.

In addition, the family of that lady may think that there is a family history of cancer. The information is, therefore, also needed by the clinical genetics service. A person may come to the clinical genetics service and say, "My aunt Molly, who lived in wherever, had a cancer". That person does not come with a number or any detail, so that is why we need actual identifiable data — the person's name, address and data of birth — for that type of information. That information is then anonymised for analysis.

These are some of the outputs that we have produced. I have left some copies for you so that you can have a look at the outputs that we produce, which are relevant. They are also available on our web page.

You might ask, "Well, what about consent?". At least 1,200 ladies are diagnosed with breast cancer every year. There are over 1,000 with lung cancer. There are 12,000 diagnoses in total. The opportunity to ask for consent, to record it properly, to make sure that the person was actually giving consent when they were getting a very difficult diagnosis and to ensure that they understand what is being said is not possible. So, the numbers leave it that we cannot have consent.

There are cancer registries throughout the world, and they operate under legislation, as do other disease registries. What this law would do is bring us into line with those registries. Cancer registries apply their own rules about confidentiality of information. We have a really secure environment for the data. Only 20 staff work in the Cancer Registry, and about a third of them have access to the named data. I do not know the named data, because I do not need it to do my job. So, who has access to the identifiable data is very restricted. There is also ethical approval needed. Once somebody needs the data for analysis, it is anonymised. If they need named data, they have to have ethical approval and take lots of additional steps.

The previous witness was questioned about opt-out. We and other registries have opt-out, so if somebody wants to opt out, they have that option, but nobody takes up that option. We have the support of patients in the work that we do. Patients are very keen to see their data used.

One of the problems that we have at the minute is that we have anonymised data gathered, but we are not allowed to send that in an anonymised form to England so that our services can be benchmarked, because we do not have a legislative framework here. So, we really need this legislative framework to allow the work of the Cancer Registry to continue and to allow us to benchmark our findings and outcomes against those in other areas internationally that have anonymised data. We are very keen for the Bill to succeed. Thank you.

The Chairperson (Ms Maeve McLaughlin): Thank you, Anna. Do any of the rest of you want to comment at this point?

Mr Dale Ashford (Northern Ireland Fire and Rescue Service): Do you want me to comment or do my opening statement?

The Chairperson (Ms Maeve McLaughlin): Yes. Go ahead.

Mr Ashford: I have written mine down, and I will read it out. Do not forget that I am not as articulate as Anna.

Thank you for the opportunity to address the Committee on the subject of the Health and Social Care (Control of Data) Processing Bill. In 2010, fire safety legislation in Northern Ireland changed, and a renewed emphasis was placed on risk assessment and on life risk rather than property risk. Consequently, there have been very few fire deaths in premises in Northern Ireland where there is a requirement for a statutory fire safety provision.

We regulate commercial and industrial premises, and, in conjunction with building control, we enforce legislation that has served the people of Northern Ireland well in keeping them safe from fire. When people die in an accidental fire in Northern Ireland, they tend to do so in their own home. Over the past five years, there have been 50 accidental fire deaths, 96% of which have happened in dwellings.

The legislative position is such that we do not have enforcement capabilities in private dwellings. People who die in fires in Northern Ireland tend to share certain characteristics. They tend to be older. Very often, they have existing medical conditions that may affect their mobility or cognitive function. Another common theme is that they have lifestyle issues, such as alcohol or drug abuse. They are often smokers and commonly live alone. We also find that, the more remotely they live from a fire station, the more likelihood there is that a fire will have serious consequences. A characteristic that virtually all accidental fire death victims in Northern Ireland share is that they are, almost without exception, known to DHSSPS. With the recent trend towards more vulnerable people spending much more of their lives in their home environments, we have effectively shifted the risk from a highly regulated, fire-safe environment in a care facility to an unregulated and potentially unsafe environment in people's homes.

I believe that by working in partnership in a meaningful way, we could significantly reduce accidental fire deaths in Northern Ireland on our watch. Identifying people who have a combination of the risk factors that I mentioned would allow us to identify who is most at risk and take meaningful steps to reduce that risk. That would allow us to transform the manner in which we carry out our prevention work. We need our endeavours to be intelligence-led and we really need to concentrate our efforts and resources where the risk is highest. Working in this way would allow us, first and most importantly, to save more lives and, secondly, to save money and operate much more effectively.

We can do much to reduce risk. We currently work with partners to identify people who are at risk and, where we have done so, we have worked in conjunction with those partners to look at possibilities to reduce the risks. The whole arena of assistive technology in this area is developing rapidly and we have many examples of activities that we have carried out to reduce those risks. They include the introduction of portable misting systems, which are, essentially, portable sprinklers linked to fire alarm systems; the fitting of cooker shut-off valves, which automatically close down a cooker when someone leaves a chip pan or grill unattended; flame-retardant clothes and furnishings; guards and barriers to prevent access to heat and flame sources; the fitting of smoke detectors; education and advice; and, often most importantly, the training of carers and family members.

The current nature of our work is not ideal. It leads to the potential for us to miss the most vulnerable people, simply because we do not know where they are. A systematic approach would allow us to properly prioritise our prevention work and provide a consistent, professional service across Northern Ireland. My colleagues in England have the benefit of similar legislation. They recently reached agreement with NHS GB to share the Exeter database, which is GP data, and a working group is developing protocols for the sharing, storing and processing of that information. I believe that we in Northern Ireland Fire and Rescue (NIFRS) could refine and improve that approach and process data in such a way that we would limit to a bare minimum the amount of sensitive data that needs to be shared. I am perfectly content to give an assurance that NIFRS would contribute to and comply with an approved code of practice to ensure that robust safeguards are in place.

There is the potential for wider benefits for the public in Northern Ireland through working in partnership with other agencies and groups. Particularly in the context of community planning partnerships in the future, NIFRS will engage in the wider health and public safety agenda, and there is the potential for us to help in other areas. I would like to develop and improve on ongoing work in English fire services aimed at reducing pressure on hospital A&E departments by taking a more comprehensive approach to public safety in its widest sense. This community risk reduction approach would reflect national best practice for fire and rescue services and be made much more effective by an intelligence-led approach.

The public has a justifiable expectation that public services should work together to keep them safe. A recent coroner's regulation 28 letter following the death of a vulnerable lady in Berkshire required the Fire and Rescue Service and various agencies in Berkshire to enter into dialogue and share information in relation to vulnerable people. Although I am not aware of such a letter being written by a coroner in Northern Ireland, I have personal experience of incidents where I believe the risk could have been mitigated or eliminated had we had access to better intelligence.

To summarise, NIFRS is dedicated to keeping the Northern Ireland public safe, and I believe that we can significantly reduce accidental fire deaths. We are duty-bound to do everything that we can to make this a reality. I recognise the need for proper safeguards for people's privacy. I believe that the enactment of the data-sharing legislation will be a significant step towards making Northern Ireland a safer place.

The Chairperson (Ms Maeve McLaughlin): Thank you.

Dr Amy Jayne McKnight (NI Rare Disease Partnership): Again, thank you very much for the opportunity to provide some oral evidence. The cornerstone of what we will say is listed in appendix 1 to the submission. I will take the opportunity to set the scene and the background a little bit, and emphasise some of the key points. The Northern Ireland Rare Disease Partnership is a unique partnership. It is a combination of individuals living with rare diseases, the voluntary and charity groups that represent them, academics and clinicians — a wide variety of individuals. We span the breadth from very rare conditions to relatively well-known rare conditions. We are represented on the Northern Ireland Rare Disease Partnership, UK rare disease partnerships and various European groups. One thing that is emphasised very strongly is that we cannot extrapolate what happens in Europe to Northern Ireland, nor — similar to what Anna said — can we use data that is derived from Northern Ireland to benchmark and share experiences across the UK.

The definition of a rare disease in Europe is one that affects less than one in 2,000 of the population. That might sound rare but, taken cumulatively, rare diseases are very common. It is believed that, in the UK, rare diseases affect approximately one in 17 individuals, but, in some areas, that figure is one in 12. More than 80% of rare diseases have a genetic contribution.

One thing that we are very keen to emphasise is that data use, sharing and governance are critical issues for rare diseases in particular. Within the rare disease community, we are keen to ensure that we derive the maximal use of data, ideally through the secondary use of data. We are aware of substantial concerns around that issue, but we are confident that the benefits of the Bill significantly outweigh any potential risks and that the use of robust safeguards will ensure data integrity and protection for the benefit of patients. We believe that the Bill is critical to the effective delivery of a consistent UK rare disease strategy and the Northern Ireland rare disease implementation plan.

In the past few years, we have held a number of open meetings and working groups and have carried out numerous surveys. We have demonstrated that patients and families living with rare diseases recognise that because there is a very small number of individuals affected with their specific set of medical conditions, as much data as possible needs to be shared. We need to make best use of all of the data that exists to share that information with bona fide researchers worldwide. Wider sharing would be anonymised to help develop effective surveillance, prevention and treatment options for rare diseases. The legislation would enable us to contribute to national audits and compare the care of patients with rare diseases in Northern Ireland with that delivered in the rest of the UK.

We are keen to emphasise that, collectively, rare diseases represent a significant public health concern and that we cannot use strictly anonymised data for the secondary use of data because, as Anna explained, we need a mechanism to link diverse data sets together in Northern Ireland. That could be genetic services or social care data, for instance. Despite the inherent risk, because of the rarity that multiple medical conditions are going to be associated with specific individuals in Northern Ireland, patients and their families are very keen to share their data for further research. In fact, they are seriously concerned that not sharing that data would be severely detrimental and limit the potential scientific and healthcare developments that would, ultimately, improve their quality of life.

Through the discussions that I mentioned and the surveys, the Northern Ireland rare disease community is 100% favourable, positive, and behind the secondary use of data sharing. Our recent research has confirmed that patients and rare disease charities in Northern Ireland are frequently very frustrated at not being able to participate in wider initiatives due to the limitations that we have when sharing information.

I move now to the control of information of a relevant person. We particularly value that provision. There has been lots of debate about the phrase "in the public interest", as we heard earlier. We suggested replacing that with, "in the interests of improving health", with health being the wider interpretation of medical, psychological and social health. We are also very keen that it is not limited to medical information. We are keen to see the Bill apply and be helpful in the arenas of education, transport and the Fire Service, which we have just heard from.

There are multiple projects under discussion in Northern Ireland to improve the lives of individuals who are living with rare diseases. They include modernising services for improved diagnosis, the development of an online information hub, and research to help to deliver a person-centred service for rare diseases. A lot of what we would like to see happen, which is happening in the rest of the UK, will not be possible unless the Bill succeeds. For example, a serious concern with rare conditions is delayed diagnosis and, indeed, the identification of rare diseases. The current process of reaching a diagnosis for patients with rare diseases is referred to as the "diagnostic odyssey". It can range from a year in the minority of cases, up to 20 years, but some patients will never get a diagnosis in their lifetime. If we cannot share the medical information that currently exists or bring information from different sources together, we will have no opportunity — or a severely limited opportunity — to improve diagnosis.

I will look at audits and comparing data with the rest of the UK. Around a third of patients in Northern Ireland wait between one and five years for an accurate diagnosis; more than one in 10 wait longer than 10 years for their diagnosis; and around half of all patients will receive at least one misdiagnosis. If we have a better way to bring together and share information, we are improving that diagnostic process.

In the sharing of data on rare diseases, clinical characteristics and medical pathways from multiple individuals is required to progress research towards a better understanding of diseases and more effective treatments and cures. At present, we cannot calculate the number of individuals in Northern Ireland who are affected by rare diseases and we urgently need a rare disease registry in Northern Ireland that functions like the Cancer Registry. Sharing data will help us to count the number of affected individuals with particular conditions and clinical needs which, again, may often overlap between conditions. If one person is affected by three separate rare diseases, we would like to know that information, rather than counting it as three separate people.

Sharing data will also help Health and Social Care to develop an effective plan for delivering optimised healthcare for individuals with rare diseases by helping it to identify who is going to need what resources and when. We believe that reliable information shared across a whole-system approach will be of strategic benefit to Northern Ireland. Unless reliable information can be shared, coordination, collaborative information-based actions and evidence-based medicine will not occur. The range of services across Northern Ireland, we believe, will be of lower quality, have less impact and produce poorer outcomes. We would like to stress that it is imperative that a collaborative approach is taken to the use of data through both health and social care systems. We believe that this legislation is urgently required.

We welcome the plan to promptly develop and publish a code of practice with regular revisions for a committee to authorise processing of confidential information. We would be happy to participate in any such committee. There has been significant debate about sharing medical data for research, and we would like to stress that we believe that it is entirely possible to have appropriate safeguards in place where it would be clearly accountable, have robust safeguards and be subject to a very transparent process to ensure that this data is used effectively and stored safely.

We are very keen that data is shared in carefully considered circumstances, but we stress that there must be flexibility in the Bill so that relative bodies with the appropriate expertise can inform evidence-based medicine. This includes health and social care teams and academic researchers who currently hold multiple registries. We believe that the committee would need expertise in clinicians, ethicists, epidemiologists and patient representatives.

Without the Bill, we will be unable to conduct rare disease research projects in Northern Ireland and contribute to UK efforts that benefit medical and social care. Once again, we would like to reiterate that this legislation is particularly essential for patients living with rare diseases and their families.

The Chairperson (Ms Maeve McLaughlin): Thank you, all three of you, for your presentation. Having listened to you, I understand the opportunities in terms of the importance of sharing data, and that being done within a legislative framework. However, I am particularly interested in what happens now. Have all three of your organisations applied for the use of secondary data to date, and what happens?

Dr Gavin: We have been doing this for 20-odd years. The Cancer Registry was set up by the Health Department, and we are registered under the Data Protection Act. It is now funded through the Public Health Agency and is located in Queen's University Belfast. We have ethical approval for the databases that we hold and we have presented our methods of operation to the Privacy Advisory Committee, which has commended us on our structures, our security and the way that we inform people about what is happening.

If somebody has a diagnosis of cancer, they will get a leaflet in their pack about the Cancer Registry. There are also posters in GP surgeries, hospitals and other places. Just this year, we produced a video about the Cancer Registry to let people know what was happening to their information and how it was used. We have been doing this within the existing legal framework, which is not really there, but within any ethical approval or whatever we can do.

The Chairperson (Ms Maeve McLaughlin): The sharing of secondary data continues.

Dr Gavin: Yes, we use secondary data to provide information on cancer for research projects that are ethically approved for monitoring services. We have produced a vast number of reports and various outputs that are very useful to the health service. They are also useful to clinicians who are monitoring the care of their own patients, and they are useful to the Department of Health, which is monitoring and planning the services for cancer patients in Northern Ireland.

The Chairperson (Ms Maeve McLaughlin): How will the legislation help? I am just playing devil's advocate.

Dr Gavin: The legislation will mean that I will not have to convince people that they are not actually breaking the law when maybe they are. It will mean that we will be able to work within a legislative framework and, more importantly, that the data we gather in Northern Ireland will be available for audits and for peer review of our outcomes with England and other places. At the moment, one of the things that we cannot do is compare our process of care for lung cancer patients, upper gastrointestinal patients, and others, with the care that similar patients get in England. Also, without this law, I think that we could be challenged, and the Cancer Registry would cease to exist.

The Chairperson (Ms Maeve McLaughlin): I will bring Fearghal in because I know that he has to go.

Mr McKinney: I apologise; I have been called away to another meeting. Thank you all for coming. It demonstrates the breadth of the demand for something like this. Maybe I will kick off with just a couple of quick points. You are saying that you would welcome committee membership. We would need to be assured that the committee would be as robust as possible. Would the Rare Disease Partnership's participation on that committee represent a conflict of interest?

Dr McKnight: I do not know the answer to that. I think that it is important that the public's voice is heard on that committee, and it is particularly important that things are conveyed down in an appropriate manner. Were you thinking of anything in particular?

Mr McKinney: No, just the question of whether your answer would always be yes to accessing the data and not be as critical because of your stated aims? That is not a criticism but merely a point that I would like to test. Dale, thank you too for your presentation. This gets to the point of the individual data being available and a much wider audience being aware of an individual's behaviour, their addictions or conditions in general. Is that not exactly getting to what our major concerns are around the privacy issue?

Mr Ashford: I have had a chat with people with NISRA and others about how we could do this if we are clever. We still need sensitive data, and I need to know addresses of people so that I can find the people who are vulnerable. I think that, if we are clever, we can do this in such a way that we share the very minimum amount of information. I mentioned a number of risk factors. I do not need to know what risk factors you suffer from or what your conditions are; I just need to know that you have a combination of those risk factors and where you live. Once I get there, I can take the steps that I need to take to keep you safe. To me, there is something around management and how we collate and share that information that will help to protect people. My needs will be different from the ladies either side of me in that I will probably need less detail. I really just need to know where the people are.

Dr McKnight: Can I just clarify my understanding of the committee? This Bill is to enable data sharing. The committee's responsibility would be to say where and when the data would be shared, so, from our perspective, the answer would not always be yes. It is yes in that we are strongly supportive of the Bill to enable that facility to share data, but not that data should always be shared.

Mr McKinney: OK. I have tested the point. I need to be excused now. Thank you.

Mr McCarthy: Thank you all for your presentation. I have a couple of questions for you, Anna, if you can help me. How important is the legislation for collaboration between Northern Ireland and other jurisdictions in relation to large-scale research, and how out of step do you think we would be without balanced legislation as proposed?

Dr Gavin: If we partake in any large inter-boundary or cross-boundary research, generally we have the data anonymised as far as possible, but, sometimes, you need to give broad categories of identifiable information, although not at the individual level. We have run into a problem with host places. For example, in England, the people who analyse the data are refusing to accept data from Northern Ireland because we do not have a legislative framework, even though the data has been collected and anonymised and is ready to be put into the system. We are having to think about whether to analyse it separately. However, in analysing it separately, there is a risk that we will not do it in exactly the same way that they do. Then, we are not part of a larger report where it is easier to see how we compare with other places. That is a real difficulty.

Mr McCarthy: If we get this legislation through, that should overcome the problem that you are talking about.

Dr Gavin: Yes, that should overcome the problem.

Mr McCarthy: The sooner that is done, the better. How out of step do you think we are without the balanced legislation as proposed?

Dr Gavin: There are many countries that have a legislative framework that allows this to happen for cancer registration and wider disease registration. That allows people to provide data to registries without the fear that they are doing something wrong or breaking the law. They can do it within that legislative framework, secure in the knowledge that the data is held confidentially, that there are good mechanisms in place through the security of the environment or the processes, and that that committee has people on it who are strict about who can have access to what data and what is the minimum that they need.

The Chairperson (Ms Maeve McLaughlin): I am not picking up that your three organisations have any particular concerns around the definition of "public interest". You do not see that as being an obstacle or a risk.

Mr Ashford: No. From the Fire Service point of view, I do not see it as a risk. An earlier speaker talked about changing it to "public safety". For us, that would probably feel like a better fit, but I do not have any objection to "public interest".

The Chairperson (Ms Maeve McLaughlin): That has been clear.

Dr Gavin: Amy's definition of health is actually a very good one. It is not just physical health. It is your physical, social and mental well-being. There is no point in just having these registries; you have to do something with them. You have to do something to improve the public's health in the wider sense, or you have to improve services. We are not interested in setting up registers of disease or counting people just for the sake of it. There has to be a definite benefit for society from doing this. There are costs and potential risks to privacy, and those have to be balanced with the outputs.

Ms McCorley: Just for clarity, are you all comfortable with "in the public interest"? You do not feel that that is a very broad remit and that it should be confined to health and social care.

Mr Ashford: That committee would need some very strong guidance in the form of a code of practice to help it to make those decisions about what "public interest" looks like. Other than that, "public interest" sounds OK to us.

Dr McKnight: We would be more concerned about the Bill going through with very tight and stringent criteria that would actually minimise the effectiveness of having the Bill. We are keen to ensure that it applies to education, transport and other Departments.

Ms McCorley: So you would like it to be broader than health and social care.

Dr McKnight: We would prefer it not to be limited to the medical side, yes.

Dr Gavin: There are, however, ways to link data without risking security. There are ways, for example, in which the census data is linked to other data sets. The Northern Ireland Longitudinal Study has linkage that cannot be unlinked to identify individuals. You can do quite good research with linked data without any risk at all of the identification of an individual.

The Chairperson (Ms Maeve McLaughlin): OK. We will reflect on that. Thank you all for your time today.