We now move on to the statement by the Cabinet Secretary for Health, Well-being and Sport on the genomics—genomics; that’s right, yes—for precision medicine strategy. Sorry, I’ve had new glasses and I can’t read properly. So, I call on the Cabinet Secretary for Health, Well-being and Sport, Vaughan Gething, to introduce the statement.

Thank you, Deputy Presiding Officer.

On 12 April this year, I published the genomics for precision medicine strategy consultation. The strategy outlines our plan to harness new genomics technologies to improve the health and prosperity of the people of Wales. Through the strategy, we want people across Wales to have access to quicker, more accurate diagnosis and better information to support treatment decisions. We also want to apply the latest techniques for improved disease prediction and gain a better understanding of disease outbreaks.

New genetic and genomic technologies are allowing us to develop a much more detailed understanding of the link between our genes and our health. Traditional laboratory genetic tests apply sequencing methods that analyse a single gene or part of a gene to identify DNA changes that cause illnesses. However, the recent emergence of newer, next-generation sequencing techniques has enabled the study of tens, hundreds or thousands of genes, or even the whole of a person’s DNA, or genome, at the same time. Parallel developments in IT, data storage, sharing and analytics have enabled us to scrutinise, observe and analyse the vast amount of information that is generated by this type of sequencing. The pace of change in this area is rapid and the cost of genomic technologies continues to fall. The strategy provides a basis for us to capture the health and economic benefits of these technologies for the people of Wales.

The new genetic and genomic technologies are playing an increasing role in the delivery of modern medicine. They are having an impact on a wider number of clinical specialties, enabling clinicians to better understand a patient’s individual disease and provide more accurate and timely diagnoses. They are also enablers for precision medicine: the development of targeted treatments for individuals, rather than the population as a whole. For example, our understanding of the genetic basis of cancer now supports the provision of targeted therapies to patients. In lung cancer, for example, four genetic markers have been identified, and these allow clinicians to give the treatments most likely to stop the growth of tumours, shrink them and lengthen quality and duration of life. As there are frequently multiple genetic markers for each disease, it is more cost efficient and quicker to test for all, or several, genes at the same time. Through the strategy, funding will be provided for the NHS all-Wales medical genetics service to deliver gene panel analysis to look at multiple targets for lung cancer simultaneously. This will allow clinicians to make better decisions about treatment options and also allow patients to take part in innovative clinical trials.

In rare diseases, genetic and genomic technologies are enabling quicker and more accurate diagnoses. Most rare diseases have a genetic basis, but it often takes a long time for patients to receive a diagnosis, if they do at all. And that leaves patients and their families with little information about the risks for their family and the options for treatment or the management of their condition. What’s more, in complex conditions like some intellectual disabilities, over 1,000 genes are involved. The ability to analyse a greater number of genes simultaneously will mean that more patients with rare diseases and intellectual disability will have access to the most up-to-date technologies for a quicker, more accurate diagnosis.

The strategy, though, is not just about pushing more DNA through sequencers and crunching data. It’s also about co-production of services that will support the public, or patient, in accessing the most accurate test in a timely manner. And, importantly, it’s about what happens next, once we get the result that may affect not just our future selves, but also the future of others close to us. The very nature of genes and DNA means that our problem can be passed on to our loved ones. Genetic counsellors and other medical professionals work tirelessly at the interface of genomics and the human condition, to clarify the impact that this knowledge may have on our health, well-being and the support that we may need.

It is clear that patient benefits in this field will not be delivered by the NHS in isolation. Links to research and industry activities are more important than ever, and the wider ecosystem for genomics must be aligned to maximise health and economic benefits for Wales. In addition to developing new services for patients in Wales, the strategy outlines actions to develop research in genetics and genomics, to grow knowledge and skills amongst the NHS and non-NHS workforce, and to build precision strategic partnerships in genomics for precision medicine. In this highly competitive and rapidly expanding field, it is important that Wales is able to work together with partners on an international stage, as this attracts additional funding, supports the development of the skills base in Wales, and underpins the faster adoption of new treatments for patient benefit.

With Welsh Government support, Wales is joining the 100,000 Genomes project through partnership with Genomics England. This will enable Welsh patients with specific rare diseases to take part in a large, cutting-edge research project, with the potential to receive quicker and more accurate diagnoses that may come from whole genome sequencing. The project has attracted £1 million in funding from the Medical Research Council, allied to £2.3 million of Welsh Government funding, and is supporting high-quality jobs and bringing additional economic benefits here to Wales.

The genomics for precision medicine strategy was developed by the genomics taskforce, built upon close working between colleagues in the Welsh Government, the NHS, the third sector and higher education institutions. The taskforce has worked hard to consult throughout the process, and to ensure that as many stakeholders as possible have been able to have their say in the development of the strategy. The strategy now focuses on developing genomics capabilities, because these technologies are becoming increasingly affordable and having a positive impact on precision medicine and the management of infectious diseases.

Investment in genomics alone, though, will not be sufficient to deliver precision medicine. Other technologies such as imaging, molecular studies, real-time monitoring of illness and data analytics all play an important role, alongside traditional clinical methods of assessing an individual’s disease. These diagnostics, of course, need to be integrated with the development of new targeted therapeutics, involving advanced therapeutics arising from cell and gene therapy approaches.

It is clear that the challenges ahead are great, as they are in many other areas of medicine and the health service. Further partnership will, of course, be necessary to make precision medicine routine practice in our national health service. But this genomics for precision medicine strategy underpins what should be a bright future to capture the health and economic benefits of genomics technologies within Wales.

Thank you for your statement, Minister. Genomics has enabled groundbreaking advances in research and medicinal applications, and I believe holds an enormous hope for us all in the future. We all know of the crisis facing humans, because of the overuse of antibiotics and the ever-mutating bacteria that produce the superbugs that seem to survive all. Finding alternatives for the treatment of illnesses that are caused by antibiotic-resistant bacteria is dependent on the study of bacteriophage genomics. Being able to maximise on our drugs’ efficiency and toxicity will be key in optimising drug therapy. So, the Welsh Conservatives welcome this focus on the area of precision medicine, and the consultation and subsequent strategy have set parameters within which we can explore how we can develop Wales’s abilities to play a crucial role in the development of precision medicines.

Now, studying the report, Cabinet Secretary, I do have four questions that I would just like to ask for further expansion on. Priority 2 mentions IT infrastructure requirements. Now, there’s obviously a need for high-quality, reliable communications infrastructure to be in place to allow these facilities to grow across Wales, and not just in urban centres, particularly if they’re going to be allied to universities and to various hospital research centres. So, what guarantees can the Cabinet Secretary give us that all corners of Wales will be linked up to a fast communication network so that we can really, really maximise on this? In my own constituency, I have a number of highly innovative companies that deliver targeted, precision medicinal implements around the world and that have built businesses that are doing incredibly well, but they have had to face the communications challenge again and again and again to enable their businesses and their research facilities, and the collaboration that they have with partners across the world to really grow. So, that would be my absolute first question.

Secondly, the strategy acknowledges that large data sets are an essential tool and that there are challenges with respect to the anonymisation of data. It also talks of the need to access patient samples and of the integration with SAIL. What processes, Cabinet Secretary, are in place to protect data, to protect the patient and patient confidentiality? Cyber attacks are a growing threat, and I think we must be mindful of security. I think it’s very important, as well, that we make sure that patients are completely secure in knowing that if they put forward any part of their treatment or their results for analysis in these data sets, it won’t be held against them or their successors, especially in terms of insurance claims, with insurance companies always wanting to know what people’s genetic histories are, and that whole growing industry that’s beginning to evolve. So, I’d like to really understand the security elements of it.

Cabinet Secretary, what support have you put in place for getting people trained in this field within Wales? Perhaps you could outline what steps are being taken with the health boards, with the research institutions and with the universities to get more of our young people interested in this growing and vitally important area.

Finally, in the report, it mentions that

‘A business case will be developed by the end of 2017’ regarding the siting of a genomics laboratory. I just wondered what progress has been made on this.

This is a really exciting area of research. I absolutely welcome the statement, and I would encourage you, and I would want to support you, in putting as much effort and money as we can into this area, because I truly believe this is one way of not only protecting ourselves in the future, but of addressing the vast health inequalities we have, not just in our country, but throughout the world.

Thank you for the comments and questions. It’s interesting that you started with antimicrobial resistance—your sage colleague to your immediate right was part of the cross-party group on science and, actually, this was a subject of the conversation that we had last week with both David Rees and Simon Thomas—so, germane challenges for the here and now, as well as for the future, in the way in which we develop our ability to understand human conditions, and also, then, to help to treat and anticipate them.

Turning to your questions about the communication challenge, well, some of this is, if you like, the technical challenge of how you get data transferred, but I think a lot of it is actually cultural, and that’s why the genomics taskforce has actually been really instrumental in actually going proactively out to stakeholders, to want to talk to them, with the number of consultation responses that have come in, and I then expect to come back on the back of the advice that I will get from the taskforce, having had the consultation, to then announce the next stage on how we develop that. It is important that we have channels that are open, and a culture that is open about how people are able to talk to each other. Because, as I’ve said in my statement, this requires the national health service, the university sector, but it also requires the third sector and, indeed, industry to be part of the answer. And that is partly my point about how we actually pool our research, because whilst there’ll be a central laboratory function, and actually having the Wales genomic centre, a lot of that has to be virtual because you can’t expect to dissipate all of those staff around the country, but they have to be able to understand what happens within this country and, indeed, the collaboration with England—we’re part of the 100,000 Genomes Project—as well as on a wider basis, too, as well. So, I do take on board the challenge that you raise in making sure that it isn’t simply a closed shop for a small group of people in one part of the country to participate. That certainly isn’t the approach we’re taking. I hope that assurance is helpful.

On protecting data, of course, the recent cyber security attacks have highlighted the challenges that exist because there are always a group of clever unscrupulous people who are prepared to try and harvest data for their own ends. Whilst we were in a much better position than England in terms of what happened with the recent attack, none of us should take that for granted or to be triumphant about it. We need to constantly reassure ourselves that the way in which we use data is both ethical, but also that we actually properly protect sensitive patient and staff data in the way we use that across the system. The SAIL data is a good example of where we’ve got anonymised data that is of a real benefit. It’s a good example also of being a small country that can make choices on a national basis and trying to have a real sense of national mission. That’s more about what we need to do, but that will also go into the way in which we deal with clinical trials. In a number of areas in Wales, we do very well with clinical trials, but we also need to recognise that there are areas where we could do better still as well. I think this is an area where we think we could do better still again, to build on our current strengths but to also understand where we think there is a different level of both ambition and achievement to be set as well. Again, I recognise the points you make about properly protecting patient data in the way we set up our systems—both the hardware, the software, and the culture of actually the way in which those data are used.

On the points about investing in the workforce, this is one of the five themes from the action points that have come out in the strategy we’ve just consulted on—how we understand properly how we invest in our workers, to get right some of the—[Inaudible.]—with my colleague the Cabinet Secretary for Education, talking about how we get things right and about the culture of our schools. So, we understand the way in which we both need new skills and acquire those new skills from the workforce of the next generation—that we’re looking after you and me in our, hopefully, old age when we reach it, if we reach it, but also about what happens in the here and now for the people already going into our system. That’s part of the reason why the collaboration with both industry and the university sector is really important, because the workforce isn’t simply going to be about how the NHS plans its individual part of it, too. Although, in that we expect to see INTPs as we develop the strategy, and as we conclude what the strategy will be at the end of the consultation response to it, and how we expect to see that set out in individual health boards and trusts organisation INTPs, but also the work with the all-Wales medical genetic service, together with the new health education body that we’re going to create. We’ll need to take steps on the creation of that over the course of this year, in shadow form, to get ready for April 2018, when it’s up and running. So, there is an honest recognition that is set out in the strategy about what we’ll need to do and how we plan for that workforce and how we obviously—and, again, there are ethical challenges in this, too—map out a service where the health service has a very definite interest in the data that we use, that are given to the health service, and how we actually work, in a grown-up way, with people in industry as well as the higher education research sector, but you’ve got the same—[Inaudible.]—protecting the ethos of what we want to do, and the value of what we do, as opposed to giving that information to someone else to sell back to us at a profit. So, there are challenges in that, but that goes into workforce development, too.

This is particularly interesting because it is new, and we’re making choices now that we haven’t had to make, but also it goes into your point that there’s significant benefit to be gained, from a health gain point of view but also from an economic point of view as well.

I certainly welcome the consultation. This is, without doubt, an area of medical advancement that holds a huge amount of potential, as the Cabinet Secretary outlined. Of course, it fits into the agenda of disease prevention and early diagnosis as a means to improving outcomes for patients, plus, of course, saving money for the NHS. There are huge saving that can be made here through careful targeting of treatment using these new technologies, so any investment here is money well spent.

I have three questions, the first of those linked to investment. What medium-term plans or longer term approximations is the Cabinet Secretary making for resource allocation in this new field of medical research and treatment, because this is something that will only develop and will only become more of a source of investing to save as time moves on?

Secondly, the statement very clearly details the technical and scientific aspects of this developing technology, but not so much the ethical and emotional side. We have touched on the ethical side through reference to data in the questions from Angela Burns. But in terms of the emotional side of it, particularly perhaps related to prevention and prediction of illnesses—. There is evidence of a particular hereditary cancer in my family. My late mother’s DNA has been stored. I’ve chosen not to investigate whether I’m susceptible at this point. A close friend of mine produced a television programme looking at whether she was susceptible to the cancer that took her mother’s life, and she decided at the end of that journey that she didn’t wish to know if she had been pre-programmed. So, there are some very difficult emotional and ethical questions here. I wonder what plans there are to invest in that emotional support for families and individuals who find themselves in a place where, perhaps, this technology could be of use to them, but they have fears about what that would entail.

Thirdly, this is, of course, a global project—a project where Wales can be proud of the innovations that we have contributed towards over the years. But many of our researchers, of course, will be engaged in pan-European research and frameworks. Will the Cabinet Secretary perhaps comment on what safeguards need to be put in place to protect that as we exit the European Union?

Thank you for the comments and questions. I will deal with your last point first. In many areas of scientific endeavour and research, we recognise there are real risks and challenges for the United Kingdom in the Brexit negotiations. We have been upfront about that in the discussions with your party, and in the White Paper that we have and in the ongoing conversations that will need to take place, not just with the research community, but also between the different Governments of the United Kingdom about our approach to that. Actually, we could have an exit that cuts off scientists—or, actually, if not cutting them off, making that collaboration more difficult. Whilst it would be a problem for Europe to be cut off or to make it more difficult to collaborate with scientists from the UK, actually, I think we would have more to lose from that in terms of the store of international knowledge that exists. So, this is definitely in our interests, and there is a lot of interest from a European point of view in maintaining that area of collaboration. None of us should take that for granted. It has to be very much part of the focus of all the Governments of the United Kingdom, about our negotiating position at a UK level, and equally, maintaining those relationships that exist. I recognise the significant concern that exists within the scientific and research community about our future relationship with European partners.

On the broader points you made about financial savings and investing in this area, as I indicated, we invested £2.3 million for Wales to be part of the 100,000 Genomes Project. We are also investing £6.8 million over the next five years in this area, because we do recognise there’s a need for money to go into developing the service. But, equally, there’s something about understanding what happens after that, because, whilst there are medium and longer term savings to be made, we also know that, when new advances are made, they’re often expensive at the initial point in time. And this is a good point in case, because, actually, as the cost comes down, and it's more likely that we can use this in a more broad-based way in medicine and within diagnosing and then making treatment choices—just as we get every new stage of any precision medicine that comes forward, it is often very expensive at the start, and the challenge is how much progress we’re able to make in our understanding and then being able to make that generally therapeutic so we can understand how we then use that practically. But we do know that, through the savings that we’ll make, there'll also be difficult cost choices about new treatments, new therapies, that come on board, and I wouldn't want to try and shy away and pretend this is simply an area of health gain to be made at low cost. There will be difficult choices for you and me and every other politician in this Chamber to make about how and where we make those investment decisions over the rest of this Assembly term and in the future.

Your final point, in which you mentioned about the broad area of genetic counselling, as I mentioned in my statement, we already have a team of genetic counsellors around a range of different conditions, not just the rare diseases and conditions that exist—but, lots of people, as they're going through and choosing to start a family, often there are choices that are made as a standard part of the IVF conversation, if families are going through that. They’ll have a conversation—they'll be referred to genetic counselling and have a conversation about what's possible, and that's an important part of that process. It's getting more mainstreamed as well. I think the challenge for us will be not just how we rely on a specific speciality within the health service, but, actually, how we normalise this as part of the conversation for healthcare professionals. And so, looking at colleagues sat over your right shoulder, in general practice, there’s a need to understand what this looks like, as well as in specialist areas of treatment beyond, and not just with doctors, but actually a whole range of other therapies, to understand, if we're having a conversation about treatment options, how would we, in a sensitive way, understand and lay out potential options for people about what they will choose to do. Because you're absolutely right: different people will make different choices, and this isn't an area where we’ll require people to act in a certain way. But it is how do we have an informed conversation with the citizen about the advances that are possible and how they can understand their potential risks and the informed choices they want to make.

Again, you think about a range of areas in pregnancy and maternity: it's a choice about whether people want to have a range of tests about the health or the nature of their unborn child. And people already make those informed choices, because we've mainstreamed that conversation within our midwifery workforce, and it's done in a sensitive way with new parents. This is about another different level of conversations about different conditions, different risks that may be inherent in who we are and who we could be in the future, about how that conversation takes place in a way that is sensitive and highly professional and equips people to make those individual choices for them and their families.

Cabinet Secretary, I'm genuinely excited about the potential of this strategy, not only as a health intervention, but as an economic intervention, too. Genomics is one of the fast-emerging industries of the much talked-about fourth industrial revolution. We’ve discussed some of the unparalleled health advantage—we're told we can expect cancer treatments, for example, 20 times more powerful than current interventions. But I am particularly encouraged that we've looked beyond the health impact to how we might position ourselves as a global leader in this mind-blowing science.

But we do need to match our ambition with rigour, and I'd urge the Cabinet Secretary to be clearheaded in precisely where Wales’s competitive advantage in this huge and rapidly evolving field might lie. High-quality, foreign direct investment in life sciences, for example, is generally attracted to Cambridge or the M11 corridor, which could leave Wales just pitching for what is left behind. So, can I ask him to tell us how clear he is on precisely where we can bring a unique contribution to the table, where our existing expertise might offer us the competitive edge? And, once we're clear on that, then we must be ruthless in pursuing these opportunities. Diolch.

It's an interesting point you make, and I'm delighted that there is something that Lee Waters has stood up and said he is genuinely excited by. But, you know, you raise an important point about how we do target our best areas to realise real gain, not just in health terms, but, you're right, about the economic sector. And, of course, the strategy was launched in 2013 jointly by the then Minister for Health and Social Services and the Minister with responsibility for the economy.

It has always been a recognition about the dual benefit to be gained. You’re right about the life sciences sector as an area for growth that we’ve already seen, but it isn’t about trying to directly compete with what happens in and around Cambridge. There will be a range of people who will always choose to go there first, but, actually, what I think is genuinely encouraging is about the way in which we are setting ourselves up in Wales to understand a different sort of conversation with the pharmaceutical industry, who, after all, will still be significant players in investing in the future of medical research and innovation, and in which our higher education sector—and, going back to the points Angela Burns made, about the way in which we use data within Wales as well. Because what the English system doesn’t have is it doesn’t have a genuinely integrated national approach, which we do have here. So, that means we’re going to be able to roll out a national approach to pathology, which can’t happen in England because they’ve got so many different bodies getting in the way of how they will make different choices.

Now, without getting into the party politics of how they’ve managed to reach that point, in the system in Wales it’s a genuine competitive advantage for us. What we’ll need to be better at, not just over the next few years, but over the next decade and more, is our ability to make national choices with only 10 organisations in the health field—the health board and trusts and then the Government with them as well—and how we actually get alongside people to make those choices. Because we’ve already seen a range of pharmaceutical players investing in Wales as a choice, because of the environment that we are creating, and because we’re able to have a conversation that recognises the potential without compromising on our values. That’s where we need to be as well. So, when I have conversations over at the life sciences hub, people are genuinely positive about making choices to move some of their investments into Wales because of that. But that is a point of difference to what takes place in these areas. I recognise you’ve mentioned about Cambridge, as opposed to these are areas for us to take advantage of. I’d be more than happy, once we’ve actually settled on the final stage for the strategy, in response to the consultation, to be able to give more detail on the specific areas within the life sciences sector more broadly that we expect to target and gain real benefit from.

Thank you for your statement, Cabinet Secretary. The fields of genomics and precision medicine are the key to winning the war on cancer and key to the future of our healthcare. I’m therefore very pleased to support and greatly welcome the Government’s genomics and precision medicine strategy. When we look at lung cancer, for example, which accounts for a quarter of all cancer deaths in Wales, traditional medicines are not very effective. By targeting the specific genetic mutation with precision medicine we can increase survival rates, particularly in non-small-cell lung cancers.

The Association of the British Pharmaceutical Industry and Cancer Research UK have been leading the calls for a Welsh strategy for stratified or precision medicine for a number of years, and it’s great news that we finally have one. I, together with my party, will work with you in order to ensure that this strategy is successful, and, in that spirit, I have just a few questions about how the strategy can be implemented.

Cabinet Secretary, the strategy highlights the need to ensure appropriate data sharing for the service development and research. What discussions have you had with your colleagues across the UK about how best we can share data to improve research and development whilst protecting individual patient information? Moving forward, new innovative treatments are key to the success of the strategy. Cabinet Secretary, how can you ensure that there is joined-up thinking with regard to the appraisal of these new, novel treatments? How will you ensure that the Welsh Health Specialised Services Committee, the all-Wales medical genetic service, the All Wales Medicines Strategy Group, and, where appropriate, the National Institute for Health and Care Excellence, work closely with the pharmaceutical industry? Finally, Cabinet Secretary, how will you ensure adoption and uptake of clinical and clinical genetics services across Wales, and how will success be monitored and assessed?

I thank you once again for your statement and for bringing forward this strategy, which will help improve how we develop and how we deliver health treatments in future. Diolch yn fawr.

Thank you for those comments and questions. I think it’s useful, when we talk of precision medicine, to understand that, in the past, we thought there’d be big, blockbuster drugs or treatments to deliver a wide-scale improvement across the whole population or across whole groups of people. We understand more and more that that’s unlikely to be the way in which medicine develops. A range of those apparent blockbuster drugs haven’t been as effective as we would have wanted them to be, in addition to us then finding different uses for them as well. This is about understanding how we more precisely have a more individualised approach to diagnostic certainty and then treatment choices as well.

I think the data sharing comments—it builds on the questions and comments from Angela Burns. Look, I don’t have direct ministerial conversations on this particular topic with other colleagues across the Governments in the UK, but there are Government-to-Government conversations about where we are. There is already an element of collaboration. The fact that we’re actively engaged in the 100,000 Genomes Project with colleagues in England is a really important marker, and also those wider research conversations that take place outside the national health service, as well as within the NHS, are a marker of the fact that these are active conversations that take place on how we share data to the best possible effect.

But it’s also, as I say, going back to Lee Waters’s point, about how we make sure that the real competitive advantages that we potentially have here in Wales are properly exploited and taken advantage of, both for our economic benefit but, again, not compromising on the values that we wish to have about the way in which patient data are used and how we want the health service to be run.

On your point about the appraisal of new developments, we’ll make sure that there is a proper, rigorous appraisal process, both in commissioning terms through WHSCC, but also, as new treatments and new therapies are developed, they’ll all need to go through a process to understand whether they offer genuine value in terms of both financially for us as taxpayers, for what we are paying for, but also for the individual citizen and their treatment choices available to them and their healthcare professionals that they will be understanding and making choices with. So, that will still be part of the process.

There’s no suggestion that, actually, we’re running along the track of saying if this comes from precision medicine then all those other indicators about effectiveness and cost effectiveness go out of the window—they won’t. It goes back to the points that Rhun ap Iorwerth was making, though. There is a potential for cost saving here, and a potential for real health gains to be made, but we always need to understand, when those indications are available to us that we have a new potential treatment option, how do we properly appraise it to make sure we’re not gearing ourselves up and spending lots of money in a way that is neither wise nor prudent.

And, on your broader point about big pharma, I think I tried to do this in responding to the points made by Lee Waters. There is an adult conversation to continue to be had that should lead to different investment choices, investing in different parts of Wales, where there’s a real advantage to be gained—so, real economic opportunity, real health gains to be made, and an area where I really do think Wales has a good story to tell, and I hope, in the future, we’ll be reporting on active and real progress that we’ll continue to make with and for citizens and the health service here in Wales.

Thank you very much. Thank you, Cabinet Secretary.