INTERVIEW: NICK MALTBY
GENERAL COUNSEL AND COMPANY SECRETARY
Genomics England is behind the UK’s 100,000 Genomes Project, which has set out to catalogue the genomes of 70,000 patients with rare diseases and cancers. GC finds out more about this unique and ground-breaking data project, and about the man masterminding the legal issues.
G C I N T E R V I E W
EDITOR AND FEATURES WRITER
GC: Could you tell me a little bit about the 100,000 Genomes project?
Nick Maltby (NM): Your genome is about 120 gigabytes. For a patient with a rare disease you probably need three – ideally child, mother and father. For a cancer patient, you need two – germline/normal and tumour. So for each patient you’re talking a lot of data. Genomic data would be combined with the disease characteristics or phenotypic data, and also the clinical data for the patient, and it’s with all of that you can start learning things.
The UK is one of the few health systems that can do a project like this – simply because we are in the public domain, we’re not insurance-driven and there are no big liability issues around doing it. If we can produce a better repository [than currently exists] that links lots of datasets, where you can look for the people with certain disease characteristics and you can, say, select them for trials, we might be able to considerably reduce the average time for drug development, which is currently around 15 to 20 years.
But given the size of each file, how you can compute across 100,000 of these? There’s a scalability issue and some of the big data companies question whether it is possible. No one’s ever done 100,000, and so it has become an NHS [the UK’s National Health Service] transformation project. It’s about personalised medicine. With genomics, there’s a raised possibility that you might be able to target drugs to individuals. Even in a cash-constrained health economy, this is seen as something that can drive the future of how we do medicine in the 21st century. The ambition is to make personalised medicine possible and thereby generate income through partnerships with industry, which can be recycled back into the programme, as well as to create a valuable resource for academics and the NHS.
GC: As general counsel, what are the main legal issues that you’re dealing with?
NM: Data, IP, procurement, contracting. I’m on the senior management team. I’ve had two stints as head of HR and one stint as head of finance. When you’re in a start-up, you can’t say ‘my role is confined to this’. You have to do what you have to do, and if there are only half a dozen of you, someone’s got to answer the media queries, someone’s got to deal with the responses to the recruitment adverts.
GC: Do you enjoy that?
NM: I thought working in a start-up was fantastic. We’re now more mature. When you work in a big organisation, people work in certain ways. In start-ups there’s an energy and excitement, even in a government start-up, because you’re in a very small group of people.
You’re doing something that you read about in the press; you go out for dinner and people have heard of it. I used to minute the science committee, and it would be eight professors, four of whom were knights, and me! And you think: ‘what are my qualifications to minute the science committee, where they’re talking about very exciting genomic things?’ It is a very high profile project to be involved with.
GC: Are you able to expand on some of the legal issues? What are the IP issues and what do they actually mean for you?
NM: We’ve had to promulgate an IP policy – trying to identify the sorts of IP that might arise from the programme and working out how we will manage the IP. We’re not quite at the point where we have lots of collaborators in the data centre doing things, but there are certain things that follow. We’ve set ourselves up as a reading library and not a lending library. If you come to us, you won’t take data away; you have to go and do your research in the data centre. It’s about working out how you can facilitate the right environment for leading research while maintaining the highest standards of data privacy and security that our patients expect.
GC: Ultimately this is going to be a commercial project, so you’re working with big pharma presumably?
NM: Working with industry is a vital part of developing new drugs and better treatments for patients in the future. What’s generally exciting to pharmaceutical and biotech companies is the linked data. As we sit here, the GENE [Genomics Expert Network for Enterprises] Consortium, which is a consortium of 12 big pharma or biotech, is working with us to understand the value in the dataset and the things you can do with it. We have great hopes for the sorts of things that they can do with us, because that’s how we will raise money going forward.
GC: Obviously the 100,000 Genomes Project is a big data project; it’s really fascinating to hear about the different ways that companies are using big data.
NM: There’s been a move towards cloud computing and things like that, but we can’t put stuff in the public cloud, so we’ve got a private cloud. We have a Medical Research Council grant for £24 million, so we are buying the storage and we get a third party company to manage it. We did interim data procurement at the end of 2014 and we’re about to finalise our main procurement. Given the challenges of doing this sort of computing and the amounts of data involved, we’re trying to build strong partnerships with companies who are leading the world to deliver this.
GC: There must be a lot of legal issues that arise from handling that much of people’s personal data. Is that something that comprises a large part of your legal advice?
NM: The trouble with linked data is that, from a [UK] Data Protection Act perspective, even if you strip off the identifiers, it’s almost certainly sensitive personal data. If it’s a rare condition, it’s particularly difficult to anonymise it, and if you have enough linked data sets, you might be able to find out who these people are. Especially in a rare disease case, where one of the things that’s quite useful is images.
Take subject access requests [a provision of the UK Data Protection Act whereby individuals can request access to data concerning them held by an organisation]. The Data Protection Act was written well before anyone had any thought of data being stored and used like this. And that’s a very big issue for us. If I logged onto our data centre and looked at some genomes, I don’t really know what to do with that information, and that’s the case for most members of the general public. But if individuals ask us for a copy of all their genome data, as is arguably their right (although the research nature of whole genome sequencing may suggest otherwise), clearly that’s a lot of storage and the Act says we can charge up to £50 for what would be hundreds or thousands of pounds’ worth of effort. So certainly there are issues stemming from the fact that the current legislative framework doesn’t really map the project and the sorts of data that we’re talking about.
GC: Further down the line, if it comes to licensing use of this data to pharmaceutical companies for a commercial purpose then presumably there are issues of risk there. How would you look to mapping and mitigating in such a case?
NM: The fact that it’s a reading library does help. We have an airlock: we say ‘you can come in and do some research, but you can’t take anything away unless we look at it’. We have policies around what tools and data you can bring in, and we look very closely at the tools and the data. We have an access review committee that looks at access, and a publication committee that looks at publications. We’ve spent a lot of time on the whole information governance framework.
GC: What’s your favourite part of the job?
NM: It’s the best job I’ve ever done. I suppose it’s being at the cutting edge of science and data and I like working with non-lawyers! It certainly gives you a different perspective on the sort of advice you gave clients when you were in private practice, because you glibly assumed that they knew what you were talking about. But the answer is, they sometimes don’t!
My background is project finance, and there’s some interesting procurement stuff and public sector contracting. So this role here is a good fit for me.
We’ve had multiple moments where we’re covering families who have finally got a diagnosis, and in some cases there are things you can do, which is what the programme is about.
GC: You were in private practice for a number of years. What made you move into an in-house environment?
NM: I was looking around at a variety of options and this was the most attractive one that came across my desk. As a partner in a large law firm, you can be a bit peripheral, certainly in terms of management of the firm, whereas in a relatively small start-up you are central to what’s going on. There are four of us on the leadership committee. Would I be on a leadership committee at a law firm? You’re doing things that are not just legal: it’s also running a business, giving direction, shaping something which goes beyond simply professional services, working with scientists and politicians. It is a revelation as to some of the things you can do in-house, and the sort of challenges.
One challenge is teaching yourself that you don’t have to do it all yourself. You’ve got external lawyers – they can go and do it! I suppose I am a very bad client, in the sense that you think, ‘I could do this myself, possibly more quickly’, or in that I’ve had a very steep learning curve here, and it’s very rare to find lawyers who understand genome sequencing and all the complications.
GC: Do you find that you end up doing a lot of the work in-house?
NM: I probably do more than I should. But then I quite like it. I’m trying to discipline myself to not do it, and to do things that are more strategic.
GC: You did a lot of procurement and project finance work when you were in private practice. Were you always drawn to the public sector work, as opposed to more corporate matters?
NM: I’ve done pure private sector commercial, but I did rail privatisation from ’93 to ’96, and then the government invented PFI, so I suppose the next 12-15 years was PFI, advising governments and hospitals, but also contractors and banks. Since ’93 it’s been a lot of government things: probably 50% health, 20% transport, then things like schools.
I certainly enjoy being able to go around and say about new public buildings: ‘that’s mine’ and ‘that’s mine’. I lived in Leeds for quite a long time, and most PFI assets in Leeds were in some way mine! There’s something tangible out there in the real world that is yours. Takeovers and acquisitions I found less interesting.
GC: What is your career highlight?
NM: I’d say it was this role – it’s like a culmination. Before this, I would have said some of the bigger PFI hospitals I was involved with.
GC: Did you always want to be a lawyer?
NM: I think probably from the fifth or sixth form, yes. I must have thought I was a words person and not a numbers person.
GC: Does that square with how you view the role of an in-house lawyer now?
NM: I went to one of these GC conferences, and was talking to a chief exec who was a lawyer. He said that the problem with lawyers is we will come up with six reasons for not doing something, rather than one reason for doing it. At the end of the day, that sort of advice is not terribly helpful when you’ve got clients or a company who want to do something.
There’s a huge debate in GC circles about retaining independence and (arguably) giving not terribly helpful advice to the business, or ‘how native do I go?’ There’s no right answer because clearly it’s a balance, and partly it comes down to how you communicate. You might think, ‘well, I’ve got six reasons but I’d like to keep a few of those to myself’, and give a more nuanced response. But then of course, there are lines you do not want to, and cannot, cross.
Then that comes down to the whole debate about should GCs be on the board? And if they’re not on the board, how do they maintain influence? And how do they have the ear of the chief exec?
GC: What do you think is next for the GC role, looking five or ten years into the future? As you say, more and more GCs are moving into a business role. Do you think that will continue?
NM: I don’t know. You hear lots of stories about the legal team being people who the business doesn’t want to talk to because they just stop people doing things. That’s a very difficult place for legal departments to be. A lot of the things that we do as lawyers should be complementary to the business − they’re a driver for transactions or they’re helping the wheels turn. There are times when you have to say to the business ‘there are risks around doing that’, and there are times when you have to say to the business ‘no’.
I think it depends on the person too, because some GCs might not have the personality to go and have the conversation. Certainly my chief exec doesn’t like notes that say ‘don’t do this’. He would rather you come and talk to him and explain why it is and have a debate and see what happens. It’s far too easy to get a reputation for being a blocker. There are plenty of blocking cards if you play them appropriately, while maintaining your credibility. You don’t get any training for this, so it’s a difficult path to tread, and it’s easy to go too far one way or too far the other.
What we forget about as lawyers is we all have these generic and transferable skills that work in a variety of contexts. We’re good at detail, we can pick up information quickly, we are used to running meetings, we’re organised, and these are all characteristics which are less general than you might think. When you translate those into other spaces, they are extremely valuable. When you’re in private practice you don’t see it because everybody else has attention to detail. You don’t see it as being anything particularly out of the ordinary. So we’re quite shy about saying actually we can do all that.
I suppose the fear about lawyers being on the board is that we’re going to say ‘I’m not sure about that, I’m not sure about this, not sure about the other’, rather than taking a balanced perspective. I saw it in private practice. But rather than go to a client with ‘here’s my memo with 10 options and you choose’, I would go to them with ‘this is the one I suggest you do, I’ve already thought about the other ones’.
GC: Are there any special skillsets that you think in-house counsel will have to cultivate in future, in addition to their legal training, that will make them become better value-adders to their business?
NM: I came to the 100,000 Genomes Project at the start when it wasn’t so intense, and so I had a lot of time to read. If you’d asked me what genomics was this time a few years ago, I would have said: ‘pardon?’
Law firms aren’t bad at sending people on courses on other areas, but whether it will ever become central, I don’t know. I’m not saying go as far as doing an MBA, but clearly I do think that some amount of technical knowledge (which I think you can pick up, arguably, on the job) is useful. To work here, you’ve got to understand big data, genomics, what’s possible and what’s not as possible, and you can do that by talking to people, by sitting in meetings, and understanding how it all works. If you can’t do that then really it’s not for you and, obviously, if you can do that you can work anywhere.
Lots of sectors are about relationships, and so you can piggyback off relationships you have. But you do need to know how the business ticks and how it works in relation to other businesses. Preferably you probably need to be business literate and financially literate, which lawyers are less good at being.
In a way, I wish I’d done a secondment in-house earlier in my career. Unless you’re in the business, I don’t think you really understand how your client ticks. I learnt things about how government works by working in government, and I’ve acted for many government departments and I wouldn’t have realised it, because you see a very narrow cross-section of what they’re doing and the sort of issues that arise on a daily basis.