The Lawyer, in association with DLA Piper, recently hosted a roundtable focusing on the growing number of obstacles and opportunities faced by law firms and businesses alike when working with digital therapeutics
Roger Wagland – Research and digital product director, The Lawyer
Tom Heylen – partner, DLA Piper
Gareth Stokes – partner, DLA Piper
Round the table
Jonathan O’Keeffe – medical director – Machine Medicine Technologies
Jossy Onwude – chief medical and product officer – Bold Health
Isabel Van De Keere – CEO and founder – Immersive Rehab
Rich Adair – senior legal counsel – Clinigen
Martha Carruthers – head of life sciences – Medopad
Francesca Rivers – solicitor – Cancer Research Technology
Ben Sadowj – global regulatory innovation and market access lead – RB
Roger Wagland: We’re going to be looking at some of the issues that people are facing in the industry, including intellectual property, data protection and management, product monetisation, and how partnerships are formed. The conversation will be led by Tom, who is the London managing partner at DLA Piper, and Gareth Stokes.
Gareth Stokes: There’s a lot of discussion at the moment placing data as the lifeblood of business, nowhere is that truer than in life sciences. Inevitably there are a large number of challenges, one being the regulatory framework which quite rightly requires the data subject to be placed at the centre of that discussion. Data subjects’ rights are paramount and determine what you can do with that data.
In some senses, there’s a tension between the public good that can come out of that and what you are allowed to do with it. This means that when designing these systems, you have to be aware of who collected the data in the first place and then making sure that data subjects remain informed throughout.
Tom Heylen: Francesca, how does Cancer Research deal with its vast amount of data, much of which must be old?
Francesca Rivers: I only joined Cancer Research Tech a few weeks ago but I was previously at Bird & Bird working in the life sciences sector where we had to navigate some of these issues. Our focus at Cancer Research is to make sure collaborations are set up that will improve patient treatment. In terms of historical data sets, we’re still in the early stages of overcoming those challenges.
Martha Carruthers : At Medopad, which is a digital health company, we focus on consent and making sure that you have appropriate consent. We go off the mindset that the data subject ultimately owns their data, and how do we take them through that journey of seeing the value that can add to detection, prevention and ultimately shortening windows between diagnosis and therapy.
Heylen: Do you think that asking for re-consent is realistic? Is that not a massive administrative undertaking?
Jossy Onwude: With the way products and tech works there is a way of getting into contact with these patients and obtaining consent again, but there is a risk of drop-off. What we need going forward is a way of having a finite amount of consent in contracts. If in an agreement you give consent for data used for x amount of years, then after x years you can ask the patient for new consent.
Rivers: But then the challenge is making the consent specific enough to satisfy the requirements of the GDPR so you’re stuck between maximising benefit from the data and making that consent clause specific enough to meet GDPR requirements.
Wagland: From a patient’s perspective, what if they are uncomfortable with giving data but obviously still need the therapeutic?
Carruthers: We attempt to put into place a secondary consent so the patient can use the therapeutic with basic consent and then we add in a secondary consent where the patient can consent to their data being used.
Heylen: Should you be able to withhold your data and still benefit from other people’s data? Shouldn’t it be that in order to use this data you have to contribute to it? Isn’t there an inherent unfairness to that?
Isabel Van De Keere: There’s a comparison to be made here with drug trials, where they are carried out with lots of people’s data, however, I think that the decision still has to be about the patients’ trust in your product.
Heylen: Are any of you getting questions or pushback or pressure from customers on data?
Heylen: When you look and see where the new therapeutics are being picked up the quickest, it’s not in the UK but in the US. I have seen clients get incredibly frustrated after years and years in the UK, and then give up and go to the US – is it the structure here that allows this?
Van De Keere: I think it’s the structure of the NHS, in the US it’s mostly privatised and not so much to do with regulation.
Ben Sadowj: Certainly, the Food and Drug Administration (FDA) has been very forthcoming and proactive in terms of guidance compared to the European Medicines Agency and the EU Commission. EU regulation and guidance is lacking in comparison.
O’Keeffe: At least the FDA will simply have the conversation. With the EMA you have to apply and pay them many thousands of pounds, and for what – to make money out of early-stage companies? The price-tag automatically acts as an inhibitor to European companies.
Heylen: Are there lobbying organisations in the UK, lobbying on behalf of digital therapeutics?
Carruthers: The Digital Therapeutics Alliance is trying to do some of that work and trying to pull together thought leaders and industry innovators.
Rivers: We are on the verge of a digital revolution, and how to use it in healthcare management, and there are lots of new regulations, but very little out there in terms of where the limits of them are.
O’Keeffe: I worked for the NHS myself, and there are a lot of things I greatly admire about it, but I would say that if you have a conversation in an NHS trust about this stuff people will make the right noises and take the right actions, but they will err on the side of patient data protection over long-term patient benefit.
Heylen: If we can move the conversation along – and talk a little bit about bringing products to market, monetisation and business structures?
Van De Keere: Once you get regulatory approval then you can go to market, but that does depend on the regions where you are selling your products because today reimbursement plans for digital products are non-existent in a lot of countries. In the US it’s moving towards a value-based system via insurance-based private healthcare, whereas in Europe it’s a mix of public and private healthcare.
Rivers: There needs to be a focus on quality in data to make sure that the outcomes we do get are evidence-based. There needs to be some funding structures – cancer research is in a privileged position where they can set up a more unique funding structure using a range of funds including donated funds to get over the first hurdle, whereas in the private sector that might be more challenging to get that cash injection to overcome the initial lag time in order to gather the data needed to prove value.
O’Keeffe: I think one really good thing about the UK is initiatives such as Innovate UK – we received a grant from Innovate UK which has made the difference between life and death for us – which was enough to get investors over the line and de-risk it.
Heylen: End of time, but just to open the floor – what do people think is important to get on the table?
Van De Keere: I think it will be very interesting to see how pharma evolves in the future. Now they’re mostly watching on the side-lines, opening hubs for start-ups or entering partnerships, but they might want to start doing some things themselves and develop things internally.
Carruthers : I think there’s a lot of movement in this space – there’s a lot of partnerships but compared to their large business it’s still a very small percentage, but it goes back to their business model, and how it’s going to work, partnering a billion $ business with businesses that aren’t valued as billion $ businesses yet.
O’Keeffe: I think fundamentally there’s also an issue surrounding IP. The IP for digital therapeutics is weaker than for a drug – an IP around a drug is rock solid. With digital therapeutics it’s a case of building an equivalent app and doing a new trial. So, it’s a serious problem for digital therapeutics.