COVID-19: Key Considerations for Health Providers & Life Science Companies
Jones Day partners Alexis Gilroy and Maureen Bennett talk about lessons already learned from COVID-19, the questions clients are asking, why it's important that the world's health care organizations share information, and how telemedicine can help.
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Dave Dalton:
COVID-19 or the coronavirus is affecting nearly every industry and sector in the global economy. Jones Day partners Alexis Gilroy and Maureen Bennett are here to explain how the healthcare and life science sectors are responding to the outbreak and they'll tell us what to look for on the regulatory front and in the telemedicine space as healthcare moves on after the crisis is behind us. I'm Dave Dalton. You're listening to JONES DAY TALKS®.
Dave Dalton:
Jones Day partner Alexis Gilroy, a national leader in the digital health industry, advises on complex transactional and healthcare regulatory issues, with an emphasis on virtual health message, such as telemedicine, telehealth, and mobile health. And partner Maureen Bennett represents life sciences and healthcare clients conducting global clinical trials and research collaborations. For nearly 20 years, Maureen has advised clients on the contractual, regulatory, and ethical issues associated with clinical research.
Dave Dalton:
Alexis, Maureen, thanks for being here today.
Maureen Bennett:
Thanks, Dave.
Alexis Gilroy:
Thanks.
Dave Dalton:
Alexis, there's been nothing like this in quite some time. Coronavirus, COVID-19, however we're terming it, this has been no doubt a crisis and it's caused some issues certainly, but already from what you've observed as this has unfolded over the last few weeks, are there lessons to be learned from this crisis? And what I mean by that is are there takeaways that companies can use to be better prepared next time? What are you observing?
Alexis Gilroy:
Of course, Dave. It's an important question and one that every executive thinks about as they are in the midst of a crisis and as they look back on one, right? How can we better ourselves? How can we plan ahead?
Alexis Gilroy:
I think while this is impacting companies across many, many sectors, as we look at how it's affecting healthcare and life science companies, I think there's a couple of key points to highlight.
Alexis Gilroy:
I think pretty much anybody you listen to talk about the coronavirus crisis, they anticipate a strain on the healthcare system, and of particular note are digital health offerings as a potential resource or help that could advance capacities, whether that's artificial intelligence assisting triage and enabling data points to track the virus and its spread, or telehealth systems that can help manage care in connecting with specialists or just effectively maintaining the worried well at home.
Alexis Gilroy:
So I think it's going to be, for healthcare systems in particular, a time to think about what offerings, digital health offerings they already have in place, how they might want to get those ready to go in the future, and in the midst of this crisis, highlighting those capabilities to meet their immediate needs.
Dave Dalton:
Well, talk about a little bit. When you mentioned the capabilities, what would be examples from a practical standpoint? How might a company who is prepared and had already ramped up in the telemedicine world, how might they benefit right now? What would they have clients, patients, people be doing?
Alexis Gilroy:
Sure. I think it's a great way to triage patients, right? So rather than rushing to the emergency room overcrowding a doctor's office, right? Where you're pooling sick patients with potentially well patients or patients of different conditions, you can use telehealth to assess them, meet their needs at a home setting, and then disperse them to the appropriate care providers.
Alexis Gilroy:
So that's one use case. The other one is to enable collaboration among healthcare providers. So there's obviously different specialties, infectious disease specialties, and others, respiratory specialties, that are going to be necessary in this crisis. And this is a good time to think about how you can enable using effectively just telecommunication systems and networks to provide support from those specialists to primary care community hospitals and other folks on the front line on meeting patients' needs.
Dave Dalton:
Sure. What are you hearing from clients right now regarding this? No one likes that this happened and it's absurd for even me to raise that point, but it is an interesting scenario I guess for people who were ready from a telemedicine standpoint. What are you hearing from clients?
Alexis Gilroy:
Sure. I think their immediate reaction is to their employees and their personnel, how do we handle this, how do we communicate about this? Of particular note for clients who are employers of healthcare providers, right, they've got a special attention to how they think about and handle this and communicate messages. They're looking to, and importantly and thoughtfully doing so, resources from CDC, FDA, Department of Health and Human Services to give them guidance on all those fronts. But I think they are starting to next turn to, tactically, how do they utilize things like telehealth or other methods? How do they make sure their supply chain is intact, et cetera, to manage what is very much an evolving issue that there's trying to stay on top of.
Dave Dalton:
For. A moving story, for sure. Let's go over to Maureen Bennett for a second. Maureen, thanks again for being with us today. This is your first podcast with us, isn't it, Maureen?
Maureen Bennett:
I'm thrilled to be with you.
Dave Dalton:
I was going to ask how you liked it. Well, that's nice day here. So far, so good. Pretty painless, huh? So let's talk for a second. You have deep experience across the board, but with regulators, research organizations, clinical trial organizations and so forth, you've got a good perspective here. From a public policy standpoint and a reaction standpoint, what can national governments do to coordinate a better response when something like COVID-19 happens, either through private healthcare sectors or however it is? What can they do better? Without being overly critical of anything, and this has been an unfortunate situation, but from your perspective, what can a government do?
Maureen Bennett:
Sure. Well, I think one of the most important steps that national governments, and also, very importantly, local governments can take at moments like this is to really make sure that they're working with and actively sharing with colleagues and their counterparts the most reliable and up-to-date information that's available regarding the virus. And this would include information about the patterns of transmission, effective means for diagnosis and containment, and of course, ultimately we hope methods for actually treating patients who contract the virus or preventative vaccines that would really take away the risk.
Maureen Bennett:
We've seen global NGOs really step up. The WHO has been a very prominent voice since the beginning. In the last couple of days, the European Commission also is attempting to coalesce thought leaders in Europe. And of course there are a number of US agencies, the CDC, NIH, FDA, as well as state governments that are all trying to work together.
Maureen Bennett:
But as we all know, in this era of social media with lots of different news outlets, public websites of all kinds, rumors can be rampant and there's almost nothing more detrimental to appropriately responding to a public health situation is where there's misinformation that might lead to panic and some missteps in approach.
Maureen Bennett:
So unfortunately, in today's world, a significant part of a regulator's role is not only actually taking the public health steps that are necessary, but also making sure that the messaging, if you will, is also done appropriately.
Maureen Bennett:
So that's one thing that is critically important. And then on a more substantive level there, it's very important that there be as effective cooperation as possible in terms of the actual creation of solutions for treatment and hopefully vaccination, but it would be a mistake to overlook the fact that there is still a tremendous lack of harmonization across the world's medical regulatory system. For example, therapeutic medicines and diagnostic devices are each subject to different marketing approval regimes per country, and those are requirements that need to be met.
Maureen Bennett:
Similarly, you mentioned clinical trials, and there are a number of clinical trials that are underway to try and find either a vaccine or some effective treatments for the coronavirus. But even if, for example, a clinical trial is approved under an FDA regulation, in order for sites to be opened up in countries around the world, then proper approvals have to be obtained from those local authorities.
Maureen Bennett:
So we are definitely seeing some fast-tracking taking place. The reality is that we are still talking about global regimes. And then on top of that, for example, in the United States, state and local public health authorities will have a tremendous role in this process, whether it pertains to the licensing issues for local healthcare providers, decisions that might be made on a very local basis or a state basis in terms of quarantine, closing schools, emergency response at healthcare facilities. So there's a lot of moving pieces in a situation like this.
Dave Dalton:
Sure. Sure. You mentioned fast-tracking a second ago, and forgive the naive question. Well, I'm entitled to one, right? I get one per show, a naive question coming: But in a crisis situation like this, isn't there somebody somewhere, you mentioned World Health Organization, maybe the CDC here in the States, can't somebody say, "Look, nonsense. I don't care how many jurisdictions we're talking across the board, whatever, we found something that can help." Is there somebody, I mean, can the UN get involved? Who, if anyone, can really accelerate approvals and getting this to people that need it?
Maureen Bennett:
Well, unfortunately there really isn't one uber source of authority, and that's a long discussion about international governments and local sovereignty and all the rest. Having said that-
Dave Dalton:
Maureen, I told you it was naive. No, go ahead. Yeah.
Maureen Bennett:
But having said that, there certainly are mechanisms. And we're already seeing, for example, some of the clinical trials that have been launched recently have been done in a very expedited fashion. Similarly, we just saw, over the past weekend, in response to the acknowledged shortage in available diagnostic devices in the US, the federal government in the US has come out with some guidance that would allow certain laboratory developed tests for COVID-19 to be deployed even in advance of what's already an expedited process of the emergency use authorization process.
Maureen Bennett:
So there are steps that are being taken to try and fast-track, but it still requires that each affected government kind of buy in.
Maureen Bennett:
And the other thing I would say, and this is also on the minds I know of a lot of health regulators, is that one wants to be careful to take expedited steps, but also not make a situation worse. So there will undoubtedly be a lot of urgency behind finding an effective therapeutic, but as we all know, in the drug development world, there are lots of opportunities for adverse effects. And while that's kind of part and parcel of the drug development process, certainly we want to make sure that in an effort to try and get something positive in the market, there isn't something that actually creates other significant unwanted results. So it's a balancing test.
Dave Dalton:
Definitely. Well, that segues very well into my next question. I mean, do you see regulatory or legislative responses coming out of this situation? Do you hear anything out of Washington that there's something we can fix, or is it too soon for that?
Maureen Bennett:
Well, I think we're seeing a lot of steps now in the last week in terms of the various agencies coordinating with one another. I think that there's a high expectation that there will be more diagnostic tools that will be available. There are, as I mentioned, some clinical trials underway for vaccines and therapeutics. Those will take some time. I think lot of the on the ground activity right now is really focused in some of the places like the state of Washington, where there is a cluster, so to speak, that may be developing, and so there is a lot of interaction between state and local authorities and the CDC in terms of the best way to manage that situation.
Dave Dalton:
Okay, good. Let's go back to Alexis for a second. Alexis, we were talking a second ago, you mentioned certain resources that might be available to companies in healthcare and life sciences trying to comply, trying to do the right thing. Emergency policies and regulatory requirements are always changing. What can companies do? Where can they go for guidance? And Maureen just used that word, but are there resources for good information out there?
Alexis Gilroy:
Dave, I think it's a great question. I am not aware just yet of a fully comprehensive set of one-stop shopping resources. I think there are some good information sets out of CDC, FDA on the US front, and various different state agencies are also pulling that together. So various clients should certainly reach out to their local authorities to see what information might be available and applicable to them.
Alexis Gilroy:
We have, at Jones Day, a development of a task force that is pulling together various different resources and making those available to clients. Hopefully it's something, Dave, maybe we can get out to our clients, any information about that so that they can use this as a resource. And I know that is important for clients not only as employers, as vendors thinking about their contractual obligations as well, but from Maureen and I's perspective, also as healthcare and life science companies and how there may be unique resources and support for them in particular.
Alexis Gilroy:
Thinking about something Maureen said a moment ago with the sort of global aspect of our regulatory infrastructure, right? And how that it might seem to consumers that you can seek services, you can access technologies, et cetera, from pretty much anywhere on the planet, our regulatory infrastructure and legal infrastructure certainly does not align to, or behind the scenes, it's quite a complex web to navigate to get to a compliance structure for that.
Alexis Gilroy:
So I think as this virus has highlighted extreme global interaction from travel and work and conferences, et cetera, that consumers participate in. I think it certainly is going to be a necessary outcome from this to create a discussion around more thoughtful global governmental regulatory infrastructure that frankly, I think, in our world that Maureen and I work in a fair bit, where we are increasingly, even prior to this virus, crossing borders, right? Because the technology, the services enable that and are necessary for the organizations that are providing these services. I think it should be an interesting outcome from this event and it should be a good thing to put us all at a better place going forward because we're going to need more thoughtful cross-border regulatory capabilities.
Alexis Gilroy:
I don't certainly have the answers on any of those fronts. It'll take a team to get there, but hopefully this will be a positive from this event, that we will stimulate that activity and really drive that forward because it really just highlights the global nature of our activities. And on a topic like health, we really need to be thoughtful about that and regulate it thoughtfully as well.
Dave Dalton:
Well, and you raised some excellent points. And we're always talking about globalization. Suddenly you've got a healthcare crisis and it really becomes real. I mean, the world's both bigger and smaller, right? But Maureen, from your perspective, I like the viewpoint you bring on this given your past experience, is it easier or harder right now advising clients? You've got so many jurisdictions, you've got a global health crisis that started in a very small sliver of China. I mean, this is a lot to get your arms around. What's the most challenging thing about practicing right now?
Maureen Bennett:
I would regard it as kind of a mixed bag. I think it's actually a tremendously exciting time to be working in this space. Certainly the challenges of multi-jurisdictional practice can be significant, but I think that the rise in business globalization, especially in our industry, has actually laid the ground works for a lot of exciting opportunities in the practice and also to try and solve some of the problems that we're talking about.
Maureen Bennett:
For example, one of the things that is of concern now of course from the US perspective is will some of our food or medical supply networks be impaired by this virus? And that of course is based on the number of products that are coming in from a number of international locations. On the other hand, because there has been a proliferation of manufacturing facilities that industry clients have used outside of the US, especially in Asia over the years, there is now an established infrastructure for how those facilities might be inspected. The FDA has had six or seven international offices for a number of years, so they're regularly interacting with regulators there. We are very used to, if we're working on a transaction, for example, doing due diligence on clinical trial programs or outsourcing manufacturing programs that may occur in several different locations. There are also, because there's so much business abroad, we now see opportunities to have research studies done in multiple jurisdictions at the same time.
Maureen Bennett:
So while I was mentioning earlier that there are some challenges based on the fact that each jurisdiction will have its own regulatory regime, the fact is now, as opposed to 10, 20, and certainly 30 years ago, we're much better positioned to be able to understand the different regulatory and business dynamics in the various jurisdictions around the world. I find it incredibly exciting and rewarding.
Dave Dalton:
Good time, interesting time, that's for certain. Hey, we're almost out of time, but let's wrap it up with this. I read an article the other day. Actually, one of your colleagues was kind enough to send it over to me, and someone said the virus might be sort of a tipping point for telemedicine. People will see the benefits. People will understand, "Gosh, this sure was convenient. The sure made us feel safer, more secure," because it provides an option that certainly wasn't there 15, even 10 years ago.
Dave Dalton:
What's your reaction to that? Is this something that could showcase, Alexis, telemedicine, telehealth, to use your term, and what it can do? Is there, if there's a tiny sliver, a little silver lining, might it show people this is a good option?
Alexis Gilroy:
I think the answer is an easy yes. And frankly, I would even expand it, not just telemedicine, but to some of the points Maureen was raising, perhaps also this highlights the need for and the capabilities involving multi-jurisdictional clinical studies, right? I think it's really just a means to demonstrate the use case, right? Of some of the core benefits of some of the novel offerings that have come of age in the last decade or so, and really, that we need to collectively recognize that, wow, there's a time and a place and a benefit behind them.
Alexis Gilroy:
They are not a panacea of kind of solving all the world's health problems by any means, but rather, they're a wonderful modality that enables repositioning, redeploying care, redeploying clinical capabilities, et cetera, so that you can expand the gene pool, if you will, for participating in various trials and learning about them through artificial intelligence and things like that.
Alexis Gilroy:
This will put a spotlight on these longstanding, in some cases, in the case of telemedicine, I mean, this has really been around as a means for delivering care for several decades now, but we're going to see it in the spotlight. And I think we will then have to face the important discussion of potentially removing some of the, I'll call it, in some cases, arbitrary regulatory barriers, unlike some of the arbitrary Medicare barriers for reimbursement of telemedicine, that simply now that we can demonstrate its safe and value oriented use in this particular moment in time, it will change the conversation.
Alexis Gilroy:
So I do think it has a strong potential to be a tipping point for telemedicine, but potentially also artificial intelligence in the case of healthcare, and also clinical trial services that are changing already prior to the virus.
Dave Dalton:
Interesting time we're living in it. This has been great. I have a feeling we're going to be talking again before too long. But thanks so much for your time today, Maureen, Alexis, take care and thanks for being with us today.
Alexis Gilroy:
Thanks
Maureen Bennett:
Happy to be here. Thanks, Dave.
Dave Dalton:
Enjoy. Thanks. See y'all.
Dave Dalton:
Bye. You can find complete bios for Alexis Gilroy and Maureen Bennett at jonesday.com. While you're there, check out our Jones Day insights page, where you'll find white papers, videos, podcasts, blogs, client commentaries, alerts, and other important and critical information.
Dave Dalton:
Subscribe to JONES DAY TALKS® in Apple Podcasts and wherever else, podcasts can be found. As always, thanks for listening. I'm Dave Dalton. We'll talk to you next time.
Dave Dalton:
Thank you for listening to JONES DAY TALKS®. Comments heard on JONES DAY TALKS® should not be construed as legal advice regarding any specific facts or circumstances. The opinions expressed on JONES DAY TALKS® are those of lawyers appearing on the program and do not necessarily reflect those of the firm. For more information, please visit jonesday.com.
