Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks or the show's website at darshantalks.com.
Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have a regular guest with us, Nirpal Virdee, and, Nirpal, as you guys have heard from his accent is from the UK and was going to talk to us a little bit about Brexit. We've had a couple of talks before, but Brexit is ever-changing and constantly evolving. And, Nirpal's going to talk to us a little bit about that and how it's going to impact the life sciences. So welcome, Nirpal. Tell us a little bit about yourself first.
Nirpal: Hey, Darshan. Always good to be back with you and going through some of these key topics. So it's been probably a bit too long, so I'm glad we were able to do this. So, yeah, I'm Nirpal. You've probably come across my podcast with Darshan before. I head up Transparency & Disclosure at Certara, and really specialize in the subject matter on our engagements with the law, guidelines, rules around the world, and sort of how we can align our services to best support sponsors. So I'm often talking about this and trying to make sure that we implement some of this guidance back to our sponsors as effectively as we can.
Darshan: So, Nirpal, you actually spoke at a conference yesterday and I have to imagine people... We're doing virtual conferences, but I imagine you get a lot of questions. What are the big questions around Brexit that you keep hearing?
Nirpal: Yeah, so very timely, actually. It was a very surreal sort of engagement just because I'm so used to having a chat with a larger crowd and really engaging with them. So it was a bit unusual to be trying to do this all virtually sitting at my desk and getting folks to give me some virtual questions. But there was a lot of interests with obviously what's happening with COVID-19 and how that translate to transparency, types of guidelines, and trying to get some of that data out. We're hearing, of course, that agencies feel that they do need to really push for more of this data to come out faster than it has done before.
So there's quite a lot of questions about Europe and it was a European audience. What's the EMA trying to do in terms of COVID-19, knowing that a lot of the transparency type of guidelines that they had in place have been on a hold that we all know due to Brexit, that we're going to be talking about. So, yeah, quite a lot of questions about that, and there was quite a bit of interest around MHRA and what might be happening in the UK. So we definitely covered a couple of pointers, maybe not in a whole lot of detail, but yeah, very interesting mix of questions, for sure.
Darshan: So let's sort of not pay the huge conference fees, and ask the questions anyways. How is the EMA dealing with Brexit and how has MHRA sort of dealt with the EMA? I know that's sort of the big 700-pound gorilla in the room, and that's a lot to chew on, but love to sort of hear your take on it.
Nirpal: Yeah. I mean, it's going to be a completely different type of relationship, right? Where UK has really been at the forefront of EMA, not only physically in terms of where its headquarters were, but obviously, the UK and its reputation and its skillset, were really one of the lead countries when it came to submission approval and evaluation and all those aspects. So it's a very different type of relationship. So MHRA, they've had to really come to terms quickly around how they would manage this process outside of EMA.
So there's been a lot of internal things going on. Some things that have actually been posted by the government, just on how progress has been made. So they've definitely been putting a whole load of information about procedures, quite a lot of replication, I suppose, of good practice that they have had from the EMA. But I think we're seeing a bit of a divergence, right, just generally with Brexit and the sort of theatricals of negotiation, which I think inevitably is leading to sort of a shift away from potentially what Europe is doing and trying to demonstrate that UK will go its own course. So that has an impact that I'm sure we can get into in a little bit more detail.
Darshan: Yeah. So really the question I started wondering though, is that if I'm a pharmaceutical company, if I'm a medical device company, if I'm a biopharmaceutical company and I'm already in Europe, should I sort of work with the expectation that from a transparency perspective I'm already compliant with what MHRA might throw at me, or would that be a problematic assumption?
Nirpal: I think that could be problematic just because of the direction that I think MHRA are going towards. So if you see very recently, they have made a publication of new rules for 2021 around registration of clinical trials. So they've definitely made some statements in there. And the interesting sort of aspect to this is it's very clear when you read some of the information that they're posting out in black and white, that the UK is leaving Europe and leaving their transition period. So they make that so categorically clear before they even give you any information about what might be changing.
So obviously, they're trying to make a key point that things are going to be different. And I know both of us have had a bit of a sort of offline conversation around some of this, but it definitely looks like there's a registration requirement coming out of MHRA from the 1st of Jan, and really pointing to following the US ClinicalTrials.gov model and registration within the US side, which I find very interesting. And also the ISRCTN registry that we associate with publication.
So they're the two options that sponsors that have registered in the UK must now follow. And there is a alert process in which you need to make it categorically clear to the MHRA that you have put those disclosures of those submissions within one of those repositories. So they've definitely tied that in. Now, the only reference I see from an EMA perspective and clinical trials register in Europe, the EudraCT, is the fact that if there is involvement of the trials with European sites, then the EU register potentially would be in scope.
So yeah, I think it's quite an... and it'd be great to get your insight as well as to how you read this. But I think it's very clear that UK wants to follow more of an international model. I suppose, the US interesting, but is probably the biggest registry that we have when it comes to study results. So you can see that angle for sure, but doesn't it feel like a bit of a snub to the EMA?
Darshan: My experience, my take on it was definitely a little bit of a snub to the EMA, but I also wondered if it's because the EMA has been... I don't want to say dragging its feet, but its EudraCT has been in production for a while. And is this sort of the British version of, "Look, we have to do something. Let's start with ClinicalTrials.gov as we know that that system is already up functioning sort of clearly. And that can accommodate some of the concerns we have. And the number of studies we're talking about may not be as big an issue."
What I find interesting is multiple things. Number one, I find the idea that they're sort of making these overtures to the US. It also speaks a little bit about what kind of overtures are they going to make the China, which I think is going to be interesting in the future. But the obvious, "We'll worry about the EMA when they come online and if we think it's sort of interesting at that point..." I think is an interesting take from MHRA.
What I do also wonder about is something you sort of raised a little early in the conversation where you talked about the fact that a lot of the expertise lies in the UK. And now with the transfer over of employees, to the extent that they transferred over, how prepared will the EMA be for transparency? Do we see more delays because of it, because they simply just have to relearn a lot of things that they've already put out themselves? What is your take on that?
Nirpal: Yeah. And the delay has been the way things have been going with the EMA since Brexit. Not to say that they haven't sort of made very clear plans and that they've adhered to plans and timelines. So I think they, yeah, for sure-
Darshan: Almost like they have different timelines.
Nirpal: Yeah. In terms of movements and lots of things, they've definitely been on timeline. But when it comes to our transparency world and trying to get sort of EMA Policy 70, for example, and that clinical data from a report perspective back live, since the pause, that hasn't happened. And we were expecting that we would come out of that at some point towards the middle of this year. So there definitely seems to be a slowdown. We know that they've had a regulation that they're working towards, we've been highly anticipating and it includes some of the patient-engagement activities that I know we talked quite a bit about, around getting patient summaries out. That again has not quite happened.
And it's sort of we're in a multi-year of delay. So, I mean, there's definitely been an impact there and how MHRA takes this forward is absolutely fascinating, and the direction they take. Europe has put a lot of emphasis on report disclosure, as well as sort of the trial data that we've spoken about in the registries. But the US has taken a different tack and we obviously heard very recently that the US from a clinical study reporting perspective and those types of clinical data, didn't feel that their pilot was the right way forward, and they stopped that.
And they've made a lot of comments about this being uncoupled from agencies, and maybe this is an industry-wide initiative that should happen, and maybe an independent body should be managing disclosure of reports and some of the more detailed information. Which is again, a very interesting position in comparison to Europe. Now, if MHRA starts to follow more of the US, could we see sort of an emphasis on that type of model, and maybe things like the reporting are not going to be a requirement in the same way as they are with Europe at this point.
So it's going to be very fascinating to see where MHRA really aligns and takes this for sure. A lot of the internal processes that they're familiar with and probably have been at the forefront of developing have in some ways been repurposed. But I think in terms of our disclosure space, especially with things being a little bit on pause, I think is going to be really interesting. And I think the only thing we've really seen from Europe around COVID-19, is obviously that's caused further delays, but they have more recently requested that the clinical data needs to become available for COVID-19 related trials. So we know that's coming back. And sort of with MHRA and a lot of things that the UK are doing, are they going to sort of try and reciprocate that sort of thing? That sort of things that we're going to need to watch out for.
Darshan: I think it's interesting. We're talking about MHRA, but the truth is that the impact of it is so far-reaching. And you and I were talking offline right before we got on about the new intended use regulation that the FDA put out literally today. It's not even... We saw that the notice came out yesterday, the question is, what is the impact of that, if any, on things like lay summaries? And is that going to be something that the FDA needs to coordinate better? Because the FDA needs to start thinking about... I mean, with ICH and stuff, there was a tremendous amount of coordination. The question becomes, as you start moving towards this new future where the UK isn't technically part of ICH, what does that look like? And will that be a closer coordination with what both EMA and MHRA expect? And will MHRH coordinate better with FDA so that the consistencies are easier?
I mean, we're already talking about things like delays in medication access during Brexit. Obviously, COVID sort of potentially exacerbated that problem, but the question that we need to start thinking about is, this might be that opportunity for MHRA to catch its breath and basically go, "Which team are we going to coordinate with better?" Obviously, everyone's on the same team in getting things to patients, but how you do it becomes a much bigger question. And it sounds like the UK is picking sides already. Would you say that with MHRA doing what it's doing, they're going to coordinate with other global authorities, like the Chinese FDA?
Nirpal: It's a high possibility. Of course, China's always an interesting one depending on the dynamic of a potential relationship. Especially, being a key ally of the US and currently US having quite a bit of issue with China, trade, and those sort of things. So it could be a very tricky position that UK may take. I feel to your earlier point, there is a likelihood of much more alignment with the FDA and MHRA. So it'd be very interesting to see how they potentially might collaborate. And of course, there might be other agencies out there, Australia and others, in which there's a lot more emphasis around sort of potential collaboration and sort of taking similar positions on some of these aspects.
And if you remember, I think even probably the earlier days of Brexit there was a House of Commons Select Committee commitments that the industry needed to do better at getting study information out, and how poor it was around compliance. And we've seen the FDA and other institutions really calling out the fact that compliance in the US is not great either. So I think there's some common themes and common directions in our transparency with as well as overall how they assess submissions, will there be some sort of closer-knit collaborations of evaluations and those sort of things? That is all sort of absolutely possibilities I think we would see.
But it comes back to just there is general sort of commitment by the UK that they want to give this perception of independence when it came to trying to rally around COVID-19, the UK opted out around its decisions on purchasing and how it would go about trying to get sort of supplies and all these sort of things. So definitely looks like it's a position that UK is taken. In Brexit overall, we've seen very recently Boris Johnson taking a bit of a position with Europe, giving them a deadline of October 15 to round when he expects a deal to be done. Otherwise, there'll be potentially moving away from the treaty. Now, that's a big thing, right? Putting together a treaty and then potentially sort of deviating from that is not in the spirit of legally binding treaties. So is that theatrics? Is that part of negotiation? Who knows, right? I'd say that-
Darshan: The Donald Trump book of negotiation, right?
Nirpal: Yeah. [crosstalk 00:19:27].
Darshan: I don't mean [inaudible 00:19:27] in a bad way. I mean, that's just, it's a little heavy-handed, but it seems to work for some people and it doesn't for other people. So is this really what we're seeing?
Nirpal: Yeah, absolutely. So I think if you look at the overall ecosystem with Brexit and the EMA, there is definitely positions that both parties are taking around what that relationship would look like. And now more than ever, it looks like it's going to be at best a very loose association. So I think from our world within life sciences and pharma, I think we're going to see a lot of action happening with the rest of the world when it comes to the UK and potential collaborations that we feel logically could make sense. But maybe also things that we didn't even see coming and sort of really trying to differentiate the UK's now standing relationship with the rest of the world versus Europe.
So, yeah, fascinating where it's going to go, but I think we've got some initial direction for MHRA. It's a start. Let's see how they get on with patient-engagement and all these other principles that we've been talking about. We haven't even got to those yet.
Darshan: No, but here's a question that I'm wondering, and again, you're beautifully placed to discuss this. You work obviously at a global level, but you're based out of the UK. So if that's true, do you see MHRA being relegated to a secondary-level organization compared to EMA and FDA, or do you see MHRA sort of pulling its weight and sort of knocking down the heavyweights like you do in Japan or even Health Canada? What is your take? Go ahead.
Nirpal: I think the UK has the talent and has the reputation to get there. Will it get there out of the blocks? Probably not, but I think time will tell. And I think coupled with a lot of those strengths, I think you're going to see a lot more weight coming from the UK and sort of more willingness to be listening to the UK. And I think people are just trying to understand what does that dynamic look with Europe and how different it is? I think people are being very cautious and stepping stones for on how they are treating UK when it comes to things like healthcare, life sciences, and those sort of aspects. But I think the potential is definitely there for there to be an overarching sort of relationship.
And sort of I'd be following it closely. Something that I do, and I know my organization does, we really try and sort of stay on top of all agency requirements. We touch so many aspects of transparency that we get a great insight as to how this will all be put together. So hopefully with all of the different branches, we're looking at transparency and how we execute on that. We'll be continuously advising our sponsors on this and learning ourselves, right?
Darshan: Of course.
Nirpal: It's a continuous learning curve around what's happening and where governance will go, policies will go, laws will go. Not to mention privacy, which I don't think we've got time, but that will take a whole hour on its own, right? [inaudible 00:23:13] that piece in two.
Darshan: Well, first of all, thank you so much for being on here. My big question for you is if people have questions about MHRA and where things are going, or EMA, or FDA, how do they reach you?
Nirpal: Yeah. Listen, I'm on LinkedIn. Feel free to follow me and send me a message. And we'll connect and we can sort of absolutely dive into any of these types of topics and how we're thinking about them, how they impact us, as I mentioned, the sort of work you need to do from a transparency perspective, strategically what you need to be thinking about. All of those sorts of things, as well as obviously the executional side of things. I'm happy to have a conversation and see if we can help. So, yeah, I think LinkedIn is probably the easiest way. I'm sure in the information that you put out with the podcast there'll be some contact information if folks want to ping me directly.
Darshan: Absolutely. Well, thank you again, Nirpal. This was great.
Nirpal: Thank you so much. Pleasure.
Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks or the show's website at darshantalks.com.
