Patient Centricity in 2020

February 4, 2020 Darshan: Welcome again to another episode of Darshan Talks. We've previously talked about clinical trial transparency, but it's important to recognize that clinical trial transparency exists as a part of a whole, and that whole is patient centricity. And if you don't understand the different levers that affect clinical trial transparency, then you are actually shortchanging yourself. Speaker 2: 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 darshantalks.com. Darshan: Let's look at patient centricity. And as I see it, patient centricity is at least four major arms. You've got innovation, you've got clinical trial transparency, the balance to clinical trial transparency, which is patient privacy, and then more importantly then all of this is access, because what's the point of doing all this if patients can't actually get access to the medications that they need? Darshan: So we've previously talked about each of these factors and we've talked about what happened in 2019 that lends pause in each of these areas. Let's talk about what the implications are now in 2020 in each of these areas. Darshan: So let's talk about first innovation. We previously talked about march-in rights and we talked about things like Bayh–Dole and we talked about how pharma companies are being pushed so that patient advocates are basically coming in and lawmakers are coming in and they're saying that the Federal Government must deploy the legal provision that allows the government to suspended drugmakers patent and license someone else to produce the drug. Darshan: That's often under the Bayh–Dole Act and there are a few other versions, but IP experts have disagreed on its applicability and I think that in the short-term there's unlikely to be any actual impact in this specific area. Obviously things might change, but at this moment I would be surprised if anything happens. Darshan: GDPR. We've talked about 2018 being the year when GDPR actually was live. 2019 interestingly was when you started seeing the first set of fines, and I think 2020 is going to be when you actually continue seeing more fines. In December there was actually a pharmacy that landed up paying fines. There have been boarding schools that have paid fines and I would not be surprised if other deeper pockets start paying fines as well. Darshan: If you are a health IT company, I would expect to see some prosecution or some reach-outs from the government in that context. If you are a pharma company, this becomes especially problematic because member states don't actually know what should be expected from you, the US itself is confused and concerned about what this means. I know CROs have actually ended up pushing companies away from Europe because of GDPR and the implications, so we will continue to see fines. Darshan: There is this black hole of information that's required for companies to make important decisions on how they should engage with Europe, so I would expect that the CROs would actually see a pullback in terms of the engagement into Europe. Darshan: So what are the implications on patient centricity? Patients in Europe would actually end up suffering because you will actually end up having a loss of innovation as a result of the increase in privacy requirements. And again, I'm not saying that privacy is a bad thing, I think privacy is a really good thing actually, but lack of clarity on the expectations around privacy is a bad thing. And I think that that has to be solved quickly. Darshan: For those of you who are saying, "Well lucky me, I don't actually have any problems in the US," well no, no, no.