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. There are going to be issues. California in 2020 went live with CCPA and if you have gross revenues exceeding $25 million, if you buy or receive for commercial purposes, the personal information of 50 thousand or more consumers, if you drive 50% of your income from selling consumers' personal information, you might be subject to CCPA.

Darshan: Again, there are exemptions for information that is processed pursuant to HIPAA, CMIA, and certain clinical trials. But again, you as a pharma company may not actually be subject to HIPAA. Do you qualify under the specific clinical trials? Is it being used for clinical trials? Each of those are questions that you need to answer, you need to look back at.

Darshan: So I expect that companies will spend a lot of time this year processing what CCPA means for them. Companies that are global and international start looking at GDPR and try to comply with not just GDPR but what the implications of the CCPA are. And again, Illinois, Nevada, New York, Oregon, Texas, and Washington are all considering their own version of GDPR or the CCPA, and that means that more states will create their own patchwork of laws. And in the short-term, companies are going to spend a lot of time, money, energy, and effort trying to comply with each individual state's expectations around privacy.

Darshan: In the longer term, I would expect that there will be some kind of federal law, but at this moment, this really just means you play whack-a-mole and you basically go after each individual state, look at what their privacy requirements are, and make sure that you comply with them.

Darshan: When you look at transparency, we've talked about Ukraine and their expectations around, for example, preclinical data, we've talked about Health Canada and their expectations around CSR disclosures, we talked about the FDA and their pilot program, but the overall impact is that, and we talked about the actual survey of 160 researchers who found that they had never actually considered accessing regulatory data.

Darshan: And I think that's going to be the most relevant piece of this. Personal conversations that I've had with bioethicists, with researchers, suggest that they didn't even know that this data was available. So there's going to be a lot of money spent in making this data available and making transparency happen, but I think the problem is going to be that it's sort of ... pharma and the industry believes in, "If you build it, they will come."

Darshan: And I think that's problematic because you've got to actually build it in a place where people already go so that that data becomes useful and manageable. And I expect that in the short-term that it'll just be money spent with no actual return on investment for patients. I don't even mean for the pharma companies, for the patients and for clinicians, I don't expect to see enough of an impact in the short-term.

Darshan: Access. I would be thinking about drug reimportation and how there has been an uptick through the Trump administration in 2019 to actually allow for importation of drugs. Short-term, I don't expect much to happen because it's 2020, it's an election year and no one's going to be passing laws. People are going to be talking about passing laws, about the steps they're going to take, but no one's really going to go out there and make this and pass on it, it's just going to be a bunch of promises at this point. That's my take on it.

Darshan: Let's see what actually happens. 2020 is already prepping up to be a really interesting year. We've talked about access. If you've listened to the Democrats and the various debates, health care and drug pricing remains a big issue for the Democrats and for the presidential candidates, so I expect access will continue to be a continuing issue.

Darshan: No one's really talking about privacy, but I expect that the states will continue to pursue that. And then as it relates to innovation, I expect that pharma companies and medical device companies will have their lobbyists actually push to enable more innovation as we continue.

Darshan: Stay tuned, listen in. If you disagree with me, let me know what you think, tell me why you disagree, love to have a good conversation. On Twitter you can find me at @DarshanTalks or you can also go to my website darshantalks.com and get more information to reach out to me. I'd love to talk to you further.

Speaker 2: This is the Darshan Talks podcast. Regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter at @DarshanTalks or the show's website at darshantalks.com.

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