She's a physician, graphic designer, and researcher in the field of health communication and data visualization. And she's the person behind the idea of citizen pharma. Thank you very much. And welcome. But first of all, I'd like to thank the organization team for making this re-health real, and I can't even imagine

how much time and effort you've spent making this happen. So thank you very much for that. I've been working as an emergency doctor for years, and I think that all of us working in healthcare

remember certain patients, situations, moments, a bit specific. And one of mine was a call during the night, 2 a.m., 3 a.m., and we arrived at the apartment, and an amazing little lady opened in the mid-'80s, and she complained of pain in the breast.

She had severe trouble with her blood pressure, felt dizzy. And so, well, we cared about her, and I've asked her, among many other things, of course, about her medication. And she gave me a big bunch of pill boxes and packages and tablets,

and I went through it and checked it. And I realized that about two-thirds of it passed the expiration date. And I asked her, did you mention that? And could be at least part of the problem you have at the moment.

And she said, well, yes, I do. I always try keeping medication from my friends and relatives who don't need it anymore, don't take it anymore, because I can hardly afford to buy the prescribed drugs I'm taking. And she felt so embarrassed about that that she started to cry,

which was a really heartbreaking moment. And one lesson out of that is real medical care, or many problems in healthcare we have, are low-tech to no-tech.

She obviously didn't understand the system, how to get reimbursed. And obviously, we have a problem taking wrong medication or expired medication. And here, we don't need an app, but we need people who care for that. And on the other hand, the other lesson is that we are living in a world of stereotypes.

Starting a discussion about fair access to medication immediately turns to a discussion about developing countries. And you have the image of poor Africans in the middle of nowhere needing donations from the registered countries because this is the target group. But of course, we have that problem at home as well.

We have it global. It's in a globalized world. We have this as a globalized problem. And in different ways and different characteristics, of course, but well, we have it. And this has been unmasked, at least in parts, in a shitstorm last year.

So what happened? It started as a usual shitstorm with headlines and messages, Twitter messages, like this one. An ex-hedge-funder raises price of AIDS drug from $1350 to $750 per pill. Detested ex-hedge-funder increases price of pill.

Greedy emokit raises price of Daraprim from $1350 to $750. So who is that guy? This ex-hedge-funder, detested ex-hedge-funder, greedy emokit? Well, that is Martin Shkreli. And he was at that time the CEO of Turing Pharmaceuticals.

And he became overnight, well, the most hated man in America. Clinton talked about him. Sanders talked about him during their campaign. Even Trump talked about him. He didn't like him as well, which is a quite interesting alliance, I think.

And he said, well, he trashes former hedge fund guy who jacked up drug price. He looks like a spoiled brat, which might not be the point. But anyway, Martin Shkreli makes it really hard to like him. He had answers like, well, I've done the right thing. It is so important. I should win the Nobel Prize for this action because it's for the good of mankind.

And one of his answers was this one. Capitalism can seem ugly if you don't understand it and you are not prepared for it. It's capitalism, stupid. So I think he confirmed all the clichés we have of big pharma and capitalism.

But nevertheless, looking at a shitstorm, it's always worth to go back to the beginning. And to see what is it all about. And in that case, it is about Daraprim, prescription drug.

The brand name is Daraprim and the compound is pyrimethamine. And it's a medication for infections like malaria and toxoplasmosis in the U.S. mainly used to treat toxoplasmosis. It's a protozoan infection or parasitic disease. And an interesting disease because many of us might have had it.

We assume that about 30% of the world population are so-called seropositive, meaning we have had contact during lifetime with that disease. And usually, we don't even mention it. Meaning there's mostly no symptoms or flu-like symptoms.

And for the healthy ones of us, it's really no problem. But 30% is quite a lot, so one, two, three, one, two, three, seems pretty much. But for the healthy ones, as I said, no danger. But it is a real danger for those with a severe immune deficit, meaning patients with HIV or during a hemotherapy

or also for newborn children who can be infected by their mothers. And here, toxoplasmosis can cause severe brain damage, eye damage. It can even be fatal. We have 750 deaths per year in the U.S. due to toxoplasmosis. So it's relevant, and therefore, Daraprim is relevant,

and therefore, it is on the WHO list of essential medicines. This list has been a breakthrough because you find all the medication needed in any healthcare system all over the world, and the aim was that access should be given,

affordable access to the medication on this list. So that is the idea. Now what about Daraprim? It has been sold until 2015 by co-pharmaceuticals for $13.50, as we've learned. And then it's sold to Turing Pharmaceuticals in August,

and in September, the prize hiked up to $750, meaning 55 times higher, 5,500%. So imagine the usual Republican ticket, the regular one, is, I think, 200 euro. So next year, it would be 11,000. I mean, it would quite be interesting to see who would still come,

but it makes a difference, obviously. Or a contraceptive pill. Usually, it's an average of some 10 euro per month, and imagine next month, it would cost 550 euro. And of course, it would have an impact on the use. Many women would no longer be able to afford it, and that would have consequences as well.

So it's dramatic. It's obviously a dramatic increase we have. And it's not even, in that case, the whole truth, because before co-pharm, it was owned by a GlaxoSmith line and distributed by them. And they sold it for $1 per pill.

So in fact, we have an increase from $1 to $750 in five years. And one of the immediate questions we have is, how can they do that? What the heck's going on? Is that legal? So how does that work?

And in that case, how did that work? Well, the first reaction usually, drugs, price increase, must have to deal with patents. Because patents meaning someone has a monopoly for it. It's like an IT. If you have a patent, you can buy it and no one else.

Sell it and no one else. But here, with Daraprim, we have an old drug. It's been available since 1953. And the patent expired a long, long time ago. So no, it is not about patents. Is it about rights? Because Turing Pharmaceuticals bought the rights. Yes and no.

Yes, because no one else would be allowed to sell Daraprim, the brand Daraprim. But other companies would be allowed to sell a generic version and produce a generic version of pyrimethamine. Generic version usually means you have the same compound, you have the same quality, same indication,

but much, much cheaper. That's the principle of generic products. So why not generic? For Daraprim, in fact, we do not have a generic version available in the United States. So yes, it's a bit about rights. But the main problem is we don't have a competition. We don't have a generic version of Daraprim.

So the only company producing and selling pyrimethamine is Turing Pharmaceuticals. And this means they have not a technical monopoly because it has expired, but a de facto monopoly on the market. Again, the first reaction is, I mean, it's capitalism,

as we've learned. Why do other companies don't start producing it immediately? If they didn't do it before, why don't they go into the market and produce it? Well, then we have another bunch of problems.

We've learned that, why is there no generic version available? We've learned that toxoplasmosis is a common disease, but only few patients need, fortunately, only few patients need treatment. Few patients for big pharma equals rare disease equals small market.

This is not good for big pharma. It can be good. Rare disease can be great to them if they have a patented drug. And then they can establish what they call a niche buster and sell it extremely expensive. We have that in Germany at the moment with hepatitis C medication.

But here, Daraprim, as we've seen, no patents. So we have small market, no patent. Big pharma is not interested in it. But maybe, if not big pharma, maybe a small producer, a tiny little producer. Well, here we face another issue that any production of medication needs an approval.

And in the US, it's an FDA approval. FDA is the Food and Drug Administration, and this is the agency being responsible for the approval process. And this approval process is time and cost consuming. So for the small manufacturers, even then, it's too much.

So having these three points here, small market, no patent, approval needed, results in once touring both the rides for Daraprim, they could raise the price to any amount they wanted.

And that's what they've done. Now, Daraprim produced the shit storm we've seen. But in fact, it's not the first time that this happens. We have dozens of other companies doing more or less the same thing. Doxycycline is an antibiotic, a really important one, also on the WHO list of essential medication,

also out of patent medication. And in 2011, it's been sold for four cent per pill. In 2015, it was $3.70 per pill. So we have a price raise of 9,000 percent. Digoxin, medication for heart diseases,

sold for 11 cent per pill. And in 2015, for $1.10. So compared to the others, that looks really cheap. But it's 1,000 percent. And I could show you dozens and dozens of other examples like that. So obviously, we have a new business model.

Finding out of patent medication without a generic version on the market seems to be very, very attractive. And obviously, the traditional market model fails here. Now, seeing that, what are the consequences? And well, one reaction could be we accept it.

I mean, it is like it is. And it's always been that we could be outrageous, blame Big Pharma, which to me is not much more than accepting it. Or we could at least try to change something.

And the question is, how can we do that? And what can we do? Or more precisely, how can we guarantee access to affordable essential medicine? And let's take the WHO list of essential medication,

because it's a global list. And at least the out of patent drugs on this list to make it easier and more pragmatic. By the way, the easiest solution would be a trade agreement, meaning free import and export. In Germany, Daraprim is still produced by GlaxoSmithKline

and it's sold for one euro per pill. So the easiest idea would be to send care packages from Germany to the United States with Daraprim. But obviously, this is totally illegal. And in times of TTIP, it becomes even more fictitious. So this won't work.

But fortunately, we have a wealth of ideas and organizations. There are only some of them caring for access for essential medicine. But all of them care for access for developing countries. And it's mainly work to get access for patented drugs,

which are very, very expensive. And they're making deals with big pharma that they donate or reduce the price. And this is great work. It's absolutely great work. But it's not really a global target, if you want.

And it's also depending on the willingness of big pharma or the willingness of the government regulations. And all of them rely on the traditional manufacturing paradigm of the pharmaceutical industry still.

So this is not wrong. But could we find alternatives to that? Could we find another way? And could we find solutions driven by needs and not by markets? And could we influence and transform the pharmaceutical industry, meaning we as the civil society and the digital community?

And could we thus use maybe not primarily the wisdom of the crowd but the money of the crowd with crowdfunding? And when we use crowdfunding, how could we do that?

So what could be the aim? And how could we find a really good solution for that? So the biggest one would be a vision, a manufacturing facility. I mean, let's buy it. Let's make it on our own.

Let's make an open-world pharmaceutical organization bought by the civil society, financed by the civil society, a non-for-profit organization. So can that work? Just two examples. There's been Institute for One World Health in the United States.

It labels itself as the first non-profit pharmaceutical company. And it works. But they are focused also on the developing world. So they do not produce for the richer countries.

It's just their target is the developing world. But they got $200 million to run their company, not with crowdfunding in that case, but with traditional fundraising. But nevertheless, obviously, they achieved the goal. Another example is cheap drugs, which has been a typical crowdfunding campaign.

And, well, they wanted to get $1 million for the seed investment for a public benefit drug company in the United States. They totally failed. They got $610.

And obviously, it is difficult. But difficult doesn't mean it's impossible. So, I mean, the idea still would be fascinating, I think. The biggest challenge anyway would be that let's buy it. Let's build it in the United States or in Europe or in India.

But we will still have to deal with the normal trade regulations, meaning no free import and export to other countries. So at least we would have to find solutions for that issue. But the biggest advantage of such a manufacturing facility would be that we could produce many, many drugs,

not only in quantity but also in diversity, many different drugs out of that WHO list, which would be wonderful. Another possibility, the approval process, crowdfunding the approval process. Do you remember that this was one of the negative incentives for companies why they do not produce generic versions?

So what about funding this process, making contracts with existing generic manufacturers and helping them through that approval process so that they can produce this? Biggest challenge here is that we have different approval processes all over the world,

so we would have to find solutions for the United States, for Europe, for Asia, for Africa, which means it's a complex thing, expensive thing. But the real advantage of that would be that we do not care for trade regulations because when we produce in the region, we don't have a problem with import and export then.

So this would be a quite pragmatic solution, I think. One step further, when we go deeper, we could also crowdfund specific drugs. What do I mean with that? Just an example. There was a crowdfunding campaign for open insulin.

We've heard about insulin in the discussion. Insulin is for the treatment of diabetes. It's one of the most important medications all over the world. It's old. Until today, we don't have a real generic version. It's a shame. And we know that about half of the population worldwide does not have access to insulin,

so there is a significant need. And they started an amazing project. They crowdfunded $16,000 for it to develop an open source protocol to produce a generic version of insulin,

meaning this is the first step for the production. But they started it and they do work and they do a great job in that project. So it's fascinating. The problem is that it's only for a few drugs because we can do it for so many of them, but these are really important.

There's a significant need for some of those drugs on the list. And it would be helpful because the pharmaceutical industry will never do that job. If all that seems to be, or sounds too old-fashioned, what about another idea? Downloadable drugs. Crowdfunding, well, the 3D print of your own medication.

If that sounds fictional to you, in August 2015, the FDA approved the first 3D printed medication. So it works in a way, but to be honest, there is still a long, long way to go.

It's one medication, it's one drug, it's enormously expensive, it's nothing for a mass production, and of course we have a bunch of safety issues when we talk about that. But nevertheless, I mean, it has the potential to radically transform

the pharmaceutical production process and distribution process. The biggest problem to my point of view is that the company who pioneered that 3D printed drug has already, I think, more than 50 patents on it.

So we are facing currently the same problems as with the traditional pharmaceutical production. The other problem is a more practical one. Yes, the FDA has approved this drug and this 3D print, but this doesn't mean that in Europe, in Asia, in Africa, this will work the same way.

So the approval process will be quite tricky, I think, but of course, I mean, it would be cool to crowdfund a drug printer for legal drugs and to produce open source software for it, and hardware, of course.

So all of these are ambitious projects, and I think there are others around, but which of them are worth a try? And here we have to take a closer look at it,

and we have to analyse the potential, the feasibility, but also the visionary aspects of the different projects. So this is a call for action. Let's connect and share and learn from Big Pharma. They consolidated and got more and more powerful. We can do the same thing. So let's connect and share, but I think we should not forget that we also need,

if you're looking for an alternative way to produce, we also need a lot of information before, and we need to know the prices paid, for example, for medicine on the WHO list worldwide, meaning data from real people in real life situations all over the world.

Even in times of big data, there is a lack of a lot of those tiny little data. Some of the drugs on the list are really old, so they don't conform to the current standards of what we call evidence-based medicine, and we should do a lot of research there concerning side effects, interactions, things like that.

No one will finance that, because usually pharmaceutical research is paid by Big Pharma, which is another issue, problematic issue, but of course they will never pay for out-of-patent drugs like this one. And here the power of the crowd could be a real help,

and the digital community could make it work so that we could make really big steps on that, and that is why we always should think about not only crowd-funding these projects, but also integrating citizen science, meaning citizens working together with scientists, with universities, with NGOs to make it real.

So again, this is really a call for action, and yes, the pharmaceutical industry is a big player, and yes, it will certainly take time and effort to change something, even the slightest steps,

but, I mean, we're seven billion, so it should be possible to make, or at least to start that. And wouldn't it be really great to initiate a fair pharmaceutical production, away from shareholder value, but aiming for something like human kind value.

So may the force be with us. Thank you. Thank you very much. Very brilliant talk. Any questions from the audience? Please, also Mike.

Your opinion, which one of the crowd-funding options is the most promising? I think the two in the middle looked good, but... That's a very difficult question, but a good one.

I think the most pragmatic ones are those where you have the specific drug, of course, specific aim, and you can calculate how much it will take, and it's kind of sexy to invest there. I think the approval process would be also quite promising, because again, it's pragmatic.

You need good contracts, but I think this regional aspect is really, really great. Still, nevertheless, I think we can also dream about the first version,

and why not finding a solution for a tax-free zone where we can produce that, and at least for the essential medication on the list. It's not a pharmaceutical industry like the other ones on the market. So limiting to these productions, why shouldn't it be possible to find a solution there in our dreams?

I don't know whether it's makeup, but still, I would like to dream about that. Thank you. Next question. Here and there. I have a question regarding the other medicines on this list.

Are there many medicines without a patient or with a valid license, or do you have to buy the license for some of them, which is impossible for crowdfunding?

That's true. So there are about 320 medications on the list for adults and about 230 for children. I think about 90% are out of patent drugs, but the problem increases a little bit,

because we, or the pharmaceutical industry in that case, developed some really important medications for treatment of cancer, for treatment of hepatitis, and these are patented drugs still, and they are nevertheless on the list of essential medication, and we will, so it will change a little bit, but nevertheless, I mean 80% or 90%,

the majority of medication on the list is out of patent medication, and we could focus on that. I wouldn't care about these patented drugs, but I think these are, the situation is so clear.

We can produce it, we can produce generic version that is legal if you get an approval, and then, I mean, hooray. Okay, one very short last question. I guess the ISO processes for approving medication is not transparent.

Wouldn't that be a good place to start, is open sourcing the standardization process? The approval process? The approval process, yeah. The approval process is transparent, meaning the rules are clear. If you think about the persons behind who are deciding yes or no, there will always be doubts,

but the process per se is transparent. It's a bit different. We have different processes in the United States, in Europe, we have the EMA, in Asia, it's different, and in Africa, it's different. So, I don't know the details about the Asian way, for example. So, I don't know, but you're totally right.

This would be one of the tasks, I think, the homework, if you want, before starting to have a look at these processes and regulations. Absolutely, yeah, absolutely important. Thank you. Okay, thank you very much. Thanks, and thank you.