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Can blockchain prevent the problem of counterfeit drugs?

European Blockchain ConventionSun, Oct 9, 2022, 12:00 AM

As the illegal trade of counterfeit drugs trade continues to rise, various technology-based solutions will continue to develop. Although blockchain is at its nascent stage, it can play a pivotal role to flatten the curve. If adopted, blockchain can vastly limit the impact of fake medicines in the global market by revolutionizing supply chains.

Transcript

[Music] okay thank you daniel okay good good morning doctor everybody i would like to i'm paul mcgarry um we would like to welcome people i mean and in this new session okay i as then you will see we are really trying to address it to an hour i mean what is the the situation of the anti-country and what we i mean we are trying to do with elk in order to avoid it we all know that i mean technology is one of the first things that can be applied and we would like really to understand the first of all to step the stage under and you can't repeat the situation today and i mean really go through the solution with and if blockchain even if at a new stage of technology can help us into it now the opportunity today to have i mean the four speakers that is coming from from different experience even if in the same healthcare environment so really i would like to i mean give the opportunity to all of you i mean that to introduce yourself and really tell something about your experience before starting the stage i will start from valentina thank you paolo and uh thank you for this kind invitation i'm valentina's tramiello head of programs at the european patients forum and i'm involved directly in the pharma ledger projects with the epf team to bring the patient perspective in this project thank you thank you and uh nuno represent well your name okay and thank you paulo my name is nun gonzalez i am innovation manager at incm the portuguese mint and official printing office imcm is a state-owned company with more than 500 years of history in maine production and 250 years as official printing office incm produces identity solutions such as civil id cards passport driver's license both physical and digital identification documents intm also produces enter counterfeit stamps or labels for brand protection and excise stamps for tobacco and for more of some more products in the consumer market i am also researcher at the institute of system and robotics and assistant professor at university of cuimbra in the area of electrical engineering engineering and computer science my phd is in computer vision and in the last years i've been focused on technology transfer projects in areas such as coding machine learning and unique identity classification steganography biometrics and industry 4.0 i am head of the research group dedicated to visual information security in a joint project between the university of queen brand i ncm we developed the technology called unicode to create unique visual identities able to link a physical object with a digital identity and to check its authenticity using a smartphone we created the physical and cloneable function by printing with inks mixed with glitter particles another innovative project i coordinate between university of queen brand imcm is the codephase project where we developed a machine learning based approach of steganography to hide information on face images well although this can be used also for any kind of images not only phase portraits and then we hide data in the image which is printer proof it is not destroyed by printing the portraits as it happens with all other digital signatures also participate in the incm team pharma ledger project i am incm co leads the enter counterfeit use case with novartis so one of the main focus of my career is to develop methods to improve the security of documents and products and to shield the bind between physical and digital worlds thank you thank you thanks very interesting okay and the stage is your stanceless thank you paulo good afternoon everyone so i'm stanislas barrow the global head of anti-falsified medicines at novartis global pharmaceutical company which has three divisions across pharma oncology on generics as well the effort on combating falsified medicines at novartis he's led by global security the the entity i'm part of but also supported by 15 functions across the organization so it's truly a cross-functional on global effort on novorti's part beside that i have about 15 years of experience in the field of attack on a feeding and product security related matters uh acquired across various industries on several regions as well as it was previously based in in the middle east and asia thank you paulo thank you timothy the last but not the least please thanks paulo thanks for having me and as you can see my name is tim marsh i'm based in the northeast of the united states i'm a mechanical engineer and i've worked primarily in healthcare since 1992 for both medical device and pharmaceutical and animal health companies if you're not familiar with gs1 gs1 is a global not-for-profit standards development organization or sdo with offices in 115 countries at gs1 i lead a small team focused on product traceability sustainability and of course blockchain in my role i serve all of our industry sectors through our 115 local offices and of course i support our healthcare team at gs1 global office in their remit to serve industry through what they have is the healthcare leadership team and through various standards developments notable for our time today is that i spent 12 years at pfizer working to identify develop and deploy anti-counterfeiting and brand protection technologies and solutions to their prescription and over-the-counter medicines i also led global projects to implement technologies to improve patient safety these included large deployments of any counterfeit technology on products such as lipitor and viagra large projects to do hospital unit dose on packaging across europe and i have a fair amount of product serialization experience in deployment of rfid and 2d coding to comply with the regulations we're most familiar with probably drug supply chain security act and the falsified medicines directive from europe and i was actively supporting and leading serialization programs and projects between 2003 and 2017 in healthcare just before joining gs1 thanks back to you paulo thank you as i was saying we have a really good speakers and the very expert we are expert friend we will represent us from the patient point of view we have expert that is representing us their point of view in in early resolution provider okay pharmaceutical company expedite pharmaceuticals from the pharmaceutical point of view and also that is i mean set in the standard which for me is one of the most important i mean approach in which we can really all collaborate in order to find a solution that can regulate or maybe compete because at the end of the day you can really think of competing because there will be always something that is a continued competition which is the anti-counterfeit and counterfeiting ethics okay just to really set up the the stage i would like really to ask you stanislaus i mean how i mean the make a sort of point of the situation okay in which how these you as a representative of novartis is one of the most important company in the world i really you are really doing against this the challenging problem of anti-counterfeiting and what how you are going to really overcome this solution thank you paulo uh indeed i think it's important to really uh stage this uh a little bit um and so that everybody understands in the audience really uh the problem we're really talking about and get a good grasp about this so maybe i'll first address the the position from the world health organization which again in early 20 2020 uh right before the the pandemic truly started already announced that tackling the issue of substandard and falsified medicines should be a priority focus area in the years to come to address the urgent global health challenge of expanding access of quality medicines to everyone and that was right before the pandemic started and now that the world is still struggling uh with a global pandemic and protecting patients on the health care professionals from the risk of falsified medicines has never been so important yet the last 12 months have shed a crude light on the reactivity the agility on the grid of criminal organizations basically maximizing their profits at the expand of patient safety on society in in general they have been opportunistic and illegally traded in whatever they could make profit with counterfeit stolen tempered illegally diverted medicines all of that are actually being defined as falsified medicines that's a who's definition but all of these correspond to what we basically call pharmacrime basically products that should never go on rich patients so the pressure on the farmer's supply chain integrity has been really substantial on i would say to a certain level uh critical over the last year or so with a particular particular rise in theft on illegal diversion cases so maybe just a few facts on trends for really everyone to to grasp the magnitude of the problem so in 2019 the pharmaceutical security institute which is basically composed of 35 of the biggest pharma company who share their operational details about forma crime related statistics and activities so uh this institute reported a record high number of incidents in 2019 5081 incidents uh recorded in 150 countries so that just gives you a bit of a flavor this was 15 increase compared to 2018 but if we want to look at that over time over the last five years basically the institute recorded a 69 percent increase over five years so you can just see year after year the problem has been just increasing in terms of therapeutic areas the most targeted genito urinary wouldn't be a surprise i mean that's how it all started years ago but things are getting to really level with some other therapeutic areas and now you see a lot more of central nervous system-related drugs anti-infectives cytostatic hormones oncology they are among the most targeted therapeutic areas and that's pretty serious also for patient and this was only 2019. then we entered 2020 and as you all know falsified and substandard masks hydroalcoholic gels testing kits treatments vaccines have reached the market shortly shortly after the genuine ones were being shipped or distributed in a number of countries and markets you even had actually falsified medical products reaching before the genuine ones and that's also a very big deal in october 2020 the world customs organization reported on the results of their enforcement operation stop which took place from may to july 2020 of that year at the beginning of the global pandemic basically or in the very first few months so it was actually a very interesting timing it was planned before but it so happened at that time novartis and several other pharma companies actively contributed to the preparation on the rollout of these global operations basically law enforcement entities from 99 countries were mobilized for this enforcement operation and this led to the seizure of 300 million units of falsified medicines 300 million 47 million units of facifal fantasy fights or medical supplies such as masks gloves testing kits on 2.8 million liters of falsified hand sanitizer gels so just to give you a bit of an overview on this again and i could carry on there are lots of examples u.s homeland security reported in 2020 that this is worth of 47 million usd of covid related products and they arrested 235 individuals again just 20 20 on just related to kavid only there is also an estimation that the black market has grown by 400 percent in 2020 fueled by the pandemic in december 2020 again so just at the end of last year interpol issued a global alert 294 countries basically warning them to prepare for organized crime networks targeting covid19 vaccines and treatments both physically on online on internet is a very big deal and problem because it's great to see e-commerce flourishing but that's also a big deal when it comes to the distribution of falsified medicines and we've seen that trend growing through the pandemic of course finally i would conclude that this factual review by saying that the vast majority of falsified medicines that we tested at novartis actually over 90 percent of them were tested level three in terms of patient safety impact on for us level as your methodology is the maximum patient safety impact you could have it leads to therapeutic failure or death of the patient over time or immediately really depends but basically it has a very serious consequence for the patient that's a vast majority of the cases of the ranking level 3 quite simply because either these products do not contain any active ingredient or they contain the incorrect one or worse they contain harmful chemicals so you see pretty much what we're dealing with here so tackling the global threat of falsified medicines requires collective action public-private partnership on a multi-branch approach this we know if we want to make a difference here but an essential objective which can make a great difference for patients is accelerating the timely and accurate detection of falsified medicines in the markets on their subsequent reporting to her health authorities in the markets but to who as well the world health organization this remains one of the biggest operational challenges for both public and private sectors that we we're facing and for that we need to leverage the power of digital innovation for both packaging verification and product authentication so we welcome this opportunity today to share more about this blockchain use case now what is i think has been a leading force on this and we're really excited to talk a bit more about this here through this forum uh with you today so with that i'll stop here with the overview parallel oh thank you it seems that it's clear i mean when i started to work with the ford european community for the fmd i mean we we understood that it's not just as we were saying i mean just the high value medicine or very high value product that is affected by the counterfeiting but we also that's all and also you say globe okay it's really a somebody that really can can affect as a consultation and about that i was saying that we need to really find out what is the right feature what is the area the derivative security feature that i mean you can you can apply single i mean approach in order also to be sure that you are not increasing the cost of the single things and really be able to balance the the feature and be able to really to be sure that you you are giving the right very protection to patient without really increasing the cost and i mean i will really to understand better from your experience i mean what that could be feature that you have and yeah thank you for for for the question anti-carter anti-counterfeit is a serious problem is in medicines and in several other consumer markets in my opinion an anti-counterfeit solution can only be effective if it achieves a good balance between physical and digital security layers i don't believe that any system can be based on digital or data security alone mainly if we are talking about protecting products not services any physical fixture um can only be used in practice in the context of digital systems consequently the most effective architectures use digital layers built on top of physical features as a provider of um anti-counterfeit solutions in ion cm we already know this for a long time the actual systems are a variety of security elements some of them overt that anyone can that anyone can see and check without tools using related usually related to the existing of anything for instance the existing uh of a hologram or some other element some covert for instance color shifting holograms with a special expected response special links uv inks micro text papers with some fibers or polycarbonate and so on and so forth the elements um can only be checked using some specific device and finally some other forensic whose validation needs a lab and a more complex process regard that i mentioned some elements whose validation can have two levels in the field an authority or expert can validate the covert layer with a special device where in a lab he or she can validate the forensic part both covert and forensic elements are not on public domain which means that they are kept in secret mainly we also learned that the ultimate security does resides in mainly three pillars complexity uniqueness and ubiquitousness so complexity since we must difficult to work the forgers the solution each time more and more complex usually by regularly adding some new features to the object the more we care about security the more cross fixtures must solution the solution be with some of the elements protecting each other in the second pillar we have uniqueness in the past 10 well depending on the point of view but maybe 20 years we are more committed to build solutions on top of unique elements per object not for reference or per product so the idea is is to have unique elements for each object for each packaging for instance this means that each single object has its own unique identity called fingerprint for instance uniqueness is is get using physically and cloneable functions which is a mathematical concept based on randomness and on coward's theory i give you an example we print stamps with inks mixed with glitter particles as i mentioned before in my bio in the unicode project and each time each time a stamp is printed or produced its instantiation is unique no other stamp as the same random dispersion of glitters for instance we can use this unique identity to protect products and to shield the supply chain and the third pillar is ubiquitousness we are reaching for around 4 billion smartphones globally and smartphones with impressive cameras are very powerful so why use a proprietary device that costs hundreds or thousands even thousands of euros per authority per per single device agents that authorities agents or experts can use in the field um and that is only used for these features why spend so much money on this on this proprietary device and if a protecting stamp or label has a dozen security elements will use several devices well the answer obvious for me is that smartphone capabilities can be much explored of course there are some features that no smartphone can yet validate but it is incredible the number of security elements was validation is now being transferred to the smartphones even smartphones got several other technologies that they integrate nowadays so users patients or authorities are entitled to interact with the products with me and with medicines for instance there's a lot of interaction uh possible interaction and then over physical features comes the digital part so digital layers of security can be very inventive there are dozens of digital layers of security and we can use cryptography cross rules machine learning learning ai to protect products and many more there are also many solutions leaning towards geo-referencing of data to protect the supply chain and this is where blockchain enters as well as a scientist i am not used and not convinced of course in talking about unbreakable systems but i am convinced that the available technology using physically and cloneable functions and blockchain is one step forward counterfeiters we just need to use this availability this technology availability to bring very strong security to medicines as we are doing in the use case of pharma ledger for instance another important issue is whether we are protecting the packaging or the product itself this is a very complex issue and of course i guess that we cannot avoid protecting the chemicals themselves the drugs but if we compare the amount of variety of technologies to protect uh in packaging and in medicines in the medicines it's themselves we see that it will always be much easier to protect packaging at least if we envision to build more interoperable systems i mean to protect in the field in pharmacies or hospitals for instance since in forensic labs the medicine must be analyzed as well always of course that's why i see that we need to invest in better temper evident packaging and to secure the supply chain just from the beginning to sum up i see that there are many many security elements out there and several providers create different solutions whose pillars are complexity uniqueness and ubiquitousness so possibly the step that is missing is to gather all these features in in interoperable collaborating system always protecting industrial property and the industrial secrets of of course so yeah this is my point of view thank you really thank you so i really i really agree with you okay it's not a unique research i will say before but there is a really different approach that you can apply and maybe i agree again that i mean blockchain with this approach of being trusted and also be i mean you can share the data in a very easy way everybody can can really access to that with really with the different uh device that we can use and also devices that are not specific to that could be really is the the solution and for that reason i really would like really to on the promise because i mean he has i mean he can share with us this type of approach how the blockchain can really facilitate be a great perfect ground for for the solution that i mean neuro was describing paulo i were you was that for me sorry um all right so um i just have a just a little perspective and then i'll go into that the architecture of the solution so um just to add to and maybe complement what we've heard so far so during during my time advisor you know this proved valuable in turning in terms of understanding the scope of the problem across legitimate and illegitimate channels so what do i mean by that legitimate channels are where you're actually buying or taking getting your medicines from a licensed uh practitioner either in the hospital or pharmacist or clinic illegitimate is everything else uh to you know websites that sell fake medicines to uh the back rooms and shops that might be selling and providing fake medicines or or medical devices and during my time you know our mantra was to deter detect and disrupt the bad actors so among other blockbuster drugs i spent considerable time working on viagra as some will regard as one of the world's most heavily counterfeited medicines and there i learned earlier that there is no silver bullet technology or solution that can solve problems with counterfeits to much to what nuna was talking about specifically so multi-layered solutions means more than simply applying you know over covert and forensic technologies on product packaging it requires a more holistic approach hopefully one that is grounded in a robust and comprehensive supply chain security program so and let's not forget that there are other stakeholders across the healthcare value chain that have to do their part and you know it takes a village to tackle this problem and it's the figures that stannis stanislaus presents this morning to us is this afternoon is these are sobering figures that it's getting even worse if i focus for a moment solely on legitimate channels where actors including patients believe they are trading and receiving genuine products it's how in my experience the counterfeits were primarily detected in the legitimate channel it was rather remarkable the majority of time it was through a product complaint from a patient or pharmacist for example my tablets are different they're different color i've been taking this medication for a long time now and suddenly my side effects are different and i don't understand why uh the packaging has changed in in a certain way that's makes me uncomfortable perhaps there's a different language on the package that wasn't there before now fortunately these instances in my experience are actually very rare and in specifically in developed economies so certainly product serialization to meet regulations like the fmd should improve overall supply chain security and positively impact patient safety however those regulations and their solutions don't necessarily the bring bring the means of detection to the patient one of the architected solutions by the pharma ledger team which i'll show you in a moment is built upon the e-leaflet with a 2d a scan of a 2d code using a phone app and this may represent a step change in reducing and eliminating counterfeits in legitimate supply chains because now you're empowering patients to actually participate in in the in the solution itself um with that let's hope this share works properly am i doing okay on time paulo i hope so okay [Music] all right just a confirmation you can see the slide yeah okay perfect so this solution uh you that is in answer to the use case that pharma ledger has very uh thoroughly developed that describes the problem of any counterfeits in the pharmaceutical medical device supply chain is what you're looking at now there's several layers to this so at the core it's based on an epi or e-leaflet or the the electronic version of the patient information leaflet if it was in the u.

s it might be built upon what's called the the med guide this is a this is a piece of material that actually is meant for a patient it's not the it's not what's meant for a doctor or pharmacist and through through use of the 2d code that we'll be putting down on products to meet regulations the fmd in this case they would use an app on their phone and scan the code presumably to get to the information that shows that instructs them on how best to take their medication whether they take it with food you know what times of day then beneath that behind scenes go goes on what goes on is a check and there the manufacturer in this case is looking at the data that's carried in the 2d code the the global trade identification number lot batch expiry and serial number they're checking for the validity of the serial number and the product combination itself the g10 and the serial number they're checking for the status has this product been recalled as an example um has there been anything specific to safety and use updates that need to be communicated to to the patient are there features available which was what nuno was talking about and i'll get to that in the next layer here is this uh product suspect so is there something happening in this region of the world or where this is uh this authentication is is occurring that gives us reason that we need to do something we need to take some action as the manufacturer and then those results are or some sort of results and responses given back to the patient if it doesn't need to be but it could be given back to the patient and now you're probably thinking tim well oh my gosh that opens up just a pandora's box of uh potential issues respective of what type of data is being shared and privacy concerns and even the messages that are given to patients in this regard are can be particularly sensitive um so the the good news is the pharma ledger team that's working on this has a work package that's meant to expose all of those concerns with that type of messaging back to a patient and then seek some resolutions and some guidance for industries as to what what are the best approaches for that let's move to the next one so as i mentioned in the previous line with number four the feature available so what is this this is um if there is a feature available the consumer patient might actually be prompted to check the feature and then provide an input this could be is the respective of fmd it could be related to the tamper evidence seals that are supposed to be placed on packaging it could be that there's a security label with some sort of overt optically detectable feature that could be interesting for the patient to to inspect and then provide a result back to to the the manufacturer uh through the app and then finally what i what i i look at is one of the most interesting and perhaps valuable uh aspects to the the broader opportunity to secure the supply chain um and improve patient safety is this this data that can be generated through these enact these activities taken on the part of anyone scanning the codes whether you're a licensed physician or pharmacist or a patient and over time this can start to build up some real good intelligence on what's really happening on the ground which is today largely uh invisible to manufacturers upstream this this type of information is very hard to find and come by and only maybe through uh very sophisticated surveillance efforts is it is it attainable so um this mfpa as it's called multi-factor product authentication is actually gonna maybe open the door on some significant improvements to that type of uh potential data and leveraging that data in the future so paulo i think that's it for me i'll stop sharing and yeah thanks very very clearly at the end as we're saying we have been able to fit in in our in our solution that is the blockchain what we are aiming i mean a different multipacker approach with different layer with different really options that could be i mean for the first one that is more simple i would say just reading a code and really validating the code even if more simple that is really look if and check if the product information is linked to the package and we have got all the scenes so as you are saying we are different layer which all these help really to compete against the contraption okay but as you say you were saying why some of that is just a single way approach okay which may be i mean you can read the code i mean and there's nothing there's also someone that is opening a channel to i mean to the end user that could be a doctor or maybe it depends where they are or what they could be also a patient and these really open a a a really a lot of questions really how to manage that because i mean you are really starting to open a channel a two-way channel with a with the end user that most most of the time could be the patient so also the the data private point of view need to be really taking consideration in these things even if we are really doing all the things that he really to protect to protect everybody but first of all the patient and that is really the reason why i was taking you at the end valentina because the most important thing is you really try to understand how this will affect the patient and how you think that i mean this solution can really help the patient really how to overcome that and also the empire with the power of the patient with all the the new device that are really almost of us thank you paulo okay yes indeed uh just to put it into context my brief interventions european patients forum is the european patient organization representing all patients across diseases and the countries in europe and of course when we talk about patients with chronic conditions we have to acknowledge that these are the people we'd live with firsthand experience because they have to self-manage their conditions most of the time and therefore they are also regular end users of pharmaceutical products but even any other uh technologies in the healthcare systems of course this makes them uh more subject to potential access to our counterfeit products this makes them more vulnerable of course and that's why i think blockchain might be really one of the solutions to address the need for safety and quality of the products we need to make sure that these two elements are guaranteed to the patients what is also very important for from a patient perspective if that patients may have they need to trust the world supply chain of course they are not able to personally check any any step of the process that leads to the production of the tablet they need to take on a daily basis they simply can trust the system therefore i think a blockchain can be the solution in this sense uh of course the the the slides shared by timothy showed us that patients can play a key role being the end users being really people living with the chronic conditions they can play a key role in identifying the discounter products but not only they need to be able to interact with the supply chain to make sure that if ever they encounter or any of these products they are able to provide the feedback to the supply chain and making sure that those products exit to the market many patients and patient organizations play a role in their care systems really not only to self-manage the conditions but also to provide peer support to other patients when it comes to patient empowerment we have to be aware also that this is a very broad concept which means patients be better understanding of the issues better be better engaged but also they need to be health literate of course this requires probably education if we are going to use blockchain tools we have to make sure that patients are able to use those tools we have to make sure that those tools are accessible for lay people of course because we we may educate as many patients as possible but we have to acknowledge that patients are all different they are all unique there are many differences among patients communities also if you look we look at the different age ranges a very young patient cannot be compared to an older one who's maybe less digital health literate so we have unfortunately to take into account of of these diversities which makes the role of the world supply chain and patient organizations more important to support the patient community okay thank you valentina so i mean uh i i would say that is something like 15 minutes left okay you i mean all the audience know that uh we are also answering and the question that i mean they can really submit in our um in the chat room i was already some question that we can answer and you all agree i mean i will try to really read it and maybe to ask someone of you to to once record you or your experience and maybe i mean if someone has to add something please feel free to do that okay the first one is i mean are they any successful existing drug track and trade system business blockchain and if yes which one i can believe that i mean the the people that the person that is in there has asked that they believe that fracking faces a solution for yankee counterfeiting okay as maybe something is going to be implemented in usa in is something of different is that you're doing european markets that i would i really ask if you have any example that if you can give us any any more information about that yeah so i would i would say i i actually don't know the answer to the question um because we i don't think there is a solution that's based solely on blockchain for traceability and track and trace what you will likely find and i do know there are some solutions out there that fit this characteristic they are traceability solutions that have a blockchain component to them and they've added they've perhaps been a traceability solution for a long time and blockchain comes into our our industry here in the last say five to seven years and it looks like an interesting way to solve some of the challenges that occur within trying to secure the supply of drugs and communicate and share data so you know blockchain is a data sharing technology it happens to be has its unique properties and value and therein lies some of the solution providers out there who are taken or have taken blockchain and plugged it into their solution um to add value provide some feature functionality that was harder before the one that i'm looking forward to seeing more about is where it enables trading partners to do more than just the one up one down exchange of information so does blockchain allow you with a platform uh that perhaps may not be your platform it may be someone else's platform in your in the supply chain but can you talk to each other and share information securely that would have not been possible before because you're on two different platforms you're on two different ecosystems of solution providers so that's uh i think that's about what all i can say with any knowledge at the moment yeah from my knowledge point of view i mean i agree with you i mean at the moment there is no any uh full track entries on the blockchain even if i know that by the 2020 the fda is implementing the u.s market the futures ability and at the moment for msd one of the solutions that we have presented was completely based on the track and trace and i agree with you that i mean this advantage is technology advantage also against you i mean i'm just talking from the secretary's point of view against the centralized database okay the risk is a distribute that is risk of or really being real against the i mean breach of the data it is something nice okay so going uh with the question i mean the the second that this campfire is how big is from the money point of video profiting i mean healthcare from uh from okay and maybe you can really give us the pharmaceutical point of view sure happy too paulo um even though that might be a complicated answer because we're what we're looking at is is criminal activity uh so as everyone would expect there is certainly no official report on this criminal organizations don't declare any of their activities and so valuation is actually extremely complex so here is probably what i can share to give an idea sense but again everything all of that has to be taken with a sort of a pinch of salty if i could put it that way um so first of all um [Music] the oecd actually has been working relentlessly for years on the valuation of this criminal activity elicit trade the grass they reported actually it's an interesting report that was published in 2019 so i would encourage everyone maybe to take a look because there are some very interesting findings here what i can say is they scrutinized the data over the last few years and they valued the trade in counterfeit pharmaceuticals to 4.4 billion that was based on 2016 data so five years ago um there are two important things to bear in mind when we look at that figure which could be either huge or see in a small it depends really the the angle you want to take but it's just limited first because it's only looking into counterfeit medicines it's very important but as i explained before it's not everything we deal with on a daily basis falsified medicines usually you look at confit medicines but you look also at stolen tampered or illegally diverted medicines which should not go to patient on all to a certain extent have patient safety impact as well considerations so we take a holistic approach this figure only covers counterfeiting so um in my world kind of feeling it's usually about pretty much half of the casey so again if you take a very simple approach that gives you half of the picture maybe you need to double that up the second part it's 2016 data because a very complicated part is to capture the data from all the law enforcement agencies in the world all the trade associations who capture that sort of information the information is a tricky part to obtain 2016 data i also explained to the audience earlier on that we have measured that pharma crime activity has grown by 69 percent over the last five years so probably increase that figure by 69 percent double it up to capture the full spectrum of falsified medicines and that could get you a bit closer and i guess to what is a realistic figure of this illegal former crime activity so my apologies if i can't be more accurate than that but there is no actual figure that has been really officially shared on the on this i would also conclude by saying if we take a different angle than just a financial one the world health organization estimates that one drug out of 10 available in the world is basically falsified and this is a very general figure obviously if you start looking at low middling up countries these figures rises very significantly in certain markets we we have seen these rights to be really 4 out of 10 5 out of 10 in very specific situations like countries that were embargo on all numbers even going higher than that so it really depends from one region to another thank you thank you it's great and i can add something more and more because i mean i was really talking uh with with the european institution they would say that also the illegal framework of the anti-counterfeit healthcare is not so really strong in the really defining approach so sometimes i mean there are people that are especially that are moving from the the drug market i mean cocaine that what is more strictly more and more they have controlled the healthcare drug and because of the intelligence this is not so so at the moment it's going it's going to get better but at the moment also some part of the body which this will not be okay then maybe i could share another figure which is interesting shit's perspective because you you just mentioned about the drug trafficking yes that's an interesting benchmark actually in temple a few years ago released a figure that their estimation from all the cases they worked on is that pharma crime can be up to 20 times more lucrative compared to drugs trafficking yeah because if we bear in mind that counterfeit medicines basically don't have any active ingredient they have nothing at the best situation they can be really chemicals and horrible stuff in there it doesn't take much to produce any of this actually the the main cost is probably packaging on this invest quite a bit but not the product itself so it's extremely lucrative for criminal organization on the ratio compared to drug trafficking is actually shocking so that's another figure so they could share yeah and probably the the collaboration that we can have all pharmaceutical company all the institutions together in a in a platform that is about blockchain can help a lot i have i got i got one more question for you new more okay this is very really i mean guidance okay i would like to understand because there's a question that asks all the features that we are really adding you are thinking to other to do well care i mean it is almost the same that we are also adding to the other market maybe the luxury market or some other things okay yes as a matter of fact the the fixtures um can be used in several markets so in medicines but also in excise stamps for tobacco for instance or alcohol or even for luxury products so actually the the the because the technologies um are to be validated by devices and it's it's the same to be validated in the in a medicine packaging or for instance in a in a bottle of wine so um usually the the the stamps should usually we um the solutions tend to add something to the packaging or to build directly on the packaging which is uh which which are different solutions and can be even complemented complemented um but as i said it's it's simple to to to do that in for instance in in in a bottle of wine or in in in a medicine packaging but the thing is that it's it's very important that solution is temper evidence so if the if the bottle for instance of the wine is is opened or if the the packaging is opened this event must be protected so it must be evident that that it was opened at it because the the the interior was changed or was added something or deleted some something so this is important that solution should be temporary evident and i see that for instance um one of one of the things that we are we've been noticing is that um the counterfeit is not um anymore in eye-hand products in luxury products or in high-hand vines or in very very expensive medicines and drugs but the the the counterfeit is bringing down to uh very um consumer mass consumer products so cheaper cheaper products because the technologies that counterfeiters use is is a mass production technology and then we need to bring this protection down to the to to these several several products and of course and the track and trace systems must help these and and they they should protect the supply chain from the beginning from the the raw materials until the consumer and in my point of view the consumer should be um should be um kept in the in the equation and should be a lobby be allowed to help authorities in protecting the products um so yes i guess um almost all fixtures can be used in a lot of markets not only medicines but also other markets and of course cross information can be shared between companies and between providers and authorities okay guys we have last four minutes and there is a two question that i'd like to really to give to you i mean one is to really important that i mean it's just not i mean very openly who are the main big customer of the counterfeiting drug okay i would really afford to try to answer the question from different angle for sure staffing from valentina i really try to understand better also if there is also something that is idiot what happens to the victim of this one and also from the patient point of view it is very important and they also ask for all of you if we can also have some other the to the pitch okay thank you paulo so i wanted just to make a point about who are the victim victims of course patients who i have by buying some somehow access to counterfeit products uh face the risk of important side effects or even death as it was mentioned by stanislav um what one point i think that is really important is especially those patients we that lack access to the appropriate medicines may face the risk of accessing counterfeit products and this is due to the issue of shortages of medicines this is something that stanislaus has already mentioned when it comes to covet 19 vaccines of course the higher the need the higher the risk that the counterfeit products enter the market and those communities that did not that have no easy access to the products because of not maybe health economics standards that don't meet the i mean the the opportunity for for the countries to address those needs may bring to these issues even more and then i'm thinking of probably countries from eastern europe might face this issue more than others but of course this doesn't mean that in western europe it's not an issue at all yeah who else wants to add the the to the list of the the the patient i think maybe we we could say i mean uh reputation for the healthcare system as a whole even the pharma industry as well i mean it's critical for us it's it's really uh super important the problem is that um if counterfeit products or falsified medicines win uh over a certain market the problem is the trust patients have in these particular drugs so a good drug that could actually cure people can be destroyed in terms of reputation over the problem of falsified medicines and we've seen that in markets actually that happens really in certain markets we've seen that in africa in south asia where the situation got out of hand for some very needed medicines uh could be anti-infectives or others or antibiotics and i think we're at the right now about to probably see that in certain markets for vaccines for covid19 so the trust that patients have and you know the worst thing that can happen is when a a patient would say i need that medicine but i can't trust the pharmacy or the clinic i go to because i'm not sure what i'm about to get so that's a fundamental element on the the worst we could basically all lose as a healthcare system yeah i completely agree with that okay and coming back to what vantina was saying before all the talk okay i can tell you that if you had i mean the advantage also have the blockchain that in the same environment you can really share different level of information be sure that me each of them will be protected so i would say that also having a traceability uh solution can also for sure protected by the anticoagulate but also really try to understand where the drugs are and we can really be sure that the shortage would not have happened so that is another i mean advantage that we can really have as soon as we are able to implement in blockchain and i would say that the let's say let's say that's the the the last one that i would say the most important okay what are the cost of preventing drug from okay that is very interesting because it's really not just i mean of course but they are going to build together okay my opinion and and then i've seen daniel coming down because i will finally go into the end i would say that i mean what that blockchain is helping us really to reduce that because uh we would like to have a solution that will reduce the cost but really increase the the the security and being altogether pharmaceutical company and also i mean uh i mean institution working on the same platform we can we can share i mean the same standard as gs1 would say i mean specific feature that we can have layer by layer okay this will help us to reduce the cost increase the in the security and also be sure that both the environment will take advantage of having the anti-counterfeiting i mean i will say not not defeat because i mean but overcome because it will be continue a sort of round robbing against i mean the counterfeiting i mean say that i mean i will really help thanks all of you okay for your great i mean experience and all the information that you share with us and thank you really thank you for everybody thank you thank you thank you very much bye-bye thank you so much for the oh sorry go ahead thanks for having us that's all go ahead yeah thank you stanislas timothy thank you so much for sharing a lot of insights from the healthcare industry i hope we managed to answer some of the questions that we had now time for another session the last one of our farm manager track and i hope you can stay for another panel longer thank you so much thank you bye

Automatic transcript — names and jargon may be misspelled.