Monitoring the shipment of a batch of medicines

The integration of single-use codes, blockchain, and AI in a SaaS platform effectively tracks and authenticates medicine batches, addressing the challenge of counterfeit substitution during distribution by ensuring secure and cost-effective traceability.

FR3136575B1Active Publication Date: 2025-01-17DANIELLE IWANDZA
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Patent Information

Application Number
FR2022005605
Authority / Receiving Office
FR · FR
Patent Type
Patents
Current Assignee / Owner
Filing Date
2022-06-10
Publication Date
2025-01-17
Estimated Expiration
2042-06-10

AI Technical Summary

Technical Problem

The existing methods for monitoring the distribution of medicines are inadequate in preventing the substitution of authentic medicine batches with counterfeit ones during the distribution process, which poses a significant threat to public health and is difficult to detect due to the complexity of the distribution chain and lack of robust, cost-effective tracing mechanisms.

Method used

A method involving the use of single-use codes and barcodes, combined with blockchain technology and artificial intelligence, to ensure the traceability and authenticity of medicine batches throughout their journey from the manufacturer to the dispenser, using a SaaS platform that includes smart tokens and smart contracts to verify and secure the packages at each repackaging stage.

Benefits of technology

This approach provides robust, cost-effective, and efficient tracking of medicine batches, preventing counterfeiting by ensuring that each repackaging step is authenticated and monitored, reducing the risk of counterfeit medicines reaching patients.

✦ Generated by Eureka AI based on patent content.

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Abstract

This description describes a verification process for the delivery of a package of medication boxes. The package is transported to a dispensing point via a route with successive segments, and is repackaged after each segment. The repackaging process includes at least: - verification of an initial label affixed to the package, bearing a unique code assigned to the package and the segment it has traveled; and - issuance of a second label to be affixed to the package, bearing a second unique code, different from the first, and assigned to the package and the next segment to be traveled.The process includes at least: - storing the first code with a server, - upon receiving data of the first code from a terminal, checking with the server that the first code has previously been stored and has not been received previously, * if the check is positive, generating, saving with the server and sending to said terminal data of the second code, with a view to using the second code for repackaging the parcel, * if the check is negative, generating an alert.
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Description

Title of the invention: Control of the delivery of a batch of medicines Technical field

[0001] The present description relates to means of anti-fraud control of the delivery of a batch of medicines. Prior art

[0002] Despite many effective actions undertaken to improve access to authentic medicines for patients, there is nevertheless a parallel market used by fraudsters who do not hesitate to introduce fake medicines by selling them cheaper than the real ones.

[0003] There is a definition of fake medicines as follows: A falsified medicine, according to European Directive 2011 / 62 / EU, is a "medicine containing a false presentation of: - its identity, including its packaging and labelling, its name or composition with regard to any of its components, including excipients, and the dosage of these components; - its source, including its manufacturer, its country of manufacture, its country of origin or its marketing authorisation holder; or - its history, including records and documents relating to the distribution channels used.

[0004] This definition does not include unintentional defects in quality and is without prejudice to violations of intellectual property rights.

[0005] The components present in these medicines, including the active substances, are usually of insufficient quality, falsified, incorrectly dosed or even absent, and thus represent a serious threat to public health.

[0006] The trafficking of counterfeit medicines represents at least 10 to 15% of the global pharmaceutical market (i.e. 100 to 150 billion dollars) and has been increasing in recent years.

[0007] Africa is one of the continents most affected by such counterfeiting: on average 30% of medicines in circulation in Africa are fake (up to 70% in some countries).

[0008] The consequence is an increased mortality rate, in the order of 700,000 to 2,000,000 deaths per year according to studies. According to the World Health Organization, 150,000 African children under the age of 5 died from this trafficking in 2013. In Africa, especially the treatments for the diseases with the greatest impact on public health are concerned (malaria, AIDS, tuberculosis) while the most expensive medicines are those most counterfeited in Latin America.

[0009] The scourge of counterfeit medicines represents a very lucrative activity for traffickers, much more so than drug trafficking: it is estimated that $1,000 invested in counterfeit medicines brings in $500,000 compared to $20,000 for drugs.

[0010] In an attempt to combat this counterfeiting, Directive (EU) 2016 / 161 of the European Parliament, known as the "falsified medicines directive", has been fully in force since February 2019. Among the technological tools available to achieve this traceability, the use of "Datamatrix" (high-density two-dimensional (2D) matrix barcode) makes it possible to include a lot of information in a small space on a box of medicines (product code, batch number, expiry date, serial number, etc.).

[0011] Such a tool makes it possible to check a posteriori whether an individual box of medicines has possibly been counterfeited. However, checking each box is tedious and the proposal of such a tool ignores the usual trafficking mechanisms of counterfeiters.

[0012] Indeed, the essential problem lies in monitoring the process of distribution and delivery of medicines.

[0013] Counterfeit trafficking often involves intercepting a package of a batch of authentic medicines to be delivered to a pharmacy and replacing it with a batch of counterfeit medicines (cheaper, non-compliant, etc.). The authentic batch is resold in another channel. A way is therefore sought to guarantee the traceability of a batch of boxes of medicines from the time they are packaged at the factory until their delivery to the pharmacy.

[0014] On a distribution chain, a batch leaving the factory and packaged is transported to a distributor. At the distributor, the batch can be repackaged and transported again to a wholesaler. At the wholesaler, the batch can be repackaged and transported again to at least one reseller. This mechanism can be continued several times depending on the destination of the batch, which can be repackaged and transported several times to its final destination: a pharmacy, a hospital or a clinic.

[0015] It will be understood that a fake batch of medicines can penetrate at a point in this distribution chain which becomes porous, particularly at the end of distribution.

[0016] An effective means of combating counterfeit medicines must therefore facilitate the monitoring of the medicine as it passes from one entity to another (from manufacturer to distributor, etc.).

[0017] Technical means are therefore sought: - robust to effectively combat the replacement of a batch on its route, - inexpensive so as not to significantly increase the price of authentic medicines compared to counterfeits, and - simple so as not to discourage rigorous control of batches of medicines on all sections of their journey. Summary

[0018] The present description improves the situation.

[0019] To this end, it proposes a method implemented by computer means, for verifying a delivery of a package of boxes of medicines, the package being transported to a dispensing point along a route comprising successive sections, the package being repackaged after each section traveled. In particular, the repackaging comprises at least: - a verification of a first label affixed to the package and comprising a first single-use code, assigned to the package and to the section traveled, and - a supply of a second label to be affixed to the package and comprising a second single-use code, different from the first code, and assigned to the package and to the future section to be traveled. The method can then include at least the steps aimed at: - storing the first code on a server, - upon receipt of data from the first code from a terminal, check with the server that the first code has been previously stored and has not been received previously, * if the verification is positive, generate, save with the server and send to said terminal data of the second code, with a view to using the second code for repackaging the package, * if the verification is negative, generate an alert.

[0020] Thus, it will be understood that at the end of each section, in the route planned for the package, a repackaging of the package then causes the steps of the above process. In particular, a single-use code is provided for each repackaging of the package. This code can typically be printed on a sticky label affixed to the package. Of course, once the package has reached its dispensing point, the step of verifying the single-use code, implemented by the server and presented above, can be carried out one last time.

[0021] In one embodiment, the terminal can execute an application to: - transmit data from the first code to the server, and - upon receipt of the data for the second code, issue a print order for the second label containing the second code and to be affixed to the package for repackaging.

[0022] The terminal can in fact issue a print order intended for a printer to print the label with the new code (second single-use code mentioned above), to be affixed to the package.

[0023] In an exemplary embodiment, the first and second labels may include an opaque coating to be scratched to reveal the first and second codes respectively. The terminal may then execute an application to: - animate a human-machine interface of the terminal allowing a user to enter the first code after scratching the first label, and - transmit to the server data resulting from the entry of the first code by the user.

[0024] In such an embodiment, the labels are printed with an opaque scratch-off coating. If a trusted user receiving the package to be repackaged typically notices that the label has already been scratched, he can transmit an alert to the server via his terminal. Otherwise, he can scratch the label and enter the code he sees on his terminal, for transmission of this code to the server.

[0025] In addition or as a variant, the first and second labels may respectively comprise first and second bar codes, the terminal may execute an application for: - carry out an optical reading by the terminal of the first bar code, and - transmit to the server data resulting from the optical reading of the first bar code.

[0026] This barcode may be, for example, a QR code printed on the label. The label may include both the barcode and the single-use code coated with the aforementioned opaque material. Alternatively, a set of several labels may be provided, comprising a label for the barcode and a label coated with the opaque material. Thus, the term "label" here means both a single label and a set of several labels.

[0027] In an embodiment where the labels include a barcode, the first and second barcodes may include at least data on the respective, presumed, locations of delivery of the package for repackaging. In such an embodiment, it is advantageous for the execution of the application at the terminal to cause: - a recovery of current location data from the terminal, and - a transmission to the server of said current location data, with the data resulting from the optical reading of the first barcode. The server can then verify consistency between: - the current location data from the terminal, and - the data of the presumed place of delivery of the package, resulting from the optical reading of the first barcode.

[0028] This consistency check can be carried out with a tolerance of a few tens of meters for example.

[0029] In addition or as a variant, the first and second barcodes may comprise at least respective data of expected delivery timestamps of the package for repackaging.

[0030] In such an embodiment, the server, upon receipt of the data from the first barcode, can then verify consistency between: - a current timestamp, and - a timestamp from the optical reading of the first barcode.

[0031] This consistency check can be carried out with a tolerance of a few tens of minutes for example.

[0032] In an embodiment where the package comprises a plurality of boxes of medication, each comprising a bar code specific to each box, the terminal can execute an application to: - carry out an optical reading by the terminal of each bar code of each box, and - transmit to the server data from the optical reading of each barcode on each box. Thus, the server, storing data specific to each box of medication, can verify the validity of the data received and resulting from the optical reading of each barcode in each box.

[0033] Thus, the implementation of such an embodiment makes it possible to ensure compatibility of the checks carried out by the server with the aforementioned Datamatrix® system.

[0034] In one embodiment, the package being packaged in a cardboard packaging comprising at least two adjacent panels, the first and second labels are self-adhesive, and configured to be affixed to the two panels of the cardboard.

[0035] Thus, if the package has been opened along its route by an unauthorized person, a label containing the bar code or the opaque coating appears cut, which damages the label and makes it impossible, for example, to read the bar code.

[0036] In addition, it is possible to provide a hologram sticker to be affixed to both sides of the cardboard.

[0037] Opening the box then causes the sticker to deform and the hologram is no longer visible in its expected form. A trusted person receiving the package with the sticker in this state can then generate an alert.

[0038] In one embodiment, the first and second one-time codes are functions of respective data from a blockchain verified by the server.

[0039] Thus, the server can check throughout the entire journey of the package to its point of dispensation, whether the blockchain data is consistent and valid.

[0040] In one embodiment, an artificial intelligence programmed to learn, in a learning phase, situations relating to alert generations, and to detect, in a current use phase, anomaly situations is implemented.

[0041] Such an implementation makes it possible to generate alerts even if a user receiving a package does not generate one. For example, despite the aforementioned delivery delay tolerance of a few tens of minutes, if all the packages arrive at the same delivery point with a systematic delay but still less than the maximum tolerance, the artificial intelligence can detect a systematic anomaly and generate an alert.

[0042] The present description also relates to a system comprising: - a server configured to implement the steps of the above method, when these steps involve a server, and - at least one terminal configured to implement the steps of the method when these steps involve a terminal.

[0043] The present description also relates to a server of such a system and a terminal of such a system (executing a specific application to be linked with the server via a communication network).

[0044] The present description relates to a computer program comprising instructions for implementing the above method, when they are executed by a processor (of a server and / or a terminal of the above type). These instructions can be distributed in respective memories of a server and / or a terminal of the above type.

[0045] The present description also relates to a non-transitory memory medium storing such computer program instructions. Brief description of the drawings

[0046] Other characteristics, details and advantages will appear on reading the detailed description below, and on analyzing the attached drawings, in which: Fig.l

[0047] [Fig.l] illustrates an example of steps of a method of the type defined above. Fig. 2

[0048] [Fig.2] details sub-steps of a step S9 of [Fig.l], of generating a second label to be affixed to the package at the end of its repackaging. Fig. 3

[0049] [Fig.3] details sub-steps of a step S2 of [Fig.l], of verification of a first label affixed to the package upon receipt. Fig. 4

[0050] [Fig.4] schematically illustrates a possible model of algorithm implementing including artificial intelligence. Fig. 5

[0051] [Fig.5] schematically illustrates a system for implementing the defined method above. Description of the embodiments

[0052] To combat counterfeit medicines, the proposed solution is intended for: - all stakeholders from the manufacturer to the dispenser (the last link before the patient: pharmacies, hospitals, clinics, etc.), - patients, - administrative authorities in countries: customs, health inspection, police, justice.

[0053] This solution is based on a SaaS (Software-as-a-Service) software platform which can be composed, as we will see in detail later, of uses of: - “smart token” (single-use code mentioned above), - Blockchain (solution later called “smart contract”), and - Artificial intelligence.

[0054] This platform ensures the traceability, authentication, security and monitoring of medicines from end to end in the distribution chain. Pharmacists and patients thus have a solution whereby they only have to scan a unique identifier recorded on the blockchain to verify its authenticity.

[0055] For example, when a batch of boxes of medicines is produced, it is linked to a unique identifier generated by means of a 2D serialization matrix code containing all the essential information about the product. This 2D code (QR-Code type) containing all the information of the medicine, is added to the blockchain so as to facilitate tracking each time the medicine passes from one entity to another.

[0056] In one embodiment, the combination of three means below may be provided for tracing, authenticating, securing and monitoring the distribution circuit in order to ensure and guarantee that the fake batch of medication does not reach the patient: - a “Smart token” to secure packages in transit, - a “Smart contract” ensuring the traceability of packages throughout the journey, - an “Artificial Intelligence” programmed to detect anomalies along the entire route.

[0057] Such a solution has the advantage of protecting a distribution circuit at a lower cost without changing the drug manufacturing model and without generating the use of additional objects which can be expensive, such as the use of loT (internet of things) technology, RFID tags, etc.

[0058] During the preparation, transport and reception stages of packages, real medicines can be replaced by fake ones. The Smart Token concept makes it possible to insure packages while protecting the medicines inside.

[0059] [Fig.l] illustrates by way of example the possible steps of such processing.

[0060] The first IS step consists of deploying IT applications for the implementation of the method with mobile terminals TER1, TER2, ..., TERi, TERi+1, ... (for example smartphones, tablets, or others) which are available to human users, actors in the distribution chain. Each of these terminals is assumed to have optical reading means (in particular a QR-code). In addition, each of these terminals is assumed to be connected to a telecommunications network (typically in IP protocol). This connection can be direct, via a GSM network which makes it possible to determine a current location of the terminal (for example by trilateration) or via a gateway whose location can also be detected.

[0061] Thus, each terminal can give the application data read by scanning a QR code, as well as a current location coordinate of the terminal (by GPS or by the aforementioned means), as well as an IP address for connection to the extended network.

[0062] The application installed in the terminal is programmed to retrieve all of this data (including GPS coordinates and IP address) without control by the user of the terminal.

[0063] At the same time, a computer supervision module is installed near the SER server in [Fig.l], this server being responsible for controlling the data sent back by the terminals thanks to the execution of the application near each terminal.

[0064] Thus, after step S10 of applying a first QR code QRC1 to a package leaving the factory, this package is routed along different sections of a route. Upon receipt of the package in one of these sections, the package carries a current code QRCi, in step S2. A user scans this code QRCi in step S3 using his terminal TERi. In step S4, the application installed on the terminal TERi is activated to transmit the data of the code QRCi with current location data of the terminal TERi, as well as its connection IP address. This data is transmitted via the aforementioned wide area network to the verification server SER.

[0065] In step S5, this data is verified by the server SER as follows: - a single token is given for a single batch and for a single route of this batch: the data of this token must not have been used previously, and therefore not previously sent to the SER server, - the QRCi code data includes a scheduled delivery time stamp for the package (within a tolerance): the time of receipt of the data from the server must neither anticipate nor exceed the time stamp present in the QRCi code data (within the tolerance), - the IP address returned by the TERi terminal is that of the terminal on which the application was previously installed and must not differ from it.

[0066] The unique token can be a specific piece of data from the QRC code, to be checked with the server. In addition or as a variant, a single-use code can also be stuck on the cardboard of the package with an opaque scratch-off coating as will be seen later (“invisible” code, as called later).

[0067] Furthermore, all of this data must be consistent with the previous sections of the package's journey, and the information previously sent by the terminals TERi-1, TERi-2, etc. Such verification may rely on a blockchain control mechanism that the server SER may also implement in step S61.

[0068] The server SER can furthermore use artificial intelligence in step S62, to sequentially analyze the plurality of data that is uploaded from the different terminals, and thus detect situations that appear normal, but in reality characterize possible fraud. For example, even if a tolerance is provided for the time of delivery of the package with respect to the timestamp, a terminal TERi that uploads a capture time that is systematically different from the timestamp, always in the same direction of difference between the upload time and the timestamp, can be judged as suspicious and can be interpreted as being available to a fraudster.

[0069] Thus, the implementation of artificial intelligence here makes it possible to detect situations unsuspected by a human, based on situations learned during a prior learning stage.

[0070] If at least one anomaly is not detected in step S5 with respect to at least one of the above criteria (KO arrow at the output of test S5), an alert is generated with the server in step SI 1 and the suspected batch is declared to the authorities, as well as the location and IP address of the terminal of the presumed fraudster.

[0071] Otherwise (OK arrow at the output of test S5), the server SER transmits in step S7 the data of a new code “QRCi+1” to the terminal TERi, so that the latter can control the printing of a self-adhesive label (or “sticker”) comprising this new code QRCi+1, in step S8. Thus, when repackaging the package in a new carton, the label of the new code QRCi+1 can be stuck for example at the junction between two sides of the carton, in step S9. Such an implementation makes it possible to ensure that if the package is opened again, the sticker with the new QR code must necessarily be torn off, which will compromise future reading at the end of a subsequent journey. Such an implementation thus makes it possible to prevent fraudsters from opening the package, emptying its contents to replace them with fakes, and resealing the package with the same QR code. Indeed, once the label with the new QR code has been applied at step S9, the package can leave for a new section of the journey, the new QRCi + 1 code being unique for this package and this next section of the journey. A new QRCi + 2 code can be generated at the destination of this new section, and so on until the final destination of the batch.

[0072] As an example, [Fig. 2] illustrates different sub-steps of step S9.

[0073] In step S91, before introducing it into a carton, each box of medication can be scanned via 2D datamatrix technology from the mobile application on the terminal. The mobile application must again geolocate the perimeter where each box is being packaged and verify the consistency of this geolocation data with the IP address of the terminal. In the event of inconsistency, the terminal's scanner functionalities can be deactivated. Such an implementation makes it possible to restrict and secure the preparation of the package to the sole point declared by the manufacturer or distributor (for repackaging) and therefore to guarantee the distribution circuit by preventing the introduction of fake medications from the user site.

[0074] Once all the boxes of medicines have been scanned and placed inside the package, the carton can be closed, for example, with standard adhesive tape.

[0075] In step S92, a holographic authentication security sticker can be affixed to the top of the carton at a specific location to verify that the carton has not been opened during transport. This tamper-proof sticker offers, in terms of security, the advantage of immediate visual identification of any sticker removed and re-affixed, which is then permanently altered in an irreparable manner (the deformation of the sticker causing the hologram to permanently not appear), which makes it possible to guarantee the inviolability of the package.

[0076] In step S93, the self-adhesive label comprising the unique QR-code QRCi is also affixed to the top of the closed carton (between the two sides). This QR-code combines both the list of medicines ordered and the verified data with an identification of the medicines contained in the carton (for example the name of the manufacturer / distributor (departure / arrival), the date of dispatch, the place of dispatch, etc.).

[0077] In an additional step S94, a label with a unique code again, “invisible” (because covered with a scratch-off coating to reveal the code for example), and possibly but not necessarily combining the previously generated QR code information, can still be affixed to the top of the carton between its two closing panels. Here typically, the unique code is linked to the package and its journey and this label must be destroyed to open the box for repackaging. Replaying this unique code is therefore impossible. For example, this label can be used as a counter-check of a package in the event of suspected fraud by an administration, to follow up on an alert to the SER server.

[0078] Thus, the method may include, for each preparation of a package before transmission in the distribution circuit, the following elements: - obtaining GPS coordinates (latitude and longitude) combined with the IP address of the user terminal, - the generation of a holographic security sticker for authentication (or “security tape”), - the generation of a unique QR code, - the generation of a unique “invisible” scratch code.

[0079] Conversely, upon receipt of a package, the four aforementioned elements are implemented: - verification of GPS coordinates combined with that of the IP address, - verification of the appearance of the holographic authentication security sticker (“security tape”), - generation of a new unique QR code, - generation of a new unique route code, invisible on an adhesive strip.

[0080] Thus, step S2 of [Fig.l], of receiving a package can be broken down into three steps illustrated in [Fig.3], with a view to the correct reception and authentication of a package.

[0081] For example, in step S21, the holographic security sticker is inspected by the user in order to see whether the hologram is visible or not. If this is not the case, he can notify the entity managing the server to generate an alert. Similarly, the general condition of the package is inspected to identify any attempts to open the package.

[0082] In step S22, the QR code appearing on the label of the carton is scanned. As presented above with reference to step S3 of [Fig.l], a scan of a QRC specific to the package itself can be carried out while the package is not yet opened, in order to verify the data of the package with the server (step S5) and to thus display on the screen of the user's terminal a list of the boxes of medicines which are supposed to be inside the carton. The user, by subsequently opening the carton, will be able to verify that all the boxes announced by the server and which appear on the list which is displayed on the screen of his terminal, are indeed in the carton.

[0083] In step S23, scratching the “invisible” code label makes it possible to obtain a unique code for the route. The user can view it after scratching the strip. and manually enter it into their terminal connected to the SER server to verify the authenticity of the package.

[0084] Once these steps have been completed, the user can open the package and check its contents. He may be required to scan each box of medication by sending the data from each scan to the SER server, so that the SER server can implement a routine for checking and checking each box constituting the contents of the package.

[0085] The “Smart contract” solution operates according to a “Hyperledger Fabric 2.0”© type blockchain mechanism for tracking and traceability.

[0086] This exchange protocol makes it possible to efficiently and securely track packages in the drug distribution chain in a private and authorized distributed network for the various actors using the SaaS platform (from the manufacturer to the pharmacy, including for patients during the consultation with a mobile application or by an SMS platform which returns information).

[0087] This processing implements the storage of all activities from the distribution circuit with the server, verified in the blockchain according to version 2.0 of the Hyperledger Fabric. It is thus possible to store and provide optimal transparency and traceability with respect to the different actors (laboratories, distributors, customs, pharmacies, hospitals, clinics and patients, etc.).

[0088] The artificial intelligence tool uses predictive analysis and continuous learning to identify anomalies in a distribution circuit. Seamless end-to-end monitoring of the circuit also detects the most difficult-to-spot anomalies.

[0089] For example, “machine learning” type algorithm models can be provided to detect in particular the following anomalies in a distribution circuit: - failure to deliver a package within a given time limit, - a package received, but damaged or opened, - a new uncontrolled arrival (by cross-referencing data relating to medicines sold in pharmacies, clinics, hospitals, etc.) - a training model for fraud detection between two points as introduced previously, - alerts on false positives (triggering of untimely alerts on distribution of authentic medicines).

[0090] [Fig.4] is a schematic illustration of a possible simplified algorithm model for identifying counterfeit medicines in a distribution circuit. The left part of [Fig.4] illustrates in particular the enrichment of the treatment by artificial intelligence and its learning. The model combines in particular the use of the "smart token" (single-use code and its tracking) with the use of the "smart contract" (consistency of overall data concerning a batch). The pharmaceutical environment is one of the most regulated internationally, and this dual treatment proves to be adapted to its recent developments.

[0091] Finally, artificial intelligence further verifies the consistency of this combination, so that by combining the three concepts: - "smart token", - "smart contract" - and “artificial intelligence”, It is possible to achieve a compact and centralized architecture, for example with the SER server, for: - trace - authenticate - secure - to watch the route of packages within a territory in order to effectively combat the fraudulent penetration of counterfeit medicines into official medicine distribution channels in that territory.

[0092] Furthermore, artificial intelligence exploits the input and output data in a neural network to produce a set of tests giving a projection of anomalies in a distribution circuit likely to evolve.

[0093] Furthermore, the use of artificial intelligence makes it possible to adjust computer control programs, for example by assigning more weight to one type of control than to another.

[0094] Thus, in an application of the above description, each laboratory prepares a package containing authentic medicines using the mobile application on a terminal connected to the SER server. The boxes of medicines are then each recorded in a database of the SER server. Indeed, the SER server is further arranged to list each box of medicines in the package using the initial 2D datamatrix reading of each box of medicines, assigning a unique code to the box, its serial number (CIP code), the batch number and the expiry date of the medicine and other information (company brand name, name of the substance) from the ANSM and European medicine database.

[0095] The package ready to leave the factory is then packaged and secured using the means presented above, then transported successively to its dispensing point.

[0096] Once the package has been checked at the dispensing point as illustrated in Figures 1 and 3 previously presented, and at each stage of the journey, when the package is opened at the dispensing point, each box of the package is scanned again in order to to obtain information specific to each box. This information is sent to the SER server.

[0097] The end user (hospital, pharmacist, patient, etc.) can verify the authenticity of the medication and its degree of confidence by scanning the 2D datamatrix. The scanned information is sent back to the SER server for verification. A normal situation is presented in the form of a "green light" for example on the user's terminal: this means that the box of medication is initially registered by a laboratory with the SER server and that its delivery conditions do not present any anomalies.

[0098] An ambiguous situation appears in the form of an "orange light" on the user's terminal: this means that the product is unknown to the server but that the conditions of its delivery seem normal. The level of authenticity and trust of the medicine is therefore unknown. The user's terminal displays a recommendation to contact a nearby pharmacy for more information.

[0099] An alert situation appears in the form of a "red light": this means that an alert is in progress on the product known to the SER server as being fraudulent. The terminal screen can then display the following details: - expired product, - batch recall, - patient safety problem, - product withdrawal required.

[0100] Thus, the present description proposes the allocation of a single-use code for a journey of a batch of medicines on a section of the journey between two points A and B, without repackaging this batch on this section of the journey.

[0101] In a particular embodiment, it may further be provided that the form taken by this single-use code is a bar code (for example a QRC or other), the information of this bar code being acquired by optical reading (by the camera of a smartphone for example) to verify the validity of the code, from a server within the meaning of the present description. For example, the verification of the single-use code may consist here in providing that the data of the bar code includes time stamp information giving a validity limit date of the code. Typically, if this date has passed, then the bar code presented is not validated by the server and the batch is suspect. The validity limit date may take into account a time required for the journey from point A to point B, and thus correspond to an expected date of arrival at point B (to within a few tens of minutes).

[0102] In a particular embodiment, it is planned to recover, from the device which carries out the optical reading of the bar code, geolocation data of this reading. optical. Typically, in the case of a smartphone, the application that must be installed on this smartphone can cooperate with the usual means of location of the smartphone to retrieve this location data and send it with the barcode data to the verification server. In this case, the server can determine whether the geolocation data from the optical reading corresponds to point B where the delivery of the batch of medicines is expected. This achievement then makes it possible to determine with certainty that the batch of medicines is not diverted to a destination other than point B.

[0103] The barcode can be printed on a sticky label to be placed at the junction of two cardboard panels constituting the packaging in which the batch of medicines is placed. Thus, a fraudster must tear the label at the junction of the two panels so that the code can no longer be read by optical reading. For example, the cartons can be pre-printed with an indication of the position in which the label must be stuck (indication of a box in which the label must be stuck for example). For example, the layer on which the barcode is printed can be fragile and tear laterally, while the underlying layer is more difficult to tear. Thus, even using a cutter, the barcode can be very damaged.

[0104] In addition to or as an alternative to using a single-use code in the form of a barcode, a single-use code (for example a sequence of characters and / or numbers) can be printed on a label to be stuck on the box, this label being coated with a layer of opaque material to be scratched off. Thus, only the person receiving the package can scratch off this layer and enter the code that appears on their terminal to transmit it to the verification server. The server can then verify that this code is valid (not previously used and intended specifically for this route), and send a message validating (or not) this code to the user of the terminal.

[0105] In addition, a label on which a hologram is printed can also be placed at the junction of the two sides of the cardboard. Thus, if an attempt is made to open the cardboard, the hologram is no longer visible in the same way and the recipient of a parcel can notice this difference and report an alert to the server.

[0106] In one embodiment, it may be provided to use artificial intelligence at the server level to teach it the normal situations of successful parcel deliveries, without fraud, and the delivery situations that have caused an alert. Such a measure then makes it possible to use artificial intelligence to detect abnormal situations (warning of possible fraud) in the data sent by the optical reading means. Such artificial intelligence can, for example, alert when it detects that at a point B, errors on the sent timestamp are often observed, or that the data read from the bar code include often errors (for example due to a slight tear in the label bearing this code), which may mean that a local traffic network is operating at point B, even if no alert is generated there.

[0107] A blockchain mechanism may also be provided to ensure the inviolability of the data uploaded by the successive optical reading means on a path consisting of several sections from point A to point B, then from point B to point C, etc., the blockchain and its consistency being verified by the aforementioned server.

[0108] Thus, the present description proposes an integrated tool for both traceability and authentication, allowing the formal identification of a batch, the collection and recording of data from its journey, and its restitution on demand.

[0109] [Fig.5] illustrates a system for implementing the above method and typically comprising the SER verification server and at least one TER terminal (or several terminals, in practice, at the end of each section of a parcel's journey, which is illustrated by the ellipses on the left of [Fig.5]).

[0110] The TER terminal may be in the form of a smartphone, a tablet, or other, and may typically include an optical reading means LO (for example a smartphone camera) cooperating with a processor PROC1 to read the label data received in the parcels. The processor PROC1 may itself cooperate with: - a memory MEM1 storing in particular instruction data of a computer program of an application of the type defined above, - a PR printing interface, to control a printer capable of printing labels containing a single-use code, and - a C0M1 communication interface connected to the SER server by a RES communication network.

[0111] Alternatively to an embodiment in the form of a smartphone, the TER terminal may include a connected computer, and a barcode scanner (for example an infrared or “shower” scanner) connected to the computer.

[0112] The server SER may itself comprise a processor PROC2 cooperating with a communication interface COM2 connected to the network RS, as well as with a memory MEM2 storing a computer program of the type presented above, in particular for the verification of the single-use codes received from the terminals and for the generation of new single-use codes for future sections of the route.

Claims

1. Claims 1. Method implemented by computer means, for verifying a delivery of a package of boxes of medicines, the package being transported to a dispensing point along a route comprising successive sections, the package being repackaged after each section traveled, Characterized in that the repackaging includes at least: - a verification of a first label affixed to the package and including a first single-use code, assigned for the package and for the section traveled, and - a supply of a second label to be affixed to the package and comprising a second single-use code, different from the first code, and allocated for the package and for the future section to be traveled, And in that the method comprises at least: - store the first code on a server, - upon receipt of data from the first code from a terminal, check with the server that the first code has been previously stored and has not been received previously, * if the verification is positive, generate, save with the server and send to said terminal data of the second code, with a view to using the second code for repackaging the package, * if the verification is negative, generate an alert, wherein the first and second labels respectively comprise first and second barcodes, and wherein the terminal executes an application to: - perform an optical reading of the first bar code by the terminal, and - transmit data from the optical reading of the first barcode to the server, wherein the first and second barcodes comprise at least respective data of expected delivery timestamps of the package for repackaging, and in which the server, upon receipt of the data from the first barcode, checks consistency between: - a current timestamp, and - a timestamp from the optical reading of the first barcode.

2. 2. Method according to claim 1, in which the terminal executes an application to: - transmit data from the first code to the server, and - upon receipt of the data from the second code, edit an order to print the second label comprising the second code and to be affixed to the package for its repackaging.

3. 3. Method according to one of the preceding claims, in which the first and second labels comprise an opaque coating to be scratched to reveal the first and second codes respectively, and in which the terminal executes an application to: - animate a human-machine interface of the terminal allowing a user to enter the first code after scratching the first label, and - transmit to the server data resulting from the entry of the first code by the user.

4. 4. Method according to one of the preceding claims, in which the first and second barcodes comprise at least data of respective, presumed, delivery locations of the package for repackaging, in which the execution of the application at the terminal causes: - a recovery of current location data of the terminal, and - a transmission to the server of said current location data, with the data resulting from the optical reading of the first barcode, and in which the server verifies consistency between: - the current location data of the terminal, and - the data of the presumed delivery location of the package, resulting from the optical reading of the first barcode.

5. 5. Method according to one of the preceding claims, in which the package comprises a plurality of boxes of medicines, each comprising a bar code specific to each box, in which the terminal executes an application for: - carry out an optical reading by the terminal of each bar code of each box, and - transmit to the server data resulting from the optical reading of each bar code of each box, and in which the server stores data specific to each box of medicines and verifies the validity of said data received and resulting from the optical reading of each bar code of each box.

6. 6. Method according to one of the preceding claims, in which, the package being packaged in a cardboard packaging comprising at least two adjacent panels, the first and second labels are self-adhesive, and configured to be affixed to the two panels of the cardboard.

7. 7. Method according to claim 6, in which a hologram sticker is further provided to be affixed to the two sides of the cardboard.

8. 8. Method according to one of the preceding claims, in which the first and second single-use codes are functions of respective data from a blockchain verified by the server.

9. 9. Method according to one of the preceding claims, implementing an artificial intelligence programmed to learn, in a learning phase, situations relating to alert generations, and to detect, in a current use phase, situations with anomalies.

10. 10. System comprising: - a server configured to implement the steps of the method according to one of the preceding claims, when said steps involve a server, and - at least one terminal configured to implement the steps of the method according to one of the preceding claims, when said steps involve a terminal.

11.

12.

13. 11. Server of a system according to claim 10.

12. Terminal of a system according to claim 10.

13. Computer program comprising instructions for implementing the method according to one of claims 1 to 9, when executed by a processor.