BUILDING A DIGITAL TRUST ECOSYSTEM
A venue for collaboration where ideas become digital healthcare solutions.
The evolution of the PharmaLedger Project
What we do
The Pharmaledger Association (PLA) provides an open-source platform as a standard framework to help support collaborative innovation in a healthcare Digital Trust Ecosystem (DTE). PLA’s digital healthcare solutions are built not to replace but to connect, by putting patients first and creating added value for all ecosystem members involved. PLA provides governance, compliance and operational oversight of the platform and products in order to enhance, scale and ensure future sustainability. Read our vision.
Who we are
We are a global not-for-profit association founded in March 2022 in Basel, Switzerland as a result of the PharmaLedger Project, a 3-year Innovative Medicines Initiative consortium project that brought together 12 global pharmaceutical companies and 17 public and private entities; including technical, legal, academia, research and patient representative organizations.
What's in it for you
Are you interested in realizing innovative projects and products that strengthen today’s Digital Trust Ecosystem within healthcare? Does your organization work within the Healthcare or Life Science sectors?
The PharmaLedger Association provides:
- an opportunity to accelerate digital innovation and learning in your organization
- access to qualified and compliant solutions
- the mechanism to pool risk and resources with like-minded partners
- the ability to contribute to overall strategy, including prioritization of projects and products
- access to a diverse team of small, medium and large organizations working toward a common goal to solve big problems that can’t be solved alone
From Projects to Products
The PharmaLedger Association is a venue for collaboration where members can facilitate innovation by helping to incubate, develop and launch products that improve the patient experience and benefit all healthcare stakeholders.
The PharmaLedger Network enables our first product to go live: a convenient, secure, precise and trusted Electronic Product Information (EPI) solution that allows anyone with a mobile phone to scan a medical box and receive important product information, offering a searchable, sustainable and secure alternative to paper leaflets that can be updated for accuracy in real time. All PLA members that print medical product leaflets can take advantage of this solution.
By becoming a member of PLA, you can directly participate in guiding our strategic direction to develop these functionalities and more.
Electronic Product Information
Detecting Falsified Medicines
Adverse Event Reporting
Link with other Health Apps
Video Electronic Product Information
Membership & benefits
Want to bring digital healthcare solutions to life? Join the PharmaLedger Association.
We have collected the main questions you might have regarding the PharmaLedger Association, including how membership can benefit your organization and how together we can bring healthcare solutions to patients and providers.
The PharmaLedger Association (PLA) is a not-for-profit association based in Switzerland with the purpose to enable and foster a Digital Trust Ecosystem (DTE) in healthcare through a standardized and trusted open-source platform and the engagement of diverse healthcare stakeholders.
PLA promotes collaboration and accelerates innovation and adoption to achieve mutual benefits in the healthcare and life science domains for patients and other stakeholders.
PLA was formed to continue the work of the Pharmaledger project. The consortium of 29 entities endorsed a strategy in 2022 to provide a sustainable governance, compliance and operating model for the platform and products designed and developed throughout the project. PLA will leverage a similar organizational and governance structure developed and proven in the project, which includes pharma manufacturers, academia, healthcare providers, patient representative organizations and technology providers.
PLA is open to new members from all healthcare ecosystem backgrounds, and strives to make engagement in PLA possible for the widest possible stakeholder network. Its aim is to be a smart strategic investment for the near and long term.
The immediate (2023) goal is to launch a blockchain-enabled product, the electronic Product Information (ePI) solution. It will establish a strong member community to jointly define the strategy and roadmap for additional products, such as Detecting Falsified Medicines, Finished Goods Traceability and clinical trial solutions in the future. Members can propose, sponsor and engage in other solutions that contribute to PLA’s vision to improve healthcare.
Our vision is that ParmaLedger will be a preferred way to connect, protect, empower, build and sustain digital healthcare in the future.
It will achieve this with a neutral, trusted, shared infrastructure for secure data exchange in healthcare – it takes an ecosystem!
Central to the problems of waste, inefficiency and fraud in healthcare is a lack of a trusted, interoperable, shared infrastructure to enable the movement of data between authorized partners in the value-chain. We aim to create a neutral, shared infrastructure, operated as a not-for-profit network to the mutual benefit of pharmaceutical and healthcare value-chain members. Once established, this network could support multiple use cases spanning the life cycle of pharmaceutical development, manufacturing, distribution, and consumption. The goal of the network would be to take on the problems that can’t be solved by one company alone – the problems that require an ecosystem-wide response. A sample of the real business challenges this network would address include:
A differentiator for this vision is that it takes a “whole ecosystem” approach to solving problems. Today, companies frequently approach these problems from their own vantage point – producing a result which doesn’t actually solve the problem from a customer or patient perspective. A patient doesn’t want to authenticate one company’s medicines, they want to authenticate any medicine they are prescribed. A clinical site doesn’t want to better track investigational products for one research sponsor, they want a better solution for all the sponsors they work with. Only problems that would benefit from this “whole ecosystem” approach will be undertaken by PLA. Solutions intended to solely provide differentiation or competitive advantage for one party would be out of scope for PLA.
The PharmaLedger project was a joint research initiative funded by the EU Commission and European Federation of Pharmaceutical Industries and Associations (EFPIA) members. It was a 3-year project that started in January 2020 and ends in December 2022. In addition to proving the value of blockchain-enabled solutions in supply chain, clinical trials and health data, a key project deliverable was to ensure sustainability and impact of the project results. For this, the project endorsed the creation of a new legal entity, the PharmaLedger Association (PLA).
PLA is a legal entity, based in Switzerland, created to oversee the governance, compliance and operation of products developed in the project. Beyond inheriting all use cases worked on by the project, PLA opens up the collaborative model to include all stakeholders in the healthcare ecosystem. PLA’s goal is to work alongside diverse stakeholders to solve problems that can’t be solved by any one organization or service provider alone. Healthcare’s biggest challenges require a collaborative, joint approach and solution. PLA makes this possible.
The core values of PLA have guided PharmaLedger from the very beginning:
PLA performs the following functions to support its purpose:
PLA products are subject to current regulations such as 21CFR11, EU Annex 11 and 21CFR820, requiring the entity to have the ability to maintain and operate a Quality Management System based on ISO9001 with additional controls based on pharmaceutical regulations.
PLA may act in the capacity of a GDPR controller and/or processor depending on the product implementation.
Technical Design, Operation & Oversight
PLA designs, develops, and operates solutions, infrastructure and supporting services (e.g., identity management).
PLA ensures governance through business Product Owners who rely on Subject Matter Experts from the membership to provide direction to the evolution of products and solutions.
Incubation of New Ideas
PLA identifies new projects or areas of research, leveraging membership to guide concept development, demonstration, testing, qualification and launch of new solutions to the market.
Marketing & Membership Management
PLA promotes its activities and benefits, attracting new members, sponsors, partners and contributors.
Contracting & Administration
PLA serves as the entity which can transact on its members’ behalf – contracting with suppliers, paying invoices, collecting membership fees, etc.
PLA supports continuous innovation through research, ideation, evaluation, development, prototyping, incubation and dissemination. This is done through the innovation lab (xLab) or through engagement with like-minded partners. A portion of the membership fees is dedicated toward research and innovation activities. With the xLab, PLA aims to continue the innovation journey started with the PharmaLedger project, and invites individuals and organizations to engage in the digital transformation journey.
PLA differentiates innovation from productization through Technology Readiness Levels (TRLs), a standard approach for assessing the maturity of solutions. Initiatives that are ideas, Proofs of Concept and Value, or demonstrators are referred to as innovation projects. Projects that are promoted to qualification for productive use are referred to as products.
While the original PharmaLedger project was EU-funded and organized, the products are designed to scale globally. The healthcare ecosystem has worldwide reach, and many ecosystem members are global actors. Thus there is no geographic limit to PLA, and all healthcare ecosystem partners are invited to join.
PLA projects and products are designed to address bigger healthcare problems that exist across any geographical boundary. Many LMIC (Low to Medium Income Countries) have pressing issues such as falsified medicines or system fragmentation that need to be addressed by collaborative solutions. PLA seeks to fulfill this and other ecosystem-wide needs.
Technology/Digital Trust Ecosystem
A DTE is an interdependent group of actors (enterprises, people, things) sharing standardized digital platforms to achieve a mutually beneficial purpose, underpinned with cryptographic trust (i.e., blockchain). While the original aim of PharmaLedger was to create “Blockchain Enabled Healthcare” solutions, the true aim is not primarily technology-driven, but rather creating value for mutual benefit among all stakeholders involved, especially patients. Thus a healthcare DTE is the external framework of how PLA works.
Yes and no. For members who will conduct transactions on a common or interoperable digital network, PLA provides products that enable such transactions. For members who do not directly access the network, PLA provides the venue to propose, sponsor, influence, design, vote and govern solutions that will impact their health or the health of their own stakeholders and members. But members do not need to be active network users to engage in PLA.
A node is simply an operational instance on the PharmaLedger Network that maintains a current copy of the blockchain. It is usually a server running on the owner’s premises, or it could be hosted by a service provider. The more nodes operated by independent actors, the more resilience and trust in the network and data integrity for all. Nodes are core to the concept of decentralization and ensure that no single node owner has control over the network. Node operation increases the resilience and availability of the network and builds trust in the integrity of the data. Participants on the network need to define (governance) node usage agreements to ensure operational aspects such as timely updates and proper cybersecurity protection.
PLA inherits from the PharmaLedger project a principle which guided all developments during the project time: “Privacy by design.” PLA does not compromise on data privacy for its rightful users and data owners. Through the design of its platform and products PLA protects its members and users by applying a self-sovereign data flow architecture, which provides people and companies the control over their owned data.
It is well known that Bitcoin mining consumes more energy than many countries. The result is the release of megatons of carbon dioxide into the atmosphere every year. Bitcoin is a public blockchain that uses a “Proof of Work” consensus mechanism, meaning that miners have to apply a lot of computing power to mint new Bitcoins.
PharmaLedger uses a different consensus mechanism that doesn’t require any more energy than a standard transaction on a server (like the energy used for you to access this web page). There is no “mining operation” as the participants on the network are already authorized to create new transactions that are simply confirmed by other nodes on the network. This ensures that the solutions are sustainable.
Basically any organization with a vested interest (business or otherwise) in healthcare should be a member. This includes:
- Pharmaceutical Manufacturers
- Distributors and Wholesalers
- Service Providers
- Healthcare Providers
- Healthcare Organizations
- Standards Organizations
- Patient Organizations
- Healthcare Technology Experts
Yes, PLA membership is limited to registered entities, not individuals. PLA membership fees are structured for all types of entities, so there is no barrier to join. Individuals can also register and engage with PLA as contributors in the xLab without paying any fees.
Members are defined by class:
- Standard members, represented by up to five seats on the Board of Directors
- Not-for-profit or public organizations including NGOs, represented by two seats on the board
- Patient Organizations, represented by two seats on the board
- PLA Patrons, with a guaranteed board seat
Submit your interest through the form on the PLA website. After evaluation, membership admission requires completion of a Membership Agreement. Upon conclusion of a simple membership agreement, each member may choose to adopt specific PLA products, run nodes, take part in new developments, etc.
Costs (membership fees) are outlined in the membership materials available by clicking “Learn More” in the Membership Section at pharmaledger.org, or by submitting a Membership Form and speaking to a PLA representative. There are no costs for patient representative organizations, not-for-profits or public institutions. Standard Members pay an annual membership fee based on the number of employees in their enterprise. PLA Patrons pay a fixed fee that entitles them to a seat on the Board of Directors.
This depends. Membership requires no additional efforts. If all that is requested is access to the network and qualification documentation, the effort is minimal. This does not take into account the effort required to implement a solution in one’s own organization, which is likely organized as an internal project. The estimated internal adoption cost of ePI or other PLA products by organizations will be shared with prospective members during the membership enrollment process.
It is important to state however, that PLA will not succeed in the long term without actively engaged members who contribute to the discussion, ideation, development, demonstration, testing, qualification and validation of its products.
PLA is what its members want and what its members do. Thus if your organization supports and contributes to a specific project or product, the effort (as with any new project) can require an investment of internal resources.
Why should you invest additional resources? The answer is so you can lead, influence, learn, and be an early adopter of solutions that bring value to your organization. Whatever the case, PLA will only prioritize initiatives (projects or products) that have a sustainable business case and/or value proposition to its members.
This depends on your role in healthcare, availability of resources, and priorities. Members can engage through simple newsletter updates and the annual General Assembly. Or members can lead and drive the definition and development of new projects. Members can also engage externally with other healthcare stakeholders or peers. .
All PLA members can contribute to the strategic direction of PLA through membership. All members are invited to provide input to the strategic direction in the annual PLA strategic planning process. Board members also provide input, as well as, review and approve the strategy.
Membership in PLA allows you to:
- Be an active part of the creation of the modern healthcare experience and of a global utility network for the industry to collaborate in true digital transformation
- Accelerate digital innovation and learning in your organization
- Receive qualified and fully tested solutions
- Pool resources and risk with like-minded partners to realize increased benefits
- Add your voice and expertise to digital healthcare development
- Benefit from collaborating with small and large organizations
- Share ideas of good solutions and let PLA fund development
- Promote your existing solutions within the PLA network
- Contribute with open-source development and find healthcare partners to work on innovative projects
- Make decisions on the prioritization of our solution pipeline
- Operate a node on the PLA network to strengthen trust and resiliency in healthcare
Once the Member Agreement is signed, your organization will be invoiced for the membership fee. You will also receive information concerning the process to be selected for a Board of Directors seat and instructions on gaining access to product solutions (requires a separate Network Usage Agreement – no costs involved). The timing and invitation for the annual General Assembly meeting will be sent as early as possible to ensure a representative can attend. If applicable, you will be informed how to access the demo environment, get involved in the xLab, and set up a node. PLA will send regular newsletter updates to its members and a dedicated email will be provided for feedback and inquiries to PLA staff.
PLA is funded through:
- membership fees
- donations, gifts, legacies, and grants of all kinds
- contributions and subsidies from public institutions
- income from service agreements
- Projects are funded by the annual budget proposed by the Board and approved by the General Assembly (a minimum of 5% of gross membership fees is allocated as defined in the bylaws).
- Direct sponsorship is also possible if an organization wants to accelerate realization of a project and has resources available.
- Funding allocations in the xLab can take the form of a “seed grant” or an RFP (Request for Proposal) process, depending on the size of the initiative
The PLA budget includes cost items for:
- Product qualification and launch
- Product quality and privacy compliance
- Technical design, operation and oversight
- Continuous innovation investments and incubation for projects
- Marketing and membership management
- Secretariat and administration
- Professional services (legal, accounting, etc.)
On a strategic level, PLA is lead by the Board of Directors. On an operational level, PLA is led by our Executive Director and a small team of SME Officers. Directors and Officers are either confirmed or hired by the General Assembly or Board of Directors. The principle of “Ecosystem Led” means that everyone in the organization has a say on who is appointed to the leadership.
Decisions are made at all levels:
- Changes to the association bylaws and membership fees are made by the General Assembly.
- Strategic decisions and the budget approval are made by the Board of Directors. Strategic decisions define or impact the direction of the association, its funding allocations, its changes in policies, etc.
- Decisions are also made by the specific project or product teams within their realm of competence.
Compliance with European (GDPR) and other national privacy regulations are a core function of PLA and are managed through a comprehensive data privacy management system and framework.
The board is responsible for oversight, including strategic planning and voting on the proposed PLA budget. Operational responsibilities lie with PLA staff or with the individual product and project teams. A comprehensive Conflict of Interest (CoI) policy ensures that any director or officer discloses potential Conflicts of Interest and is excluded from voting on any matter in which they have a material and direct financial interest. The use of PLA products does not represent a Conflict of Interest due to the non-commercial nature of PLA and the open-source nature of the software platforms. PLA currently does not offer any contractual services to member companies, but rather coordinates and facilitates the software development and network governance of the ecosystem.
The board may decide, by vote, to accept additional liability risk to the association (e.g., running an operational validator node as part of the network). Any such decisions will be accompanied by a “Board Paper” which will outline the PLA staff’s position on the matter and outline associated risks and opportunities. It is intended that these board papers will also allow board members to consult with their internal counsel prior to voting. PLA has applied for D&O insurance to cover respective risks of board members. Currently, PLA does not intend to seek any debt financing and does not intend to run a debt-based budget process.
PLA products are open-source solutions that have undergone a rigorous testing and release process. By agreeing to use PLA products in a separate Network Usage Agreement and through their own internal system validation processes, members confirm the fit for use and agree to accept solutions based on the product release notes and the assurance of the system validation documentation that accompanies each release.
Projects and Innovation
New products should be defined (and resourced) as part of the PLA strategy, so the first check is to ensure a project is on the agreed roadmap. PLA uses “TRLs” or Technology Readiness Levels to determine the maturity of its projects and products. Innovation projects are generally TRL1-5, while products are TRL 6-9.
PLA will have a formally defined process available in early 2023. An xLab lead will accept, evaluate, and consolidate research and project requests. They may request additional information, especially if there is documentation available or a prototype. When a project proposal is in line with the PLA Strategy, then it can immediately start to be developed. If the idea is new and not part of the strategy, it may require to be either included in the strategy or submitted for exceptional approval.
Products that are mature enough to be qualified must also be a part of the strategy or be separately approved in order to ensure compliance with antitrust policies.
Technology Readiness Levels are a commonly accepted measure of technical maturity for solutions and are adopted by PLA as follows:
TRL1 – basic principles observed
TRL2 – technology concept formulated
TRL3 – experimental proof of concept
TRL4 – technology validated in lab
TRL5 – technology validated in relevant environment
TRL6 – technology demonstrated in relevant environment
TRL7 – system prototype demonstration in operational environment
TRL8 – system complete and qualified
TRL9 – actual system proven in operational environment
The xLab is the innovation arm of PLA. The xLab allows PLA to incubate and develop prototypes and demonstrators, and to evaluate technical feasibility, risks, and potential benefits of new innovation projects. The xLab is open to individuals and provides funding.
What We Are Working On
Stakeholders want ePI. ePI enjoys widespread support from key ecosystem stakeholders including patients, HCPs (Health Care Providers), pharmacists, health authorities & governments, as well as industry. In short, stakeholders want ePI!
Creating Digital Value for patients. Our aspiration is to build a solution for patients that is valued by patients. Patients and HCPs have been involved in development and proof-of-concept testing of PLA’s product, with positive opinion received. The PLA product seeks to address the complex challenges in the ecosystem to make ePI a reality. We think by providing a better Product Information experience and providing utility through enhanced safety and security, we can catalyze the move to digital. It’s taking a step toward digitally-enabled healthcare in the future.
Meet unmet need. In the 3-year period of the Pharmaledger Project (Jan 2020 to Dec 2022), markets initiating ePI pilots quadrupled, currently at 47 markets world-wide! International healthcare companies have an unmet need. PLA aims to meet this unprecedented demand with a solution which supports scale, avoiding the complexity of developing and operating multiple national solutions.
With healthcare companies each marketing several thousand finished good SKUs in these markets, complexity and cost of implementing ePI mounts significantly as more markets pilot ePI, then seek to scale. The current path of market-specific solutions is not ideal.
This is particularly important where shared packs are used – a package which is exactly the same but supplied to multiple markets. A common ePI solution is needed across all the shared markets using the shared pack, else the shared pack would need to be broken. To maintain the benefits of shared packs – like reducing shortages, reducing discards, and opening up access to products – simplifying to common standards supports both ePI and Shared Packs.
PLA’s ePI product provides the patient or HCP with the latest approved version of the Product Information direct from the marketing authorization holder (MAH). In the paper leaflet world today, the MAH is responsible for the correct leaflet in the carton. We propose to keep this accountability, but electronically, avoiding the need (and costs) for an intermediary to manage it centrally.
When ePI’s are updated in the MAH Systems of Record, the latest leaflet is pushed to the solution so the user always gets the latest ePI.
The ePI is accessible through a scan of the barcode on the product package. The scan reads the “GTIN” or Global Trade Identification Number and the batch and uses blockchain as a resolver to determine the correct MAH of the product. The latest approved version of the Product Information is then provided to the user.
The barcode on the product can also provide additional information, such as the validity of the expiry date and serial number. These can also be checked to verify the product packaging.
An important aspect is that no patient or user information is captured. The patient’s use of the app to identify the product and access the information is private. The product owner will not have any scan information to identify the user in any way, as this is private.
In the future, the unique identification of the product offers a host of potential services to the patient, depending on user consent:
– Notification if the Product Information is updated
– Notification if the product batch is recalled
– Additional checks on the authenticity of the package (serial number, product status or even authentication features on the package)
– Drug interaction issues with other scanned medicines (in a virtual medicine cabinet)
– Adherence reminders created with a link to the prescription
– Proper disposal instructions of excess medicine based on the expiry date
– Adverse event reporting
– Adding specific medicine information to the patient’s electronic health record (EHR)
– Video media
– And many more to come!
Currently there is not a great deal of alignment among health authorities as to the best approach, nor within the industry, or sometimes even the same company! So what to do about it?
The current situation is that there are 47 markets experimenting with national solutions, all with different technology approaches. This adds complexity and cost to develop and operate. It also does not work with shared pack markets (different countries using a common pack). PLA offers a solution which seeks to leverage standards and a common approach to enable ePI at scale, globally. There is no other solution that offers this today. We are seeking collaboration to do this, as an industry and with patient engagement. If companies do not take a stand now, then they are going down the path of national pilots, with the added complexity, cost and scale-limitation that comes with it.
We accept that one standard for the world is not possible, and exceptions will happen. But we have a unique opportunity to standardize and optimize ahead of growth.
PLA members are invited to provide their input and leverage their experience in the evolving ePI world to develop the solution further, as standards emerge and legislation develops.
The solution is designed and built to quality assurance standards, to provide a compliant, reliable and trustworthy ePI – to the same high standards the healthcare industry has with the paper leaflets. This is an essential enabler for us to make the paradigm shift from paper as the ‘primary’ product information to electronic as the ‘primary’ and the ultimate replacement of paper inserts.
Other compliance requirements come into play when we transition to digital, including Privacy, Data Protection, Accessibility and Pharmacovigilance. We propose to solve for these once with one common solution and then implement it to multiple markets.
The ePI product from Pharmaledger is only one part of the end-to-end process a MAH (Marketing Authorization Holder) would need for compliant, scaleable ePI. PLA partners would also need to work to develop their internal business processes to ensure the ‘Right ePI’ for the ‘Right Product’ using the ‘Right Barcode’, at scale. Standards and a common approach support this.
The blockchain is only one ‘component’ of the PharmaLedger ePI solution. Like any technology solution, there is a technology stack: the platform, the middleware and the user app. The power of the solution is the combination of the stack technologies working together.
The blockchain acts as a ‘Connector’ and a ‘Resolver’ to match the ‘Right ePI’ to the ‘Right Barcode’ for the ‘Right Product’. It is the platform part of the technology stack.
The blockchain resolver is connected to a network of ‘Enterprise Wallets’. Each pharmaceutical company will have an Enterprise Wallet to store their ePI documents. This is manually managed in the first release, but designed to be fully automated and linked to the company back-end Systems of Record for scalability. This is the middleware.
The Patient or HCP will use the app to access the ePI. PharmaLedger has built one for the first release, but could easily be adapted to use a national app or 3rd party app by connecting it to the Enterprise Wallet.
The three parts of the Technology Stack, the Blockchain Resolver + Enterprise Wallet Network + App, work together to give the ‘Right ePI’ for the ‘Right Barcode’ for the ‘Right Product’.
As with any system, there is no perfect solution, or one without challenges. We propose a scalable solution which is country agnostic, privacy preserving, open to any manufacturer, without a single point of failure, uses standards, reduces complexity and gives value to the patient.
Approximately 90% of Rx packs by volume have serialization barcodes on the package. The Data Matrix barcode is the industry de facto standard (it exists today) and it uniquely identifies every pack down to batch and serial number. Can we use this barcode for ePI? The answer is yes!
The Data Matrix holds data which can provide ePI plus other valuable services to enhance safety, security and support digital health transformation.
Manufacturers already have invested in assets and quality control processes to ensure that the correct barcode is on the correct package, linked to master data. This is a valuable enabler for scaling. Ideally, we don’t want to add another one!
PLA uses the Data Matrix as the ‘digital key’ in our solution through an app which can read and resolve the Data Matrix barcode to the correct leaflet.
That is not to say QR codes do not have a role. QR codes have become very popular across the world for accessing a website. We offer a web app for users, which can be accessed using a QR code without the need to download an app from Google Play or the App Store. This lowers the barrier to accessibility while also taking the advantages of the serialization barcode.
The Pharmaledger App can also scan a wide variety of barcodes including EAN/UPC identifiers that could work for non-prescription pharmaceutical products in the future, which would benefit the patient.
The strategy, as with any new technology approach, is to build trust and convenience into the digital solution.
- The first step is to present the concept and demonstrate the functionality to key stakeholders. This has been done during the course of the project on several occasions.
- The next step is a productive pilot of the qualified solution in an operational environment. This proves that the solution works reliably as designed and is acceptable to the users in terms of functionality, performance and ease of use. Based on the feedback, the solution can be improved to address local requirements and user feedback.
- The last step is productive implementation, which could be phased by brands, geography, specific hospitals or pharmacies, or other criteria.
At all steps, there must be a campaign for general awareness and adoption. This is initially driven by PLA, and then jointly driven by PLA and health authorities. The goal in the end is that the doctor, who is the ultimate source of trust to patients, will confidently recommend the app to their patients.
When ePI is established as a stable, proven solution in one or more markets, adoption can be streamlined by jumping directly to Step 3, but the general awareness and information campaign is always required.
PharmaLedger relies on the GS1 DataMatrix as a data carrier to identify unique medicine products in its electronic Product Information (ePI) and Detecting Falsified Medicines solutions. Currently, identifying products and accessing product information by scanning the DataMatrix requires a special app, since the code is not yet recognized by the standard smartphone cameras which automatically recognize QR codes. Although QR codes are popular for convenience-oriented applications, we believe there are several reasons to support the broadest possible adoption of GS1 DataMatrix as the only barcode for medicinal product identification in healthcare:
- The GS1 DataMatrix is the recommended barcode for medicine identification and is mandated by regulation in most markets that require serialization and traceability, and for new markets which plan to implement such regulations.
- The GS1 DataMatrix must be present on the secondary pack in these markets. Adding an additional barcode can create confusion with patients and healthcare providers, at exactly the time when they require certainty about their medicine.
- The DataMatrix, containing the Global Trade Identification Number (GTIN), Batch, Serial Number, and expiry date, is designed to enable scanning even if damaged and provides the smallest artwork footprint on the package.
- We have examined security aspects in the Detecting Falsified Medicines use case and are convinced that the DataMatrix provides a higher level of security. Although both the QR and DataMatrix codes can easily be copied, we have successfully implemented additional checks in a demonstrator which increase user confidence in the product package authenticity. In addition to the serial number, these checks include validity of batch and expiry date, embedded security feature verification with the smartphone camera, and flagging of suspect product batches.
- The GS1 DataMatrix is a data carrier that can enable not only ePI and Detecting Falsified Medicines, but also many more future supply chain capabilities as depicted in the figure below.
In addition to new supply chain applications, we envision many digital services for patients made possible by a data carrier like the GS1 DataMatrix. These include recall notifications, adherence reminders, adverse event reporting, drug interaction alerts, and expired or excess drug disposal guidance. These services will increase patient safety and value, and help overcome the adoption challenge of a dedicated app requiring a download from an app store. PharmaLedger developed an open-source app for easy scan of DataMatrix barcodes with the help of patients who understand what’s possible using the data embedded in the barcode. Patients (and everyone) want to protect their privacy, and if a dedicated app can guarantee that in the future, then more education and awareness are required for broad adoption.
We refer to the GS1 Position Paper “The key role of GS1 DataMatrix barcodes for product identification in healthcare”, dated December 2021.
Patient engagement and empowerment are key themes of the PharmaLedger project. By achieving industry consensus on a single barcode, the GS1 DataMatrix, we can make a step forward toward achieving our overall objectives and benefiting patients.
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