BUILDING A DIGITAL TRUST ECOSYSTEM
FOR HEALTHCARE

A venue for collaboration where ideas become digital healthcare solutions.

ABOUT PLA

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

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innovation

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.
Watch our ePI demo.

Electronic Product Information is just the beginning. Future solutions built on the PharmaLedger Network will expand functionality to include adherence reminders, adverse event reporting and links with other health apps.

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
Adherence Reminders
Adverse Event Reporting
Link with other Health Apps
Multi-Language
Video Electronic Product Information
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Membership & benefits

Want to bring digital healthcare solutions to life? Join the PharmaLedger Association.

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got questions?

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.

pharmaledger association

What is the PharmaLedger Association?

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 an attractive, feasible and smart strategic investment for the long term.
The immediate (2023) goal is to launch a blockchain-enabled product, the electronic Product Information (ePI) solution. It must 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 the PLA purpose to improve healthcare.

What is the vision of the PharmaLedger Association?

A vision for 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.
What’s a DTE?

How is the PharmaLedger Association different from the PharmaLedger project?

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.

What are the core values of PLA?

The core values of PLA have guided PharmaLedger from the very beginning:

What exactly is PLA's role?

PLA performs the following functions to support its purpose:
Quality Compliance
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.
Privacy Compliance
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).
Product Ownership
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.

How does PLA support innovation?

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.

What is the geographical reach of PLA?

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

What is a Digital Trust Ecosystem DTE in healthcare?

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.

Is PLA a blockchain network?

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.

What does it mean to operate a node on the PharmaLedger Network?

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.

How is data privacy ensured to PLA members and product end users?

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.

Membership

Who should be a member of PLA?

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
Academia
Standards Organizations
Nonprofits
Patient Organizations
Healthcare Technology Experts

Do I have to be part of a company or organization to join PLA?

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.

What are the different levels of membership?

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

How do I become a member of PLA?

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.

What is the cost of joining PLA?

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.

How much effort do I need to put in once I become a member?

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.

How do different stakeholders participate in PLA?

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. .

How can I influence the direction of PLA investments?

All PLA members can contribute to the strategic direction of the 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.

What are some of the advantages of being part of PLA?

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

What happens after I become a member of PLA?

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 the PLA staff.

Funding

How is PLA funded?

PLA is funded through:
membership fees
donations, gifts, legacies, and grants of all kinds
contributions and subsidies from public institutions
income from service agreements

Who provides funding for the projects submitted to PLA?

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

Where does my membership fee go?

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.)

Organizational Structure

Who leads PLA and how are decisions made?

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.

What legal form does PLA have?

PLA is a not-for-profit Swiss Association, based in Basel, Switzerland, where it is registered as such in the commercial registry. A Swiss Association is a standard and straightforward way to create an organization with a purpose and members. Basel is a hub for the Life Science sector and home to over 700 companies with connections to healthcare.

How is privacy addressed in PLA?

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.

Projects and Innovation

How do projects turn into products?

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.

How can I bring my idea, project or product to PLA?

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.

What is the PLA xLab?

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.

Products

What are we working on?

Learn more about our use cases on our YouTube channel.

What's the first PLA product?

Electronic Product Information (ePI) is the most mature use case in the PharmaLedger project and was selected as the “go-to-market” product for productive launch in 2023. ePI provides the patient or user with the latest approved version of the Product Information, 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 original manufacturer of the product. The latest approved version of the Product Information is then provided to the user by the manufacturer.
The barcode on the product also provides additional information such as expiry and serial number. These can also be checked to verify the product.
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 information. The product owner will not have any scan information to identify the user in any way, as this is private information.
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
Adherence reminders created with a link to the prescription
Disposal of excess medicine instructions based on the expiry date
Adverse event reporting
Adding specific medicine information to the electronic health record (EHR)
And many more to come!

Join PharmaLedger and help bring digital healthcare solutions to the hands of patients and healthcare professionals around the globe.

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