Horizon 2020: PharmaLedger In-depth Ethical and Legal Study

January 25, 2022

An in-depth ethical and legal study was prepared as a guide to assist the developers of PharmaLedger to ensure the platform and its solutions meet all of the General Data Protection Regulation (GDPR)’s ethical and legal requirements.

PharmaLedger is a project sponsored by both the European Federation of Pharma Industries and Associations (EFPIA) and the Innovative Medicines Initiative (IMI). As a grantee of the Horizon 2020 programme which funds projects focused on innovation, the goal of PharmaLedger is to create a more trusted healthcare ecosystem through the creation of a blockchain-enabled platform.

One of the intentions of the three-year project is to give individual patients, as well as organisations, control over and access to their personal and confidential health data. However, the implementation of blockchain technologies into highly regulated industries such as healthcare tends to move slowly largely due to legal and regulatory uncertainty surrounding compliance with existing legislation.

A document was put together to assist those working on the project, the “PharmaLedger In-depth ethical and legal study.” This was prepared as a guide to assist the developers of PharmaLedger to ensure the platform and its solutions meet all of the General Data Protection Regulation (GDPR)’s ethical and legal requirements. You can download the document below.

About the PharmaLedger In-Depth Ethical and Legal Study

The in-depth ethical and legal study addresses in detail EU legislation, as well as case law and doctrine concerns that pertain to blockchain technology. Additionally, it provides legal and ethical implications of the blockchain-based medical industry solutions our PharmaLedger project wants to create.

The study is intended to provide a thorough analysis (from both an ethical and legal standpoint) of the domains PharmaLedger is targeting with its solutions: healthcare data, clinical trials, and pharmaceutical supply chains. Based on the individual requirements and concerns of each specific domain, there are recommendations for implementing the design of the PharmaLedger project.

The first section of the document pertains to data and privacy protection. Due to the majority of currently existing laws and regulations being created for centralised data systems and the decentralised nature of our PharmaLedger platform, certain concepts are examined, such as responsibility for legal compliance. Among other common concerns covered are the append-only characteristics of blockchain platforms. In the section on clinical trials, the document examines whether regulatory standards, ethical standards and informed patient consent can be properly secured through novel technologies.

The final section of the document focuses on the ethical and legal challenges within the pharmaceutical supply chain. For example, given the scope of the industry and the number of parties involved within the supply chain of healthcare medications, the viability of supply chain transparency is explored.

Purpose of PharmaLedger In-depth Ethical and Legal Study

While this study is meant to assist the developers of our PharmaLedger project in achieving legal and ethical compliance with the GDPR requirements, it is not intended to provide legal advice. Modifications of this document may be necessary in the future to adapt to any changes and improvements made within industry practices, standards, and regulations, as well as technical infrastructures. Through our PharmaLedger project, we hope to positively impact the healthcare ecosystem and all stakeholders involved by creating more trust with our blockchain-based platform.