Horizon 2020: PharmaLedger Ethical and Legal Inventory

April 7, 2022

Legal and ethical requirements are explained with recommendations in PharmaLedger’s Ethical and Legal Inventory document.

PharmaLedger is a three-year 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 focusing on innovation, PharmaLedger’s objective is to create a widely trusted blockchain-based platform within the healthcare industry.

Due to the highly regulated nature of the healthcare industry, it is PharmaLedger’s responsibility to ensure the platform is in compliance with all mandatory laws and regulations. The Ethical and Legal Inventory document was created to assist the project and our partners to understand and meet the applicable legal and ethical requirements. You can read and download the full report below.

Privacy and Data Protection

In order to build a platform that is beneficial to the entire healthcare ecosystem, legal and ethical challenges must be addressed as early as possible. Therefore, another purpose of the inventory document is to raise awareness on critical regulatory matters such as privacy and data security.

The three main areas of focus within the inventory are as follows: privacy and data protection, clinical trials and the pharmaceutical supply chain. High-level guidance on the ethics, laws and regulations that pertain to confidentiality, drug development, manufacturing and distribution are also discussed. Aside from the legal framework, the privacy and data protection section details topics such as principles for protecting data, rights of data subjects and differentiating data types.

As long as individuals can be identified by their data, compliance with the General Data Protection Regulation (GDPR) is required. However, identifying the controller and processor of data in a blockchain-based platform relies on the governance model being used. While the specific governance model and technical architecture of our platform are still being developed, it is important to establish these components before we classify which party will be a data controller, joint controller, processor, etc.

Clinical Trials

The clinical trials section of the document begins by outlining the ethical conditions that must be met before trials may begin. Stakeholders legally authorised to access trial data, transparency guidelines, guidance on protecting patients and informed consent are also highlighted. While some of the principles mentioned in this section are not directly applicable to the PharmaLedger platform since it’s still in development, the chapter does include a summary of aspects applicable to the potential use of the platform in clinical trials in the future. This will prepare PharmaLedger for future scenarios where such studies are performed.

Pharmaceutics Supply Chain

After exploring a summary of key regulations relevant to the pharmaceutical supply chain, the next chapter then provides an overview of how medicines enter the European market. Additional information included within this section relates to ensuring patient safety throughout specific manufacturing and distribution practices, packaging regulations, labelling requirements and mandatory safety features. The conclusion provides simplified explanations of reporting falsified medicines and detecting supply shortages.

While healthcare industry regulations maintain the safety of its participants, the number of laws requiring compliance can also create challenges concerning the integration and adoption of emerging technologies. A thorough understanding of all legal and ethical responsibilities is critical during the design stage of any new platform. This ethical and legal inventory document ensures PharmaLedger is designed in compliance with all necessary healthcare regulations.