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Ensuring Trust in Pharmaceutical Supply Chains by Data Protection by Design Approach to Blockchains
1KU Leuven Centre for IT & IP Law (CiTiP), Leuven, Belgium.
Abstract:
Pharmaceutical supply chains are complex structures that include various participants. Furthermore, blockchains are viewed as a promising solution to increase effectiveness and overcome some of the main challenges in these supply chains-especially lack of trust. The European Union (EU) set strict rules in the domain of pharmaceutical supply chains in order to protect patient safety and public health. In addition, blockchains bring legal requirements. Among these requirements, personal data protection is of utmost importance. This is because, as has been argued for years, blockchains and the EU data protection regime are in conflict by their natures. However, it is also claimed that when rightly designed and combined with other technological solutions, blockchains potentially offer great opportunities to enhance data protection. Nevertheless, potential for blockchains in the pharmaceutical supply chain is not yet been realized as most use cases are in the proof of concept or pilot stage. This article examines the debates surrounding blockchains and data protection. The goal is to draw constructive conclusions on whether blockchain solutions can be designed in data protection-enhancing ways and whether this might help realize the potential for blockchain in pharmaceutical supply chains-particularly by creating trust. For this purpose, the example of an ongoing EU-funded innovative research project called PharmaLedger as a case study to concretize its theoretical examinations is examined. This project is chosen because it gathers a wide variety of stakeholders representing different interests and aims to create a digital trust ecosystem in health care by providing a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions while accelerating the delivery of innovation that benefits the entire ecosystem from manufacturers to patients.
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