Counterfeit and substandard medicines remain a major global public health threat, with the World Health Organization estimating that up to 10% of medicines in low- and middle-income countries are falsified or substandard, exceeding 20% for some therapeutic classes in sub-Saharan Africa. Blockchain technology, with its decentralised, immutable, and transparent digital ledger architecture, has been proposed as a promising solution for strengthening pharmaceutical supply chain traceability, yet little is known about the readiness of community pharmacies in Nigeria to adopt it. This study assessed the knowledge, current practices, and implementation readiness of blockchain-based traceability for counterfeit medicine prevention among community pharmacists in Bayelsa State, Nigeria, and examined the barriers and enablers influencing adoption. A descriptive cross-sectional survey design was employed, using a structured, validated questionnaire administered electronically through the Association of Community Pharmacists of Nigeria (ACPN), Bayelsa State Chapter. A total of 119 valid responses were obtained, exceeding the minimum sample size derived from Yamane's and Cochran's formulae, representing a 79.3% response rate. Data were analysed using descriptive and inferential statistics, including Chi-square tests. Findings revealed that although 71.4% of respondents had heard of blockchain technology, mean knowledge scores across core blockchain concepts were uniformly low (1.26-1.72 on a 5-point scale), reflecting a substantial awareness-comprehension gap. Authentication practices were overwhelmingly manual, with 77.3% relying on visual inspection of NAFDAC numbers and only 9.2% using digital scanning; 68.9% of pharmacists had encountered suspected counterfeit medicines in the past year. Implementation readiness was below average (Mean = 2.70/5.0), driven by strong training willingness (Mean = 3.74) but deficient infrastructure (Mean = 1.80). Resistance to change and high cost were the leading barriers, while user-friendly applications and mandatory regulation were the strongest enablers. The study concludes that community pharmacies in Bayelsa State are not yet structurally ready for blockchain-based traceability, although a receptive attitudinal environment and strong professional motivation exist to support a phased transition. It is recommended that NAFDAC and the Pharmacists Council of Nigeria develop a phased regulatory framework and integrate blockchain literacy into continuing professional development, that government prioritise infrastructure investment, and that technology developers design mobile-first, user-friendly, offline-capable systems, to enable a coordinated transition toward blockchain-enabled pharmaceutical traceability in Nigeria.
Objectives: The authors explore how large pharmaceutical corporations may integrate emerging decentralized technologies-such as blockchain and decentralized autonomous organizations (DAOs)-within their merger, acquisition and partnership frameworks, and how these strategies intersect with broader innovation and external sourcing models. In this context, blockchain is considered primarily as an enabling infrastructure for decentralized governance and programmable coordination-supporting mechanisms such as tokenized incentives, auditable decision trails, and new forms of intellectual property (IP) and collaboration structures. Methods: This study employed a qualitative case study methodology, combining document analysis and semi-structured interviews with internal stakeholders from a leading large-cap pharmaceutical company (herein after "Company"). Participants included executives and professionals from corporate development, scientific research, external innovation, and digital strategy units.The analysis examined how a large-cap "Company" approaches mergers, acquisitions, and partnerships, and how emerging technologies may influence these frameworks. The study focused on strategy alignment, organisational attitudes towards decentralisation, integration constraints, and perceptions of innovation value along the external sourcing continuum. Results: Acquisition and innovation strategy by the "Company" is driven by long-term alignment between external opportunities and internal priorities. Over time, the "Company" increasingly turned to external sources of innovation, leveraging technologies to improve innovation scouting, target identification, and operational forecasting. While decentralisation technologies such as DAOs are viewed as promising for early-stage innovation and collaboration, their integration is hindered by legal ambiguity, internal governance rigidity, and unfamiliarity with token-based economics. The "Company" views mergers and acquisitions (M&As) and licensing as critical to sustaining its pipeline, and sees potential for emerging technologies to accelerate preclinical decision-making and improve visibility into academic and biotech ecosystems. Conclusions: This study contributes insights into how large-cap pharmaceutical firms might adapt their innovation models in response to technological change and external pressures. While established mechanisms such as M&A and partnerships remain dominant, digital and decentralized technologies offer complementary tools for scouting, collaboration, and portfolio expansion.
Switzerland’s healthcare system is complex, involving a regulated interplay among the federal, cantonal, and local governments. Swiss federalism classically gives power to the cantons, except in areas where the Constitution confers powers to the Confederation. In healthcare, the powers conferred to the Confederation are essentially of a legislative nature, and relate to the regulation of financing, quality and safety of medicines, certain areas of public health, as well as research and development [1]. Outpatient care is mainly provided by the private sector and is essentially based on a liberal system. Most healthcare professionals, including pharmacists, work independently in private care structures. This dynamic interplay between the public and private sectors, along with split responsibilities, significantly influences the system, resulting in a decentralized and fragmented healthcare framework [2]. This fragmentation extends to medicine reimbursement policies, which are regulated under the Federal Law on Compulsory Health Care (LAMal in French). Outpatient services are covered by the compulsory health insurance mandated for all residents of Switzerland, obtained from private health insurance providers [3]. The reimbursement and prices of prescribed medicines are strictly regulated by the Federal Office of Public Health (FOPH), which evaluates whether the medicinal product meets the criteria of effectiveness, appropriateness, and cost-effectiveness before including it on the “List of Pharmaceutical Specialties” (LS). Medicines are either reimbursed if included in the LS or not, with no partial reimbursement. Furthermore, reimbursement may be limited to specific conditions, e.g. based on the clinical situation or the patient’s characteristics. In principle, reimbursement is restricted to indications and conditions of use approved by Swissmedic, the Swiss agency for therapeutic products.
The pharmaceutical industry plays an important role in protecting community health by researching, developing and distributing drugs to prevent and cure illnesses. As an integral part of healthcare industry, it faces several challenges such as rising research and development costs, extended approval timelines, supply chain inefficiencies and low patient involvement. This paper examines role of decentralized autonomous organizations (DAOs) in addressing these challenges. It reviews DAO frameworks, decision-making models, reward mechanism, and roles of stakeholders using case studies such as VitaDAO and Molecule to explain their functioning and adoption of DAOs in pharmaceutical industry. DAOs offer a promising alternative to traditional hierarchical systems by promoting innovation and empowering stakeholders. To advance drug discovery and development, DAOs provide a shared platform for scientists, patients, funding agencies and regulatory authorities to work in a democratic and collaborative way to make decisions and manage operations in drug industry. Despite its several benefits, DAOs also face significant challenges, including regulatory uncertainty, data protection, and ensuring longterm sustainability. Future directions include integration of AI into pharmaceutical DAOs, privacy-enhanced DAOs, and cross-DAO cooperation to promote global collaboration across borders.
Substandard medicines in Nepal represent an under-documented yet critical threat to universal health coverage (UHC) and patient safety, disproportionately impacting marginalized communities. This opinion piece seeks to illuminate the prevalence, drivers, and far-reaching consequences of compromised pharmaceuticals, drawing on both local and global evidence. This paper offers pragmatic strategies to strengthen regulatory capacity and accountability by spotlighting ethical imperatives and systemic gaps. Bridging best practices from international frameworks with Nepal's unique context, I aim to catalyze policy discourse, cultivate public awareness, and spur multi-sectoral collaboration. Ultimately, the goal is to foster equitable and high-quality healthcare for all, reinforcing the moral imperative of safeguarding the integrity of Nepal's medicine supply.Substandard medicines are a pressing, under-recognized public health crisis in Nepal. Despite expanded healthcare access, compromised pharmaceuticals undermine patient well-being and public trust (1,2). The World Health Organization (WHO) estimates that at least one in ten medicines in low-and middle-income countries (LMICs) is substandard or falsified (3). In Africa, reports indicate up to 18.7% of sampled pharmaceuticals are compromised (4). This global issue is significantly influenced by two of the world's major suppliers of medicine, both domestically and internationally: India and China (5). According to estimates from India's Health Ministry, 5% of the nation's medicines are counterfeit and 0.3% are spurious, with one study suggesting that 75% of counterfeit medicines supplied globally originate in India (6). While recent, precise prevalence data for counterfeit drugs from China is not readily available, its role as a global manufacturing powerhouse is undisputed; for example, the country produces approximately 120 billion aspirin tablets annually for the North American market alone (7). A 2024 literature review highlights the historical scale of the issue, noting that 31% of the world's falsified and counterfeit medications are produced in China and Hong Kong (8). This geopolitical context is critically important for Nepal. The country's porous borders with these major pharmaceutical producers (9), combined with its own under-regulated supply chains, significantly heighten its susceptibility to the circulation of substandard drugs (10).A Nepal Health Research Council (NHRC) study found that 15.16% of 244 tested medicine batches failed pharmacopeial standards (11). Alarmingly, 62.16% of these were government-supplied. Compromised products included essential antibiotics, analgesics, and iron supplements, with failures in dissolution, assay, fill volume, and sterility. A 2010-2020 review of drug recall notices in Nepal revealed a surge in recalled products, most frequently antimicrobials (2). These findings indicate an ethical breach: public health facilities primarily serve the underprivileged, disproportionately imposing the burden of substandard medicines on them-a direct affront to the principle of justice (12). Patients, often unaware of compromised drug quality due to identical appearance, are denied meaningful informed consent. This erodes trust in the healthcare system and fuels antimicrobial resistance, a global health security threat with severe implications (3).Limited regulatory capacity exacerbates these dangers. In the Nepalese context, chronic under-resourcing of the Department of Drug Administration (DDA) and the National Medicines Laboratory hampers rapid testing and enforcement (13,14). Testing delays can extend for months, allowing compromised medications to circulate (15). While decentralizing drug procurement to local governments was intended to improve responsiveness, this policy has inadvertently weakened quality control due to a lack of local testing facilities and specialized personnel (14).Nepal's crisis of substandard medicines undermines human rights and core ethical principles.Tolerating this compromise of patient safety is incompatible with universal health coverage (UHC) (16). In Nepal, where a significant portion of the population relies on public health facilities for essential medicines, the prevalence of substandard drugs, especially in public health facilities (17), directly undermines the core tenets of UHC. Specifically, it violates the principle of access to quality healthcare: even if services are nominally affordable or free, receiving ineffective or harmful medication means that true, effective healthcare is not being delivered. Furthermore, the consequences of substandard medicines -prolonged illness, treatment failure, or adverse drug reactions -often lead to increased financial hardship for patients who may require further treatment, hospitalization, or experience loss of income due to illness. This directly contradicts the UHC goal of protecting people from financial risks associated with healthcare (18). This creates a two-tiered system, where those with resources can seek higher-quality care in the private sector, while the most vulnerable are left exposed to potentially dangerous treatments. Addressing this inequity and ensuring the integrity of the medicine supply is not just a matter of policy but a fundamental requirement for social justice. Success requires sustained political commitment, collaboration across sectors, and a steadfast focus on the public interest. Nepal must act decisively to eliminate substandard medicines and ensure equitable, high-quality healthcare for every citizen. This is not merely a matter of improving healthcare statistics; it is about upholding the fundamental dignity and rights of every citizen of Nepal.To address this crisis comprehensively, I argue that Nepal must move beyond isolated interventions and adopt a multi-pronged, systemic approach grounded in international best practices and adapted to the local context. The solution to the challenge of substandard medicines is complex, requiring a foundational shift from reactive detection to proactive prevention and quality assurance throughout the entire supply chain.First, the cornerstone of any effective strategy must be the robust implementation of a national quality assurance framework based on established WHO principles (19). This involves the mandatory adoption and enforcement of Good Manufacturing Practices (GMP) for domestic producers, ensuring that quality is built into products from the outset (20).Critically, this must be complemented by the nationwide implementation of Good Storage Practices (GSP) and Good Distribution Practices (GDP), which are presently lacking in Nepal (2). As detailed in WHO guidelines, this requires establishing a comprehensive Quality Management System that governs every stage of the supply chain, from procurement to delivery. This includes temperature-controlled storage and transport, proper documentation to ensure traceability, and rigorous training for all personnel involved (21,22). The goal is to create a secure, transparent, and controlled environment where opportunities for degradation or the introduction of falsified products are minimized.Second, this preventative framework must be supported by strengthening practices at the point of care through the enforcement of Good Pharmacy Practices (GPP). While pharmacistled detection of visibly substandard medicines is challenging and should not be the primary line of defense, pharmacists are integral to maintaining quality assurance (23). The US Agency for International Development (USAID) funded Medicines, Technologies, and Pharmaceutical Services (MTaPS) program has already highlighted the significant impact of GPP implementation on product quality and patient safety in Nepal (24). The urgency of this is underscored by recent local evidence from the Supervision, Performance Assessment, and Recognition Strategy (SPARS) pilot. The baseline assessment from the SPARS pilot, conducted in 2022 across 284 health facilities, revealed alarmingly poor medicines management practices, with an overall median score of only 34% across key performance indicators. Particularly low scores in domains such as storage management and stock management highlight critical, systemic gaps that a robust GPP framework is precisely designed to address (25). Therefore, a renewed focus on GPP-including proper storage, inventory management using the First-Expired-First-Out (FEFO) principle, and patient counselling (26,27)-is not merely a recommendation but an evidence-based necessity to safeguard medicine quality at the final stage of the supply chain.Third, a fundamental overhaul of the national regulatory body is imperative. While establishing a new, fully autonomous commission with civil society oversight represents an ideal long-term goal, a more pragmatic and immediate strategy is to empower the existing Department of Drug Administration (DDA). Given Nepal's resource constraints, strengthening the current regulatory infrastructure is a more feasible first step. Following successful models from other nations, such as the autonomous South African Health Products Regulatory Authority (SAHPRA) (28), granting the DDA greater operational and financial autonomy would be transformative. An empowered DDA could then engage in the kind of international collaboration essential for modern pharmacovigilance, such as the recent Memorandum of Understanding between SAHPRA and Australia's Therapeutic Goods Administration (TGA) to share regulatory information and expertise (29). Recent progress within Nepal indicates a readiness for such advancement; for instance, with support from USAID MTaPS, the DDA has begun modernizing its document management system by installing secure, access-controlled repositories to increase efficiency and security (30).While these foundational improvements are commendable, they must be viewed as the first steps in a much longer journey. Full regulatory maturity requires sustained investment to build upon these gains. This must include a significant increase in the number of trained inspectors and a shift towards a risk-based inspection model that prioritizes systematic laboratory testing of products from importers and wholesalers before they enter the market, thereby ensuring quality at the source rather than attempting to recall products that have already been dispensed.Finally, these systemic and regulatory reforms should be amplified by leveraging modern technology and strengthening post-market surveillance. A vital component underpinning all these reforms is compliance with Good Practice (GxP) principles. GxP is an acronym for a collection of quality guidelines and regulations designed to ensure that products within heavily regulated industries, such as pharmaceuticals, are consistently safe, effective, and fit for their intended use (31). This framework is not a single standard but an ecosystem of practices-including GMP, GSP, and GPP-that collectively safeguard product integrity.While technology is not a panacea, rigorous track-and-trace systems-using technologies like blockchain or simple 2D barcoding-offer a powerful tool for enforcing GxP compliance and achieving end-to-end visibility. This enables regulators to verify authenticity and rapidly identify diversions in the supply chain (32,33). Such systems, proven to be cost-effective in settings like Bangladesh (34), would support the broader GxP framework (31) and provide crucial data for the empowered DDA. Within this enhanced surveillance system, pharmacists, supported by legally protected reporting mechanisms, become vital nodes for reporting suspected adverse events or quality issues, thereby creating a feedback loop that strengthens the entire regulatory ecosystem (35).The integrity of a nation's medicine supply is a direct reflection of its commitment to health equity and social justice. For Nepal, the continued presence of substandard medicines in the supply chain represents a fundamental contradiction to its goal of achieving universal health coverage. The systemic reforms proposed-implementing a robust GxP framework, empowering an autonomous regulator, and leveraging technology for surveillance-are not merely technical exercises; they are essential acts of building trust with the nation's most vulnerable citizens and affirming their right to safe, effective healthcare. Moving forward, the challenge is not one of awareness, but of political will and sustained action. Ensuring the quality of every pill and vial is not just a matter of public health policy-it is a fundamental test of Nepal's promise of equitable healthcare for all.
The rising cost of drug development and the monopolization of pharmaceutical intellectual property have contributed to opaque pricing and limited access to life-saving therapeutics. This paper introduces VitaDAO, a novel decentralized autonomous organization (DAO) designed to address critical inefficiencies in early-stage biopharmaceutical research and drug pricing. By leveraging blockchain technology, token-based governance, and IP tokenization through NFTs, VitaDAO democratizes the funding and ownership of longevity-focused therapeutics. The model aligns incentives across patients, researchers, and investors, fostering open science and equitable commercialization pathways. It proposes a new framework for holding, funding, and managing pharmaceutical IP and research data that seeks to reduce drug prices, enhance transparency, and accelerate access to innovative therapies. This work sits at the intersection of health economics, pharmaceutical RD, and decentralized governance, offering a disruptive alternative to traditional pharma business models.
Angela Hemesath, William M. Tian, Bryce W. Polascik, Suzanna Joseph · 10 authors
Purpose:. To combine the perspectives of health and commercialization experts on the ethical and regulatory needs for non-fungible token (NFT) implementation in healthcare.Design:. PerspectiveMethods:. For a multidisciplinary perspective by an interdisciplinary group, current event articles and research articles were interpreted and assessed.Results:. Health data has become fragmented and disorganized, resulting in poor accessibility, increased administrative costs, and integrity vulnerability. Healthcare is uniquely suited to adopt blockchain and NFT technology as potential solutions. The incorporation of blockchain technology may offer multiple improvements in data-sharing through consensus, tokenization, and decentralization. However, the current regulatory infrastructure to support blockchain is poorly defined.Conclusions:. Healthcare NFTs would revolutionize patient control over their health data and promote more ethical transparency of data ownership while also reducing administrative security costs. However, blockchain poses unprecedented requirements of healthcare regulation within the unique realms of patient privacy and data ownership. Large-scale implementation of blockchain cannot be achieved without regulatory collaboration.
Open access
Pharmaceutical Economics and Policy
Health Systems, Economic Evaluations, Quality of Life
Chigozie Athanasius Nnadiekwe, Ikechi Saviour Igboanusi, Jae‐Min Lee, Dong-Seong Kim
The proposed framework leverages Non-Fungible Tokens (NFTs) to revolutionize supply chain management by ensuring product authenticity. Each product document stored in a repository is minted as an NFT. The NFT is a digital twin of the product's certification, containing metadata for tracking its origin, authenticity, and key details. When a buyer verifies the product's authenticity, the NFT is burned as a final step, ensuring that the product cannot be re-certified without a new issuance. This framework creates a transparent, tamper-proof, and decentralized system to enhance trust and accountability in the supply chain. By integrating the Ethereum-based Pure Chain network and smart contracts, this solution benefits from high availability, immutability, and the ability to automate key processes. The system verified and retrieved the base URI of a designated product identity (ID) whose NFT was stored in a GitHub repository. A vulnerability check of the smart contract codes with solidcheck.io shows that the smart contracts are 84 % secured with no serious security threats, as all considerations were made in the contract code design.
Matthew M. Kavanagh, Luis Gil Abinader, Fatima Hassan, Eli A. Friedman
Scientific advances to fight infectious diseases have been remarkable. International law and global governance have sought, and often failed, to keep pace, secure equity, and stop outbreaks. We trace the law and governance model emerging from early failure in the AIDS response and identify four elements: use of law by national governments to compel sharing; decentralized generic manufacturing; mechanisms for voluntary sharing of patents and technology transfer; international funding. In combination, these created a remarkable new ecosystem. We find that when COVID-19 hit and mRNA vaccines were rapidly developed, global North governments opposed mobilizing this synergistic model. Instead, equity efforts focused on financing purchase of vaccines from originator companies with little use of law. Amidst monopolies and scarcity of doses, vaccine nationalism fatally undermined this effort. Whether more synergistic law and governance emerges from rapidly changing global health law will likely dictate the efficacy of future global infectious disease response.
Mark Gaynor, Kathleen N. Gillespie, Allison Roe, Erica F. Crannage · 5 authors
Background: In recent years, blockchain technology has made great strides in diverse industries but has fallen behind within the pharmaceutical industry. The pharmaceutical industry is complex and would benefit greatly from the distributed database and emphasis of information privacy promoted by blockchain technology. This paper identifies the potential best application for blockchain technology in the United States pharmaceutical industry by identifying current trends, companies exploring the possibilities of blockchain technology, and industry concerns with opportunities for improvement. Methods: We utilized a 4D framework using ease of implementation, novelty, necessity, and fit of the overall industry to examine the adoption of blockchain technology in the pharmaceutical industry. Based on the 2D framework of difficulty and novelty as driving factors for the development of foundational technologies in the world of business by Iansiti and Lakhani in The Harvard Business Review, each application was ranked and scored for the best potential implementation. The potential applications proposed in this paper can be grouped into two main categories. The first category, management, includes best use cases such as health records, clinical trials, and inventory systems. The second category, monitoring, highlights cases such as pharmaceutical products, preventing counterfeits, optimizing supply chains, and addressing prescription misuse and abuse.Results: Each application was ranked by the four metrics in the framework, giving the greatest weight to necessity and ease of implementation. Using the highlighted methodology above, the applications for best implementation include Prescription Drug Misuse and Abuse Prevention, Prevention of Counterfeits, Clinical Trial Outcomes, and Smart Contracts. Conclusion: Blockchain technology offers a new and promising solution to pharmaceutical industry needs. Each application of blockchain technology must fit within the framework of necessary, ease of implementation, familiarity amongst stakeholders, and fit of the overall industry to promote the most appropriate use. By using the extended framework proposed by Iansiti and Lakhani we show that blockchain, in all these domains, shows promise to improve pharmaceutical industry performance.
The pharma supply chain system utilized smart contracts aims to enhance transparency and efficiency in the drug distribution of process.Smart contracts, deployed on a blockchain, secure various supply chain stages, such as manufacturing, distribution, etc.This system ensures real-time visibility, reduces counterfeiting risks, and enables swift response to issues like recalls.Additionally, it fosters trust among stakeholders by providing an immutable record of transactions, ultimately promoting integrity and accountability within the pharma supply chain.
The chapter examines how block chain technology can revolutionize pharmaceutical supply chain management. Through real-time tracking and traceability, the authenticity of medications can be ensured, thereby combating the persistent issue of counterfeit drugs and enhancing patient safety. Additionally, the clinical trial process stands to benefit from block chain and transparent and secure nature. Smart contracts can streamline patient recruitment, informed consent, and trial result reporting, promoting trust and accountability in the clinical trial ecosystem. Despite the potential benefits, the adoption of DeFi and block chain in healthcare presents several challenges, including regulatory compliance, scalability, and integration with existing healthcare systems. This chapter discusses the current state of block chain integration in healthcare and identifies future research directions to overcome these hurdles.
Afrooz Moatari‐Kazerouni, Dinesh R. Pai, Alejandro E. Chicas, Amin Keramati
Purpose The authors propose a blockchain platform for managing clinical trial data to enhance data validity, integrity, trust and transparency in the pharmaceutical research process. The authors also provide an extensive review of how blockchain technology supports the business processes of clinical trials. Design/methodology/approach A systematic literature review was conducted to identify the existing applications of blockchain in pharmaceutical process management. A conceptual design for a blockchain infrastructure to address clinical trial challenges is developed by outlining the entire clinical trial value chain and identifying the coordination and communication among its stakeholders. A stakeholder analysis is conducted to ensure that the clinical trial processes satisfy the requirements and preferences of each stakeholder. Findings The proposed blockchain platform offers a promising solution for enhancing integrity, trust and transparency in the clinical trial process. Additionally, blockchain can help streamline communication and collaboration between stakeholders by enabling multiple parties to access and share data in real time, lowering the possibility of delays or errors in data analysis and reporting. Practical implications The proposed blockchain platform can benefit patients by empowering them to have better-controlled access to their data and by allowing researchers to maintain adherence to reporting requirements. Additionally, the platform can benefit granting agencies, researchers and decision-makers by ensuring the integrity of clinical trial data and streamlining communication and collaboration between stakeholders. Originality/value This study builds on existing blockchain applications in pharmaceutical process management by developing a blockchain framework that can address clinical trial concerns from an integrated perspective.
BACKGROUND: Intellectual property (IP) is a substantial competitive advantage in the health care industry. However, the COVID-19 pandemic highlighted the need for open innovation and collaboration for the greater good. Despite this, the industry faces challenges with innovation owing to organizational and departmental barriers. A secure platform is necessary to facilitate IP sharing without compromising the rights of IP owners. OBJECTIVE: This study proposes a blockchain-based framework to secure IP transactions in health care and bring social impact. METHODS: This study reviews existing researches, publications, practical cases, firm and organization websites, and conferences related to blockchain technology, blockchain in health care, blockchain in IP management, IP pledge research, and practice of IP management blockchain. The platform architecture has 7 components: pledgers, advanced research technology (ART), IP pledge platforms, IP databases, health care research, seeking ART, and transaction condition setting. These components work together seamlessly to support the sharing and pledging of ART and knowledge, while ensuring the platform's transparency, security, and trust. RESULTS: The open IP pledge framework can promote technology dissemination and use, reduce research and development costs, foster collaboration, and serve the public interest. Medical organizations' leadership and support and active participation from stakeholders are necessary for success. By leveraging blockchain technology, the platform ensures tamper-proof and transparent transactions and protects the rights of IP owners. In addition, the platform offers incentive mechanisms through pledge tokens that encourage stakeholders to share their ART and contribute to the platform. CONCLUSIONS: Overall, the proposed framework can facilitate technological innovation, tackle various challenges, and secure IP transactions. It provides a secure platform for stakeholders to share their IP without compromising their rights, promoting collaboration and progress in the health care industry. The implementation of the framework has the potential to revolutionize the industry's approach to innovation, allowing a more open and collaborative environment driven by the greater good.
Abhijeet Ghadge, Michael Bourlakis, Sachin Kamble, Stefan Seuring
Research on Blockchain implementation in the Pharmaceutical Supply Chains (PSC) is lacking despite its strong potential to overcome conventional supply chain challenges. Thus, this study aims to provide critical insight into the nexus between Blockchain and PSC and further build a conceptual framework for implementation within the pharmaceutical industry. Following a systematic literature review and text mining approach, 65 interdisciplinary articles published between 2010 and 2021 were studied to capture the decade long developments. Descriptive and thematic analysis showcases nascent developments of Blockchain in PSC. The drivers and barriers to adoption, implementation stages, and applications identified through the thematic analysis guide in setting the agenda for future research, primarily focussing on the use of Blockchain for drug counterfeiting, recall issues, along with other sector-specific challenges such as patient privacy, regulations and clinical trials. Research on Blockchain for PSC has been slow compared to other sectors, but has accelerated since the Covid-19 pandemic. Identified influential factors, implementation process and apparent applications are expected to influence researchers and practitioners in developing a roadmap for adopting Blockchain in the pharmaceutical industry. The proposed conceptual framework is novel and provides valuable directions to producers, regulators and governments to implement Blockchain in the pharmaceutical industry.
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.
Blockchain has a number of built-in functions, including a distributed ledger, shared storage, verification, encryption, and immutability, and it has progressed from speculation to realistic implementations in industries including healthcare. Without the need for a central body, blockchain technology allows for a transparent and distributed setting. One of the fields where blockchain is considered to hold a lot of promise is healthcare. Data analysis, which has the potential to merge disparate networks and increase Electronic Health Record (EHR) accuracy, should be prioritised in order to transform healthcare. Blockchain technologies can help with access management, data sharing, and maintaining an audit trail of medical operations. It may also be used to help with opioid prescribing and supply chain management, as well as risk data identification, access monitoring, data storage, and the management of a patient audit trail. The healthcare system is changing to allow for a more patient-centred approach. The healthcare networks based on the blockchain may increase security and resiliency by giving patients control of their data. The biggest problems with prescription protection in the illicit medicine supply chain are related to how the medicines are made in the first place. Since tracing the correct and active pharmaceutical ingredients during actual manufacturing is complex, identifying medications that do not include the expected active ingredients can result in patient injury or death. Blockchain’s unique features enable it to provide a basis for full medication tracking through origin till end customer, and the ability to detect fake medications. This chapter covers the introduction to blockchain technology, its background concepts, and importance of blockchain in the domain of healthcare. A framework for the medical supply chain using blockchain has been proposed. The chapter concludes with various research challenges in the domain of blockchain medical supply chain along with the case study.