Harvard Case - A Bitter Pill for Pharmaceutical Counterfeits: Behind China's Serialisation Technology
"A Bitter Pill for Pharmaceutical Counterfeits: Behind China's Serialisation Technology" Harvard business case study is written by Tan Wee Liang, Sin Mei Cheah. It deals with the challenges in the field of Information Technology. The case study is 13 page(s) long and it was first published on : Aug 4, 2021
At Fern Fort University, we recommend that the Chinese government and pharmaceutical industry collaborate to implement a comprehensive and robust serialization system, leveraging technology and analytics to combat counterfeiting effectively. This system should be built upon a strong foundation of IT infrastructure, data management, and cybersecurity, with a focus on digital transformation across the pharmaceutical supply chain.
2. Background
This case study examines the challenges faced by China's pharmaceutical industry in combating counterfeit drugs. The rising prevalence of counterfeit medicines poses a significant threat to public health and economic stability. The case highlights China's efforts to implement serialization technology, a system that assigns unique identifiers to individual drug packages, to track and trace pharmaceuticals throughout the supply chain.
The main protagonists of the case are:
- The Chinese government: Responsible for setting regulatory frameworks and policies to combat counterfeiting.
- The pharmaceutical industry: Facing the challenge of implementing serialization technology and ensuring its effectiveness.
- Consumers: The ultimate victims of counterfeit drugs, risking their health and well-being.
3. Analysis of the Case Study
Porter's Five Forces Framework can be applied to analyze the competitive landscape:
- Threat of new entrants: High, due to the ease of counterfeiting and the lack of stringent regulations in some regions.
- Bargaining power of buyers: Low, as consumers often lack the knowledge to differentiate genuine drugs from counterfeits.
- Bargaining power of suppliers: Moderate, as pharmaceutical companies rely on a limited number of suppliers for raw materials and packaging.
- Threat of substitute products: Low, as there are few substitutes for essential medications.
- Competitive rivalry: High, as numerous players operate within the pharmaceutical industry, leading to price competition and a focus on market share.
Key challenges:
- Implementation costs: Implementing serialization technology requires significant investment in IT infrastructure, software development, and data management.
- Data security and privacy: Ensuring the security and privacy of sensitive patient data is crucial, especially with the increasing use of Internet of Things (IoT) devices in the pharmaceutical supply chain.
- Interoperability and standardization: Achieving interoperability between different serialization systems across various stakeholders is essential for seamless data exchange.
- Resistance to change: Organizational change management is crucial to overcome resistance from stakeholders who may be hesitant to adopt new technologies.
- Lack of awareness: Raising awareness among consumers about counterfeit drugs and the importance of serialization is vital.
4. Recommendations
Phase 1: Foundation and Implementation
- Establish a National Serialization Authority: Create a dedicated body responsible for setting standards, overseeing implementation, and coordinating efforts across stakeholders.
- Develop a Comprehensive Serialization Framework: Define clear regulations, standards, and guidelines for serialization technology, including data formats, security protocols, and interoperability requirements.
- Invest in IT Infrastructure and Data Management: Prioritize digital transformation within the pharmaceutical industry, investing in robust IT infrastructure, data analytics, and cloud computing platforms to support serialization.
- Implement a Phased Rollout: Start with high-risk medications and gradually expand the program to encompass all pharmaceutical products.
- Leverage Technology and Analytics: Utilize AI and machine learning to identify patterns and anomalies in data, enabling proactive detection and prevention of counterfeiting.
- Promote Collaboration and Knowledge Sharing: Encourage collaboration between government agencies, pharmaceutical companies, and technology providers to share best practices and accelerate innovation.
Phase 2: Expansion and Sustainability
- Integrate with Global Standards: Align with international serialization standards to facilitate cross-border trade and enhance global supply chain security.
- Develop Consumer Awareness Campaigns: Educate consumers about counterfeit drugs, the importance of serialization, and how to identify genuine products.
- Implement a Robust Cybersecurity Framework: Protect sensitive data and systems from cyberattacks by investing in advanced cybersecurity measures and training.
- Foster Innovation and Entrepreneurship: Encourage the development of innovative solutions, such as blockchain technology and Internet of Things (IoT) applications, to enhance supply chain transparency and security.
- Continuously Monitor and Evaluate: Regularly assess the effectiveness of the serialization system, identify areas for improvement, and adapt to evolving threats.
5. Basis of Recommendations
These recommendations are based on the following considerations:
- Core competencies and consistency with mission: The recommendations align with the Chinese government's mission to protect public health and ensure the safety of pharmaceuticals.
- External customers and internal clients: The recommendations benefit consumers by providing them with greater confidence in the authenticity of medications, while also supporting pharmaceutical companies in safeguarding their brand reputation and protecting their bottom line.
- Competitors: The recommendations aim to create a level playing field for all pharmaceutical companies by deterring counterfeiters and promoting a fair market environment.
- Attractiveness: The benefits of implementing a comprehensive serialization system outweigh the costs, as it can lead to significant reductions in counterfeit drug prevalence, improved public health outcomes, and increased consumer trust.
6. Conclusion
By implementing a robust serialization system and leveraging technology and analytics, China can effectively combat counterfeit drugs, protecting public health and fostering a more secure pharmaceutical supply chain. This approach requires a collaborative effort between the government, pharmaceutical industry, and technology providers, with a focus on digital transformation, data management, and cybersecurity.
7. Discussion
Alternatives not selected:
- Stricter enforcement of existing regulations: While important, this approach alone may not be sufficient to deter counterfeiters, especially with the increasing sophistication of counterfeit operations.
- Focus on consumer education alone: While raising awareness is crucial, it is not a standalone solution and needs to be complemented by robust technological measures.
Risks and key assumptions:
- High implementation costs: The initial investment in infrastructure and technology may be significant, but the long-term benefits in terms of reduced counterfeit drug prevalence and improved public health far outweigh the costs.
- Data security and privacy concerns: Addressing data security and privacy concerns is paramount, requiring robust cybersecurity measures and adherence to relevant regulations.
- Resistance to change: Overcoming resistance from stakeholders who may be hesitant to adopt new technologies requires effective change management strategies and clear communication of the benefits of serialization.
8. Next Steps
- Establish a National Serialization Authority: Within the next six months, the Chinese government should establish a dedicated body responsible for overseeing the implementation of the serialization system.
- Develop a Comprehensive Serialization Framework: Within one year, the government should develop a comprehensive framework outlining regulations, standards, and guidelines for serialization technology.
- Pilot Implementation: Within two years, the government should initiate pilot programs in select provinces to test and refine the serialization system before nationwide rollout.
- Public Awareness Campaign: Within one year, the government should launch a public awareness campaign to educate consumers about counterfeit drugs and the importance of serialization.
By implementing these recommendations and taking decisive action, China can effectively combat counterfeit drugs, safeguarding public health and ensuring a more secure pharmaceutical supply chain for the future.
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Case Description
In January 2014, CITIC 21CN Technology Company Limited (CITIC), a firm that had been under the radar, took the Hong Kong stock market by storm after its stock price soared 372% upon Alibaba Group's acquisition. Alibaba, the world's largest e-commerce company, took a controlling stake of CITIC and subsequently renamed it AliHealth. CITIC had operated a state-owned pharmaceutical product monitoring platform overseeing the massive supply chain of manufacturers, distributors, drugstores, and medical organisations in China. Developed in 2006, the proprietary system was used for pharmaceutical serialisation aimed at safeguarding public health. Using cryptography-based authentication and traceability technologies, the system efficiently traces illegal activities across the supply chain from manufacturing to point of use and expedites recalls of counterfeit medicine. Given China's plan to extend the serialisation mandate to all categories of medicine, the company appears poised for strong growth in the coming years. To scale the system, what more could have been done? Should the system adopt the latest blockchain technology? Should the company dedicate more effort to strengthen stakeholder engagement?
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