Patent as a Generator Rather than Inhibitor of Drug Accessibility in Developing Countries: a Critical Examination of India's Patent Model

<p>Patent's reputation as a constructive mechanism in the developing world was not a common notion. The prospect of utilising pharmaceutical patents to generate drug accessibility in developing countries did not seem possible. However, little credit was given to patents. Through motivating innovation, foreign investment, trade relations and industrialisation, patents can form a prowess pharmaceutical industry in the developing world. This thesis explores the possibility to increasing the availability of low cost drugs in emerging economies through patent enforcement. The analysis focuses on India as a case study. India has long been at the forefront of the developing world fight for low cost drugs markets. This stand once meant the exclusion of patent protection of pharmaceutical innovation and the formation of low cost copied generic drugs industry. However given developing countries' recent submissions to the international pressure to enforce patent protection on pharmaceutical innovations, it is time to re-examine the role patents play in developing countries, this time in the avenue of reducing drugs' pricing. India's current economy and the evolution of its pharmaceutical industry evolvement, make it as an exemplary case study to utilise patent to fulfil this end. Accordingly, the issue of widening the scope of patent protection in India to include pharmaceutical incremental innovation is examined. Notwithstanding the responsibility of India to endorse wider patent scope, legally and practically, the thesis does not ignore the moral obligation the developed world has towards India's poorer population to offer low cost drugs during the stages of its pharmaceutical industry emergence. The preliminary justification to conduct this observation is to show that patent is not only to answer the healthcare needs of the developed world population, but also the developing world. As such the thesis argues that India ought to stand at the forefront again, this time, demonstrating the potential within patent to establish low cost patented pharmaceuticals marketplace in developing countries.</p>

Patent as a Generator Rather than Inhibitor of Drug Accessibility in Developing Countries: a Critical Examination of India's Patent Model

<p>Patent's reputation as a constructive mechanism in the developing world was not a common notion. The prospect of utilising pharmaceutical patents to generate drug accessibility in developing countries did not seem possible. However, little credit was given to patents. Through motivating innovation, foreign investment, trade relations and industrialisation, patents can form a prowess pharmaceutical industry in the developing world. This thesis explores the possibility to increasing the availability of low cost drugs in emerging economies through patent enforcement. The analysis focuses on India as a case study. India has long been at the forefront of the developing world fight for low cost drugs markets. This stand once meant the exclusion of patent protection of pharmaceutical innovation and the formation of low cost copied generic drugs industry. However given developing countries' recent submissions to the international pressure to enforce patent protection on pharmaceutical innovations, it is time to re-examine the role patents play in developing countries, this time in the avenue of reducing drugs' pricing. India's current economy and the evolution of its pharmaceutical industry evolvement, make it as an exemplary case study to utilise patent to fulfil this end. Accordingly, the issue of widening the scope of patent protection in India to include pharmaceutical incremental innovation is examined. Notwithstanding the responsibility of India to endorse wider patent scope, legally and practically, the thesis does not ignore the moral obligation the developed world has towards India's poorer population to offer low cost drugs during the stages of its pharmaceutical industry emergence. The preliminary justification to conduct this observation is to show that patent is not only to answer the healthcare needs of the developed world population, but also the developing world. As such the thesis argues that India ought to stand at the forefront again, this time, demonstrating the potential within patent to establish low cost patented pharmaceuticals marketplace in developing countries.</p>

Innovation in Informatics to Improve Clinical Care and Drug Accessibility for Rare Diseases in China

Background: In China, there are severe unmet medical needs of people living with rare diseases. Relatedly, there is a dearth of data to inform rare diseases policy. This is historically partially due to the lack of informatics infrastructure, including standards and terminology, data sharing mechanisms and network; and concerns over patient privacy protection.Objective: This study aims to introduce the progress of China's rare disease informatics platform and knowledgebase, and to discuss critical enablers of rare disease informatics innovation, including: data standardization; knowledgebase construction; national policy support; and multi-stakeholder participation.Methods: A systemic national strategy, delivered through multi-stakeholder engagement, has been implemented to create and accelerate the informatics infrastructure to support rare diseases management. This includes a disease registry system, together with more than 80 hospitals, to perform comprehensive research information collection, including clinical, genomic and bio-sample data. And a case reporting system, with a network of 324 hospitals, covering all mainland Chinese provinces, to further support reporting of rare diseases data. International standards were incorporated, and privacy issues were addressed through HIPAA compliant rules.Results: The National Rare Diseases Registry System of China (NRDRS) now covers 166 rare diseases and more than 63,000 registered patients. The National Rare Diseases Case Reporting System of China (NRDCRS) was primarily founded on the National Network of Rare Diseases (NNRD) of 324 hospitals and focused on real-time rare diseases case reporting; more than 400,000 cases have been reported. Based on the data available in the two systems, the National Center for Health Technology Assessment (HTA) of Orphan Medicinal Products (OMP) has been established and the expert consensus on HTA of OMP was produced. The largest knowledgebase for rare disease in Chinese has also been developed.Conclusion: A national strategy and the coordinating mechanism is the key to success in the improvement of Chinese rare disease clinical care and drug accessibility. Application of innovative informatics solutions can help accelerate the process, improve quality and increase efficiency.

Do Drug Accessibility and OOP Burden Affect Health-Related Quality of Life of Patients With Chronic Diseases? — EQ-5D-5L Evaluation Evidence From Five Districts in China

Purpose: The dependence of patients with chronic diseases on drugs may affect their health-related quality of life (HRQoL). This study aims to assess the relationship between the direct economic burden caused by out-of-pocket (OOP) payments, drug accessibility, sociodemographic characteristics, and health-related quality of life.Methods: 1,055 patients with chronic diseases from Gansu, Hebei, Sichuan, Zhejiang, and Tianjin were investigated. Data collection included basic conditions and economic and health insurance conditions of patients with chronic diseases. The CLAD and Tobit regression models were used to analyze and compare the health-related quality of life and influencing factors of patients with chronic diseases in five districts. Differentiated analysis was conducted through sub-sample regression to explore the variable health effects of patients with single and multiple diseases.Results: A total of 1,055 patients with chronic diseases participated in the study, 54.4% of whom were women. The overall average utility score was 0.727, of which Sichuan Province was the highest with 0.751. Participants reported the highest proportion of pain/discomfort problems, while patients reported the least problems with self-care. The improvement of drug accessibility and the reduction of the burden of out-of-pocket expenses have significant positive effects on HRQoL. Various sociodemographic factors such as age and gender also have significant impact on HRQoL of patients with chronic diseases. HRQoL of patients with multiple chronic diseases is more affected by various influencing factors than that of patients with single disease.Conclusion: In order to improve the quality of life of patients with chronic diseases, it is of great importance to ensure the accessibility of drugs and reduce patients' medication burden. Future focus should shift from preventing and controlling chronic diseases as individual diseases to meeting the comprehensive health needs of people suffering from multiple diseases.

Effect of the Expanded Senior Citizens Act of 2010 (Republic Act 9994) on Drug Accessibility among the Elderly

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