- Email: [email protected]
Auditing TRIPS Impact on Access vs. Monopoly on Public Health
S6
Abstract
pollution. At the same time, underdiagnosis and the large number of cases of cancers not being detected makes the situation more alarming.3,4 Methods: A detailed search was conducted from national5 and international6 databases related to chronic disease care in India and globally to identify publicly released reports relevant to chronic diseases such as diabetes, cancer, and cardiovascular disease, with more emphasis and focus on diabetes and cancer. Results: The prevalence of diabetes has increased 10-fold between 1971 and 2000.6 It is expected to increase to 101.2 million by 2030,7 and 77.2 million people in India are said to have prediabetes.8 More than 20% of the population in India have at least 1 chronic disease and > 10% have > 1 chronic disease.9 According to the World Health Organization, if 1 adult in a low-income family has diabetes, as much as 25% of family income may be devoted to diabetes care.10 In an industrialized country such as Germany, due to lifestyle changes, it is expected that there will be a > 20% increase in new cases of cancer between 2010 and 2030.11 Awareness level, knowledge of disease symptoms, and screening practices were the key attributes evaluated in a study of breast cancer.3 It was observed among the participants that 56% had not heard of and 65% were not practicing breast self-examination. According to Ernst and Young, baseline cost of treatment (estimated Indian Rupees 300,000–400,000 lakhs) being higher than the annual house hold income for > 80% to 85% of households in India, cancer poses a significant threat to the Indian population.3 With the launch of sodium glucose co-transporter 2 inhibitors and teneligliptin, oral drugs have taken diabetes care to the next level, which has shown improved glycemic control and reduction in glycosylated hemoglobin.12,13 Key risk factors (eg, alcohol per capita consumption in adults aged > 15 years) has increased by 55% between 1992 and 2012.3 Prevalence of all forms of tobacco use in India in 2015 was 17%, and it is one of the key factors associated with the increased risk of head and neck, lung, and bladder cancers. Conclusions: Despite the steep increase expected in chronic diseases, India’s health care professional and infrastructure shortage is one of the major reasons for the country’s high mortality rate. However, the public sector’s lackadaisical performance due to limited investments and suboptimal utilization of available resources has hampered the growth of health care facilities. The growing burden of noncommunicable diseases (NCDs)/communicable diseases is the leading cause of death pertaining to the ageing population, high calorie consumption, and low physical activity levels, accounting for 60% of all deaths in India. In addition, NCDs/communicable diseases account for ~40% of hospital stays and nearly 35% of all recorded outpatient department visits. An ageing population and changes in societal behavior are contributing to a steady increase in these common and costly long-term health problems. The middle class is growing, and with urbanization accelerating, people are adopting a more sedentary lifestyle. This is pushing obesity rates and cases of diseases such as diabetes upward. The government’s low spending on health care places much of the burden on patients and their families, however, as evidenced by the country’s out-of-pocket spending rate, one of the world’s highest. Although the government has taken significant measures to improve access to quality care, it has also seen the emergence of innovative delivery models by private players to address growing chronic care demands. Technology (telemedicine) has a key role to play. Advancements in precise detection and diagnosis of disease will go far to minimize the cost of treating chronic conditions. The economic burden is further diminished due to poor health, as the probability of dying due to chronic diseases is 26% among the most productive years (ie, the 30- to 70-year-old age group). It is estimated that the increasing NCD burden is expected to lead to as much as US$ 4.58 trillion loss of output between 2012 and 2030. Cardiovascular diseases are the major contributors (48%) to the economic burden.
Key words: cancer, chronic disease, diabetes, India, lifestyle disease. Disclosure of Interest: None declared.
References 1. Preventing chronic diseases: A vital investment: WHO global report, 2005;6-7. http://www.who.int/chp/chronic_disease_report/en/ downloaded on 10/04/2016. 2. HDFC bank investment advisory group, Indian healthcare industry, sector update, March 11, 2015;1-2. 3. Call for action: expanding cancer care in India, July, 2015;5. Ernst & Young. 4. India has 1.8 million cancer patients but only one oncologist to treat every 2,000, Business Standard, May 24, 2014. 5. IMS point of view: Anti-diabetics therapy. IMS India. September, 2015. 6. Non communicable diseases in the southeast asia region, situation and response, World Health Organization, 2011. http//apps. searo.who.int/PDS_PDS_DOCS/B4793.pdf. 7. Whiting D. et al. IDF diabetes atlas; Global estimates of the prevalence of diabetes for 2011 and 2030, Diabetes Research and Clinical Practice.2011; 94, (3): 311-321. http//www.sciencedirect. com/science/article/pii/S0168822711005912). 8. Anjana R. et al. Prevalence of diabetes and prediabetes (impaired fasting glucose and/or impaired glucose tolerance) in urban and rural India: phase I results of the Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study. Diabetologia. 2011;54(12): 3022–3027. 9. Patel V. et al. Chronic diseases and injuries in India. The Lancet. 2011; 377: 413–428. 10. Fact sheet diabetes the cost of diabetes. WHO media centre. March 2013. http//www.who.int/mediacentre/factsheets/fs236/en/. 11. Cancer in Germany, 9th Edition 2014, Robert Koch Institute; 6. 12. Johnson & Johnson arm introduces novel diabetes drug. DNA. April 16, 2015. http//www.dnaindia.com. 13. Zydus launches diabetes drug at INR 7/day, 1/6th of MNCs’ price. TNN. November 21, 2015. http//www.timesofindia.timesofindia. com.
Auditing TRIPS Impact on Access vs. Monopoly on Public Health V.C. Vivekanandan NALSAR University of Law, Shameerpet, India Two decades of the TRIPS (Trade Related Intellectual Properties) agreement aimed at strengthening the “monopoly” rights of innovators and creators has brought in visible gains for the investors banking on intellectual property rights for trade and commerce across the nation states. However, such an agreement and implementation spree has been reluctant to answer the question of access to medicines to vast majority of the population, including that of the developed countries. Although adherence to the standards of TRIPS and up- gradation to ‘TRIPS Plus” has been the central focus of various bilateral and multilateral talks for investment and trade among trading blocks, the issue of “access” finds a muted response. A decade ago in the year 2007, the World Intellectual Property Organization (WIPO) adapted the WIPO development agenda endorsed by the member states, which led to the adoption of “45 Development Agenda Recommendations” and thereupon the establishment of the Committee on Development and Intellectual Property,1 which reignited the hope of shaping the intellectual property agenda to balance “access versus monopoly.” However, in the intervening decade, the rise of the Anti-Counterfeiting Trade Agreement, the Trans-Pacific
Abstract Partnership, the Transatlantic Free Trade Area/Transatlantic Trade and Investment Partnership, and the Trade in Services Agreement has bypassed the momentum created by the WIPO Development Agenda in addressing the reformation of the dominant discourse of Patent Regime focusing sideling the “access” issues of public health. The central issue is that of the old patent regime, which advocates that “monopoly” rights lead to “innovation” and thereby will address the public health issues versus the counterview that “monopoly” rights itself is not a linear solution to public health but needs to use it as an “appropriate intervention tool” to spur innovation. Thus, the “monopoly” question needs to be subjugated to the final question of “access” of drugs for all for a better public health. This article aims to track and disseminate the recent developments on the question of the access versus monopoly debate from the emerging agreements outside the TRIPS and Development Agenda dialogue and its impact on the future of public health. Disclosure of Interest: None declared.
Reference 1. Development Agenda for WIPO. http://www.wipo.int/ip-development/ en/agenda/. Accessed April 11, 2016.
S7
Conclusions: The phenomenon of publication bias not only occurs before submission of manuscripts, but it may also happen after submission to a journal.4 It still forms an issue in discussions about evidence-based medicine. Thus, publication of trial results is required by internationally applicable guidance, and ongoing discussions are needed to keep attention by stakeholders to achieve a greater transparency in the area of clinical research. Key words: author, editor, peer review, publication bias. Disclosure of Interest: None declared.
References 1. Bassler, D. et al: Bias in dissemination of clinical research findings: structured OPEN framework of what, who and why, based on literature review and expert consensus, BMJ Open 2016;6:e010024. 2. http://www.alltrials.net/news/who-calls-for-all-clinical-trialresults-to-be-published/. 3. Ioannidis J, et al. Publication and other reporting biases in cognitive sciences: detection, prevalence and prevention,= . Trends Cogn Sci, 18/5, 2014; 235–241. 4. van Lent M, et al. Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals. PLOS ONE, 9/8, 2014; e104846.
Publication Bias V. Strüver Hochschule Hannover, Hannover, Germany Background: According to the Declaration of Helsinki, as well as the Statement on Public Disclosure of Clinical Trial Results of the World Health Organization, every researcher has the ethical obligation to publish research results on all trials with human participants in a complete and accurate way within 12 months after the end of the trial.1,2 Nevertheless, for several reasons, not all research results are published in an accurate way in case they are released at all. This phenomenon of publication bias may not only create a false impression on the reliability of clinical research business, but it may also affect the evidence of clinical conclusions about the best treatments, which are mostly based on published data and results. Objectives: The aim of this article was to present different types of publication bias with regard to authors, peer reviewers, and editors. Already implemented approaches for a reduction in the publication bias phenomenon will be provided to strengthen confidence in the clinical research business. Methods: Literature on publication bias for this narrative review article was identified by searching the PubMed database using the key words “publication bias in clinical research.” The search was limited to articles available as free full-text papers with publication dates later than 2010. Likewise, a Google search with the same key words was performed. Results: Based on the reviewed literature, publication bias can be classified into 3 different types. The first type can be defined as publication bias, which occurs through the author before the submission of the manuscript to a journal in terms of nonpublication or incomplete publication of negative research results. Both other types describe publication bias after submission of the manuscript to a journal. In these cases, either the peer reviewer or the editor of a journal can cause bias during the publication process. For reducing the publication bias phenomenon in clinical research, most of the leading journals meanwhile insist on a registration of the study in public registries such as clinicaltrials.gov as a condition for successful publication.3 Also, the implementation of a blinded peer-reviewing process, in which the peer reviewer will do the review without knowing any author details, represents an improvement in publication bias.
Ensuring Patient Identity in an Increasing Interoperable Health Care Ecosystem J. Moczygemba Texas State University, College of Health Professions, San Marcos, Texas The United States Department of Health and Human Services is charged with improving the health, safety, and well-being of all Americans. Since 2004, when former President George W. Bush set a goal for all Americans to have an electronic health record by 2014, the Office of the National Coordinator (ONC) for Health Information Technology under the Department of Health and Human Services has been steadily making progress. By moving from paper to electronic health records, many benefits can be achieved, including enhanced patient safety, improved care coordination, increased patient participation, practice efficiencies, and cost savings. The vision for 2024 as stated in an ONC report is an “interoperable health information technology (IT) ecosystem that makes the right data available to the right people at the right time across products and organizations in a way that can be relied upon and meaningfully used by recipients.”1 At the heart of a highly functional interoperable health information technology ecosystem is accurate patient identity. Ensuring patient identity is essential for patient safety and quality of care. Accurate patient identification is the foundation for successfully linking patient records within an integrated health care delivery system and across the health care ecosystem.2 The first of 5 building blocks in achieving ONC’s vision for 2024 tackles the need for standards that address essential services for interoperability, which include methods to accurately match individuals, providers, and their information across data sources.3 Furthermore, health care organizations need to ensure that a robust information governance program is implemented to address patient identity integrity. Key words: electronic health record, health care, health information technology, information governance, Office of the National Coordinator, patient identity. Disclosure of Interest: None declared.
Abstract
pollution. At the same time, underdiagnosis and the large number of cases of cancers not being detected makes the situation more alarming.3,4 Methods: A detailed search was conducted from national5 and international6 databases related to chronic disease care in India and globally to identify publicly released reports relevant to chronic diseases such as diabetes, cancer, and cardiovascular disease, with more emphasis and focus on diabetes and cancer. Results: The prevalence of diabetes has increased 10-fold between 1971 and 2000.6 It is expected to increase to 101.2 million by 2030,7 and 77.2 million people in India are said to have prediabetes.8 More than 20% of the population in India have at least 1 chronic disease and > 10% have > 1 chronic disease.9 According to the World Health Organization, if 1 adult in a low-income family has diabetes, as much as 25% of family income may be devoted to diabetes care.10 In an industrialized country such as Germany, due to lifestyle changes, it is expected that there will be a > 20% increase in new cases of cancer between 2010 and 2030.11 Awareness level, knowledge of disease symptoms, and screening practices were the key attributes evaluated in a study of breast cancer.3 It was observed among the participants that 56% had not heard of and 65% were not practicing breast self-examination. According to Ernst and Young, baseline cost of treatment (estimated Indian Rupees 300,000–400,000 lakhs) being higher than the annual house hold income for > 80% to 85% of households in India, cancer poses a significant threat to the Indian population.3 With the launch of sodium glucose co-transporter 2 inhibitors and teneligliptin, oral drugs have taken diabetes care to the next level, which has shown improved glycemic control and reduction in glycosylated hemoglobin.12,13 Key risk factors (eg, alcohol per capita consumption in adults aged > 15 years) has increased by 55% between 1992 and 2012.3 Prevalence of all forms of tobacco use in India in 2015 was 17%, and it is one of the key factors associated with the increased risk of head and neck, lung, and bladder cancers. Conclusions: Despite the steep increase expected in chronic diseases, India’s health care professional and infrastructure shortage is one of the major reasons for the country’s high mortality rate. However, the public sector’s lackadaisical performance due to limited investments and suboptimal utilization of available resources has hampered the growth of health care facilities. The growing burden of noncommunicable diseases (NCDs)/communicable diseases is the leading cause of death pertaining to the ageing population, high calorie consumption, and low physical activity levels, accounting for 60% of all deaths in India. In addition, NCDs/communicable diseases account for ~40% of hospital stays and nearly 35% of all recorded outpatient department visits. An ageing population and changes in societal behavior are contributing to a steady increase in these common and costly long-term health problems. The middle class is growing, and with urbanization accelerating, people are adopting a more sedentary lifestyle. This is pushing obesity rates and cases of diseases such as diabetes upward. The government’s low spending on health care places much of the burden on patients and their families, however, as evidenced by the country’s out-of-pocket spending rate, one of the world’s highest. Although the government has taken significant measures to improve access to quality care, it has also seen the emergence of innovative delivery models by private players to address growing chronic care demands. Technology (telemedicine) has a key role to play. Advancements in precise detection and diagnosis of disease will go far to minimize the cost of treating chronic conditions. The economic burden is further diminished due to poor health, as the probability of dying due to chronic diseases is 26% among the most productive years (ie, the 30- to 70-year-old age group). It is estimated that the increasing NCD burden is expected to lead to as much as US$ 4.58 trillion loss of output between 2012 and 2030. Cardiovascular diseases are the major contributors (48%) to the economic burden.
Key words: cancer, chronic disease, diabetes, India, lifestyle disease. Disclosure of Interest: None declared.
References 1. Preventing chronic diseases: A vital investment: WHO global report, 2005;6-7. http://www.who.int/chp/chronic_disease_report/en/ downloaded on 10/04/2016. 2. HDFC bank investment advisory group, Indian healthcare industry, sector update, March 11, 2015;1-2. 3. Call for action: expanding cancer care in India, July, 2015;5. Ernst & Young. 4. India has 1.8 million cancer patients but only one oncologist to treat every 2,000, Business Standard, May 24, 2014. 5. IMS point of view: Anti-diabetics therapy. IMS India. September, 2015. 6. Non communicable diseases in the southeast asia region, situation and response, World Health Organization, 2011. http//apps. searo.who.int/PDS_PDS_DOCS/B4793.pdf. 7. Whiting D. et al. IDF diabetes atlas; Global estimates of the prevalence of diabetes for 2011 and 2030, Diabetes Research and Clinical Practice.2011; 94, (3): 311-321. http//www.sciencedirect. com/science/article/pii/S0168822711005912). 8. Anjana R. et al. Prevalence of diabetes and prediabetes (impaired fasting glucose and/or impaired glucose tolerance) in urban and rural India: phase I results of the Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study. Diabetologia. 2011;54(12): 3022–3027. 9. Patel V. et al. Chronic diseases and injuries in India. The Lancet. 2011; 377: 413–428. 10. Fact sheet diabetes the cost of diabetes. WHO media centre. March 2013. http//www.who.int/mediacentre/factsheets/fs236/en/. 11. Cancer in Germany, 9th Edition 2014, Robert Koch Institute; 6. 12. Johnson & Johnson arm introduces novel diabetes drug. DNA. April 16, 2015. http//www.dnaindia.com. 13. Zydus launches diabetes drug at INR 7/day, 1/6th of MNCs’ price. TNN. November 21, 2015. http//www.timesofindia.timesofindia. com.
Auditing TRIPS Impact on Access vs. Monopoly on Public Health V.C. Vivekanandan NALSAR University of Law, Shameerpet, India Two decades of the TRIPS (Trade Related Intellectual Properties) agreement aimed at strengthening the “monopoly” rights of innovators and creators has brought in visible gains for the investors banking on intellectual property rights for trade and commerce across the nation states. However, such an agreement and implementation spree has been reluctant to answer the question of access to medicines to vast majority of the population, including that of the developed countries. Although adherence to the standards of TRIPS and up- gradation to ‘TRIPS Plus” has been the central focus of various bilateral and multilateral talks for investment and trade among trading blocks, the issue of “access” finds a muted response. A decade ago in the year 2007, the World Intellectual Property Organization (WIPO) adapted the WIPO development agenda endorsed by the member states, which led to the adoption of “45 Development Agenda Recommendations” and thereupon the establishment of the Committee on Development and Intellectual Property,1 which reignited the hope of shaping the intellectual property agenda to balance “access versus monopoly.” However, in the intervening decade, the rise of the Anti-Counterfeiting Trade Agreement, the Trans-Pacific
Abstract Partnership, the Transatlantic Free Trade Area/Transatlantic Trade and Investment Partnership, and the Trade in Services Agreement has bypassed the momentum created by the WIPO Development Agenda in addressing the reformation of the dominant discourse of Patent Regime focusing sideling the “access” issues of public health. The central issue is that of the old patent regime, which advocates that “monopoly” rights lead to “innovation” and thereby will address the public health issues versus the counterview that “monopoly” rights itself is not a linear solution to public health but needs to use it as an “appropriate intervention tool” to spur innovation. Thus, the “monopoly” question needs to be subjugated to the final question of “access” of drugs for all for a better public health. This article aims to track and disseminate the recent developments on the question of the access versus monopoly debate from the emerging agreements outside the TRIPS and Development Agenda dialogue and its impact on the future of public health. Disclosure of Interest: None declared.
Reference 1. Development Agenda for WIPO. http://www.wipo.int/ip-development/ en/agenda/. Accessed April 11, 2016.
S7
Conclusions: The phenomenon of publication bias not only occurs before submission of manuscripts, but it may also happen after submission to a journal.4 It still forms an issue in discussions about evidence-based medicine. Thus, publication of trial results is required by internationally applicable guidance, and ongoing discussions are needed to keep attention by stakeholders to achieve a greater transparency in the area of clinical research. Key words: author, editor, peer review, publication bias. Disclosure of Interest: None declared.
References 1. Bassler, D. et al: Bias in dissemination of clinical research findings: structured OPEN framework of what, who and why, based on literature review and expert consensus, BMJ Open 2016;6:e010024. 2. http://www.alltrials.net/news/who-calls-for-all-clinical-trialresults-to-be-published/. 3. Ioannidis J, et al. Publication and other reporting biases in cognitive sciences: detection, prevalence and prevention,= . Trends Cogn Sci, 18/5, 2014; 235–241. 4. van Lent M, et al. Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals. PLOS ONE, 9/8, 2014; e104846.
Publication Bias V. Strüver Hochschule Hannover, Hannover, Germany Background: According to the Declaration of Helsinki, as well as the Statement on Public Disclosure of Clinical Trial Results of the World Health Organization, every researcher has the ethical obligation to publish research results on all trials with human participants in a complete and accurate way within 12 months after the end of the trial.1,2 Nevertheless, for several reasons, not all research results are published in an accurate way in case they are released at all. This phenomenon of publication bias may not only create a false impression on the reliability of clinical research business, but it may also affect the evidence of clinical conclusions about the best treatments, which are mostly based on published data and results. Objectives: The aim of this article was to present different types of publication bias with regard to authors, peer reviewers, and editors. Already implemented approaches for a reduction in the publication bias phenomenon will be provided to strengthen confidence in the clinical research business. Methods: Literature on publication bias for this narrative review article was identified by searching the PubMed database using the key words “publication bias in clinical research.” The search was limited to articles available as free full-text papers with publication dates later than 2010. Likewise, a Google search with the same key words was performed. Results: Based on the reviewed literature, publication bias can be classified into 3 different types. The first type can be defined as publication bias, which occurs through the author before the submission of the manuscript to a journal in terms of nonpublication or incomplete publication of negative research results. Both other types describe publication bias after submission of the manuscript to a journal. In these cases, either the peer reviewer or the editor of a journal can cause bias during the publication process. For reducing the publication bias phenomenon in clinical research, most of the leading journals meanwhile insist on a registration of the study in public registries such as clinicaltrials.gov as a condition for successful publication.3 Also, the implementation of a blinded peer-reviewing process, in which the peer reviewer will do the review without knowing any author details, represents an improvement in publication bias.
Ensuring Patient Identity in an Increasing Interoperable Health Care Ecosystem J. Moczygemba Texas State University, College of Health Professions, San Marcos, Texas The United States Department of Health and Human Services is charged with improving the health, safety, and well-being of all Americans. Since 2004, when former President George W. Bush set a goal for all Americans to have an electronic health record by 2014, the Office of the National Coordinator (ONC) for Health Information Technology under the Department of Health and Human Services has been steadily making progress. By moving from paper to electronic health records, many benefits can be achieved, including enhanced patient safety, improved care coordination, increased patient participation, practice efficiencies, and cost savings. The vision for 2024 as stated in an ONC report is an “interoperable health information technology (IT) ecosystem that makes the right data available to the right people at the right time across products and organizations in a way that can be relied upon and meaningfully used by recipients.”1 At the heart of a highly functional interoperable health information technology ecosystem is accurate patient identity. Ensuring patient identity is essential for patient safety and quality of care. Accurate patient identification is the foundation for successfully linking patient records within an integrated health care delivery system and across the health care ecosystem.2 The first of 5 building blocks in achieving ONC’s vision for 2024 tackles the need for standards that address essential services for interoperability, which include methods to accurately match individuals, providers, and their information across data sources.3 Furthermore, health care organizations need to ensure that a robust information governance program is implemented to address patient identity integrity. Key words: electronic health record, health care, health information technology, information governance, Office of the National Coordinator, patient identity. Disclosure of Interest: None declared.