CHAPTER 1 INTRODUCTION 1.1 Rationale and justification of the study Oral diseases, such as dental caries and periodontal diseases are most common chronic infectious diseases. Most caries and periodontal diseases are preventable, as recommended by resolution WHA 53.17 of the Fiftythird World Health Assembly in 2000 (1). However, the consequences of oral diseases are not only affected to oral cavity, but also to other systemic diseases such as diabetes, cardiovascular diseases, or respiratory diseases, preterm and low birth weight (2). There are several bacterial strains in normal flora of the oral cavity. Most of them are pathogens. Bacteria exist mainly inside the dental plaque and dental calculus and on the surface of soft tissue. Dental plaque was formed from mixture of food, saliva and other organic compounds inside oral cavity and it is the main cause of oral
MEDICINE PRICES AND PRICING POLICIES IN VIETNAM Tuan Anh Nguyen A thesis submitted in fulfillment of the requirements for the degree of Doctor of Philosophy School of Public Health & Community Medicine Faculty of Medicine, University of New South Wales, Australia April 2011 THE UNIVERSITY OF NEW SOUTH WALES Thesis/Dissertation Sheet Surname or Family name: Nguyen First name: Tuan Anh Other name/s: Abbreviation for degree as given in the University calendar: PhD School: Public Health and Community Medicine Faculty: Medicine Title: Medicine prices and pricing policies in Vietnam Abstract 350 words maximum: Availability of affordable medicines is one precondition to realizing the fundamental human right of access to essential healthcare. Although Vietnam is progressing well with several health-related targets of the Millennium Development Goals being achieved ahead of time, attaining equitable access to affordable medicines remains problematic. In this thesis, a mixed-method approach was adopted in the analysis of medicine prices and polices. The literature was reviewed, followed by an analysis of Vietnam‘s pharmaceutical market and legislation. A quantitative study of medicine prices, and a qualitative study on how and why high, unaffordable prices occurred, were conducted. The findings were synthesized to form policy recommendations. The studies demonstrated that medicine prices in Vietnam were unreasonably high. Adjusted for Purchasing Power Parity in 2005, prices in the public sector were 46.58 times the international reference price for innovator-brand medicines and 11.41 times for the lowest-priced generic equivalents. Monopoly of supply was an important cause of high innovator-brand prices. More complex, intrinsic features of Vietnam‘s healthcare system were also reported by key stakeholders as driving up prices. Economic survival pressures, in an imperfectly competitive market, were said to force both pharmaceutical companies and prescribers to be inextricably linked financially. Ethics and personal values however did influence prescribers‘ behaviour and their response to corrupt procedures. Overall, intractable, systemic features contributing to high prices included unrealistic low salaries for prescribers, poor economies of scale in domestic production, inefficiencies in the local distribution network, malfunctioning pricing policies and a general lack of transparency and accountability in administrative procedures. A range of policy measures and changes are required to improve access to medicines in Vietnam. Short- term recommendations include amendments to pharmaceutical policies, with better enforcement of current regulations. Medium-term measures include the public health insurance system taking an active role in price setting, pooling procurement through a national tendering procurement system and reform of the domestic market through rationalization with appropriate capital and technological investment to achieve improved efficiencies and economies of scale. Longer-term goals include health system improvements to address poor governance, low remuneration of prescribers, with additional measures to limit the scope for corrupt practices. Declaration relating to disposition of project thesis/dissertation I hereby grant to the University of New South Wales or its agents the right to archive and to make available my thesis or dissertation in whole or in part in the University libraries in all forms of media, now or here after known, subject to the provisions of the Copyright Act 1968. I retain all property rights, such as patent rights. I also retain the right to use in future works (such as articles or books) all or part of this thesis or dissertation. I also authorise University Microfilms to use the 350-word abstract of my thesis in Dissertation Abstracts International (this is applicable to doctoral theses only). ……… Signature ……………… Witness …………………… …….… Date The University recognises that there may be exceptional circumstances requiring restrictions on copying or conditions on use. Requests for restriction for a period of up to 2 years must be made in writing. Requests for a longer period of restriction may be considered in exceptional circumstances and require the approval of the Dean of Graduate Research. FOR OFFICE USE ONLY Date of completion of requirements for Award: THIS SHEET IS TO BE GLUED TO THE INSIDE FRONT COVER OF THE THESIS ORIGINALITY STATEMENT ‗I hereby declare that this submission is my own work and to the best of my knowledge it contains no materials previously published or written by another person, or substantial proportions of material which have been accepted for the award of any other degree or diploma at UNSW or any other educational institution, except where due acknowledgement is made in the thesis. Any contribution made to the research by others, with whom I have worked at UNSW or elsewhere, is explicitly acknowledged in the thesis. I also declare that the intellectual content of this thesis is the product of my own work, except to the extent that assistance from others in the project's design and conception or in style, presentation and linguistic expression is acknowledged.‘ Signed Date ii COPYRIGHT STATEMENT ‗I hereby grant the University of New South Wales or its agents the right to archive and to make available my thesis or dissertation in whole or part in the University libraries in all forms of media, now or here after known, subject to the provisions of the Copyright Act 1968. I retain all proprietary rights, such as patent rights. I also retain the right to use in future works (such as articles or books) all or part of this thesis or dissertation. I also authorise University Microfilms to use the 350 word abstract of my thesis in Dissertation Abstract International (this is applicable to doctoral theses only). I have either used no substantial portions of copyright material in my thesis or I have obtained permission to use copyright material; where permission has not been granted I have applied/will apply for a partial restriction of the digital copy of my thesis or dissertation.' Signed …………………………………………… Date …………………………………………… AUTHENTICITY STATEMENT ‗I certify that the Library deposit digital copy is a direct equivalent of the final officially approved version of my thesis. No emendation of content has occurred and if there are any minor variations in formatting, they are the result of the conversion to digital format.‘ Signed …………………………………………… Date ……………………… …………………………………… iii DEDICATION This thesis is dedicated to my parents, Dinh Thiem Nguyen and Thi Lien Doan, for nurturing me and teaching me to care about others. iv v ACKNOWLEDGEMENTS I would like to thank the Ministry of Education and Training of Vietnam, Vietnam government for awarding me a PhD scholarship to study in Australia. I would also like to acknowledge the Vietnam team who conducted the survey of medicine prices and availability, and the Ministry of Health of Vietnam for giving me permission to use the survey data in this thesis. I am grateful to all members of the Drug Price Management Division, Drug Administration of Vietnam for sharing their views as well as their cooperation and support when I conducted fieldwork in Vietnam. My project also rests on the cooperation, generosity and courage of the sixty study participants who gave their time and shared their valuable opinions and sensitive information in the interviews. I owe a debt of gratitude to my supervisor, Associate Professor Rosemary Knight. Without her mentorship, support, and depth of knowledge, this thesis would not have been completed. Her calm, insights, compassion and elegant language were central to the conceptualisation, design, analysis and reporting of this thesis, as was her vision and ability to approach problems from a global perspective. My co-supervisors, Associate Professor Andrea Mant and Dr. Quang Minh Cao were patient, thoughtful and encouraging. Their critical comments and feedback were invaluable along every step of this project. Their practical and consistent support has kept me going to the end of my PhD journey. Dr. Husna Razee was my qualitative co-supervisor, whose experience and knowledge in qualitative research greatly contributed to the qualitative study for this thesis. My special thanks go to Dr. Geoffrey Brooks for sharing his excellent knowledge of economics and Australian pharmaceutical policy and practice, and for taking me under his wing as my second father. His critical feedback greatly improved the quality of this thesis. Support was also received from Dr. Pat Bazeley who assisted me in developing the qualitative coding schemes, steered me through the perils of NVIVO and mixed methods research and fed me from her research farm. vi I am grateful to Mr. Martin Auton (Global project officer - Pricing, Health Action International Global) and Ms. Alexandra Cameron (Coordinator medicine pricing project, WHO) for their cross-analysis of the survey data and for giving me valuable comments on the quantitative study for this thesis. Great thanks are also due to Mr. Wayne Critchley (Former Executive Director, Patented Medicine Prices Review Board Government of Canada) for providing critical feedback on the policy analysis components of the thesis. My colleagues in the School of Public Health and Community Medicine at UNSW also provided great ideas and valuable comments, including Mr. Kevin Forde, Dr. Niahm Stephenson, Dr. Ilse Blignault, Dr. Brahmaputra Marjadi, and Dr. Joanne Spangaro. I would like to thank my former supervisor, Associate Professor Tessa Ho, for her warm encouragement and caring, even when she was not able to supervise me due to her move to another university. Sincere thanks to my fellow PhD students who shared with me both my frustration and happiness, especially Dr. Keith Masnick. My wife Thu Ha Dang, my daughter Thanh Mai Nguyen and my son Dang Nhat Minh Nguyen are my life. Without their love, encouragement and support, I would not have had the strength and determination to pursue my dream. [...]... The Vietnam medicine prices and availability survey 2005 1 Vietnam s medicine pricing regulations and laws Informants from Vietnam s pharmaceutical industry, government medicine pricing authorities and other stakeholders involved in the medicine supply chain 2 Review the process, characteristics and problems of the current pharmaceutical supply chain in Vietnam 2 Annual reports of the Drug Administration... the prices, availability and affordability of a sample of medicines in Vietnam, using established WHO/Health Action International methods and compares the results with those of other similar countries Chapter 5, Medicine pricing policies in Vietnam, analyses the features, strengths and weaknesses of the legislation and regulations determining medicine pricing policies in Vietnam, and their impact on prices. .. pricing policies that the Vietnam government has put in place to date; and iv) To identify underlying factors causing high medicine prices in Vietnam 4 1.3 Research design and methodological considerations 1.3.1 Overall research design (Figure 1.1) Objectives Aim Medicine prices and pricing policies in Vietnam To recommend feasible solutions for affordable medicine prices in Vietnam Strategies Instruments... received for medicines under this program was a major factor easing the burden of increasing prices for medicines Notwithstanding the significance of legislative measures, medicine prices in Vietnam have kept growing (Inspectorate of the MOH of Vietnam, 2007) Prices to patients for some medicines were up to ten times their imported prices (Trương Ngọc, 2007) Low compliance with medicine pricing regulations... availability, and affordability of medicines in Vietnam To assess the effectiveness of the government‘s medicine pricing policies Study 1 Integration To analyse the impact of pharmaceutical demand and supply in Vietnam on medicine prices Study 2 Study 3 Study 4 1 Briefly consider the main features of Vietnam s health care system Analyze the prices, availability and affordability of a sample of medicines in Vietnam. .. medicines in Vietnam, and to develop feasible policy recommendations to achieve more affordable medicines in Vietnam Specifically, the thesis has the following objectives: 3 i) To analyze how demand and supply of pharmaceuticals in Vietnam impact on medicine prices; ii) To assess the price, availability and affordability of a sample of medicines in Vietnam; iii) To assess the effectiveness of medicine pricing. .. CHAPTER 5 MEDICINE PRICING POLICIES IN VIETNAM 113 5.1 INTRODUCTION 113 5.2 METHODS 113 5.3 RESULTS 114 5.3.1 Context of medicine pricing regulations in Vietnam 116 5.3.2 The price declaration and publication of medicine pricing policies 118 5.3.2.1 The reasonableness of declared prices and published prices 118 5.3.2.2 Other declaration and publication... policies in Vietnam The thesis studies include a review of the relevant international literature, followed by an analysis of Vietnam s health care and pharmaceutical system and its impact on medicine prices A quantitative study of medicine prices examines the empirical evidence and is followed by an analysis of the legislative and regulatory framework that underpins medicine pricing policies An innovative... background and orientation to the study 6 1.3.4 Currency used in this thesis 7 1.4 FLOW OF RESEARCH AND INTERCONNECTION OF CHAPTERS 8 CHAPTER 2 MEDICINE PRICES, PRICING POLICIES AND PATIENT ACCESS: A REVIEW OF THE INTERNATIONAL LITERATURE 11 2.1 INTRODUCTION 11 2.2 NATIONAL MEDICINES POLICIES AND ACCESS TO MEDICINES 12 2.2.1 Rational selection and use of essential medicines... Vietnam 2 Annual reports of the Drug Administration of Vietnam 2003-2008 3 Government‘s electronic databases and web pages 2 Consultations with Vietnam medicine pricing authorities To identify underlying factors causing high medicine prices in Vietnam 2 Identify the dominant components of medicine prices and the underlying causes Synthesis of the findings from the four studies to develop policy recommendations . Abbreviation for degree as given in the University calendar: PhD School: Public Health and Community Medicine Faculty: Medicine Title: Medicine prices and pricing policies in Vietnam Abstract 350 words. 11 2.2 NATIONAL MEDICINES POLICIES AND ACCESS TO MEDICINES 12 2.2.1 Rational selection and use of essential medicines 14 2.2.2 Sustainable financing 15 2.2.3 Reliable health and supply systems. insurance in containing medicine prices 89 3.6 CONCLUSIONS 90 CHAPTER 4. AVAILABILITY AND AFFORDABILITY OF MEDICINES IN VIETNAM 93 4.1 INTRODUCTION 93 x 4. 2 METHODS 93 4.2.1 Sampling 93