The American Journal of Tropical Medicine and Hygiene, 2007
In 2004, the Institute of Medicine concluded that a global high-level subsidy was the best way to... more In 2004, the Institute of Medicine concluded that a global high-level subsidy was the best way to make effective antimalarial drugs-currently, artemisinin-combination therapies (ACTs)-widely available at affordable prices and at the same time substantially delay the emergence and spread of artemisinin-resistant strains of falciparum malaria. The subsidy would be available to manufacturers of all ACTs meeting pre-specified efficacy, safety, and quality criteria. Buyers would pay very low prices, allowing drugs to flow through existing channels, with the aim of reaching consumers at a similar price to chloroquine, the most frequently used (although no longer effective) malaria drug. Unsubsidized artemisinin monotherapies would be more expensive than subsidized ACTs (co-formulations), thereby largely eliminating their use through market forces. Conditions favoring the emergence of artemisinin-resistant malaria would be greatly reduced. The global high-level subsidy is a powerful idea that is moving from economic concept to pragmatic reality.
Counterfeit Drugs Kill" is the slogan the World Health Organization (WHO) uses in its anti-counte... more Counterfeit Drugs Kill" is the slogan the World Health Organization (WHO) uses in its anti-counterfeiting campaign. International organizations, governments of developed and developing countries, and the pharmaceutical industry created the IMPACT initiative (International Medical Products Anti-Counterfeiting Taskforce) to take on the thriving illegal industry that makes profits by selling fake drugs. However, before committing resources, policy makers want to assess the burden caused by counterfeit drugs in comparison with other health problems that compete for the limited resources available.
ABSTRACT Pharmaceuticals are a key input in health care systems. For many diseases, they provide ... more ABSTRACT Pharmaceuticals are a key input in health care systems. For many diseases, they provide the basis of treatment or even the entire treatment. In OECD countries, pharmaceuticals account on average for 10–15% of total health expenditure1. In developing countries, the share of pharmaceuticals is usually higher (up to 50% and more), partly because there is only a limited range of other, more sophisticated services available.
All rights reserved 1 2 3 4 13 12 11 10 This volume is a product of the staff of the Internationa... more All rights reserved 1 2 3 4 13 12 11 10 This volume is a product of the staff of the International Bank for Reconstruction and Development/ The World Bank. The findings, interpretations, and conclusions expressed in this volume do not necessarily reflect the views of the Executive Directors of The World Bank or the governments they represent. The World Bank does not guarantee the accuracy of the data included in this work. The boundaries, colors, denominations, and other information shown on any map in this work do not imply any judgement on the part of The World Bank concerning the legal status of any territory or the endorsement or acceptance of such boundaries. v
about this series... This series is produced by the Health, Nutrition, and Population Family (HNP... more about this series... This series is produced by the Health, Nutrition, and Population Family (HNP) of the World Bank’s Human Development Network. The papers in this series aim to provide a vehicle for publishing preliminary and unpolished results on HNP topics to encourage discussion and debate. The findings, interpretations, and conclusions expressed in this paper are entirely those of the author(s) and should not be attributed in any manner to the World Bank, to its affiliated organizations or to members of its Board of Executive Directors or the countries they represent. Citation and the use of material presented in this series should take into account this provisional character. For free copies of papers in this series please contact the individual authors whose name appears on the paper. Enquiries about the series and submissions should be made directly to
Many health projects rely on a regular supply of quality pharmaceuticals. Here is a practical gui... more Many health projects rely on a regular supply of quality pharmaceuticals. Here is a practical guide how to assure drug quality along the distribution chain and win the fight against substandard and counterfeit drugs, which otherwise harm people's health and undermine the success of major treatment programs. Pharmaceuticals are an essential element of health care. In developing countries, up to 66 percent of public and private health expenses are used to buy medicines. Unfortunately, data shows that much of this money is wasted on fake and substandard drugs. This paper outlines some keys to ensuring the quality of medicines, as this multi-dimensional task is a priority for every national regulatory drug authority. The paper deals with quality assurance questions for products that are in circulation already and looks at issues such as: accreditation of suppliers, distribution logistics and quality of drugs, proper testing of pharmaceuticals, how to identify counterfeit (fake) drug...
Romania has a pharmaceutical market of 5.47 billion lei (1,550 million Euro) in 2006, where the m... more Romania has a pharmaceutical market of 5.47 billion lei (1,550 million Euro) in 2006, where the market for prescription drugs was about 4.58 billion lei, of which 80 percent are financed by health insurance. Government policies have been more liberal than in other countries in the region, allowing easy market access and access to funding with relatively high reimbursement rates for new drugs. This creates pressure on the financing system (health insurance), which has to absorb increasing drug costs at a rate beyond the growth rate of the overall economy. This report analyzes the current situation and makes suggestions how the system can be adjusted in order to maintain access to effective medicines for all - while considering the limited resources available in an economy that is still far behind the European Union (EU) average. This report outlines options for steps to address deficiencies identified by the Ministry of Public Health (MOPH) and other stakeholders. This report is stru...
Regulation of pharmaceuticals is a complex task. Andreas Seiter's note reviews the role of dr... more Regulation of pharmaceuticals is a complex task. Andreas Seiter's note reviews the role of drug regulatory authorities in developing countries and discusses how to set priorities in line with the overall health policy agenda.. Most diseases in developing countries could be treated with existing and well-known medicines. However, essential pharmaceuticals often are not available, not accessible, or not used appropriately. As bad or worse, use of substandard and counterfeit drugs wastes money, and may cause treatment failures and unnecessary deaths. A first step in providing access to quality medicines for all is to establish a sound regulatory system that guarantees that only safe and effective drugs are produced, imported and marketed, and provides guidance for appropriate use of these drugs.
About the World Bank Group and Staff Exchange Program (SEP). Partnership programs at a glance. A ... more About the World Bank Group and Staff Exchange Program (SEP). Partnership programs at a glance. A word of Thanks, by Benedicte Boullet. Moving in, moving on. A first Voice Secondment Program (VSP) cohort graduates, by Gizem Eren-Baig. Pharmaceutical expenditure management: a challenge for middle-income countries, by Andreas Seiter. In partnership with the German development service, by Michael Broemmel. Partnering with Africa: a better way to reduce poverty, by Isidore Ondoki. The International Labor Organization's (ILO's) local economic development program: partnership in action, by Julie G. Viloria-Williams and Anne Posthuma. Building partnership for urban development: the work of the cities alliance, by Chii Akporji and Christiane Einfeldt. A closer look at partnership building through the staff exchange program, by Brad Julian. Cooperation matters: a Dutch-German partnership for energy access, Arno D. Tomowski and Joerg Baur. Embracing Cocoa as a means for poverty allevia...
Pharmaceuticals are a critical input for the health sector. At the same time, the drug business s... more Pharmaceuticals are a critical input for the health sector. At the same time, the drug business sustains many individual and corporate livelihoods and produces handsome returns for those involved in the trade. Good governance is critical for the sector to maximize returns for public health and minimize risks for patients from ineffective or contaminated drugs. Given the large financial volume of the market, the potential for corruption is significant. Vulnerable points are those at which decisions about market access and purchasing are made. This includes institutional functions such as licensing, inclusion into formularies and public procurement as well as the individual prescriber, who selects drugs for a specific patient. Given the political and institutional resistance against more transparency from the beneficiaries of the status quo, assessment of governance and corruption in the sector is not a straightforward exercise. We developed a more indirect approach that relies on a b...
What factors must be weighed when deciding whether to promote local manufacturing of pharmaceutic... more What factors must be weighed when deciding whether to promote local manufacturing of pharmaceuticals in developing countries? Andreas Seiter's note summarizes pros, cons and key issues. Pharmaceuticals are essential in every health care system. The objective of pharmaceutical policy is to make sure that there is a reliable supply of good quality medicines at affordable prices. Local manufacturing is sometimes offered as a potential solution to the access problem. Supporters of this concept suggest that local production in a developing country should result in a cheaper final product. Skeptics argue that small manufacturing units don't achieve economies of scale, and that higher unit costs outweigh potential advantages such as lower transportation costs.
• Access to essential medicines is a key pillar of any health system seeking to deliver universal... more • Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. Science-based, independent regulation of medical products is a critical part of ensuring that only quality essential medicines reach the patients who need them.
Main pharmaceutical policy goals in Ghana are access to essential medicines for everybody, qualit... more Main pharmaceutical policy goals in Ghana are access to essential medicines for everybody, quality assurance for all drugs on the market, a functioning and efficient supply chain as well as rational use of medicines by professionals and patients. There is also a commitment to strengthen the domestic pharmaceutical industry, outlined under health industry in the national health policy. Key challenges are limited capacity to enforce regulation, high levels of provider indebtedness due to poor management and flaws in the payment system, a weak public sector supply chain that is increasingly being substituted by the private sector and a fragmented national private sector (manufacturing and distribution), lacking capital to make necessary investments into quality improvements. The National Health Insurance System has significantly improved access to medicines for insured patients, measured in increased utilization of facilities and rapidly growing turnover of revolving drug funds. The risk is now that non-rational prescribing and fraud lead to a growing medicine bill that threatens financial sustainability of NHIS. On the other hand, NHIA has the resources and purchasing power to influence provider behavior as well as the market in terms of quality and price.
O VER THE PAST few decades, countries have experimented with a variety of approaches to controlli... more O VER THE PAST few decades, countries have experimented with a variety of approaches to controlling the cost of onpatent prescription drugs. From direct price controls, to health technology assessment, to market friendlier methods that encourage discounts, pharmaceutical policies reflect countries’ political, cultural, and economic environments. They are also unique in the ways in which they are established in the context of a country’s broader health care system. The concept of “limit prices,” introduced in this article, would serve as an interesting approach in the United States that could strike a balance across these dimensions. On the political and cultural dimension, limit prices would be consistent with the US market-friendly approach to controlling health care expenditures. The Centers for Medicare and Medicaid Innovation (CMMI) could encourage and support limit pricing pilots with payers and
This series is produced by the Health, Nutrition, and Population Family (HNP) of the World Bank's... more This series is produced by the Health, Nutrition, and Population Family (HNP) of the World Bank's Human Development Network (HDN). The papers in this series aim to provide a vehicle for publishing preliminary and unpolished results on HNP topics to encourage discussion and debate. The findings, interpretations, and conclusions expressed in this paper are entirely those of the author(s) and should not be attributed in any manner to the World Bank, to its affiliated organizations or to members of its Board of Executive Directors or the countries they represent. Citation and the use of material presented in this series should take into account this provisional character. Enquiries about the series and submissions should be made directly to the Editor,
International Agencies • Assess the impact of international financing, donations and procurement ... more International Agencies • Assess the impact of international financing, donations and procurement policies on local distributors and retailers. Donations bypass local supply and distribution pathways. Subsidized drugs may undermine the profitability of local distribution and therefore damage the distribution system. • Channel donor funds through existing local private sector supply and distribution channels. Tender and donations programmes could make use of local private sector supply and distribution networks for the manufacture, procurement and distribution of products. 2 Health care services may be provided by several sectors: • Government or public sector; • Faith-based or NGOs; • Employer provided; • Private sector. The share of services offered by each provider depends on the country. Often, while government services are free, faith-based/NGO, employer-provided and private sector health services are delivered by the private sector. Faith-based/ NGO services and those supplied by employers (eg. plantations and mines) are often on a not-for profit basis.
The American Journal of Tropical Medicine and Hygiene, 2007
In 2004, the Institute of Medicine concluded that a global high-level subsidy was the best way to... more In 2004, the Institute of Medicine concluded that a global high-level subsidy was the best way to make effective antimalarial drugs-currently, artemisinin-combination therapies (ACTs)-widely available at affordable prices and at the same time substantially delay the emergence and spread of artemisinin-resistant strains of falciparum malaria. The subsidy would be available to manufacturers of all ACTs meeting pre-specified efficacy, safety, and quality criteria. Buyers would pay very low prices, allowing drugs to flow through existing channels, with the aim of reaching consumers at a similar price to chloroquine, the most frequently used (although no longer effective) malaria drug. Unsubsidized artemisinin monotherapies would be more expensive than subsidized ACTs (co-formulations), thereby largely eliminating their use through market forces. Conditions favoring the emergence of artemisinin-resistant malaria would be greatly reduced. The global high-level subsidy is a powerful idea that is moving from economic concept to pragmatic reality.
Counterfeit Drugs Kill" is the slogan the World Health Organization (WHO) uses in its anti-counte... more Counterfeit Drugs Kill" is the slogan the World Health Organization (WHO) uses in its anti-counterfeiting campaign. International organizations, governments of developed and developing countries, and the pharmaceutical industry created the IMPACT initiative (International Medical Products Anti-Counterfeiting Taskforce) to take on the thriving illegal industry that makes profits by selling fake drugs. However, before committing resources, policy makers want to assess the burden caused by counterfeit drugs in comparison with other health problems that compete for the limited resources available.
ABSTRACT Pharmaceuticals are a key input in health care systems. For many diseases, they provide ... more ABSTRACT Pharmaceuticals are a key input in health care systems. For many diseases, they provide the basis of treatment or even the entire treatment. In OECD countries, pharmaceuticals account on average for 10–15% of total health expenditure1. In developing countries, the share of pharmaceuticals is usually higher (up to 50% and more), partly because there is only a limited range of other, more sophisticated services available.
All rights reserved 1 2 3 4 13 12 11 10 This volume is a product of the staff of the Internationa... more All rights reserved 1 2 3 4 13 12 11 10 This volume is a product of the staff of the International Bank for Reconstruction and Development/ The World Bank. The findings, interpretations, and conclusions expressed in this volume do not necessarily reflect the views of the Executive Directors of The World Bank or the governments they represent. The World Bank does not guarantee the accuracy of the data included in this work. The boundaries, colors, denominations, and other information shown on any map in this work do not imply any judgement on the part of The World Bank concerning the legal status of any territory or the endorsement or acceptance of such boundaries. v
about this series... This series is produced by the Health, Nutrition, and Population Family (HNP... more about this series... This series is produced by the Health, Nutrition, and Population Family (HNP) of the World Bank’s Human Development Network. The papers in this series aim to provide a vehicle for publishing preliminary and unpolished results on HNP topics to encourage discussion and debate. The findings, interpretations, and conclusions expressed in this paper are entirely those of the author(s) and should not be attributed in any manner to the World Bank, to its affiliated organizations or to members of its Board of Executive Directors or the countries they represent. Citation and the use of material presented in this series should take into account this provisional character. For free copies of papers in this series please contact the individual authors whose name appears on the paper. Enquiries about the series and submissions should be made directly to
Many health projects rely on a regular supply of quality pharmaceuticals. Here is a practical gui... more Many health projects rely on a regular supply of quality pharmaceuticals. Here is a practical guide how to assure drug quality along the distribution chain and win the fight against substandard and counterfeit drugs, which otherwise harm people's health and undermine the success of major treatment programs. Pharmaceuticals are an essential element of health care. In developing countries, up to 66 percent of public and private health expenses are used to buy medicines. Unfortunately, data shows that much of this money is wasted on fake and substandard drugs. This paper outlines some keys to ensuring the quality of medicines, as this multi-dimensional task is a priority for every national regulatory drug authority. The paper deals with quality assurance questions for products that are in circulation already and looks at issues such as: accreditation of suppliers, distribution logistics and quality of drugs, proper testing of pharmaceuticals, how to identify counterfeit (fake) drug...
Romania has a pharmaceutical market of 5.47 billion lei (1,550 million Euro) in 2006, where the m... more Romania has a pharmaceutical market of 5.47 billion lei (1,550 million Euro) in 2006, where the market for prescription drugs was about 4.58 billion lei, of which 80 percent are financed by health insurance. Government policies have been more liberal than in other countries in the region, allowing easy market access and access to funding with relatively high reimbursement rates for new drugs. This creates pressure on the financing system (health insurance), which has to absorb increasing drug costs at a rate beyond the growth rate of the overall economy. This report analyzes the current situation and makes suggestions how the system can be adjusted in order to maintain access to effective medicines for all - while considering the limited resources available in an economy that is still far behind the European Union (EU) average. This report outlines options for steps to address deficiencies identified by the Ministry of Public Health (MOPH) and other stakeholders. This report is stru...
Regulation of pharmaceuticals is a complex task. Andreas Seiter's note reviews the role of dr... more Regulation of pharmaceuticals is a complex task. Andreas Seiter's note reviews the role of drug regulatory authorities in developing countries and discusses how to set priorities in line with the overall health policy agenda.. Most diseases in developing countries could be treated with existing and well-known medicines. However, essential pharmaceuticals often are not available, not accessible, or not used appropriately. As bad or worse, use of substandard and counterfeit drugs wastes money, and may cause treatment failures and unnecessary deaths. A first step in providing access to quality medicines for all is to establish a sound regulatory system that guarantees that only safe and effective drugs are produced, imported and marketed, and provides guidance for appropriate use of these drugs.
About the World Bank Group and Staff Exchange Program (SEP). Partnership programs at a glance. A ... more About the World Bank Group and Staff Exchange Program (SEP). Partnership programs at a glance. A word of Thanks, by Benedicte Boullet. Moving in, moving on. A first Voice Secondment Program (VSP) cohort graduates, by Gizem Eren-Baig. Pharmaceutical expenditure management: a challenge for middle-income countries, by Andreas Seiter. In partnership with the German development service, by Michael Broemmel. Partnering with Africa: a better way to reduce poverty, by Isidore Ondoki. The International Labor Organization's (ILO's) local economic development program: partnership in action, by Julie G. Viloria-Williams and Anne Posthuma. Building partnership for urban development: the work of the cities alliance, by Chii Akporji and Christiane Einfeldt. A closer look at partnership building through the staff exchange program, by Brad Julian. Cooperation matters: a Dutch-German partnership for energy access, Arno D. Tomowski and Joerg Baur. Embracing Cocoa as a means for poverty allevia...
Pharmaceuticals are a critical input for the health sector. At the same time, the drug business s... more Pharmaceuticals are a critical input for the health sector. At the same time, the drug business sustains many individual and corporate livelihoods and produces handsome returns for those involved in the trade. Good governance is critical for the sector to maximize returns for public health and minimize risks for patients from ineffective or contaminated drugs. Given the large financial volume of the market, the potential for corruption is significant. Vulnerable points are those at which decisions about market access and purchasing are made. This includes institutional functions such as licensing, inclusion into formularies and public procurement as well as the individual prescriber, who selects drugs for a specific patient. Given the political and institutional resistance against more transparency from the beneficiaries of the status quo, assessment of governance and corruption in the sector is not a straightforward exercise. We developed a more indirect approach that relies on a b...
What factors must be weighed when deciding whether to promote local manufacturing of pharmaceutic... more What factors must be weighed when deciding whether to promote local manufacturing of pharmaceuticals in developing countries? Andreas Seiter's note summarizes pros, cons and key issues. Pharmaceuticals are essential in every health care system. The objective of pharmaceutical policy is to make sure that there is a reliable supply of good quality medicines at affordable prices. Local manufacturing is sometimes offered as a potential solution to the access problem. Supporters of this concept suggest that local production in a developing country should result in a cheaper final product. Skeptics argue that small manufacturing units don't achieve economies of scale, and that higher unit costs outweigh potential advantages such as lower transportation costs.
• Access to essential medicines is a key pillar of any health system seeking to deliver universal... more • Access to essential medicines is a key pillar of any health system seeking to deliver universal health coverage. Science-based, independent regulation of medical products is a critical part of ensuring that only quality essential medicines reach the patients who need them.
Main pharmaceutical policy goals in Ghana are access to essential medicines for everybody, qualit... more Main pharmaceutical policy goals in Ghana are access to essential medicines for everybody, quality assurance for all drugs on the market, a functioning and efficient supply chain as well as rational use of medicines by professionals and patients. There is also a commitment to strengthen the domestic pharmaceutical industry, outlined under health industry in the national health policy. Key challenges are limited capacity to enforce regulation, high levels of provider indebtedness due to poor management and flaws in the payment system, a weak public sector supply chain that is increasingly being substituted by the private sector and a fragmented national private sector (manufacturing and distribution), lacking capital to make necessary investments into quality improvements. The National Health Insurance System has significantly improved access to medicines for insured patients, measured in increased utilization of facilities and rapidly growing turnover of revolving drug funds. The risk is now that non-rational prescribing and fraud lead to a growing medicine bill that threatens financial sustainability of NHIS. On the other hand, NHIA has the resources and purchasing power to influence provider behavior as well as the market in terms of quality and price.
O VER THE PAST few decades, countries have experimented with a variety of approaches to controlli... more O VER THE PAST few decades, countries have experimented with a variety of approaches to controlling the cost of onpatent prescription drugs. From direct price controls, to health technology assessment, to market friendlier methods that encourage discounts, pharmaceutical policies reflect countries’ political, cultural, and economic environments. They are also unique in the ways in which they are established in the context of a country’s broader health care system. The concept of “limit prices,” introduced in this article, would serve as an interesting approach in the United States that could strike a balance across these dimensions. On the political and cultural dimension, limit prices would be consistent with the US market-friendly approach to controlling health care expenditures. The Centers for Medicare and Medicaid Innovation (CMMI) could encourage and support limit pricing pilots with payers and
This series is produced by the Health, Nutrition, and Population Family (HNP) of the World Bank's... more This series is produced by the Health, Nutrition, and Population Family (HNP) of the World Bank's Human Development Network (HDN). The papers in this series aim to provide a vehicle for publishing preliminary and unpolished results on HNP topics to encourage discussion and debate. The findings, interpretations, and conclusions expressed in this paper are entirely those of the author(s) and should not be attributed in any manner to the World Bank, to its affiliated organizations or to members of its Board of Executive Directors or the countries they represent. Citation and the use of material presented in this series should take into account this provisional character. Enquiries about the series and submissions should be made directly to the Editor,
International Agencies • Assess the impact of international financing, donations and procurement ... more International Agencies • Assess the impact of international financing, donations and procurement policies on local distributors and retailers. Donations bypass local supply and distribution pathways. Subsidized drugs may undermine the profitability of local distribution and therefore damage the distribution system. • Channel donor funds through existing local private sector supply and distribution channels. Tender and donations programmes could make use of local private sector supply and distribution networks for the manufacture, procurement and distribution of products. 2 Health care services may be provided by several sectors: • Government or public sector; • Faith-based or NGOs; • Employer provided; • Private sector. The share of services offered by each provider depends on the country. Often, while government services are free, faith-based/NGO, employer-provided and private sector health services are delivered by the private sector. Faith-based/ NGO services and those supplied by employers (eg. plantations and mines) are often on a not-for profit basis.
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