Andreas Seiter - Academia.edu (original) (raw)
Papers by Andreas Seiter
The American Journal of Tropical Medicine and Hygiene, 2007
Clinical pharmacology and therapeutics, 2009
Ethics of Science and Technology Assessment
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.
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.
Journal of Ambulatory Care Management
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
The American Journal of Tropical Medicine and Hygiene, 2007
Clinical pharmacology and therapeutics, 2009
Ethics of Science and Technology Assessment
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.
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.
Journal of Ambulatory Care Management
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