Person:
Seiter, Andreas
Health, Nutrition, and Population Global Practice
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Pharmaceutical Policy,
Health
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Health, Nutrition, and Population Global Practice
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January 31, 2023
Biography
Andreas Seiter is the Global Lead for Private Sector in the World Bank’s Health, Nutrition and Population Global Practice. His role is to work with World Bank teams and clients to strengthen private sector participation in the pursuit of Universal Health Coverage. He joined the Bank in 2004 and has been working on projects in more than 30 countries in all regions. Before joining the World Bank, he was with Novartis, a leading pharmaceutical company, where he spent 18 years in various positions in medical affairs, marketing, global policy and communications. Andreas is a German national and was trained as a physician.
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Publication
Private Sector Pharmaceutical Supply and Distribution Channels in Africa : A Focus on Ghana, Malawi and Mali
(World Bank, Washington, DC, 2011-08) McCabe, Ariane ; Seiter, Andreas ; Diack, Aissatou ; Herbst, Christopher H. ; Dutta, Sheila ; Saleh, KarimaSustainable access to affordable, high-quality medicines is an important component in all health care systems but remains limited in many African countries. Supply and distribution of medicines are a fundamental aspect of the success of any health system. Disruptions to this supply undermine health outcomes as supply chains have an impact on the availability, cost, and quality of medicines for patients. Common problems associated with the supply and distribution of pharmaceuticals often include poor supply chain management, stock pilfering, insufficient human resources, and limited financing resulting in chronic stock outs. In resource-poor settings where public services fail to meet demand, the private and voluntary sectors are increasingly being called on, prompting some policy makers to consider private mechanisms as alternatives to state-run drug procurement and distribution systems. This study reviews some of the ways in which some countries in Africa organize their private pharmaceutical supply and distribution channels, focusing on three diverse countries: Ghana, Malawi, and Mali. It discusses some of the strengths and challenges associated with such arrangements, as well as relevant options to improve access, availability, quality and affordability of privately supplied pharmaceuticals. -
Publication
Assessment of Governance and Corruption in the Pharmaceutical Sector : Lessons Learned from Low and Middle Income Countries
(World Bank, Washington, DC, 2010-01) Diack, Aissatou ; Seiter, Andreas ; Hawkins, Loraine ; Dweik, Imad SubhiPharmaceuticals 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. The authors developed a more indirect approach that relies on a broader assessment of the functioning of the sector and detection of patterns that suggest governance or management problems. From a developmental perspective, the focus is on reducing the impact of bad governance (high drug prices, stock-outs, bad quality of drugs in circulation, irrational use of drugs) rather than identifying the actors and bringing them to justice. Even if the governance level cannot be touched due to political resistance, it may be possible to address the problem from a technical or management angle. For example, electronic procurement platforms and inventory management systems make manipulation more difficult and allow for a faster discovery of irregularities. The assessment framework was applied in eight countries, with adjustments based on client demand and political viability. In most cases, a follow-up after the assessment could be documented, showing that the data provided had relevance and impact in the national policy dialogue. Three of the eight countries signed up to a longer term program to increase transparency in the sector (medicines transparency alliance), others initiated specific projects to address issues that were presented as a result of the initial assessment. In summary, the authors work could demonstrate that it is possible to effectively address pharmaceutical governance issues in the context of a broader sector assessment an approach that may face less political resistance than an inquiry based on a "governance and corruption" labeled instrument. -
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Health and Economic Consequences of Counterfeit Drugs
( 2009) Seiter, A."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. -
Publication
The Pharmaceutical Sector in Ghana
(World Bank, Washington, DC, 2009-11) Seiter, Andreas ; Gyansa-Lutterodt, MarthaMain 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. The National Health Insurance System (NHIS) 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, National Health Insurance Authority (NHIA) has the resources and purchasing power to influence provider behavior as well as the market in terms of quality and price. The purpose of this policy note is to provide a compact overview of the situation, trends and opportunities in the pharmaceutical sector in Ghana as relevant to the strategic objectives in the five year program of work. It summarizes data from a number of recent studies and reports that were done by a range of partners inside and outside the country as well as discussions with key stakeholders in the sector. The intent is to give decision makers up-to-date background information and provide some suggestions for specific policy initiatives designed to achieve the work program objectives, with a particular focus on the role health insurance can play to stabilize and improve service delivery, increase access to quality medicines and promote rational use. The overall legal framework for the pharmaceutical sector is set by the Food and Drugs Law from 1992, amended by Act 523 in 1996. It defines the role of the food and drugs board as separate entity under control of the Ministry of Health (MOH), responsible for regulating the sector. The Food and Drugs Board (FDB) also runs the official drug quality control laboratory that is in charge of testing quality samples obtained from manufacturers, importers, distributors or other sources. The FDB is also working on an improvement of its public website in an effort to strengthen communication with the general public to increase transparency and improve governance. -
Publication
Turkey: Pharmaceutical Sector Analysis
(Ankara, World Bank, 2008) Celik, Yusuf ; Seiter, AndreasPharmaceuticals are essential to achieve health outcomes, but are at the same time a major cost factor in every health system. From a patient perspective, access to pharmaceuticals is a proxy for the functioning of the health system. With increasing economic strength, patients become more demanding with regard to access to modern, sophisticated drugs and providers become more aggressive in marketing those drugs. This paper reflects the situation in the pharmaceutical sector in Turkey, identifies critical issues, and discusses policy options based on current trends and the overall policy objectives of the Turkish government. This paper is structured as follows: chapter one gives introduction; chapter two gives overall policy objectives in the pharmaceutical sector in Turkey; chapter three presents institutional and regulatory framework; chapter four presents reimbursement rules; chapter five focuses on governance issues in the pharmaceutical sector; chapter six gives market overview; chapter seven gives payment for pharmaceuticals in Turkey; chapter eight presents prescribing practices - rational use of medicines; and chapter nine gives conclusions and way forward. -
Publication
A Practical Approach to Pharmaceutical Policy
(World Bank, 2010) Seiter, AndreasThis book discusses the wide range of challenges faced by policy makers in the pharmaceutical sector, presents the current know-how in terms of policy measures, and provides specific examples of policy packages that can be used in defined circumstances, even if one assumes a certain degree of political resistance and capacity limits on the side of the implementing agency. This book focuses on developing countries and tries to address the issues faced by both low- and middle-income countries. The book does not cover the vaccines market and its respective policies because too many differences exist between the markets for vaccines and pharmaceuticals to cover both subsectors in one publication of this type. The book ends with an outlook on how things might evolve in the longer term. It assumes that some form of convergence will take place toward "models that work," thus reducing the fragmentation of policies and enhancing regulatory and economic efficiencies over time-one hopes to the benefit of all stakeholders in the sector and, in particular, those who, as patients, currently do not have reliable access to effective and safe medicines. -
Publication
The Pharmaceutical Sector of the Western Balkan Countries
(World Bank, Washington, DC, 2008-02) Imasheva, Aizhan ; Seiter, AndreasThere is a strong political will in the Western Balkan states to align the region's pharmaceutical legislation and practice with that of the European Union. Accordingly, recent policy changes were aimed at harmonization of policies with other European countries. Several national drug laws were updated or completely re-written in the last several years. More specifically, provisions were made for the simplification of drug registration requirements, licensing of professionals and businesses in the sector, implementation of ethics standards, price controls and reimbursement of drugs through national health insurance systems. Countries in the region have introduced various measures for cost containment, mostly through positive lists with various co-payment levels or expenditure caps for prescribing physicians. Some institutional buyers are using pooled procurement with open tenders to ensure lower prices. Nevertheless, there are still a number of challenges such as lack of enforcement of rules and standards, limited access to drugs for low income populations, inefficiencies in resource allocation and in the distribution chain, lack of control over physicians prescribing behavior and occasional conflicts between public health and industrial policy objectives. For the foreseeable future, there will be a need for further capacity building in the pharmaceutical sector, with a focus on increased oversight and higher professional standards, more efficient use of limited public resources, equity of access and rational use of medicines. Nevertheless, drug expenditure is set to grow in this region as it did in other countries in Eastern Europe, typically at a rate of about twice GDP growth, due to inevitable factors such as innovation, aging populations, increasing incomes and better access to healthcare. -
Publication
Strengthening the Pharmaceutical System in the Kingdom of Saudi Arabia: Towards a Medicine Policy to Support Vision 2030
(World Bank, Washington, DC, 2020) Alghaith, Taghred ; Almoteiry, Khalid ; Alamri, Adwa ; Alluhidan, Mohammed ; Alharf, Adel ; Al-Hammad, Bander ; Aliafali, Ibrahim ; Seiter, Andreas ; Pisani, Elizabeth ; Herbst, Christopher H. ; El-Saharty, Sameh ; Alazemi, NaharThis document presents the major issues that were discussed in the process of working towards the development of a new medicines policy in Saudi Arabia, examining current national practice in light of international practices and experiences. The document is designed to foster discussion and help inform the development of a new national medicine policy. A detailed accounting of the evidence informing policy choices to be highlighted in an updated medicine policy are presented in Part I of this discussion paper; a proposed new National Medicine Policy itself is presented in Part ll. A new Medicine policy, once finalized and approved, will need to be implemented in a highly dynamic environment and must therefore allow for flexibility. It will need to be followed by the implementation of regulations, closely monitored, and adapted as necessary over time.