Publication:
Final Report with Recommendations for Reforming Bulgaria’s Pharmaceutical Sector

Loading...
Thumbnail Image
Files in English
English PDF (1.5 MB)
861 downloads
English Text (158.01 KB)
328 downloads
Date
2015-05
ISSN
Published
2015-05
Author(s)
Editor(s)
Abstract
This report presents a review of current issues in the pharmaceutical sector in Bulgaria, examining drug policy, regulation, pricing, formulary selection, distribution, expenditure, and to the extent possible, patterns of use in Bulgaria. Its recommendations are intended to serve as options for reform, by articulating short and long term strategies for managing pharmaceutical expenditure, improving system sustainability, and driving value for money in Bulgaria, thereby improving efficiency, equity, affordability and ultimately, access to prescription medicines. Although small, the Bulgarian pharmaceutical market is showing strong growth. Medicines comprise not only a disproportionate share of health care expenditure (38 percent of total health expenditure, compared with an EU average of around 25 percent), the burden of out of pocket (OOP) costs is also excessive, possibly as high as 81 percent of total pharmaceutical expenditure. Of perhaps greatest concern is that rapid expenditure growth is taking place without obvious improvements in health outcomes, and at the expense of population equity. Bulgaria does not yet have an integrated national medicines policy, and the pharmaceutical sector is characterized by various highly prescriptive and at times, arguably inconsistent policy levers. While the regulatory framework has been largely brought into line with current EU standards, existing mechanisms for listing, pricing and subsidizing medicines are not ensuring adequate value for money for the National Health Insurance Fund (NHIF), and are contributing to inefficiencies in the health sector. Current pharmaceutical policy settings appear focused on limiting NHIF outlays rather than prioritizing access and affordability, and afford little financial protection to patients.
Link to Data Set
Citation
World Bank. 2015. Final Report with Recommendations for Reforming Bulgaria’s Pharmaceutical Sector. © World Bank. http://hdl.handle.net/10986/23248 License: CC BY 3.0 IGO.
Associated URLs
Associated content
Report Series
Other publications in this report series
Journal
Journal Volume
Journal Issue

Related items

Showing items related by metadata.

  • Publication
    Financing, Pricing, and Utilization of Pharmaceuticals in China
    (Washington, DC, 2010) World Bank
    This paper examines the financing, pricing, and utilization of pharmaceuticals in China the pharmaceutical system as it has evolved, and some changes that would improve it in the context of the national health reform process. The present paper builds upon earlier critical reviews and other papers published in the series china health policy notes. The paper is divided into four parts. The first section provides an overview of the Chinese pharmaceutical market: how the sector has grown; China's position in the global market; and size, composition, and trends in the domestic market. The second section examines the evolution and status of China's system of essential medicines, an area emphasized in the government's health reform plan announced in April 2009. It shows how the use of essential medicines has evolved over the two decades since the idea was formally adopted, and discusses why practice has fallen far short of the ideal. The third section looks at the issue that dominates today's debate: managing high pharmaceutical costs. It reviews the components of drug pricing, underscoring the argument that there is considerable scope for reducing prices. It looks at government attempts to control drug prices, and suggests why they did not succeed. Finally, the fourth section suggests measures to re-chart the path to reform.
  • 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 Subhi
    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. 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.
  • Publication
    The Pharmaceutical Sector of the Western Balkan Countries
    (World Bank, Washington, DC, 2008-02) Imasheva, Aizhan; Seiter, Andreas
    There 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
    Turkey
    (Ankara, World Bank, 2008) Celik, Yusuf; Seiter, Andreas
    Pharmaceuticals 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
    Pharmaceutical Reform : A Guide to Improving Performance and Equity
    (World Bank, 2011-09-21) Roberts, Marc J.; Reich, Michael R.
    This publication, which is based on the unique methodology and tools developed for the World Bank Institute/Harvard School of Public Health Flagship Course on Health System Reform and Sustainable Financing, provides a powerful set of resources to help policy makers better navigate the complicated process of reforming pharmaceutical systems. Its problem solving approach complements technical resources and training curricula available on the discrete elements of a pharmaceutical sector. The application of the flagship approach to the pharmaceutical sector is both useful and timely. Ensuring the availability of medicines and the effective management of their procurement and distribution is central to the drive to achieve coverage and access to basic health care that is both universal and financially sustainable. Together, the methodology and case materials contained in this publication provide a rich resource from which policy makers in developing countries may draw to guide their efforts to meet these challenges. This book is designed to help participants gain a better understanding of all that goes on in the pharmaceutical sector. As noted above, it uses the flagship framework that we helped develop over the past decade. The essence of that approach is not to try to tell policy makers in detail what they should do. Rather it comprises a set of analytical tools that are combined into an overall, structured methodology for developing, adopting, and implementing reform proposals. The flagship framework also includes a comprehensive review of reform alternatives and a systematic review of their strengths and weaknesses in various situations. Throughout this book the authors have used the flagship framework to structure our analysis of pharmaceutical reform, continuously and explicitly applying its methods and concepts to the pharmaceutical sector. With a few minor exceptions, all the examples and all of the reform options come directly from pharmaceutical reform efforts around the world. The authors have also given specific attention to issues in pharmaceutical policy related to reproductive health.

Users also downloaded

Showing related downloaded files

  • Publication
    Global Economic Prospects, June 2024
    (Washington, DC: World Bank, 2024-06-11) World Bank
    After several years of negative shocks, global growth is expected to hold steady in 2024 and then edge up in the next couple of years, in part aided by cautious monetary policy easing as inflation gradually declines. However, economic prospects are envisaged to remain tepid, especially in the most vulnerable countries. Risks to the outlook, while more balanced, are still tilted to the downside, including the possibility of escalating geopolitical tensions, further trade fragmentation, and higher-for-longer interest rates. Natural disasters related to climate change could also hinder activity. Subdued growth prospects across many emerging market and developing economies and continued risks underscore the need for decisive policy action at the global and national levels. Global Economic Prospects is a World Bank Group Flagship Report that examines global economic developments and prospects, with a special focus on emerging market and developing economies, on a semiannual basis (in January and June). Each edition includes analytical pieces on topical policy challenges faced by these economies.
  • Publication
    Global Economic Prospects, June 2023
    (Washington, DC: World Bank, 2023-06-06) World Bank
    Global growth is projected to slow significantly in the second half of this year, with weakness continuing in 2024. Inflation pressures persist, and tight monetary policy is expected to weigh substantially on activity. The possibility of more widespread bank turmoil and tighter monetary policy could result in even weaker global growth. Rising borrowing costs in advanced economies could lead to financial dislocations in the more vulnerable emerging market and developing economies (EMDEs). In low-income countries, in particular, fiscal positions are increasingly precarious. Comprehensive policy action is needed at the global and national levels to foster macroeconomic and financial stability. Among many EMDEs, and especially in low-income countries, bolstering fiscal sustainability will require generating higher revenues, making spending more efficient, and improving debt management practices. Continued international cooperation is also necessary to tackle climate change, support populations affected by crises and hunger, and provide debt relief where needed. In the longer term, reversing a projected decline in EMDE potential growth will require reforms to bolster physical and human capital and labor-supply growth.
  • Publication
    Poverty, Prosperity, and Planet Report 2024
    (Washington, DC: World Bank, 2024-10-15) World Bank
    The Poverty, Prosperity, and Planet Report 2024 is the latest edition of the series formerly known as Poverty and Shared Prosperity. The report emphasizes that reducing poverty and increasing shared prosperity must be achieved in ways that do not come at unacceptably high costs to the environment. The current “polycrisis”—where the multiple crises of slow economic growth, increased fragility, climate risks, and heightened uncertainty have come together at the same time—makes national development strategies and international cooperation difficult. Offering the first post-Coronavirus (COVID)-19 pandemic assessment of global progress on this interlinked agenda, the report finds that global poverty reduction has resumed but at a pace slower than before the COVID-19 crisis. Nearly 700 million people worldwide live in extreme poverty with less than US$2.15 per person per day. Progress has essentially plateaued amid lower economic growth and the impacts of COVID-19 and other crises. Today, extreme poverty is concentrated mostly in Sub-Saharan Africa and fragile settings. At a higher standard more typical of upper-middle-income countries—US$6.85 per person per day—almost one-half of the world is living in poverty. The report also provides evidence that the number of countries that have high levels of income inequality has declined considerably during the past two decades, but the pace of improvements in shared prosperity has slowed, and that inequality remains high in Latin America and the Caribbean and Sub-Saharan Africa. Worldwide, people’s incomes today would need to increase fivefold on average to reach a minimum prosperity threshold of US$25 per person per day. Where there has been progress in poverty reduction and shared prosperity, there is evidence of an increasing ability of countries to manage natural hazards, but climate risks are significantly higher in the poorest settings. Nearly one in five people globally is at risk of experiencing welfare losses due to an extreme weather event from which they will struggle to recover. The interconnected issues of climate change and poverty call for a united and inclusive effort from the global community. Development cooperation stakeholders—from governments, nongovernmental organizations, and the private sector to communities and citizens acting locally in every corner of the globe—hold pivotal roles in promoting fair and sustainable transitions. By emphasizing strategies that yield multiple benefits and diligently monitoring and addressing trade-offs, we can strive toward a future that is prosperous, equitable, and resilient.
  • Publication
    World Development Report 2017
    (Washington, DC: World Bank, 2017-01-30) World Bank Group
    Why are carefully designed, sensible policies too often not adopted or implemented? When they are, why do they often fail to generate development outcomes such as security, growth, and equity? And why do some bad policies endure? This book addresses these fundamental questions, which are at the heart of development. Policy making and policy implementation do not occur in a vacuum. Rather, they take place in complex political and social settings, in which individuals and groups with unequal power interact within changing rules as they pursue conflicting interests. The process of these interactions is what this Report calls governance, and the space in which these interactions take place, the policy arena. The capacity of actors to commit and their willingness to cooperate and coordinate to achieve socially desirable goals are what matter for effectiveness. However, who bargains, who is excluded, and what barriers block entry to the policy arena determine the selection and implementation of policies and, consequently, their impact on development outcomes. Exclusion, capture, and clientelism are manifestations of power asymmetries that lead to failures to achieve security, growth, and equity. The distribution of power in society is partly determined by history. Yet, there is room for positive change. This Report reveals that governance can mitigate, even overcome, power asymmetries to bring about more effective policy interventions that achieve sustainable improvements in security, growth, and equity. This happens by shifting the incentives of those with power, reshaping their preferences in favor of good outcomes, and taking into account the interests of previously excluded participants. These changes can come about through bargains among elites and greater citizen engagement, as well as by international actors supporting rules that strengthen coalitions for reform.
  • Publication
    World Development Report 2018
    (Washington, DC: World Bank, 2018) World Bank
    Every year, the World Bank's World Development Report takes on a topic of central importance to global development. The 2018 Report, Learning to Realize Education's Promise, is the first ever devoted entirely to education. Now is an excellent time for it: education has long been critical for human welfare, but is even more so in a time of rapid economic change. The Report explores four main themes. First, education's promise: Education is a powerful instrument for eradicating poverty and promoting shared prosperity, but fulfilling its potential requires better policies - both within and outside the education system. Second, the learning crisis: Despite gains in education access, recent learning assessments show that many young people around the world, especially from poor families, are leaving school unequipped with even the most foundational skills they need for life. At the same time, internationally comparable learning assessments show that skills in many middle-income countries lag far behind what those countries aspire to. Third, promising interventions to improve learning: Research from areas such as brain science, pedagogical innovations, or school management have identified interventions that promote learning by ensuring that learners are prepared, that teachers are skilled as well as motivated, and that other inputs support the teacher-learner relationship. Fourth, learning at scale: Achieving learning throughout an education system will require more than just scaling up effective interventions. Change requires overcoming technical and political barriers by deploying salient metrics for mobilizing actors and tracking progress, building coalitions for learning, and being adaptive when implementing programs.