BACKGROUND: The Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) was established in 2013 with the intention of developing a coordinated mechanism between volunteering EU stakeholders and developers of Orphan Medicinal Products (OMPs) to support the exchange of information aimed at enabling informed decisions on pricing and reimbursement at Member State level and to evaluate the value of an OMP based on a Transparent Value Framework. The objective of the collaborative approach was to support more equitable access to authorised therapies for people living with rare diseases, rational prices for payers and more predictable market conditions for OMP developers. Over the past 10 years, the MoCA has conducted a series of pilot projects, examining a variety of different products and technologies at different stages of development; and with contributions from a variety of patient representatives, participation from EU payers from a range of Member States and, recently, with EUnetHTA members and the European Medicines Agency participating in the meetings as observers. RESULTS: 10 years on from the establishment of the MoCA, the European landscape has significantly evolved, not only in the field of drug development with increasingly transformative therapies based on novel technologies, but also in terms of larger numbers of approved treatments, increased budget impact and the resulting associated uncertainties; as well as in terms of stakeholder collaboration and interactions. The value of early dialogue with OMP developers, including the EU payer community via their national decision-making authorities, is a key element within this early interaction and contributes to identifying, managing and reducing uncertainties allowing a prospectively planned approach earlier in development and, consequently, to support more timely, sustainable and equitable access to new OMPs, particularly where there is a high unmet medical need. CONCLUSIONS: The voluntary, informal nature of the MoCA interactions creates a flexible framework for non-binding dialogue. A forum for such interactions is needed to achieve the aims of the MoCA and both to support healthcare systems in planning as well as to underpin timely, equitable and sustainable access to new therapies for patients with rare diseases within the EU.

• Klíčová slova
• Access to medicines, Early dialogues, Multi-stakeholder, Orphan medicinal products, Value evaluation,
• MeSH
• lidé MeSH
• rozpočty * MeSH
• vyvíjení léků MeSH
• vzácné nemoci * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Evropa MeSH

Provider payment mechanisms were adjusted in many countries in response to the COVID-19 pandemic in 2020. Our objective was to review adjustments for hospitals and healthcare professionals across 20 countries. We developed an analytical framework distinguishing between payment adjustments compensating income loss and those covering extra costs related to COVID-19. Information was extracted from the Covid-19 Health System Response Monitor (HSRM) and classified according to the framework. We found that income loss was not a problem in countries where professionals were paid by salary or capitation and hospitals received global budgets. In countries where payment was based on activity, income loss was compensated through budgets and higher fees. New FFS payments were introduced to incentivize remote services. Payments for COVID-19 related costs included new fees for out- and inpatient services but also new PD and DRG tariffs for hospitals. Budgets covered the costs of adjusting wards, creating new (ICU) beds, and hiring staff. We conclude that public payers assumed most of the COVID-19-related financial risk. In view of future pandemics policymakers should work to increase resilience of payment systems by: (1) having systems in place to rapidly adjust payment systems; (2) being aware of the economic incentives created by these adjustments such as cost-containment or increasing the number of patients or services, that can result in unintended consequences such as risk selection or overprovision of care; and (3) periodically evaluating the effects of payment adjustments on access and quality of care.

• Klíčová slova
• COVID-19, Compensations, Economic incentives, Payment mechanisms,
• MeSH
• COVID-19 * MeSH
• lidé MeSH
• motivace MeSH
• pandemie MeSH
• poplatky a výdaje MeSH
• rozpočty MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

Using data from Spain, we show the impact of significant health-sector budget cuts introduced in 2012 on the rates of cesarean sections and on infant health outcomes at birth, which we use as a proxy for the quality of birth centers. Exploiting a difference-in-differences fixed-effects approach at the hospital level, we estimate a 3% increase in C-sections as a result of the budget restrictions, with no significant consequences on health outcomes at birth. Given the additional evidence in the literature on the negative short- and long-term effects of non-medically indicated C-sections, our paper provides important policy implications for population health.

• Klíčová slova
• Cesarean sections, Health spending cuts, Inappropriate healthcare,
• MeSH
• císařský řez * MeSH
• kojenec MeSH
• lidé MeSH
• porod * MeSH
• rozpočty MeSH
• těhotenství MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Španělsko MeSH

INTRODUCTION: Long-term care (LTC) is organized in a fragmented manner. Payer agencies (PA) receive LTC funds from the agency collecting funds, and commission services. Yet, distributional equity (DE) across PAs, a precondition to geographical equity of access to LTC, has received limited attention. We conceptualize that LTC systems promote DE when they are designed to set eligibility criteria nationally (vs. locally); and to distribute funds among PAs based on needs-formula (vs. past-budgets or government decisions). OBJECTIVES: This cross-country study highlights to what extent different LTC systems are designed to promote DE across PAs, and the parameters used in allocation formulae. METHODS: Qualitative data were collected through a questionnaire filled by experts from 17 OECD countries. RESULTS: 11 out of 25 LTC systems analyzed, fully meet DE as we defined. 5 systems which give high autonomy to PAs have designs with low levels of DE; while nine systems partially promote DE. Allocation formulae vary in their complexity as some systems use simple demographic parameters while others apply socio-economic status, disability, and LTC cost variations. DISCUSSION AND CONCLUSIONS: A minority of LTC systems fully meet DE, which is only one of the criteria in allocation of LTC resources. Some systems prefer local priority-setting and governance over DE. Countries that value DE should harmonize the eligibility criteria at the national level and allocate funds according to needs across regions.

• Klíčová slova
• Allocation formula, Equity, Funds allocation, Long-term care, Payer agencies,
• MeSH
• dlouhodobá péče * MeSH
• lidé MeSH
• Organizace pro hospodářskou spolupráci a rozvoj * MeSH
• rozpočty MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

A well-established political economic literature has shown as multi-level governance affects the inefficiency of public expenditures. Yet, this expectation has not been empirically tested on health expenditures. We provide a political economy interpretation of the variation in the prices of 6 obstetric DRGs using Italy as a case study. Italy offers a unique institutional setting since its 21 regional governments can decide whether to adopt the national DRG system or to adjust/waive it. We investigate whether the composition and characteristics of regional governments do matter for the average DRG level and, if so, why. To address both questions, we first use a panel fixed effects model exploiting the results of 66 elections between 2000 and 2013 (i.e., 294 obs) to estimate the link between DRGs and the composition and characteristics of regional governments. Second, we investigate these results exploiting the implementation of a budget constraint policy through a difference-in-differences framework. The incidence of physicians in the regional government explains the variation of DRGs with low technological intensity, such as normal newborn, but not of those with high technological intensity, as severely premature newborn. We also observe a decrease in the average levels of DRGs after the budget constraint implementation, but the magnitude of this decrease depends primarily on the presence of physicians among politicians and the political alignment between the regional and the national government. To understand which kind of role the relevance of the political components plays (i.e., waste vs. better defined DRGs), we check whether any of the considered political economy variables have a positive impact on the quality of regional obstetric systems finding no effect. These results are a first evidence that a system of standardized prices, such as the DRGs, is not immune to political pressures.

• Klíčová slova
• Budget cuts, DRG, Health care deficits, Health care spending, Italy, Politicians, Regional governments,
• MeSH
• financování zdravotní péče MeSH
• klasifikační systém DRG ekonomika   trendy   MeSH
• lidé MeSH
• politika * MeSH
• rozpočty statistika a číselné údaje   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Itálie MeSH

The potential of Human Biomonitoring (HBM) in exposure characterisation and risk assessment is well established in the scientific HBM community and regulatory arena by many publications. The European Environment and Health Strategy as well as the Environment and Health Action Plan 2004-2010 of the European Commission recognised the value of HBM and the relevance and importance of coordination of HBM programmes in Europe. Based on existing and planned HBM projects and programmes of work and capabilities in Europe the Seventh Framework Programme (FP 7) funded COPHES (COnsortium to Perform Human Biomonitoring on a European Scale) to advance and improve comparability of HBM data across Europe. The pilot study protocol was tested in 17 European countries in the DEMOCOPHES feasibility study (DEMOnstration of a study to COordinate and Perform Human biomonitoring on a European Scale) cofunded (50%) under the LIFE+ programme of the European Commission. The potential of HBM in supporting and evaluating policy making (including e.g. REACH) and in awareness raising on environmental health, should significantly advance the process towards a fully operational, continuous, sustainable and scientifically based EU HBM programme. From a number of stakeholder activities during the past 10 years and the national engagement, a framework for sustainable HBM structure in Europe is recommended involving national institutions within environment, health and food as well as European institutions such as ECHA, EEA, and EFSA. An economic frame with shared cost implications for national and European institutions is suggested benefitting from the capacity building set up by COPHES/DEMOCOPHES.

• Klíčová slova
• Decision scheme, European platform, HBM, Policy, Prioritisation, Resources,
• MeSH
• lidé MeSH
• mezinárodní spolupráce * MeSH
• monitorování životního prostředí * ekonomika   metody   MeSH
• náklady a analýza nákladů MeSH
• pilotní projekty MeSH
• rozpočty MeSH
• rozvoj plánování * ekonomika   metody   MeSH
• sběr dat MeSH
• směrnice jako téma MeSH
• studie proveditelnosti MeSH
• veřejná politika MeSH
• vytváření politiky * MeSH
• zdravotní politika MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Evropa MeSH

• MeSH
• dějiny 20. století MeSH
• dějiny 21. století MeSH
• kardiologická služba nemocniční * ekonomika   normy   MeSH
• kardiologie dějiny   metody   normy   MeSH
• lidé MeSH
• poskytování zdravotní péče ekonomika   normy   MeSH
• pracovní síly MeSH
• rozpočty MeSH
• Check Tag
• dějiny 20. století MeSH
• dějiny 21. století MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• historické články MeSH
• Geografické názvy
• Česká republika MeSH

After the profound economic and political changes most of the East European countries started market-oriented reforms. During the last 10 years rapid development of the private pharmaceutical sector and a slow privatisation process was observed. The balance between the private and public sector became very important for achieving NDP goals. The goal of this study is to evaluate the availability and development of the NDP structures in East European countries--Bulgaria (BG). Romania (Rom), Macedonia (Mac), Bosnia Herzegovina (BiH). For the assessment of the availability of NDP structures a questionnaire focused on seven main NDP components was used. These components are: legislation and regulations; essential drug selection and drug registration; drug allocation in the health budget/public sector financing policy; public sector procurement procedures; public sector distribution and logistics; price policy; information and continuing education on drug use. According to the survey the most developed NDP structures are drug legislation and regulations (incl. quality control), drug registration and drug distribution. We can assume that the people have access to different drugs of appropriate quality and in time. The systems for public drug financing, procurement and price policy are under developing or not efficient enough. The financial availability of drugs is difficult. There is a lack of objective drug information and postgraduate education is not oriented on the ED. It means that there is no guarantee for rational drug prescription and usage of drugs on the markets.

• MeSH
• esenciální léky zásobování a distribuce   MeSH
• farmaceutický průmysl zákonodárství a právo   organizace a řízení   MeSH
• kontinuální vzdělávání MeSH
• lékové předpisy MeSH
• náklady na léky MeSH
• přidělování zdravotní péče MeSH
• privatizace MeSH
• průzkumy a dotazníky MeSH
• rozpočty MeSH
• veřejný sektor MeSH
• zákonodárství lékové * MeSH
• zdravotní politika * ekonomika   MeSH
• Publikační typ
• časopisecké články MeSH
• srovnávací studie MeSH
• Geografické názvy
• Bosna a Hercegovina MeSH
• Bulharsko MeSH
• Republika Severní Makedonie MeSH
• Rumunsko MeSH
• Názvy látek
• esenciální léky MeSH

Health-care reform is everywhere. Although different countries are moving at different speeds, using somewhat different means and different routes, they are all trying to arrive at the same place. The place is called "better value for money in health care". Presents details of the health-care reforms taking place in the Czech Republic, identifying and discussing the main strands of Czech reforms: the dissolution of the regional health authorities; the reorientation of district health authorities; the move to a pluralistic semi-competitive insurance-based system; hospitals receiving funding by winning contracts with purchasers; contracts becoming more sophisticated and being based on cost, volume and quality factors; changes in the incentives and rewards for GPs; the drive towards a primary-care-led health-care system; and privatization.

• MeSH
• ekonomické soutěžení MeSH
• poskytování zdravotní péče ekonomika   organizace a řízení   trendy   MeSH
• privatizace MeSH
• programy národního zdraví ekonomika   organizace a řízení   MeSH
• reforma zdravotní péče organizace a řízení   MeSH
• regionální zdravotnické plánování organizace a řízení   MeSH
• rodinné lékařství ekonomika   organizace a řízení   MeSH
• sazby - stanovení a přezkoumání MeSH
• státní lékařství organizace a řízení   trendy   MeSH
• veřejný sektor MeSH
• všeobecné zdravotní pojištění MeSH
• výdaje na zdravotnictví MeSH
• zdravotní pojištění * MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH

This paper describes the present state and discusses the future prospects of the Czechoslovak health services. The crisis in the state of health of the Czechoslovak population is briefly outlined and the main conditions of the social transformation are considered. The key features of the proposed new system of health care in the Czech republic are critically evaluated. Collaboration with individuals and institutions in the United Kingdom in the preparation, evaluation and implementation of the consecutive stages of this reform will be much appreciated.

• MeSH
• dostupnost zdravotnických služeb normy   MeSH
• ekonomické soutěžení MeSH
• financování organizované MeSH
• interinstitucionální vztahy MeSH
• lidé MeSH
• poskytování zdravotní péče ekonomika   organizace a řízení   trendy   MeSH
• předpověď MeSH
• rozpočty MeSH
• sociální změna MeSH
• zdravotní pojištění MeSH
• zdravotní priority * MeSH
• zdravotnické plánování - směrnice MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Československo MeSH