Public Health Care Budget Research Articles

The impact of EU public procurement regulations on tenders in Spain: a study with adalimumab.

Pharmaceutical spending accounts for a significant portion of public healthcare budgets. To manage these costs, EU countries implement various cost-containment policies, including competitive tendering for pharmaceuticals. This study examines the impact of EU public procurement regulations on medication procurement practices. A search for all published tenders of adalimumab in Spain from 2018 to 2024 in the Spanish Public Sector Procurement Database, a period that coincides with the implementation of European legislation and the emergence of adalimumab biosimilars. All available documentation for each tender was reviewed, including the tender offer, technical specifications, specific administrative clauses, appointments of evaluation commissions, supporting memorandum, and evaluation reports. Our findings reveal substantial price reductions following the introduction of adalimumab biosimilars, yet highlight significant variability in tender criteria and practices across different regions. Despite adherence to EU directives, the inconsistent application of economic and non-economic factors and an erratic criteria concerning price undermine the intended balance of quality and cost, complicating procurement processes and potentially affecting the availability of a given treatment for patients.

Delving into public-expenditure elasticity: Evidence from a National Health Service acute-care hospital network.

The sustainability of public hospital financing in Spain is a recurring issue, given its representativeness in annual public healthcare budgets which must adapt to the macroeconomic challenges that influence the evolution of spending. Knowing whether the responsiveness of hospital expenditure to its determinants (need, utilisation, and quasi-prices) varies according to the type of hospital could help better design strategies aimed at optimising performance. Using SARIMAX models, we dynamically assess unique nationwide monthly activity data over a 14-year period from 274 acute-care hospitals in the Spanish National Health Service network, clustering these providers according to the average severity of the episodes treated. All groups showed seasonal patterns and increasing trends in the evolution of expenditure. The fourth quartile of hospitals, treating the most severe episodes and accounting for more than 50% of expenditure, is the most sensitive to quasi-price factors, particularly the number of beds per hospital. Meanwhile, the first quartile of hospitals, which treat the least severe episodes and account for 10% of expenditure, is most sensitive to quantity factors, for which expenditure showed an elasticity above one, while factors of production were not affected. Belonging to one or another cluster of hospitals means that the determinants of expenditure have a different impact and intensity. The system should focus on these differences in order to optimally modulate expenditure not only according to the needs of the population, but also according to the macroeconomic situation, while leaving hospitals room for manoeuvre in case of unforeseen events. The findings suggest strengthening a network of smaller hospitals (Group 1)-closer to their reference population, focused on managing and responding to chronicity and stabilising acute events-prior to transfer to tertiary hospitals (Group 4)-larger but appropriately sized, specialising in solving acute and complex health problems-when needed.

A Framework for the Fair Pricing of Medicines.

As high-cost medicines put increasing pressure on public health care budgets, the need to identify 'fair' prices for medicines has never been greater. This paper proposes a framework, built upon fundamental economic principles, that allows for the consideration of 'fair' prices for medicines. The framework incorporates key considerations from conventional supply-side and demand-side approaches for specifying a cost-effectiveness 'threshold', including the health opportunity cost borne by other patients ([Formula: see text]) and society's willingness to pay for marginal improvements in population health ([Formula: see text]). The costs incurred by manufacturers in developing and supplying new medicines are also considered, as are the incentives for manufacturers to strategically price up to any common price per unit of benefit (cost-effectiveness 'threshold') specified by the payer. The framework finds that, at any 'fair' price, a medicine's dynamically calculated incremental cost-effectiveness ratio (ICER) lies below [Formula: see text]. When pricing medicines collectively, the framework finds that a common price below [Formula: see text] is required to maximize population health (consumer surplus) or to maximize total welfare (consumer and producer surplus). This framework has important policy implications for payers who wish to improve population health outcomes from constrained health care budgets. In particular, existing approaches to 'value-based pricing' should be reconsidered to ensure that patients receive a 'fair' share of the resulting economic surplus.

Budget Impact Analysis of the Use of Gilteritinib for the Treatment of Patients with Relapsed or Refractory FLT3+ Acute Myeloid Leukaemia in Public Healthcare Institutions in Mexico

INTRODUCTION: More than a third of patients with acute myeloid leukaemia (AML) have mutations in the FMS-like tyrosine kinase 3 gene (FLT3+). Patients with these mutations have a poor prognosis and are at high risk of refractory AML or treatment failure and relapse. In the last few years there have been several advances in treatment options available for relapsed/ refractory (R/R) FLT3+ AML patients, including gilteritinib. Although gilteritinib has demonstrated clinical efficacy in clinical trials, it has higher drug acquisition costs and the economic impact of including it as a new therapy is uncertain. This study aims to estimate the budget impact of the introduction of gilteritinib as an additional AML treatment on the public healthcare system in Mexico. METHODS: The target population (adult AML patients with R/R FLT3+) was calculated assuming an incidence rate of 1/100,000 and 25/100,000 in individuals 18-79 years and 80+ years respectively, 57% of patients would be R/R and 33% FLT3 positive, 2% undergo haematopoietic stem-cell transplantation (HCST), and 72% have their treatment costs covered by public funding. The cost of current AML treatment (mitoxantrone, etoposide and cytarabine [MEC], and/or fludarabine, cytarabine, granulocyte-colony stimulating factor and idarubicin [FLAG-IDA]) was obtained from the Institute for Social Security and Services for State Workers in 2021. Costs were converted to 2022 costs using the Mexican inflation rate, and compared for the following 5 years (assuming 2022 costs remained unchanged), when including gilteritinib as an additional treatment regimen for AML. The budget impact analysis over a 5-year time horizon, included direct drug costs, post-progression treatment costs, resource utilization, HSCT, and grade ≥3 adverse events. All costs were converted to USD (1 USD=20.55 MxP). RESULTS: Based on 2023 population estimates of a total 198 FLT3+ R/R AML patients, the projected consolidated treatment cost per patient is $36,848, $38,041, and $59,621 for MEC, FLAG-IDA and gilteritinib, respectively. When incorporated into a yearly estimate over 5 years, the addition of gilteritinib as a treatment option would result in a spending increase of $109,397 in 2023 rising to $475,761 in 2027. This would be an increase on the public healthcare budget of 0.0024% in 2023 to 0.0105% in 2027. CONCLUSION: Introducing gilteritinib as an orphan drug in Mexico for the treatment of R/R FLT3+ AML would have a minimal impact on the public healthcare budget over the next 5 years.

Singular and Combined Healing Activity of Aqueous Extract of Artemisia Jordanica and Achillea Fragrantissima in Rabbit’s Incision, Excision and Burn Models.

Context: Treating wounds of various ailments is a large part of the public health care budget. The Artemisia jordanica (Aj) and Achillea fragrantissima (Af) plants are folk medicinal plants that are still increasingly used to treat wounds by healers. Objective: The purpose of this study was to investigate the activity and wound healing by using the singular and combined aqueous extracts of both herbs Aj and Af. Wound healing activity was followed through excision, incision, and burn wound models. Methods: Animals were divided into eight groups (n = 8), each group was divided into two sub-groups (n = 4), one for incision and the second for both excision and burn models. Groups were treated with either 5% or 10% w/w of combined or single herb(s). Betadine and petroleum gel were used as positive and negative control, respectively. Wound contraction rate, tensile strength, period of epithelization and histological transformations were used as scores to evaluate the effect of treatments on wound healing in wounds models. Results and discussion: Wound healing activity of 10% combined aqueous extracts of (Aj-Af) has shown a worthy attainment which has evidenced by inducement of tensile strength on the 22.1 ± 1.34 day of the treatment as compared with positive control on the 21.8 ± 0.73 day of the treatment. The wound contraction rate was occurred on the 17.4 ± 0.7 day of the treatment (p < 0.05) compared with positive and negative control on the 18.5 ± 0.14 and 24.5 ± 0.7 days of the treatment, respectively. Histological observation indicates that the wounds treated with 10% Aj-Af extract have showed thickening of epidermis and formation of granulation tissue with more prominent collagenation and blood vessels formation. Conclusions: Singular and combined aqueous extracts of Aj and Af exhibited good healing activities compared with negative and positive control (p < 0.05). Both singular and combined extracts induced significant healing markings; tensile strength, wound contraction rate, granulation and collagenation compared with negative and positive controls. Moreover, healing potential activity of combined extract (mainly 10%) revealed better marginal healing activity regarding single-herb use.

Priority setting at the clinical level: the case of nusinersen and the Norwegian national expert group

BackgroundNusinersen is one of an increasing number of new, expensive orphan drugs to receive authorization. These drugs strain public healthcare budgets and challenge principles for resource allocation. Nusinersen was introduced in the Norwegian public healthcare system in 2018. A national expert group consisting of physicians was formed to oversee the introduction and continuation of treatment in light of specific start and stop criteria.MethodsWe have studied experiences within the expert group with a special emphasis on their application of the start and stop criteria, rationing of treatment, and experienced moral dilemmas. A research interview with six members of the national expert group was performed, then analysed with manifest content analysis. The analysis was supplemented with publically available sources on priority setting and the process leading up to the introduction of nusinersen and the establishment of the expert group.ResultsSixty-six patients have received treatment within the first 25 months since the national expert group’s establishment. Treatment has not been discontinued for any patient. No patients under 18 years of age have been denied treatment, as those who were referred at this age were all deemed to fulfill the start criteria. The expert group has, however, increased geographical treatment equity and facilitated important cooperation at the national level. Furthermore, it has enhanced open and critical discussions of both medical issues and new ethical dilemmas.ConclusionAlthough facilitating equal access to treatment for SMA patients, the national expert group has not discontinued treatment for any patient. It is suggested that in order for clinicians to be able to ration care for individual patients, they require both adequate support and sufficient formal authority. Start and stop criteria need to be re-evaluated as more knowledge and experience are gained regarding the treatment.

Effects of Public Healthcare Budget Cuts on Life Satisfaction in Spain

This paper investigates the impact the changes in the health care budget had on the reported levels of satisfaction in Spain during the recent economic crisis. We match individual-level data from six different waves of the European Social Survey (ESS) with regional-level expenditures in both public and private health care services between 2008 and 2018. Specifically, we analyze the effect of the three main public health care spending components (hospital and specialized health care, pharmacy and primary health care) and the aggregate private expenditures on health care borne directly by households, i.e., out-of-pocket payments. The results provide clear evidence in favor of the contention that hospital and specialized health care is positively related to life satisfaction. This result is robust as it is not affected by cyclical fluctuations of the economy nor by individual preferences. In contrast, political preferences do seem to play a role in determining how government expenditures in pharmacy and primary services influence the levels of well-being of its citizens.

Implementing a test to assess reaction, attention and inhibition capacity in elderly

Falls and fall-related injuries correspond to major, public health problems, especially among the elderly (Tinetti 2003). These injuries are a considerable burden on public health-care budgets in m...

Older People Health and Access to Healthcare: A Retrospective Look at Inequality Dynamics Over the Past Decade

The past decade of austerity measures has severely hit Public Healthcare provision in Italy, entailing significant reductions in per-capita expenditure, particularly in Regions put under ‘Healthcare Budget Recovery Plans’, mostly in the South of the country. Building on data on individuals aged 50 or older drawn from the Survey of Health, Ageing and Retirement in Europe, we compute time- and area-specific Concentration and Horizontal Inequity indexes, to assess the evolution of inequity in older people health and healthcare access (i.e. GP contacts and specialists’ visits) across Italian macro-areas since the Great Recession onset. Results show that in the North, while health has been improving on average, income-related inequality in health has increased; in the South, while on average health has not improved, the concentration of bad health among the income-poor has decreased. Sizeable inequity in access to specialists’ visits emerges throughout the country, and generally worsened since before the crisis onset. Evidence overall suggests that in the South, along the crisis, under worsened income conditions and Public Healthcare budget cuts, poorer older individuals might have substituted specialised care with increased family doctors’ visits.

The Financial Burden of Road Traffic Injuries in Mozambique: A Hospital-Related Cost-of-Illness Study of Maputo Central Hospital.

Road traffic injuries (RTIs) are increasingly being recognized for their significant economic impact. Mozambique, like other low-income countries, suffers staggering rates of road traffic collisions. To our knowledge, this is the first study to estimate direct hospital costs of RTIs using a bottom-up, micro-costing approach in the Mozambican context. This study aims to calculate the direct, inpatient costs of RTIs in Mozambique and compare it to the financial capacity of the Mozambican public health care system. This was a retrospective, single-centre study. Charts of all patients with RTIs admitted to Maputo Central Hospital over a period of 2months were reviewed. The costs were recorded and analysed based on direct costs, human resource costs, and overhead costs. Costs were calculated using a micro-costing approach. In total, 114 patients were admitted and treated for RTIs at Maputo Central Hospital during June-July 2015. On average, the hospital cost per patient was US$ 604.28 (IQR 1033.58). Of this, 44% was related to procedural costs, 23% to diagnostic imaging costs, 17% to length-of-stay costs, 9% to medication costs, and 7% to laboratory test costs. The average annual inpatient cost of RTIs in Mozambique was almost US$ 116million (0.8% of GDP). The financial burden of RTIs in Mozambique represents approximately 40% of the annual public health care budget. These results help highlight the economic impact of trauma in Mozambique and the importance of an organized trauma system to reduce such costs.

PHP155 - THE DEVELOPMENT AND EMPIRICAL APPLICATION OF A MULTIPLE SOCIETAL VALUE CRITERIA APPROACH TO RESOURCE ALLOCATION AMONG DISEASE CATEGORIES

Historically, resource allocation in healthcare is mainly driven by demand (as opposed to actual need) and fails to incorporate a series of value judgements that are essential from a social welfare maximisation perspective. The objective of this study was to develop and apply a multiple societal value criteria approach in order to highlight the preferences regarding the priorities for resource allocation among disease categories within the context of a hypothetical (and anticipated) increase in the public healthcare budget of Greece. The approach broadly follows the principles of multiple criteria decision analysis. Initially, a list of relevant resource allocation criteria, under specific properties (completeness, non-redundancy, non-overlap, independence) was developed, following a detailed literature review. Societal value judgments were sourced via a multidisciplinary panel of experts. The panel, via compositional scoring elicitation, provided the scores for each alternative (sixteen disease categories, classified according to the Global Burden of Disease study) in each criterion. Finally, the weight for each criterion in the decision algorithm was determined and “total value” in terms of priority preference was estimated under an additive value function. The criteria that were deemed relevant to the decision-making process and their respective weights were: burden of disease of each disease category (0.245), capacity-to-benefit from further allocation of resources (0.190), direct cost and projected changes in the next 5years (0.160), indirect cost (0.132), intensity of unmet needs (0.109), incidence of catastrophic expenditure (0.091) and “option value” (0.073). Combining the performance scores of each disease category - against each criterion - and criteria weights, highest “total value” scores were recorded for neoplasms, circulatory diseases, injuries, neurological diseases and diseases of the musculoskeletal system (top-5 choices in descending order). Incorporation of societal value criteria in resource allocation decisions can highlight priorities and lead to different sets of planning decisions than solely demand-driven allocation.

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review.

Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries.Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017.Results: The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application.Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries.

Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries.Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country. Data on the extent of reimbursement of biologic drugs (separately for original products and biosimilars) in the years 2014 and 2015 were also collected for each country, along with data on the total pharmaceutical and total public health care budgets.Results: Our survey revealed that no specific criteria were applied for the pricing and reimbursement of biosimilars in the selected CEE countries; the price of biosimilars was usually reduced compared with original drugs and specific price discounts were common. Substitution and interchangeability were generally allowed, although in most countries they were at the discretion of the physician after a clinical assessment. Original biologic drugs and the corresponding biosimilars were usually in the same homogeneous group, and internal reference pricing was usually employed. The reimbursement rate of biosimilars in the majority of the countries was the same and amounted to 100%. Generally, the higher shares of expenditures were shown for the reimbursement of original drugs than for biosimilars, except for filgrastim, somatropin, and epoetin (alfa and zeta). The shares of expenditures on the reimbursement of biosimilar products ranged from 8.0% in Estonia in 2014 to 32.4% in Lithuania in 2015, and generally increased in 2015. The share of expenditures on reimbursement of biosimilars in the total pharmaceutical budget differed between the countries, with the highest observed value for Slovakia and Hungary and the lowest—for Croatia.Conclusions: The requirements for the pricing and reimbursement of biosimilar products as well as the access of patients to biologic treatment do not differ significantly between the considered CEE countries. Biosimilar drugs significantly influence the reimbursement systems of these countries, and the expenditure on the reimbursement of biosimilars is increasing as they are becoming more accessible to patients.

Health Systems Sustainability and Rare Diseases.

The paper is addressing aspects of health system sustainability for rare diseases in relation to the current economic crisis and equity concerns. It takes into account the results of the narrative review carried out in the framework of the Joint Action for Rare Diseases (Joint RD-Action) "Promoting Implementation of Recommendations on Policy, Information and Data for Rare Diseases", that identified networks as key factors for health systems sustainability for rare diseases. The legal framework of European Reference Networks and their added value is also presented. Networks play a relevant role for health systems sustainability, since they are based upon, pay special attention to and can intervene on health systems knowledge development, partnership, organizational structure, resources, leadership and governance. Moreover, sustainability of health systems can not be separated from the analysis of the context and the action on it, including fiscal equity. As a result of the financial crisis of 2008, cuts of public health-care budgets jeopardized health equity, since the least wealthy suffered from the greatest health effects. Moreover, austerity policies affected economic growth much more adversely than previously believed. Therefore, reducing public health expenditure not only is going to jeopardise citizens' health, but also to hamper fair and sustainable development.

Implication of external price referencing and parallel trade on pharmaceutical expenditure: indirect evidence from lower-income European countries.

External price referencing (EPR) is applied more and more frequently worldwide by payers to control pharmaceutical prices. Together with the parallel trade of pharmaceuticals, EPR may result in lower pharmaceutical prices in higher-income countries and higher prices in lower-income countries, which implies that pharmaceutical expenditure grows more rapidly in the latter than in the former group. Our objective was to assess this hypothesis. We used hierarchical linear models on country-level panel data to show that-after controlling for compounding factors such as GDP, the proportion of the old-age population or life expectancy-the annual growth rate of pharmaceutical expenditure was 2.1% points larger in the lower- than in the higher-income members of the European Union between 2000 and 2008. This difference in trends became non-significant (0.6% points) after the onset of the global economic crisis. There was no significant difference between lower- and higher-income countries in the growth rate of non-pharmaceutical health expenditure in either period. Our results indirectly support the presence of price convergence of pharmaceuticals among European countries, and EPR and parallel trade may provide a reasonable explanation to the observed trend difference of pharmaceutical expenditure in the two groups of countries between 2000 and 2008. This higher growth rate of pharmaceutical expenditure put extra burden on public health care budgets in lower-income countries and resulted in disproportionately more cost-containment measures compared to higher-income countries after 2008. It remains to be seen whether the disappearance of the difference in trend growth rates due to special health policy interventions in countries with economic difficulties is temporary or permanent.

An assessment of Canadian systems for triaging referred out genetic testing.

The field of genetics is evolving rapidly, significantly expanding the number of clinically useful genetic tests. The cost of genetic testing has created an increasing burden on public health care budgets. In Canada, funding bodies have responded by developing independent systems. Key individuals in each province and territory participated in a semi-structured interview regarding the process in their jurisdiction to approve funding for referred out genetic testing and their decision-making criteria. Two themes were identified: the importance of clinical utility in decision-making and the utilization of genetic specialists as gate keepers. Allocation of a specific budget appears to be associated with some fiscal responsibility. Collaboration between provincial and territorial bodies may lead to a more unified approach across Canada.

A Budget Impact Model for Paclitaxel-eluting Stent in Femoropopliteal Disease in France

PurposeThe Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent.MethodsA model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only.ResultsThe model estimated a net cumulative 5-year budget reduction of €6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses.ConclusionAdoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

An experimental investigation of mixed systems of public and private health care finance

This paper presents the results of a revealed-choice experiment testing the theoretical predictions of a model of a mixed system of public and private finance. We investigate behavioural responses in individuals’ willingnesses-to-pay for private health insurance to changes in the public sector allocation rule (needs-based vs. random), the supply of health care resources, and the size of the public health care budget. Of particular interest is how willingness-to-pay for private insurance feeds back into the determination of the equilibrium price of health care resources, the probability of public treatment and which individuals are left untreated. Our findings are generally consistent with the predictions of the theoretical model, although individuals consistently exhibit greater willingnesses-to-pay for private insurance than predicted resulting in a larger than predicted amount of private insurance being purchased. A commonly used risk-aversion measure only partially explains this observed deviation. We also find that, relative to a system of public financing only, a mixed system of health care finance results in higher health care prices and sicker, poorer people being left untreated.

Overcoming challenges in market access of generic medicines in the European Union

Generic medicines have become essential contributors for governments in their effort to contain public health care budgets. Therefore, market access of generic medicines should be made possible immediately after expiry of the patent protecting the originator medicine. Generic medicines can only enter the market when the patent on the originator medicine is expired and when a marketing authorisation and pricing and reimbursement approval have been obtained from the national competent authorities. Arguments on patent validity or patent infringement which result in litigation before national courts, backlogs in national approval systems, defensive patenting strategies (‘evergreening’), patent linkage and third-party interventions during the process of marketing authorisation and pricing and reimbursement are well-documented causes for delayed market access of generic medicines. The establishment of a unitary European Union patent together with a unified and specialised patent litigation system, the reduction of backlogs in national agencies, avoiding third-party interventions as much as possible and automatic approval of pricing and reimbursement status upon marketing authorisation approval of the generic medicines are just a few examples of policies which could enhance market access of generic medicines in the European Union. This article aims to provide an overview of the regulatory framework regarding market access of generic medicines in the European Union and lists the hurdles which impede market access. Recommendations to enhance market access of generic medicines round off this article.

Confiabilidade dos dados relativos ao cumprimento da Emenda Constitucional nº. 29 declarados ao Sistema de Informações sobre Orçamentos Públicos em Saúde pelos municípios de Pernambuco, Brasil

The present study analyzes the reliability of data on compliance with Constitutional Amendment 29 (CA29) reported to the Public Healthcare Budget Information System (known as SIOPS) by municipalities in the State of Pernambuco, Brazil. A quantitative, analytical cross-sectional study was conducted using the years 2000 to 2005 as the reference. Invoices audited by the State Accounts Court were used as the parameter for determining reliability of the percentage of compliance with CA29 as reported to SIOPS, using the intraclass correlation coefficient (ICC) to measure data agreement. The results show a mismatch between the databases, suggesting slight to moderate agreement between the SIOPS data and those from the State Accounts Court. The low degree of agreement may result from lack of consensus among municipalities regarding definition of health-related revenues and expenses or the existence of different criteria used by SIOPS and the State Accounts Court for calculating the CA29.