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Worldwide, more than 2 billion people lack access to medicines, leading to more than 10 million people dying needlessly as a result of this lack of access. Most of these deaths occur in Sub-Saharan Africa. To gain a deeper understanding of how barriers at different levels of the health system influence access in the region, and what lessons might be learned, this thesis focussed on three distinct cases: internationally controlled essential medicines (medicines listed on WHO’s Essential Medicines List and one of three international drug control conventions, such as morphine and phenobarbital), the treatment of snakebite envenoming, and commodities for sexual and reproductive health (SRH). Using these three cases, this thesis demonstrated that access to medicines remains a critical issue for the majority of people living in Sub-Saharan Africa. It shows that while access to essential medicines for specific care fields or diseases may be subject to topic-specific barriers, many of the barriers are transcendent and are the result of an interplay of conditions across the health system that affect all areas of access. By looking at the similarities between care fields and diseases, and not the dissimilarities, this thesis has shown that a system-wide approach is needed to strengthen health systems in the Sub-Saharan region. Such an approach should be targeted at individuals, households and the community, the delivery of health services, and governance at the health sector, national and international level. A complex issue such as this needs active involvement from all actors, including patients and communities, community- and faith leaders, healthcare workers, civil society, governments, researchers, and international actors.

Colombia has a notorious dependency on the importation of medicines, as well as a large part of the materials (active ingredients and excipients) required for their manufacture. This problem generates health and macroeconomic consequences, which are exacerbated in the context of national deindustrialization and technological disruption. In this way, it is accepted that the availability and access to medicines and other essential health technologies are a fundamental requirement to achieve the health autonomy of a country. Therefore, it is crucial to coordinate efforts between several social sectors to develop a public agenda focused on creating conditions that allow strengthening the scientific and technological capabilities of the local pharmaceutical industry, thereby, improving the country’s pharmaceutical supply. This document presents conceptual and practical topics that should be considered to defining and materializing a public policy aimed at strengthening the local pharmaceutical industry and favoring Colombia’s sanitary autonomy., Colombia depende de la importación de medicamentos, así como de gran parte de los materiales (principios activos y excipientes) requeridos para su elaboración; problemática que genera consecuencias sanitarias y macroeconómicas, las cuales se agudizan en el contexto de desindustrialización nacional y de disrupción tecnológica. De esta manera, se acepta que la disponibilidad y acceso a medicamentos y otras tecnologías sanitarias esenciales son un requisito fundamental para alcanzar la autonomía sanitaria de un país. Por lo tanto, resulta imprescindible coordinar esfuerzos entre diversos sectores sociales para desarrollar una agenda pública enfocada a la creación de condiciones que fortalezcan las capacidades científicas y tecnológicas de la industria farmacéutica local, y con ello, mejorar el suministro farmacéutico del país. En el presente documento se presentan conceptos teóricos y prácticos que deberían ser considerados en la definición y materialización de una política pública encaminada a fortalecer la industria farmacéutica y favorecer la autonomía sanitaria de Colombia.

Health spending has been growing at a much higher rate than the income of countries practically all over the world. This increase is due to many factors such as the demographic and epidemiological transition, the increase in the expectations of the middle class and, mainly, the presence of more and better health technologies, such as medicines and medical devices. The case of Brazil does not escape the general rule. Expenditure on medicines increased by 40% from 2010 to 2015. Currently, this expenditure represents 16% of the public health budget. To face this challenge, the country has implemented pharmaceutical pricing policies among its strategies. This document presents the main strategies that the country has adopted, and the results achieved to date; highlighting the importance of regulatory designs aligned with the policy objectives and the local contexts.

Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making.Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions.Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data access

Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making.Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions.Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data access

Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making.Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions.Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data access

Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making.Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions.Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data access

Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national collaboration to improve data collection and inform decision-making.Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions.Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data access

[eng] Background: Drug distribution network management is one of the most important facilities in the ministry of health. This network is faced with several issues. The present survey was done to assess the roles of health policy makers in drug distribution among pharmacies. Methods: A Judgmental sampling method was used in this study. Five managers of the Department of Drugs, Food and Narcotics of the Ministry of Health, Tehran, Iran who were determined the country’s pharmaceutical policy, were selected in this survey. Designed questionnaire was presented to all 5 health policy makers. The data were stratified and the descriptive analysis method was used to test their partial and general hypotheses. Cronbach’s alpha test was used to assess the validity of the questionnaires. Results: As the Alpha= 0.850 was obtained for questions in the presented questionnaire, they have been approved as reliable. The study hypothesis (the impact of health policymakers’ trust on drug distribution marketing strategies) was accepted because 60% of respondents believed in the effect of gaining policymakers’ trust in marketing strategy and 35% of them believed gaining the trust of policymakers has a huge impact on marketing strategy. Conclusion: Findings showed that adhering to pharmacy quotas, provincial distribution criteria for drugs, adhering to approved drug prices, and having effective and efficient management affect marketing strategies. However, to found other factors affected the health policy makers drug distribution, several studies should perform., [spa] Antecedentes: La gestión de la red de distribución de medicamentos es uno de los servicios más importantes del Ministerio de Sanidad. Esta red se enfrenta a varios problemas. La presente encuesta se realizó para evaluar el papel de los responsables de la política sanitaria en la distribución de medicamentos entre las farmacias. Métodos: En este estudio se utilizó un método de muestreo criterioso. En esta encuesta se seleccionaron cinco gerentes del Departamento de Medicamentos, Alimentos y Narcóticos del Ministerio de Salud de Teherán, Irán, que determinaban la política farmacéutica del país. El cuestionario diseñado se presentó a los cinco responsables de la política sanitaria. Los datos se estratificaron y se utilizó el método de análisis descriptivo para probar sus hipótesis parciales y generales. Se utilizó la prueba alfa de Cronbach para evaluar la validez de los cuestionarios. Resultados: Al obtenerse un Alfa= 0,850 para las preguntas del cuestionario presentado, éstas han sido aprobadas como fiables. La hipótesis del estudio (el impacto de la confianza de los políticos sanitarios en las estrategias de marketing de la distribución de medicamentos) fue aceptada porque el 60% de los encuestados creía en el efecto de ganarse la confianza de los políticos en la estrategia de marketing y el 35% de ellos creía que ganarse la confianza de los políticos tiene un gran impacto en la estrategia de marketing. Conclusión: Los resultados mostraron que el cumplimiento de las cuotas de las farmacias, los criterios de distribución provincial de los medicamentos, el cumplimiento de los precios aprobados de los medicamentos y la existencia de una gestión eficaz y eficiente afectan a las estrategias de marketing. Sin embargo, para encontrar otros factores que afecten a la distribución de medicamentos por parte de los responsables de las políticas sanitarias, habría que realizar varios estudios.

Introduction: Dedicated Funds for Innovative Medicines were introduced in 2017 for cancer and non-cancer drugs in Italy. After three years, their impact on patient access to the relevant treatments and critical issues about their management has been poorly investigated. Aims and scope. This paper aims at bridging the literature gap and providing possible reforms scenarios. Methods: Our analysis relied on a qualitative approach. The personal opinions of twelve Italian experts coming from the Ministry of Economy and Finance, the Scientific Committee of the Italian Medicines Agency, the Regions and Patient Associations, the Oncologists’ Scientific Societies and Hospital Pharmacists were elicited through a Delphi approach. A consensus on final recommendations was reached in two rounds. Results: Experts were in favour of maintaining dedicated Funds for Innovative Medicines and had a distinct preference for a single Fund. Most of them suggested to extend access to Funds to more than three years, if, for the relevant indication, there are no alternatives to the innovative drug and provided that this does not represent a barrier to new entries. Responders advocated for Funds being covered by on top resources and the production of more evidence on their impact. They finally claimed a speeder flow of information to the regions on expenditure for innovative treatments and an enhancement of controls on prescribing behaviour, to avoid prescriptions be dependent on Funds capacity. Conclusions: The consensus document provides for eight recommendations that could be taken into account for possible reforms and future research on this topic.

This paper provides an empirical investigation into the types of partnerships that have emerged during the pandemic to develop COVID-19 vaccines and to identify relevant factors that characterize these partnerships. We provide legal and policy considerations to our results that suggest an opportunity for policymakers to help shift the collaborative landscape to increase the potential for knowledge-sharing, the development of fundamental insight, and the adequate production of resulting technological goods, both in this pandemic and the next. Volume 39, Issue 42, 8 October 2021, Pages 6291-6295

This paper provides an empirical investigation into the types of partnerships that have emerged during the pandemic to develop COVID-19 vaccines and to identify relevant factors that characterize these partnerships. We provide legal and policy considerations to our results that suggest an opportunity for policymakers to help shift the collaborative landscape to increase the potential for knowledge-sharing, the development of fundamental insight, and the adequate production of resulting technological goods, both in this pandemic and the next. Volume 39, Issue 42, 8 October 2021, Pages 6291-6295

Introduction: Dedicated Funds for Innovative Medicines were introduced in 2017 for cancer and non-cancer drugs in Italy. After three years, their impact on patient access to the relevant treatments and critical issues about their management has been poorly investigated. Aims and scope. This paper aims at bridging the literature gap and providing possible reforms scenarios. Methods: Our analysis relied on a qualitative approach. The personal opinions of twelve Italian experts coming from the Ministry of Economy and Finance, the Scientific Committee of the Italian Medicines Agency, the Regions and Patient Associations, the Oncologists’ Scientific Societies and Hospital Pharmacists were elicited through a Delphi approach. A consensus on final recommendations was reached in two rounds. Results: Experts were in favour of maintaining dedicated Funds for Innovative Medicines and had a distinct preference for a single Fund. Most of them suggested to extend access to Funds to more than three years, if, for the relevant indication, there are no alternatives to the innovative drug and provided that this does not represent a barrier to new entries. Responders advocated for Funds being covered by on top resources and the production of more evidence on their impact. They finally claimed a speeder flow of information to the regions on expenditure for innovative treatments and an enhancement of controls on prescribing behaviour, to avoid prescriptions be dependent on Funds capacity. Conclusions: The consensus document provides for eight recommendations that could be taken into account for possible reforms and future research on this topic.

BACKGROUND: Pharmacies in Europe have undergone considerable changes in their regulation over the last decades, also regarding nonprescription medicines (NPMs). In 2001, selected NPMs were released for sale outside pharmacies in Denmark. To ensure consumer safety, it was decided that NPMs must be stored behind the counter. In 2018, an amending act came into force, which allowed self-selection of NPMs. The purpose of this study was to examine the rationales and related arguments, including their validity and relevance, behind the policy on self-selection of NPMs in Denmark. METHODS: A qualitative study design, combining document analysis and individual interviews with key stakeholders, was used. Legislative documents were retrieved from the Parliaments' homepage. Interviewees were recruited through purposeful sampling. Interviews were analyzed using directed content analysis. Rationales and supporting arguments were identified, thematized and analyzed as to their validity and relevance. RESULTS: In total, 24 stakeholders (including political parties) were represented in the documents, whereof 7 were interviewed. Ten supported the new policy and 13 were against; 1 was on both sides. Six rationales and 9 supportive arguments were found. The advocates' main rationale was increased accessibility and arguments related to freedom of choice and discretion. The opponents' main rationale for not adopting the policy was consumer safety and arguments related to perception of NPMs and counseling. The validity and relevance were questionable in both advocates' and opponents' arguments, yet slightly better in the case of the opponents'. Although not mentioned in the documents, economic interests were probably behind some stakeholders' position. CONCLUSION: The formal rationale behind the adoption of self-selection of NPMs was increased accessibility. However, bearing in mind the rationales and their supporting arguments, economic interests and previous changes within the sector, i

Introduction: Although there is a significant utilization gap of biologic medicines in the EU, many studies estimate equity in patient access to biopharmaceuticals only based on their availability on the national list of reimbursed medicines. Hidden access barriers may facilitate financial sustainability of pharmaceuticals in less affluent EU countries; however, they have rarely been documented in scientific publications. Our objective was to explore these access barriers for tumor necrosis factor (TNF) alpha inhibitors in rheumatoid arthritis (RA) in five Central and Eastern European countries. Methods: A detailed interview guide was developed based on multi-stakeholder workshops and a targeted literature review. In each participant country 3-3-3-3 interviews with payers, rheumatologists, patients/patient representatives, and industry representatives were conducted. Responses were aggregated at a country level and validated by primary investigators in each country. Results: Limited number of RA centers and consequently significant travelling time and cost for patients in distant geographical areas, uneven budget allocation among centers, limited capacity of nurses, narrowed patient population in national financial protocols compared to international clinical guidelines in initiating or continuing biologics, high administrative burden in prescribing biologics and limited health literacy of patients were the most relevant barriers to timely patient access in at least three participant countries. Conclusion: Assessing only the availability of TNF alpha inhibitors on the national list of reimbursed medicines provides limited information about real-world patient access to these medicines. Revealing hidden access barriers may contribute to initiate policy actions which could reduce inequity in patient access.

Background: Pharmacies in Europe have undergone considerable changes in their regulation over the last decades, also regarding nonprescription medicines (NPMs). In 2001, selected NPMs were released for sale outside pharmacies in Denmark. To ensure consumer safety, it was decided that NPMs must be stored behind the counter. In 2018, an amending act came into force, which allowed self-selection of NPMs. The purpose of this study was to examine the rationales and related arguments, including their validity and relevance, behind the policy on self-selection of NPMs in Denmark. Methods: A qualitative study design, combining document analysis and individual interviews with key stakeholders, was used. Legislative documents were retrieved from the Parliaments' homepage. Interviewees were recruited through purposeful sampling. Interviews were analyzed using directed content analysis. Rationales and supporting arguments were identified, thematized and analyzed as to their validity and relevance. Results: In total, 24 stakeholders (including political parties) were represented in the documents, whereof 7 were interviewed. Ten supported the new policy and 13 were against; 1 was on both sides. Six rationales and 9 supportive arguments were found. The advocates' main rationale was increased accessibility and arguments related to freedom of choice and discretion. The opponents' main rationale for not adopting the policy was consumer safety and arguments related to perception of NPMs and counseling. The validity and relevance were questionable in both advocates' and opponents' arguments, yet slightly better in the case of the opponents'. Although not mentioned in the documents, economic interests were probably behind some stakeholders' position. Conclusion: The formal rationale behind the adoption of self-selection of NPMs was increased accessibility. However, bearing in mind the rationales and their supporting arguments, economic interests and previous changes within the sector

Background: Pharmacies in Europe have undergone considerable changes in their regulation over the last decades, also regarding nonprescription medicines (NPMs). In 2001, selected NPMs were released for sale outside pharmacies in Denmark. To ensure consumer safety, it was decided that NPMs must be stored behind the counter. In 2018, an amending act came into force, which allowed self-selection of NPMs. The purpose of this study was to examine the rationales and related arguments, including their validity and relevance, behind the policy on self-selection of NPMs in Denmark. Methods: A qualitative study design, combining document analysis and individual interviews with key stakeholders, was used. Legislative documents were retrieved from the Parliaments' homepage. Interviewees were recruited through purposeful sampling. Interviews were analyzed using directed content analysis. Rationales and supporting arguments were identified, thematized and analyzed as to their validity and relevance. Results: In total, 24 stakeholders (including political parties) were represented in the documents, whereof 7 were interviewed. Ten supported the new policy and 13 were against; 1 was on both sides. Six rationales and 9 supportive arguments were found. The advocates' main rationale was increased accessibility and arguments related to freedom of choice and discretion. The opponents' main rationale for not adopting the policy was consumer safety and arguments related to perception of NPMs and counseling. The validity and relevance were questionable in both advocates' and opponents' arguments, yet slightly better in the case of the opponents'. Although not mentioned in the documents, economic interests were probably behind some stakeholders' position. Conclusion: The formal rationale behind the adoption of self-selection of NPMs was increased accessibility. However, bearing in mind the rationales and their supporting arguments, economic interests and previous changes within the sector

Background: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection o

The issue of securing access to patented pharmaceutical products has been in the forefront of global legal debate for many years. This debate intensified further following the enactment of the TRIPS agreement and the global enforcement of Intellectual Property Rights such as patents through the World Trade Organization. To combat the problem, compulsory licensing has been forwarded as one solution, though hitherto mainly discussed from the human rights and right to health perspectives. Less attention has been focused on excessive prices of medicines as an anticompetitive practice in and out of themselves, and how competition law and legal-economics theories and models can inform this deadlocked issue. Such a treatment of excessive prices under competition law would constitute a sound legal basis for anti-competetive enforcement such as compuslory licensing but also make other tools available to competition authorities such as fines. This could be done making use of the flexibilities entailed in this regard in the TRIPS agreement context, mainly through article 31(k) and article 40. Shifting focus to the European Competition Law, the notion of “unfair” or excessive prices has been enshrined in article 102 TFEU regarding exploitative pricing abuses by a dominant firm, although the application and enforcement of this has been rather limited in practice. Recent case law and an evoloution of thought regarding competition law and legal-economics theories point however to a possible policy shift in this regard. The paper hence analyses the unlocked potential entailed in competition law in treating excessive pharmaceutical prices as an anticompetitive practice where applicable and discusses the legal-economic theories underpinning this discourse.

The aim of this paper is to provide an empirical framework based on a discrete-time Markov chain to assess the costs and benefits of Performance Based Agreements (PBAs) for the reimbursement of pharmaceuticals. We provide an empirical testing using a case study referring to a treatment recently approved for reimbursement in Italy. The implementation of this framework is challenging for the agencies dealing with pricing and reimbursement decisions given the uncertainty associated with the treatment effectiveness and safety. On the other hand, empirical evidence shows that the awareness of the expected costs associated with different reimbursement schemes is necessary to inform decision-makers.

Background: European legislation prohibits direct-to-consumer advertising of prescription medicines, but allows drug manufacturers to provide information to the public on health and diseases. Our aim was to measure the frequency of disease awareness campaigns in Latvian media and assess their compliance with international and European standards. Methods: Materials on health/disease and treatments were collected between April and September 2015 from 12 newspapers and magazines and six online portals. Disease awareness campaigns were assessed using a previously developed instrument based on the WHO Ethical Criteria for Medicinal Drug promotion and European standards (EU law and pharmaceutical industry self-regulatory guidelines). Collected materials were used to examine the information provided on medical conditions and their diagnosis and treatment. The inter-rater reliability was calculated. Results: We collected 263 materials from print (n = 149) and online media (n = 114); 94 were news items and 169 were disease-awareness advertisements. Cancer, cardiovascular problems, allergies and respiratory diseases were common topics. Of the 157 campaigns assessed, non-compliance was identified in 149 cases (inter-rater reliability 90%), mainly due to misleading or incomplete information, lack of balance and the absence of a listed author/sponsor. Six disease awareness campaigns directly mentioned a pharmaceutical product by brand name and other four included the logo or name of a manufacturer, referred to a condition and indirectly mentioned a treatment, all in contravention with European law. Conclusions: The compliance of disease awareness campaigns in Latvian media with international and European standards is low. This raises concerns about the nature of information being conveyed. Through lack of balance, missing sponsorship information, and misleading or incomplete information, these campaigns could contribute to inaccurate self-diagnosis and generate demand among t

Today’s patients are vocal, informed and eager to participate in processes which affect them. This also applies to the pharmaceutical policy arena – and to debates around the research and development of new drugs, their access and use. Patients and consumers play varied roles in pharmaceutical policy. They represent peers in dedicated platforms hosted by health authorities, provide input on their preferences and experiences in medicines’ use, advocate for reimbursement of new therapies, and can also be the target audience of awareness campaigns and pharmaceutical advertising. There are many instances for patient involvement throughout a drug’s life cycle which also represent unique opportunities for research. This thesis presents an analysis of challenging issues in pharmaceutical policy from a patient perspective untangling how the dissemination of information across stakeholders influences the uptake of new pharmaceutical products. Within the realm of pharmaceutical policy, we have explored initiatives or practices which are intrinsically perceived as positive developments but that, after thorough examination, demand further monitoring and action. Three key points stand out. First, the importance of applying rigorous standards for drug approval and reimbursement as a corner stone for appropriate medicine use. Placing public interests at the core means aligning clinical research with public priorities, designing clinical studies that explore outcomes relevant to patients and respond to questions which are valid from a societal perspective. The introduction of comparative requirements at the time of market approval could encourage manufacturers to go being incremental innovation and to focus on therapeutic areas with limited treatment options, thus addressing more pressing health problems and meeting societal needs. Second, the need to ensure proper representation in regulatory and pharmaceutical policy debates. Bearing in mind that the formation of ph

This Breve first highlights the importance of pharmaceutical procurement policies. It then focuses on the goals of National Drug Policies. Based on these goals, it looks into the reasons for intervening in pharmaceutical markets and different forms of intervention. The subsequent sections analyze in further detail the procurement of in-patent and off-patent medicines, since there are fundamental differences in the procurement of these two medicine types. Finally, the Breve concludes by summarizing the most important issues for policymakers to keep in mind when defining procurement policies.

The following Breve provides an overview of the main challenges that societies, health care systems, and policy makers are currently facing to confront cancer. This brief analyzes the main characteristics of cancer, and shows how these influence the development of new drugs. At the same time, it looks at some of the implications for patients. It also presents some thoughts on the pharmaceutical industry related to cancer treatments. Finally, it summarizes some policy lessons emerging from the analysis, and explains why basic research, better market regulation and a stronger focus on cancer prevention should be the main priorities to fight cancer in the future.

BACKGROUND: Statins are among the most commonly prescribed drugs worldwide in the prevention of cardiovascular diseases and their effectiveness is largely acknowledged. The consumption of statins increased four-fold during the 2000-2010 decade in Italy, almost quadrupling its level, and national and regional control policies were developed. Restrictions to reimbursement were fixed at the national level, whereas co-payment was introduced in some, but not all, regions. The aim of the present study is to assess the impact of such policies on the consumption of statins in Italy between 2001-2007 among outpatients. METHODS: The statin use in outpatients was measured in terms of defined daily doses per 1,000 inhabitants per day (DDD/1000 inh. day) from May 2001 to December 2007. The study was conducted in 17 out of 21 regions, nine of which had implemented a co-payment policy. Time trends in consumption before and after the introduction of co-payment policies and reimbursement criteria were examined using segmented regression analysis of interrupted time-series, adjusting for seasonal components. RESULTS: The consumption of statins increased by 22.9 DDD/1000 inh. day in May 2001 to 54.7 DDD/1000 inh. day in December 2007. On average, there was a 1.7% increase in statin use each month before the national guideline changed while the increase was about 0.5% afterwards. The revision of the reimbursement criteria was associated with a significant decrease in level (coefficient = -2.80, 95% CI -3.70 to -1.90 p-value <0.001) and trend (coefficient = -0.33, 95% CI -0.37 to -0.29 p-value <0.001). The introduction of co-payment was associated with a significant change in trend of consumption so that the overall use of the drug increased by 0.04 (95% CI 0.02 to 0.07, p-value < 0.001) DDD/1000 inh. day per month in the post-intervention period, but there was no evidence of a change in level of consumption (p-value = 0.163). CONCLUSIONS: Consumption of statins in Italy increased almos

Policy debate about funding criteria for drugs used to treat rare, orphan diseases is gaining prominence. This study presents evidence from a discrete choice experiment investigating the preferences of the public regarding public funding for drugs used to treat rare diseases and common diseases using a convenient sample of university students. We find that: other things equal, the respondents do not prefer to have the government spend more for drugs used to treat rare diseases; that respondents are not willing to pay more per life year gained for a rare disease than a common disease; and that the public weighs relevant attributes of the coverage decisions (e.g., costs, disease severity, treatment effectiveness) similarly for both rare and common diseases. The results confirm the importance of severity and treatment effectiveness in preferences for public funding. Though the first study of its kind, the results send a cautionary message regarding the special treatment of orphan drugs in coverage decision making.

In Iceland, drugs provided in hospitals during regular inpatient care are free of charge to the patients but outside institutional care fall under the State Social Security Institute's budget. This article details the measures taken to control drug costs and their impact in Iceland. The cancellation of reimbursement for antibiotics in 1991 resulted in a slight decrease in sales. The change in the list of "hospital only" medicines caused massive protests from pharmacists and physicians. The pharmaceutical policy in Iceland has been problematic in its formulations and implementations. Recommendations in the light of the problems of Icelandic pharmaceutical policies have been provided in the article.

In Iceland, drugs provided in hospitals during regular inpatient care are free of charge to the patients but outside institutional care fall under the State Social Security Institute's budget. This article details the measures taken to control drug costs and their impact in Iceland. The cancellation of reimbursement for antibiotics in 1991 resulted in a slight decrease in sales. The change in the list of "hospital only" medicines caused massive protests from pharmacists and physicians. The pharmaceutical policy in Iceland has been problematic in its formulations and implementations. Recommendations in the light of the problems of Icelandic pharmaceutical policies have been provided in the article.

Since its national debut in 1987, Fresh Air with Terry Gross has been a highly acclaimed and much adored weekday magazine among public radio listeners. Each week, nearly 4.8 million people turn to Peabody Award-winning host Terry Gross for insightful conversations with the leading voices in contemporary arts and issues. The renowned program reaches a global audience, with over 620 public radio stations broadcasting Fresh Air, and 3 million podcast downloads each week. Fresh Air has broken the mold of 'talk show' by weaving together superior journalism and intimate storytelling from modern-day intellectuals, politicians and artists alike. Through probing questions and careful research, Gross's interviews are lauded for revealing a fresh perspective on cultural icons and trends. Her thorough conversations are often complemented by commentary from well-known contributors. Fresh Air is produced at WHYY-FM in Philadelphia and broadcast nationally by NPR., INT. 1: DR. THOMAS MOORE, Senior Fellow at George Washington's Center for Health Policy Research and author of the new book, Deadly Medicine: Why Tens of Thousands of Heart Patients died in America's Worst Drug Disaster (Simon & Schuster) Moore tells the story of a certain line of drugs that prevented irregular heartbeats but were consequently shown to be dangerous and even fatal. Yet the drug remained on the market due in large part to the giant pharmaceuticals power over the FDA. Deadly Medicine is MOORES's third book on the medical system. INT. 2: DR. ROBERT TEMPLE, Director of the FDA's Office of Drug Evaluation. TEMPLE is a large figure in Thomas Moore's new book. He is the man Moore says let the harmful drugs remain on the market virtually unrestricted, even though the risks were known. He gives the reason why the FDA let the drugs remain on the market. REV. Interview with ROBERT TEMPLE continues.

Since its national debut in 1987, Fresh Air with Terry Gross has been a highly acclaimed and much adored weekday magazine among public radio listeners. Each week, nearly 4.8 million people turn to Peabody Award-winning host Terry Gross for insightful conversations with the leading voices in contemporary arts and issues. The renowned program reaches a global audience, with over 620 public radio stations broadcasting Fresh Air, and 3 million podcast downloads each week. Fresh Air has broken the mold of 'talk show' by weaving together superior journalism and intimate storytelling from modern-day intellectuals, politicians and artists alike. Through probing questions and careful research, Gross's interviews are lauded for revealing a fresh perspective on cultural icons and trends. Her thorough conversations are often complemented by commentary from well-known contributors. Fresh Air is produced at WHYY-FM in Philadelphia and broadcast nationally by NPR., INT. 1:AIDS activist MARTIN DELANEY. In 1980 he was suffering from life-threatening Hepatitis. He treated it with drugs then unapproved in the U.S. In 1985 DELANEY, a former Jesuit seminarian, founded Project Inform--which gathers information and speeds access to AIDS treatments. DELANEY is involved in both worlds of the AIDS epidemic. He works with the a growing underground movement in California. He has helped to bring thousands of Compound Q, an unapproved AIDS drug, out of China. DELANEY also works closely with Washington officials, especially in the FDA. DELANEY's life and work are discussed extensively in Jonathon Kwitny's controversial new book, "Acceptable Risks." (Poseidon Press) INT. 2:Lawyers SUZANNE GOLDBERG and MARK HUVARD (pronounced HUE-vahrd). Both are involved with a lawsuit against the U.S. Federal Courts. A recent federal court ruling allows employers to slash insurance coverage for AIDS victims. (Cited in the ruling was a 1974 law, which allowed companies to cut coverage for patients with diseases like cancer and Alzheimer's) Representatives of the American MedicalAssociation, the Association of Retired Persons, and the American Bar Association have all written letters to the U.S. Solicitor General, stating that the ruling was wrong. The original plaintiff in the case has already died from AIDS complications.

© 2016-IOS Press and the authors. All rights reserved.Kazan hosted Russia's second International Conference QiQUM 2015 on Cochrane evidence for health policy, which was entirely independent of the pharmaceutical or other health industry, bringing together 259 participants from 11 countries and 13 regions of the Russian Federation. The Conference was greeted and endorsed by world leaders in Evidence-based medicine, health and pharmaceutical information, policy and regulation, and the World Health Organization. Participants discussed the professional and social problems arising from biased health information, unethical pharmaceutical promotion, misleading reporting of clinical trials with consequent flaws in health care delivery and the role of Cochrane evidence for informed decisions and better health. The first in history Cochrane workshop, facilitated jointly by experts from Cochrane and the WHO, with 40 participants from Kazakhstan, Kyrgyzstan, Tajikistan and Russia introduced the concept of Cochrane systematic review and the Use of Cochrane evidence in WHO policy setting. Websites document conference materials and provide interface for future collaboration: http://kpfu.ru/biology-medicine/struktura-instituta/kafedry/kfikf/konferenciya/mezhdunarodnaya-konferenciya-39dokazatelnaya.html and http://Russia.cochrane.org/news/international-conference.

Kazan hosted Russia's first international conference on medicines that was entirely independent of the pharmaceutical industry, attracting 414 participants from 9 countries and 20 regions of the Russian Federation. The meeting was greeted and endorsed by world leaders in pharmaceutical information, policy and regulation. Delegates discussed the professional and social problems arising from unethical drug promotion, including compromised evidence from clinical trials and consequent impairments in health service delivery. The Conference adopted a resolution prioritizing policy development and health system needs, notably including the development of clinical pharmacology. A website documents conference materials and provides an interface for future collaboration: http://evidenceupdate-tatarstan.ru/confer. © 2011 - IOS Press and the authors. All rights reserved.

© 2016-IOS Press and the authors. All rights reserved.Kazan hosted Russia's second International Conference QiQUM 2015 on Cochrane evidence for health policy, which was entirely independent of the pharmaceutical or other health industry, bringing together 259 participants from 11 countries and 13 regions of the Russian Federation. The Conference was greeted and endorsed by world leaders in Evidence-based medicine, health and pharmaceutical information, policy and regulation, and the World Health Organization. Participants discussed the professional and social problems arising from biased health information, unethical pharmaceutical promotion, misleading reporting of clinical trials with consequent flaws in health care delivery and the role of Cochrane evidence for informed decisions and better health. The first in history Cochrane workshop, facilitated jointly by experts from Cochrane and the WHO, with 40 participants from Kazakhstan, Kyrgyzstan, Tajikistan and Russia introduced the concept of Cochrane systematic review and the Use of Cochrane evidence in WHO policy setting. Websites document conference materials and provide interface for future collaboration: http://kpfu.ru/biology-medicine/struktura-instituta/kafedry/kfikf/konferenciya/mezhdunarodnaya-konferenciya-39dokazatelnaya.html and http://Russia.cochrane.org/news/international-conference.

Kazan hosted Russia's first international conference on medicines that was entirely independent of the pharmaceutical industry, attracting 414 participants from 9 countries and 20 regions of the Russian Federation. The meeting was greeted and endorsed by world leaders in pharmaceutical information, policy and regulation. Delegates discussed the professional and social problems arising from unethical drug promotion, including compromised evidence from clinical trials and consequent impairments in health service delivery. The Conference adopted a resolution prioritizing policy development and health system needs, notably including the development of clinical pharmacology. A website documents conference materials and provides an interface for future collaboration: http://evidenceupdate-tatarstan.ru/confer. © 2011 - IOS Press and the authors. All rights reserved.