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Biologics are playing an increasingly important role in health care globally but are placing a substantial burden on payers. The development of biosimilars-drugs that are highly similar to and have no clinically meaningful differences from originator biologics-is critical to improving the affordability and accessibility of these medications. Medicines regulators, however, have had varied success with biosimilars to date. We examined agency guidance documents, peer-reviewed articles, and gray literature related to biosimilars in Australia, Canada, the European Union, the United Kingdom, and the United States to evaluate variations in the approaches to biosimilar approval taken by their respective medicines regulators. We found that the medicines regulators take similar approaches to biosimilar approvals, but that differences in their policies and their jurisdiction's laws regarding testing requirements, indication extrapolation, exclusivities, and substitution may contribute to the varied successes of biosimilars observed. Policies supportive of product-specific guidance, extrapolation, shorter exclusivity periods, and substitution were correlated with greater success in biosimilar approval and uptake. As medicines regulators work to promote biosimilars, understanding the impact of these laws and policies is crucial. Reforms consistent with these policies can create regulatory environments more supportive of biosimilar approvals, promoting access to affordable biologics for patients globally.
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Introduction: Hypertension significantly impacts the global cardiovascular disease burden, presenting a pronounced challenge within Latin America and the Caribbean. The Pan American Health Organization's (PAHO) HEARTS initiative endeavours to meet this challenge by enhancing comprehensive cardiovascular risk management, inclusive of improved access to antihypertensive medications. This study scrutinises the challenges and barriers in accessing these medications, which are crucial for effective hypertension management in these regions. Methods: The research employed a two-phase approach: an initial analysis of National Essential Medicines Lists (NEMLs) from 22 countries involved in the HEARTS initiative for the presence of antihypertensive medications, followed by an in-depth pharmaceutical market analysis in six selected countries to evaluate the availability, pricing, and procurement practices of these medications. Results: The study revealed notable inconsistencies in the inclusion of recommended antihypertensive medications across NEMLs, particularly the lack of fixed-dose combinations (FDCs). The market analysis brought to light significant limitations in medicine registration and substantial variations in pricing, which adversely impact the accessibility and affordability of essential antihypertensive treatments. Furthermore, an examination of procurement practices identified considerable diversity across countries, highlighting potential areas for optimisation, including the use of the PAHO Strategic Fund. Conclusions: The barriers to accessing essential antihypertensive medications in Latin America and the Caribbean are multifaceted, stemming from outmoded NEMLs, limited market availability of advised medications, and disparate procurement processes. Leveraging pooled procurement mechanisms such as the PAHO Strategic Fund, coupled with vital updates to NEMLs, stands to markedly improve both the accessibility and affordability of these treatments.
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OBJECTIVES: To assess the potential number of EU PICOs based on EUnetHTA 21 guidance and to explore further evidence-based opportunities to produce more predictable and workable EU PICOs. METHODS: The consolidated EU PICOs of two future hypothetical medicines in first line non small cell lung cancer (1L NSCLC) and third line multiple myeloma (3L MM) were derived using published HTA reports of two recent medicines in similar indications based on EUnetHTA 21 proposed guidance. Sensitivity analysis assessed the impact of additional PICO requests. The number of analyses requested was estimated. RESULTS: In 1L NSCLC and 3L MM, six and nine EU Member States (MS), respectively, had published HTA reports. PICO consolidation resulted in 10 PICOs for 1L NSCLC and 16 PICOs for 3L MM, increasing to 14 and 18 PICOs respectively when England's NICE scope was included to proxy remaining MS. A minimum of 280 and 720 analyses would be requested, exponentially increasing as additional outcome measures and subgroups are requested. CONCLUSIONS: The PICO approach outlined by EUnetHTA 21 results in a significant number of analysis requests and substantial resources. Use of complementary analyses alongside evidence-based methods to derive PICOs and engaging with the health technology developer throughout the process, would create a workable EU PICO that is predictable and most impactful for the EU, resulting in a timely and high-quality assessment report that is more usable at a MS level.
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In Brazil, the judicialization of public health for access to medications has resulted in significant challenges to the management of public policies, especially at the municipal level. To evaluate the profile of drug litigations against the Campinas municipal health system from 2017 to 2021, this study analyzed the characteristics of litigants, medicine dispensation, and the timing of court decisions. A quantitative, analytical, and comparative cross-sectional study was conducted using data on the dispensation of 506 types of medications and 493 court cases. The analysis included sociodemographic, procedural, medical-sanitary, and pharmaceutical assistance management variables. The time of court decisions was assessed using the KruskalâWallis test complemented by the Dunn test. The plaintiffs were predominantly adults, females, and self-declared students, and some cases involved nonresidents. Most of the lawsuits were represented by private lawyers, gratuitousness of justice and with decisions favorable to the plaintiff. However, only 43% of the patients obtained a preliminary injunction or early tutelage. The median time needed for a court decision from the date of case filing was 12 days until the granting of a preliminary injunction or early tutelage and 6.5 months until a judgment or dismissal without a decision on the merits. Approximately 32.4% of the medications dispensed by the judicial pharmacy already belonged to the list of the Brazil's Unified Health System in 2020; 46.3% were prescribed by their generic name; 75.5% had therapeutic equivalents, and 94.9% had marketing authorization from the Brazilian National Health Surveillance Agency. Judicialization in Campinas is an alternative way of accessing medications, but it is time-consuming and benefits only a small portion of the population (0.068%). The characteristics of the plaintiffs and judicialized medicines highlight the need to review health policies to promote equitable and efficient access to essential treatments for the population.
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Salud Pública , Humanos , Brasil , Femenino , Masculino , Estudios Transversales , Adulto , Salud Pública/legislación & jurisprudencia , Persona de Mediana Edad , Atención a la Salud/legislación & jurisprudenciaRESUMEN
Gaps in access to quality essential medicines remain a major impediment to the effective care of children with cancer in low-and middle-income countries (LMICs). The World Health Organization reports that less than 30% of LMICs have consistent availability of childhood cancer medicines, compared to over 95% in high-income countries. Information provided within this policy brief is drawn from a review of the literature and a mixed-methods study published in the Lancet Oncology that analyzed determinants of cancer medicine access for children in Kenya, Tanzania, Uganda, and Rwanda. Three key policy options are presented to guide strategic policy direction and critical health system planning for strengthening access to cancer medicines for children: pooled procurement, evidence-based forecasting, and regional harmonization of regulatory processes. Enhancing regional pooled procurement to address fragmented markets and improve medicine supply, investing in health information systems for improved forecasting and planning of childhood cancer medicine needs, and promoting regulatory harmonization to streamline medicine approval and quality assurance across East Africa are recommended. This policy brief is intended for policymakers, clinicians, and health-system planners involved in the procurement, supply chain management, policy and financing of childhood cancer medicines.
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Antineoplásicos , Política de Salud , Accesibilidad a los Servicios de Salud , Neoplasias , Humanos , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Niño , África Oriental , Neoplasias/tratamiento farmacológico , Antineoplásicos/provisión & distribución , Antineoplásicos/uso terapéutico , Predicción , Países en Desarrollo , Medicamentos Esenciales/provisión & distribuciónRESUMEN
Background: We sought to identify what barriers and facilitators determine current perceived access to childhood cancer care in South Africa through in-depth interviews with stakeholders in South Africa's public and private sectors. Methods: Qualitative semi-structured interviews were conducted with 29 key health system stakeholders, including policy-makers and regulators, medical insurance scheme informants, medicine suppliers, healthcare providers and civil society stakeholders. Identified barriers and facilitators in access to medicines and broader care were structured according to the pharmaceutical value chain (PVC). Results: Barriers and facilitators were identified across all components of the PVC. Key barriers included (1) a lack of political commitment to childhood cancers, (2) discontinuation of essential chemotherapeutics, (3) incomplete insurance coverage for childhood cancers, (4) stock-outs of essential medicines, (5) the inability to access care, including travel to healthcare facilities and (6) low awareness on childhood cancers among primary healthcare (PHC) workers. Proposed priority interventions included pricing flexibilities, increased transparency and consistency in decision-making and healthcare spending, and improved training of PHC staff, nurses and pharmacists on childhood cancers. Conclusion: This first comprehensive study of determinants of access to medicines used in childhood cancer in South Africa provides context-specific evidence for targeted policy development.
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Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities. This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country's domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance.
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Industria Farmacéutica , Naciones Unidas , Humanos , Industria Farmacéutica/legislación & jurisprudencia , Sector Privado , Fraude/prevención & control , Sector PúblicoRESUMEN
Background: Conscientious objection (CO) in healthcare is a controversial topic. Some perceive CO as freedom of conscience, others believe their professional duty-of-care overrides personal-perspectives. There is a paucity of literature pertaining to pharmacists' perspectives on CO. Aim: To explore Australian pharmacists' decision-making in complex scenarios around CO and reasons for their choices. Method: A cross-sectional, qualitative questionnaire of pharmacists' perspectives on CO. Vignette-based questions were about scenarios related to medical termination, emergency contraception, IVF surrogacy for a same-sex couple and Voluntary Assisted Dying (VAD) Results: Approximately half of participants (n = 223) believed pharmacists have the right to CO and most agreed to supply prescriptions across all vignettes. However, those who chose not to supply (n = 20.9%), believed it justifiable, even at the risk of patients failing to access treatment. Strong self-reported religiosity had a statistically significant relationship with decisions not to supply for 3 of 4 vignettes. Three emergent themes included: ethical considerations, the role of the pharmacist and training and guidance. Conclusion: This exploratory study revealed perspectives of Australian pharmacists about a lack of guidance around CO in pharmacy. Findings highlighted the need for future research to investigate and develop further training and professional frameworks articulating steps to guide pharmacists around CO.
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BACKGROUND: On July 4, 2021, China officially introduced the drug patent linkage system, which has made more localized adjustments than have similar systems in the US and South Korea. This study describes the characteristics and outcomes of China's patent linkage system. METHODS: For this study, we used the database of China's patent information registration platform for marketed drugs to capture all listed patents and patent certifications from June 25, 2021, to June 30, 2023. We used descriptive statistics for the above data to assess the impact of patent linkage on branded drug manufacturers, generic drug manufacturers, and the public's access to medicines. RESULTS: During the study period, the patents of 632 branded drugs were listed, and 5058 ANDAs submitted patent certifications to the Registration Platform. Of these 632 branded drugs, 462 (73.1%) drugs were approved before the year of patent registration, and the average number of listed patents per drug was 1.8, with a standard deviation of 1.4. However, of these 5058 ANDAs, P1 certifications accounted for 85.1%, and P3 and P4 certifications accounted for 16% combined. In addition, according to the detailed statistics of P2 certifications, we found that the proportion of patent invalidation cases was 46.4%. The remaining validity of the patents corresponding to P3 certifications was longer, with a median value of 17 months, and the IQR was 10-30.75, ranging from - 2 to 204 months. CONCLUSIONS: China's patent linkage aims to promote the balance of multiple interests -innovation, imitation and public health-and has its own system characteristics. Patent listing and patent certification are the key indicators reflecting the implementation effect of the system. From the perspective of system outcomes, ANDAs have been connected to the patent linkage system in an orderly manner, but the growth of patent challenges is not obvious. Moreover, manufacturers of foreign branded drugs that have not yet entered the Chinese market need to pay more attention to the role of patent listing.
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Medicamentos Genéricos , Internacionalidad , Humanos , República de Corea , ChinaRESUMEN
CONTEXT: The European Union (EU) governs global health through its constituent laws, institutions, actors, and policies. However, it is unclear whether or how these political factors interact to position the EU as a political determinant of global health. METHODS: The authors conduct a case study of the political factors influencing the adoption of the EU's Biotechnology Directive 98/44/EC and Orphan Medicines Regulation 141/2000. FINDINGS: The European Commission (EC) generally framed both of its proposals around economical and biomedical paradigms aligned with the needs of the EU's industry and patients, whereas the European Parliament (EP) contested some of these frames and proposed amendments supporting global access to medical products. The political factors influencing the adoption (in the Biotechnology Directive) or rejection (in the Orphan Regulation) of the EP's amendments include the complementarity between the EP and EC proposals, the EP's power in the intra- and interinstitutional negotiating process, the existence and support of civil society, and the alignment with member state priorities in the Council. CONCLUSIONS: In the late 1990s, the EU was an internally fragmented and politicized player concerning global health matters. These political factors should be considered for a coherent post-2022 EU strategy on global health.
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Biotecnología , Unión Europea , Salud Global , Producción de Medicamentos sin Interés Comercial , Política , Producción de Medicamentos sin Interés Comercial/legislación & jurisprudencia , Producción de Medicamentos sin Interés Comercial/economía , Humanos , Política de Salud , Enfermedades Raras/tratamiento farmacológicoRESUMEN
OBJECTIVES: Dynamic and adaptive services that provide timely access to care are pivotal to ensuring patients with palliative needs experience high-quality care. Patients who have palliative care needs may require symptomatic relief with medicines and, therefore, may engage with community pharmacists frequently. However, there is limited evidence for pharmacists' involvement in community palliative care models. Therefore, a scoping review was conducted to identify pharmacists' role in community palliative care. METHODS: A systematic search strategy was implemented across PubMed, PsychINFO, CINAHL, and Embase databases. Articles were screened by abstract and full text against inclusion and exclusion criteria. KEY FINDINGS: Five articles (two from Australia, two from England, and one from Scotland) met the inclusion criteria and described interventions involving pharmacists in community palliative care. This review has identified that the inclusion of trained pharmacists in community palliative care teams can improve the quality of care provided for patients with palliative needs. Pharmacists are able to undertake medication reviews and provide education to patients and other healthcare professionals on the quality use of palliative care medicines. Additionally, the underutilization of community pharmacists in palliative care, the need for further training of pharmacists, and improved community pharmacy access to patient information to deliver community palliative care were identified. CONCLUSION: Pharmacists can play a vital role in community palliative care to enhance the quality of life of patients. There is a need for greater pharmacist education/training, improved interprofessional communication, improved access to patient information and sustainable funding to strengthen community-based palliative care.
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Cuidados Paliativos , Farmacéuticos , Humanos , Servicios Comunitarios de Farmacia/organización & administración , Cuidados Paliativos/organización & administración , Grupo de Atención al Paciente/organización & administración , Farmacéuticos/organización & administración , Rol Profesional , Calidad de la Atención de SaludRESUMEN
Monitoring access to pediatric medicines as part of the Sustainable Development Goal (SDG) agenda for 2030 requires surveying age-appropriate medicines. This study aimed to develop tracer sets of essential age-appropriate medicines for use in SDG indicator 3.b.3 or in conjunction with other methodologies for monitoring access to medicines. Two sets of medicines were developed, one for young children (1 month to 5 years) and one for school-aged children (5-12 years). Priority diseases were selected based on the global burden of disease and linked to active ingredients of first choice according to treatment guidelines and the World Health Organization (WHO) Model List of Essential Medicines for Children (EMLc). To ensure clinical relevance, the Delphi technique was employed to identify areas of (dis)agreement among clinical pediatric experts. During two consultation rounds, experts were invited to indicate (dis)agreement. Five experts per age group were largely in agreement with the initial selections, but various therapeutic alternatives were suggested for addition. A second consultation round with five experts did not lead to major adjustments. The final sets included 26 treatment options for both groups. Specific age-appropriate formulations were selected from the WHO EMLc 2023. These two globally representative tracer sets of medicines consider the particular needs of children and could aid countries in the critical monitoring of accessibility to pediatric medicines.
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Background: Both constrained access to essential medicines and combatting marketing of substandard and falsified (SF) medicines are unmet health sector goals in Africa. Objective: To answer the question of how improved access can reduce the continuous surge of SF medicines in Africa. Design: We conducted a scoping review based on standard protocol. Methods: We searched articles published in the English language from PubMed/Medline, Cochrane Library, Embase, Scopus, Web of Science, and Google Scholar by using a systematic search query. Results: Seventy-one articles were included in this review. Access to quality essential medicines is still a major problem in developing countries in Africa and will continue as a threat for the next decade of health care. Ensuring access to quality medicines and preventing SF medicines in Africa need a systematic approach to address their underlying causes. Failure to ensure access to medicines is the major reason for the availability of SF medicines. Improving access to quality medicines can reduce SF medicine marketing and use. Manipulating the entire supply chain for efficiency, avoiding trade agreements that could reduce access, using compulsory licensing provisions, and pharmaceutical price control, providing incentives for drug development, and promoting rational use of medicines can improve access. Conclusion: Ensuring access to medicines and preventing SF medicine marketing cannot be achieved in the planned period in developing countries in Africa unless a comprehensive strategy is used. Improving access to quality medicines can reduce SF medicine marketing and use, that is, ensuring access through uninterrupted supply, improved efficiency, enhanced local production, preventing SF medicine entry, improved medication use system, and improved affordability. Therefore, it is essential to improve supply chain capability, address challenges of the supply chain, improve leadership and governance, establish country-specific anti-counterfeiting and anti-substandardization committees, and collaborate with all relevant stakeholders.
Reduce Marketing and Use of Substandard and Falsified Medicines in Africa Ensuring access to quality medicines and preventing SF medicines in Africa need ensuring access through uninterrupted supply, improved efficiency, enhanced local production, preventing SF medicine entry, improved medication use system, and improved affordability.
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INTRODUCTION: The large number of deaths among children with HIV is driven by poor antiretroviral treatment (ART) coverage among this cohort. The aim of the study was to assess the availability and stock-outs of paediatric and adult ART formulations in Kenya and Uganda across various regions and types of health facilities. METHODS: A survey on availability and stock-outs of paediatric ART at health facilities was adapted from the standardized Health Action International-WHO Medicine Availability Monitoring Tool. All preferred and limited-use formulations, and three phased-out formulations according to the 2021 WHO optimal formulary list were included in the survey, as well as a selection of adult ART formulations suitable for older children, adolescents, and adults. Availability data were collected in June-July 2022 and stock-out data were obtained over the previous year from randomly selected public and private-not-for-profit (PNFP) facilities registered to dispense paediatric ART across six districts per country. All data were analysed descriptively. RESULTS: In total, 144 health facilities were included (72 per country); 110 were public and 34 PNFP facilities. Overall availabilities of preferred paediatric ART formulations were 52.2% and 63.5% in Kenya and Uganda, respectively, with dolutegravir (DTG) 10 mg dispersible tablets being available in 70.2% and 77.4% of facilities, respectively, and abacavir/lamivudine dispersible tablets in 89.8% and 98.2% of facilities. Of note, availability of both formulations was low (37.5% and 62.5%, respectively) in Kenyan PNFP facilities. Overall availabilities of paediatric limited-use products were 1.1% in Kenya and 1.9% in Uganda. At least one stock-out of a preferred paediatric ART formulation was reported in 40.0% of Kenyan and 74.7% of Ugandan facilities. Nevirapine solution stock-outs were reported in 43.1% of Ugandan facilities, while alternative formulations for postnatal HIV prophylaxis were not available. CONCLUSIONS: Recommended DTG-based first-line ART for children across all ages was reasonably available at health facilities in Kenya and Uganda, with the exception of Kenyan PNFP facilities. Availability of paediatric ART formulations on the limited-use list was extremely low across both countries. Stock-outs were reported regularly, with the high number of reported stock-outs of neonatal ART formulations in Uganda being most concerning.
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Infecciones por VIH , Instituciones de Salud , Uganda , Kenia , Humanos , Infecciones por VIH/tratamiento farmacológico , Niño , Instituciones de Salud/estadística & datos numéricos , Fármacos Anti-VIH/provisión & distribución , Fármacos Anti-VIH/uso terapéutico , Fármacos Anti-VIH/administración & dosificación , Piridonas/provisión & distribución , Piridonas/uso terapéutico , Antirretrovirales/provisión & distribución , Antirretrovirales/uso terapéutico , Compuestos Heterocíclicos con 3 Anillos/provisión & distribución , Compuestos Heterocíclicos con 3 Anillos/uso terapéutico , Compuestos Heterocíclicos con 3 Anillos/administración & dosificación , Adolescente , Preescolar , Accesibilidad a los Servicios de Salud , Nevirapina/provisión & distribución , Nevirapina/uso terapéutico , Nevirapina/administración & dosificación , Lactante , Masculino , Femenino , Lamivudine/provisión & distribución , Lamivudine/uso terapéutico , Lamivudine/administración & dosificación , Oxazinas , PiperazinasRESUMEN
OBJECTIVES: Access to innovative and effective medication is a citizen's right. The main objectives of this study were to build an indicator to measure access to medicines within hospitals, the Global Medicines Access Index, and to identify the main existing barriers. METHODS: Cross-sectional study carried out in Portuguese National Health Service hospitals. A consensus methodology (expert panel of 7 members) was used to define which dimensions should be included in the index and the weighting that each should take. The panel identified 6 dimensions: access to innovative medicines, proximity distribution, shortages, access to medicines before financing decision, value-based healthcare, and access to medication depending on cost/funding. Data were collected through an electronic questionnaire (September 2021). RESULTS: The response rate was 61.2%. Most hospitals used medicines with and without marketing authorization before the funding decision. Monitoring and generating evidence of new therapies results is still insufficient. The identified barriers were the administrative burden as the major barrier in purchasing medicines, with a relevant impact on shortages of medicines. Most respondents (87%) had a proximity distribution program, mainly implemented in the pandemic context, and the price/funding model was only identified by 10% as a barrier to access. The 2021 Global Medicines Access Index was 66%. Shortages and value-based use of medicines were the dimensions that had more influence in lowering the index value. CONCLUSIONS: The new formula used to obtain a unique and multidimensional index for access to hospital medicines seems to be more sensitive and objective and will be used to monitor access.
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Accesibilidad a los Servicios de Salud , Estudios Transversales , Humanos , Portugal , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Accesibilidad a los Servicios de Salud/normas , Encuestas y Cuestionarios , Preparaciones Farmacéuticas/provisión & distribución , Preparaciones Farmacéuticas/economía , Hospitales/estadística & datos numéricosRESUMEN
Background: To guarantee uninterrupted service delivery, quality-assured products must be affordable and continuously available across all sectors, including the private sector, which provides more than 60% of healthcare services in Nigeria. We investigated the private sector availability and affordability of under 5 malaria commodities to establish the level of access in this sector. Methods: We surveyed patent medicine and pharmacy stores across seven states in Nigeria and the Federal Capital Territory to establish the availability and affordability of selected malaria commodities for children under 5 years. Availability was measured as the percentage of visited outlets with the product of interest on the day of visit, while affordability was assessed by establishing if it cost more than a day's wage for the least-paid government worker to purchase a full course of malaria diagnostic test and/or medication. Results: Artemisinin-based antimalarials for uncomplicated and severe malaria were the most available commodities. SPAQ1 and SPAQ2 used for seasonal malaria chemoprevention campaign were surprisingly also available in some outlets. However, only about half (48.3% and 53.3%) of the surveyed outlets had stock of artemether/lumefantrine (AL1) and artesunate injection, respectively. The median price of surveyed products ranged from USD (United States Dollars) 0.38 to USD 2.17 per treatment/test. Except for amodiaquine tablet and artemether injection, which cost less, all other originator brands cost the same or more than the lowest-priced generic. Antimalarial products were affordable as their median prices were not more than a day's wage for the least-paid government worker. However, when the cost of testing and treatment with artemisinin-based combination therapies (ACTs) was assessed, testing and treatment with dihydroartemisinin/piperaquine were unaffordable as the they cost more than 1.5 times the daily wage of the least-paid government worker. Conclusion: The overall private sector availability of under-five malaria commodities in surveyed locations was suboptimal. Also, testing and treatment with recommended ACTs were not affordable for all surveyed products. These findings suggest the need for interventions to improve access to affordable under-five malaria commodities.
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OBJECTIVES: Highly active antiretroviral therapies against the human immunodeficiency virus are available for patients in France in community pharmacy or in hospital pharmacy. More than 20 years after the implementation of the dual delivery system, it seems necessary to question the relevance of the dual dispensing circuit both in terms of service provided to patients and expenditure for health insurance. METHODS: The health insurance files were used to quantify the delivery of antiretrovirals therapies in the community pharmacy and in the hospital pharmacy. A survey was performed involving patients to find out their point of view on dispensing in hospital pharmacy and were the patients came from. The differential cost from the health insurance point of view between the two delivery system was calculated on the basis of the quantities delivered and the purchase prices at the hospital center in 2018. RESULTS: More than 80% of the quantities of antiretrovirals therapies are now delivered by community pharmacies. The arguments in favor of the antiretrovirals therapies dispensation by hospital pharmacy forwarded by patients are the anonymity and constant medicines availability. Health insurance is required to refund a drug at different prices depending on the delivery place, for about 37 per box in favour of hospital dispensing. CONCLUSION: This study presents a complete inventory of the dual delivery system for antiretroviral therapies. Hospital and community therefore remain complementary to welcome outptients who will seek different delivery methods there. Little known to patients and professionals, this dual delivery system generates complexities at the stages of prescription, dispensing and reimbursement. It only concerns a minority of patients and its benefit for health insurance seems uncertain.
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Servicios Comunitarios de Farmacia , Infecciones por VIH , Farmacias , Servicio de Farmacia en Hospital , Humanos , Preparaciones Farmacéuticas , Infecciones por VIH/tratamiento farmacológico , PrescripcionesRESUMEN
In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.
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Accesibilidad a los Servicios de Salud , Humanos , América Latina , Costos y Análisis de CostoRESUMEN
BACKGROUND: There is growing interest in pharmaceutical innovation in low- and middle-income countries (LMICs), but information on existing activities, capacities, and outcomes is scarce. We mapped available data at the global level, and studied the national pharmaceutical innovation systems of Bangladesh and Colombia to shed light on pharmaceutical research and development (R&D) in the Global South, including challenges and prospects, to help fill existing knowledge gaps. METHODS: We gathered and analyzed data from three types of sources: literature, semi-structured interviews with key informants, and publicly available data on R&D funding, R&D scientific capacity measured by human resources, and clinical trial activities. RESULTS: Pharmaceutical R&D activities are occurring in many LMICs, but 16 countries have emerged as frontrunners. Investment in R&D in LMICs has increased in the past decade, particularly from middle-income countries (MICs). Capacity is also growing, with an increase in the number of research organizations and the amount of funding available from external sources. The total number of clinical trials and the proportion of trials in LMICs increased markedly, and there is also growing activity in the earlier, more innovative and riskier Phase 1 and 2 trials. Non-commercial entities comprise the majority of clinical trial funders and sponsors in LMICs. Finally, investments have borne fruit, as indicated by a number of innovative medicines developed in LMICs. The Bangladesh and Colombia country studies showed that there is still a need for both targeted R&D policies to strengthen capacities in the pharmaceutical sector, and more government support to overcome the challenges of a lack of funding and coordination among different actors. CONCLUSIONS: By triangulating between the data sources, it was possible to paint a broad picture of who was involved in pharmaceutical R&D in LMICs, in which particular countries, for which diseases, in which R&D phases, and with what results-as well as how these trends have changed over time. Prioritizing pharmaceutical R&D is an important strategy for better meeting health needs. The trendlines are promising, but focused attention is still needed to realize the potential for greater innovation in the Global South.