Conscientious objection - a cross-sectional, vignette-based, mixed methods exploration of Australian pharmacists' perspectives.

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.

The EU as a Political Determinant of Global Health: The Case of Research and Development Incentives for Orphan Medicines and Biotechnology.

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 Union as a political determinant of global health. METHODS: A case study of the political factors (Rushton and Williams, 2012) 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 Directive) or rejection (in the Regulation) of the EP's amendments include: the complementarity between the EP and EC proposals; the EP's power in the intra- and inter-institutional negotiating process; the existence and support of civil society; and the alignment with Member State(s)' priorities in the Council. CONCLUSIONS: In the late 1990s, the EU was an internally fragmented and politicised player concerning global health matters. These political factors should be considered for a coherent post-2022 EU strategy on global health.

Characteristics and outcomes of the drug patent linkage system in China.

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.

The role of pharmacist in community palliative care-a scoping review.

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.

Availability and stock-outs of paediatric antiretroviral treatment formulations at health facilities in Kenya and Uganda.

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.

Monitoring Access to Child Medicines: Introducing a Standardized Set of Age-Appropriate Medicines.

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.

Improving access to medicines to reduce marketing and use of substandard and falsified medicines in Africa: Scoping review.

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.

Portuguese Global Medicines Access Index 2021-An Indicator to Measure Access to Hospital Medicines.

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.

Private sector availability and affordability of under 5 malaria health commodities in selected states in Nigeria and the Federal Capital Territory.

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.

[Drug dispensation at both community and hospital pharmacy, the highly active antiretrovirals example]. / Le double circuit de dispensation, exemple des traitements antirétroviraux : quelle pertinence ?

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.

On the Judicialization of Health and Access to Medicines in Latin America.

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.

Rising pharmaceutical innovation in the Global South: a landscape study.

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.

"'It is very difficult in this business if you want to have a good conscience': pharmaceutical governance and on-the-ground ethical labor in Ghana": a letter to editors.

Establishing effective pharmaceutical governance is a challenge for government agencies, private enterprises, and professionals working on the ground, demanding complex ethical decisions from the actors involved, especially in a lower-middle-income country like Ghana. This letter aims to share the author's perspectives and additional considerations on the analyses of the reports in the paper "It is very difficult in this business if you want to have a good conscience": pharmaceutical governance and on-the-ground ethical labor in Ghana by Hampshire et al. The letter's authors discuss the need to advance universal health coverage in Ghana, the everyday ethics, and the disparities between the collective and individual moral consciousness of the participants, as well as other aspects of governance in the pharmaceutical sector.

Initiatives to promote access to medicines after publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases.

BACKGROUND: Rare diseases affect a small number of people compared to prevalent diseases. The vast majority of these diseases are of genetic origin, have no cure, are chronic and can lead to death. Although the right to access medicines is included in the constitutionally guaranteed right to health in Brazil, problems in the supply of medicines for rare diseases are reported in the country. This study aimed to describe and analyse the initiatives to promote access to medicines for treating rare diseases in the Unified Health System, Brazil, after the publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases. Based on the model published by the WHO Regional Office for Europe, which described access to medicines in prelaunch, perilaunch and postlaunch policies, the initiatives referring to each category were summarized based on documentary research searched in online databases from January 2014 to December 2020. RESULTS: Different actions and policy interventions were identified, which went through the expansion of resources for research and development, health regulations, incorporation of new drugs, review and publication of clinical guidelines, and expansion of the network of care facilities by the Ministry of Health. On the other hand, aspects related to care policies, pricing methods, technological development, and development of pharmaceutical service processes were not implemented. CONCLUSIONS: Although it is impossible to determine the explicit motivation of such actions concerning the Policy, its publication certainly was a landmark in Brazilian society, allowing greater recognition of the needs of rare disease patients and the specificities of treatment'. However, this study suggests that the steps that make up the life cycle of medicines are not linked, lacking articulation and integration of the care network, and consequently, there is no evidence that rare disease policy publication has generated a broad impact on the promotion of access to medicines to treat rare diseases in Brazil.

Public health advocacy strategies to influence policy agendas: lessons from a narrative review of success in trade policy.

BACKGROUND: Despite accumulating evidence of the implications of trade policy for public health, trade and health sectors continue to operate largely in silos. Numerous barriers to advancing health have been identified, including the dominance of a neoliberal paradigm, powerful private sector interests, and constraints associated with policymaking processes. Scholars and policy actors have recommended improved governance practices for trade policy, including: greater transparency and accountability; intersectoral collaboration; the use of health impact assessments; South-South networking; and mechanisms for civil society participation. These policy prescriptions have been generated from specific cases, such as the World Trade Organization's Doha Declaration on TRIPS and Public Health or specific instances of trade-related policymaking at the national level. There has not yet been a comprehensive analysis of what enables the elevation of health goals on trade policy agendas. This narrative review seeks to address this gap by collating and analysing known studies across different levels of policymaking and different health issues. RESULTS: Sixty-five studies met the inclusion criteria and were included in the review. Health issues that received attention on trade policy agendas included: access to medicines, food nutrition and food security, tobacco control, non-communicable diseases, access to knowledge, and asbestos harm. This has occurred in instances of domestic and regional policymaking, and in bilateral, regional and global trade negotiations, as well as in trade disputes and challenges. We identified four enabling conditions for elevation of health in trade-related policymaking: favourable media attention; leadership by trade and health ministers; public support; and political party support. We identified six strategies successfully used by advocates to influence these conditions: using and translating multiple forms of evidence, acting in coalitions, strategic framing, leveraging exogenous factors, legal strategy, and shifting forums. CONCLUSION: The analysis demonstrates that while technical evidence is important, political strategy is necessary for elevating health on trade agendas. The analysis provides lessons that can be explored in the wider commercial determinants of health where economic and health interests often collide.

How and why pharmaceutical reforms contribute to universal health coverage through improving equitable access to medicines: a case of Ghana.

Background: Examining how and why a country prioritizes and implements pharmaceutical reforms tends to show complex processes and myriad efforts made toward improving access to medicines. This study examines factors that enabled the prioritization and implementation of selected pharmaceutical reform items and how these factors contributed to improving equitable access to medicines and universal health coverage in Ghana. Methods: An analytical framework was developed to identify variables to explore in answering the study questions and frame the analysis and presentation of findings. Documents analyzed included the National Medicines Policies, Health Sector Program of Work, and other health policies. Quantitative data were sourced from databases maintained by World Health Organization and the Institute for Health Metrics and Evaluation. Results: The three main factors, evidence, financial and technical support, and alignment to national and global policies, influenced the prioritization and implementation of access to medicines reforms. The reforms targeted rational selection and use of medicines, medicine pricing, sustainable medicine financing, and regulatory and supply chain systems. Although there were limited quantitative data to quantify access to medicine policies" impact on universal health coverage, it can be reasonably assumed that, in Ghana, access to medicine policies has contributed to financial protection and improved access to quality health services. Conclusion: Access to medicine policies targeted at promoting rational medicine selection and use, regulating medicine pricing and improving sustainable financing for medicines as well as the regulatory and supply chain systems arguably contributed to the attainment of UHC and must be sustained. Therefore, data collection and reporting indicators for access to medicines must be prioritized.

Access to medicines through global health diplomacy.

The World Health Organisation (WHO) emphasizes that equitable access to safe and affordable medicines is vital to attaining the highest possible standard of health by all. Ensuring equitable access to medicines (ATM) is also a key narrative of the Sustainable Development Goals (SDGs), as SDG 3.8 specifies "access to safe, effective, quality and affordable essential medicines and vaccines for all" as a central component of universal health coverage (UHC). The SDG 3.b emphasizes the need to develop medicines to address persistent treatment gaps. However, around 2 billion people globally have no access to essential medicines, particularly in lower- and middle-income countries. The states' recognition of health as a human right obligates them to ensure access to timely, acceptable, affordable health care. While ATM is inherent in minimizing the treatment gaps, global health diplomacy (GHD) contributes to addressing these gaps and fulfilling the state's embracement of health as a human right.

Global inequities in access to COVID-19 health products and technologies: A political economy analysis.

This paper presents a political economy analysis of global inequities in access to COVID-19 vaccines, treatments, and diagnostic tests. We adapt a conceptual model used for analysing the political economy of global extraction and health to examine the politico-economic factors affecting access to COVID-19 health products and technologies in four interconnected layers: the social, political, and historical context; politics, institutions, and policies; pathways to ill-health; and health consequences. Our analysis finds that battles over access to COVID-19 products occur in a profoundly unequal playing field, and that efforts to improve access that do not shift the fundamental power imbalances are bound to fail. Inequitable access has both direct effects on health (preventable illness and death) and indirect effects through exacerbation of poverty and inequality. We highlight how the case of COVID-19 products reflects broader patterns of structural violence, in which the political economy is structured to improve and lengthen the lives of those in the Global North while neglecting and shortening the lives of those in the Global South. We conclude that achieving equitable access to pandemic response products requires shifting longstanding power imbalances and the institutions and processes that entrench and enable them.

Willingness to pay brand premiums for generic medicines in Kenya: A bidding game experiment.

BACKGROUND: Recent growth in the market share of higher priced branded generic medicines in low- and middle-income countries (LMICs) has raised concerns around affordability and access. We examined consumer willingness to pay (WTP) for branded versus unbranded generic non-communicable disease (NCD) medicines in Kenya. METHODS: We randomly assigned NCD patients to receive a hypothetical offer for either a Novartis Access-branded medicine or for an unbranded generic equivalent. We then analysed WTP data captured using a bidding game methodology. RESULTS: We found that WTP for Novartis Access medicines was on average 23% higher than for unbranded generic equivalents (p = 0.009). The WTP brand premium was driven almost entirely by wealthier patients. CONCLUSIONS: Our findings suggest that the dominance of branded generics in LMICs like Kenya reflect in part consumer preferences for these medicines. Governments and other health sector actors may be justified in intervening to improve access to these medicines and equivalent non-branded generics, particularly for the poorest patients who appear to have no preference for branded medicines.

Patients, payers and developers of Orphan Medicinal Products: lessons learned from 10 years' multi-stakeholder dialogue on improving access in Europe via MoCA.

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