In this update we examine the inaugural report of the Health Economics Methods Advisory group on defining appropriate benefits for economic evaluation and the responses it has generated. We also review recent research on the timeliness of commercial health plan coverage policy updates following US FDA label revisions, which reveals substantial delays and wide variation across plans that may limit patient access to specialty therapies.

The first Joint Clinical Assessment (JCA) report has been completed. In this update we examine what this inaugural report reveals in practice and draw out the implications for manufacturers.

Geographical indications have emerged as one of the most important intellectual property tools for protecting traditional products that are deeply connected with a specific geographical region. They represent not only the quality and uniqueness of products but also the cultural identity, heritage, and collective knowledge of local communities. In recent decades, globalization and industrialization have increased competition in markets, often threatening the survival of traditional products and rural artisans. In such a situation, geographical indications provide legal recognition and commercial value to products whose qualities are linked to their place of origin. Products such as Darjeeling Tea, Banarasi Sarees, Kanchipuram Silk, Champagne, and Roquefort Cheese demonstrate how geographical indications can create economic opportunities and preserve local traditions. The protection of geographical indications plays a significant role in strengthening rural economies by generating employment, encouraging local entrepreneurship, increasing export potential, and supporting sustainable development. Rural producers often lack financial resources and market access, which places them at a disadvantage in competitive markets. Through geographical indication protection, producers gain exclusive rights over the use of the product name, helping them secure better prices and prevent misuse by unauthorized traders. This creates trust among consumers and enhances the reputation of regional products. This research paper examines the concept of geographical indications, their legal framework at international and national levels, and their contribution to rural economy development. It also explores the economic, social, and cultural significance of geographical indications, along with the challenges faced in their implementation and protection. The paper highlights the importance of effective policies, awareness, infrastructure, and market support in ensuring that geographical indications truly benefit rural communities.

This article examines the transformation of international wildlife law from a species-trade model centred on the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) to a broader ecological legality model in which habitat protection, forest legality, supply-chain traceability and market access increasingly shape conservation outcomes. It asks how trade-based wildlife conservation is shifting from the control of listed species towards the verification of the ecological legality of habitats and supply chains. Using Vietnam as a case study, the article analyses the interaction between CITES, the Convention on Biological Diversity (CBD), the European Union Deforestation Regulation (EUDR), the European Union-Vietnam Free Trade Agreement (EVFTA), and Vietnamese laws on biodiversity, forestry, fisheries and environmental protection. It argues that Vietnam’s principal challenge is not formal participation in wildlife and biodiversity regimes, but the construction of a compliance infrastructure capable of connecting CITES permits, timber legality, protected areas, environmental impact assessment (EIA), illegal, unreported and unregulated (IUU) fishing control, traceability and sanctions. The article contributes to wildlife law and policy scholarship by showing that the future of trade-based conservation lies not only in stricter prohibitions, but in legally credible systems that connect species, habitats and markets.

A comprehensive understanding of sheep husbandry practices in a given production environment provides essential baseline information for designing sheep breeding and development plans. This study characterized the Washera sheep husbandry practices of farmers under the smallholder production systems in north-west Ethiopia. Data were collected from a total of 480 randomly selected farmers using a semi-structured questionnaire survey. Qualitative and quantitative data were analyzed using Frequency Procedures in the Statistical Package for Social Science version 22 and the General Linear Model Procedure in the Statistical Analysis System version 9.0, respectively. Sheep constituted the largest proportion (38.42%) of livestock species owned by farmers. Natural pasture (index = 0.445) was the primary feed source for sheep. Most (97.1%) farmers graze their sheep freely (84.6%) on natural pasture. The majority of farmers (84.6%) face seasonal feed shortages mainly in the dry season (74.1%). About 52.2% of the farmers conserve feed to cope with seasonal feed shortages. Rivers were the main water source for sheep in both the dry (65.4%) and wet (63.3%) seasons. Most farmers (59.2%) house their sheep in separate pens with stilted floors (72.3%). Sheep sale decisions were made jointly by male and female household heads. The main opportunities for enhancing sheep production in the area include favorable agroecology, an adaptive breed, and market access. However, production and productivity are greatly affected by feed shortages and disease occurrences, mainly linked to poor sheep husbandry practices. Therefore, the potentials and challenges of sheep production in this study need to be considered in designing future sheep breeding and improvement programs in the area.

Purpose The local food sector is embracing digital platforms as one of the supply chain (SC) configurations to hone SC efficiency. However, factors determining the successful development of digital platform-based local food supply chains (LFSCs) remain underexplored. This study aims to propose a framework of critical success factors (CSFs) for digital platform-based LFSCs. Design/methodology/approach The authors have adopted a multiple-case study approach where cases are both successful (active) and failure (inactive) initiatives and represent diverse business models. Findings Drawing on a digital platform lens, the authors have explored 12 CSFs, grouped under 4 overarching factors (value-oriented, organizational, user-related and contextual). The former two are micro-level factors, whereas the latter two are meso- and macro-level factors, respectively. This research infers that these factors are interdependent. Practical implications By identifying micro-level factors as fundamental enablers, this research informs platform managers that they should give utmost attention in designing and securing these factors. Furthermore, recognition of meso-level CSFs as a functional enabler informs managers that they should strategically cultivate the network size and exert effort to encourage users’ behavioral change. Alongside, by establishing macro-level CSFs as a structural enabler, this study informs policymakers on the necesity of creating a supportive regulatory framework and enhancing budget provisions for financial grants directed towards digital local food platforms. Social implications By leveraging the identified CSFs, practitioners can increasingly develop effective and viable digital platforms for local food, thereby broadening market reach for small- and medium-sized producers. Increased market access for these producers can, in turn promote rural development and SC equity. Simultaneously, the rise in viable platforms for local foods can enhance consumers’ (specifically urban consumers’) access to fresh local produce, thereby improving food security and their dietary quality. Moreover, the arrangement of hybrid communication by platform orchestrators can lessen information asymmetries and strengthen relationships between producers and consumers, hence fostering social capital within the SC. All these corroborate the societal contribution of this study. Originality/value This study extends SC literature by demonstrating that the digital platform-based LFSCs cannot be successfully developed by simply replicating CSFs pertinent to the traditional LFSCs; instead, platform-specific CSFs are required. Furthermore, this research shows that CSFs span multiple levels and are interdependent. This study also contributes to platform literature by adding a relational aspect to platform theory.

ABSTRACT The transition to organic farming is increasingly promoted as a pathway toward sustainable agriculture, yet its implications for smallholder welfare in developing countries remain empirically underexplored. This study investigates the welfare effects of adopting organic vegetable farming among smallholder producers in Ghana's Ashanti Region, a hub for intensive vegetable cultivation. Using cross-sectional data from 385 farmers and employing the Endogenous Switching Regression model to address selection bias, we examine both the drivers of adoption and its impact on multiple welfare outcomes. Our findings reveal that being a farmer native to the district, off-farm employment, crop diversification, and access to stable markets significantly influence the decision to adopt organic practices. Impact estimates suggest that adoption improves household welfare by enhancing consumption expenditure and reducing food insecurity. However, adoption is also associated with reduced dietary diversity and lower incomes, highlighting potential trade-offs. These outcomes underscore the need for complementary interventions such as targeted input support and structured market linkages to maximize the benefits of organic farming for rural livelihoods. This study contributes to the empirical literature on sustainable agriculture by providing evidence of the welfare consequences of organic farming adoption in Sub-Saharan African contexts, with important implications for policy and program design. Key policy highlights Organic vegetable farming improves food security and household consumption for smallholder farmers in Ghana, but may lead to reduced dietary diversity and lower incomes. Organic adoption increases with market access but declines among native, off-farm employed, and diversified farmers. Policies should provide input subsidies, training, and access to organic farming resources. Stronger marketing support linking producers to premium markets through national and continental trade institutions is needed to improve incomes. Promoting farmer cooperatives and improving awareness of international trade opportunities can enhance bargaining power and welfare gains for small organic producers.

The “Sustainable Livelihood Development of Rural Communities in Low Land Along the Mara River Basin” project, implemented by Mogabiri Farm Extension Centre (MFEC) in Tarime District, Tanzania, seeks to address persistent socio-economic challenges in rural communities by promoting climate adaptation, income diversification, and gender equality. Despite its ambitious objectives, the project operates within a complex socio-economic and cultural environment that can undermine its intended outcomes. Evaluating such projects requires a critical examination of both their successes and the barriers that persist. Using a mixed-methods approach, this evaluation combined quantitative data from 265 smallholder farmers (SHFs) and qualitative insights from focus group discussions (FGDs), key informant interviews (KIIs), and document reviews. In terms of “What Works?”, findings indicate that 75% of SHFs adopted climate-resilient practices (p < 0.05), and 90% of communities implemented gender-responsive action plans (p < 0.01), with 68% of households engaging in income diversification activities such as poultry farming and beekeeping. However, the question of “What Doesn’t Work?” revealed notable shortcomings, including limited market access (p = 0.03) and cultural barriers restricting full gender participation (p = 0.04). The persistence of these challenges, despite project successes, underscores the need for a deeper investigation into structural and contextual factors that constrain the effectiveness of such initiatives. Understanding “Why?” these barriers remain highlights the interplay of systemic market integration challenges and cultural resistance to gender equity. While the project has made commendable progress, addressing these underlying issues is crucial for achieving long-term success. Strengthening market linkages, expanding gender-sensitive interventions, and fostering sustainability through community ownership and local partnerships are recommended to enhance scalability and impact.

ABSTRACTSubsistence farming households are at risk of food insecurity and poor nutritional status due to dependence on farm production for consumption. This study aimed to examine the relationship between household farming systems, food security and infant nutrition status pre‐ and post‐harvest. Households with mothers and infants and young children < 24 months were recruited from rural villages in Morogoro and Shinyanga, Tanzania. Demographics, anthropometrics, dietary intakes and household food insecurity were recorded. ANCOVA was used to examine differences and interactions between farming systems, seasons, food security, and nutrition status. The results showed high food insecurity pre‐harvest, highest within the Mixed Crop Livestock (MCL) farming system (82%) and Mixed Food Crop (MFC) farming system (74%). Post‐harvest, food insecurity was lowest for MCL households (21%) and highest for Single Food Crop (SFC) households (49%). MFC infants and young children had lower WAZ and LAZ and Cash Crop (CC) infants and young children had higher WAZ and LAZ pre‐harvest. Within the MFC and MCL farming systems, a significant increase pre to postharvest in MUAC was observed (p < 0.01 and p < 0.001, respectively). This study highlighted high food insecurity, poor dietary intakes and poor nutrition status pre‐harvest. Our findings revealed that the CC farming system had a greater income‐generating pathway and that MCL and MFC families had food group diversification post‐harvest. Therefore, interventions to improve nutrition status should improve both farming systems, while addressing seasonal gaps through food storage and preservation, market access and nutrition education for better child nutrition.

Agricultural marketing networks such as cooperatives are widely promoted as mechanisms to improve farmers' market access and income; however, adoption rates remain low in many developing contexts, including Iran. Despite extensive literature based on the Theory of Planned Behavior (TPB), existing studies often fail to fully capture context-specific institutional and social barriers, and rarely integrate qualitative insights into quantitative model development. This study addresses these gaps by employing an exploratory sequential mixed-methods design to develop and test an integrated behavioral model of farmers' participation in agricultural marketing networks in Fars Province, Iran. In the qualitative phase, semi-structured interviews with 32 farmers were conducted to identify context-specific barriers and underlying mechanisms shaping participation decisions. Thematic analysis revealed four main categories of barriers: economic, institutional, social-informational, and psychological. These findings were systematically transformed into measurement constructs and used to develop a structured questionnaire for the quantitative phase. In the second phase, data from 332 randomly selected farmers were analyzed using Partial Least Squares Structural Equation Modeling (PLS-SEM). The results show that attitude (β = 0.30, p < 0.001), perceived behavioral control (β = 0.18, p < 0.05), and social networks (β = 0.37, p < 0.001) significantly influence farmers' intention to participate, while subjective norms (β = 0.07, p > 0.05) and knowledge (β = 0.01, p > 0.05) do not. Trust significantly shapes farmers' attitudes (β = 0.60, p < 0.001) and also has a weaker direct effect on intention (β = 0.09, p < 0.05). Importantly, the composite perceived barriers construct exerts a significant negative effect on intention (β = - 0.06, p < 0.05), reflecting the structural constraints identified in the qualitative phase. The study contributes to the literature by demonstrating how qualitative insights can be systematically translated into measurable constructs within a TPB-based framework, thereby improving contextual validity and explanatory power. It further distinguishes between different forms of social influence, showing that behavioral effects are driven more by observed peer participation through social networks rather than perceived normative pressure. These findings provide important implications for designing trust-based, socially embedded agricultural policies that extend beyond information-driven interventions.

ABSTRACT This study aimed to develop an integrated support framework for faith-based social enterprises (FBSEs), grounded in a blended value creation approach from an institutional logics perspective. Data were collected from 105 respondents managing FBSEs within the Catholic Church across Kenya, Uganda, and Zambia. Using an abductive approach and content analysis, the study identified key aspects essential for the creation of an effective support framework. The findings revealed four primary areas of support within a blended value ecosystem: (1) capacity building and business advisory, (2) collaborative networks and market access, (3) access to finance and financial solutions, and (4) data-driven insights. Additionally, coaching, mentorship, and business advisory were recognized as critical ongoing support mechanisms, vital for the long-term development of FBSEs. The study highlights the need to transition from a siloed, standalone approach to supporting FBSEs toward an integrated, sustainable, and future-oriented framework, grounded in a blended value perspective.

The persistent digital divide in rural Indonesia necessitates innovative solutions for last-mile connectivity. This study presents an empirical evaluation of SpaceX's Starlink as a potential solution, employing a mixed-methods case study in five remote hamlets in Sukajadi Village, West Java. Quantitative data was collected through systematic field measurements using Speedtest CLI and iPerf3 over 30 days to assess download/upload speeds, latency, and packet loss. Qualitative data was gathered via in-depth interviews and observations to understand the socio-economic impact and user experience. Results demonstrate Starlink's robust technical performance, with average download speeds of 132.25 Mbps, upload speeds of 18.53 Mbps, and latency of 32.80 ms—significantly outperforming traditional satellite services and competing with urban fixed broadband. Qualitatively, Starlink proved transformative, enabling online education, expanding market access for local businesses, and improving access to e-government services. However, the study identifies a critical paradox: despite technical excellence and high user satisfaction (85%), the substantial cost of hardware (IDR 5,900,000) and monthly subscription (IDR 750,000) creates a significant adoption barrier for 80% of households. The research concludes that while Starlink is technically viable for last-mile connectivity in rural Indonesia, its successful integration into digital inclusion strategies requires innovative policy interventions, subsidy models, or community-based sharing schemes to address economic accessibility. This study provides crucial empirical evidence for policymakers and network planners considering LEO satellite solutions for bridging the digital divide in similar underserved regions.

This study examined the effect of women participation in the Agro-Processing, Productivity Enhancement and Livelihood Improvement Support (APPEALS) Programme on their household livelihoods in Kano and Kaduna States, Nigeria. Specifically, the study described the socio-economic characteristics of the participants, identified their livelihood activities, examined the effect of programme participation on their income, and identified constraints faced in the programme. Primary data were collected from 278 women beneficiaries, and descriptive statistics and a paired sample t-test were used to analyse changes in their income before and after programme participation. Results showed that women were largely young to middle-aged, socially integrated, and engaged in diverse livelihood activities, with farming (39.6%) and trading (23%) being most common. The paired t-test revealed a statistically significant increase in income across all livelihood categories, with mean income rising by ₦50,000 in farming, ₦56,500 in trading, ₦55,500 in processing, ₦46,000 in livestock, and ₦58,000 in artisan work (p &lt; 0.01). Despite these gains, women faced constraints including poor market access (57.6%) and limited extension services (50.4%). The study concluded that APPEALS substantially improved women’s economic outcomes and recommends strengthening market linkages and gender-responsive support services.

Navigating Health Technology Assessment (HTA) processes presents significant challenges for pharmaceutical companies seeking market access in Australia. While previous research has examined HTA decision-making from payer perspectives, pharmaceutical companies' internal decision-making processes remain understudied. To investigate how pharmaceutical companies' market access teams manage uncertainties in the HTA process for medicines in Australia using the ISO 31000 risk management framework to examine decision-making practices. A mixed-methods study was conducted involving an online questionnaire and semi-structured interviews with 18 respondents with recent experience with HTA submissions from 14 pharmaceutical companies, representing approximately 50% of PBS expenditure. Data were analysed using a deductive approach that mapped to ISO 31000 risk management process, supported by thematic analysis and descriptive statistics. Market access teams aim to secure PBS listing by balancing price (45% relative importance), speed (30%), and population coverage (25%) with submission costs. They function as intermediaries between global stakeholders and local market requirements, operating without formal risk management frameworks. Key challenges include managing global-local tensions, navigating increasingly complex stakeholder relationships, addressing rising submission costs (averaging AUD$830,000), and coping with workforce limitations. Risk assessment practices are predominantly informal and experience-based, while communication barriers hinder effective stakeholder engagement. Through mapping to the ISO 31000 framework, this study established the market access processes of pharmaceutical companies, with focus on uncertainty and decision-making. Enhanced communication may reduce risk and improve HTA system efficiency. Addressing these challenges, as well as improving management of uncertainty, would improve patient access to medicines.

Pathing the way from regulatory approval to market access for gene therapy products (GTPs): An integrative review in the US, EU5, Japan and China.

IntroductionThe growing advancement of innovative stem cell technologies requires careful evaluation of their economic, clinical and societal impacts. Early economic evaluations are essential for developing new medical technologies and supporting key decisions about commercialisation and market access. This scoping review explores Early Health Technology Assessment (eHTA) approaches specifically related to human stem cell technologies. By examining how eHTA can support the commercialisation of these therapies, we aim to clarify its role in optimising resource allocation and enhancing both the clinical and societal benefits of stem cell technologies.Methods and analysisTo explore the use of eHTA in the development of stem cell-related technologies, a scoping review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses - Scoping Review Extension guidelines. Systematic searches were conducted across scientific databases (MEDLINE, International HTA database, EconLit, PAIS Index and EconPapers), grey literature sources (Overton) and through hand-searching to identify eligible articles published from inception to 14 April 2026. No limits were imposed on language. Reviewers will independently record data from eligible studies using a standard data abstraction form. The gathered information will be synthesised both quantitatively and narratively.Ethics and disseminationFormal ethical approval is not required, as this study does not involve the collection of primary data. The findings will be shared through professional stem cell networks, published in national and international health technology assessment conference proceedings and submitted for open-access, peer-reviewed publication.

This study examines the socio-economic and environmental impacts of coffee-based agroforestry systems (AFS) in the Despagne community, Haute Voldrogue, Jérémie, Republic of Haiti, an area highly vulnerable to climate change and environmental degradation. Using a mixed and participatory research approach that combines household surveys, focus group discussions, and field observations, the study highlights the critical role of diversified agroforestry systems in promoting ecological restoration, strengthening food security, and enhancing income diversification among rural households. Results indicate that farmers’ monthly incomes range from 10,000 to 75,000 HTG, depending on land size, crop diversity, and market access. Agroforestry plots integrating coffee with bananas, yams, vegetables, and various fruit trees significantly contribute to soil fertility restoration, improved moisture retention, and biodiversity conservation. These diversified systems also reduce vulnerability to climate variability by stabilizing yields and providing multiple sources of food and income throughout the year. However, several structural challenges persist. The predominance of older producers aged between 40 and 65 years, limited youth involvement in agriculture, weak extension services, and geographical isolation continue to hinder long-term sustainability and access to profitable markets. In addition, climate instability, recurrent soil erosion, and the spread of coffee leaf rust disease further exacerbate production risks and threaten farmers’ livelihoods. Despite these constraints, the community perceives coffee agroforestry as a transformative strategy for resilience, sustainable land management, and inclusive local development in vulnerable rural regions.

Adoption of biosecurity measures by broiler farmers in Bangladesh

EU legislation for the registration of new bio-based products: Current challenges and barriers. A case study of products derived from municipal bio-waste for use in the agriculture and chemical industry sectors

Abstract In northwestern Vietnam, agroforestry is promoted to enhance environmental sustainability and support livelihoods, especially in resource-constrained situations. However, farmers adapt agroforestry in diverse ways, and there is still limited structured understanding of how differences in farm resources and configurations shape adoption patterns and support needs. Lack of knowledge about adoption patterns limits the design of cost-effective interventions. To fill this gap, we employed a participatory approach to develop a farm typology that links farm structure, agroforestry adoption patterns and group-specific constraints. Survey data from 101 households were analyzed using archetype analysis to identify distinct farm profiles. These profiles were validated through a series of farmer workshops to explore group-specific constraints and support needs. The archetype analysis identified three distinct agroforestry archetypes, each reflecting unique resource constraints. Archetype 1 and Archetype 2 both represent small-scale farmers with limited agricultural labor and diversified livelihood activities, but they differ in land configuration: Archetype 1 farmers manage more consolidated land and maintain high crop and tree diversity, whereas Archetype 2 farmers operate highly fragmented, small plots with limited potential to diversify. Archetype 3 farmers operate the largest farms among the three groups; they rely on annual crops and show the lowest agroforestry adoption level, with moderate species diversity in their agroforestry systems. Across archetypes, farmers emphasized needs for market access, as well as financial support for production inputs, tree seedlings and irrigation systems, system diversification and technical knowledge. Yet the rationale for these needs differed across groups. Our study is novel in combining data-driven archetype analysis with participatory validation to generate an action-oriented understanding of farm heterogeneity. The results show that support strategies should not only respond to common needs but also to the distinct constraints shaping agroforestry adoption across different farm contexts, highlighting the importance of context-specific, constraint-aware agroforestry policy and extension.