Pharmaceutical Policy Research Articles

Cardiovascular diseases remain the leading cause of mortality globally and in Italy, with a growing burden exacerbated by aging populations and underdeveloped strategies for managing chronic cardiovascular conditions. This position paper, resulting from the 2024 ANMCO General Assembly, addresses the current state of cardiovascular chronicity management in Italy, highlighting critical gaps and proposing sustainable, integrative solutions. Despite improvements in acute cardiovascular care, the lack of structured post-acute management, insufficient adoption of secondary prevention protocols, limited access to innovative therapies, and a slow digital transition continue to hinder effective chronic care. The document stresses the pivotal role of cardiologists, not only in acute intervention but also in long-term care and secondary prevention, emphasizing the need for a multidisciplinary, multichannel healthcare model. The paper explores the potential of e-Health and artificial intelligence to revolutionize chronic disease management. It advocates for the widespread implementation of integrated care pathways, digital tools like electronic health records and telemedicine platforms, which together could enhance early detection, patient monitoring, and therapeutic adherence while reducing unnecessary hospitalizations. It also underscores the necessity of updating national and regional pharmaceutical policies to improve equitable access to disease-modifying therapies. Furthermore, the integration of palliative care in end-stage cardiovascular disease and the enhancement of post-acute care networks are deemed essential. Ultimately, the document advocates for a comprehensive systemic and cultural transformation - spearheaded by scientific societies such as ANMCO - where technological innovation, organizational reform, and patient-centered care align to ensure a sustainable and universally accessible healthcare system. This vision is consistent with the objectives of the PNRR, the 2030 Agenda, and, most importantly, the foundational principles of the Italian Constitution.

Estimating the shares of the value of branded pharmaceuticals accruing to manufacturers and to patients in the Thai healthcare system.

Comparative analysis of pharmaceutical care, professional development, and policy compliance in chain vs. independent pharmacies: A Cross-sectional study

Health workers (HWs) and their representative health worker organisations (RHWOs) contribute to the design of pharmaceutical policy in low- and middle-income countries (LMICs), but their roles remain underappreciated. HWs and RHWOs can influence drug development, distribution, financing and access; however, which specific aspects HWs and RHWOs contribute to, and how they create change, remains insufficiently mapped within the global health literature. This protocol describes our process for conducting a scoping review to derive, describe, and classify existing literature on how HWs and RHWOs engage in pharmaceutical policy processes in LMICs. This review will follow the updated Arksey and O'Malley five-stage scoping review framework supported by iterations of methodological guidance and will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We will search Ovid Medline, Ovid Embase and CAB Global Health for English-language peer-reviewed literature published between 2005 and 2025. Studies must discuss HW and RHWO involvement or influence in pharmaceutical policy or describe the roles, governance contexts or strategies of HWs or RHWOs in the context of pharmaceutical policy. Two reviewers will independently screen titles, abstracts and full texts using Covidence software to determine eligibility. We will chart data using Excel and summarise the findings thematically. We will consult stakeholders in the final stage of this review to provide feedback on the results of our review and guide our findings further in terms of actionable policy implications. Ethics approval is not required for this scoping review of published literature. Findings will be disseminated through peer-reviewed publications, academic presentations and policy engagement with global health actors. This review will inform future research and support evidence-informed pharmaceutical policymaking in LMICs.

SHOULD EARLY-STAGE NIH FUNDING INFLUENCE PHARMACEUTICAL DRUG PRICING?

Regulatory gaps in over-the-counter antifungal access for vulvovaginal candidiasis in Uganda: A policy analysis framework

IntroductionThis study aims to examine the extent to which health status, socioeconomic characteristics, and access to needed medications contribute to differences in total Medicare costs and drug spending among beneficiaries with and without Alzheimer's disease and related dementias (ADRD).MethodsWe used Medicare fee-for-service (FFS) claims data from 2018, 2019, 2021, and 2022, linked with the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey, to examine factors associated with total Medicare spending, Part D drug spending, and Part B drug costs. Decomposition analysis was conducted to quantify the contribution of individual characteristics to observed cost differences by ADRD status.ResultsOur model explained 48% of the total Medicare spending difference and 80% of the Part D drug cost gap between beneficiaries with and without ADRD. Depression, heart disease, self-reported poor health, and functional limitations were major contributors to total spending differences. Dual eligibility was a primary driver of higher Part D costs. However, the model did not adequately explain differences in Part B drug costs.ConclusionThese findings underscore the need for targeted interventions in mental health, cardiovascular care, and pharmaceutical policy. Further research is needed to better understand unmeasured drivers of Medicare spending, especially physician-administered drug costs under Part B, among beneficiaries with ADRD.

Abstract This article addresses some practical questions about the international behaviour of pharmaceutical and biotechnology firms making vaccines against COVID-19 and, by doing so, seeks to operationalize the idea that these firms had distinct foreign policies. Building on the existing literature on non-state actors as foreign policy actors, this article asks how firms formulated and implemented their foreign policies during the COVID-19 pandemic. At two specific points during the pandemic, pharmaceutical and biotechnology firms had strong hands to play in their negotiations with multiple states. First, when governments were scrambling to secure advanced purchase agreements for vaccine doses early in the pandemic and were willing to make major concessions to the firms; and second, when the firms' vaccine candidates had been authorized for use and multiple governments wanted their deliveries as quickly as possible, with firms controlling when governments received their orders. Following Christopher Hill's work, the firms are found to have undertaken five sets of activities that, taken together, amount to them having foreign policies: setting objectives and goals; deciding their pandemic strategies; establishing timelines for the achievement of each goal; deciding on instruments; and implementing their strategies to achieve their objectives. The vaccine firms had distinct strategies and notably gave profits different degrees of importance in their pandemic foreign policies.

The pharmaceutical industry and its allies often claim that various aspects of Canadian pharmaceutical policy result in new drugs not being introduced into the Canadian market. These arguments ignore international evidence that shows that only a minority of new drugs offer major therapeutic gains. A corollary to the industry's message is the threat that new drugs will not be made available if governments or regulatory agencies introduce measures that threaten the profits of pharmaceutical companies. The government should not be intimidated by these threats and should continue to take actions that increase accessibility to necessary medications for all residents of Canada.

This is a rejoinder to an article challenging the pharmaceutical industry's claims that Canada lags in access to innovative drugs due to substandard policies. This rejoinder is in agreement with the article's main argument that Canada succeeds in attracting the new drugs that matter most, and that higher prices or stronger intellectual property protection would have a negligible impact on the timing and degree to which new drugs are launched here generally. At the same time, the rejoinder does acknowledge the legitimacy of the industry's concerns around system inefficiencies stemming from federal-provincial fragmentation but posits that national pharmacare could resolve industry and payer concerns alike. The article calls for thoughtful reform, deeper research into unmet needs and a shift in focus toward patient-relevant outcomes.

Background: The quality of decision-making processes is increasingly recognized as critical to public trust and policy sustainability. Objectives: This narrative review aims to identify and describe process-focused decision support models (DSMs) applied in pharmaceutical policy, and to examine their potential contributions to improving procedural quality in decisions related to pricing, reimbursement, and access to medicines. Methods: Relevant peer-reviewed and gray literature published between 2000 and 2025 was considered, drawing from key databases (e.g., PubMed and Scopus) and international policy reports (e.g., WHO, ISPOR, and HTA agencies). Studies were included if they provided insights into DSMs addressing at least one dimension of decision process quality. Results: Findings are synthesized narratively and organized by tool type, application context, and key quality dimensions. Frequently referenced tools included the Quality of Decision-Making Orientation Scheme (QoDoS), WHO-INTEGRATE, and AGREE II. QoDoS emerged as the only tool applied across regulatory, HTA, and industry settings, evaluating both individual- and organizational-level practices. WHO-INTEGRATE highlighted equity and legitimacy considerations but lacked a structured format. Overall, most tools demonstrated benefits in promoting internal consistency, transparency, and stakeholder engagement; however, their adoption remains limited, especially in low- and middle-income countries. Conclusions: Process-focused DSMs offer promising avenues for enhancing transparency, consistency, and legitimacy in pharmaceutical policy. Further exploration is needed to standardize evaluation approaches and expand the use of DSMs in diverse health systems.

BackgroundThe emergence of innovative anticancer medicines has revitalized cancer treatment prospects, and improving the accessibility of innovative anticancer medicines is a key goal of national pharmaceutical policies. Despite significant efforts by the National Medical Security Administration to reform the National Reimbursement Drug List (NRDL), concerns regarding the utilization of these newly included anticancer drugs persist. This study aims to assess the accessibility of 23 Innovative Negotiated Anticancer Medicines (INAMs) in Jiangsu Province, a developed region in eastern China.MethodsA retrospective survey was conducted across 319 healthcare institutions in Jiangsu Province, with 285 included for analysis. Data were obtained from procurement records of 23 INAMs. We evaluated the use of these medicines based on three aspects: availability, price measured by the defined daily dose cost (DDDc), and affordability.Results43.5% of the 23 INAMs encountered difficulties in obtaining them, and 30.4% of 23 INAMs were very difficult to obtain. There was a notable disparity in the availability of 23 INAMs between secondary and tertiary healthcare institutions. The median DDDc for Group A and Group C showed a progressive annual reduction. The DDDc of 19 INAMs decreased during the study period, while three drugs remained unchanged, and one drug's DDDc actually increased. Family poverty caused by medicines was more pronounced among rural residents. The affordability of rural patients was significantly lower than that of urban patients (p < 0.05) in 2021 and 2022.ConclusionThe accessibility of INAMs improved from 2020 to 2022. However, the accessibility of INAMs is influenced by various factors, and disparities still exist in access across different healthcare institutions and between urban and rural areas. Effective and sustainable policies need to be developed to ensure equitable access to medicines for all patients.

The pharmaceutical sector, being both labor-intensive and innovation-driven, heavily depends on robust incentive frameworks to optimize employee performance. In the backdrop of the Union Budget 2024–25 and recent RBI monetary interventions, this study explores how fiscal and monetary policies shape the design and implementation of both financial and non-financial incentives in the pharmaceutical industry of Madhya Pradesh. Using a comparative design, this paper examines two sets of pharmaceutical companies—one with higher exposure to government-linked policy benefits and one operating independently of such benefits. The study aims to identify differences in incentive adoption, employee engagement, and performance outcomes. Primary data was collected from 160 respondents including HR managers, middle managers, and frontline employees through structured questionnaires. Statistical analysis using SPSS involved ANOVA, regression analysis, and factor extraction to identify relationships between incentive type, policy exposure, and productivity indices. Results indicate that organizations which integrated fiscal benefits (such as production-linked incentives, GST rebates, and public procurement preferences) offered more structured financial and non-financial incentives, including performance bonuses, career development plans, wellness programs, and recognition schemes. Furthermore, policy-backed firms demonstrated significantly higher performance ratings and lower attrition. The findings emphasize the need for aligning macroeconomic policy tools with enterprise-level HR strategies. Recommendations include targeted policy communication, incentive-linked tax deductions, and incentive audit mechanisms under MSME and pharmaceutical policy reforms.

Experts recommend preparedness to manage chronic diseases in case of disaster-related resource disruption. This study's goal is to identify factors underlying personal medical preparedness (PMP) among participants from a hurricane-prone region. A cross-sectional survey was completed during the 2023 Atlantic hurricane season with 120 insured adults age ≥50 in Southeast Louisiana with hypertension and ≥1 regular medication. PMP was measured using the validated Household Emergency Preparedness Instrument Access and Functional Needs Section (HEPI-AFN). Multivariable logistic regression analysis tested associations between PMP and exposure variables, including demographics, health, and hurricane experience. The sample included 50% women, 43% Black, with mean age 62.6 (SD = 8.1) years and mean 51.3 (SD = 18.1) years living in hurricane-impacted area. Participants were prepared on an average 79% (SD = 21) of applicable HEPI-AFN items; 42 (35%) were prepared on 100% of PMP items. The most missed item was having 2 weeks of extra medication; open-responses noted refill policies as a common barrier to PMP. No factors were associated with increased odds of PMP. While many participants in this insured, disaster-experienced sample are medically prepared, restrictive pharmaceutical refill policies may be a barrier. Research is needed to understand the impact of prescription refill and other policies on PMP.

IntroductionAccess to essential medicines is crucial for achieving the Sustainable Development Goals and Universal Health Coverage. In Georgia, as in many low- and middle-income countries, out-of-pocket payments (OOPs) for medicines remain a major financial burden, particularly for low-income households. Despite the launch of Georgia’s Universal Health Coverage Program in 2013, medicines still constitute the largest share of OOP health expenditures, increasing the risk of impoverishment. This study, therefore, aims to assesses the impact of three pharmaceutical policy interventions introduced between 2017 and 2023 on monthly household drug expenditures.MethodologyThe analysis utilizes pooled data from Georgia’s Household Income and Expenditure Surveys (2015–2023), covering over 88,000 households. Interrupted Time Series (ITS) analysis was employed to evaluate the effects of three policy actions: the 2017 drug reimbursement plan, the 2022 introduction of parallel imports from Turkey, and the 2023 implementation of external reference pricing. Regression models accounted for seasonality and complex survey design, including weights and clustering. Monthly median drug expenditures were adjusted to January 2015 prices.ResultsOnly after the introduction of external reference pricing policy in 2023 a significant reduction was observed — an immediate drop of 6.96 GEL (2.51 USD) per household (p = 0.016) and a monthly decline of 1.28 GEL (0.46 USD) (p = 0.002), representing a 29% decrease and saving Georgian households approximately 43.3 million GEL (15.59 million USD) in 2023. The 2022 parallel import policy led to an initial decrease (2.26 GEL; p = 0.39) but was followed by a significant increase over time (coefficient = 1.43, p < 0.001).ConclusionAddition of external reference pricing policy significantly reduced household pharmaceutical spending and shows promise as a policy tool for other low- and middle-income countries. However, sustained impact requires continued monitoring and complementary measures to ensure equitable access and long-term benefits.

Pharmaceutical policy in europe: Time for a common priceless solution?

Evaluating China's pharmaceutical services policies: An integration of policy tools and policy modeling consistency index analysis

Sustainability of drug discovery, development and use as embedded in European pharmaceutical policies

Chronic hepatitis C virus (HCV) management has historically been challenging, particularly in Egypt, the country with the highest global disease prevalence. The introduction of direct-acting antivirals (DAAs) has revolutionised treatment, providing high rates of sustained virologic response (SVR) with fewer adverse events compared to previous therapies. In Egypt, the locally produced generics of sofosbuvir/daclatasvir (SOF/DAC) have been integral to the national HCV elimination programme, treating millions effectively and affordably, demonstrating similar efficacy and safety to brand-name drugs. Although not currently present in most international guidelines, this cost-effective regimen offers a viable option for large-scale elimination programmes similar to Egypt's successful experience. This review synthesises real-world Egyptian data and highlights the efficacy and safety of the SOF/DAC combination in various population groups. High sustained virological response (SVR) rates were observed across diverse patient populations, including those with advanced liver disease. However, limitations regarding long-term follow-up, especially HCC surveillance, were identified, underscoring the need for further research. Additionally, the review underscores the success of local Egyptian pharmaceutical policies in reducing treatment costs and securing access for all infected individuals. The Egyptian experience offers valuable insights into the potential for replicating its success, particularly in other high-burden regions.

IntroductionWhile many countries have successfully promoted generic drug use, South Korea faces challenges with low utilization and high expenditure shares, despite various policy reforms. This study aimed to evaluate the effectiveness of generic drug policies in South Korea, by comparing the prices, competition, and usage trends of generic drugs between South Korea and the Group of Twenty (G20) countries.MethodsWe analyzed 26 off-patent active ingredients marketed in South Korea and G20 countries from 2014 to 2023. Generic drug prices were calculated by dividing total sales by total volume in 2023, with the average price for each country subsequently determined. Generic competition was measured by the number of generic drugs available in each country. The usage trends of generic drugs were assessed using the sales and volume ratios of off-patent original drugs to generic drugs in 2023.ResultsSouth Korea had more generic drugs for 19 of the 26 analyzed ingredients (73.1%) compared to other G20 countries. However, for recently off-patent ingredients, the number of generic drugs was smaller in South Korea. The generic prices for 18 ingredients (69.2%) were lower in South Korea than in the G20 and Advanced Eight (A8) countries. Similar to the generic competition, generics with larger market sizes had higher prices in South Korea. Conversely, the prices of recently off-patent ingredients were higher in South Korea compared to the G20 countries. For 24 ingredients (92.3%), the sales and volume ratios of generic drugs in South Korea were considerably lower compared to the G20 countries.ConclusionThis study confirms that the pharmaceutical policies and regulatory frameworks for generic drug are fragmented and inefficient in South Korea. Consequently, these fragmented and inefficient policies disrupt the virtuous cycle mechanism of generic price and usage driven by effective competition. To address these challenges and promote the use of generic drugs, the findings of this study suggest the need to develop and implement policies in South Korea that focus on optimizing the pharmaceutical expenditure structure, enhancing post-listing price management system for generic drugs, supporting the accelerated development of generic drugs, and promoting the prescription and use of generic drugs.