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.

The Impact of Additive PICOs in a European Joint Clinical Health Technology Assessment.

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.

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 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.

[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.

Access to opioid analgesics for medical use at hospital level in the Democratic Republic of Congo: An exploratory mixed-method study.

OBJECTIVE: To investigate the availability of and access to opioid analgesics at hospital level in the Democratic Republic of Congo. METHODS: Exploratory mixed-method study combining a descriptive survey of the availability of opioid analgesics at hospital pharmacies with a qualitative survey that explored the experiences and perceptions of healthcare workers, managers, patients and caregivers, by means of a short questionnaire and of semi-structured interviews. The study was conducted in a convenience sample of 12 hospitals, located in five different provinces, in 2021. RESULTS: The quality and completeness of stock data for opioid analgesics were generally poor. Stock-outs were frequent. Only five hospital pharmacies had records on prescriptions of opioids in 2020. In-patients and caregivers indicated they generally must purchase opioids out-of-pocket, sometimes far from the place of residence. Doctors and nurses confirmed that prescribed opioids are often unavailable at the hospital pharmacy. Furthermore, they suggested an important need of training in pain management with opioids, and of effective regulation to ensure opioid availability. Pharmacists and managers recognised important weaknesses in the processes of needs quantification, stock management, planning and supply. CONCLUSIONS: Our exploratory study suggests the need of a complex set of coordinated actions to be undertaken by all relevant actors in DRC to correct the poor practices in opioids' management and to improve opioids' availability, affordability and adequate use. This will require a change of mindset to overcome the neglect of the health needs of persons with acute and chronic pain.

Does EU and US paediatric legislation improve the authorization availability of medicines for children in other countries?

AIM: For over 15 years, the pharmaceutical industry has been engaged in developing medicines for children to comply with the European Union (EU) and the United States (US) regulatory requirements. We assessed the authorization availability of these medicines in countries without paediatric regulatory obligations. Special attention was given to the authorization availability of paediatric formulations. METHODS: Medicines for children were sampled from the US Food and Drug Administration and European Medicines Agency websites. We carried out systematic content analysis of product information and compared paediatric labelling in Australia, Brazil, Canada, Russia and South Africa with the EU or the US. The authorization availability of paediatric formulations in originator and generic medicines was reviewed. In Kenya, the authorization availability of sampled medicines and paediatric formulations was investigated. RESULTS: A total of 161 medicines authorized in the EU or the US were sampled. Whilst at least one paediatric indication was found in 70% of the medicines, the EU and US level of authorization was on average 38% in Australia, Brazil, Canada, Russia and South Africa. Paediatric formulations were authorized on average for 40% of originator and 36% of generic medicines. Kenya had the lowest authorization availability of medicines (40%) and formulations (26%). CONCLUSIONS: The authorization availability of novel medicines for children is lower in countries without paediatric regulatory obligations. Paediatric formulations often do not reach other countries if left unregulated, and their generic uptake is low. To increase authorization availability, submission of paediatric development results should become obligatory in each jurisdiction. Policy initiatives to stimulate the introduction of developed formulations should be encouraged.

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.

A multi-country survey on access to healthcare and treatment services among individuals with critical medical care needs during the first wave of the pandemic.

BACKGROUND: Healthcare services were significantly interrupted during the early phase of the COVID-19 pandemic. The aim of the present study was to determine the associations between sociodemographic factors and healthcare access during the first wave of the COVID-19 pandemic among individuals with critical care needs. METHODS: This was a secondary analysis of the data of 5,156 participants recruited from 152 countries during the first wave of the COVID-19 pandemic. The dependent variables were self-reported difficulty of access to health care, challenges with obtaining medication, and the use of alternative medical services. The independent variables were age at last birthday; sex at birth, level of education, employment status and the macro-social vulnerability status. The confounding variable was the country income level. Three multivariable logistic regression analyses were conducted to determine the associations between the dependent variables and the independent variables after adjusting for the confounder. RESULTS: Difficulty accessing health care services and obtaining medications was experienced by 1922 (37.3%) and 3746 (72.7%) participants respectively. Also, 1433 (27.8%) used alternative medical care. Retirees (AOR:1.59), unemployed (AOR:1.198), people living with HIV (AOR:2.36) and at increased risk of COVID-19 (AOR:2.10), people who used drugs (AOR:1.83) and transacted sex (AOR:1.971) had significantly higher odds for reporting difficulty with access to health care. Males (AOR:1.23), respondents with secondary level of education (AOR:1.39), retirees (AOR:2.19), unemployed (AOR:1.47), people living with HIV (AOR:2.46), people who used drugs (AOR:1.79), transacted sex (AOR:2.71) and those who might be (AOR: 1.66) and were at (AOR: 2.3) increased risk of severe COVID-19 had significantly higher odds for reporting difficulty with access to medications. People who used drugs (AOR:2.093) transacted sex (AOR:1.639), who might be (AOR: 1.211) and were at (AOR: 1.511) increased risk of severe COVID-19, and who had difficulty accessing usual healthcare (AOR: 9.047) and obtaining medications (AOR:2.16) had significantly higher odds of reporting alternative medical care use. People living with HIV (AOR:0.562) had significantly lower odds of using alternative medical care. CONCLUSION: We identified populations who had challenges with access to healthcare and obtaining medications used alternative medical care except for people living with HIV. Priority attention should be given to alternative medical care use during future health pandemics.

SDG indicator 3.b.3 - an analysis of its robustness and challenges for measuring access to medicines for children.

BACKGROUND: Sustainable Development Goal (SDG) indicator 3.b.3 monitors progress in medicines' accessibility for adults and has significant limitations when applying to medicines for children. An adapted indicator methodology was developed to fill this gap, but no proof of its robustness exists. We provide this evidence through sensitivity analyses. METHODS: Data on availability and prices of child medicines from ten historical datasets were combined to create datasets for analysis: Dataset 1 (medicines selected at random) and Dataset 2 (preference given to available medicines, to better capture affordability of medicines). A base case scenario and univariate sensitivity analyses were performed to test critical components of the methodology, including the new variable of number of units needed for treatment (NUNT), disease burden (DB) weighting, and the National Poverty Line (NPL) limits. Additional analyses were run on a continuously smaller basket of medicines to explore the minimum number of medicines required. Mean facility scores for access were calculated and compared. RESULTS: The mean facility score for Dataset 1 and Dataset 2 within the base case scenario was 35.5% (range 8.0-58.8%) and 76.3% (range 57.2-90.6%). Different NUNT scenarios led to limited variations in mean facility scores of + 0.1% and -0.2%, or differences of + 4.4% and -2.1% at the more critical NPL of $5.50 (Dataset 1). For Dataset 2, variations to the NUNT generated differences of + 0.0% and -0.6%, at an NPL of $5.50 the differences were + 5.0 and -2.0%. Different approaches for weighting for DB induced considerable fluctuations of 9.0% and 11.2% respectively. Stable outcomes with less than 5% change in mean facility score were observed for a medicine basket down to 12 medicines. For smaller baskets, scores increased more rapidly with a widening range. CONCLUSION: This study has confirmed that the proposed adaptations to make SDG indicator 3.b.3 appropriate for children are robust, indicating that they could be an important addition to the official Global Indicator Framework. At least 12 child-appropriate medicines should be surveyed to obtain meaningful outcomes. General concerns that remain about the weighting of medicines for DB and the NPL should be considered at the 2025 planned review of this framework.

Demonstrating proof of concept for value-based agreements in Europe: two real-world cases.

OBJECTIVES: Value-based agreements (VBAs) link access, reimbursement, or price to the real-world usage and impact of a medicine, thereby enabling patient access while reducing clinical or financial uncertainty for the payer. VBAs have the potential to support improved patient outcomes, given the value-oriented approach to care, and lead to overall savings, while enabling payers to share risk and reduce uncertainty. METHODS: This commentary outlines the key challenges, enablers, and a framework for successful implementation by comparing the experience of two VBAs for AstraZeneca medicines, aiming to increase confidence in their future use. RESULTS: Engagement by payers, manufacturers, physicians, and provider institutions, and robust data collection systems that are accessible, simple to use, and add little burden to physicians were key to successfully negotiating a VBA that worked for all stakeholders. In both country systems, a legal/policy framework enabled innovative contracting. CONCLUSIONS: These examples demonstrate proof of concept for VBA implementation in different settings, and may inform future VBAs.

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.

The human cost of economic sanctions and strategies for building health system resilience: A scoping review of studies in Iran.

OBJECTIVES: This review aimed to analyse the impacts of international economic sanctions on the overall health status of Iranians and the health system performance of Iran, in addition to identifying effective strategies for making the health system resilient to sanctions. STUDY DESIGN: A scoping review. METHODS: Three databases and grey literature were reviewed, and additional papers were identified in the lists of references. Two authors reviewed papers to check duplications and screen through inclusion/exclusion criteria. Furthermore, a narrative approach was employed to synthesise the findings. RESULTS: Given overall health impacts, economic sanctions are believed to have adverse effects on Iranian's health and cause significant financial hardships in accessing healthcare services. These hardships mostly affect those in marginalised and vulnerable groups. Economic sanctions degrade Iran's health system by negatively impacting health services' availability. The detrimental effects of sanctions on economic and social circumstances were also documented. Economic sanctions could also adversely affect health research and education. Most strategies identified for health system resilience to sanctions are related to the health system governance. CONCLUSIONS: Even if essential medicines and supplies are exempted from the sanction regime, the impact of economic sanctions on public health is unavoidable. The quantification of the effect economic sanctions on different health-related areas needs by further research. The measures identified for dealing with sanction can be considered in other countries but more work is needed to explore how health of people can be resilient against negative consequences of sanctions.

Between Regional Recommendations and National Implementation: An Analysis of the East African Community Partner States' Legislative Responses to TRIPS Obligations.

With the access-to-medicines conundrum facing its populations, the East African Community has adopted a policy framework which promotes a collective approach to resolving the access gap in the region. To this end, crucial policy documents on the implementation of TRIPS obligations, harmonisation of drug regulation and boosting regional manufacturing capacity have been adopted. This paper is a case study of the regional policy on the implementation of TRIPS obligations, specifically examining the extent to which partner states' implementation of TRIPS obligations mirrors the regional recommendations. The paper finds that, while many partner states follow the regional recommendations on implementing TRIPS obligations, coherence remains a big challenge. This, the paper concludes, may affect the overall usefulness of a regional approach to solving the access conundrum.

Strengthening the Interface of Evidence-Based Decision Making Across European Regulators and Health Technology Assessment Bodies.

OBJECTIVES: Access to medicines in Europe depends on a benefit-risk decision taken by regulators and a relative effectiveness assessment performed by health technology assessment bodies (HTABs) to inform, as one element, a reimbursement decision. Although various similarities in evidence needs exist, understanding of their needs is currently suboptimal and therefore the evidence generated does not always meet their needs. Subsequently, delays in decision making can be expected, negatively affecting access. To overcome this, this study reviewed the evidentiary needs of European regulators and HTABs at European level and analyzed how their collaboration can further facilitate optimal evidence generation plans, evidence use, and evidence presentation. METHODS: Through systematic literature review, expert interviews, and pairwise comparison of assessment reports by the European Medicines Agency and European network for health technology assessment, respective clinical evidence requirements and impact of product-specific collaboration between European Medicines Agency and HTABs were established. RESULTS: Clinical evidence needs are quite similar but differences exist in comparator choice, preferred efficacy endpoints, and target population. Results of the impact of collaboration to date were mixed: preapproval joint advice procedures were successful and highly valued by all stakeholders; information exchange at the time of regulatory decision is coming together, yet the European Public Assessment Report can be further optimized; and collaboration on postlicensing evidence generation requirements shows potential but needs solidifying. CONCLUSIONS: These findings demonstrate the potential to further improve the evidence utilization across stakeholders to avoid duplication and streamline decision making, to ultimately improve access to medicines for European patients.

Patenting and patent challenges in South Korea after introducing a patent linkage system.

BACKGROUND: South Korea introduced the patent linkage system in 2015 as part of the implementation of free trade agreements with the United States. This study assessed trends in brand-name drug patenting and generic patent challenges in South Korea after the introduction of the system. METHODS: From 2012-19, we constructed a novel dataset that combines information about listed patents with their corresponding brand-name drugs and patent challenges against these brand-name drugs. We analyzed brand-name drug patenting and generic patent challenges and elucidated factors in timely patent challenges using event history analysis. RESULTS: During the study period, 659 brand-name drugs listed their patents in the K-Orange Book and patent challenges against 95 brand-name drugs were initiated. The number of listed patents and their nominal patent term varied by the characteristics of the brand-name drugs. Patent challenges of generic drugs were marginal in South Korea even though the surge of patent challenges of generics were noticed right after the introduction of the patent linkage system. CONCLUSIONS: Patenting and patent challenges are critical factors when introducing generic drugs into the market under the patent linkage system. However, the impact of the patent linkage system on patenting and patent challenges could be varied by the specific form of the patent linkage system and the contexts of pharmaceutical markets.

Disclosure, transparency, and accountability: a qualitative survey of public sector pharmaceutical committee conflict of interest policies in the World Health Organization South-East Asia Region.

BACKGROUND: Weak governance over public sector pharmaceutical policy and practice limits access to essential medicines, inflates pharmaceutical prices, and wastes scarce health system resources. Pharmaceutical systems are technically complex and involve extensive interactions between the private and public sectors. For members of public sector pharmaceutical committees, relationships with the private sector can result in conflicts of interest, which may introduce commercial biases into decision-making, potentially compromising public health objectives and health system sustainability. We conducted a descriptive, qualitative study of conflict of interest policies and practices in the public pharmaceutical sector in ten countries in the World Health Organization (WHO) South-East Asia Region (SEAR) (Bangladesh, Bhutan, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand, and Timor-Leste) between September 2020 and March 2021. RESULTS: We identified 45 policy and regulatory documents and triangulated documentary data with 21 expert interviews. Key informants articulated very different governance priorities and conflict of interest concerns depending on the features of their country's pharmaceutical industry, market size, and national economic objectives related to the domestic pharmaceutical industry. Public sector pharmaceutical policies and regulations consistently contained provisions for pharmaceutical committee members to disclose relevant interests, but contained little detail about what should be declared, when, and how often, nor whether disclosures are evaluated and by whom. Processes for preventing or managing conflicts of interest were less well developed than those for disclosure except for a few key procurement processes. Where processes for managing conflicts of interest were specified, the dominant strategy was to recuse committee members with a conflict of interest from relevant work. Policies rarely specified that committee members should divest or otherwise be free from conflicts of interest. CONCLUSIONS: Robust processes for conflict of interest prevention and management could ensure the integrity of decision-making and build public trust in pharmaceutical processes to achieve public health objectives. Upstream approaches including supportive legislative frameworks, the creation of oversight bodies, and strengthening regulatory institutions can also contribute to building cultures of transparency, accountability, and trust.

Implications of national tax policy on local pharmaceutical production in a southwestern state nigeria - qualitative research for the intersection of national pharmaceutical policy on health systems development.

BACKGROUND: Universal access to quality and affordable medicines is one of the targets of the Sustainable Development Goals (SDGs). Access to essential medicines is defined as the availability of medicine at an affordable price in public and private health institutions including retail pharmacies in the proximity of less than an hour from the home of the population. The dependence on importation to meet the drug needs of an expanding population has implications on the growth of the local pharmaceutical industry, availability, and affordability of essential medicines in the country. This study aims to understand the dynamics of tariffs and tax policy on local drug production in the pharmaceutical industry in Nigeria. METHODS: This was a qualitative study involving the use of Key Informant Interviews (KIIs). A total of 15 stakeholders were interviewed. Interviews conducted were analysed thematically. The data generated were analysed using Atlas.Ti version 8.2. RESULTS: Assessment of the pharmaceutical industry sub-sector underscores myriads of challenges facing the industry and explains why the pharmaceutical industries in Nigeria are performing sub-optimally. Key stakeholders in the sector expressed concern about the fact that substantial percentage of drugs consumed in Nigeria are imported. Local manufacturers are underperforming due to several factors. Some highlighted factors were unfriendly tax environment, high cost of production, infrastructural deficit, low patronage from the government, and lack of access to low-interest rate loans. However, tax incentives and tax cuts are proven strategies to encourage and facilitate the growth of entrepreneurs in the pharmaceutical industry. CONCLUSIONS: Stakeholders' perspective of implications of the tax environment on the pharmaceutical sector of Nigeria revealed the unfriendliness of the government policy to local manufacturers. Although the checklist for availability and prices of essential medicines in Osun state, Nigeria revealed that the pre-selected drugs were available in the facilities, the observed prices further affirmed the relative difficulty that is experienced by local manufacturers to compete with imported brands of the same drugs.

Improving the availability of prescription drugs in Lebanon: a critical analysis of alternative policy options.

The economic downfall in Lebanon and the destruction of the Beirut Port have had a crippling effect on all players in the health sector, including hospitals, healthcare providers, and the pharmaceutical and medical supply industry. The outbreak of COVID-19 has further aggravated the crisis. To address the challenges facing the pharmaceutical industry, Lebanon must create a stable and secure source of prescription drug production. Two alternative approaches are presented to address the crisis: (1) amending the subsidy system and supporting local pharmaceutical production, and (2) promoting the prescription and use of generic drugs. Investing in local production is promising and can lead to establishing trust in the quality of drugs produced locally. These efforts can be complemented by promoting the prescription and use of generic drugs at a later stage, after having had established a well-operating system for local drug production.

Increasing access to quality anticancer medicines in low- and middle-income countries: the experience of Uganda.

Cancer is one of the leading causes of death with 9.6 million deaths registered in 2018, of which 70% occur in Africa, Asia and Central and South America, the low-and middle-income countries (LMICs). The global annual expenditure on anticancer medicines increased from $96 billion in 2013 to $133 billion in 2017. This growth rate is several folds that of newly diagnosed cancer cases and therefore estimated to reach up to $200 billion by 2022. The Uganda Cancer Institute, Uganda's national referral cancer center, has increased access to cancer medicines through an efficient and cost-saving procurement system. The system has achieved cost savings of more than USD 2,000,000 on a total of 37 of 42 essential cancer medicines. This has resulted in 85.8% availability superseding the WHO's 80% target. All selected products were procured from manufacturers with stringent regulatory authority approval or a proven track record of quality products.