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Context: The European Union (EU) governs global health through its constituent laws, institutions, actors, and policies. However, it is unclear whether or how these political factors interact to position the EU as a political determinant of global health. Methods: The authors conduct a case study of the political factors influencing the adoption of the EU's Biotechnology Directive 98/44/EC and Orphan Medicines Regulation 141/2000. Findings: The European Commission (EC) generally framed both of its proposals around economical and biomedical paradigms aligned with the needs of the EU's industry and patients, whereas the European Parliament (EP) contested some of these frames and proposed amendments supporting global access to medical products. The political factors influencing the adoption (in the Biotechnology Directive) or rejection (in the Orphan Regulation) of the EP's amendments include the complementarity between the EP and EC proposals, the EP's power in the intra- and interinstitutional negotiating process, the existence and support of civil society, and the alignment with member state priorities in the Council. Conclusions: In the late 1990s, the EU was an internally fragmented and politicized player concerning global health matters. These political factors should be considered for a coherent post-2022 EU strategy on global health. [ABSTRACT FROM AUTHOR]

Pharmaceutical sector corruption undermines patient access to medicines by diverting public funds for private gain and exacerbating health inequities. This paper presents an analysis of UN Convention Against Corruption (UNCAC) compliance in seven countries and examines how full UNCAC adoption may reduce corruption risks within four key pharmaceutical decision-making points: product approval, formulary selection, procurement, and dispensing. Countries were selected based on their participation in the Medicines Transparency Alliance and the WHO Good Governance for Medicines Programme. Each country’s domestic anti-corruption laws and policies were catalogued and analysed to evaluate their implementation of select UNCAC Articles relevant to the pharmaceutical sector. Countries displayed high compliance with UNCAC provisions on procurement and the recognition of most public sector corruption offences. However, several countries do not penalise private sector bribery or provide statutory protection to whistleblowers or witnesses in corruption proceedings, suggesting that private sector pharmaceutical dispensing may be a decision-making point particularly vulnerable to corruption. Fully implementing the UNCAC is a meaningful first step that countries can take reduce pharmaceutical sector corruption. However, without broader commitment to cultures of transparency and institutional integrity, corruption legislation alone is likely insufficient to ensure long-term, sustainable pharmaceutical sector good governance. [ABSTRACT FROM AUTHOR]

Background: Improving access to adolescent contraception information and services is essential to reduce unplanned adolescent pregnancies and maternal mortality in Uganda and Kenya, and attain the SDGs on health and gender equality. This research studies to what degree national laws and policies for adolescent contraception in Uganda and Kenya are consistent with WHO standards and human rights law. Methods: This is a comparative content analysis of law and policy documents in force between 2010 and 2018 governing adolescent (age 10–19 years) contraception. Between and within country differences were analysed using WHO's guidelines "Ensuring human rights in the provision of contraceptive information and services". Results: Of the 93 laws and policies screened, 26 documents were included (13 policies in Uganda, 13 policies in Kenya). Ugandan policies include a median of 1 WHO recommendation for adolescent contraception per policy (range 0–4) that most frequently concerns contraception accessibility. Ugandan policies have 6/9 WHO recommendations (14/24 sub-recommendations) and miss entirely WHO's recommendations for adolescent contraception availability, quality, and accountability. On the other hand, most Kenyan policies consistently address multiple WHO recommendations (median 2 recommendations/policy, range 0–6), most frequently for contraception availability and accessibility for adolescents. Kenyan policies cover 8/9 WHO recommendations (16/24 sub-recommendations) except for accountability. Conclusions: The current policy landscapes for adolescent contraception in Uganda and Kenya include important references to human rights and evidence-based practice (in WHO's recommendations); however, there is still room for improvement. Aligning national laws and policies with WHO's recommendations on contraceptive information and services for adolescents may support interventions to improve health outcomes, provided these frameworks are effectively implemented. Plain language summary: The unmet need for contraception among adolescents is high in Uganda and Kenya, and has many negative consequences, including unwanted pregnancy, exposure to unsafe abortion, and maternal morbidity and mortality. National laws and policies play an important role in determining adolescents' access to contraception. For example, national laws and policies can shape the government programs that provide (or withhold) contraception, and the social norms influencing adolescents' access to contraception. Therefore, this research compares national laws and policies that determine access to contraception services and information for adolescents in Uganda and Kenya with WHO's recommendations for access to contraception. This is an analysis of the content of Ugandan and Kenyan laws and policies in force between 2010 and 2018. The content of these documents was analyzed using WHO's nine recommendations for how contraception information and services should be provided: non-discrimination, availability, accessibility, acceptability, quality, informed decision-making, confidentiality, participation, accountability. Ninety-three documents were screened and 26 documents were included in the analysis: 13 policies from Uganda and 13 policies from Kenya. On average, Ugandan policies include one WHO recommendation for adolescent contraception per policy and Kenyan policies include two WHO recommendations. This recommendation most frequently mentioned in all policies is the accessibility of contraception (for example, for adolescents living remotely, integrated in adolescent HIV or pre-/post-natal care, etc.). Together, all Ugandan policies mentioned 6/9 WHO recommendations whereas all Kenyan policies cover 8/9 WHO recommendations. In conclusion, Ugandan and Kenyan policies are consistent with many of WHO's recommendations for access to contraception, however, there is still room for improvement. [ABSTRACT FROM AUTHOR]

Background: Cervical cancer claims 311,000 lives annually, and 90% of these deaths occur in low- and middle-income countries. Cervical cancer is a highly preventable and treatable disease, if detected through screening at an early stage. Governments have a responsibility to screen women for precancerous cervical lesions. Yet, national screening programmes overlook many poor women and those marginalised in society. Under-screened women (called hard-to-reach) experience a higher incidence of cervical cancer and elevated mortality rates compared to regularly-screened women. Such inequalities deprive hard-to-reach women of the full enjoyment of their right to sexual and reproductive health, as laid out in Article 12 of the International Covenant on Economic, Social and Cultural Rights and General Comment No. 22. Discussion: This article argues first for tailored and innovative national cervical cancer screening programmes (NCSP) grounded in human rights law, to close the disparity between women who are afforded screening and those who are not. Second, acknowledging socioeconomic disparities requires governments to adopt and refine universal cancer control through NCSPs aligned with human rights duties, including to reach all eligible women. Commonly reported- and chronically under-addressed- screening disparities relate to the availability of sufficient health facilities and human resources (example from Kenya), the physical accessibility of health services for rural and remote populations (example from Brazil), and the accessibility of information sensitive to cultural, ethnic, and linguistic barriers (example from Ecuador). Third, governments can adopt new technologies to overcome individual and structural barriers to cervical cancer screening. National cervical cancer screening programmes should tailor screening methods to under-screened women, bearing in mind that eliminating systemic discrimination may require committing greater resources to traditionally neglected groups. Conclusion: Governments have human rights obligations to refocus screening policies and programmes on women who are disproportionately affected by discrimination that impairs their full enjoyment of the right to sexual and reproductive health. National cervical cancer screening programmes that keep the right to health principles (above) central will be able to expand screening among low-income, isolated and other marginalised populations, but also women in general, who, for a variety of reasons, do not visit healthcare providers for regular screenings. [ABSTRACT FROM AUTHOR]

Access to essential medicines for the world’s poor and vulnerable has made little progress since 2000, except for a few specific medicines such as antiretrovirals for HIV/AIDS. Human rights principles written into national law can create a supportive environment for universal access to medicines; however, systematic research and policy guidance on this topic is lacking. To examine how international human rights law and WHO’s essential medicines policies are embedded in national law for medicines affordability and financing, and interpreted and implemented in practice to promote universal access to essential medicines. This thesis consists of (1) a cross-national content analysis of 192 national constitutions, 71 national medicines policies, and legislation for universal health coverage (UHC) from 16 mostly low- and middle-income countries; (2) a case study of medicines litigation in Uruguay, and (3) a follow-up report of eight right to health indicators for access to medicines from 195 countries. Some, but not all, of the 12 principles from human rights law and WHO’s policy are embedded in national UHC law and medicines policies (part 1). Even the most rights-compliant legislation for access to medicines is subject to the unique and inconsistent interpretation of domestic courts, which may be inconsistent with the right to health in international law (part 2). Many national health systems for which data were available still fail to meet the official targets for eight indicators of access to medicines (part 3). International human rights law and WHO policy are embedded in national law for essential medicines and practically implemented in national health systems. Law makers can use these findings and the example texts in this thesis as a starting point for writing and monitoring governments’ rights-based legal commitments for access to medicines. Future research should study the effect of national law on access to medicines and population health. [ABSTRACT FROM AUTHOR]

Access to essential medicines for the world's poor and vulnerable has made little progress since 2000, except for a few specific medicines such as antiretrovirals for HIV/AIDS. Human rights principles written into national law can create a supportive environment for universal access to medicines; however, systematic research and policy guidance on this topic is lacking. To examine how international human rights law and WHO's essential medicines policies are embedded in national law for medicines affordability and financing, and interpreted and implemented in practice to promote universal access to essential medicines. This thesis consists of (1) a cross-national content analysis of 192 national constitutions, 71 national medicines policies, and legislation for universal health coverage (UHC) from 16 mostly low- and middle-income countries; (2) a case study of medicines litigation in Uruguay, and (3) a follow-up report of eight right to health indicators for access to medicines from 195 countries. Some, but not all, of the 12 principles from human rights law and WHO's policy are embedded in national UHC law and medicines policies (part 1). Even the most rights-compliant legislation for access to medicines is subject to the unique and inconsistent interpretation of domestic courts, which may be inconsistent with the right to health in international law (part 2). Many national health systems for which data were available still fail to meet the official targets for eight indicators of access to medicines (part 3). International human rights law and WHO policy are embedded in national law for essential medicines and practically implemented in national health systems. Law makers can use these findings and the example texts in this thesis as a starting point for writing and monitoring governments' rights-based legal commitments for access to medicines. Future research should study the effect of national law on access to medicines and population health. [ABSTRACT FROM AUTHOR]

Background: WHO has a pivotal role to play as the leading international agency promoting good practices in health and human rights. In 2005, mifepristone and misoprostol were added to WHO's Model List of Essential Medicines for combined use to terminate unwanted pregnancies. However, these drugs were considered 'complementary' and qualified for use when in line with national legislation and where 'culturally acceptable'. Discussion: This article argues that these qualifications, while perhaps appropriate at the time, must now be removed. First, compelling medical evidence justifies their reclassification as a 'core' essential medicine. Second, continuing to subjugate essential medicines for medical abortion to domestic law and cultural practices is incoherent with today's human rights standards in which universal access to these medicines is an inextricable part of the right to sexual and reproductive health, which should be supported and realised through domestic legislation. Conclusion: This article shows that removing such limitations will align WHO's Model List of Essential Medicines with the mounting scientific evidence, human rights standards, and its own more recently developed policy guidance. This measure will send a strong normative message to governments that these medicines should be readily available in a functioning and human-rights-abiding health system. [ABSTRACT FROM AUTHOR]

The article discusses how a human rights approach and the principle of the progressive realization of the right to health can support the efforts of governments to prioritize access to essential medicines and gradually fulfill access to health care for all patients. Topics discussed include need for transparent and independent reimbursement ranking process of medical treatments for prioritization, and progressive realization to ensure effective use of available resources by governments.

Background Adverse drug reactions (ADRs) are common and have serious repercussions for older-adults. This descriptive-analysis elucidates clinical presentations, severity and responsible drugs of incident ADRs in the SENATOR (S oftware EN gine for the A ssessment & optimization of drug and non-drug T herapy in O lder pe R sons) phase I feasibility study. Methods SENATOR-phase-I was a European multicentre-prospective-observational study. Participants were ≥ 65 years, experiencing acute-hospitalisation and on pharmacological treatment for ≥ 3 conditions. Adverse events (AEs) were identified by trigger list at recruitment, day-14/discharge and classified as ADRs when association with an administered drug was adjudicated as being probable/certain, according to the World Health Organization Uppsala Monitoring Centre ADR causality criteria. Results Of 644 participants recruited, 382 (59.1%) experienced 732 AEs, 363 AEs (49.6%) being incident. 139 participants (21.6%) experienced 177 (48.8%) ADRs. Full drug details were recorded in 156 patients (88%). Cardiovascular-system drugs accounted for one-third of ADRs (55, 35.3%). Five drug classes caused three-quarters of ADRs (135, 76.3%); diuretics 28.2% (furosemide 24.4%), opioid analgesics 16.7%, anti-bacterials for systemic use 14.1%, anti-thrombotic agents 10.3%, and drugs used in diabetes 7%. 68 patients (10.6%) experienced 81 (45.8%) clinically significant moderate-severe ADRs. Significant serum electrolyte disturbance (32, 18.1%), acute kidney injury [AKI] (22, 12.4%), unspecified adverse event (UAE; 21, 11.9%), dyspepsia/nausea/vomiting (20, 11.3%), new-onset major constipation (19, 10.7%) were the most common presentations of ADRs, accounting for 114, (64.4%) of all ADRs. In moderate-severe ADRs; AKI (12, 14.8%), acute bleeding (11, 13.6%), new-onset major constipation (11, 13.6%), UAE (11, 13.6%), significant serum electrolyte disturbance (10, 12.4%) were the most common presentations. Conclusion This analysis highlights that; 1-in-5 older adults will experience an incident ADR during acute hospitalisation. 1-in-10 patients experience moderate-severe incident ADRs. 3-of-4 ADRs were caused by 5 drug classes (diuretics, opioids, anti-bacterials, anti-thrombotics and anti-diabetic agents). This study allows for identification of potentially high risk medications which could be targeted for future ADR prevention. [ABSTRACT FROM AUTHOR]

Background: Uganda has one of the highest maternal deaths at a ratio of 336 per 100,000 live births. As Uganda strives to achieve sustainable development goals, appropriate antenatal care is key to reduction of maternal mortality. We explored women's reported receipt of seven of the Uganda guidelines components of antenatal care, and associated factors in hard to reach Lake Victoria island fishing communities of Kalangala district.Methods: A cross sectional survey among 486 consenting women aged 15-49 years, who were pregnant at any time in the past 6 months was conducted in 6 island fishing communities of Kalangala district, Uganda, during January-May 2018. Interviewer administered questionnaires, were used to collect data on socio-demographics and receipt of seven of the Uganda guidelines components of antenatal care. Regression modeling was used to determine factors associated with receipt of all seven components.Results: Over three fifths (65.0%) had at least one ANC visit during current or most recent pregnancy. Fewer than a quarter of women who reported attending care at least four times received all seven ANC components [(23.6%), P < 0.05]. Women who reported receipt of ANC from the mainland were twice as likely to have received all seven components as those who received care from islands (aOR = 1.8; 95% CI:0.9-3.7). Receipt of care from a doctor was associated with thrice likelihood of receiving all components relative to ANC by a midwife or nurse (aOR = 3.2; 95% CI:1.1-9.1).Conclusions: We observed that the delivery of antenatal care components per Ugandan guidelines is poor in these communities. Cost effective endeavors to improve components of antenatal care received by women are urgently needed. Task shifting some components of ANC to community health workers may improve care in these island communities.Trial Registration: PACTR201903906459874 (Retrospectively registered). [ABSTRACT FROM AUTHOR]