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.

A comparative human rights analysis of laws and policies for adolescent contraception in Uganda and Kenya.

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.

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.

Components of antenatal care received by women in fishing communities on Lake Victoria, Uganda; a cross sectional survey.

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).

Universal cervical cancer control through a right to health lens: refocusing national policy and programmes on underserved women.

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.

Realising the right to sexual and reproductive health: access to essential medicines for medical abortion as a core obligation.

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.

The psychotropic education and knowledge test for nurses in nursing homes: striving for PEAK performance.

OBJECTIVES: The psychotropic education and knowledge test for nurses in acute geriatric care (PEAK-AC) measures knowledge of psychotropic indications, doses and adverse drug reactions in older inpatients. Given the low internal consistency and poor discrimination of certain items, this study aims to adapt the PEAK-AC, validate it in the nursing home setting and identify factors related to nurses' knowledge of psychotropics. METHOD: This study included nurses and nurse assistants employed by nursing homes (n = 13) and nursing students at educational institutions (n = 5) in Belgium. A Delphi technique was used to establish content validity, the known groups technique for construct validity (nrespondents = 550) and the test-retest procedure for reliability (nrespondents = 42). Internal consistency and item analysis were determined. RESULTS: The psychotropic education and knowledge test for nurses in nursing homes (PEAK-NH) (nitems = 19) demonstrated reliability (κ = 0.641) and internal consistency (Cronbach's α = 0.773). Significant differences between-group median scores were observed by function (p < 0.001), gender (p = 0.019), educational background (p < 0.001), work experience (p = 0.008) and continuing education (p < 0.001) for depression, delirium and pharmacotherapy topics. Items were acceptably difficult (nitems = 15) and well-functioning discriminators (nitems = 17). Median PEAK-NH score was 9/19 points (interquartile range 6-11 points). Respondents' own estimated knowledge was related to their PEAK-NH performance (p < 0.001). CONCLUSION: The PEAK-NH is a valid and reliable instrument to measure nurses' knowledge of psychotropics. These results suggest that nurses have limited knowledge of psychotropic use in nursing homes and are aware of their knowledge deficits. The PEAK-NH enables educational initiatives to be targeted and their impact on nurses' knowledge to be tracked.

Legislating for Good Governance in the Pharmaceutical Sector through UN Convention Against Corruption (UNCAC) Compliance.

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.

The Right to Science as a Guidepost for Fair Access to COVID-19 Vaccines: Investigating the Interpretive Role of the United Nations Committee on Economic, Social and Cultural Rights.

Facing the unmet need for new, affordable medicines for public health crises, how should states' duty to ensure that everyone shares in the benefits of science be understood in relation to pandemic vaccine supply, and how has the United Nations Committee on Economic, Social and Cultural Rights monitored the implementation of this right? In this paper, we examine the contours and content of state obligations with regard to pandemic vaccine supply under the right to science (article 15(1)(b) of the International Covenant on Economic, Social and Cultural Rights), focusing on three aspects of state obligations: mobilizing public resources for developing and disseminating the benefits of scientific progress in areas of public health need; preventing unreasonably high medicines prices; and international cooperation, particularly in a globalized health emergency. The committee regularly assesses state parties' implementation of their obligations under the covenant, culminating in the issuing of concluding observations, which often serve as a basis for the next round of periodic reporting by states and can thereby direct future state action. Our analysis of the committee's concluding observations reveals that the committee has inconsistently applied its own guidance on the right to science regarding medicines and intellectual property in these monitoring exercises. These findings inform a rights-based response to medical innovation for health crises and advance the Sustainable Development Goal target on medicines research and development.

A Needle in a Haystack? Human Rights Framing at the World Trade Organization for Access to COVID-19 Vaccines.

How and why is implicit and explicit human rights language used by World Trade Organization (WTO) negotiators in debates about intellectual property, know-how, and technology needed to manufacture COVID-19 vaccines, and how do these findings compare with negotiators' human rights framing in 2001? Sampling 26 WTO members and two groups of members, this study uses document analysis and six key informant interviews with WTO negotiators, a representative of the WTO Secretariat, and a nonstate actor. In WTO debates about COVID-19 medicines, negotiators scarcely used human rights frames (e.g., "human rights" or "right to health"). Supporters used both human rights frames and implicit language (e.g., "equity," "affordability," and "solidarity") to garner support for the TRIPS waiver proposal, while opponents and WTO members with undetermined positions on the waiver used only implicit language to advocate for alternative proposals. WTO negotiators use human rights frames to appeal to previously agreed language about state obligations; for coherence between their domestic values and policy on one hand, and their global policy positions on the other; and to catalyze public support for the waiver proposal beyond the WTO. This mixed-methods design yields a rich contextual understanding of the modern role of human rights language in trade negotiations relevant for public health.

Decolonizing Health Governance: A Uganda Case Study on the Influence of Political History on Community Participation.

This paper presents a case study of how colonial legacies in Uganda have affected the shape and breadth of community participation in health system governance. Using Habermas's theory of deliberative democracy and the right to health, we examine the key components required for decolonizing health governance in postcolonial countries. We argue that colonization distorts community participation, which is critical for building a strong state and a responsive health system. Participation processes grounded in the principles of democracy and the right to health increase public trust in health governance. The introduction and maintenance of British laws in Uganda, and their influence over local health governance, denies citizens the opportunity to participate in key decisions that affect them, which impacts public trust in the government. Postcolonial societies must tackle how imported legal frameworks exclude and limit community participation. Without meaningful participation, health policy implementation and accountability will remain elusive.

Impact of the European Union on access to medicines in low- and middle-income countries: A scoping review.

This Scoping Review synthesises evidence of the impacts of European Union (EU) law, regulation, and policy on access to medicines in in non-EU low- and middle-income countries (LMICs), and the mechanisms and nature of those impacts. We searched eight scholarly databases and grey literature published between 1995-2021 in four languages. The EU exerts global influence on pharmaceuticals in LMICs in three ways: explicit agreements between EU-LMICs (ex. accession, trade, and economic agreements); LMICs' reliance on EU internal regulation, standards, or methods (ex. market authorisation); 'soft' forms of EU influence (ex. research funding, capacity building). This study illustrates that EU policy makers adopt measures with the potential to influence medicines in LMICs despite limited evidence of their positive and/or negative impact(s). The EU's fragmented internal and external actions in fields related to pharmaceuticals reveal the need for principles for global equitable access to medicines to guide EU policy.

Esta revisión exploratoria sintetiza la evidencia disponible sobre el impacto que ejercen las leyes, las políticas y las regulaciones de la Unión Europea (UE) sobre el acceso a los medicamentos en países de bajo y mediano ingreso (PBMI) que no pertenecen a la UE. La búsqueda se realizó en ocho bases de datos académicas, incluyendo literatura gris. Se incluyeron publicaciones en cuatro idiomas entre 1995 y 2021. Como resultado principal se encontró que la UE ejerce su influencia sobre los productos farmacéuticos en los PBMI a través de tres mecanismos principales: i) acuerdos explícitos entre la UE y los PBMI, por ejemplo, acuerdos de ascensión a la UE o tratados comerciales, ii) utilización de la normativa, estándares o métodos de la UE por parte de los PBMI (reliance) para, por ejemplo, autorizar el ingreso de nuevos medicamentos a partir de la autorización previa por parte de la UE) y, iii) formas blandas de influencia de la UE, por ejemplo, a través de financiación a la investigación o al desarrollo de capacidades locales. Esta revisión revela que los tomadores de decisión de la UE adoptan medidas que, a pesar de la escasa evidencia que sustenta su impacto, positivo o negativo, tienen el potencial de influir en el acceso a los medicamentos de los PBMI. El accionar fragmentado de la UE respecto a los productos farmacéuticos, tanto a nivel interno como externo, son una clara muestra de la necesidad de crear principios que guíen las políticas de la UE frente al acceso equitativo a los medicamentos a nivel global.

Should COVID-19 Vaccines Authorized for Emergency Use Be Considered "Essential" Medicines?

A critical debate in the race to develop, market, and distribute COVID-19 vaccines could define the future of this pandemic: How much evidence demonstrating a vaccine's safety and efficacy should be required before it is considered "essential"? If a COVID-19 vaccine were to be designated an essential medicine by the World Health Organization, this would invoke special "core" human rights duties for governments to provide the vaccine as a matter of priority irrespective of resource constraints. States would also have duties to make the vaccine available in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at an affordable price. This question is especially critical and unique given that COVID-19 vaccines have in many cases been authorized for use via national emergency use authorization processes-mechanisms that enable the public to gain access to promising medical products before they have received full regulatory approval and licensure. In this paper, we examine whether unlicensed COVID-19 vaccines authorized for emergency use should ever be considered essential medicines, thereby placing prioritized obligations on countries regarding their accessibility and affordability.

An intersectional human rights approach to prioritising access to COVID-19 vaccines.

We finally have a vaccine for the COVID-19 crisis. However, due to the limited numbers of the vaccine, states will have to consider how to prioritise groups who receive the vaccine. In this paper, we argue that the practical implementation of human rights law requires broader consideration of intersectional needs in society and the disproportionate impact that COVID-19 is having on population groups with pre-existing social and medical vulnerabilities. The existing frameworks/mechanisms and proposals for COVID-19 vaccine allocation have shortcomings from a human rights perspective that could be remedied by adopting an intersectional allocative approach. This necessitates that states allocate the first COVID-19 vaccines according to (1) infection risk and severity of pre-existing diseases; (2) social vulnerabilities; and (3) potential financial and social effects of ill health. In line with WHO's guidelines on universal health coverage, a COVID-19 vaccine allocation strategy that it is more consistent with international human rights law should ensure that vaccines are free at the point of service, give priority to the worst off and be allocated in a transparent, participatory and accountable prioritisation process.

Universal access to essential medicines as part of the right to health: a cross-national comparison of national laws, medicines policies, and health system indicators.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Essential Medicines in Universal Health Coverage: A Scoping Review of Public Health Law Interventions and How They Are Measured in Five Middle-Income Countries.

Very few studies exist of legal interventions (national laws) for essential medicines as part of universal health coverage in middle-income countries, or how the effect of these laws is measured. This study aims to critically assess whether laws related to universal health coverage use five objectives of public health law to promote medicines affordability and financing, and to understand how access to medicines achieved through these laws is measured. This comparative case study of five middle-income countries (Ecuador, Ghana, Philippines, South Africa, Ukraine) uses a public health law framework to guide the content analysis of national laws and the scoping review of empirical evidence for measuring access to medicines. Sixty laws were included. All countries write into national law: (a) health equity objectives, (b) remedies for users/patients and sanctions for some stakeholders, (c) economic policies and regulatory objectives for financing (except South Africa), pricing, and benefits selection (except South Africa), (d) information dissemination objectives (ex. for medicines prices (except Ghana)), and (e) public health infrastructure. The 17 studies included in the scoping review evaluate laws with economic policy and regulatory objectives (n = 14 articles), health equity (n = 10), information dissemination (n = 3), infrastructure (n = 2), and sanctions (n = 1) (not mutually exclusive). Cross-sectional descriptive designs (n = 8 articles) and time series analyses (n = 5) were the most frequent designs. Change in patients' spending on medicines was the most frequent outcome measure (n = 5). Although legal interventions for pharmaceuticals in middle-income countries commonly use all objectives of public health law, the intended and unintended effects of economic policies and regulation are most frequently investigated.

Antenatal Care Practices Among Hard-to-Reach Fishing Communities on Lake Victoria: A Community-Based Cross-Sectional Survey.

Background: Uganda has one of the highest maternal deaths in sub-Saharan Africa, with a mortality ratio of 336 per 100 000 live births. Early regular antenatal care (ANC) helps prevent adverse outcomes, including deaths, through prevention, identification, treatment, and/or referral of at-risk women. We explored ANC practices and associated factors among women from hard-to-reach Lake Victoria islands fishing communities in Kalangala district, Uganda. Methods: A cross-sectional survey among 486 consenting women aged 15 to 49 years, who were pregnant or had a birth or abortion in the past 6 months was conducted in 6 island fishing communities of Kalangala district, Uganda, during January to May 2018. ODK software interviewer-administered questionnaires were used to collect data on sociodemographics and ANC practices. Regression modeling using STATA version 15 was used to determine factors associated with ANC visits. Results: Women's median (range) age was 26 (15-45) years, 63% (304/486) had up to primary level education, 45% (219/486) were housewives (stay home mums), 87% (423/486) were married. ANC visits ranged from 0 to 10, with over three-fifths of women having their first visit late after 3 months of being pregnant (63%, 198/316). Women without a history of pregnancy loss (adjusted odds ratio [AOR] = 1.8, 95% CI 1.1-3.0), those not staying with their partners (AOR = 2.5, 95% CI 1.1-6.0), and those whose partners were working in fishing-related activities (AOR = 1.8, 95% CI 1.0-3.0) were likely to have started care late. Women from communities with a public health facility and those with partners working in none fishing-related activities had the highest predicted number of visits. Conclusion: Antenatal practices among these communities are characterized by late start of care. Community-led early ANC awareness interventions are needed. Targeted health policies need to consider public ANC facilities for each island for improved antenatal outcomes and maternal health.