Access to insulin: applying the concept of security of supply to medicines.

Security of supply of medicines is fundamental to ensure health for all. Furthermore, improving access to medicines is included in sustainable development goal 3. However, the concept of security of supply has mostly been applied to food, water and energy. Diversity of supply, vulnerability to disruption, expenditure, infrastructure, stability of exporting countries, ownership of production, price stability, access and equity, affordability, intellectual property, safety and reliability of supply, and countries' capacity to adapt to market changes are all elements of security of supply. Based on these elements, we assessed security of supply for insulin, since access to insulin is a global problem. We found that three multinational companies, in Denmark, France and Germany, control 99% of the value of the global insulin market. Prices and affordability of insulin and access to it vary considerably between countries. Some countries are vulnerable to insulin shortage because they import insulin from only one source. Many countries spend large amounts of money on insulin and costs are increasing. Some countries lack an adequate infrastructure for procurement, supply chain management and distribution of insulin. Applying the security of supply concept to insulin showed that diversification of suppliers needs to be fostered. Global health actors should adopt a security of supply approach to identify medicines that are susceptible to supply issues and address this concern by strategic promotion of local production, strengthening regulatory harmonization, and adding local products to the World Health Organization's programme on prequalification of medicines.

La sécurité de l'approvisionnement en médicaments est fondamentale pour garantir une bonne santé pour tous. De plus, l'amélioration de l'accès aux médicaments figure dans l'Objectif de développement durable n°3. Or, le concept de sécurité d'approvisionnement a jusqu'à présent été principalement appliqué aux aliments, aux boissons et à l'énergie. La diversité d'approvisionnement, la vulnérabilité face aux perturbations de la chaîne d'approvisionnement, les infrastructures, la stabilité des pays exportateurs, la propriété des moyens de production, la stabilité des prix, l'accès et l'équité, l'accessibilité des prix, la propriété intellectuelle, la sûreté et la fiabilité de l'approvisionnement ainsi que la capacité des pays à s'adapter aux évolutions du marché sont autant de notions inhérentes à la sécurité d'approvisionnement. À partir de ces éléments, nous avons évalué la sécurité d'approvisionnement pour l'insuline, étant donné que l'accès à l'insuline constitue un enjeu mondial. Nous avons constaté que trois multinationales (au Danemark, en France et en Allemagne) contrôlent 99% de la valeur du marché mondial de l'insuline. Les prix, leur accessibilité ainsi que l'accès à l'insuline varient considérablement d'un pays à un autre. Certains pays sont vulnérables face aux pénuries d'insuline, car ils n'importent l'insuline qu'auprès d'une seule source. De nombreux pays dépensent énormément d'argent pour l'insuline, et les coûts sont en augmentation. Certains pays n'ont pas d'infrastructures appropriées pour les achats, la gestion de la chaîne d'approvisionnement et la distribution de l'insuline. L'application du concept de sécurité d'approvisionnement à l'insuline nous a montré que la diversification des fournisseurs doit être encouragée. Les acteurs mondiaux de la santé devraient adopter une approche de sécurité d'approvisionnement pour identifier les médicaments susceptibles de connaître des problèmes d'approvisionnement et répondre à cet enjeu par la promotion stratégique d'une production locale, le renforcement de l'harmonisation réglementaire et l'ajout de produits locaux dans le programme de l'Organisation mondiale de la Santé sur la préqualification des médicaments.

La seguridad en el suministro de medicamentos es fundamental para garantizar la salud de todos. Además, la mejora del acceso a los medicamentos está incluida en el objetivo de desarrollo sostenible 3. Sin embargo, el concepto de seguridad en el suministro se ha aplicado principalmente a los alimentos, el agua y la energía. La diversidad del suministro, la vulnerabilidad a las perturbaciones, el gasto, la infraestructura, la estabilidad de los países exportadores, la propiedad de la producción, la estabilidad de los precios, el acceso y la equidad, la asequibilidad, la propiedad intelectual, la seguridad y la fiabilidad del suministro y la capacidad de los países para adaptarse a los cambios del mercado son todos elementos que se incluyen en la seguridad en el suministro. Con base en estos elementos, se ha evaluado la seguridad del suministro de insulina, ya que el acceso a esta es un problema mundial. Se ha descubierto que tres empresas multinacionales, en Dinamarca, Francia y Alemania, controlan el 99 % del valor de mercado mundial de insulina. Los precios y la asequibilidad de la insulina y el acceso a ella varían considerablemente de un país a otro. Algunos países son vulnerables a la escasez de insulina porque la importan de una sola fuente. Muchos países gastan grandes cantidades de dinero en insulina y los costes aumentan. Algunos países carecen de una infraestructura adecuada para la adquisición, la gestión de la cadena de suministro y la distribución de insulina. La aplicación del concepto de seguridad en el suministro a la insulina demostró que es necesario fomentar la diversificación de los proveedores. Los agentes de la salud mundial deberían adoptar un enfoque de seguridad en el suministro para identificar los medicamentos que son susceptibles de problemas de suministro y abordar esta preocupación mediante la promoción estratégica de la producción local, el fortalecimiento de la armonización de los reglamentos y la incorporación de los productos locales al programa de la Organización Mundial de la Salud sobre la precalificación de los medicamentos.

Promote health, keep the world safe, serve the vulnerable" in the Eastern Mediterranean Region (Editorial).

23 May 2018 will be remembered as an important day in the history of the World Health Organization (WHO) and global health. It was the day when the 194 Member States that constitute the World Health Assembly (WHA) - the highest decision-making body of WHO, making it effectively the global parliament for health - unanimously adopted the thirteenth general programme of work (GPW 13) for the Organization, covering the next five years (2019-2003). In its 70 years of existence, WHO has already seen 12 GPWs, but GPW 13 marks a new departure in many ways, heralding the Organization's entry into a new era of work with new ways of tackling the task of improving people's health and well-being across the globe.

Conflicting interests, institutional fragmentation and opportunity structures: an analysis of political institutions and the health taxes regime in Pakistan.

Pakistan is the world's fifth most populous country, with large segments of its population at risk from non-communicable diseases caused by consumption of harmful products, including tobacco and sugar-sweetened beverages. Even though evidence exists that increased taxes on harmful products leads to consumption reductions as well as increased revenues, Pakistan's health taxes remain low. We seek to understand the reasons for the deficient health tax regime. Much of the existing literature emphasises industry tactics, resources and motivations. We take a different approach and instead focus on political institutions in Pakistan which could help explain deficiencies in the health taxes regime. We employed a mixed method design. We conducted: (1) a detailed analysis of media content, (2) semistructured interviews with key stakeholders (and attended relevant meetings) and (3) an analysis of primary and secondary literature, including legal and policy documents. We identify two key aspects of Pakistan's political institutions which may help explain deficiencies in health taxes. First, we identified structural issues in the design and functioning of key institutions responsible for health taxes, including with respect to federalism, intraelite conflict, interagency coordination and intra-agency fragmentation. Second, we found evidence of an entrenchment of industry interests within governmental institutions, which are characterised by weak frameworks for regulating conflicts of interest. We conclude that gaps and conflict within political institutions, owing to weak design, instability and fragmentation, create political opportunity for industry actors to influence the system to advance their interests. The findings of this research indicate towards needed interventions.

Proposal of International Council for Harmonization (ICH) Guideline for the Approval of Biosimilars.

Objectives: Since the initial release of biosimilars 18 years ago, regulations for their licensing have changed considerably; however, there is no global consensus on these regulations. Establishing harmonized regulatory guidelines for the approval of biosimilars with support from the ICH, an independent, non-profit association under Swiss law, will significantly enhance the affordability of biological drugs. Methods: Regulatory guidelines from the Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and World Health Organization (WHO) were analyzed for historical changes and elements critical to the safety and efficacy of biosimilars. Results: Analysis of all EMA and FDA filings show that none of the animal testing and clinical efficacy testing failed because animals do not have the required receptors to initiate pharmacologic responses, and efficacy studies cannot be statistically powered to conclude any results. New analytical technologies will enable good biosimilarity determination, avoiding both tests. Conclusion: Scientifically based ICH guidelines that remove redundant studies will reduce development costs, improve safety, and allow global drug distribution based on single compliance. These guidelines are particularly necessary for emerging countries lacking the expertise and resources to evaluate biosimilar filings.

Translating political commitments into actions to enhance Universal Health Coverage in the Eastern Mediterranean Region.

Background: Many countries in the Eastern Mediterranean Region (EMR) have developed packages of services for achieving Universal Health Coverage (UHC), however, policymakers, especially in resource-constrained countries, still face challenges in delivering equitable, efficient and sustainable health services. Aims: To provide guidance for EMR countries and develop packages of services for UHC. Methods: We used information gathered from narrative reviews, national experiences and expert consultations to develop step-by-step guidance for the development of national packages of services for the achievement of UHC by countries in the EMR. Results: The processes used to develop packages of services varied between EMR countries and these processes may not have involved all relevant stakeholders. We highlight in this paper the iterative processes, including several phases and steps, to be used by EMR countries for developing packages of services for UHC. These processes also make provision for continuous monitoring and revision to make necessary improvements as morbidity patterns evolve. Conclusion: Developing a package of services for the achievement of UHC is a significant milestone for EMR countries and it is central to shaping the healthcare system for effective delivery of services.

Framing health taxes: learning from low- and middle-income countries.

Health taxes are effective policy instruments to save lives, raise government revenues and improve equity. Health taxes, however, directly conflict with commercial actors' interests. Both pro-tax health advocates and anti-tax industry representatives seek to frame health tax policy. Yet, little is known about which frames resonate in which settings and how framing can most effectively advance or limit policies. To fill this gap, we conducted qualitative research in 2022, including focus group discussions, in-depth interviews, document reviews and media analysis on the political economy of health taxes across eight low-income and middle-income countries. Studies captured multiple actors constructing context-specific frames, often tied to broader economic, health and administrative considerations. Findings suggest that no single frame dominates; in fact, a plurality of different frames exist and shape discourse and policymaking. There was no clear trade-off between health and economic framing of health tax policy proposals, nor a straightforward way to handle concerns around earmarking. Understanding how to best position health taxes can empower health policymakers with more persuasive framings for health taxes and can support them to develop broader coalitions to advance health taxes. These insights can improve efforts to advance health taxes by better appreciating political economy factors and constraining corporate power, ultimately leading to improved population-level health.

A Rare Case of Recurrent Pneumonia in Heterotaxy Syndrome, Polysplenia/Left Isomerism.

Heterotaxy syndrome (HS) or situs ambiguous refers to the abnormal arrangement of viscera across the body axis, and abnormalities arise depending on the isomerism of the right or left atrial appendage. The cause remains unexplained and is attributed to a combination of genetic mutations and environmental factors. It is a rare condition and may remain undiagnosed for a long time. In this report, we aim to highlight an unusual presentation and aggravation of an infection due to the underlying isomerism of the left atrial appendage. We discuss the case of a female patient who presented with symptoms of fever and cough. The patient underwent prolonged antibiotic treatment, and her recovery was slow. The presence of bilobed lungs, vertical left-bronchus, and polysplenia on CT scan explained the left-sided aspiration pneumonia. The hypofunctioning spleen (polysplenia) caused her to have a weak immunological response, necessitating prolonged antibiotic use. She was followed up over time and had a recurrence of pneumonia within a few months. The condition is associated with high morbidity and mortality, and the role of early diagnosis and reporting to prevent complications is paramount. The recurrent pneumonia observed in the patient also raises questions related to long-term antibiotic use and immunization in the case of polysplenia in this patient population.

Defining research to improve health systems.

Robert Terry and colleagues present working definitions of operational research, implementation research, and health systems research within the context of research to strengthen health systems.