Repurposing of Medicines in the EU: Launch of a Pilot Framework

Repurposing of authorised medicines has been under discussion for a long time. Drug repurposing is the process of identifying a new use for an existing medicine in an indication outside the scope of the original approved indication. Indeed, the COVID-19 health crisis has brought the concept to the frontline by proving the usefulness of this practise in favour of patients for an early access to treatment. Under the umbrella of the Pharmaceutical Committee and as a result of the discussions at the European Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) a virtual Repurposing Observatory Group (RepOG) was set up in 2019 to define and test the practical aspects of a pilot project thought to provide support to “not-for-profit” stakeholders generating or gathering data for a new therapeutic use for an authorised medicine. The group's initial plan was impacted by the outbreak of the SARS-CoV-2 pandemic and the launch of the pilot needed to be postponed. This article describes the progress and the activities conducted by the group during this past and yet extraordinary 2020–2021 to keep the project alive and explores on the background of this topic together with the obvious opportunities this health crisis has brought up in terms of repurposing of medicines.

Medicines and vaccines supply chains challenges in Nigeria: a scoping review

Background Medicines and vaccines supply chains represent critical systems for realising one of the major targets of the United Nations’ third Sustainable Development Goals (SDGs)—access to safe, effective, quality, and affordable essential medicines and vaccines, for all. However, evidence suggests the system is confronted with several challenges in many low-medium income countries, including Nigeria. This scoping review aims to summarize the available evidence on the challenges of medicines and vaccines supply chain system in Nigeria. Results We searched relevant databases including Scopus and Web of Science for studies published between January 2005 and August 2020 on the challenges associated with medicines and vaccines supply chain systems in Nigeria. Our findings implicate several factors including difficulty with medicines or vaccines selection, procurement, distribution, and inventory management. Others included poor storage infrastructure, financial constraints, insecurity, transportation challenges, inadequate human resources, weak, or poorly implemented policies. These challenges mostly resulted in stock-outs of essential medicines which notably got worsened during the current COVID-19 pandemic. Conclusion Our study is a wake-up call on the need to prioritise the critical sector of the supply chain systems for medicines and vaccines in Nigeria. Effective implementation of existing policies, improved security, strengthening of the health system through adequate budgetary allocations, and provision of infrastructure including regular availability of electricity are keys to surmounting the challenges and improving access to medicines or vaccines in Nigeria.

Access to Medicines and Medical Equipment during COVID-19: Searching Compatibility between the WTO and the WHO

Affordable access to medicines is a key determinant of a country’s resilience to health crises. The modern hyper-connected international trade and production networks have a vital role to play in ensuring this accessibility, especially in the context of a pandemic. This article focuses on the medicines and medical equipment and analyses the synergistic role of the two international organisations—The World Trade Organisation (WTO) and The World Health Organisation (WHO), in assuring affordable access to these goods globally. WHO is responsible for global healthcare regulations; however, the medical supply chain originates in a few developed countries, manufactured in bulk (in case of medicine) at low cost in developing countries, and finally traded worldwide. Here, the role of WTO comes—it facilitates global trade cooperation and intellectual property rights monitoring, both key elements in medical goods production and trading. Despite the need for cooperation in mitigating COVID-19, much of the global response to COVID-19 has been fragmented and inward-looking. This lack of coordination has serious repercussions especially for developing countries. We use qualitative content analysis methodology, connecting concepts of cooperation theory and global governance, to identify the joint role of the two organisations in fostering global cooperation in medical goods accessibility.

Pneumonic Plague: Incidence, Transmissibility and Future Risks

Pneumonic plague outbreaks are relatively infrequent in modern times, but in the early part of the 20th century, they were commonplace including several well-documented epidemics responsible for the deaths of thousands. The transmissibility of this disease seems to be discontinuous since in some outbreaks few transmissions occur, while in others, the progression of the epidemic is explosive. Modern epidemiological studies explain that transmissibility within populations is heterogenous with relatively few subjects likely to be responsible for most transmissions and that ‘super spreading events’, particularly at the start of an outbreak, can lead to a rapid expansion of cases. These findings concur with outbreaks observed in real-world situations. It is often reported that pneumonic plague is rare and not easily transmitted but this view could lead to unnecessary complacency since future risks such as the spontaneous incidence of anti-microbial strains, climate change leading to a disruption of natural cycles within plague foci and use of plague as a bioweapon cannot be discounted. Carers and first responders are vulnerable, particularly in poorer countries where access to medicines and protection equipment may be limited, outbreaks occur in inaccessible areas or where there is a lack of surveillance due to a paucity of funds.

Productive Development Partnership in Brazil

Brazil was one of the first countries to adopt significant health policies to better attend people with HIV. The integrated analysis of the high cost of medicines, public health, and access to medicines comprises an extremely complex task, and Productive Development Partnerships (PDP) was the mechanism used by the Brazilian government, with a view to technological development and training of national production complex. The PDP of atazanavir was formalized in late 2011, and the agreement includes the transfer of technology, manufacturing, and distribution of the drug. The PDP emerges as a solution found by the government to minimize the Ministry of Health drug spending and encourage the local production. However, one should not ignore that there are risks associated with regulatory barriers and problems in negotiations with the holders of technology. Thus, this chapter presents a case study of the successes the management information of the productive development partnerships in Brazil as a collaborative tool for global health.

Experiences of COVID-19 patients admitted in a government infectious disease hospital in Nepal and its implications for health system strengthening: A qualitative study

Introduction The COVID-19 pandemic has affected the health systems in many ways. It has put unprecedented strain on health systems worldwide and exposed gaps in public health infrastructure. A health system comprises all institutions and resources working towards improving and maintaining health. Among the different aspects of health system strengthening, a patient’s experiences and expectations play a crucial role in determining how well the health facilities function. This study aims to explore health system strengthening’s implications based on experiences and feedback provided by COVID-19 patients admitted to a government tropical and infectious disease hospital in Nepal. Methods In this qualitative study, we collected the voluntary handwritten feedback by the admitted COVID-19 patients to document the feedback and experiences from a book, maintained by the hospital. We performed thematic content analysis using the World Health Organization’s six building blocks of health system as a theoretical framework which included service delivery, health workforce, information, leadership and governance, financing, and access to medicines. Results Most patients in this study had positive experiences on service delivery and health workforce. Some also highlighted the gaps in infrastructure, cleanliness, and hygiene. Many suggested positive experiences on other dimensions of the health system such as financing, governance and leadership, and access to medicines reflected upon by the patients’ thankfulness to the hospital and the government for the treatment they received. The responses also reflected the inter-connectedness between the different building blocks of health system. Conclusion This study approached a unique way to strengthen the health system by exploring patients’ feedback, which suggested an overall positive impression on most building blocks of health system. However, it also highlighted certain gaps in infrastructure, cleanliness, and hygiene. It reinforces the hospital management and government’s role to continue its efforts to strengthen the health system.

Perspectives of patients and consumers on the use of generic medicines

INTRODUCTION Access to medicines constitutes a public health challenge worldwide. Promoting utilization of generic medicines is one of the strategies that has been proposed to optimize pharmaceutical spending and thus allow greater coverage. However, its use is not yet widespread enough. This study seeks to explore the perspectives and acceptability to the use of generic medicines from patients and consumers. METHODS We searched in Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a evidence synthesis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS We identified four systematic reviews that together include 47 primary studies, of which one corresponds to a randomized trial. A low rate of patients or consumers has a negative perception regarding generic medicines, including dimensions such as risk, quality, safety, risk of adverse effects, among others.