Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

Cambodia has experienced exponential economic growth in recent years and is expected to graduate from least developed country (LDC) status within the next decade. Membership of the World Trade Organization (WTO) will require Cambodia to grant product and process patents for pharmaceuticals upon LDC graduation. This study aims to measure the impact of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on the price of HIV and hepatitis C medicine in Cambodia once it graduates from LDC status and is obliged to make patents available for pharmaceutical products and processes. Using scenarios based on likely outcomes of accession to the TRIPS Agreement, it measures the impact on the price of the HIV treatment program and compares that impact with the hepatitis C treatment program. Graduation from LDC status would be expected to result in a modest increase in the cost of the antiretroviral (ARV) treatment program and very large increases in the cost of the direct acting antivirals (DAA) treatment program. If annual treatment budgets remain constant, patent protection could see 1,515 fewer people living with HIV able to access ARV treatment and 2,577 fewer people able to access DAA treatment (a drop in treatment coverage of 93%).

County-Level Sociodemographic Characteristics and Availability of COVID-19 Therapeutic Drugs.

This cross-sectional study examines access to COVID-19 treatments in US counties by race and ethnicity, poverty rate, uninsured rate, and other population and community characteristics.

[Scientific research in times of pandemics.] / La ricerca scientifica in tempi di pandemia.

When a pandemic occurs, scientific research moves fast in order to achieve readily results, such as effective therapies to fight the SARS-CoV-2 and vaccines. But this high-speed science, engaged by the emergency and characterized by the explosion of online publications in preprint form not subject to scrutiny by peer reviewers, carries some risks. And it represents a challenge to maintain research integrity and to comply with those globally recognized standard principles of fairness. Competition and the pressure to publish immediately - a way of encouraging rapid data sharing - can favor the dissemination of incomplete if not erroneous results obtained from partial studies, which feed false news, such as the benefits of a drug, and illusory hopes. It is commonly through press releases that "speed science" disseminates information to an audience that wants to be informed and reassured. Financial and political interests often mix with the urgency to find solutions. Covid-19 has highlighted in particular the risk of a politicization of science at the expense of transparency.

[The importance of the logistic warehouse in pandemic period: the experience of the USL Umbria 1 (Perugia, Italy) during covid-19.] / L'importanza del magazzino logistico in periodo di pandemia: l'esperienza dell'USL Umbria 1 durante covid-19.

The pandemic period has generated major problems in the pharmacies of hospitals and local health care companies regarding the distribution of drugs to patients undergoing treatment with chronic drugs. This is because the patient, during the lockdown, was forced to leave the house and go several miles away to reach the place where the drug was dispensed. Moreover, very often, the place was placed in covid-19 hospitals, like the one in Perugia, and was also a risk for the patient himself. The logistical organization allows, in addition to the advantages of traceability, efficiency and savings, with the arrival of the drug at home, a very high patient compliance that also translates into greater security in a pandemic period. To the Usl Umbria 1 of Perugia (Italy) has been centralized the activity of warehouse for all the South area that includes three hospitals and four sanitary districts. Such warehouse, through computerized procedure, guarantees the direct distribution with sending of the medicines directly to the district of belonging of the patient. In this way the patient was not forced to make long and risky trips to continue their chronic therapies. Moreover, this logistic warehouse has also allowed to cope with the correct management of many medicinal specialties that have been used against the SARS-CoV-2 virus avoiding their temporary deficiency for patients already on therapy according to the normal therapeutic indications (anti-inflammatory, antiretroviral and immunomodulatory). This paper aims to demonstrate how logistical organization is of vital importance for a National Health System that has to face increasing costs, ensure the traceability of all processes and, last but not least, survive a worldwide pandemic period.

Healthcare risk management during the SARS-CoV-2 virus pandemic in the European Union: The guaranteed access to medicines.

BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.

[Building the scientific commons. Conflictualities and pluralism in the light of clinical trials Covid-19]. / Faire du commun dans les sciences - Conflictualités et pluralisme à l'épreuve des essais cliniques COVID-19.

TITLE: Faire du commun dans les sciences - Conflictualités et pluralisme à l'épreuve des essais cliniques COVID-19. ABSTRACT: La crise de la COVID-19 s'est ouverte sur un déficit de moyens thérapeutiques permettant de lutter efficacement contre cette maladie pour les cas les plus graves et sur de nombreuses initiatives visant à mettre en évidence un traitement efficace. Si différentes options ont été explorées, parmi lesquelles la transfusion de plasma de patients guéris, la lutte contre les mécanismes immunitaires déclenchant une réponse trop forte (les orages cytokiniques) ou, à moyen terme, la vaccination, ce sont dans un premier temps surtout les médicaments antiviraux qui ont nourri les espoirs. Après l'identification d'un certain nombre de principes actifs montrant des effets in vitro, il s'agissait d'obtenir rapidement des réponses quant à leurs effets bénéfiques in vivo et aux risques induits. Aussi, s'est-on senti en droit d'attendre que la science nous apporte les connaissances nécessaires sur ces médicaments, qu'elle nous parle, une fois sollicitée, de manière claire et d'une seule voix ; et cela, dans une situation d'urgence où la synchronisation des rythmes de la recherche et du soin n'a rien d'une évidence.

COVID-19, host response treatment, and the need for political leadership.

Health officials and scientists have warned that we face the threat of a potentially devastating influenza pandemic. Instead, we are now in the midst of a global coronavirus (COVID-19) pandemic. National and international pandemic preparedness plans have focused on developing vaccines and antiviral treatments. Another way to confront the COVID-19 pandemic (and future pandemics) might be to treat patients with inexpensive and widely available generic drugs that target the host response to infection, not the virus itself. The feasibility of this idea was tested during the Ebola outbreak in West Africa in 2014. This experience should inform our approach to treating COVID-19 patients. It could also save lives during outbreaks of other emerging infectious diseases and episodes of everyday acute critical illness. If this "bottom up" syndromic approach to treating acute critical illness were shown to be effective, it could have a dramatic impact on health, equity and security throughout the world. HIGHLIGHTS: Uncertainty about the outcome of COVID-19 is driving the social, economic and political distress associated with the pandemic. Treating the host response to COVID-19 with inexpensive and widely available generic drugs might save lives and mitigate this distress. Undertaking research on this idea will require political leadership.

It Takes a Village : Contending With Drug Shortages During Disasters.

Critical drug shortages have been widely documented during the coronavirus disease 2019 (COVID-19) pandemic, particularly for IV sedatives used to facilitate mechanical ventilation. Surges in volume of patients requiring mechanical ventilation coupled with prolonged ventilator days and the high sedative dosing requirements observed quickly led to the depletion of "just-in-time" inventories typically maintained by institutions. This manuscript describes drug shortages in the context of global, manufacturing, regional and institutional perspectives in times of a worldwide crisis such as a pandemic. We describe etiologic factors that lead to drug shortages including issues related to supply (eg, manufacturing difficulties, supply chain breakdowns) and variables that influence demand (eg, volatile prescribing practices, anecdotal or low-level data, hoarding). In addition, we describe methods to mitigate drug shortages as well as conservation strategies for sedatives, analgesics and neuromuscular blockers that could readily be applied at the bedside. The COVID-19 pandemic has accentuated the need for a coordinated, multi-pronged approach to optimize medication availability as individual or unilateral efforts are unlikely to be successful.

How Do We Combat Bogus Medicines in the Age of the COVID-19 Pandemic?

The COVID-19 pandemic has brought concurrent challenges. The increased incidence of fake and falsified product distribution is one of these problems with tremendous impact, especially in low- and middle-income countries. Up to a tenth of medicines including antibiotics and antimalarial drugs in the African market are considered falsified. Pandemics make this worse by creating an ecosystem of confusion, distraction, and vulnerability stemming from the pandemic as health systems become more stressed and the workload of individuals increased. These environments create opportunities for substandard and falsified medicines to be more easily introduced into the marketplace by unscrupulous operators. In this work we discuss some of the challenges with fake or falsified product distribution in the context of COVID-19 and proposed strategies to best manage this problem.

Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic.

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.