Policy options for sustainable access to off-patent antibiotics in Europe.

Securing sustainable access to existing antibiotics optimises agent choice for individual treatments and is crucial to curb antibiotic resistance. Access to antibiotics is often restricted in many countries, due to general market unavailability or episodic shortages. This article outlines key policy options to maintain availability of existing antibiotics and enhance antibiotic supply chain resilience focusing on the perspectives of European Union (EU) and European Economic Area (EEA) institutions and member states.

Fragmented markets for older antibiotics and child formulations, Denmark, Norway, Sweden.

Antibiotic resistance is one of the most urgent threats to public health. The development of antibiotic resistance can be reduced by the use of narrow-spectrum antibiotics that target specific bacteria, meaning that fewer non-harmful bacteria are killed and other harmful bacteria are not exposed to selection pressure. However, many narrow-spectrum antibiotics were introduced decades ago and therefore lack regulatory documentation in line with current standards.

Availability of essential, generic medicines before and during COVID-19 at selected public pharmaceutical supply agencies in Ethiopia: a comparative cross-sectional study.

Objectives: Lockdowns and border closures impacted medicine availability during the COVID-19 pandemic. This study aimed to assess the availability of essential, generic medicines for chronic diseases at public pharmaceutical supply agencies in Ethiopia.

Design: Comparative cross-sectional study.

The knock-on effects of COVID-19 pandemic on the supply and availability of generic medicines in Ethiopia: mixed methods study.

Background: COVID-19 pandemic posed a major impact on the availability and affordability of essential medicines. This study aimed to assess the knock-on effects of the COVID-19 pandemic on the supply availability of non-communicable chronic disease (NCD) medicines and paracetamol products in Ethiopia.

Methods: A mixed methods study was conducted to assess the supply and availability of twenty-four NCD drugs and four paracetamol products listed on the national essential medicines list for hospitals.

Antimicrobial Resistance: Is Health Technology Assessment Part of the Solution or Part of the Problem?

Antimicrobial resistance is a serious challenge to the success and sustainability of our healthcare systems. There has been increasing policy attention given to antimicrobial resistance in the last few years, and increased amounts of funding have been channeled into funding for research and development of antimicrobial agents. Nevertheless, manufacturers doubt whether there will be a market for new antimicrobial technologies sufficient to enable them to recoup their investment.

Patient Access in 14 High-Income Countries to New Antibacterials Approved by the US Food and Drug Administration, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, or Health Canada, 2010-2020.

Background: Inaccessibility of medicines in low- and middle-income countries is a frequent challenge. Yet it is typically assumed that high-income countries have complete access to the full arsenal of medicines. This study tests this assumption for new antibacterials, which are saved as a last resort in order to prevent the development of resistance, resulting in insufficient revenues to offset costs.

A case study on bacteraemia: available treatment options, antibiotic R&D and responsible antibiotic-use strategies.

Objectives: This case study addresses: (i) antibiotic treatment options for bacteraemia (SAB), for both empirical and targeted therapy; (ii) the current status of and priorities for the antibiotic pipeline to ensure access of effective antibiotics for SAB; and (iii) strategies for responsible antibiotic use relevant to the clinical management of SAB.

Methods: Evidence to address the aims was extracted from the following information sources: (i) EUCAST and CLSI recommendations, summaries of product characteristics (SPCs), antibiotic treatment guidelines and the textbook ; (ii) the www.clinicaltrial.

National Facilitators and Barriers to the Implementation of Incentives for Antibiotic Access and Innovation.

Prominent reports have assessed the challenges to antibiotic innovation and recommended implementing "pull" incentives, i.e., mechanisms that give increased and predictable revenues for important, marketed antibiotics.

The effect of generic market entry on antibiotic prescriptions in the United States.

When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database.

A one health framework to estimate the cost of antimicrobial resistance.

Objectives/purpose: The costs attributable to antimicrobial resistance (AMR) remain theoretical and largely unspecified. Current figures fail to capture the full health and economic burden caused by AMR across human, animal, and environmental health; historically many studies have considered only direct costs associated with human infection from a hospital perspective, primarily from high-income countries. The Global Antimicrobial Resistance Platform for ONE-Burden Estimates (GAP-ON€) network has developed a framework to help guide AMR costing exercises in any part of the world as a first step towards more comprehensive analyses for comparing AMR interventions at the local level as well as more harmonized analyses for quantifying the full economic burden attributable to AMR at the global level.

Infection prevention and control research priorities: what do we need to combat healthcare-associated infections and antimicrobial resistance? Results of a narrative literature review and survey analysis.

Background: Infection prevention and control (IPC) is one of the most cost-effective interventions against antimicrobial resistance (AMR). Yet, IPC knowledge gaps often receive little prominence in AMR research agendas. In this article, we construct IPC research priorities, in order to draw attention to these critical research needs.

Financing Pull Mechanisms for Antibiotic-Related Innovation: Opportunities for Europe.

Antibiotic innovation is in serious jeopardy as companies continue to abandon the market due to a lack of profitability. Novel antibiotics must be used sparingly to hinder the spread of resistance, but small companies cannot survive on revenues that do not cover operational costs. When these companies either go bankrupt or move onto other therapeutic areas, these antibiotics may be no longer accessible to patients.

Industrial perceptions of medicines regulatory harmonization in the East African Community.

Background: Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration of medicines.

Introduction and geographic availability of new antibiotics approved between 1999 and 2014.

Background: Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood.

Should Antibiotics Be Controlled Medicines? Lessons from the Controlled Drug Regimen.

This study aimed to identify the antibiotic-relevant lessons from the controlled drug regimen for narcotics. Whereas several elements of the United Nations Single Convention on Narcotic Drugs (1961) could be advantageous for antibiotics, we doubt that an international legally binding agreement for controlling antibiotic consumption would be any more effective than implementing stewardship measures through national AMR plans.

A Grant Framework as a Push Incentive to Stimulate Research and Development of New Antibiotics.

Antibiotic research and development (R&D) has failed to produce innovative antibiotics in the past two decades, which is due to both scientific and economic factors. We reviewed national and international funding agencies and critically assessed current grant funding mechanisms. Finally, we propose four complementary grant-funding incentives aimed to help developers along the R&D pipeline.

Antibiotic Pipeline Coordinators.

The World Health Organization (WHO) has published a global priority list of antibiotic-resistant bacteria to guide research and development (R&D) of new antibiotics. Every pathogen on this list requires R&D activity, but some are more attractive for private sector investments, as evidenced by the current antibacterial pipeline. A "pipeline coordinator" is a governmental/non-profit organization that closely tracks the antibacterial pipeline and actively supports R&D across all priority pathogens employing new financing tools.