Frequently Asked Questions

What is antimicrobial resistance and why is it a major threat to global health?
Antibiotics are being overused, which means they are becoming less effective. That is because, each time we use an antibiotic, bacteria are given the chance to adapt and develop resistance. Without action to tackle this, experts predict that most antibiotics could stop working. Common infections and simple surgery would once again become deadly.

How can antimicrobial resistance be controlled? 
We can’t stop antibiotic resistance completely, but we can bring it under control. The key is to closely manage access to antibiotics to ensure they are used only when needed. This requires action at all levels of society, including governments, health authorities, the agricultural and pharmaceutical industries.

What is the role for pharmaceutical companies in controlling AMR?
To help slow the rise of antibiotic resistance, the role for pharmaceutical companies is clear: to develop new medicines to replace ones that no longer work, make them available and accessible to those who need them, and ensure all antibiotics are produced and promoted responsibly. 

What is the Antimicrobial Resistance Benchmark?
The Antimicrobial Resistance Benchmark provides the only independent comparison of what pharmaceutical companies are doing to bring antimicrobial resistance under control and improve appropriate access to antimicrobials in low and middle-income countries. The 2020 AMR Benchmark was published on 21 January 2020.

What does the Benchmark aim to achieve?
The goal of the AMR Benchmark is to guide pharmaceutical companies to take effective action to tackle the problem of drug resistance. By giving pharmaceutical companies public recognition for their actions on AMR, the Benchmark provides accountability as well as an incentive for them to expand their activities. The Benchmark identifies good practices that are already being implemented as guidance for other companies to make further progress. Stakeholders such as investors and governments use the Benchmark analysis to inform their own strategies for influencing the industry.

What does the Benchmark analyse?
The Benchmark compares the actions and policies of 30 pharmaceutical companies, including those with the largest R&D divisions, major market presence and specific expertise in developing new antimicrobials. It evaluates their activities in antibiotic and antifungal R&D, their antibiotic manufacturing strategies and policies, as well as the steps they take to ensure antimicrobials are available and being used carefully. The Benchmark evaluates companies in three research areas: Research & Development; Responsible Manufacturing; Appropriate Access & Stewardship.

How were the 30 companies selected?
The Access to Medicine Foundation worked with an expert advisory board to define which companies should be evaluated in the 2018 Benchmark. Each group of companies was selected using different criteria. To select the large R&D-based pharmaceutical companies, the Foundation looked at the size of companies’ R&D activities and their presence on the market. It selected generic medicine manufacturers selling the highest sales volume and/or sales value of antibiotics, and/or if they are a large vendor of active pharmaceutical ingredients (API).  Small- to medium-sized pharmaceutical enterprises (SMEs) were selected for having at least one product targeting WHO priority pathogens in their late-stage (phase II and beyond) clinical pipeline. Moreover, newly in scope SMEs for 2020 were required to have at least one novel candidate that met at least one WHO criteria, with novelty defined per the four criteria set by WHO for Innovativeness, in their pipeline to be selected for inclusion.  

How was the data collected and verified?
The Benchmark analyses data from several sources, including a questionnaire sent directly to the companies. The data submitted by the companies for analysis has been cross-checked against publicly available sources. For example, regarding R&D clinical pipelines, projects declared by the companies were verified against clinical trials registries, including the NIH ClinicalTrials.gov and the EU Clinical Trials Register, to confirm their existence and the clinical phase. For example, R&D projects had to be ongoing, approved or awaiting approval between the 09 September 2017 and 21 June 2019, when the data collection period ended.  The status of market approval for late-stage R&D projects were monitored after the end of the period of analysis on 21 June 2019 and until 16 October 2019. If approved between these dates, the status was updated in the pipeline for each company within the report. In another example, collaborations submitted by companies (such as R&D projects or educational programmes) were confirmed using the websites of the corresponding partner, such as Wellcome Trust or BARDA. Data was accepted for evaluation if it related to a policy, project or other activity that was in effect during the period of analysis. 

Does the data reflect a set time period? 
The 2020 Benchmark includes relevant data from 09 September 2017 to 21 June 2019.   

How was the methodology for the Benchmark developed?
The AMR Benchmark has been developed, researched and published independently by the Access to Medicine Foundation, drawing on its ten years of experience in developing industry metrics related to public health. To build the methodology, the Foundation identified where stakeholders agree that pharmaceutical companies can and should be taking action to curb AMR. These opportunities for action were then translated into 19 metrics for evaluating company behaviour and published in a methodology report.

Which experts did you work with?
To develop the methodology, the Foundation sought input and gathered feedback from reports and a variety of stakeholders, such as governments, non-governmental organisations (NGOs), pharmaceutical companies and industry associations, investors, academia, public-private partnerships and relevant international organisations. Strategic guidance was provided by the Expert Committee (EC) for the Antimicrobial Resistance Benchmark, an independent body of experts, from top-level academic centres, donor governments, local governments in low- and middle-income countries, investors and companies.

Who conducted the Benchmark analysis?
The data-collection, analysis and scoring was completed in-house by a research team dedicated to the Benchmark. The Foundation wrote up its findings, with reviews by external experts. The research was also reviewed by the Chair of the Committee Hans Hogerzeil, Professor Emeritus of Global Health of the University of Groningen, and formerly of WHO.

How is the Benchmark funded?
The Benchmark has been independently developed by the Access to Medicine Foundation, using funding from the UK Department for International Development and the Dutch Ministry for Health, Welfare and Sport. The Foundation is a non-profit organisation.

When will the next Benchmark be published?
The 2020 AMR Benchmark was published on 21 January 2020. The next AMR Benchmark is planned for publication in 2022.

What is a priority pathogen?
The Benchmark looked at whether pharmaceutical companies are developing new medicines or vaccines for bacteria and fungi that pose the greatest threat to human health because of their widespread resistance against the existing standard of care. For example, the list includes strains of the Enterobacteriaceae bacteria that are already resistant to the beta-lactam class of broad-spectrum antibiotics. To identify priority pathogens, the Benchmark used the most recent priority pathogens lists published by the WHO and the CDC. The WHO and CDC use a variety of criteria to flag a pathogen as an AMR priority, including mortality, treatability and prevalence of resistance. The Benchmark also assessed companies’ projects targeting the most critical priorities in these lists, i.e. targeting the pathogens classified in the WHO and CDC lists as ‘’Critical’’ or ‘’Urgent’’, respectively. Since November 2019, C. auris was listed as an ‘’Urgent’’ pathogen by the CDC and was included as part of the Benchmark analysis.   

What is stewardship?
Stewardship is the broad term given to a range of actions and policies that are designed to support efforts to use antibiotics conservatively. For example, governments can implement prescription-only policies for antibiotics, to prevent people from buying them over the counter without a diagnosis of a bacterial infection. Pharmaceutical companies can pool the data they have collected on where their products are becoming less effective, so that hospitals and other agencies can make informed decisions about which antibiotics they should be using.

What do you mean by appropriate access?
Today, more people die because they can’t get hold of antibiotics when they need them than die due to resistant or untreatable infections. People living in poorer countries are on the frontlines for antimicrobial resistance – they generally get poor healthcare advice yet face higher rates of resistance and infectious diseases. It is important that efforts to control the use of antibiotics do not overshadow the need to improve access. When access to an antibiotic is provided, it must be appropriate: the right medicine matched to a susceptible pathogen and in the right doses.

Poor access to antibiotics and healthcare advice can prompt people to use antibiotics in ways that encourage resistance. For example, a worried parent may split a single course of antibiotics between two sick children – which will leave both at greater risk of resistance.

Why are pharma companies leaving the anti-infectives market?
The commercial incentives for pharmaceutical companies to stay and invest in the antibiotic market are weak. R&D is risky and expensive, antibiotics offer slim margins, and growth in demand comes mainly from poorer countries with smaller healthcare budgets. New products are likely to be tightly controlled to minimise the risk of antimicrobial resistance. Plus, antibiotic supply chains are complex, with batches being passed between multiple distributors before they reach the patient. This leads to low visibility and accountability, and little alignment to ensure supply matches demand. Since the 2018 AMR Benchmark, two large research-based companies – Novartis and Sanofi – have retreated from new antibiotics R&D, while two further companies – Achaogen and Melinta – have filed for bankruptcy.

How does the Benchmark's pipeline analysis compare with those by WHO and PEW Trusts?
The Benchmark analysis incorporated an additional review and verification step using the clinical pipelines reported by the WHO in their publication, 2019 Antibacterial Agents in Clinical Development: an analysis of the antibacterial clinical development pipeline (December 2019), and the Pew Trust’s Antibiotics Currently in Global Clinical Development (September 2019). Inclusion criteria differed between each reporting entity, such as the companies in scope, as well as the following:  
i. adapted projects in the pipeline (ATMF only)
ii. local acting agents (ATMF only)
iii. vaccines (ATMF, Pew only)
iv. other biologic agents (i.e. phage, lysins) (WHO, Pew only)
v. Tuberculosis (ATMF, WHO only)
vi. Fungi (ATMF only)

ATMF used both references to compare among the analyses which companies, projects, and phases were included in each of the clinical pipelines, respectively. Benchmark analysis complements the WHO and Pew Trusts analyses by comparing specific companies on specific aspects of antimicrobial R&D.

The Frequently Asked Questions mentioned below refer to the paper "Antibiotic shortages, stockouts and scarcity." 

Why did the Access to Medicine Foundation publish a white paper about antibiotic shortages?
There is an emerging crisis in the global anti-infectives market – antibiotic supply is patchy, complex and at risk of collapsing. By publishing this article, the Foundation aims to jump-start the broader conversation about how pharmaceutical companies and other actors can take action to strengthen antibiotic supply.

How did the Foundation reach the conclusions set out in the white paper?
To write the paper, the authors first reviewed the Foundation’s own research into how pharmaceutical companies align supply and demand and improve supply chain management in low- and middle-income countries. They also conducted a broad review of publicly available research into antibiotic market dynamics, antibiotic supply chain fragility and current and historic incidences and trends in antibiotic shortages. Further, the authors shared drafts of the paper with leading experts in supply chain management and the antibiotic market.

When was the white paper published? 
The white paper was published on Thursday May 31, 2018, on the website of the Access to Medicine Foundation.

What are the systemic factors undermining global antibiotic supply?
There is a web of systemic factors that cause antibiotic shortages. For example, an active ingredient is generally produced at only a few factories, so manufacturing failures can have huge knock-on effects. The commercial incentives for pharmaceutical companies to stay and invest in the antibiotic market are weak. R&D is risky and expensive, antibiotics offer slim margins, and growth in demand comes mainly from poorer countries with smaller healthcare budgets. New products are likely to be tightly controlled to minimise the risk of antimicrobial resistance. Plus, antibiotic supply chains are complex, with batches being passed between multiple distributors before they reach the patient. This leads to low visibility and accountability, and little alignment to ensure supply matches demand. 

What is the difference between a shortage and a stockout?
A stockout occurs when a doctor or pharmacist cannot dispense an antibiotic because there are no stocks available in that location at that time. A shortage occurs when supply does not meet demand. Shortages can occur on a national level (i.e., although antibiotics are globally available, specific regions or countries do not have access to them), or at a global level (i.e., when all countries struggle to access the medicine in question in sufficient quantifies). 

What are the main causes of antibiotic shortages?
There are many factors that can lead to a shortage of antibiotics. It could be that a factory fails to meet manufacturing standards or faces a technical issue that halts production. There could be a shortage of ingredients needed to make the medicine. A disease outbreak may cause demand to spike unexpectedly and outstrip supply. A key supplier or manufacturer may decide to leave the market, reducing the available supply. Logistical issues can also play a role. The Foundation’s white paper unpacks the reasons why the market and supply chains are not robust enough to absorb the impact of these individual causes.

How common are antibiotic shortages?
Data on shortages is generally collected at the national level. Not all countries collect or publish this information, which means there is no definitive answer to how common shortages are. Nevertheless, shortages of generic antibiotic products have been frequently reported on a global and national scale and many formulations of antibiotics for specific populations, including children, have limited availability. In 2010, for example, national shortages of injectable streptomycin (a broad-spectrum antibiotic used to treat TB) were reported in 15 countries, with 11 more countries predicting their stocks would run out before they could be replenished. In the United States alone, 148 national antibiotic shortages between 2001 and 2013 were identified by researchers from George Washington University, USA, with multiple shortages affecting 22% of drugs in that time period. 

What happens when antibiotics aren’t available?
There is little information available about the exact consequences of antibiotic shortages on patients’ outcomes, but the mortality rates due to treatable infectious diseases give some indication. According to a 2015 Europe-based survey, half of the hospital pharmacist respondents reported that patients were given inferior drugs during shortages, while more than a third said stockouts led to medication errors. National agencies have also reported that some patients experienced negative outcomes because of a less effective or more toxic alternative. Less effective or more toxic treatment alternatives can contribute to AMR because every time we use an antibiotic, we give bacteria the chance to adapt and develop resistance. To reduce the threat of AMR, doctors must ensure appropriate prescribing, where the right antibiotic is used against the right organism. 

What can be done to prevent antibiotic shortages and improve antibiotic supply?
Public health depends on having reliable access to affordable, quality assured antibiotics. The paper makes clear that providing access is a core responsibility of governments, supported by regulators and the industry. It recommends that the international community takes a unified approach to fixing the market, ensuring that there are multiple suppliers competing at critical links in the chain. Success will depend on the development of stronger incentives for pharmaceutical companies to enter and stay in the market. Pharmaceutical companies must also make a step change in their supply chain management, expanding best practices to antibiotic products.

What is the role for pharmaceutical companies in strengthening antibiotic supply chains?
As set out in the white paper, there are three broad tactics that experts and stakeholders – such as non-governmental organisations (NGOs), governments, academics, and industry representatives – expect pharmaceutical companies to use to improve the effectiveness and efficiency of supply chains in LMICs. These tactics are: (1) demand planning; (2) ensuring sufficient, uninterrupted supply; and (3) strengthening the distribution chain. The paper also identifies six steps pharmaceutical companies can take to help secure the long-term future of the market. These cover a range of areas, including long-term planning for inventory and stock management, changing staff incentives to encourage the development of distribution chains beyond urban areas, and the need to improve agility vis-à-vis public health needs. 

Are pharmaceutical companies taking action to strengthen antibiotic supply?
To show where action is possible, the white paper identifies examples of what pharmaceutical companies are already doing to strengthen antibiotic supply, drawn from the 2016 Access to Medicine Index, 2017 Access to Vaccines Index and 2018 Antimicrobial Resistance Benchmark. For example, several companies have invested in networks of production facilities to combat over-reliance on small numbers of suppliers. Other companies have processes to minimise the impact of shortages and stockouts, including managing local reserve stocks or prioritising needier populations when stocks run low.

How can antibiotic shortages lead to antimicrobial 
When demand spikes and antibiotic shortages occur, doctors often resort to using less optimal treatments. Not only are these less effective, but they also bring an increased risk of antimicrobial resistance (AMR). This is because, every time we use an antibiotic, we give bacteria the chance to adapt and develop resistance. To reduce the threat of AMR, doctors must ensure that the right antibiotic is used against the right organism.



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