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Home » Methodology
To develop the Benchmark’s methodology, the Foundation has applied its proven process for building consensus on the role of pharmaceutical companies in tackling global health priorities. The Access to Medicine Foundation published the methodology for the 2018 Antimicrobial Resistance Benchmark in August 2017.
The Foundation’s discussions identified general alignment on critical areas of pharmaceutical industry responsibility:
The Benchmark captures companies’ R&D activities targetting infectious diseases. It maps R&D and rewards efforts to target pathogens whose distribution and drug resistance makes them a priority target for R&D. It also recognises companies that plan for the stewardship and accessibility of new products that target priority pathogens, following market entry.
The Benchmark compares company strategies for limiting the impact of antibiotic manufacturing on resistance. It assesses how companies take antibiotic discharge into account in their manufacturing and environmental risk-management strategies. It also asks how companies maintain the quality of their antibiotics.
The Benchmark assesses companies’ access strategies for antimicrobial medicines in low- and middle-income countries, alongside their global stewardship strategies for antibiotics. The aim is to understand how companies approach these twin challenges, including whether and how each company integrates these approaches.
During the consensus building process, three categories of pharmaceutical companies were selected for inclusion in the Antimicrobial Resistance Benchmark. The selection of companies was based on several size and opportunity criteria, including: (1) relevance of marketed portfolio, (2) relevance of antimicrobial pipeline, and (3) commitment to addressing AMR.
The Benchmark covers pharmaceutical companies with marketed antimicrobial products and/or R&D projects and the ability and a commitment to address AMR. Thirty companies are in scope, selected based on a combination of factors, including R&D focus and experience, antibiotic market share and public commitment to AMR.
All infectious diseases are in scope for analysis. Certain pathogens have been deemed by stakeholders to be a priority for efforts to curb AMR, particularly for R&D. Priority pathogens identified by the Benchmark include drug-resistant pathogens as defined by WHO’s R&D Priority List and by CDC’s Biggest Threat List.
The product scope covers antimicrobial medicines on the market and in development, and vaccines in development. Each of the Benchmark’s three Research Areas has a tailored product scope:
The geographic scope is global since antimicrobial resistance is emerging across the globe. However, indicators relating to access have an exclusive focus on low- and middle-income countries as the challenges of sufficient access and affordability are significantly higher in poorer countries.
How we measure
The AMR Benchmark uses an analytical framework of three Research Areas and 16 metrics. Whether a company is measured in a specific Research Area depends on its antimicrobial portfolio and R&D pipeline.
A.1 R&D investments
Financial R&D investments dedicated to the development of antimicrobial medicines and vaccines. The denominator is a company’s (i.e. research-based or generic) total revenue of its pharmaceutical and vaccine products. For clinical-stage biopharmaceutical companies this, is an absolute measurement.
A.2 R&D projects
Size of pipeline and public health value of investigational antimicrobials and vaccines under development. Public health value is evaluated based on criteria such as targeting a priority pathogen and/or new mode of action.
A2.1. Pipeline size
The size of a company’s R&D pipeline targeting priority pathogens, including medicines, vaccines and adaptations (developed in-house or through collaborations).
A2.2. Novelty of pipeline
The novelty of investigational clinical antimicrobial medicines targeting priority pathogens that the company is developing (in-house or through collaborations). A compound is considered novel when it meets at least one of the four criteria: a new chemical class; a new target; a new mode of action; and/or an absence of cross-resistance to existing antimicrobials.
A2.3. Vaccines in pipeline
The number of new vaccines that the company is developing for priority pathogens in scope (in-house or through collaborations).
A.3 R&D collaborations
The company engages in open collaborations to overcome the scientific challenges of creating new antimicrobial medicines and vaccines targeting priority pathogens.
A.4 Facilitating access and stewardship
The proportion of late-stage antimicrobial R&D projects targeting priority pathogens for which the company provides evidence of having: 1) access-to-medicine provisions for the countries in scope; and 2) global stewardship provisions in place. Late-stage R&D includes projects in phase II and III of clinical development (developed in-house or through collaborative R&D). Access-to-medicine provisions refer to plans for ensuring the future appropriate availability and affordability of novel products in countries in scope.
B.1 Environmental risk-management strategy
The company has an environmental risk-management strategy to minimise environmental impact of manufacturing discharge of antibiotics that: 1) applies to its own facilities, to third-party manufacturers of antibiotic API and drug products and to waste-treatment plants; 2) includes auditing; and 3) includes discharge limits.
B.2 Disclosure on environmental risk management
The company publicly discloses: 1) its environmental risk management strategy to minimise environmental impact of manufacturing discharge of antibiotics; 2) results of audits on this strategy of the company’s manufacturing sites; 3) results of audits on this strategy of third parties’ manufacturing sites of antibiotic Active Pharmaceutical Ingredient (API) and drug products and of wastewater treatment plants; 4) the identities of their third parties manufacturing antibiotic API and drug products, and antibiotic waste treatment plants; and 5) the levels of antibiotic discharge.
B.3 Manufacturing high-quality antibiotics
The company has mechanisms in place to ensure that its own and third-party production facilities manufacturing antibiotic drug products maintain high quality of antibiotic production consistent with international standards developed and accepted by recognised national and international authorities.
C.1 Registration of antibiotics
The company files to register its newest antibiotics in the highest number of countries in scope.
C.2 Pricing of antimicrobials
The company implements an appropriate access strategy that includes affordability considerations of its highest volume antibiotics and non-antibiotic antimicrobial medicines for countries in scope.
C.3 Ensuring sustainable delivery
The company has mechanisms in place to improve supply chain efficiency aimed at preventing stockouts and improving demand forecasting of its highest volume antibiotics and non-antibiotic antimicrobial
medicines, so as to ensure sustainable delivery to countries in scope.
C.4 Supporting educational stewardship activities
The company engages and/or supports educational activities that are non-product specific to educate healthcare professionals (HCP) on antibiotic stewardship.
C.5 Ethical promotional activities
The company adopts ethical marketing practices that advance appropriate use of antibiotics in its promotional activities and has mechanisms in place to incentivise ethical marketing practices by its in-house and/or third-party sales representatives.
C.6 Brochure and packaging
The company implements brochure and packaging adaptation to facilitate appropriate use of antibiotics by patients, beyond local regulatory requirements, for its highest volume antibiotics. The company considers needs – literacy, language, cultural, demographic and environmental considerations – when adapting brochure and packaging.
C.7 AMR surveillance
The company has/supports/contributes to local and/or global antibiotic resistance surveillance systems