COMPANY PROGRESS SINCE 2021 NOVEMBER 2023 AMR Benchmark Opportunities: progress update
acknowledgements
The Access to Medicine Foundation would like to thank the following people and organisations for their support. FUNDERS The UK Foreign, Commonwealth and Ddvelopment Office The Dutch Ministry of Health, Welfare and Sport The Wellcome Trust AXA Investment Managers Stewart Investors Stewart Investors
access to medicine foundation The Access to Medicine Foundation is an independent non-profit organisation that seeks to transform the healthcare ecosystem by motivating and mobilising companies to expand access to their essential healthcare products in low- and middle-income countries. Naritaweg 227-A 1043 CB, Amsterdam The Netherlands For questions about this report, please contact Marijn Verhoef, Director of Operations and Research mverhoef@accesstomedicinefoundation.org +31 (0) 20 215 35 35 www.accesstomedicinefoundation.org
When the Access to Medicine Foundation released the first Antimicrobial Resistance (AMR) Benchmark in 2018, drug resistance was already on the rise and spreading fast, with the World Health Organization (WHO) officially classifying it as one of world’s top ten health threats in 2019. ¹ At t he time, projections suggested that annual deaths from AMR could escalate to 10 million by 2050.2 Today, AMR is already claiming the lives of at least 1.27 million people each year.3 If its spread is not curbed, we could reach, if not surpass, previous predictions far sooner than we thought. Worryingly, it is also becoming increasingly clear that climate change impacts AMR, with rising temperatures, for example, accelerating the burden of infectious diseases. 4 Drastic and urgent action is needed if we are to combat the drivers of drug resistance, protect the planet and prevent the unneces- sary loss of lives. AMR knows no boundaries or borders, but the reality is the lives of people in low- and middle-income countries (LMICs) are most at risk. Tragically, people living in these countries face a 50% higher chance of dying from AMR than people living in high-income countries.35 While AMR is a complex global issue that must be tackled through collaborative, coordinated actions from global health stakeholders, we cannot turn the tide against drug resistance without action from pharmaceutical companies. Not only do they have the power to improve appropriate access to effective and safe antimi- crobial products, including lifesaving antibiotics, but they operate on several fronts where some of the drivers of AMR risk can be curbed.
Driving progress
To enable progress, the Access to Medicine Foundation sets “Opportunities” for individual companies to pursue – a groundbreaking, practical and proven approach to moving companies in the right direction on critical access-to-medicine priorities. Across three iterations of the AMR Benchmark (2018, 2020, and 2021), the Foundation has pinpointed specific actions each major company in scope can take to combat drug resistance and ensure appropriate access to antimicrobials. Beyond tracking and evaluating these companies' efforts, the Foundation actively engages with companies on how to drive change – guiding and encouraging them to move forward. The Foundation's research has shown that good practice has become more common, specifically in access planning in research and development (R&D) to make new medicines available in LMICs, as well as in the steps taken to curb the release of antibacterial waste into the environment. 6 While every positive step is critical, more transformative actions are urgently needed. Table of contents Industry analysis 5 10  Company progress updates 38 References Companies were given Opportunities in the 2021 AMR Benchmark. Research-based pharmaceutical companies GSK, Johnson & Johnson, MSD, Novartis*, Otsuka, Pfizer, Sanofi, Shionogi Generic medicine manufacturers Abbott, Alkem, Aurobindo, Cipla, Fresenius Kabi, Hainan Hailing, Sun Pharma, Teva, Viatris *Since the publication of the 2021 AMR Benchmark, Novartis has completed a 100% spin- off of its generics and biosimilars business, Sandoz. On 4 October 2023, Sandoz became an independently listed company. This report provides updates on Opportunities iden- tified in Novartis's 2021 Benchmark Report Card, looking at progress over the two-year period and incorporating information about both Sandoz and Novartis. To stimulate large-scale change, the Foundation identified key Opportunities for the 17 companies evaluated in the 2021 AMR Benchmark, which included eight leading research-based pharmaceutical companies and nine generic medicine manufacturers (see figure on p.3). These tailored Opportunities, included within each company's 2021 Report Card, provided calls-to-action, encouraging companies to do more to curb AMR and improve access to antimicrobial products in LMICs. Now, in 2023, this report provides a vital update on the progress achieved by these 17 companies in response to these Opportunities. Tracking the progress companies have made over the last two years provides an important touchpoint for determining where successful steps are being taken and how the Foundation's work has contributed to such progress. It also provides key insights as to where companies have not yet taken sufficient action, showing them where they can focus their resources. At t he same time, this can also point to systemic challenges that continue to hinder progress, providing other global health stakeholders with valuable insights they can use to support companies.
17 companies, 69 targeted Opportunities for tackling AMR
Companies are all different in the way they operate, where they operate, and in their portfolio of investigational and marketed products, which is why the Foundation set out tailored Opportunities for each company, accounting for R&D pipelines (where applicable), product portfolios, and other factors. By doing this, the aim was to provide companies with clear, practical and feasible ways in which they can each maximise their contributions to successfully improving access and addressing AMR. The Benchmark evaluates companies in areas where they have the greatest opportunity and responsibility to limit AMR; specifically, R&D, managing antibacterial manufacturing waste, and ensuring appropriate access to – and responsible stewardship of – antimicrobial medicines. A total of 69 Opportunities were identified across these areas in the 2021 Report Cards of the 17 companies (see figure). Using data submitted by companies and information from the public domain, the Foundation conducted an analysis of whether there has been progress on each Opportunity. The industry analysis in this report reveals collective trends, both in terms of action and inaction, shedding light on the factors that have influenced the extent of progress achieved thus far – and where more action is required from companies. Opportunities are split across the Benchmark's 3 Research Areas
▶ For Opportunities related to access, some progress can be seen – especially in expanding product registration and engaging in long-term initiatives to boost availability and affordability. ▶ Despite a handful of acquisitions to expand R&D pipelines, R&D projects target- ing priority pathogens and urgent AMR threats are still lacking. ▶ Some positive examples of progress on Opportunities to limit AMR risk from manufacturing, yet minimal movement to increase public disclosure. ▶ No progress on Opportunities to delink bonuses from sales volume; some progress on improving surveillance disclosure and mitigating conflicts of interest.
RESEARCH & DEVELOPMENT
Few companies show progress on expanding R&D pipeline With the current arsenal of antibiotics and antifungals losing its effectiveness due to AMR, new treatments are drastically needed. Five companies were pre- sented with Opportunities that highlighted how they could expand the breadth of their pipelines to include more antimicrobial R&D projects targeting priority pathogens and urgent AMR threats. So far, two companies – Pfizer and Shionogi – have demonstrated progress, while Novartis, Otsuka and Sanofi have not. Both companies that demonstrated progress have added projects to their pipelines via acquisitions or strategic partnerships. Pfizer, through an acquisition, added SPR206 to its pipeline and progressed three existing candidates to later stages of development. SPR206, an investiga- tional intravenously (IV)-administered polymyxin product candidate, is ready to enter Phase II and targets multidrug-resistant (MDR) gram-negative bacterial infections. MDR gram-negative bacterial infections, such as pneumonia, meningitis, bloodstream infections, and surgical site infections, are predominantly found in hos- pitals, and are resistant to multiple antibiotics. Developing products that can target these infections effectively will protect patients. Shionogi expanded its pipeline by adding, through a strategic partnership, a novel oral antifungal therapy in Phase Ill to treat invasive aspergillosis and by acquiring two combination products in Phase I that target pathogens including carbapen- em-resistant A. baumannii, P. aeruginosa, and Enterbacterales. These products, designed for both oral and IV administration, are based on xeruborbactam, a novel boronic acid ß-lactamase inhibitor.  •
RESPONSIBLE MANUFACTURING
More companies are integrating AMR risk into their environmental risk strategies When manufacturing lifesaving antibiotics, it is critical that AMR does not become an unintended side effect – which is why companies must manage their antibiotic waste responsibly. In 2021, five out of the 17 companies in scope – Alkem, Fresenius Kabi, Hainan Hailing, Otsuka and Sun Pharma – did not specify any strategy to limit AMR risk Given that small- and medium-sized enterprises (SMEs) struggle to survive the financial 'valleys of death' of the drug development process while carrying out 75% of antibacterial and antifungal R&D, acquisitions like those undertaken by Pfizer and Shionogi play a pivotal role in sustaining innovation and ensuring global access to these crucial developments. 7 When antibiotics are developed solely as an IV treatment, patients need to visit a hospital for administration of the medicine. By developing both an oral and an IV formulation in parallel, patients could potentially spend less time receiving treatment at a hospital; reduced bed occupancy could, in turn, also alleviate pressure on hospitals. through responsible manufacturing. Since then, four of these companies have reported some progress, with the exception of Hainan Hailing, which has not demonstrated any significant progress in this area. FIGURE 1 Progress on Opportunity to limit AMR risk from manufacturing Of the 5 companies that did not previ- ously specify any strategy to limit AMR risk through responsible manufacturing, 4 now report some progress. Fresenius Kabi reports that it is in the process of fully implementing the manu- facturing standards of the AMR Industry Alliance and reports that approximately one-third of all its own sites and half of its assessed suppliers now comply with discharge limits in the receiving environment. Otsuka has developed an analytical method to quantify the levels of delamanid, its sole product in scope of the AMR Benchmark, and has plans to measure discharge levels. While Sun Pharma and Alkem do not report on environmental risk-management strategies covering AMR, Alkem has publicly reported that it has implemented Zero Liquid Discharge (ZLD) – a treatment process in which the site does not discharge any water into the envi- ronment – across 64% of its manufacturing sites. Sun Pharma reports the use of ZLD systems at all 12 of its manufacturing sites. These developments indicate a growing awareness and commitment among these companies to integrate responsible manufacturing practices that address AMR risk into their broader environmental strategies. • The AMR Industry Alliance is a coa- lition of companies and associations that aims to drive progress on AMR. In the absence of independent regulation targeting the AMR risk from antibiotic manufacturing, the Antibiotic Manufacturing Standard facilitated by BSI Standards Limited." In 2023, the Foundation published a report zeroing in on responsible manufacturing practices. It identifies examples of how some companies are developing and maintaining solutions that will help them limit their antibiotic waste more effectively. This report, which includes specific recommendations, can help guide companies to make further progress on their Opportunities. If wastewater containing high levels of  active pharmaceutical ingredients (APIs) is released into the environment, it poses a serious risk to human health, while also causing environmental harm. 89 Limited reporting on supplier compliance with discharge limits While several companies show progress in their efforts to collaborate with suppli- ers to reduce AMR risk, only a few have disclosed the extent to which their suppli- ers adhere to discharge limits from antibiotic waste. Pfizer reports that 86% of its 100-plus supplier sites are now compliant with discharge limits in the receiving environment (e.g., rivers and waterways). Similarly, Shionogi reports that 71% of its supplier sites are compliant, up from 33% in 2021. Companies' submissions for this report outline the challenges associated with improving compliance among their suppliers, as there is currently no specific reg- ulation stipulating permitted antibiotic waste release levels into the environment. While contractual provisions offer a solution, enforcing such contracts can be difficult, often due to limited alternative supplier options. Consequently, companies are taking proactive measures to support and assist their suppliers in addressing compliance challenges. For instance, Abbott supports suppliers by providing free wastewater analysis and logistics assistance. Public disclosure on managing antibiotic waste keeps falling short Out of 17 companies, 16 were presented with the Opportunity to increase public disclosure on their AMR-focused manufacturing approaches. However, to date, none of the companies have disclosed audit results or antibacterial discharge levels of their own sites or those of their suppliers. The one example of progress comes from Viatris, which now publicly discloses that all its own manufacturing sites com- ply with certain discharge limits set by the AMR Industry Alliance.
appropriate access
Expanded registration of essential off-patent and/or generic medicines To save patients' lives and curb AMR, it is crucial that every patient has access to the right antibiotic or antifungal medicine at the right time. An important element of this is for companies to ensure that their older, off-patent and/or generic products are widely registered with national regulatory authorities, including in low- and middle-income countries (LMICs). Of the nine companies given the Opportunity to expand registration of such products, six – Abbott, Aurobindo, Cipla, Sanofi, Teva and Viatris – have made progress, to varying degrees. Viatris, for instance, filed six products listed on the 2023 WHO Model List of Essential Medicines (EML) in an • average of two additional LMICs in scope. Teva reports that it has filed five of its essential medicines for registration in at least one additional LMIC. FIGURE 2 Movement on expanding registration of critically-needed off- patent and/or generic products to more LMICs Of the 9 companies with an Opportunity to expand regis- tration of off-patent and/or generic products, 6 have made some degree of progress. The 2023 WHO EML presents essential medicines that should be available to every healthcare system. Of these medicines, 90% are already off-patent, offering huge potential for generic med- icine manufacturers to expand access. In 2023, a first-of-its-kind report from the Foundation examined what five of the world's largest generic and biosimilar medicine manufacturers are doing to expand access to essential medicines – and provides tailored Opportunities for each company to bolster efforts.'' Nonetheless, several companies expressed market viability concerns as a barrier to expand registration filings in LMICs. This includes tenders that predominantly take prices into account and not quality or environmental aspects. In addition, for in-li- censed products, expanding registration can be constrained by contractual terms with licensors. Based on companies' submissions for this report, broader medicine registration in LMICs could be facilitated by clarity about demand, harmonised regis- tration procedures and non-price tender criteria. • In a report published in 2022, the Foundation set out a wide range of strategies that are available to companies for overcoming such barriers and improving access appropriately and sustainably. The report includes six case studies showing what companies and their partners are already doing to expand appropriate access. 12 Pfizer and Sanofi take steps to ensure access and availability in LMICs Pfizer and Sanofi – which both had Opportunities in this area – have established global not-for-profit programmes to expand access to antibiotics and antifungals in LMICs. Both initiatives show a strong potential for securing sustainable access to medicines and vaccines in these countries. Pfizer's Accord for a Healthier World initiative, launched in May 2022, was expanded in January 2023 and aims to offer individuals in 45 LMICs access to the company's complete portfolio of both on-patent and off-patent medicines and vaccines. This includes 4 antibacterial vaccines, 11 branded antibiotics and 4 branded antifungals, which the company has shared a commitment to provide on a not-for-profit basis. Sanofi's non-profit Global Health Unit, launched in 2021, aims to increase product availability in LMICs by supplying 30 essential medicines to 40 LMICs, including 2 antibiotics – metronidazole and rifampicin. Efforts to enhance accessibility and affordability of MDR-TB products All three companies – Johnson & Johnson, Otsuka and Viatris – with the specific Opportunity to expand access and improve affordability of multidrug-resistant tuberculosis (MDR-TB) products report progress on access strategies for MDR-TB medicines. These strategies include price reductions, extended shelf life, pooled procurement mechanisms and expanding registration in multiple LMICs. Johnson & Johnson offered a reduced price of its six-month bedaquiline treatment course to the Stop TB Partnership's Global Drug Facility (GDF) and the countries GDF supplies. At USD 130, this marks a 55% reduction from the previous price, when the same treatment course was supplied to GDF at USD 289. 14 In June 2023, Johnson & Johnson granted the GDF appropriate licences, which allow GDF to purchase generic versions of bedaquiline for the majority of LMICs. 15 Moreover, after public pressure from organisations such as Unitaid, Johnson & Johnson announced in September 2023 that it will not enforce any of its patents for bedaquiline in all 134 LMICs.16 The bacteria that cause MDR-TB are resistant to the two most potent TB drugs, making equitable access to MDR-TB products vital.つThis allows generic competition in all LMICs, including those that do not procure bedaquiline via GDF. Viatris has registered or submitted registration filings for pretomanid in four additional countries in scope. Collaborating with MedAccess and the TB Alliance, Viatris announced a 34% reduction in the price of pretomanid, ensuring it is now available at a maximum of USD 240 for a six-month treatment course. 17 Additionally, Viatris reports that the shelf life of pretomanid has been extended from 36 to 48 months, allowing for extended storage periods. ● Otsuka reports that since 2021, it has registered or submitted registration filings for delamanid in seven countries in scope and is initiating a technology transfer for its paediatric formulation of delamanid to Viatris in India, with a focus on improving affordability and accessibility. This is in addition to a completed technology transfer for the adult formulation. Moreover, Teva also reports improving MDR-TB product availability by supplying linezolid and pyridoxine (a vitamin supplement used in tuberculosis regimens) to the Stop TB partnership in 2022.
Expanding access to cefiderocol through collaboration agreement
In 2022, Shionogi engaged with the Global Antibiotic Research & Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI) in a collabora- tion agreement to scale up global cefiderocol production and distribution, specifi- cally to meet demand in LMICs.18   → As part of the collaboration agreement, Shionogi and GARDP signed a licens- ing agreement, providing GARDP the right to bring cefiderocol to market in 135 countries where access to cefiderocol has faced delays. In 2023, GARDP entered a non-exclusive sublicensing agreement with Orchid Pharma for the manufacturing of cefiderocol.'9 To spur the uptake of the product in LMICs, the agreement stipulates that Orchid Pharma will submit the product to WHO's medicines prequalification (PQ) programme.
STEWARDSHIP
Specific strategies by companies are needed to reduce the misuse and overuse of antibacterial and antifungal medicines. Critically, steps to strengthen responsible practices must be applied globally and committed to for the long term to ensure changes made are sustainable, and not transient. In 2021, seven companies were presented with an Opportunity to share raw surveillance data, which can reveal areas where infection rates are rising and resist- ance is emerging. Since 2021, four of the companies – GSK, Johnson & Johnson, MSD and Shionogi – have seized the Opportunity by disclosing their raw data via Vivli's AMR Register. Sharing this information is key in tracking the emergence and spread of resistant pathogens, particularly when it covers countries without national surveillance efforts. For example, the data can be used to inform treatment guidelines used by doctors and can ensure appropriate prescribing of antibiotics. Where companies contribute to educational activities for healthcare profession- als on how best to manage the risk of AMR, they must proactively avoid conflicts of interest. The two companies with Opportunities in this area, Abbott and GSK, have both demonstrated progress by no longer using branded materials in any of their educational programmes. However, limited to no progress has been observed by all 11 companies with an Opportunity to fully decouple sales bonuses from sales volumes. Fully decoupling sales bonuses from antibiotic sales volumes is key to reduce the risk of stimulating inappropriate prescribing. Although incentives can encourage employees to work towards achieving access-related goals, bonuses and rewards for sales represent- atives are commonly linked to sales volume. This can negatively affect access to medicine by increasing the risk of mis-selling or over-selling products. This also reduces the frequency of resupply, which optimises logistics and reduces waste. Ensuring widespread access to group antibiotic cefiderocol – a novel antibiotic effective against aerobic gram-negative bacteria – will bolster the treatment of patients' infections, such as complicated urinary tract infections (including pyelonephritis), for which limited treatment options currently exist. Companies with an Opportunity to fully decouple sales bonuses from sales volumes. Opportunity by 2023 Abbott, Alkem, Cipla, GSK, Hainan Hailing, Johnson & Johnson, MSD, Novartis, Pfizer, Sun Pharma, Viatris Since the previous Benchmark, companies have taken decisive action in certain areas – actions which will help hold back the rising tide of AMR. Yet, there are areas where this analysis also identifies little movement towards realising critical Opportunities. Concerted efforts are now needed by companies to help drastically curb drug resistance and prevent unnecessary loss of life. Addressing AMR is a daunting task, but the Foundation has identified tangible, clear ways in which companies can take action against this global health threat. By focusing on critical gaps that remain, they can have a huge impact in turning the rising tide of drug resistance. The Foundation will continue to engage with pharma- ceutical companies, monitor progress and encourage them to move forward.
This section of the report goes company-by-company, look- ing at the 17 companies analysed in the 2021 Antimicrobial Resistance Benchmark and whether they have made progress on the Opportunities highlighted in their respective 2021 Report Cards. The company updates feature the 2021 Opportunities in the left-hand column, with updates in the right-hand column. To see each company's full 2021 Report Card for more context and information, please follow the links on the first page of every company's progress update, or see the Access to Medicine Foundation website to look across all 17 companies. ▷ GSK plc ▶ Johnson & Johnson ▶ Merck & Co, Inc (MSD) ▶ Novartis AG ▷ Otsuka Pharmaceutical Co, Ltd ▶ Pfizer Inc ▷ Sanofi ▶ Shionogi & Co, Ltd ▶ Abbott Laboratories ▶ Alkem Laboratories Ltd ▷ Aurobindo Pharma Ltd ▶ Cipla Ltd ▶ Fresenius Kabi AG ▷ Hainan Hailing Chemipharma Corp Ltd ▷ Sun Pharmaceutical Industries Ltd ▶ Teva Pharmaceutical Industries Ltd ▶ Viatris Inc
▶ Read GSK's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Johnson & Johnson's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read MSD's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Novartis's full 2021 AMR Benchmark Report Card online for additional information and context. Since the publication of the 2021 AMR Benchmark, Novartis has completed a 100% spin-off of its generics and biosimilars business, Sandoz. On 4 October 2023, Sandoz became an independently listed company. This report provides updates on opportunities identified in Novartis's 2021 Benchmark Report Card, looking at progress over the two-year period and incorporating information about both Sandoz and Novartis.
AMR Benchmark Opportunities: progress update
▶ Read Otsuka's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Pfizer's full 2021 AMR Benchmark Report Card online for additional information and context.
AMR Benchmark Opportunities: progress update
▶ Read Sanofi's full 2021 AMR Benchmark Report Card online for additional information and context.
AMR Benchmark Opportunities: progress update
▶ Read Shionogi's full 2021 AMR Benchmark Report Card online for additional information and context.
AMR Benchmark Opportunities: progress update
▶ Read Abbott's full 2021 AMR Benchmark Report Card online for additional information and context.
AMR Benchmark Opportunities: progress update
▶ Read Alkem's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Aurobindo's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Cipla's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Fresenius Kabi's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Hainan Hailing's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Sun Pharma's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Teva's full 2021 AMR Benchmark Report Card online for additional information and context.
▶ Read Viatris's full 2021 AMR Benchmark Report Card online for additional information and context.
AMR Benchmark Opportunities: progress update
1 WHO. Ten threats to global health in 2019. Accessed January 18, 2023. https://www. who.int/news-room/spotlight/ ten-threats-to-global-health-in-2019 2 Jim O'Neill. Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations.; 2014. Murray CJ, Ikuta KS, Sharara F, 3 et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022;399(10325):629-655. doi:10.1016/S0140-6736(21)02724-0 MacFadden DR, McGough SF, 4 Fisman D, Santillana M, Brownstein JS. Antibiotic resistance increases with local temperature. Not Clim Chang 2018 86. 2018;8(6):510-514. doi:10.1038/$41558-018-0161-6 Drug-Resistant Infections Are One of S the World's Biggest Killers, Especially for Children in Poorer Countries. We Need to Act Now. | Center For Global Development | Ideas to Action. Accessed November 2, 2023. https:// www.cgdev.org/blog/drug-resist- ant-infections-are-one-worlds-big- gest-killers-especially-children-poor- er-countries 6 Antimicrobial resistance programme | Access to Medicine Foundation. Accessed November 2, 2023. https:// accesstomedicinefoundation. org/cross-sector-programmes/ antimicrobial-resistance-programme Access to Medicine Foundation. 7 Biotechs Are Saving the World from Superbugs. Can They Also Save Themselves?, 2021. Accessed April 8, 2022. https://accesstomedicinefoun- dation.org/resource/biotechs-are-sav- ing-the-world-from-superbugs-can- they-also-save-themselves 8 AMR Industry Alliance. AMR Industry Alliance Launches Antibiotic Manufacturing Standard to Help Mitigate the Impacts of Antimicrobial Resistance - AMR Industry Alliance. Accessed January 16, 2023. https:// www.amrindustryalliance.org/ mediaroom/amr-industry-alli- ance-launches-antibiotic-manufactur- ing-standard-to-help-mitigate-the-im- pacts-of-antimicrobial-resistance/ Access to Medicine Foundation. o Methods matter: What steps are companies taking to help curb AMR by manufacturing responsibly? Published online August 2023 10 UNEP. Bracing for Superbugs: Strengthening Environmental Action in the One Health Response to Antimicrobial Resistance | UNEP - UN Environment Programme.; 2023. Accessed February 7, 2023. https:// www.unep.org/resources/superbugs/ environmental-action 11 Spatlight on the generics industry: New analysis looks at access efforts of 5, major companies | Access to Medicine Foundation. Accessed November 2, 2023. https://access- tomedicinefoundation.org/news/ is-the-generics-industry-stepping- up-on-access-to-medicine-new-anal- ysis-spotlights-actions-of-5-major- companies 12 Access to Medicine Foundation. Lack of access to medicine is a major driver of drug resistance. How can pharma take action? Published online June 2022. https://accesstomedicinefoun- dation.org/medialibrary/62c2fod- cda565_atmf_appropriate_access_to_ antimicrobials_2022-1666595298.pdf 13 Global Tuberculosis Programme. Accessed November 2, 2023. https:// www.who.int/teams/global-tuberculo- sis-programme/diagnosis-treatment/ treatment-of-drug-resistant-tb/ types-of-tb-drug-resistance 14 Stop TB's Global Drug Facility Announces Historic Price Reductions up to 55% for Bedaquiline, a Life- Saving Drug to Treat Drug-Resistant TB | Stop TB Partnership. Accessed November 2, 2023. https://www. stoptb.org/news/stop-tbs-glob- al-drug-facility-announces-histor- ic-price-reductions-to-55-bedaqui- line-life-saving 15 Johnson & Johnson's Non-exclusive License to Stop TB's Global Drug Facility for Distribution of Approved Generics of SIRTURO 100mg (Bedaquiline 100mg) and Results of the Global Drug Facility's International Tender for Bedaquiline Frequently Asked Questions. Accessed November 2, 2023. https://pharmstd.com/ pdfs/2013_annual_report_EN.pdf 16 Johnson & Johnson Confirms Intent Not to Enforce Patents for SIRTURO® (bedaquiline) for the Treatment of Multidrug-Resistant Tuberculosis in 134 Low- and Middle-Income Countries | Johnson & Johnson. Accessed November 2, 2023. https://www.jnj.com/ johnson-johnson-confirms-in- tent-not-to-enforce-patents-for-sir- turo-bedaquiline-for-the-treat- ment-of-multidrug-resistant-tuber- culosis-in-134-low-and-middle-in- come-countries 17 Price reduction paves the way for expanded access to highly effective multidrug-resistant tuberculosis treatment - MedAccess. Accessed November 2, 2023. https:// medaccess.org/price-reduc- tion-paves-the-way-for-expanded-ac- cess-to-highly-effective-multidrug-re- sistant-tuberculosis-treatment/ 18 Shionogi, GARDP and CHAI announce landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in 135 countries | GARDP. Accessed November 2, 2023. https://gardp. org/shionogi-gardp-and-chai-an- nounce-landmark-license-and-col- laboration-agreements-to-treat-bac- terial infections by -expanding -ac- cess-to-cefiderocol-in-135-countries/ 19 Critical agreement paves way for new model to accelerate access to important antibiotics for serious bacterial infections | GARDP. Accessed November 2, 2023. https://gardp.org/critical-agree- ment-paves-way-for-new-mod- el-to-accelerate-access-to-impor- tant-antibiotics-for-serious-bacteri- al-infections/ Report Design Scribble Design The Access to Medicine Foundation gratefully respects the permission granted to reproduce the copyright material in this report. Every reasonable effort has been made to trace copy- right holders and to obtain their permission for the use of copyright material. 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