What the High-level meeting should prioritise when engaging
the pharmaceutical industry on combatting AMR
April 2024
Antimicrobial resistance (AMR) is a global multisectoral challenge and there can be no sustainable
resolution without an active involvement of the pharmaceutical companies. Therefore, as national level
delegates come together for the High-Level Meeting (HLM) on AMR at UNGA in September 2024 they must
utilise their position both as funders of innovation and access, and as customers or procurers of
antimicrobials from these companies, to emphasise on their roles and responsibilities for tackling AMR
across the following 5 themes:
1. Access: The lack of access and inadequate access to the right treatment as drivers of antimicrobial
resistance stands well established. The Access to Medicine Foundation's 2021 AMR Benchmark andsubsequent Appropriate Access Research Study highlight the enormous opportunity for leading
manufacturers of antimicrobial products to tackle AMR by increasing the quality and reach of theiraccess strategies. Companies have several options to increase access to essential antibiotics,
antifungals, diagnostics and vaccines, including registration, technology transfers, voluntary licensing
and local manufacturing so that more people and countries benefit. The September political declarationmust encourage and mandate early and broader access planning by pharmaceutical companies bothfor existing as well as novel products. Governments can accelerate company efforts by providing strong
and clear feedback on local demand and by investing in regulatory harmonisation schemes to make iteasier, faster and cheaper for pharmaceutical companies to file for registration within multiple
countries at the same time.
2. Stewardship: The overuse and misuse of antibiotics is another leading cause of antimicrobial resistance.
The Access to Medicine Foundation's Appropriate Access Research Study highlights the opportunity forpharmaceutical companies to check this through stronger stewardship practices including responsible
promotion and sales practices such as delinking of financial incentives from sales volumes. To support
pharmaceutical companies to achieve this, the September political declaration must emphasise theneed for more countries to invest in pull incentives like upfront market entry payment or a subscriptionstyle model following England’s National Health System (NHS) to ensure a viable market forpharmaceutical companies developing new products. Furthermore, the HLM must mandate theincorporation of the appropriate use and stewardship guidelines as part of all national treatment
guidelines and ensure that WHO’s Model List of Essential Medicines and AWaRe classification are usedappropriately.
3. Supply: Pharmaceutical companies, specifically large R&D-based companies, have a central role inensuring a continuous supply of high-quality medicines to support adherence, check resistance andprevent substandard and falsified products from entering markets. The HLM must call for an increasedrole by these companies to ensure a continuous supply of high-quality products including through their
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support for local manufacturing initiatives. Governments can catalyse this further by making securityof supply an important criterium in national and pooled procurement processes on top of the lowest
price in tenders.
4. R&D: While antimicrobial resistance is growing at an alarming scale the same cannot be said for theR&D pipeline of antimicrobial products. The Access to Medicine Foundation’s R&D report on biotechs
highlights that biotechs account for 75% of all late-stage antibacterial R&D projects today, yet withmany of the large research-based companies leaving antimicrobial R&D, these biotechs are struggling
to secure the financing and resources needed to develop and commercialise these much-needed
medicines. The unwavering priority is for the large R&D companies with the knowledge and theresources to deepen their investment and engagement in antibacterial and antifungal R&D with a focus
on pathogens in the highest threat categories, and to further tailor the detail and specificity ofstewardship and access plans. While push and pull incentives from governments and funderorganisations is critical to address this R&D challenge for antimicrobials, it is critical for the large
pharmaceutical companies to stay engaged in this space. The September political declaration mustemphasise that better financing and support from large pharmaceutical companies beyond theirinvestment in the AMR Action Fund is required and must be accelerated.
5. Responsible Manufacturing: Pollution caused by the release of antibiotic manufacturing waste into theenvironment is being increasingly recognised as one of the leading drivers of AMR. In the absence of aglobal regulatory landscape, the onus of checking the spread of AMR through manufacturing practices
lies largely with pharmaceutical companies not just at their own manufacturing sites but across theentire supply chain. The Access to Medicine Foundation's Responsible Manufacturing Report highlights
the huge gap that continues to exist in wastewater management practices of these companies and calls
for increased transparency and accountability. There is a need for the September political declaration
to call on the pharmaceutical industry to increase the uptake of responsible manufacturing practices.
Already since the 2016 political declaration considerable progress has been noted catalysed by
procurement decisions of some countries. In addition to calling for accountability and transparency,
governments specifically in LMICs which house a large number of suppliers for active pharmaceuticalingredients (APIs) and related antibacterial products must explore the possibility of public-private
partnerships (PPPs) to support the smaller yet critical players when it comes to ensuring responsible
manufacturing across the entire supply chain.

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