Progress being made on AMR, but marketplace reforms needed

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AMR Industry Alliance discusses the findings from their latest progress report, which pays heed to the importance of a global, multi-stakeholder approach to tackle AMR.

Antimicrobial resistance – the evolution of disease-causing microbes to evade antibiotics – is one of the most significant public health challenges facing the world today. A recent study published in The Lancet found that antimicrobial resistance (AMR) was associated with 4.95 million deaths in 2019, comparable to the devastating human loss caused by COVID-19, which has claimed nearly six million lives in the two years since the pandemic began.

While there are numerous ways to help tackle the emergence and spread of AMR, and actors across all sectors are making important changes, greater action is needed – and on a global scale. To help further understanding and serve as a catalyst for action, over one hundred biotech, diagnostics, generics and research-based pharmaceutical companies and associations formed the AMR Industry Alliance.

The Alliance’s mission is to harness the power of the life sciences industries and curb AMR through its bold set of shared goals and commitments. This involves the promotion of greater therapeutic and diagnostic innovation to prevent, diagnose and treat infections; addressing barriers to patient access to treatments; encouraging the appropriate use of antibiotics; and advancing responsible manufacturing of these drugs.

Recently, the Alliance published its third Progress Report to highlight the life sciences industries’ collective efforts to address AMR in four key areas: research and science; access; appropriate use; and manufacturing and the environment. The report, based on independent, quality-assured research conducted by the not-for-profit policy research organisation RAND Europe, provides a snapshot of the progress being made, along with recommendations for further action by all stakeholders.

Among the key findings:

Significant industry investment

AMR Industry Alliance members invested over $1.8 billion in R&D efforts to fight AMR in 2019 and 2020. Collaboration has been growing; eight out of 10 Alliance members are working with academic institutions, while about half are working with country-level governing bodies or hospitals and medical labs in the fight.

However, continued investment is at risk. One-third of Alliance members report they will decrease investment unless market conditions improve. On the other hand, 73% report they would increase investment given appropriate reimbursement mechanisms, valuation mechanisms and advanced market commitments.

Access is a key priority

A strong majority (81%) of Alliance members are engaged in activities to improve patient access to the most appropriate and timely treatments, vaccines, and diagnostics. Members are working to reduce regulatory barriers, address supply chain disruptions and keep falsified products off the market.

Yet there is opportunity to build on existing efforts to strengthen equitable access to novel and off-patent antibiotics and diagnostics across diverse geographies. Industry can work more closely in collaboration with governments, NGOs, and healthcare providers to create a regulatory and economic environment that supports a sustainable supply of high-quality antibiotics, especially in lower-middle income countries.

Appropriate use progress

One of the key drivers of AMR is the inappropriate use of the current stock of antibiotics. The more antibiotics are prescribed, the faster bacteria build up a resistance to them. Many Alliance members have appropriate use and stewardship strategies in place. Common approaches include education and awareness campaigns and collecting and sharing surveillance data to support better stewardship.

To build on this progress, stakeholders need to expand awareness efforts to wider audiences, including healthcare professionals and the patient population. This will help educate more people about the risk of AMR, while also promoting the appropriate prescribing of antibiotics to support better stewardship.

Responsible manufacturing and environmental protection

Reducing antibiotic emissions from manufacturing activity is a key step toward reducing AMR. Recognising this imperative and in the absence of international or national standards for antimicrobial manufacturing emissions, in 2018, the Alliance established the Common Antibiotic Manufacturing Framework (CAMF), a set of guidelines to assess risk and reduce antibiotic emissions across global supply chains, as well as a list of Predicted No-Effect Concentrations (PNECs) to serve as discharge targets for manufacturers.

Currently almost all (98%) of manufacturing sites owned by Alliance members either fully or partially meet the CAMF requirements. In fact, over 75% fully meet these requirements. Further, nearly nine out of 10 (88%) products manufactured at sites owned by Alliance members have been assessed against PNEC targets, with 87% of assessed products meeting those targets.

The Alliance’s pioneering work in driving reductions in antibiotic-manufacturing emissions can be used to help inform the development of international standards and national policies to best ensure environmentally responsible manufacturing more broadly. By working with legislators, regulators and policymakers, industry can help address gaps and accelerate adoption of responsible manufacturing practices.

The latest AMR Industry Alliance Progress Report not only offers a snapshot of the current state of AMR mitigation efforts, it also offers recommendations for how to strengthen a global effort to defeat one of the world’s most serious health threats.

At its core, the AMR crisis is caused by the evolution of tiny harmful microbes over time to defeat the world’s current arsenal of antibiotics. This evolution is a biologically dictated race for survival.

How can we win this race? Simply put, we must stop the spread, and we must fill the pipeline.

Mitigation efforts – such as reducing over-prescription of antibiotics and reducing antibiotic emissions in the environment – are absolutely essential to reducing the spread of AMR.

However, winning the battle against AMR also requires the world to restock the pipeline of new antibiotic innovations that are capable of treating AMR-related infections. Without these innovations, antimicrobial-resistant infections will continue to take lives of cancer patients with weakened immune systems, older people having routine medical procedures like hip replacements, new mothers having caesarean sections, women with chronic urinary tract infections. These should not be deadly events, but they become potentially deadly when we do not have the drugs to treat infections we once could.

Today, the number of antibiotics becoming obsolete due to resistance exceeds the number of new therapies being approved. We have not had a new class of antibiotics approved since the 1980s. In addition, there is a unique market dynamic at work with antibiotics. New antibiotics are used sparingly to preserve effectiveness and are often kept in reserve to be used only in extreme cases, for infections that have become resistant to older antibiotics. This makes it difficult for developers to have a predictable and stable return on their investment, stifling future innovation.

Nearly three out of four (73%) AMR Industry Alliance members report they would increase R&D investment if market conditions improve. So-called ‘pull’ incentives offer the fastest, most effective reform policies. A strong pull incentive approach addresses today’s marketplace challenges by aligning reimbursement and valuation mechanisms with the value they provide to patients, not how widely prescribed they are by physicians.

While gradual progress is being made, many existing efforts at market reform are in relatively early stages of implementation and have yet to scale. Accelerating and broadening these programs would draw greater investment into antibiotic R&D and help build the more robust pipeline of new treatments we need to fully address AMR.

The AMR Industry Alliance Progress Report should serve as a wakeup call to governments, NGOs and healthcare system stakeholders worldwide. The Report demonstrates that life sciences industries are active and willing partners in global efforts to tackle AMR. Yet it also signals that greater collaboration is needed at all levels to promote greater responsibility in the appropriate use and manufacturing of antibiotics. New regulatory policies will be needed to create better market incentives to drive the antibiotic innovation and give the world the drugs we need to defeat this deadly public health threat.

AMR Industry Alliance

This article is from issue 21 of Health Europa Quarterly. Click here to get your free subscription today.


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