Antibiotics are the foundation of modern medicine. These essential medicines fi ght bacterial infections by killing the bacteria or by making it hard for the bacteria to grow and multiply. From simple surgeries and dental procedures to cancer treatment, antibiotics support health systems’ ability to deliver safe care to patients.
By one estimate, antibiotics have extended average human life expectancy by more than 20 years since their discovery almost a century ago. But they are becoming less and less effective as a result of bacteria developing resistance, making people more vulnerable to infections. According to the World Health Organization (WHO), the rise in rates of antibiotic-resistant infections due to misuse and overuse of antibiotics has become one of the top 10 biggest health issues facing the world.
It is estimated that bacterial antimicrobial resistance (AMR) was directly responsible for 1.27 million global deaths in 2019 and contributed to 4.95 million deaths.
This is a problem that will get progressively worse unless policy reforms are implemented. As the country observes National Infection Prevention and Control Week, the research-based pharmaceutical industry reiterates our call to accelerate the creation of a vibrant and sustainable innovation ecosystem to support R&D for new antibiotics and other antimicrobials addressing pathogens prioritized by leading public health bodies. Developing antibiotics is a long, complex, and risky process, and many in development fail along the way.
It takes 10 to 15 years for an antibiotic candidate to progress from the preclinical to the clinical stages. For antibiotics in existing classes, on average, only one of every 15 drugs in preclinical development will reach patients. For new classes of antibiotics, only one in 30 candidates will reach patients.
When they do successfully make it through the rigorous R&D and approval processes, new antibiotics are used sparingly to preserve effectiveness and are often placed on shelves to be used only when more common classes of antibiotics do not work. Because bacteria continually develop resistance to our existing antibiotics, we will always need a robust pipeline of new ones — so it is critical to have sustained investment to keep pace with growing resistance. In 2020, more than 20 leading pharmaceutical companies stepped up and created the AMR Action Fund to invest nearly $1 billion in antibiotic R&D and support the pipeline for the next few years.
The AMR Action Fund is now the world’s largest public-private partnership supporting the development of new antibiotics. The concept for an investment fund to support companies developing potentially lifesaving antimicrobial therapeutics originated in conversations among the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the WHO, the European Investment Bank, and the Wellcome Trust, a London-based charitable foundation focused on health research. The AMR Action Fund invests in companies that are developing urgently needed therapeutics for priority pathogens and advocate for market reforms to change how society values these lifesaving drugs.
It aims to help launch two to four new antimicrobials within the next decade and create a sustainable ecosystem of investment and innovation to take on one of the biggest global health challenges of our generation. To ensure that novel antibiotics are used appropriately and are accessible to the patients who need them, the AMR Action Fund and the companies it invests in are guided by four key principles. First, the new antibiotics to be developed should address unmet medical needs prioritized by the WHO, the Centers for Disease Control and Prevention (CDC), and other leading health authorities.
The overall guiding principles for any decisions and actions by the AMR Action Fund and its portfolio companies should be to advance medical science, contribute to slowing the emergence of resistance, and support appropriate patient access. Second, the AMR Action Fund will work to ensure portfolio companies design and undertake clinical trials in a way that supports appropriate use and broad access. For example, companies are expected to pursue indications that reflect the highest unmet needs, generate data that informs appropriate use in vulnerable populations, and develop formulations that facilitate access.
Third, ensuring affordable access to new and existing antibiotics, particularly in low- and middle-income countries (LMICs), will require new partnerships with governments, donors, international organizations, industry, and civil society. The AMR Action Fund will advocate for creating new mechanisms and strengthening existing partnerships to facilitate increased appropriate access to novel antibiotics in low- and middle-income countries. Portfolio companies will identify countries where commercialization is regarded as unfeasible within a reasonable time horizon and therefore these new mechanisms and additional support will be needed to enable access and appropriate use of novel antibiotics.
In addition, governments need to strengthen healthcare systems to support access and appropriate use, and create market conditions that enable a sustainable return on investment, recognizing the value of novel antibiotics addressing high unmet needs. Fourth, the AMR Action Fund will work with portfolio companies to build access and appropriate use into antibiotic development strategies, and support companies to develop and make public Access and Appropriate Use Plans when assets are in Phase III clinical trials. These plans will include the strategies to be adopted by portfolio companies to promote access and appropriate use.
Developing antibiotics to combat infectious diseases is one of the crucial tasks of the biopharmaceutical industry. Investments and a policy environment conducive to innovation will be important to reinforce our pipeline of antibiotics that could be resilient in the face of antimicrobial resistance. Teodoro B.
Padilla is the executive director of Pharmaceutical and Healthcare Association of the Philippines (PHAP). PHAP represents the biopharmaceutical medicines and vaccines industry in the country. Its members are in the forefront of research and development efforts for COVID-19 and other diseases that affect Filipinos.
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