Key Messages

• A continuous pipeline of new classes of antibiotics that can overcome increasing bacterial resistance is essential, but the current pipeline is insufficient due to a range of scientific, regulatory and financial factors. Solutions will require creative partnership between our industry, governments, the WHO and other stakeholders.
• In parallel with this effort, effective antibiotic stewardship is also required: antibiotics must be prescribed and used responsibly in order to maximize their benefit. Here too partnership is required - between governments, the pharmaceutical industry (R&D-based and generic), WHO and healthcare professionals.
• The IFPMA and its member companies and associations pledge the following:
  1.Continue our investment in R&D programs dedicated to the development of new antibacterial agents.
  2.Work in partnership towards a responsible global approach with UN Agencies (principally WHO), national governments, healthcare providers, NGOs and other stakeholders in the areas of education, prevention, innovation, access, financing and capacity-building initiatives.
  3.Support the WHO’s work to advise on the appropriate use of these vital medicines.

Background

The introduction and widespread use of antibiotics led many people to believe that we could successfully treat all infections. But a hallmark of antibiotics is that they lose their effectiveness over time as bacteria naturally evolve and mutate and so become resistant to the medicine’s power. Over the last twenty years the problem has worsened as antibiotic-resistant bacteria have become more prevalent, while at the same time, the number of new antibiotics being developed has declined. The problem of AMR extends across the globe. In the EU, multidrug-resistant bacteria cause about 400,000 infections a year and at least 25,000 deaths annually. But while there are high levels of resistance in developed countries, the most alarming levels of resistance are in developing countries.  We now face the possibility of a future without effective antibiotics for several types of bacteria that cause life-threatening infections in humans.

The increased level of antimicrobial resistance is a function in large part of the widespread global use of antibiotics. The over-prescription, mis-prescription and non-compliant use of antibiotics have made the situation even worse. AMR has also increased because of the limitations of existing diagnostic tools, which can lead to inappropriate prescription of antibiotics

The growth in antimicrobial resistance has been accompanied by a sharp decline in the development of new antibacterial medicines. The R&D-based pharmaceutical industry continues to invest billions of dollars in the development of new antibiotics, and there remains considerable expertise in this field within the industry and some promising pipeline candidates. However, we are not seeing sufficient development of new and novel classes of antibiotics to treat infections. This lack of new antibiotics is a result of the difficulty of the scientific challenge, challenging regulatory requirements, and inadequate financial incentives.