Anti-microbial resistance (AMR) represents a major threat to human health, estimated to be directly responsible for nearly 1.3 million deaths per year. Novartis and Sandoz are committed to making a meaningful contribution to the global fight against AMR, focusing our efforts on responsible manufacturing, appropriate access, responsible use, and innovation.
Anti-microbial resistance (AMR) represents a major threat to human health. It occurs when bacteria evolve to resist anti-bacterial medicines; a natural phenomenon that has been progressively accelerated by the overuse, underuse and misuse of antibiotics over the decades. While it is often referred to as the “silent pandemic”, latest research* suggests the threat is anything but dormant. Based on these data, AMR is now estimated to be directly responsible for nearly one million three hundred thousand deaths per year, as many as HIV and malaria combined; resistant infections were associated with a total of nearly five million deaths annually, making them potentially the third largest cause of death worldwide, after ischemic heart disease and stroke.
Covid-19 threatens to accelerate the problem. Secondary bacterial infections increase pandemic-related mortality rates and the use of antibiotics to treat them can accelerate the spread of resistance.
Now is the time to act. If we work together across sectors and borders, there is still a window of opportunity for action – but it will not stay open forever. While it will not be possible to prevent AMR completely, there are ways to substantially mitigate its impact. A successful response will depend on our ability to recognize and address the interconnected effects of antibiotics on humans, animals (via widespread preventive use) and the environment (from manufacturing and disposal) – embodied in a holistic One Health approach.
The global response strategy proposed by many leading experts focuses on a balanced, multi-sectorial engagement, based on four interconnected action pillars: responsible manufacturing, appropriate access, responsible use, and innovation.
- Responsible manufacturing: proper use of resources, optimal hygiene and safe waste disposal throughout the value chain.
- Appropriate access: Six million people around the world die every year because they don’t have access to quality antibiotics; there is an urgency in getting the right drug to the right patient at the right time. This means both preventing millions of avoidable deaths due to lack of antibiotics and preventing the development and spread of AMR due to lack of appropriate treatments. It also requires better regulation of antibiotics so that they're no longer available for over-the-counter sale and improving distribution and supply so that HCPs aren’t forced to rely on less appropriate therapies when an optimal one isn’t available.
- Responsible use: appropriate education to prevent overuse, underuse or misuse of existing antibiotics. Diagnostics and surveillance can also help to radically improve point-of-care decisions.
- Innovation includes the discovery and development of new antibiotics as well as incremental innovation (e.g., reformulations) to meet unmet medical needs. New antibiotics alone will not eliminate AMR, because every new medicine will also be subject to resistance.
At Novartis, we are determined to play our part and focus our anti-AMR efforts on the following areas:
- Responsible manufacturing: Our Sandoz Division is the leading provider of generic antibiotics worldwide. The Sandoz site in Kundl, Austria, is the hub of the last vertically integrated antibiotics production chain in Europe, with 75 years quality production experience; we recently announced a major investment to further upgrade technology and processes. We are also involved in coalitions including the AMR Industry Alliance to drive global standards, as well as the CEO Water Mandate to advancing water stewardship.
- Appropriate access: We are working to ensure the availability of appropriate antibiotics around the globe. This includes the strengthening of Sandoz high-quality, affordable antibiotics portfolio to reinforce our leading position in generic penicillin.
- Responsible use: We collaborate with a range of organizations worldwide for educational activities addressing doctors, pharmacists & patients focusing on the One Health approach. Our partners include Medshr, the Commonwealth Pharmacists Association and the Ecumenical Pharmaceutical Network. We also incorporate responsible use of antibiotics into various community healthcare models, such as the Healthy Family Programs, to support capability-building programs in low- and middle-income countries (LMICs). Finally, we have extended our strategic research collaboration with Ares Genetics aimed at driving cutting-edge digital solutions for the development and life cycle management of antibiotics, to help healthcare professionals make better diagnoses.
- Innovation: We believe the barriers to innovating in antibiotics are too great and the problem of appropriately managing AMR is too complex for one company to tackle alone. This is why Novartis has partnered with a broad group of pharmaceutical stakeholders, including the International Federation of Pharmaceutical Manufacturers & Associations and 23 out of its member biopharmaceutical companies as investors, the WHO, the European Investment Bank and the Wellcome Trust for the creation of the AMR Action Fund. The AMR Action Fund is the world’s largest public-private partnership investing in antibiotics, antifungals and other antimicrobial treatments. In addition, we focus on addressing the needs of pediatric populations through adaptive development projects aimed at adjusting formulations of older antibiotics to those most fit for purpose in rural communities and LMICs.