In 1928, modern medicine arrived through the work of a small lab in London where Dr. Alexander Fleming discovered penicillin. Fleming’s discovery of the world’s first antibiotic touched off a medical revolution that transformed health care, dramatically improving and extending lives in the decades ahead.
Yet today, as our reliance on antibiotics has grown, so too has the “silent pandemic” of antimicrobial resistance. AMR occurs when microbes evolve to resist antimicrobial medicines, particularly antibiotics. This is a natural phenomenon accelerated by antibiotic misuse and degradation, as well as substandard manufacturing.
According to the Global Antibiotic Research and Development Partnership, more than 214,000 babies die each year from AMR infections. A study published in The Lancet found that AMR led to 1.27 million deaths in 2019 — a number nearly twice previous estimates and expected to grow significantly in coming decades. To put the data in context, the estimated AMR-related death toll is approximately equivalent to one death every 25 seconds — or to the combined impact of HIV and malaria in 2020.
As a predominantly natural phenomenon, AMR cannot be eliminated but only controlled. Fortunately, there are practical and interconnected tools to delay the occurrence of resistance and slow its spread. At Novartis and Sandoz, the company’s generics division and the leading global supplier of generic antibiotics, our global AMR strategy is based on four pillars. These pillars are aligned with Novartis’ environmental, social, and governance agenda, which emphasizes access and innovation while promoting sustainability.
New drugs are not a silver bullet. Stronger medicines alone will not eliminate AMR [antimicrobial resistance] since every new medicine will also eventually become subject to resistance.
—1. Responsible manufacturing
The first step is to promote environmentally friendly production to ensure that antimicrobial effluents don’t leak into groundwater. This requires that the manufacturing process uses limited quantities of resources and is operated with optimal hygiene and waste disposal practices.
Together with the Austrian government, Sandoz recently invested more than $150 million to improve antibiotics manufacturing processes along these lines at our plant in Kundl. This is significant, as the plant is the hub of the last vertically integrated antibiotics production chain in Europe — meaning that key processes are not outsourced — with 75 years of quality production experience.
Responsibly managing water is essential to responsible manufacturing, which is why Novartis endorsed the global CEO Water Mandate and has committed to be a good water steward everywhere we operate. Demonstrating these commitments, Novartis has been working with local authorities and other private partners in Kenya to rehabilitate three boreholes in Machakos County, expanding access to clean water to more than 100,000 people.
2. Appropriate use
Improper use of antimicrobial drugs drives greater resistance to the bacteria, fungi, viruses, and parasites they are designed to kill. Antibiotics should be prescribed by licensed physicians with knowledge of current guidelines and best practices — and not be available over the counter at pharmacies.
Education and awareness initiatives should support these practices by ensuring doctors, pharmacists, and patients understand the risks of contributing to AMR through overuse, underuse, and misuse of antibiotics. This should include guidance on the safe disposal of unused antibiotics.
To accomplish this, Novartis has partnered with the Commonwealth Pharmacists Association to support capability-building programs in low- and middle-income countries with limited access to training and resources. Sharing specific knowledge about antimicrobial use ensures that clinics in these countries don’t become new breeding grounds for AMR.
Additionally, Sandoz recently extended its collaboration agreement with Ares Genetics to develop novel, low-cost, rapid genome-based diagnostic technologies, which can help health care professionals make more accurate diagnoses and more efficiently match patients with appropriate antibiotics worldwide.
Finally, Novartis incorporates responsible use of antibiotics into various community health care models, such as MedShr — a health staff app for clinical discussion — and Healthy Family programs, which use innovative business strategies to address social issues that impact access to health care in LMICs.
3. Equitable access
Nearly 6 million people around the world die every year because they don’t have access to quality antibiotics. Often, this lack of access drives patients to buy whatever OTC antibiotics are available, or worse, to buy counterfeit or substandard medicines with insufficient quantities of active ingredients. The result is not only a failure to kill dangerous microbes, but to apply selection pressures that favor the survival and reproduction of naturally resistant ones, further driving AMR.
The solution is not reducing appropriate antibiotic use, as these life-saving medicines are vital to solving many global health challenges. Rather, the key is to get the right medicine to the right patient at the right time. Doing this effectively requires better regulation of antibiotics so that they are no longer available for sale OTC, and improving distribution and supply so that doctors aren’t forced to rely on less appropriate therapies when an optimal one is not available.
4. Innovation and global collaboration
Antibiotic innovation is an important part of the solution. This means both the development of new molecular entities as well as reformulation of older antibiotics to enhance their efficacy, supported by global mechanisms to fund their development and promote proper use.
But new drugs are not a silver bullet. Stronger medicines alone will not eliminate AMR since every new medicine will also eventually become subject to resistance. Instead, manufacturers must collaborate not only to develop ever-newer antibiotics, but also to ensure that the elements outlined above are adequately addressed.
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 stakeholders, including the International Federation of Pharmaceutical Manufacturers & Associations and 23 of its member biopharmaceutical companies, the World Health Organization, the European Investment Bank, and the Wellcome Trust for the creation of the AMR Action Fund.
The fund has already made strategic investments in new antibiotic development, and we’re confident the partnership will catalyze decisive global action.
Even if AMR cannot be entirely beaten, we believe it can be beaten into a corner. This requires action at every level.
Patients must understand the threat of AMR and how to use and dispose of antibiotics. Health care providers must consider the AMR-related consequences of every prescription. Policymakers and development agencies must see health systems strengthening to address AMR as a worthwhile investment. And, finally, we call on pharmaceutical partners to join Novartis and Sandoz, and engage together across the four pillars, to urgently address this unprecedented threat to global health and the survival of modern medicine.
About the authors
Dr. Lutz Hegemann
Global Health President Dr. Lutz Hegemann is responsible for integrating global health and environmental, social, and governance matters into the core of the Novartis business. This includes our global health programs in communicable and noncommunicable diseases, our business in sub-Saharan Africa as well as the Novartis Foundation. Since joining Novartis in the Consumer Health Division in 2005, Hegemann held roles of increasing responsibility. He began his career as a public health physician and scientist.
Richard Saynor
Richard Saynor was appointed CEO at Sandoz in 2019, with a mission to turn the Novartis generics and biosimilars division into the world’s leading and most valued generics company. Today, these efforts are well on track. Sandoz reaches 500 million patients a year with its broad portfolio of affordable medicines. Saynor was named Leader of the Year in the 2020 Global Generics & Biosimilars Awards for his efforts. Saynor has a wealth of experience in the pharmaceutical industry. He previously held regional leadership roles at Sandoz between 2005 and 2010.
