Dr. Najy Alsayed MD, M.Sc., MBA
Global Therapeutic Area Head – Infectious Diseases, Menarini
A leading expert voices highly cautious optimism over the very few steps taken today that could help tackle the threat to patients’ lives and their medical care from antimicrobial resistance (AMR).
With AMR contributing to millions of deaths and costing the global economy billions of dollars, Najy Alsayed, Head of Infectious Diseases at Menarini emphasises the urgency in fighting the AMR threat, where microorganisms develop resistance to antimicrobial medicines. While warning that the model to produce novel antibiotics is broken, we continue to work with authorities on implementing potential solutions, should the political awareness be translated into decisive actions.
AMR threat
Menarini is a mid-sized European pharmaceutical company focusing on oncology, cardiovascular and respiratory and infectious diseases. Alsayed sees three major elements to the AMR threat: life-threatening clinical impact; associated rising healthcare costs; and a threat to the future progress of modern medicine.
Pointing to a 2019 paper in The Lancet which showed 4.95 million annual AMR deaths globally (a figure which could rise to 38.5 million by 2050), he adds: “We must take decisive actions to curb this accelerating threat.”
Healthcare-associated costs of USD66 billion a year are projected to rise to USD1.2 trillion by 2050, but he is particularly concerned about the impact on patients. In one example, he fears that half of organ transplant patients will be affected by an AMR-related infection due to their immunocompromised systems, and 30–40% of these patients will die as a result.
We must take decisive actions to
curb this accelerating threat.
Broken model
At present, he believes there is a “broken model” against tackling AMR, with constraints on the availability of novel antibiotics to clinicians and patients. Of 16 antibiotics approved in the last decade, only two are available in high-income countries, with access further limited in low and middle-income countries.
“That access is constrained because of the failure of the current model,” says Alsayed, pointing to development costs and little investment, meaning novel antibiotics are becoming not commercially viable in many countries and to the patients who need them the most, even in countries where these antibiotics have already been launched.
Lessons can be learned from how the orphan diseases crisis has been successfully addressed over the past 25 years. Facing similar challenges to novel antibiotics, with poor patient access, commercial viability and sustainability — alongside lack of investments attractivity — the action taken, through the designated Orphan Medicine EU-Legislation, has led to significantly improved patient access, pipeline and investments, boosting orphan medicines for patients with rare diseases.
Emerging solution
Another positive step comes from the Italian reserved antibiotics model, announced during the G7 meeting in June 2024. It acknowledged the “significant and accelerating threat of AMR and the need for novel antibiotics.” Under this, Italian policymakers and government created an antibiotic patient access model through which novel antibiotics will be “evaluated, priced and reimbursed” and “patient access will be facilitated accordingly.”
He also highlighted that RDTs (rapid diagnostic tests) are important in ensuring novel antibiotics are promptly and appropriately delivered to patients. With pharmaceutical companies like Menarini collaborating with biotech companies, he believes that through the collaborative efforts and partnerships — alongside governments and EU policymakers, pharma industry, patient associations and other key AMR stakeholders — decisive solutions will emerge to address both the current broken model and patient access failures.
