A promising therapy using viruses to kill antibiotic-resistant bacteria is gaining ground in Switzerland, but its unique nature clashes with existing drug laws, limiting patient access and hindering development.
LAUSANNE, SWITZERLAND – In the global fight against antibiotic-resistant superbugs, an old weapon is being made new again. Phage therapy, which uses naturally occurring viruses to precisely target and destroy bacteria, offers a powerful alternative as our arsenal of effective antibiotics dwindles. Swiss researchers and clinicians are at the forefront of this revival, successfully treating last-resort patients. Yet, despite its life-saving potential, this innovative therapy is caught in a regulatory limbo, facing legal and structural barriers that prevent its widespread adoption.
The core of the issue lies in a fundamental mismatch: bacteriophages, or phages, are living, evolving organisms, whereas modern drug regulations were designed for static, chemically synthesized molecules. This has left phage therapy in Switzerland operating in a legal gray area, primarily accessible on a case-by-case basis under compassionate use exceptions rather than as a standard, approved treatment. While this approach has saved lives, it cannot scale to meet the growing threat of antimicrobial resistance (AMR), a crisis the World Health Organization has declared one of the top global public health threats.
The Viral Assassins
Bacteriophages are the most abundant life forms on Earth. These viruses are the natural predators of bacteria, each one evolved to infect and kill a specific bacterial species or even a specific strain. The mechanism is brutally efficient: a phage injects its genetic material into a target bacterium, hijacks its cellular machinery to create hundreds of new phages, and then bursts the cell open, releasing the viral army to hunt for more bacteria. This high specificity is a key advantage over broad-spectrum antibiotics, which wipe out both harmful and beneficial bacteria, causing collateral damage to the patient’s microbiome.
Discovered over a century ago by Félix d’Hérelle, phage therapy was used in some parts of the world before being largely eclipsed by the advent of penicillin and other antibiotics in the 1940s. With the rise of superbugs like methicillin-resistant Staphylococcus aureus (MRSA) and carbapenem-resistant Enterobacteriaceae (CRE), which are impervious to multiple drugs, scientists have revisited this forgotten tool with renewed urgency.
Swiss Innovation Meets a Regulatory Wall
Switzerland has emerged as a key European hub for modern phage therapy research and application. At the heart of this effort is the Lausanne University Hospital (CHUV), which operates a state-of-the-art Center for Research and Innovation in Phages (CRIP). This specialized unit can identify, isolate, and produce therapeutic-grade phages tailored to a patient’s specific infection.
Despite these advanced capabilities, the path to the patient is not straightforward. The Swissmedic, the national regulatory authority for drugs and medical devices, has no specific framework for approving phage therapies. To be marketed as a standard medicine, any new treatment must undergo a rigorous marketing authorization process, including extensive and costly multi-phase clinical trials to prove safety and efficacy. This system is ill-suited for phage therapy for several reasons:
- Personalization: Effective phage therapy often requires a “cocktail” of different phages precisely matched to the patient’s infecting bacteria. This personalized “N-of-1” approach is fundamentally at odds with the traditional model of a single, standardized drug tested on a large, uniform population.
- Manufacturing and Standardization: Producing live viruses to the stringent standards of Good Manufacturing Practice (GMP) is a major challenge. Ensuring a phage preparation is free of bacterial debris and toxins, is stable, and has a consistent potency is far more complex than for a chemical compound. While the CHUV facility has made significant strides in creating GMP-compliant processes, these are resource-intensive.
- Intellectual Property: Natural phages cannot be easily patented, which discourages the massive private investment from pharmaceutical companies that typically funds expensive clinical trials. Without a clear path to profitability, the commercial incentive is weak.
As a result, Swiss doctors currently rely on a workaround known as a “magistral formula.” Under Swiss law, a pharmacy can prepare a medicinal product for an individual patient based on a doctor’s prescription without requiring a full marketing authorization. The CHUV’s phage production facility effectively acts as this specialized pharmacy. While this allows for critical compassionate use in desperate cases, it is not a sustainable solution for making the therapy widely available.
Forging a Path Forward
Researchers and health officials are actively working to bridge this regulatory gap. The national network PhageNet.CH connects academic labs, hospitals, and policymakers to streamline research and advocate for a clearer legal framework. Their goal is to establish a system that ensures safety and quality without stifling the personalized nature of the therapy.
Dr. Grégory Resch, head of the CRIP at CHUV, is a leading voice in this effort. His team has successfully treated dozens of patients with chronic, antibiotic-resistant infections, from prosthetic joint infections to complex lung infections in cystic fibrosis patients. “We are at the beginning of a new era,” Resch stated in a public interview, emphasizing the need for robust data. “What we need to do now is demonstrate with clinical data the effectiveness of this therapy.”
One proposed solution is to adapt the regulatory model used for blood products or cell therapies, which also involve biologically active and variable components. This could involve authorizing the production process and the facilities themselves, rather than each individual phage cocktail. This would allow for flexibility while still maintaining strict oversight of safety and quality control.
Looking abroad, Swiss regulators can draw lessons from other countries. Belgium, for example, has officially recognized phage preparations under its magistral formula framework, creating a clear legal basis for their use. In the United States, the FDA allows for emergency use authorizations for phages in specific cases. Meanwhile, countries like Georgia have over a century of continuous clinical experience with phage therapy, offering a wealth of historical data.
The challenge for Switzerland, and for the world, is to modernize its regulatory thinking to keep pace with scientific innovation. As the threat of superbugs grows, the need for new weapons is becoming more acute. Phage therapy stands as a powerful and promising candidate, but its journey from the lab to the mainstream clinic will depend as much on legal and bureaucratic evolution as it does on scientific discovery.
