French National Assembly Adopts Amendment on Hospital-Made Bacteriophage Treatments

France has taken another step in the debate over the legal framework for bacteriophage therapy. On October 23, 2026, the National Assembly adopted amendment No. 2783 to the 2027 Social Security Financing Bill (Projet de loi de financement de la sécurité sociale, or PLFSS). The amendment addresses the conditions under which hospitals could prepare bacteriophage-based treatments, with the aim of facilitating access to personalized phage therapy while maintaining appropriate pharmaceutical safeguards.

The official parliamentary record reports 16 votes in favour, 13 against and 26 abstentions. However, the amendment's adoption must be distinguished from the fate of the bill to which it was attached. On the same day, the National Assembly rejected the PLFSS 2027 as a whole at first reading. Consequently, the vote on amendment No. 2783 did not, by itself, establish a new legal framework or immediately change the conditions under which patients can receive phage therapy. The proposal remains dependent on the subsequent legislative process.

The distinction is particularly important for the phage therapy community. The vote demonstrates that the regulatory conditions surrounding hospital-prepared bacteriophages are being addressed at parliamentary level, but the practical consequences will depend on the provisions ultimately enacted and the regulations adopted to implement them.

Why are hospital-prepared bacteriophages different?

Bacteriophages are viruses that infect bacteria. Their specificity can make them attractive candidates for treating infections caused by bacteria that are resistant to conventional antibiotics or that persist despite standard treatment. Unlike many broad-spectrum antibiotics, individual phages may infect only particular bacterial strains. Identifying a suitable phage therefore often requires testing candidate preparations against the bacterial isolate obtained from the patient.

This characteristic is central to personalized phage therapy, but it also creates practical and regulatory challenges. A preparation that is active against one patient's bacterial isolate may be ineffective against another isolate belonging to the same bacterial species. Treatment may consequently require bacterial identification, phage susceptibility testing, selection of appropriate phages and the preparation of a suitable formulation.

These steps must be supported by reliable manufacturing procedures and quality controls. The identity and activity of the phages, the quality of the preparation, its microbiological purity and its traceability all matter when a product is intended for administration to a patient.

The pharmaceutical framework must also accommodate the differences between standardized medicines produced for broad populations and preparations tailored to individual clinical situations. Hospital-made preparations can potentially respond to needs that are difficult to meet through conventional commercial products, but they cannot be separated from requirements relating to safety, quality and clinical oversight.

France has already made progress in developing the infrastructure needed for phage production. In 2026, the Hospices Civils de Lyon announced that it had received authorization from the French National Agency for Medicines and Health Products Safety (ANSM) to manufacture therapeutic phages as pharmaceutical starting materials under Good Manufacturing Practice requirements. This development illustrates the importance of regulated production capacity, but it does not constitute a general authorization for every hospital to manufacture and administer personalized phage treatments.

The parliamentary amendment addresses a related but distinct issue: how to establish a clearer legal basis for hospital preparations and define the requirements that would govern their use.

What does amendment No. 2783 propose?

The amendment seeks to clarify the circumstances in which an existing pharmaceutical specialty should not be considered suitable for a patient's clinical situation. In the context of bacteriophages, the suitability of a treatment would be assessed in particular in relation to the specificity of the phages and their activity against the bacterial strain isolated from the patient.

This provision reflects an important feature of phage therapy. The existence of an authorized medicine does not necessarily mean that it will be effective against the specific bacterium causing an individual infection. Where a phage's activity depends on the characteristics of a bacterial isolate, treatment selection cannot always follow the same logic as the prescription of a conventional medicine.

The proposed clarification should not, however, be interpreted as an unrestricted exemption from pharmaceutical regulation. It would establish a criterion for assessing whether an existing medicine is suitable; it would not automatically authorize any hospital to prepare or administer a bacteriophage product.

The amendment also provides for specific requirements governing hospital preparations containing bacteriophages. These requirements would be defined through a decree issued after consultation with the Conseil d'État. The proposed framework addresses the selection and characterization of phages, production, quality control, traceability, pharmacovigilance and the possibility of pooling resources between healthcare establishments.

Such provisions could help clarify responsibilities at different stages of the process. Phage selection and characterization are needed to establish which viruses are being used and whether they are appropriate for the targeted bacterium. Production and quality control are necessary to ensure that preparations meet defined standards, while traceability allows a preparation to be linked to its production history and clinical use. Pharmacovigilance, meanwhile, is essential for identifying and investigating potential adverse effects.

The proposed arrangements for cooperation between hospitals could also be significant. Not every healthcare establishment will have the technical facilities, specialist personnel or production capacity required to prepare bacteriophages. Cooperation could make it possible to concentrate some of these capabilities in specialized centres and improve coordination between institutions.

Nevertheless, the amendment does not itself establish a nationwide phage production network. The precise requirements, responsibilities and operational procedures would depend on the final legal text and any implementing regulations.

A proposed financial incentive for healthcare establishments

The amendment includes a financial measure intended to support hospitals involved in preparing bacteriophage-based medicines. It proposes a reduction in the taxe sur les salaires for eligible healthcare establishments, with the amount and implementation arrangements to be determined by decree. A compensatory mechanism involving an additional tax on tobacco excise is also provided for in the proposal.

The measure reflects the fact that developing hospital-based phage preparation capacity requires more than a legal authorization. Facilities need suitable equipment, trained personnel, validated procedures and systems for quality control and documentation. These requirements can represent a substantial financial burden, particularly when preparations are produced for a limited number of patients rather than through large-scale commercial manufacturing.

A tax reduction could help offset part of these costs for eligible institutions. Its actual impact, however, would depend on the amount of the reduction, the establishments covered and the resources required to maintain compliant production. The proposal does not guarantee that every hospital would receive sufficient funding to establish or sustain a phage preparation service.

Nor would a financial incentive alone resolve all the barriers to access. Patients would still need clinical assessment, microbiological testing, identification of an appropriate phage and access to a preparation that meets the relevant quality requirements.

The debate reveals concerns about implementation

The parliamentary discussion highlighted questions about the legal drafting and practical implications of the amendment. Thibault Bazin, speaking on behalf of the commission's position during the session, raised concerns about whether the proposal would effectively facilitate access to treatment, whether the criterion used to determine the suitability of existing medicines was sufficiently precise, and whether the proposed tax reduction was framed appropriately.

One concern was that a legal criterion designed for bacteriophage preparations could potentially have implications beyond phage therapy if its wording were interpreted too broadly. Another related to the delegation of details concerning the tax reduction to a future decree.

These objections concern the construction and implementation of the proposed measure. They do not establish that phage therapy lacks clinical value, but they underline the importance of defining the scope of any regulatory exception clearly and ensuring that its application remains compatible with pharmaceutical quality and patient safety.

The divided vote also demonstrates that adoption of the amendment should not be interpreted as a resolution of all the legal and financial questions surrounding hospital-prepared phages. Those questions will need to be addressed as the legislative process continues.

What could change for patients?

If provisions of this kind are ultimately enacted and implemented, they could help clarify the circumstances in which hospitals may prepare personalized bacteriophage treatments and the requirements governing those preparations.

A clearer framework could support the development of specialized hospital services, facilitate cooperation between institutions and establish more explicit requirements for the selection, production and monitoring of phage preparations. The proposed financial incentive could also contribute to the sustainability of some hospital-based activities.

For patients with complex infections, these developments could be relevant. Personalized phage therapy is particularly interesting in situations where available antibiotics provide insufficient benefit or where a bacterial isolate is susceptible to a phage that can be selected and prepared for clinical use. A more predictable regulatory framework could help institutions organize the practical steps required to make such treatments available.

However, a clearer legal framework would not mean immediate or universal access to phage therapy. The availability of treatment would continue to depend on the patient's clinical circumstances, the identification of an appropriate bacterium and phage, the ability to produce a suitable preparation, and the capacity of healthcare teams to administer and monitor treatment.

The amendment would also not establish the clinical efficacy of phage therapy for every infection. Regulatory provisions governing access and preparation are distinct from the evidence required to determine whether a treatment is safe and effective in a particular indication.

Personalized hospital preparations must also be distinguished from standardized phage products developed for broader use. The two approaches may complement one another, but they involve different manufacturing and clinical-development pathways. A framework for hospital preparations would not, on its own, resolve the wider challenges involved in developing standardized products and generating robust clinical evidence.

A broader proposal for public development of phage therapy

Amendment No. 2783 is related to a separate legislative initiative: bill No. 3077, entitled A bill to guarantee the public development of phage therapy to combat antimicrobial resistance. Introduced on July 23, 2026, by Hendrik Davi and other members of parliament, the proposal was referred to the National Assembly's Social Affairs Committee.

The bill takes a broader approach to the development of phage therapy in France. In addition to provisions concerning hospital preparations, it proposes a public support fund for the infrastructure required to develop, produce, control and distribute phage preparations, as well as to establish and maintain public phage banks. It also provides for a report to Parliament assessing implementation, access, production capacity, quality and clinical use.

These proposals address a structural challenge that extends beyond the legal status of individual preparations. Even if hospitals have a clearer basis for preparing phages, sustained access will depend on the availability of production facilities, specialist expertise, testing capabilities and funding.

The two initiatives must nevertheless be kept separate. The adoption of amendment No. 2783 did not amount to the adoption of bill No. 3077, and the broader proposal follows its own legislative path. Whether either initiative leads to new legal obligations or funding arrangements will depend on the subsequent parliamentary process and the final texts adopted.

What happens next?

The next stage is to determine how the PLFSS 2027 proceeds through Parliament following its rejection by the National Assembly at first reading. The amendment's provisions will need to be considered within the subsequent legislative process before they can become legally operative. If the relevant measures are ultimately enacted, the implementing decree will be important in defining the practical requirements for hospital preparations.

The separate bill No. 3077 provides another possible route for pursuing a public framework for phage therapy, including measures concerning infrastructure and public phage banks. Its progress will need to be followed independently of the PLFSS amendment.

For now, the October 23 vote should be understood as a parliamentary development rather than a change already in force. It has brought hospital-prepared bacteriophages further into the legislative debate, but it has not yet resolved the regulatory, financial and organizational questions surrounding access to personalized phage therapy in France.

Conclusion

The adoption of amendment No. 2783 marks a concrete development in the French debate over hospital-prepared bacteriophage treatments. The proposal addresses the suitability of existing medicines, the regulatory requirements for hospital preparations and a potential financial incentive for participating healthcare establishments.

If ultimately enacted, these provisions could help clarify how personalized phage preparations are produced and managed in clinical practice. Their practical impact would nevertheless depend on the final legislation, implementing rules, hospital capacity and sustainable funding.

The essential distinction is between the adoption of a parliamentary amendment and the establishment of an operational legal framework. The vote on October 23 achieved the former, but the latter remains to be determined.

For France's phage therapy community, the subsequent legislative stages will be crucial in determining whether this initiative contributes to a more coordinated and sustainable system for developing and delivering bacteriophage treatments to patients.

Sources: The analysis is based on the National Assembly's official public vote No. 9074, the text of bill No. 3077, the Senate's PLFSS 2027 legislative dossier, and the Hospices Civils de Lyon announcement concerning authorized therapeutic phage manufacturing.