The role of drug regulatory authorities and health technology assessment agencies in shaping incentives for antibiotic R&D: a qualitative study

Abstract

Background

Few antibiotics have entered the market in recent years despite the need for new treatment options. Some of the challenges of bringing new antibiotics to market are linked to the marketing authorization and health technology assessment (HTA) processes. Research shows great variation in geographic availability of new antibiotics, suggesting that market introduction of new antibiotics is unpredictable. We aimed to investigate regulatory authorities’ and HTA agencies’ role in developing non-financial incentives to stimulate antibiotic research and development (R&D).

Methods

We conducted individual, semi-structured, stakeholder interviews. Participants were recruited from regulatory authorities (EMA and FDA) and HTA agencies in Europe. Participants had to be experienced with assessment of antibiotics. The data were analyzed using a deductive and inductive approach to develop codes and identify key themes. Data were analyzed using thematic analysis including the constant comparison method to define concepts, and rival thinking to identify alternative explanations.

Results

We found that (1) interpretation of key concepts guiding the understanding of what type of antibiotics are needed vary (2) lack of a shared approach on how to deal with limited clinical data in the marketing authorization and HTA processes is causing barriers to getting new antibiotics to market (3) necessary adaptations to the marketing authorization process causes uncertainties that transmit to other key stakeholders involved in delivering antibiotics to patients.

Conclusions

A shared understanding of limited clinical data and how to deal with this issue is needed amongst stakeholders involved in antibiotic R&D, marketing authorization, and market introduction to ensure antibiotics reach the market before resistance levels are out of control. Regulatory authorities and HTA agencies could play an active role in aligning the view of what constitutes an unmet medical need, and direct new economic models towards stimulating greater diversity in the antibiotic armamentarium.

Keywords:

• Regulatory authorities
• Marketing authorization
• HTA
• Antibiotics
• Antibiotic R&D
• Novelty
• Public health need
• Unmet medical need

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1186/s40545-023-00556-x.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1186/s40545-023-00556-x.

Acknowledgements

We would like to thank the participants of this study, as well as people who shared information about antibiotic assessment during the recruitment process. Reflexivity analysis: CK works as a clinical doctor at the urgent care centre in Oslo. She is currently doing a PhD at the Norwegian Institute of Public Health (NIPH), supervised by HSB. Her work focuses on market introduction of antibiotics. HSB has a background and PhD in clinical pharmacy and pharmacotherapy. She currently works as a senior researcher at NIPH and professor at the University of Oslo (UiO). Her work primarily focuses on drug statistics, antibiotic use, and antibiotic classification. LM has a background in clinical pharmacy and pharmacotherapy and has worked at the Norwegian medicines agency and functioned as a clinical assessor, alternate member of CHMP, and member of the Infectious Disease Working Party at the EMA. She currently works as an associate professor at the section for pharmacology and pharmaceutical biosciences at the UiO. UG has a background and PhD in clinical medicine. He currently works as a senior researcher at the department for global health at the NIPH primarily conducting research on health policy and global health governance, including R&D and access to medicines.

Author contributions

CK, HSB, LM designed the study and developed the interview guide. CK sent out the invitation to participate in the study based on lists of potential participants discussed within the research group. CK conducted the primary analyzes. UG supported the process by overseeing the use of method and by giving guidance. HSB and LM conducted a secondary independent analyzes. Finding were discussed within the research group. CK drafted the article. HSB, LM and UG commented on the draft and contributed to the writing. All authors read and approved the final manuscript.

Funding

Open access fee was covered by a membership agreement the Norwegian Institute of Public Health (NIPH) have with BioMed Central. This research is part of the PhD program at the Faculty of Medicine at the University of Oslo, conducted at the NIPH within the project DRIVE-AB. DRIVE-AB was supported by the IMI Joint Undertaking under the DRIVE-AB grant agreement number 115618, the resources of which are composed of financial contribution from the European Union’s 7th Framework Programme and the European Federation of Pharmaceutical Industries and Associations companies’ in-kind contribution. The funding organizations did not participate in design of the study, collection, analysis, interpretation of data, or in writing the final article.

Declarations

Ethics approval and consent to participate

This research proposal was submitted to the Norwegian Centre for Research Data (NSD), and the Norwegian Regional Committees for medical and health research ethics (REC) was approached, but the research was not considered in need of approval. Written or oral consent to participate in the study, including whether the participant was comfortable with the interview being audiotaped, was obtained before the interview from all participants.

Competing interests

The authors declare that they do not have any competing interests.

Supplementary Information

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