The World Health Organization (WHO) is implementing a 3-year project to assist France in addressing the challenge of shortages and lack of availability of off-patent antibiotics in human and animal care.
The project seeks to identify the root causes of shortages and the lack of availability of off-patent antibiotics in France and to suggest effective countermeasures from a One Health perspective (in humans and animals, while taking into account the environment).
The project is funded by the European Union via the Technical Support Instrument and implemented by WHO in cooperation with the European Commission/European Commission’s Directorate General for Reform Support (DG REFORM).
Context
The lack of availability of essential medicines is an increasing concern in France and globally. COVID-19 pandemic exacerbated medicine shortages (supply chain disruptions). Lack of availability may be due either to shortages or to the absence/discontinuation of medicine from the marketing of the.
Antibiotics, one of the pillars of modern medicine, are also particularly affected by supply chain disruptions. In France, the number of alerts for drug shortages notified in human medicine to the French drug agency (ANSM) increased 20-fold in 10 years (2008–2018). Anti-infectives, including antibiotics, are one of the three therapeutic classes that are the most affected by supply chain disruptions and represent 21% of all reported drugs shortages in France.
In addition to shortages, certain off-patent antibiotics face a long-term lack of availability because they are not marketed or are not marketed anymore.
In the veterinary sector, safeguarding the availability of established veterinary antibiotics is crucial as very few or no new antibiotics will be developed for use in veterinary medicine.
The phenomenon of increased shortages is due to multiple factors, including economic viability, the complexity of the production and supply chain and regulatory issues.
The lack of availability of essential antibiotics has serious consequences for public health: human and animal health care professionals are forced to use alternatives outside the recommendations in treatment guidelines. This can lead to suboptimal treatment, courses compromising clinical outcomes and increasing the risk of antibiotic resistance. Extensive use of such alternatives treatments may create new shortages and lead to increased healthcare costs.
Project Description
To address the challenge of increasing shortages and lack of availability of essential antibiotics, in 2020 the French Government (including five ministries and two national drug agencies) requested support from the Directorate-General for Structural Reform Support (DG REFORM) of the European Commission to identify appropriate countermeasures, using the Technical Support Instrument.
The project aims to address the root causes of the recurrent shortages and lack of availability on the market of off-patent antibiotics in France in humans and animals and identify effective countermeasures.
To reach this goal, the Action builds on the following components:
- improving knowledge and awareness of factors leading to shortages and lack of availability of off-patent antibiotics in the human and veterinary sector
- designing measures to address the root causes of shortages and lack of availability of off-patent antibiotics, and to share insights and lessons learned with stakeholders including those at the European level and
- providing support to implement the measures and to monitor and evaluate their implementation and impact.
For more information:
Contact points:
Valeria Gigante, Team lead (gigantev@who.int)
Jonathan Rodrigues, Project Manager (jrodrigues@who.int)
Action implementation
The implementation of the Action is organized in three steps:
Analysis of antibiotic shortages and lack of availability in human and veterinary medicine (Phase 1 – November 2020 to December 2021)
The Action reviewed quantitative data on shortages and lack of availability of antibiotic from the market. This allowed the identification of the root causes leading to disruptions in the supply chain and of key problems linked to the lack of availability in the human and veterinary health sectors. At the end of Phase 1, possible measures to tackle these root causes were suggested reviewing previous measures implemented in France and abroad and designing new tailored measures.
Identifying measures to mitigate shortages and lack of availability (Phase 2 – January to November 2022)
The most suitable measures for addressing the root causes of shortages in the human and veterinary health sectors in France were selected based on a decision framework designed within this project. In consultation with relevant stakeholders, a shortlist of possible measures to mitigate shortages and lack of antibiotic availability at the national and European level was established. The measures to be implemented in France will be decided by the relevant French authorities in the beginning of Phase 3 of the project.
Implementation and monitoring plan (Phase 3 – December 2022 to December 2023)
For the measures selected by the relevant French authorities, a monitoring and evaluation framework will be developed. The framework will enable the French authorities to take actions to implement the selected measures and to monitor and evaluate their implementation and impact. In close collaboration with relevant ministries and concerned stakeholders, WHO will monitor and evaluate the implementation of selected measures.
While this project focuses on shortages and lack of availability of antibiotics in France, some of the findings might be relevant and applicable to other European countries. The outputs of this project will therefore be shared with other Members States of the European Union.