The current development of new antibacterial treatments is inadequate to address the increasing burden of antibiotic resistance and meet global needs, as recently described by the World Health Organization (WHO) in its most recent annual antibiotic pipeline report.
The European Commission aims to address the problem by setting up incentives for the development of new antibiotics, including through the current revision of the EU pharmaceutical legislation.
Concerns for limited options of incentives
In a joint publication, ReAct Europe and the European Public Health Alliance (EPHA) express concerns as only a limited number of options for introducing such incentives have been considered during the European Commission targeted consultations.
One of the options that risk being included in the proposed revision to the legislation are so called “Transferable Exclusivity Extension” (TEE).
A TEE would allow a company that brings a new antimicrobial agent to the market the right to extend the exclusivity period for another product or sell these rights to another company. This approach may be appealing to EU policymakers, as it does not require any payments upfront.
However, as outlined in the joint ReAct Europe-EPHA paper, a wide range of evidence by academics and expert studies indicate against pursuing such a policy instrument, summarized in the following 10 reasons:
10 reasons why a TEE is not efficient for advancing antibiotic development
1. It will create additional excessive social costs, which will directly affect European patients and national payers.
2. It is ethically questionable as one therapeutic area will be subsidized at the expense of another
3. It presents significant risks of overcompensation and disproportional reward for drug developers.
4. It will cause additional problems of predictability of financing for EU healthcare systems.
5. It would primarily favour large companies and only secondarily small and medium enterprises (SMEs).
6. It risks allowing a weak link between the value of innovation and its rewards
7. It does not ensure patients’ access to the new antibiotic brought to market
8. It does not consider the availability of viable compounds in the pipeline in early discovery and development to actually “pull” from.
9. It does not inherently ensure obligations of stewardship and appropriate use and would require that conditions and compliance stipulations be attached to the voucher to ensure appropriate use.
10. It will set a bad precedent and can lead to huge social costs outside of the EU.
Call on the European Commission
Together with other organizations endorsing the paper, ReAct Europe and EPHA call on the European Commission to ensure that the benefits of such incentives outweigh the potential costs, while incorporating conditions that address issues of equitable access, affordability, stewardship, and appropriate use of these newer agents.
Failure in bringing new antibiotics to the market calls for an EU coordinated approach
The complex failure in bringing new antibiotics to the market calls for an EU coordinated approach in addressing the problem from the beginning to the end of the R&D process, by pursuing more comprehensive solutions. Other recently EU-funded projects have identified the use of milestone prizes and the role of the EU HERA as a “pipeline coordinator” to shape and speed up the development of new antibiotics as examples of more efficient alternatives.
Read full paper
ReAct Europe EPHA joint position paper: Antibiotic incentives in the revision of the EU Pharmaceutical legislation (900 kB, PDF)
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ReAct report: Governments need to take more leadership to ensure global sustainable access to effective antibiotics
While the world is caught up in responding to the COVID-19 pandemic, it has gone largely unnoticed that more than thirty years has passed since the last class of antibiotics was discovered. Meanwhile global consumption of antibiotics continues to increase. In response, bacteria have developed resistance and are spreading as a silent but steady pandemic threatening to devastate healthcare and modern medicine as we know it.
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