Antimicrobial resistance (AMR) poses a significant and growing threat to global public health, with the potential to render many of our most critical medical treatments ineffective. In the EU alone, every year more than 35,000 people die of resistant infections, with annual healthcare costs and productivity losses totalling a staggering €11.7bn to the economy. The cost of inaction of AMR is already too high, and the imperative to implement decisive actions could not be more urgent.
At the same time, developing new treatments to fight resistant infections is becoming increasingly difficult. The pipeline is incredibly thin, with only 32 traditional antibiotics in clinical development at present targeting the WHO list of priority pathogens. This is due to scientific, regulatory and especially economic challenges due to the well-known market failure in the antimicrobial space.
The biopharmaceutical industry and several other stakeholders over the years have been consistently calling for the implementation of a package of ‘push’ and ‘pull’ mechanisms to reinvigorate R&D in novel antimicrobials that effectively address AMR. There is now broad political consensus and commitment at European and global levels on this, including by the EU, the G7 and the United Nations.
Last year, as part of a broader legislative package to revise the EU pharmaceutical legislation, the European Commission proposed Transferable Exclusivity Vouchers (TEV) as a novel EU-level pull incentive. This would give companies that successfully bring a novel priority antimicrobial to market a transferable right to extend the regulatory data protection (RDP) period of another product. Companies could alternatively sell this right to another company, which in turn would apply the extension to a product in their portfolio.
Innovative biopharmaceutical companies, big and small, are united in support of TEV at EU level. Not only would TEV be a credible instrument that is easily implementable within the current EU legislative framework; it would also support appropriate use of antimicrobials as the incentive remains de-linked to sales volume. In addition, there is no need for upfront government funding, contrary to other models such as a lump sum market entry reward. Most importantly, the TEV is the only mechanism currently under discussion with the potential to generate an incentive of the adequate size and predictability to stimulate antimicrobial R&D.
However, due to the stringent eligibility criteria and limited applicability in the Commission proposal, the attractiveness of the EU-proposed voucher system is severely limited. Even with the support of much needed complementary access or reimbursement reforms, such as those implemented in the UK or Sweden, it is difficult to see how the EU could reach its “fair share” with such a weak voucher scheme.
Paradoxically, instead of strengthening the proposal to allow it to achieve its intended objectives, EU policymakers are currently discussing ways to erode the TEV mechanism even further, based on concerns around the unpredictability of its costs to health systems. Such erosions would risk delivering not just a weaker incentive, but an ineffective one. This is despite recent research from economic consultancy Charles River Associates (CRA) showing that the annual cost of AMR on existing European health systems is much higher than the proposed cost of implementing TEV; for example, it is twice as high in Belgium and almost eight times as high in Italy.
The revision of the EU pharmaceutical legislation represents a once-in-a-generation window of opportunity to implement an effective pull incentive for combating AMR in the EU. If designed correctly and backed by political ambition and courage, TEV can offer a practical, flexible, and financially attractive solution. The time is now for EU policymakers to show courage and leadership, and remain in a constructive dialogue with industry to better understand what is really needed to reinvigorate the antimicrobial pipeline for the benefit of patients and health systems. By doing so, they will take a crucial step towards safeguarding public health and ensuring the availability of effective treatments for future generations.