Antimicrobial resistance is the ‘silent’ pandemic: Globally, it costs 5 million lives a year, and is set to rise to more than 8 million lives lost a year by 2050. In the European Union alone, it is the cause of 35,000 deaths a year, and this number is also expected to increase. Decisive action is needed to avert this growing threat to public health.
A major challenge is that the current model for medicines development is not well suited to incentivising innovation on new antimicrobials. Because careful stewardship of antimicrobial medicines is necessary to combat the resistance challenge, sales of new antimicrobials must remain low, keeping likely return on investment insufficient to guarantee that companies will undertake the costly research and development needed. Of course, companies are turning huge profits with the sales of other medicines, but this is not necessarily re-invested in R&D guided by health priorities such as antimicrobial resistance.
The European Commission has proposed transferable data exclusivity vouchers in an attempt to incentivise antibiotic drug development. As we have already discussed, this plan has serious shortcomings. It proposes that, in exchange for the development of a ‘priority antimicrobial’, a company will receive a voucher that provides an extra year of market monopoly for a product authorised in the EU. The voucher would also be transferrable to another company. In practice, this means voucher recipients will likely seek to extend their market monopoly on high-priced medicines, keeping prices high and adding pressure on health care systems. For example, a Medicines for Europe note on transferrable exclusivity vouchers looked at what an additional year of exclusivity might cost EU healthcare systems for some blockbuster medicines: For rheumatoid arthritis treatment adalimumab (Humira), they estimated €1 billion in lost savings; for breast cancer medicine trastuzumab (Herceptin), €600 million; and for monoclonal antibody rituximab (MabThera), €333 million.
The transferable exclusivity voucher proposal therefore shifts the burden for the development of new antibiotics onto the shoulders of a random group of patients. Whether such a scheme would actually incentivise needed R&D on novel new antimicrobials is unclear, as pointed out in a Lancet commentary. There are better ways to solve the crisis in new antibiotic drug development.
A more workable solution was proposed in December 2024, endorsed by the Alliance for Reducing Antimicrobial Resistance (ARMoR), the European Consumer Organisation (BEUC), Health Action International, Medicines Law & Policy, Salud por Derecho and Wemos. In a technical briefing note and a position paper, along with an infographic, the proposal lays out what the European Commission can do to create an ecosystem of push (in the form of support for R&D) and pull (in the form of guaranteed reward) incentives that would encourage the development of antimicrobials and ensure access to them where they are needed.
Among the incentive structures described are:
Support for R&D is needed to incentivise early stage and/or riskier (but potentially more innovative) research, to ‘push’ progress on new antimicrobials. Even before ‘pull’ incentives (see below) can start to take effect, there is a need for investment in pre-clinical research. Not-for-profit drug development partnerships, such as the Global Antibiotic Research and Development Partnership (GARDP) and the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), are important initiatives that should receive additional funding and support. Possible funding sources in the EU could include programmes such as Horizon and EU4Health.
Revenue guarantees that offer holders of valuable antimicrobials a minimum viable profit to incentivise investment in antimicrobial R&D. This ‘pull’ model falls under the concept of ‘delinking’ the cost of medicines development from the eventual sales revenue generated from the product. Revenue guarantees could be offered at different tiers, depending on the value add of the antimicrobial product, and would come with the condition that market authorisation holders would provide sustainable access to the products in all EU member states, including by securing necessary market authorisation.
Sweden has already established pilot programmes along this line of thinking; other countries – such as Australia, Canada, Japan, the US, and Switzerland have concluded that it is a promising approach. Following a successful pilot in the United Kingdom, the UK has now adopted this approach as its standard model for purchasing new antibiotics.
Coordination to ensure product applicability, in particular for priority pathogens. Other criteria – including medicines that can be used in children or viability for use in low- and middle-income countries – could be placed as conditions of eligibility for both push and pull incentive mechanisms. Networks that facilitate financial support and technical collaboration can also ensure that the eventual antimicrobials are fit-for-purpose.
A commitment to responsible stewardship of new antimicrobial products is also essential. This means both ensuring that new antimicrobials are used rationally, and that access to antimicrobials is equitable and affordable, including in low-and middle income countries. A commitment to technology, intellectual property and knowledge sharing could be made a commitment of eligibility to push/pull incentives. Global surveillance programmes can be used to monitor any resistance or other issues once a new antimicrobial has secured marketing authorisation.
This combination of incentives has a greater chance to spur the R&D needed on new antimicrobials because it directly targets the product profiles needed, and does so without risking keeping existing care for other diseases at high prices. The European Parliament should consider it.
Kaitlin Mara, MSc, has been writing about international intellectual property and innovation policy for a over 15 years.