The need for incentives and concerted, collective, commitment to fight against AMR
As Member States representatives meet in Bucharest to discuss next steps towards making the EU a best practice region in combatting AMR, EFPIA reaffirms its commitment to be a part of that fight
Scientific advances in medicines, diagnostics, imaging, devices, surgery, genomics and data science have led to high expectations around our own health and healthcare more broadly. Life expectancy in Europe has increased by around a decade over the last 50 years. Across the board, from c-sections to routine surgeries, hospital admissions to vaccine preventable diseases, in general, we expect to get better through interventions or even to avoid getting ill in the first place.
While as an industry we continue investing in research and development to deliver the new medicines of tomorrow and make progress in the fight against disease, anti-microbial resistance (AMR) looms large as a significant threat to global health progress.
There is wide-recognition of the serious threat posed by AMR. The projections are both stark and deeply concerning. A failure to address AMR could result in an estimated 10 million deaths worldwide by 2050. Across Europe, an estimated 33,000 people die each year as a result of hospital infections caused by resistant bacteria such as Escherichia coli (E. coli), Klebsiella pneumoniae (K.Pneumoniae), Enterococcus faecium, Pseudomonas aeruginosa and Methicillin-resistant Staphylococcus aureus (MRSA).
Like many significant healthcare challenges, no single actor has the answer and no one can address the challenge alone. Wide-ranging collaboration is needed from governments, the human and animal health industries, healthcare professionals, patients, farmers and environmental experts to tackle AMR. It is only through concerted action across all sectors and stakeholders that ultimately we will find effective solutions. In other words, taking a “One Health” approach recognised by the European Commission in its 2017 EU One Health Action plan against AMR.
Action plans need to encompass infection prevention, appropriate use, surveillance, the environmental dimension, and also crucially to address the need for novel economic models and incentives to boost both research and development of new antibiotics and vaccines targeting resistant pathogens. Indeed, what remains largely unaddressed and what is needed most are incentives that provide a competitive return on investment to incentivise pharmaceutical companies to take on the necessary risk and uncertainty that comes with the development of new antibiotics, due to the very specific life cycle of these medicines.
A robust suite of incentives across the lifecycle of novel antibiotics and vaccines can stimulate R&D investment, an approach recognised by both public and private sector leaders in the G20 declaration. Industry supports the 2018 European Parliament own initiative report, calling for a legislative framework to promote sustainable investment in new antimicrobials, which includes:
- Push incentives, aimed to de-risk early research, such as research grants, tax credits, or public–private partnerships collaborating on R&D, like IMI
- Pull incentives, which reward successful delivery of new solutions against AMR thus making the investment more attractive; examples of these could be transferrable exclusivity extensions (TEE) or market entry rewards (MER)
- HTA and reimbursement reforms, aimed to better capture the societal value of antibiotics and enable their appropriate access
Because the current economic model makes it unattractive to innovators and investors to take on the necessary risk and uncertainty that comes with the development of new antibiotics and vaccines, we need to think differently. A suite of incentives needs to be put in place to support sustainable investment in antimicrobial R&D. To have a meaningful impact on the pipeline of new products, these incentives – push and pull – should be designed to stimulate R&D across the full R&D lifecycle, from discovery through development. As part of this suite of incentives, EFPIA believes that there is an urgent need for novel pull incentives that would create supportive market conditions for development of innovative products.
Our industry’s commitment to tackling AMR is embodied in the Davos Declaration of January 2016, and the subsequent Industry Roadmap from September 2016, which lay out proactive actions and commitments EFPIA members are taking to support regarding: access and ensure appropriate use of our medicines and diagnostics, reduce the development of antimicrobial resistance, as well as invest in research and development to meet public health needs. We are developing concrete metrics and working on meeting these commitments through the AMR Industry Alliance, where we are partnering with generic and diagnostic companies to support a comprehensive approach and measure industry’s progress to curb AMR. It is only through concerted action across all sectors and stakeholders that we ultimately will find effective solutions.
 Alessandro Cassini, MD et al., “Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis”, The Lancet, Volume 19, Issue 1, P56-66, January 1, 2019, https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(18)30605-4/fulltext.