Sustainable financing models to support the fight against antimicrobial resistance

Shyam Bishen, head of the Center for Health and Healthcare

The growing problem of antimicrobial resistance, or AMR, has been called a “silent pandemic,” a “slow-motion tsunami,” and one of the “top 10 global health threats to humanity in the 21st century.”

Antimicrobial resistance occurs when bacteria, viruses, fungi and others microbes no longer respond to the drugs (antibiotics, antivirals, antifungals) used to treat these. It is a natural process that occurs as the genetic makeup of pathogens changes over time, but is accelerated by the misuse and overuse of antimicrobials in the treatment of humans, animals and plants.

More than 80% of the global AMR deaths occur in developing countries and it leads to more deaths in the World Health Organization (WHO) African region. than anywhere else in the world.

AMR is envisaged by 2050 could kill as many as 10 million peoplewith the The global cost is estimated at $100 trillionAccording to Investor Action on AMR (IAAMR), this resulted in a 3.8% decline in global GDP.

AMR: The road to AVVN 79

On September 26, the The United Nations will convene a high-level AMR meeting.

This is the second time such a meeting has taken place at the UN General Assembly (UNGA). The first, in 2016, resulted in the adoption of a political declaration recognizing that “prevention and control of infections in humans and animals are key to combating AMR.”

Leading up to this, British economist Jim O’Neill assessed the global implications of AMR and recommended:incentives to develop new medicines, vaccines and diagnostics”. But the Wellcome Trust, which commissioned the report with the British government, says little progress has been made.

This remains a key component in tackling the AMR crisis and while some innovation has taken place, there are also challenges that need to be overcome. Emerging financing models will play an important role.

The dry antibiotic pipeline

Since 2017, only 13 new antibiotics have received marketing authorization, but only two of them represent a new chemical class and can be labeled as “innovative”. Usually it takes between It takes ten to fifteen years for new drugs to move from candidate stage to clinical trialsbut only two to three years before antibiotic resistance emerges.

In June 2024, the WHO report on antibacterial agents in clinical and preclinical development found that there is a “urgent need for new, innovative agents for serious infections and to replace those that become ineffective as a result of widespread use.”

There are several reasons for the lack of development of new antibiotics, but… market failure play a major role, with few incentives for the pharmaceutical industry, low sales volumes and uncertain returns on investment for investors.

The net present value (NPV) – the expected profitability of a drug development project – for one antibiotic development project is estimated at -$50 million, compared to $1.15 billion for a musculoskeletal drug.

The ‘discovery gap’ then began major pharmaceutical companies left the antibiotic market between 2000 and 2010, when they shifted focus to more profitable drugs against cancer and lifestyle diseases.

Nowadays it is mainly academic institutions and small and medium-sized enterprises (SMEs) that carry out these activities research into new antibiotics – but her they lack the resources and, increasingly, the expertise to commercialize the compounds through clinical trials.

Towards innovative financing models for antibiotics

This year’s UNGA high-level meeting is expected to end with the adoption of a action-oriented political declaration with a shared vision to accelerate progress.

Only 11% of countries have “set aside funding in their national budgets for the implementation of multi-sectoral solutions”. national action plans on antimicrobial resistance”, reads the statement, which includes a commitment to specific financing with the aim of achieving “at least 60% of the funded plans by 2030”.

The need to “explore, encourage and promote a range of innovative incentives and financing mechanisms for multisectoral health research and development to address antimicrobial resistance” is emphasized, with public-private partnerships at the heart of these efforts.

Over the past decade, several initiatives have been launched to stimulate antibiotic development, with the EU, the US and the UK leading the way. encourage financing efforts.

Although, as research shows, many of these initiatives have freed up vital funding for R&D focus on early stage financing for academic and research institutions, while SMEs equally need financing for clinical trial phases.

At the global level, organizations including CARB-X and the Global Partnership for Antibiotic Research and Development (GARDP) working to bridge the financing gap.

Combine pull and push stimuli

In June 2023, the European Observatory on Health Systems and Policies published a policy brief urging “a holistic package of incentives” to revive the antibiotic pipeline.

It recognized the success of push incentives, but called for the need to align them with pull incentives, such as financial rewards linked to R&D results, reimbursement reforms and regulatory changes, to “increase revenue and create viable markets for antibiotics”.

Addressing market drivers, improving returns on investment and supporting small and medium-sized enterprises would help align push and pull incentives, the letter said.

There are different pull financing models is used across Europe, from subscription payments and market access rewards to transferable exclusivity renewals and milestone payments, which guarantee subsidies at different stages.

In Britain, the government’s five-year action plan on antimicrobial resistance included a world-first pilot, rewarding companies fixed annual fee for antimicrobials based on an assessment of their value to the NHS.

Building on the success, NHS England is looking to establish a subscription model for antimicrobial products to offer a fixed annual fee contract; disconnected from the volume of the product used.

‘Delinkage’ is emerging as a promising model, according to ReAct – the Network for Action on Antibiotic Resistance, which can “afford the costs of research and development and eliminate the need to charge high prices or maximize sales volumes”.

Combining push and pull stimuli mix or hybrid financing models is widely regarded as the most effective way to accelerate the development and deployment of new antibiotics.

The political declaration on AMR concludes with the need to convene another high-level meeting in 2029 to review the implementation of the declaration.

2029 will mark a century since Fleming’s discovery of penicillin, but without coordinated global efforts, innovation and financing to end the AMR crisis now, all the progress he initiated could be reversed by 2030.