Limited innovation and profitability driving slow motion AMR crisis, Piot calls for action [Advocacy Lab Content]

Professor Peter Piot, Belgium’s special advisor to European Commission president Ursula von der Leyen for European and Global Health Security, has called antimicrobial resistance (AMR) a crisis already underway and gaining importance.

Piot was speaking at the recent High-Level Conference on the Future EU Health Union organised by the Belgian Presidency, “AMR causes one million deaths annually, and we must address it,” he said. At the conference, biopharmaceutical company Pfizer warned that a continued rise in AMR could lead to 10 million deaths annually across the globe by 2050.

In Belgium, the effects of antibiotic resistance are also increasingly felt. According to Sciensano, 7% of hospitalised patients are infected with resistant bacteria. This alone leads to some 2,600 deaths per year, Pharma.be told Euractiv.

“As pharma.be, we ask Belgium to join in the effort to provide better ‘pull incentives’ for the development of new antibiotics at the European level. This is the only way to make complex development more feasible and win the battle against antibiotic resistance in the long run.”

Former Belgian Health Minister Maggie De Block, an advocate for addressing AMR, echoed the urgency of action to Euractiv. “Given the high rates of AMR in EU countries, there is a need for more incentives for research into new antibiotics or alternative methods, such as bacteriophage therapy. This research should aim to bring new antibiotics or alternatives to the patient,” she explained.

The imperative of innovation

The recent Call-to-Action by the AMR Industry Alliance, released ahead of the upcoming UN High-level Meeting on Antimicrobial Resistance in September 2024, underscores the gravity of the situation, highlighting why the urgency of addressing AMR cannot be overstated.

Despite the critical need for novel antimicrobial solutions, their development has experienced a concerning decline. Only one new antimicrobial has gained approval annually since the early 1990s.

Due to the low profitability of the antibiotics market, the pharmaceutical industry faces challenges in developing new antibiotics and maintaining existing ones on the market, the Federal Agency for Medicines and Health Products (FAMHP) told Euractiv.

“To reverse this trend, it is essential to implement incentive measures aimed at stimulating investments in the pharmaceutical industry. The FAMHP has set the goal of studying existing economic models and exploring various possible economic incentives worldwide. This expertise enables decision-makers to assess their feasibility for Belgium,” a spokesperson said.

Urgent push incentive to fund clinical trials

In 2022, cancer treatments secured 2,388 patents, while antimicrobials only managed 115, underscoring a significant innovation gap. The oncology pipeline boasts over 2,000 products, while antimicrobial development struggles with just 80.

The World Health Organization acknowledges the inadequacy of recent antibiotics against resistance, but a promising preclinical pipeline offers hope globally. However, transitioning these innovations into clinical trials requires immediate push incentives.

Europe leads in antimicrobial innovation with 52% of preclinical developments, followed by the Americas at 35%. Despite this, financial obstacles persist, as seen in Belgium’s Aelin Therapeutics’ struggles to fund MRSA antibiotics. Urgent action is vital to advance critical antimicrobial research.

Multidrug-resistant infections

Pfizer has been noted for its steadfast commitment to combating AMR, while some other companies have retreated. On 22 March the company received a positive CHMP Opinion for its antibiotic combination for the treatment of patients with multidrug-resistant infections and limited treatment options.

A Pfizer spokesperson told Euractiv: “The recent positive CHMP opinion for Pfizer’s novel antibiotic combination is a positive step for patients with Gram-negative infections resistant to nearly all available antibiotics and demonstrates Pfizer’s commitment to helping address the global public health threat of antimicrobial resistance.”

Pfizer recognises there is an urgent need for new and novel antimicrobials right now, but financially sustainable R&D has been a challenge across the industry.

A spokesperson commented: “There is broad agreement that multifaceted solutions like public-private partnerships are needed to reinvigorate antimicrobial development and ensure long-term market sustainability. Without reform and additional R&D, our ability to fight AMR is severely limited.”

How to incentivise R&D of novel antimicrobials

The European Union is actively seeking effective incentives to drive the research and development (R&D) of novel antimicrobials, particularly given the revisions to the general pharmaceutical legislation that emphasises the significance of combating AMR.

On 19 March, the European Parliament’s ENVI Committee adopted a set of 100 compromise amendments to the European Commission’s comprehensive revision of the EU pharmaceutical legislation.

The Commission’s proposal to implement a Transferable Exclusivity Voucher (TEV) remains intact, albeit with more stringent conditions and shorter durations. This voucher would extend regulatory data protection for successful products, serving as a funding source for new antimicrobials. Additionally, it complements ‘milestone payments’ and a subscription model for joint procurement.

Strengthening the TEV mechanism

Pharma legislation expert Antoine Mialhe, Senior Managing Director, Healthcare & Life Sciences at Brussels-based FTI Consulting, raises concerns regarding the feasibility of alternative models. “TEV is the most credible option to significantly boost R&D investment in late-stage clinical trials. Alternative models could work but will require strong financial commitments from Member States,” Mialhe told Euractiv.

He questions whether in the current economic context, where pressure on budget spending and austerity measures are being increasingly adopted, that Member States will agree and contribute financially to funding large-scale trials.

Mialhe stresses that policymakers hold an important responsibility to ensure we are prepared to tackle that risk appropriately.

[By Nicole Verbeek, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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