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AMR: Stability in research and development key, pharmaceutical industry warns

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While novel antibiotics are critically important in the fight against antimicrobial resistance (AMR), the lack of security and incentives is setting development back, the pharmaceutical industry warns.

Antimicrobial resistance – often called ‘the silent pandemic’ – is of increasing concern to health policymakers. In 2019, AMR directly caused the deaths of 1.2 million people worldwide, while contributing to an additional 4.95 million, according to a study published in the scientific journal The Lancet.

“It is happening now,” Christopher Fearne, Health Minister of Malta, said during a discussion at European Health Forum Gastein, urging lawmakers to not delay.

“Remember climate change a few years ago, when we used to say unless we do this or that, we’re going to see climate change, we are going to have devastating fires, and floods and heatwaves, well, it is here. And it is the same with AMR,” he said.

Antimicrobial resistance is caused by the misuse and overuse of antibiotics, which lead to some microorganisms, called superbugs, developing resistance to the medicines or antimicrobial agents that were originally effective at treating infections they cause. This makes it more difficult to treat infections and can pose serious health risks to individuals and populations.

In the EU only, 670,000 bacteria-resistant infections are registered annually, with 33,000 deaths as a direct consequence, the European Centre for Disease Prevention and Control (ECDC) reports.

Difficult landscape for pharmaceutical development

Developing new antibiotics provides alternative treatment options when existing ones become ineffective against resistant bacteria. However, stakeholders from the pharmaceutical industry warned of the difficult situation they face worldwide in the research and development of new antibiotics.

According to the Progress Report by the Global AMR R&D Hub & WHO, there is no viable market for novel antibiotics and the return on investment does not cover the costs of their development, manufacturing and distribution.

Kevin Outterson, executive director of CARB-X, a nonprofit organisation focused on supporting the development of new antibacterial products, explained the need for incentives to boost the investment.

He cited an article published in the Wall Street Journal which showed that all six US companies that gained approval from the Food and Drugs Administration (FDA) for new antibiotics since 2017 are now bankrupt, have been acquired at a very low price or are in the process of shutting down.

Pol Vandenbroucke, from the European branch of Shionogi, a Japanese pharmaceutical company working in the development of antibiotics, agreed on the need for incentives that guarantee sustainability in the long term and predictability for inversion.

“It’s very important for us to know that ten years from now, all the investments that we’ve made, all the failures that we’ve had, actually will be repaid in a significant way,” he added.

The tricky issue of incentives

Pharmaceutical R&D normally works with two types of incentives: push and pull. The first ones aim to support the process from the early stages such as basic science and clinical trials, not taking into account access to the market.

Pull incentives aim to create a market for new antibiotics by providing financial rewards or market advantages to companies that successfully develop and bring effective antibiotics to market.

Vandenbroucke from Shionogi stressed that both push and pull incentives must be complimentary, “both faces of what the solution should be”.

Outterson shares the same views. “if you looked at the preclinical pipeline [….] taking things that are coming out of universities, there’s really a tremendous amount of innovation,” he said. But he added that looking at the market, where pull incentives need to be used, “there’s not a lot of outstanding drugs in the pipeline”.

“If you want pull incentives to succeed, you need push incentives that are focused on investment in innovative things. And if you want to push incentives to succeed, we need those companies when they eventually get approval by EMA or FDA not to go bankrupt,” Outterson said.

A worrying lack of awareness

Together with the need for more financial investments, stakeholders stressed the importance of raising awareness.

Malta’s Fearne said that the lack of knowledge of the extent of the issue is worrying not only among the general public but also among lawmakers and stakeholders outside of health.

Fearne cited an OECD study that found that by 2035, for certain countries and for certain antibiotic bacterium pairs including some that are acquired in hospital settings, up to 90% of infections will be resistant.

“It’s been growing slowly and we kind of take it for granted that you go to a hospital and you are at risk of catching something,” added Anca Toma, executive director of the European Patients Forum (EPF).

Malta’s health chief said he regretted that in some cases, governments need public outcry to start taking visible measures and stop ignoring the problem. “We need to make sure that this is coming out and people are aware of it,” he added.

Fearne explained that currently, we are in between pandemics, “the calm between storms”, so it is the perfect time to have pandemic preparedness agreed and implemented.

EU’s strategy against AMR

At the European level, the Commission addressed the problem in the recommendations on AMR that came together with the proposed reform of pharmaceutical legislation.

Health Commissioner Stella Kyriakides explained in June this year that the proposed recommendation uses push and pull incentives to fund research and innovation, reward successful development and secure access to effective antimicrobials.

The proposed solution is a 15-year trial of a ‘transferable data exclusivity voucher scheme’ for novel antibiotics to incentivise their developers.

This voucher will grant an additional year of regulatory data protection to the developer of the novel antibiotics, which can either be used for one of its own products or sold to another marketing authorisation holder.

The Commission stressed that vouchers will be granted ‘under very strict and clear conditions’ pursuing the aim of rewarding innovation only on the exceptional novel antibiotics that will be eligible under the incentive system.

While the industry welcomes this idea member states seem sceptical about its implementation.

[Edited by Giedre Peseckyte/Nathalie Weatherald]

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