Antimicrobial resistance: EU health ministers approve recommendation

EU health ministers gave the go-ahead to the European Commission’s recommendation to step up EU action to combat antimicrobial resistance (AMR), also welcoming its One Health approach.

The aim of the recommendation, formally approved on Tuesday (13 June), is to encourage the prudent use of antimicrobials – such as antibiotics in human and animal health – to reduce the risks that microorganisms will become resistant to medical intervention.

Misuse and overuse of antibiotics in recent years have led some microorganisms, also called superbugs, to develop antimicrobial resistance, meaning that medicines become less effective and infections persist in the body, increasing the risk of spreading to others.

This antimicrobial resistance is sometimes referred to as a ‘silent pandemic’.

The World Health Organisation (WHO) estimated that some 4.9 million deaths annually are associated with antimicrobial resistance. In the EU alone, AMR  is responsible for 35,000 deaths every year.

One Health approach

During the gathering of EU-27 health ministers, EU health Commissioner Stella Kyriakides recognised the importance of taking ambitious action to combat AMR taking a One Health approach.

“We need to have a global picture where AMR is concerned and we need to tackle this across the world and cannot be limited to just our continent,” she added.

For Sweden’s health minister Jacob Forssmed, this proposal has been a priority of the current Swedish presidency of the EU Council since it was presented in April.

The Council’s recommendation sets out concrete targets at the EU level for antimicrobial consumption and resistance in human health, including a 20% reduction in total human consumption of antibiotics by 2030.

Some of the other measures are to implement better surveillance at all levels, including hospitals and long-term care facilities, to strengthen infection prevention and control, as well as improve awareness among the public and professionals through training and communication campaigns.

Rapid EU work

Commissioner Kyriakides welcomed the agreement on an issue that is “at the heart of the European citizens” and recognised the work of the different EU institutions.

“The speed of adoption of this text shows that we are all on the same page,” said Kyriakides referring to the fact that the European Parliament adopted the same recommendation less than two weeks ago (1 June).

MEPs also stressed that robust National Action Plans in fighting AMR should be a priority for member states’ national health systems.

EU health ministers especially welcomed the plan to strengthen national action on AMR and the One Health approach of the recommendation which highlights the link between human health, animal health, and the environment.

“It’s only by having such an approach that we can effectively deal with the whole problem of antimicrobial resistance,” said Manuel Pizarro, Portugal’s health minister.

Chris Fearne, minister of health for Malta, agreed that bringing animal, plant and environmental health into national action plans is an important recommendation, as well as setting specific targets also in this field.

AMR in the new pharmaceutical legislation

In its revamp of the bloc’s regulatory framework for pharmaceuticals, the Commission proposed a 15-year trial of a ‘transferable data exclusivity voucher scheme’ for novel antibiotics to incentivise their developers, which Kyriakides called “possibly a world-pioneering measure”. 

The 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.

“We’re the first regulators to go down this road,” said EU’s health chief Stella Kyriakides when presenting the measures, adding that the Commission had to think out of the box and “be a little bit innovative to solve a problem that has been out there for the last number of years”.

The controversial aspect of the scheme is that it will transfer the costs of the vouchers to member states’ health systems, as it will delay the market entry of generics of products covered by the vouchers.

The Commission ensured that these will be granted under extremely strict conditions “to minimise the cost to health systems and to ensure a fair return on investments to developers, often small SMEs,” Kyriakides told the ministers.


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