Antimicrobial resistance: National strategies key, says EU Parliament
The European Parliament adopted its recommendations for the the EU’s response to antimicrobial resistance (AMR) on Thursday (1 June), calling for national strategies and boosting innovation.
The resolution calls for the prudent use of antibiotics for humans and animals, good infection prevention and control measures, and more research and development into novel antimicrobials and alternatives to antimicrobials.
Misuse and overuse of antibiotics in recent years have led some microorganisms, also called superbugs, to develop AMR, meaning that medicines become less effective and infections persist in the body, increasing the risk of spreading to others.
“The use of antibiotics must further be reduced, both in human prescription and also in animal health, where we can so that this life-saving medicine can still be kept in a useful form and not lose its effectiveness,” said Socialist MEP Tiemo Wölken during a debate with Health Commissioner Stella Kyriakides on Thursday.
While parliamentarians agree with the Commission’s proposed target of reducing total human consumption of antibiotics in the EU by 20% by 2030, they insist that national measures must also ensure that at least 70% of antibiotics consumed belong to the “access group” as defined in the WHO’s AWaRe classification.
“It’s important that we strengthen the One Health approach which ensures that we see health as a complete package from the environment, human health and animal health that is of central importance,” Wölken said.
Parliament wants to see ‘National Action Plans’ against AMR, as a priority for member states’ national health systems that would be updated at least every two years.
Additionally, MEPs want to improve data collection, including real-time data, both on AMR and antimicrobial consumption. They also ask the Commission to establish an EU-level database, according to the Parliament’s press release.
While lowering the use of antibiotics is part of the solution, on the other hand, the need for antibiotics research is also highlighted.
“We mustn’t close our eyes to the fact that in the current use of antibiotics, we’ve gone down a blind alley. We need a different means of treatment, [we need] to ensure that we have ongoing antibiotics research in the EU,” Wölken stressed.
EU to test disputed incentive scheme to develop novel antibiotics
The revamp of the bloc’s regulatory framework for pharmaceuticals, presented by the European Commission on Wednesday (26 April), features a new and somewhat controversial system of incentives to promote the development of new antimicrobials.
Commission’s take on novel antibiotics
Kyriakides agreed, emphasising that reducing the use of antimicrobials has an impact on sales volumes and on the return on investment for marketing authorisation holders.
“This is responsible for the current market failure and the lack of new antimicrobials,” she told EU lawmakers.
As the last novel antimicrobials came onto the market in the 1980s, she said that the EU needs to bring innovation urgently.
This problem is addressed in the Commission’s Council recommendations on AMR that came together with the proposed reform of pharmaceutical legislation.
“We’re using push incentives by research and innovation funding and pull incentives to reward successful development and secure access to effective antimicrobials,” Kyriakides said.
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”.
In practice, 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.
Although backed by the industry, the system is also contested by some stakeholders, including the EU’s consumer association BEUC, which recently warned in a policy paper that vouchers were “a big mistake” that would end up harming patients and markets.
These vouchers would give developers of a new antibiotic the possibility to extend its exclusivity period on another medicine of its choice, undermining the reform’s other gains, BEUC director general Monique Goyens said after the presentation.
The Commission is ensuring 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 said.