Debate: Coordinated action to address antimicrobial resistance
Date: THURSDAY, 1 JUNE 2023
Speaker: Stella Kyriakides
Language: EN

Many of us have been calling antimicrobial resistance the silent pandemic, and we are all aware that we can no longer say that it is silent. The pandemic has further highlighted the challenges we are facing with antimicrobial resistance, and we know that over 35 000 EU citizens every year lose their lives from antibiotic-resistant infections. And this is a number that is rising, because bacterial resistance is also rising, so we need to give it the highest priority. We need to take action that needs to be both ambitious and also urgent. We have proposed the reform of our pharmaceutical legislation and this came with a Council Recommendation on AMR to strengthen our response. And through the recommendation, we have asked Member States to ensure the prudent use of antimicrobials and that unused and expired antimicrobials are disposed of in a very safe way. We have put forward measurable EU national targets on antimicrobial consumption and resistance to be achieved by 2030. More prudent use measures are proposed in the legislation. For example, we have adequate pack size, we have plans and reporting of resistance to microbes, we have prescription status. So there is a great deal we need to do. And I want to say here that what we are trying to achieve can only be achieved if we have a toolbox of measures that is in place in order to fight AMR. On the veterinary side, the legislation on veterinary medicinal products and medicated feed will help to meet our farm to fork strategy targets of halving overall EU sales of antimicrobials used for farmed animals and agriculture by 2030. The recommendation invites Member States to implement infection prevention and control measures so that we curb the spread of antimicrobial resistant pathogens. And it calls particularly for stronger measures in healthcare settings and long-term care facilities. This is building on what we have learned during the pandemic of the situation that we saw in long-term care facilities and in healthcare settings. With EU funding support, Member States are encouraged to take measures to improve the health and the welfare of food-producing animals in order to decrease the spread of infectious diseases. And if we manage to do this, we will reduce the use of antimicrobials. However, reducing the use of antimicrobials has an impact on sales volumes and on the return of investment for marketing authorisation holders. And this is responsible for the current market failure and the lack of new antimicrobials. Let me just share with you that the last antimicrobials that came onto the market, the novel ones, were in the 1980s, so we clearly need to do something urgently to bring innovation in, to bring new antimicrobials into the market. And this is why we’re using push incentives by research and innovation funding and pull incentives to reward successful development and secure access to effective antimicrobials. And that is why we have proposed what is possibly a world pioneering measure: the transferable data exclusivity vouchers to develop new antimicrobials. To be clear, 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. We have also presented procurement mechanisms for access to new and existing antimicrobials, and this would guarantee revenue for marketing authorisation holders regardless of sales volumes. Other medical countermeasures such as alternative treatments, diagnostic tests and vaccines targeting antimicrobial resistance pathogens are also covered here. At the global level, the proposed recommendation looks to the Member States and the Commission to support concrete actions on AMR in the pandemic agreement currently being negotiated at the G7 and G20. I would also want to say, in addition, on bacteriophages, which has often been discussed, the revised pharmaceutical legislation would make it possible to establish an adapted, tailor-made framework to take the specificities of these medicinal products into account. And really, as we have often said, we need a One Health approach to tackle AMR, and that is a priority for the EU’s global health strategy. And that’s why we have encouraged, at EU level, the Member States to exchange and cooperate via the AMR One Health network. So I have really gone through a list of the measures that we are taking, the actions that we are putting into place to tackle AMR. But I want to close by saying that I believe that we all come from a common point and that is that we urgently need to address antimicrobial resistance. We cannot afford not to act. We need to have ambitious actions and we need to ensure that we combine bringing new, innovative antimicrobials onto the market, but at the same time having awareness of prudent use and of what we need to do to strengthen our health systems. So I look forward to hearing your views and look forward to working with you on this important topic.