The European Commission proposed on 26 April 2023 a major revision of the EU’s pharmaceutical legislation. The package also includes a proposal for a Council Recommendation containing complementary measures to combat AMR in the fields of human health, animal health and the environment, through the so-called One Health approach.
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1. What is antimicrobial resistance (AMR) and why is it a “silent pandemic”?
Antimicrobial resistance (AMR) is the ability of micro-organisms to survive or to grow despite the presence of an antimicrobial agent that normally inhibits or kills that micro-organism.
AMR causes more than 35,000 deaths every year in the EU/EEA. A continued rise in AMR would result in an estimated 10 million deaths globally each year, in a reduction of 2% to 3.5% in global gross domestic product and would cost the world economy up to USD 100 trillion by 2050.
2. What is the One Health approach and why should AMR be tackled in that way?
AMR is one of the health problems that best illustrates the One Health approach. The One Health approach is based on the principle that human, animal and environment health are intrinsically linked. One Health can only be reached when joint efforts are taken in these three areas.
AMR results from over- or misuse of antimicrobials, in both the healthcare and food production systems.
Therefore, to be effective, the fight against AMR must address human, animal and environmental concerns in a comprehensive manner involving a wide range of actors. Tackling AMR using this broad approach is the most efficient way.
3. Why should AMR be tackled at global level?
AMR is a multi-faceted cross-border threat to health that does not stop at borders. Therefore, it cannot be tackled by individual countries alone. It is key to organise cooperation between countries, including at the global level. The COVID-19 pandemic has clearly demonstrated the need for a strong and coordinated response to global health threats.
AMR is at the centre of the EU Global Health Strategy and an important topic tackled in all fora and instruments currently dealing with global health architecture, from the G7, the G20, the Transatlantic Task Force on Antimicrobial Resistance to the World Health Organization (WHO) international agreement on pandemic prevention, preparedness and response, currently under negotiations. AMR also features as a high priority for international organisations, such as the World Health Organization, the UN Food and Agriculture Organization , the World Organisation for Animal Health and the United Nations Environment Programme.
4. What has been done so far at EU-level to tackle AMR?
AMR has been high on the EU agenda for more than 20 years. Through the 2011-2016 Commission Action Plan and the 2017 EU One Health Action Plan against AMR, the Commission has put forward a number of initiatives covering human, animal and environment health and research and innovation. This is done with the support of EU health and research programmes. In addition, the Commission supports global action, by notably ensuring a stronger EU global presence, building stronger bilateral partnerships and cooperating with international partners.
Since then, some major initiatives have contributed to further strengthening EU response to AMR. For instance, the Farm to Fork Strategy and the Zero Pollution Action Plan aim to reduce by 50% the overall EU sales of antimicrobials for farmed animals and in aquaculture by 2030. The Regulations on veterinary medicinal products and on medicated feed provide tools that contribute to reaching this target.
In addition, EU health and research programmes provide important funding to combat AMR. For instance, under the EU4Health programme, 50 million have been set aside for a new joint action at EU level on AMR. The Horizon 2020 programme has mobilised over 690 million to support research and innovation on AMR as part of a broader research portfolio on infectious diseases, and support to AMR research and innovation is now continuing under the Horizon Europe programme.
Finally, the recent Commission proposals of autumn 2022 aims at reinforcing environmental monitoring of AMR in freshwater, wastewater, and agricultural soils. This will help better assess combination effects and give a better access to data for all.
5. Why is the Commission proposing this Recommendation?
AMR is a cross-cutting and cross-border issue that requires a strong and coordinated response. No Member States can address it on their own. The Recommendation, once adopted by the Council, will signal the strong political will of Member States to achieve the measures presented and to cooperate in this area.
AMR has been identified as one of the top three health threats the EU faces. While much progress has been achieved in terms of reducing sales and use of antimicrobials in the veterinary sector, it is now crucial to further address the human health dimension, where Member States’ efforts remain pivotal, and increase actions in the environmental area. The COVID-19 pandemic brought awareness of infection prevention and control, including hygiene measures, to promote a reduction in the transmission of microbes, including resistant ones. These developments can and should also be harnessed to combat AMR.
6. What are the main objectives of the Recommendation?
One of the main objectives of this Recommendation is to foster a prudent use of antimicrobials. Therefore, it recommends concrete targets on AMR and antimicrobial consumption in the human sector. In addition, the Recommendation aims to boost national One Health action plans on AMR, improve infection prevention and control, foster research and innovation, incentivise innovation and access to antimicrobials and other medical countermeasures, reinforce surveillance and monitoring of AMR and antimicrobial consumption, enhance global cooperation, and improve public awareness, education, and training of professionals.
7. What are the targets for AMR?
The Recommendation provides several targets to be achieved by 2030 (compared to the 2019 baseline), among which:
- a reduction of 20% of the total consumption of antibiotics in humans;
- at least 65% of the total consumption of antibiotics to come from the Access group of antibiotics as defined in the AWaRe classification of the WHO (antibiotics in this group show lower potential for the development of AMR);
- a reduction of the incidence of bloodstream infections with three key antibiotic-resistant bacteria (15% for meticillin-resistant Staphylococcus aureus; 10% for third-generation cephalosporin-resistant Escherichia coli; 5% for Carbapenem-resistant Klebsiella pneumoniae);
- the achievement of the Farm to Fork Strategy and Zero Pollution Action Plan target of 50% reduction of the overall EU sales of antimicrobials used for farmed animals and in aquaculture.
8. Why do we need targets on AMR?
What gets measured gets done.
The setting of concrete measurable targets is an effective way to achieve goals related to the prevention and reduction of AMR within a specified timeframe and to monitor progress over time.
Several Member States have set targets through their existing national action plans, taking into account their levels of antimicrobial consumption and spread of key resistant pathogens.
The establishment of recommended targets at EU level is an additional step forward to drive action at EU level and achieve common goals while duly considering national situations without compromising patient health and safety.
9. What is the link between this Recommendation and the proposal to revise the pharmaceutical legislation?
When it comes to AMR, this Recommendation and the proposal to revise the pharmaceutical legislation aim to reinforce, following a One Health approach, the environmental dimension of the production and use of medicines, and to foster the prudent use of antimicrobials. Our proposals also aim to ensure innovation and access to antimicrobials and other AMR medical countermeasures.
In particular, both proposals provide for incentives to reward successful development and secure access to effective antimicrobials. In addition to the voucher scheme proposed under the revision of the pharmaceutical legislation, financial pull incentives in the form of procurement mechanisms could be brought in. For that purpose, a Commission study on bringing AMR medical countermeasures to the market has assessed four major types of procurement mechanisms: revenue guarantee, market entry rewards combined with revenue guarantee, lump-sum market entry rewards and milestone payments. The Commission has presented these options to Member States and is now discussing with them the implementation of one of these four multi-country financial incentive mechanisms in a complementary manner to the regulatory framework applicable to the medicinal products for human use.
10. How will achievements be monitored and evaluated?
The Commission will put in place a monitoring framework and will report on progress in the implementation of the Recommendation four years after its adoption.
11. How will the EU support the implementation of the Recommendation?
Under the EU4Health programme, 50 million have been set aside for a new joint action on AMR, similar to the previous EU-JAMRAI which finished in 2021. The new joint action, to start early next year, should bring together the authorities of all EU Member States, Norway, Iceland, and Ukraine to support them to implement diverse policies and measures to tackle AMR across the One Health approach:
- strengthening National Action Plans;
- improving surveillance;
- upgrading infection prevention and control measures;
- fostering the prudent use of antimicrobials and rolling out awareness-raising campaigns.
Under the EU4Health programme, another 22 million have been set aside through the Health Emergency Preparedness and Response Authority (HERA) to establish a coordination network which will prepare the implementation of bringing AMR medical counter measures to the market, as well as for procurement.
12. Is this Recommendation legally binding?
Council Recommendations are not legally binding. They have been frequently used for EU actions within the field of health, where the EU has a supporting role.
13. What are the next steps?
The Recommendation will now be discussed at Council level.
AMR is a priority for the Swedish Presidency of the EU, which has already indicated its intention to adopt it by the end of this semester. If not, the following Presidency will continue to discuss it.
EU Action on Antimicrobial Resistance
Revision of EU pharmaceutical legislation - guide
Factsheet on putting patients in the centre
Factsheet on driving innovation for pharmaceutical industry
Factsheet on tackling antimicrobial resistance
Pharmaceutical Strategy for Europe
Source: European Commission
