COMMISSION STAFF WORKING DOCUMENT Synopsis report Accompanying the document Communication from the Commission to the Council and the European Parliament A European One-Health Action Plan against Antimicrobial Resistance (AMR)
Date: 2017-06-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: action programme, animal disease, antibiotic, cooperation policy, drug surveillance, infectious disease, innovation, public health, research and development, veterinary drug

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 29.6.2017  SWD(2017) 240 final   COMMISSION STAFF WORKING DOCUMENT Synopsis report Accompanying the document Communication from the Commission to the Council and the European Parliament A European One-Health Action Plan against Antimicrobial Resistance (AMR) {COM(2017) 339 final}  
 
 
SYNOPSIS REPORT 

1.  INTRODUCTION 

This  report  covers  feedback  and  input  from  citizens  and  from  administrations,  associations 
and other organisations (hereinafter ‘stakeholders’) as regards a Commission Communication 
on  a  One  Health  action  plan  to  support  Member  States  in  the  fight  against  antimicrobial 
resistance (AMR) (hereinafter ‘the new One Health action plan’). 

Stakeholders  had  the  opportunity  to  provide  their  feedback on  a  Commission  roadmap  on  a 
One Health action plan against AMR1 from 24 October 2016 to 28 March 2017. In addition, 
an open public consultation (OPC)2, targeting citizens and stakeholders, on the content for a 
new One Health action plan against AMR was open from 27 January to 28 April 20173. 

22  stakeholders  submitted  their  feedback  on  the  Commission  roadmap.  The  OPC  received 
replies from 584 participants: 421 citizens and 163 stakeholders. 16 of the 163 stakeholders 
had also provided comments on the Commission roadmap.  

The stakeholders represented a great variety of sectors. Over a fifth of the respondents were 
public  or  private  administrations,  followed  by  non-governmental  organisations  (NGOs), 
pharmaceutical industry stakeholders and human healthcare providers. More than half of the 
respondents  (52%)  were  umbrella  organisations  or  associations  representing  the  interests  of 
stakeholders. 

As for the citizens, 406 came from 22 Member States while 15 came from non-EU countries. 
The vast majority of the respondents were highly educated (87% had tertiary education), were 
employed in the human (39%) or animal (12%) healthcare sectors and admitted to being very 
well or well informed about AMR and its consequences (48% and 40% respectively), making 
the sample highly qualified to respond to the OPC. 

The contributions received confirmed the strong support from citizens and stakeholders for a 
new One Health action plan, and the importance of a comprehensive approach. Contributions 
have been taken into account in defining concrete actions under the three main pillars of the 
new  One  Health  action  plan.  Most  of  the  contributions  taken  into  account  presented  policy 
options which had a clear EU added value for Member States, which were relevant in terms of 
tackling  AMR  research  and  development  (R&D)  related  challenges,  or  which  would  help 
ensure  that  the  EU  has  a  strong  voice  on  AMR  at  international  level.  Contributions  which 
went beyond the scope of EU competences were not taken into account. 
A more detailed factual report on feedback received in the OPC will be published in parallel2. 
It will offer a more comprehensive overview of the contributions received. 

1 
2 

3 

http://ec.europa.eu/dgs/health_food-safety/amr/docs/communication_amr_2011_748_en.pdf 
http://ec.europa.eu/dgs/health_food-safety/amr/consultations/consultation_20170123_amr-new-action-
plan_en.htm 
The cut-off date is 28 April 2017. Contributions received by the European Commission after that date 
could not be taken into account in preparing this report. 

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2.  MAKING THE EU A BEST PRACTICE REGION 

Almost  half  of  the  citizens  (46%)  attributed  equal  importance  to  conducting  actions  against 
AMR in the human health, animal health and environmental sectors and more than a quarter 
(27%)  were  in  favour  of  actions  in  both  the  human  health  and  animal  health  sectors.  The 
views expressed by the stakeholders also corresponded to a One Health approach addressing 
actions in all three sectors (human health, animal health, and environmental sectors). 

2.1. Better evidence and awareness of the challenges of AMR 

Stakeholders  familiar  with  the  EU  surveillance systems  considered  that more  improvements 
are needed on data collection in the animal health side than in the human health side. They 
pointed to the following possibilities to improve surveillance in the EU, which will be further 
explored in the implementation phase of the new One Health action plan: 

  Moving towards a standardised system of data collection in order to reduce disparities 

in the quality of national data; 

  For antimicrobial consumption data: 

o  In  the  human  health  sector,  more  granularity  in  the  collection  of  data  (e.g. 
collection at regional, sub-regional, or even local level; stratified by healthcare 
sector; age/gender specific); 

o  In the animal health sector, consumption data by species; by target population 
(e.g. fattening pigs or breeding sows and boars rather than all pigs); by farming 
system (e.g. intensive farming) and to start collecting data on antimicrobial use 
in companion animals (e.g. cats and dogs); 

o  In both sectors, collecting data on the diagnoses or reasons for prescription; 

  For antimicrobial resistance data, stakeholders called for broadening the scope of the 
surveillance  systems  to  cover  more  pathogens  in  the  human  health  sector.  In  both 
sectors  they  advocated  for  a  database  of  resistance  genes  and  for  the  use  of  genetic 
methods to improve data quality. 

In  order  to  strengthen  the  evidence  base,  another  stakeholders’  proposal  that  was  put  into 
concrete action in the Communication on the new One Health action plan, is helping Member 
States in assessing the economic and health burden of AMR. 

Other  stakeholders’  proposals  require  further  consideration  and  were  not  translated  into 
concrete actions in the new One Health action plan. These include assessing the economic and 
health impact of vaccines against major infectious diseases in humans and the effectiveness of 
vaccination  schemes,  infection  control  measures,  farming  systems  and  nutrition  practices  in 
animals. 

In terms of awareness, stakeholders were very positive about the Commission complementing 
Member  States’  AMR  awareness-raising  activities.  Almost  four  times  as  many  (79%)  rated 
the Commission’s efforts as helpful or very helpful compared to those who found these to be 
less helpful (21%).  

Stakeholders mainly called for initiatives driven by Member States which would be country-
specific,  tailor-made  and  as  targeted  as  possible  to  citizens  and  consumers,  but  also  to 
pharmacists, doctors, dentists, patients, veterinarians, and farmers. These national campaigns 
are outside of the scope of the new One Health action plan. 

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2.2. Better coordination and implementation of EU rules to tackle AMR 

To  improve  coordination  of  Member  States’  action  on  AMR,  stakeholders  considered 
important  holding  regular  discussions  within  a  One  Health  dedicated  network  on  AMR, 
gathering experts from the human health, animal health and environmental sectors. They also 
called  on  the  Commission  to  coordinate  and  facilitate  the  sharing  of  best  practices  and 
exchange of information on Member States’ national action plans (NAPs) against AMR. The 
Commission addressed positively this request in the new One Health action plan. 

87% of the stakeholders considered that it would be either very helpful or helpful for Member 
States  to  define  measurable  goals  to  reduce  infections  in  humans  and  animals,  the  use  of 
antimicrobials  in  the  human  health  and  animal  health  sectors  and  AMR  in  all  three  sectors. 
Concrete actions to  support Member States in implementing  their NAPs against  AMR were 
included in the new One Health action plan. 

2.3. Better prevention and control of AMR 

To  reduce  antimicrobial  use  and  prevent  the  spread  of  AMR,  stakeholders  favoured  new 
Commission  initiatives  in  humans,  followed  by  new  Commission  initiatives  in  animals  and 
agriculture. 

Stakeholders  strongly  called  for  EU  initiatives  on  infection  prevention  and  control  and  on 
prudent use of antimicrobials. The following proposals were translated into concrete actions 
in the new One Health action plan: 

  Supporting activities in the human health sector, e.g. including training and policies on 

healthcare-associated infection (HAI) control for all healthcare professionals; 

  Promoting  antimicrobial  stewardship  teams  in  hospitals  and  healthcare  facilities  and 
enhancing  antimicrobial  stewardship  policies  for  all  clinicians  in  primary  healthcare 
and hospitals; 

  Supporting  Member  States  in  producing  treatment  guidelines  and  decision-support 

tools; 

  Promoting initiatives in the animal health sector aiming to improve animal husbandry 

practices for infection prevention and control; 

  Promoting feeding and animal nutrition strategies developed by national authorities in 

collaboration with feed industry experts. 

Stakeholders also suggested proposals concerning actions under Member State competences. 
The Commission did not include them in the new One Health action plan. These included: 

  Member States to develop clear national vaccination programmes in the human health 
sector  with  vaccination  goals,  which  acknowledge  the  role  of  vaccines  in  the  fight 
against AMR and to identify and address key barriers to the introduction and roll-out 
of national vaccination schedules; 

  Member  States  to  establish  national  vaccination  programmes  in  the  animal  health 

sector that reflect the diversity in livestock species and husbandry conditions; 
  Member States to include vaccination schedules in their NAPs against AMR; 
  Member States to encourage prescribers’ access to rapid diagnostics in order to help 
them  in  their  decision-making  and  to  set  up  measures  targeting  human  and  animal 
health providers to promote the use of rapid diagnostics; 

  Member  States  to  include  the  use  of  rapid  diagnostics  in  educational,  training  and 

antimicrobial stewardship programmes. 

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Finally, some stakeholders in the homeopathic and alternative medicine sectors called for the 
promotion  of  homeopathic  and  alternative  medicinal  products  (traditional,  complementary 
and alternative medicine) in the fight against AMR. These proposals were not addressed by 
the Commission in the new One Health action plan due to the lack of clear evidence. 

2.4. Better addressing the role of the environment 

Stakeholders  expressed  strong  support  for  initiatives  aiming  to  monitor  antimicrobials  and 
resistant microorganisms in the environment. A few stakeholders pointed out that health and 
economic  impact  studies  should  be  conducted  before  defining  limitations  on  antimicrobial 
discharges to the environment. 

Stakeholders  familiar  with  antimicrobial  discharge  pathways  to  the  environment  had  the 
opinion that action should be taken to limit antimicrobial discharges from the pharmaceutical 
manufacturing process. Several stakeholders urged the Commission to adopt an EU strategic 
approach  to  pharmaceuticals  in  the  environment.  This  action  was  included  in  the  new  One 
Health  action  plan,  and  will  be  followed,  where  appropriate,  by  proposals  for  measures.  A 
range  of  options  could  be  considered  in  the  strategic  approach,  e.g.  in  relation  to 
manufacturing  effluents  and  collection  of  unused  antimicrobials.  As  outlined  in  its 
Communication,  the  Commission  intends  to  maximise  the  use  of  data  from  existing 
monitoring  systems  to  improve  knowledge  of  the  occurrence  of  AMR  and  the  spread  of 
antimicrobials in the environment and thus better inform policy measures. 

2.5. A stronger partnership against AMR and better availability of antimicrobials 

Success  against  AMR  depends  on  efforts  from  all  levels  of  governance  and  multitude  of 
societal  actors.  Stakeholders  considered  that the promotion  of  dialogue  between  all relevant 
stakeholders  is  crucial  in  order  to  discuss  human  and  animal  antimicrobial  development 
challenges,  the  regulatory  framework  for  alternatives  to  the  use  of  antimicrobials,  and  to 
accelerate vaccine development for multidrug-resistant pathogenic bacteria. 

To optimise development plans, pharmaceutical industry stakeholders strongly advocated for 
early  and  continuous  dialogue  with  all  relevant  stakeholders  throughout  the  entire  product 
development  cycle.  They  particularly  called  for  dialogue  on  a  regulatory  framework  that 
prioritises the development of antimicrobial medicines, vaccines and diagnostic tests; further 
enables  efficient  pathways  for  medicinal  product  development;  and  accelerates  review 
pathways  for  antimicrobial  medicinal  products  targeting  serious  and  life-threatening 
infections.  Stakeholders  in  the  animal  health  sector  asked  for  dialogue  to  properly 
differentiate in the development phase which new antimicrobials are intended for human use 
and for use in animals. 

In line with these comments and suggestions, and as indicated in its Communication on the 
new  One  Health  action  plan,  the  Commission  included  initiatives  to  promote  regular 
dialogues  among  stakeholders  and  to  encourage  them  to  develop  and  share  their  strategies 
against AMR. 

Stakeholders  had  multiple  constructive  suggestions  on  how  to  guarantee  the  availability  of 
effective antimicrobials (e.g. safeguarding of Internet sales and improving and reformulating 
older  antimicrobials  in  order  to  be  kept  longer  on  the  market).  The  Commission  carefully 
considered these suggestions and addressed them in the new One Health action plan. 

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3.  BOOSTING RESEARCH, DEVELOPMENT AND INNOVATION ON AMR 

Research, development and innovation are essential strategic pieces in the fight against AMR. 
Stakeholders familiar with medicinal product development indicated as the main obstacles to 
bringing  new  antimicrobials  to  patients  in  Europe  the  lack  of  funding  in  R&D  on  AMR, 
followed  by  the  lack  of  economic  models  incentivising  R&D  on  AMR  and  a  challenging 
regulatory environment. 

3.1. Improve knowledge on detection, effective infection control and surveillance 

Stakeholders involved in R&D called for funding of basic research, but also for research on 
communication, behavioural sciences and methods to promote a change in how antimicrobials 
are  used.  As  indicated  in  its  Communication  on  the  new  One  Health  action  plan,  the 
Commission  remains  committed  to  supporting  research  to  better  understand  epidemiology, 
resistance mechanisms or AMR-related challenges and to improve early detection of disease 
outbreaks. 

3.2. Develop new therapeutics and alternatives 

In view of prioritising research, 76% of the stakeholders agreed that the EU should develop a 
list of R&D priorities for resistant pathogens, i.e. a priority pathogens list. This option will be 
further explored in the implementation phase of the new One Health action plan. 

In  addition,  views  and  proposals  from  stakeholders  called  for  supporting  scientific 
communities  to  easily  access,  share  resources  and  use  existing  data  to  convert  into  new 
knowledge and for supporting scientific research on novel alternatives to antimicrobials (e.g. 
medicinal product repurposing). This input will be translated into policy options to facilitate 
efforts  in  the  development  of  new  antimicrobials  and  novel  alternatives  and  to  address 
scientific challenges. 

3.3. Develop new preventive vaccines 

In  order  to  select  the  appropriate  pathogens  for  the  development  of  new  vaccines  against 
AMR  pathogens  and  HAIs,  stakeholders  considered  that  it  would  be  beneficial  to  clearly 
define priorities and to establish the necessary tools to support this development. In the new 
One  Health  action  plan,  the  Commission  indicated  its  commitment  to  supporting  the 
development of new effective preventive vaccines. 

3.4. Develop novel diagnostics 

Stakeholders considered rapid diagnostic tests essential to inform prescribing and therefore to 
use antimicrobials appropriately in the human and animal health sectors. They also called for 
supporting and funding targeted research for innovative, rapid and more mobile technologies 
in order to facilitate and accelerate the detection and identification of pathogens. 

Other  options  addressed  by  stakeholders  fall  under  Member  State  competences  and  include 
promoting  alternative  reimbursement  systems  for  rapid  diagnostics  and  encouraging  the 
uptake of rapid diagnostics in the human and animal health sectors. 

3.5. Develop new economic models and incentives 

Stakeholders  widely  supported  the  development  of  new  funding  and  business  models  for 
improved access to innovative technological solutions to prevent and control AMR and HAIs.  

In terms of incentives, stakeholders familiar with funding instruments expressed considerable 
enthusiasm  for  funding  possibilities  under  the  European  Framework  Programme  Horizon 
2020 (95% considered it very important or important), followed by funding provided by the 

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Innovative  Medicines  Initiative  (IMI)  public-private  partnership  (92%  considered  it  very 
important or important). 

But  whereas  these  push  mechanisms  were  very  well  regarded,  pharmaceutical  industry 
stakeholders advocated for complementing them with pull mechanisms rewarding innovation 
earlier in the product life cycle and reducing the proportion of manufacturer revenue derived 
from antimicrobial sales volume in order to align with stewardship principles. These options 
will be explored in the implementation phase of the new One Health action plan. 

3.6. Close  knowledge  gaps  on  AMR  in  the  environment  and  how  to  prevent 

transmission 

Stakeholders agreed that a clear understanding of the transmission dynamics between AMR in 
the environment and humans, animals, and food is lacking. In their contributions stakeholders 
consistently  pointed  to  funding  research  on  the  impact  of  antimicrobial  discharges  into  the 
environment and the mitigation of the risk that this may pose. 

4.  SHAPING THE GLOBAL AGENDA 

The challenges of AMR are globally shared and due to travel and trade, the spread of AMR 
can be further facilitated.  

Citizens expressed strong support for both EU-centred and worldwide action on AMR, which 
is in line with the actions presented in sections 2 and 4 of this report. Stakeholders considered 
global  coordinated  action  crucial  and  expressed  a  preference  for  EU  efforts  in  the  non-EU 
European  region,  followed  by  the  South  Asian  region  and  the  North  African  region.  These 
preferences were reflected in the new One Health action plan, with capacity building activities 
foreseen  in  EU  candidate  and  potential  candidate  countries  and  neighbouring  countries 
(including those where the European Neighbourhood Policy applies), which applies to certain 
non-EU European and North African countries. Further, activities with the South Asian region 
are also foreseen under the Better Training for Safer Food (BTSF) initiative. 

4.1. A stronger EU global presence 

Stakeholders expressed clear support for reinforcing cooperation with normative international 
organisations (e.g. WHO, OIE, FAO4, and Codex Alimentarius) to tackle AMR. Stakeholders 
additionally  pointed  to  international  actions  including  that  imports  to  the  EU  (e.g.  food) 
should  meet  EU  standards  and  that  the  Commission  should  support  the  establishment  of 
international databases on the monitoring of antimicrobial use and occurrence of resistances. 
Stakeholder  suggestions  relating  to  advocating  EU  standards  and  measures  on  AMR  and 
reinforcing technical cooperation in areas covered by the WHO Global Action Plan on AMR 
were reflected in the new One Health action plan. 

A few stakeholders also urged for action to address  discharges to the environment from the 
pharmaceutical industry by enforcing on-site inspections and amending rules under the Good 
Manufacturing  Practices  to  include  environmental  and  waste  management  criteria.  In  its 
Communication, the Commission underlined its support for efforts to manage pharmaceutical 
manufacturing  effluents  effectively.  Enforcing  on-site  inspections  on  environmental  matters 
in countries outside of the EU would be beyond the mandate of the Commission. 

4 

WHO:  World  Health  Organisation,  OIE:  World  Organisation  for  Animal  Health,  FAO:  Food  and 
Agriculture Organisation of the United Nations. 

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4.2. Stronger bilateral partnerships for stronger corporation 

Stakeholders  perceived  positively  fostering  bilateral  partnerships  with  key  EU  trading 
partners and major regional and global players (e.g. USA, Canada, Brazil, China, India, and 
South-Africa).  The  Commission  is  committed  to  working  with  strategic  partners  in  the  new 
One Health action plan. Capacity building, trade and partnership agreements, as well as non-
binding cooperation were endorsed by stakeholders. Several stakeholders called for stronger 
action with countries that export large volumes of antimicrobials to Europe, yet proposals that 
encroached on national sovereignty were disregarded. 

4.3. Cooperating with developing countries 

In their comments, stakeholders asked for international actions including raising awareness of 
AMR  globally  and  assisting  countries  that  most  require  support  through  surveillance  and 
stewardship  capacity  building.  While  the  EU  can  raise  political  awareness  in  international 
forums (e.g. United Nations), public awareness-raising activities in third countries are beyond 
the capacity of the Commission, hence any proposals for activities relating to the Commission 
directly launching public awareness-raising campaigns in third countries were dismissed. 

4.4. Developing a global research agenda 

Stakeholders  expressed  favourable  opinions  on  research  coordination.  In 
terms  of 
international action, they advocated for improving mapping and coordination of global R&D 
efforts,  and  globally  supporting  R&D  efforts,  particularly  regarding  the  WHO  list  of  R&D 
priorities on AMR and addressing multidrug-resistant tuberculosis. 

5.  CONCLUSION 

Overall,  citizens  and  stakeholders  expressed  through  their  replies  very  strong  support  for  a 
new Commission Communication on a One Health action plan to support Member States in 
the fight against antimicrobial resistance (AMR). They believed that AMR is a major public 
health issue in which the EU can bring real added value and propose concrete measures. 

The feedback provided on the Commission roadmap was used to inform policy-making in the 
area of AMR and to define the action areas under the three main pillars of the new One Health 
action plan. The open public consultation results confirmed the input received on the roadmap 
and  provided  additional  insights.  The  contributions  mentioned  in  this  report  have  to  a  great 
extent  been  translated  into  concrete  actions  in  the  new  One  Health  action  plan  or  are  being 
further analysed to be put into possible actions during the implementation phase. 

In order to make the EU a best practice region, stakeholders acknowledged the importance of 
developing sound monitoring and surveillance systems at EU level in order to inform policies. 
Although  stakeholders  rated  positively  the  information  collected  by  current  EU  surveillance 
systems on AMR and antimicrobial consumption, they particularly called for the collection of 
antimicrobial  consumption  data  amongst  individual  species  in  the  animal  health  sector.  To 
strengthen  the  evidence  base  they  also  advocated  for  generating  evidence  through  health 
economics and evaluation studies which show the value of policies or interventions. 

Stakeholders were also very vocal on the relevance of slowing down the emergence of AMR 
by  developing  infection  prevention  and  control  measures,  antimicrobial  stewardship 
programmes  and  prudent  use  policies.  Stakeholders  in  the  human  health  sector  called  for 
priority actions on infection prevention and patient safety in hospital environments. They also 
called  for  the  promotion  of  vaccination,  in  particular  at  Member  State  level,  as  an effective 
public  health  measure  to  prevent  infections  and  consequently  reduce  the  need  for  using 
antimicrobials.  In turn, stakeholders in  the animal health sector asked for  new initiatives on 

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infection  prevention,  animal  husbandry  practices  and  best  practice  feeding  regimes,  and 
expressed their concern over the reduced availability of existing antimicrobials and the poor 
availability of vaccines in certain markets. 

Stakeholders strongly supported initiatives aiming to monitor antimicrobials and AMR in the 
environment, provided these are backed by a sound science-driven evidence base. They urged 
the Commission to adopt an EU strategic approach to pharmaceuticals in the environment. 

In terms of research, development (R&D) and innovation on AMR, stakeholders were largely 
in favour of developing a list of priority pathogens at EU level to prioritise R&D and direct 
pharmaceutical  industry  R&D  investment  to  the  greatest  threats.  Pharmaceutical  industry 
stakeholders  strongly  advocated  for  early  and  continuous  dialogue  with  all  relevant 
stakeholders throughout the entire product development cycle, and for a regulatory framework 
that  prioritises  the  development  of  new  antimicrobials,  alternatives,  vaccines  and  diagnostic 
tests. Stakeholders involved in R&D also asked for increased sharing of resources and better 
use of existing data. As regards the development of new diagnostics, stakeholders asked for 
targeted  funding  for  innovative,  rapid  technologies  but  most  prominently  for  actions  to 
encourage their uptake and include them in antimicrobial stewardship programmes. 

Stakeholders expressed support towards the development of new funding and business models 
to  encourage  the  development  of  new  antimicrobials,  alternatives,  vaccines  and  rapid 
diagnostics in  order to  prevent  and control resistant infections and in  particular HAIs. They 
conveyed great importance to push mechanisms such as the European Framework Programme 
2020 and the Innovative Medicines Initiatives, but pharmaceutical industry stakeholders also 
advocated for pull mechanisms rewarding innovation earlier in the product life cycle. 

At  international  level,  stakeholders  were  largely  in  favour  of  reinforcing  cooperation  with 
international  organisations  to  tackle  AMR  and  fostering  bilateral  partnerships  with  key  EU 
trading partners and major regional and global players. Stakeholders indicated preference for 
capacity building and cooperation in the non-EU European region, but also called for stronger 
partnerships  with  China  and  India,  given  their  role  in  antimicrobial  manufacturing  and  as 
major  exporters  of  food  products  to  the  EU.  Finally,  stakeholders  called  for  more  capacity 
development and cooperation activities in low- and middle-income countries. 

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