Communication from the Commission to the European Parliament and the Council on patient safety, including the prevention and control of healthcare-associated infections {COM(2008) 837 final} {SEC(2008) 3004} {SEC(2008) 3005}
Date: 2008-12-15
Institutions: European Commission
Subjects: disease prevention, health care, health policy, organisation of health care

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.12.2008 
COM(2008) 836 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

on patient safety, including the prevention and control of healthcare-associated 
infections 

{COM(2008) 837 final} 
{SEC(2008) 3004} 
{SEC(2008) 3005} 

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

on patient safety, including the prevention and control of healthcare-associated 
infections 

1. 

INTRODUCTION 

Despite the obvious benefits of modern medicine there is growing awareness that healthcare 
interventions  may  sometimes  result  in  preventable  harm  to  the  patient.  Patient  safety1  is  an 
issue  of  increasing  concern  in  healthcare  systems  all  over  the  world.  Infections  in  hospitals 
and  other  healthcare  settings  are  a  particular  problem  for  patients  and  health  services  in  all 
countries and receive considerable media and political attention. 

Among  the  most  commonly  occurring  adverse  events2  are  healthcare  associated  infections 
(HCAIs)3, medication-related events and complications during or after surgical interventions. 
Some  adverse  events  are  linked  to  the  intrinsic  risks  of  necessary  interventions  or 
medications.  Other  adverse  events,  however,  are  caused  by  potentially  avoidable  medical 
errors,  for  example,  errors  in  diagnosis,  failure  to  act  on  the  results  of  tests,  prescribing, 
dispensing or administering the wrong medicine, or in the wrong dose or in combination with 
an  inappropriate  medicine,  or  by  the  failure  of  medical  equipment.  The  Commission  has 
already  taken  specific  steps  in  many  areas  to  address  the  issue  of  patient  safety.  However 
these have focused mostly on specific sources of risk such as the safety of medicines, medical 
this 
to  antimicrobials.  Building  on 
devices  and 
Communication  on  patient  safety  aims  to  outline  an  integrated  approach,  placing  patient 
safety at the core of high quality healthcare systems by bringing together all factors that have 
an impact on the safety of patients. 

those  achievements, 

resistance 

Although patient safety is narrower in its definition than healthcare quality more generally, it 
is  a  key  foundation  of  any  high  quality  health  system.  Implementing  effective  quality  and 
patient  safety  improvements  is  of  concern  to  many  European  countries,  regardless  of  the 
characteristics  of  their  health  systems,  and  is of  interest  to  many  international  organisations 
such  as  the  WHO,  which  recently  published  an  overview  of  quality  strategies  in  the  27 
European  Union  Member  States,  or  the  OECD,  which  is  currently  working  on  healthcare 
quality indicators. Building on this experience and in collaboration with Member States, the 
Commission is developing a reflection process to consider how far the EU can play a role in 
assisting Member States on quality of healthcare issues. 

1 

2 
3 

Patient safety is defined by the WHO as freedom for a patient from unnecessary harm or potential harm 
associated with healthcare. 
An adverse event is an incident which results in harm to a patient. 
For  the  purpose  of  this  Communication,  HCAI  are  defined  as  any  disease  or  pathology  (illness, 
inflammation) related to the presence of an infectious micro-organism (bacteria, fungi, viruses, parasites 
and  other  transmissible  agents)  or  its  products  as  a  result  of  exposure  to  healthcare  facilities  or 
healthcare procedures. 

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2. 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

CALL FOR ACTION 

In October 2004, the World Health Organization (WHO) launched the World Alliance 
for  Patient  Safety4  in  response  to  World  Health  Assembly  Resolution  55.185  urging 
WHO  and  Member  States  to  pay  the  closest  possible  attention  to  the  problem  of 
patient safety.  

In April 2005 the Luxembourg declaration on Patient Safety6, recognised that access 
to high quality healthcare is a key human right to be valued by the EU, its Institutions 
and the citizens of Europe. 

The High Level Group on Health Services and Medical Care7, which was established 
in  2004  to  provide  a  mechanism  for  practical  cooperation  on  making  health  systems 
work together better, set up a working group on patient safety. In 2007, the High Level 
Group endorsed a recommendation prepared by this working group, identifying areas 
where  European  collaboration  and  coordination  on  patient  safety  could  bring  added 
value. 

In  2006,  in  its  Conclusions  on  Common  Values  and  Principles  in  European  Union 
Health  Systems8,  the  Council  acknowledged  that  patients  can  expect  each  health 
system in the EU to secure a systematic approach to ensuring patient safety, including 
the  monitoring  of  risk  factors,  and  adequate  training  for  healthcare  workers,  and 
protection against misleading advertising. 

In  2006,  the  Council  of  Europe  adopted  a  Recommendation  of  the  Committee  of 
Ministers  to  its  member  states  on  management  of  patient  safety  and  prevention  of 
adverse events in healthcare9. 

Patient safety is identified as an area for action in the Commission's Health Strategy 
White Paper of October 200710. One of the actions set out in the second programme of 
the  Community  action  in  the  field  of  health  (2008-2013)11  with  the  objective  of 
improving  citizens'  health  security  is  to  promote  measures  to  improve  patient  safety 
through high quality and safe healthcare, including in relation to antibiotic resistance 
and nosocomial infections. 

(7) 

Building  on  all  of  these  developments,  patient  safety,  including  the  prevention  and 
control  of  healthcare  associated  infections,  was  made  a  strategic  item  under  the 
Commission's legislative and work programme 2008. Accordingly, the Commission is 

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11 

http://www.who.int/patientsafety/en 
World Health Assembly Resolution WHA55.18. Quality of care: patient safety (18 May 2002). 
http://europa.eu.int/comm/health/ph_overview/Documents/ev_20050405_rd01_en.pdf 
Commission Decision of 20 April 2004 setting up a High Level Group on Health Services and Medical 
Care - C(2004) 1501. 
Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 
22.6.2006, p. 1). 
Recommendation  Rec(2006)7  of  the  Committee  of  Ministers  to  member  states  on  management  of 
patient safety and prevention of adverse events in health care. 
White Paper "Together for Health: A Strategic Approach for the EU 2008-2013" - COM(2007) 630. 
Decision  No  1350/2007/EC  of  the  European  Parliament  and  of  the  Council  of  23  October  2007 
establishing a second programme of Community action in the field of health (2008-2013) (OJ L 301, 
20.11.2007, p. 3). 

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putting forward this Communication and a proposal for a Council Recommendation on 
patient safety, including the prevention and control of healthcare associated infections. 

3. 

THE ISSUE 

3.1. 

Prevalence and Burden of Adverse Events 

There is a limited but growing body of evidence concerning the extent of adverse events in 
health  systems  in  EU  Member  States.  National  studies  from  the  UK,  Spain  and  France 
provide the bulk of current evidence in Europe on in-patient adverse event prevalence and its 
implications. 

In  the  UK,  a  report  by  England's  Chief  Medical  Officer  in  2000,  An  Organisation  with  a 
Memory,  revealed  that  patient  safety  was  a  major  problem:  data  showed  that  at  least  400 
patients  died  or  were  seriously  injured  in  adverse events involving  medical  devices  in  1999 
and  that  nearly  10,000  people  had  experienced  serious  adverse  reactions  to  medicinal 
products. According to the 2006 Spanish National Study on Hospitalisation-Related Adverse 
Events  (ENEAS),  9.3%  of  hospital  patients  in  Spain  in  2005  suffered  adverse  events  and 
42.8%  of  these  were  deemed  preventable.  A  recent  French  national  survey  of  in-patient 
adverse events (Michel, 2007), found that in the course of seven days’ observation per unit at 
least one adverse event occurred in 55% of surgical units and 40% of medical units. 35.4% of 
the adverse events were considered to have been preventable. 

From  the  national  studies  mentioned  above,  and  from  interviews  with  key  stakeholders 
conducted for the impact assessment informing this initiative, it is estimated that, in the EU, 
between  8%  and  12%  of  patients  admitted  to  hospitals  suffer  from  adverse  effects  while 
receiving healthcare. 

HCAIs,  a  key  focus  of  the  current  initiative,  are  among  the  most  frequent  and  potentially 
harmful causes of unintended harm, affecting an estimated one in twenty hospital patients on 
average,  corresponding  to  4.1  million  patients  every  year  in  the  EU12.  HCAIs  are  often 
difficult  to  treat  due  to  antimicrobial  resistance  of  the  micro-organisms  causing  these 
infections. 

Many  factors  contribute  to  the  worrying  magnitude  of  HCAI  rates.  Organisational  and 
behavioural factors include high bed occupancy, increased movements of patients within and 
between healthcare systems, sub-optimal staff to patient ratios, insufficient compliance with 
hand hygiene and other infection prevention and control practices, incorrect use of indwelling 
devices  by  healthcare  staff.  Other  factors,  such  as  the  inappropriate  use  of  antimicrobial 
agents, are relevant beyond healthcare institutions. 

Owing  to  the  ability  of  HCAI  and  other  infectious  micro-organisms  to  colonise  humans  for 
prolonged periods, patients may disseminate them during and after their hospital stay. In this 
way HCAIs can affect all healthcare settings, care homes and even the patient's home. 

12 

Refer to the impact assessment. 

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3.2. 

The public perception of patient safety 

Responses to the public consultation on patient safety that the Commission conducted from 25 
March to 20 May 200813 indicated that about 20% of the 185 respondents had suffered from 
an  adverse  event.  An  overwhelming  majority  of  participants  gave  strong  support  for  both 
national and Community action on patient safety. There is also evidence of widespread public 
concern throughout the EU about patient safety and adverse events as a significant issue that 
needs to be addressed14. 

3.3. 

The State of Play 

Some  aspects  of  patient  safety  are  already  addressed  at  Community  level.  For  instance,  the 
safety  of  medicines  is  addressed  in  the  legislation  on  pharmaceuticals,  including  on 
pharmacovigilance,15 which is currently being reviewed with a view to significantly improve 
patient  safety;  the  safety  and  performance  of  medical  devices  in  the  medical  devices 
Directives16;  and  medication  errors  arising  from  look-alike  and  sound-alike  medicines  are 
being examined by the European Medicines Agency, which is developing new requirements 
for medicinal products naming. There is legislation addressing the safety of human tissues and 
cells17 as well as blood and blood components18. The ‘open method of coordination’ (OMC) 
addresses  quality  of  healthcare,  including  safety  and  patient  centeredness.  The  European 
Centre  for  Disease  Prevention  and  Control  (ECDC)19  operates  surveillance  networks  and 
assists  the  European  Commission  in  operating  early  warning  systems  for  emergency 
situations.  The  Recommendation  on  cross-border  interoperability  of  electronic  health  record 
systems20  aims  at  improving  care  and  reducing  adverse  events  by  making  key  clinical  data, 
contained  in  electronic  health  records  (including  data  on  medications),  accessible  when  the 
patient  is  treated  in  another  country.  There  are  also  a  number  of  European  Community 
projects  on  patient  safety,  including  HCAIs,  financed  under  the  Research  Framework 
Programmes or the Programmes of Community action in the field of health21. 

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19 

20 

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of 

on 

the 

2005 

errors, 

medical 

example, 

Eurobarometer 

http://ec.europa.eu/health/ph_consultations/consultations_en.htm. 
For 
http://ec.europa.eu/health/ph_publication/eurobarometers_en.htm. 
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human 
and  veterinary  use  and  establishing  a  European  Medicines  Agency,  OJ  L  136,  30.4.2004,  p.  1-33; 
Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67-128. 
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating  to  active  implantable  medical  devices  (OJ  L  189,  20.7.1990,  p.  17);  Council  Directive 
93/42/EEC  of  14  June  1993  concerning  medical  devices  (OJ  L  169,  12.7.1993,  p.  1);  Directive 
98/79/EC  of  the  European  Parliament  and  of  the  Council  of  27  October  1998  on  in  vitro  diagnostic 
medical devices (OJ L 331, 7.12.1998, p. 1). 
Directive  2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  on  setting 
standards of quality and safety for the donation, procurement, testing, processing, preservation, storage 
and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48). 
Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27  January  2003  setting 
standards of quality and safety for the collection, testing, processing, storage and distribution of human 
blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30). 
Regulation  (EC)  No  851/2004  of  the  European  Parliament  and  of  the  Council  of  21  April  2004 
establishing a European Centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1). 
Commission  Recommendation  C(2008)  3282  of  2  July  2008  on  cross-border  interoperability  of 
electronic health record systems. 
OJ L 271, 9.10.2002, p. 1; OJ L 301, 20.11.2007, p. 3. 

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These actions, however, do not fully meet the needs of patients or governments to improve the 
safety of patients in EU healthcare systems. They tend to focus on specific causes or factors, 
and  do  not  address  the  overall  cultural,  leadership,  systemic,  communication  and  process 
barriers to improved safety. 

4. 

RATIONALE FOR A EUROPEAN ACTION 

Among  the  challenges  that  make  action  on  patient  safety  particularly  pressing  are  rising 
public  expectations,  an  ageing  society  and  advances  in  medical  treatment.  Health  systems 
across  Europe  face  common  challenges  as  they  adapt  to  constant  developments  in  medical 
science.  Although  the  problem  of  patient  safety  is  primarily  the  responsibility  of  Member 
States, the European Union can encourage cooperation between  Member  States and support 
their actions in areas where EU intervention can have an added value. 

This initiative intends to foster political commitment by Member States to make patient safety 
a priority in national public health objectives. Evidence suggests that EU Member States are 
at different levels of political awareness and priority-setting and, therefore, at different stages 
in  the  development  and  implementation  of  effective,  comprehensive  patient  safety 
programmes, strategies and processes22. 

The EU can also play a role in collecting comparable and aggregate data at Community level 
and  in  disseminating  best  practices  among  the  Member  States  to  establish  efficient  and 
transparent  patient  safety  programmes,  structures  and  policies.  To  facilitate  mutual  learning 
among  Member  States,  a  common  'language'  or  'taxonomy'  for  patient  safety  and  common 
indicators need to be developed. 

These actions will help patients to make informed choices about their care in terms of safety. 
This is particularly relevant for patients that access healthcare in a Member State other than 
their own. Patients should know how safe those health systems are, and what support they or 
their family can expect when harmed by an adverse event. 

Finally, the limited time-span of EU projects means that there is no guaranteed longer-term 
action on patient safety in the Community. The EU can play a role in considering how best to 
achieve  and  sustain  effective  collaboration  on  patient  safety  between  Member  States  in  the 
longer term. 

In summary, EU activity in the area of patient safety can provide added value in the following 
ways: the EU can provide political weight and visibility to patient safety; economies of scale 
can  be  achieved  through  Community-wide  collection  of  data  and  sharing  of  best  practice; 
patients  can  benefit  from  an  increased  dissemination  of  information  on  levels  of  safety  and 
available  remedies  and  redress;  and  sustainability  of  EU  action  on  patient  safety  can  be 
ensured. 

22 

Safety improvement for Patients in Europe (SIMPATIE) project funded under the Community's Public 
Health Programme 2003 – 2008, www.simpatie.org, and Technical report ‘Improving patient safety in 
the EU’ prepared for the European Commission, published 2008 by the RAND Corporation. 

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5. 

OBJECTIVES AND AIM OF THIS INITIATIVE 

The objective of this initiative is to protect EU citizens from preventable harm in healthcare 
by  supporting  Member  States  to  put  in  place  adequate  strategies  to  prevent  and  control 
adverse  events  in  healthcare,  including  healthcare  associated  infections,  and  to  improve  EU 
citizens' confidence that they have sufficient, comprehensive and comprehensible information 
on  safety  and  available  redress  in  EU  health  systems.  This  initiative  on  patient  safety  is 
intended  to  create  a  framework  to  stimulate  policy  development  and  future  action  in,  and 
between, Member States to address the key patient safety issues and problems confronting the 
EU. 

6. 

OPERATIONAL ACTIONS AT MEMBER STATE LEVEL 

Member States have the prime responsibility for protecting and improving the health of their 
citizens. As part of that responsibility, it is for them to decide on the organisation and delivery 
of health services and medical care, reflecting Article 152 of the Treaty. However, as shown 
above, effective cooperation and coordination between countries can lead to increased patient 
safety. 

Accordingly, a number of actions to be implemented either at national or European level (or a 
combination  of  the  two)  are  put  forward  by  this  Communication  and  the  accompanying 
proposal  for  a  Council  Recommendation  on  patient  safety,  including  the  prevention  and 
control of healthcare associated infections. 

Member States are recommended to: 

(1) 

(2) 

(3) 

Support  the  establishment  and  development  of  national  policies  and  programmes  on 
patient safety in general terms. 

Inform and empower patients by involving them in the patient safety policy process, 
by  informing  them  of  levels  of  safety  and,  if  things  go  wrong,  how  they  can  find 
accessible and comprehensible information on complaints and redress systems.  

Set  up  or  improve  comprehensive  blame-free  reporting  and  learning  systems  so  that 
the extent and type and causes of adverse events are captured to enable resources to be 
efficiently  channelled  into  developing  solutions  and  interventions  which  can  then  be 
shared  at  the  EU  level.  Such  reporting  on  adverse  events  should  be  done  in  a 
constructive, rather than a punitive or repressive, manner so that healthcare providers 
feel confident that they can report without fear of negative consequences. 

(4) 

Ensure  that  patient  safety  is  embedded  into  the  education  and  training  of  healthcare 
workers, as the providers of care. 

In  addition,  the  proposal  for  a  Council  Recommendation  puts  forward  a  number  of  specific 
recommendations on the key patient safety issue of healthcare associated infections. Member 
States  are  recommended  to:  implement  prevention  and  control  measures  to  support  the 
containment  of  HCAIs;  enhance  infection  prevention  and  control  at  the  level  of  healthcare 
institutions; establish or strengthen active surveillance systems; foster education and training 
of healthcare workers on infection prevention and control; improve the information given to 
patients; and support research. 

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7. 

OPERATIONAL ACTIONS AT EU LEVEL 

At the EU level, the Commission should, in close collaboration with Member States: 

(1) 

(2) 

(3) 

(4) 

Take  the  necessary  initiatives  to  develop  common  definitions,  terminology  and 
indicators  on  patient  safety.  This  action  should  build  on  the  work  undertaken  by 
international  bodies  such  as  the  WHO,  the  OECD  and  the  Council  of  Europe  and 
exploit,  where  appropriate,  the  results  of  relevant  research  projects  at  the  EU  level. 
Agreed indicators should also be developed for public reporting of safety levels. 

Facilitate  sharing  information  and  best  practice  on  patient  safety,  including  on  the 
prevention  and  control  of  HCAIs.  Sharing  major  patient  safety  alerts  should  also  be 
possible at the EU level. 

Continue  promoting  European  research  programmes  on  patient  safety  particularly 
focusing on filling the current research gaps and on complementing existing research 
on national level. 

Consider  how  best  to  achieve  and  sustain  effective  collaboration  on  patient  safety 
between Member States in the longer term. 

8. 

IMPLEMENTATION 

In  order  to  facilitate  the  coherent  implementation  of  the  recommended  actions  the 
Commission  will,  where  necessary,  develop  guidelines  in  close  cooperation  with  Member 
States,  including  on  the  prevention  and  exposure  of  healthcare  workers  to  healthcare-
associated pathogens. 

The  Commission  can  in  particular  foster  with  ECDC  the  development  of  guidance  on  best 
practice  on  the  prevention  and  control  of  healthcare  associated  infections,  promote  the 
availability  of  training  opportunities  and  assist  Member  States  to  develop  infection  control 
training  and  curricula  for  infection  control  staff  and  healthcare  workers.  In  addition  to  the 
current  coordination  of  European  surveillance  of  healthcare  associated  infections  and 
information  exchange  about  outbreaks,  the  Commission  can  foster  with  ECDC  the 
development  and  implementation  of  surveillance  of  infection  control  structure  and  process 
indicators in order to evaluate the implementation of the recommended actions in the Member 
States  and  assist  Member  States  to  establish  or  strengthen  surveillance  on  healthcare 
associated infections. 

Not later than three years after the adoption of this Communication and the Recommendation, 
the Commission will produce an Implementation Report assessing the impact of this initiative, 
on the basis of the information provided by Member States, to consider the extent to which 
the proposed measures are working effectively and consider the need for further action. 

9. 

CONCLUSION 

Adverse events in  healthcare can potentially affect every patient and family and represent a 
serious  health  burden  for  the  EU.  Moreover,  the  need  to  bring  together  expertise  and  make 
efficient  use  of  the  limited  available  resources  means  that  patient  safety  is  an  area  where 
European  cooperation  can  add  particular  value  to  the  actions  of  the  Member  States.  The 

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Commission  has  already  taken  individual  initiatives  in  the  past,  such  as  addressing  certain 
aspects of patient safety in Community legislation, or fostering research and collaboration on 
patient  safety  by  Community  co-funded  projects.  But  more  action  is  needed  to  ensure  that 
these  individual  strands  of  work  are  sustained  and  brought  together  into  a  coherent  overall 
strategy for patient safety, both at Community level and within Member States. 

With  this  Communication  and  the  accompanying  proposal  for  a  Council  Recommendation, 
the Commission aims to put in place an integrated approach to patient safety. This offers the 
potential  to  maximise  the  scope  for  cooperation  and  mutual  support  in  this  difficult  area 
across the EU as a whole. It will support Member States in putting in place their own national 
and regional strategies for patient safety. And by doing so, it will provide patients and their 
families with a tangible benefit from European integration in their daily lives. 

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