EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 15.12.2008 
SEC(2008) 3004 
  
COMMISSION STAFF WORKING DOCUMENT 
 
accompanying the 
COMMUNICATION FROM THE CO MMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 
 
on patient safety, including the preventi on and control of healthcare-associated 
infections 
 
and the 
 
Proposal for a 
 
COUNCIL RECOMMENDATION 
 
on patient safety, including the preventi on and control of healthcare associated 
infections 
  
IMPACT ASSESSMENT  
{COM(2008) 836 fianl} {COM(2008) 837 final} 
{SEC(2008) 3005} 
 
ii IMPACT ASSESSMENT1 
on a proposal for a Council Recommendation on patient safety and quality of health 
services, including the prevention and cont rol of healthcare-associated infections 
                                                 
1 On the basis of the Impact Assessment Guidelines of 15 June 2005 (SEC(2005) 791) 
 
EN iii   EN TABLE OF CONTENTS 
1. Procedural issues and consultation of third parties ...................................................... 7 
1.1. Organisation and timing............................................................................................... 7 1.2. Consultation and expertise ........................................................................................... 7 1.3. The Impact Assessment Board................................................................................... 11 2. Terminology............................................................................................................... 11  
3. The problem and its causes ........................................................................................ 12 3.1. Adverse Events: The Size of the Problem.................................................................. 12 3.2. The Public Perception of Adverse Events.................................................................. 16 3.3. Current Member State Actions................................................................................... 16 3.4. Current EU Actions.................................................................................................... 17 3.5. Problems still to be addressed .................................................................................... 18 4. The right of the Union to act – Subsidiarity test ........................................................ 22 5. Objectives.................................................................................................................. . 25 
5.1. General objective........................................................................................................ 2 5 
5.2. Specific objectives...................................................................................................... 2 5 
5.3. Operational objectives................................................................................................ 25 
6. Policy options............................................................................................................. 2 6 
7. Analysis of impacts .................................................................................................... 29 7.1. Policy option I: No additional EU action – status quo............................................... 31 7.2. Policy option II: Strengthened cooperati on with the Member States and other 
bodies, supported by technical guidance.................................................................... 36 
7.3. Policy option III: Strengthen ed cooperation with the Member States and other 
bodies, supported by soft law inst ruments, such as a Commission 
Communication and a Council Recommendation...................................................... 38 
7.4. Policy option IV: Strengthen ed cooperation with the Member States and other 
bodies, supported by a regulatory instrume nt, such as a Commission Decision ....... 39 
8. Comparing the options ............................................................................................... 40 8.1. Advantages and disadvantages of the po licy options identified in section 6............. 40 
8.2. Conclusions ............................................................................................................... . 44 
9. Monitoring and evaluation ......................................................................................... 44 9.1. Progress indicators and surveillance .......................................................................... 44 
 
EN iv   EN 9.2. Evaluation................................................................................................................ ... 45 
 
EN v   EN EXECUTIVE SUMMARY  
The goal of this paper  is to present the impact assessment on a proposal for a 
Communication and a Council Recommendation on patient safety  and quality of 
health services, including the prevention  and control of healthcare-associated 
infections . 
Patient safety is a growing issue across Eur ope. It is estimated that between 6.7 and 15 
million hospital admissions and over  37 million consultations in the primary care setting 
result in an adverse event for the patient as  a result of receiving that healthcare. 
However, Member States have varying levels of awareness  of the extent and type of 
adverse events occurring in their health syst ems and dedicate varying levels of resources 
and expertise to counter the problem. Due to the varying levels of policy commitments it 
is currently not possible to obtain and co mpare incidence rates across Europe, as 
reporting does not yet take plac e everywhere and, where it do es, not on the basis of the 
same criteria and definitions . That also implies that not enough information  is available 
on safety levels in healthcare systems or on the help available for those harmed by 
healthcare. Current research findings , learning, experiences and expertise available in 
the EU are not sufficiently benefiting patients . Not enough authoritative guidance is 
available to support patient sa fety efforts, such as agreed case definitions, guidance on 
best practice and requirements fo r infrastructure and processes.  
Although the problem of patient safety is primarily the resp onsibility of Member States, 
the European Union can support their efforts by taking actions where it has competence 
and - more broadly - in facilitating the exchang e of good practice. Action by the EU is 
underpinned by the need to address the conse quences of: 1. cross-border provision of 
healthcare resulting from mobility of patients and professionals, 2. trans-border spread of infections, and 3. the lack of EU -wide data collecti on and monitoring.  
The general objective of the Recommendation is to prevent and reduce human illness 
and diseases and to obviate so urces of danger to human health  (as stipulated in Article 
152 of the Treaty), through 1. protecting EU citizens from preventable
2 harm in 
healthcare, 2. supporting the Member States to put in place adequate strategies to 
prevent and control adverse events in he althcare, including healthcare-associated 
infections and 3. improving EU citizens' confidence that they have sufficient and 
comprehensible information on levels of sa fety and available redress in EU health 
systems. 
Four policy options were identified and analysed  in terms of their possible social, 
economic and environmental impact: I. No  additional EU action but ongoing research 
and projects continue – the status quo, II. St rengthened cooperation with the Member 
States and other bodies, supported by techni cal guidance, III. Strengthened cooperation 
with the Member States and ot her bodies, supported by soft law instruments, such as a 
Commission Communication and Council R ecommendation, and IV. Strengthened 
cooperation with the Member States and other bodies, supported by a regulatory 
instrument, such as a Commission Decision. 
                                                 
2 "Preventable" was, in our scenarios defined as wh at is considered avoidable with current state of 
the art knowledge and policies, but it should be noted that preventability also evolves over time when more experience and knowledge about patient safety is being gathered. 
 
EN vi   EN Based on this impact assessment, the po licy option of a proposal for a Commission 
Communication and a Council Recommendation on patient safety  and quality of 
health services, including the prevention and control of healthcare associated 
infections, is preferred . In a quantitative simulation - that used as a base, incidence 
rates reported in the literature and an evalua tion of MS current po licies against what is 
considered best practice in the relevant literature– we tried to give an idea about the 
potential for reduction in adve rse events. It was estimate d that a reduction of 750.000 
preventable3 adverse events across EU could be re aped with the preferred option – if all 
MS established a patient sa fety policy (above a ll reporting and learning systems) that 
performed as good as countries currently listed in the second best out of five categories 
(with a 10 % incidence rate).  
The cost savings and health benefits of patient  safety policies would not come for free - 
as healthcare institutions will have to rede ploy personnel form healthcare to patient 
safety monitoring and reporting. To e g reap a 20% reduction in he althcare associated 
infections, dedicated infecti on control staff will be need ed. Secondly, also government 
spending for patient safety will be nece ssary to allow for upfront investment and 
supporting action at national level. However there is solid evid ence and agreement about 
the cost effectiveness of such  policies in the long  term with cost sa vings between 50.000 – 
1.5 million Euros for a 300 bed hospital.  
                                                 
3  
 
7 1. PROCEDURAL ISSUES AND CONSULTATION OF THIRD PARTIES  
1.1. Organisation and timing 
1. In October 2004, the World Health Or ganization (WHO) launched the World 
Alliance for Patient Safety in response to a World Health Assembly Resolution (2002) urging countries to pay the closes t possible attention to the problem of 
patient safety. 
2. A topic chosen by the European Commissi on for the first Global Patient Safety 
Challenge covering 2005 and 2006 was h ealthcare-associat ed infections 
(HCAIs.) 
3. The focus on HCAIs followed the Commi ssion's report to the Council (COM 
(2005) 0684) on the implementation of  Council Recommendation (2002/77/EC) 
on the prudent use of antimicrobial ag ents in human medicine. The report 
outlined a variety of measures already take n by Member States in line with the 
Council Recommendation; it also highl ighted the areas of the Council 
Recommendation needing further attenti on, one of which was infection control 
to reduce the spread of  resistant organisms. 
4. Not only emergence (under selective pressu re of antimicrobials)  but also spread 
is an important driver of the problem of resistance and therefore the Commission decided to take an initiative in the area of infection control by developing recommendations on the pr evention and control of HCAIs. 
5. More generally, on patient safety, a c onference organised by Luxembourg, as 
Council Presidency, adopted in Apr il 2005 the Luxembourg Declaration on 
Patient Safety
4. 
6. Following this, the patient safety working group of the High Level Group on 
Health Services and Medical  Care was set up to identify areas where European 
collaboration and coordination of act ivities could bring added value. 
7. In 2007, the Working Group agreed on some  recommended actions, which were 
subsequently endorsed by Member St ates, through the High Level Group  
8. Against this background, patient safety, including the preven tion and control of 
HCAIs, was made a strategic item unde r the Commission's legislative and work 
programme 2008. The intention is to adopt a proposal in late 2008. 
1.2. Consultation and expertise 
1.2.1.  External consultation and expertise 
High Level Group on Health Services and Medical Care  
The patient safety working group of the High Level Group on Health Services and 
Medical Care has met regularly since 2005. As well as representatives from the Members 
States, it includes pan-European organisatio ns representing doctors, nurses, patients, 
                                                 
4 http://europa.eu.int/comm/health/ph_overview/Documents/ev_20050405_rd01_en.pdf 
 
EN 8   EN hospitals, pharmacists and dentists as well as the Organisation for Economic Co-
operation and Development (OECD), the C ouncil of Europe (CoE) and WHO. This 
working group has played a key role in defi ning the issues described in this impact 
assessment, as well as refi ning the options for action. 
Other stakeholder mechanisms such as th e EU Health Policy Forum, the European 
Consumers Consultative Group, the Health Sy stems Working Party and the EU Social 
Dialogue Group on Hospitals have also had presentations on the issues. 
Network on communicable diseases and the European Centre for Disease Prevention 
and Control (ECDC)  
In the field of infection cont rol, a document on 'Strategies fo r improving patient safety by 
prevention and control of healthcare-associated infections' was drafted with the help of a 
panel of experts. This incor porated comments from the su rveillance authorities of the 
Community network on communicable diseas e established by Deci sion No 2119/98/EC 
of the European Parliament and the Council5. The strategies in this document form the 
basis for recommendations on the pr evention and control of HCAIs. 
Expertise and data were also  obtained from the ECDC.  
EC funded projects  
Projects funded by the Public Health Programme6 and by the Research Framework 
Programmes7 have also addressed aspects of the problem of patient safety and HCAIs. 
Details of some of these are in  section 3 and/ or in Annex 1. 
Public consultation – preliminary results  
A web-based public consultation on actions on patient safety was launched on 25 March 
2008 and closed on 20 May 2008. 184 responses were received. 
The participants can be divided into ei ght categories, as in  the table below. 
Table 1: Overview of the responses received 
Group Number of responses 
NGO's 36 
Competent authorities total 32 
CA's at national level  17 
(CY; CZ; FI; IE; LV; SE; UK; MT, ES) 
CA's at regional level 10 
                                                 
5 OJ L 268/1 Decision No 2119/98/EC of the European Parliament and of the Council of 24 
September 1998 setting up a network for the epidemiological surveillance and control of 
communicable diseases in the Community 
6 http://ec.europa.eu/health/p h_projects/project_en.htm 
7 http://ec.europa.eu/research/index.cfm 
 
EN 9   EN CA's at local level 5 
Health professional associations 25 
Hospitals 21 
Patient and Consumer organisations 12 
Industry 8 
Academia 6 
Anonymous responses and others 44 
Participants total 184 
 
As shown in the table above, the NGO's repr esented the biggest gr oup with 19% of the 
total responses, followed by the competent au thorities with 17%, health professionals 
with 14%, hospitals with 11%, patient and c onsumer organisations with 6%, industry 4%, 
with and academia with 3%. Twenty-four perc ent of the responses were anonymous or 
could not be categorised in any of the gr oups mentioned. In addition, 19 replies were 
received outside of the on-line system. 
From a preliminary analysis, the responses in dicated strong support for both national and 
Community action on patient safety, as  illustrated in the chart below. 
Figure 1: Importance of a national or EU Patient Safety (PS) Strategy 
Importance of a National or EU PS-Strategy
171163144
0%10%20%30%40%50%60%70%80%90%100%
National PS- Strategy EU PS-StrategyVery important/ important not particularly important/ not important 
 
In the questionnaire, the Commission put forw ard nine possible areas of action. All of 
these received strong support fr om an overwhelming majority of participants. The chart 
below shows how the areas were ranked. In fact, political leadership and financial 
support  (26%) and a reporting and learning system  (20%)  were viewed as the most 
 
EN 10   EN essential components followed by health professional involvement in policy 
development (11%) and patient safety education for health professionals (11%)  (Figure 
2). 
Figure 2: Priority ranking of essential components of a patient safety strategy 
Priority ranking of Essential Components of a Patient Safety Strategy
26%
20%
5%11%11%8%5%7%4% 3%
political leadership and financial support a reporting and learning system
patient involvement in policy development health professional involvement in policy development
patient safety education for health professionals standards and/ external assessment for patient safety
patient safety indicators a dedicated patient safety research agenda and budget
a compensation system for those harmed by healthcare other 
A summary report of the consu ltation containing a detailed an alysis of the contributions 
received is being drafted and will be published shortly. 
On the specific topic of HCAIs, a separate  consultation on the document 'Strategies for 
improving patient safety by prevention and cont rol of healthcare-associated infections' 
was held from 28 November 2005 to 20 January  2006. Contributions we re received from 
national and regional health authorities, hospi tal and professional organisations, networks 
on prevention and control of HCAIs, research  institutes and patie nt associations. The 
Commission has evaluated the replies. The resu lts of the consultation will be published in 
the near future. 
External expert support to the impact assessment  
The IA was supported by an external project to  inform this impact assessment, with focus 
on the impact (and potential impacts) of th ree key areas of possible action on patient 
safety – the introduction of reporting and learning systems, redress mechanisms and 
developing and using knowledge and eviden ce. The project included a thorough review 
of peer-reviewed and grey literature, c onducted preliminary data extraction and 
interviewed over thirty patient safety policy-makers and experts. 
The ECDC and the panel of e xperts in the field of infe ction control also provided 
scientific input to the impact assessment. 
On 4-5 June 2008, the Commission met hosp ital managers and infection control 
managers from EU hospitals and with a re presentative of the European Federation of 
Nurses to discuss the validity of the vari ous assumptions made on the prevention and 
control of HCAIs in this impact assessment. 
1.2.2.  Internal consultation and expertise 
Other activities of the Commission or its agenc ies addressing specific aspects of patient 
safety  
 
EN 11   EN There are a number of other ongoing or pla nned activities co-ordin ated by the European 
Commission or its agencies aiming to addre ss specific patient safety issues. These are 
described in more detail in section 3. 
Inter-service coordination  
An inter-service steering group was esta blished in autumn 2007. DGs EMPL, ENTR, 
MARKT, RTD, SG, INFSO and EAC attended eith er or both of its two meetings on 14 
November 2007 and 2 June 2008. 
1.3. The Impact Assessment Board 
The draft Impact Assessment was submitted to the Board on 11 June 2008. The present 
version of the IA takes account of the recommendations given by the Board in its opinion of 14 July. The key amendments made to th e impact assessment following the issuing of 
the Board opinion are: 
– Clarification of the baseline scenario, including identification of existing policies and 
the problems of the current situation, as we ll as best practice in Member States, now 
included in the problem section (section 3).  
– Clarification on the EU dimension of  the identified problems and finally 
– Clarification of the objectives at general, specific and operational level 
We therefore streamlined the 'problems still to be addressed' section and reduced issues 
from nine to seven and focussed in particul ar on those with a clear EU component such 
as the need for homogenous patient safety data to be able to compare safety levels across the EU. Also the objectives were streamlin ed as to allow for a more transparent 
comparison of options. 
We inserted a new section into the descripti on of the baseline scenario to better link it 
with the projects listed in Annex I and describe d in more detail current best practice, as 
well as levels of meticillin-resistant Staphyloc occus aureus (MRSA) as an example of the 
problem of HCAIs in the Member States. 
2. T
ERMINOLOGY  
Patient safety is defined as freedom for a patient from unnecessary harm or potential 
harm associated with healthcare. A patient sa fety incident is an event or circumstance 
which could have resulted, or did result, in unnecessary harm to a patient. An adverse 
event is an incident which results in harm  to a patient. Harm implies impairment of 
structure or function of the body and/or any deleterious effe ct arising there from. Harm 
includes disease, injury, suffering, disability and death and may thus be physical, social 
or psychological8. 
HCAIs are defined as any dise ase or pathology (illness, inflammation) related to the 
presence of an infectious micro-organism (bacteria, fungi, viruses, parasites and other 
                                                 
8 The International classification for patient safety: Version 1.0 for use in field testing 2007 - 2008 
(ICPS). Geneva: WHO World Alliance for Patient Safety; 2007. 
 
EN 12   EN transmissible agents) or its products as a resu lt of exposure to healthcare facilities or 
healthcare procedures.  
3. THE PROBLEM AND ITS CAUSES  
3.1. Adverse Events: The Size of the Problem 
There is a limited but growi ng body of evidence concerning th e prevalence and incidence 
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. From  these studies and from Key Informant 
Interviews conducted for an external project  informing the impact assessment, it is 
estimated that in EU Member States betw een 8% and 12% of patients admitted to 
hospitals suffer from adverse eff ects whilst receiving healthcare. 
In the UK, a National Health Serv ice (NHS) report in 2000, An Organisation with a 
Memory , revealed that poor 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 exp erienced serious adverse 
reactions to drugs . According to the 2006 Spanish Na tional 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 
the 7 days’ observation per unit at least one adverse event was observed in 55% of 
surgical units and 40% of medical units . 35.4% of the adverse events were 
considered to have been preventable . More detail on these studies is in Annex 2. 
Data from OECD on the prevalence of advers e event mortality in the table below show 
that adverse events occurred in many Member St ates, but also indicate that there are large 
gaps in the data about patient safety. Compar ability of incidence data is also limited as 
low prevalence rates might simply mean low reporting and apparently  higher prevalence 
rates may indicate better data capture through more advanced reporting systems.  
Table 2: Prevalence and burden of adverse event mortality 
    Adverse care events   Adverse drug events 
    Total 
deaths Deaths per 
100,000 Years lost /100,000
   Total 
deaths Deaths per 
100,000 Years lost /100,000
 
EU-27        
 Austria 99 1.0 16  4 0.0 1 
 Czech Republic 5 0.0 0  3 0.0 0 
 Denmark 6 0.1 1   -  -  - 
 France 492 0.5 2  848 0.9 3 
 Germany 635 0.5 5  72 0.1 1 
 Greece 128 0.9 11  2 0.0 0 
 Hungary 30 0.2 4  4 0.0 1 
 Ireland 17 0.4 8  3 0.1 2 
 Italy4 347 0.4 4  11 0.0 0 
 Luxembourg 1 0.2 1  2 0.4 3 
 
EN 13   EN  Netherlands 17 0.1 0  3 0.0 0 
 Poland 232 0.5 5  22 0.1 1 
 Portugal 23 0.2 1  13 0.1 1 
 Slovakia 4 0.1 0  1 0.0 0 
 Spain 255 0.5 5  264 0.4 2 
 Sweden 120 0.6 1  9 0.1 0 
 UK 413 0.5 3  36 0.0 1 
No data available for: Belgium, Bu lgaria, Cyprus, Estonia,  Finland, Latvia, Lithuania, Malta, Romania, 
Slovenia 
International        
 USA 2460 0.7 6  317 0.1 2 
 Australia 176 0.7 2  47 0.2 2 
 New Zealand 8 0.2 4  5 0.1 3 
 Canada 197 0.5 4  22 0.1 0 
  Japan 424 0.2 3   76 0.0 1 
 
Source: OECD Health Data 2007 
Despite the gaps in data, what is available,  and the results of re search studies, reveal 
similar patterns, and suggest substantial health costs and economic costs (and hence 
substantial potential savings ) due to adverse events. 
The sources of adverse events and harm in healthcare settings are many. The Spanish 
ENEAS study indicates the main causes of adve rse events in Spain. As shown in table 3, 
medication related adverse events account fo r 37% of the total, followed by nosocomial 
infection-related (25%) and procedure-related adverse events (25%). A complete overview of the scale of the patient safety  problem can be found in chapter 3.3 of the 
external study supporting this impact assessment. 
Table 3: Type of adverse events  
Adverse events AE's % 
Related to the care provided 50 7.63 
Medication-related 245 37.4 
Nosocomial infection-related 166 25.34 
Procedure-related 164 25.04 
Diagnosis-related 18 2.75 
Others 12 1.83 
TOTAL 655 100.00 
 
Source: ENEAS 2006 
The results of the public c onsultation on patient safety confirmed the diversity of 
experienced adverse events (examples ci ted included medicati on-related, error in 
diagnosis, communication problems, surger y-related events, medical device or 
equipment related events and HCAIs). Medicati on-related events and errors in diagnosis 
 
EN 14   EN were the most frequently experienced in re spondents' own country and in other Member 
States. 
HCAIs, a key focus of the current initiativ e, are among the most important causes of 
unintended harm. Incidence figures for all ty pes of HCAIs are not available for all EU 
Member States. However, on the basis of recent national HCAI prevalence surveys and 
the results of hospital-wide surveillance pr ogrammes of nosocomial bacteraemia in EU 
Member States, it can be calculated that HC AIs affect 5% of hospital patients on average 
and the total number of hospital patients acqui ring at least one HCAI in the EU every 
year can be estimated at 4.1 million. Approxi mately 37,000 deaths are estimated to occur 
every year from these inf ections (see Annex 3). 
For MRSA, a well-known micro-organism cau sing HCAIs, data for all EU Member 
States are available; significant differences i n  l e v e l s  o f  M R S A  r a t e s  c a n  b e  s e e n  a s  
illustrated in Figure 3. 
Figure 3: Staphylococcus aureus : trends of meticillin-r esistance by country 1999-
2006 (EARSS Annual Report 20069) 
                                                 
9 The European Antimicrobial Resistance Surveillance System (EARSS) is a project co-funded by 
the Public Health Programme. The 20 06 annual report can be found at 
http://www.rivm.nl/earss/Images/E ARSS%202006%20Def_tcm61-44176.pdf 
 
EN 15   EN  
Southern European countries, the United Kingdom and Ireland report the highest MRSA-
rates, whereas northern European countri es still have proportions of MRSA in 
bacteraemia patients below 5%. 
HCAIs mostly occur during or af ter hospitalisation but can also  develop in the context of 
ambulatory care. Patients who acquire HCAIs ma y be acutely ill and more likely suffer 
co-morbidities and/or chronic disease. Thus  elderly people are often concerned - an 
increasing proportion of the patient populat ion. Individuals receiving antimicrobial 
chemotherapy (changing the composition of the host flora), patients with systemic or local immune defects, or with  devices such as intravenous lines and urinary catheters in 
places that by-pass their natural immune defences, are also at particular risk. 
Moreover, the infectious mi cro-organisms have frequently acquired resistance to 
antimicrobial agent(s), normally effective in  the treatment of non-HCAIs. Consequently, 
infections and colonisations caused by these micro-organisms are of ten difficult to treat 
and to eradicate from the healthcare envir onment. Owing to the ability of infectious 
micro-organisms that can cause HCAIs to co lonise patients for prolonged periods, these 

 
EN 16   EN patients may disseminate the micro-organisms both during and after th eir hospital stay. 
In this way the entire healthcare system, as well as the society as a whole, is carrying the 
burden of the increasing numbers of individua ls infected or colonised with healthcare-
associated pathogens. 
HCAIs thereby pose a consid erable, and tangible, th reat to public health. 
The main drivers relating to the incidence of  HCAIs are depicted in the flow chart in 
Annex 4.  
3.2. The Public Perception of Adverse Events 
The 2005 Eurobarometer survey on perception of medical errors  
Whilst estimating the extent of adverse events in our health systems is essential, it is also 
important to understand patients' perception of  how safe they think EU health systems 
are. The challenge is not only to ensure the safety of those system s, but also convince 
citizens who are potential patients, or the frie nds and family of patients, that they are 
safe. Patient confidence is crucial. Theref ore, in 2005, the European Commission carried 
out a Eurobarometer survey on the perception of  medical errors in the EU. The poll also 
covered the then pre-accessi on and candidate countries  and the Turkish Cypriot 
Community. The Commission published the results in 200610. 
Almost 4 in 5 EU citizens (78%) classified medical errors as an important problem in 
their country. 38% ranked the issue as very important and 40% saw the topic as fairly 
important. 23% said they or their family had been the victim of a medical error; 18% said 
this was in a hospital, while 11% said th ey had been prescrib ed the wrong medication. 
Over half of Europeans believed they cannot avoid serious medical errors in hospitals. 
The perception of citizens, therefore, is that this is a significant problem. 
3.3. Current Member State Actions  
Best Practice  
Best practice in EU MS has been identifie d using as a reference the World Alliance for 
Patient Safety's definition of the core com ponents of best practi ce in patient safety, 
especially in relation to the existence of reporting and learning systems, and MS have 
then be classified accordingly. Characteristic s of best practice in MSs, or 'exemplary' 
systems according to RAND's definitions, more details of which are included at Annex 5, include a well-developed, blame-free nationa l reporting and learning system (in addition 
to local systems to suppor t this), which covers all adverse events, an established redress 
system that includes alte rnatives to going to court (e.g. a 'no fault' liability system), the 
MS being active in initiati ves to develop and use knowle dge and evidence on patient 
safety and an established national institute or other 'competent authority' dedicated to patient safety.  
RAND found that four MSs – Belgium,  Denmark, the Netherlands and the UK – 
currently carry out best practice when th eir systems were evaluated against these 
characteristics, categorising them as havi ng ‘exemplary’ systems, including a mature, 
blame-free reporting system and an institute de dicated to patient safety. Three countries 
                                                
 
10 http://ec.europa.eu/health/ph_publication/eurobarometers_en.htm 
 
EN 17   EN (Germany, Czech Republic, Slovak Republic) were categorised as ‘very good’; they had 
well-established and functioning reporting systems but these were not fully blame-free. 
Eight Member States (Sweden, Republic of Ireland, Spain, Bulgaria, France, Finland, 
Portugal, Austria) were classified as ‘good’  as they had only pa rtial reporting systems 
which did not cover all types of adverse ev ents. Five countries (Hungary, Lithuania, 
Latvia, Poland, Italy) were classified as ‘f air’ as their reporting systems were not at a 
national level. Finally, three countries (Slo venia, Greece, Cyprus) were considered to 
have ‘poor’ patient safety systems in that  they had no patient safety reporting and 
learning system.  
Of course, whilst it is logical to assume th at there will be a positive direct causal 
relationship between the preferab le characteristics of a patient safety system in Member 
States, as defined by RAND, a nd patient safety outcomes, the immaturity of patient 
safety research and evaluation means that we ca n not prove this for sure at this point in 
time. Further research, monitori ng and evaluation should make th is link clearer in future.  
In the area of HCAIs, strategi es to prevent and control HC AIs have been developed in 
different Member States and show positiv e results where a strong commitment for 
effective implementation exists. Best prac tice examples include entry screening of 
patients for colonisation with resistant micro- organisms, isolation of patients colonised 
with resistant micro-organisms, screening of  healthcare staff, deco lonisation of patients 
and healthcare staff, strict hygiene practices , surveillance and restri ctive antibiotic use. 
For example, the uncompromising “search-and-destroy” policy (based on the above-mentioned best practices) in th e Netherlands and in Nordic countries is thought to play an 
important role in the low prevalen ce of MRSA in th ese countries. 
Therefore, for patient safety efforts in ge neral and specific measures to prevent and 
control HCAIs, there is clearly much to be gained by shari ng knowledge and best 
practice;  
3.4. Current EU Actions 
3.4.1.  European Commission Activities 
Medication errors are already the focus of cu rrent EU legislation and initiatives. For 
example, the Commission is responsible  for legislation in the areas of 
pharmacovigilance, which it is in the pro cess of revising. The European Medicines 
Agency is currently developing new requireme nts for the naming of centrally-authorised 
medicines to try to reduce medication errors due to look-alike and sound-alike medicines. 
The Commission has also recently revised its le gislation on the safety of medical devices. 
Within the Open Method of Coordination, th e Commission adopted in  June 2006 a set of 
common indicators for the social protection and social inclusion process including health 
and long-term care. 
In addition, the Commission is de veloping e-health systems at  the European level (e.g. 
through the lead market initiative).Using new technology to improve patient safety in 
healthcare setting is one key el ement of this. Patient safety research is also included in 
the Commission’s 7
th Framework Programme, which also covers eHealth patient safety 
solutions. 
 
EN 18   EN The Commission also continues the follow-up of Council Recommendation 
(2002/77/EC) on the prudent use of antimicrobial  agents in human me dicine. Indeed, the 
growing levels of resistance in micro-orga nisms causing HCAIs due to inappropriate use 
of antibiotics is of concern. Therefore, the Commission is pl anning a second report to the 
Council on the implementation of Council Recommendation (2002/77/EC), outlining the progress made and the issues needing further attention. 
3.4.2.  Projects Co-Funded by the European Community 
A number of European Co mmunity co-funded projects on patient safety, including 
HCAIs, have either been completed or are cu rrently still carrying out  their work. A full 
list can be found at Annex 1 but two of th e most important are described below. 
EUNetPaS (European Union Network for Patient Safety) was launched in February 2008. 
It aims to establish an umbrella network of Member States and EU stakeholders to 
encourage and enhance collaboration in th e field of Patient Safety by evaluating, 
validating and diffusing new knowledge and good practices. 
The IPSE project (Improving Patient Safety in Europe) aims to reduce the burden of 
HCAIs and their related threats of antim icrobial resistance (AMR) by providing 
evidence-based guidance and educational tool s, strengthening the status of infection 
control professionals, strengthening su rveillance and developing indicators. 
3.5. Problems still to be addressed 
The Health Strategy White Paper
11 adopted last year demonstrates how much has already 
been achieved in health policy at the EU level in a range of areas, based on different parts 
of the Treaty, for example in health and safe ty at work, pharmaceuticals, public health, 
food safety, research and environment. Fo llowing the introduction of specific public 
health provisions into the EU Treaties12, in the 1990s a large number of individual issues 
have been addressed such as cancer, communicable diseases, rare diseases, health promotion and most recently alcohol related ha rm and healthy diets. All these initiatives 
were intended to co-ordinate and stimulate a wide range of activities in the specific 
health policy field.  
The patient safety policy area is no di fferent. As described in Section 1.1, EU 
involvement in patient safety policy dates back to the World Health Assembly resolution 
of 2002 and led to the recommendations by the High Level Group on Health Services 
and Medical Care in 2005. Al ongside policy discussions; se veral focused initiatives 
developed, including the work of the Networ k on Communicable Diseases and of ECDC, 
as well as a number of EU-funded projects (see Annex 1) and initiativ es in related areas 
of R&D and technological development.  
However, despite current best practice in MS s and the measures already being taken at 
the EU level in specific patient safety areas  already described, ther e is still a need for 
further action on patient safety at the EU le vel. The measures currently being taken in 
some MSs or at the EU level are not in them selves sufficient due to: (i) the absence of a 
clear and firm political commitment to action on patient safety from  all MSs; (ii) the 
                                                
 
11 White Paper "Together for Health: A Strategic Approach for the EU 2008-2013", COM(2007) 630 
12 Initially in Article 129 of the Maastricht Treaty a nd then in a strengthened form in Article 152 of 
the Treaty of Amsterdam 
 
EN 19   EN limited time-span of EU co-funded projects , meaning there could be no guaranteed 
longer-term action on patient safety at the EU level; (iii) failure of current initiatives to 
optimise the safety of cross-border patients.Th e current initiative is built on a number of 
diverse actions as described, and is intende d to create a framework to stimulate policy 
development and future action in, and betw een, Member States, to address the key 
remaining patient safety issues and problem s confronting the EU, which are set out in 
more detail below. 
1. Member States have varying levels  of awareness of the human and 
economic costs of adverse events occurri ng in their health systems and we 
see, therefore, varying levels of politi cal commitment 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-set ting and, therefore, at di fferent stages in the 
development and implementation of eff ective, comprehensive patient safety 
systems. 
The prevention and control of HCAIs is im portant for healthcare institutions as 
well as for national healthcare budgets and society at large. In the absence of 
political commitment, healthcare institutio ns will not always be motivated to 
invest adequately in the prev ention and control of HCAIs. 
The variability of the existence of patient safety policies, systems, processes and 
cultures among EU Member States was identified by the SI MPATIE project. 
RAND Europe reviewed its findings categorised the 23 EU Member States involved according to their patient safety systems, policies, structures and 
processes. Best practice has already been  explained earlier. Currently only four 
EU MS meet that best practice. 
The EU could play a role in ensuring th e communication of the core components 
of 'best practice' patient safety systems to all MSs. To achieve the necessary political commitment at national level, a 'push' from the EU level will support 
Member States to make patient safety  a priority in national public health 
objectives. 
2. No comparable data on incidence rates across EU and hence no possibility 
to compare patient safety levels and policies 
Closely linked to the fact that not all MS  have patient safety policies in place is 
the uneven picture on adverse events incide nce in all EU MS, as shown in table 
2. It is currently not possibly to obtain a nd compare data on patient safety levels 
for all EU MS. Therefore, comparable and aggregate data on the level of adverse 
events in healthcare settings, and on how  many of these were realistically 
preventable, should be collected.  
When there is not enough information avai lable to MS authorities or the public 
on the extent and type of adverse events in healthcare systems it is difficult for those authorities to decide where to best  dedicate scarce resources to improve 
patient safety or for patients to make an informed judgment. An additional consideration is that the cross-border mobility of patients means that some patients may face a choice or decision to  access healthcare in a Member State 
 
EN 20   EN other than their own. Others may have no choice but to do so. How do those 
patients know whether those health systems are as safe, safer or less safe than their own and what types of harm are they  at particular risk from if accessing 
health systems at home or in another MS? 
Also, when a patient is harmed  or even dies as a result of an adverse event, what 
support can that patient or their family expect from the healthcare system or 
authorities? Patients accessing healthca re, either in their home country or 
another Member State, need to know how  to make a formal  complaint, what 
help, support and redress is available to them if they are harmed by that 
healthcare and how to access it. There is clearly a case to have data in all 
Member States which will help people to make informed choices or decisions about their care in terms of safety, suppor t and possible redress, as well as to 
inform the relevant authorities. 
Hence the need to develop a common 'l anguage' or taxonomy' for patient safety 
within the EU - to make comparisons and learning easier and to be used to drive 
up performance. It is evident that  such a common taxonomy can only be 
achieved jointly at the EU level. 
The incidence of HCAIs is often underestimated because of inadequate 
surveillance. Insufficient data on the incidence of HCAIs in healthcare institutions makes it difficult to guid e and evaluate the implementation of 
infection control measures and to comp are rates between institutions as a 
measure of performance. At national level,  insufficient surveillance data make it 
difficult to compare healthcare institutions  in terms of HCAI incidence rates and 
hamper the follow up of the epidemiology of HCAIs in order to detect trends 
and emerging resistant micro-organisms.  In addition, agreed structure and 
process indicators are lacking to eval uate the performance of healthcare 
institutions in a comparable way. 
A comprehensive set of co mmon indicators to monitor healthcare safety in 
Member States, including HCAI levels, is necessary. 
3. Current research findings, learning, ex periences and expertise available in 
the EU do not sufficiently benefit pati ents because dissemina tion of effective 
patient safety interventions and soluti ons is not coordinated or routinely 
carried out at the EU level. 
When patients access healthcare in their own country, or in another Member 
State, they expect to receive the safest possible care – that is healthcare that has 
minimised the possibility of adverse events and preventable harm occurring. Patients would benefit from those reporti ng and learning systems that do exist in 
MSs being mined, and research findings  being analysed, to inform the 
development of effective solutions a nd interventions which would then be 
shared throughou t the EU. The EU can play a role in ensuring this dissemination 
of solutions and interventions. 
4. Senior management in healthcare in stitutions does not have enough 
commitment towards the p revention and control of adverse incidents, 
above all HCAIs. Not enough resea rch on the cost-effectiveness of 
prevention and control of HCAIs. 
 
EN 21   EN Experience shows that, in most Member States, healthcare institutions approach 
HCAIs in a reactive instead of a proac tive way. The prevention and control of 
HCAIs is often perceived by the senior ma nagement of healthcar e institutions as 
a net cost factor and often measures ar e only put in place after the healthcare 
institution has been confronted  with an outbreak of HCAIs. 
Although evidence is available, there is not enough research on the cost-
effectiveness of prevention and control in healthcare institutions and at the level of national healthcare budgets and for society at large. In addition, there is not enough dissemination of best practices in healthcare institutions  that have been 
shown to be cost-effective. 
This part of the action to improve patient safety is best addressed at the 
local/regional level, but political owners hip and stewardship at national and EU 
level is essential to support the cultural change necessary. In addition, tools such 
as the Public Health Programme are us eful to stimulate research on cost-
effectiveness of public health interventions and to disseminate these results throughout the EU. 
5. Not enough awareness among healthca re staff on the issue of HCAIs and 
insufficient training on ways to p revent and control HCAIs. Not enough 
authoritative guidance is available to suppo rt infection contro l staff, such as 
EU agreed case definitions, guid ance on best practice and minimum 
requirements for infrastructure. 
To bring about the necessary changes, a first step is that all staff in healthcare 
institutions need to be informed a bout the problem of HCAIs. In addition, 
healthcare staff are often insufficiently trained on ways to prevent and control 
HCAIs. The lack of awareness and tr aining results for example in poor 
compliance with hygiene practices which is an important driver in the incidence 
of HCAIs. This is a fundamental pr oblem in the majority of healthcare 
institutions throughout the EU. 
Although HCAIs are a multifaceted problem, ways to prevent and control it are 
well understood. Nevertheless,  the information is rather fragmented and 
authoritative guidance pooling the best  expertise available is lacking. 
At EU level, the ECDC can play an impor tant role in pooling the best expertise 
to develop training and guidance, and as sist Member States in implementing 
training and curricula for a ll healthcare staff and fo r infection control staff
13. 
6. Antimicrobial resistance 
A particularly important problem is that of the growing levels of resistance in 
the micro-organisms involved in HCAI . This means that infections and 
colonisations caused by them are often difficult to treat and difficult to eradicate from the healthcare environment. The inappropriate use of antibiotics is a key 
                                                
 
13 A European Core curriculum for training for infection control staff has been developed by the 
IPSE project and can be found at: http://helics.univ-
lyon1.fr/Working%20packages/WP1/Core%20Curriculum%20Report.pdf. After the end of the IPSE project, many of the IPSE activities will be taken over by ECDC. 
 
EN 22   EN driver in the problem of antimicrobi al resistance. A Council Recommendation 
2002/77/EC, based also on the provisions of  Article 152, dealt with the prudent 
use of antimicrobial agents in human medicine, and outlined clear-cut measures to be taken at national and EU level to  reduce antimicrobial resistance. In 2005, 
the Commission issued a report to C ouncil (COM (2005) 0684) on the measures 
taken and the areas needing further a ttention. The Commission is following up 
this important issue and plans a second report to  Council in 2009. 
7. Spread of micro-organisms causing HCAIs 
Throughout the EU, there is an increased movement of patients and healthcare 
staff within healthcare institutions. Ther e is also an increased movement of 
patients and healthcare staff between he althcare institutions (nationally and 
internationally) These increased movement s contribute to the spread of micro-
organisms causing HCAIs. Budgetary constraints in healthcare institutions can not only lead to high bed occupancy rates a nd poor staff to patient ratios but also 
to insufficient infrastructure (such as isolation facilities) to control the spread of micro-organisms. 
Although there is no evidence available at this time to  suggest that the cross-
border movement of patients in itself pr esents a specific additional risk to 
patient safety, the fact that patients ar e increasingly making us e of their rights to 
access healthcare in other MSs (as set out in  the Directive on the Application of 
Patients' Rights in Cross-Border Health care), means that the problems described 
above can be detrimental to citizens of  other MSs too, making the EU a valid 
participant in actions to attempt to so lve these problems. Surveillance at EU 
level, based on data gathered by the Memb er States, can detect emerging threats 
quickly and can coordinate a quick a nd effective response to these micro-
organisms that are not constrained by national borders. 
4. T
HE RIGHT OF THE UNION TO ACT – SUBSIDIARITY TEST  
The problem of patient safety is primarily the responsibility of Member States. The 
European Union can support their efforts by taking actions where it has competence and - more broadly - in facilitating the exchange of good practices. As far as specific work on 
patient safety is concerned, the following areas of competence are relevant: 
• Article 152 (public health)  states that “Community act ion, which shall complement 
national policies, shall be directed towards [..] preventing human illness and diseases, 
and obviating sources of danger to human h ealth. [..] The Commun ity shall encourage 
cooperation between the Member St ates in the areas referred to in this Article and, if 
necessary, lend support to their action”. This su pports work on systemic patient safety 
as well as that on HCAIs. 
• Article 153 (consumer protection)  provides an additional asp ect especially linked to 
people's right to information. Both articl es fall under shared Community and Member 
State competence. 
 
EN 23   EN • Besides the Treaty basis, Annex I of Commission Decision 2000/96/EC14 identifies 
nosocomial infections (or hospital acquired inf ections) as one of the health issues to 
be progressively covered by the Community  network established under Decision No 
2119/98/EC. 
• The High Level Group on Health Services and Medical Care has endorsed a number 
of recommended actions in the area of patient safety where European level 
collaboration and coordination of act ivities could bring added value. 
In areas closely related to pa tient safety, Member States have previously agreed on the 
right and the added value of the Union to act: 
• Council Recommendation (2002/77/EC) of 15 November 2001 on the prudent use of 
antimicrobial agents in human medicine. 
• Directive 2002/98/EC of the European Par liament and of the Council of 27 January 
2003 setting standards of quality and safety  for the collection, testing, processing, 
storage and distribution of human bl ood and blood components and amending 
Directive 2001/83/EC. 
• 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, st orage and distribution of human tissues and cells 
The legal base exists to take action at EU level; this is how ever not enough to justify EU 
involvement. The subsidiarity test assesses whether EU action is necessary, in other 
words whether action by a Member State or a group of Member States cannot sufficiently 
solve the problem. The test then evaluates wh ether action at EU-level  adds value to the 
work done by Member States (the 'added-value test'), and it asks if the measures chosen are proportionate to the objectives  (the 'boundary test'). This se ction looks at the first two 
elements of the test. 
Necessity Test
 
The arguments justifying the necessity of EU action on patient safety focus on 3 
elements: 
• Trans-boundary spread of infections 
• Cross-border provision of healthcare resulting from mobility of patients and 
professionals 
• Need for EU-wide data co llection and monitoring. 
Firstly, HCAIs can easily be transmitted from one Member State to another because of 
the mobility of patients. Micro-organisms are not constrained by national boundaries and 
can rapidly spread between countries as evid enced by the internati onal spread of MRSA 
and Clostridium difficile  PCR ribotype 027. In this area, it is therefore crucial that all MS 
                                                 
14 Commission Decision (2000/ 96/EC) of 22 December 1999 on th e communicable diseases to be 
progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council. O.J. No L 28, 3.2.2000 
 
EN 24   EN are actively engaged and cooperation and coor dination at EU will assist Member States 
in their actions. 
As regards the cross border movements of pa tients and healthcare professionals, they are 
currently still low, with only an estimated 1% of patients receiving treatment in another 
Member States in any year, but this is greater  in border regions and is likely to increase 
with general population mobility.  
For many, concerns about the safety or quality  of healthcare systems in other Member 
States are the main factors impeding their us e of services elsewher e. In addition, some 
patients crossing borders to re ceive healthcare will also not be guaranteed the same level 
of redress (or any at all) that they would be  entitled to in their own health system, if 
something does go wrong.  
Finally, the European Commission as an internat ional institution is well placed to collect 
comparable data from the EU-27. Analysis at  EU level allows aggr egation of data and 
more effective analysis of trends and deve lopments as well as identification of best 
practice and solutions. This is all the more important as there is little co-operation 
between Member States to pr ovide comparable data. Even  though some Member States 
have well-developed data systems, these ar e not always compatible, and some Member 
States have very limited data.  
The other benefits of this  activity will be discusse d under the added-value test. 
Added-value test  
The added-value of EU activit y in the area of patient safe ty concentrates around three 
main factors: 
• EU providing political weight and visibility, thus putting pati ent safety at the centre of 
MSs health priorities 
• Economies of scale – benefits of community  wide collection of data, filling in the 
gaps in research. 
• Effective knowledge sharing through  exchange of best practice. 
Ensuring patient safety should be a very high pr iority – perhaps the hi ghest priority – for 
Member States' healthcare systems. The EU's  focus on this issue can help to improve 
knowledge and awareness, to s uggest cost-effective solutions and thus persuade Member 
States to make more efforts towards keeping patients safe. Current evidence suggests that 
EU Member States are at different levels of  political awareness about the patient safety 
issue and therefore also as regards devel opment of effective, comprehensive patient 
safety systems. 
On the other hand, available evidence from so me MSs and non EU countries such as the 
US and New Zealand suggests that incidence rates, type s of errors and potential 
effectiveness gains are similar in all health systems. At the moment, however, with reporting of adverse events not done everywhere , there are still significant data gaps as 
regards the patient safety levels and policie s in the EU, which is why common definitions 
and data collection at EU level are needed. A broad list of indicato rs on patient safety 
will be needed in light of the systemic nature  of the patient safety issue, as well as the 
 
EN 25   EN multitude of causes. The Member States can thus also benefit from economies of scale 
linked to EU involvement. 
Finally, cooperation at European  level using the best  available evidence and expertise has 
great potential to bring added value both to individual patients a nd to health systems 
overall. By tackling common problems at th e EU level, European expertise can be 
pooled, inequalities stemming fr om unsafe care reduced, and duplication of effort and 
resources avoided. One aspect where EU level action provides added-value is the 
effective use of ICT systems for patient safe ty purposes where cross-border issues such 
as inter-operability arise. A nother aspect would be to agree upon case definitions for 
HCAIs and common indicators to measure the implementation and performance of 
measures to prevent and control HCAIs. 
Similarly, Member States may implement – to different degrees – rules and incentives for 
the prevention and control of HCAIs, and pr ofessional groups and ke y stakeholders may 
continue to provide non-statutory guidance. However, in most Member States, these 
actions have so far not achieved the necessa ry organisational and behavioural changes 
needed to bring down the incidence of HCAIs. 
5. OBJECTIVES  
5.1. General objective 
The general objective is to prevent and reduc e human illness and diseases and to obviate 
sources of danger to human health, as s tipulated in Article 152 of the Treaty. 
5.2. Specific objectives 
1. to protect EU citizens from preventabl e harm in healthcare, including from 
HCAIs. 
2. to support the Member States to put in place the proper and adequate strategies 
to prevent and control adverse events  in healthcare, including HCAIs, by 
pooling the best available eviden ce and expertise in the EU. 
3. to improve EU citizens' confidence that they have sufficient and comprehensible 
information available on levels of safe ty and available redress in EU health 
systems, including healthcare provider s in their own country and in other 
Member States. 
4. These objectives should result in fewer preventable deaths and illnesses and in a 
reduction in costs treating unn ecessarily sick patients. 
5.3. Operational objectives 
1. Increase political awareness on the scale a nd size of the patient safety issue, as 
well as promoting adequate Member States' political commitment and acceptance. 
2. Gather homogenous and comparable data  and information on patient safety 
systems, initiatives and safety outcomes at EU level. 
 
EN 26   EN 3. Share best practice and experience of MS efforts to establish efficient and 
transparent patient safety systems, st ructures and policies, including reporting 
and learning systems, education and tr aining developments, use of indicators 
and/or standards and efforts to improve culture, on adverse events in healthcare. To share at the EU level, experiences of successful (as well as less successful) 
patient safety interventions and solutions at the healthcare setting level, for 
example the introduction of a new patien t identification system or efforts to 
reduce mistakes from look-alike medicines,  implemented in one or more 
Member State and evaluate the transferab ility of those soluti ons, and also share 
major patient safety alerts among all MSs. 
4. In the area of HCAIs, foster with the European Centre for Disease Prevention 
and Control (ECDC) the establishment of  surveillance methods, indicators to 
allow evaluation of the implementation and effectiveness of measures to prevent and control HCAIs, guidance on best pr actices and minimum infrastructure 
requirements, as well as training curricula for healthcare staff. 
5. Develop common definitions and terminology for patient safety at the European 
Union level, including case definitions for HCAIs. 
6. Explore indicators for safety and quality of care. 
7. Consider other existing data sources, such as patient complaints, compensation 
systems, clinical databases, monitoring systems and other adverse incident reporting systems (such as t hose in the areas of medical device vigilance and 
pharmacovigilance) as complementary sources of information on patient safety. The compatibility of the data sources and the different reporting systems should 
be regularly reviewed. 
8. Develop and promote the research agenda on patient safety, at both MS and EU 
levels, particularly focusing on filling the current research gaps, including 
further research on the cost-effectiveness of prevention and c ontrol of HCAIs.  
9. Promote the availability of information for patients and their families on how to 
complain, and what redress is available and how to access that redress, when 
patients are harmed by healthcare. 
10. Promote collaboration on patient safety issues between Member States, ECDC, 
EU institutions and key European and international organizations such as the WHO, OECD and CoE to ensure an integrated and consistent approach towards safer patient care. 
6. P
OLICY OPTIONS  
Option I: No additional EU action –status quo 
The baseline scenario has been ex tensively described in section 3. 
Under this option, the Member States, stakeholders and inte rnational organisations would 
pursue their activities on patient safety wit hout any further co-ordination or incentives 
from the Commission. 
 
EN 27   EN Member States' representatives would come together with stakeholders on a voluntary 
basis as now to discuss patient safety issu es and possible EU activities such as EU 
funded projects. Similarly, Member States would implement – to different degrees – 
rules and incentives to increase patient sa fety including the prev ention and control of 
HCAIs; networks, professional groups and ke y stakeholders will continue to provide 
guidance15. 
The Commission would continue  co-funding projects on patient  safety including HCAIs 
via the Public Health Progr amme and the Framework Programme for research and 
technological development. Community actio ns trying to improve specific aspects of 
patient safety such as pharmacovigilance or medical device safety w ould also be carried 
forward. 
The baseline scenario reflects the current situat ion and, therefore, includes the effects of 
the existing policies and projects as listed in section 3 and in Annex I. That means that 
this option also includes estimated effects of  the EUNetPaS project that would continue 
to exist regardless of further action at EU level. 
Option II: Strengthened cooperation with the Member States and other bodies, 
supported by technical guidance 
Under this option, the Commi ssion would strengthen cooperat ion with Member States 
and other bodies by making in creased use of the instrume nts described under option I. 
For example, the Commission could increase the focus on patient safety including HCAIs in the Health Programme and the Framework Programme for research and 
technological development. The Commission coul d also step up its efforts in stimulating 
Member States to cooperate on the issue of  HCAIs and to develop technical guidance 
through the ECDC and the netw ork of surveillance bodies. 
Article 5 of Regulation (EC) No 851/2004 of th e European Parliament and of the Council 
establishing a European centre for disease prevention and control
16 stipulates that " The 
Centre, through the operation of  the dedicated surveillance networks and the provision 
of technical and scientific expertise to th e Commission and Member States, shall support 
the networking activities of the competent bodies recognised by the Member States. " 
Member States have designated such bodies under Commission Decision 2003/542/EC17 
and ECDC could coordinate these bodies to: 
• identify main problems at European level and facilitate mutual information, 
consultation, cooperation, and action thr ough the Community network (Decision No 
2119/98/EC) 
• establish / strengthen EU-wide surveill ance on HCAIs and develop a strategy for 
access to data from surveillance systems fo r HCAIs, risk factors and indicators 
• establish guidance on best practice on th e prevention and control of HCAIs, and 
minimum infrastructure requirements 
                                                 
15 e.g. guidance developed by ‘Improving Patient Safety in Europe (IPSE)’, a project funded by the 
Public Health Programme. 
16 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. O.J. No L 142, 30.4.2004 
17 Commission Decision 2003/542/EC of 17 July 2003 amending Decision 2000/96/EC as regards 
the operation of dedicated surveillan ce networks. O.J. No L 185, 24.7.2003 
 
EN 28   EN • foster training and e ducation initiatives 
• A comparable structure within which guidan ce on general patient sa fety issues could 
be developed is missing – with the exception of the ne wly established network for 
patient safety, EUNetPaS. However, as pr eviously mentioned, this is a time-limited 
pilot network funded under the Public Hea lth Programme which will work only in 
limited areas of patient safety. 
Option III: Strengthened cooperation with the Member States and other bodies, 
supported by soft law instruments, su ch as a Commission Communication and a 
Council Recommendation 
Under this option, the Commi ssion would strengthen cooperat ion with Member States 
and other bodies by making incr eased use of the instruments described under option I. In 
addition, the Commission would develop a Communication and seek a political 
commitment from the Member States vi a a Council Recommendation on patient safety 
and quality of health serv ices, including the preventi on and control of HCAIs. 
The Communication would describe  the broader context of pa tient safety, highlight the 
need for and types of action in the area  and outline the Commission's strategy on 
improving patient safety. 
The Council Recommendation would include ge neral recommendations on patient safety 
and provide specific recommendations on the prevention and contro l of HCAIs. The 
recommendations in the proposed Council R ecommendation would be complementary to 
Council Recommendation 2002/77/EC based on Ar ticle 152 of the Treaty and would be 
consistent with the findings of its implementation report. 
Option IV: Strengthened cooperation with the Member States and other bodies, 
supported by a regulatory instrument, such as a Commission Decision 
This option would involve extension of Opti on II with a legislativ e proposal building on 
Decision No 2119/98/EC by adopting Commissi on Decisions covering aspects on the 
prevention and control of HCAIs in acco rdance with Article 7 of Decision No 
2119/98/EC, i.e. by comitology. Decision No 21 19/98/EC established a Network for the 
epidemiological surveillance and control of  communicable diseases in the Community, 
and Commission Decision 2000/96/EC  already provided that nos ocomial infections (i.e. 
HCAIs) are a special health issue to be progressively c overed by the Community network 
under Decision No 2119/98/EC. 
For example, Article 3 c) of Decision No 2119/98/EC would allow the Commission 
adoption of a Decision covering case definiti ons for HCAIs; Article 3 d) – e) would 
allow the adoption of a Commi ssion Decision covering the natu re and type of data and 
information to be collected and transmitted in the field of epidemiological surveillance 
on HCAIs and the ways in which such data ar e to be made comparable and compatible, 
including epidemiological and micr obiological surveillance methods.  
Under this option, general patient safety issu es could not be addressed in the Decision 
due to the lack of an appropr iate legal basis which is limited to infection control and 
prevention. 
Discarded options  
 
EN 29   EN Legislation, including a Regulation or a Dire ctive on patient safety was ruled out as it 
would be extremely difficult to  justify a specific and detailed legislative action covering 
all the aspects of the proposal on the grounds of subsidiarity and proportionality, in 
particular as this is an area where primary responsibility lies with the Member States and 
there is no explicit legal basis for legislative action in this area in the Treaty. Owing to the legal unfeasibility of th is option, no screeni ng for effectiveness,  efficiency and 
consistency and no analysis of impacts is included. 
7. A
NALYSIS OF IMPACTS  
In order to assess the possi ble health and economic impacts of the different policy 
options, quantitative simulation scenarios have  been developed to support the present IA. 
These scenarios use only data for hospital set tings, not for outpatient care, as the former 
is much better documented than the latter and is  also the main setting for HCAI. It has to 
be stated that the scenarios constitute only a rough approxima tion of the policy options at 
stake. It was not the intention to overstate th e impacts, but rather to present a simulation 
of effects of co-ordinated and comprehens ive policies to reduce health burden due to 
patient safety incidents with fairly accepted degree of plausibility. The scenario analysis 
is meant to highlight in part icular the extent to which more political ownership and 
leadership would improve patient safety outcomes.  
Our scenario for general patient safety polic ies starts from the assumption that patient 
safety outcomes in various MS groups di ffer according to the systems in place and 
consequently are spread along the range of prevalence estimates for hospital-related incidents found in the literature range fr om 7 % to 16.6 % with a median of 10 %
18.  
                                                 
18 To note: Prevalence rates in outpatient care are significantly lower than in hospital settings and 
are, according to national experien ce available from one country Spai n in the range of less than 2 
% and mainly caused by mismedication.  
 
EN 30   EN Table 4: Alternative scenarios used in simulations  
 Baseline  Scenario 1  Scenario 2  Scenario 3  Scenario 4  
 
  
Country Category  prevalence of 
adverse events 
related to 
hospitalisations  ‘poor’ 
countries 
become ‘fair’  ‘poor’ and 
‘fair’ countries 
become ‘good’  ‘poor’, ‘fair’, 
and ‘good’ 
countries 
become ‘very 
good’  All countries 
become 
‘exemplary’  
‘exemplary’  7 7 7 7 7 
‘very good’  10 10 10 10 7 
‘good’  12 12 12 10 7 
‘fair’  14 14 12 10 7 
‘poor  17 14 12 10 7 
SOURCE: RAND Europe  
 
Table 5: In-patient care: esti mated number of adverse events  
 Baseline  Scenario 1  Scenario 2  Scenario 3  Scenario 4  
Simulated 
outcome  prevalence of 
adverse events 
related to 
hospitalisations  ‘poor’ countries 
become ‘fair’  ‘poor’ and 
‘fair’ countries 
become ‘good’  ‘poor’, ‘fair’, 
and ‘good’ 
countries 
become ‘very 
good’  All countries 
become 
‘exemplary’  
Adverse events  10,274,289  10,074,578  9,577,161  8,499,351  6,311,945  
Permanent 
disability  1,562,411  1,532,041  1,456,399  1,292,496  959,857  
Death  558,819  547,956 520,902  462,280  343,307  
Preventable 
adverse events  4,397,396  4,311,919  4,099,025  3,637,722  2,701,512  
Preventable 
length-of-stay 
(person-years)  50,845  49,857  47,395  42,061  31,236  
SOURCE: RAND Europe  
 
Table 6: In-patient care: estimated potential health benefits relative to baseline  
 Baseline  Scenario 1  Scenario 2  Scenario 3  Scenario 4  
Simulated prevalence of ‘poor’ ‘poor’ and ‘poor’, ‘fair’, All countries 
 
EN 31   EN Outcome  adverse events 
related to 
hospitalisations  countries 
become ‘fair’  ‘fair’ countries 
become ‘good’  and ‘good’ 
countries 
become ‘very 
good’  become 
‘exemplary’  
Avoided Adverse 
events  0 199,711  497,417  1,077,810  2,187,406  
Avoided 
Permanent 
disability  0 30,370  75,642  163,903  332,639  
Avoided Death  0  10,863  27,054  58,622  118,973  
Avoided 
Preventable 
adverse events  0 85,476  298,371  759,673  1,695,883 
Avoided 
Preventable 
length-of-stay 
(person-years)  0 988 3,450  8,784  19,609 
SOURCE: RAND Europe  
 
As of now, data gaps for the EU do not allow us to establish a dire ct causal relationship 
between good patient safety policies, syst ems and structures, and patient safety 
outcomes. Our estimates were therefore based on how close the MS patient safety system 
is to what is generally  considered best practice in the literature. We took as a reference 
the World Alliance for Patient Safety's definition of best practice, especially in relation to the existence of reporting and learning systems and classified MS accordingly. 
The non-binding character of almost all of th e options at stake limits the significance of 
this exercise, however the assumptions reflect experiences in the past with similar health policy initiatives where e.g. Council or Commission Recommendations - though legally 
non binding - triggered quite substantial improvements due to quick implementation at 
MS level. (see example of cancer screening recommendation). We have assumed that for 
a health issue as dependent on leadership as patient safe ty, similar effects can be 
envisaged. 
We reviewed the above mentioned overall s cenario by developing, with the help of 
infection control experts from ECDC etc. also a separate pot ential reduction scenario for 
HCAI-related events only .The figures we obtained were even higher in that case, which is because the overall advers e event scenario applies an average rate of 42% 
preventability. That reflects the fact that not every medical error will be easily avoidable, 
some errors e.g. those related to proce sses and communication will be much more 
difficult to rectify as they probably require c onsiderable changes in the way medial staff 
communicate and coordinate. Nosocomial infect ion-related adverse events usually score 
much better on preventability (60% and high er) so that their reduction potential is 
underweighted in the overal l reduction scenario.  
7.1. Policy option I: No additional EU action – status quo 
1. Economic impacts
 (direct and indirect costs of adverse  events, costs of  patient safety 
policies)  
 
EN 32   EN Current economic burden due to patient safety adverse events  
Preventable medical errors prolong the suffe ring of patients, increase healthcare costs 
and have other direct and indirect economic im plications, such as loss of productivity and 
disability. With adverse events ranging fr om 7.5% to 16.6 % of all hospital admissions, 
and with as much as half of those being prev entable events, (in partic ular infected-related 
events are very often preventable by appropriate measures and therefore also the focus of this initiative), the potential cost savings fo r health care systems in all MS are apparent.  
National experience from Spain suggests that ad verse events resulted in a prolongation 
of 2.2 days of avoidable stays per patient - a high number.  Furthermore, there are 
additional costs resulting also  from additional procedures  and treatments which are 
necessary after adverse events (this is the cas e in around two thirds of  adverse events). In 
France it was observed that a longer hospitalis ation period was associated with 40,5 % of 
all adverse events and the French study fu rthermore revealed that every hospital, 
regardless of size is affected, and that in th e course of a 7 day observation of each unit at 
least one adverse events was observed in 55 % of surgical and 40 % of medical units.  
The cost effectiveness of patient safety pr ojects is furthermore documented by the fact 
that there are already today, e. g. in Ge rmany, around 400 hospitals involved voluntarily 
in such projects – which they would probably not undertake if there was not a net benefit 
to be reaped. 
The economic impacts are particularly well documented in the specific case of HCAI: 
The UK National Audit Office estimated the co st of hospital-acquired infections to 
be at £1 billion per year for the UK
19 in the late 1990s (equivalent to £1.6b now).  
This was in fact an under-estimate in that it did not include infect ions in high-risk or 
specialised units such as renal dialysis or those occurring in tertiary referral centres. 
Costs will be different for other countries and will change with time; however the relative magnitudes will be similar. 
Overall in the European Union, it has b een estimated that there are around 4.1 million 
hospital patients suffering from at least one HCAI in the EU per year and that, based on 
an average excess hospital stay of 4 days
20, HCAIs generate approximately 16.4 
million extra hospital days per year. Assuming an average EU hospital cost of 334 € 
(not including pos t-hospital costs21), the resulting healthcare cost for the EU27 can be 
estimated conservatively at € 5.48 billion. 
In addition, it has been estimated that patie nts that acquired a HC AI take on average 6 
more days to return to work22. If we assume that 1/3 of the patients acquiring an HCAI 
                                                 
19 Action on healthcare associated infections (HCAI) in England: Regulatory Impact  Assessment. Department 
of Health, UK 
(http://www.dh.gov.uk/prod_consum_dh/idcplg?Idc Service=GET_FILE&dI D=246&Rendition=Web)  
20 Emori TG, Gaynes RP. An overvi ew of nosocomial infections, including the role of the microbiology 
laboratory. Clin Microbiol Rev 1993; 6(4):428-442.  
21 Hospitals in Europe Link for Infection Control thr ough Surveillance. C. Suetens. ESQH Workshop, Brussels, 
30 November 2001  
22 Plowman R, Graves N, Griffin M, Roberts JA, Swan A, Cookson B, et  al. The socio-economic burden of 
hospital acquired infection. London: PHLS, 2000 and Plowman R, Graves N, Gr iffin MAS, Roberts JA, 
Swan AV, Cookson B, Taylor T. The rate and cost of hospital-acquired infections occurring in patients 
admitted to selected specialties of a district genera l hospital in England and the national burden imposed. J 
Hosp Infect 2001; 47:198-209.  
 
EN 33   EN are productive, this represents a total loss of 8.2 million worki ng days in the EU per year, 
resulting in a productivity loss  of €1.37 billion (at an averag e EU labour productivity of 
€167.20/day23 (see Annex 6)). This figure does not yet take into acc ount the productivity 
loss due to people staying away from work to  take care of rela tives having acquired a 
HCAI. The costs of 37,000 attributable deaths annually have also no t been taken into 
account. 
Investment costs for a general framework for patient safety  
Most administrative and compliance costs ar e related to the setting up and maintenance 
of a reporting and lear ning system which is at the core of any patient safety system and 
policy. Such systems already (at least partially or locally) exist in 20 MS. A new system would have to be set up in seven MS and ad aptations and extensions of coverage would 
need to be made in up to 16 MS. There are co sts to be expected at both the national and 
healthcare setting levels, and moreover the co sts of setting up the systems will basically 
occur in the short term while the cost sa vings will come only in the longer-term.  
Healthcare institutions will have to res pond to additional reporting and surveillance 
duties in cases were more efforts are neede d. In our scenarios fo r the different policy 
options, we made the following assumptions on investments in human resources: a 5-10 
% reduction of HCAI across the EU with a st affing level of one infection control nurse 
per 600 beds; a 20-30 % reduction for one infection control nurse per 250 beds
24. One 
can assume an EU average annual co st of €42,000/infection control nurse25 and a total of 
2.88 million beds (see Annex 7) and a current st affing level of one infection control nurse 
per 1000 beds which would mean employing an additional 1,920 nurses in scenario one, 8640 in scenario two for the EU. Costs for ot her surveillance and improved infrastructure 
could not be obtained. 
Government-spending will also increase in mo st cases. As a general indication, the per 
capita spending on patient safety investments in the UK and the US, both with advanced 
patient safety systems, can be used: 0,86 £ per capita in UK ; 0,22 US $ per capita in US.  
Cost-effectiveness of patient sa fety (including HCAI policies) 
 
Although the upgrading of organisational structures for patient safety will result in 
additional costs in some MS, recent literatu re and national expe rience on the issue 
suggests that benefits from system-level pa tient safety improving strategies can well 
exceed costs, leading to net financial gains and reduce prevalence of adverse events.  
                                                 
23 The figure of €167.20 per day is based on an average EU GDP output of €20.9/hour  
24 Recommended levels of infection control nurses of  1 per 100 – 250 beds have been cited in the 
literature (see section 7.3.2) 
25 The breakdown is as follows: gross salary: €30,000; benefits (15%): €4,500.00; computer and 
equipment: €3,500.00; training: €4,000.00 
 
EN 34   EN 
 
SOURCE: Wendin (2008) 
Figure 4: Key financial impacts of adverse events  
A cost benefit analysis in the US on interventions addressing adverse events with 
obstetric trauma, bedsores, surgical site  infections, catheter -related bloodstream 
infections, MRSA and drugs sugge sts that the implementation of patient safety strategies 
can lead to between 50% and 96% reduction in me dical error rates and net savings 
from 50 thousand to 1.5 million € for a 300-bed hospital . For HCAI in particular, a 
UK study from 2000 indicated that a 10% reduc tion in the number of hospital acquired 
infections in the UK could result in a saving of £93 million per year26. 
2. Health impacts  (mortality and morbidity)   
Health gains from better prevention in health care settings will al so be significant.  
The supporting study for this IA suggests that  under the 'no policy change' option, i.e. no 
increased action on patient safe ty at the EU level, the EU  is likely to see around 10 
million adverse events related to hospitalisations (including those infection-related) of which almost 4.4 million would be preventable
27, resulting in more than 50.000 
preventable person-years additional hospitalisat ion time. The US Institute of Medicine 
estimated that preventable adverse patient ev ents, including hospital- acquired infections, 
are responsible for 44,000-98,000 deaths annua lly in the US at a cost of $17-$29 
billion28. 
                                                 
26 Plowman R, Graves N, Griffin M, Roberts JA, Swan A, Cookson B, et  al. The socio-economic 
burden of hospital acquired infection. London: PHLS, 2000. 
27 This reflects the share of preventability in all adverse events used in the Spanish ENAS study of 
2005. This is only an average, in some cases e.g.  for infections preventability will be much higher, 
in others, e.g. process related medial errors lower. 
28 To Err Is Human: Building a Safer Health System (2000). Institute of medicine. Committee on 
quality of health care in America. Na tional academy press. Washington, D.C. 
 
EN 35   EN For HCAI in particular, on the basis of recent national HCAI prevalence surveys in 
Europe and the results of hospital-wide  surveillance programmes of nosocomial 
bacteraemia in different Member States, it  can be calculated th at HCAIs affect an 
estimated 5% of hospital patients on averag e and the total number of hospital patients 
acquiring at least one HCAI in the EU every year can be estimated at 4.1 million (with a 
total incidence of 4.5 million HCAIs per year). Approximately 37,000 deaths are 
estimated to occur every year as a co nsequence of infection (see Annex 3). 
The most frequent infections are urinary tract infections (U TIs, on average 28% (i.e. 1.26 
million UTIs in the E27 per year) in the national prevalence surveys), followed by respiratory tract infections (25%, i.e. 1.13 m illion respiratory infections in the EU27 per 
year), surgical site infe ctions (SSIs; 17%, i.e. 765,000 SSIs in the EU27 per year), 
bacteraemia (10%, i.e. 450,000 cases of bacter aemia in the EU27 per year) and others 
(including diarrhoea, with in creasing importance due to Clostridium difficile  (especially 
ribotype 027)). MRSA is isolated in  approximately 5% of all HCAIs. 
Based on surveillance data (p eriod 2004-2005) on patients stay ing more than 2 days in 
intensive care units (ICUs) in European hospitals, 7.2% developed pneumonia (mainly 
due to intubation), 3.1% developed blood stream infections (mainly catheter-
associated)
29. Similar ICU surveillance data for the period 2000-2003 showed that 4.9% 
developed urinary tract infections30. The EPIC (European Prevalence of Infection in 
Intensive Care) 1-day-prevalence study in 1992 found an ICU related infection in 20.6% 
of intensive care patients31. 
Health equity  
Patient safety events and in particular HCAI affect in particular vu lnerable citizens such 
as the elderly, acutely ill people, people w ith impaired immune systems (e.g. transplant 
patients receiving immunosuppres sive therapy, cancer patien ts receiving chemo- or 
radiotherapy, HIV positive peopl e), who represent an important  and growing share of the 
EU population: The elderly (65y or older) represent 16.5% (80 million) of the EU population
32. Around 4.5 million people in the EU suffer from cancer33 and the there are 
estimated to be about 700,000people with HIV in the EU at34. 
For policy option I, the baseline, we would assume that some progress in avoiding 
adverse events will be made in MS where patient safety is already on the political agenda and efforts would continue even without an  additional EU initiative to frame patient-
safety efforts.  
We assume this because there are some EU projects ongoing (see Annex 1) that address 
some aspects of patient safety, but these pr ojects are also time-limited and will therefore 
                                                
 
29 The IPSE (Improving Patient Safety in Europe) Annual Report 2006 (http://helics.univ-
lyon1.fr/Documents/IPSE_Annual_Report_2006.pdf) 
30 HELICS Implementation Phase II, final report March 2005 
31 The prevalence of nosocomial in fection in intensive care units in Europe. Results of the European 
Prevalence of Infection in Intensive Care (EPIC)  Study. EPIC International Advisory Committee. 
Vincent JL et al. JAMA. (1996) 275(5):362 
32 Europe in figures — Eurostat yearbook 2006-07 
33 Research in the behavioural and social sciences to improve cancer control and care: a strategy for 
development. Eur. J. Cancer 40 (2004) 316-325 
34 The European Communicable Disease Epidemiological Report 2007, ECDC 
(http://www.ecdc.eu.int/pdf/Epi_report_2007.pdf) 
 
EN 36   EN not always deliver continued decreases in adverse events. However, there would be a 
substantial number of MS wit hout a general patient safety po licy in place at  all - which 
implies that patients and/or healthcare practi tioners will still not able to report adverse 
events and near misses in their countries. W ithout systematic reporti ng there will be no 
solid basis for monitoring or launching a nati onal patient safety policy. In some MS 
patients also do not have the possibility to  seek redress afte r medical errors.  
We assume that the gaps between advanced  MS with a developed policy agenda for 
patient safety and those that have not would continue to ex ist under the base line scenario. 
– given the importance of political commitment and senior staff stewardship. Hence substantial differences in the disease burden due to patient sa fety will continue to exist 
between Member States, which is discriminatory and affects equal access to high quality healthcare services.  
Given the root causes of HCAI, the figures are not expected to decline either, despite the 
efforts of some Member States and funding through the Public Hea lth and the Research 
Programmes. Moreover, in regard to HCAI it  is not only patients, but also health 
professionals who are at risk: Their job quality  and safety is affected if the necessary 
measures are not in place to protect them. This is in conflict with Article 13 of the Charter of Fundamental Rights of the European Union
35. 
7.2. Policy option II: Strengthened coopera tion with the Member States and 
other bodies, supported by technical guidance 
As regards general policy frameworks for patient safety, we can assume under this 
option, which would require a strengthened cooperation of MS and other bodies, that 
increased knowledge sharing will help MS improve their patient safety systems and 
hence their performance in prevention of medical errors. It  is not yet clear whether this 
policy option could also include some tec hnical guidance for general patient safety 
issues, but this could certainly be done for HCAI based on the Commission Decision. 
Establishing common indicators and monitori ng could be developed under this option, 
too, but only in technical subgroup the Hi gh Level Group that does not have political 
weight or a formal basis for its work. 
1. Health and economic impacts  
For this policy option, we assumed more progr ess would occur, in particular through 
knowledge sharing - so that in  our simulation scenario all EU MS with ‘poor’ and ‘fair’ 
patient safety reporting and learning systems would be able to a dvance and experience 
similar adverse event rates as countries classi fied as having already ‘good’ patient safety 
reporting and learning systems. That would mean  that instead of having an average of 14 
% adverse events in hospital admissions, th ose countries would come closer to the 
performance of average countries which is in our scenario given with  12 %. In concrete 
terms that would mean that adverse pr eventable events would be reduced by 298.371 
cases as compared to the baseline scenario resulting also in a reduction of 3450 prevented 
personal years of hospitalisation. However, the differences in Member States with their 
varying levels of politica l commitment to make patient safety a priority in national public 
health objectives will only be pa rtly remedied under this option.  
                                                 
35 Charter of Fundamental Rights of the European Union (2000/C 364/01). O.J. No C 364, 
18.12.2000 
 
EN 37   EN In our specific scenario on nosocomial infections we assume that strengthened 
cooperation with the Member States and othe r bodies, supported by  technical guidance 
would reap an overall 5% decr ease of HCAI, a quarter of the potential for reduction in 
infection-related incidents reported in the literature. In the absence of a political commitment to bring about the needed orga nisational and behaviour al changes, reaching 
the achievable 20-30% decrease of HCAIs
36,37 (requiring an intensive prevention and 
control programme including surveillance and training of healthcare staff) is unlikely. 
We assume HIA reduction successes are appl icable across the board, given that some 
infection-related safety policie s are in place in all EU 27..  
A projected 5% decrease w ould in our HCAI-scenario result in 225,000 HCAIs fewer 
every year. As explained above, the higher numbe rs are due to the fact that HCAI cases 
are the easiest and quickest to prevent. 225.000  cases imply a considerable decrease of 
the HCAI morbidity and mortality burden. A 5% decrease would also save €274 million 
in health expenditure and represent a gain  of €68.5 million in productivity. A UK study 
from 2000 indicated that a 10% reduction in th e number of hospital acquired infections in 
the UK could result in a saving of £93 million per year38. 
Considering the above, it becomes clear that prevention and control of HCAIs, even at 
suboptimal levels of 5%, is already highly cost-effective. 
2. Employment effects  
In all options (exception stat us quo) slightly positive employm ent effects can be expected 
due to the need for more resources for repor ting and surveillance as well as infection 
control in health-care institutions.  
Projected on the EU27 situ ation with a total of 2.88 m illion beds (see Annex 7), 
employing one infection control nurse per 600 beds39 and assuming a current staffing 
level of one infection control nurse per 1000  beds would mean employing an additional 
1,920 nurses. Assuming an EU average annua l cost of €42,000/infection control nurse40, 
this would mean an additional annual expe nditure of about €80 million for policy option 
II. Costs for surveillance and improved in frastructure have not been obtained. 
3. Environmental Impacts  
Environmental impacts seem to be confined to  the specific area of healthcare-associated 
infections, to a lesser extent  be linked of other causes of  medical errors. Under policy 
option II, minor environmental impacts are likely to occur due to an increased use of disposable medical products and disinfectant chemicals, but it is  very difficult to estimate 
those.  
                                                
 
36 Harbarth S, et al. The preventable proportion of nosocomial infections: an overview of published 
reports. J Hosp Infect 2003; 54:258-266 
37 Haley RW, Culver DH, White JW, et al. The efficacy of infection surveillance and control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-205. 
38 Plowman R, Graves N, Griffin M, Roberts JA, Swan A, Cookson B, et  al. The socio-economic 
burden of hospital acquired infection. London: PHLS, 2000. 
39 Recommended levels of infection control nurses of  1 per 100 – 250 beds have been cited in the 
literature (see section 7.3.2) 
40 The breakdown is as follows: gross salary: €30,000; benefits (15%): €4,500.00; computer and 
equipment: €3,500.00; training: €4,000.00 
 
EN 38   EN 7.3. Policy option III: Strengthened coop eration with the Member States and 
other bodies, supported by soft law instruments, such as a Commission Communication and a Council Recommendation 
The option would not only bring together vari ous fragmented and specific patient safety 
initiatives at EU level (e g in the area of research, innovation policy and 
pharmacovigilance) under one framework, but  would above all provide a high level 
political commitment from MS to take action on patient safety. It could address the overall cultural leadership systemic comm unication and process barriers and could 
integrate HCAI as part of an overall pati ent safety policy. As explained above, success 
for patient safety depends on leadership and cultural change which is why we assume 
substantial benefits for this option, where MS's ownership is greatest. In particular we 
assume that some MS that have no patient sa fety reporting system w ould start developing 
such systems and launch development of ge neral patient safety policies. The more 
advanced MS would benefit from increas ed knowledge sharing and data gathering, 
including technical guidance for both systemic  and infection-related issues. We therefore 
assumed in our general scenar io a larger impact of EU-l evel action under policy option 3, 
with the result of all EU countries advancing to the relatively bett er levels of adverse 
events reported by the literature. That means that we assume the exemplary countries remain as efficient as they are and all othe r MS move towards the reported average of 
10% adverse events (‘very good’). This is still a conservative estimate (given the average 
preventability rate) but even so we coul d avoid more than 7 50.000 preventable adverse 
events and reduce by more than 8000 a dditional person-years of hospitalisation. 
For our HCAI–only reduction scenario we came up with even better successes given that 
for infections, the ways to control them ar e well understood, and qui ck to implement, and 
above all they are highly preventable. 
1. Health and economic impacts
 
According to the literature, a 20% (Harbarth et al.41) to 32% (Haley et al.42) reduction in 
hospital acquired infections can be achieved using an intensive infection prevention and 
control programme including surveillance. I ndeed, the SENIC (Study on the Efficiency 
of Nosocomial Infection Cont rol) study, performed by Haley et al.  in US hospitals from 
1970-1976, found that an intensive infectio n prevention and control programme 
including surveillance reduced hospitals' infection rates by 32%43.  
Essential components of such  programs included conducting organized surveillance and 
control activities and having a trained, effectual infecti on control physician, an infection 
control nurse per 250 beds, and a system fo r reporting infection rates to practicing 
surgeons. The same study estimated that the cost of infection control teams was only 7% of the infection costs. Theref ore, if infection control pr ogrammes were effective in 
preventing only 7% of HCAIs, the costs of  the programmes would already be covered. 
                                                
 
41 Harbarth S, et al. The preventable proportion of nosocomial infections: an overview of published 
reports. J Hosp Infect 2003; 54:258-266 
42 Haley RW, Culver DH, White JW, et al. The efficacy of infection surveillance and control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-205. 
43 Haley RW, Culver DH, White JW, et al. The efficacy of infection surveillance and control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-205. 
 
EN 39   EN We assume now that under this policy option all EU MS would implement most of that 
so that the estimated reducti on could actually reap the po ssible 20% decrease. A 20% 
decrease would mean up to 900.000  HCAIs less every year, resu lting in a major decrease 
of the HCAI morbidity and mortality burden which would save €1.10 billion in public 
health expenditure and represent a gain of €274 milli on in productivity. 
2. Employment effects  
In all options (except the status quo) s lightly positive employment effects can be 
expected as more resources are needed for reporting and surveillance as well as infection 
control in healthcare institutions. Haley et al.44 mentions the need for 1 infection control 
nurse per 250 beds as part of an intensiv e infection prevention and control programme. 
The Aucoin report45 proposes 1 infection control nurse per 100 sp ecialised care beds, 1 
infection control nurse per 133 normal care beds and 1 inf ection control nurse per 250 
long-term care beds. The EU has a total of 2.88 million beds. Employing one infection 
control nurse per 250 beds and assuming a curre nt staffing level of one infection control 
nurse per 1000 beds would mean employing an additional 8,640 nurses. Assuming an EU average annual cost of €42,000 per nurse, th is would mean an additional annual 
expenditure of about €363 million for polic y option III. Costs for surveillance and 
improved infrastructure have not been obtained. 
Considering the above, it becomes clear that successful prevention a nd control strategies 
are highly cost-effective. 
3. Environmental Impacts
 
Environmental impacts seem to be mainly confined to the specific area of HCAIs. Under 
option III, minor environmental impacts are li kely to occur because of increased use of 
disposable medical products and disinfectant chemicals, but it is  very difficult to estimate 
those.  
7.4. Policy option IV: Strengthened coopera tion with the Member States and 
other bodies, supported by a regulator y instrument, such as a Commission 
Decision 
As stated, a Commission Decisi on could only address infecti on-related, and not general 
and systemic patient safety issues given the lack of a legal base for this. That would 
mean that this policy option would only reap  benefits comparable to those of policy 
option III if it is accompanied by a Recomm endation. If not, we assume the general 
patient safety benefits to be in the range of those identified under policy option II.  
As regards HCAI, we do not assume, however , that the benefits would be much bigger 
than those identified in policy option III. Th at is because Article 3 of Decision No 
2119/98/EC does not provide a lega l basis to address all the op erational objectives of the 
proposal, and therefore essentia l parts (e.g. creation of inf ection prevention and control 
                                                 
44 Haley RW, Culver DH, White JW, et al. The efficacy of infection surveillance and control 
programs in preventing nosocomial infections in U.S. hospitals. Am J Epidemiol 1985;121:182-
205. 
45 Aucoin et al. 'D’abord, ne pas nuire…Les in fections nosocomiales au Québec, un problème 
majeur de santé, une priorité. Rapport du Comité d'examen sur la prévention et le contrôle des 
infections nosocomiales.' La Direction des co mmunications du ministère de la Santé et des 
Services sociaux, Quebec, Canada (2005). 
 
EN 40   EN programmes in hospitals or developing specific training) of the integrated strategy to 
combat HCAIs would have to  be left out. Whereas it w ould be feasible to use 
Commission Decisions to reinfor ce certain aspects of the inte grated strategy after it has 
been put in place via e.g. a Council Recommendation, it is expected that this option 
without an integrated strategy will not perform much better than the option of 
strengthened cooperation with the Member States. In particular, there would be no 
additional push resulting from an overarching patient safety policy.  
A synoptic overview of the different policy options and the extent to which they could 
achieve the identified specific objectives is presented in Table 7. Figures were rounded. 
 Policy option I Policy option II Policy option III  Policy option IV 
Specific 
objective 1 
Protect EU 
citizens from 
harm  Little progress, 
which would occur basically in 
countries where 
patient safety is a political priority Reduction of 
300.000 preventable adverse events in 
total Reduction of 
750.000 preventable adverse 
events in total  
 O with slight 
improvements + ++ + to ++ 
Specific 
objective 2 
Support MS 
to put in place patient 
safety 
strategies No additional EU 
level support Some additional EU 
level support 
through technical 
guidance on HCAI Political ownership 
and leadership of 
all MS, exchange of 
best practice 
Quick 
implementation 
possible Political ownership 
if accompanied by a 
Recommendation, 
Decision addresses 
some aspects of 
HCAI which would 
be legally binding. 
 O + ++ + to ++ 
Specific 
objective 3  
Improve EU 
citizens 
confidence  O + ++ + to ++ 
8. COMPARING THE OPTIONS  
8.1. Advantages and disadvantages of the po licy options identified in section 6 
Option I No EU action – the status quo 
Advantages Disadvantages 
The patient safety working group of the high level 
working group on healthcare is the main platform 
for patient safety information-sharing and learning at the European level, bringing together Member 
States, stakeholders and international organisations. 
The involvement of the key players has helped to 
ensure that synergies are developed and that overlap 
of efforts can be avoided. The patient safety working group is, as the name 
suggests, a technical subgroup of another 
Committee and does not have political weight. It will not necessarily continue to exist as there is no 
formal basis of its work. 
While organisations like the WHO's World Alliance 
for patient safety have launched some patient safety 
 
EN 41   EN programmes and campaigns on particular aspects of 
patient safety such as clean hand policy, there has been no attempt to approach the patient safety 
problem comprehensively, ad dressing all the factors 
that could improve patient safety outcomes. 
It is clear that there are still big gaps in the data in 
most EU Member States on the extent and causes of 
adverse events. Without increased action at EU level these gaps are likely to continue to exist in 
many Member States. 
Projects funded by the Commission have proved a 
valuable tool to progress towards a better understanding of the problems and finding possible 
solutions. 
These initiatives involve the professionals in the 
field and offer flexibility for Member States to tailor 
the results to their national situations. Coordination of these projects under different 
Community programmes is quite difficult. 
The projects do not always  include all Member 
States. In many instances those involved in the best 
systems are leading the projects and the results are not likely to benefit the whole EU. 
The projects have a limited time frame and limited 
resources so that there is a risk of losing continuity 
once the project is fini shed. The projects do not 
always have the financial capacity to transfer their 
results to the political level in order to make them 
more widely operatives. 
Community initiatives aimed at improving patient 
safety in areas such as pharmacovigilance and medical device safety and technology already exist. These actions do not fully meet the demands of the 
current situation or th e needs of patients or 
governments to tackle this major public health 
concern. 
These initiatives only focus on specific patient 
safety concerns, such as in the area of product 
safety, and do not seek to address the overall 
cultural, leadership, systemic, communication and process barriers to improved safety. 
The OMC for healthcare an d long-term care may be 
useful in the future to monitor and compare 
Member States' performance in the area of patient safety against a number of indicators that could be 
developed. Poor performance against such indicators in 
individual countries may prompt Member States to 
try to improve their performance in patient safety but would not provide adequate guidance on what 
actions could work best in their settings. 
As such, the OMC initiative could complement a 
proposal on patient safety, but would not be 
sufficient to address this important issue in itself. 
No extra resources needed for the prevention and 
control of HCAIs The non-statutory guidance on the prevention and 
control of HCAIs has up till now not been able to 
address the problems related to HCAIs as listed in 
section 3. 
This option fails to profit from Community added 
value by pooling the best expertise and identifying 
best practices on HCAIs as described in section 4. 
The EUNetPaS project would continue to September 2010. The EUNetPaS project is largely an operational 
mechanism and does not bring with it the full 
political commitment to improving patient safety 
from MS governments which we are seeking. 
 
EN 42   EN EUNetPaS is also a time-limited project, (30 
months running from February 2008 to August 2010) co-funded under the Public Health 
Programme, there will be doub ts as to its long-term 
sustainability once its funding runs out. The project will not fully address the objectives of the 
Commission's initiative, even in the short-term.  
For example, the project is not seeking to establish 
and implement a common taxonomy and EU-wide 
patient safety indicators. The sharing of effective 
patient safety interventions is limited to medication safety whereas the Commission's initiative aims to 
share best practice and effective solutions in all 
areas of harm. EUNetPaS will be, in the short-term at least, a useful operationa l tool for Member States 
to add EU value on patient safety. However, it is a 
time-limited, specific proj ect and should not be 
regarded as having either the same purpose or effect 
as a broad- ranging political initiative. 
 
Option II) Strengthened cooperation with  the Member States and other bodies, 
supported by technical guidance 
Advantages Disadvantages 
The advantages listed under option I would be 
further underlined by a more active involvement of 
the Commission in current activities. Guidelines are not legally binding on Member 
States so this option presents a real risk that 
Member States could ignore them. 
Coordination between Member States has 
sometimes proved to be ineffective l without any 
legal instrument supporting the actions. 
Mechanisms to fund proj ects addressing HCAIs are 
in place (under the Public  Health and Research 
Framework Programmes) and the focus on patient 
safety and HCAIs could be increased. Although time-limited projects can increase 
understanding of problems, they cannot overcome structural differences am ong Member States nor 
assure political commitment. 
ECDC could provide added value in coordinating 
the Member States' activities and providing guidance on the prevention and control of HCAIs. 
 Coordination between MS by itself may not be 
sufficient to control HCAIs since many Member States have varying levels of political commitment 
to taking action. Therefore, strengthened 
coordination supported by technical guidance may not be sufficient to bring about the needed 
organisational and behavioural changes. 
 
Option III) Strengthened cooperation with  the Member States and other bodies, 
supported by soft law instruments, such  as a Commission Communication and 
Council Recommendation 
Advantages Disadvantages 
A Communication would provide an overarching 
structure for the Community's diverse initiatives on Neither a Commission Communication nor a 
Council Recommendation is legally binding. 
 
EN 43   EN patient safety. 
It could address the overall cultural, leadership, 
systemic, communication and process barriers to 
improved patient safety. In consequence, morbidity 
and mortality due to patient safety issues could decrease substantially. 
It would present findings and good practice 
principles on patient safety to be applied in the EU and highlight the need for actions. 
A Council Recommenda tion could include 
recommendations on patient safety and specific recommendations on the prevention and control of 
HCAIs. 
A Council Recommendation would represent a 
strong political commitment to address patient 
safety and HCAIs. 
The literature and this impact assessment show that 
improved prevention and control of HCAIs is 
highly cost-effective. 
A Council Recommendation allows for monitoring 
and evaluation of the recommended measures. 
This option corresponds to what is indicated in the 
Commission's Legislative and Work programme as 
a strategic initiative for 2008. This option would require detailed negotiations in 
the Council in order to achieve consensus. 
Investments are necessary to  bring about the needed 
organisational and behavioural changes. 
 
Option IV) Strengthened cooperation with  the Member States and other bodies, 
supported by a regulatory instrument , such as a Commission Decision 
Advantages Disadvantages 
The legal basis exists to put in place via a 
Commission Decision some of the elements needed 
to improve the prevention and control of HCAIs. 
A Commission Decision is a legally binding 
instrument which would promote a strong political 
commitment to address the issues covered. With a Decision only some of the elements to 
improve prevention and control of HCAIs can be 
put in place, but not all. Moreover, general patient safety issues, could not be addressed. 
Essential parts of the integrated strategy to combat 
HCAIs (e.g. creation of infection prevention and control programmes in hospitals or developing 
specific training on HCAI s prevention and control ) 
would have to be left out. 
It would be feasible to use Commission Decisions to 
reinforce certain aspects of an integrated strategy on 
HCAIs after it has been put in place via e.g. a 
Council Recommendation. However it is expected 
that this option without an integrated strategy will not perform much better than the option of 
strengthened cooperation with the Member States. 
 
 
EN 44   EN 8.2. Conclusions 
Based on the above, the policy option of a proposal for a Comm ission Communication 
and a Council Recommendation on patient safety and quality of health services, including the prevention and c ontrol of HCAIs is preferred. 
9. M
ONITORING AND EVALUATION  
9.1. Progress indicators and surveillance 
Problem definition 
Issues to be monitored Indicators Source of info How often data gathered 
and analysed?  
Level of awareness of extent and type of adverse events among 
Member States Quality and 
harmonization of 
the level of 
awareness of MS  Data from the 
EUNetPaS 
project Once a year from 2010 
Availability of information for 
patients on safety levels and help 
available in case of harm in 
different healthcare systems  Patients' awareness 
of differences in 
safety levels and 
overall satisfaction  Reporting and 
learning system 
within the 
EUNetPaS project Once a year from 2010 
Objectives 
Creation of homogenous and 
comparable data and information on patient safety systems, initiatives 
and safety outcomes at EU level. Access and level of 
use of up-to-date and comprehensive 
information system. Competent 
authorities Yearly report 
Develop common definitions and 
terminology for patient safety at the EU level Unified 
terminology in use. An external 
evaluation. Within a future 
evaluation of proposed SANCO health related 
initiatives  
Develop case definitions for 
HCAIs, in accordance with Decision 2119/98/EC Commission 
Decision covering case definitions for 
HCAIs ECDC, external 
expertise Continuous follow-up 
Creation of European reference data 
for comparisons between countries and hospitals Existence of 
functional surveillance 
systems An external 
evaluation. 
Existing 
European 
surveillance systems, ECDC 
(for 
communicable 
diseases). Within a future 
evaluation of proposed SANCO health related 
initiatives 
Foster with ECDC the 
establishment of surveillance methods and indicators to allow 
evaluation of the implementation Availability of 
surveillance methods, indicators, 
guidance on best ECDC Continuous follow-up. 
 
EN 45   EN and effectiveness of measures to 
prevent and control HCAIs, guidance on best practices and 
minimum infrastructure 
requirements, as well as training curricula for healthcare staff. practices and 
minimum infrastructure 
requirements, as 
well as training curricula for 
healthcare staff 
agreed at EU level. 
Monitor the implementation and effectiveness of the 
recommendations on the prevention 
and control of HCAIs. Process (e.g. 
standard operating 
procedures on hand 
hygiene) and structure (number 
of infection control 
personnel) indicators to be 
developed by 
ECDC, building on the work of the 
IPSE project. ECDC In reports to the Council 
at the interval specified 
in the Council 
Recommendation. 
Decrease of level of HCAIs in Member States. Prevalence and 
incidence of HCAIs 
in Member States. National 
competent 
authorities, 
ECDC The annual ECDC 
epidemiological report on 
communicable diseases 
in Europe. 
Develop and promote the research agenda on patient safety, including 
the use of information and 
communication technology (ICT), new tools for the diagnosis, 
prophylaxis and treatment of 
HCAIs, as well as further research on the cost-effectiveness of 
prevention and control of HCAIs.  Number of accepted 
applications on 
patient safety. Public Health 
Programme 
DG RTD Yearly statistics 
 
9.2. Evaluation 
It is envisaged to evaluate the overall patie nt safety initiative, including implementation 
of the Recommendation, using external experts to assess its relevance, effectiveness and 
efficiency. This evaluation could be part of a comprehensive evaluation project for 
different health related initiatives. In rela tion to HCAI, Member States will also submit 
reports on implementation of the Recommendati on. The proposed indica tors and data to 
be collected in the future should enable the measurement of the economic and social 
impact of initiative. 
 
46 ANNEX 1: EU- FUNDED PATIENT SAFETY / HCAI S PROJECTS  
The MARQuIS  research project (" Methods of Assessing Response to Quality 
Improvement Strategies" ) was designed to help assess the value of different quality 
strategies and to provide information for countries contracting care for patients moving 
across borders and for indivi dual hospitals reviewing the design of their quality 
strategies. The results also  provided evidence-based ad vice for developing quality 
approaches at EU level for healthcare institutions. 
The SIMPATIE  project (" Safety Improvement for Patients in Europe" ) aimed to 
facilitate free movement of people and services by developing EU-wide commonality 
and transparency in methodology on patient safe ty in healthcare in stitutions. The project 
used Europe-wide networks to establish a co mmon set of vocabulary, indicators, internal 
and external instruments for improvement in safety in healthcare.  
The, EUNetPaS ("European Union Network for Patient Safety" ) was launched in 
February 2008. It aims to establish an um brella network of Member States and EU 
stakeholders to encourage and enhance colla boration in the field of Patient Safety by 
evaluating, validating and diffusing new knowledge and good practices.  
The HELICS implementation phase I  project ( Hospital in Europe Link for Infection 
Control through Surveillance ) aimed to lay the practical foundations for a European 
Network on hospital acquired infections by th e creation and analysis of two databases 
(on surgical and intensive care unit (ICU)  infections); developing consensus for 
prevalence surveys and survei llance of emerging infections in immuno-compromised 
patients; validating a European methodology to create evidence-based  scientific advice, 
recommendations or standards; and setting up an inventory of training and fellowships on 
infection control. 
The HELICS implementation phase II  project ( Hospital in Europe Link for 
Infection Control through Surveillance ) aimed to create a robust and validated 
surveillance system and establish reference da ta sets for surveillance of Surgical Site 
Infections (SSIs) and infections in ICUs. Data on SSIs and infections in ICUs were 
collected on a pilot basis and a database was established to collect regular data on these 
infections. 
The IPSE  project ( "Improving Patient Safety in Europe" ) aims to reduce the burden 
of HCAIs and their related threats of antimicrobial re sistance (AMR) by providing 
evidence-based guidance and educational tool s, strengthening the status of infection 
control professionals, strengthening su rveillance and developing indicators. 
PSIP  (Patient safety through intelligent procedures in medication) is an ICT project 
under the 7th Framework Programme aiming at pr oducing systematic epidemiological 
knowledge on adverse drug events and impr oving the medical cycle in a hospital 
environment through innovative data mining and semantic mining techniques using 
available hospital data. 
 
EN 47   EN ANNEX 2: E VIDENCE OF THE SCALE OF THE PATIENT SAFETY PROBLEM  
Studies from the UK, Spain and France provid e the bulk of current evidence in Europe 
on in-patient adverse event prevalence and its implications. The UK studies demonstrate the scope and universal nature of the problem, the costs of compensation claims and most 
common incident types. Spain’s study also  covers the scope of the problem, the 
proportion of incident types by severity, the root causes and consequences in extended 
hospital stays. The French study also shows the universality of the problem of patient 
safety and the root causes. 
The UK, a National Health Serv ice (NHS) report in 2000, An Organisation with a 
Memory , revealed a big problem of poor patient safety: existing data (admittedly poor) 
showed that at least 400 pati ents 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 drugs.  
Compared to the UK, there is a slightly lowe r nation-wide incidence of adverse events in 
Spain . According to the 2006 Spanish National Study on Hospitalisation-Related 
Adverse Events (ENEAS)
46, adverse events among all hospital patients in Spain in 
2005 was 9.3% 47and 42.8% of these were deemed preventable . More specifically, the 
incidence of patients with adverse events directly related to their hospital care (excluding primary care, out-patient tr eatment and those caused at another hospital) was 8.4% 
(473/5,624). A total of 17.7% of these patients had more than one adverse event related 
to their hospital care. 
The Spanish study found that adverse events not only result in an ex tended hospital stay 
(31.4%), but also in re-admi ssion to a hospital (24.4%), with  some patients having more 
than one adverse event which caused thei r re-admission. Adverse events extended 
hospital stays by an average of 4 days and by 7 days where re-admission was needed. A 
total of 3,200 additional days (6.1 per patien t) were caused by adverse events, 1,157 of 
which were avoidable. 
The third European national study is a recent French national survey of in-patient 
adverse events (Michel, 2007) .This, prospectiv ely assessed with ward staff, found that in 
the course of the 7 days’ observation per unit at least one adverse event was observed 
in 55% of surgical units and in 40% of medical units .
48 The investigators and the ward 
staff considered 35.4% of the adverse events to have been preventable  (39.6% in 
medicine and 32.1% in surgery). This result in dicated that every type  of hospital and unit 
is affected by adverse events, and hence subs tantiates the classification of in-patient 
                                                 
46 ENEAS was a retrospective cohort study. A sa mple of 24 hospitals was random layered by 
hospital size, in which the hospitals to take part in the study were chosen at random according to 
the sample size required to compiling all of the discharges for the study period which met the criteria for inclusion. 6 small-sized (under 200 beds), 13 medium-sized (200-499 beds) and 5 
large-sized (500 beds or more) were incl uded, with a total of 5,624 case records. 
47 A total of 1,755 (32%) of the 5,624 patients were screened as possible AE's, 3,869 of whom were 
ruled out due to their not meeting the requiremen ts of any of the scre ening guide alerts. On 
reviewing the patients screened as positive, 501 false positives and 191 patients showing solely 
incidents were found. A total of 1,063 patients with AE's during hospitalisation were detected, the incidence of patients with healthcare-related AS's being 9.3% (525/5,624).  
48 Excluding obstetric wards, but in cluding public, private and teachi ng hospitals. Total participation 
rate was 40%. The 8754 patients included in the study were followed up on average over 4 days, giving a total of 35 234 days of observation (17 105 in medicine and 18 129 in surgery). 
 
EN 48   EN adverse events as a public health probl em. A longer period of hospitalisation was 
associated with 40.5% of all adverse events. 
 
EN 49   EN ANNEX 3: T HE BURDEN OF HEALTHCARE -ASSOCIATED INFECTIONS IN EUROPE : AN 
ESTIMATE FROM MULTICENTRE PREVALENCE SURVEYS OF NOSOCOMIAL INFECTIONS49 
Hospital-wide incidence figures for all types of nosocomial infections are not available 
from European countries. The type of survei llance generating these figures, hospital-wide 
surveillance of all nosocomial infection types, was abandoned worldwide in the early nineties because of poor cost-effectivene ss in terms of prevention of nosocomial 
infections(1). 
Given this lack of hospital-wide figures , the total annual number of nosocomial 
infections occurring on a yearly basis in the EU can be estimated by  converting the mean 
prevalence of national or multicentre prevalen ce surveys to incidence figures according 
to the method described by Freeman et al. (2) and applied by Gastmeier et al. (3). 
A review of recent prevalence surveys in industrialized countries showed that the mean 
prevalence of nosocomial infe ctions in acute care hospitals is approximately 7.1%, 
ranging from 3.5% to 10.5% (table 1). 
Table 1
. Overview of recent prevalence su rveys of nosocomial infections in 
industrialised countries 
  NI 
Prevalence RefN 
hospitalsN 
patients 
Spain, 96-99 8.9% (4;5) 233 210985 
UK, 1996 9.0% (6;7) 157 37111 
Germany, 1997 3.5% (8) 72 14996 
France, 2001 (1996) 6.6% (9;10) 1533 162220 
Norway, 2003 5.1% (11;12) 71 12257 
Suisse, 2002 8.1% (13;14) 60 7540 
Italy, INF-NOS, 2002 7.5% (15) 15 2165 
Greece, 2000 9.3% (16) 14 3925 
Italy, Lombardy, 2000 4.9% (17) 88 18667 
Slovenia, 2001 4.6% (18) 19 6695 
Canada, 2002 10.5% (19) 25 5750 
UK & IE, 2006 7.6% (20;21) 273 75763 
France, 2006 5.0% (22) 2337 358353 
Scotland, 2007 9.5% (23) 45 11608 
                                                 
49 Calculation by ECDC, unpublished results 
 
EN 50   EN The Netherlands, 2007 6.9% (24) 30 8424 
Total, mean 7.1%     
 
Assuming an overall average leng th of hospital stay of 10 days (LA), a mean length of 
stay of 22 days in patients who acquire on e or more nosocomial in fections (LN) and a 
mean interval between admission to onset of first infection (INT) of 8 days (figures 
corroborated by ref.(3)), this pr evalence figure of 7.1% converts to an incidence figure of 
approximately 5.1% according to the formul a I=P*LA/(LN-INT) w ith a 95% confidence 
interval ranging from 4.3% to 5.9%. The figur e of 5% compares relatively well to best 
nationwide figure of 5.7 per 100 admissions yet available from the US (25).  
According to Eurostat figures, in the EU (2005 figures completed by earlier years if 
missing, ref. http://epp.eurostat.ec.europa.e u/ and Health in Eu rope 2005 pocketbook 
edition), the number of hospital admissions is approximately 81 million per year (on average 16247 admissions/100 000 inhabitants/yea r). The yearly number of patients with 
at least one nosocomial infection in the EU  can thus be estimated at 4,131,000 patients 
(95% CI 3483000-4779000). Since several patient s acquire more than one infection 
during the same hospitalisation (average from the national pr evalence surveys review 1.1 
infections per infected patient) the yearly  number of nosocomia l infections can be 
estimated at 4,544,100 (95% CI 3831300-5256900). 
The impact of nosocomial inf ections on the excess length of  stay in the hospital and 
mortality (attributable morbidit y and mortality) depends on the type of infection (highest 
for pneumonia and bloodstream infections) and estimates vary considerably in scientific 
literature. Based on overall estimates of attr ibutable mortality in nosocomial infections 
by the CDC (26;27), approximately 37,179 d eaths (0.9%; 95%CI 31347-43011) directly 
caused by nosocomial infections occur every year in the EU and an additional 111,537 (95%CI 94041-129033) deaths occur to whic h infections contributed. Nosocomial 
infections also generate approximately 16 million extra days of hospital stay per year (average of 4 days per infection (26)). 
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control of nosocomial infections. The Na tional Foundation for Infectious Diseases 
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(2) Freeman J, Hutchison GB. Prevalence, incidence and duration. Am J Epidemiol 
1980; 112(5):707-723. 
(3) Gastmeier P, Brauer H, Sohr D, Geffe rs C, Forster DH, Daschner F et al. 
Converting incidence and prev alence data of nosocomial infections: results from 
eight hospitals. Infect Control Hosp Epidemiol 2001; 22(1): 31-34. 
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(8) Gastmeier P, Kampf G, Wischnewski N, Hauer T, Schulgen G, Schumacher M et 
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(11) Eriksen HM, Iversen BG, Aavitsland P. Prevalence of nosocomial infections in 
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(12) Bruun T, Loewer HL. Prevalence surveillan ce system of nosocom ial infections in 
Norway. Euro Surveill 2007; 12(8):E070830. 
(13) Sax H, Ruef C, Pittet D. Résultats de  l'enquête nationale de prévalence des 
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(15) Nicastri E, Petrosillo N, Martini L, Larosa M, Gesu GPIG. INF-NOS Study 
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Greek Infection Control Network. Pr evalence study of hospital-acquired 
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(18) Klavs I, Bufon LT, Skerl M, Grgic-Vi tek M, Lejko ZT, Dolinsek M et al. 
Prevalance of and risk factors for hospital- acquired infections in Slovenia-results 
of the first national survey, 2001. J Hosp Infect 2003; 54(2):149-157. 
 
EN 52   EN (19) Gravel D, Taylor G, Ofner M, Johnst on L, Loeb M, Roth VR et al. Point 
prevalence survey for healthcare-associat ed infections within Canadian adult 
acute-care hospitals. J Hosp  Infect 2007; 66(3):243-248. 
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Prevalence Survey of Hea lthcare-associated Infecti ons in Acute Hospitals 2006. 
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2006_resultats_preliminaires.pdf . 2007.  
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prevalence-study/report/full-report.pdf , 1-240. 2007.  
(24) PREZIES. PREZIES landelijk surveillan ce netwerk ziekenhuisinfecties. 
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(25) Haley RW, Culver DH, White JW, Mo rgan WM, Emori TG. The nationwide 
nosocomial infection rate. A new need fo r vital statistics. Am J Epidemio 1985; 
121(2):159-167. 
(26) Emori TG, Gaynes RP. An overview of nos ocomial infections, including the role 
of the microbiology laboratory. C lin Microbiol Rev 1993; 6(4):428-442. 
(27) Martone WJ, Jarvis WR, Culver DH, Hale y RW. Incidence and nature of endemic 
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Hospital Infections, 3rd ed. Little , Brown and co. , Boston, 1992: 577-596. 
 
EN 53   EN ANNEX 4: T HE MAIN DRIVERS RELATING TO THE INCIDENCE OF HCAI S 
 

 
EN 54   EN ANNEX 5: PATIENT SAFETY SYTEM CATEGORIZATION BY RAND 
A. ‘Exemplary’ category 
Among the twenty three countries studied, four Member States can be grouped as ‘exemplary’ 
countries in relation to patient safety. 
Criteria:  
The country in this rank has a ‘mature’ system  for patient safety re porting and learning at 
national and local levels. But, th e system may or may not include patient reporting; 
The country has an established redress mechanis m (e.g. a no-fault liability system, Tribunals of 
Inquiry and Compensati on and/or litigation); 
The country is very active in participating and/or leading EU -level and international-level 
initiatives to develop and use knowledge and evidence on patient safety (e.g. OECD patient 
safety indicator study, World Alliance on  Patient Safety, High Level Working Group, 
SIMPATIE project, EU NetPaS); The country has an institute dedicated to patient safety; 
Some of these countries are reviewing and eval uating their Patient Safety systems for further 
improvements; Some countries have already c onducted their own country-specific studies of the extent of the 
problem of patient safety; and, 
Nomination by other expert-respondents from other countries who confirm the exemplary 
nature of the countries in the Top Rank.
 
B. ‘Very good’ category 
Three countries were categorised as ‘very good’,  This group was a distinct category because 
the reporting and learning syst ems included pati ent reporting. 
Criteria:  
The country has a well-establis hed and functioning reporting and learning system at national 
level for patient safety exists in the country AND patients can re port to the system. But, the 
system may not be fully blame-free; There is a redress mechanism; The country may have a (new) instit ute dedicated to patient safety; 
The country may be evaluating and/or implemen ting changes to the existing Patient Safety 
systems; The country may have conducted its own study on the extent of the problem; and, 
The country is actively particip ating in EU-level and/or inte rnational-level initiatives to 
develop and use knowledge and evidence on patient safety (e.g. OECD patie nt safety indicator 
study, World Alliance on Patient Safety, High Level Working Group, SIMPATIE project, EU 
NetPaS). 
C. ‘Good’ category 
The 
‘good ’ grouping was the largest one with 8 EU Member States included.  
Criteria:  
The country has a well-establis hed and functioning reporting and learning system at national 
and local levels for patient safety exists in th e country, but the system may not be fully blame-
free and/or may be limited to some adverse events; 
 
EN 55   EN There is a redress mechanism; 
The country may have a (new) instit ute dedicated to patient safety; 
The country may be evaluating and/or implemen ting changes to the existing Patient Safety 
systems; The country may have conducted its own study on the extent of the problem; and, 
The country is actively particip ating in EU-level and/or inte rnational-level initiatives to 
develop and use knowledge and evidence on patient safety (e.g. OECD patie nt safety indicator 
study, World Alliance on Patient Safety, High Level Working Group, SIMPATIE project, EU 
NetPaS). 
D. ‘Fair’ category 
The ‘fair’ group included 5 countries 
Criteria:
 
A reporting and learning system fo r patient safety exists in the country but may not be at the 
national level, or may not be fully developed at national level becaus e it lacks the learning 
dimension or is not yet electronic (user-friendly); 
There may or may not be a redress mechanism in  place and what is in place, is only court-
based compensation; 
The country may have an institute for healthcare  quality and safety but may not be dedicated 
only to patient safety; and, The country is actively particip ating in EU-level and/or inte rnational-level initiatives to 
develop and use knowledge and evidence on patient safety (e.g. OECD patie nt safety indicator 
study, World Alliance on Patient Safety, High Level Working Group, SIMPATIE project, EU 
NetPaS). 
E. ‘Poor’ category 
Three countries belonge d to the ‘poor’ group  
Criteria:
 
There is currently no national pa tient safety reporting and lear ning mechanism in the country, 
but there may be partial systems at local level; There is no redress mechanism that is fair to both patients and professi onals in the country; 
As a minimum, the country is a member of the High Level Working Group and may also be 
active in developing and using kno wledge and evidence at EU level through participation in, 
for example, World Alliance, OECD, SIMPATIE, IPSE, EU NetPaS etc; 
The country may have an institute for quality and safety in healthcare, but it is not dedicated to 
patient safety; and, Nomination by peers or self as  being an example of a count ry having poor patient safety 
activities. 
These criteria are summarised  in the table below. 
 
EN 56   EN Taxonomy of selected EU countries working on Patient Safety Improvement Strategies 
Star category  
‘Objective’ criteria for country taxono my exemplary very good good fair poor 
The country has a well-developed nationa l reporting and learning system (RLS) 
in addition to local systems 
  
  
  
  
  
The country’s RLS is blame-free 
 
 
  
  
  
The country’s RLS includes both reporting and learning components 
 
  
  
 
  
The country’s RLS is not restricted to specific adverse events (i.e. includes the 
full range of incidents) 
  
  
 
  
  
Patients can participate in reporting to  the country’s repo rting and learning 
system 
 
 
 
  
  
The country has an established ( de jure ) redress system that includes more than 
going to court (e.g. a no-fault liability  system, Tribunals of Inquiry and 
Compensation and/or litigation/tort-based) 
 
 † 
  
 
  
The country is active in in itiatives to develop and use knowledge and evidence 
on patient safety. Examples include, but ar e not limited to: OECD patient safety 
indicator study, World Alliance on Pa tient Safety, High Level Working Group, 
SIMPATIE project, EU NetPaS 
 
  
  
  
  
The country is activ e in leading initiatives to develop and use knowledge and 
evidence at either EU or international levels 
  
  
 
  
  
The country has an established national institute, or other Competent Authority 
and it is dedicated to patient safety 
  
  
  
  
  
There is currently, or there has been, an evaluation of the existing patient safety 
system(s) of the country in que stion for further improvements 
  
  
  
  
  
The scope of the national pr oblem of patient safety ha s been, or is currently 
being, empirically investigated to some de gree (either at national or local level) 
in the country in question 
 
  
  
  
  
 
EN 57   EN SOURCE: RAND Europe 
LEGEND: 
 (full fulfilment of criteria); 
  (partial fulfilment, at le ast in progress or planned); 
  (not fulfilled).  
NOTE: † One country in this 4-star category did not fulfil this  criteria at all (i.e. has only a de facto tort-based redress 
mechanism), but it was included among the other countries in this category because it fulfilled all other criteria and was 
therefore not deemed to warrant being placed in the lower category.       
 
EN 58   EN ANNEX 6: CALCULATION OF LABOUR PRODUCTIVITY50 
Population
(million)Male
(million)Female
(million)Employed men
(million)Employed women
(million)Hours worked by 
men (million)Hours worked by 
women (million)GDP
(€ million)GDP per hour 
worked (€)
Austria 8,2 4,0 4,2 3,0 2,6 245.000
Belgium 10,4 5,1 5,3 3,5 2,9 298.000Bulgaria 7,8 3,8 4,0 2,3 2,1 21.000Cyprus 0,7 0,3 0,4 0,2 0,2 13.000Czech Rep 10,2 5,0 5,2 3,7 2,9 98.000Denmark 5,4 2,7 2,7 2,2 1,9 208.000Estonia 1,3 0,6 0,7 0,4 0,4 11.000Finland 5,2 2,5 2,7 1,8 1,8 155.000France 60,6 29,4 31,2 20,2 18,0 1.710.000Germany 82,5 40,4 42,1 28,8 25,1 2.247.000Greece 11,1 5,5 5,6 4,1 2,6 181.000Hungary 10,1 4,8 5,3 3,0 2,7 88.000Ireland 4,1 2,0 2,1 1,5 1,2 160.000
Italy 58,5 28,4 30,1 19,9 13,6 1.417.000
Latvia 2,3 1,1 1,2 0,7 0,7 13.000Lithuania 3,4 1,6 1,8 1,1 1,1 21.000Luxembourg 0,5 0,2 0,3 0,1 0,2 29.000Malta 0,4 0,2 0,2 0,1 0,1 4.000Netherlands 16,3 8,1 8,2 6,5 5,4 502.000Poland 38,2 18,5 19,7 10,9 9,2 243.000Portugal 10,5 5,1 5,4 3,7 3,3 147.000Romania 21,7 10,6 11,1 6,8 5,7 79.000Slovakia 5,4 2,6 2,8 1,7 1,4 38.000Slovenia 2,0 1,0 1,0 0,7 0,6 27.000Spain 43,0 21,2 21,8 15,9 11,2 904.000Sweden 9,0 4,5 4,5 3,3 3,2 288.000UK 60,0 29,4 30,6 22,8 20,2 1.791.000
EU27 488,8 238,6 250,2 168,9 140,3 306.418,4 217.605,3 10.938.000 20,9
                                                 
50 Eurostat (2005 data). Hours worked based on Eurostat data with: an EU average of 93% and 66% of employed men and women respect ively working full-time, with an 
EU average of 40 and 20 hours respectively for a full-time job and a part-time job; an EU average of 5 weeks of holidays. Days off sick from work have not been taken 
into account. 
 
EN 59   EN ANNEX 7: CALCULATION OF INPATIENT DAY COST51 
1998 1999 2000 2001 2002 2003 2004 2005 #beds cost/day
Austria 723,9 878,4 698,7 853,6 845,8 835,7 776,5 770,9 8,20 63.213,80 319,00 319,00 20.165.202,20
Belgium 787,5 782,3 777,8 767,4 759,2 752,3 749,1 744,8 10,40 77.459,20 501,00 350,70 27.164.941,44Bulgaria 838,1 747,7 739,3 699,2 646,6 626,7 611,6 593,3 7,80 46.277,40 38,00 54,29 2.512.201,71Cyprus 412,5 408,8 416,9 404,2 438,2 431,1 421,0 380,0 0,70 2.660,00 255,00 255,00 678.300,00Czech Rep 876,0 860,2 867,5 867,0 872,5 868,0 859,3 850,3 10,20 86.730,60 110,00 157,14 13.629.094,29Denmark 449,5 434,4 425,1 417,7 412,8 398,0 389,8 380,0 5,40 20.517,30 773,00 541,10 11.101.911,03Estonia 722,8 716,5 682,9 681,8 605,9 591,2 581,0 548,4 1,30 7.129,20 73,00 104,29 743.473,71Finland 776,3 759,7 753,4 745,2 735,9 723,6 705,6 704,2 5,20 36.618,40 267,00 267,00 9.777.112,80France 847,7 832,6 817,1 794,3 783,5 768,4 749,6 734,8 60,60 445.288,80 524,00 366,80 163.331.931,84Germany 929,3 920,2 912,2 901,9 887,8 874,4 857,6 846,4 82,50 698.280,00 625,00 437,50 305.497.500,00
Greece 508,0 496,6 495,2 478,2 472,1 470,3 469,8 473,8 11,10 52.591,80 389,00 389,00 20.458.210,20
Hungary 831,1 836,8 839,1 784,8 783,8 782,5 782,0 786,2 10,10 79.406,20 41,00 58,57 4.650.934,57Ireland 654,2 639,7 628,9 606,0 593,0 581,6 574,4 559,6 4,10 22.943,60 349,00 349,00 8.007.316,40Italy 548,7 486,8 470,9 461,4 444,6 417,9 400,6 400,9 58,50 234.526,50 541,00 378,70 88.815.185,55Latvia 922,2 885,2 855,1 809,5 773,4 779,3 : 766,4 2,30 17.627,20 51,00 72,86 1.284.267,43Lithuania 961,5 938,0 923,2 869,4 892,8 866,1 840,8 814,7 3,40 27.699,80 42,00 60,00 1.661.988,00Luxembourg 1055,1 712,5 657,1 651,7 644,3 638,2 631,8 625,4 0,50 3.127,17 761,00 532,70 1.665.841,68Malta 562,8 547,1 544,2 759,8 745,8 750,3 755,2 743,7 0,40 2.974,80 217,00 217,00 645.531,60Netherlands 512,3 505,7 492,1 464,7 459,1 440,5 438,2 437,2 16,30 71.263,60 400,00 400,00 28.505.440,00Poland 744,0 735,1 718,7 717,5 709,9 644,7 : 652,2 38,20 249.140,40 91,00 130,00 32.388.252,00Portugal 387,6 385,8 381,6 374,9 365,1 366,2 365,1 365,5 10,50 38.374,00 296,00 296,00 11.358.704,00Romania 749,7 749,6 762,7 769,2 747,1 657,4 658,3 661,8 21,70 143.610,60 40,00 57,14 8.206.320,00Slovakia 804,4 796,3 785,5 765,4 755,5 722,5 689,0 677,1 5,40 36.563,40 66,00 94,29 3.447.406,29
Slovenia 559,1 554,0 540,6 516,9 508,9 496,0 480,1 483,9 2,00 9.678,00 240,00 240,00 2.322.720,00
Spain 380,9 376,0 372,7 362,5 356,7 347,8 344,5 339,0 43,00 145.770,00 321,00 321,00 46.792.170,00Sweden 380,4 373,8 358,5 349,0 338,1 327,1 316,2 305,2 9,00 27.468,00 610,00 427,00 11.728.836,00UK 424,7 415,7 413,1 408,5 405,3 404,6 398,3 388,7 60,00 233.220,00 830,00 581,00 135.500.820,00
EU27 679,8 661,9 652,6 640,9 628,6 607,5 595,9 590,4 488,80 2.880.159,77 334,02 962.041.612,74Beds per 100,000 inhabitants inhabitants 
(million)cost/bed
/daycost/bed/ 
day corr
 
                                                 
51 Hospital beds: Eurostat (2005 data); shaded cells for number of be ds were calculated by linear regression. Cost/bed/day: based on healthcare unit cost for inpa tient day for patients with 
cardiovascular disease (J. Leal et al. Eu r. Hearth J. (2006) 27, 1610-1619); shaded cells for cost/bed/day are estimates extrap olated from healthcare unit cost s in countries with similar 
comparative price levels (compa rative price levels: Eurostat 2005 data).The estim ates on cost/bed/day for the individual Member  States are debatable as they were collected for treating 
cardiovascular disease (usually very expensive treatment) and not HCAIs for which figures for all Member States are not availab le; in addition, these costs may not reflect the situation for 
2008. When checking these figures with hosp ital representatives from different Member States, it was felt that the figures for the 'old' Member States represented an overestimation and the 
figures for the new Member States represented an underestimation.  Therefore, the following correc tion factors were applied: fig ures in bracket 0-200 euro were divided by 0.70; figures in 
200-400 bracket were not adapted; figures in excess of 400 euros were multiplied by 0.70.