EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 15.12.2008 
SEC(2008) 3005  
  
COMMISSION STAFF WORKING DOCUMENT 
 
accompanying document to the Communicati on and Recommendation on patient safety, 
including the prevention and control of healthcare-associated infections 
SUMMARY OF THE IMPACT ASSESSMENT 
{COM(2008) 836 fianl} 
{COM(2008) 837 final} 
{SEC(2008)3004} 
 
 
 
EN 2   EN COMMISSION STAFF WORKING DOCUMENT 
 
accompanying document to the Communicati on and Recommendation on patient safety, 
including the prevention and control of healthcare-associated infections 
SUMMARY OF THE IMPACT ASSESSMENT 
1. P ROBLEM DEFINITION  
1.1. Nature of the issue or pr oblem that requires action 
Patient safety is defined by W HO as freedom for a patient from  unnecessary harm or potential 
harm associated with healthcare. There is a limited but growing body of  evidence concerning 
the prevalence and incidence of adverse events in health systems in EU Member States. National studies from the UK, Spain and Fran ce 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 Memb er States between 8%  and 12% of patients 
admitted to hospitals suffer from advers e effects whilst receiving healthcare. 
Healthcare-associated infections (HCAIs), a ke y focus of the current initiative, are among the 
most frequent and potentially harmful causes of  unintended harm, affecting an estimated one 
in twenty hospital patients on average, correspon ding to 4.1 million patients every year in the 
EU. HCAIs are often difficult to treat due to an timicrobial resistance of the micro-organisms 
causing these infections. Other cau ses of adverse events are medication-related errors such as 
patients receiving the wrong medicine, or the wrong dose, surgical errors, medical device 
failures and errors in diagnosis or the failure to act on the results of tests. 
1.2. Consequences of no change in policy 
The Commission has already taken specific steps in  many areas to address the issue of patient 
safety. However; efforts to addr ess the challenges of patient sa fety have focused mostly on 
specific sources of risk such as the safety of  medicines, medical devices and resistance to 
antimicrobials. These actions, however, only tend to focus on specific ca uses or factors, and 
do not seek to address the overall cultural, l eadership, systemic, co mmunication and process 
barriers to improved safety. 
Although the problem of patient safety is primar ily the responsibility of  Member States, the 
European Union can encourage cooperation betw een Member States and lend support to their 
actions in specific areas where EU intervention can have an added value. EU action is essential given the trans-boundary spread of inf ections, cross-border provision of healthcare 
resulting from mobility of patients and professi onals, and a need for EU-wide data collection 
and monitoring. A further added value of EU  intervention comes from the provision of 
political weight and visibilit y, thus putting patient safety at  the centre of Member States' 
health priorities, offering economies of scale,  and finally providing  effective knowledge 
sharing through exchange of best  practice. Without increased action by the European Union, 
adverse events will continue to constitute a considerable burden on Member States healthcare systems in terms of health and economic impacts. 
 
EN 3   EN 2. OBJECTIVES  
2.1. 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. 
2.2. Specific objectives 
(1) To protect EU citizens from preventable 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 health care, including HCAIs,  by pooling the best 
available evidence and expertise in the EU. 
(3) To improve EU citizens' confidence that they have sufficient and comprehensible 
information available on levels of safety a nd available redress in EU health systems, 
including healthcare providers in their own country and in other Member States. 
2.3. Operational Objectives 
A total number of ten operational objectives were identified that can be summarised as 
follows: To increase the political awareness of  Member States on the scale and size of the 
patient safety issue; to gather  homogeneous and comparable data  on patient safety; to develop 
common terminology and indicators; to share be st practice and experience; to develop and 
promote the research agenda on patient safety; to  promote the availability of information for 
patients and their families and to promote collaboration on patient safety issues between Member States, EU institutions and key European and international organisations. 
In the area of HCAIs, the operati onal objectives were to foster with the European Centre for 
Disease Prevention and Control (ECDC) the establishment of surveillance methods; of 
indicators to allow evaluation of the implementa tion and effectiveness of measures to prevent 
and control HCAIs and of guidance on best  practices and minimum infrastructure 
requirements, as well as training cu rricula for healthcare workers. 
3. P
OLICY OPTIONS  
3.1. Options identified: 
Four policy options have been considered as possible means to meet the policy objectives 
identified in the previous section. 
(1) No additional EU action – status quo:  Under this option, the Member States, 
stakeholders and international organisati ons would pursue their activities on patient 
safety without any further co-ordinat ion or incentives from the Commission. 
(2) Strengthened cooperation with the Memb er States and other bodies, supported 
by technical guidance: Under this option, the Co mmission would strengthen 
cooperation with Member States and othe r bodies. The Commission could for example 
increase the focus on patient safety in the Health Programme and the Framework Programme for research and technological development. The Commission could also 
 
EN 4   EN step up its efforts in stimu lating Member States to coope rate on the issue of HCAIs 
and to develop technical guidance through th e ECDC and the network of surveillance 
bodies. 
(3) Strengthened cooperation with the Memb er States and other bodies, supported 
by soft law instruments, such as a Commission Communication and a Council 
Recommendation: Under this option, the Commissi on would strengthen cooperation 
with Member States and ot her bodies and, in addition, develop a Communication and 
a Council Recommendation on the issue in orde r to foster the political commitment 
towards patient safety in Member States and set out a series of concrete recommendations to reduce the number of a dverse events in healthcare systems. 
(4) Strengthened cooperation with the Memb er States and other bodies, supported 
by a regulatory instrument, such  as a Commission Decision: This option would 
involve extension of Option 2 with a le gislative proposal based on Decision No 
2119/98/EC addressing certain aspects of the prevention and control of HCAIs in 
accordance with Article 7 of this Decisi on (Comitology). This legislative proposal 
could, however, not address general patient safety issues due to the lack of an 
appropriate legal basis. 
3.2. Options discarded at an early stage 
Legislation, including a Regulatio n or a Directive on patient safe ty, 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. 
4. A
NALYSIS OF IMPACTS  
4.1. Methodology used in assessing the impacts 
In order to assess the possible health and ec onomic impacts of the different policy options, 
quantitative simulation scenarios have been developed to support the impact assessment. 
These scenarios use only data for hospital setti ngs, not for outpatient car e, as the former is 
much better documented than the latter and is also  the main setting for HCAI. As of now, data 
gaps for the EU did not allow us  to establish a direct causal relationship between good patient 
safety policies, systems and structures, and patient safety outcomes. Our estimates were 
therefore based on how close the Member States' patient safety systems are to what is generally considered best practice in the literature. 
Our scenario for general patient safety policies starts from the assumption that patient safety 
outcomes in various Member State groups differ according to the systems in place and consequently are spread along the range of prev alence estimates for hospi tal-related incidents 
found in the literature that range from 7.5% to 16.6% with a median of 10%.We reviewed this 
overall scenario by also developi ng, with the help of infectio n control experts from ECDC, a 
separate potential reduction scenar io for HCAI-related events only. 
4.2. Health and Economic impacts 
Policy option 1 
 
EN 5   EN The supporting study for this IA suggests that under the 'no policy change' option, i.e. no 
increased action on patient safety at the EU le vel, the EU is likely to see around 10 million 
adverse events related to hospitalisations (inclu ding those infection-related) of which almost 
4.4 million would be preventable, resulting in more than 50.000 preventable person-years 
additional hospitalisation time. 
For HCAI in particular, on the basis of recent national prevalence surveys in Europe and the 
results of hospital-wide surveillance progra mmes of nosocomial bacteraemia in different 
Member States, it can be calculated that HCAIs a ffect an estimated 5% of hospital patients on 
average 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 to tal incidence of 4.5 million HCAIs per year). 
Approximately 37.000 deaths are estimated to occu r every year as a cons equence of infection. 
Policy option 2 
For this policy option, that requires a strengthe ned cooperation with the Member States and 
other bodies, we assumed more progress w ould occur, in partic ular through knowledge 
sharing. In our simulation scenar io all EU Member States with ‘poor’ and ‘fair’ patient safety 
reporting and learning systems would therefore be  able to advance and experience similar 
adverse event rates as countries  classified as already having  ‘good’ patient safety reporting 
and learning systems. That would mean that instead of having an average of 14% adverse 
events in hospital admissions, those countries would come closer to the performance of 
average countries which, in our scenario have 12%. In concrete terms that would mean that 
adverse preventable events would be reduced  by 298.371 cases as compared to the baseline 
scenario, resulting also in a reduction of 3.450 prevented pers onal years of hospitalisation. 
In our specific scenario on HCAIs we assume that strengthened cooperation with the Member 
States and other bodies, supported by technical guidance would reap an overall 5% decrease 
of HCAI, a quarter of th e potential for reduction in infection-related incidents reported in the 
literature. In the absence of a political commit ment to bring about the needed organisational 
and behavioural changes, reaching the achieva ble 20-30% decrease of HCAIs, (requiring an 
intensive prevention and control programme includi ng surveillance and training of healthcare 
staff) is unlikely. We assume HCAI reduction su ccesses are applicable across the board, given 
that some infection-related safety policies are in place in all EU 27.  
A projected 5% decrease would, in our HCAI scenario, result in 225.000 fewer HCAIs every 
year. This high share of reduced HCAIs compared to the reduction in overall adverse events is 
due to the fact that HCAI cases are the easie st and quickest to prevent. 225.000 cases imply a 
considerable decrease of the HCAI morbid ity and mortality burden. A 5% decrease would 
also save €274 million in health expenditure  and represent a gain of €68.5 million in 
productivity. 
Policy option 3 
Under this option, that includes the develo pment of soft law instruments such as a 
Communication or Recommendation, a high level pol itical commitment from Member States 
to take action on patient safety could be atta ined. The overall cultural, leadership, systemic, 
communication and process barriers  to increased patient safety could be addressed and HCAI 
integrated as part of an overall  patient safety policy. We assume substantial benefits for this 
option, where MSs' ownership is greatest. We therefore assumed in ou r general scenario a 
larger impact of EU-level action under policy op tion 3, with the result of all EU countries 
 
EN 6   EN advancing to the relatively better levels of adverse events repo rted by the literature. That 
means that we assume the exemplary countries re main as efficient as they are and all other 
Member States move towards the reported averag e of 10% adverse events  (‘very good’). This 
is still a conservative estimate (given the aver age preventability rate) but even so we could 
avoid more than 750.000 preventable adverse events and reduce by more than 8000 additional person-years of hospitalisation. 
For our HCAI–only reduction scenario we came up with even better suc cesses given that for 
infections, the ways to control them are we ll understood, and quick to implement, and above 
all they are highly preventable. We assume th at the estimated reduction could actually reap 
the possible 20% decrease, meaning a decrease  of up to 900.000 HCAIs every year, resulting 
in a saving of €1.10 billion in  public health e xpenditure and representing a gain of €274 
million in productivity. 
Policy option 4 
For this option, the strengthened cooperation with Member Sates and other bodies is 
supported by a regulatory instrument, such as a Commission Decision. Such a Decision could, 
however, address infection-relate d, and not general and systemic  patient safety issues, given 
the lack of a legal base for this. Therefore, we assume the general patient safety benefits to be 
in the range of those id entified under policy option 2. 
As regards HCAI, we do not assume that the benefits would be much bigger than those 
identified in policy option 2. That is because  our legal basis would not address all the 
operational objectives of the proposal  and, therefore, essential part s of the integrated strategy 
to combat HCAIs would have to be left out. As  a result, we do not expect this option to 
perform much better than the option of strengthened cooperation with the Member States 
(option 2). 
4.3. Employment effects 
In all policy options (with the exception of the status quo) slightly positive employment 
effects can be expected due to the need for mo re resources for report ing and surveillance as 
well as infection control in  healthcare institutions.  
Projected on the EU27 situation with a tota l of 2.88 million beds, employing one infection 
control nurse per 600 beds and a ssuming a current staffing level of  one infection control nurse 
per 1000 beds would mean employing an add itional 1.920 nurses. Assuming an EU average 
annual cost of €42.000 / infection control nurse, this would mean an additional annual expenditure of about €80 million for policy option 2. For policy option 3, we assumed that one additional infection control nurse per 250 beds has to be employed, resulting in 
employing an additional 8.640 nurses and an an nual expenditure of about €363 million. The 
employment effect of policy option 4 would be comparable to the one of policy option 2. 
4.4. Environmental impact 
Environmental impacts seemed to be primarily confined to the specific area of healthcare-
associated infections, and only to a much lesser extent can they be linked to other causes of 
adverse events. Under policy options 2 and 3, minor  environmental impacts are likely to occur 
due to an increased use of disposable medical products and disinfectant chemicals, but it was 
 
EN 7   EN very difficult to estimate those. The enviro nmental impact of policy option 4 would be 
comparable to the one of policy option 2. 
5. C OMPARING THE OPTIONS  
A synoptic overview of the diffe rent policy options and the ex tent to which they could 
achieve the identified specific objectives is pr esented in the table below. 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 ++ 
 
Based on the above, the policy option of a pr oposal for a Commissi on Communication and a 
Council Recommendation on patient safety and quality of health services, including the prevention and control of HCAIs, appeared as the preferred one. 
6. M
ONITORING AND EVALUATION  
A set of indicators and data to be collected wa s proposed to enable future measurement of the 
economic and social impact of initiative. It is envisaged to evaluate th e overall patient safety 
initiative, including implementa tion of the Recommendation, using external experts to assess 
its relevance, effectiveness and efficiency. This evaluation coul d be part of a comprehensive 
evaluation project for different  health related initiatives.