Commission staff working document - Accompanying document to the communication 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}
Date: 2008-12-15
Institutions: European Commission
Subjects: disease prevention, health care, health policy, organisation of health care

EN 

EN 

   EN 

 
 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 15.12.2008 
SEC(2008) 3005  

COMMISSION STAFF WORKING DOCUMENT 

accompanying document to the Communication 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 

   EN 

 
 
 
  
 
 
 
COMMISSION STAFF WORKING DOCUMENT 

accompanying document to the Communication and Recommendation on patient safety, 
including the prevention and control of healthcare-associated infections 

SUMMARY OF THE IMPACT ASSESSMENT 

1. 

PROBLEM DEFINITION 

1.1. 

Nature of the issue or problem that requires action 

Patient safety is defined by WHO 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  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  between  8%  and  12%  of  patients 
admitted to hospitals suffer from adverse effects whilst receiving healthcare. 

Healthcare-associated infections (HCAIs), a key focus of the current initiative, are among the 
most frequent and potentially harmful causes of unintended harm, affecting an estimated one 
in twenty hospital patients on average, corresponding to 4.1 million patients every year in the 
EU. HCAIs are often difficult to treat due to antimicrobial resistance of the micro-organisms 
causing these infections. Other causes 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  address  the  challenges  of  patient  safety  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 causes or factors, and 
do not seek to address the overall cultural, leadership, systemic, communication and process 
barriers to improved safety. 

Although the problem of patient safety is primarily the responsibility of Member States, the 
European Union can encourage cooperation between 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  infections, cross-border provision of healthcare 
resulting from mobility of patients and professionals, 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  visibility,  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 

2 

   EN 

 
 
2. 

OBJECTIVES 

2.1. 

General Objective 

The  general  objective  is  to  prevent  and  reduce  human  illness  and  diseases  and  to  obviate 
sources of danger to human health, as stipulated in Article 152 of the Treaty. 

2.2. 

Specific objectives 

(1) 

(2) 

(3) 

To protect EU citizens from preventable harm in healthcare, including from HCAIs. 

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 evidence and expertise in the EU. 

To  improve  EU  citizens'  confidence  that  they  have  sufficient  and  comprehensible 
information available on levels of safety and 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  best  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 operational 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 implementation and effectiveness of measures to prevent 
and  control  HCAIs  and  of  guidance  on  best  practices  and  minimum  infrastructure 
requirements, as well as training curricula for healthcare workers. 

3. 

POLICY 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) 

(2) 

No  additional  EU  action  –  status  quo:  Under  this  option,  the  Member  States, 
stakeholders  and  international  organisations  would  pursue  their  activities  on  patient 
safety without any further co-ordination or incentives from the Commission. 

Strengthened  cooperation  with  the  Member  States  and  other  bodies,  supported 
by  technical  guidance:  Under  this  option,  the  Commission  would  strengthen 
cooperation with Member States and other 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 

3 

   EN 

 
(3) 

(4) 

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 network of surveillance 
bodies. 

Strengthened  cooperation  with  the  Member  States  and  other  bodies,  supported 
by  soft  law  instruments,  such  as  a  Commission  Communication  and  a  Council 
Recommendation: Under this option, the Commission would strengthen cooperation 
with Member States and other bodies and, in addition, develop a Communication and 
a  Council  Recommendation  on  the  issue  in  order  to  foster  the  political  commitment 
towards  patient  safety  in  Member  States  and  set  out  a  series  of  concrete 
recommendations to reduce the number of adverse events in healthcare systems. 

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  Option  2  with  a  legislative  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  Decision  (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 Regulation or a Directive 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. 

4. 

ANALYSIS OF IMPACTS 

4.1.  Methodology used in assessing the impacts 

In  order  to  assess  the  possible  health  and  economic  impacts  of  the  different  policy  options, 
quantitative  simulation  scenarios  have  been  developed  to  support  the  impact  assessment. 
These  scenarios  use  only  data  for  hospital  settings,  not  for  outpatient  care,  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 prevalence estimates for hospital-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 developing, with the help of infection control experts from ECDC, a 
separate potential reduction scenario for HCAI-related events only. 

4.2. 

Health and Economic impacts 

Policy option 1 

EN 

4 

   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 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,  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  programmes  of  nosocomial  bacteraemia  in  different 
Member States, it can be calculated that HCAIs affect 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 total incidence of 4.5 million HCAIs per year). 
Approximately 37.000 deaths are estimated to occur every year as a consequence of infection. 

Policy option 2 

For this policy option, that requires a strengthened cooperation with the Member States and 
other  bodies,  we  assumed  more  progress  would  occur,  in  particular  through  knowledge 
sharing. In our simulation scenario 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 personal 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 the potential for reduction in infection-related incidents reported in the 
literature. In the absence of a political commitment to bring about the needed organisational 
and behavioural changes, reaching the achievable 20-30% decrease of HCAIs, (requiring an 
intensive prevention and control programme including surveillance and training of healthcare 
staff) is unlikely. We assume HCAI reduction successes 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 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. 

Policy option 3 

Under  this  option,  that  includes  the  development  of  soft  law  instruments  such  as  a 
Communication or Recommendation, a high level political commitment from Member States 
to take action on patient safety could be attained. 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  our  general  scenario  a 
larger  impact  of  EU-level  action  under  policy  option  3,  with  the  result  of  all  EU  countries 

EN 

5 

   EN 

 
advancing  to  the  relatively  better  levels  of  adverse  events  reported  by  the  literature.  That 
means  that  we  assume  the  exemplary  countries  remain  as  efficient  as  they  are  and  all  other 
Member States 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  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 successes given that for 
infections, the ways to control them are well understood, and quick to implement, and above 
all  they  are  highly  preventable.  We  assume  that  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  expenditure  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-related, 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 identified 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 parts 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 more resources for reporting and surveillance as 
well as infection control in healthcare institutions.  

Projected  on  the  EU27  situation  with  a  total  of  2.88  million  beds,  employing  one  infection 
control nurse per 600 beds 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 
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 annual 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 

6 

   EN 

 
very  difficult  to  estimate  those.  The  environmental  impact  of  policy  option  4  would  be 
comparable to the one of policy option 2. 

5. 

COMPARING THE OPTIONS 

A  synoptic  overview  of  the  different  policy  options  and  the  extent  to  which  they  could 
achieve  the  identified  specific  objectives  is  presented  in  the  table  below.  Figures  were 
rounded. 

Policy option I 

Policy option II 

Policy option III  

Policy option IV 

Specific 
objective 1 

Protect 
citizens 
harm  

EU 
from 

Little  progress,  which 
would  occur  basically 
countries  where 
in 
patient 
is  a 
safety 
political priority 

Reduction 
of 
300.000  preventable 
adverse  events 
in 
total 

of 

Reduction 
750.000 
preventable  adverse 
events in total 

O with slight 
improvements 

+ 

++ 

+ to ++ 

Specific 
objective 2 

No additional EU level 
support 

Support MS to 
in  place 
put 
patient  safety 
strategies 

Specific 
objective 3  

Improve  EU 
citizens 
confidence  

Some  additional  EU 
support 
level 
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 

O 

+ 

+ 

++ 

+ to ++ 

++ 

+ to ++ 

Based on the above, the policy 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 HCAIs, appeared as the preferred one. 

6. 

MONITORING AND EVALUATION 

A set of indicators and data to be collected was proposed to enable future measurement of the 
economic and social impact of initiative. It is envisaged to evaluate the overall patient 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. 

EN 

7 

   EN