Proposal for a Council Directive implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU (text with EEA relevance)
Date: 2009-10-26
Institutions: European Commission
Subjects: environmental risk prevention, health care profession, health risk, infectious disease, medical device, occupational health, occupational safety, protective equipment, trauma

EN 

EN 

   EN 

 
 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 26.10.2009 
COM(2009) 577 final 

Proposal for a 

COUNCIL DIRECTIVE 

implementing the Framework Agreement on prevention from sharp injuries in the 
hospital and healthcare sector concluded by HOSPEEM and EPSU 

(text with EEA relevance)  

EN 

   EN 

 
 
 
  
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Grounds for and objectives of this proposal 

The  aim  of  the  proposal  is  to  give  legal  effect  to  the  Framework  Agreement  on  prevention 
from  sharp  injuries  in  the  hospital  and  healthcare  sector,  signed  on  17  July  2009  by 
HOSPEEM  (European  Hospital  and  Healthcare  Employers’  Association)  and  EPSU 
(European  Federation  of  Public  Services  Unions).  These  two  bodies  were  recognised  as 
European social partners in the hospital and healthcare sector by the Commission in 2006 in 
accordance with Article 138 of the EC Treaty.  

The Framework Agreement (hereinafter ‘the Agreement’) aims to protect workers at risk of 
injury  from  all  medical  ‘sharps’  (including  needle-sticks)  and  to  prevent  the  risk  of  injuries 
and  infections  caused  by  medical  sharps.  It  provides  for  an  integrated  approach  to  risk 
assessment, risk prevention, training, information, awareness-raising and monitoring and for 
response  and  follow-up  procedures.  The  Agreement  and  this  proposal  will  contribute  to 
achieving the safest possible working environment in the hospital and healthcare sector. 

1.2. 

General context 

Injuries  caused  by  needles  and  other  sharp  instruments  are  one  of  the  most  common  and 
serious risks to healthcare workers in Europe and represent a high cost for health systems and 
society in general. 

It  is  recognised  that  hospital  and  healthcare  workers  (nurses,  doctors,  surgeons,  etc.), 
particularly  in  certain  departments  and  activities  (emergencies,  intensive  care,  surgical 
operations,  etc.),  frequently  risk  infection  due  to  injuries  caused  by  needles  or  other  sharp 
instruments  (scalpels,  suture  equipment,  etc.).  The  consequences  may  be  very  serious, 
possibly leading to serious diseases such as viral hepatitis or AIDS. 

Some studies estimate the number of needle-stick injuries at approximately 1 200 000 per year 
in Europe. 

In  the  Community  strategy  2007-2012  on  health  and  safety  at  work1,  the  Commission 
announced  its  intention  of  continuing  its  work,  through  consultation  of  the  European  social 
partners  as  provided  for  in  Article  139  of  the  EC  Treaty,  on  ways  of  improving  risk 
prevention with regard to needle-stick infections, among others. 

On several occasions, the European Parliament has expressed concern at the life-threatening 
risks faced by healthcare workers from contaminated needles. 

1 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions  ‘Improving  quality  and 
productivity  at  work:  Community  strategy  2007-2012  on  health  and  safety  at  work’  (COM(2007)  62 
final,21 February 2007), point 4.3. 

EN 

2 

   EN 

 
                                                 
In  its  resolution  of  24  February  2005  on  promoting  health  and  safety  at  the  workplace2, 
Parliament  called  for  revision  of  Directive  2000/54/EC  specifically  to  address  the  risk  of 
working with needles and medical sharps. 

On  6  July  2006  the  European  Parliament  adopted  a  resolution3  on  protecting  European 
healthcare  workers  from  blood-borne  infections  due  to  needle-stick  injuries.  The  resolution 
called  on  the  Commission  to  submit  a  legislative  proposal  on  the  basis  of  Articles  137  and 
251 of the EC Treaty for a directive amending Directive 2000/54/EC4 on biological agents at 
work. 

Under  Article  138(1)  of  the  EC  Treaty,  the  Commission  has  the  task  of  promoting  the 
consultation  of  management  and  labour  at  Community  level  and  is  to  take  any  relevant 
measure to facilitate their dialogue by ensuring balanced support for the parties. To this end, 
before  submitting  proposals  in  the  social  policy  field,  the  Commission  has  to  consult 
management  and  labour  (i.e.  the  European  social  partners)  on  the  possible  direction  of  EU 
action  and  the  content  of  the  envisaged  proposal.  Furthermore,  Article  138(4)  of  the  EC 
Treaty  provides  that  management  and  labour  may  inform  the  Commission  of  their  wish  to 
initiate the process provided for in Article 139 of the EC Treaty, i.e. dialogue between them at 
Community level, which may lead to contractual relations, including agreements. 

On  21  December  2006  the  Commission  launched  the  first  stage  in  the  consultation  of  the 
European social partners. The second stage was launched on 20 December 2007. 

The consultation documents called on the European social partners to: (1) forward an opinion 
on the objectives and content of the legislative and non-legislative initiatives envisaged; (2) 
notify  the  Commission  if  they  intend  to  initiate  negotiations,  in  accordance  with 
Article 138(4) and Article 139 of the EC Treaty. 

By  joint  letter  of  17  November  2008,  EPSU  and  HOSPEEM  informed  the  Commission  of 
their intention of negotiating a framework agreement on the prevention from sharp injuries in 
the hospital and healthcare sector. 

As the Commission fully recognises the negotiating autonomy of the European social partners 
on  topics  falling  within  their  competence,  the  preparation  of  the  legislative  proposal  for  a 
directive  amending  Directive  2000/54/EC  on  biological  agents  at  work  was  consequently 
suspended pending the outcome of the negotiations between the social partners. 

On 2 June 2009, the European social partners agreed on the Agreement. 

On 17 July 2009, EPSU and HOSPEEM signed the Agreement and informed the Commission 
of their request to submit the Agreement to the Council for a Council decision, in accordance 
with Article 139(2) of the EC Treaty. 

2 

3 

4 

European Parliament resolution of 24 February 2005 on promoting health and safety at the workplace 
(2004/2205(INI)), OJ C 304 E, 1.12.2005, p. 400. 
European Parliament resolution of 6 July 2006 with recommendations to the Commission on protecting 
European healthcare workers from blood-borne infections due to needle-stick injuries (2006/2015(INI)), 
OJ C 303 E, 13.12.2006, p. 754. 
Directive  2000/54/EC  of  the  European  Parliament  and  of  the  Council  of  18  September  2000  on  the 
protection  of  workers  from  risks  related  to  exposure  to  biological  agents  at  work  (seventh  individual 
directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 262, 17.10.2000, p. 21. 

EN 

3 

   EN 

 
                                                 
1.3. 

Existing provisions on issues relating to the proposal 

Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage 
improvements  in  the  safety  and  health  of  workers  at  work5  lays  down  general  preventive 
measures  to  protect  the  health  and  safety  of  workers.  It  sets  out  minimum  requirements 
concerning, among other things, risk assessment and the informing, training and consulting of 
workers.  In  particular,  Article  6  of  the  Directive  sets  out  general  principles  of  prevention, 
namely  ‘avoiding  risks’,  ‘combating  risks  at  source’  and  ‘replacing  what  is  dangerous  with 
what is not dangerous or with what is less dangerous’. In addition to Directive 89/391/EEC, 
some of its individual directives also apply to the prevention of infection risks among staff in 
the healthcare sector: 

(a)  Directive  2000/54/EC  of  the  European  Parliament  and  of  the  Council  of  18  September 
2000 on the protection of workers from risks related to exposure to biological agents at work 
(seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)6 
contains  provisions  aimed  at  preventing  these  risks  and  lays  down  specific  minimum 
requirements in this area. It establishes employers’ obligations concerning risk prevention. In 
particular, for any activity likely to present a risk of exposure to biological agents, the nature, 
degree and duration of exposure for workers must be determined in order to assess any risk to 
the health and safety of workers and to determine the measures to be taken. 

(b) The aim of Council Directive 89/655/EEC of 30 November 1989 concerning the minimum 
safety  and  health  requirements  for  the  use  of  work  equipment  by  workers  at  work  (second 
individual  Directive  within  the  meaning  of  Article  16(1)  of  Directive  89/391/EEC)7  (as 
amended  by  Directives  95/63/EC8  and  2001/45/EC9)  is  to  improve  safety  for  workers  using 
work equipment, such as medical equipment used in hospitals. Employers must choose work 
equipment in accordance with working conditions and the risks to workers so as to eliminate 
or minimise these risks. 

(c) Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety 
requirements for the use by workers of personal protective equipment at the workplace (third 
individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)10 states that 
the  use  of  personal  protective  equipment  is  required  where  risks  cannot  be  avoided  or 
sufficiently  limited  by  technical  means  of  collective  protection  or  by  work  organisation 
methods  or  procedures.  All  personal  protective  equipment  must  be  appropriate  to  the  risks 
involved,  without  itself  leading  to  any  increased  risk.  It  must  correspond  to  prevailing 
conditions at the workplace and be adapted to the person wearing it. 

5 
6 
7 
8 

9 

10 

OJ L 183, 29.6.1989, p. 1. 
OJ L 262, 17.10.2000, p. 21. 
OJ L 393, 30.12.1989, p. 13. 
Council  Directive  95/63/EC  of  5  December  1995  amending  Directive  89/655/EEC  concerning  the 
minimum  safety  and  health  requirements  for  the  use  of  work  equipment  by  workers  at  work  (second 
individual  Directive  within  the  meaning  of  Article  16(1)  of  Directive  89/391/EEC),  OJ  L  335, 
30.12.1995, p. 28. 
Directive  2001/45/EC  of  the  European  Parliament  and  of  the  Council  of  27  June  2001  amending 
Council Directive 89/655/EEC concerning the minimum safety and health requirements for the use of 
work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of 
Directive 89/391/EEC), OJ L 195, 19.7.2001, p. 46. 
OJ L 393, 30.12.1989, p. 18. 

EN 

4 

   EN 

 
                                                 
It should also be noted that Annex I, Part II, to Council Directive 93/42/EEC of 14 June 1993 
concerning  medical  devices11  stipulates  that  ‘the  devices  and  manufacturing  processes  must 
be designed in such a way as to eliminate or reduce as far as possible the risk of infection to 
the patient, user and third parties. The design must allow easy handling and, where necessary, 
minimise contamination of the device by the patient or vice versa during use’ (point 8.1). Any 
device  placed  on  the  market  must  also  have  received  the  CE  mark,  attesting  its  conformity 
with the essential requirements of that Directive. 

1.4. 

Consistency with other policies and objectives of the Union 

The aim of this proposal is consistent with EU policies and objectives. 

Promoting  a  safe  and  healthy  working  environment  and  accordingly  reducing  the  economic 
costs of health and safety problems at work contributes to achieving the overall goals of the 
Lisbon Strategy for Growth and Jobs, namely economic growth and employment.  

Further,  the  Renewed  Social  Agenda  ‘Opportunities,  access  and  solidarity  in  21st  century 
Europe’12 states that the EU health workforce is a vital component in delivering high-quality 
health services. 

The envisaged action is in line with EU public health policy. The White Paper ‘Together for 
Health:  A  Strategic  Approach  for  the  EU  2008-2013’13  stresses  that  patient  safety  is  a  key 
area  of  concern.  Any  measure  to  protect  the  health  and  safety  of  workers  in  the  healthcare 
sector contributes to the quality of services delivered to patients and reduces the possibility of 
patients experiencing adverse effects from their healthcare. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

2.1. 

Consultation 

Following  the  resolution  of  the  European  Parliament  of  6  July  2006  calling  on  the 
Commission to submit a legislative proposal on the basis of Articles 137 and 251 of the EC 
Treaty  for  a  directive  amending  Directive  2000/54/EC  on  biological  agents  at  work,  the 
Commission launched a two-stage consultation of the European social partners in accordance 
with Article 138 of the EC Treaty14. 

The first stage of the consultation process was launched on 21 December 2006 on the possible 
direction  of  Community  action  to  strengthen  the  protection  of  European  healthcare  workers 
from blood-borne infections due to needle-stick injuries. The social partners were also asked 
whether they would consider a joint voluntary initiative under Article 139 of the EC Treaty. 

11 
12 

13 
14

OJ L 169, 12.7.1993, p. 1. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  Regions  ‘Renewed  social  agenda: 
Opportunities, access and solidarity in 21st century Europe’ (COM(2008) 412 final of 2 July 2008), p. 
12. 
COM(2007) 630 final of 23 October 2007, pp. 8–9. 
http://ec.europa.eu/social/keyDocuments.jsp?type=50&policyArea=0&subCategory=0&countr 
y=0&year=2006&advSearchKey=&mode=advancedSubmit&langId=en and 
http://ec.europa.eu/social/keyDocuments.jsp?pager.offset=10&langId=en&mode=advancedSubmit&pol
icyArea=0&subCategory=0&year=2007&country=0&type=50. 

EN 

5 

   EN 

 
                                                 
 
On  20  December  2007,  the  second  stage  of  the  consultation  process  was  launched  on  the 
substance of the envisaged Community action. 

On  the  whole,  the  workers’  organisations  considered  that  while  the  existing  legislation 
covered  the  risks  in  general  terms,  more  specific  legislation  would  reinforce  worker 
protection, so were in favour of a Community initiative in the form of legislation. 

The  employers’  organisations,  however,  considered  that  the  existing  legislation  already 
afforded appropriate protection and were unanimously opposed to any Community initiative 
in the form of legislation. 

As  regards  the  possible  negotiation  of  an  agreement  between  the  European  social  partners 
under  Article  139  of  the  EC  Treaty,  most  of  the  employers’  and  workers’  organisations  did 
not  rule  out  the  possibility  of  negotiating  a  sectoral  agreement  (in  the  hospital  sector  in 
particular).  Further  to  the  consultation,  EPSU  and  HOSPEEM,  the  main  umbrella 
organisations representing employers’ and workers’ organisations, informed the Commission 
that they could consider the possibility of starting negotiations on the issue with a view to a 
possible agreement. 

2.2. 

Collection and use of expertise 

External expertise on the problem of needle-stick injuries in the EU and the likely impact of 
possible  policy  options  was  gathered  through  a  study  carried  out  by  an  external  consultant 
selected by the Commission after an open call for tenders. The purpose of the study was to 
conduct  an  in-depth  analysis  of  the  socio-economic,  health  and  environmental  impact  of  a 
possible Community initiative on the protection of EU healthcare workers from blood-borne 
infections due to needle-stick injuries and other sharp objects and instruments. 

On  7  February  2008,  the  European  social  partners  held  a  technical  seminar  with  scholars, 
healthcare workers and employers (professors, surgeons, doctors and nurses), who presented a 
wide  range  of  case  studies  and  statistics.  The  seminar  provided  an  opportunity  for  the 
exchange of good practice and data on healthcare injuries. It addressed the various types of 
exposures  (cutaneous,  mucous  and  non-intact  skin)  and  the  related  occupational  infections 
(bacterial,  viral,  protozoan,  fungal  and  tumoral).  It  also  reviewed  all  the  causes  of  injuries 
(syringes,  butterflies,  lancets  and  catheters)  and  the  prevalence  of  each.  This  clearly 
confirmed  that  the  remit  for  occupational  risks  to  be  tackled  in  the  hospital  sector  should 
cover  all  types  of  injuries  caused  by  medical  sharps,  including  needle-sticks.  The  European 
social partners accordingly informed the Commission of their intention to launch negotiations. 

2.3. 

Impact assessment 

The Commission has not prepared a specific impact assessment on this proposal, as it is not 
required to do so when it proposes to give legal effect to an agreement between social partners 
in accordance with Article 139(2) of the EC Treaty. 

3. 

LEGAL ASPECTS OF THE PROPOSAL 

3.1. 

Legal basis 

The proposal is based on Article 139(2) of the EC Treaty.  

EN 

6 

   EN 

 
Article 139(2) of the EC Treaty provides that agreements concluded by the European social 
partners  at  Community  level  in  matters  covered  by  Article  137  of  the  EC  Treaty  are  to  be 
implemented ‘at the joint request of the signatory parties, by a Council decision on a proposal 
from  the  Commission’.  It  goes  on  to  say  that  ‘The  Council  shall  act  by  qualified  majority, 
except where the agreement in question contains one or more provisions relating to one of the 
areas  for  which  unanimity  is  required  pursuant  to  Article  137(2).  In  that  case  it  shall  act 
unanimously.’ 

The objective of the Agreement concluded by HOSPEEM and EPSU is to achieve the safest 
possible working environment by preventing injuries to workers caused by all medical sharps 
(including needle-sticks) and protecting workers at risk. It thus aims to ensure ‘improvement 
in  particular  of  the  working  environment  to  protect  workers’  health  and  safety’,  an  area 
governed  by  Article  137  of  the  EC  Treaty,  in  which  the  Council  can  decide  by  qualified 
majority.  Article  139(2)  of  the  EC  Treaty  is  hence  the  appropriate  legal  basis  for  the 
Commission proposal.  

Article  139(2)  of  the  EC  Treaty  does  not  provide  for  Parliament’s  involvement  in  the 
legislative  procedure.  However,  in  line  with  previous  commitments,  the  Commission  will 
inform  Parliament  of  its  proposal  so  that  it  can,  where  it  so  desires,  send  an  opinion  to  the 
Commission  and  the  Council.  The  same  applies  to  the  European  Economic  and  Social 
Committee. 

3.2. 

Analysis of the Agreement  

According  to  the  Commission  Communication15  laying  down  the  rules  for  implementing 
agreements under Article 139 of the EC Treaty, ‘the Commission will prepare proposals for 
decisions to the Council following consideration of the representative status of the contracting 
parties, their mandate and the “legality” of each clause in the collective agreement in relation 
to Community law, and the provisions regarding small and medium-sized undertakings set out 
in Article [137(2)(b) of the EC Treaty].’ This ex-ante assessment is set out below. 

3.2.1.  Representativeness of the signatory parties and their mandate  

The European social partners’ ability to be consulted and to negotiate agreements depends on 
their  representativeness.  One  of  the  criteria  defining  that  ability  in  Commission  Decision 
98/500/EC of 20 May 1998 on the establishment of Sectoral Dialogue Committees promoting 
the Dialogue between the social partners at European level16 states that they ‘shall consist of 
organisations which are themselves an integral and recognised part of Member States’ social 
partner structures and have the capacity to negotiate agreements, and which are representative 
of several Member States.’  

3.2.1.1  Representativeness  of  EPSU  and  HOSPEEM  in  the  public  and  private  parts  of  the 
hospital and healthcare sector 

In  2008  the  Commission  launched  a  study  (published  on  29  May  2009)  on  the 
representativeness  of  the  EU  social  partners  in  the  hospital  sector17.  It  states  that  ‘the  vast 
majority  of  the  sector’s  employees  work  in  public  hospitals’.  Nonetheless,  HOSPEEM  and 

15 

16 
17 

Commission Communication concerning the application of the Agreement on social policy (COM(93) 
600 final of 14 December 1993). 
OJ L 225, 12.8.1998, p. 27. 
http://www.eurofound.europa.eu/docs/eiro/tn0802017s/tn0802017s.pdf. 

EN 

7 

   EN 

 
                                                 
EPSU  represent  both  parts  of  the  hospital  and  healthcare  sector.  Indeed,  when  the  hospital 
social dialogue committee was being set up in 2006, the Commission ensured that the private 
part  of  the  sector  was  also  represented  on  the  employers’  side  through  the  signing  of  a 
cooperation agreement between HOSPEEM and HOPE (European Hospital and Healthcare 
Federation).  HOPE  represents  national  public  and  private  hospital  associations  and  hospital 
owners, comprising federations of local and regional authorities and national health services 
with 10 affiliations in seven countries. Through this cooperation agreement, HOPE has given 
a specific mandate to HOSPEEM in European social dialogue activities. 

On the workers’ side, EPSU covers all the Member States and its membership is open to all 
trade  unions,  whether  they  operate  in  the  private,  public  or  non-profit  areas.  Most  unions 
affiliated  with  EPSU  organise  workers  throughout  the  whole  of  the  healthcare  sector:  these 
may  be  general  services  unions  (such  as  Unison,  Ver.di  and  Abvakabo  FNV)  or  general 
healthcare/social  services  unions  (such  as  CGT  Santé-Sociaux  and  EDDSZ).  EPSU  also 
includes  a  large  number  of  professional  unions  (such  as  DNO,  RCM  and  Marburger  Bund) 
among its members. These unions all organise both privately and publicly employed workers 
in  the  healthcare  sector.  In  countries  where  public-sector  and  private-sector  healthcare 
workers come under different trade unions, EPSU in general represents both the public-sector 
and  the  private-sector  unions  (e.g.  Belgium  and  Austria).  Lastly,  EPSU  also  includes 
organisations that act solely in the private sector. 

3.2.1.2 Representativeness of HOSPEEM and EPSU in the hospital and healthcare sector 

At  the  time  the  European  social  dialogue  committee  for  hospitals  was  set  up  in  2006,  the 
Commission  assessed  the  representativeness  of  EPSU  and  HOSPEEM,  which  clearly  stated 
that they represented public, private and non-profit hospitals and hospital associations, which 
form  an  integral  part  of  healthcare  delivery  and  provide  such  services  as  accommodation, 
meals, nursing care, medical treatment and rehabilitation of patients, while medical therapy is 
administered  by  professional  physicians.  The  designations  of  most  of  their  national  affiliate 
members  also  demonstrate  that  the  European  social  partners  are  representative  of  the 
healthcare  sector.  Lastly,  the  representativeness  study  highlighted  the  multi-sectoral 
dimensions of HOSPEEM and EPSU (with HOSPEEM stemming from CEEP, recognised as 
a cross-industry European social partner representing public employers). 

Both EPSU and HOSPEEM cover countries outside the EU.  

EPSU  covers  all  of  the  27  Member  States.  EPSU  brings  together  the  largest  national  trade 
unions  in  the  sector  and  represents  the  majority  of  its  unionised  employees.  All  national 
affiliates of EPSU are involved in bargaining or ‘quasi-bargaining’, i.e. de facto negotiations 
or consultation. 

HOSPEEM (including HOPE) covers a total of 16 Member States (AT, BE CZ. DE, DK, EE, 
FR, IE, IT, LU, LV, NL, PL, SE, SK and UK) (no employers’ association exists in six of the 
11 Member States not covered). According to the study, HOSPEEM covers far more countries 
than any other European association. 

3.2.1.3 Activities covered by the European social partners  

According  to  the  information  provided  by  EPSU  and  HOSPEEM,  the  European  social 
partners cover activities in the range Q86 to Q88 (NACE codes), which include Human health 
activities, Hospital activities, Medical and dental practice activities, General medical practice 

EN 

8 

   EN 

 
activities,  Specialist  medical  practice  activities,  Residential  care  activities,  Residential 
nursing care activities, Residential care activities for mental retardation, mental health and 
substance  abuse,  Residential  care  activities  for  the  elderly  and  disabled,  Other  residential 
care  activities,  Social  work  activities  without  accommodation  for  the  elderly  and  disabled, 
Other social  work activities without accommodation, Child day-care  activities, Other  social 
work activities without accommodation. 

3.2.1.4 Capacity to negotiate  

One of the criteria for representativeness at European level is the capacity of European social 
partners to negotiate on behalf of their members. The Commission assessed this negotiating 
capacity 
the  hospital  sector.  The 
representativeness study states that EPSU has a mandate to negotiate on matters concerning 
European social dialogue in accordance with its constitution. HOSPEEM also has a mandate 
to negotiate on behalf of its members in matters concerning European social dialogue. 

in  2006  when  social  dialogue  was  set  up 

in 

In  conclusion,  the  signatories  to  the  Agreement  have  sufficient  representative  status  with 
regard to the hospital and healthcare sector in general and the workers who may be covered 
by it. Therefore all the conditions for representativeness of the signatories are met. 

3.2.2.  Legality of the clauses in the Agreement 

The  Commission  has  scrutinised  all  the  clauses  in  the  Agreement  and  has  found  none  to 
contravene Community law. 

The substance of the Agreement falls within the scope of Article 137(1)(a) of the EC Treaty 
(improvement of the working environment to protect workers’ health and safety).  

The  Agreement  contains  a  ‘minimum  standards’  clause,  which  states  that  the  Agreement  is 
without  prejudice  to  existing  or  future  national  and  Community  provisions  that  are  more 
favourable to workers’ protection from injuries caused by medical sharps (Clause 11). 

The Commission therefore considers that the Agreement meets the condition of legality. 

3.2.3.  Provisions regarding small and medium-sized enterprises 

Under  Article  137(2)  of  the  EC  Treaty,  legislation  in  the  social  field  must  ‘avoid  imposing 
administrative,  financial  and  legal  constraints  in  a  way  which  would  hold  back  the  creation 
and development of small and medium-sized undertakings’. 

Although there are no specific clauses in the Agreement setting out specific arrangements for 
SMEs, no clause appears to impose inappropriate burdens on SMEs. 

3.3. 

Subsidiarity and proportionality 

The aim of this proposal is to achieve the safest possible working environment by preventing 
injuries  to  workers  caused  by  all  medical  sharps  (including  needle-sticks)  and  protecting 
workers at risk in the hospital and healthcare sector at European level. Thus, action taken by 
the Member States alone cannot suffice to achieve an EU-wide minimum level of protection 
against medical sharps, which can therefore be better achieved by action at Community level. 
Both  the  European  social  partners  and  the  Commission  are  convinced  of  the  need  for 
Community action in this area.  

EN 

9 

   EN 

 
The fact that the substantive provisions of the Agreement incorporated in the proposal were 
drafted  by  the  legitimate  representatives  of  workers  and  employers  acting  at  EU  level  (i.e. 
those most concerned by the various measures on the ground) is another guarantee of respect 
for the principle of subsidiarity.  

As  for  proportionality,  the  proposal  goes  no  further  than  necessary  in  ensuring  that  the 
objectives  are  met.  The  Member  States  and  the  Community  have  a  degree  of  latitude  in 
maintaining  or  adopting  provisions  that  are  more  favourable  to  workers’  protection  from 
injuries caused by medical sharps (Clause 11). It should also be noted that the Agreement is 
termed a ‘framework’ Agreement.  

The  proposal,  which  is  taken  at  the  right  level  and  does  not  go  further  than  absolutely 
necessary  to  achieve  the  objectives  at  EU  level,  therefore  complies  with  the  principles  of 
subsidiarity and proportionality.  

3.4. 

Choice of instrument 

The  term  ‘Council  decision’  in  Article  139(2)  of  the  EC  Treaty  is  to  be  understood  in  its 
general meaning as referring to the legally binding instruments provided for in Article 249 of 
the  EC  Treaty.  It  is  for  the  Commission  to  decide  and  propose  which  of  the  three  binding 
instruments (directive, regulation or decision) is most suitable. The aim of the Agreement is to 
establish minimum requirements which, given the type and substance of the Agreement, are 
best applied indirectly through provisions to be transposed into national law by the Member 
States and/or the social partners. The appropriate instrument is therefore a Council directive to 
which the Agreement is annexed. 

3.5. 

Correlation table 

The  Member  States  are  required  to  send  the  Commission  the  text  of  national  provisions 
transposing the Directive, together with a correlation table between those provisions and the 
Directive. 

3.6. 

European Economic Area 

As the Agreement is relevant to the European Economic Area, the Directive will be applicable 
to the non-EU Member States of the European Economic Area, following a decision by the 
EEA Joint Committee.  

4. 

BUDGETARY IMPLICATIONS 

The proposal has no implications for the Community budget. 

5. 

DETAILED EXPLANATION OF THE SPECIFIC PROVISIONS 

5.1. 

Text of the Directive 

Article 1 

This Article will make the Agreement between the social partners, annexed to the Directive, 
legally  binding  across  the  European  Union,  which  is  the  purpose  of  a  Council  decision 
adopted under Article 139(2) of the EC Treaty. 

EN 

10 

   EN 

 
Article 2 

The proposed Article is the standard Article relating to penalties. It is expected to contribute 
substantially to the effective implementation of the Agreement. 

Articles 3, 4 and 5 

These  Articles  set  out  the  usual  provisions  on  transposition  into  Member  States’  law  and 
specific provisions regarding the possibility for transposition by way of collective bargaining.  

5.2. 

Text of the Agreement in the Annex to the Directive 

Clause 1: Purpose 

This  Clause  lays  down  out  the  overall  objective  of  the  Agreement  (to  achieve  the  safest 
possible working environment by preventing injuries to workers caused by all medical sharps, 
including  needle-sticks,  and  protecting  workers  at  risk).  To  this  end,  it  provides  for  an 
integrated  approach,  establishing  policies  in  risk  assessment,  risk  prevention,  training, 
information, awareness-raising and monitoring, and for response and follow-up procedures.  

Clause 2: Scope 

This  Clause  makes  it  clear  that  the  Agreement  applies  to  all  workers  in  the  hospital  and 
healthcare  sector  and  to  all  who  are  under  the  managerial  authority  and  supervision  of  the 
employers.  

Clause 3: Definitions 

The Agreement employs various terms: workers, workplaces, employers, sharps, hierarchy of 
measures,  specific  preventative  measures,  workers’  representatives,  workers’  health  and 
safety  representatives and subcontractors.  Clause  3 sets  out the meanings of these terms for 
the purpose of this Agreement. 

Clause 4: Principles 

This Clause lays down the principles which must be observed when taking action under the 
Agreement.  

Paragraph 1 points to the vital role of a well-trained, adequately resourced and secure health 
service  workforce  in  preventing  risks.  It  also  states  that  preventing  exposure  is  the  key 
strategy for eliminating and minimising the risk of injuries and infections. 

Paragraph  2  concerns  the  role  of  health  and  safety  representatives  in  risk  prevention  and 
protection. 

Paragraph 3 sets out the duty of  the employer to ensure the health and safety of workers in 
every aspect relating to the work. 

Paragraph 4 makes it the responsibility of each worker to take care of his or her own safety 
and that of other persons affected by their actions at work. 

EN 

11 

   EN 

 
Paragraph  5  deals  with  the  participation  of  workers  and  their  representatives  in  the 
development of health and safety policy and practice. 

Paragraph  6  explains  that  the  principle  of  the  specific  preventative  measures  is  never 
assuming that no risk exists. It also points to the hierarchy of measures concerning the safety 
and health protection of workers as set out in the relevant Community Directive, i.e. to avoid 
risks, to evaluate remaining risks which cannot be avoided, to combat risks at source and to 
reduce risks to a minimum, is applicable. 

Paragraph  7  concerns  collaboration  between  employers  and  workers’  representatives  with  a 
view  to  eliminating  and  preventing  risks,  to  protecting  workers’  health  and  safety  and  to 
creating a safe working environment.  

Paragraph  8  recognises  the  need  for  action  involving  information  and  consultation  in 
accordance with national law and/or collective agreements. 

Paragraph 9 deals with the effectiveness of awareness-raising measures. 

Paragraph 10 stresses the importance of a combination of several measures for achieving the 
safest possible workplace environment. 

Paragraph 11 states that incident reporting procedures should focus on systemic factors rather 
than  individual  mistakes  and  that  systematic  reporting  must  be  considered  as  accepted 
procedure. 

Clause 5: Risk assessment 

Paragraph 1 states that risk assessment procedures are to be conducted in compliance with the 
relevant provisions of Directives 2000/54/EC and 89/391/EEC. 

Paragraph  2  stipulates  what  is  to  be  included  in  risk  assessments  and  specifies  potentially 
hazardous situations to be covered by them. 

Paragraph  3  lists  the  factors  to  be  taken  into  account  in  risk  assessments  with  a  view  to 
identifying how exposure can be eliminated and considering possible alternative systems. 

Clause 6: Elimination, prevention and protection 

Paragraphs 1 and 2 list several measures to be taken to eliminate the risk of injuries with a 
sharp and/or infection and to reduce the risk of exposure. 

Paragraph 3 and 4 address situations where there is a risk to the safety and health of workers 
owing to their exposure to biological agents for which effective vaccines exist. Under these 
circumstances workers are to be offered vaccination, which is to be carried out in accordance 
with  national  law  and/or  practice.  Furthermore,  workers  are  to  receive  information  on  the 
benefits  and  drawbacks  of  vaccination  and  non-vaccination.  Vaccination  must  be  free  of 
charge. 

Clause 7: Information and awareness-raising  

As medical sharps are considered work equipment in accordance with Directive 89/655/EEC, 
this Clause lays down several information and awareness-raising measures to be taken by the 

EN 

12 

   EN 

 
employer, in addition to the provision of information and written instructions in accordance 
with Article 6 of that Directive. 

Clause 8: Training 

This Clause stipulates that workers are to receive training in certain policies and procedures 
associated with injuries caused by sharps, including those listed. This training is in addition to 
measures  laid  down  in  Article  9  (‘Information  and  training  of  workers’)  of  Directive 
2000/54/EC on the protection of workers from risks related to exposure to biological agents at 
work. 

The  Clause  also  imposes  various  obligations  on  employers  with  regard  to  training  and 
stipulates that the training is mandatory for workers. 

Clause 9: Reporting 

Paragraph  1  stipulates  that  the  existing  procedures  for  accident  reporting  involving  injuries 
are to be adapted and should be revised in conjunction with health and safety representatives 
and/or  appropriate  employers  and  workers’  representatives.  Reporting  procedures  should 
include  technical  details  with  a  view  to  improving  data  collection  on  this  type  of  hazard 
(which is underestimated) at local, national and European level. 

Paragraph  2  imposes  an  obligation  on  workers  to  report  any  accident  or  incident  involving 
medical sharps immediately. 

Clause 10: Response and Follow-up 

This  Clause  deals  with  policies  and  procedures  that  are  to  be  in  place  where  an  injury 
involving a sharp occurs. In particular, it specifies several steps that are to be taken, such as 
the provision of post-exposure prophylaxis and the necessary medical tests, appropriate health 
surveillance, the investigation of the causes and circumstances of the accident, the recording 
of the accident and the counselling of the workers. 

It states that confidentiality of injury, diagnosis and treatment must be respected. 

Clause 11: Implementation 

This Clause lays down several provisions regarding the implementation of the Agreement. 

It  lays  down  a  ‘minimum  standards’  clause,  which  states  that  the  Agreement  is  without 
prejudice to existing or future national and Community provisions which are more favourable 
to workers’ protection from injuries caused by medical sharps. 

It states that the Commission could refer the interpretation of the Agreement to the signatory 
parties,  who  will  give  their  opinion,  without  prejudice  to  the  roles  of  the  Commission,  the 
national courts and the European Court of Justice. 

EN 

13 

   EN 

 
Proposal for a 

COUNCIL DIRECTIVE 

implementing the Framework Agreement on prevention from sharp injuries in the 
hospital and healthcare sector concluded by HOSPEEM and EPSU 

(text with EEA relevance)  

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular 
Article 139(2) thereof, 

Having regard to the proposal from the Commission18, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

The  social  partners  may,  in  accordance  with  Article  139(2)  of  the  Treaty,  jointly 
request that agreements concluded by them at Community level in matters covered by 
Article  137  of  the  Treaty  be  implemented  by  a  Council  decision  on  a  proposal  from 
the Commission.  

By letter of 17 November 2008, the European social partner organisations HOSPEEM 
(European  Hospital  and  Healthcare  Employers’  Association,  a  sectoral  organisation 
representing employers) and EPSU (European Federation of Public Services Unions, a 
European  trade  union  organisation)  informed  the  Commission  of  their  wish  to  enter 
into negotiations in accordance with Article 138(4) and Article 139 of the Treaty with 
a view to concluding a Framework Agreement on prevention from sharp injuries in the 
hospital and healthcare sector. 

On  17  July  2009  the  European  social  partners  signed  the  text  of  a  Framework 
Agreement on prevention from sharp injuries in the hospital and healthcare sector. 

Since  the  objectives  of  the  action  to  be  taken,  namely  to  achieve  the  safest  possible 
working environment by preventing injuries to workers caused by all medical sharps 
(including needle-sticks) and protecting workers at risk in the hospital and healthcare 
sector,  cannot  be  sufficiently  achieved  by  the  Member  States  and  can  therefore  be 
better  achieved  at  Community  level,  the  Community  may  adopt  measures  in 
accordance  with the principle of subsidiarity as set out in Article 5 of  the Treaty. In 
accordance with the principle of proportionality as set out in that Article, this Directive 
does not go beyond what is necessary in order to achieve those objectives. 

(5)  When  drafting  its  proposal  for  a  Directive,  the  Commission  took  account  of  the 
representativeness  of  the  signatory  parties,  having  regard  to  the  scope  of  the 

18 

OJ C, p. 

EN 

14 

   EN 

 
                                                 
Agreement, for the hospital and healthcare sector, their mandate and the legality of the 
clauses in the Framework Agreement and its compliance with the relevant provisions 
concerning small and medium-sized undertakings. 

(6) 

(7) 

(8) 

(9) 

The Commission informed the European Parliament and the European Economic and 
Social Committee of its proposal. 

The purpose of the Framework Agreement as set out in Clause 1 thereof is to further 
the achievement of one of the objectives of social policy, namely the improvement of 
working conditions. 

Clause  11  allows  the  Member  States  and  the  Community  to  maintain  and  introduce 
provisions which are more favourable to workers’ protection from injuries caused by 
medical sharps. 

The  Member  States  should  provide  for  effective,  proportionate  and  dissuasive 
penalties in the event of any breach of the obligations under this Directive. 

(10)  The  Member  States  may  entrust  the  social  partners,  at  their  joint  request,  with  the 
implementation of this Directive, as long as they take all the steps necessary to ensure 
that they can at all times guarantee the results imposed by this Directive, 

HAS ADOPTED THIS DIRECTIVE: 

Article 1 

This  Directive  implements  the  Framework  Agreement  on  prevention  from  sharp  injuries  in 
the  hospital  and  healthcare  sector  signed  by  the  European  social  partners  HOSPEEM  and 
EPSU on 17 July 2009, as set out in the Annex. 

Article 2 

The Member  States  shall  lay  down  the  rules on penalties  applicable to  infringements  of the 
national provisions adopted pursuant to this Directive, and shall take all measures necessary 
to  ensure  that  they  are  implemented.  The  penalties  provided  for  shall  be  effective, 
proportionate  and  dissuasive.  The  Member  States  shall  notify  those  provisions  to  the 
Commission at the latest by the date specified in Article 3 and shall notify it without delay of 
any subsequent amendments affecting them. 

Article 3 

1.  The  Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with this Directive or shall ensure that the social partners have 
introduced  the  necessary  measures  by  agreement  by  [two  years  after  adoption]  at  the  latest. 
They  shall  forthwith  communicate  to  the  Commission  the  text  of  those  provisions  and  a 
correlation table between those provisions and this Directive.  

EN 

15 

   EN 

 
When  the  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive or be accompanied by such a reference on the occasion of their official publication. 
The Member States shall determine how such reference is to be made. 

2. The Member States may have a maximum additional period of one year to comply with this 
Directive,  where  this  is  necessary  to  take  account  of  particular  difficulties  or  in  case  of 
implementation  by  collective  agreement.  They  shall  inform  the  Commission  thereof  by 
[deadline  for  implementation]  at  the  latest,  stating  the  reasons  why  an  additional  period  is 
needed.  

3. The Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 4 

Article 5 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

For the Council 
The President 
[…] 

EN 

16 

   EN 

 
 
 
 
ANNEX  

FRAMEWORK AGREEMENT 

ON PREVENTION FROM SHARP INJURIES IN THE HOSPITAL AND 
HEALTHCARE SECTOR 

Preamble: 

1. Health and safety at work is an issue, which should be important to everyone in the hospital 
and  healthcare  sector.  Taking  action  to  prevent  and  protect  against  unnecessary  injuries  if 
properly carried out, will have a positive effect on resources; 

2. Health and safety of workers is paramount and is closely linked to the health of patients. 
This underpins the quality of care;  

3. The process of policy making and implementation in relation to medical sharps should be 
the result of social dialogue; 

4.  HOSPEEM  (European  Hospital  and  Healthcare  Employers'  Association)  and  EPSU 
(European  Public  Services  Union),  the  recognized  European  Social  partners  in  the  hospital 
and healthcare sector, have agreed the following: 

General Considerations: 

1.  Having  regard  to  the  Treaty  establishing  the  European  Community  and  in  particular 
Articles 138 and 139 (2) thereof; 

2.  Having  regard  to  Council  Directive  89/391/EEC  of  12  June  1989  on  the  introduction  of 
measures to encourage improvements in the safety and health of workers at work19; 

3.  Having  regard  to  Council  Directive  89/655/EEC  of  30  November  1989  concerning  the 
minimum safety and health requirements for the use of work equipment by workers at work20; 

4. Having regard to Directive 2000/54/EC of the European Parliament and of the Council of 
18 September 2000 on the protection of workers from risks related to exposure to biological 
agents at work21; 

5. Having regard to the Community strategy 2007-2012 on health and safety at work22; 

6. Having regard to the Directive 2002/14/EC of the European Parliament and of the Council 
of 11 March 2002 establishing a general framework for informing and consulting employees 
in the European Community23; 

19 
20 
21 
22 
23 

OJ L 183, 29.6.1989. p. 1. 
OJ L 393, 30.12.1990, p. 13. 
OJ L 262, 17.10.2000, p. 21. 
COM(2007) 62 final, 21.2.2007. 
OJ L 80, 23.3.2002, pp. 29–34. 

EN 

17 

   EN 

 
                                                 
7. Having regard to the  resolution of the European Parliament of 6 July 2006  on protecting 
European  healthcare  workers  from  blood-borne  infections  due  to  needlestick  injuries 
(2006/2015(INI)); 

8. Having regard to the first and second stage consultation of the European Commission on 
protecting  European  healthcare  workers  from  blood-borne  infections  due  to  needlestick 
injuries; 

9. Having regard to the outcomes of the EPSU-HOSPEEM technical seminar on needlestick 
injuries of 7 February 2008; 

10. Having regard to the hierarchy of general principles of prevention laid down in Article 6 
of Council Directive 89/391/EEC as well as to the preventative measures defined in articles 3, 
5 and 6 of Directive 2000/54/EC; 

11. Having regard to the joint ILO/WHO guidelines on health services and HIV/AIDS and to 
the joint ILO/WHO guidelines on post-exposure prophylaxis to prevent HIV infection; 

12. With full respect to existing national legislation and collective agreements; 

13. Whereas action needs to be taken to assess the extent of the incidence of sharp injuries in 
the  hospital  and  healthcare  sector,  scientific  evidence  shows  that  preventive  and  protection 
measures can significantly reduce the occurrence of accidents and infections; 

14.  Whereas  a  full  risk  assessment  process  is  a  precondition  to  take  appropriate  action  to 
prevent injuries and infections; 

15. Whereas the employers, and workers' health and safety representatives need to cooperate 
to prevent and protect workers against injuries and infections from medical sharps; 

16. Whereas healthcare workers are primarily but not exclusively concerned by sharp injuries; 

17.  Whereas  students  undertaking  clinical  training,  as  part  of  their  education,  are  not 
considered  as  workers  under  this  agreement,  they  should  be  covered  by  the  prevention  and 
protection  measures  outlined  in  this  agreement,  with  liabilities  being  regulated  according  to 
national legislation and practice; 

Clause 1: Purpose 

The purpose of this framework agreement is: 

•  To achieve the safest possible working environment; 

•  To prevent workers' injuries caused by all medical sharps (including needlesticks); 

•  To protect workers at risk; 

•  To set up an integrated approach establishing policies in risk assessment, risk prevention, 

training, information, awareness raising and monitoring; 

•  To put in place response and follow-up procedures; 

EN 

18 

   EN 

 
Clause 2: Scope 

This  agreement  applies  to  all  workers  in  the hospital  and  healthcare  sector,  and  all  who  are 
under  the  managerial  authority  and  supervision  of  the  employers.  Employers  should  deploy 
efforts to ensure that subcontractors follow the provisions laid down in this agreement. 

Clause 3: Definitions 

Within the meaning of this agreement: 

1. Workers: any persons employed by an employer including trainees and apprentices in the 
hospital  and  healthcare  sector-directly  related  services  and  activities.  Workers  who  are 
employed  by  temporary  employment  business  within  the  meaning  of  Council  Directive 
91/383/EC supplementing the measures to encourage improvements in the safety and health at 
work  of  workers  with  fixed-duration  employment  relationship  or  a  temporary  employment 
relationship24 fall within the scope of the agreement. 

2.  Workplaces  covered:  healthcare  organisations/services  in  public  and  private  sectors,  and 
every  other  place  where  health  services/activities  are  undertaken  and  delivered,  under  the 
managerial authority and supervision of the employer. 

3.  Employers:  natural/legal  persons/organisations  having  an  employment  relationship  with 
workers. They are responsible for managing, organising and providing healthcare and directly 
related services/activities delivered by workers. 

4.  Sharps:  objects  or  instruments  necessary  for  the  exercise  of  specific  healthcare  activities, 
which  are  able  to  cut,  prick,  cause  injury  and/or  infection.  Sharps  are  considered  as  work 
equipment within the meaning of Directive 89/655//EEC on work equipment. 

5. Hierarchy of measures: is defined in order of effectiveness to avoid, eliminate and reduce 
risks  as  defined  in  article  6  of  Directive  89/391/EEC  and  articles  3,  5  and  6  of  Directive 
2000/54/EC. 

6.  Specific  preventative  measures:  measures  taken  to  prevent  injury  and/or  transmission  of 
infection  in  the  provision  of  hospital  and  healthcare  directly  related  services  and  activities, 
including  the  use  of  the  safest  equipment  needed,  based  on  the  risk  assessment  and  safe 
methods of handling the disposal of medical sharps. 

7.  Workers’  representatives:  any  person  elected,  chosen  or  designated  in  accordance  with 
national law and/or practice to represent workers. 

8.  Worker's  health  and  safety  representatives  are  defined  in  accordance  with  Article  3(c)  of 
Directive  89/391/EEC  as  any  person  elected,  chosen  or  designated  in  accordance  with 
national law and/or practices to represent workers where problems arise relating to the safety 
and health protection of workers at work. 

9.  Subcontractor:  any  person  who  takes  action  in  hospital  and  healthcare  directly  related 
services and activities within the framework of working contractual relations established with 
the employer. 

24 

OJ L 183, 29.6.1989, p. 1. 

EN 

19 

   EN 

 
                                                 
Clause 4: Principles 

1.  A  well  trained,  adequately  resourced  and  secure  health  service  workforce  is  essential  to 
prevent the risk of injuries and infections from medical sharps. Exposure prevention is the key 
strategy  for  eliminating  and  minimizing  the  risk  of  occupationally  acquired  injuries  or 
infections. 

2. The role of health and safety representatives is key in risk prevention and protection. 

3. The employer has a duty to ensure the safety and health of workers in every aspect related 
to the work, including psycho-social factors and work organisation. 

4. It shall be the responsibility of each worker to take care - as far as possible - of their own 
safety  and  health  and  that  of  other  persons  affected  by  their  actions  at  work,  in  accordance 
with their training and the instructions given by their employer. 

5.  The  employer  shall  develop  an  environment  where  workers  and  their  representatives  are 
participating in the development of health and safety policies and practices. 

6. The principle of the following specific preventative measures indicated in clauses 5 - 10 of 
the  present  agreement  means  never  assuming  that  there  is  no  risk.  The  hierarchy  of  general 
principles of prevention according to article 6 of Directive 89/391/EEC and articles 3, 5 and 6 
of Directive 2000/54/EC is applicable. 

7.  Employers  and  workers'  representatives  shall  work  together  at  the  appropriate  level  to 
eliminate  and  prevent  risks,  protect  workers´  health  and  safety,  and  create  a  safe  working 
environment, including consultation on the choice and use of safe equipment, identifying how 
best to carry out training, information and awareness-raising processes. 

8. Action needs to be taken through a process of information and consultation, in accordance 
with national laws and/or collective agreements. 

9.  The  effectiveness  of  awareness-raising  measures  entails  shared  obligations  of  the 
employers, the workers and their representatives. 

10. In achieving the safest possible workplace a combination of planning, awareness-raising, 
information, training, prevention and monitoring measures is essential. 

11.  Promote  a  "no  blame"  culture.  Incident  reporting  procedure  should  focus  on  systemic 
factors rather than individual mistakes. Systematic reporting must be considered as accepted 
procedure. 

Clause 5: Risk Assessment 

1.  Risk  assessment  procedures  shall  be  conducted  in  compliance  with  articles  3  and  6  of 
Directive 2000/54/EC, and Articles 6 and 9 of Directive /89/391/EEC. 

2. Risk assessment shall include an exposure determination, understanding the importance of 
a  well  resourced  and  organised  working  environment  and  shall  cover  all  situations  where 
there is injury, blood or other potentially infectious material. 

EN 

20 

   EN 

 
3.  Risk  assessments  shall  take  into  account  technology,  organisation  of  work,  working 
conditions,  level  of  qualifications,  work  related  psycho-social  factors  and  the  influence  of 
factors related to the working environment. This will: 

•  Identify how exposure could be eliminated; 

•  Consider possible alternative systems; 

Clause 6: Elimination, prevention and protection 

1.  Where  the  results  of  the  risk  assessment  reveal  a  risk  of  injuries  with  a  sharp  and/or 
infection,  workers´  exposure  must  be  eliminated  by  taking  the  following  measures,  without 
prejudice to their order: 

•  Specifying  and  implementing  safe  procedures  for  using  and  disposing  of  sharp  medical 
instruments  and  contaminated  waste.  These  procedures  shall  be  regularly  reassessed  and 
shall  form  an  integral  part  of  the  measures  for  the  information  and  training  of  workers 
referred in clause 8; 

•  Eliminating the unnecessary use of sharps by implementing changes in practice and on the 
basis of the results of the risk assessment, providing medical devices incorporating safety-
engineered protection mechanisms; 

•  The practice of recapping shall be banned with immediate effect; 

2. Having regard to the activity and the risk assessment, the risk of exposure must be reduced 
to  as  low  a  level  as  necessary  in  order  to  protect  adequately  the  safety  and  health  of  the 
workers concerned. The following measures are to be applied in the light of the results of the 
risk assessment: 

•  Place effective disposal procedures and clearly marked and technically safe containers for 
the  handling  of  disposable  sharps  and  injection  equipment  as  close  as  possible  to  the 
assessed areas where sharps are being used or to be found; 

•  Prevent the risk of infections by implementing safe systems of work, by:  

a.  Developing  a  coherent  overall  prevention  policy,  which  covers  technology, 
organisation  of  work,  working  conditions,  work  related  psycho-social  factors  and  the 
influence of factors related to the working environment; 

b. Training; 

c.  Conducting  health  surveillance  procedures,  in  compliance  with  article  14  of 

Directive 2000/54/EC; 

•  Use of personal protective equipment; 

3. If the assessment referred to in clause 5 reveals that there is a risk to the safety and health 
of  workers  due  to  their  exposure  to  biological  agents  for  which  effective  vaccines  exist, 
workers shall be offered vaccination. 

EN 

21 

   EN 

 
 
 
 
4.  Vaccination  and,  if  necessary,  revaccination  shall  be  carried  out  in  accordance  with 
national law and/or practice, including the determination of the type of vaccines. 

•  Workers  shall  be  informed  of  the  benefits  and  drawbacks  of  both  vaccination  and  non-

vaccination; 

•  Vaccination  must  be  offered  free  of  charge  to  all  workers  and  students  delivering 

healthcare and related activities at the workplace; 

Clause 7: Information and awareness-raising 

As sharps are considered as work equipment within the meaning of Directive 89/655/EC, in 
addition to information and written instructions to be provided to workers specified in article 
6 of Directive 89/655/EC, the employer shall take the following appropriate measures: 

•  To highlight the different risks; 

•  To give guidance on existing legislation; 

•  To promote good practices regarding the prevention and recording of incidents/accidents; 

•  To raise awareness by developing activities and promotional materials in partnership with 

representative trade unions and/or workers’ representatives; 

•  To provide information on support programmes available; 

Clause 8: Training 

In addition to measures established by article 9 of Directive 2000/54/EC, appropriate training 
shall be made available on policies and procedures associated with sharps injuries, including: 

•  The correct use of medical devices incorporating sharps protection mechanisms; 

•  Induction for all new and temporary staff; 

•  The risk associated with blood and body fluid exposures; 

•  Preventive measures including standard precautions, safe systems of work, the correct use 
and  disposal  procedures,  the  importance  of  immunisation,  according  to  the  procedures  at 
the workplace; 

•  The reporting, response and monitoring procedures and their importance; 

•  Measures to be taken in case of injuries;  

Employers  must  organise  and  provide  training  which  is  mandatory  for  workers.  Employers 
must release workers who are required to attend training. This training shall be made available 
on a regular basis taking into account results of monitoring, modernisation and improvements. 

Clause 9: Reporting 

EN 

22 

   EN 

 
1.  This  includes  the  revision  of  the  reporting  procedures  in  place  with  health  and  safety 
representatives and/or appropriate employers/workers representatives. Reporting mechanisms 
should include local, national and European wide systems. 

2.  Workers  shall  immediately  report  any  accident  or  incident  involving  sharps  to  the 
employers and/or the person in charge, and/or to the person responsible for safety and health 
at work. 

Clause 10: Response and Follow-up 

Policies  and  procedures  shall  be  in  place  where  a  sharp  injury  occurs.  All  workers  must  be 
made aware of these policies and procedures. These should be in accordance with European, 
national/regional legislation and collective agreements, as appropriate. 

In particular the following action shall be taken: 

•  The employer takes the immediate steps for the care of the injured worker, including the 
provision of post-exposure prophylaxis and the necessary medical tests where indicated for 
medical reasons, and appropriate health surveillance in accordance with clause 6 §2,c 

•  The employer investigates the causes and circumstances and records the accident/incident, 
taking  -where  appropriate-  the  necessary  action.  The  worker  must  provide  the  relevant 
information at the appropriate time to complete the details of the accident or incident; 

•  The employer shall, in cases of injury, consider the following steps including counselling 
of workers where appropriate and guaranteed medical treatment. Rehabilitation, continued 
employment  and  access  to  compensation  shall  be  in  accordance  with  national  and/or 
sectoral agreements or legislation; 

Confidentiality of injury, diagnosis and treatment is paramount and must be respected; 

Clause 11: Implementation 

This  agreement  will  be  without  prejudice  to  existing,  future  national  and  Community 
provisions which are more favourable to workers’ protection from medical sharps’ injuries. 

The  signatory  parties  request  the  Commission  to  submit  this  framework  agreement  to  the 
Council  for  a  decision  in  order  to  make  this  agreement  binding  in  the  member  states  of  the 
European Union. 

If  implemented  through  Council  decision,  at  European  level  and  without  prejudice  to  the 
respective  role  of  the  Commission,  national  courts  and  the  European  Court  of  Justice,  the 
interpretation of this agreement, could be referred by the Commission to the signatory parties 
who will give their opinion. 

The signatory parties shall review the application of this agreement five years after the date of 
the Council decision if requested by one of the parties to the agreement. 

Brussels, 17 July 2009 

For EPSU: Karen Jennings – For HOSPEEM: Godfrey Perera 

EN 

23 

   EN