5 PREVENTION FROM SHARP INJURIES
IN THE HOSPITAL AND HEALTHCARE SECTOR
(31086)
15305/09
COM(09) 577
| Draft Council Directive implementing the Framework Agreement on prevention
from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM
and EPSU
|
| Legal base |
Article 139(2)EC; QMV |
| Document originated | 26 October 2009
|
| Deposited in Parliament |
5 November 2009 |
| Department | Work and Pensions
|
| Basis of consideration |
EM of 16 November 2009 |
| Previous Committee Report |
None |
| To be discussed in Council
| No date set |
| Committee's assessment | Politically and legally important
|
| Committee's decision | Not cleared; further information requested
|
Background
5.1 According to the Commission, injuries caused
by needles and other sharp instruments (such as scalpels) are
one of the most common[10]
and serious risks to healthcare workers in Europe, and represent
a high cost for health systems and society in general: and it
adds that the workers in certain departments and activities, notably
emergencies, intensive care, and surgical operations, are particularly
at risk, with potentially serious consequences in relation to
such blood-borne diseases as viral hepatitis and AIDS, and that,
even if an infection is not confirmed in the majority of cases,
those affected suffer considerable stress and anxiety, and usually
have to take antiretroviral drugs with unpleasant side-effects.
5.2 It points out that, although existing Community
legislation[11] lays
down general preventive principles and measures, the European
Parliament called upon it in July 2006 to submit an appropriate
legislative proposal, amending Directive 2000/54/EC on biological
agents at work. It says that, before doing so, it embarked —
as required under Article 138(2) of the Treaty — on a consultation
with management and labour (the European social partners[12]
in the hospital and healthcare sector, recognised by the Commission
in 2006) on the possible direction and content of such a measure,
asking them also if they intended to negotiate a framework agreement.
It notes that the workers' organisations favoured more specific
legislation to reinforce protection, whereas the employers were
opposed to any such initiative. However, it says that HOSPEEM
and EPSU signed an Agreement in July 2009 establishing minimum
provisions for the prevention of sharp injuries, and that, in
accordance with Article 139(2) of the Treaty, they had subsequently
requested it to put this forward for a Council Decision to underpin
its application within the Community. The Commission adds that,
in the context of Article 139, the term "Council Decision"
can be interpreted as referring to either a directive, regulation
or decision, and that it has decided that a Council Directive
would be the most appropriate approach to pursue.
The current proposal
5.3 The draft of such a Directive is set out in this
document, and its effect would be to make the Agreement between
the social partners legally binding across the Community, and
to provide both for its transposition into Member States' law
and for penalties. However, the Council cannot amend a proposal
of this kind, and can only accept or reject it.
5.4 The Agreement itself is annexed to the proposal,
with the stated aim of achieving the safest possible working environment,
and provides for an integrated approach to risk assessment and
prevention, training, information and awareness-raising and monitoring.
In particular, it would:
- apply to all workers in the sector;
- establish certain basic principles, including
the role of a well-trained, adequately resourced workforce, and
the key need to prevent exposure; the role of health and safety
representatives; the duty of employers and the responsibilities
of individual workers; the participation of workers in the development
of policy and practice; the need for collaboration between employers
and workers representatives; and the need for reporting to focus
on systemic factors rather than individual mistakes;
- set out risk assessment procedures, including
the hazardous situations to be covered, and the factors to be
taken into account in eliminating exposure and considering alternative
systems.
- address the measures needed to eliminate the
risk of injuries, reduce the risk of exposure, and the protection
to be afforded where effectives vaccines exist.
The Government's view
5.5 In his Explanatory Memorandum of 16 November
2009, the Parliamentary Under-Secretary of State at the Department
for Work and Pensions (Lord McKenzie of Luton) says that the proposed
Directive gives an option of implementation through national legislation
or through social partners agreement, and that the Government
will explore both approaches to see which is most suitable.
5.6 He notes that the scope is limited to the hospital
and healthcare sectors, and "directly related services/activities",
and is supported by key stakeholders, representing employers and
employees, and by pressure groups,[13]
whose membership is drawn from a range of organisations representing
health care workers, individual clinicians, and manufacturers
of the safer needles technology (including the Association of
British Healthcare Industries). He adds that many of the measures
are already covered by existing health and safety legislation,
as well as by healthcare specific legislation, codes of practice
and guidelines. (For example, employers are already required to
ensure that exposure to biological agents including blood-borne
viruses, is prevented or adequately controlled, and that staff
receive sufficient training and instruction, and where appropriate
vaccination, whilst National Institute for Clinical Excellence
(NICE) guidelines state that "needle safety devices must
be used where there are clear indications that they will provide
a safer system of working for healthcare professionals".)
Also, the Health and Social Care Act 2008 (Registration Requirements)
Regulations 2009 and supporting codes of practice require that
staff be protected from infection through the implementation of
a range of procedures, many of which are covered by the proposed
Directive.
5.7 The Minister points out that similar legislation
has already been introduced in the United States, requiring all
hospitals and healthcare facilities to introduce needle protective
devices, although he notes that research in the UK shows that
these alone will not reduce the numbers of injuries, unless combined
with training on universal precautions, handling and disposal
of sharps, and effective reporting systems. He says that all these
are included in the proposed Directive, and are supported by NHS
employers and public sector unions.
5.8 The Minister says that, although the Commission
is not required to do an Impact Assessment on proposals to implement
social partner agreements, the Government carried out a preliminary
Impact Assessment in 2008 on draft proposals to amend the Biological
Agents Directive to prevent the risk of sharp injuries to workers,
and that this showed that these would be effectively cost-neutral,
with the benefits from a reduction in injuries balancing out the
additional costs involved in implementing procedures and additional
training for staff. He adds that the Government is currently in
the process of updating that Assessment, and will provide this
as soon as it is ready. However, the Department of Health estimates
that the costs to the NHS and others, such as social care, should
be minimal because much of the proposed Directive is simply requiring
compliance with existing good practice.
Conclusion
5.9 This strikes us as a useful initiative, but
we have considerable doubt whether it is consistent with the provisions
of the EC Treaty to use a Directive to implement it. Our concerns
mirror those raised in our Report of 19 November on the draft
Directive implementing the revised Framework Agreement on parental
leave,[14] which
we ask the Minister to consider.
5.10 Despite what the Commission says in its explanatory
memorandum, neither Article 249 nor any other provision of the
EC Treaty gives it discretion to set aside the express requirement
of Article 139(2) that agreements between the social partners
are to be implemented either by a collective agreement or by "a
Council decision on a proposal from the Commission". A Decision
is mentioned because a Decision, not a Directive, is the means
by which a separate agreement made at Community level is made
binding on those to whom it is addressed.
5.11 In addition, Article 139(2) does not refer
to the adoption of "measures", which would be expected
if the choice of legal instrument was intended to be left open,
as can be seen from other Articles under this Title of the EC
Treaty. Nor does it refer to cooperation of any kind with the
European Parliament, stating simply that the Council shall act
by QMV and, by clear inference, alone. A reference to the role
of the European Parliament would be expected under this Title
of the EC Treaty if a Directive had been contemplated by Article
139(2) EC, as Article 137(2) EC and many other provisions under
this Title attest. Indeed, Article 137(2) EC would be the correct
legal base for a Directive on the prevention from sharp injuries
in the hospital and healthcare sector. The Directive on "the
protection of workers from risks related to exposure to biological
agents at work"[15]
is a clear precedent for this.
5.12 Our concern goes wider than the present proposal.
Article 155 of the Treaty on the Functioning of the European Union
(TFEU) re-enacts Article 139 EC word for word except for cross-references
to Article 153 of the TFEU rather than to Article 137 EC. So it
is important that the meaning of Article 155 TFEU be clarified.
5.13 We would be grateful to the Minister for
a response to our concerns on the legal base before considering
this proposal further. In the meantime, we will continue to hold
the document under scrutiny.
10 Some studies suggest that each year there are about
1.2 million such injuries number in Europe. Back
11
Notably Council Directive 89/391/EEC, Council Directive 89/655/EEC,
Council Directive 93/42/EEC and Directive 2000/54/EC. Back
12
The European Hospital and Healthcare Employers' Association (HOSPEEM)
and the European Federation of Public Services Unions (EPSU). Back
13
Such as the Safer Needles Network. Back
14
HC 5-i (2009-10), chapter 5 (19 November 2009) Back
15
2000/54/EC Back
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