6 Patient safety
| (a)
(30285)
17427/08
COM(08) 836
+ ADDs 1-2
(b)
(30286)
17430/08
COM(08) 837
+ ADDs 1-2
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Commission Communication on patient safety, including the prevention and control of healthcare associated infections
Commission staff working documents: impact assessment of the proposal and summary of assessment
Draft Council Recommendation on patient safety, including the prevention and control of healthcare associated infections
Commission staff working documents: impact assessment of the proposal and summary of assessment
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| Legal base | (a) —
(b) Article 152(4) EC; co-decision; QMV
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| Document originated | (Both) 15 December 2008
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| Deposited in Parliament | (Both) 22 December 2008
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| Department | Health |
| Basis of consideration | EM of 8 January 2009 on each document
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| Previous Committee Report | (Both) None
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| To be discussed in Council | (Both) No date set
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| Committee's assessment | (Both) Politically important
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| Committee's decision | (Both) Not cleared; further information requested
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Background
6.1 Article 152 of the EC Treaty requires provides a legal base
for action by the Community which is directed to improving public
health and preventing human illness and which complements the
policies of the Member States. The Article encourages cooperation
between Member States and requires them to coordinate their public
health policies and programmes. It authorises the Commission to
take any useful initiative to promote such coordination. Article
152(4) authorises the Council to adopt Recommendations for the
purposes set out in the Article.
6.2 The EC already has legislation to promote the
safety of patients, such as the Council Recommendation on the
use of antimicrobial agents,[22]
the Directive on quality and safety standards for blood and blood
components[23] and the
Directive on quality and safety standards for human tissues and
cells.[24]
6.3 In 2004, the World Health Organisation established
the World Alliance for Patient Safety and in 2006 the Council
of Europe adopted a Recommendation on the management of patients'
safety and the prevention of adverse events in healthcare.
6.4 In 2007, the EC's High Level Group on Health
Services and Medical Care endorsed a working party's recommendation
on matters affecting patient safety where European cooperation
would be valuable.[25]
Document (a)
6.5 Document (a), the Commission's Communication,
says that that further action by the Community is needed because
of:
- the differences in Member States'
commitment to make patients' health a priority;
- the differences in Member States' awareness of
the costs of adverse incidents in healthcare (such as infections
transmitted during treatment, mistakes in the prescription of
drugs or avoidable errors in diagnosis);
- the lack of comparable data on the incidence
of adverse events;
- inadequacies in the dissemination of information
about patient safety and the prevention of harm;
- insufficient commitment by senior managers in
healthcare institutions to the prevention of adverse incidents;
and
- inadequate awareness and training of healthcare
staff in the prevention and control of adverse incidents.
6.6 So the Commission proposes a Recommendation to
Member States (document (b)) that, in collaboration with Member
States, it should:
- develop common definitions
and indicators of patient safety;
- facilitate the sharing of information and best
practice;
- promote EC research; and
- consider how best to achieve and sustain effective
collaboration between Member State in the longer-term.
The Commission proposes that it should report on
the effects of the Recommendation and Communication not later
than three years after their adoption.
Document (b)
6.7 Document (b) is the draft of a Recommendation
to Member States. The draft provides that, in addition to implementing
the 11 specific recommendations in the body of the document, Member
States "should" take the supporting action listed in
Annex 2 to it.
6.8 The recommendations are as follows:
General patient safety
i) Member States should support the establishment
and development of national policies and programmes on patient
safety;
ii) Member States should empower and inform citizens
and patients about safety policies and programmes;
iii) Member States should establish or strengthen
systems for reporting adverse incidents and disclosing information
about them;
iv) Member States should promote the education
and training of healthcare workers in patient safety;
v) Member States should classify, codify and
measure patient safety, working with the Commision to develop
common definitions, indicators and statistics; and
vi) Member States should share knowledge, experience
and best practice at European level.
Prevention and control of healthcare associated
incidents
vii) each Member State should adopt and implement
a national strategy for the prevention and control of healthcare
associated incidents; and
viii) each Member State should consider the
establishment of a mechanism for the coordinated implementation
of its national strategy and for the exchange of information and
coordination with the Commission, the European Centre for Disease
Prevention and Control and other Member States.
Additional recommendations
ix) Member States should disseminate the contents
of the Recommendation to healthcare organisations, professional
bodies and educational institutions and encourage them to follow
the approaches it suggests;
x) Member States should complement the key elements
of recommendations i) to viii) by taking the supporting action
in Annex 2; and
xi) Member States should report to the Commission
on the implementation of the Recommendation within two years of
its adoption and subsequently on request.
6.9 Annex 2 of the draft Recommendation lists 20
further things that Member States "should" do. For example,
in support of the recommendation that Member States should empower
and inform citizens and patients, Annex 2 says that Member States
should disseminate information to patients about complaints procedures
and means of redress and should consider the development of core
competencies in patient safety for patients.
The Government's views on documents (a) and (b)
6.10 In his Explanatory Memoranda of 8 January, the
Minister for Health Services at the Department of Health (Mr Ben
Bradshaw) tells us that the proposals in the Communication are
in line with policies in the UK on patient safety and that the
majority of the measures advocated in the draft Recommendation
have already been introduced in the UK. He provides details of
the policies and arrangements which currently apply in England,
Scotland, Wales and Northern Ireland.
Conclusion
6.11 We are grateful to the Minister for providing
a separate and very informative Explanatory Memorandum on each
of these documents. We note that the UK, Belgium, Denmark and
the Netherlands were the only Member States whose patient safety
systems were categorised as "Exemplary" by an evaluation
conducted by the Rand Corporation.[26]
6.12 We share the views of the Commission and
the Government about the importance of patient safety and the
need to prevent adverse incidents while patients are receiving
treatment. Article 152 of the EC Treaty appears to provide an
appropriate legal base for the Community action the Commission
proposes. We accept that because patients may want to cross borders
to receive medical treatment in other Member States, because there
are economies of scale in the central collection of information
and the commissioning of research on matters of common interest
and because there are benefits in identifying and disseminating
best practice throughout the EC, action of the kind proposed in
documents (a) and (b) can comply with the principle of subsidiarity.
6.13 We are concerned, however, that the draft
Recommendation repeatedly asserts what Member States "should"
do. Recommendations are not legally binding and, in our view,
it is inappropriate for them to appear to impose mandatory duties
on Member States in the way that document (b) does.
6.14 Moreover, we question whether some of the
individual recommendations go into too much detail. For example,
Annex 2 of the Recommendation says that Member States should consider
the development for patients of core competencies in patient safety.
6.15 We should be grateful for the Minister's
comments on the points in the two previous paragraphs. We also
ask him for progress reports on the negotiations. Meanwhile, we
shall keep documents (a) and (b) under scrutiny.
22 Council Recommendation 2002/77/EC. Back
23
Directive 2002/98/EC. Back
24
Directive 2004/23/EC. Back
25
The High Level Group was set up by the Commission in 2004 and
its members are experts from the Member States. Back
26
See page 16 and Annex 5 of ADD 1 to documents (a) and (b). Back
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