Legal base	(a) — (b) Article 152(4) EC; co-decision; QMV
Department	Health
Basis of consideration	(Both) Minister's letter of 9 February 2009
Previous Committee Report	(Both) HC 19-v (2008-09), chapter 6 (28 January 2009)
To be discussed in Council	No date set
Committee's assessment	(Both) Politically important
Committee's decision	(Both) Cleared; but further information requested

Previous scrutiny of documents (a) and (b)

11.1 When we considered these documents in January,[36] we noted the reasons given in document (a) for the Commission's view that action by the Community is needed to improve the safety of patients. We also noted that the Commission proposes 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 States in the longer-term.

In addition, the Commission proposes a Recommendation to Member States (document (b)).

11.2 The draft Recommendation provides that, as well as implementing 11 specific recommendations, Member States "should" take the supporting action listed in Annex 2 of the draft.

11.3 The specific 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 Commission 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.

11.4 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 for patients of core competencies in patient safety.

11.5 In his Explanatory Memoranda of 8 January, the Minister for Health Services at the Department of Health (Mr Ben Bradshaw) told 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.

11.6 In our report on the documents, we said that we shared 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. We were 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. Moreover, we questioned 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. We asked the Minister for his comments on these points and for progress reports on the negotiations.

The Minister's letter of 9 February 2009

11.7 We are grateful to the Minister for replying so promptly. He says that he agrees with us that it is inappropriate for the draft Recommendation to make repeated assertions about what Member States "should" do. Moreover, he agrees that the draft goes into too much detail. The Department has raised these concerns in the negotiations and will seek agreement to a more appropriate tone and level of detail.

11.8 The Minister's letter also provides a progress report. In January, there were initial discussions of the proposals in the Council Working Group. Officials representing the UK expressed broad support for the proposals but registered the Government's concerns about them. Other Member States shared the concerns. The Commission offered to amend the draft. The amendments are expected shortly. The negotiations will continue in the working group. The Minister says that he will give us a further progress report. The Czech Presidency aims to achieve the Council's agreement to the draft Recommendation during its Presidency.

Conclusion

11.9 We are glad that the Minister shares our reservations about the draft Recommendation and will seek suitable amendments. In the light of his letter, we see no need to keep documents (a) and (b) under scrutiny and we have decided to clear them. We should, however, be grateful for the further progress the Minister has offered.