Patient Safety: A Priority for the European Commission Mr Lee McGill Health and Consumers Directorate-General European Commission Royal College of Physicians Roundtable Meeting London, 21 July 2008

The need for action on patient safety Despite the aim across Europe to provide safe, high quality healthcare, there is an increasing awareness that patients receiving care can incur injuries and adverse events as a consequence of receiving healthcare; only a few EU Member States have collected information on the prevalence of adverse events, so data on safety levels and the associated economic costs of unsafe care is either partial or does not exist at all in many Member States; studies and research that have been carried out up until now suggesting sizeable health costs and economic costs arising from adverse events. Experience and common sense suggest that targeted programmes, policies and initiatives can improve patient safety levels.

Extent of the problem The UK Department of Health, in its 2000 report, An organisation with a memory, estimated that adverse events occur in around 10% of hospital admissions or about adverse events a year. It is estimated that between 6.7 and 15 million hospital admissions and over 37 million consultations in the primary care setting result in an adverse event for the patient as a result of receiving that healthcare in EU27.

Legal basis Article 152 (public health) “Community action, which shall complement national policies, shall be directed towards [..] preventing human illness and diseases, and obviating sources of danger to human health. [..] The Community shall encourage cooperation between the Member States in the areas referred to in this Article and, if necessary, lend support to their action. [..] Community action in the field of public health shall fully respect the responsibilities of the Member States for the organisation and delivery of health services and medical care.”

EU added value? - Commission involvement in patient safety to date Patient Safety Working Group of the High Level Group on Health Services and Medical Care. Recommendation on Patient safety by patient Safety Working Group (October 2007). Community co-funded patient safety projects. Current EC Policies and legislation.

Original basis of the Commission’s planned patient safety initiative Commission Legislative and Work Programme 2008 Strategic initiatives Health package a) Communication and Council Recommendation on Patient Safety and Quality of Health Services b) Council Recommendation on health care associated infections

Merging Communication and Council Recommendation on Patient Safety and Quality of Health Services+ Council Recommendation on health care associated infections↓↓ Communication and Council Recommendation on patient safety and quality of health services, including the prevention and control of healthcare-associated infections

Timing (2008) Impact Assessment paper submitted to the Impact Assessment Board (IAB) - 13 June IAB opinion - 14 July Inter-service consultation – September/October Adoption of the Communication & Proposal for a Council Recommendation by the Commission - end of November

Commission Communication A Communication would provide an overarching structure for the Community's many initiatives on patient safety. It could address the overall cultural, leadership, systemic, communication and process barriers to improved patient safety. It would map findings and good practice principles on patient safety to be applied in the EU and highlight the need for further action.

Council Recommendation (CR) A CR could include recommendations on systemic patient safety issues and specific recommendations on the prevention and control of HAIs. A CR would represent a strong political commitment to addressing patient safety and HAIs. A CR allows for monitoring and evaluation of the recommended measures.

EU initiative vs MS actions? A 'soft law' Council Recommendation, will allow Member States sufficient freedom to organise health care nationally as they do at present, while addressing this major challenge of improving patient safety according to agreed best practice.

Sources of Information for the Recommendation Public consultation on patient safety (May 2008). Recommendation from the PSWG. Recommendation Rec(2006)7 of the Council of Europe to member states on management of patient safety and prevention of adverse events in health care (May 2006). Expert Group on HAIs.

Purpose of the public consultation The results will help in the development of the systemic patient safety aspects of Commission's proposals on patient safety issues planned for the end of That proposal will address the important issue of patient safety throughout the European Union (EU) and will include a detailed first pillar, addressing healthcare- associated infections (HCAI), on which separate public consultations have already been held.

The consultation - timings Open from 25 March – 23 May 2008 Final report by the end of the summer

Participants in the public consultation Participants total185 (+ off-line responses) Competent authorities (CAs) total including CAs national level including CAs regional level including CAs local level (CY;CZ;DE;FR;IE;LV;MT;SE;UK;GR) 11 5 NGOs35 Health Professional Associations25 Hospitals20 Patient organisations8 Consumer organisations3 Industry8 Academia 6 Other9 Anonymous responses39

UK participants Department of Health Royal College of Physicians, London Royal College of Nursing General Medical Council General Osteopathic Council Nursing and Midwifery Council North Lancashire PCT Cragavon Area Hospital, NI Greater Glasgow and Clyde NHS Trust, Scotland Healthcare Commission NHS Confederation EU Office Medical Defence Union Medical Protection Society National Pharmacy Association Novartis Pharmaceuticals, UK National Concern for Healthcare Infections Four anonymous replies from the UK

Personal/family experience (1) Respondents were asked about personal or family members’ first– hand experience of an adverse event in a healthcare setting in: a) their home country Q 1 & 2

Status quo good enough? Q 7

National political support for patient safety needed? Q 8

A national and/or EU-level patient safety strategy needed? Q 9 & 10

Which adverse events are of most concern? Q 11

Essential components of a national level patient safety strategy/policy Q 12

The importance of a dedicated financial resource for patient safety Q

Patient & public involvement in patient safety improvements Q

The importance of a positive patient safety culture at the local healthcare management level Q

The role of health professionals in patient safety Q

A role for reporting & learning systems Q

Other information & the sharing of that information (1) Q 35 & 36

Other information & the sharing of that information (2) Q 37 & 38

A need for patient safety standards? Q 39 & 40

A need for external assessment? Q 41 & 42

Patient safety research & development Q

Complaints and redress Q

Member State actions Q 58

A role for the EU? Q 59

Conclusions (1) Respondents overwhelmingly ranked as important or very important the need for (continued) action on: Budgetary commitment to patient safety; Patient and public involvement; Local healthcare management engagement; Education and training of health professionals; A common taxonomy and set of indicators; Reporting and learning systems; Standards and external assessment; More Research; More information on Redress for patients.

Conclusions (2) Patient Safety is a priority for citizens and stakeholder groups. Much that can be done at Member State level. A definite role for the European Union. What concrete proposals at the EU level are appropriate? A big role for UK stakeholders Conclusions

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