25.8.2009   

EN

Official Journal of the European Union

C 200/63

—

better definition of the role of local and regional authorities within the scope of the proposed actions, in line with the role these play within the national arrangements for health services;

—

better definition of participation by citizens and associations thereof in the programming and decision-making processes associated with risk management;

—

the inclusion of a reference to the processes, indicators and standards for risk management and patient safety within the context of approval, accreditation and certification systems for healthcare providers;

—

the definition of specific channels of legal and regulatory protection that promote the reporting by healthcare operators of errors, adverse events and situations where incidents were narrowly averted;

—

embedding risk management and patient safety in (higher) education and further training for doctors and other healthcare professionals;

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the inclusion of additional recommendations to increase the efforts, already under way in individual scientific committees, to define regulatory and procedural instruments specifically dedicated to the safe use of pharmaceuticals.

Rapporteur

:

Mr Piero Marrazzo (IT/PES), President of the Lazio Region

1.

emphasises that the Committee has on several previous occasions expressed concern and interest in this issue, calling on the Commission to make specific proposals, stating that ‘structured and coordinated European-level cooperation with a view to exchanging experience, sharing knowledge and simplifying arrangements relating to developments in health technology may bring clear value added to the Member States’ (see opinion CdR 153/2004 fin);

2.

notes that other organisations such as the WHO, the OECD and the Council of Europe have already considered and tackled the issue of safety in healthcare;

3.

notes that the Commission proposal fits in to this context and places significant emphasis on the effective involvement of Member States in the matter, thus emphasising subsidiarity as a key tool for properly understanding the phenomenon and as the instrument of choice for seeking solutions to it;

4.

considers that the Commission, by opting to promote increased cooperation between Member States via a communication from the Commission and a Council Recommendation, is responding to the Committee of the Regions' request;

5.

notes that the Commission communication and the proposal for a Council Recommendation on patient safety are quite properly aimed at securing political commitment from all EU countries so that the Member States, individually or collectively, implement the proposed recommendations, with the support of the Commission, and take practical steps to improve patient safety;

6.

considers that the defining characteristics of the proposal are closely related:

7.

notes that the initiative does not remove any competencies in the area of health from the Member States in that the Council Recommendation is a legal instrument that leaves the Member States sufficient freedom to organise, as is currently the case, their healthcare systems at national, regional or local level.

8.

notes that several reports show that safety in diagnosis and treatment, and the risk of iatrogenic harm, is widely perceived by the European public to be a major issue, not only in relation to safeguarding their own health and that of their loved ones, but more generally as an issue of public safety;

9.

stresses that local and regional authorities are, in many countries, directly responsible for providing health services and thus have a particular interest in improving systems for safety and quality in healthcare;

10.

considers that the negative consequences of iatrogenic harmimpact directly on the public perception of the quality and safety of the services provided, which in many countries is one of the key factors in the public's assessment of the effectiveness of local and regional authorities;

11.

believes that the spread of the phenomenon, associated with an increase in litigation, constitutes not just an ethical, social and public health problem for the authorities directly responsible for providing health services, but also an economic one, in the light of the rising costs of insurance policies and the rising trend in compensation for damages payable to members of the public;

12.

therefore believes that, whilst there are already a number of sectoral initiatives (safety of medicines and medical equipment, resistance to antimicrobials, etc.) in many areas of patient safety and of risk reduction in healthcare, an initiative such as that set out in the proposal and the recommendation, aimed at establishing an integrated approach to reducing the many potential causes of iatrogenic harm, is very useful;

13.

believes that the proposals and principles set out in the proposal and the recommendation fulfil the requests made in the past by the Committee of the Regions in the area of health, i.e. encouraging the exchange of good practices in the area of patient safety whilst respecting the subsidiarity principle and helping to reduce disparities in the availability and quality of healthcare services;

14.

considers that the amendments and additions to the recommendation set out below could make a useful contribution to its implementation by emphasising or improving certain aspects that are of particular interest to the Committee of the Regions, and specifically recommends:

(a)

to ensure better definition of the role of local and regional authorities within the scope of the proposed actions, in line with the role these play within the national arrangements for health services.

(c)

to harmonise the technical arrangements for collecting and sharing data.

(d)

to include in the approval, accreditation and certification process factors related not only to structural standards or technical equipment, but also to aspects of the process aimed at requiring the use of best practice, would be a practical measure to ensure patient safety.

(a)

participation by citizens and associations thereof, not only in consultative bodies but also in executive ones, becomes binding.

(b)

it is helpful to guide and harmonise the arrangements for communicating with the patient at the time of seeking informed consent, by analogy to the provisions already in place concerning information on the use of pharmaceuticals.

(c)

the problem of disseminating knowledge and skills relating to risk management techniques needs to be tackled holistically and specifically in higher education curricula as a key element in disseminating knowledge and skills relating to issues of patient safety.

(2)

ensuring better definition of the role of local and regional authorities within the scope of the proposed actions, in line with the role these play within the national arrangements for health services.

(3)

The EU's efforts to address the issue should, given its importance, be backed up by more rapid action.