Full text 
Procedure : 2009/0003(CNS)
Document stages in plenary
Document selected : A6-0239/2009

Texts tabled :


Debates :

PV 23/04/2009 - 4
CRE 23/04/2009 - 4

Votes :

PV 23/04/2009 - 8.13
Explanations of votes

Texts adopted :


Thursday, 23 April 2009 - Strasbourg OJ edition

4. Patient safety (debate)
Video of the speeches

  President. – The next item is the report (A6-0239/2009) by Mrs Sartori, on behalf of the Committee on the Environment, Public Health and Food Safety, on the proposal for a Council recommendation on patient safety, including the prevention and control of healthcare associated infections (COM(2008)0837 – C6-0032/2009 – 2009/0003(CNS)).

The rapporteur cannot be here and will be replaced in the initial introduction by Mrs Grossetête.


  Françoise Grossetête, deputising for the rapporteur.(FR) Mr President, yes, I am replacing Mrs Sartori, who is in fact detained in Italy, and I pass on her full apologies because she was particularly keen to be present here today.

We are going to speak mainly about medical procedures because, sometimes, they can have harmful consequences for patients’ health, whether because of the undesirable effects of medicines, because of medical error, or because of infections contracted in the place of medication.

Of these risks, we can mention more particularly nosocomial infections, which affect one in every 20 hospital patients, in other words 4 100 000 people a year. The European Commission figures on this issue are, moreover, very worrying.

Adverse events occur among 8% to 12% of hospital patients in the Member States of the European Union. This gives an annual number of between almost 7 million and 15 million hospital patients, to which can be added the some 37 million patients who call on primary healthcare.

Nosocomial infections alone affect on average one in every 20 hospital patients, making a total of over 4 million patients a year. In total, every year, nosocomial infections cause the deaths of around 37 000 people in Europe.

In order to meet the objective of reducing these infections by 900 000 cases a year by 2015 – in other words a 20% reduction – the Member States and the European institutions are being called on to introduce the necessary measures.

The report recommends in particular: promoting the education and training of health staff and paramedical staff, with particular attention being paid to nosocomial infections and the resistance to antivirals of the viruses that cause them; improving knowledge of this problem amongst patients by asking the Commission to draw up a document for patients on the basis of a handbook for the prevention of nosocomial infections produced by the World Health Organization – the WHO – in 2003; supporting research in this area, with particular attention being paid to new technologies, nanotechnologies and nanomaterials; and increasing the presence of nurses and specialist infection control nurses.

Finally, it is important, as the text emphasises – and Mrs Sartori has been very insistent on this point – to improve patient training on the issue.

It is imperative that the Commission be asked to draw up a patient-oriented document for the prevention of nosocomial infections and that it be presented to Parliament and the Council. The Commission should also make provision for three-yearly monitoring of the progress achieved in this area by the Member States and by the European Union.

A survey carried out in France, for example, shows that 83% of the people questioned have heard of nosocomial infections, and that these risks are the main source of concern for French people when being admitted to hospital. On the other hand, the general public does not feel it is properly informed of the causes and the consequences of nosocomial infections.

In the next few years, the effort to prevent nosocomial infections must lay greater emphasis on information for health professionals and for the population as a whole.


  Daniela Filipiová , President-in-Office of the Council. – (CS) Ladies and gentlemen, the area of patient safety and healthcare quality is one of the main priorities of the Czech Presidency in the area of public health. We are aware of the importance of continually improving patient safety and related improvements in healthcare quality in relation to cross-border healthcare.

The main aim of the Council’s draft proposal on patient safety and the quality of health care, including the prevention and control of hospital-acquired infections, is to define an integrated approach under which patients can transfer safely to high quality health care centres and where all factors having an impact on this will be taken into account.

This initiative arose based on findings of an alarming growth in the occurrence of adverse events throughout Europe, with hospital-acquired infections being among the most frequently-occurring adverse events. This is a major challenge which is connected with the increasing expectations of the public in this area, the ageing population in Europe and the constant advances in medicine and medical science generally. Hospital acquired infections are also attracting ever more attention from the media and politicians.

These were the reasons behind the decision of the Czech Presidency to organise the ministerial conference which took place in Prague on April 15-16 under the banner of ‘Bacterial Threats to Patient Safety in Europe’. It focused especially on hospital antibiotic programmes, the influence of health care system parameters on the occurrence of antibiotic resistance and hospital-acquired infections and also management and responsibilities in this area.

But let us return to the draft proposal. The Czech Presidency is aware that the organisation of health systems falls fully within the competency of Member States. Of course this initiative, in my opinion, will provide a suitable stimulus for the further development of national policies aimed at greater protection for the health and lives of citizens.

Generally speaking, the Council agrees with the need for better cooperation and coordination in this area at all levels, i.e. local, regional, national and EU, as well as the need to share relevant information. The creation of a system for reporting the occurrence of adverse events therefore constitutes a significant measure. The system will ensure immunity of course, in order to encourage reporting.

Emphasis is also placed on more training of health workers in the area of patient safety and the creation of common definitions and terminology as well as comparable indicators which will allow easier identification of problems. This will enable subsequent assessment of the effectiveness of measures and interventions aimed at increasing patient safety and easier communication of experience and information between Member States.

The Czech Presidency is at present completing negotiations on the draft proposal in the working bodies of the Council and it will try to get it accepted by the EPSCO Council in June this year. Of course, it was precisely due to the importance of this issue that the Council decided also to consult the European Parliament as its opinion contributes significantly to the ongoing discussion.

I firmly believe that the Council and Parliament share the common aim of increasing patient safety in the EU. In this spirit the Council will also carefully consider the amendment proposals contained in your report on the draft proposal.

In conclusion I would again like thank everyone taking part in preparing the EP report and the rapporteur Amalia Sartori, who drew up the report.


  Androulla Vassiliou, Member of the Commission. − Mr President, I would like first of all to thank the committee on the Environment, Public Health and Food Safety for its work on this dossier, and especially the rapporteur, Ms Amalia Sartori, for her efforts on what is a health-care priority of the highest order.

Patient safety is about reducing adverse events which occur in all health-care settings – in hospitals, in primary care, in long-term care or in the community.

It is estimated that, in EU Member States, between 8% and 12% of patients admitted to hospitals suffer from adverse effects whilst receiving health care. These figures are unacceptably high. They paint a disturbing picture that affects not only patients but also their families and friends. In addition to this, adverse events are a huge burden on health-care budgets and on the economy as a whole.

Health-care-associated infections are a specific example of a very common adverse event. The total number of hospitalised patients acquiring at least one health-care-associated infection in the EU every year has been estimated at EUR 4.1 million – equivalent to 1 in 20 hospitalised patients.

Approximately 37 000 deaths are estimated to occur every year because of these infections. Clearly, we must strive to improve significantly this situation.

Member States have all recognised the patient safety challenge they face and have taken measures to tackle the problem. However, we know that among the 27 Member States there are varying levels of awareness, resources and expertise available to counter the problem.

It is likely that patients in all Member States are not benefiting from current research findings and the systematic exchange of best practice and expertise. Therefore, I feel that patient safety is another area where the EU can provide real added value to make all European patients safer, while of course respecting Member States’ responsibility for delivering health care on their territories.

That is why the European Commission put forward its communication and a proposal for a Council Recommendation on patient safety, including the prevention and control of health-care-associated infections. I look forward to hearing your views.


  Antonios Trakatellis, on behalf of the PPE-DE Group. (EL) Mr President, the numbers quoted by Mrs Grossetête and the Commissioner are truly overwhelming and show that many patients are exposed to worrying incidents in hospitals, the most frequent being health care-associated infections.

The number of infections could obviously be reduced considerably; first of all, greater discipline is needed in hospitals because, on the one hand, there are people who visit patients in hospital and there is always the risk of transferring bacteria and, on the other hand, hygiene rules need to be applied strictly by both patients and staff and staff need constant information and training on healthcare-associated infections.

However, I believe that the crux of the matter today is that we should collect accurate data, because there are differences from one hospital to another and from one clinic to another, even in the same country; for example, we need to know if healthcare-associated infections are more frequent in surgery patients or in internist clinics, we need to know the strain and the resistance of bacteria; all these data are very important if we are to be able to establish the causes and thus achieve an effective reduction in healthcare-associated infections.

We therefore need to collect detailed data in order to address healthcare-associated infections.


  Linda McAvan, on behalf of the PSE Group. Mr President, I think that this recommendation is a very good example of the added value that the European Union can bring to health care where, although we have limited competences, bringing together experts from Member States can really make a difference to peoples’ lives. As Mr Trakatellis said, the figures that the Commissioner spoke about, on adverse reactions to medical care and on health-care-associated infections, are quite shocking. Nobody should go into hospital and come out more ill than they were in the first place and many of us will know people who have had this problem. It is a problem right across the European Union, and that is why it is extremely important that your initiative on health-care-associated infections should go ahead.

I think that we have a lot to learn from each other, and we can certainly avoid a lot of problems for our citizens if we work together to tackle this issue and bring the best heads in Europe together.

The second point I want to talk about is one mentioned very briefly in our parliamentary report, and that is needle-stick injuries. I know the Commission has been looking at this issue for a long time now, and there is a cooperation between employers and trade unions on this issue, but we still have a situation where an estimated one million workers in the health services across Europe are affected by needle-stick injuries. This could be avoided if the needles they were using were replaced with a safer kind.

I hope, Madam Commissioner, that you will be returning to the Commission and that in the new Parliament session you will bring forward a proposal on needle-stick injuries, which is very important for many health-care workers and is a very avoidable problem in our health-care system.


  Marios Matsakis, on behalf of the ALDE Group. Mr President, approximately 10% of patients admitted to hospitals and about 15% of patients receiving primary care in the EU suffer some kind of adverse event, ranging from a mild, fully recoverable condition to a life-threatening or fatal occurrence. In other words, about one in four of our patients suffer damage because of the treatment and not because of their disease. This statistic is even more dramatic when we consider that the number of health-care-associated deaths in Europe is almost twice the number of deaths caused by road traffic accidents.

Ms Sartori’s report can do much to improve matters, but, as always, the success of any policy depends very much on its application, and in this respect national governments have the responsibility to prove, by their deeds, whether they really care about their citizens. Health-care systems, especially in the 12 newer Member States, need in many cases a complete overhaul, with attention required to the structural improvement of hospitals, the modernisation of equipment and up-to-date training of health personnel. Such changes can occur only with the help of the EU, both in terms of finance and expertise, and such help must be made readily available for the sake of patients’ safety.


  Siiri Oviir (ALDE). - (ET) Open health care is a primary benefit and right. The 37 000 deaths per year caused by infections acquired as a result of health care services is too high, and as citizens of the European Union we cannot permit or accept this. Based on the principle of subsidiarity, European Union institutions and above all the Commission must take on an important role in the promotion of the dissemination of information and best practices.

I must emphasise the importance of offering specific and rapid solutions for the decisive and permanent reduction of nosocomial infections in Europe. In this area, I support the rapporteur’s recommendations in this report.


  Daniela Filipiová, President-in-Office of the Council. – (CS) Mr President, ladies and gentlemen, I would like to thank all MEPs for their comments, suggestions and observations. I have to say that I was delighted to hear that in principle the opinions of the European Parliament and Council coincide over this issue. The Council will of course carefully consider all of the European Parliament’s amendment proposals and based on this it will assess whether or not to incorporate them into the final version of the draft proposal.


  Androulla Vassiliou, Member of the Commission. − Mr President, today’s debate illustrates Parliament’s high level of interest and concern regarding patient safety. It also sends a signal that this is an area of great potential for EU added value.

For the most part, the Commission welcomes the proposed amendments: for example we welcome the proposal for Member States to designate competent authorities for patient safety at the various levels of state and local government administration. This reflects the fact that some Member States have devolved systems of health care. We also agree that the scale and cost of data collection should not be disproportionate to the expected benefits.

In relation to proposed amendments specific to health-care-associated infections, we welcome the provision for adequate protection for health-care staff. We also support the highlighting of the morbidity and mortality burden of health-care-associated infections and the need to recruit more infection-control nurses.

However, I must raise some reservations and objections concerning the reduction of targets. Some suggested that Member States should provide the means necessary to bring about a 20% reduction in the number of persons affected by adverse events, including an overall reduction in the EU of 900 000 cases each year. The Commission does not think it is appropriate to set such targets at EU level as Member States are at different stages and it would be very difficult to set suitable, realistic and achievable targets that would be appropriate for them all.

I have taken very careful note of what Ms McAvan said about needle-stick injuries and I will think about a proposal for a special initiative. Minister Filipiová made a reference to the responsibility of Member States in this aspect. Our initiative on patient safety and health-care-associated infections fully respects the Member States’ competence to finance structure and deliver health services as they see fit. The purpose of our proposal is to help Member States to put in place the proper and adequate strategies to reduce or avoid adverse events in health care, including health-care-associated infections, by pooling the best available evidence and expertise in the EU and lending Commission support to achieving economies of scale in this area.

Once this patient safety recommendation is adopted in the Council, it will signal an unprecedented political commitment from Member State governments to prioritise patient safety in their health-care policies. Action to reduce adverse events of all types, including health-care-associated infections in all health-care settings and in all EU Member States, is a goal we all share. This proposal can play a big part in achieving this goal.


  Françoise Grossetête, rapporteur.(FR) Mr President, I wish first to thank all the Members who have spoken on Mrs Sartori’s report. I would like to thank them for the proposals they are making.

I would also like to say to Mrs Vassiliou, who appears not to share the quantified objectives set out in Mrs Sartori’s report, that we are, of course, taking her remark into account, but it is important, in any case, for us to do our utmost to ensure a high level of protection, both for patients and for health staff. Also, whilst it is not desirable to have a quantified proposal, taking into account the diversity of the care delivered in the European Union, I believe that it is all the same important for us to do our utmost to ensure the highest possible levels of safety.

That is the added value of the European Union.


  President. – The debate is closed.

The vote will take place today at 12 noon.

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