Get Involved

Help improve patient safety in your country by asking your local Minister of Parliament or your relevant Member of the European Parliament the questions below.

Based on binding and non-binding legislation, as well as EU initiatives and agreed texts by EU Member States, the questions aim to require policymakers to respond to the current gaps and loop holes in healthcare systems that cause adverse events for patients.

Ask them about their commitment to safety and how they intend to implement the Pact for Patient Safety in your country.

Need help finding your Member of the European Parliament? Click here.

Select a commitment below to learn more about it:

Commitment 1
Commitment 2
Commitment 3
Commitment 4
Commitment 5
Commitment 6
Commitment 7
Commitment 8
Commitment 9
Commitment 10

Pact Commitment 1

Involve patients: Each healthcare provider to systematically and structurally involve patients, or their independent representatives, in all aspects of patient safety strategy

Patient empowerment, both in terms of involving patient organizations in policy making and informing patients on patient safety measures, is one of the main targets of the Council Recommendation on patient safety, including prevention and control of healthcare associated infections adopted in 2009. According to the last European Commission assessment published in June 2014, [insert your country] has [not/only partially] reached this target.

Parliamentary question:
In line with this recommendation adopted by the Council at EU level, can you indicate how you intend to foster patient empowerment in [insert your country] in the future in order to comply fully with the recommendations?

Relevant links:

  • Council Recommendation on patient safety, including prevention and control of healthcare associated infections (2009): click here
  • Commission’s second implementation report on patient safety, including the prevention and control of healthcare associated infections: click here

The Eurobarometer on Patient involvement (published in May 2012) showed that the main barriers to patients’ involvement in healthcare are patients’ attitudes, patients’ lack of knowledge and awareness, and practitioners’ lack of time and support. Respondents suggested that there is a need for improved communication between practitioners and their patients, and that more time was required to allow this.

Parliamentary question:
Given the view of citizens in (insert country), how does the Health Ministry intend to overcome these barriers to foster patient’s involvement in healthcare and comply with the Council Recommendations?

Relevant link:

  • Eurobarometer on Patient Safety (2012): click here

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Pact Commitment 2

Publish data: Each healthcare provider to systematically and consistently collect data on key parameters of patient safety (including usage of medicines and medical technology products) and publicly release figures every year

The Cross-border healthcare directive binds each Member States to set up a national Contact Point to facilitate the exchange of information concerning healthcare providers, patients’ rights, complaints procedures and mechanisms for seeking remedies for patients wishing to receive care in another Member State.

Parliamentary question:
As part of the implementation of this Directive, how does the Ministry of Health (or relevant contact point) plan to make publicly available information related to quality care and safety of healthcare institutions so that patients can make informed decisions about where they receive care?

Relevant link:

The Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) committee recently discussed the joint actions taken by the European Commission and the Member States to restore confidence in medical devices after the scandal of defective breast implants produced by the French PIP company. In the light of this analysis, the EPSCO Committee called for new legislation which aims at developing a common understanding of, and better co-ordination and communication on, surveillance data.

Parliamentary question:
In the light of the commitment made by all Member States,can the Ministry of Health indicate which measuresit intends to adopt domestically to implement a European surveillance data system?

Relevant link:

  • Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices legislation: click here

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Pact commitment 3

Provide access: Access to full patient records for patients According to a survey on European hospitals undertaken by the European Commission, while 81% of hospitals have instituted electronic health records, only 4% of patients are granted access to their online record.

Parliamentary question:
What is the current situation in [insert your country], and how does the health Ministry intend to develop a strategy to ensure patients access to their online record?

Relevant link:

  • Commission Communication on e-Health – making healthcare better for European citizens: an action plan for a European e-Health Area: click here

The Cross-border healthcare directive invites the European Union to support and facilitate cooperation and exchange of information among Member States working within a voluntary network connecting national authorities responsible for eHealth. In particular, the eHealth network shall support Member States in developing common identification and authentication measures to facilitate transfer ability of data in cross-border healthcare.

Parliamentary question:
As part of the implementation of this Directive, how does the Ministry of Health (or relevant contact point) intend to develop common identification and authentication measures to facilitate transferability of data in cross-border healthcare?

Relevant link:

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Pact commitment 4

Incentivise safety: Make management accountable for health systems and provide effective redress and compensation rights for patients
The Council Recommendation on patient safety, including prevention and control of healthcare associated infections adopted in 2009 called on Member States to implement reporting mechanisms for patients and their relatives to report their adverse experiences while receiving care. Currently, only six Member States` systems fully respond to the Recommendation’s requirement.

Parliamentary question:
Excluding the current legal instruments to report medical malpractices existing in our national system, how does the Ministry of Health intend to develop specific tools to allow patients to report adverse events?

Relevant link:

  • Council Recommendation on patient safety, including prevention and control of healthcare associated infections (2009): click here

The Report of the Patient Safety and Quality of Care Working Group of the European Commission published in May 2014 suggests that case handling and analysis of incidents should be undertaken by experts who have insight into the subject and various methods of analysis.

Parliamentary question:
How does the Ministry of Health currently handle the reporting of incidents by patients and their relatives? Is there a plan in place to carry out effective reporting which is separate from formal complaint and litigation procedures?

Relevant link:

  • Recommendations on reporting and learning systems for patient safety incidents across Europe (2014); click here

The Council Recommendation on patient safety, including prevention and control of healthcare associated infections adopted in 2009 encourages the establishment and/or strengthening of blame-free reporting and learning systems on adverse events in healthcare institutions.

Parliamentary question:
How does the Ministry of Health currently support effective blame-free reporting and learning systems on adverse events in healthcare?

Relevant link:

  • Council Recommendation on patient safety, including prevention and control of healthcare associated infections (2009): click here

The Eurobarometer on patient safety and quality of care published in June 2014 showed that almost four in ten adverse events are not followed by any compensatory action after being reported. In particular, respondents who reported an adverse event (or whose family member reported an event) were asked what happened as a result, the most common response was that nothing happened (37%). Only one in five received an apology from the doctor or nurse (20%), while 17% said an explanation for the error was provided by the healthcare facility.

Parliamentary question:
In light of these results and the corresponding loss of faith by citizens in the safety of their health system, how does the Ministry of Health proposed to provide a more effective compensatory systems when adverse events occur?

Relevant link:

  • Eurobarometer on patient safety and quality of care (2014): click here

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Pact commitment 5

Raise Awareness: Annual report on patient safety by the Minister of Health before the national parliament and include patient safety on agenda of all meetings in healthcare.

The Eurobarometer on patient safety and quality of care published in June 2014 showed that 53% of respondents felt that they are likely to be harmed while receiving care in their country. However, there is a wide variation in opinion across countries, from 82% of respondents in Cyprus to 21% of those in Austria.

Parliamentary question:
Given that (insert number) of citizens in (insert your country) believe they will be harmed while receiving care, how does the Ministry of Health intend to address patient perceptions? Will the Ministry provide a report on patient safety which addresses the concerns of citizens?

Relevant link:

  • Eurobarometer on patient safety and quality of care (2014): click here

The Eurobarometer on Patient safety and quality of care published in June 2014 asked respondents who should be responsible for patient safety at the national level. More than half the respondents suggested the Ministry of Health or a related national authority (55%), while 53% say responsibility lies with hospitals, health centres, clinics, doctors or pharmacists.

Parliamentary question:
Given the wide variation in patient perception of responsibility for patient safety, how does the Ministry of Health intend to improve accountability for adverse events and inform patients about where to address complaints and errors?

Relevant link:

  • Eurobarometer on patient safety and quality of care (2014): click here

The Council Recommendation on patient safety, including the prevention and control of healthcare associated infections adopted in 2009 encourages healthcare institutions to prioritise prevention and control of healthcare associated infections in their long-term strategies. All hierarchical levels and functions should cooperate to achieve result-oriented behaviour and organisational change, by defining responsibilities at all levels, organising support facilities and local technical resources and setting up evaluation procedures.

Parliamentary question:
Based on the Council Recommendations, how does the Health Ministry intend to encourage and address a higher degree of attention on prevention and control of healthcare associated infections? What is the current prevalence of HAIs in our health systems or at local, organisational level and how many deaths per year are occurring in (insert country) as a result of HAIs?

Relevant link:

  • Eurobarometer on patient safety and quality of care (2014): click here

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Pact commitment 6

Clear and legally binding guidelines at national and regional level on patient informed consent for all treatments.

Article 3(2)a of the Charter of Fundamental Rights of the EU states that any intervention in the field of medicine and biology cannot be performed without free and informed consent of the person concerned. In 2009, the Council Recommendation on patient safety, including prevention and control of healthcare associated infections, called on Member States to disseminate information on patient safety standards, safety measures to reduce or prevent errors and the rights to informed consent to treatment.

Parliamentary question:
What guidelines currently exist for ensuring that all patients have given informed consent for all treatments? What measures are in place for redress when informed consent is not secured before a procedure?

Relevant links:

  • The Charter of Fundamental Rights of the EU (2000): click here
  • Council Recommendation on patient safety, including prevention and control of healthcare associated infections (2009): click here

The Council Conclusions on Common values and principles in European Union Health Systems adopted in 2006 encourages patient involvement in their treatment. It means that national health systems should be transparent with patients, and offer them choices where possible(e.g. a choice between different healthcare service providers). Each system aims to offer individuals information about their health status, and the right to be fully informed about the treatment being offered to them, and to consent to such treatment.

Parliamentary question:
Given the commitment by (insert country) to these Council Conclusions, what are the current structures in place to ensure the patients are aware of their choices, informed about the treatments available as well as the corresponding risks? If guidelines are not followed, how can patients make formal complaints?

Relevant link:

  • Council Conclusions on Common values and principles in European Union Health Systems (2006): click here

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Pact commitment 7

Clear and legally binding guidelines at national and regional level on risks to patients including those associated with medicines, clinical, management and equity.

The Council Recommendation on patient safety, including prevention and control of healthcare associated infections, invites Member States to consider innovative ways to integrate primary and hospital care, and health and social care. To avoid unnecessary harm to patients, it is imperative to prevent adverse events outside of treatment settings. This includes discharge planning and support, medical guidance and other post treatment requirements outside of acute settings.

Parliamentary question:
What information is currently available to patients regarding the risks associated with both acute and non-acute care, particularly those risks associated with medicines, clinical, management and equity?

Relevant link:

  • Council Recommendation on patient safety, including prevention and control of healthcare associated infections (2009): click here

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Pact commitment 8

Clear and legally binding guidelines at national and regional level on evidence – based use of medicines and medical technologies The EU statement on common values for health adopted in 2006 expresses that in order to provide high-quality treatment, and ensure sustainability over the long term, healthcare decisions must be evidence-based. All systems have to deal with the challenge of prioritising health care in a way that balances the needs of individual patients with the financial resources available to treat the whole population.

Parliamentary question:
In the light of the European values for health, how does [insert your country] intend to develop specific evidence-based clinical guidelines on the use of medicines and medical technologies to decrease any potential harm associated with the delivery of care?

Relevant link:

  • Council Conclusions on Common values and principles in European Union Health Systems(2006/C 146/01): click here

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Pact commitment 9

Clear and legally binding guidelines at national and regional level on the use of approved treatments and technologies according to the medical need of the patient. The European Medicines Agency, along with several European patients association, have emphasised safey issues regarding the increasing use of “off-label medicines” which are medicines prescribed for a use not included as an indication on the drug’s label (as approved by regulators). Off label prescribing is meant to help several categories of patients, such as: children (due to the difficulty in undertaking clinical trials with children), and people affected with rare diseases. However, there are many instances in which off-label prescribing results in harm to patients.

Parliamentary question:
Given the current lack of legislation at EU level and the absence of monitoring and surveillance at the EU level regarding off-label and unlicensed usage of medical treatments, how does the Ministry of Health intend to balance the rights of patients for whom no other alternative clinical therapies are available, and the risks to patients connected with an unauthorised and unlicensed treatment?

Relevant link:

  • EMEA – Evidence of harm from off-label or unlicensed medicines in children: click here
  • Irish Patient Association. Patient Safety,Patients’ Rightsand Off-LabelPrescribing: click here

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Pact commitment 10

Clear and legally binding guidelines at national and regional level on sufficient healthcare staffing to support patient safety. The Council recommendation on patient safety, including prevention and control of healthcare associated infections encourages Member States to promote, at the appropriate level, education and training of healthcare workers on patient safety. The European Commission Report 2014 on the implementation of the Council Recommendation showed that the area of education and training is under implemented. Patient safety is not widely embedded in the undergraduate and postgraduate education of healthcare workers, and is mostly acquired by on-the-job-training and the continuing professional education of health professionals, except in six Member States.

Parliamentary question:
What is the current level of patient safety education provided to healthcare professionals within (insert country)? Have the Ministry of Health and Ministry of Education discussed the need to support curricula to support the provision of safer healthcare for patients and professionals?

Relevant link:

  • Council Recommendation on patient safety, including prevention and control of healthcare associated infections (2009): click here

The European Commission Action Plan for the EU health workforce adopted in 2012 estimates a potential shortfall of around 1 million healthcare workers by 2020 rising up to 2 million if long-term care and ancillary professions are taken into account. This means around 15% of total care will not be covered compared to 2010. Additionally, the Council Conclusions on the economic crisis and healthcare adopted in 2014 invites EU Member States to further cooperate on ways to strengthen health workforce policies to avoid a potential shortfalls which might worsen the healthcare operators working conditions and impacts on patient safety and quality of care.

Parliamentary question:
In the light of this ongoing work at EU level for which (insert country) participates, how do the Ministries of Health and Education intend to forecast workforce needs and improve effective recruitment and retention strategies for health professionals to better protect patients from adverse events?

Relevant links:

  • Commission Staff Working Document on an Action Plan for the EU Health Workforce: click here
  • Council conclusions on the economic crisis and healthcare: click here

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