EU Policies & Directives

Patient Safety

Patient Safety is a health care discipline that emerged with the evolving complexity in healthcare systems and the resulting rise of patient harm in healthcare facilities. It aims to prevent and reduce risks, errors and harm that occur to patients during provision of health care. 

Patient safety is fundamental to delivering quality essential health services. Indeed, there is a clear consensus that quality health services across the world should be effective, safe and people-centred. In addition, to realize the benefits of quality health care, health services must be timely, equitable, integrated and efficient. 

Every year, millions of patients suffer injuries or die because of unsafe and poor-quality health care. Many medical practices and risks associated with health care are emerging as major challenges for patient safety and contribute significantly to the burden of harm due to unsafe care. Below are some of the patient safety situations causing most concern. According to WHO:

Medication errors are a leading cause of injury and avoidable harm in health care systems: globally, the cost associated with medication errors has been estimated at US$ 42 billion annually.

Health care-associated infections occur in 7 and 10 out of every 100 hospitalized patients in high-income countries and low- and middle-income countries respectively.

Unsafe surgical care procedures cause complications in up to 25% of patients. Almost 7 million surgical patients suffer significant complications annually, 1 million of whom die during or immediately following surgery .

Diagnostic errors occur in about 5% of adults in outpatient care settings, more than half of which have the potential to cause severe harm. Most people will suffer a diagnostic error in their lifetime.

Unsafe transfusion practices expose patients to the risk of adverse transfusion reactions and the transmission of infections (14). Data on adverse transfusion reactions from a group of 21 countries show an average incidence of 8.7 serious reactions per 100 000 distributed blood components.


A Global Health Priority

Safety of patients during the provision of health services that are safe and of high quality is a prerequisite for strengthening health care systems and making progress towards effective universal health coverage (UHC) under Sustainable Development Goal 3 (Ensure healthy lives and promote health and well-being for all at all ages).

Recognizing that Patient Safety is a global health priority, the World Health Assembly (WHA) 72.6 adopted in May 2019 a Resolution on Patient Safety which endorsed the establishment of World Patient Safety Day to be observed annually by Member States on 17 September.

The Seventy-second World Health Assembly also mandated for development of a global patient safety action plan.

This global action plan was adopted by Seventy-Fourth World Health Assembly in 2021 with a vision of “a world in which no one is harmed in health care, and every patient receives safe and respectful care, every time, everywhere”.

The purpose of the action plan is to provide strategic direction for all stakeholders for eliminating avoidable harm in health care and improving patient safety in different practice domains through policy actions on safety and quality of health services, as well as for implementation of recommendations at the point of care. The action plan provides a framework for countries to develop their respective national action plans on patient safety, as well to align existing strategic instruments for improving patient safety in all clinical and health-related programmes.

Read/Download the WHO Global Patient Safety Action Plan 2021-2030



Patient Safety and Quality of Care in the EU

It is estimated that 8-12% of patients admitted to a hospital in the EU suffer from adverse effects whilst receiving healthcare, such as healthcare-associated infections, errors in diagnosis and medication-related and surgical errors. Unsafe care not only has consequences for patients’ health and EU citizens’ trust in healthcare systems, but also a significant impact on economy.

The implementation of strategies to reduce harm varies widely across the EU. The European Commission plays a central role in helping member states to share best practices, and has taken a number of steps to improve patient safety in Europe.

The European Commission asked an Independent Expert Panel on Effective ways of Investing in Health (EXPH) to provide an Opinion on the development of quality of health care, with a special emphasis on patient safety, in the EU. Based on scientific evidence and on past EU projects on quality and safety, the Expert Panel stated that services should be:

  1. Effective and improve health outcomes
  2. Safe and prevent avoidable harm related to care
  3. Appropriate and compliant with current professional knowledge as well as meeting agreed standards
  4. Patient-centred, and involve patients/people as key partners in the process of care
  5. Efficient, leading to the best value for the money spent, and equitable for all, in relation to need, utilization and quality

The Expert Panel acknowledged that the EU Commission could play a crucial role in boosting the quality of health care and the safety of patients and came up with a list of actions that could be taken at EU level, including:

  1. Setting up a “EU Health Care Quality Board” to coordinate all EU initiatives in health care quality
  2. Setting up an EU-level “Health System Performance Analysis Framework” to make it easier to compare health policies and their impact
  3. Initiating a process for drafting recommendations on health care quality
  4. Funding more research into making health systems more resilient in order to promptly respond to any upcoming challenges
  5. Setting up a Health Technology Assessment (HTA) network so EU countries can share knowledge about health technologies, health care processes and health system impact assessment and avoid duplicating efforts
  6. Encouraging blame-free reporting concerning information technology and systems and developing EU surveillance systems
  7. Building a Europe-wide health education programme from a patient-centred approach including health literacy, patient safety and health care
Read/Download the “Future EU Agenda on Patient Safety and Quality of Care” Opinion



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