Managing healthcare costs: can patient safety be traded-off? – Lunch debate in the European Parliament organised by the EAASM

“Too many patients die unnecessarily”

This was one of the key findings of an EU Parliament debate entitled “Managing healthcare costs: can patient safety be traded-off?” hosted by MEPs José Inácio Faria (Portugal/ALDE) and Cristian-Silviu Busoi (Romania/EPP) and organised by the European Alliance for Access to Safe Medicines (

Dr. Torben Mogensen from the Danish Safety Council stated that many patients are still dying unnecessarily within healthcare systems despite efforts to enhance patient safety over a number of years. Only by applying systems that capture medical records electronically and a radical shift of culture to create a blame-free highly collaborative team environment with the patient as a key actor could lives be saved and adverse events reduced more significantly. The staggering statistic that 1 in 10 patients who enter a hospital receive some form of harm still exists across Europe, Dr. Mogensen said.
Dr. Mogensen’s presentation can be found here.

This situation was echoed by MEP Cristian Busoi “Patient safety is a serious growing global public health threat, due to unsafe medical practices and healthcare that cause infections, injuries and death. Hundreds of millions of patients are affected worldwide each year. In Europe alone, it is estimated that between 8 % and 12 % of patients suffer from adverse events while receiving healthcare in hospitals, and nearly half of these events could be avoided.” He went on to recommend “A national patient safety policy is essential but it must reflect the context and needs of the individual country. Policy-makers require an accessible resource for the task of developing the national patient safety policy and strategic plan. However these plans need to strike the balance by being comprehensive but uncomplicated and flexible to implement”.

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 Closing remarks by MEP Christian-Silviu Busoi (EPP/Romania)

According to MEP Faria financial tensions inside health systems are placing barriers to innovative medical technologies. He cited that a new Transparency Directive on pricing and reimbursement to allow faster patient access to new medicines had been withdrawn due to strong opposition by the European Council. Faria said “…strong financial pressures are leading to the temptation of rationing health care provision, and to the adoption of measures that risk being detrimental to patient safety”. However this is being counter balanced by the European Parliament recent adoption in the ENVI Committee (The Committee on the Environment, Public Health and Food Safety) of an “Own-initiative Patient Safety report” where it states its concerns and suggestions for action regarding patient safety, healthcare-associated infections and antimicrobial resistance. The document is due to be voted in Plenary in two weeks’ time and is being led by the rapporteur MEP Piernicola Pedicini and driven by the efforts of MEPs Faria and Busoi.

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Co-host MEP José Inácio Faria (Portugal/ALDE) on the European Parliament’s priority on patient safety

Dr Aurélien Perez from European Commission’s DG SANTE also present, explained the ongoing good work to set up a framework for a sustainable EU collaboration on patient safety and quality of care, as requested by Council Conclusions on Patient Safety and Quality of care of 1st December 2014 and by the Pedicini led report, and insisted on the need to better coordinate patient-related policies.

The debate also centred on the practice of medicines being used off–label or for conditions that the medicine has not actually been licensed for. Mike Isles, Executive Director of EAASM stated “There are many important situations where medicines have to be used off–label, in children’s conditions for instance, however in many instances proper procedures are not in place and so patients are being harmed.”  
Mr. Isles’ presentation can be found here.

The EAASM has called for mandatory adverse event reporting when a medicine is prescribed off label combined with the establishment of the number of adverse events. Patients should be fully informed when a medicine is being used off-label and should give their written consent.

The patient safety debate also discussed the refurbishment and re-use of single use medical devices. Dr Mogensen said “It is totally unacceptable that a medical device designed for a single use in a human being is being refurbished and used again with sometimes disastrous consequences, it is a false economy as medical compensation claims counteract this, notwithstanding the harm and suffering of the patient.“

Kaisa Immonen-Charalambous of the European Patients Forum showed how patients are becoming more active and vocal, giving rise to more “Patient-centred” approaches to healthcare. She stated that «…patients are moving from passive recipients to active partners and self-management with shared decision-making in an integrated care setting is the way forward, but this requires a fundamental change in culture towards openness, transparency and support for patients at all levels of the healthcare system.”
Ms. Immonen-Charalambous’ presentation can be found here.

 Patient safety and quality of care – presentation by Kaisa Immonen-Charalambous, European Patients Forum

 “Managing healthcare costs: can patient safety be traded-off?»

Notes to Editors

“When is a Medicine Not a Medicine” is a report published by the EAASM which covers a number of the topics mentioned in the debate and can be obtained at when is a medicine not a medicine?

For further comment, please contact on +44 7540 462867


The European Alliance for Access to Safe Medicines (EAASM) is an independent, pan-European initiative dedicated to protecting patient safety by ensuring access to safe and legitimate medicines. Its key activities include campaigning for the safer use of unlicensed or off-label medicines and also the exclusion of counterfeit and substandard medicines from the supply chain, raising public awareness around such issues, and promoting effective legislation and enforcement in relation to falsified medicines.