Lunch with debate “Managing healthcare costs: can patient safety be traded-off?

1. Lunch with debate • “Managing healthcare costs: can patient safety be traded-off? • Event organised by the European Alliance • for Access to Safe Medicines (EAASM) • and • hosted by MEP José Inácio Faria (Protugal/ALDE political group) and MEP Cristian-Silviu Busoi (Romania/EPP political group) • Wednesday 6th May 2015 at 12:30 in the European Parliament Members’ Salon

2. Agenda • 12:30 – 12:40 • 12:40 – 12:55 • 12:55 – 13:10 • 13:10 – 13:25 • 13:25 – 1420 • 14:20 – 14:30 • Welcome words by MEP José Inácio Faria (Portugal/ALDE) on the Parliament’s priorities on patient safety • Brief introduction on the ‘Patient Safety First’ series • by Mike Isles, Executive Director of EAASM • Patient safety and the Danish experience: presentation by Dr Torben Mogensen, Danish Patient Safety Council • Patient safety and quality of care; presentation by Kaisa Immonen-Charalambous, European Patients Forum • Roundtable discussion with all participants. • Closing remarks by MEP Christian-Silviu Busoi (EPP/Romania)

3. Lunch with debate • “Managing healthcare costs: can patient safety be traded-off? • Event organised by the European Alliance • for Access to Safe Medicines (EAASM) • and • hosted by MEP José Inácio Faria (Protugal/ALDE political group) and MEP Cristian-Silviu Busoi (Romania/EPP political group) • Wednesday 6th May 2015 at 12:30 in the European Parliament Members’ Salon

4. “Managing healthcare costs: can patient safety be traded-off” Mike Isles Executive Director

5. EAASM - An independent voice for patient safety • Formed in 2007 with the clear objective of fighting against counterfeit medicines and promoting patient safety around Europe • High profile, multi-sectoral and independent voice for patient safety across Europe • It is a not-for-profit Community Interest Company

6. EAASM – mile stone reports • www.eaasm.eu

8. http://www.medizin-direkt.com - the fake website ran for 9 weeks in Germany • More than 360,000 hits • 3rd most popular online pharmacy • Conservative estimates of orders €35m sales • Estimated European sales of falsified meds are €1-3bn rising to €10bn by 2020

9. When is Medicine Not a Medicine? • How are “off label” adverse reactions recorded. • Who is regulating this? • Are there other anomalous issues, such • as unlicensed products being used • instead of licensed ones? • Does this, in certain situations, • compromise patient safety.

10. Consensus Statement • The Establishment of the number of Adverse Events (AEs) relating to unlicensed/off-label use of medicines • The introduction of a professional Code of Practice for mandatory reporting by healthcare professionals of AEs involving unlicensed/off-label medicines as currently there is no mechanism for recording or reporting AEs in this context • To Improve public awareness so that patients are aware of when unlicensed/off-label medicines are used and the importance of AE reporting, and very importantly that patients give their consent for those medicines to be used

11. Parliament Own initiative report “Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance”.

12. EAASM contribution to the report on Patient Safety/or calls for action • Identifying products used outside of their licensed indication despite the availability of a licensed product • Identifying the use of unlicensed products to replace the fully licensed medicines such as in the area of pre-operative skin disinfection • Investigate the possible malpractice involved in the refurbishment and re-use of medical devices originally designed and labeled (under EU approval) for single use • Ensuring appropriate use of medicines thanks to the EMA guidelines • Reporting on adverse events related to off-label use • Ensuring informed consent and patient empowerment

13. Parliament Own initiative report “Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance”. • Developing a list and guidelines on the off label use of medicines • to investigate the possible malpractice involved in the refurbishment and re-use of medical devices originally designed and labeled (under EU approval) for single use • to ensure that medical professionals inform patients when a medicine is to be used off label and the risks and preventive measures relating to adverse events and the complaints procedures.

14. Study on Off Label use 2014 • Question E-003668/2015 by Mairead McGuinness (PPE) • Subject: Adverse events linked to use of medicines • Reduced healthcare spending due to austerity measures jeopardises quality of care and can expose patients to a greater risk of adverse events. • Increasing trend in some Member States towards economic off-label use (OLU) of medication is indicative of this development, which undermines the important work of the European Medicines Agency and 50 years of EU pharmaceutical legislation, one of Europe’s great success stories to the benefit of its citizens. • The Commission has rightly reacted to this situation by announcing a study on OLU in 2014. • The EAASM welcomes the fact that the Consortium will contact stakeholders such as healthcare professionals’ and patients’ organisations, Member State representatives and industry

15. What impact of the cost cutting measures? • “We don’t yet know the full impact of cost-cutting measures.” • The full scale effect of the crisis may not be apparent for years… • There are likely to be further adverse effects on health due financial insecurity, inadequate and delayed access to health services, and the longer-term consequences of cuts starting to emerge. WHO Europe 2014 p.37

16. The economic crisis and healthcare expenditure in the European Union • Following an increase in spending on healthcare beforehand, since the crisis in 2008 spending on healthcare fell. • Between 2009 and 2012, expenditure on health fell in half of EU countries and significantly slowed in the rest OECD and Commission Health at a Glance 2014, p. 120-121 •  On average health spending decreased by 0.6% each year between 2009 and 2012 OECD and Commission Health at a Glance 2014, p. 120

17. United Kingdom • £20bn saving over 5 years • Achieved by efficiencies

19. Agenda • 12:30 – 12:40 • 12:40 – 12:55 • 12:55 – 13:10 • 13:10 – 13:25 • 13:25 – 1420 • 14:20 – 14:30 • Welcome words by MEP José Inácio Faria (Portugal/ALDE) on the Parliament’s priorities on patient safety • Brief introduction on the ‘Patient Safety First’ series • by Mike Isles, Executive Director of EAASM • Patient safety and the Danish experience: presentation by Dr Torben Mogensen, Danish Patient Safety Council • Patient safety and quality of care; presentation by Kaisa Immonen-Charalambous, European Patients Forum • Roundtable discussion with all participants. • Closing remarks by MEP Christian-Silviu Busoi (EPP/Romania)

20. “Managing healthcare costs: can patient safety be traded-off” Mike Isles Executive Director

21. Lunch with debate • “Managing healthcare costs: can patient safety be traded-off? • Event organised by the European Alliance • for Access to Safe Medicines (EAASM) • and • hosted by MEP José Inácio Faria (Protugal/ALDE) and • MEP Cristian-Silviu Busoi (Romania/EPP) • Wednesday 6th May 2015 at 12:30 in the European Parliament Members’ Salon

22. Agenda • 12:30 – 12:40 • 12:40 – 12:55 • 12:55 – 13:10 • 13:10 – 13:25 • 13:25 – 1420 • 14:20 – 14:30 • Welcome words by MEP José Inácio Faria (Portugal/ALDE) on the Parliament’s priorities on patient safety • Brief introduction on the ‘Patient Safety First’ series • by Mike Isles, Executive Director of EAASM • Patient safety and the Danish experience: presentation by Dr Torben Mogensen, Danish Patient Safety Council • Patient safety and quality of care; presentation by Kaisa Immonen-Charalambous, European Patients Forum • Roundtable discussion with all participants. • Closing remarks by MEP Christian-Silviu Busoi (EPP/Romania)