European developments in evaluation and standardisation.

1. European developments in evaluation and standardisation. J. Bacou, HAS EPSO, Oslo, April 16th 2015

2. Is Healthcare standardisation a public health objective? YES - IF HC environment is standardised (equipment, resources, organisation…) - for homogeneous group of patients - WHEN evidence based standards of care exist.

3. European context • Patient mobility << 1% • HC professionals mobility? • Growing interest of EU standardisation bodies for the HC market. • Tentative standards for border line issues (esthetic surgery, cleft palate, chiropractors, alternative medicines…)

4. Regulatory Framework - Directive 2006/123/CE (so called « Bolkenstein ») Excluding HC services - Directive EU/2011/24 (cross-border) Encouraging MSs to establish national standards and guidelines, - Regulation EU 1025/2012 European standardistion : «the legal framework allowing the Commission to request one or several European standardisation organisations to draft a European standard or European standardisation deliverable for services should be applied while fully respecting the distribution of competences between the Union and the Member States as laid down in the Treaties. in accordance with which it remains the exclusive competence of the Member States to define the fundamental principles of their social security, vocational training and health systems including definition of requirements, quality and safety standards applicable to them”.

5. Europeen standardisation system: Pros • Declared objective: to improve Patient safety and Quality of care. • Standards based on consensus, • Economies of scale: one EU standard instead of 28 national standards bigger market size = 600 M people, • Instrument of industrial politicy

6. Europeen standardisation system: Cons • Clinical dimension of care not taken into account, • No management of conflicts of interests, • Private funding. • Controled by standardisation bodies (NEN, AFNOR…) • Strong business orientation

7. Necessary improvements : • Betterintegration of Public Health objectives whendefining standardisation priorities, • Revisedmethodologytakingintoaccount • New scientificevidence • The point of view of ALL stakeholders • Conflicts of interests • Realistic time scheduleallowing a betterinvolvement of public authorities.

8. Standards recently promoted by CEN: • Don’t address the clinical dimension of HC • Usually aim at promoting • A HC profession (ie chiropactors) • A patient group (ie patients suffering of cleft palates) • Are quickly published preventing a significant comittment of public authorities • Have a very limited impact on HC practices.

9. DG HEALTH propositions • 2014 work program wouldfund a feasabilitystudy : • Mapping of existing standards in HC (at national and international level), • Define an EU framework to develop HC standards at EU level: • Rejected by 10 MSs and withdrawn by the EC • Conducted by CEN without EC mandate and funding. • 2015 ending of the PaSQ joint action • New coordinating structure based on expert groups • Replacing PSQCWG and JA PaSQ • Involving al stakehodersincludingindustry

11. Council Conclusions on PS • WELCOMES the work of the European Network for Patient Safety and Quality of Care (Joint Action PaSQ) on the implementation of the Council Recommendation 2009/C150/01 as regards theexchange and implementation of good practices in Member States; • RECOGNISES a need for continued and sustainable collaboration at EU level on patient safety and quality of care; • Develop further work on the dimensions of quality in healthcare, taking into account existing knowledge, including the work of the "Joint Action on patient safety and quality of care" (PaSQ); • Finalise by December 2016 a framework for a sustainable EU collaboration on patient safety and quality of care, also taking into account the results of the "Joint Action on patient safety and quality of care" (PaSQ);

12. PaSQ network today 28 NCPs composing the backbone of the PaSQ network Representatives of the main EU stakeholders and international organisations 61 partners represented by about 200 colleagues 220 HCOs participating in WP5 implementation 300 HC professionals involved in the Exchange Mechanism 700 contacts receiving PaSQ newsletter

13. 1 - About 35 events (international meetings, workshops, webinars, study tours) have been organised in the EU MS to: -exchange information regarding selected clinical and organisational good practices -build relationship between experts and practitioners and decision makers to promote the implementation of good practices in different settings2 - About 200 EU HCOs have implemented and have assessed transferability of selected clinical good practices. 3 - About 500 good practices are available in the PaSQ database with relevant contact details. 4 – A network of 700 national stakeholders have been developed PaSQ Added value

14. Higher  involvement  of clinicians (from hospital and other healthcare facilities) Increased involvement of PS&QC  experts, risk manager from hospitals  or frontline health care workers. agenda pushed closer to healthcare provider and patient organization. Needs expressed by stakeholders for further PS and QC cooperation

15. 1 - PaSQ network has demonstrated that knowledge exchange and mutual learning is a credible alternative to European standardization. Furthermore, this approach contributes to the provision of safe and high quality care in accordance with point 2 & 7 of Art 168 of the treaty 2 - The sustainable collaboration should further develop this approach, by increasing knowledge transfer via existing PaSQ web tools (database and exchange mechanism) and proposing further implementation tools to support MS in. patient involvement/empowerment reporting and learning / rapid alert systems quality improvement systems European Peer review system implementation of good clinical practices A Sustainable network for Patient Safety and Quality of Care

16. Principles: PaSQ proposal for a sustainable collaboration: European peer review system for Care Quality Improvement Organisations(CQIO) • Organised by CQIO for CQIO • Participation on a voluntary basis • Non binding recommendations • Communication at national, regional and local level.

17. Objectives: Standards and principles: PaSQ proposal for a sustainable collaboration: European peer review system for Care Quality Improvement Organisations(CQIO) • To help organisations to identify gaps and initiate improvements • To share principles, exchange solutions and create a community • To give external recognition and credibility when needed • Established by PaSQ network • Adapted from the main international organisations (International Accreditation Program, European Partnership for Supervisory Organisations…) to EU MS context(s) • Reviewed on a regular basis

18. Quality Improvement systems DIVERSITY Voluntary Independant Pay service IHI CHKS NIAZ CBO AQUA JC/QIOs AZQ IQWIG ACHS Licensing Boards Private Insurance Schemes GER AUS US Inspection Control QualityImprovement CMS AHPRA AHRQ NL KBV PSR ACSQHC G-BA IGZ KNMG GMC NPHA ARS FR NICE UK NHS England HAS CQC Monitor Mandatory Public funding

19. First Steps: PaSQ proposal for a sustainable collaboration: European peer review system for Care Quality Improvement Organisations(CQIO) 1 - Visits of peers in participating MSs to better understand existing CQIO in the EU2 - Drafting of EPRS process and standards 3 - Piloting of Peer Review in one or two MS

20. Thank you for your attention