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An introduction to the EU Patients Rights Directive: whats new for patients? MHN seminar, Ann Marie Borg Monday 24 th June 2013 Outline From Kohll and Decker to Directive 2011/24/EU Milestones A Key features of Directive


  1. An introduction to the EU Patients’ Rights Directive: what’s new for patients? MHN seminar, Ann Marie Borg Monday 24 th June 2013

  2. Outline • From Kohll and Decker to Directive 2011/24/EU • Milestones A • Key features of Directive 2011/24/EU • Main provisions of the Directive B • What’s new? • Opportunities and Challenges C • Willingness to seek healthcare abroad • Conclusions D

  3. Milestones Adoption of First ECJ High level Watts Exclusion Regulation rulings on reflection Ruling of health 883/04 on patient process on services social security mobility: patient mobility from the coordination: Kohll & & HC Services Introduction Decker developments Directive of the EHIC in the EU 2004 1998 2003 2006 2006

  4. Milestones Start of Adoption of Common Adoption of Directive consultation Commission position 2011/24/EU process on proposal on adopted on patients’ Community cross-border under the rights in action on healthcare Belgian cross-border health Presidency healthcare services 2006 2008 2010 2011

  5. B. Key features of Directive 2011/24/EU • A Directive sets the goals to be achieved but Member States have discretion to choose the means • Not directly applicable but MS need to TRANPOSE the provisions of the Directive into their national legislation What’s new? From Kohll & Decker.. Small vs Big Taking stock Key features Challenges -- PRD Way forward Conclusions

  6. B. Key features of Directive 2011/24/EU • Article 114 TFEU on the functioning of the internal market (exclusive EU competence) & • Article 168 TFEU on public health (limited EU competence) Can we reconcile both legal bases? ? What’s new? From Kohll & Decker.. Small vs Big Taking stock Key features Challenges -- PRD Way forward Conclusions

  7. B. Key features of Directive 2011/24/EU • Codify ECJ judgments & clarify “old” patients’ rights on reimbursement and entitlement for patients who seek planned, non-emergency cross- border healthcare • Create “new” patients’ rights on quality and safety standards, access to information relevant to making informed (consumer) choices, complaint procedures and redress mechanisms What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions

  8. B. Key features of Directive 2011/24/EU High quality & safe healthcare • Facilitate patient access to high quality and safe cross- border healthcare • Provide information to patients to make informed choices Reimbursement rights • Set up a harmonised framework for reimbursement of healthcare received in another MS Health systems co-operation • Foster co-operation among EU health systems • Encourage the setting up of voluntary networks: European Reference Networks, Health Technology Assessment… What’s new? Importance Problems Solutions Next Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions

  9. B. Key features of Directive 2011/24/EU Let’s take a closer look… What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions

  10. Main provisions of Directive 2011/24/EU Citizen-friendly information  Article 6 • Patients are entitled to access all information relevant for making informed decisons on their health and cross-border healthcare options  setting up of National Contact Point (NCP) • Consultation with patient organisations What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions Importance Problems Solutions Next

  11. Main provisions of Directive 2011/24/EU National health sytem safeguards: Prior Authorisation (PA) • National authorities OBLIGED to grant PA to patients when HC cannot be provided within “a time- limit which is medically justifiable” • Patients REQUIRE PA in cases of overnight hospital stay, highly specialised and cost-intensive treatment • PA may be REFUSED when there are concerns over quality of care & patient safety, no undue delay What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions Importance Problems Solutions Next

  12. Main provisions of Directive 2011/24/EU National health system safeguards: Conditions of reimbursement • Patients have right to be reimbursed for healthcare up to what it would have cost had they received it in their home country • MS may decide to reimburse the full cost and other related costs What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions Importance Problems Solutions Next

  13. C. What’s new? Previous scenario  EU Regulation 883/2004 on social security (implementing Regulation 987/2009)  E111 (tourists/emergencies) - EHIC  E112 (planned HC) – PA necessary condition Now  Directive 2011/24/EU(patient-oriented approach) - consumer choice, flexibility, more transparency & information on quality and safety standards What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Small vs Big Taking stock Key features Challenges -- PRD Conclusions Way forward

  14. The path to patient empowerment? What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Small vs Big Taking stock Key features Challenges -- PRD Conclusions Way forward

  15. Opportunities Challenges • Patient entitlement to clear and • Difficulties for patients to deduce comprehensive information whether treatment is covered in national health basket and • Mechanisms to ensure remedies & reimbursable compensation in case of harm • Difficulties in determining exact • Patient access to medical records pricing of procedures (total cost of • Support for patients with rare procedure from provider abroad & diseases level up to which it is reimbursed • One-stop-shop for nationally) incoming/outgoing patients • Affluent, high SES patients search for • Faster treatment access for patients the best, less invasive treatment experiencing long waiting times with latest technologies  amplify • Increased transparency of providers existing health inequalities & pricing of medical procedures • Determining “undue delay” • MS urged to upgrade & improve • Continuity of patient care national performance and quality of • Patients paying for treatment costs care upfront What’s new? From Kohll & Decker.. Key features Conclusions Small vs Big Taking stock Challenges -- PRD Way forward

  16. Willingness to seek healthcare abroad Eurobarometer survey on cross-border health services in the EU (2007) Small Member States could experience greater patient outflows What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions Importance Problems Solutions Next

  17. Willingness to seek healthcare abroad Eurobarometer report on European Union citizenship (2012) • 3/4 Maltese citizens feel they are EU citizens which is above the current EU average • Nearly 50% of Maltese citizens who would like more information about their rights as EU citizens say that they would like to know more about receiving medical assistance in another EU MS Is this an indication of the way forward with patients using the Directive to exercise their rights as EU citizens? What’s new? Small vs Big Taking stock Challenges --PRD Way forward From Kohll & Decker.. Key features Conclusions Importance Problems Solutions Next

  18. D. Conclusions  How did the EU Patients’ Rights Directive come about and evolve?  What are its legal bases, scope, specific aims and key provisions?  How does it complement previous EU Regulations?  What are “new” patients’ rights? From Kohll & Decker … Key features What’s new? Small vs Big Taking stock Challenges --PRD Conclusions Importance Problems Solutions Next

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