Eleni Antoniou Senior Policy Officer Thalassaemia International Federation TIF European Thalassaemia amp Sickle Cell Disease Symposium Session 12 Achieving Healthcare Reforms through Patient ID: 1033311
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1. TIF.ACCESS Programme: Guidance and Best Practices for Patient Associations Eleni AntoniouSenior Policy OfficerThalassaemia International FederationTIF European Thalassaemia & Sickle Cell Disease SymposiumSession 12: Achieving Healthcare Reforms through Patient Advocacy | Sunday, 13/12/2020
2. A “WH-” ANALYSISWhatWhyWhereWhoand How
3. WHAT?TIF.ACCESS stands for “TIF’s International Forum on ACCessibility, Effectiveness and Sustainability of TherapieS for Haemoglobin Disorders”It is a global initiative for the promotion of the availability & accessibility of advanced therapies for patients with thalassaemia & other haemoglobin disorders
4. WHAT?It encompasses an array of activities addressed to different stakeholders:Key Messages:AccessAvailabilityKey Message:SolidarityKey Messages:Synergies Increase of negotiating powerEvidence-based policy-makingKey Messages:CollaborationNetworkingKey Message:Early DialoguePatient SafetyPROSKey Messages:CollaborationNetworking
5. WHY?To ensure the equal access of all patients with haemoglobin disorders to novel therapies, by bridging the knowledge communication gap that exists amongst interested stakeholders
6. WHY?Source : Laura J. Frost & Michael R. Reich, Access, Harvard Center for Population and Development Studies, 2008.AffordabilityTo have the industry make advanced medicines and medical treatment affordable and in line with each country’s social system, economy, and medical environmentAvailabilityTo have the payers make advanced medicines for haemoglobinopathies available everywhereAdoptionTo have patients accurately recognize treatment benefits and to encourage them to consciously adopt the use of such medicinesArchitectureTo have patient associations establish a strategy and mechanism to accomplish the above three A’s, including the medical infrastructure, such as health insurance systems, as well as education systems to develop medical professionals
7. WHERE?CyprusItalyPilot testing in CyprusTwo (2) Multi-Stakeholder MeetingsOne (1) Meeting at the ParliamentOne (1) Meeting with the Minister for HealthFirst multi-stakeholder meeting on 18 December 2020In 2021, TIF.ACCESS activities are taking the globe with the support of TIF’s Expert Patient Advocates
8. WHO?TIF.ACCESS engages ALL relevant stakeholders:
9. HOWGuidance & Best PracticesA joint effortAt the national level
10. HOWGuidance & Best PracticesA joint effortAt the international level
11. Available Policy Advocacy Tools11
12. Recommendations of the European Parliament (2017): A reference document for policy advocacyHow can ACCESS to medicines be guaranteed?
13. REGULATION (EC) No 141/2000 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 1999 on orphan medicinal productsREGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human useEudraLex - Volume 3 - Scientific guidelines for medicinal products for human use / EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelinesREGULATION (EC) No 726/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines AgencyREGULATION (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products EU Policy Documents on Access to Innovative Medicines & Therapies REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/ECJoint evaluation of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products {SEC(2020) 291 final} - {SWD(2020) 164 final}COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONSPharmaceutical Strategy for Europe{SWD(2020) 286 final}“The Commission, the European Medicines Agency (EMA), the medicines regulatory authorities in the Member States and the European Economic Area work together in the European medicines regulatory network to ensure that patients have access to high-quality, effective and safe medicines.”
14. Since 2016The EMA and/or FDA approved:7GENE THERAPY PRODUCTS2Chimeric Antigen Receptors / T-cell products for B-cell cancers4Products for serious monogenic disordersMore than 800 cell- and gene- therapy programmes are now in clinical developmente.g.Duchenne’s Muscular DystrophyHuntington’s DiseaseSickle Cell DiseaseAnd more to come…
15. 13 December, 202015The time to ACT is NOW
16. 13 December, 202016THANK YOUAny questions?Contact me at thalassaemia-ea@thalassaemia.org.cy