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Reshaping EU Health Policy for Melanoma Patients Francesco De Lorenzo ECPC President

Reshaping EU Health Policy for Melanoma Patients Francesco De Lorenzo ECPC President. 30 th of March 2014. ALL CANCER PATIENTS. ECPC Members in Action Conference 2009. ECPC: "Nothing about us, without us". Representing 342 cancer patient groups in 46 countries

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Reshaping EU Health Policy for Melanoma Patients Francesco De Lorenzo ECPC President

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  1. Reshaping EU Health Policy for Melanoma Patients Francesco De Lorenzo ECPC President 30thof March 2014 ALL CANCER PATIENTS ECPC Members in Action Conference 2009

  2. ECPC: "Nothing about us, without us" • Representing 342 cancer patient groups in 46 countries • All cancers – common and rare • Run and governed by patients • Promoting timely access to appropriate prevention, screening, early diagnosis, treatment and care for all cancer patients • Reducing disparity and inequity across the EU • Encouraging the advance of cancer research & innovation • Increasing cancer patients' influence over European health and research policy • High visibility with EU Commission, EU Parliament (MEP MAC), EMA

  3. ECPC Board and Office Members Board President Francesco De Lorenzo -FAVO, IT Secretary Jana Peluchova - Diagnoza CML, CZ Vice-President Kathy Apostolidis-KEFI, GR Vice-President Vlad Voiculescu - ARIL, RO Board Member Sarah Lindsell - The Brain Tumour Charity, UK Board Member RafalSwierzewski KRWINKA,PO Board Member Elena Caruso. ABAPO, IT

  4. European Medicines Agency (EMA) • Kathi Apostolidis and Rafal Swierzewski are the ECPC representatives in EMA’s Patients’ and Consumers’ Working Party of the Committee for Medicinal Products for Human Use (CHMP). • Their main task is to extend an intensive cooperation between cancer patients and the European Medicines Agency, so that cancer patients are strongly involved in all possible procedures within EMA. • Feel free to contact the EMA via the ECPC Board Members.

  5. Coordination & Advocacy National level European level ECPC Advocacy :bridging diversity to support cancer survivors

  6. European Cancer Patient Coalition Activities:

  7. Planned activities • Working Groups: Rare Cancers, Paediatric Oncology, Melanoma – personalised medicine, Biobanking, Access to employment and social benefits, Access to medicines and radiotherapy, Head and Neck Cancers. • European Projects:

  8. Estimated number of cases, all cancer combined, both sexes, Europe GLOBOCAN 2008 5 yr. PREVALENCE INCIDENCE MORTALITY 6,617,411 2,445,000 1,234,000

  9. Melanoma Independent Cancer Advisory Board (M-ICAB) Why M-ICAB? right here, right now….2013 - 2015 Melanoma remains an underserved cancer where targeted therapies for advanced disease are at a turning point.

  10. ECPC Achievements: • Produced by ECPC in February 2010 • 3 EuropeanConferencesorganised by ECPC withrecommedations to policymakers • Over the last years, ECPC has built a community of stakeholders to support patients. • MICAB paperpublished in September 2013 on ecancer

  11. A summary of the most important issues raised by:The Melanoma White PaperReshaping Eu Healthcare ForMelanoma Patients: A Paper From The Independent Community Advisory Board (M-icab)

  12. Melanomapatientssuffertwice • Needforsystematicthinking • Needforprofessionaleducation • Needfor a joint action • Needforequalaccessto treatment • Need to meet melanoma patients’ needs • EU’s cross-border healthcare directive need for easier access to novel treatments • EU’s general data protection regulation • Need for getting patients involved • The agenda for a change THE MOST IMPORTANT ISSUES RAISED:

  13. It is killing thousands of European citizens that could be saved It is a waste of lives, a waste of money, and a personal tragedy for patients and their families Melanoma patients suffer twice: from their disease, and from neglect of their situation MELANOMA PATIENTS SUFFER TWICE Melanoma is on the rise in Europe Melanoma remains largely ignored at national and at European level In Europe, melanoma patients hardly exist in the eyes of European institutions

  14. Yet it is vital for patients to have access to trials. efforts are required to improve access to trials, not - as at present – to prevent patients from taking part Little collaboration among those working in research and industry, and among patient groups. This means there is a lot of duplication of efforts. Many organisations limit their activity to taking care of local needs NEED FOR SYSTEMATIC THINKING Low access to information about clinical trials/databases in Europe Low patient advocacy for better standards

  15. NEED FOR PROFESSIONAL EDUCATION Dermatologists – especially in Eastern Europe – must be educated and encouraged to network to improve their ability to diagnose. Pathologists and family doctors must be educated as well.

  16. NEED FOR A JOINT ACTION There is an urgent need for a platform at European level where every actor - patients, doctors, dermatologists and other professionals - can come together to shape a common agenda. There is a need to speak with one clear voice, and to ensure that national patient associations are represented at European level. • Our goals will not be achieved if we are acting alone

  17. NEED FOR EQUAL ACCESS TO TREATMENT Effective treatments are lacking but even where they exist, access is often prevented for a number of reasons (regulatory issues, delays in reimbursement, inequalities between member states, etc.). At the same time as the EU is developing its cross-border healthcare directive, even more obstacles are raised to prevent patients from crossing borders to take part in clinical trials. That is unacceptable. • Action is required quickly to prevent thousands of melanoma patients dying unnecessarily

  18. NEED TO MEET MELANOMA PATIENTS’ NEEDS Research and innovation are limited by inadequate funding, stringent data protection rules, lack of coordination, and outdated clinical trial requirements. Where national strategies exist, they differ in scope and in the crucial aspect of financing Duplication and fragmentation impede melanoma research in Europe, often because researchers, doctors and patients have little information about ongoing trials, and it is difficult to recruit adequate numbers of patients to help speed up introduction of the best new treatments into daily clinical practice

  19. EU’s CROSS-BORDER HEALTHCARE DIRECTIVE Highlights inequalities in patient access from country to country as a result of inadequate national budgets Member States: sometimes do not reimburse duly authorized drugs; sometimes discourage their prescription in first-line therapy or exclude them from regional formularies; frequently take longer than permitted by EU legislation to make decisions on pricing and reimbursement – from a few months to several years THE IMPACT OF THE CURRENT ECONOMIC CRISIS IS INTENSIFYING THE TREND

  20. NEED FOR EASIER ACCESS TO NEW TREATMENTS Insufficient coordination of the processes for authorising, pricing or reimbursing diagnostics further complicates access to molecular testing and innovative treatments The diverse methods of deciding prices and reimbursement across the Member States often fail to capture or reward appropriately the potential value of a new medicine. This may lead to underestimate the true value of a melanoma treatment package, for instance to ignore the impact of non-treatment, or the benefits of shortened hospitalisation or reduced side-effects

  21. EU’s GENERAL DATA PROTECTION REGULATION Threatens to limit bio-banks and retrospective clinical research in ways that could be detrimental to health; The regulatory frameworks for medicinal products and in-vitro diagnostics are insufficiently connected, leading to missed opportunities. Predictive assays to personalize treatment are currently insufficient Data protection rules should facilitate access to medical data that is crucial for both prospective and retrospective medical research

  22. NEED FOR GETTING PATIENTS INVOLVED Patients are too frequently excluded from discussions on melanoma treatment, and even when they are not, they have little voice, as THE AGENDA IS ALREADY FIXED BY OTHERS are not involved in clinical trial design and clinical trial authorisation applications have little or no say in long-term budget planning or in discussions on pricing and reimbursement cannot make informed choices about treatment options because of the lack of centralised databases on melanoma research and treatment, and insufficient cross-EU centres of excellence

  23. THE AGENDA FOR A CHANGE - 1 TO FACILITATE ACCESS TO INNOVATIVE TREATMENTS to address the lack of information on clinical effectiveness and cost-effectiveness to stimulate collaborations between academia, industry and health care systems even at an international level to allow patients to participate in such research collaborations independent of where they live to rapid and efficient implementation of the Cross-Border Health Care Directive to make good its promise of better access to health care for EU citizens and greater coopera-tion between EU Member States

  24. THE AGENDA FOR A CHANGE - 2 TO PROMOTE RESEARCH ON MELANOMA: to create platforms for effective collaboration between academia, industry and healthcare systems to improve access to limited numbers of trial subjects to share knowledge and expertise in order to get the most out of research efforts to better coordinate clinical trials and recruitment facilitating access to information for researchers, doctors and patients

  25. THE AGENDA FOR A CHANGE - 3 TO INCLUDE PATIENTS IN MELANOMA POLICY FORMATION: To have them as formal members on regulatory and payer bodies such as the EMA To entitle them as individuals to a voice in the choice of treatment and care that they are offered, and to help them make informed choices about how and where they may be able to enter a trial To promote melanoma care without frontiers within the EU To respect their rights to information

  26. THE ROLE OF THE MELANOMA COMMUNITY The entire melanoma community needs to join forces to be effective!

  27. Italian Legislative Best Practices Reduction of the time to disability recognition for cancer patients Law 102/2009 Law 80/2006 Reduced timelines for assessment for disability recognition after a cancer diagnosis from 12 months to 15 days, which allows the cancer patient to get access to economic and social benefits Reduction nationwide timelines for assessment for disability recognition from 18-20 months to 2-3 months by computerizing recognition procedures

  28. ItalianLaw 189/2012 Innovative drugs are madeimmediatelyavailable allover the countrysoonafter AIFA’s authorization (asagainstpreviousdelaysof 16-24 months) ItalianLaw 98/2013 Innovative drugsavailablewithin 100 daysfollowingapplicationfordrugregistrationto AIFA PharmaceuticalCompanies - 30 DaystoApply

  29. ECPC’S OFFER TO MELANOMA PATIENTS ECPC is willing to: Partner with Melanoma Patient Network as a partnership is required to address the issues melanoma patients are facing Support Melanoma Patient Network Europe on common integrated projects/endeavours (e.g. policy work, dissemination, etc.)

  30. Thank you very much! Nothing about us – without us! Please get in touch! Francesco De Lorenzo delorenzo@ecpc.org ECPC- Melanoma Independent Community Advisory Board (MICAB) CHAMPIONING THE INTERESTS OF EUROPEAN CANCER PATIENTS (change footnote using Menu "View > Change headline/footnote")

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