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EC/HMA/EMA workshop on electronic Product Information (ePI) Session 1: Setting the scene Why ePI? Towards digital transformation of health and care Kristina Kurgonait (EC) Patrizia Tosetti (EC) 28 November 2018 Why ePI? Article 59(4)

  1. EC/HMA/EMA workshop on electronic Product Information (ePI) Session 1: Setting the scene – Why ePI? Towards digital transformation of health and care Kristina Kurgonaitė (EC) Patrizia Tosetti (EC) 28 November 2018

  2. Why ePI? Article 59(4) Directive 2001/83/EC "[…] an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals. " Two external study reports – Consultation of Member States NIVEL and University of Leeds • Summarised in the background document 1. "PIL-S study" – current shortcomings in the leaflets of • Published on the Commission website, medicinal products for human use together with the external study reports 2. "PILS-BOX study" - feasibility and value of a possible insertion of “key information section” EMA/HMA/EC workshop on electronic Product Information (ePI) 2

  3. Why ePI? – EU initiatives on PI EC report on PI EMA action plan • Adopted and published on 22 March 2017 • Developed and adopted in Q4 • Number of recommendations identified 2017 • Scope for improvement within the boundaries of existing • Identified concrete deliverables legislation and timelines • ePI was given the highest priority (implementation started in 2017) ePI formats: • e-formats bring new opportunities EC/EMA/HMA joint collaboration: • Potential benefits in developing key principles […] to • Mapping current digital initiatives in EU provide the information to individual EU citizens • Multi-stakeholder workshop on ePI • e-formats should be complementary to paper PL […] to • ensure availability of the information to all patients Develop key principles for the use of ePI EMA/HMA/EC workshop on electronic Product Information (ePI) 3

  4. Why ePI? - moving towards digital transformation of health and care Exploring electronic formats – Why? • Public health priority • Need for coordination of multiple ongoing initiatives in the EU • Maintain the role of regulatory authorities in providing information to patients Digital transformation – Why? • Digitalisation is a priority in the EU • Digital Single Market Strategy (2015) • Communication on Digital Health & Care (2018) • Right timing moving towards ePI EMA/HMA/EC workshop on electronic Product Information (ePI) 4

  5. Health Priorities in the Digital Single Market Strategy Source: Commission Mid-Term Review of the EMA/HMA/EC workshop on electronic Product Information (ePI) Digital Single Market Strategy, May 2017 5

  6. Commission Communication on Digital Transformation of Health and Care COM(2018)233 Secure access and exchange of health data Data sharing for better reseach and personalised healthcare Empowering patients with digital tools

  7. eHealth Digital Service Infrastructure for cross-border exchange of health data • ePrescriptions • Patient Summary EMA/HMA/EC workshop on electronic Product Information (ePI) 7

  8. Any questions? Further information European Commission, DG SANTE http://ec.europa.eu/health/index_en.htm pcwpsecretariat@ema.europa.eu See websites for contact details European Medicines Agency www.ema.europa.eu Heads of Medicines Agencies www.hma.eu European Commission www.ec.europa.eu Follow us on @EMA_News #ePI4Medicines EMA/HMA/EC workshop on electronic Product Information (ePI) 8

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