CELLS LEGISLATION STAKEHOLDER EVENT September 20th 2017 1 Health - PowerPoint PPT Presentation

EVALUATION OF THE BLOOD, TISSUES AND CELLS LEGISLATION STAKEHOLDER EVENT September 20th 2017 1 Health

Comment via Twitter from today for 7 days • #BloodTissuesCellsEU Health

SESSION 1: WELCOME AND INTRODUCTION • Martin Seychell • Deputy Director General • DG-Santé, European Commission • Anna-Eva Ampélas • Head of Unit • DG-Santé, European Commission • Medical Products: Quality, Safety and Innovation Health

Substances of Human Origin ORGANS Out of scope Health

EU Blood sector For Transfusion Platelets Plasma Red blood cells Key facts 14 million citizens donate 20 million whole blood units per year • Allowing for 26 million transfusions per year (RBC >> platelets, plasma) • 1350 authorized blood establishments in the EU (+1200 mobile/satellites) • Needed for surgery, trauma, oncology, … • Health

EU blood sector For manufacturing Plasma Manufacturing/Fractionation = Medicinal nal Products ducts ( C Clotting ng factor tors, , album umin, n, immunogl noglobul obulins ns etc. ) Key facts About 8 million liter of EU-collected plasma manufactured by public and • private fractionators Global exchange of collected plasma and plasma derivatives • Indications: immunodeficiencies, haemophilia, clotting disorders, … • Health

EU Tissues Replacement Tissues and cells and cells sector Indications T&C types • Bone Orthopedic surgery • Ocular tissue Blindness • Skin Burn wounds • Cardiovascular Heart insufficiency tissues Starting materials for • … innovative therapies Key facts 1357 authorized tissue establishments in the EU • > 300,000 units distributed for transplantation per year • Often local collection for local supply, but also regional exchange • Health

EU Tissues Haematopoietic Stem Cells and cells sector Indications T&C types • Bone marrow Blood cancers • Peripheral blood Starting materials for innovative therapies stem cells • Umbilical cord stem cells Key facts 1047 authorized tissue establishments in the EU • > 30,000 units distributed for transplantation per year • Global exchange network to match donors and recipients at best • Health

EU Tissues Reproductive Cells and Tissues and cells sector T&C types Indications • Oocytes Fertility treatments • Sperm Fertility conservation • (gametes) • Embryos • Ovarian tissue • Testicular tissue Key facts 1723 IVF clinics authorized as tissue establishments in the EU • > 500,000 units distributed for clinical application per year • Mainly organised locally, with international flows of gametes (and couples) • Health

EU Legal Basis Art. 168 /Mandate TFEU Art .168 (4) "The European Parliament and the Council … shall … adopt: (a): measures setting high standards of quality and safety of organs, and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures. Art. 168 (7) … These measures (para 4(a)) shall not affect national provisions on the donation or medical use of organs and blood."  Mandate for quality and safety standards at EU-level  Member States may complement these with national measures  Member States decide what can be donated and used Health

EU Legal Acts Blood and blood Tissues and components Cells 1. Basic Acts (Council and EP) Directive 2002/98/EC Directive 2004/23/EC Main Provisions : Designation of Competent Authorities  Authorisation and Inspection  Traceability and alert systems  Quality Management and responsible persons  Principle of voluntary and unpaid donation  Consent and data protection  2. Technical Directives (Commission) 4 Directives implementing 4 Directives implementing technical requirements technical requirements 3. Soft Law Tools (Commission+Experts) Rapid Alert System Blood Rapid Alert System T&C Guidelines on Q systems Guidelines on inspections Health

EU requirements Human Collect/ Test Process Store Distribute Dona- Testing Procure- Process Preser- Distribu- Donation application Procure tion tion ment -ing vation/ Storage Selection/deferral, HIV, Hepatitis B, Quality Professionals 1 consent… Hepatitis C.. requirements National 2 Competent Oversight: autorisation, inspection, vigilance, traceability ,… Authorities European EU-level support: rapid alerts, coding system… 3 Commission Health

The Evaluation Purpose  The purpose of the evaluation is to provide a comprehensive assessment of the directives, examining their functioning across the EU .  In particular the evaluation will assess the extent to which the Main Directives have met their original objectives and whether they remain fit for purpose assessing also the contribution of the Implementing Directives.  The evaluation is expected to provide a sound evidence base which will be used to consider the need for any changes to the legislation. Health

Assessment Criteria 1. Relevance • Still up to date? (science, technology, epidemiology, commercialisation, new actors)? • Increasing safety and quality? 2. Effectiveness Negative side-effects or barriers? 3. Efficiency • Benefits and costs for establishments, clinicians, authorities? 4. Coherence • Consistent with other legislation, any gaps and overlaps? 5. EU Added Value • Could the results be achieved better at national or global level? Health

Evidence Base 1. Evidence from monitoring 2. Previous implementation reports 3. Issues arising from implementation (complaints, infringement procedures, interpretation/scope questions) 4. Consultation Open public - for citizens (online)  Targeted public - for organisations (online)  Meetings for stakeholder organisations   This public event 5. External contract - review of evidence and filling of gaps (ICF Consulting) Health

Stakeholder responses 163 responses from organisations 43 responses from individual citizens  A ll responses will be published online (where consent allows)  A summary report will be published online by the Commission  Preliminary summary at the end of the programme today (by ICF) Health

External Study  Contractor – ICF Consulting  Support Commission in evaluating legislations  Supported by 3 experts : Imogen Swann, Margarethe Heiden, and Sinead Masterson  Contractor to  focus on examining evaluation questions  independently document an evidence base, i.e. an independent study by mid 2018 European Commission Brussels, xxxx 2018 SWD(2018) xx final  Commission to bring together the work of the Commission Staff contractor, EC services and results of the public Working Document consultation in Commission Staff Working Document by end 2018 Health

Timeline Key elements Estimated timing Roadmap consultation Q1 2017 Public consultation Q3 2017 External contract Q2 2017 – Q3 2018 Commission evaluation report Q4 2018 18 Health

SESSION 2: The key importance of donors – The gift of life • MODERATOR : Arlette Delbosc Ministry of Health, France • Discussion on donors and their protection, addressing topics such as voluntary unpaid donation, compensation, donor safety and follow up, donor recruitment and donor registries. Health

International Federation of Blood Donor Organizations (FIODS) • Alice Simonetti Health

The key importance of donors: the IFBDO point of view • ETHICS The principle of voluntary AND unpaid donation (VUD) needs to be further stressed and specified, as it represents one of the main guarantees for the safety and quality standards for blood and blood components, as outlined in the legislation under review, and for donors’ and patients’ protection. • COOPERATION We stress the need for a wider recognition of voluntary organizations in the field of blood and plasma donation, their role in the transfusion system in cooperation with EU & national health institutions, and their work for donors’ recruitment and retention. • UNIFORMITY AND GUIDELINES We recognize the necessity to set basic and common standards for blood and blood components collection in order to ensure the donors’ and recipients’ safety. • ORGANISATION AND SHARED RESPONSIBILITY The EU should encourage/request member countries to set up plans on how to secure self-sufficiency in plasma and PDMP from voluntary and unpaid donations, as already emphasized by the Council of Europe. 20 September 2017 – B RUSSELS , Centre de Conférence A. Borschette Alice Simonetti, International Federation of Blood Donor Organizations (FIODS)

International Haemovigilance Network (IHN) • Arlinke Bokhorst Health