Introduction to EU 'SoHO' Sector Screening Meeting with the Republic of Serbia December 5, 2014 Directorate General for Health and Consumers Unit D4

Size: px

Start display at page:

Download "Introduction to EU 'SoHO' Sector Screening Meeting with the Republic of Serbia December 5, 2014 Directorate General for Health and Consumers Unit D4"

Cecil Doyle
6 years ago
Views:

1 Introduction to EU 'SoHO' Sector Screening Meeting with the Republic of Serbia December 5, 2014 Directorate General for Unit D4

2 1. Introduction: SoHO & the Legal Basis 2. The Legislative Framework 3. Blood / Tissue & Cells / 4. The SoHO Sector and Enlargement 2

3 1. Introduction 1.1 Substances of Human Origin Blood and blood components Tissues and Cells 3

4 1. Introduction 1.2 SoHO Landscape Flow Donor SoHO Recipient Process Donation/ Collection Test Process Store Distribute Human application Actors Procurement site (PS) Blood/Tissue Establishment(s) (TE) Site of Human Application (SiHA) / Transplant Center Oversight National Competent Authority (NCA) 4

5 1. Introduction DONOR (female) LIVING DEAD 1 Donor Donation Episode 1 CORD BLOOD Donation Episode 2 AMNION Donation Episode 3 BRAIN DEATH Recipient 1 Recipient 2 ORGANS TISSUES KIDNEY LIVER PANCREATIC ISLETS CORNEA CV MUSCULO SKELETAL Recipient 3 Right Lobule Left Lobule TE 1 Hepatocites isolation and preservation Recipient 6 TE 2 TE 3 Recipient 7 Recipient 9 Recipient 8 Recipient 10 Recipient 4 Recipient 5 TE: Tissue Establishment R Femur L Femur R Tibia L Tibia R Achiles R Patellar R Humer TE 4 Cleaned Decontaminated Frozen 80ºC Pharma Comp 2 Advanced therapy TE 5 New process T. Plateau Diaphisis PharmaComp 1 Pooled Recipient 11 Recipient 12 Recipient 13 Recipient 14 Recipient 15 Recipients? >100 Recipient 16 Recipient 50 recipients 5 5

6 1. Introduction: SoHO & the Legal Basis 2. The Legislative Framework 3. Blood / Tissue & Cells / 4. The SoHO Sector and Enlargement 6

7 2. The Legislative Framework 2.1 The legal basis - EU action in health The Treaty of the Functioning of the European Union Article 168 (former article 152 TEC) A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities Health largely falls under the subsidiarity principle Union action shall complement national policies Foster cooperation between Member States (MS) and third countries Exception to the subsidiarity principle: some common safety concerns, including substances of human origin 7

8 2. The Legislative Framework 2.1 The legal basis - SoHO TFEU - Article 168 4(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." -- Clear Mandate for EU-level action concerning quality & safety of SoHO -- Parallel approach across 3 SOHO segments Blood, T&Cs and 8

9 2. The Legislative Framework EU 'SoHO' Legislation DIRECTIVE 2002/98/EC setting standards of Q&S for the collection, testing, processing, storage and distribution of human blood and blood components DIRECTIVE 2004/23/EC setting standards of Q&S for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells DIRECTIVE 2010/53/EU on standards of Q&S of human organs intended for transplantation 9

10 2. The Legislative Framework EU legislation on SoHO Donation Minimum standards Q&S Distribution Obligations of MS Competent Authorities Donor selection and evaluation Provisions on Quality & Safety Exchange of information, reports, penalties Traceability and SARE reporting Data protection 10

11 2. The Legislative Framework EU 'SoHO' Legislation - Implementing Directives 2004, 2005 COMMISSION DIRECTIVE 2005/61/EC traceability requirements and notification of SARE haemovigilance 2006 COMMISSION DIRECTIVE 2006/86/EC traceability requirements, biovigilance & certain technical requirements [ ] 2012 Implementing Directive 2012/25/EU information procedures for the exchange, between MS, of human organs (transposition deadline April 2014) 11 traceability, biovigilance

12 2. The Legislative Framework 2.3 Framework in Practice: 3 levels of requirements Donation /Collection n Test Process Store Distribute Human application 1 Actors Selection/deferral, consent HIV, Hepatitis B, Hepatitis C.. Quality requirements 2 National Competent Authorities Oversight: vigilance, traceability, accreditation, inspection 3 European Commission EU-level support: rapid alerts, traceability system 12

13 2. The Legislative Framework 2.4 Limits to SoHO Legislation Donation Collect / Procure Testing Preserve Store Process Human application ( > 95%) Transfusion Transplantation Blood, T/Cs Legislation Pharmaceutical Legislation Research Transport Manufacturing Medicinal Products (<5%) 13

14 1. Introduction: SoHO & the Legal Basis 2. The Legislative Framework 3. Blood / Tissue & Cells / 4. The SoHO Sector and Enlargement 14

15 3733 establishments and hospital blood banks (29 countries reporting) units issued (29 countries reporting) units transfused (17 countries reporting) recipients of blood components (16 countries reporting) Data from the 2011 serious adverse reactions and events reports - EU MS, Liechtenstein and Norway 15

16 3.1 Blood and blood components 'Mother' Directive 2002/98/EC - Sets standards for the quality and safety of the; collection, testing, processing, storage and distribution of human blood and blood components Implementing Directives: -2004/33/EC technical requirements for blood -2005/61/EC traceability / notification of SAREs -2005/62/EC quality system for blood establishments 16

17 3.1 Blood and blood components Mother Directive Chapter II OBLIGATIONS ON MEMBER STATES AUTHORITIES - Licensing of establishments - Inspections & Control measures Chapter III PROVISIONS FOR BLOOD ESTABLISHMENTS - Responsible Person - Personnel / Training Chapter IV QUALITY MANAGEMENT -Quality System for BEs -Documentation -Record Keeping Chapter V HAEMOVIGILANCE -Traceability - Notification of SAREs Chapter VI PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS - Info to/from Donors -Donor Eligibility / Examination -VUD Chapter VII DATA PROTECTION Chapter VIII EXCHANGE OF INFORMATION, REPORTS AND PENALTIES 17

18 3.1 Blood and blood components Mother Directive CHAPTER II - OBLIGATIONS ON MEMBER STATES AUTHORITIES Article 5 Designation, authorisation, accreditation or licensing of blood establishments 1.Member States shall ensure that activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated, authorised, accredited or licensed by the competent authority for that purpose. 3. The competent authority, having verified whether the blood establishment complies with the requirements set out in this Directive, shall indicate to the blood establishment which activities it may undertake and which conditions apply. Article 8 Inspection and control measures 1.Member States shall ensure that the competent authority organise inspections and appropriate control measures in Blood establishments to ensure that the requirements of this Directive are complied with. 2. Inspection and control measures shall be organised by the competent authority on a regular basis. The interval between two inspections and control measures shall not exceed two years. [..] 18

19 1. Introduction: SoHO & the Legal Basis 2. The Legislative Framework 3. Blood / Tissue & Cells / 4. The SoHO Sector and Enlargement 19

20 TISSUES Bone, tendons, cartilages Are procured from deceased donors. As bone tissue has the ability to completely regenerate bone grafts, it is used to repair bone fractures. Tendons are used mostly for reconstruction in the knee. Skin Skin can be either procured from deceased or from living donors. Skin grafts are mainly used for the treatment of burns. Cardiovascular tissues Are procured from deceased donors, they are mainly used to replace blood vessels or aortic and pulmonary valves for patients with congenital heart defects. Corneas Corneas procured from deceased donors are used in ocular surgery. 20

21 CELLS Haematopoietic stem cells (HSC) HSC are procured from living donors (bone marrow, peripheral blood stem cells and cord blood donation) and mainly used to treat diseases of the blood, bone marrow, or certain types of cancer. Pancreatic islets Pancreatic islets are isolated from the pancreas of a deceased organ donor and can be used to treat type 1 diabetes. Hepatocytes Hepatocytes are cells that can be used for treatment of liver disease. Reproductive cells Eggs and sperm, are used in the field of medically assisted reproductive technology for treating infertility. 21

22 Procurement organisations Reporting countries Number of POs - traditional tissues Number of POs - HPC Number of POs - ART Number of POs- TC for ATMP Number of qualified laboratories for donor testing 27 MS + 2 EEA Procurement Organisations (POs)

23 Tissue establishments Total number of authorised TEs: 2047 (27 MS + 1 EEA countries; 2011 data)

24 Tissue establishments Private and public TEs (24 MS + 1 EEA country; 2011 data) 24

25 3.2 Tissues and Cells Legislation 'Mother' Directive 2004/23/EC - Sets standards for the quality and safety of the; collection, testing, processing, preservation, storage and distribution of human tissues and cells Implementing Directives: -2006/17/EC technical requirements for donation, procurement and testing -2006/86/EC traceability, notification of SAREs and technical requirements for coding, processing, preservation, storage and distribution 25

26 3.2 Tissues and Cells Legislation Mother directive Chapter II - Obligations on NCA s Supervision of procurement Accreditation TE s and preparation processes Inspection and control Traceability and SAR/E Import/export Register of TEs Chapter III - Donor selection & evaluation V.U.D., compensation and promotion Consent Data protection and confidentiality Selection, evaluation and procurement Chapter V, VI coding, reports, penalties consultation of committees Chapter IV - Quality and safety provisions Quality management Responsible person/personnel Reception, processing storage, labelling, packaging, distribution 3 rd parties 26

27 3.2 T&Cs Legislation Obligations on establishments Process Donation Collection Testing Preserve Store Human application Transport Directive 2004/23/EC, Chapter IV (Quality and Safety T&C) Quality Management Responsible person and Personnel T&C reception, processing, storage, distribution Labelling 3rd parties Commission Directive 2006/17/EC technical requirements for donation, procurement and testing 27

28 3.2 T&Cs Legislation Obligations on Member States Process T.E. 1 Donation Collection Testing T.E. 2 Preserve Donation Collection Testing T.E. Store Transport Preserve Donation Collection Testing Human application Process Store Transport Preserve Human application Process Store Transport Human application Directive 2004/23/EC, Chapter II (Obligations CA s) Directive 2004/23/EC, Chapter III (Donation and selection) Supervision of procurement V.U.D., compensation and promotion Accreditation TE s and preparation processes Consent Inspection and control Data protection and confidentiality Traceability and SAR/E (+ Comm Dir 2006/86/EC) Selection, evaluation and procurement Import/export Directive 2004/23/EC, Chapter V: coding, reports, penalties Register of TE s 28

T.E. 1 T.E. 2 Do na tio n Colle ction T.E. Do na tio n Te sti ng Colle ction Do na tio n Pr es erv e Te sti ng Colle ction Pr oc es s St or e Tr an sp ort Pr es erv e Te sti ng Human applicati on Pr

29 T.E. 1 T.E. 2 Do na tio n Colle ction T.E. Do na tio n Te sti ng Colle ction Do na tio n Pr es erv e Te sti ng Colle ction Pr oc es s St or e Tr an sp ort Pr es erv e Te sti ng Human applicati on Pr oc es s St or e Tr an sp ort Pr es erv e Human applicati on Pr oc es s St or e Tr an sp ort Human applicati on T.E. 1 T.E. 2 Do na tio n Colle ction Do na tio n T.E. Te sti ng Colle ction Do na tio n Pr es erv e Te sti ng Colle ction Pr oc es s St or e Tr an sp ort Pr es erv e Te sti ng Human applicati on Pr oc es s St or e Tr an sp ort Pr es erv e Human applicati on Pr oc es s St or e Tr an sp ort Human applicati on T.E. 1 T.E. 2 Do na tio n Colle ction Do na tio n T.E. Te sti ng Colle ction Do na tio n Pr es erv e Te sti ng Colle ction Pr oc es s St or e Tr an sp ort Pr es erv e Te sti ng Human applicati on Pr oc es s St or e Tr an sp ort Pr es erv e Human applicati on Pr oc es s St or e Tr an sp ort Human applicati on 3. Blood / T&Cs / 3.2 T&Cs Legislation Obligations on the Commission M.S.1 M.S.2 M.S.27 Harmonised technical requirements (with Consultative Committee) Donation, procurement and testing (CD 2006/17/EC) Autorisation of TE s and processes (CD 2006/83/EC) Notification of SAR/E (CD 2006/83/EC) Guidelines for inspections Communication of SAR/E between CA s and EC Traceability: EU coding system Monitor and where needed enforce national implementation 29

30 Biovigilance - RATC Launched on 1 February 2013 Web based informatics tool developed in-house Used only for alerts related to human tissues or cells circulated between Member States To be used in parallel with existing national vigilance systems Alerts issued for Q&S defects and / or IFA 30

31 Biovigilance - RATC 31

32 1. Introduction: SoHO & the Legal Basis 2. The Legislative Framework 3. Blood / Tissue & Cells / 4. The SoHO Sector and Enlargement 32

33 Deceased-donors Heart Heart transplantation is performed on patients with endstage heart failure or severe coronary artery disease. Lung Extends life expectancy and enhances the quality of life for end-stage pulmonary patients. Pancreas A pancreas transplant involves implanting a healthy pancreas 33 (one that can produce insulin) into a person who has diabetes.

34 Deceased & living donors Kidney Are the most frequently transplanted organs. Extends life expectancy and enhances the quality of life of a patient with endstage renal disease. Liver Liver transplantation is the replacement of a diseased liver in case of end-stage liver disease and acute liver failure. 34

35 ORGAN TRANSPLANTS IN THE EU Source: Council of Europe / ONT 2014 Newsletter 35

36 DECEASED ORGAN DONORS Source: 2014 Transplant Newsletter (Council of Europe / ONT) 36

37 3.2 Legislation Mother Directive 2010/53/EC - Sets standards for quality and safety of human organs intended for transplantation I. Scope, objectives and definitions II. Quality and safety of organs National Quality Programmes Organ procurement, procurement organisations, transplantation centres Transport of organs Organ and donor characterisation Traceability Reporting of serious adverse events and reactions III. Donor and recipient protection and donor selection and evaluation Unpaid and Voluntary Donation Quality and safety aspects of living donation Data protection IV. National oversight authority or authorities V. Organ Exchange with third countries VI. General provisions 37

38 3.2 Legislation EU Action Plan 3 2 Increasing organ availability Make transplantation systems more efficient and accessible 1 Improve quality and safety EU LEGAL FRAMEWORK 10 PRIORITY ACTIONS ( ) 38

39 EU ACTION PLAN OBJECTIVES Increase Organ Availability Enhance Efficiency and Accessibility of Transplantation Systems Quality and Safety 10 PRIORITY ACTIONS 1 transplant coordinators 2 quality improvement programmes 3 living donation programmes 4 communication skills of professionals 5 information on citizens rights 6 7 EU-wide agreements 8 interchange of organs 6 enhance organisational models 9 evaluation of post-transplant results 10 common accreditation system Working Groups Tx coordinators Living donation Projects Training Tx coordinators Intensive Care Awareness Follow-up registers Interchange of organs Twinning Involves National Authorities, as well as health professionals 39

40 1. Introduction: SoHO & the Legal Basis 2. The Legislative Framework 3. Blood / Tissue & Cells / 4. The SoHO Sector and Enlargement 40

41 4. Commission Support Further use of funding mechanisms such as TAIEX for; Workshops Expert missions Study visits The aim of TAIEX (Technical Assistance and Information Exchange) is to fund short-term peer-to-peer technical assistance, advice and training. Use of IPA projects in Candidate Countries Non-financial support knowledge-sharing etc Participation of Candidate Countries in SoHO CA Expert Group meetings 41

42 Thank you Questions? 42

European actions in the field of transplantation & blood transfusion

European actions in the field of transplantation & blood transfusion Andrzej Rys Director Directorate Health Systems and Products Madrid, 27 June 2013 1 Blood Tissues and cells Organs 2 Blood transfusion