European actions in the field of transplantation & blood transfusion

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1 European actions in the field of transplantation & blood transfusion Andrzej Rys Director Directorate Health Systems and Products Madrid, 27 June

2 Blood Tissues and cells Organs 2

3 Blood transfusion Transplantation: organs, tissues & cells EU action in health Implementation of EU's public health strategy 3

4 Blood transfusion Blood transfusions can very often be life-saving: Replacing massive blood loss due to trauma, Replacing the blood lost during surgery, Compensating acute symptoms of certain illnesses or the side effects of some therapies (e.g. infusion of platelets in leukemia or after chemotherapy), Treating various inherited chronic blood diseases (e.g. severe anaemia, thalassaemia, hemophilia, etc.) Blood (plasma) is used for manufacturing medicinal products: immunoglobulins, clotting factors, etc. 4

5 Blood transfusion in EU 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 and Croatia, Liechtenstein and Norway 5

6 Blood transfusion in EU 6

7 Organ transplantation 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 7 (one that can produce insulin) into a person who has diabetes.

8 Organ transplantation 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. 8

9 Organ transplantation in EU LD = living organ donors DBD = organ donation after brain death DCD = organ donation after cardiac death 9

10 DECEASED ORGAN DONORS 2011 data Organ transplantation in EU Source: Council of Europe / ONT 2012 Newsletter 10

11 LIVING DONOR KIDNEY TRANSPLANTS Organ transplantation in EU Overall, a diverse EU landscape with Potential for more organs from deceased donors from living donors Potential to learn from each other Source: Council of Europe / ONT 2012 Newsletter 11

12 Tissues and cells 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. 12

13 Tissues and cells 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. 13

14 Tissues and cells in EU 3700 tissue establishments (TE) TE for Reproductive ART cells 35% 35% 28% TE (bone, TISSUE cornea, valves, 28% vessels, etc Cornea, bones, skin, cardio-vascular tissues: tissues donated transplantations recipients of a tissue transplant HSC: donations potential donors 37% TE HPC for 37% Haematopoietic stem cells units cord blood stored 2011 data 14

15 Tissues and cells in EU Reproductive cells Partner donation couples treated babies born Non-partner donation SPERM donations 4300 babies born EGGS donations 5200 babies born TE for Reproductive ART cells 35% 35% 28% 37% TE (bone, TISSUE cornea, valves, 28% vessels, etc TE HPC for 37% Haematopoietic stem cells 2010 data 15

16 Tissues and cells in EU 16

17 Tissues and cells in EU 17

18 Tissues and cells in EU 18

19 EU action in health Legal base - The Treaty of Lisbon Article 168 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 EU action shall complement national policies, foster cooperation between Member States (MS) and third countries. Exceptions to the subsidiarity principle: some common safety concerns, including substances of human origin (SoHO): blood, tissues & cells, organs 19

20 EU action in health The European Union's public health strategy is implemented through: 1) Legislation 2) Financial instruments 3) EU-wide cooperation 20

21 EU legal framework EU legislation on SoHO 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 21

22 EU legal 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 22

23 EU legislation on SoHO Implementing Directives EU legal framework 2004, COMMISSION DIRECTIVE 2005/61/EC traceability requirements and notification of Serious Adverse Reactions and Events (SARE) COMMISSION DIRECTIVE 2006/86/EC traceability requirements, notification of Serious Adverse Reactions and Events & certain technical requirements [ ] Implementing Directive 2012/25/EU information procedures for the exchange, between MS, of human organs (transposition deadline April 2014) 23

24 EU support tools ORGANS Increasing organ availability Make transplantation systems more efficient and accessible Improve quality and safety EU LEGAL FRAMEWORK Action plan on Organ Donation and Transplantation ( ): Strengthened Cooperation between Member States 24

25 OBJECTIVES 10 PRIORITY ACTIONS Increase Organ Availability Enhance Efficiency and Accessibility of Transplantation Systems 1 transplant coordinators 2 quality improvement programmes 3 living donation programmes 4 communication skills of professionals 5 information on citizens rights 6 enhance organisational models 7 EU-wide agreements 8 interchange of organs EU support tools ORGANS 3 Working groups: WG on deceased donation produced on manual for Competent Authorities with national examples on how to set-up transplant donor coordination systems Quality and Safety 9 evaluation of post-transplant results 10 common accreditation system WG on indicators WG on living donation 25

26 Financial instruments The health programme can "Transplantation & Blood transfusion" Madrid, June 2013 contribute funding to projects on health promotion, health security and health information. The main instrument the European Commission uses to implement the EU Health Strategy. The research programme (FP7) can support projects in areas such as biotechnology and medical technologies. EU cohesion policy can support investments in health in EU countries and regions. 26

27 EU-wide cooperation Strategic health issues are discussed by representatives from the national authorities and the European Commission in the Council's senior-level working party on public health. The EU health policy forum brings together stakeholder organisations active in the field of public health and healthcare. The European Commission also leads committees and expert groups (e.g. Haemovigilance WG, Rapid alerts WG, WG on living donation, WG on deceased donation, etc.)

28 Thank you! policy/index_en.htm 28

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