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Human Tissue Authority Implementation of the European Organ Donation Directive

Human Tissue Authority Implementation of the European Organ Donation Directive. 19 May 2011 Imogen Swann. Aims of this presentation:. To explain: the background to the Directive scope of directive implementation process consultation timelines.

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Human Tissue Authority Implementation of the European Organ Donation Directive

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  1. Human Tissue Authority Implementation of the European Organ Donation Directive 19 May 2011 Imogen Swann

  2. Aims of this presentation: • To explain: • the background to the Directive • scope of directive • implementation process • consultation • timelines

  3. Background to the Organ Donation Directive

  4. Treaty of Rome - the legal base to act Article 152 of the Treaty provides the European Community with ...an obligation, to implement binding measures laying down high standards of quality and safety for the use of blood, organs, and substances of human origin. • blood – 2005 • tissues and cells – 2007 • organs – 2012

  5. EU policy options • Option 1, the European Commission will continue with its current activities in the field of organ donation and transplantation, which involves primarily sponsoring research and pilot programmes in this field, and participating in international cooperation such as in the Council of Europe • Option 2 proposes a non-regulatory approach to the field of organ donation and transplantation. This option will establish a European Action Plan on Organ Donation and Transplantation for the period from 2009 to 2015. •  Option 3 combines the Action Plan described under Option 2 with a "flexible" directive, supporting key elements of the Action Plan in the area of quality and safety. • Option 4 combines the Action Plan described under Option 2 with a "stringent" directive. This stringent directive will be modelled on the Tissue and Cells Directive and will therefore contain detailed regulation about the quality and safety systems Member States have to put in place.

  6. IA benefits of option 3 • Increase in donations – est > 21, 000 more per annum • Economic benefits – saving across MSs 1.2 billion euro • Increased public trust and confidence • Standardised approach to quality and safety across Europe

  7. Policy options - outcome • DIRECTIVE 2010/45/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety of human organs intended for transplantation • Action Plan - lays down ten priority actions grouped under three challenges: • increasing organ availability; • enhancing the efficiency and accessibility of transplantation systems; • improving quality and safety.

  8. Where we are today... • March 2011 Human Tissue Authority appointed Competent Authority • DH drafting Regulations to transpose the Directive • HTA & NHSBT contributing to the policy decisions to inform the drafting • HTA drafting Directions to supplement the Regulations

  9. Timelines • Regulations & directions – public consultation – August – September • DH & HTA to consider responses and make amendments • Regulations laid before Parliament – January 2012 • Some Regs to come into force April 2012 to allow licence applications • Full implementation 2012

  10. Stakeholder key dates • Consultation – August – October • HTA Training workshops January & March 2012 • Licence applications – April 2012 • Regulations come into force 27 August 2012

  11. Directions will provide detail on requirements for establishing a framework for quality and safety • mandatory serious adverse events and reactions • transport • characterisation • traceability

  12. Information • FAQs http://www.hta.gov.uk/_db/_documents/FAQ_Final_draft_200411_doc.doc • Enquiries enquiries@hta.gov.uk

  13. www.hta.gov.uk http://twitter.com/HTA_UK http://www.Facebook.com/HumanTissueAuthority

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