AN OVERVIEW OF THE EUROPEAN TISSUES AND CELLS DIRECTIVES - A EUROPEAN COMMISSION PERSPECTIVE

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AN OVERVIEW OF THE EUROPEAN TISSUES AND CELLS
DIRECTIVES - A EUROPEAN COMMISSION PERSPECTIVE
REGULATING TISSUES AND CELLS FOR HUMAN
APPLICATION THE PAST, THE PRESENT, THE
FUTURE Human Tissue Authority. London 25 March

• Eduardo Fernandez Zincke
• European Commission
• Health and Consumer Protection Directorate
  General
• Public Health and Risk Assessment Directorate
• Health Measures Unit C6

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Article 152 (4) (a)

• 4 ...Shall contribute to the achievement of the
  objectives referred to in this Articles through
  adopting
• Measures setting high standards of quality and
  safety of organs and substances of human origin,
  blood and blood derivatives, these measures not
  prevent any member States from maintaining or
  introducing more stringent protective measures

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Conference on Safety and Quality in Organ
Donation and Transplantation in the European
Union
MEETING ON THE THERAPEUTIC USE OF HUMAN ORGAN AND
TISSUES
Treaty of Nice
Porto Conclusions (2000)
Statement by the commission (2004)
Article 152 (2000)
Tissues and cells Directive (2004)
Blood Directive (2002)
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The Tissues and Cells Legal Framework
Transposition deadline 7 April 2006
Transposition deadline 1 November 2006
Transposition deadline 1 September 2007
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TRANSPOSITION TO DATE (February 2008)
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TISSUES AND CELLS DIRECTIVE

• Supervision of human tissues and cells
  procurement
• Accreditation, designation, authorisation, or
  licensing of tissue establishments and tissues
  and cells preparation processes
• Quality systems
• Inspection and control measures
• Traceability/Coding system
• Import/export of human tissues and cells
• Register of Tissue establishment and reporting
  obligations
• Notification of Serious adverse events and
  reactions

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COMMITTEES/GROUPS

• Regulatory Committee Technical requirements and
  their adaptation to Scientific and technical
  progress Processing
• Regular meetings with Competent Authorities
• National Experts technical meetings

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TISSUE ESTABLISHMENTS Number

• 21 Member States have data/estimations available
• 2360 tissue establishments
• Reproductive medicine establishments not
  reflected in most of the questionnaires

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TISSUE ESTABLISHMENTS TYPES
Skin Haematopoietic stem cells Keratinocytes
Cord blood Beta-pancreatic
cells Muskulo-skeletal Hepatocytes Tendons
Pancreatic cells Femoral heads CMN Fascia
lata Cellules dendritiques Volets
craniens Other stem cells Collagen
membrane Cell cultures Spongiosa Cells
banks Ossicular bone Amniotic membrane Cardiova
scular Limbal stem cells Vascular tissue
vessels Ophthalmic tissue cornea Heart
valves Reproductive cells/tissues Multi tissue
banks IVF Human Duramater Sperm
insemination Parathyroid
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TISSUE ESTABLISHMENTS TYPES
Skin Haematopoietic stem cells Keratinocytes
Cord blood Beta-pancreatic
cells Muskulo-skeletal Hepatocytes Tendons
Pancreatic cells Femoral heads CMN Fascia
Lata Cellules dendritiques Volets
craniens Other stem cells Collagen
membrane Cell cultures Spongiosa


Ossicular bone
Cells banks Amniotic
membrane Cardiovascular Limbal
stem cells Vascular tissue vessels

Heart
valves Ophthalmic tissue Cornea

Others Reproductive cells/tissues Multi
tissue banks IVF Human Duramater Sperm
insemination Parathyroid
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Accreditation of Establishments
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Accreditation and inspection
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TESTING REQUIREMENTS HIV (n25)

• MORE STRINGENT REQUIREMENTS 6 Member States
• HIV ag NAT HIV ag/NAT NAT HIV Ag NAT
  
• EC REQUIREMENTS 17 Member States 2 EFTA
  countries
• LOWER REQUIREMENTS

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TESTING REQUIREMENTS HBV (n25)

• MORE STRINGENT REQUIREMENTS 3 Member States
• NAT NAT NAT
• EC REQUIREMENTS 18 Member States 2 EFTA
  countries
• LOWER REQUIREMENTS 2 Member States
• HBsAg only

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TESTING REQUIREMENTS HCV (n25)

• MORE STRINGENT REQUIREMENTS 3 Member States
• NAT NAT NAT
• EC REQUIREMENTS 20 Member States 2 EFTA
  countries
• LOWER REQUIREMENTS 0 Member State