The Generative Brain

Commission Directive 2006/17/EC on technical requirements for donation, procurement and testing of human tissues and cells (donor exclusion criteria including prion disease)

Commission Directive 2006/17/EC of 8 February 2006 is the EU implementing act that sets who may donate human tissues and cells and which tests donors must have. It was adopted under Article 28 of the parent Tissues and Cells Directive 2004/23/EC and had to be transposed by 1 November 2006. For prion disease the key text is Annex I, point 1.1.4, which excludes donors at risk of passing on a prion disease: people diagnosed with CJD or variant CJD or with a family history of non-iatrogenic CJD, people with rapidly progressive dementia or degenerative neurological disease, recipients of human pituitary hormones such as growth hormone, recipients of cornea, sclera or dura mater grafts, and people who had undocumented neurosurgery, with room for further variant CJD precautions. This list is wider than the blood donor list in Directive 2004/33/EC, and it reflects the known iatrogenic routes of CJD through grafts and pituitary hormones. No laboratory test for prions is required; the exclusion rests on history and interview. The directive was amended once, by Directive 2012/39/EU on HTLV-I and reproductive cell testing, which left the prion criteria unchanged. Regulation (EU) 2024/1938 on substances of human origin repeals the parent Directive 2004/23/EC from 7 August 2027, and ECDC and EDQM guidelines will carry much of the technical detail; whether and where the prion exclusion carries over is not stated in the regulation text. Information only, not legal or medical advice.

Key facts

  • The directive was adopted by the Commission on 8 February 2006 under Article 152(4)(a) EC and points (b), (d), (e), (f) and (i) of Article 28 of Directive 2004/23/EC; Member States had to transpose it by 1 November 2006 and it entered into force on the twentieth day after publication.
  • It has nine articles and four annexes: Annex I donor selection for tissues and cells other than reproductive cells, Annex II laboratory tests, Annex III reproductive cells, Annex IV donation and procurement procedures.
  • It was published in OJ L 38 of 9 February 2006, pages 40 to 52, per EUR-Lex search excerpts; EUR-Lex itself could not be read.
  • Article 3 requires donors of tissues and cells other than reproductive cells to meet the Annex I selection criteria, and donors of reproductive cells to meet Annex III.
  • Annex I point 1.1.4 excludes donors at risk of transmitting prion disease, for example people diagnosed with CJD or variant CJD, people with a family history of non-iatrogenic CJD, people with a history of rapidly progressive dementia or degenerative neurological disease including those of unknown origin, recipients of human pituitary-derived hormones such as growth hormones, recipients of cornea, sclera or dura mater grafts, and people who had undocumented neurosurgery in which dura mater may have been used.
  • The same point adds that for variant CJD further precautionary measures may be recommended, the same open clause as in the blood donor directive.
  • The Annex I exclusions apply unless a documented risk assessment approved by the responsible person justifies otherwise.
  • Living allogeneic donors are subject to the same exclusion criteria as deceased donors, except the cause of death criterion, and are screened by questionnaire and interview with a trained health professional.
  • Annex II requires HIV 1 and 2, hepatitis B, hepatitis C and syphilis testing, HTLV-I testing for donors linked to high-prevalence areas, and optional further tests; no prion or CJD test is required.
  • Annex III on reproductive cell donors contains no prion, CJD or neurological exclusion, and refers to Annex I only for autologous donors.
  • The blood donor counterpart, Directive 2004/33/EC, permanently defers only people with a family risk of TSE, corneal or dura mater graft recipients and people treated with pituitary-derived medicines; the tissue list adds a CJD or variant CJD diagnosis, rapidly progressive dementia, scleral grafts and undocumented neurosurgery.
  • ECDC's table of current EU donor requirements cites Directive 2006/17/EC as the source of the prion row for tissue and cell donors, and says the current requirements apply until an ECDC guideline replaces them.
  • Directive 2012/39/EU of 26 November 2012 amended Annexes II and III, switching HTLV-I testing from high-incidence to high-prevalence areas on ECDC evidence and easing repeat sampling for partner reproductive cell donation; transposition was due by 17 June 2014 and the prion criteria were not touched.
  • The directive is one of several implementing acts of Directive 2004/23/EC, alongside 2006/86/EC (traceability, adverse events, processing), 2015/565 and 2015/566, and Member States may apply stricter rules than this EU baseline.
  • The EMA CHMP/CAT position statement of June 2011 on CJD and advanced therapy medicinal products states that the prion-related donor exclusion criteria of Directive 2006/17 apply to tissues and cells used in such products, that the TSE criteria of Directive 2004/33/EC apply where blood cells are used, and that national authorities may add criteria.
  • Regulation (EU) 2024/1938 entered into force on 6 August 2024 and applies from 7 August 2027; its Article 85 repeals Directives 2002/98/EC and 2004/23/EC with effect from 7 August 2027 and does not name Directive 2006/17/EC.
  • ESHRE reads the regulation as ending the implementing acts of Directive 2004/23/EC, naming 2006/17/EC, from August 2027 (search excerpt only).
  • Under the regulation, following ECDC guidelines on communicable disease risk or EDQM technical guidelines counts as meeting its standards; the regulation text does not mention prions, CJD or TSE.

Timeline

  1. 2004Directive 2004/23/EC on tissues and cells adopted, the parent act.
  2. 2006Commission adopts Directive 2006/17/EC.
  3. 2006Published in OJ L 38 (search excerpt).
  4. 2006Transposition deadline for Member States.
  5. 2011EMA CHMP/CAT position statement on CJD and advanced therapy medicinal products adopted.
  6. 2012Directive 2012/39/EU amends Annexes II and III on testing.
  7. 2014Transposition deadline for Directive 2012/39/EU.
  8. 2024Regulation (EU) 2024/1938 on substances of human origin signed.
  9. 2024SoHO regulation enters into force.
  10. 2027SoHO regulation applies and repeals Directive 2004/23/EC, the parent act of this directive.
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