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PHS Guideline 1996-2001

OECD Group for biotechnology 1999. WHO Reports on Xt 1998-2000. Canada public consultation 2000-2001 (based on CoE science). CoE State-of-the-art reports 2000-2003. UKXIRA Xt adInterim Regulatory Authority. PHS Guideline 1996-2001. SACX Secretary Advisory Committee On Xt.

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PHS Guideline 1996-2001

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  1. OECD Group for biotechnology 1999 WHO Reports on Xt 1998-2000 Canada public consultation 2000-2001 (based on CoE science) CoE State-of-the-art reports 2000-2003 UKXIRA Xt adInterim Regulatory Authority PHS Guideline 1996-2001 SACX Secretary Advisory Committee On Xt Australia public consultation (2002-2004)

  2. Why Xt was unique? • Tensions between individual and public health (return of infectious diseases) • Individual informed consent is not enough to legitimize the medical technology. Need for “public consent”? • Paradox of informed consent: information and consent to unknown risks US – individual consent, Sponsor and patient responsibility EC/CoE - (State) precautionary principle CA/AU – public consultation

  3. The precautionary principle and the prevention of xenogenetic infections • The Nuffield Council (UK) - Report 1996: first application of the precautionary principle (PP) from the environment (Rio Declaration1992) to health • Council of Europe - Recommendation 1399/99: call for a moratorium on all clinical trials as an application of PP • European Commission - Communication from the Commission on the precautionary principle (February 2000): “PP as general principle for human, animal, plant and environmental health” Precaution should imply a prudent approach to technology…

  4. Regulatory models for xeno

  5. European regulatory approach • EC 2001 • Opinion of the DG Health • Directive 18/2001 • Directive 20/2001 • Directive 44/1998 • CoE 2000-2003 • Rec 1399/1999 • Two State-of-the-art reports - Rec 10(2003) • ECHR’s opinion

  6. The risks of xenotransplantation are considered potentially so significant that informed consent should usually be obtained from close contacts such as relatives and family. Ideally, the informed consent of close relatives and family should be obtained even if this might set aside other moral principles like autonomy, privacy and confidentiality. These principles are never absolute obstacles and communities are entitled to limit them where there is serious harm to the individual concerned or to other people. CDBI/CDSP-XENO (2000-2003) Report on the state of the art in the field of xenotransplantation Limiting human rights for public health reasons

  7. Waiving human rights Opinion on the State-of-the-art concerning xenotransplantation, Health Consumer Protection, Directorare General, European Commission, 1st October 2001 Some of the measures that may need to be taken in a surveillance system may have legal implications as they could be in violation of the Declaration of Helsinki. In the recent EC directive for conduct of clinical trials, the right of a subject to withdraw from a clinical trial is explicitly stated (EC 2001), and this could be a problem for prolonged surveillance in xenotranplantation clinical trials. As xenotransplantation has implications for public health, it may be that certain rights may have to be modified in such a way that surveillance can be continued. Patients (and others?) could therefore have to agree to waive some of their human rights.

  8. Council of Europe, Committee of Ministers, Recommendation Rec(2003)10 of the Committee of Ministers to member states on xenotransplantation Article 21 – Compulsory constraints – If, after the xenotransplantation has been carried out, the recipient or his or her close personal contacts refuse to comply with the constraints associated with xenotransplantation, public authorities should intervene and take appropriate measures, where public health protection so requires, in conformity with principles of necessity and proportionality.

  9. ECHR on Xt, 2003 “(T)he Convention (Human Rights) in Article 5(1)(d) permitted the lawful detention of persons to limit the spreading of infectious diseases. With regard to Article 8 of the Convention, which protects the right to respect for, inter alia, private and family life, ……in certain circumstances it might be considered that an individual, by giving consent to a particular interference, had waived his or her rights”

  10. EC and MS Tacit moratorium • Directive 2001/20/EC, Article 6, Ethics Committee – “In the case of xenogenic cell therapy, there shall be no time limit to the authorisation period” • Directive 2001/18/EC, Article 9, Consultation of and information to the public – “Member States shall consult the public…Member States shall lay down arrangements for this consultation, including a reasonable time-period, in order to give the public or groups the opportunity to express an opinion Public consultation (Aarhus Convention 1998)

  11. Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells This Directive should apply to tissues and cells including… reproductive cells (eggs, sperm), foetal tissues and cells and adult and embryonic stem cells. Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products ‘Advanced therapy medicinal product’ means any of the following medicinal products for human use: a gene therapy medicinal product, a somatic cell therapy medicinal product, a tissue engineered product ,as defined in Part IV of Annex I to Directive 2001/83/EC. A tissue engineered product may contain cells or tissues of human or animal origin, or both. The polity and the market: from citizens’ natural tissues to marketable tissue products EU as polity EU as single market Necessity to regulate cells and tissues: EGE 1998: “Moral obligation to regulate tissues” Controversies between France and Germany on “biologics” or “pharmaceutical”

  12. Directive 2004/23 The European philosophy of the ethical/safe citizen/donor: “We are all potential donor” (3) Philosophy of voluntary and unpaid donation, altruism and solidarity between donor and recipient.(18) Voluntary and unpaid tissue and cell donations are a factor of safety (19) Anonymity of both donor and recipient, and anonymisation (Art.14) Traceability donor and recipient - This Directive should not interfere with provisions of Member States defining the legal term ‘person’ or ‘individual’. Regulation 1394/2007 EMA centralised authorisation procedure in the market for all ATMP Comitology procedures for future amendments and guidelines (made by the Commission and controlled by Parliament). CAT - Creation of an interdisciplinary committee of experts (Committee for Advanced Therapies) within the European Medicines Agency (EMEA) Online public consultations + civil society representatives in CAT

  13. From citizens/donors to citizens/consumers and products Unpaid, anonymity solidarity European citizens/donors Natural tissues Dir 23/2004 Donation and storage Ontological change Reg 1394/2007Definition of ATMP and authorisation Bioartificial products Marketable products EU Market

  14. The EU integrated vision • Single regulatory framework  Reg 1394/2007 all ATMPs • Single Committee (CAT)  representing all expertise: science, policy, society • Unified donors and traceability  Detailed guidelines on good clinical practice specific to advanced therapy medicinal products (2009) • Unified risks  Guideline on xenogeneic cell-based medicinal products (2010); Guideline on cell-based medicinal products (EMEA/CHMP/410869/2006); Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products • Unified clinical trials  Detailed guidelines on good clinical practice specific to advanced therapy medicinal products (2009)

  15. Single regulatory framework for ATMPs

  16. Single expert committee  CAT – EMA • Multidisciplinary, best expertise in: • Scientific areas gene therapy, cell therapy, tissue engineering, medical devices, pharmacovigilance, risk management, and ethics. • Experience representatives of patient associations and clinicians Composition: 5+5 members from EMA (Science) 20+20 members from MS (Policy) 2+2 physicians from expression of interest (Expert public) 2+2 representatives of patients’ associations from expression of interest (Lay public)

  17. Unified donors and traceability

  18. Unified risks

  19. Unified clinical trials

  20. Some reflections • Reframing regulatory strategies (complex harmonization governance?): - Precaution used both to grant safety and to foster innovation  to risk normalization - From epistemic subsidiarity  to epistemic harmonization - From ethics subsidiarity  to EU ethics through the CAT - From legislation  to comitology procedures

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