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in Action

Democracy. in Action. The HFE Act and Parliament. Democracy. in Action. An interface of regulation, politics, ethics and science. US physician Richard Cabot - ethics and science “ need to shake hands ”.

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in Action

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  1. Democracy in Action The HFE Act and Parliament

  2. Democracy in Action • An interface of regulation, politics, ethics and science • US physician Richard Cabot - ethics and science “need to shake hands” • Latest developments (Edinburgh, Toronto) - importance of effective framework to foster responsible innovation in an ethically and scientifically complex area • Barak Obama – Federal funding – Embryonic Stem-cells • Baroness Warnock - “The law must not outrage the feelings of too many people; but it cannot reflect the feelings of them all. It must therefore be drawn with a view to the common good.” -1990

  3. March 2004: House of Commons Science and Technology Committee - inquiry into Human Reproductive Technologies and the Law Democracy in Action • March 2005: Committee publishes report; Ian Gibson MP Chairman

  4. Democracy in Action • Report covers regulation of assisted reproduction, problems with 1990 HFE Act, operation of the HFEA, provision of infertility services and legislative and regulatory models • Committee calls for new legislation to define nature of inter-species embryos and make their creation legal for research purposes subject to 14-day rule and prohibition on implantation in a woman - called for greater liberalisation with artificial gametes, sex selection for family balancing • Series of divisions on the draft report in Committee; Special Report is produced setting out concerns of Committee members about the process of agreement • Government responds August 2005

  5. August 2005: Government launches consultation on the 1990 HFE Act (closing date November 2005) Democracy in Action

  6. Democracy in Action • Committee follow-up session and Estimates Day debate in the House of Commons in July 2006 • White Paper published in December 2006 – includes proposal to ban hybrid embryo research subject to later parliamentary legislation

  7. January 2007: Science and Technology Committee launches Inquiry on Government proposals for the regulation of hybrid and chimera embryos Democracy in Action • April 2007: Committee publishes Report

  8. Democracy in Action • Government’s White Paper proposals “unnecessarily prohibitive” and calls for legislation to allow research using some forms of human-animal chimera or hybrid embryos through licensing • Unanimous report • Government responds June 2007

  9. Shining a light on a difficult area Science Community • Stephen Minger – Kings London • Lyle Armstrong – Newcastle University Science Journalists • Pallab Gosh – BBC • Mark Henderson – The Times • Alok Jha - Guardian • Nic Flemming - Telegraph

  10. May 2007: Draft Human Tissue and Embryos Bill published and Joint Committee appointed Democracy in Action • August 2007: Joint Committee publishes report • Opposes creation of RATE, recommends free vote on hybrid embryo research • October 2007: Government responds – agrees not to create RATE and makes proposals on regulation of inter-species embryos

  11. Key Individuals Baroness Deech Ian Gibson Lord Mackay of Clashfern Sir Robert Winston

  12. Content of the Draft Bill • Establishment of Regulatory Authority for Tissue and Embryos (RATE)? • Balance between the role of Parliament and the Regulator? • Legal definitions for ‘Embryo’ and ‘Gamete’ (including artificial gametes)? • Licence conditions for storage, use and donation of gametes and embryos? • Fresh Gametes and Internet supply? • Consent for use of stored embryos or gametes? • Screening and selection of gametes and embryos?

  13. PGD and Sex Selection for family balancing? • Access to information for donors or children? • Payment for donors or surrogacy? • Creation of cytoplasmic hybrid embryos for research • Use of embryos for Research? – stemlines? • Welfare of the child – need for a father ? • Terminations/Tissue Retention/Organ Donation

  14. The Committee made a series of recommendations on the draft Bill Democracy in Action • Including the development of “a clear framework based on the principle of devolved regulation” (para 56) • It found the evidence against establishing a Regulatory Authority for Tissue and Embryos (RATE) “overwhelming and convincing” (para 92) • It proposed its own working definition of inter-species embryo (para 176): An inter-species embryo is an embryo which— (a)contains genetic material of human and animal origin, and (b) in which the genetic material of human origin consists of at least a complete haploid set of human chromosomes in one or more cells.” In this definition genetic material means DNA in a form capable of being expressed, mutated and replicated heritably (i.e. genes).” The Committee recommended a free vote on the creation and use of inter-species embryos for research purposes (para 177).

  15. June 2007: Science and Technology Committee announces inquiry into Scientific Developments Relating to the Abortion Act 1967 Democracy in Action • October 2007: Committee publishes Report • Covers upper gestational limit, access and procedure, foetal abnormality and women’s health • Rules out a consideration of “ethical and moral issues”

  16. Democracy in Action • HFE Bill introduced into the House of Lords 8 November 2007 • Government made a few concessions to science community consent in respect of: • The use of existing cell lines where informed consent not possible for the creation of embryos • The use of sick children’s cells to create embryos for medical research with parental consent • Liberalisation of the use of HFEA held data prospectively and regulations promised on use of existing data • Large majorities in support of IVF and embryo research

  17. Democracy in Action • Into Commons 5 February 2008 • Report stage and Third Reading 22 October 2008 • Amendments relating to abortion selected as being within the scope of the bill but not reached for debate under terms of Government programme motion • Royal Assent 13 November 2008 • Minority report on evidence selection and de-selection: rejected by 6 votes to 1

  18. Democracy in Action • Where next? • Majority of the Act to be brought into force on 1 October 2009. Provisions relating to legal parenthood will be introduced on 6 April 2009 • Funding • Department of Health consultation on regulations closes at the end of March 2009 • A Parliamentary Standing Committee on Bioethics?

  19. Democracy in Action The HFE Act and Parliament

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