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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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slide1

Democracy

in Action

The HFE Act

and Parliament

slide2

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
slide3
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
slide4

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
slide5
August 2005: Government launches consultation on the 1990 HFE Act (closing date November 2005)

Democracy

in Action

slide6

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
slide7
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
slide8

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
slide9

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
slide10
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
slide11

Key Individuals

Baroness Deech

Ian Gibson

Lord Mackay

of Clashfern

Sir Robert Winston

slide12

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?
slide13

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
slide14
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).

slide15
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”
slide16

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
slide17

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
slide18

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?
slide19

Democracy

in Action

The HFE Act

and Parliament

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