HEAL UoS

Posts Tagged ‘HFEA’

HEAL member publication: ETHICS, EMBRYOS, AND EVIDENCE: A LOOK BACK AT WARNOCK

In 2015, Bioethics, Gratuitous self-promotion, Publications, Reproduction on August 10, 2015 at 9:14 am

We’re delighted to flag up that Dr Natasha Hammond-Browning’s article on ‘ETHICS, EMBRYOS, AND EVIDENCE: A LOOK BACK AT WARNOCK’ has been accepted for publication in Medical Law Review, and was published online on August 1st, 2015. The article can be accessed here (subscription required).

Abstract
The Report of the Committee of Inquiry into Human Fertilisation and Embryology, the Warnock Report, forms the basis of the UK legislation on embryo research, and its influence continues to be felt, even though over 30 years have passed since its publication. The Warnock Committee was the first of its kind to consider how advancements in human fertilisation and embryology should be regulated. This article examines the evidence submitted to the Warnock Committee, upon which its members ultimately reached their conclusions. With ongoing debate as to the status of the human embryo, it is important to recognise that the legislative position is one that was reached after extensive consultation and consideration of submitted evidence by the Warnock Committee. This article considers the differing ethical viewpoints that were expressed by organisations both prior and post-publication of the Warnock Report, and how the Committee used that evidence to reach their conclusions, and ultimately calls for a new Warnock-style committee.

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World first – UK Govt to back mitochondrial donation/replacement

In 2013, Genetics, Reproduction on June 28, 2013 at 7:50 am

The news this morning is again covering the mitochondrial donation/replacement debates, after Professor Dame Sally Davies, the Chief Medical Officer, announced yesterday that draft regulations will be published later in 2013 for public consultation, with the intention that the final version of the proposed regulations will be debated in Parliament in 2014.

These developments have been the subject of a number of consultations in the UK in recent years. The Government announcement focuses – understandably – on the HFEA’s consultations in 2011, on the safety and efficacy of the procedures, and in 2012, the public dialogue on the support or concerns held regarding the use of such procedures for ‘treatment cycles’ in humans (as opposed to research only, where the resulting embryos cannot be developed beyond 14 days due to restrictions on embryo research). However, the Human Genetics Commission first reported its conclusions in 2010 (HGC, since closed under the Arms’ Length Bodies Review of quangos); and in June 2012 the Nuffield Council on Bioethics published its report following public consultation.

In a shameless plug, in a recently published article Jones and
Holme consider some of the issues raised by mitochondrial donation/replacement. See further Jones and Holme,’Relatively (im) material: mtDNA and genetic relatedness in law and policy’, Life Sciences, Society and Policy 2013, 9:4, open access link: http://www.lsspjournal.com/content/pdf/2195-7819-9-4.pdf (alternatively, try http://www.lsspjournal.com/content/9/1/4).

HFEA consultation on mitochondrial replacement

In 2012, Genetics, Reproduction on December 14, 2012 at 4:12 pm

The HFEA’s consultation on mitochondrial replacement was launched in September 2012, to consider the social and ethical issues arising from these techniques. The Oversight Group’s terms of reference can be found here, and the members are listed here. HEAL responded to the consultation (which closed last week). Our full response can be read here: HFEA mtDNA 2012 HEAL consultation response.

Our closing remarks cautioned that:
“Assuming either technique is to be permitted for human use it is vital that appropriate follow-up studies should be undertaken (and financial resources made available to support the research) to measure the levels of both short and long-term risks, not only to the offspring, but where relevant, to future generations, following mitochondrial replacement. Without such research there will be insufficient data for prospective patients to assess the levels of potential risk vs their desire for a child that is genetically related to them.”

We look forward to reading the outcome of the consultation in 2013. Previous blog posts on this area can be found here, here and (more tangentially) here.

DH Consultation on the futures of the HFEA and HTA

In 2012, Reproduction on July 2, 2012 at 9:00 am

The Department of Health launched today a consultation on the future of two key regulators, the Human Fertilisation and Embryology Authority and the Human Tissue Authority as part of the Coalition Government’s plan to cut the number of arm’s-length bodies and reduce bureaucracy announced in Liberating the NHS: Report of the arm’s-length bodies review (2010). The Public Bodies Act 2011 provided powers to transfer the functions of the HFEA and HTAto other bodies, but not to abolish them. Substantive change to the terms of the regulatory framework would require further legislation. The consultation runs until 28 September.

The logic of streamlining is that providers of health care are subjected to overlapping licensing/registration and inspectorate regimes that might be better co-ordinated, or possibly integrated into a single scheme of regulation under the umbrella of the Care Quality Commission (as in the preferred option). One test of this will be public confidence in the CQC, which has been criticised by the Public Accounts Committee and  seems likely to receive further adverse scrutiny in the report of the Mid Staffordshire NHS Foundation Trust Public Inquiry in the Autumn.

The research approval functions in relation to embryo research may no longer need to be separated out from the wider system of research ethics committees, supported by the Health Research Authority, as under the Human Tissue Act 2004 where the HTA licenses tissue storage but specific projects are approved by RECs. The preferred option in the consultation adopts this approach.

The consultation does not address the policy making functions of the two authorities. One important historical role of the HFEA has been to develop principled approaches to difficult ethical issues raised by assisted reproductive technologies. Work under way includes a national donation strategy, chaired by Professor Sheila Maclean, and work on public consultation on the use of techniques to prevent mitochondrial disease. It is not clear where such deliberative engagement and policy work will fit into the new regulatory landscape. Parliamentarians have expressed concern over the ‘democratic deficit’ in leaving such considerations to non-elected groups but this consultation document does not set out the thinking on the best way to resolve them in the future.

Jonathan Montgomery is Chair of the Health Research Authority but the views expressed here are personal only.

mtDNA in Manchester: Exploring mitochondrial donation

In 2012, Genetics, Reproduction on May 16, 2012 at 8:23 am

Last week I participated in a fascinating Interdisciplinary Dialogue event around ‘The genetic family in question’ at the Morgan Centre for the Study of Relationships and Personal Life at Manchester University, organised by Dr Petra Nordqvist. This was linked to her project with Prof. Carol Smart on ‘Relative Strangers’ (the subject of last week’s blog post).

Coincidentally, both Dr Rebecca Dimond (Cardiff) and I offered papers on mitochondrial donation, so we were fortunate to have an entire afternoon session dedicated to considering the policy, law, social and other potential implications raised by these developing techniques – these are currently lawful for research purposes only (ie not lawful for use in the treatment of patients), following a licensing decision by the HFEA in 2005. Rebecca talked us through some insightful aspects of her interviews with family members with mitochondrial conditions, whereas my focus lay with the law and policy issues that may arise if Regulations are introduced to make lawful the use of these techniques in treatment. This area is, of course, subject to considerable attention in 2012 with the Nuffield Council on Bioethics due to publish its Report soon, and the HFEA in conjunction with Sciencewise-ERC due to undertake public dialogue later this year.

Our abstracts are below … a further post will follow on the morning’s session soon.

Relatively (im)material? mtDNA and genetic relatedness in legal discourse – Dr Caroline Jones

Mitochondrial donation poses the latest regulatory challenge for policy-makers in the context of assisted conception. In 2012 the Nuffield Council on Bioethics and the Human Fertilisation and Embryology Authority are consulting on ethical issues raised by this technique; including the potential relationships created by the use of three parties’ genetic material and the associated ramifications (eg whether or not there is a need to establish records of such donations and, if so, to whom should information be provided?) Hence, this technique poses both novel and familiar questions about ‘the genetic family’. This paper will explore the construction of the relative (in)significance of mitochondrial DNA in recent parliamentary debates, and current policy and consultation documents, in order to reflect on the ways in which the role of genetic connections – or lack thereof – are mediated in legal discourse and policy formation.

Who is the ‘third parent’? Mitochondria donation and implications for identity and kinship – Dr Rebecca Dimond

What is the link between mitochondrial DNA and a person’s identity?  What relationship does a woman have to a child conceived using her donated mitochondria?  These are key questions that the Nuffield Council on Bioethics have asked in exploring the ethical issues surrounding emerging techniques to prevent inherited mitochondrial disorders. There is currently no cure for mitochondrial disease but experimental reproductive technologies have now been developed which can allow women with mitochondrial disease to have children free from the disease. The technique involves replacing faulty mitochondria during an IVF cycle with healthy mitochondria from a donated egg. As the donated mitochondria (which contain a small number of genes) would be inherited by future generations, this technique requires a change in the law in order for it to be offered to patients and this has prompted calls for evidence by the Nuffield Council and HFEA. By drawing on interviews with patients with mitochondrial disease and media representations of the ‘three parent embryo’, in this presentation I consider how these techniques raise fundamental questions of identity and kinship.

Bioethics is a crowded space

In 2012 on January 20, 2012 at 1:21 pm

There have been calls for a national bioethics commission in the UK for many years, including from Sir Ian Kennedy in his Reith Lectures, Unmasking Medicine in 1980. They have been resisted for just as long, mainly (e.g. as explored in Parliament in the debate on an amendment proposing such a commission in 2008) on the basis that there were already bodies working in this terrritory, including the Human Genetics Commission, the Human Fertilisation and Embryology Authority and the Nuffield Council on Bioethics.

In the light of the disbanding of the Human Genetics Commission at the end of March 2012 and the announced intention of the Government to dissolve the Human Fertilisation and Embryology Authority it will be interesting to see how organised bioethics develops. The announcement of two separate consultations on aspects of mitochondrial disease shows one of the problems of co-ordinating activity in the crowded space of the current system.

The Department of Health has identified the need for public consultation on the use of new techniques, which alter the mitochondrial DNA of an egg or embryo,  in assisted conception to prevent the transmission of serious mitochondrial disease. It has asked the Human  Fertilisation and Embryology Authority to undertake this consultation and  issued a call for evidence, to be submitted by 15 March 2012.  The core group to consider the issues, which includes HEAL member Anneke Lucassen, has been asked ‘to collate and summarise the current state of expert understanding on the safety and efficacy of methods to avoid mitochondrial disease through assisted conception.’ 

On the same day, the Nuffield Council on Bioethics also issued a call for evidence (by 24 February 2012) for its own work in the area. It has established a working group   ‘(a) to identify and examine ethical issues relevant to the clinical use of techniques of in vitro mitochondrial transfer, (b) to elaborate these issues with a view to stimulating and informing further discussion, deliberation and debate, and (c) to prepare a report on the above, to be delivered in Spring 2012.’

These concurrent enquiries into the area have different concerns and the fact that they call for evidence on the same day cannot be accidental. The HFEA’s interest is expressed to be primarily about safety in order to suppport its responsibility to make licensing decisions and the NCoB is concerned about broader ethical issues. However, it might be considered that the overlapping processes point to the value of more explicit co-ordination of actitivies. It is reminiscent of the oddity that we saw in the 199os when both the Department of Health and the Nuffield Council on Bioethics undertook work on Xenotransplantation.

This Time Last Year: internet sperm traders

In News 2010 on October 10, 2011 at 8:32 am

In October 2010, two men who reportedly made £250,000 from the provision of fresh sperm via the internet were given suspended prison sentences. The pair – Ricky Gage and Nigel Woodforth – were convicted for the illegal provision of sperm without a licence, contrary to the provisions of the Human Fertilisation and Embryology Act 1990. Nine month suspended sentences were handed down, and the pair were fined £15,000 each and ordered to undertake 200 hours community service and contribute towards the prosecution’s costs.

This was the first case to test and clarify these provisions, despite the fact the first internet sperm trader in Britain started up in 2002 (Man Not Included: it has since closed and the director was jailed for fraud – but no prosecution was sought at the time in relation to the provision of sperm without a licence).

Links:

BBC News: http://www.bbc.co.uk/news/uk-england-berkshire-11521464;

HFEA: http://www.hfea.gov.uk/6086.html

Bionews: http://www.bionews.org.uk/page_73005.asp

http://www.bionews.org.uk/page_71341.asp

On Man Not Included: http://news.bbc.co.uk/1/hi/england/london/7337576.stm

Looking back five years: egg donation for research

In 2006, Reproduction on September 1, 2011 at 3:01 am

In September 2006 the Human Fertilisation and Embryology Authority launched a consultation, ‘Donating eggs for research: safeguarding donors’, asking whether or not egg donation for research purposes should be permissible, and if so, how could donors be best protected?

For a brief overview of the consultation, see this Bionews commentary: http://www.bionews.org.uk/page_12842.asp; and for a summary of the BMA’s Medical Ethics Committee’s views, see Veronica English’s follow up piece: http://www.bionews.org.uk/page_37900.asp.

In February 2007, the HFEA announced its decision to permit ‘altruistic’ donation for research purposes – see the Report.