The debate about single embryo transfer isn't NICE
Sandy Starr, Communications Officer at the Progress Educational Trust
Progress Educational Trust28 January 2009
This month sees the coming into force of new regulations by the UK's Human Fertilisation and Embryology Authority (HFEA), which seek to ensure that elective single embryo transfer (eSET) for women under 40 becomes standard practice in IVF treatment in the UK.
Under these regulations, public and private fertility clinics will be required by the HFEA to 'maintain a documentary record of the licensed centre's Multiple Births Minimisation Strategy... the outcome of regular audits and evaluations of the progress and effectiveness of the strategy... and a summary log of cases in which multiple embryos have been transferred to a patient who meets the criteria for single embryo transfer as set out in the strategy'. Where multiple embryos are transferred, clinics must provide the HFEA with 'a clear explanation of the reasons for transferring more than one embryo in that particular case' and 'a note confirming that the risks associated with multiple pregnancy have been fully discussed with the patient' (1).
The most outspoken criticism of eSET in the UK has focused not on multiple births as such, but on the inequity of measures to reduce multiple birth that also reduce the chances of IVF patients conceiving, when those unable to afford private IVF treatment are offered so few chances on the National Health Service (NHS) to begin with. The standard point of reference for such criticism is the clinical guideline issued in 2004 by the National Institute for Clinical Excellence (NICE), specifying that 23 to 39-year-old patients are entitled to expect three free cycles of IVF treatment on the NHS (2). Such levels of provision are, at present, far from a reality (3).
While concern over this inequity is entirely legitimate, it also risks obscuring or distracting from other aspects of eSET that deserve to be debated. I outline five of these aspects here.
First, is eSET coercive? Of the four different options for promoting eSET that the HFEA considered during a public consultation in 2007, the one it eventually chose - requiring all clinics to have a 'Multiple Births Minimisation Strategy' and to be compelled to justify any deviation from this strategy - was nominally the most liberal (4). And yet while stricter policies would have been contentious, they might have benefited from greater transparency and specific biomedical justification. By contrast, compelling every clinic in general terms to minimise multiple births places coercion at one remove from the patient. This could be characterised favourably, as a flexible regime where the clinic gets to exercise discretion. Or it could be characterised unfavourably, as an insidious regime where the patient doesn't know who's calling the shots.
Second, what does the 'e' in 'eSET' actually mean, in both specialist and lay terms? There is an ambiguity at present as to whether 'elective' single embryo transfer means that the patient consciously elects whether or not to have more than one embryo transferred, or whether it simply means that there is a possibility of transferring more than one embryo (because more than one is available), and that therefore someone (be it patient or practitioner) will make a decision as to how many to use. These two meanings have very different implications for the patient.
Third, has sufficient consideration and prominence been given, in discussion of eSET, to the other principal method of avoiding multiple births - namely selective abortion, or multifetal pregnancy reduction (MFPR)? This procedure was ruled out early on in the development of the HFEA's new policy, with the Expert Group on Multiple Births stating in 2006 that 'without repeating all the moral arguments about abortion, it is obvious to our group that eSET is the preferable option' (5). This reticence is understandable, but perhaps 'all the moral arguments about abortion' are unavoidable in this area. Neither the fraught politics of abortion, nor the invasiveness and 'yuck factor' associated with MFPR as compared with eSET, justify sidelining MFPR in public discussion.
Fourth, what are the state's obligations to the citizen when it comes to IVF provision, and does the citizen have concomitant obligations to the state? Implicit in the fact that IVF is (supposed to be) offered for free on the NHS is a good-faith assumption that the state should provide assistance to those who wish to have children, with conditions (a limit of three free cycles) placed upon this provision in order to manage public expense. By contrast, it could be argued that eSET involves a bad-faith assumption, that unless pregnancies brought about under the auspices of public health are of a defined type and exist within defined parameters, then patients risk acting against their own interests or those of their children.
Finally, is the model of patient 'choice' that has become a central plank of UK health policy predicated on the relationship between state and citizen, or (as critics of the choice agenda often argue) on the relationship between business and consumer? Until we arrive at a coherent understanding of what patient choice means, we will be hard-pushed to establish how eSET affects it.
(1) 'Multiple births minimisation strategy' (.pdf 14.9KB), Human Fertilisation and Embryology Authority, 30 September 2008, p1-2 [http://www.hfea.gov.uk/docs/2008-09-11_MBSET_General_Directions__final__2_.pdf]
(2) 'Fertility: assessment and treatment for people with fertility problems' (.pdf 3.96MB), National Institute for Health and Clinical Excellence, 25 February 2004, p5, 24, 44 [http://www.nice.org.uk/nicemedia/pdf/CG011niceguideline.pdf]
(3) See 'Primary care trust survey: provision of IVF in England 2007' (.pdf 55KB), Department of Health, 23 June 2008 [http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_085665?IdcService=GET_FILE&dID=167586&Rendition=Web]
(4) 'The best possible start to life' (.pdf 3.96MB), Human Fertilisation and Embryology Authority, p17-18 [http://www.hfea.gov.uk/docs/The_best_possible_start_to_life_HFEA_public_consultation_paper_April_2007.pdf]
(5) 'One child at a time: reducing multiple births after IVF' (.pdf 480KB), Peter Braude, Expert Group on Multiple Births after IVF, October 2006, p32 [http://www.hfea.gov.uk/docs/MBSET_report_Final_Dec_06.pdf]
Reproduced with permission from BioNews, an email and online sources of news, information and comment on assisted reproduction and genetics.