Rationing]Po cies 0 Access to In Vitro FertOlOlsatioJI1 in the 1 altional JfJIealth Service 9 UK Aurora Plomer Jain Smith N orma Martin-Clement

This paper reports on a study ofthe local pol icies and specific rationing strategies for in vitro rel tiJi-ation (lVF) adopted by H ealth Authorities in England and Wales A ll Heal th Au thorities in Eng la 1d and Wales were asked for this information and a representative ~i mJle then took part in a follow-up interview A majority otJ-Iealth A uthorities had adopted formal cliyilJ ili ty criteria in orcler to funcl access to IVF treatmen t Th ese criteria were both overt and covert and ranged from the clinical to the social They inelucl ecl in irti li ty age limits number ofch ild ren status ofthe couple and sexua l orientation Soc ial cri teria (encied to exclude fiom public funding individuals who wer e not in a stab le heterosexual relationship W e found a multiplici ty of approaches which werE lOt necessari ly consisten t with each other nor based on the purported goal ofp ro moting clinicdl Jnl I cost effectiveness Some policies were discrimin atory against certa in ca tegories o f women I urth er~ th ere app ea red to be a disel cp8ncy between some Health A uthorities exclusion po lie igts and the 1990 legis lati ve famework on access to IVF treatment in the UK

THE technique of in vitro fertilisation (IVF) has been availab le since the late 1970s to ass ist cou ples unable to conceive by natural means 1 In the 1980s IVF rem ained largely

experim ental and wa s conducted almos t exclusshyively in the pri vate sector wi th each cyc le of treatshym ent costing upwards of pound2000 In th e late 19805 and ear ly 1990s a sma ll nunber of -J at ional Hea lth Service (I H S) clinics began to fund treatmen t T he numbers stead il y incrased in the m id-1990s with the latest surveys in 1997 showing that two shythirds of Health Authorities w ere funding the service T he budget allocuted however tended to be small and a majority were using fo rmal eligibilshyity criteria to select patients 1 In this respect formal and explic it rationing strate(j ies for IVF w ere unusua l no signifi ca nt move from implicit to expl icit ration ing had occurred for the majority o f treatments be tween 1992 and 19964

W e carried out a sUI-vey t o fin d ou t from H ea lth A uthorit ies th emselves th e r ea sons be shyhind the adop ti o n of specific rat ion ing criteria and th e fac tors w hi ch had prompted t hem to develop r ati onin g policies on IVE

The context of health care rationing in lhe UK The Na ti ona l Health Serv ice was cre ated after World W ar [I w ith th e aim o f providing a free comprehensive and universal hea lt h serv ice available to all people an d co verin g all nec shyessary forms of health care A lthough it was hoped at the time that the dema nd for health care w ould diminish as th e healt h of th e na ti on improved the in escapable log ic was th at if the ass umpt ion did no t prove ri ght then hard even trag ic cho ices 6 reg arding th e priority r ankin g of treatments would have to be m ade

[n practice and until the I 980s I-ationi ng took place to a limited extend at a macro level i n the distr ibution of resou n es to th e D epartment of H eal th and to Health A uthorities by central govshyernmen t and more sig nificantly and mostly impl ic itly at local or m icro level by health care professionals delivering services I All this was to change by th e early 1990s when the new political orthodoxy came to see problems of scarcity as the product of w aste rath er th an underfund ing 4

Efficiency was form aJl y adopted as a g uiding

60

principle for the NHS7 and came to embrace not only managerial decisions on resource allocationS but the enhancement of clinical practice which was to be based on systematic scientific evaluashytion of the clinical effectiveness of interventions9

The administrative changes were completed by legislative changes in 1990 (National Health Service and Community Care Act 1990) literally s pliL1ing the NHS into purchasers and providshyers to facilitate the introduction of an internal market This consisted of a system of contracting of services by purchasers (Health Authorities and GPs) from providers (NHS trusts) Health Authorities were now required to develop annual local purchasing plans These plans were to be based on an assessment by each Health Authority of the health needs of the local population 10

Resources were to be spent on high quality value-for-money services through contracts with providers Consequently Health Author ities had to determine which services to prioritise Rationing which had previously taken the form of patient selection at the point of service delivshyery s hifted to a meso level to Health Authority managers who now had the responsibility of distributing resources by ranking treatments on the basis of their clinical and cos t- effectiveness 9

The priority generally accorded to IVf was unsurprisinglylow [VF was typically targeted for exclusion alongside tattoo removal cosmetic surgery and buttock lift treatments which were deemed to be insufficienty urgent to warrant claims on the public purse 11 Alternatively when funds were allocated for IVF treatment lVF came at the bottom of the priority list and the budget allocations were JIlsignificant In addition there was evidence that th ese limited budgets came with strings attached as Health Authorities began to stipulate eligibility conditions for treatment

Methods The collection of data was divided into two linked phases In phase 1 all of the Directors of Public Health (DsPH) in England and Wales were conshytacted by letter in February 1996 The DsPH were invited to send information about their local purshychasing policy for IVF and were also asked whether they would be prepared to take part in a follow-up interview A second reminder letter was sent six weeks later to non-responders In phase 2 the responses from phase 1 were

Rep roductive Heahh Matters Vol 7 No 14 November 1999

analysed with a view to identifying a representashytive sample of potential interviewees so as to elicit further details both on the process of policy formation for IVF rationing and on the justificashytions for the particular choice of eligibility criteria

Fifteen funders and five non-funders were identified and contacted by phone to take part in a follow -up interview Ninety-five per cent of respondents had already indicated a willingness to be interviewed in response to the initial letter and all of the twenty HAs who were subsequently selected agreed to take part in a face-to-face semi-structured interview The interview consistshyed of a set of open-ended questions which HAs were invited to answer They were asked what prompted the decision to develop a policy and what was thejusti1ication for the choice ofcriteria

The interviews took place between July and November 1996 These were taped and a transhyscript sent to the interviewees in March 1997 giving them the opportunity to make amendshyments delete or anonymise their comments

Results The documentation which was sent to us by Health Authorities in response to our letters varied tremendously both in its content and format in line with other surveys Of the 101 HAs who responded to our original letter 17 (17 per cent) said that the policy was under review two were using provider-derived protocols two used the ad hoc advice of the Department of Public Health on a case-by-case basis one used onl y presence on the waiting li st as of April 1995 and one had protocols under review Of the remaining 78 17 (22 per cent) had a clear policy of not funding IVF treatment Thus 61 respon ses could be analysed for any guidelines that were being used to define patient eligibility

The rationing factors most commonly menshytioned by the 61 HAs who were prepared to fund IVF treatment were these

bull infertiljtyofthewomanorcouple bull womans age bull male partners age bull children from existinq relationship bull children from past relationships bull marital status or relationship bull sexual orientation bull the welfare of the child

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P(() n1cr Sm i t h M artin-Clem ent

Additional criteria mentio ned includ ed

bull wo man mu st be able to produce her ow n eggs bull both partners mLst be able to produce

suitable gametes bull couple must be pepared to accept donor

sperm bull partners Body Mass Index bull w omans body w eight bull smok in g bull place of resiclenc e and bull neither partner is HIV positi ve

Fo r th e most commonly cite d rationing fa c tors the combined r esults o f r esponses in both ph ases of th e study y ielded the following res ults

lnfertility Infertility common ly appeared as a threshold condition triggering further criteria limiting eli qibility fo r t reatment Thirty- four authorities expreltsly said in the literature submitted that th ey ere prepared to fund IVF treatm ent only to treat infertility Of the se some had gon e to great lengtls to establi sh detailed clinical protocol s on th e d iag nos is of infertility w hil st others had none Infer ti lity was typically defined by r efershyen ce to a specified peri od of time d uring w hich a couple see king treatment were to have been trying and failed to conceive But there Iver e significant variations in the spec i fled periods of time w hich ranged from one to five years with the maj ority stipul il Ling a two- or three-year peri od (see T able 1)

In th e intervi ew s HAs found it difficult to justi fy the precise p eriod of ti me they stipulated One HA who required a couple to have been tryinq to conceive for three ye ars r ecugnised that this was longer than th e period o f tw o yea rs in the World H ealth Organizations definition o f infertili ty ft justified this on th e grounds that 10 per cent o f couples may stili conceive arter t wo

Tabl e 1 Length of infertility to be eligible for IVF treatment (34 Health Authorities)

1 yea r 2years 3 years 4+ yea rs

Numbmiddotr of respollses 5

bull One HA used either I or3 years depending on the woman s age H fwo HAs used 15 years

y ears and the tim e to do tests required to estab lish inFertility would stretch th e two -yea r period to three yea rs (HA 11) Another H A required couples to have been try ing to concei ve for two y ea r s after th eir initial vi sit to their GP al lhough it advised co uples in its publi c informa shyti on leafle t to vi sit their GP alter one year of un success ful attempts (HA10) Some hea l th autJlshyorities had erred on the generous side by choosshying a 12-month period a ~ an arbitrary cut-o Ff even though there is sti l l J percentage of coupl es w ho wil l conceive fter 18 to 24 months (HA17) Some opted for a peri od o f 12 months as the co rrect poi nt at which to beg in simple first-line advice from th e GP (HA 1) Some relied o n the guid elin es in th e 1992 EffectJve Health Care Bulletin (HA9) w hilst others left the dec ision to the referring GP or the prov ider unit (HA19)

Even w hen they considered that infertility was establi shed some HAs imposed furth er restricshytion s on eligibility fo r treatment dependin~1 on the causes of infertility One HA only funded cases where infertility had caused severe anxiety or d epression (HA15)

Some HAs provided anecdotal evidence that social factors were being taken into acco unt by clinicians in deciding whether infertile patients deserved treatment e] Funding m ay wel l no t be given to treat a Iuman w ho appears to be very promi sc uous and poor but given to treat a cllurch-goi ng pleasant middle class lady who seems to have no apparent reason for infertility in a stable rel ati onsllip (H A 12J It was thought that patients we re less l ike ly to receive funding i f they w ere perceived to be respo nsible for their ow n problem for havi ng caused their infertility even though such m oral and ethical judgements w ere not likely to figure expressly in the priority rat ing (HA15)

Infertility still figured as a de- Facto threshold for treatment for the vas t m ajority o f the HA s w hu had not express ly mentioned it in tileir docum entati on S they restricted treatment to (heterosexual) coup les m arried or in stab le r elationships w ho had no children frol11 the ex isting or previous relation ships

Woman s age Of the 61 respon ses from HAs wi th eligibility criteria 54 (89 per cent) mentioned a specified age limit for treatm ent All had an upper limit w hich ranged betw een 34 and 50 yea rs the

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Reproducti ve J-ealth Matters Vol 7 No 14 Novemb er 1999

commonest age being 40 (n =13) Of the 16 who mentioned a lower age limit the specified age varied from 20 to 29 with the commonest being 25 (n =11)

The setting of an upper age limit tended to be justified on grounds of clinical effectiveness (HAs 5101415161720) One HA cited recent articles in the 8M) and Lancet to support an age limit of around 35-37 (HA4) But whatever the age limit set reasons other than clinical effectiveness were also involved in setting that limit In one HA the maximum and minimum age for both partners was arrived at from the consensus shown by GP questionnaires and the effectiveness of the treatment although the exact cut-off point was admitted to be arbitrary (HA 15) Another HA described its choice of 35 as a n arbitrary decis ion based on pseudo-evidence (HA 7) In one HA the age limit Ivas originally set at 42 but one consultant wanted it to be 38 (HA2)Jt was then set arbitrari ly at 40 which was thought to be acceptable to the informed man-in-the-street One HA set the age limit at 40 although it was felt that on purely clinical considerations it ought to be 25-30 (HA 1) In another HA an upper age limit of 35-37 was originally considered but age 35 was chosen on the grou nds that the numbers of women coming forward for treatment would thereby be reduced (HA4)

The setting of minimum age limits appears to ha ve been based on grounds other than clinical effectiveness One authority justified this on the grounds that the final budget wou ld be sma ll and therefore peoples hopes would not be raised when they could not be fulfilled (HA4) Another admitted that There is no actual biological reason It was a social thing rather than a biological one (HAn

Male partners age Fourteen of the 61 HAs with eligibility criteria (23 per cent) mentioned a specified age limit for the male partner One HA set a minimum age limit of 25 years All had an upper age limit of between 35 and 55 The commonest upper limit was lt50 (n=5)

Only two of tIle 15 funding HAs who were interviewed had an age limit for male partners One said that the upper age limit was a mixture of socia l a nd biological reasoning as there is some evidence that male reproshyductive function deteriorates with age and also a large age gap between parent and child did

not seem appropriate (HA15 ) The other desshycribed it as a va lue judgement part of the process of seeing what was sensible (HAS) Amongst those whic h did not have an age limit for the man one expressly justified this on the grounds that clinical effectiveness was not affected (HA 10)

Children from the current relationship Forty-eight of the 61 HAs (79 per cent) menshytioned the presence or absence of children in the current relationship as an important factor Of these 44 (92 per cent) required that the woman should have no children with the current partner Three were prepared to provide treatshyment where the couple already had one child Two would only do so if the child was under age 2 in the one case and under age 16 in the other

Several HAs cited equity or fairness as a reason for restricting treatment to couples wit h no children in the current relationship (eg HAs 8141618) The common aim was to meet a health need depicted in the mechanistic langshyuage of one Health Authority as helping a uterus to work ifit has not worked (HAS)

The interviews established that HAs were conscious that the no-chi ldren criterion for inclusion was a social rather than clinical critershyion (HAs 711) but one thought this was supportshyed by social consensus (HA 11)

Children from previous relationships Thirty-seven (61 per cent) of the 61 HAs menshytioned children from previous relationships as an excluding factor Of these 37 34 (92 per cent) required that there s hould be no such chi ldren Only two of the 37 were willing to cons ider a cou ple wl1en there was one such child Against the trend one H A actually looked favourably on appl ications from couples with children in previous relationships on the advice of the gynaecologist provider who took the view that clinical effectiveness would thereby be enhanced (HAi7)

The policy of excluding those with previous children tended to be justified on utilitarian grounds There is only a very limited resource and this is an attempt to spread th e benefit of having a child as widely as possible (HA 16) But in the interviews several HAs expressed diffi shyculties with this criterion One mentioned th at the exclusion of children from previous reJationshy

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Pl nlllc r miIl1 Martin-Clement

ships is now causing probl ems because people who have had a Family and then been sterilised in a previous relationship are now requesting IVF (HA17) Another HA wa s finding it difficult to justiFy its policy in cases where the previous child of one partner did not live with the couple although they had still decided not to alter their policy (HAS)

Relationship between partners Thirty-three (54 per cent) of the 61 HAs with eligibility criteria expressly mentioned in their documentation that they were only prepared to treat couples A small minonty (3 of the 33) expressly required the couple to be married Almost two-thirds of the 33 (64 per cent) required that the relationship be stable but not necessarily based on marriage Altogether 73 per cent ofmiddot HAs I-estricted treatment to couples who vvere either married or in a stable (heterosexual) relationship However the actual percentage of HAs limiting access to these couples is likely to be even higher as information supplied to us by HAs in their own documentation varied tremenshydously Furthermore otiler rationing factors such 3S infertility had the same limiting efFect albei t in an indirect manner

Of the three HAs who required couples to be married two did not prescribe a minim Li J

number of years of marriage one requi r ed tile couple to have been married For at least three years By contrast the stability of relationshipo tended to be assessed by the number of years tile couple had been together which varied bet(rn one and three years with six HAs requirinCl at least two years and eight requiring three ycars together

The reasons given in the interviews for including couples only varied from concerns over the welfare of the child to a deliberate attempt to exclude single women and lesbian couples Restricting treatment to couples wa s a definite policy decision based on the welfare of the Lmiddothild (HAl) One HA stood out in the intl ~rview for having decided to concentrate on the infertility problems of women only women all the way we Jeft the men right out of it 1his was because the Authority did not want to get involved in questions of what is a couple or about lesbian couples (HAS)

Another HA had opted for provldinq IVF treaiment on an ad-hoc basis only For patients in

exceptional medical circumstances (eg cancer of the ovaries) as they did not want to use social criteria they regard thi s as pernicious because you start to make quite major value judgements (HA6)

Sexual orientation Sexual orientation was also speciFica ll y menshyt ioned by several HAs in the documentation sent to us A significa n t minority 9 of 61 (15 per cent) expressly limited funding to couples who were in a stable heterosexual relationship But tile qualitative interview s suggested that exshyclusion on grounds of sexual orientation was more widespread and tended to operate inshydirectly

One HA who had no w r itten policy restricting funding to heterosexual couples nonethelCss described its policy as deliberate (HA16) A request for treatment from a single women had been refused and whilst there had been no requests for treatmen t from les lian couples and no real decision has been made tIle DPH would be inclined to refuse to Fund treatment (HA16) One HA who had no specific written criteria said when prompted on its views during the interview that no doubt the relationship would have to be heterosexual rather than homosexual (HA12) nother said that one consultant was known only to treat hetelOsex ultJ1 couples (HA 13) One HA who had not considered the question thought that it would have to go back to the Board (HA4) and another said that whilst the question of homosexual couples was not even considered a single woman or lesbian couple would not qualiFy Ior treatment (HA7)

One HA 11ad cullsciously excluded lesbian women by default as the req uirement for a stable marriage or two-year relationship would exclude single women (HA3) fnother had consciously excluded lesbiltl11 cOllrles as they are not by definition infertile sillce Illfertility requires heterosexual sex without success for one or two years so they would not be eligible For infertility treatment because they are not infertile (HA2) As one HA who had dropped a previous requireshyment to restrict treatment to heterosexual couples candidly admitted the same result could be achieved by relying on the cle linition of infEftility alone (HA2) Alternatively IVF treatment was de facto restricted to heterosexual couples if tl1e Authority did not Fund donor tl-eatment (HA141

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Those excluding non-heterosexual relationshyships described them as an unnatural bond (HA15) or failure to provide a secure family background (HA16) One HA thought that unshyequal treatment of lesbian couples w asjustified on the grounds that there are so many normal couples in whom there is a functioning male that one couJd not get through all of them If people have the bad luck to have other problems it does not necessarily mean that they have to be treated on an equal basis By contrast one HA which had used to treat heterosexual couples only decided to remove the exclusion as it was thought that the welfare of the child would be a more appropriate guiding principle (HA 11) Another which had expressly sought to exclude single women had nevertheless deliberately refrained from specifying the sexual orientation of the couple as it was thought that the number of gay couples likely to want treatment would be so small that there was no need to exclude them (HA20)

The welfare ofthe child The welfare of the prospective child was cited by a sign ifi cant minority of the 61 HAs as a guiding principle for exclusion 16 (29 per cent) One HA relied on the welfare of the child as the on ly absolute criterion We are not helping couples who are probably not fit to be parents (HA1) In some cases restricting trea tment to couples w as said to be a definite policy decision based on the welfare of the child (HA 7) In addition to the status of couple and sexual orientation the welfare of the child was sometimes used to justify other exclusion factors such as HIV (HA2) drug abuse (HA3) child abuse or violence (HAi0) or smoking (HAi5)

A minority had deliberately refrained from adopting a formal policy on the welfare of the child and left the decision to the provider (HAs 91420) Only one HA appeared to be aware that the clinician providing the treatment was already under a legal duty to consider the welfare of the chUd (H14)

Health Authorities who would not fund IVF The reasons given by HAs who did not fund lVF were threefold First when compared to a ll other health care priorities IVF was considered to be of low priority (HAs 81319) One HA estimated the extra cost of funding lVF to be of the order of pound500000 per year if they had this extra money

Rep roductive Health Mailers Vol 7 No 14 November middot999

they said they would rather spend it on cancer care (HA6) Second non-runders were not conshyvinced that IVF was an effective treatment (HA6) and were prepared to invest in some infe rtility services but not IVF (HAs 81319) Finally they were uncomfortable with the use of social criteria for the allocation of scarce resources Our job is not to give you a child or a child in your home or a child with this partner as opposed to any other partner (HAS)

In summary amongst the HAs who had chosen to fund IVF treatment the main findings which emerged were these

bull a majority had adopted formal eligibility criteria

bull the eligibility criteria ranged from the clinical to the social

bull although there was convergence in the choice of formal clinical criteria such as infertility and age limits there were considerable variat shyions in the detailed spec il1cation of these criteria and

bull there was convergence on the choice of social criteria such as number of children the status of the couple or sexual orientation Social criteria tended to exclude from public funding individuals who were not in a stabte heteroshysexual relationship The exclusion facto rs operated both overtly and covertly

Analysis Although clinical effectiveness was introduced by the Conservative government in the early 1990s as a rationing tool in the drive towards an efficient evidence-based health service the role this has played in the majority of HAs until now has been margina1 4 The results of our survey on rationing strategies for IVF are consistent with these findings Whilst clinical effectiveness was cla imed to be given a high priority by HAs there were significant variations in the clinical criteria adopted and the knowledge base used to justify some of the clinical guidelines adopted was poor

Some HAs themselves pointed out that clinical effectiveness is not a hard and fast concept that can be captured by exact mathematical formulae (eg an age limit of 36 as against 37) Moreover as some of its critics have noted the concept of clinical effectiveness is more diffuse and vaJueshyladen than might appear at first glance middotI2 Is

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PJomel~ Smith Marll n-Clemenl

depression caused by failure to conceive more lITcctively treated by psychological counselling or by IVF Does treatment with a success rate of around 30 per cent count as clinically effective Should the deAnition of infertility include psychological factors which prevent cOIlCeption or physiological factors only7 More fundamentshyally does the inabiliry to have children give rise to a clinical need which in turn requires medical treatment These and other similar questions should clispel any illusion that the concept of clinical effectiveness can provide a bright di vidshying 1i Ie between treatments which are effective and Ihose which are not let alone treatmcnts which are suitable for public funding and those which are not

Nevertheless when the accepted clinicltll evidence at the time showed that the highest

rates of live births lith IVF were to be found amongst women aged 25 to 34 with th e sharpshyest drop occurring after 39 local variations in funding policies seem difficult to justifyB Subsequent studies on the clinical effectiveness of IVF cast serious doubts on the clinical soundness of tile criteria adopted by some HAs The most comprehensive study on the clinical eFFectiveness of lVF in the UK was published in 199GH The study conducted by Templelon el ai covered 36961 cycles of IVF treatment The authors looked at the effect of the womans age on the success rate for live bil lhs ~md Found that the highest live birth rates were in the age

group 25-30 years with the sharpest decline in women over 40 years At all ages over 30 use

of donor eggs was associated with a sigshy

nificantly higher live birth rate than use of the womans own eggs

Previous pIegnancies and live births were significantly associated with treatment success

The cri teria adopted by some HAs to allocate public funding for IlF treatment are not conshy

sistent with the results of this survey If health care rationing is to be

done on the basis of evidence -based medicine (EBM) then rationing strategies on the funding of IYF need to be reconsidered to reflect these flndings more accurately

In spite of the lluge politicill weight put 011

clinical and cost effectiveness it is unrealistic to expect the priority ranking of treatments til be

15based on these factors alone The two best

known rationing strategies for health resources the Oregon experiment and the QUA LY formula ultimately rely on a mix of clinical and social moral criteria In the case of the Oregon experi shyment the ranking of treatments eligible for public funding was partly the result of political and moral priorities determined by public consultation partly th e discretion of heal th commissioners using factors such as benefit quality of welJ-being and partly incidence of condition public health impact clinical effectiveshyness social costs and cost of non-treatment II In the end proponents of the Oregon experiment have conceded that the final ranking is no longer supposed to mel a gold standard but simply to appear intuiti vely sensible17

An alternati e tool fo r liltioning health resources is the QUALY formula first advanced by health economists in the mid-1980s which seeks to rate the effect of clinIcal interventions on

the quality of life of the patient adjusted for Ytdrs of life18 Although the formula has been claimed by its propon ents to be egalitarian because it does not formally favour one category of patients over

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Reproducti ve J-ealth Matters Vol 7 No 14 Novemb er 1999

commonest age being 40 (n =13) Of the 16 who mentioned a lower age limit the specified age varied from 20 to 29 with the commonest being 25 (n =11)

The setting of an upper age limit tended to be justified on grounds of clinical effectiveness (HAs 5101415161720) One HA cited recent articles in the 8M) and Lancet to support an age limit of around 35-37 (HA4) But whatever the age limit set reasons other than clinical effectiveness were also involved in setting that limit In one HA the maximum and minimum age for both partners was arrived at from the consensus shown by GP questionnaires and the effectiveness of the treatment although the exact cut-off point was admitted to be arbitrary (HA 15) Another HA described its choice of 35 as a n arbitrary decis ion based on pseudo-evidence (HA 7) In one HA the age limit Ivas originally set at 42 but one consultant wanted it to be 38 (HA2)Jt was then set arbitrari ly at 40 which was thought to be acceptable to the informed man-in-the-street One HA set the age limit at 40 although it was felt that on purely clinical considerations it ought to be 25-30 (HA 1) In another HA an upper age limit of 35-37 was originally considered but age 35 was chosen on the grou nds that the numbers of women coming forward for treatment would thereby be reduced (HA4)

The setting of minimum age limits appears to ha ve been based on grounds other than clinical effectiveness One authority justified this on the grounds that the final budget wou ld be sma ll and therefore peoples hopes would not be raised when they could not be fulfilled (HA4) Another admitted that There is no actual biological reason It was a social thing rather than a biological one (HAn

Male partners age Fourteen of the 61 HAs with eligibility criteria (23 per cent) mentioned a specified age limit for the male partner One HA set a minimum age limit of 25 years All had an upper age limit of between 35 and 55 The commonest upper limit was lt50 (n=5)

Only two of tIle 15 funding HAs who were interviewed had an age limit for male partners One said that the upper age limit was a mixture of socia l a nd biological reasoning as there is some evidence that male reproshyductive function deteriorates with age and also a large age gap between parent and child did

not seem appropriate (HA15 ) The other desshycribed it as a va lue judgement part of the process of seeing what was sensible (HAS) Amongst those whic h did not have an age limit for the man one expressly justified this on the grounds that clinical effectiveness was not affected (HA 10)

Children from the current relationship Forty-eight of the 61 HAs (79 per cent) menshytioned the presence or absence of children in the current relationship as an important factor Of these 44 (92 per cent) required that the woman should have no children with the current partner Three were prepared to provide treatshyment where the couple already had one child Two would only do so if the child was under age 2 in the one case and under age 16 in the other

Several HAs cited equity or fairness as a reason for restricting treatment to couples wit h no children in the current relationship (eg HAs 8141618) The common aim was to meet a health need depicted in the mechanistic langshyuage of one Health Authority as helping a uterus to work ifit has not worked (HAS)

The interviews established that HAs were conscious that the no-chi ldren criterion for inclusion was a social rather than clinical critershyion (HAs 711) but one thought this was supportshyed by social consensus (HA 11)

Children from previous relationships Thirty-seven (61 per cent) of the 61 HAs menshytioned children from previous relationships as an excluding factor Of these 37 34 (92 per cent) required that there s hould be no such chi ldren Only two of the 37 were willing to cons ider a cou ple wl1en there was one such child Against the trend one H A actually looked favourably on appl ications from couples with children in previous relationships on the advice of the gynaecologist provider who took the view that clinical effectiveness would thereby be enhanced (HAi7)

The policy of excluding those with previous children tended to be justified on utilitarian grounds There is only a very limited resource and this is an attempt to spread th e benefit of having a child as widely as possible (HA 16) But in the interviews several HAs expressed diffi shyculties with this criterion One mentioned th at the exclusion of children from previous reJationshy

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Pl nlllc r miIl1 Martin-Clement

ships is now causing probl ems because people who have had a Family and then been sterilised in a previous relationship are now requesting IVF (HA17) Another HA wa s finding it difficult to justiFy its policy in cases where the previous child of one partner did not live with the couple although they had still decided not to alter their policy (HAS)

Relationship between partners Thirty-three (54 per cent) of the 61 HAs with eligibility criteria expressly mentioned in their documentation that they were only prepared to treat couples A small minonty (3 of the 33) expressly required the couple to be married Almost two-thirds of the 33 (64 per cent) required that the relationship be stable but not necessarily based on marriage Altogether 73 per cent ofmiddot HAs I-estricted treatment to couples who vvere either married or in a stable (heterosexual) relationship However the actual percentage of HAs limiting access to these couples is likely to be even higher as information supplied to us by HAs in their own documentation varied tremenshydously Furthermore otiler rationing factors such 3S infertility had the same limiting efFect albei t in an indirect manner

Of the three HAs who required couples to be married two did not prescribe a minim Li J

number of years of marriage one requi r ed tile couple to have been married For at least three years By contrast the stability of relationshipo tended to be assessed by the number of years tile couple had been together which varied bet(rn one and three years with six HAs requirinCl at least two years and eight requiring three ycars together

The reasons given in the interviews for including couples only varied from concerns over the welfare of the child to a deliberate attempt to exclude single women and lesbian couples Restricting treatment to couples wa s a definite policy decision based on the welfare of the Lmiddothild (HAl) One HA stood out in the intl ~rview for having decided to concentrate on the infertility problems of women only women all the way we Jeft the men right out of it 1his was because the Authority did not want to get involved in questions of what is a couple or about lesbian couples (HAS)

Another HA had opted for provldinq IVF treaiment on an ad-hoc basis only For patients in

exceptional medical circumstances (eg cancer of the ovaries) as they did not want to use social criteria they regard thi s as pernicious because you start to make quite major value judgements (HA6)

Sexual orientation Sexual orientation was also speciFica ll y menshyt ioned by several HAs in the documentation sent to us A significa n t minority 9 of 61 (15 per cent) expressly limited funding to couples who were in a stable heterosexual relationship But tile qualitative interview s suggested that exshyclusion on grounds of sexual orientation was more widespread and tended to operate inshydirectly

One HA who had no w r itten policy restricting funding to heterosexual couples nonethelCss described its policy as deliberate (HA16) A request for treatment from a single women had been refused and whilst there had been no requests for treatmen t from les lian couples and no real decision has been made tIle DPH would be inclined to refuse to Fund treatment (HA16) One HA who had no specific written criteria said when prompted on its views during the interview that no doubt the relationship would have to be heterosexual rather than homosexual (HA12) nother said that one consultant was known only to treat hetelOsex ultJ1 couples (HA 13) One HA who had not considered the question thought that it would have to go back to the Board (HA4) and another said that whilst the question of homosexual couples was not even considered a single woman or lesbian couple would not qualiFy Ior treatment (HA7)

One HA 11ad cullsciously excluded lesbian women by default as the req uirement for a stable marriage or two-year relationship would exclude single women (HA3) fnother had consciously excluded lesbiltl11 cOllrles as they are not by definition infertile sillce Illfertility requires heterosexual sex without success for one or two years so they would not be eligible For infertility treatment because they are not infertile (HA2) As one HA who had dropped a previous requireshyment to restrict treatment to heterosexual couples candidly admitted the same result could be achieved by relying on the cle linition of infEftility alone (HA2) Alternatively IVF treatment was de facto restricted to heterosexual couples if tl1e Authority did not Fund donor tl-eatment (HA141

64

Those excluding non-heterosexual relationshyships described them as an unnatural bond (HA15) or failure to provide a secure family background (HA16) One HA thought that unshyequal treatment of lesbian couples w asjustified on the grounds that there are so many normal couples in whom there is a functioning male that one couJd not get through all of them If people have the bad luck to have other problems it does not necessarily mean that they have to be treated on an equal basis By contrast one HA which had used to treat heterosexual couples only decided to remove the exclusion as it was thought that the welfare of the child would be a more appropriate guiding principle (HA 11) Another which had expressly sought to exclude single women had nevertheless deliberately refrained from specifying the sexual orientation of the couple as it was thought that the number of gay couples likely to want treatment would be so small that there was no need to exclude them (HA20)

The welfare ofthe child The welfare of the prospective child was cited by a sign ifi cant minority of the 61 HAs as a guiding principle for exclusion 16 (29 per cent) One HA relied on the welfare of the child as the on ly absolute criterion We are not helping couples who are probably not fit to be parents (HA1) In some cases restricting trea tment to couples w as said to be a definite policy decision based on the welfare of the child (HA 7) In addition to the status of couple and sexual orientation the welfare of the child was sometimes used to justify other exclusion factors such as HIV (HA2) drug abuse (HA3) child abuse or violence (HAi0) or smoking (HAi5)

A minority had deliberately refrained from adopting a formal policy on the welfare of the child and left the decision to the provider (HAs 91420) Only one HA appeared to be aware that the clinician providing the treatment was already under a legal duty to consider the welfare of the chUd (H14)

Health Authorities who would not fund IVF The reasons given by HAs who did not fund lVF were threefold First when compared to a ll other health care priorities IVF was considered to be of low priority (HAs 81319) One HA estimated the extra cost of funding lVF to be of the order of pound500000 per year if they had this extra money

Rep roductive Health Mailers Vol 7 No 14 November middot999

they said they would rather spend it on cancer care (HA6) Second non-runders were not conshyvinced that IVF was an effective treatment (HA6) and were prepared to invest in some infe rtility services but not IVF (HAs 81319) Finally they were uncomfortable with the use of social criteria for the allocation of scarce resources Our job is not to give you a child or a child in your home or a child with this partner as opposed to any other partner (HAS)

In summary amongst the HAs who had chosen to fund IVF treatment the main findings which emerged were these

bull a majority had adopted formal eligibility criteria

bull the eligibility criteria ranged from the clinical to the social

bull although there was convergence in the choice of formal clinical criteria such as infertility and age limits there were considerable variat shyions in the detailed spec il1cation of these criteria and

bull there was convergence on the choice of social criteria such as number of children the status of the couple or sexual orientation Social criteria tended to exclude from public funding individuals who were not in a stabte heteroshysexual relationship The exclusion facto rs operated both overtly and covertly

Analysis Although clinical effectiveness was introduced by the Conservative government in the early 1990s as a rationing tool in the drive towards an efficient evidence-based health service the role this has played in the majority of HAs until now has been margina1 4 The results of our survey on rationing strategies for IVF are consistent with these findings Whilst clinical effectiveness was cla imed to be given a high priority by HAs there were significant variations in the clinical criteria adopted and the knowledge base used to justify some of the clinical guidelines adopted was poor

Some HAs themselves pointed out that clinical effectiveness is not a hard and fast concept that can be captured by exact mathematical formulae (eg an age limit of 36 as against 37) Moreover as some of its critics have noted the concept of clinical effectiveness is more diffuse and vaJueshyladen than might appear at first glance middotI2 Is

65

PJomel~ Smith Marll n-Clemenl

depression caused by failure to conceive more lITcctively treated by psychological counselling or by IVF Does treatment with a success rate of around 30 per cent count as clinically effective Should the deAnition of infertility include psychological factors which prevent cOIlCeption or physiological factors only7 More fundamentshyally does the inabiliry to have children give rise to a clinical need which in turn requires medical treatment These and other similar questions should clispel any illusion that the concept of clinical effectiveness can provide a bright di vidshying 1i Ie between treatments which are effective and Ihose which are not let alone treatmcnts which are suitable for public funding and those which are not

Nevertheless when the accepted clinicltll evidence at the time showed that the highest

rates of live births lith IVF were to be found amongst women aged 25 to 34 with th e sharpshyest drop occurring after 39 local variations in funding policies seem difficult to justifyB Subsequent studies on the clinical effectiveness of IVF cast serious doubts on the clinical soundness of tile criteria adopted by some HAs The most comprehensive study on the clinical eFFectiveness of lVF in the UK was published in 199GH The study conducted by Templelon el ai covered 36961 cycles of IVF treatment The authors looked at the effect of the womans age on the success rate for live bil lhs ~md Found that the highest live birth rates were in the age

group 25-30 years with the sharpest decline in women over 40 years At all ages over 30 use

of donor eggs was associated with a sigshy

nificantly higher live birth rate than use of the womans own eggs

Previous pIegnancies and live births were significantly associated with treatment success

The cri teria adopted by some HAs to allocate public funding for IlF treatment are not conshy

sistent with the results of this survey If health care rationing is to be

done on the basis of evidence -based medicine (EBM) then rationing strategies on the funding of IYF need to be reconsidered to reflect these flndings more accurately

In spite of the lluge politicill weight put 011

clinical and cost effectiveness it is unrealistic to expect the priority ranking of treatments til be

15based on these factors alone The two best

known rationing strategies for health resources the Oregon experiment and the QUA LY formula ultimately rely on a mix of clinical and social moral criteria In the case of the Oregon experi shyment the ranking of treatments eligible for public funding was partly the result of political and moral priorities determined by public consultation partly th e discretion of heal th commissioners using factors such as benefit quality of welJ-being and partly incidence of condition public health impact clinical effectiveshyness social costs and cost of non-treatment II In the end proponents of the Oregon experiment have conceded that the final ranking is no longer supposed to mel a gold standard but simply to appear intuiti vely sensible17

An alternati e tool fo r liltioning health resources is the QUALY formula first advanced by health economists in the mid-1980s which seeks to rate the effect of clinIcal interventions on

the quality of life of the patient adjusted for Ytdrs of life18 Although the formula has been claimed by its propon ents to be egalitarian because it does not formally favour one category of patients over

66

Pl nlllc r miIl1 Martin-Clement

ships is now causing probl ems because people who have had a Family and then been sterilised in a previous relationship are now requesting IVF (HA17) Another HA wa s finding it difficult to justiFy its policy in cases where the previous child of one partner did not live with the couple although they had still decided not to alter their policy (HAS)

Relationship between partners Thirty-three (54 per cent) of the 61 HAs with eligibility criteria expressly mentioned in their documentation that they were only prepared to treat couples A small minonty (3 of the 33) expressly required the couple to be married Almost two-thirds of the 33 (64 per cent) required that the relationship be stable but not necessarily based on marriage Altogether 73 per cent ofmiddot HAs I-estricted treatment to couples who vvere either married or in a stable (heterosexual) relationship However the actual percentage of HAs limiting access to these couples is likely to be even higher as information supplied to us by HAs in their own documentation varied tremenshydously Furthermore otiler rationing factors such 3S infertility had the same limiting efFect albei t in an indirect manner

Of the three HAs who required couples to be married two did not prescribe a minim Li J

number of years of marriage one requi r ed tile couple to have been married For at least three years By contrast the stability of relationshipo tended to be assessed by the number of years tile couple had been together which varied bet(rn one and three years with six HAs requirinCl at least two years and eight requiring three ycars together

The reasons given in the interviews for including couples only varied from concerns over the welfare of the child to a deliberate attempt to exclude single women and lesbian couples Restricting treatment to couples wa s a definite policy decision based on the welfare of the Lmiddothild (HAl) One HA stood out in the intl ~rview for having decided to concentrate on the infertility problems of women only women all the way we Jeft the men right out of it 1his was because the Authority did not want to get involved in questions of what is a couple or about lesbian couples (HAS)

Another HA had opted for provldinq IVF treaiment on an ad-hoc basis only For patients in

exceptional medical circumstances (eg cancer of the ovaries) as they did not want to use social criteria they regard thi s as pernicious because you start to make quite major value judgements (HA6)

Sexual orientation Sexual orientation was also speciFica ll y menshyt ioned by several HAs in the documentation sent to us A significa n t minority 9 of 61 (15 per cent) expressly limited funding to couples who were in a stable heterosexual relationship But tile qualitative interview s suggested that exshyclusion on grounds of sexual orientation was more widespread and tended to operate inshydirectly

One HA who had no w r itten policy restricting funding to heterosexual couples nonethelCss described its policy as deliberate (HA16) A request for treatment from a single women had been refused and whilst there had been no requests for treatmen t from les lian couples and no real decision has been made tIle DPH would be inclined to refuse to Fund treatment (HA16) One HA who had no specific written criteria said when prompted on its views during the interview that no doubt the relationship would have to be heterosexual rather than homosexual (HA12) nother said that one consultant was known only to treat hetelOsex ultJ1 couples (HA 13) One HA who had not considered the question thought that it would have to go back to the Board (HA4) and another said that whilst the question of homosexual couples was not even considered a single woman or lesbian couple would not qualiFy Ior treatment (HA7)

One HA 11ad cullsciously excluded lesbian women by default as the req uirement for a stable marriage or two-year relationship would exclude single women (HA3) fnother had consciously excluded lesbiltl11 cOllrles as they are not by definition infertile sillce Illfertility requires heterosexual sex without success for one or two years so they would not be eligible For infertility treatment because they are not infertile (HA2) As one HA who had dropped a previous requireshyment to restrict treatment to heterosexual couples candidly admitted the same result could be achieved by relying on the cle linition of infEftility alone (HA2) Alternatively IVF treatment was de facto restricted to heterosexual couples if tl1e Authority did not Fund donor tl-eatment (HA141

64

Those excluding non-heterosexual relationshyships described them as an unnatural bond (HA15) or failure to provide a secure family background (HA16) One HA thought that unshyequal treatment of lesbian couples w asjustified on the grounds that there are so many normal couples in whom there is a functioning male that one couJd not get through all of them If people have the bad luck to have other problems it does not necessarily mean that they have to be treated on an equal basis By contrast one HA which had used to treat heterosexual couples only decided to remove the exclusion as it was thought that the welfare of the child would be a more appropriate guiding principle (HA 11) Another which had expressly sought to exclude single women had nevertheless deliberately refrained from specifying the sexual orientation of the couple as it was thought that the number of gay couples likely to want treatment would be so small that there was no need to exclude them (HA20)

The welfare ofthe child The welfare of the prospective child was cited by a sign ifi cant minority of the 61 HAs as a guiding principle for exclusion 16 (29 per cent) One HA relied on the welfare of the child as the on ly absolute criterion We are not helping couples who are probably not fit to be parents (HA1) In some cases restricting trea tment to couples w as said to be a definite policy decision based on the welfare of the child (HA 7) In addition to the status of couple and sexual orientation the welfare of the child was sometimes used to justify other exclusion factors such as HIV (HA2) drug abuse (HA3) child abuse or violence (HAi0) or smoking (HAi5)

A minority had deliberately refrained from adopting a formal policy on the welfare of the child and left the decision to the provider (HAs 91420) Only one HA appeared to be aware that the clinician providing the treatment was already under a legal duty to consider the welfare of the chUd (H14)

Health Authorities who would not fund IVF The reasons given by HAs who did not fund lVF were threefold First when compared to a ll other health care priorities IVF was considered to be of low priority (HAs 81319) One HA estimated the extra cost of funding lVF to be of the order of pound500000 per year if they had this extra money

Rep roductive Health Mailers Vol 7 No 14 November middot999

they said they would rather spend it on cancer care (HA6) Second non-runders were not conshyvinced that IVF was an effective treatment (HA6) and were prepared to invest in some infe rtility services but not IVF (HAs 81319) Finally they were uncomfortable with the use of social criteria for the allocation of scarce resources Our job is not to give you a child or a child in your home or a child with this partner as opposed to any other partner (HAS)

In summary amongst the HAs who had chosen to fund IVF treatment the main findings which emerged were these

bull a majority had adopted formal eligibility criteria

bull the eligibility criteria ranged from the clinical to the social

bull although there was convergence in the choice of formal clinical criteria such as infertility and age limits there were considerable variat shyions in the detailed spec il1cation of these criteria and

bull there was convergence on the choice of social criteria such as number of children the status of the couple or sexual orientation Social criteria tended to exclude from public funding individuals who were not in a stabte heteroshysexual relationship The exclusion facto rs operated both overtly and covertly

Analysis Although clinical effectiveness was introduced by the Conservative government in the early 1990s as a rationing tool in the drive towards an efficient evidence-based health service the role this has played in the majority of HAs until now has been margina1 4 The results of our survey on rationing strategies for IVF are consistent with these findings Whilst clinical effectiveness was cla imed to be given a high priority by HAs there were significant variations in the clinical criteria adopted and the knowledge base used to justify some of the clinical guidelines adopted was poor

Some HAs themselves pointed out that clinical effectiveness is not a hard and fast concept that can be captured by exact mathematical formulae (eg an age limit of 36 as against 37) Moreover as some of its critics have noted the concept of clinical effectiveness is more diffuse and vaJueshyladen than might appear at first glance middotI2 Is

65

PJomel~ Smith Marll n-Clemenl

depression caused by failure to conceive more lITcctively treated by psychological counselling or by IVF Does treatment with a success rate of around 30 per cent count as clinically effective Should the deAnition of infertility include psychological factors which prevent cOIlCeption or physiological factors only7 More fundamentshyally does the inabiliry to have children give rise to a clinical need which in turn requires medical treatment These and other similar questions should clispel any illusion that the concept of clinical effectiveness can provide a bright di vidshying 1i Ie between treatments which are effective and Ihose which are not let alone treatmcnts which are suitable for public funding and those which are not

Nevertheless when the accepted clinicltll evidence at the time showed that the highest

rates of live births lith IVF were to be found amongst women aged 25 to 34 with th e sharpshyest drop occurring after 39 local variations in funding policies seem difficult to justifyB Subsequent studies on the clinical effectiveness of IVF cast serious doubts on the clinical soundness of tile criteria adopted by some HAs The most comprehensive study on the clinical eFFectiveness of lVF in the UK was published in 199GH The study conducted by Templelon el ai covered 36961 cycles of IVF treatment The authors looked at the effect of the womans age on the success rate for live bil lhs ~md Found that the highest live birth rates were in the age

group 25-30 years with the sharpest decline in women over 40 years At all ages over 30 use

of donor eggs was associated with a sigshy

nificantly higher live birth rate than use of the womans own eggs

Previous pIegnancies and live births were significantly associated with treatment success

The cri teria adopted by some HAs to allocate public funding for IlF treatment are not conshy

sistent with the results of this survey If health care rationing is to be

done on the basis of evidence -based medicine (EBM) then rationing strategies on the funding of IYF need to be reconsidered to reflect these flndings more accurately

In spite of the lluge politicill weight put 011

clinical and cost effectiveness it is unrealistic to expect the priority ranking of treatments til be

15based on these factors alone The two best

known rationing strategies for health resources the Oregon experiment and the QUA LY formula ultimately rely on a mix of clinical and social moral criteria In the case of the Oregon experi shyment the ranking of treatments eligible for public funding was partly the result of political and moral priorities determined by public consultation partly th e discretion of heal th commissioners using factors such as benefit quality of welJ-being and partly incidence of condition public health impact clinical effectiveshyness social costs and cost of non-treatment II In the end proponents of the Oregon experiment have conceded that the final ranking is no longer supposed to mel a gold standard but simply to appear intuiti vely sensible17

An alternati e tool fo r liltioning health resources is the QUALY formula first advanced by health economists in the mid-1980s which seeks to rate the effect of clinIcal interventions on

the quality of life of the patient adjusted for Ytdrs of life18 Although the formula has been claimed by its propon ents to be egalitarian because it does not formally favour one category of patients over

66

Those excluding non-heterosexual relationshyships described them as an unnatural bond (HA15) or failure to provide a secure family background (HA16) One HA thought that unshyequal treatment of lesbian couples w asjustified on the grounds that there are so many normal couples in whom there is a functioning male that one couJd not get through all of them If people have the bad luck to have other problems it does not necessarily mean that they have to be treated on an equal basis By contrast one HA which had used to treat heterosexual couples only decided to remove the exclusion as it was thought that the welfare of the child would be a more appropriate guiding principle (HA 11) Another which had expressly sought to exclude single women had nevertheless deliberately refrained from specifying the sexual orientation of the couple as it was thought that the number of gay couples likely to want treatment would be so small that there was no need to exclude them (HA20)

The welfare ofthe child The welfare of the prospective child was cited by a sign ifi cant minority of the 61 HAs as a guiding principle for exclusion 16 (29 per cent) One HA relied on the welfare of the child as the on ly absolute criterion We are not helping couples who are probably not fit to be parents (HA1) In some cases restricting trea tment to couples w as said to be a definite policy decision based on the welfare of the child (HA 7) In addition to the status of couple and sexual orientation the welfare of the child was sometimes used to justify other exclusion factors such as HIV (HA2) drug abuse (HA3) child abuse or violence (HAi0) or smoking (HAi5)

A minority had deliberately refrained from adopting a formal policy on the welfare of the child and left the decision to the provider (HAs 91420) Only one HA appeared to be aware that the clinician providing the treatment was already under a legal duty to consider the welfare of the chUd (H14)

Health Authorities who would not fund IVF The reasons given by HAs who did not fund lVF were threefold First when compared to a ll other health care priorities IVF was considered to be of low priority (HAs 81319) One HA estimated the extra cost of funding lVF to be of the order of pound500000 per year if they had this extra money

Rep roductive Health Mailers Vol 7 No 14 November middot999

they said they would rather spend it on cancer care (HA6) Second non-runders were not conshyvinced that IVF was an effective treatment (HA6) and were prepared to invest in some infe rtility services but not IVF (HAs 81319) Finally they were uncomfortable with the use of social criteria for the allocation of scarce resources Our job is not to give you a child or a child in your home or a child with this partner as opposed to any other partner (HAS)

In summary amongst the HAs who had chosen to fund IVF treatment the main findings which emerged were these

bull a majority had adopted formal eligibility criteria

bull the eligibility criteria ranged from the clinical to the social

bull although there was convergence in the choice of formal clinical criteria such as infertility and age limits there were considerable variat shyions in the detailed spec il1cation of these criteria and

bull there was convergence on the choice of social criteria such as number of children the status of the couple or sexual orientation Social criteria tended to exclude from public funding individuals who were not in a stabte heteroshysexual relationship The exclusion facto rs operated both overtly and covertly

Analysis Although clinical effectiveness was introduced by the Conservative government in the early 1990s as a rationing tool in the drive towards an efficient evidence-based health service the role this has played in the majority of HAs until now has been margina1 4 The results of our survey on rationing strategies for IVF are consistent with these findings Whilst clinical effectiveness was cla imed to be given a high priority by HAs there were significant variations in the clinical criteria adopted and the knowledge base used to justify some of the clinical guidelines adopted was poor

Some HAs themselves pointed out that clinical effectiveness is not a hard and fast concept that can be captured by exact mathematical formulae (eg an age limit of 36 as against 37) Moreover as some of its critics have noted the concept of clinical effectiveness is more diffuse and vaJueshyladen than might appear at first glance middotI2 Is

65

PJomel~ Smith Marll n-Clemenl

depression caused by failure to conceive more lITcctively treated by psychological counselling or by IVF Does treatment with a success rate of around 30 per cent count as clinically effective Should the deAnition of infertility include psychological factors which prevent cOIlCeption or physiological factors only7 More fundamentshyally does the inabiliry to have children give rise to a clinical need which in turn requires medical treatment These and other similar questions should clispel any illusion that the concept of clinical effectiveness can provide a bright di vidshying 1i Ie between treatments which are effective and Ihose which are not let alone treatmcnts which are suitable for public funding and those which are not

Nevertheless when the accepted clinicltll evidence at the time showed that the highest

rates of live births lith IVF were to be found amongst women aged 25 to 34 with th e sharpshyest drop occurring after 39 local variations in funding policies seem difficult to justifyB Subsequent studies on the clinical effectiveness of IVF cast serious doubts on the clinical soundness of tile criteria adopted by some HAs The most comprehensive study on the clinical eFFectiveness of lVF in the UK was published in 199GH The study conducted by Templelon el ai covered 36961 cycles of IVF treatment The authors looked at the effect of the womans age on the success rate for live bil lhs ~md Found that the highest live birth rates were in the age

group 25-30 years with the sharpest decline in women over 40 years At all ages over 30 use

of donor eggs was associated with a sigshy

nificantly higher live birth rate than use of the womans own eggs

Previous pIegnancies and live births were significantly associated with treatment success

The cri teria adopted by some HAs to allocate public funding for IlF treatment are not conshy

sistent with the results of this survey If health care rationing is to be

done on the basis of evidence -based medicine (EBM) then rationing strategies on the funding of IYF need to be reconsidered to reflect these flndings more accurately

In spite of the lluge politicill weight put 011

clinical and cost effectiveness it is unrealistic to expect the priority ranking of treatments til be

15based on these factors alone The two best

known rationing strategies for health resources the Oregon experiment and the QUA LY formula ultimately rely on a mix of clinical and social moral criteria In the case of the Oregon experi shyment the ranking of treatments eligible for public funding was partly the result of political and moral priorities determined by public consultation partly th e discretion of heal th commissioners using factors such as benefit quality of welJ-being and partly incidence of condition public health impact clinical effectiveshyness social costs and cost of non-treatment II In the end proponents of the Oregon experiment have conceded that the final ranking is no longer supposed to mel a gold standard but simply to appear intuiti vely sensible17

An alternati e tool fo r liltioning health resources is the QUALY formula first advanced by health economists in the mid-1980s which seeks to rate the effect of clinIcal interventions on

the quality of life of the patient adjusted for Ytdrs of life18 Although the formula has been claimed by its propon ents to be egalitarian because it does not formally favour one category of patients over

66

PJomel~ Smith Marll n-Clemenl

depression caused by failure to conceive more lITcctively treated by psychological counselling or by IVF Does treatment with a success rate of around 30 per cent count as clinically effective Should the deAnition of infertility include psychological factors which prevent cOIlCeption or physiological factors only7 More fundamentshyally does the inabiliry to have children give rise to a clinical need which in turn requires medical treatment These and other similar questions should clispel any illusion that the concept of clinical effectiveness can provide a bright di vidshying 1i Ie between treatments which are effective and Ihose which are not let alone treatmcnts which are suitable for public funding and those which are not

Nevertheless when the accepted clinicltll evidence at the time showed that the highest

rates of live births lith IVF were to be found amongst women aged 25 to 34 with th e sharpshyest drop occurring after 39 local variations in funding policies seem difficult to justifyB Subsequent studies on the clinical effectiveness of IVF cast serious doubts on the clinical soundness of tile criteria adopted by some HAs The most comprehensive study on the clinical eFFectiveness of lVF in the UK was published in 199GH The study conducted by Templelon el ai covered 36961 cycles of IVF treatment The authors looked at the effect of the womans age on the success rate for live bil lhs ~md Found that the highest live birth rates were in the age

group 25-30 years with the sharpest decline in women over 40 years At all ages over 30 use

of donor eggs was associated with a sigshy

nificantly higher live birth rate than use of the womans own eggs

Previous pIegnancies and live births were significantly associated with treatment success

The cri teria adopted by some HAs to allocate public funding for IlF treatment are not conshy

sistent with the results of this survey If health care rationing is to be

done on the basis of evidence -based medicine (EBM) then rationing strategies on the funding of IYF need to be reconsidered to reflect these flndings more accurately

In spite of the lluge politicill weight put 011

clinical and cost effectiveness it is unrealistic to expect the priority ranking of treatments til be

15based on these factors alone The two best

known rationing strategies for health resources the Oregon experiment and the QUA LY formula ultimately rely on a mix of clinical and social moral criteria In the case of the Oregon experi shyment the ranking of treatments eligible for public funding was partly the result of political and moral priorities determined by public consultation partly th e discretion of heal th commissioners using factors such as benefit quality of welJ-being and partly incidence of condition public health impact clinical effectiveshyness social costs and cost of non-treatment II In the end proponents of the Oregon experiment have conceded that the final ranking is no longer supposed to mel a gold standard but simply to appear intuiti vely sensible17

An alternati e tool fo r liltioning health resources is the QUALY formula first advanced by health economists in the mid-1980s which seeks to rate the effect of clinIcal interventions on

the quality of life of the patient adjusted for Ytdrs of life18 Although the formula has been claimed by its propon ents to be egalitarian because it does not formally favour one category of patients over

66

another critics have poirilted out that it would discriminate against the physicully or mentally handicapped19 The formula has also been crit icised as ageist 2o In the case or IVF it is not clear how the formula cou ld avoid the use of moral and evaluative judgments in comparing the potential impact of IVF on the quality of lire of a couple whose on ly child was killed in an accident a couple who had chosen not to have a child but would like one now in their late thirties a single woman of 35 who has stil l not found her ideal partner and a woman of 30 who is homosexultll

The problems revealed by rationing strategies like these suggest that the rationing of scarce health resources cannot be conducted on the basis of simple value-free cosl and clinical formulae or without reference to soc ial moral and political criteria This has led some to argue that it is best to revert to the old practice of mudd ling through elegantly21 but the political reality is that rationing is at least for the time being here to stay The best that may be hoped is that the distribution of health resources and priority ranking of treatments may at least ciuim some moral and political legitimacy This would require rankings not only to reflect community values but also to fulfil the minimal req uirement of being reasonable and fair if not fully rational or logical On this basis nobody wou ld deny that it may indeed be moraJly and politically le(Jit ishymate to allocate more resources to the treatment of cancer or kidney dialysis than to IVF treatshyment From this point of view that the funding of IVF treatment should have a low priority in an overall ranking of treatments is not in dispute

What is problematic however is the further overt or covert use of social criteria such as marital status or sexual orientation to determine eligibility for treatment - when the criteria in question ale not clinical but social a nd system shyatically discriminate against who le categories of individu als on the basis of their social status and sexual orientation

The Human Fertilisation and Embryology Act 1990 legal considerations It may be argued that the use of social criteria to determine who should receive IVF treatment is in any event required by the Human Fertilisation and Embryology Act 1990 That Act allows clinic-

Reproductive Health Matters Vol 7 No 14 November 1999

ians to determine who should receive treatment on the b1sis of the welfare of children specificshyally the Act says ISection 13(5)J that in detershymining who should receive treatment services providers ale required to take into account

the welfare ofuny child who may be born as a result of the treatment (including the need of that child for iI father) unci orany other chilci who may be afTectcci by the birth 22

The original bill carried no qualifications on eli(Jibilily for treatmenl 22 Section 13(5) w as inshyserted in response to various moves to amend the bill by members or Parliamen t whose motivashytion was to lxclude individuals from ttreatment on the basis or their marital status andor sexual orien tation 21 Butthe actual wording con lains no such exclusion furthermore the slatutory Code of Practice drawn up by the HFEA to provide guidance to clinicians for assessing those who seek treatment bears no support for such blanket exclusions I nslead the Code of Practice requires licensed IVF centres to bear in mind

bull their commitment to having and bringing up a child or children

bull their ability to provide a stable and supportive envilonment for any child produced as a result of treatment

bull their ages and likely future ability to look after or provide for a childs needs

bull their ability to meet the needs of any child or children who may be born as a result of treatment including the implications of any possible multiple births and

bull the effect of a new baby or babies upon any existing child of the family

There is a notable degree of overlap between these criteria and those adopted by several HAs and some criteria eg age limits or the requireshyment of marriage or a s table relationship could be construed as indicative of an applicants abilshyity to meet the HFEA conditions But there are crucial differences between the formal criteria adopted by HAs and the iactors listed in the HI~A Code oFPractice

First the Act requires clinicians providing the service to assess the suitability of each individual patient By contrast some HAs policies operate so as to exclude whole cutegories of patients regardless of their individual circumstances

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Plo m er S 1 l Il Martill -Clement

Secondly the factors listed in the Code of Practice are not supposed to operate as rigid criteria Instead they constitute evidence of the woman sl couples ability to meet the needs or welfare of the prospective child they are not intended to be applied in an all-or-no thing manner Clinicians are required to use their discretion whilst the highly specific eligibility criteria dl-awn by some HAs do not allow them to do so Under the Code of PIactlce clinicians may not automatically rule out a patient who happens to be single or has children from previous relationships The relative weight of various factors has to be assessed by reference to each individuals circumstances

Thus an institutionalised discrepancy exists between the rationing policies drawn by HAs which operate on a blanket basis and the Code of Practi ce which requires eligibility guidelines to be applied to individual cases As a result patshyients who may be deemed legally and clinically suitable for treatment by a consultant providin G the service may be denied NHS funding by HAs on the basis of local eligibility criteria [n the worst cases where individuals cannot access funding for treatment because of their sexual orientation or marital status the rationing polshyicies appear to be in conflict with the prima facie meaning of the wording in the Human Fert ilisa shytion and Embryology Act 1990 and the guidance in the HFEA Code of Practice

The HFEA has no control over the rationing policies of Health Auth orities as its remit is limitshyed to the licensing and regulation of clinics delivering the service Hovever the discrepanshycies b tween the Act and Code of Practice and local policies identified in this study would be relevant factors for a court to consider if asked to judge the legality of the exclusion policies adoptee by some Health Authorit ies

The policies of Health Authorities may be legally scrutinised by the courts who are rn shypowered to determine whether these policies are ultra-vires (illegal because they are in excess of the Authorities powers) But illegality is difficult to establish The accepted legal wisdom is that courts will not normally query the Ilgality of a policy concerning the allocation ur scarce Ieshysources because the economic distribution of resources is generally seen as ] politiedl quesshytion which is the preserve of PClrliament or a body entrusted by Parliament21 [n cases conshycerning the closure of hospitals termination of

services or denial of treatment English courls have consistently found against patient claimants on the basis that

[t is not for this court or indcc( i any court to substitute its ownjuclgcment for theJudgement of those who are responsible for th e allocation of resources 25

Non-vithstanding these stlOng obstacles the possibility remains of rationing policies being held illegal by the courts on the judicial review grounds of irrationality or unreasonableness A technical discussion of the natLll-e of judicial revievv is beyond the scope of this paper Nevershytheless a 1994 rUl i ng2G suggests how a legal challenge might be raised Mrs S who was 37 was refused [VF tl(atment on the grounds that she was over the aqc limit of 35 In a letter to Mrs S the Health Author ity explained that because of its limited resources and the high demand for IVF treatment it had decided to make the best use of these resources by setting criteria aimed at limiting the treatment to those for whom it felt there would be the greates t clinical benefit

The judge refused to And that the cut-off point of 35 was irrational because at the time there was clinical support for the view that treatment after age 35 was less effective The judge also rejected an altern at ive sU~Jgestion that the policv was irrational because it set i blanket cut-ofr point and took no account of the individual circumstances of each patient He held that whilst a clinical d ecision on a case-by-case basis is clearly desirable it is not unreasonable for a Health Authority to adopt a general policy based on what is known about the clinical effectiveness of a treatment after a certain age This ruling clearly establishes that I-ationing strategies of exclusion or limited ilccess to funding For IVF based on clinical effec tiveness ale not illegal

What is far from clear 1S whether blanket policies based on the sexual orientation or social status of the woman patient instead are equally lawful Arguably they are not Furthermore it is highly probable L1t)t such blanket exclusions re indppendently in breach of Articles 8 12 and 14 of the European ConvPl1t ion on Human Righ ts which respectively protect th e r ight to respect for family life the right to foun d a family and the securement of such rights without discrimination on any ground sLi ch as sex birth or other status

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1

Rep roductive Health M atters Vo 7 No 14 November 1999

Conclusion The legal and administrative changes of the early 1990s forced HAs to adopt rationing strategies to allocate health resources Our survey of HA rationing policies for lVF treatment discloses

several sources of concern On the process of policy formation the devolution of rationing decisions to local HAs has resulted in a multiplishycity of approaches which are not necessarily consistent with each other nor based on the purported goal of promoting clinical and cost effectiveness In a substantial number of authorishyties social criteria play a significant part in determining access to treatment Some of the criteria are controversial and discriminatory as they operate in a blanket manner to systematicshyally exclude from funding certain categories of women and couples Finally there also appears to be a discrepancy between the blanket exclusshyion policies adopted by some Health Authorities

and the legi slative framework on access to IVF treatment contained in the HFE Act 1990 and the statutory HFEA Code of Practice These are probably in breach of Articles 8 12 and 14 of the European Convention on Human Rights even if not of English domestic law

Acknowledgements Th e authors would like to thank Bobbie Dew for her invaluable contribution in collecting the data and conducting Interviews and a1l the Health Authorities who participated in the survey parshyticularly those who agreed to b e interviewed This study was made poscible through generous funding from the University ofLeeds

Correspondence Aurora Plomer Department of Law University of Leeds Fax 44- 113-233-5056 E-mail lawapleedsacuk

References and Notes Gunning J English V 1993 Human In- Vitro Fertilization Dartmouth

2 College of Health 1992First Report of the National Survey of the Funding and Provision of Infertility ServicES College of Heal th London

3 Stone V Riese l J 1997 Repoli of the Fifth National Survey of the

funding and Provision of Infeliility Services COllege of Health London

4 Kleil1 R D ay P Redrnaynes 1996 Mannqing Scarcity Priority selling and rationing in the NHS Opel1 Un iversity Press Buckingh am

5 White Paper 1944 A National -Iealth Service Cmd 6502 111150 London

6 Calabresi G Bobbitt p 1978 Tragic Choices Norton and Company IlW York

7 NHS Manltl0ement Executive 1994 ManaSinu Ihe New N-IS Functions and Responsibilities in the New NI-IS NilS Executive Leeds

8 NHS Management Execulive Department of Health 1995 Statement of Responsibilities

~nd Accountabilities Depallmcnt of Health London

9 NflS Lxccutive 1996 Promoting Clinical Effectiveness a Framework For Action in and through the NHS NBS Executive Leed s

10 NHS M anagement Executive 1992 Local Voices involving the

local community in purchasing deciltions NHS Executive Leeds

11 Redmnync 5 Klein R 1993 Rationing in practicethe case of in vi tro Imiddotcrtilisation British M edicalJournal30G1l21 -4

12 Gray SF Bevan G amp Frankel S 1997 Purchasil1g [vidence the corollary of ev idence-based pUlchasinfjJournal of Public HeuIll Medicinc 19(1)6-10

13 HUIWln Fertili sation amp

Embrylom Authority 1995 I ourlh Annual Report Human Fertilizalion and Embryology Authority London

14 Templeton A M orris JK Parslow W 1996 Factols that affect outcome of in-vitro fertilisation treatment Lancet Nov 2334g (9039)1394 Also flprgtrtecl in H FTA 1997 Sixth

Annual Report H FE A London 15 The following give an insight

in to the range and breadth of the political and ethical debate on rationing in the NHS at the time the survey was conducted House of Commons Health Commillee 19951st repori (session 1994-S) Priority selting in the NHS purchasing HC 134shy1 HMSO London Academy of Medical ROy~1 Colleges British Medical Association National Association of Heath Authorit ies and Trusts NHS Executive 1996 Priority Setting in the NHS a discussion document South East Insitute of Public Health Tunbridge Well s Royal Co IIC(lC of Ph ysicians o f London 1995 Setting priorities in the NHS Roya l College of Physic ians olLondon London British Medical A socation Health PoliCy and Economic Research Unit 1995 Rationing revisited it d iscussion paper Discu ss ion Paper No 4 BMA London

16 Sllosberg MA (ed) 1992 Rutioninq America s M edical Care the Oregon Plan and

69

1

Rep roductive Health M atters Vo 7 No 14 November 1999

Conclusion The legal and administrative changes of the early 1990s forced HAs to adopt rationing strategies to allocate health resources Our survey of HA rationing policies for lVF treatment discloses

several sources of concern On the process of policy formation the devolution of rationing decisions to local HAs has resulted in a multiplishycity of approaches which are not necessarily consistent with each other nor based on the purported goal of promoting clinical and cost effectiveness In a substantial number of authorishyties social criteria play a significant part in determining access to treatment Some of the criteria are controversial and discriminatory as they operate in a blanket manner to systematicshyally exclude from funding certain categories of women and couples Finally there also appears to be a discrepancy between the blanket exclusshyion policies adopted by some Health Authorities

and the legi slative framework on access to IVF treatment contained in the HFE Act 1990 and the statutory HFEA Code of Practice These are probably in breach of Articles 8 12 and 14 of the European Convention on Human Rights even if not of English domestic law

Acknowledgements Th e authors would like to thank Bobbie Dew for her invaluable contribution in collecting the data and conducting Interviews and a1l the Health Authorities who participated in the survey parshyticularly those who agreed to b e interviewed This study was made poscible through generous funding from the University ofLeeds

Correspondence Aurora Plomer Department of Law University of Leeds Fax 44- 113-233-5056 E-mail lawapleedsacuk

References and Notes Gunning J English V 1993 Human In- Vitro Fertilization Dartmouth

2 College of Health 1992First Report of the National Survey of the Funding and Provision of Infertility ServicES College of Heal th London

3 Stone V Riese l J 1997 Repoli of the Fifth National Survey of the

funding and Provision of Infeliility Services COllege of Health London

4 Kleil1 R D ay P Redrnaynes 1996 Mannqing Scarcity Priority selling and rationing in the NHS Opel1 Un iversity Press Buckingh am

5 White Paper 1944 A National -Iealth Service Cmd 6502 111150 London

6 Calabresi G Bobbitt p 1978 Tragic Choices Norton and Company IlW York

7 NHS Manltl0ement Executive 1994 ManaSinu Ihe New N-IS Functions and Responsibilities in the New NI-IS NilS Executive Leeds

8 NHS Management Execulive Department of Health 1995 Statement of Responsibilities

~nd Accountabilities Depallmcnt of Health London

9 NflS Lxccutive 1996 Promoting Clinical Effectiveness a Framework For Action in and through the NHS NBS Executive Leed s

10 NHS M anagement Executive 1992 Local Voices involving the

local community in purchasing deciltions NHS Executive Leeds

11 Redmnync 5 Klein R 1993 Rationing in practicethe case of in vi tro Imiddotcrtilisation British M edicalJournal30G1l21 -4

12 Gray SF Bevan G amp Frankel S 1997 Purchasil1g [vidence the corollary of ev idence-based pUlchasinfjJournal of Public HeuIll Medicinc 19(1)6-10

13 HUIWln Fertili sation amp

Embrylom Authority 1995 I ourlh Annual Report Human Fertilizalion and Embryology Authority London

14 Templeton A M orris JK Parslow W 1996 Factols that affect outcome of in-vitro fertilisation treatment Lancet Nov 2334g (9039)1394 Also flprgtrtecl in H FTA 1997 Sixth

Annual Report H FE A London 15 The following give an insight

in to the range and breadth of the political and ethical debate on rationing in the NHS at the time the survey was conducted House of Commons Health Commillee 19951st repori (session 1994-S) Priority selting in the NHS purchasing HC 134shy1 HMSO London Academy of Medical ROy~1 Colleges British Medical Association National Association of Heath Authorit ies and Trusts NHS Executive 1996 Priority Setting in the NHS a discussion document South East Insitute of Public Health Tunbridge Well s Royal Co IIC(lC of Ph ysicians o f London 1995 Setting priorities in the NHS Roya l College of Physic ians olLondon London British Medical A socation Health PoliCy and Economic Research Unit 1995 Rationing revisited it d iscussion paper Discu ss ion Paper No 4 BMA London

16 Sllosberg MA (ed) 1992 Rutioninq America s M edical Care the Oregon Plan and

69

Pl omer Smith Martin- Clemtlll

Beyund Brookings Institution Washington DC

17 Hadlrn D middotJ991 Setting Health Carc Priorities in Oregon Journal 01 the American Medical A ssoc iation 2652218-25

18 WilJ i1ms A 1985 The eC01omics of coronary artery bypass grafting British Medical Jouma1291326 and Maynard A 1987 Logic in medicine British

M eeicai Journal 2951537 19 Crisp R 1991 QUALYs ane the

mentally handicapped Bulletin ofil ledical Elhics April 13-16

20 H arris J 1987 QUALYfying the value of life Journat of vIedicai Etll ic 13117- 12 3

21 Hunter D 1997 Desperately

Sccking Soiulio lls Longman London

22 HC Debs Vol 174 2lst June 1990 Col 1021 Section 13(5) of the Act

23 Douglas G Assisted Reprod uction and the Welfare of th e Ch ild Current Legal

ProlJI1lns 4middot6 53-74 The survey of clinics co nducted by Douglas in 1993 revealed thai the aims of those wh o sought to eXClude sing le wo m en appeared to have succeedeu in practice as clinic ialls offering IVf treatment tended to restrict treatment to heterosexual couples in a stable relationship - See also Millns S 1995

Maing socialjuclgements that go bey ond the purely medical The r eprocluctive Ievolution and acuSs to fertility treatment services In J Bridgman S Millns led 1 Lawaod Body

Poilrics Reg w ating tile Female Bod Dartmouth Publishing Co A ldc rsllOl

24 Newclick C 1995 Wilo Shou ld W tJ rcat Clarendon Press Ox ford

25 Lorel Don ald~on MR in R v Secretary orState for Soc ial Senccs ex-piirte Walker (1992)

3 BMLR 32 26 In R v Shrflhld Health Authori

ex pa rIlt SCiJII (17 October 1994 transc ript)

Resume Les autorites sariita ires ont ete obligees pour maint s raisons dappiquer des strategies de rationnement pour allouer les ressources de sante Larticle rend compte dune etude des stratshyegies de rationnement adoptees par les autorites de sante en Angleterre et au Pays de Galles pour la feco nciation in vitro (FIV) Tous les departements de sante ont ete invites adonner des informations sur leur politique en matiere de FIV un echan tilton represenlatif a ensuite pri s part a un entretien de su ivi La majorite des autori l es sanitaires ava it adopte un critere officie l de recevabilite afin de financer I acces au traitemenr pOUl ta FIV Ces crithes etaient a la fois publics et caches et touchaient des facteurs cli niques et sociaux lis comprenlt1ient la stcri l ite les limiles dage Ie nombre denfants la situation du cou p le et I rientation se uelle Lcs criteres sociaux tendaient aexclure du Anancement public les indishyvidus qui nentretenaient pas une rdation heterosexuelle stable Nous avolls trou Vl line multiplicite dapproches qui netaient pas n(cessshyairemcnt coherentes les unes avec les autres pas plu s quelles netaient fond ees sur Iobjectif declare - promouvoir Iefficacite clinique Et finanshyCietT Certa ines eta ient franchement discriminashytoires a Iegard de certaines categories de femilles

Resumen Las autoridades de salud se han visto forzada s a adoptar estrategias de racionamiento para la distribucion de reClIlSos Este informe da cuenta de un estudio de las cstrateg ias de racionamiento especiAcas adoptaclas POl las Autoridades de Sa lud en lnglaterra y Gales (Reino Unido) en relO3cion a la fecundacion in vitro lFIV) Se les sol icito a todas las Autoridades de Salud en estos paises informaci6n sobre sus politicas locales con respecto a la FIV una muestra representashytiva participo posteriormente en una entrevista de segu imiento La mayoria habfan adoptado uiterios de seleccion formates con el An de fin anciar el acceSlJ al tratamiento de FIV Oicl1os criterios eran tanto abiertos como encubiertos y aba rca ban factores clfnicos y sociales La tendshyen cia era de excluir del finallciamiento publico a personas que no degstabCl n en una relacion heteroshysexual estable fos preocupaba encontrar multshyiples enfoques qlle no necesatia mente coincicifan entre si ni que (staban basaelos ell la supuCsta meta de promover lltJ eflcacia clinica y financiera mas algunos que discriminaron abiertamente en contra de ciertas categorias ell mujeres

70