Round robin summary - March 2012 Co-payment for unlicensed drug Egg donation Recruitment and training of Lay members
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- Melvin Fox
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1 Round robin summary - Co-payment for unlicensed drug Egg donation Recruitment and training of Lay members In January we received three round robin requests to the Network. Below are the requests followed by a summary of the collated responses from CECs. Thank you to those CECs who responded. I would like to encourage all CECs to engage in the round robin exercise. Sharing experience and knowledge helps other committees but can also be beneficial to responding committees as many of the issues and cases provide useful educational opportunities. 1. Co-payment for unlicensed drug An ethics committee has been approached for advice from a consultant who has received a request from an NHS patient to be allowed to pay for top up treatment on the NHS for a drug which is not licensed for the patient s condition. The drug, IVIg is used for the treatment of a number of different neurological (and other) conditions, including Guillain Barre Syndrome (GBS). There is randomised control trial evidence of its efficacy in GBS, but in other neurological conditions the level of evidence is expert opinion only. The treatment is relatively expensive, and it is therefore designated by the patient s local NHS Trust as a high cost therapy. The cost of each course to the NHS is approximately 1,500, a recent quote from the private sector was 10,000 per course. Permission for its use out of licence has to be sought on a case by case basis. A patient with a neurological condition for which this drug is not licensed has asked to be allowed to pay for top up treatment on the NHS when a request for IVIg was refused by their Trust on the grounds of lack of proven efficacy. The patient cannot afford to pay the full private cost of treatment but could afford the 1,500. The ethics committee is interested to know if other committees have considered similar cases of requests for co-payment for treatment, and what the views of other CECs are on this issue. We received responses from ten CECs to this case and a range of ethical considerations were discussed. 1. Some responders commented on what constitutes evidence of effectiveness in cases such as these where for example the rarity of the condition makes it unlikely that large scale trials can be conducted. Responders thought that expert opinion was relevant as a form of evidence in these circumstances, although not necessarily sufficient to justify treatment depending on other factors such as cost and fairness. Responders agreed that if IVIG was to be provided either within the NHS or by top up payment the agreement of the treating consultant that provision of IVIG was in the patient s best interests would be required. One committee cautioned that it would be important to establish there was no conflict of interest for the treating consultant, for example a relationship with the pharmaceutical company providing the drug. AS comment Expert opinion is a recognised category of evidence but there is a difference between expert opinion, that is, for example, the consensus view of a recognised body of experts in the field and the personal view of an individual consultant. 2. The discrepancy between the cost of IVIG to the NHS and the cost of a course of treatment in the private sector was noted by some responders. Some questioned whether the high cost in the private sector constituted exploitation of patients while others wondered if additional costs of
2 treatment (other than the cost of the drug itself) were not being included in the NHS cost. Clarity of what the real cost of treatment with IVIG was considered important as those CECs sympathetic to top up payment were clear that the patient should pay the full cost of treatment and not just the cost of the drug. 3. Several responders specified that an important ethical consideration was an assessment of the benefit of the treatment to this particular patient (and any risks involved). More information on this from the treating team might be helpful. One committee also considered the potential benefit to other patients by increasing the evidence base and thus informing future treatment decisions in similar cases. 4. Responders also emphasised the importance of the patient having been provided with accurate information about the likelihood of benefit and of any risks involved so that they could make an informed choice about paying for treatment. If this was the case then many responding committees were sympathetic to the idea of allowing top up payment for the IVIG on the grounds of respecting the patient s autonomous wishes. 5. However all responding committees also recognised that the ethical consideration of justice required that other patients within the NHS should not be unfairly disadvantaged by allowing some patients to pay for part of their treatment. Some committees raised questions about any additional costs of the treatment that may be incurred, for example treating adverse reactions or complications of treatment, or increased use of nursing time and equipment. Theoretically these costs could be calibrated and included in any co-payment arrangement but this may be difficult in practice. AS comment Of course a patient may choose to pay for private health care, for example a surgical procedure, and if he or she late has complications from the procedure may seek and be offered NHS care. The difference in the situation being considered in this case seems to be that by providing the treatment within the NHS system the NHS is instigating a procedure which may result in future demands on NHS care rather than simple responding to a need generated by a procedure conducted outside its initial control. 6. There was also a feeling of discomfort expressed by some responders that allowing top up payment for part of a patient s treatment within the NHS system would lead to the creation of a two tier NHS system with some patients who could afford it receiving a higher standard of care (or at least more choice about their treatment). While this already happens to some extent with patients able to seek treatment in the private sector, the integration of private and NHS funded care within the NHS system was seen as qualitatively, and morally, different. One committee described a certain yuk factor in allowing patients to be treated differently within the NHS based on their ability to pay more. 7. A further interesting and relevant point was made by two committees. Whereas the initial referral seems to suggest that the primary reason for the PCT restricting funding for IVIG is because of the cost (it is an expensive drug and therefore there are strict efficacy criteria, another reasons is that there is overall a shortage of IVIG and there is a national policy on the use and commissioning of IVIG to ensure that sufficient supplies are available for treating sever and life threatening conditions where there is good evidence of efficacy. Thus even if it can be ensured that all costs are met by the patient there is still a justice consideration around the fair
3 distribution of a scarce resource and the risk to other patients of not receiving a drug for which there is strong evidence of benefit to them. AS comment the most recent national clinical guidelines on use of IVIG are available at Interestingly the updated guidelines take into account expert opinion in their assessment of evidence and cite one example of the committee accepting expert opinion when no RCT evidence was available. The journal, Clinical Ethics published a Five minute Focus on top up payments in 2008 (Slowther A. Co-payment for medical treatment ) ce.rsmjournals.com.pugwash.lib.warwick.ac.uk/content/3/4/168.full.pdf+html?sid=2f901b92-5b c9b48b8983 The DH guidance on co-payment can be found at DH_096428
4 2. Egg donation arrangements with European clinics A committee has been asked to review a proposed arrangement (underwritten by a formal contract) between their local IVF unit and a centre in Spain. The purpose of the link is to facilitate patients needing ovum donation to seek help in the Spanish centre which, in contrast to the Local Centre, has sufficient donor eggs. According to this arrangement, patients will receive some of the investigations and follow-up at the local unit, and travel to Spain at the optimal time to receive the donated egg/embryo. One objective would be to reduce the cost and burden on patients. Similar arrangements already exist between other UK centres and centres in Spain. Some of these arrangements are publicly advertised on the internet. The committee was also advised that the HFEA has knowledge of the arrangements. The IVF unit clinicians argue that the severe shortage of donated ova in the UK make arrangements such as this necessary. This shortage may be related to the more restricted financial remuneration paid in the UK compared to Spain for example, or because of the different rules on anonymity of donors in that country. Having a formal agreement between the local IVF centre and the Spanish centre will provide patients with some reassurance of quality and that they will be treated according to an approved protocol. The clinicians concerned felt this to be important and would reduce the likelihood of patients seeking treatment abroad in less controlled circumstances if they cannot obtain services locally. Overseas IVF centres readily advertise their services in print and on the internet. The ethics committee would welcome views from other CEC on the following: 1- Whether they have discussed similar cases in the past? 2- Whether they would view such arrangements favourably? 3- If the committee were to take a less favourable view, what measures might be available for a committee to escalate concerns locally? Responses were received from ten committees. In general responders were supportive of a practice that would increase the opportunities for infertile women to conceive with egg donation, acknowledging that the shortage of egg donors in the UK meant that many women either suffered considerable distress at not being able to have a child, or sought treatment overseas, possibly in unregulated clinics. The principles of respect for autonomy and beneficence would seem to support the fertility clinic s attempts to improve this situation. However concerns were expressed on a number of issues outlined below: 1. Responding committees noted that there was a contract between the UK clinic and the Spanish clinic but expressed some concern over how this would work in practice. For example if a woman or her foetus was harmed as a result of negligence on the part of the Spanish clinic where would the legal liability lie? Would the UK clinic be legally responsible for the care provided in Spain or would the woman have to seek redress in the Spanish courts. While these are legal issues rather than ethical they do raise the ethical issue of a doctor s duty of care to her patient and the scope of that duty. 2. A key concern was the possible reasons for an increase in donor availability in Spain and whether this related to payment of donors to a higher level than reimbursement of expenses which is the regulatory requirement in the UK. The reason for the UK cap on donor payment is a concern to
5 avoid undue coercion of donors from financial incentives. If this is thought to be an ethical concern then a UK clinic providing treatment for women that includes egg donation achieved through financial incentives would appear to conflict with the ethical principles underpinning UK regulation. Several committees stated that they would support the clinic s proposal providing it was consistent with UK regulatory and ethical guidance. One responder however did point out that there are different regulatory requirements regarding organ donation across Europe (for example Spain has an opt out system and the UK has an opt in system) but organs are shared across Europe and a UK transplant team could accept a kidney donated in Spain. The question was raised as to whether there was a difference between organ and egg donation. (AS comment currently the HFEA provide advice on gamete donation from other countries including imported gametes and donors from abroad travelling to the UK). A further concern expressed regarding consistency across treatments being provided in UK clinics is whether the children born as a result of the proposed treatment model would have a right to know the identity of their genetic parent as children of UK egg donors now have. If this was not the case the question would then be whether the argument of beneficence for the couple who would be able to have a child, and the benefit of any child born in existing, outweighs the harm to that future child of not knowing their genetic parent. Of course if that argument is persuasive it would also hold for UK egg donation. Thus reassurance was sought by responding committees that the regulatory criteria regarding payment of donors and access to donor information were applicable to the treatment provided in the Spanish clinic. 3. A more general point was made by many responders regarding the need for more egg donors in the UK. Committees thought that more should be done to recruit egg donors, including consideration of reversing the legislation on access to donor information by children born as a result of egg donation. 4. A further consideration raised by one committee was the possibility of patients awaiting NHS IVF treatment being pressurised into transferring to the new model which is not publicly funded. AS comment The HFEA has recently released updated guidance on gamete donation following a public consultation. The amended guidance can be accessed at
6 3. Recruitment and training of lay members A CEC with a number of very active and committed lay members who have mostly involved with the committee at its inception are now looking to recruit new lay members. All original members of the committee, including lay members, received training. The committee wishes to enquire from other committees about their process of recruiting (e.g. advertising, word of mouth etc) and training lay members, and whether any of the other committees has taken a more formal approach to the process involving a role description etc. We received eleven responses to this enquiry. Most committees have lay members. Some have advertised for lay members externally in the local press, although one committee commented that this avenue was blocked by the Trust because of lack of funding. Other committees report approaching local patient forums. One committee has a lay member role description drawn up in consultation with the Trust patient experience manager. Some committees have application forms based on the UKCEN core competencies, and some conduct interviews with new members. Most committees also rely on word of mouth and personal recommendations for recruitment. Training for all CEC members was reported as an issue, mainly due to lack of funding for the committee. Some committees provide in house training if they have an ethicist on the committee. One committee has invited a philosopher to give a talk to the committee. Others arrange joint training with other committees locally. AS comment I will ask those committees who have application forms/role descriptions if they are prepared to share them with other committees. UKCEN hosts a preconference workshop on the day prior to the annual UKCEN conference. This is free for members of CECs who have paid their annual network subscription. More details are available on the. UKCEN website.
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