2004 Ethics and Health Monitoring report - Health Council of the Netherlands (Gezondheidsraad)

Advisory report | 29-06-2004

The report addresses seven developments relating to six specific topics. In the case of advanced home care technology, both councils have made observations based on their respective fields of expertise. The remaining sections of this report cover a wide range of subjects.

Section 1, Fertility insurance: medical and non-medical reasons, is concerned with a new development in reproductive medicine, an area which is subject to ongoing monitoring by the Health Council within the context of the CEG. Men who are to undergo treatment likely to affect their fertility (e.g. chemotherapy or radiotherapy) are offered the opportunity of having their sperm frozen, thus ensuring their ability to father a child at a later date. It is not yet possible to offer such ‘fertility insurance’ to women, girls or prepubertal boys. In the Netherlands, however, ovarian tissue is already being frozen for the benefit of female patients, and there are plans to commence the freezing of testicular tissue to provide some fertility insurance for boys. Nevertheless, it is by no means certain that such frozen material can actually be used for reproduction at a later date: this will depend on further scientific developments. The Councils’ observations relate to the current status of this technology, with an inventory of the normative aspects involved. Is it responsible to offer cryopreservation of ovarian or testicular tissue at this time? If so, what preconditions must be met in order to ensure a responsible procedure? The normative aspects include non-medical reasons for requesting such interventions. It seems reasonable to assume that some women, realising that they are unlikely to conceive while still producing ova (either through their own choice or due to circumstances) will wish to prolong their natural period of fertility by having ovarian tissue frozen for later use. While it may or may not be appropriate to dismiss this out of hand as an undesirable development, it certainly demands timely consideration and debate.

The Health Council’s observations with regard to Terminal sedation (Section 2) contribute to the ongoing discussion concerning the relationship between palliative care and active termination of life. Terminal sedation involves putting the patient into a deep sleep in the expectation that this state will persist until death occurs. In many cases, the artificial provision of nourishment and fluids is also withdrawn. This greatly reduces the patient’s level of consciousness prior to their death and may also actively shorten their life. There is some uncertainty with regard to how terminal sedation differs, and may be seen to differ, from active termination of life. It is argued that the frequently used ‘criterion of intention’ (i.e. what does the physician wish to achieve through the intervention?) cannot resolve this uncertainty. Instead, it should be asked whether the use of terminal sedation and the withdrawal of fluids and artificial nourishment can be justified on acceptable medical/professional grounds (medical indication, informed consent, subsidiarity, and proportionality). If the latter approach is adopted, terminal sedation falls into the category of ‘active termination of life’ only if the physician undertakes an intervention which cannot be justified on acceptable medical-professional grounds, where that intervention actively and deliberately shortens the patient’s life. This distinction offers physicians the assurance that, where appropriate, their actions will be adjudged in the light of the medical and professional norms for good care provision, rather than the norms of (criminal) law. The resulting clarity will in turn offer greater certainty that the use of terminal sedation does not infringe upon fundamental standards and values, and that all action taken is conscientious. This facilitates further discussion on how and when terminal sedation can contribute to a dignified death process. Further studies are required to gain a better understanding of current practice. Here too, the proposed approach may result in greater clarity.

In Section 3, Pesticides, cosmetics, paints: the protection of test subjects in exposure studies, the Health Council draws attention to the fact that test subjects taking part in scientific studies do not always enjoy the same degree of legal protection. While such protection is well defined by the Wet Medisch wetenschappelijk onderzoek met mensen (Medical Research Involving Human Subjects Act 1999; WMO), the extent to which this act covers those taking part in experiments which are not directly ‘medical’ in nature is not clear. In studies intended to establish safe levels of exposure to, say, pesticides, paint or cosmetics, the risks to test subjects are no less than those involved in research that does fall under the provisions of the WMO. In preparing this section, a questionnaire was submitted to the Medical Ethics Review Committees (METCs) and to a number of private sector companies in an attempt to gain some idea of the extent of current exposure research which does not automatically fall under the WMO. It is estimated that at least one thousand volunteers took part in such studies in the Netherlands in 2003. A recent American debate addressed the issue of whether it can ever be morally acceptable to use human subjects in this type of research. In principle, according to the current observation, doing so is no more problematic than using healthy volunteers in pharmaceutical research. However, it is necessary to ensure that all research programmes are subject to the same assessment criteria applied in pharmaceutical studies. At present, this can only be established if the research has been reported to an METC and if the METC has agreed to monitor the proceedings. The current uncertainties must be resolved in order to ensure that test subjects enjoy the same degree of protection in all types of exposure research, medical or non-medical. The most obvious way of doing so would be to bring all research involving human subjects within the scope of the WMO.

Sections 4 and 5 are both concerned with the transfer of advanced technology out of the hospital and into the patient’s own home. This is a current development which offers significant advantages to patients and their carers, but which also has consequences demanding further thought and consideration. The two councils’ observations on this topic are complementary. In Section 4, Advanced homecare technology: moral questions concerning an ethical ideal, the Health Council presents a number of specific examples illustrating that the ramifications go beyond a shift in the locus of technology-based care activities. Because certain care activities are now undertaken by members of the patient’s family, new relationships arise between the roles and responsibilities of all parties involved. This may threaten the quality of care. It raises the question of what may and may not be expected from the informal carers, and how their role relates to that of the professional healthcare providers.
In Section 5, Advanced homecare technology: moral questions concerning a new healthcare practice, the Council for Public Health and Health Care (RVZ) examines the question of how the potential advantages of this development can be exploited without negatively impacting standards of patient care and without overburdening the informal carers. The institutional and organisational aspects are also examined. A brief ‘intermezzo’ has been inserted between Sections 4 and 5, presenting interviews with the users of homecare technology.

Section 6, Informal care, cost control and personal responsibility, has been prepared by the Council for Public Health and Health Care (RVZ) and is relevant to the content of the foregoing two sections. After all, the use of homecare technology will often require the services of informal carers such as family members. There are, however, further reasons for making greater use of informal carers. The rising costs of healthcare services have required some paring back of formal care, whereupon informal care has been encouraged in order to ‘fill the gap’. Informal care is also encouraged further to the current government’s policy of placing greater responsibility with the individual citizen. However, the increasing use of informal carers raises various ethical issues which are examined in this section. They include the degree to which informal care can be provided and accepted on a voluntary basis, a fair division of care between the public and private domains, the desirability of some form of payment or compensation for informal carers, the position and rights of both patient and carer, and the division of responsibility between the formal healthcare sector and the informal carer.

Section 7 is concerned with the Increasing economic component of healthcare and how this affects professional ethics. Here, the RVZ calls attention to the growing influence of economic considerations in both the organisation and provision of healthcare services. Healthcare providers are increasingly expected to take monetary considerations into account, alongside the medical aspects of their professional activities. It must then be asked whether this development has any effect in terms of the professional ethics of care givers. The position of current professional ethics must also be considered in the light of the changing context. Will professional ethics be adapted to suit the circumstances? Or will it act as a buffer, protecting against the risks and excesses of economic demands? The RVZ’s observations suggest that two core values of professional ethics are at stake: the importance of trust between healthcare provider and the patient, and the importance of professional standards, particularly those of quality. The conclusion is that professional ethics will indeed change and that it will not be able to offer a sufficient counterweight to the risks presented by the increased emphasis on economic aspects. In view of this (and other developments) current professional ethics is in need of re-examination and revision.