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ISBN: 978 -99932- 0- 884-6 Printed by Printweli Ltd. Corrodino © Copyright. All rights reserved by the author.

Cover: 'The Boat'

2 Essays in Bioethics

Essays in Bioethics

Prof. Pierre Mallia MD MPhil PhD MA(law) MRCP FRCGP DipCTherapeutics) ICGP, CBiol

Email: [email protected]

3 .:::; Essays ill Bioethics Table of Contents

Introduction ...... 6 Graduation Ceremony November 2008 ...... 9 Reproductive Health ...... 17 InVitro Fertilization 18 IVF and discrimination 20 IVF controversy ...... 25 Killing the baby to save the mother ...... 30 The morning after pill ...... 33 National sexual health policy ...... 39 Are we inciting unlawful sex? ...... 44 Primary Health Care ...... '" ...... 49 Primary Care Reform 50 Connection of health reform with values 60 Cross border health care 67 The morality of Vocational Training for Family Physicians 72 The House 75 The pandemic flu 80 When doctors dissent 85 Concern on antipsychotic treatment ...... 89 Gender, Genomics and the Family ...... 95 Genomics issues and privacy ...... 96 Problems facing biobanks ...... 101 Gender issues 104 Bioethics and the 109 The morality of family practice ...... 114 Dumping children on grandparents ...... ,", .. " .. 119 Patients' rights ,.,", ...... ,"',."., ...... ,.,",.,', ...... ,"",.,." ...... ,.,',., 125 Biopolitics ...... 126 Informed Consent and the nurses' complaint ...... 131 Disposing of dead people ...... ,...... 136 Ethics in psychiatry ...... :...... 139 When caring goes astray ...... 143 Profits and research in the pharmaceutical industry ...... " ...... ", .. " .. " ..... 148 Issues in the Beginning and End of life ...... , 153 The Elderly ...... 154 Ordinary vs. extraordinary treatment 159 What is and what is not euthanasia 164 Treat me right - on Advance Directives , ... ,,,,, .. ,, .. , ... , .. ,, .. ,, .. , .. ,, .. ,,,,, ... , .. ,, 169 Doing Ethics""""""".""".""""",.".".".",.""""."",."."""",.".".""".", 175 Introducing the PUME matrix 176 Ethics matrices 180 Principles 182 Philosophy of Medicine 184

5 Essays in Biocthies

Introduction

This short book is a collection of selected articles published between 2008 and 201 0 in The Malta Independent and in the Medical journal The Synopse. They are not grouped chronologically but by subject and have been selected primarily upon their interest to the medical student and the mature reader wishing to know about current controversial bioethical issues in Malta.

The articles are grouped under five main headings, but they must still be read in the context of what was going on at the time of writing. Nevertheless they carry significant thoughts which continue to apply, but which are nevertheless mine and my responsibility. I do however find that the main arguments serve a good basis for discussion both in class and over a good capucchino or meal.

I have selected an oration I was asked to give at a graduation ceremony to set the scene. I had little time to write it and found myself lost. In writing it I touched aboutthe realities that were hitting us in our daily lives locally and internationally. Doing bioethics is not easy and indeed, before many debates, we 'sharpen our knives'. But we need to come together in dialogue not so much with open minds but with open hearts. The more we strongly feel about an argument, the less chance we have in dialogue. This does not mean compromising our values. It does mean opening one's attitude to understanding.

The first section is on reproductive health. The writings here range from the discussions on legislating for assisted reproduction, to other areas of sexual health such as the use of the morning after pill and the national Sexual Health policy document. The second section deals with primary health care. At the time of going to print this issue is still being discussed, albeit at an advanced

6 Essays ill Bioethics

stage. What underpins these articles are the moral values of family doctors and how these should be put into the context of a vaiable primary health scheme which can serve patient, doctor and country.

The third section is on gender, family and genomics. These three topics are interrelated for obvious reasons, although, given more articles, could easily have merited a section each. Nevetheless, as stated above, issues were discussed as they arose and therefore reflect the weight (or moral weight) being given to the area during that period.

Patients' rights naturally follow and various topics are dicussed here from informed consent to disposing of dead people and psychiatric ethics. The discussion of informed consent is a cornerstone of biomedical ethics and the student should tease this out of the main context of the article, which in and of itself carries also a different message.

The Eluana Englaro case gave, for a while, heated controversy on end-of-life issues. When these articles were written I was being invited on a number of television discussion programmes. What is reflected here is that not all that we may consider as euthanasia, is in actual fact euthanasia and at the time I was intrigued by how much, as a Catholic country, we ignore the teachings of the faith and go off at a tangent, even though one has to admit that the issues are still very sensitive.

Finally I thought a section on 'howto do ethcs', would be interesting. There are various models of thinking and discussion, but one often finds that in an argument many principles come into conflict with one another and we need to find a way of balancing within specific situations without falling into 'situational ethics', whilst conversely a tool of separating the moral issue being discussed from consequential issues of that same argument is discussed. I

7 Essays ill BioetTzics developed and used this tool both in class and on the media and find it a convenient way to stick to the main line of argument thus not allowing the discussion to wonder off in a direction differentfrom what we had intended to discuss in the beginning. These articles were reproduced on The Synapse, as they are more oriented to academic discussion, but they have seNed well on discourses on the media, and I feel that anyone with an interest in ethics may find them useful. The use of the matrix is illustrated with examples, which of themselves form, hopefully, interesting reading.

Finally, I acknowledge that the field of bioethics is a controversial one. Even in those areas where we agree on principle, we may find differences in the specifics. The articles are in no way intended to be didactic and neither are they intended to carry scholarly authority other than the promotion of a general discussion. They are useful for my method of interacting with students and the public, which is always claiming that I do not know ethics any more than anyone else. I may know some rules and existent laws and regulations. But ethics is thought at home, at schools, within our cultures and during our upbringing. We move forward by discussing and reverting back to our first principles. By doing so we may enter a crises. We may find that the roots of our beliefs are based on faith at the end of the day. We know that it should be so, but this is only intuition. Nevertheless a challenge to our knowledge is a moment of opportunity and he who knows his weakness has indeed gained a strength. At the end of the day, in order to stand up to be counted, we may find no logical basis, but merely asserting a belief - such as the value of life. It is with such assertions after all that legislators have to deal, irrespective of whether they are backed by strong argument or faith in their universality.

I hope that this selection can form the basis of interesting discussions and perhaps give a small insight into what makes us tick as a population when it comes to normative ethical values in biomedical ethics and health care.

8 Essays in Bioethics

Graduation Ceremony November 2008

Graduation ceremony November 2008, Chapel of the Old University Building in Valletta:

May I at the outset thank our Rector, Prof. Juanito CamillerL and our Registrar, Mr. Anthony Gellel, for inviting me to give this oration, which not only came as a surprise but to which I do not feel worthy. Of course I am not a lawyer and recommendation for genetic testing, the subject of my work, comes from a biopsychosocial perspective of a mere physician working in the community and specialized in the infamous field of bioethics. If I were a priest I should have been more welcome to give a talk on ethical values. Being a doctor, one may contest whether this breed is in a position to lecture us on values.

However I find some solace in the words of the famous American Physician William Osier who said that to study about patients without books is like traveling through an unchartered sea without a map. But to study books without patients is like not going to sea at all. There is a moral equivalence respectively between ethics and science. To do ethics without science is indeed not going to sea at all. And just as in medicine we realize that it is not the patient, but the disease, which is the enemy; so should we in bioethics realize that it is not the science that is the enemy, but certain challenges to values by those who would take a free ride in a post-modern society and whose discourse may not do justice to what people deserve.

When we think about genetics we think about enhancement, physical and mental, about genetically modified. foods, about creating embryos in the laboratory in order to take their cells, and a myriad of other things which challenge morality. At the end of the day, the buck stops here - with the law. Recommendations for laws concerning genetics are not simply concocted in

9 in Bioethics

parliament and often do not form part of political agendas and electoral programmes. Yet our experience with legislating the use of invitro fertilization in order to help infertile couples has shown how sensitive even politically such subjects are.

Legislation about genetics invariably has to ask whether there is anything special about genetic tests as opposed to other medical tests. In this regard we see that the EC and UNESCO documents differ between themselves, with the UNESCO document taking the position that indeed there is something special about genetic testing. This cannot be seen purely through a scientific eye. It has to be seen within a legitimate social context. In this regard an analogy would be appropriate. A recent case in the UK prosecuted and found guilty a pathologist who was taking children's organs for use in research without appropriate parental consent. Taking a whole heart is different than just taking a small cubic section of the same organ. Why should it be different? The person is dead and so is the organ. So taking a small sample, or the whole thing, from a purely scientific point of view may not seem so much of a big deal. And yet the problem lies in what significance we attach to objects and organs, even of dead people. That someone is buried without a heart does not make any difference either from the scientific and indeed religious point of view. Yet it is something very personal, with considerable weight attached to it. It may have been different from this point of view if a kidney was taken. Legally there may not be much difference either were it not for tort law which would take into account the harm or injury caused. Certainly taking a heart without consent can cause more injury to the parents involved than taking a kidney. It is not merely a question of property or ownership; but one which is value-laden.

It is the same with genetic testing. The problem lies not with the novelty of such tests. In fact novelty is often met with enthusiasm. The problem is that it is telling us something significant about ourselves, which may then be used inappropriately. Genetic tests

10 Essays in Bioethics are predictive and can even tell us something about relatives, who may in turn wish not to know. But beyond this scientific difference lies a whole armada apropos what we actually feel about genetic tests. Certainly if a blood sample is kept in a laboratory, this can reveal a considerable amount of information about the individual, but also about, for example, the population that person comes from. Anonymising samples may therefore not be enough. I should have a right to refuse a sample of mine, even if anonymised, to be used for research, even if legitimate, to which I have a moral objection on religious, racial or any other social ground.

Privacy is a contestable concept. Biobanks are being created in order to have a supply of samples on which we can work to have better cures and understanding of our bodies. Yet privacy often demands that information be destroyed after its use for specific research. Imagine having found a slab in your garden. You are about to throw it away when you notice something like an inscription. An expert is brought it. It is obviously taken away from you for translation. The translated material is so sensitive, you are told, that it has to be destroyed.

Now there are three ways to destroy the information. You can destroy translation, If you really wanted to destroy all evidence however you would have to destroy the professor; and last but not least, the slab. Of course we would all agree that destroying people is going a bit too far. At most you can bind them to a secrecy act. But destroying the slab may also seem too much for those interested in history and archaeology and the mere value of such things.

We can therefore understand why scientists find it so hard to destroy the samples that genetic material is taken from. Interestingly, under some biolaws, a genetic sample is any sample taken for the specific study of DNA. If the same sample were taken for anything else, it would not be considered a genetic sample. But we have many samples from which DNA analysis may be done. If we are

11 Essays in Bioethics

to destroy information after its use, it is reasonable however to understand that our sample will be destroyed as well. Certainly however we are so much at the beginning of such research that it may be worth the while getting the legal profession to analyse concepts of a much broader consent which safeguards enough information given to people who donate such samples. People may consent, for example, to their samples being used for the advancement of science. They may not consent that pharmaceutical agencies, with whom scientists must work, may at the end of the process have also a financial interest. In Iceland, such companies have abused their information and biobanks simply do not have the time and the money to pursue such things legally. Even in the United Kingdom, the UK Biobank Ethics and Governance Council only has a custodian role on samples but does not have legal power.

The question of genetics is of course also tied closely to the question of technology. It is also related to our values and cultures. Some discourse may not do justice to what people deserve, wanting to keep them, as it were, a pre-technological era. In this regard the proper engagement of religions is important and they should not try to hide behind some form of rational reasoning alone. In his book Truth and Tolerance, Ratzinger acknowledges that we cannot and should not stop technological advancement. "It is obvious", he say, "that one cannot declare some people to be living in a kind of 'nature conservation park' for religious and cultural history, into which the modern age would not be allowed to come. Any such attempts are not merely undignified and, ultimately, lacking in respect for people, they are also completely unrealistic. The meeting of cultures and the gradual growing together of the separate geographical areas of history into one common history of mankind are grounded in the nature of man himself. Ukewise, one cannot make use oneself ofthe possibilities offered

12 Essays in Bioe/hies

by technological civilization, while at the same time forcing upon other people one's own dream of a pretechnological world. NI

He continues to say that, "it is in fact quite undisputed nowadays, not only that the spread of modern civilization is in fact incapable of being prevented but that making its instruments available to those cultures as yet untouched by it is a question of justice N.

Conversely, since the goose and the gander have been known to eat the same fodder we cannot apply this only to remote cultures but must do so also within our own societies. Let us listen again to what he says. "In situations that are quite different one cannot preserve fully developed religions as such, shutting them up in a kind of religious nature reserve, and at the same time superimpose the technological view of the world. Technological civilization is not in fact religiously and morally neutral, even if it believf}s it is. It changes people's standards and their attitudes and behaviour, It changes the way people interpret the world, from the very bottom up. The religious cosmos inevitably starts to shift on account of technology. N

Therefore this search for pluralism is far from a search for a relativistic attempt to reconcile religions or religion with science. It is also at par with our attempts to reconcile modern thought and technology with religious and social values, lest the latt.er be pushed onto a mere mythical level. Our tendency is in fact to try and keep the two separate. Even religious people rpoy try to argue from a purely philosophical point of view without bringing in healthy theological discourse, thinking that such values may not contribute to the argument. What in fact does not contribute are unhealthy scientific arguments - Extrapolation of one particular study, drawing from it broad conclusions.

I Ratzinger, 1., Truth and Tolerance, Ignatius Press, San Francisco, 2004, pp. 75-77

13 Essays in Bioethics

In speaking about genetics therefore we must concentrate on bringing these stakeholders into a pluralistic dialogue. Modern Catholic theology is in synchrony with this as well, contrary unfortunately, to what many seem to believe. Piero Coda, theologian of a Catholic movement whose founder this Alma Mater has had the pleasure of conferring an honoris causa, argue, with his team, that pluralism must not be a mere word. It must be applied in practice. We cannot engage in a pluralistic dialogue with the presumption that we are already in the right and that it is others whom we have to convince. This is so pertinent in the dialogue with science. Scientific progress breeds many fears of the unknown. This is why we use the rhetoric of Playing God. In reality what this rhetoric is admonishing is that we are not omnipotent and that therefore we cannot know all the consequences.

But this does not mean that we should not engender a progressive culture? For this culture to embrace religious values, the latter must come in a facilitative dialogue and not a didactic one. Coda and Gambon, at the Lateran University in Rome, put forward the Trinitarian model which is being developed into the social school of thought. In a Trinitarian spirit we need to empty ourselves from preconceived ideas in order to become one with people we are dialoguing with. This spirit of perichoresis and kenosis, can be used and thought as a prinCiple of discussion by all parties. For it is both sides, as it were, that has to create this emptiness.

But are truth and tolerance opposites? Can we come into dialogue with modern traditions which hold that there are no truths - what is today dubbed as a relativistic society? In reality it is very difficult to define true relativism, for the majority, even unbelievers, hold some form of religion, even if it is science itself. They would understand that there are some things which are good and some things which are evil. Given that Ratzinger, again, says, quite rigr,rly, that "Plato was right when he identified the highest

14 Essays in Bioethics divinity with the idea of good. To put it the other way round", he says, "if we cannot know the truth about God, then truth about what is good and bad remains equally inaccessible. Then there is no good and evil; only the reckoning up of consequences remains: ethics is replaced by calculation. "2

He acknowledges that as the theory of evolution states, progress has its price. This 'price', what I like calling the dissipated entropy, as it were tells us that order comes at the cost of considerable energy, some of which is seen to be wasteful, as we see in natural survival of the fittest. This second law of thermodynamics has also its practical consequence in society. We did not get to where we are today in one giant step. Rather even giant leaps came at considerable prices and failed experiments and, in society, failed attempts at dialogue.

As we start sharpening our knives for the second attempt at legislating ethical issues, it is perhaps time to consider sharpening our thought instead and build on what we have achieved. For I do not see the proposal for biotechnology law as a failed attempt but rather as a first step. We must study in open dialogue to give our population the technology it deserves, and at the same time guard the values which we all hold and guard against misinformation or mere unjustified extrapolation of fact. We are all not omnipotent; we do not know all the consequences. Yet man, in his nature, is a thinking and knowledge seeking creature and was created perhaps to do so. In being sent out of the Garden of Eden to toil the land, we cannot be accused of not having obeyed our nature. There are those who long for the garden of Eden and run backward towards us with hands raised in the air shouting and telling is to turn back. But turn back we cannot for this is not our call; it is the price for being free. In the knowledge that the serpent still crawls the ground, we move forward with our heads a few feet above.

2 Ibid., p. 230

15 Essays ill Bioethics

May I take this opportunity to thank my mentors and friends, my wife and parents, and those professors who have encouraged my advance, without whose support I would have found it much more difficult to move forward this field of biomedical ethics.

16 chapter Reproductive Health

• InVitro Fertilization • IVF and discrimination • IVF controversy • Killing the baby to save the mother • The morning after pill • National sexual health policy • Are we inciting unlawful sex?

17 ill Bioethics

Invitro Fertilization

After so much debate over the last couple of years on IVF, one cannot say the final word has been said. We have certainly driven ourselves into a cui de sac, especially when both Archbishops and President of the Republic made relevant statements effectively halting the debate. Yet parliament still has an obligation to regulate a technology which has been introduced into the country. Shying away certainly does no good; neither does deviating arguments to issues on the embryo.

In fact the failure of discussions on IVF have centred mostly around concerns for the embryo. One columnist asserted it was about 'embryocide', making allegations that we are not being charitable to the truth. Whilst embryocide is certainly a concern, it is not the main issue in IVF. Embryocide, if it occurs, can be stopped. The main problem is a conflicting issue between a morality of a cherished institution and the ethical decision-making which is the responsibility of our parliamentarians, who unfortunately did not engage in a fruitful discussion on how to legislate, other than a report made by the Parliamentary Committee for Social Affairs.

The main concerns on IVF are that the Roman Catholic Church officially considers this technology as illicit. It is illicit not because of killing of embryos but because the natural conjugal act of the couple is taken away from procreation and it involves the manual stimulation of the male. The second problem which no one seemed to address is the second article in the constitution asserting this Religion as the official religion; is there any implications towards legislation.

Certainly one cannot mince morality with ethical decision­ making. The Church's position is not likely to change in the near future. Yet many within the Church, not least the director of Cana Movement on a radio programme with me on RTK, asserted that if

18 in Bioe/hies

regulated legitimate couples should be able to avail themselves of this technology.

Certainly the use of IVF by couples has to be seen within the light of an existent relationship; no one will go through the expense without commitment to each other. IT may not be within the normative values of the country to offer it to anyone else - singles, for example. Vet it is certainly a right of couples to make and ethical decision with regards to IVF, based on counsel obtained even from their pastoral connections, and an obligation on the part of the state to regulate what has been going on for years.

Many see IVF as a good in itself. This cannot be overseen. It has given many couples satisfaction. The government may, due to other pressures or beliefs, not decide to offer this on a national health service. But the fact that it allows private hospitals to make use of this technology shows it acknowledges its value. It cannot therefore shy away from legislating to regulate, and indeed protect the embryo from actions it deems immoral. To this effect, the same document Donum Vitae, which sees IVF as illicit, guides governments to regulate IVF according to sound principles to protect life, where this is existent.

Although it is noble for married couples who turn up to be infertile to accept their condition and not have children, this certainly cannot be imposed on them by society. That couples have a right to try whatever means to have children does not mean that children are being treated as objects owned by parents. It is not incompatible with moral law to treat such children as gifts as any other children. Con~ersely it is natural that as we frown upon the breakdown of marriages, we do so as well on any unregulated use ofthis technology. Whilst liberal countries will not shy away from offering this technology to who is ready to pay for it, we must not allow legitimate couples to suffer because of imaginative slippery slope arguments. It would mean defining what constitutes a legitimate couple; but that, then, is a different argument.

19 Essays in Bioethics

IVF and the law

What bothers government politicians most about InVitro Fertilization legislation are consequential issues. Some media contributors have commented that if IVF is given only to married couples, this would constitute a form of discrimination against co-ha biting couples, homosexual couples and indeed single (potential) parents who simply wish to have a child and do not want to marry. As commented in this column previously, some couples are also seeing the 'benefit' of cohabiting and not getting officially married because of the advantages not only in housing and benefits, but also in 'settling' their children in a Church school (an abuse, of course, of otherwise humanitarian aid). These parents do not need to go through the normal channels of polls but are assured a post for their child. This is not mere speculation as I haye had young parents admit this to me in my practice.

Regarding the IVF issue, it is true that in today's world, any law which is specified for a particular group of people may indeed be interpreted, or factually would be, discriminatory by other groups of people. The fact is that the world, as we say, was not built in seven days, and we are moving at a pace which bewilders all, not least politicians. A recent column by Fr. Joe Borg pointed out how even the Church authorities may find themselves accused of discrimination for using Church venues only for what they consider good causes, and would not have a right for example, to refuse a group of witches the use of a hall, or not have a right to give double bedrooms in hostels used by the Church for retreats, for married couples only, following the Church's teaching. Of course this would have extreme consequences, which I doubt will go uncontested. Should we then not be allowed to refuse communion to those whom the Church considers cannot receive it? Should we introduce

20 Essays ill Bioethics legislation favouring abortion or euthanasia when most other countries adopt it and thus be seen that we discriminate against our own people?

If the EU has accepted our Constitution, I believe that we are able to legislate within its precepts without discriminating against anybody. The point which needs to be carry through however is that this is not a law about which couples are legitimate, neither about homosexuality, and neither about the right of would-be single parents. It is simply a law to allow IVF, but to regulate it within our existing structures. Therefore we need not concern ourselves, at this stage, who is entitled or not. The government has a right to see, especially if it is to offer the services through Mater Dei, that consequential issues around IVF itself are regulated. There is no doubt therefore that if in our Constitution, we assert that the Roman Catholic religion is our official religion, unless this is changed in the interim, any regulation of IVF have to fit around this law. Freedom of religion does not mean that if a religion allows homosexual couples to use IVF in other countries, then we should do this. This is not discriminating against homosexuals, but simply using existing legislation. At a later stage, should other forms of relationships come to rest on legal grounds, then of course they would automatically and legitimately invoke their rights.

Incidentally Pope John Paul L had spoken out in favour of homosexuals, actually saying that the Church and everyone else has to answer to God for the suffering we may have caused these individuals. But this does not translate immediately into a law not being formulated within the parameters of the faith as dictated by our constitution.

Now there is a clear dilemma here as well. For according to the teaching of the Church IVF is illicit. But the government has seen an obligation not to make IVF illegal. Yet it still has a right to adopt standards that are important for our normative values,

21 in Biocthics such as the protection of life and the protection of the family. What constitutes a 'family' is then another different matter, for a different part of the law. It is not the IVF legislation that will or should state this. In the definitions that every law gives (and I am not a lawyer) one can simply point to other parts of the legislature, for example of what constitutes a legal marriage.

It is clear however that the law can impose that freezing of embryos be prohibited, and that one fertilizes only one or two ova at a time. Other more liberal countries have done this and I do not see why it will not be possible here. Moreover the fact that IVF, as in nature, carries with it significant risks of miscarriages, the legislator can inform that this would be without prejudice to the laws on abortion; the fact that on the opinion of some there is some form of known intention to lose eighty or so percent through miscarriages does not mean that in actual fact one is inducing abortions and can only be one of the many interpretations no matter how strongly one asserts himself.

I personally am strongly against abortion, but would not go so far as to say that just because a method as IVF does not perform better than nature (in the natural process about 80% of fertilized eggs are miscarried as well), then this foreseen but unintended miscarriage is an abortion. If the technology were better than nature we would be obliged to use it then, as we would have reason to say that since the technology causes less loss of life than the natural process, we should therefore resort to the technology. The fact is that we do not know the reason why many embryos do not implant themselves in the uterus, both in nature as well as through IVF. The most commonly held scientific belief is that they have abnormalities which nature thus discards. It would be nature itself therefore that discards the embryos introduced into the woman following IVF.

The law can also protect marriage by assuring that it is given to 'legitimate couples', leaving other parts of the law, or future

22 Essays ill Hivethies legislation, to interpret this. A law on IVF is not a law on what constitutes a family. Nevertheless the law can make exceptions in certain cases. One may not extend it to all cohabiting couples. For example couples, both partners of which come from separated marriages which lasted several years and produced a number of children each, may probably be prohibited from using IVF. IVF may, in the same way, be restricted to a specified limit beyond natural fertily, prohibiting, thus elderly women from seeking the service. IT would have to give a reason, for example, the protection of resulting children, to introduce this form of selection. It is reasonable to expect at least the govemment services, which are paid through our taxes, for this service not to be offered as a commodity to all and sundry.

On the other hand we do have the phenomenon of many young couples that separate at an early stage, most probably because of changing pressures in society and lack of serious preparation. May of these people usually seek annulments and in the meantime form long-lasting relationships with partners they will eventually marry again, once the annulment procedures go through. Yet the woman's biological clock is ticking away.

It may be wiser to seek a less long road for annulment procedures, but in the meantime it is not fair not to treat this small category of infertile couples. This would be an affirmative action in favour of the family and would put pressure on annulment procedures, which run into years, God only knows why. It is not a matter of making annulments easier, it is simply a matter of assessing cases faster.

Any parent who has seen his son or daughter's marriage breaking down, would want them to have the possibility of settling down again. Even clergy, in their pastoral care, are known to tell people not to wait for all the proceedings and to get on with their lives. If one had to make a statistic on annulment cases, one would

23 ill Bioetliics certainly find that the successful cases of annulment were quite clear from the beginning. There is also the abuse that this is good income on those who make a living on these procedures and one suspects that the prolongation may not be incidental.

In conclusion, fear of discrimination need not deter us from regulating IVF through a law. We need to set our standards, and more importantly we need to know whether we want it or not - something which has often been asserted by various Ministers. It is not a question to whom we are to offer it; it may be a question on whether to extend it for humanitarian reasons, to couples who are seeking to continue their lives within existing legal frameworks. We have to act with what the law presently sees as legal unions. Should parliament decide to look into legal unions and change definitions, that would be another matter and then any new acceptable union would be entitled to everything the law has to offer. But arguing that one can win a battle on grounds of discrimination means that one can even now win the same form of battle, for example, on joint income tax returns. They may feel justly discriminated. But legally, I doubt it.

24 Essays ill BioetJiics

IVF Controversy

rd In the Sunday Times of May 3 , Dr. Josie Muscat speaks again on the IVF controversy. I have often expressed my opinion in favour of IVF for infertile coupes, grappling myself to come to terms with the dilemma it poses vis-a-vis our faith's Institutions' statements. Nevertheless I do feel that couples have a right to have children and that if medical science can help in this regard without crossing ethical boundaries, it should do so and couples should have a right to make the ethical decision whether to go forward or not. Many pastoral services indeed encourage them to do so. However I think that Dr. Muscat's article deserves some attention as it may help resolve some differences which exist in regard to this technology. I start with the premise that many of our differences are disputes - that it they do not involve a difference in values. The latter would indeed amount to a conflict, rather than a dispute. We have to assess therefore whether our disagreements are about disputes or about a true conflict.

Indeed for those who object to IVF based on the Church's document, Donum Vitae, the difference is a conflict. IVF should not be used period. It is illicit as it involves the use of a third party to bring about a birth which should be brought about solely by the union of a man and a woman. But when many within the faith, including theologians, argue thatthis may be too stringent a punishment on the poor couples trying to conceive and that we should not be judgemental on those who seek these services as long as legislation does not threaten the family value or the principles of sanctity of life, then, many still receive a conflicting message. It would seem therefore that, this conflict aside, there really exist disputes on who should receive IVF and whether we should freeze embryos. In reality, prima facie, these seems based on divergent ethical values and therefore one should call them conflicts. But I honestly believe that we inherently hold the same values and that these issue can be resolved.

25 Essays ill Bioethics

Dr. Muscat hints at the legitimacy of freezing embryos. He states that we lose patients because we do not offer this service. Many women go abroad because where they freeze embryos they stand a greater chance of success without having to go through the same procedure repeatedly. Now I have honoured Dr. Muscat myself when I as president of the Malta College of Family Doctors. I do believe he is a true pioneer in Malta both in the political field (ironically) and in the medical field of primary and secondary care. From a successful GP, he developed full fledged private services, group practices, under­ water birth, and of course treatment of infertile couples. He is indeed a maverick in the good sense of the word. However, whilst accepting that his endeavors to change the face of services offered to infertile couples are indeed revolutionary for a conservative country as ours, I honestly also believe that perhaps, the ethical implications may be unestimated. Whilst I do not intend to enter into any media debate and will surely invite those concerned when we study the issue academically in the newly created Bioethics Research Programme at the University, I hope that future debate will help us all arrive to compromises which are satisfactory not only to infertile couples and those offering the service, but to the ethical values of the general Maltese population as well.

Therefore I do not think that we should judge our limits by what other countries offer. If some Maltese coupes can go to other countries because they freeze embryos, then this cannot be our measuring stick. Neither, in my humble opinion, can we state that since only those who have the money to do so can have access to these services, will make it morally correct. The Hippocratic Oath, which Dr. Muscat invoked, does not oblige us to do so. The rich will always have access to more services than others; moreover it is those who have money who usually have access to the more controversial things in life. This does not make them a moral feasibility for all.

26 ill Bioethies

Even if there were arguments about when the human embryo should have moral status (many try to invoke the time of the primitive streak, or the time when a primitive brain has developed, the fact is that we cannot on our own, as an island, decide this issue. Of course we can legitimately participate in debates. But we cannot change the world view to accommodate our laws. It is perhaps true that from in Medieval times, the sould was considered to enter the body when the brain was formed. One need only read Dante and his invocation of the 'motor primo' sending the soul when the brain has formed. It is also true that up till a couple of weeks the embryo can form twins and therefore this puts into question whether a soul splits up - not naturally, as this can be argued to have been planned in the genes, but in vitro, where we can split an early embryo into ten or more begging the question whether we are creating souls. This is epistemology however; the study of knowledge. From a phenomenological point of view - the study of the world we are 'thrown' in, being­ in-the-world has it that morally we speak of the moral conferment on the embryo when fertilization has occurred. This is also backed by epistemological thought as all biologists would agree that any form of life begins at fertilization.

So when we come to legislating for IVF, which I am all in favour for, we have to respect our socio-cultural position. Legislating in favour of giving IVF to stable couples and protecting the embryo is the least we can do. Even if we do not see the freezing of an embryo as an insult to this small being, we must concede the consequential issue that freezing embryos will result in many of them being unused. This happens simply because success does not always happen at the exhaustion of all these embryos. It can happen before and you are left with those you can spare. Now many theories have been thrown around by those who pontificate (to use Dr. Muscat's wording). Some say you can donate them; others say you can use them for research. The base line is that if we are to uphold our moral values and respect the embryo from

27 Essays ill Bioethics conception, we cannot leave it in a state of frozen limbo. From this we can learn from the experience of other countries.

Last but not least there is the faith of the public in the profession. We offer services to assist people in need. If these are not offered by the state, we can do so privately. But should it be the fact that the state be more weary of moral implications than in the private sector. If this not be the case the public will certainly get the impression that monetary end justify any moral doubts. Whilst I am not putting into question anybody's motives, one cannot deny that where morality is concerned, we may disagree on some boundaries, but if we live in a democratic country, the goose and the gander must have the same fodder and it would be lame of a country where government services are bound by moral rules, which the people opted (by election of parliament) which do not hold true for private lives and businesses.

I concede that not having space in the SCBU is not an excuse for not offering private services. One has to question however that we payor our SCBU services from our taxes, which then are used by those who have had the money to get IVF services privately (even if at great sacrifices to their personal lives). The fact remains that many do not get IVF because they cannot afford it. Our SCBU is equipped to deal with the run of the day intensive care in the newborn. Should this include services to those who are opting for this expensive service. Of course ethically we always have a duty to care and we cannot judge people or leave them without a service, saying that once they conceived privately, they should seek SCBU services privately. But discussion in biomedical ethics involves the principle of justice, which inevitably has to discuss allocation of resources. We cannot have people abuse these services, for abuse it may seem to some, if people have the money to start something only to finish it at the expence of the tax payer. This may be because the service is not offered privately. Even if it were, we cannot oblige people to seek SCBU services privately,

28 Essays in Bioetlzics

even if they have had IVF in this sector. But it leaves an open question - at minimum food for thought. It has after all already given rise to much controversy on our media.

I sincerely hope that we can work together to arrive to a just solution to this problem - as problem it is for patient advocates - and work out together our disputes. If we turn these disputes into conflict then we are facing more profound difference in values. This would be more serious than people think. Not only will this impede our progress in this area, it would endanger the whole process, as many moralist including I dare say myself, are not willing to compromise on moral issues dictating when life begins. I have been known, in a spirit of dialogue, to discuss the status of the embryo from purely academic point of view. One can view it as merely a template of DNA. But we all started off as one cell. That is a mere fact of life. Is it up to us when to put moral status of when that cell should have rights? I am quite sure that Dr. Muscat's values are in the right place as everyone else's in this matter. In the end, if the law stalls, it would not be in the interest either of those who receive the service of IVF, or of those who offer it. Until we come up with a formula whereby freezing embryos would not leave them on the shelf indefinitely, perhaps we can look at the more legitimate freezing of ova. But this is still undergoing peer scrutiny. Perhaps our doctors can be involved in this avant-garde technology. As far as I know we are not, yet.

Dr. Josie Muscat replied in a letter to the editor to this article stating that in essence we agree with not freezing embryos. Dr. Muscat continues to be an influential figure locally in this area.

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Killing the baby to save the mother

Three women have taken the Irish government to the European Court of Human Rights claiming that their health is being compromised when they are not allowed to have an abortion. Whilst the sentence can have consequential implications even locally it is worth noting how the laws on abortion work in both Ireland and the UK. Abortion is illegal in both these countries but their abortion acts determine under which medical circumstance they can be carried out.

In Ireland, if a pregnancy is a threat to the woman's life, she may be offered a termination of pregnancy. Many would find this reasonable. It contrasts with the more stringent criteria offered by the principle of double effect which was described and used by the Belgian Episcopal Conference of 1985 which was a turning point for the Catholic Church where at that time a pregnant woman could not receive treatment due to possible harm or death of the baby. Under double effect we can cause a foreseen harm so long as it is unintended and the killing is indirect. There must also be a proportionality between the harm caused and the good obtained and the harm must not be the means of bringing about the good (hence indirect). The latter makes all the difference as otherwise critics who say this is rather hypocritical would be right. Therefore if a woman has an ectopic pregnancy or an endometrial cancer, the fallopian tube or the uterus may be removed even if the death of the baby is foreseen. It is indirect as by simply eliminating the baby one would not bring about the good and intended effect. For a normal abortion, even if carried out with the health or life of the mother in mind, a direct killing of the baby (for example, when the latter is caught in the passage during delivery, or, an abortion for psychological reasons) would not satisfy the principle of double effect..

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Therefore Ireland has indeed gone forward from the double effect principle as it would allow even a direct killing of the baby once the life of the mother is in danger. Nevertheless many women in Ireland do not qualify therefore for an abortion and so they travel to the UK. In the UK (which includes Northern Ireland) abortion is allowed if a doctor certifies that the pregnancy causes significant harm or potential harm to the health of the mother. This includes both medical and psychological harm. The key here is defining 'health'. Health is a very broad term and even if one had not to exaggerate, if a woman becomes diabetic, or is hypertensive and can claim that there is a detriment to her health, she could invoke this law. In 1967 an amendment (which exempted Northern Ireland), allowed for a mother to be able to seek termination of pregnancy if she was either mentally incapable or if the child, through pre-natal diagnosis, showed congenital malformations or diseases (which includes, for example, Cystic Fibrosis). The fact that many women from Ireland travel to the UK to have an abortion under this Act shows that in the UK there need not be a direct threat to the life of the woman, but merely to her health. We know that defining health can be very broad indeed. Therefore for all intents and purposes many see the UK as being a country where one can obtain an abortion for practically any reason.

Since abortion is treated as a health issue there has recently been a controversial case in which the courts in the UK decided that a 14 year old girl who sought an abortion had a right to confidentiality and the consent of her parents was not necessary. There are woman locally who go to the UK for abortions with no particular reason other than that they already have the number of children that they can handle. It can easily be seen that whenever a woman would want to terminate her pregnancy, all she would have to prove is that she mentally cannot handle the raising of a child.

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It is interesting that doctors are still allowed to find a conscientious objection to the abortion. Whilst they are obliged to refer any patient requesting an abortion to a colleague who does not have this kind of objection, and therefore they cannot claim that they are being an accomplice to the abortion, it does show that although there is a law for health reasons, clearly the law also recognizes that health cannot be imposed to trump over life and death decisions. Even in Ireland, where an abortion is possible if there is a threat to the life of the mother, doctors are still allowed an objection of conscience.

The European Court of Human Rights' verdict will thus reflect an EU position on this balance between right to health of the woman and right to life of the fetus. For an objection of conscience may still be allowed; but it will show whether the law gives more weight to 'health' (in general) and a threat to a woman's life. Once the country has already accepted that if the woman's life is in danger, abortions are allowed, the balance would not be choosing between two lives, but a life against general health. This has the unfortunate consequence of subjecting reproductive health to a highly contested moral issue as there is no way to measure objectively and quantitatively how much detriment the pregnancy causes on the health of the mother.

Abortion continues to be a very elusive issue. Whilst there are those of good faith who say that if the woman's life is in danger, then she is allowed to terminate the pregnancy which is seriously threatening her, there are also those who hold that any threat to health, be it physical or psychological, can justify aborting the baby. This argument is tantamount to confuse health with rights and is only a step 'on principle' away from using health as an excuse.

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Talk of' morning-after'

The question of the morning-after pill (emergency contraception) has touched the political scene again and as a consequence the media, in which I was invited to participate. How these questions tend to resurface every now and then shows that we are not settled as a people on many issues. However there are inherent difficulties in understanding the pharmacological issues on both sides of the argument.

That emergency contraception should not be used as an abortificient should not give us cause to argue. It is immoral and indeed illegal in our country, which not only stills cherishes the fact that it upholds certain traditional values due to Catholic origins, but has asserted even in our constitution that our parliamentarians are bound by our normative values in the laws they make. This does not mean they should follow canon law, but certainly should reflect the general populations' assertion in the constitution. The protection of the embryo and of the family are usually the highest on these agendas. I cannot see parliament as saying that life begins at any other stage other than conception, notwithstanding many different philosophical positions.

Emergency contraception has two functions. It is a contraceptive, as the name implies, but if used after ovulation, it has the potential of not allowing any fertilized eggs to implant. It works in three ways, First it changes the lining of the uterine wall and of the fallopian tubes (more popularly known as 'the tubes'). This lining would usually facilitate the movement of sperm and ova towards each other. The resultant change in lining therefore counters this function. This is the first conception function that this medication has. Secondly, if used before ovulation, it will send forward (and thus prolong) the date of ovulation. If someone is due to ovulate, this will come at a later stage. Ovulation is the process where the female gametes (the ova) are released into the fallopian tubes

33 Essays ill Bioethics from the ovaries. If this is halted for a while, the result is also a contraceptive effect.

However due to the first contraceptive effect described above, if it is used affer ovulation, and therefore you have eggs released into the system, there is of course a good chance that after intercourse, a sperm reaches and fertilizes it. It has been shown that the earlier these emergency contraceptives are used, the more effective they are, which implies that the longer you wait to use them the more chance there is that you are targeting a fertilized egg. But for our purposes, we must not use a qualitative, but a quantitative argument and having a one percent chance or a ten percent chance (numbers are fictitious and used only for argument), one still stands a risk of aborting this fertilized egg. Since the ling of the uterus has been changed, this fertilized egg cannot implant itself and is aborted. It has been known to fail however and therefore one is never completely protected. When it fails, no resultant defects in the foetus have been shown.

There are a number of important pOints at this stage. The conclusion that if one uses the morning after pill before ovulation, one is using it as a contraceptive, and if one uses it after ovulation, one is risking an abortion, is safe but makes its use difficult nevertheless. Newer contraceptives are said not to affect fertilized eggs chances of implantation and will therefore change the matter. For how is one to ascertain that ovulation has indeed not occurred. Doctors usually rely on a history of one's menstrual cycles to calculate whether ovulation can occur. Moreover many women do feel that they are ovulating. However there is always the risk of abuse. A doctor must always base the doctor-patient relationship on trust and therefore the doctor certainly cannot carry any moral responsibility if the patient lies. But this is really beyond the pOint. Conversely there are tests available which may tell if one has ovulated or not. But the patient must consent to such tests, and it goes without saying that if she refuses, the doctor has a right to an objection on grounds of conscience - a conscientious objection.

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It goes without saying that just because one is using it as a contraceptive before ovulation, does not mean there is no moral agenda or that we are condoning contraception. But certainly contraception on its own has less moral gravity than when there is a risk of an abortion. We are talking here from the premises of taking for granted that contraception is used locally, and therefore not confusing the issues. But one must, when taking a holistic view, also take into account contraception from a moral aspect. In cases of rape, it has been put forward by the Catholic British Episcopal Conference that the woman has a right to protect herself from pregnancy if she has not ovulated. Since one an RTK programme someone called in querying an Episcopal conference, it is worth pointing out that this is an well-organized event which is vetted through Rome, although not an official central document of the Chruch. It is not however similar to when a Bishop speaks his mind on an issue. It is a pastoral document to guide Catholics in the area. Since by definition, Catholic means universal, it would apply in' theory to the rest of the Catholic world. An important other Episcopal Conference was that of the Belgian Bishops, who is 1985 asserted that women can get treatment during pregnancy even if it results in harm or death of the fetus, as this would be considered a foreseen but unintended harm. The principle of double effect was thus asserted.

I have written on instances of rape, invoking the principle of double effect, by arguing that when a woman is raped one has to look at the problem holistically and in that dire situation, asking about ovulation and indeed giving a conditional option of an ovulation test, may not be putting the woman through a humane procedure. However double effect, by definition, requires proportionality, and what I had written is of course challengeable. It was asserted only for rape however and not under the circumstances of use as a morning-after contraceptive under normal conditions. But rape has a much broader definition than we tend to think. It need not be a dramatized situation. Any intercourse to which the woman

35 Essays in Bioethics

objects and is forced to undergo under some form of duress, even in marriage, can legally constitute unconcensual sex, which amounts to rape. Such is the case of drunken men going home and forcing their wives, with or without violence.

To come back to the subject however we must answer the pertinent question: should government legalize the morning after pill. Under the present circumstances one has to give a clear' no'. One cannot afford to have such a drug which risks being given over the counter as contraceptives are often given. In theory any form of hormonal contraception requires the prescription of the doctor, but in practice I have many patients who tell me they simply asked for it over the counter. That this is practice in some countries does not make it right. Conversely, a clear 'yes' can be given if the newer forms do not endanger fertilized eggs.

Before discussing regulation, one ha? to assert another important fact. Doctors, with or without the emergency contraceptive pill can still use the normal contraceptive pill in what is known as an 'off-label' manner, Off label simply means not using the drug in the dose or frequency it was packaged for. Since emergency contraception is a high dose of oestrogen a doctor can titrate the dose and give it using the available products. Although this cannot be classified as bad clinical practice, since one packet with proper doses exists, this correct pharmacological practice is put into question. Now if one asserts that, given the moral burden of contraception itself, there are instances in which the doctor may help a woman (before ovulation - and thus being certain of not procuring an abortion) to prolong her ovulation and thus offer some protection against fertilization, it would mean that the only method available to the doctor is this off-label method.

The question arises as to how much the doctor wishes to risk using this method. If a complication had to occur, which most hormonal treatment carry, it would certainly be more difficult to

36 Essays ill Bioethics

defend oneself in front of a medical council or in a court of law. If on the other hand there is an available titred-dose package, one is clearly safe and one simply has to explain the risks involved. It is also much safer for the patient to use as it is not uncommon, especially in a situation which is causing anxiety, that patients fail to remember the instructions given.

But this leaves the government with a dilemma. Certainly I would say that unless one makes a framework for the correct usage and dispencing of such material, to avoid abuse and its use as an abortificient the government would not be in a position to legalise this drug. If the government however introduces measures to provide tools for doctors to work with, one can never makes a fool proof system. The question is whether we trust people, and more importantly whether we trust doctors. Until such time as these issues are resolved, one cannot merely legalize the use of a drug, which in the UK, for example, has found itself as an over­ the-counter drug. I honestly do not think it is merely a question of rights. If we honestly believe that life begins at conception, we must protectthat life. An architect declares a house uninhabitable if the beams are rotten so as to protect life, even if the chances of them giving in are small. In the same way our government is upheld to a moral status to protect life, even if the chances of killing it are slim.

One may argue, but we import guns for legitimate reasons, and these not only can also be used to kill, but have proved themselves to be dangerous in this regard. The difference is that here you can prove and take action, and by no means is the argument of weapons in society exhausted.

I was a fan of M.A.S.H. when it was on Paramount Comedy. This was a group of surgeons and doctors working in the Korean war. They saw the results of war every single day of their lives. Soldiers came in wounded into the operating theather and many left it

37 Essays ill Bioethics dead. Death was very dramatic down there. But once a fighter pilot came in for a minor would. When asked how he was coping with the war he seemed quite jolly about it. He said that his work was simple flying a jet dropping bombs and leaving. His job was simple and there was no mental burden for him. Since he was not seeing the people he was killing, his conscience seemed to have absolved him. In contrast another pilot went mad because he realized the damage he was causing on a daily basis. The first pilot went into a denial. One I am not seeing that microscopic fertilized egg which I can hold on the tip of a needle, I can easily den myself the reality that I am killing someone who in a few years time would be grown like us.

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National Sexual Health Policy

It is a fact that sexual practices among young people has increased over the past decade or so. Teenage pregnancies and single motherhood have become almost a norm and most GPs would admit that whereas a decade and a half ago one would perhaps have seen a handful of 'unwanted' pregnancies, nowadays one sees at least one or two news cases a month and we cannot really refer to them as unwanted, thanks to policies which helped single parents, and which now verge on being abused, as sometimes mentioned in this column. By abuse of course one would include not declaring a known father in order to benefit from assistance intended to help only mothers who truly find themselves in dire situations. In a recent Public-Health­ Ethics meeting the difference between 'public health' and the 'health of the public' was raised, which can help identify what should and what should not be public health measures.

If it were only about pregnancies outside marriage one would not be in a strong position morally to speak about it being a public health issue. Rather it would be a problem affecting individuals of the public and therefore more of a health of the public issue. The importance of this distinction is the moral responsibility we put on correcting anything which harms the population health-wise. It is important therefore to appreciate that if I am in a theater and I smoke a cigarette I am causing harm to others and it is therefore a public health issue. If one the other hand I eat a hamburger, I am not causing harm to the pubic around me (other than indirectly by increasing the expenditure burden perhaps due to the ailments obesity can cause the country - but this is not public health). Nevertheless public health usually falls within the realm of departments of health and therefore these two examples are usually lumped under a general term pubic health and many a public health specialist may indeed disagree that the hamburger does not within the realm. What we can agree on is that it can cause an indirect effect by diverting costs of health

39 in Bioethics care from otherwise more important areas. It is not the eating of the hamburger per se which causes imminent danger to the public, as is the case of a cigarette, but the general concern of obesity in a population which in turn causes more morbidity. There is this subtle difference of what is a direct effect on the health of others and what is a behavior which can cause damage to self.

When it comes to sex education there is however an imminent danger to the public, namely sexual transmitted disease. We may all agree that abstinence is what should be preached and practice, and that perhaps condoning the use of a method (condoms) which are known to decrease sexual transmission of infection may be interpreted by some as actually condoning the act itself. I would not agree to that but be that as it may, the moral issue is two-fold: one the one-hand it is true that providing easy solutions can have an impact on young minds who may get the message that sexual practice is acceptable as long as you are careful, but on the other hand there is also the grave moral responsibility to prevent harm, especially to innocent partners (the recent surveys show that many STDs come from extramarital relationships as well.

It is the genito-urinary infections which make this a public health issue and therefore of moral concern. Pregnancies to single mothers can be a health issue to individual - most probably a mental health issue - if they undergo stress in the process. This would be what I referred to as a health-of-the-public issue. Therefore we can all be relatively healthy but still have public health issues (such as cigarette fumes or a bad water supply), which will cause harm to many. Public health does not depend on the sum of individuals who are healthy or ill - it depends on practices and environmental issues. The health of the public can on the other hand be affected, without having in issue for public health. If single mothers are stressed due to non-planned pregnancies, it is not really a public health issue as otherwise there would be no point in the classification as every ailment would be a public health issue.

40 Essays in Rioethics

Sexual practices in and of themselves are not necessarily a public health issue (although one needs to ask whether it is a mental health issue, as it has been proposed that lack of home security may lead young people to other forms of intimacy) and therefore one understands the resistance to condone the use of condoms, etc. What is a public health issue is the disease which may be transmitted through this practice. Statistics show facts and if other methods, such as advocating abstinence) fail, then we have a problem of sexually transmitted disease on our hands.

Principles of ethics include the principle of doing good (beneficence) and of doing no harm (nonmaleficence). DOing no harm does not consist only in a reference to a future action but refers first and foremost to not causing harm (by omitting, for example to take the right action), by preventing harm, by removing from harms way, and finally by promoting the good. Health Promotion is about the principle of Nonmaleficence and anyone preventing this would automatically be acting meleficently (I here distinguish maleficent from malevolence, as one may be unintentional and the other quite so).

Why mention this? A sister column pointed out that the Curia may be pulling strings to keep back a sexual health policy. I would doubt that this is so as clergy are involved in the teaching of bioethics. In teaching bioethics to doctors and public health officials we are training people to be responsible for individual and public health. As doctors we cannot shy away from issues such as sexual health. Of course doctors with a relativist morality, or who are morally neutral can be wrong not to respect societies' normative values and its elected government which has the responsibility to implement those values. On the other hand consultants cannot be silenced when it is part of their duty to inform and educate the public as part of preventive medicine. To do so is to take us back to the era which itself triggered off the field of bioethics, when medicine went wrong because doctors followed government orders rather than ethical codes.

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The bare fact is that condoms do prevent the transmission of infections from one person to another and if we do not consider it a moral duty to promote the use of such measures, doctors are indeed liable to malpractice - they are breaching their professional duty of informing patients and should a harm be caused because of this omission you have a connection between the breach of duty and the harm caused, which, in tort law, is negligence.

Now the dilemma which is being raised is this: should a health policy promote the use of condoms? Doctors, even given their moral right to refuse to participate in things which they consider immoral, have duties. A doctor who sees teenagers, for example, who admit to sexual practices, is duty-bound to inform them of methods that exist to prevent infection. Failing to do so is to be legally and morally negligent. One is failing patients who can get ill and in turn failing one's duty towards SOCiety as this same person may infect others.

Now we cannot simply leave this to individual family doctors. Medicine does not work that way. If individual doctors promote health this way, the collective body, through health promotion measures is obliged to do likewise. Whilst individual doctors play an important role in education, so does the department of health. Just as we take measures to prevent the transmission of airborne viruses, we should take measures to prevent the transmission of sexual infection. Those of us who have children understand that sexual education carries with it the fear that we are telling them that sex is OK as long as they use protective measures; but we also understand that prevention from disease should be condoned and that moral values cannot be left solely to the classroom. We have to consider peer pressure and admit that our society has failed in imparting the same values we were brought up with. It is not right that our children suffer for it because we did not inform them of dangers in the hope that they would avoid certain practices.

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Of course I will not bother to answer those who retort that it seNes these people right and that they should not have had sex in the first place and that they should carry the responsibility of their actions. Medicine does not work that way. If it did we would prefer to give a kidney to a 40 year old father of two, instead of a 65 year old widow, or we would decide not to treat people from our tax money who have spent their lives smoking one or two packets of Cigarettes a day. Equality and fairness must reign for health, which cannot be subject to meritocracy.

The condom does not condone; it prevents condemnation to contagion! We may shrink from use of the term publicly, but whoever deleted that term from the draft document of the Sexually Transmitted Infections Prevention Committee should not be working in social policy and health. Admission of preventive measures is not an admission of guilt and neither an admission of practices. It may be an admission of failure - at least where other methods could have in theory prevented the rise in sexual practices amongst the young in particular. If we speak of a moral wrong, we cannot accept the moral responsibility of treating disease that come out of that 'wrong' without also trying to prevent it. It is not the contraceptive which we are speaking about, it is the deadly infection. Those who see contraception as an evil must surely recognize that one is accepting that evil not for its own sake, but to prevent two greater evils - transmission of disease, and, lack of professional responsibility to prevent that same disease.

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Are we inciting unlawful sex?

A few weeks ago, I wrote about the sexual health policy and since then have been invited to several TV programme upon the issue. In that article it was pointed out that the intention of a Sexual Health Policy should not be interpreted as giving the green light for promiscuous or even extramarital sex. Conversely the focus in this regard is merely intended to prevent the transmission of infectious diseases. It is not an method to advise on pregnancy prevention, which is analyzed in more detail here. Many doctors may be uncomfortable with giving such advice to minor (especially) and may find it difficult where to draw a line between what is clinically indicated and what may seem as giving advice on something which can hardly be treated as morally neutral. Nevertheless a doctor has responsibilities to patients which he or she cannot neglect.

In the previous article the issue was tackled from a negligence point of view. It was stated that doctors, and by extension, the public health authorities, must act in such a way as to prevent and not merely treat illness. In this regard advice on measure to prevent the transmission of sexually transmitted diseases (STDs) become a matter of duty and care and not something which one may opt-out on moral grounds. Put more bluntly, if a girl gets a sexually transmitted disease, such as AIDS, the doctor can be held liable if he or she had not given timely and appropriate information which could have prevented the disease if the consultation called for it. Therefore if a young girl asks for advice, the doctor may indeed express his opinion, but is still obliged to impart proper medical information. Even if the doctor has no problem with contraception for purposes of preventing pregnancy, as it frequently happens that young girls may ask for contraception for this sole reason, the doctor would have to explain that the contraceptive pill may prevent pregnancy, but does not protect against STDs(still can get STDs). It is not the first time that at this stage one reads an awareness on the face of the patient which was not there before. They may opt to continue using condoms only.

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But now there are two problems that need discussion. In the first instance, young girls are often uncomfortable discussing sexual problems in front of their parents and would usually go to a doctor of their thrust. So many ask whether this is ethical and indeed legal. Secondly doctors must be aware of not being guilty of facilitating unlawful sex.

As regard to the first problem, our visiting professor from Toronto in the Department of Family Medicine has explained how in Canada it is now recommended that teenage young adults see their doctors alone. The reason is quite obvious. It is very unlikely that teenagers will willingly speak about their problems, especially if they are of a sexually or drug-abuse related problem, in front of their parents. If one considers a chaperon to be necessary, a close friend or trusted relative of the teenager would be appropriate. The situation is different locally and many doctors will be aware of the law, even if ethically they may feel they can do so. It is hoped therefore that such a policy, together with revision of the Medical Council guidelines, will shed more light in this regard. It should be lawful for doctors to respect the confidentiality of young adults and it is proper that judges will uphold such a right in a court of law. Clearly however, doctors are answerable to the medical council, and the same council must have its own guidelines in this regard.

The second problem is that of facilitating unlawful sexual intercourse. Legally under-age sexual intercourse can be considered unlawful. It is especially so if the boyfriend is over eighteen and his girlfriend still a year or two under. In the UK, such unlawful sexual intercourse is considered under the age of 16. In Malta I am not aware that it is any less than the age of 18. But at his stage I am only concerning myself with the argument: does a doctor who prescribes contraception commit an unlawful act by facilitating unlawful sexual intercourse if the girl is under-age?

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Clearly many parents may hold the doctors responsible and many indeed will be angry that their daughters discuss these issues with doctors without their consent, which is why legal, not only ethical, guidelines are necessary. We are concerned here with 'health', which includes sexual health, and not with facilitating sexual conduct. The UK has faced his issue following what had come to be known as the Gillick case. In 1982, Mrs Gillick, mother of four under-16 girls was concerned that her daughters be given contraceptive and sexual advice without her consent. The judge decided that this form of advice or treatment was the same as any other and thatthe girls had a right not only to the advice and treatment but also to confidentiality and the consent of the mother was not necessary. The mother took the' case to a court of appeal in 1985 and won; the judges stating that parental rights under common law (the practice of case law in the UK whereby the law is built upon previous cases by judges themselves) were binding no matter how mature or independent the young adult. An emergency situation would of course be exceptional.

Following further appeals, the conflict between these two laws was then resolved in the House of Lords, and at that, only by a majority of three to two. Nevertheless the House of Lords is the ultimate arbiter and it was decided that a minor can give consent to treatment if they fulfilled the criteria of autonomy and informed choice: they have to show they are capable of understanding the risks and benefits, and that the treatment is in their best interests. From this the Gillick criteria were decided upon, which, leaves space for trying to persuade the minor to involve the parents. So the criteria, now known as Fraser Criteria, after Lord Fraser who presided over the case involve that:

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• There is sufficient understanding of risks/benefits • The minor cannot be persuaded to involve their parents • Their health is likely to suffer if they are not treated (this includes mental health)

It is noteworthy that recently it was reported that this holds even for advice on abortion - for our purposes we need not delve into this as it is unlikely that such a document in our cQL,Jntry would deal with abortion.

However there were certain things that arose out of this case. Under the Sexual Offences Act of 1956 it is an offence to incite or cause a person under the age of 16 to engage in sexual activity. The Law Lords decided that for medical purposes doctors would not be liable for criminal sexual offence by prescribing contraception and would not be seen as inciting or encouraging a minor to have sex. This would incidentally clearly expose the parents to this danger since their advice is parental and not professional, which is a further argument why we should have trained people and not leave the burden solely on the parents. Clearly the moral aim of why contraception is recommended is therefore taken into consideration under the law.

Nevertheless Lord Scarman stated that clearly a doctor who gives contraception not because in his clinical judgement the treatment is medically indicated (and this would therefore include prevention of illness), but with the intention of facilitating her to have unlawful sexual intercourse, 'may well be guilty of a criminal offence' ((1985) 3 All ER 402, 425). This clearly means that if a girl simply walks into a clinic, is under age, and asks for contraception simply to protect herself against pregnancy, and the doctor obliges without much ado, would be morally (and legally) wrong.

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I am not a lawyer and therefore cannot oblige myself to extrapolate from British law to local law. Clearly as doctors, we are concerned when it comes to people under 18. We all want to give the best treatment to young adults. We do not want to break the law either. Neither do we want to do what is morally dubious. Of course I have recommended to the Medical Council that it is wise that young adults are free to discuss drug and sexually related problems not in the presence of parents, as under this controlling influence they may withhold important information which they would otherwise have discussed in private. This is consequently detrimental to their health. It should also be lawful o give contraceptive advice because otherwise the doctor may be liable for not preventing harm. But it should also be lawful only if the doctor has as his or her interest only the health of the individual and certainly not to facilitate unlawful acts.

It is in this light that any document related to sexual health should be seen. Certainly the medical profession, the department of health, and indeed parents and schools, cannot be seen as inciting sex when giving health-related advice. And since many of our schools are Church schools supported by the state, the document should be written in a way to make this comfortable for all - as health education is a right and not an option. It may be difficult to accept that Catholic Schools give such advice. But we accept pollution in order to have cars and it would certainly be abusive and ignorant of anyone who accuses Church schools of encouraging sex if they give any appropriate health education related to teenage behavior. This is about health related to certain behaviors and it certainly remains morally right for schools and doctors alike to preach abstention first - not merely on moral grounds but on health related grounds - as, after all, are the WHO guidelines.

48 chapter

Primary Health Care

• Primary Care Reform • Connection of health reform with values • Cross border health care • The morality of Vocational Training for Family Physicians • The House Call • The pandemic flu • When doctors dissent • Concern on antipsychotic treatment

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Reform of Primary Care within the NHS November 29, 2008

This short report is intended to be a framework and a basis for discussion as requested by the Hon. Minister for Health and Social Policy, Mr. John Dalli. The World Health Organization and the World Organization of National Councils of Associations and Academies, in a joint publication, have agreed that the basis of any health care system should be primary care.3 Whilst it is acknowledged that primary care systems vary from country to country both according to need and of course due to diverse modes of implementation, it is now becoming more and more clear that any system which is not based in the community will find itself in financial difficulty much of the work which can be done by primary care physicians will result in being done by secondary care centres.

Aim The presumed aim of the government is to provide an efficient system of primary care which is easily accessib le by the population whilst at the same time reduce current costs related mostly to referrals which can be dealt with in the primary care setting. This in turn should contain costs whilst at the same time improve access to patients by providing a more personalized system.

Objectives The objectives of any system should be the following: 1. Health expenditure and health status 2. Efficiency 3. Accessibility 4. Equity 5. Social responsibility 6. Relevance to health needs4

3 Boelen, c., Hag, c., Hunt, V., Rivo, M., Shahady, E., "Improving Health Systems: The Contribution of Family Medicine", World Organisation of Family Doctors, World Health Organisation, 2002. 4 Fitzpatrick, R, "Organizing and Funding Health Care", in Scambler Graham (ed), Sociology as Applied to Medicine, 5'h edition, Saunders 2003, London, Oxford, New York, Ch. 19, p.292.

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Preamble The current health Centres are a metamorphosis of the original Polyclinics introduced by a Labour administration. The former were introduced in ex-communist countries, most of which have by now eliminated them, seeing them as non-efficient entities. In our country many still refer to Health Centres as Polyclinics and indeed there has been no substantial change other than cosmetic to the day 0 day running of the services. Even an attempt to introduce filing systems has failed in the past.

Conversely the Prime Minister has recently acknowledged the important role that Private Family Physicians play in our society. They charge a very nominal fee and provide a service which is gnomic of what a primary care system should be - that of having a personal doctor who knows you from birth to death (potentially) and who sees everyone indiscriminately of gender, age, race etc. Indeed the knowledge of primary care physicians, family doctors, is so broad that they are justly now recognized as a speciality.

The Blopsychsocial model The biopsychosocial model has become the philosophical paradigm of primary care. Inherently this means that the family physician (FP) knows the patient and the family well enough to be able to deal not only with the disease as a biological entity, but also with how it is related to the psychological and social circumstances of the patient. The latter changes according to regions. It is obvious that such a model cannot be provided by existing health centres, as the doctors there do not play a role of FPs, although privately they do, as they do not see patients on a continuous basis.

Conversely private FPs have always found it notorious that people can 'shop around' between doctors as there is no patient registration. This can be dangerous for the patient and leads to an unhealthy competition. Indeed competition may be a factor which gives an impetus to provide a better service; but undue market forces within a health care system may be counterproductive.

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Dual system and registration This dual system of health centres and private FPs has led to considerable confusion. Many health centres are grossly overworked, whilst private FPs may be under-worked. The lack of stimulus to work in health centres has led to their being underserved by doctors, who are largely unmotivated, even owing to undue charges related to , for example, refusing right to see patients after 5pm which are not emergencies.

The above has also led to private FPs being unable to take vacation leave, sick leave and study leave, without considerable loss to income.

Registration within this dual system will present severe problems. IF patients are given a choice some may see the benefit of registering with a private FP; others will feel insecure and register only with health centres. The latter would deceive the end of improving the primary point of care and leave it as it is. It may simply have an effect, in some areas, in which health centres are simply burdened with more numbers, leaving private practices with less. Also there are areas which are underserved - for example, people from Zurrieq must go to the Floriana health centre and people from Zejtun to Paola. This is of course disadvantageous to people living in these areas. Doctors in these areas therefore have more patients and con afford to charge lower fees. In fact the introduction of health centrres has been associated with higher fees and if it were not for the fact that some doctors, notably politicians, charge less (which is seen as unethical by local regulations), fees could have gone even further up, amplifying what is already a system not providing equity.

Opportunities for primary care Government must look at the potential opportunities afforded by primary care, in particular private FPs. Subsidizing FPs can be advantageous in many ways - something which Pilot studies would of course have to demonstrate. In the UK, for example, GPs even

52 Essays ill Bioethics do procedures, following proper training, like hysteroscopies and endoscopies, reducing waiting times and costs considerably. Locally this can be implemented over time, but certainly the following procedures can easily be done:

Cautery Cryosurgery Minor Surgery Blood analysis (various office equipment are available) Urinalyses Primary Care Ultrasound including pregnancy and screening

FPs will vary in the services they offer but this can be addressed overtime.

Problems with Private FPs Certainly one cannot paint a picture of bliss when it comes to private FPs. Not all are members of the Malta College of Family Doctors; not all see Continuing Medical Education as an obligation - indeed there is no coherent system which offers adequate and relevant CMe other than that introduced by the MCFD. Also FPs vary in their practice and in what they feel comfortable seeing. Some would not see babies; others would not tackle issues like drug addiction or domestic violence.

Moreover some have adequately equipped clinics of their own. Others simply carry a bag and stay in a pharmacy. Most would provide out of hour service, but this is often at their own discretion. When they put off their mobile phone is up to them.

Some doctors have a special interest in an area and some of these may have found it opportune to practice only in that area. There are only one or two Group Practices.

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Problems facing private FPs These ore considerable and one cannot expect such a report to exhaust them all. Yet an improved system would have to address these issues. Amongst which one can list:

Lack of adequate rest and leave, including sick leave Lack of proper insurance to covet in case of prolonged absence from work Lack of proper recognition by authorities Lack of adequate facilities to offer patients; such as physiotherapy, OT, etc Lack of prescription power 24/7 coverage of patient time with no protected time. Lack of proper programme of CME, which in turn is not obligatory Lack of government authority over Colleges and Groups uniting doctors, seeing that they are adequately democratic; this led some doctors to not being members of any group.

Vocational Training and the Specialist Registration One may rightly question what is the use of a VT programme if it is not obligatory; indeed what is the use of a specialist register if it is not recognized by the government that to work in the community one has to be on this register. Government has a due responsibility to the public not only in seeing that doctors working in health centres ore on the specialist register (as provided by EU regulations), but is morally responsible also for the doctors it allows to work in the private sector, especially in Malta, where these take on a considerable amount of work.

There is a lot to be said in this regard, which is beyond the scope of this report. Yet an system, to be effective, must prevent doctors

54 Essays ill Bioethics having simply a first degree (MD) to work in the community. If FP is a speciality, then it is NOT about the doctor, but it is about the RIGHT OF THE PATIENT. Patients have a right to be seen by doctors specialized in family practice and community care; government has an obligation to see that such provision is adhered to; and doctor have a duty not to practice unless they are adequately trained, as is the case for all other specialities. FP cannot remain the 'cinderella of medicine. If it is a speciality in its own right then VT must be made obligatory to all new doctors, and existing doctors working in the community who are not already on the Specialist Register, must be prohibited from practicing, on pain of removal from the medical council register, until they complete an adequate training programme directed towards them. In short the MD cannot remain an 'exit' degree in the sense that anyone working as an SHO in surgery or ENT, can in the eveing, spend a couple of hours in a pharmacy to boost his or her income. This is outright immoral once it is recognized that an FP must be a specialist.

The question of Speciality, of course, has a lot to do with the a needs assessment of the country, and may include needs particular to a specific area, and other procedures which the government deems it necessary that FPs provide - such as the procedures mentioned above.

There may be a minimum requirement of setting up of clinics imposed. Conversely, it would be ridiculous to have standards of clinics, whilst at the same time allow the 'doctor with the bag' (on its own) to practice, and to allow young doctors specializing in another field, to dip their fingers into the community without the prerequisite knowledge.

Whilst it is acceptable that some doctors may not feel comfortable in all areas, (eg drug addiction or family counseling), there should be a minimum standard provision, and indeed still have everything included in the curriculum. Thus a doctor must be able to detect

55 Essays ill Bioethics child abuse and be trained to do so and know the proper course of action. In turn, a proper course of action must be standardized and provided by the NHS.

If the government wants to decrease referral it must increase its trust in FPs. This in turn breeds an obligation to train FPs and hold them accountable for CME. Conversely one must move away from a system in which any mishap reported by a patient works only to decrease morale amongst doctors. One must certainly see that reported incidents are justified.

Health Centres These centres can remain as a back up service but many doctors working within will surely not welcome being solely a back­ up service. Indeed one cannot envisage a situation without a transition period. One may have to introduce pilot studies as is being done with drug distribution. There may be a need to provide out of hour service, for example, to allow for FPs to have adequate rest and sick leave or to attend courses. This would be required if there is patient registration - as patients would obviously complain should they not find their doctor.

Health Centres can and should provide better community services for Physiotherapy, occupational therapy etc. It is indeed pitiful to see patients who have just had a stroke and have to travel to hospital in the heat of summer in a van. The trips, waiting times etc, can leave the whole morning from 7am to 1pm occupied for a mere 15 minute contact with a professional. Many patient give up in this service after some time only to get worse and then of course taxing the system due to inadequate potential recovery.

Group Practices Government may also think of schemes to improve and encourage group practices. In this way a patient may be registered with a group and doctors can follow a roster. Those who do not have premises

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may lease government facilities. Conversely doctors may work in solo practices and have an extended group to provide to covering for each other when absent from work. This networking of doctors has worked elsewhere and will provide a more simple way of doctors to make sure a service is available in their absence. At the least a centralized service can tell patients which doctors are available.

Funding "(T)he most serious and most clearly documented problems are those associated with fee-for-service. This system encourages doctors to perform those procedures specifically rewarded by fees, which in most systems tend to be technical investigations and more interventionist treatments. To put it bluntly, many fee-for-service systems do not recognize talking to the patient as a distinct item of service! Fee-for­ service requires more mechanisms than other methods of payment to control potentially wasteful treatments or investigations. "5 This has to be balanced against the wasteful resource of having high referral rates to hospital, which in and of itself, leads to an increased amount of investigations as doctors in the secondary care setting are held to a different standard of care than those in primary care. That is to say, once they are in the secondary care setting, doctors attending these centres must 'investigate fully'. Some form of incentive and trust in the primary care setting must allow doctors to investigate accordingly in order to decide and play the role of gate-keeper to the secondary setting, without causing him or her (the doctor) undue risk of not referring a patient without having performed basic tests.

Of course any change must consider funding. One cannot implement change without investing; and neither can one think of quick fixes. One must consider investments as an opportunity for deceasing long term costs (as presumably any improvement will bring about improvements in morbidity) and waiting lists. This may need also implementing certain changes within the secondary and tertiary systems, which is beyond the scope of this report, but which may need to be tied to any changes in primary care.

5 Ibid., p. 294-295.

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There are various ways to fund the proposed system, amongst which two have been popular mention.

The first is to have fixed salaries. To cover a population of 400000, giving a load of 1000 patients per doctor, one would need 400 FPs. This is in tune with current SAC register (although I do not have the exact figure). A salary of 50,000 - 65,000 euro per doctor would give the government a contained cost. The disadvantages is that a fixed salary may reduce the motivation of a personalized care when one does not realize that market forces no longer play a role.

Conversely paying doctors for every visit may lead to abuse, even on the part of patients. Therefore a compromise would be to give a limited number of coupons to every individual, which may be transferable within a family. This way the government has control over the amount it spends, will continue to provide a free service, and unless a person can be justified that he or she would require more visits, the patient will use the coupons wisely, knowing that after they finish, they will have to resort again to a fee-for-service.

Coupons can also be issued for a limited amount of procedures and investigations.

Government must invest in more training of teachers, and of VT. Teachers must have a proper premises where to train trainees. Also CME must be given its due importance. If this is to be left to a college, it must be supervised by some form of authority to see that each doctor not merely reaches a number of yearly credits, but over a span of years gets refreshers courses in all areas.

Conclusion To conclude, the main objectives of primary care are prevention, management of chronic diseases and management of acute and emergency cases, acting as a gatekeeper to secondary

58 ill Bioethics care. This change must come about by giving FPs more power but at the same time obliging them to be on the specialist register and preventing other doctors from having access to patients. It is to be seen as a government obligation to provide adequately trained doctors in the community, otherwise calling themselves specialists would have no significance other than patient perception, which the government cannot afford. If we are to reach targets of decreased referrals and improved outcomes, these must be monitored and abuses, even on the part of patients reduced. There must be some form of gate-keeping even in accessing a doctor, with practice assistants receiving calls and making appointments. Otherwise considerable time can be taken by intruding, as happens, on the time of other patients, whilst the doctor takes a call. Visiting can also be related to the time needed for the consultation. Naturally there will be teething problems which would have to be adjusted with pilot studies or as time goes by - such as those requiring more time for counseling; or dealing with the heart-sink patient or the patient who makes undue pressure on his or her doctor. Some people may need repeated visit for the same condition and this may require some further form of relief for payment, as well as a compromise on the part of the doctor to avoid unnecessary visits, as it has been shown that this can be an incentive to increase income.6

6 Idem.

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Connecting health reform with values

A recent Hastings Centre Report was dedicated to connecting American Values with Health Reform, given the Obama plan to reform health care fro all. Whist Malta is planning reform, with special regard to the primary health system, very little has been said about how to connect our values to this reform. Perhaps because we take our values for granted or perhaps because it may be difficult in this day and age to define exactly what our values are. In a recent column I wrote how many may start considering that health care should not be totally free. Of course I came out completely opposing this view and in my little opinion, any party considering this would be committing political suicide. This shows the different ways we understand the value of 'justice'.

But party politics is not only about votes; it reflects what the people want or perceive or take for granted. We all agree that the government cannot continue to give out property the way it did. Now it is acceptable for people to purchase their own apartments. Those still under government hands are given to disadvantaged, such as single parents who cannot work. This is a social justice based on a value which politicians recognize stricks a cord in the Maltese heart. Some may use it to advantage for votes, but the majority of politicians would truly believe in it. On the other hand politicians do recognize that you cannot kill private industry and this applies also to health care. Yet health costs are very high. A simply test can easily cost someone more than a month or two's salary. So some form of justice has to be tought about in provision of health care.

Now in a country which has oscillated from a socialist state to one of democratic values; from a country formerly highly staunchly catholic to one in which Catholic thought is being questioned by many, as revealed in the recent survey done at university, one begins to question whether common Maltese values do

60 Essays ill Bioethics indeed exist. Indeed most European countries have had similar oscillations to ours and it would be interesting to find out whether the general population is in disagreement with Europe's original position to out its Christian roots from the constitution.

Yet time and again we have shown ourselves to be consistent in certain values. We belive in Justice, even though we may argue on how to define justice. We believe in freedom and have come to cherish it because it was threatened. We still have many values which we have obtained from our Catholic faith; for example, notwithstanding the differences of faith reflected in the above survey with regards to marriage, the absolute majority of students were against abortion. Whatever surveys may say, I strongly belive that we still cherish the value of the family, even though many families are breaking down. But the call for divorce, although challenging to our faith and although many of us would not want to see it introduced, is, I genuinely believe, based on our innate nature of a strong belief in family. Those who have been separated may not have been fully prepared and or found themselves in. a difficult and painful situation. For them, the chance to divorce is a chance to start over again.

When it comes to health care we all would agree that everyone should have a right to health care service. We would all agree that those at least not able to pay are to receive the same optimal health service for free. This is based also on the ethos of medicine as we understand it and not simply on charity or mercy. But even if you are well off, health care costs will run into the thousands and one may find one life savings demolished, as happen so often in the United States. If health had to depend on whether you can afford insurance and that your company does not go bankrupt when you are a pensioner in order to continue receiving it we all risk having people being treated on the fact of whether they were in a good employment or not. Therefore I would say that we all belive in fairness and equality, when it comes to our health.

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We should be treated fairly means that health cannot depend on merit. Even if I am a drunk and a 'bum', or if I am homeless, I should receive the same treatment as a politician. We have challenged our fairness because it is innate in our nature to pass through windows when the corridors behind doors are too long. Yet we would all want this practice to be abolished.

The main value at stake in health care is the dignity of the human person, from the time one is born to the time one dies. We want our physicians, nurses and carers to have the integrity to treat us well not only when we have pleasant personalities or when we look good or smart. The greatness of a health care professional is shown when he or she deals with the least amongst the lot. But carers are not carpets on which one wipes their shoes. Sometimes we do not appreciate this and expect things out of the ordinary.

We do share a value of solidarity. Certainly health centres have not contributed to this value. They may have been good for their time, but giving a service does not necessarily mean that you have a personal doctor who can share som solidarity with you throughout the process of your illness. This is a shortcoming of not having a doctor of your choice.

We want to be equal. One may be tempted to think that the fact some go to health centres and others to their private doctors means that we are not equal. If going to a doctor meant paying the fees doctors receive on the whole European continent then maybe there would have been a basis to this argument. But doctors charging a pittance does not render private practice inaccessible. It is however a privilege which some very few may not be able to afford, especially if one requires some tests which the same private GP can offer. Many values have been described in health care?; not all may apply directly to Malta, but the following have major relevance.

7 See, for example, Hasting Centre Report: Connecting American Values with Health Reform. 2009.

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Equality. In our situation, equality in health care probably means the whole thing. As a social security state we need to provide health care to all in adequate time. The time issue is the main factor, which affects our delivery. Those who can afford private health care get immediate care; those who choose state health care should get it in an adequate time frame. With the ensuing popularity of the EU health law, patients can have a right to get service abroad or privately if not treated within an adequate time frame. Government (and therefore the people) will suffer more in the long run if services and waiting lists are not improved.

Justice. There are various models of justice, beyond the scope of discussion in a brief article as this. But social justice requires that we share the burden of the cost of health care. This is usually done through national insurance policies or some other form of insurance. National insurance has proved dysfunctional in either not giving enough or being put into a common pot serving other areas as well. Conversely corporate profits made by large private insurance, especially where prices are not regularised, renders this type of access expensive, and at the same time, having much of its money go to profits and not health care itself. On the other hand, if insurance is not mandatory, it will be unfair as it will prohibit people from being insured for pre­ existing conditions and be laden with risk-rated premiums.

Fairness. For a system to work, we all need to contribute towards it in one form or another. Some may have a better means than others to contribute, but probably no-one should be allowed not to contribute at all. In a social system, this means, that although some receive benefits which others do not, we should all pay taxes in order to make us conscious of our contribution to society and not to make some feel that others 'ride' the system unfairly. We should all have a fair access to insurance. Certainly, when people who can afford a knee replacement get it done within a week, whilst others wait over four years, would mean that the imbalance has become to large to justify.

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Solidarity. Insurance are a good form of solidarity, but carry significant disadvantages as described above. Corporate profits deprive the system of much needed funds in an area that perpetually remains a scarce resource. Insurance work best when they are a national entity which is specifically directed to health care. In this way, as in Canada, for example, people who suffer from pre-existing conditions or have higher risk factors than other will not be put at a disadvantage.

Medical Progress. Many have a powerful faith in science; this is perpetuated because we hear of people doing well and we also experience the benefits of health care. We therefore wish to have access to all medical progress and indeed encourage this in our research. It may not be possible however for the system to keep up with ever increasing costs. New machines and technology would have to maintain an equal access and opportunity for all. Medical progress must not seek to eliminate illness and death for these at best can be forestalled. In the meantime care for chronic conditions have gone upwards and we need therefore to focus on caring rather than eliminating diseases. It is now recognized that progress has led to unsustainable health care costs. Seeking the elimination of aging and. death have been ethically questionable therefore, as has been talk of genetic enhancements of germ line cells, whilst maintaining to recognize the role that genetics and pharmacogenetics play in controlling and perhaps eliminating diseases. To focus on care, we need to encourage more doctors to enter the primary care field as well.

Quality. Quality in medicine depends to a large extent on political systems. The Hastings report shows how the two extremes of communism and radical free-market policies have been disastrous for health care. Just because I have access to many investigative procedures does not mean that the quality delivered is better. Indeed it may cause undue pressure on patients. Conversely newer drugs costs much more and a cost-effective analysis

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may not justify their radical use. On the other hand, it is also a waste of resources to put certain drugs and investigations solely under tight consultant control. Systems need to be re-evaluated continuously in a field which is developing at a fast rate.

Efficiency. This can mean technical efficiency and the efficiency of the system. Doctors coming from specialized centres know that it is not realistic to expect a system with one non-specialized hospital, which carries therefore the burden of all specialities, to shoulder costs for a minority. Riding the shoulders of giants continues to remain a plausible alternative, where we can access specialized services abroad. Conversely I hear of tests being sent abroad because there is no fume cupboard; tests which were formerly done here and gave quite a good service.

On the other hand when we speak of efficiency the first thing that comes to mind are the waiting lists. We need to ask ourselves what realistic goals are and reach those targets. Whilstthis is easier said than done, if efficiency is to be a value of health care, its measurement, which is reasonable public satisfaction, must somehow be measured. Cooperation, between individuals within the team, between the private and public sectors, and not least between the population and the health system (such as following advice for not spreading viruses) lends itself to a more efficient system.

Stewardship. This means accepting responsibility and acting on that responsibility in order to preserve and maintain something of value - in our case the health of our population. Without health we cannot enjoy life; and without better quality of life, health system would be meaningless. However stewardship calls for a collective conscience - it is not for a privileged few, and neither can it be based on a merit system. Someone who has smoked all . his life still benefits from health services in a conscience oriented society. The person remain valuable in and of himself and even to his or her family. Telling relatives that their father cannot have

65 Essays in Bioethics all the services because he was a smoker was never acceptable in health care. We are now changing attitudes and frown upon peoplewhoabusetheirhealthandthentaxthesystem. Weneedto maintain high moral ground and respect individuals for what they are, with all their faults, whilst putting pressure on life modification by health promotion, without on the other hand, 'medicalizing' society. This calls for a good dose of realism. Stewardship means accepting responsibility towards each other and leaving it to proper authorities, like courts, to pass judgements. When health professionals make decisions based on merit or who people are, they should question whether they uphold this value of service towards humanity. It is not for me as a health professional to pass judgement. In fact it is for me to be a patient advocate, no matter what judgements society passes on some of its members. Insurance that penalizes the disabled or someone who falls ill (by increasing premiums when they have had insurance cover before the onset of the illness) have failed in their stewardship. Just as we feed the hungry, and dress the unclothed, we attend to the sick. Stewardship defines our society.

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Cross border health care

There are a number of EU directives which apply to the rights of EU citizens to receive medical health care when outside their country but within the European Union. This applies mostly to emergency treatment and has also proved of benefit to those who cannot receive a procedure, for example, within their country of origin either due to lack of the service or merely because of undue prolonged waiting. Yet the EU was set up as an economic zone and therefore include the facilitation of transfer of workers between EU states.

When it comes to transfer of workers, especially those traveling with their family, primary health becomes all the more important. EU states differ considerably between themselves on the type of service they offer. Some are mostly state-based; others insurance based. Certainly if one is to travel to another country, say Holland, with one's family, it is a concern, if not a headache, to consider what kind of health services are offered for day-to-day ailments which necessitate the calling of a doctor. In Malta one may be used to call one's GP at home and gets prompt service. But this is a private service which is not, by right, entitled to other EU citizens. They would have to pay for it. Considering the small fee local family doctors charge, it is worth the while of any EU citizen travelling here to call a family doctor at one's home. Even if one had to go to a health centre, the service would be given on the same day. Not so in the UK, for example, where locals would have to wait up to a couple of weeks for an appOintment and only emergencies treated on the same day and probably not at home.

Certainly, finding out about a health system is the last thing on many people's minds when travelling to another country. If one is intending to travel for a few months or a few years, one has already many headaches like finding a house or apartment, schools for the children etc. If the EU is to become what it was intended to become - a zone in which all EU citizens can transfer

67 Essays ill Bioethies for work opportunities, and not remain merely an opportunity zone for the younger generation only, then one has to cater for the transfer of families.

This is certainly not new. In research, for example, there are various schemes which provide for the transfer of researchers from one country to another. One fund, the Marie Curie, was set up to allow the transfer of those researchers who had less opportunity in their area of research in their locality, to transfer to more renowned centres. These funds catered for the transfer of one's family and even, in some cases, schools.

But such opportunities may exist only within certain schemes. Certainly to 'remove barriers', one must make it as easy as, say, an Americans transferring with their children and spouses from one state to another. One big obstacle which we find in Europe (but which Americans do not find) is primary health care - or in more lay terms, the family doctor (many may still refer to him/her as GP).

Imagine again traveling to Holland and once their, one's daughter is ill with gastritis. It would certainly be less of a headache if the system there were the same as in Malta. One would be given several telephone numbers and one simply calls the doctor. IT may not be easy to find a system that works as efficiently and effectively as Malta. I say this not because I am a local family doctor as well, but because it is the reality. For a mere five or seven euros one sees a GP in one's office, perhaps after an hours' wait. If one were to call to a GP in another country one certainly would spend ten to fifteen times as much. One appreciates was one has (or has left behind) when one does not have it any longer. Yet some form of harmonization would be very convenient.

This agenda is being taken up locally by the Bioethics Research Programme of the Medical School at Mater Dei. Together with the Faculty of Medicine at the University of Maastricht, we

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hope to propose a project of study of this cross border primary care problem. There are several areas of concern which are all related to primary care. In the first instance what one considers emergencies are not always emergencies. A mother once told me (when we had introduced the system that after 5 pm, health centers had to see only emergencies), that for her, a fever, or a mere sore throat of a two-year old was an emergency, especially when the media feeds the public signs to look out for and when they here of other people's experiences. Did not that baby with a sore throat end p in hospital with croup? Did not that rash turn out to be meningitis? Did not that fever reflect an appendix? Mothers can be very anxious. It is the family doctor's job to reflect and decide what should be referred to hospital and what should be treated at home. It is also his or her job then to reassure the parents and give them some form of safety net if things get worse.

Other jobs of family doctors are preventive medicine, taking care of chronic conditions and giving other form of social advice. Someone travelling to another State would be concern about his or her hypertension or diabetes. Where are they to go for their follow-up visits; where do they get their treatment from; who are they to call in case of worry or an emergency? If one has a son who suffers from Asthma or an allergy, one cannot rely solely on self-management. Although it is easy to call one's doctor back home, when one is away for longer period of time, one needs a point of contact. Someone cannot simply turn up at an emergency every time something goes wrong. Conversely, whilst people get used to the primary care system as time goes along, it would be much easier if system were approximately the same.

Now there are various theories of EU integration. They vary from mere economic with no need for making systems uniform to theories, which allow for more coherent and integrated systems. Would it not be easy if my Family Doctor at home would simply ask me where I am going and through a computerized system find out

69 Essays ill Bioethics the local family doctors and transfer my records electronically? That would be one headache, which can save lives, off one's list. One can then dedicate more time to settle down at work and finding schools and where to live.

Whatever theory of EU integration one uses, the main concern is, at the end of the day, the facilitation of transfer of workers between states. Many directives have been written in this spirit. This includes, for example, the EU Directive on Data Protection which is not there to protect this fundamental right and freedom of the individual (privacy) but to facilitate the transfer of information (data) between EU States. It assumes that fundamental rights are protected within the framework of local laws. The same can be true when thinking health. A directive for countries would indicate to member states what they should be after. This would not only, incidentally, bring more harmonization for those who are traveling, but as with other directives, would ensure that all EU citizens, would, at the end of the day, be receiving appropriate health care.

This is no easy matter. One would need to study the systems in all other States and take common denominators and see what the needs are to harmonize systems. Certainly the WHO stipulates that good primary health care systems are the key to an overall good health care system. We often go along with the wrong impression that a good hospital equates with a good health care system. This is wrong. A good hospital is just that a good hospital. When the system is wrong, that good hospital is taxed to an extent that disallows it from functioning effectively and efficiently. We need not go far to understand this!! The increased waiting time in our local hospital was, at least partially, identified with a weakness in our primary health care. Inappropriate referrals because local GPs do not have adequate facilities, or indeed self-referral by patients themselves, has led the department of health to call for GPs to work at the emergency department, to see patients who did not actually need to turn up at casualty.

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This happens in many countries where general practice is not yet developed into an efficient system. Of course such a system would need the registration of patients with a family doctor; doctors need to be more organized to cover each other when they are off duty or on leave, or indeed sick; whether group practice or solo practice, one has to see that there is harmony within the system, and last but not least one has to ensure that all doctors working in the community are on the Specialist register and are equipped to deal with semi-emergencies, which would in turn relieve hospitals. Registration alone is not the answer. Registration brings with it organisation, without which it would simply not work.

Whilst we are re-thinking our primary health care system, it would be wise to watch out fro these developments. Certainly there are many other EU-funded projects dealing with this important area. We need to be able not only to handle EU Citizens who come here; but to ensure that local people who seek opportunity within the EU continue to get optimal care and a family service. Our system is in need of a re­ vamp. The tensions which have arisen lately are simply the result of an accumulation of problems which have been tackled poorly. It is also true that were it not for private GPs, no one in Malta would be able to answer the question, 'who is your doctor?', or to react to 'take this to your doctor'. Health centres are made of excellent doctors working in a poor system, created in a communist period (Polyclinics were introduced in Russia) which even they have largely purged.

Perhaps what is also in need of a re-vamp isthe National Development Day which the Malta College of Family Doctors started when I was President to bring all stakeholders together - we had doctors from all sectors, Ministers, and others - to discuss where we want to go over the next ten to twenty years. It started by people being weary that their turf needs protection. But change will bring about benefits besides the sacrifices. Experience in other areas has shown that the benefits always outweigh the sacrifices. In re-thinking our primary system, however we may wish to look at the future of the EU as well and keep ourselves posted on this issue.

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The morality of Vocation Training for FPs.

The Synapse : Vocational Training is an obligation in all specialities under the EU Health laws. This means that if a subspeciality is listed on the specialist register of a country, it is not only an exam which is required to work, but specific Vocational Training (VT). The EU obliges government to guarantee for patients that anyone working with the National Health Services should have VT.

Patient Registration seems to be entering our country and there are already proposals which will soon be handed out to the stake holders. It is good that the Association of Private Family Doctors will be involved in this. What is suggested here is however solely my responsibility and ideas. It would be wise however that the APFD asserts its rights that those who can accept people to register with doctors must be on the specialist register. This asserts not only their right to practice in a field which has now been shown to require specialization (we are certainly not pulling people's legs when we assert this) but it gives the government a guarantee of quality.

Tied to this however must come a strong proposal that those who hold an MD alone, unless they qualified for the specialist register by the one-off grandfather clause, will not be allowed to practice. There are varying opinions on this. Some continue to assert that an MD degree should be an exist degree that is, one can do anything with it. If one obliges VT, then it will only be an entrance degree. I would not argue for other areas, but certainly, if we feel that VT is not only a guarantee, but it worth something extra, then it is about patient rights, and as patient advocates we must uphold this principle. It is not a question of protection of turf, but a question of who enters that turf must be duly qualified. This happens in surgery and other specialitities. Although I may take the risk and remove an appendix, I would be in a very tight position if I were to defend myself in front of a medical

72 Essays ill Bioethics council. I cannot see how someone can escape negligence and malpractice. Although there are instances where countries require GPs to work in areas of specialization, they would not be on the specialist register and there is a limit to what they can do. This means in effect that what they do is still regulated and the MD qualification would not be enough.

We must also consider that we are in the EU and that by giving registration to private family doctors, the government has in effect acknowledged that private FPs are now part of the NHS and ties itself with this directive.

Actually this directive ties countries even if family medicine is not considered a speciality. In Italy the government has taken to control primary care and employs a fixed quantity of doctors calculated on a thousand patients per doctor. VT is imposed, even though family medicine is still not on their specialist register. It is not merely about the register therefore. It is about quality, and about asserting that before we send doctors working in the community, they have been exposed to the local situations and know how to deal with non-manifest agendas, which often are not seen in the hospital setting. One must be astute to detect domestic violence, and offer treatment to substance abuse and help the family to cope. Being versant with all the available services does not come that quick. If one is to be registered with a doctor, this doctor must cover a comprehensive care from children to elderly and from palliative care to offering some minor procedure and investigations. All WONCA core competencies must be satisfied.

The key therefore, for a successful implementation of patient registration, is to make sure that the doctors are adequately placed. This does not mean that someone who works in a department may not form part of a group or network, so long as he or she is on the specialist register. But it does mean that

73 Essays in Bioethics doctors should not be allowed to be following one speciality and be allowed to sit in a pharmacy seeing patients which they will abandon as soon as they pass their membership exams. Having Vocation Training is about patients' rights. It is not about the right to chose to do VT or not. The govemment has now taken in and acknowledged the important role private doctors do for our NHS. With this come moral responsibilities to our patients.

It will also mean making a jump in quality assurance, pharmacovigilance, infectious disease surveillance etc. If we have doctors who do not have patients registered with them practicing in parallel, this may mean that these quality improvements will not occur.

Certainly conditions must be satisfied for GPs to have patients registered with them. The first is a minimum number of hours in their practice - usually 20 hours have been suggested. Secondly they should be networked to cover for out-of-hours and emergency calls and when one is on leave. Networking works just as good in other countries as group practices, which have not proved popular. It will also prevent business-like services, bringing in doctors from other countries who are not on the specialist register of their own country or have not done vocational training to practice here at the expense of quality and due care.

But the fact we are seeing a silver lining is indeed a step forward for patients and doctors alike. The effort invested by many over the years and especially in recent months is paying off.

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The House Call

There is no doubt that in Malta the population is still privileged to have its family doctors provide a service in their homes, no matter what reason they give. It is enough to call one's doctor in the morning and ask him to visit you without giving details of necessity, other than perhaps if it is an emergency. The doctors usually either comes immediately or during a convenient time of the day, which patients often get used to. Patients call their doctors home for reasons ranging from running a fever to being tied down to staying at home because the company doctor will not find them their or because they are waiting for the washing­ machine-man. This is fine by today's standards and doctors comply (even because it is a market force). Even rain is a good enough reason for many.

New changes in practices may bring in changes in attitudes and practices which allow doctors a better schedule but which inevitably bring about the removal of privileges, especially when we do not realize they are abusive. It is not that doctors don't get wet; but some people can do their best to open the door faster than usual when it is. Then you have to work your way through those plastic/canvas sheets which protect heir doors from the splashing of cars, which inevitably shower you every so often.

When should house calls be done? We do not have clear guidelines here and in the UK there are discretions left to the doctor. But we would do well, if we are to introduce a system as the one we are contemplating, which documents when doctors should make domiciliary calls and educate people when they should not. That you are waiting for your company doctor may indeed sound legitimate to you, but it is not for your personal doctor. In many countries which National Health Services, laws have had to be effected to guide professionals and patients alike. Unfortunately such has not occurred with our Health Care

75 Essays in Bioethics system and it is not the first time that doctors have had to worry about charges which certainly should not have been issued simply because they did not do a house call when it was uncalled for and when they offered alternatives.

Certainly it is not an emergency in and of itself which defines that a house call should be done. For example, health centre doctors were supposed to see patients after 5pm only for emergencies. Even if a sore throat is not an emergency, a woman once told me, 'but to me it is an emergency if my child has a sore throat'. What she needed was reassurance. A colleague in a health center got charged because he failed to do a house call for a child who was running a temperature. Even though a fever can be an emergency and one has to exclude dangerous causes, it is not necessarily a cause for a domiciliary visit. This is the whole point.

There is only one condition which, legally (and when I say legally I am not referring to our law, but to what can be translated into negligence of a doctor should he or she fail to effect that call), requires a domiciliary visit (in lay terms, a 'house call'): intransportability: when a patient cannot be transported to the clinic. This is usually tied to three practices and does not necessarily involve an emergency:

1. A list of patients who cannot make use of normal means of transport (including public transport) 2. An obligation on the part of the family to provide transport (in Italy this is law!) 3. An obligation on the part of departments of health to educate people on the correct use of these services.

It should be noted that 'rain' and' company doctor' do not venture into the list. But to clarify what we mean by 'intransportability', many countries have a definite list to guide both patients and doctors. This includes:

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• People on the above-mentioned list • People who cannot be transported • Severe cardiac insufficiency • Severe respiratory insufficiency • Severe arteriopathy (circulatory insufficiency which renders person incapable of walking) • Severe encephalopathy (brain damgge) • Paralysis • Terminally ill • Severe disability • Elderly people with fractures • Stroke patients Psychotic patients • Temporary disabilities • And, for protective reasons (including protection to self or others)

Of course a competitive system like ours makes such a list almost useless. I say almost because should a doctor refuse he or she is still liable to attend to a patient under tort law (which defines negligence). A doctor would be guilty of omission should he fail to provide a house call under these circumstance, without providing an alternative.

What is the alternative? Sometimes, if it is not an emergency, some advice on the phone suffices. At other times he may offer that he or she see the patient at the clinic. Note that this is legitimate. If the doctor feels satisfied that the patient can make use of transport he is legally not obliged to visit him or her at home providing he has still offered to see the patient at the clinic. Alternatively one can make an arrangement for a day and time convenient for both. In emergencies one has to note as well that it is the patient's inability to be transported which defines the situation. Thus, even if a fever is an emergency, the doctor is obliged to go only if the patient cannot come to the doctor. In reality this applies in our

77 Essays ill Bioethics system only for Health Centre, and even here unfortunately the system has tended to err of the doctor's side as described above. It is because tings are not written down clearly.

Doctors have to do urgent call within a reasonable period of time. It should be noted that the services of a doctor however are to be defined within the scope of the whole system. He is part of an integrated system. Doctors can send transport for patients if they are unable to attend to people. Many countries also have exact codes to follow in case of complaints. The doctor has to clearly have breached one of the above duties and only then is he investigated. A controller therefore decides whether a breach has occurred and then decides whether to issue a warning to the doctor or to proceed to further procedures. In private practice locally a patient only has recourse to the medical council to which one should complain in writing. The medical council then decides whether there is cause to proceed to investigate and may ask the doctor to explain himself.

Although the medical council has a right to fine a doctor or even to remove one's license, it is a more prolonged procedure. On the other hand experience has shown that when things escalate quickly with the professionals finding themselves having to repeatedly defend themselves in situations where they acted within their rights, the system tends to be abuse by trigger happy individuals who do not even bother to complain through the proper channels but who phone their member of parliament. The honorary member in turn makes a report to the department who in turn now feel under the undue pressure of the parliamentarian. Believe me, it is not that easy to tell a parliamentarian that the doctor was not at fault especially because the complainant usually is a constituent whom the parliamentarian wishes to please. I have seen a letter giving a 'mild warning' to a doctor under such a circumstance explaining that 'even a fever can be an emergency'. This very statement shows that the people

78 Essays ill Bioethics who wrote it had no idea of why a house call should be made in the first place and that the parent who made the call had an obligation to take his child to the health centre, Moreover the doctor had indeed offered advice and asked the parent to call again after an hour, something the parent did not do; instead the following morning he called his MP,

These things only happen when and where there are no clear guidelines, It is hoped that with the document of primary care, this attention to details will be given, especially since it makes mention of some form of controller of the system,

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Pandemic flu: ethics and patient responsibility

First it was the avian flu and now it is the swine flu. What we often ignore is the fact that these are normal influenza. What makes them different from the seasonal influenza are two main facts. First viruses tend to be mild or strong according to certain strains. For example, we thought that this swine flu would be much stronger than it actually is. It is therefore the experience of the first patients and the first hospitals which start determining outcomes. The same virus can however mutate and change its characteristics. Therefore we are never so sure, even if we develop vaccines. Secondly, what makes the seasonal influenza less fearful is the symbiotic relationship medicine has with the pharmaceutical industry. It gives us time to develop vaccines, and these, through the good work of health promotion, are popular with many people. There is thus what is called a 'herd' immunity. This means that even if you are not protected with a vaccine, chances are that you are protected a little against getting it because the vaccine keep the numbers in check. Of course we promote more strongly the vaccination programme in people who are more at risk -elderly, children, and those suffering from certain chronic diseases.

What makes a pandemic special is this fact amongst other technicalities. People are not vaccinated because there is no time to develop a vaccine. Therefore the number of people getting a virus can simply jump from a handful of people to hundreds and thousands within a day. There is no herd immunity and the more virulent the virus, the worse. Of course the influenza as such takes its normal course. Some are milder than others. But the problem with a pandemic, as we are continuously told on the media by our dedicated doctors and director at the department of health, is the fact that once you have a larger than usual chunk of the population who is ill, the virus spreads even more quickly. Suddenly many people are on sick leave, and this includes health workers. So there will not only not be enough health workers, but

80 Essays in Bioethics indeed the hospitals and clinics are overloaded more than usual, with less personnel. Moreover medication can become scarce; many went through the experience of buying medication - even at a higher than usual price, just for storing it.

Panic can easily strike with people hoarding food, and even not going to work so as not to come into contact with the virus. People often tend to be more afraid because of fear induced by the media. This fear is good to the extent that it makes us think and act beforehand. This is where the ethics of public resource allocation and indeed doctor and patient responsibility come in.

It goes without saying that developing vaccines costs money and these vaccines may be more costly than the usual ones because they are out of the blues and involve greater risks in developing due to the possibility of mutations of the virus - if it mutates, chances are the vaccine will then not work. But if it proves useful public health authorities cannot waste this resource and the government will feel obliged, ethically, to give it to those most at risk - which includes two main categories. First those patients, mentioned above, who are more at risk, and secondly health care workers. Of course we need health care workers, be they doctors, nurses, and indeed everyone who makes, in his or her own small way, the health system function smoothly every day. A chain is as strong as its weakest link. So if we protect them by giving them free and immediate vaccines, then the chances are good that the hospital will suffer less from people out on sick leave. Indeed it may be unethical for a health worker to refuse vaccination and decisions have to be taken with regards to these individuals. They cannot under these circumstances, be treated as normal citizens, because they are the soldiers fighting the war. Perhaps there will be herd immunity within the hospital community, but in reality anyone who gets the virus can easily transmit it in this highly vulnerable zone. We have to remember that the hospital will have its normal complement of ill people who are all more vulnerable to obtain an infection.

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It goes without saying that health care professions are bound by ethical duties. Hospital transmission is not a new concept. We all remember the MRSA bacterium - a bacterium resistantto penicillins and which is found mostly in hospitals. The cause of this virus was not merely overuse of antibiotics, but the spread involved health workers not washing their hands between one patient and another. Alcoholic liquids which can be rubbed onto the hands and that evaporate quickly are now in common use. The importance of precautions has been demonstrated in Canada, as explained by our visiting professor in the department of family medicine. When there was the SARS virus, places like Ontario, where even family doctors where not taking precautions such as using gowns, face masks etc suffered considerably more from the transmission of the virus than places where these precautions were taken. Sick people come to the clinic. It is not only they who can, by their coughs and sneezing, transmit the virus in waiting rooms, but the doctors and nurses who come into direct contact with them - their hands carry the virus from one person to another, and they can easily swallow the air where a patient has just coughed.

But the most important control is the population itself. Patient responsibility has come to be an important aspect of health care. Apart from the fact that we have to respect others and our own health, we have to follow the measures which are prescribed by the department of health. These lists may be long, but some common sense would take us far. Thus not going to work when one is ill is probably the most important issue. Working parents send their children to school when they already have running noses. Schools are a great source of infection. Children bring the bugs into our homes. What is worse - schools start in the winter when people tend to remain indoors more and thus are more likely to catch a cold. Patient responsibility comes individually but also collectively. We have to work together. It is inexcusable that people with flu, who are advised not only to stay at home, but also to quarantine themselves in their rooms, if possible with

82 Essays in Bioethics only one family member being in contact with them, refuse to follow the procedure and think that the world without them will stop and go to work. This is not to be commendable and seen as heroic any longer. They are a threat.

Another dangerous practice, is when people deliberately decide not to take the vaccine or to pretend that the government should always supply everyone. This is a scarce resource and we must accept that a possible pandemic is a special occasion. Whilst people stockpile pills, some may be afraid of vaccines because once they took it and felt they got more ill. Whilst it is true that the first time you take a vaccine, you can get mildly ill with the vaccine itself, when one takes vaccines regularly this stops occurring. Moreover many feel that they take a vaccine in vane because they still get common colds. A common cold is not the flu, and there are several going around each year. We need to educate the public more that a vaccine is against one particular virus which is the flu which the WHO has considered important enough to develop due to dangers it poses. We would get a pandemic every year if we did not have vaccines. We do not, on the other hand, need a vaccine for every common cold which last a couple of days.

There is also our collective responsibility. The Church authorities were very responsible when they accepted the suggestion that people not receive communion by hand. One patient of mine complained that whilst this practice was fine, he spent the whole mass with someone coughing in the bench behind him. People who are coughing should not go to mass, period. I am sure that the Church would agree; as one is always exempt from this sacrament when ill. Neither should we perhaps send people to give them this sacrament at home during this period. If the worse comes to the worst and a pandemic is imminent, it is probably prudent for the country to close down public places such as schools and churches for a while. We can use the media to our advantage for this and hearing mass on the television for a couple

83 Essays ill Bioethics of weeks can save lives. But what about pubs, restaurants and the work place? If you stop everything you affect the economy which is what pandemics will cause anyway. You will probably be deceiving the end. People will suffer and you can get job loses. So prudence must keep us from over-reacting. We need to close down those places which can be closed without a great social impact.

Whilst one does not wish to sound insensitive food for the soul is as important as food for the body; and if schools close down, many parents will not be able to go to work; we have to discuss these things in good time and use the scout motto: Be Prepared.

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When doctors dissent 25 January 2010

The medical council has recently distributed a letter to all medical practitioners admonishing them not to give advice against receiving the AH1 N1 vaccine. This letter raises several issues, which, if not contemplated well, may lead to public mistrust in the profession in general. The main question is whether medicine is subject to the personal opinion of the practitioner or whether the practitioner should always impart impartial information which the health authority tells him or her to do so.

Whilst doctors have traditionally cherished their independence when it comes to imparting treatment, times have also changed. This is acknowledged in the ever-lengthening publication of the British Medical Association, Medical Ethics Today. "What patients now expect from doctors is quite different from the expectations of the parents and grandparents. Much of this is due to societal change and differing views about how, for example, fundamental concept such as benefit, harm, and best interests should be interpreted"8. In addition, the increasing focus on patients' rights has led to a position where the arbiter of what is ethical lies usually in the hands of the law. Therefore doctors, whilst still allowed to express their opinion, have to make it clear that this may be only their opinion and they still have to emphasize what the health authorities are usually pointing out to the public. Family Doctors are especially numerous enough and strategically placed to give relevant and timely information to the public. Dealing with risk communication is difficult enough for the public health authorities and health departments and should probably not be made more difficult by the front-liners.

Doctors do indeed read and continue to receive evidence-based information. Sometimes however there are indeed conflicting articles in the medical journals, such as a recent article which

nd 8 Medical Ethics Today, British Medical Association, 2 ed. 2004, BMJ Books, p.24.

85 Essays ill Bioethics was rather strongly against vaccination, which appeared in the British journal of General Practice. The journals do however point out that these article are opinions and do not reflect standard policy and neither are they intended to confuse doctors or to encourage them to do other than what departments of health recommend. They are simply meant to keep the on-going debates and to continue in the scientific tradition developed by Karl Popper (a philosopher of scienceO who said that good science means that anything is always challengeable.

We are dealing with human lives however and when doctors are faced with health authorities, who do not simply come up with ideas, but are following the advice of the World health Organisation and the World Medical Association, then one is taking simply too much on his or her shoulders when one advises patients not to take a vaccine which is being promoted to avoid pandemics. There are indeed pOliticians who may go public and make an issue about industry or the United State, who are gaining by promoting such a vaccine. We do not hide behind the fact that medicine has to make use of industry and that there are many companies who indeed get rich in such times, as there are people who get rich during times of war. It does not mean we do not buy arms and not defend ourselves. An interview with a Nordic politician appeared on the internet who actually strongly came out saying that the whole vaccine thing was a hoax to make us spend money. Others said it was an exercise to test how we can manage an eventual bird flu pandemic. Others even said that people are trying to kill half of the world's population. One would expect doctors to go reasonably beyond such scaremongering and that if they do not have any solid information, not mere opinions, that vaccination is dangerous, then they should not give their patients wrongful information. Patients trust their doctors. The doctor-patient relationship is a fiduciary relationship, and if doctors go around telling people not to take the vaccine, then many people will indeed not take it because they trust their GP/Family doctor.

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If in all honesty doctors cannot refrain from discouraging their patients not to take the vaccine then they should be ready to point to the relevant evidence and accept if they are wrong. Prudence, a virtue which we cherish to hopefully have in our practices, should move us to a point where we should only tell people what the health departments are advising and when asked about risks, discuss these frankly and without scaring people off. It is interesting that a student asked me this week whether we should give our personal opinion. If asked for a personal opinion then maybe we can consider this; if not then we have to ask ourselves whether we are giving this information to try to push the patient one way or another in making a choice. What this boils down to is the Principle of Respecting the Autonomy of Patients.

Respecting autonomy means that we need to respect that people are able to make their own choices, even if they come for advice. An autonomous patient is someone who does something with intention, with understanding and without any controlling influences. Controlling influences, in turn, affect the voluntary choice of the individual. The concept of an informed choice, and informed consent is a derivative of the principle to respect autonomy. For a valid informed choice, the patient must receive at least the information which a reasonable person would want to know; the doctor has to make sure that the patient is understanding, is competent to make a choice, and is making a voluntary choice, and finally the consent has to be given. The voluntary choice, in turn, is affected by three main things: coercion, manipulation (a thwarting of the truth), and persuasion.

Some question whether persuasion is legitimate. A person who needs persuasion is evidently still unable to make a chOice voluntarily. He or she needs that push. There is a clear difference between trying to persuade someone and giving further information so that the person can make a choice. We should allow people then to make their own choices, for clearly if I

87 if! Bioethics continue to give more and more information until the patient is 'persuaded', then one not only risks manipulation of the truth (for I may be emphasizing only my bias), but we certainly would be putting pressure on the individual. Discretion is the rule of the day. Clearly when it comes to answering questions about our personal opinion, one has to take this into consideration. I have to be aware that giving my personal opinion is a legitimate question and reflects the trust the person has in me. I must realise at this point the power I hold in my hands, lest I be guilty of malpractice - which is a failure to impart a duty of a standard of care I owe, as a professional, to the patient. Should harm be caused by this breach of duty, I would be held liable for negligence.

Thomas Percival, one of the first to write about modern medical ethics (after Hippocrates) in 1803 made a statement which is still relevant today, as evidenced in the BMA book mentioned above: the life of a sick person can be shortened not only by the acts, but also by the words of the manner of the doctor. This was written in the context of not discouraging sick people. But it is also applicable today, when we have made a paradigm shift towards preventive medicine. My words can indeed affect outcomes. If I am putting my personal opinion on the line instead of that of the official health statements on a country, I must clearly be considering that I must be able to justify my words and acts in front of a medical council - the ultimate thermostat of the actions of each medical professional.

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Concern by media on antipsychotic treatment by General Practitioners

A feature appearing recently in the Malta Today referred to an article which appeared in the last issue of the Malta MedicalJournal that raised concern that General Practitioners were prescribing an atypical antipsychotic to children. This was concluded from a survey (in technical terms - a retrospective study) of the referral tickets which family doctors makes when referring children to the Child Guidance Clinic. It is no surprise that the conclusions of such an article appears in the media and indeed one wonders how it did not have more impact. Nevertheless, since the article 'hit' the media, probably in an unintentional way, it merits some comment from an ethical point of view as well.

The objective of the study was 'to assess the accuracy of the diagnosis and appropriateness of antipsychotic medication prescribed to children and adolescents referred to child guidance clinic, and how many of these remained on the said medication after consultant psychiatrist and multidisciplinary team review'. The authors claimed 'good interrater reliability, but admit to bias and not communicating with the GPs who issued the tickets - the main notion which undermines the study, as we shall see, whilst raised an ethical concern.

The results of this study showed that 154 (63.1 %) out of a total of 244 children referred, carried an admission diagnosis which differed from the working diagnosis affer 6 months of presumed evaluation by the team and review by a child psychiatrist. The study naturally raises a number of concerns, namely:

1. Are General Practitioners misdiagnosing children to their detriment? 2. Are General Practitioners prescribing antipsychotics without consultation with psychiatrists? 3. Is there indeed a lack of Continuing Medical Education in this area?

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What is said here is therefore not intended in any way to undermine any of the results, but intends to review critically some of the interpretations in the said article to evaluate such conclusions.

It should be pointed out that the authors do not make any reference to Maltese General Practitioners, but it may be assumed that due to the article being published in the Maltese Medical Journal and the authors all being Maltese. The reason for this observation is that the preamble to the study makes reference to studies outside Malta and with systems that are completely different from the local one. It is dubious therefore how relevant they are to the present study. If anything it points in the direction of a general global problem and not a local one.

The authors admit that one of the limitations of the study was that data was collected retrospectively and that 'it was solely collected from medical files without actually interviewing the children', and that moreover, 'No contact with the referring GP was made to acquire any missing data'. There is an ethical concern here that even though the results were anonymised, the data used was still identifiable. People often confuse these pOints as FP-funded EU projects have been trying to hammer in. Yet I have seen it ignored on Research Ethics Committees so often. The importance of this lies in the context of the conclusion. Clearly if GPs were contacted, they may have given a clear explanation of the drug which the child was taken. In particular the authors do not concede that within the Maltese system, a practitioner making a referral must indicate the drugs that the patient is on. In many cases this does not mean that the referring practitioner has actually started the drug.

In my experience, when referring a child to the Child Guidance Unit the child was already on treatment which was not changed as it was started by a psychiatrist seen privately. It is quite unlikely that General Practitioners in Malta actually start children

90 Essays in Bioethics on antipsychotics without referring early on in the course of management to a psychiatrist and only refer when this treatment has not worked. Indeed this sole particular puts into question the whole study by these authors as clearly an interview with the referring GPs would not only have obtained the necessary consent, which evidently was not obtained, but would have clarified whether the GPs themselves had started their patients on this treatment. Consent was still necessary as the researcher do not state that an effort was made by themselves to make the referral ticket information anonymised, and indeed non-identifiable. They do not indicate that GPs were not contacted because of the nature of the study being anonymised. This means that the information at hand was of an identifiable nature. Without going into the merits that therefore of whether informed consent should have been obtained, clearly many GPs would have objected to this 'non-objective' used of their referral notes. The point is not so much the ethical issue here, but the validity of the whole study itself.

Indeed GPs usually do consult with psychiatrists, whilst the authors claim the opposite. This could clearly indicate lack of information on the referral note, which, combined with the admitted observer bias and the non-blind nature of the study, would have been important. It is indeed inexcusable to state that one takes referral notes at face value when one knows of such limits and when one makes such important conclusions. The authors indeed go on to question the 'number of unrecorded children on sulpiride within the community', and directly imply this is the fault and negligence of general practitioners. They conclude that 'The misuse of supliride by the primary level care doctors is of concern considering that this is an antipsychotic with a number of long term and short term side effects'

The authors point out that the efficacy of the atypical neuroleptics in children and adolescents is in the treatment of schizophrenia

91 Essays in Bioethics and pervasive developmental disorders. It is also used as an antidepressant in children. However it is clear that the conflict did not seem to be about whether the children referred should have been on an antipsychotic: rather it was the choice of drug. "Atypical antipsychotic medication was prescribed as treatment for children prior to admission to CGC. In all cases but one, the antipsychotic started by the consultant psychiatrist was the newer atypical antipsychotic risperidone", pointing out however that sulpiride is not indicated in children under 14 years of age.

One may make several conclusions from this analysis.

a. The authors make the assumption (not stated) that the referring physician was the same who started the patient on Sulpiride. In the Maltese system this is not necessarily the case due to patients not being registered with doctors. This is an admitted weakness of the article by the author but indeed puts into question the conclusions and recommendations drawn. b. Many statements are taken from studies done in a diverse range of countries whilst the prose of the article seems to intend the local scenario. This could be the 'bias' the authors are referring to. c. That the prescription of an antipsychotic seems not to be a problem related solely to Malta but from the references shown it seems to be an across the board international issue. In particular the problem was prevalent in Australian GPs who have very stringent post-graduate qualifications and re-certification programmes. d. The problem is not restricted to General Practitioners and neither has it been conclusively identified as being a primary care issue, unless one includes self-referral to specialists as a primary contact. e. The antipsychotic was usually changed to another modern antipsychotic by the child psychiatrist at the CGC.

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f. There is no evidence that CME is the problem; it would seem more appropriate to accept the part of the conclusion attesting to better intraprofessional communication. g. The study, having been conducted only upon referral notes, is at most an audit; accepting audits at face value, one would have to accept that many patients are 'misdiagnosed', in order to benefit from free medicine.

So where does the answer lie after all this? As has been stated so often in this column, Family Medicine is now a Speciality for a reason - it needs specialization and Vocational Training. It is the authories' responsibility to see that the interpretation of the EU law is done correctly. Government is not only responsible for the training of doctors working within the state-sponsored health centres, but is responsible as well for any doctor it warrants to work in the community, private or otherwise. This has been a specific issue, which, if anything shows the value and moral importance of Vocational Training. Both positive and negative experience in talking with Vocational Trainees and indeed from personal experience indicates that when it comes to psychiatry it is more of an interprofessional issue. Don Quixote was a kind and chivalrous person, but he still confused the windmill for the dragon, which, I fear, is what this article did.

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• Genomics issues and privacy • Problems facing biobanks • Gender issues • Bioethics and the family • The morality of family practice • Dumping children on grandparents

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Genomics. Issues of privacy in a digital world

New technologies are changing the nature of scientific practice. Experiences like that of the Genome Wide Association Studies (GWAS) are showing that you no longer have to take DNA and break it down to do analysis and experiments. Nanotechnology will give us moreover the technology just to feed a sample right through a machine and one will be able to read away the sequence immediately. There is in fact so much information being handed down in biotechnology that scientists complain of not being able to handle it. Bioinformatics is already large enough to demand the development of more efficient and effective means of managing data. The converse is already true, however, and we can now handle much information coming from different sources at the same time. But sequencing technology is creating so much data that people do not have the software to analyse it deal with it and indeed what it means.

This effect on bioinformatics was made possible by the large amount of funding of the infrastructure. International agreements have seen that there is a united and open access agenda. The 1996 Bermuda principles was the first international strategy meeting on human genome sequencing. The 2003 Fort Lauderdale agreement made data sharing from large scale biotechnology research projects possible. This benefited the research community by having genetic information without the need of having to generate it first. This standing on the shoulder of giants means that the data is richer and of a higher quality than what individual laboratories can produce. The agreements saw to it that all data had to be made available. This followed traditional scientist ethical and gentlemanly behaviour. It also however put sequencing straight on the web and as a result was highly effective to the setting up of a number of ethical principles, which have been embodied in legislatives of national bodies. For example, the NIH made a Data Sharing Policy in 2002 and Canada made possible the release and resource sharing (2005 Genome

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Canada - release and resource sharing). In 2006 the UK Medical Research Council followed suit. The rationale behind these instructions is that publicly funded research should be available to all.

The significance of these data-generating projects lies in the fact that scientists not only have a reference library, but they also have a map to direct their studies. One can make the analogy of having a map of the world. This was generated originally by putting together data obtained from various sources and measurements. But now one uses the map of the world not only to find geographical information but also, for example, to plan a path to travel from one city to another, or to plan a holiday - once I am in a particular place, I may as well hop over to another interesting place which happens to be close by. Similarly a scientist can use this Human Genome Project map to plan one's research as well. It thus enables 'data mining' and sharing. In this regard therefore there was the development of special data repositories (as the GWAS mentioned above) - also, dbGaP, GAIN, WTCCC etc.

The problem of this wide access of course creates concerns. One reaction was to have access only for scientists, by having a password­ protected system. Another effect of the policies was that each new project has to actually demonstrate why the data should be made available to it and shared with it and why exemptions should be justified. If one intends not to share data, conversely, one must state why one intends to do so. This system thus creates a certain amount of responsibility of scientists towards each other. Previous data was shared between colleagues based on mutual trust. This is now being revised, as people who use the data are so far removed from those who generate it - at the click of a mouse people can move data around the world. It all happens instantaneously. Biobanks are just 'holding houses' and are distributed widely.

This raises issues for privacy to do with three major areas: obtaining consent, identifiability, and governability of the data.

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Consent It is recognized that to have Biobanks it is impossible to obtain informed consent as required by the declaration of Helsinki. It is also difficult to obtain consent for the secondary use of data. That is to say, all the uses of the data cannot be stipulated (and thus information given to the participants/donors of the samples) when consent is obtained. It is also impossible when data is globally shared, to remove tiny bits of segments of DNA when people want to withdraw, for example. It is also physically impossible to trace data when it has been transferring itself continuously all over the web.

This leads to the idea of obtaining a broad consent. But broad consent should not be seen as opposing informed consent. Rather it is a subcategory of informed consent when we decide that some of the conditions can be waivers due to feasibility and when we are sure that no harm is being done to individuals. This does mean we need to give some powers to a governing body (see governability below), but also that it undermines individual control and that third parties take the transfer decisions.

Denfifiability A fundamental principle is to safeguard the identity of the individual. This is difficult when DNA is a unique identifier, when . data is shared globally, and when accessibility other than the researchers (through ancestor tracing) have access. People should however, and therefore, be able to choose, whether they involve their samples in research projects involving Biobanks. This poses challenges when the principle of open access is actually sustainable according to the agreements mention previously, as we are talking not only of sequence data but also of other health information. It is difficult to hold the principal investigators responsible for data (as data controllers, and as data protection laws uphold), when this data is beingshared .. This is also beyond the scope of Research Ethics Committees which simply do not have the means, and often the expertise, to do this. Regulating access

98 Essays in Bioethics is therefore difficult. Policies are therefore being developed to set up Data Access Committees (DACs) for each dataset. However it is clear that nobody can have oversight of 0/1 data linkages and data sets it is simply just increasing day by day.

Governance systems In order to have RECs being governing bodies, we must accept that some individual control is lost; that one is transferring decisions of control to third parties who do not have the expertise; and also that decisions of RECs are not always publicly available, are not transparent and indeed are not accountable. They are also not bound by previous precedence, as with case law in the UK. Moreover there are few patient representatives. Largely, in fact, RECs have an uncertain legal basis, and they rarely have enforcement powers. Once one gets over the hurdle of an REC, it is not the same REC that oversees what is being done.

On the other hand, with the establishing of Data Access Committees (DACs), it is acceptable that no one can have oversight of all that is going on, but you have a governance system that has clear objectives, clear procedures, and are accountable bodies for oversight. Decisions must be fair and transparent and they must also be legitimate. If they act on behalf of patients, they must have patient representatives as well.

We must ensure however that we do not overload the system or duplicate information. This analysis has not yet been done. We therefore have to regulate access on the global level. But whilst the impetus for global data sharing has come from funders, we are dependent on national legal frameworks for such an activity to happen, which is done through general law. Legal frameworks provide minimum standards and provide sanctions for extreme behaviours. Ethics provides a basis for decision making where we

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do not have legal principles. We need to build trust and rule and indeed mutual recognition of our national regulatory systems. A recent clinical trial reported in the BMJ (reference needed) showed the difficulty of research trials which crossed a number of jurisdictions and the researchers had to incur extra time and costs; they concluded it was a menace.

To regulate global sharing, we need to use global standards, restrict access to the general public, and reform RECs and make them more accountable and rigorous in order to give them governance, equipping them with a pivotal role. The restriction is necessary because it is probably not the researchers who are the main risk - they are putting their professional credibility and integrity on the fine but those who may have different interests, such as insurers and employers.

We need however to develop mechanisms so that individuals can control their data. One idea is to tag information and oblige data bases to be linked, so that the tag can be traced. At the moment this does not seem to be feasible but incoming nanotechnology may make it possible.

In conclusion, a debate on data sharing needs to be developed. Data sharing s having a significant effect on scientific practice, giving a new twist to informed consent, privacy, and regulations. The law will always lag behind, but it has a pivotal role to play. We need to think about ways to strengthen and regulate national regulatory frameworks and indeed on regulating the internet. We need to have mutual recognition of national regulatory system and perhaps a harmonization of some laws in this regard. Any new system, finally, must be proportionate and not duplicate and make life more difficult for researchers but at the same time protect the patient.

100 Essays ill Bioethics

Problems facing biobanks The Synapse:

Biobanks - collection of samples for genetic research - are the future of research into linking genetic-related diseases, especially those of a non-Darwinian mode of inheritance, to their epigenetic environment. Pharmcogenetics is also the 'Newfoundland' where information will help considerably with choice of pharmaceuticals individualized for patients. For these kinds of studies large quantities of samples from populations are needed together with a detailed amount of data from the person. The data is kept by a controller who will then give the samples (anonymised) to those carrying out research. Since this is a relatively new mode of research and the person making the donation of the sample, or acknowledging that a sample may be used for scientific research, does not know for what kind of research the sample is to be used, has made this area problematic.

Many documents however have considered this problem and there are ongoing projects, even at EU level, to make further recommendations. Mainly the areas of concern are how one should obtain consent to use such samples, and secondly how one can use such samples in the best interests of patients and indeed give something back to the donor if it is found relevant to his or her health. The problem lies within the fact that many biobanks accept donations only from patients who would agree that they not be given any information they find from their sample. The reason is indeed to protect the patient from any abuse from insurance or employers, who may make use of genetic information. Whilst insurance do want to assess risk, it would not be a fair analysis if one has genetic information if he or she altruistically consented to a sample to be used for research purposes, whilst the rest of the population does not reveal (because it does not know) this information.

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Laws which protect patients from insurance, such as in the United States, have largely failed because the latter are allowed to ask patients to waiver this protection right. Conversely Countries like Canada, where insurance is on a national level, genetic tests do not matter because insurance do not analyse risk on an individual level but make a national risk assessment.

When it comes to obtaining consent, a broad consent is necessary. This still involves the usual condition for obtaining informed consent: information, understanding of why the sample is being taken, a VOluntary choice, competence, and of course a consent process. Indeed however a more detailed process done by a competent individual is necessary to explain what genetic testing does; it has ben shown that people do have at large an idea of what genetics is, but when it comes to research they will usually wish to know that their sample will be used for legitimate purposes and that it would not be used to label any particular group or for purposes to which they may have a moral objection - such as pharmacogenetics on contraception, to mention but an example.

The Biobanks Ethics and Guidance Council is an 'oversight body', in the UK which sees that biobanks use their samples and data appropriately and that researchers are transparent, accountable and consistent in their practices. One major area of concern, which varies from legislation to legislation, and which therefore should be explained to patients upon obtaining the sample, is the definition of what constitutes data. Some would say that data is simple obtained from the sample, but is not the sample itself. But what if the patient requests that his or her data be destroyed, thus opting out of the biobank system - a right which is always given. One would have to go back to the patient to obtain consent, and presumably it will then become a genetic sample. But it does not resolve the question of destruction of information. Clearly we have to explain to patients their rights and inform them correctly that if they want to opt out they may also have to request that

102 Essays ill Bioethics the sample be destroyed. Legislations so far have not seen this coming, unfortunately.

There have been instances where controller have handed samples for tests to research companies, who have then made use of the same sample for further tests, either not going to patients for consent, or requesting consent themselves. This leaves the data controller out of control and usually they do not have the money or the time to pursue such issue legally. Certainly such occurrences can harm science in the long run by losing public trust.

Finally one has to consider how information can be given back to people without putting them in danger of discrimination. It has been argued that much of the research is still at a stage where it is really not relevant to individual health. Conversely, when information does become relevant, even if someone has signed a consent form, protecting him from information, he should have an idea if he has been given enough guidance on how to seek information. Publishing an article in a peer reviewed joumal is not convenient and certainly does not make information accessible 'publicly'. The answer is said to be found in explaining to people on which sites and public media to look out for.

Some people will only donate if they are given the right to know about anything which is relevant to their health. We are still in the early stages of biobanking and in the UK the biobank would simply not take the sample unless the person consents. What may be necessary is for people to be allowed not to give genetic information to potential employers and insurances, and not be guilty of fraudulent behaviour in the process. These legal implications are the studies being carried out in the EU FP6 PRIVILEGED project, which is an extended project on the EU directive on data protection with particular relevance to genetic information. At the end of the day we want to protect the trust that people have in science.

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Gender Issues - separating the categories. Gender issues are an important area in bioethics, especially when it comes to understanding the delivery of health care. Ample studies, albeit done mostly by women, which in itself may be of great significance in showing who gives importance to these issues, have shown that in the United States, more importance was, and perhaps still is, given to the health of men than of women. For example, in the treatment and detection of heart attacks, men were given prominence. It is not the point here to enter into these debates, but anyone who wants to express an honest opinion cannot deny that we are still coming out of an androgenic society.

Gender issues delve into three particular areas. First the health of the man and the woman. Especially in primary care, GPs are now more sensitive to the screening needs of both. It is hoped that a system which will register patients will facilitate a recall system for regular check ups, which in turn will have a positive outcome on prevention and thus decrease waiting lists in the hospital secondary care setting. It is in this area that we must be ware of subtle preferences based on utility - a utilitarian ethics, if you may.

Second, there are gender issues of ambiguous sex. In these medical conditions, such as Klienefelter's syndrome, the male has chromosomes such as to render him as infertile. However the typical 'spot diagnosis' of Klienefleter's is now several under review as many of these patients have gone by undetected. Many have had ambiguous genitalia and were brought up as males because they had small genitalia. It is highly relevant that during the development in the uterus, the V-chromosome, makes the female develop into a male, and obviously an imbalance will prduce these ambiguous features. The problem is that at certain stages of life, they realise that the female component has taken over. The person is indeed a female but has been caught for a long while on the biological borders.

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These conditions have nothing, on the other hand, to do with gender issues regarding homosexuality. The world was taken by force over recent years and homosexuals have been gaining a lot of recognition. Vide the recent intervention on Xarabank by Fr. Gouder admitting finally that they are part of God's plan. Of course one has to reconcile this with sexual activity and unions, which are more of a social issue. We have to accept that what major religions have traditionally kept as immoral, need not be illegal. With regards to sexual activity, the Church, for example, would not condone sex outside marriage, period. Sex is a function of procreation and should be done within the context of marriage. Therefore there is no discrimination in telling homosexuals what one says to heterosexuals - to abstain from sexual contact outside marriage.

In a social context it is quite a different matter and we must look more closely into the biological, social and psychological well­ being of individuals. Whilst it may be fine to tell young adults to abstain, it may be acceptable on a legal basis, for social stability, to understand the nature of such variants of human nature without condemning them. One has to accept however that it would be very dangerous to live in a relativistic society where if what I do seems morally right for me, then I don't care what society has to say. The fabric of society is built on mutual understanding of natural moral rules; natural in so far as man, living in a community, can with reason, come to understand what is good and what is bad for that society. Since by nature man is a reasoning being (or, animal, if one wants), then it is only natural (hence natural law - as opposed to Divine law, which is also consequential), that man comes to understand those laws of nature which will help him cope as a society.

Now there is a danger here, expressed once by C.K. Chesterton. Those who challenge societies' moral rules are taking a free ride on the fabric of morality which has been built through this

105 Essays in Bioethics natural process over millennia. Once we have a solid social structure, some feel that the privilege of modifying some of those structure translates immediately into a right. In many instances man has come so far as to understand that this is true. Today, for example, there may not be that need as before that the man is the only bread winner. But it is only right that all of society engage in discourse aimed at understanding what is morally right and what is wrong. If we give in to pragmatic and relativistic moralities, without giving time to a clear moral understanding and perspective, then that very fabric which has taken much time to build will certainly suffer.

The third is more social and perhaps outside my area of expertise, but is pertinent to this argument. Take for example the traditional family. Do we still all feel that children have a right to a mother and father. There is certainly a difference between paternal and maternal love. One is perhaps more conditional and authoritative. I used to give in to feminist (as opposed to the more recent feminine philosophical position) thought that nurture overtakes nature, until I had my own children, where I observed that no matter what I did to treat my children equally, at the age of two my daughter would chose nothing but pink and my son watches nothing but Ben 10. One may argue that the nurture here is television, but certainly one cannot deny that there are biological differences between male and female children, which translate into significant psychological and social expressions.

If we are to speak of gender equality on a social aspect we must pay attention to this classification. I will mention one, whose case I know, of a lady who graduated, out of government investment, of course, in social services and indeed worked into her sixties. There was no one to take her position and her supervisor strive hard to keep her in the services. As a Family Doctor for almost two decades I can vouch for the thirst there is for good, competent, and experienced social workers. The

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Parliamentary secretary told her that there is 0 doubt that her services are required, but she can do so only voluntarily! Now this is where our social fabric will break down. There are so many males continuing, rightly so, to be on government payrolls because we as a society (or the government) still requires their services. Not to say that some males are not kept, even though they are needed, and women must accept that this may hit them as well. But to ask one to continue working voluntarily is not only unfair and inconsiderate, not to mention a total breach of ethics; it can be interpreted legally as offensive to the male/female issue if it is found to have been an abusive statement because of the person's sex.

Conversely we should not confuse the gender issues of female emancipation, with the other gender issues. Where medical condition as described come into play, the understanding allow the progress to be more swift. But to confuse emancipation with understanding of sexual orientation is confusing two separate issues. This is where perhaps, programmes like Xarabank can be more helpful. When we are discussing discrimination of women, we are not discussing discrimination of homosexuals, even if they insist on being called females and using female facilities. Here we are entering a field which is about sexual orientation, which may be fine and acceptable to us all, but it seems that the latter is taking a free ride on the former, which has been in progress for more than two centuries. One may hinder the progress of the other.

We must treat them separately, one as a pure discrimination because you are a woman; the second as a discrimination because you are homosexual (you may indeed psychologically feel to be a woman but in a man's body. If we cannot understand this difference we will indeed remain on the Xarabank. Xarabanks were intended to take us from one place to another and not to give us merely a tour of the island. I am sure that the producers

107 Essays ill Bioethics want this progress as well. Indeed this is what one expects from a national television. At the end it will dedicate appropriate time to both issues.

Whilst any form of discrimination is illegal, there are different types of discrimination. For example bioethics can help much in gender issues which I have classified as the first and second type, but not third, which is a sociological issue more than anything else. If we truly want progress we have to respect the academia of it. Ethics is not only an opinion; as moral law, it is based on rational thought.

This essay was criticized by on the basis of classification. However the scope and context of this article were different as understood by her and I chose to allow it to remain the same without prejudice to her comments.

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Bioethics and the family

The Parliamentary Committee for Social Affairs has reviewed the position of the Church in an interesting and widely publicized intervention by Rev. Prof. Emanuel Agius. With regards to reproductive technologies it was pointed outthat both documents of the Church referring to this subject the older Donum Vitae (Gift of Life) of 1987, and the latest Dignitas Personae (The Dignity of 01/ men), of 2008, both have expressed concerns about some methods of reproductive technologies which involve the use of third parties (be them donors or the use of a laboratory) and, in particular, both express the protection of the family.

Whilst in Malta things have started to change drastically, the family unit still plays a major role in our social fabric. When one works abroad, things can be quite different in health care, with families, or partnerships, as they are called, not formed in the traditional manner. Indeed it is perhaps one arm of liberty to challenge tradition. Local doctors have to face these situations and cannot be put in a position (or should not adopt a position) of paternalistically imposing on patients, or deciding who should take certain procedures and who should not.

The best way to illustrate the changes are by relating some case histories which perhaps have become common in our society with regard to family. The names are fictitious, but not the cases themselves. They are however common enough to avoid infringement of privacy.

Case 1 Sharon is living with a partner and is infertile. She suffers from endometriosis, which produces infertility, but which paradoxically cures the endometriosis during a period of eventual pregnancy. Due to her hormonal condition she is also obese, which was the reason given by her first husband for leaving her, although they had been together for several years before they married. The marriage

109 Essays ill Bioethics lasted only a few months. She is now in a stable relationship with her partner and they have been living together for some years. It would seem that she would qualify for an annulment, which has not yet been forthcoming. The partner is not married. They wish to have children through Invitro Fertilization, the only method which seems will work for them, following specialist advice.

Case 2 Claire is a 32 year old woman, separated, with five children, the eldest being fourteen years of age. Her husband left her for another woman about two years ago and he does not give her alimony regularly causing her several social problems. After a consultation discussing the difficulty she finds with raising these children she confirms that she would still like to form another stable relationship as she is still young. Her case for an annulment however seems bleak and although there is no doubt about her fertility, she said she would not mind having another child with a potential future husband as she feels that this is an expression of love. She casually mentions she is getting older and would even consider using the available technologies and medical help to succeed. Having a child with a partner seems very important.

Case 3. Mario has realised he was gay since childhood. He has three sisters and has grown up in an environment in which a fetish to wear his sister's clothes has developed into his having a feminine personality. His parents, after several months of anxiety when he 'came out' have accepted the situation and keep a portrait picture of him in the living area, in which he is dressed in girls clothes. Indeed no one would be able to tell him from the picture. During the week he dresses up normally but his mannerism is effeminate. He says that 'sometimes' he goes out dressed as a girl. After a consultation for a common cold he speaks to me about an article he has read where men can be considered to have children biologically. He then changes the subject to the potential of using a surrogate mother to have a child.

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Case 4 A couple are attending the repr6ductive clinic and come to the doctor to explain the options they were given. The husband was found to have a very low sperm count. The wife, whose personality seemed predominant of the husband, showed clearly she understood the process and stated that, "in the last resort they can refer us abroad to mix my husband's sperm with that of a donor and inseminate me with the mixture". The husband, at this seemed to fold his shoulders and retire slightly into a metaphorical shell. When question he showed that it would only be a last resort. The doctor could tell he was uncomfortable with this.

Although these scenarios show specific issues related to the case, perhaps teasing out the generalities is important. In the first case we have a woman who has a case for an annulment, which is still forthcoming, but who is infertile and needs IVF. In the second case we have a woman who probably will not get an annulment but wishes, since she is young, to have another stable union and considers the use of technology to have children, even though she already has five. In the third, we have a scenario which has created much controversy: homosexual unions and whether they have a right to children, not to mention the issue of surrogacy. The family in the fourth case certainly need counselling to understand each other and shows how much it would be a violation to the family if counselling were not legislated for.

The questions are whether these cases challenge our tradition concept of the family, and deeper still whether this change in perception offamilies will cause a disruption ofthe social fabric. Whilst the latter is quite unlikely in the short term, the former is quite possible. Moral documents such as Donum Vitae and Dignitas Personae ask governments to consider the concept of the family when legislating on biotechnology laws. If we look at Western societies it does not seem as yet that the family unit has been disrupted and it seems in human nature to succeed quite well, as related in Baraak Obamas

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pre-election semi-biography. Conversely there is no doubt that the family is certainly challenged and that new concepts of families - such as single parenthood, can only be encouraged, either out of altruism or out of wanting them to be there, by a certain form of affirmative action known as social support.

Yet our culture is quite different in the sense that one cannot really claim it to be multicultural. Should our society be forced to accept these changes? We do support families in distress out of charitable urge. If this were to change it would not be fair that those who chose not to marry and build a family would still expect social support. We give the free apartment to the single mother not because we want to encourage single mothers but because we want to give a helping hand. And yet is it having an adverse effect? Are people taking advantage of this situation?

Be this as it may the point here, ethically, is what should doctors, and politicians, do when faced with reproductive choices. Both find themselves in a difficult situation as the morality laid down by the Church, which indeed cannot be otherwise when considered academically, is difficultto lay down in medical and pOlitical practice. Should a doctor not refer, and be paternalistic by not referring patients for new technologies because they are not legally united? Do doctors get to choose?9 What about homosexual unions?

Whilst the doctor can only work within the law, it is appreciated that what is immoral is not necessarily legal. The doctor is expected to clearly layout the options and either refer the couple for clinical ethics counselling, or to counsel them herself, even about the social and religious issues, as required by the biopsychsocial paradigm with which primary health care doctors work today. The couple is then able to make and ethical decision based on an informed process. Indeed it would be negligent on a part of health care professionals notto discuss seriously the social and cultural issues at hand.

9 Editorial, "Do I get to chose who should have a baby?", Curbside Consultation col­ umn, The American Family Physician. March 1,2003, Vo16, No. 5, p. 1139-1141.

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The task for the politician is more complicated, and includes a clear legislation to cater for the last paragraph. But if presumably all politicians in our society want to abide by the second article of the constitution and legislate according to the Roman Catholic faith, it is doubtful that they would not be able to legislate normatively - that is, the way society accepts as norm. This norm has of course its main players, the Catholic faith being on the front line, as evidenced by the introduction to this essay. It would be reasonable to expect politicians to introduce the law slowly and thus to favour the traditional family and allow the use of medical technology such as IVF for married couples, and perhaps the younger separated couples whose first marriage ended tragically and who aspire for at least a legal union. When it comes to more vivacious applications, parliament may certainly use restraint. Whether this infringes on human rights can be a legal conundrum; it certainly can however be based on upholding conservative values whilst accepting the recent changes of the times. One cannot see, and neither reasonably expect, the Maltese parliament to legislate in favour of neither surrogate motherhood, nor artificial insemination by donor sperm. The latter will certainly be sen by many as violating the integrity to the union and fidelity of the couple.

It seems that this legislation will make heroic history by attempting this first law in biotechnology applications. No reason to sit back; there are more to come: biobanks, genetic testing, End-of-life choices .....

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The morality of Family Medicine When we speak about the morality of family practice we are in effect speaking about patient rights and whether patients are owed something more than any doctor being able to see patients in the community, now that it is recognized that this requires special training, which would include dealing with family problems, domestic violence, drug abuse, palliative care and helping families and patients alike cope with illness amongst the few on the list. It is not merely being able to treat colds and pains and making a choice whether to refer to hospital or not. It is about the type of the consultation process which recognises also the deeper non-manifest agendas to the presenting complaint.

Conversely it is also about protecting the rights of the workers involved, which in this case means the Family Physicians themselves. IT may sound strange to speak about workers' rights in relation to family doctors, but the reality is that the jungle which exists in Malta, the free-for-all attitude amongst doctors that all can enter each other's fields, reigns by far more than in any other speciality in family practice. In fact the very point of family medicine being on the specialist register is a laugh in the face not only to doctors but to the community unless it is put on the protective level of a speciality. It is not simply a badge that one carries on one's door plate. Most people cannot tell the difference, even if colleges do their utmost to promote the specialist.

In Italy they have simply calculate the amount of people there are in the country by a thousand, which gives them the amount of family doctors they need based on a presumption that each doctor will handle a thousand persons. In fact a doctor can take up to a thousand and five hundred, and patients are allowed to shift between doctors if they want to. They will simply have to change their registration. There are no limitations to how many doctors they can change. Doctors are grouped or networked to cover for each other, and are paid extra by the government for

114 Essays in Bioethics house calls. The advantage of this system is that no other doctor is allowed to penetrate it. One is allowed to practice for a fee but of course once the system is free, one will not get any patients unless by some fortune he is very popular. Doctors are paid a fee per capita and have extra for any investigations and house calls (of course limits may be imposed).

Not to say that they do not have problems, which have been discussed somewhat in an earlier article of this column; but we can learn from their experience. After all we have a very British culture when it comes to medicine and the concept of GpwSls - GPs with a Special Interest is very important in primary care in the UK and it is taking on in Italy as well, as shown in a recent article in one of their family physician journals.

For an Italian doctor to qualify into this system, a qualified doctor must work for three years in a clinic and do some rotation, similar to the vocational training we have in Malta. Only after that can they enter the system. And it is competitive of course, and one can only apply in the area where a vacancy has arisen. The EU imposes on governments that family physicians would have completed three years of vocational training before entering the National Health Service. This applies also to Malta but the problem is that we do not have an NHS other than health centres when we speak about primary care. Last week I praised the parliamentary secretary for acknowledging the important role the private family doctor has in our system, but as yet no plan is being made for the foreseeable future of family medicine. As it is therefore most of family medicine occurs privately and any Tom, Dick and Harry can practice. We have also had cases where some work illegally before they are given a warrant - at a great risk of course.

Now we have an even bigger threat. Private clinics are bringing foreign )mostly Eastern European) doctors to provide 24 hour service. As things stand within the EU, so long as these doctors

115 Essays ill Bioethics are on the specialist register of their country, they can do so; but in reality, since privately one does not need to be on this register locally, they need neither be on the same register in their own country. We can get doctors therefore who have never seen the entrance of a hospital as there are still many hospitals where, to get your degree all you need is books. Ironically family medicine in Italy is not yet consider a speciality. But Eastern European countries have been fast to provide quick-fixes to allow their countrymen all the opportunities that Europe offers.

There are two problems to this. The first is that family medicine is not protected. People can come from abroad and not even know the language, culture and attitudes of the population. They learn the trade names of drugs and simply dispense. I have always, as many western colleagues, been a sceptic when is came to medicine under communist regimes and I doubt how much things have changed. But of course one can be wrong. The issue is more that we have to accept anyone who comes here and we are not protecting our patients by creating a proper NHS which is tightly sealed to protect us from anyone wishing to open shop. In a highly mobile zone such as the EU, many countries have recognized this. I cannot simply say that now, that I am an EU citizen, wish to go work as a family doctor in the UK, or in Germany, or in Italy, as these countries have regulations which I have to follow. Since locally doctors can work withoutthe imposed three years of vocational training, any doctor from within the EU can do so as well. Our vocational training applies only to health centres, which until recently, we have been hearing, have to go. Even if they remain, the Parliamentary Secretary has affirmed that he wishes people to know who their GP is. Does this mean he is ready to formally recognise that private doctors need to be protected and have their minds at rest, which in effect translate into knowledge that these doctors are on the specialist register and have had their vocational training done? If not it means that the government, unless it decides that is it responsible (which I

116 Essays ill Bioethics believe it is) also for the doctors it sends into the community (after all it is the government which issues the warrant), cannot have any control on the jungle we have to work in.

I remember a most frustrating moment when I practiced in a pharmacy where I had a colleague specialist in Geriatrics doing some general practice in the evening to earn some extra money. I had to make way for him during my time if he overshot in time. I came in one day to find a patient of mine was waiting, but had to wait with him in the waiting room. When the patient this other colleague was seeing was done, the colleague looked at the patient and thought he was there to see him. 'Come in', he said. The patient embarrassingly looked from me to him and backwards and allowed himself to be led into the clinic. Are we here to confuse patients? Are we here to compete for patients? I am sure this happens every day somewhere on the island and doctors have many stories to relate. It does not do well for intra­ professional relationships either.

The second problem is more of a professional one - that of membership into the Malta College of Family Doctors, which has imposed upon itself that a doctor can now become a member only if he is on the specialist register. But to be in the specialist register you must do your vocational training. Since vocational training is not obligatory, not only are there a few who actually do it - and over three years we have been reduced to five or six out of the hundred who qualify, but ironically it is actually the government who is indirectly choosing who is to entitled to become a member of the Malta College of Family Doctors.

This ridiculous state of affairs, which amounts to nothing less than government control, can only be removed if either the same College provides its own form of vocational training - not an easy matter - or that everyone intending to work in the community be obliged to do vocational training.

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But the real insult to injury as we have said are the EU regulations themselves now. IT is worth repeating: sihce any doctor can do private practice in Malta, then any European doctor who has not done vocational training can do so as well. The EU regulations are good and are there to protect patients - on the assumption however that it is the State which runs the NHSs, and not private physicians. The spriti of EU law is that governments are responsible for all doctors they send out into the community. The medical council has no authority to refuse any medical certificate even if it is a university we formerly frowned upon. In fact the EU tells us to frown upon any doctor within the EU if he or she has not done his or her vocational training. That is the true message. I would not mind anyone coming from the EU zone that has done their vocational training. But the reality that is happening is not the case. Moreover I doubt how much the medical council asks for these VT certificates, when it actually does not ask them to Maltese-qualified doctors.

Practicing in Malta does not require being on a specialist register. Before the EU we prided our certificates to be exit exams, which meant we were good enough to practice. But our entry meant that anyone can now come here. Therefore VT does not only have the benefit of providing doctors trained in community work and to deal with the social and psychological issues of patients and family, but they have the added benefit of restricting who can work in the area. We would be wise to use Italy's simple formula. All we would need is 400 doctors working in the community. The government can even allow this to be a private practice as it is. It would simply be a measure to ensure quality over quantity.

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Dumping children on Grand Parents

An eighteen year old girl finds herself soon enough to be a single mother. She receives children allowance. She refuses to find a job. Yet she lives with her mother and goes out in the evenings to enjoy life. Following year. She is pregnant again. She calls me one fine day to see her child. I arrive twenty minutes later as I happen to be in the area. Her mother says she went out but is soon to return, which within five minute she duly does. She arrives, dressed to kill, with a child and the baby in one pram. The mother is exhausted and complains that she forces her to take them out once in a while.

A married couple have two girls. They both work. The mother's parents visit their GP. The mother (the grandparent) is very distressed. After a few consultations she tells the doctor that most of her stress is related to her two grandchildren. Her husband (the grandfather) is with her. She says that every single day they bring their children to them early and he has to take them to school by call and then pick them up. They then have to do their homework before their parents collect them. Now, in summer, he is complaining that they sent the children to summer school; he reasons that since it is he who has to take them to the summer school, they could have relieved them at least for the summer. Now they are taking a 'break', as this couple went with their two girls for a fortnight ~o Sweden!

A GP complains to me that a family calls him weekly to see their two young boys. They live in the fifth floor of government apartments not served with a lift. The problem, he tells me is that this elderly couple come to stay with their two young grandchildren, which they look after whilst their parents go to work. They grandparents complain that this daughter has always been dependent on them - her sister is conversely very independent even though she has three kids. They also complain that she is married to a black person and that since it is difficult for him to find work, they

119 Essays in Bioetlzics have always given them a helping hand. Since they are not their children, with every sniffle they call the doctor. They themselves pay for the visit so as not to 'burden' the parents with extra expenses. The problem for this doctor is the flight of steps.

Are young couples 'dumping' their children on the grandparents? The sooner we realise that this is indeed the case, the sooner we will be on the path to cure this ailment.

Grandparents feel obliged that even after having raised a family, now in their retirement they have to help their children in this way. They feel guilty that if they do not do so, they may somehow not be helping out their own children who both have to work. Conversely, a recent sUNey showed that young couples do not avail themselves of day care services, as of course this costs some money, and their parents come cheap; in fact free.

Whether it is the fault of young couples that dump their children on their parents, or it is the fault of the grandparents who have not learnt how to say 'no'. Whether it is the fault of society, which obliges both partners to work to make, ends meet or the pressure that women have as much of a right to work as men. Whether the market price of flats today is based on a market value of two salaries, and that couples, think they are spending less when they go to supermarket when in fact they end up with baskets full of delicatessens they could do without is beyond the scope here.

This is about young couples not taking responsibility for their choices. Whether they need it or not it is abusive as they do not realize that the grandmother or the grandfather, are at an age where they would enjoy very much helping out but when their health is taxed by this daily burden which has no limit. It seems that this goes on for years on end until the children reach teenage.

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This is about the grandparents who are now not acting as grandparents but take ten out of the fourteen daily hours with the children. They come to doctors with complaints and worries which should be burdened by parents, whilst the mother and father are away. It is they who worry about calling the doctor and giving the children medication.

This is about the children who have lost a sense of identity and home. The grandparents take on the importance of parents. You see that some form a greater bond with the grandparents than they form with their own mother. When they are ill at school, they do not have 'home'; they have their grandparent's home. The nanna is called.

This problem is rampant in Malta. On the one hand you have a considerable proportion of single parents who, without the help they find from their parents, would not cope. On the other you have couples who find it more comfortable to both go to work once their own parents are ready to raise their kids for them. On the one hand we have helped the single parents so much that it has become an asset to them. On the other hand, couples feel that they can afford a better life style if they have two incomes instead of one.

In my opinion it is not about the right for women to work. Abroad most women work, and they manage their children without their parents. It is better indeed to send children to day centres but to maintain one identity of a home, rather than confusing the child who now does not know which place to call home. In some cases it goes even further. One single parent who is separated finds herself with another partner, with whom of course she would like to spend the night. So as not to 'shock' the child, she says, she leaves her son with her own parents. One appreCiates at least that she does not want to 'shock' the son. This 'sacrifice' comes also with the perk of getting the child out of the way.

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Is this being judgemental? Perhaps. I like to think of it as a social problem and not judge individuals. That fact that everyone is doing it means that somehow society has permitted this. Whilst we debate IVF and divorce, much worse is going on behind the scenes. What kind of example are we setting for our children? We have created a culture of tattoos and ear-rings even on baby boys' ears, but are not helping the culture of family. No wonder, then, when things start to strain, which they will, the easiest thing to do is to get separated.

Infact, separation becomes easier as the kids are already sorted out with the grandparents and one does not have to worry. In fact some whining here and there will help drive in the pOint that now 'she (or he) needs us more than before'. But in point of fact it is they who frustrate me as a doctor more than the young parents. They are not letting go. They do not tell their children, 'look, now you are married. You have responsibilities. I can give you a helping hand, but I cannot take over your daily duties. Sort out your own life.' When you do not let people sort out their problems they cease to grow.

The result is that many parents never become mature. My wife and I have sacrificed so much to raise our three kids. We do have parents both willing to help but we feel we should not abuse them. My wife has given up her small business. I have given up several opportunities to go abroad, and other local jobs, which only took me away from my family. We are not saints. To us this is normal. We anger at how other couples juggle and manipulate their kids and parents alike. Family is good and nice. At the end of the day, they may have their holidays. We do not, because we live on one salary, and there are enough doctors in private practice going around to fill ten entire hospitals in one area; so the work is not as it used to be. But we take pride in raising our own kids. Our grandparents love them, hug, them, sometimes they keep them for us when we wish to go for a well-deserved

122 Essays in Bioethics meal, but then they give them back to us. They do not give them back to us only for the night.

Like us I hope there are still other parents out there to outnumber this phenomenon. But at least in some areas, this does not seem to be the case. They prefer not to give up jobs so that they do not give up on luxuries. If I go to the Gates and Saint Peter cringes his face, I will have one thing to show - that I never did buy that Brittanica Encyclopeaia which I always wanted. There was always a fee here or there and not all my children went into Church schools, whilst with my taxes I paid for the child of that single mother who explicitly told me in my clinic, innocently not knowing the pain she caused me in my mind, that she will wait until she settles her two kids into a church school before she marries the (unknown) father with whom she is living in a government flat she obtained because these two 'poor' kids are listed as having an unknown father.

They have it all. They get to have a flat, they get to have their kids almost automatically go to a church school; they get their parents to look after their children. And they lead the dolce vita. Good luck to them. But we need to ask ourselves some serious questions is we truly believe in family values. If we do not want separations we must support the families. We do not housewives get a helping hand as well. They are in the same boat as those who receive the relief, which amounts to almost minimum wage because they choose to call their partner the unknown partner. We have set up a culture of the 'unknown unknown.'

We should perhaps think laterally on this. It is very moral to help the suffering; but see who is really suffering, it may be more moral to promote and encourage the family which one would uphold. These couples need to see the benefits of marriage. If marriage becomes a financial burden; or at most, a loss of privileges that one would obtain if one were not officially married, then we are

123 Essays in Bioethics not really helping society at all. I thank God for not being badly off. But I see patients who strive to make ends meet. Does it make sense that a single mother is given a salary which encourages her to stay at home with mom, whilst a married woman is pressured to go out to work - not so much for the money but because she is a woman? Are they not both women and both mothers?

Incentives were introduced with good moral reasoning. But times changes and situations change, and we morally must look at the consequences and make amends. We now have problems of a very different nature. The burden has fallen on the young families and on their parents. It is rather hypocritical to speak against divorce when you push them to the edge. We have the morality to speak against divorce when we strive to make the pastures green. In the meantime the help provided by grandparents have not led to more stable families, but to people who never grow; never are old enough to take responsibility.

124 chapter Patients' rights

• Biopolitics • Informed Consent and the nurses' complaint • Insurance • Disposing of dead people • Ethics in psychiatry • When caring goes astray • Profits and research in the pharmaceutical industry

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Biopolitics

By biopolitics the French usually mean the politics of life. Indeed this is a reflection of the gift of life. In bioethics, this term has taken a rather different meaning; it reflects that at the end of the day, whatever discussions we have in the field of advancing medical technology and their moral impact. Whatever position we take, we must at some point come to valid and workable solutions which can only be reflected in the law.. The field of bioethics is therefore full with persons coming from diverse fields as medicine, religion, law and indeed lay.

European countries have made considerable progress in this area. Biotechnology la~s range from those specific to patient rights, to those on more specific areas, such as genetics, reproductive technology, biobanks etc. Of course laws arise when their need arises too. In our case, unfortunately, this has not been the case. It is true thatthe country had (and still has) more urgent matters to attend to. But certainly there are enough people around, and much ground work has been done to start implementing laws in this area. It is true that there are EU directives which guide us. But these are only directives, which government must either adopt or work a formula which fits our needs.

Indeed it is about needs. To take an analogy, General Practitioners, cater to the needs of the population. By population one does not necessarily mean the population of the whole country, but the population of the area in which one works in. There are certainly areas which are underserved in various respects, and others which are over served. Whilst one area may have a health centre, another area make the use of a health centre which is several villages away - like Safi and Zurrieq people must travel to Floriana. Quite unlikely! Therefore General Practitioners find themselves filling niches which are quite different. In one area people all come with a health insurance to cover all their tests, in another area you get a high percentage of people who refuse a normal prescription and ask that they get their medications through their free-medication card.

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Countries therefore have different bioethical needs. Whilst some countries are liberal, others are more conservative. If Malta does not put its act together in the field of bioethics, it will continue to miss out on opportunities to participate in important meetings which either make or influence changes in the directives. It will then be more difficult to take a stand on various issues.

A stumbling block which we have experienced is the moral controversy which arises with every technology introduced. The obvious example is the use of artificial means of reproduction, which have been being used in our country for decades now. Yet we have managed somehow to shy away from legislating. When I was Secretary to the Bioethics Consultative Committee we worked for several years to produce a document which reflected the general Maltese normative value towards this field. This was followed by several years in which the document was shelved. A few years ago, the Parliamentary committee for social affairs took up the issue under the Chairmanship of the Hon. Clyde PulL But the report was not taken up by parliament and enacted into law due to statements made by the Curia and followed up by the President. Evidently, the work was not enough. There now seems however to be a general agreement that what is taken to be immoral on one side need not be imposed to be illegal upon society. Yet government has to find the courage to move in one direction or the other. The change in personalities which have occurred may facilitate this process.

It is always painful for a conservative society to accept that trends in human rights go beyond what is generally considered to be moral or immoral. This is what has occurred with reproductive technology. Yet Maltese infertile couples seem to have no problem with accepting this technology, and they seem to be getting enough pastoral support to make the ethical choice of going forward with their decisions. It is also evident that the ecclesiastical authorities look upqn these couples with great charity, as none so far have been condemned in any way or

127 Essays ill Bioethics given any form of prohibitions, as is given, for example, to couples who choose to separate.

But reproductive technology is not only what biotechnological laws are about. They are indeed about patient rights. The only one we have so far, which is not in and of itself, a law on biotechnology, is the Data Protection Act. We certainly however take full advantage of this law and personally have worked on several EU-funded, so-called Framework Projects, which have the objective of making proposal to the EU directive on data protection, making it more amenable to health care and patient rights, especially when it comes to medical dat<;l and genetic biobanks.

But the EU directive of Data Protection is not about protecting fundamental rights and freedoms of the individuals, which is left to local legislation. It is rather, to facilitate transfer (legitimate transfer) of data between EU states. Therefore when it comes to Health Care, having a law to protect rights and freedoms where it comes to information is not enough. We must have laws which go beyond simply protecting data, but reinforce patients' rights. These must be reinforced in areas especially where patients may be treated as a commodity, such as insurance, employment and genetic services. Whilst we had a Charter, which applied only to St. Lul'

Patients must have a law which gives them not only rights to medical secrecy and confidentiality, but rights to clearly delineate whose property the medical file is - whether it is the patients', or, as has been expressed by the local union, the hospital's. When it comes to accessing information, a third party, such as an insurance or a research worker, may have easier access, perhaps due to know-how, than patients themselves.

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Conversely, a law on biobanks would, for example, govern the methods used to obtain samples for genetic experimentation, and explain what rights patients have, May I, for instance, at any time, decide that I want may sample to be taken away from the biobank, or insist, that I want a process of information before each and every experiment it is to be used on, Anonymizing information is not enough, for I may have a moral objection to the experiment itself, and although I would not be identified, I may not wish my sample to participate in that experiment, Certainly some form of broad consent must be obtained, but having no formal measures which govern the use of population samples may render them to be too vulnerable,

When it comes to genetics, the nightmare is the abuse of genetic information by employers or lawyers, Of course their ends are legitimate as they both want to assess risk, But the means for them to obtain information are so easy that there has to be a law which disallows them to make use of this material, which is mainly a research tool. UNESCO and EU guidelines both prohibit or limit the use of genetic information, for example, to have an insurance policy, A genetic test is predictive and can also tell me something about relatives, This information, when used to assess risk, becomes unfair, because it simply does not balance against the general population, Moreover if insurance companies and employers, etc, may use such information, which can easily be misinterpreted, it would discourage people from coming forward to donate samples to be used exclusively for research,

IF there is no law to protect my sample from use other than for research, I may even be liable to fraud if I do not hand over that information to someone who can be seen to be legitimately requesting it,

We need to develop a culture of bioethics and biopolitics in order to protect people not merely from advancing technologies,

129 Essays ill Bioethics but from the side effects which these technologies may have, as described in the example above. Health care has moved forward from simply treating a condition. We speak about health promotion and health prevention, and holistic approaches. We must cater therefore for patient rights in all its forms, starting from given people the right to express wishes in advance (vide article on Advance Directives), to protecting them from that which even they do not know about, but which scholars have conceived.

For many patients, it is a fact that many things which we know we know, or things which we know that we don't know, are, for them, things which they don't know that they don't know. This is the extreme form of vulnerability which only law on biotechnology can partially remedy. IT should be the duty of every health care professional thus to explain to patients their rights to their clients or patients.

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Informed Consent raised at Nurses' meeting This weekthe union of nurses and midwives raised several complaints in their regard. Obviously in hospital work conditions can be dire especially when staff decrease. It seems that gone are the days, when nurses used to divide their night duties and one would see half the staff resting whilst the other half labour. However I wish to concentrate on an important point raised during their meeting: that of obtaining consent before an operation. The news tended to be short in this regard but I seemed to have caught this phrase. In any case it would be timely to discuss the issue.

It is reasonable that the responsibility in obtaining consent is so great a burden, that nurses may feel that this is legally beyond their call of duty. Indeed if they are to carry it out, they must properly be called nurse practitioners in this area. One never tires on writing on this important topic and indeed it takes two whole lectures to cover the process with students. It cannot therefore remain simply a paper which the patient never reads and signs before he or she is taken into theatre for a procedure. I know for a fact that many responsible consultants carry out the process quite well; but I continue to hear from my own patients that they were never really told what the risks are, for example, of anaesthesia. Do patients have a right to know? Or should we continue with the former, rather paternalistic, attitude, that it is better that people do not know details which may cause them alarm and indeed refuse to have the procedure done? Both sides of the argument have their defenders, but unless the patient expresses a wish not to know and autonomously decides to leave himself or herself in the hands of the health care team, then today's interpretation of rights, leaves no space, under tort law, where patients be left in the dark about important and perhaps not so important details.

So if it is negligent simply to present a paper to a patient to sign we must see what we mean by autonomy, informed consent, and indeed what is on that small sheet, which presumably is there

131 in Bioethics to cover the hospital authorities if anything goes wrong. Starting with the latter, this is not what the consent form is supposed to do. Indeed it is wrong to call it a consent form in the first place. The term 'Informed Consent', presumes that you have gone through a process, which takes more than five minutes, of giving relevant information to patients. Conditions also apply. It is indeed a false sense of security, as we shall see, when a patient signs a form - especially if he or she is already on a stretcher, or already in a surgical gown - at the last moment. If something goes wrong, a lawyer will enjoy a good breakfast by proving that the patient did not and indeed could not have acted autonomously. If there was no autonomy, the consent process was invalid.

Autonomy is a process by which a person has the jurisdiction to act on behalf of his or her own body. For autonomy to be valid, one must show that there was an intention on the part of the patient to act in the way he/she did; that there was a clear understanding, and that there were no controlling influences. Thus if a relative forces someone to act in a certain way, autonomy is put into question. But this is only the beginning. We must then go through the process of informed consent. This has several conditions, the first of which is of course actually giving the patient enough information to be able to make a choice. If I am an autonomous person, and am not given enough information, even though I was capable of acting autonomously, I have nevertheless failed to do so. No consent form is valid without my being empowered to sign it.

The question inevitably arises: what amount of information should I give to a patient? Whilst cultural issues do come into play - for example, whilst it has been shown that Nordic countries have a more stringent protocol and insist that all information available be given to the patient, Southern European countries tend to be more conscientious not to burden the patient. Yet this does not exempt a proper process taking place. We must insist therefore that at a minimum, the information that a reasonable person would want

132 Essays ill Bioethics to know be given. The most important of course are the risks, and it takes some training to be able to give information about risk, without being coercive or manipulative, unintentionally. We may easily brush off information so as not to put the patient off; in reality we may also be afraid of reprimands from superiors if the patient decides, based on the information given, not to go forth with the procedure. I have personally witnessed a nurse being reprimanded for this. Indeed what is the process all about if not to leave a surviving chance for the patient to exercise his or her right?

Sometimes even the information of what a reasonable person would want to know, is not enough. Therefore it may not be enough to inform patients of possible sequelae or complications. Some people want to know more and therefore specific patient standards are appropriate. These may be proper for a particular group of patients, especially vulnerable groups, or indeed for individuals who insist on knowing more. The latter does not mean that the patient is not a good candidate for the operation. It may be simply that there is some doubt or anxiety. We often forget that the hospital experience is an alien land for many people. A kind word goes farther than a comprehensive list of information.

Other conditions apply. Is the patient really understanding what is being said? Anxiety or indeed the effect of drugs or a fever may effect this. It goes a long way to explain that taking consent (as I would definitely not call it consent) at the last minute, without at least reading what the patient is signing is not the correct way of doing this. I actively ask patients, and indeed relatives who have gone through procedures, how consent was taken. Some do not even recall the process other than having signed a sheet when they were about to be taken for a procedure. Others say that they were quite satisfied when the doctors explained everything in the out patient department.

Indeed this is where the process should be done, unless we are

133 Essays in Bioethics dealing with an emergency, in which case even the whole informed consent process may be waived in order to save the life of the patient. At out patients, we are dealing with a person not yet in his Pygamas. The patient is less vulnerable, less anxious and still has time to go home and reflect. When an operation carries even a very small chance of death, one has to reflect on his or her life choice. Some are more courageous than others and certainly it is not the professional to make that judgement or call. Is the patient making a voluntary choice? Is he being pressured by someone in the family? Has he been given the correct information; enough to make a valid judgement? Finally, is the patient competent? Children, for example often have their choices made by parents, but it is becoming more clear that even children may make valid choice on their health care. Paediatricians are aware of forceful parents or undue pressure which can be put on children.

The actual giving of consent is a final and important process. Signing a paper is perhaps something which legal advisors require. It is important to appreciate that it carries with it a false sense of security, since, as we have seen, any flaw in the above process may render it invalid.

To return to our argument therefore one may legitimately validate nurses' complaints of taking such a huge responsibility. They do it on a presumed informed consent process having been given to the patient already. Clearly a protocol would go far to remedy this situation, even if it may take some time to implement. A hospital ethics committee, a much needed part of our infrastructure, would bring consultants and those involved together to formulate a safe way forward in this regard. There is no doubt on the excellent service we offer; it is a pity that such an important process, which omitted can leave one liable to negligence if a harm had to occur, is often taken lightly. Whilst one is aware that such blank statements may leave those who do indeed go properly through the process offended, I humbly

134 Essays in Bioethics submit this is not oriented to them. It is a fact however that the practice is also widespread and it would be negligent as well to try to defend what is wrong. It is a duty of health care professionals to go through the process of informed consent. They cannot rely on each other. A protocol may be necessary. It is important to realize that a harm may simply be the omission of this proper process taking place. One should not take lightly what is being pointed out by the professionals themselves.

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Disposing of dead people

The death of a relative may be one of the most painful episodes in one's life. Whilst the body of the dead person is owned by the immediate relatives, the use of the body and/or body parts is legally limited usually to the choice of one's burial. There are however a number of issues which are raised in ethical discussions.

One of the main questions is whether a dead person has rights. This is by no means simply a question of morality; legislations tend to vary in the way a dead person is defined. In the PRIVIREAL study on data protection, which hence also raised the question of whether dead people still have rights to the protection of their data, EU countries tended to fall under three categories. There was a group in which it seemed that the definition of 'person' was not extended to dead people, and hence these could have no rights. Another group included clearly dead people within the framework of defining what is a person. A third group seemed somewhere in between: whilst not clearly defining that the dead are 'legal persons', the law implies that certain rights can be extended and that therefore there is a bowing to favouring them as persons still. Malta fell in this third category at the time of the study.

Keeping samples from dead persons is no therefore problematic unless clear informed consent has been obtained. By 'informed' the EU data protection directive clearly implies that one should have informed the person when alive the reason why the sample was to be kept. Although there it is still unclear where we are heading with existing samples, the direction of newly collected samples is quite clear. Neither do legislators wish that one obtains broad consents to obtain samples for use in any kind of research whatsoever. This may be pushing it too far for many researchers as it is difficult to say what the samples will be needed for in the future. Yet the philosophy behind these laws are to protect the fundamental rights and freedoms of the individual and it is

136 Essays in Biaethics perhaps a rights, when I am still alive, to explicitly allow my organs/ samples to be used extensively and without my knowledge of the kind of experimentation. I may for this reason appoint a power of attorney.

More controversial is the taking / donation of organs. Whilst locally having a donor card has some weight, it is still not legal. Relatives may still refuse to have organs of a recently deceased person donated notwithstanding the prior consent of the individual. This translates itself from the unclarity of the law as explained above. Once dead I do not have any rights. Nevertheless relatives often concur with such requests and keeping the body of a dead person under support systems to keep the circulation going is not considered unethical. Usually, once a person is brain dead, life support systems should be removed. This falls under the remit of the family having a clear legal right to dispose of the body in a way they seem fit and which falls within the boundaries of the law. They cannot keep body parts for themselves and neither can they keep samples for future use.

Thus we have heard of cases in the UK and the United States where the wife of a deceased husband wanted to keep the sperm for future use. Such cases would probably be considered unethical in most countries, yet these cases have centred also around the explicit wishes of the dead person. Problematic as well could be the use of sperm put into banks by the husband whilst receiving treatment during his life. Such procedures are common when the treatment can affect the fertility or the germ line genes. The local recommendations of the Bioethics Consultative Committee on Transplantation and on Reproductive Technologies foresaw this possibility and deemed it ethically viable. When the same person dies, it becomes legally a question of whether his consent to use them after his death was given explicitly. Morally it is quite another thing and perhaps life should be respected not only in its termination but also with regards to the new life being contemplated.

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Nowadays body preservation has also been discussed, In the United States a company cryo-preserves dead bodies up-side down (as in the event of thawing the brain would be the last to thaw), with the hope of reviving the body in the future, Whilst presumably this is only done by those who can afford it and who have paid beforehand, thus having given consent; it becomes more troublesome if one wants to cryo-preserve a relative or child, Although for many this is science-fiction, it is a reality which can readily become available for marketing purposes, Whilst it is certain that these uncertain technologies will find objection at EU level, it also takes advantage of the vulnerable - the mourners who would believe they are dOing a disservice to their loved ones if they do not use this technology, In this series we have encountered a similar problem when discussing the storage of cord blood locally, Certainly however the law would not seem to be able to prohibit this as it legally falls within the remits of disposing the body as deemed fit by the family, Yet is raises the question of ownership and whether it is indeed dignified not to allow a dead person to decompose properly,

Whilst one certainly questions this raising of the 'dead', it is not something unthinkable for those who lose young children to diseases in the hope that a cure is found and therefore give them the chance to live the life which the disease had taken, If this is science fiction; so was cloning, Those who would use this technique for money do not pose the question of whether cryo­ preservation is even a good method of preserving and whether life can even be restored, It simply plays on false hopes and wrong facts and one can even offer the service before one is clinically dead,

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Ethics in Psychiatry

Psychiatrists in the UK have recently lamented the need for a code of ethics for psychiatry (Sarkar & Adshead, 2003; Hudson & Raymont, 2004; Sen et al, 2006). There is a clear difference between a code of ethics and a code of practice (such as the non-statutory one of the UK Mental Health Act of 1983) or indeed a code of conduct. Sarkar and Adshead argue for the need to protect the patient in a world which is becoming more and more contractarian and utilitarian. Indeed the public often views psychiatrists as having to protect the it from psychiatric patients and because of this the latter are put at a higher risk for detention. Codes of conduct and practice are therefore not sufficient for psychiatrists (Sarkar & Adshead, 2003) as patients put trust in their professional to "protect their interests when they are not well enough to protect themselves".

There are a number of issues in which psychiatric ethics differs from mainstream clinical ethics, mostly having to do with the vulnerability of this group of patients and indeed their mental incapacity. Indeed Sarkar and Adshead argue that the relative incapacity of patients to make decisions for themselves puts them in an especially vulnerable situation because they depend on others. In the UK this translates often into a 'complete loss of autonomy' and even patients' competent refusal may, under British law, be over-ridden, even though psychiatric patients, even in-patients, may be perfectly capable of taking some decisions and participating in one's choice for treatment (Hudson & Raymont 2004). Even in Forensic psychiatry it has been noted that for public interests, the interests of the patient may not have been fully observed and that a code of ethics which trumps justice over other principles needs to be addressed in these specific areas (Sen et al, 2006).

A common point raised is the vulnerability of patients, which may lead to sexual abuse - an exploitation of the vulnerability. This has been raised frequently in the United States, but certainly,

139 Essays ill Bioetlzics according to GMC data and information from voluntary groups, Sarkar and Adshead point out that the problem is not uncommon in the UK. In point of fact it seems to be entirely legal in the UK to have sexual relationships with a psychiatric patient 'so long as the patient is not detained' (Ibid.).

Thirdly, the Royal College of Psychiatrists (1996) points out of the need for psychiatrists to ensure that the risk of detaining patients more than necessary is reduced. Psychiatry risks harming people by treating them unjustly and in fact those patients who commit offences may actually be kept in psychiatric detention for longer periods than they would actually have spent in prison for the same offence(Sarkar, above).

Current legislative frameworks in the UK seem to protect third parties more than they protect the mentally ill patient. It sees the professional role of psychiatrists as having an obligation to protect the public from these people. This conflicts with the altruistic role of psychiatrists and indeed the profession complain that such attitude is in conflict with the Declaration of Madrid (World Psychiatric Association, 1996) which puts values towards patients and altruism as the defining intention of the profession.

These problems therefore frequently put psychiatrists in at odds with the principle of Nonmaleficence (Robertson & Waiter, 2007) and the current western view of the relationship between a doctor and a patient being a contract is at odds with Hippocratic ideals. It also risks making the psychiatric encounter too utilitarian, that is based on the value of a person balanced against his or her value/ risk to SOCiety (Robertson, Morris & Wlater, 2007). This risk/benefit analysis on patients is perhaps morally repugnant reflective equilibrium, which justifies the plea of modern psychiatrists. This, apart from the fact that patients may in the long run lose trust in the profession.

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Michele Foucault has noted how 'madness' was not always seen as a responsibility of the medical profession. Indeed mental patients were often detained with criminals in France. In time they fell under the care of doctors and eventually the field of psychiatry came to be. Moreover treatment in psychiatry was often unorthodox, especially those preceding current Electroconvulsive therapy. Certainly hitting someone in the head with a stick is not normal. Detaining people in cages and boxes seems repulsive today, yet we still on occasion detain people in strait jackets and others locked up in small rooms without proper facilities; if nursing staff are unavailable they may not get their daily walk outside. This is more the responsibility of the state than the institution itself often. But the vulnerabilities of mental patients remain. Locally it is heard that patients may have to be classified under more severe mental illness in order to benefit for medication. I certainly have patients who have had to accept this.

Whilst it is only psychiatrists who can see what kind of treatment and/or action is justified and what is not, one has to acknowledge that if the field is not to recede back to a state where psychiatric patients are locked away (albeit not permanently but for longer periods than they should); that is, if societies' feelings are to be trumped, because of fear, over the limited autonomy of mentally ill patients, then society must certainly listen to the psychiatrists themselves, who are the people entrusted by society to look after in the best possible manner our mentally ill. For this reason alone it is imperative that the all-important field of biomedical and clinical ethics is not left only to legislators and other professionals who are not themselves medical people and certainly cannot share them same encounter with patients.

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References: Hudson, S., Raymont V" "Mental incapacity and medical ethics", The British Journal of Psychiatry, 184; 2004: 84-85. Robertson, M., Morris, K., Waiter, G., "Overview of psychiatric ethics V: utilitarians and the ethics of duty",Australian Psychiatry, 15 (5); 2007: 402-410. Robertson, M., Waiter, G., "Overview of psychiatric ethics I: professional ethics and psychiatry", Australian Psychiatry, 15(3); 2007: 201-206. Royal College of Psychiatrists, Assessment and Clinical Management of Risk of Harm to Other People, (Council Report CR53). London: Royal College of Psychiatrists, 1996. Sarkar, S., Adshead, G., "Protecting altruism: a call for a code of ethics in: British psychiatry", Editorial, The British Journal of Psychiatry, 183; 2003: 95-97. Sen, P., Gordon, Ho, Adshead, G., Irons, A, "Ethical dilemmas in forensic psychiatry: two illustrative cases", Journal of Medical Ethics, 33; 2007: 337-341. World Psychiatric Association, Declaration of Madrid; 1996. Elmhurst, NY: WPA

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When caring seems to go astray

A recent letter in the media, written by someone who has worked in hospital for some years now, complained about many doctors walking around thinking they are Gods and that they have lost their caring touch. Only this week I was speaking to someone who teaches nurses, amongst others, and it seems that he too has had an experience in which his doctor did not give him the due care he expected. At one point he used a maxim: doctors cure, nurses care.

I will not go into the debate of whether the above statement is true or not. I have seen excellent doctors and nurses and both doctors and nurses who have lost their care for the patient. There are a number of things to say in this regard - pOinted out in no particular order and perhaps by no means exhaustive ..

1. Cultural There is certainly a cultural element - call it a Mediterranean culture - which predisposes some people to act differently when they are in their own country and when that country happens to be the hot Mediterranean. I say hot in both the real and metaphoric sense of the word. Problems at hospital abound and it is not surprising that it gets to people who work there. Working conditions have improved at Mater Dei - for doctors the workload remains the same and indeed the walking distances between one department and another has increase. To be sure this does not excuse attitudes. But when one compares the amount of people handled one is bound to be cranky at times. Only last week I saw a visitor coming out of hospital in an undergarment, sandals and shorts. It speaks of a population. And although one expects more from the educated in that population, we all still have roots in a climate which needs improvement overall. It may not be easy for caregivers to give their utmost when people turn up dressed like that. I once had a lady take out an apple when she entered the office and started to

143 Essays ill Bioethics eat it. She had been waiting for two hours in the waiting room but chose that moment to chew it. When I asked if she was diabetic, she just said that she was hungry. On another occasion, when I was still a houseman, a woman came to the gynae department at three in the morning because of pruritis in her private parts. She said she had had this for three weeks. But she was staying with her grandson in another ward and when the child went to sleep in the wee hours of early morning, decided to hop over to the gynaecological department. Now before the cock crows we used to see only emergencies. Team work somehow failed at the time because I was still called to see her? She simply said, 'Isn't that why you are here'. We may pay for hospital services with our taxes, but this doe not give unlimited rights. Put differently, serving people (with care) does not mean you are their servant.

2. Team work The maxim quoted above may indeed be true without compromising good overall care for people. Whilst we should all, as health care professionals engender good care (probably compassion more than anything else), there is a difference between good communication and good virtues. But the point is that when working in a team, there are those who may concentrate on the more technical aspect and those who are more in contact with the patient. Take surgery, for example. I would rather have a good diagnostician and a surgeon excellent at his work. If he then can compliment that with a good attitude, so much the better. But good attitudes alone do not work. His workload is such that his time with patients is only during ward rounds and even then it is a process of decision-making. Again there is no excuse for wanting good humanity with patients; but perhaps in state hospitals one can excuse some attitudes when the work done gets ten on ten. Nurses on the other hand , remain within their own wards and get to know the patients. I have known good nurses and I have known bad. So one cannot aim complaints only at doctors. I have seen patients poo in the

144 Essays ill Bioethics nappy just after they are mobilized to have it changed. They then waited a whole day for another change. But on the whole nurses form the patients' companions during their stay in hospital and they are the ones to attend to the general needs. So it is right that most of the 'care' as we know it comes from nurses.

3. The difference between communication and ethics There is a difference however between good communication skills and ethics. IT is not a manner of 'bedside manners'. One can make good ethical choices and yet still be an 'introvert and sour person. Giving bad news is not easy even when all else is going OK. Only experience can perfect this technique and the environment and timetables sometimes do not help. We yet expect our carers to give us the necessary time; to cry with us when we cry and to be happy with us when we enjoy good news. Within state hospitals we sometimes expect too much, although not the impossible. Yet how we communicate is all important too. Can ethics and communication be separated?

4. The difference between principles and virtue One cannot put ethics and bedside manners in a nutshell. What united good ethical principles with good personality and communication skills is virtue. Indeed, today we tend to teach virtue ethics to young doctors. The 'good' choice has to be accompanied by an attitude of character. It is therefore not only about giving bad news, and the right to know, but it is also about compassion, fortitude and perseverance in difficult and tiring situations. On the other hand the administration can do better in seeing that doctors get the rest they deserve by international standards, and neither can this be an option on the part of the staff to work extra. If I am tired I am more bound to lose it once in a while. If we expect good virtues, we must also protect against bad vices, which sometimes a good rest can cure. So if we wish more care, we have to care for our doctors and nurses as well.

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5. Education has to be peripatetic However good education can never replace good example. know several physicians from whom I learnt considerably simply by being near them, both as a student and as a young doctor when I called them in to see my patients. Their attitude is perhaps almost genetics, but it certainly instilled good attitudes in me. In this there is a psychological truth; they we introspect and identify ourselves with those around us whom we admire. If, conversely, that person whom we admire gets cranky at times we either get the message that it is OK to It go once in a while, or we get the message that it is OK period. So the peripatetic teacher has to teach even when he or she fails.

We all fail. That is a truth. I have done so, so many times with my patients that sometimes I feel undeserving of my profession. That doctor who believes he is the best or that he has never failed a patient in communication has probably never introspected and reflected, or, quite simply, does not care. But we need to draw important conclusions. When we speak about state-funded hospitals, the burdens are quite high.

The backing in Malta can be all too missing. It is good to identify the wrong and correct it; but you cannot do this without at times rewarding the good as well. I am not speaking of performance bonuses, but a good word by superiors and by those who govern. We are often too quick to issue a report or a charge simply because a gruntled patient goes to his parliamentarian. Once we remove the undue power of these individuals, one would have to go through proper channels.

In private practice, doctors like myself can be more calm and there is no excuse for not caring for someone. You are on your own and there is no nurse or other professional to make up for you. It is not as many think, only a matter of market forces. Privately, if you are overworked, you can get just as cranky. But perhaps there is also an element of more motivation, admittedly;

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everyone is human, and being a doctor myself I cannot throw that stone as I have failed miserably here as' well. With God's grace, people continue to have faith in me - perhaps they have learnt to understand me as well. .

At hospital doctors work as a team: together and with other paramedical professionals. There are intra professional and interprofessional relationships to keep going. if these work well, then caring will not only be the personal attitude of an individual but it can also be built into our culture. To do this we have to invest - to bring people to encourage us and to have the backing when necessary. -It is a working environment just as any other.- We expect much from this environment. But we do not appreciate that it taxes people to see the sick every single day of their lives, whether they are earning a living from it or not. Sometimes the wrong person is simply at the wrong place at the wrong time and starts the day for the wrong person on the wrong footing. We all know, deep down, that someday we can be that patient. No matter the privileges one would enjoy, disease is disease. If we survive, that too is the ultimate experience of understanding our own patients. I should know. I was hospitalised too. With us doctors it can be the converse - you want people to be themselves and not be afraid of you because you are a doctor. You are no God! We just want to be treated (with care) like ev€,:ryone else.

There are more than one facet of caring. For one it may be dOing a technical job well, efficiently and effectively. For another it may simply be giving a good word. It is also true that when someone fails in one respect or another: for example not giving all information, someone, in the myriad of what is a hospital, did not effect his or her part. Although we blame the doctor under whose care we fall, it is not necessarily his or her negligent behaviour. But it would help if we communicate to them so that they can manage more effectively and check the hierarchy below them. Complaining above their heads will not usually be either helpful, or 'effective'.

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Profits and Research in the Pharmaceutical Industry

I was pleasantly surprise when Minister Dalli mentioned that one of the issues he will be conceming himself with on an EU level is the pharmaceutical industry. Indeed many are concerned with the high costs of medicine; but on the other hand one has to consider that this is a highly volatile field where research not only costs millions (and the investor wants a return on that research) but where patient safety is paramount when a drug is still under trial.

There was a time when most research was done by Universities and these obtained funds from the private sector. Nowadays the costs run so high that universities can only contribute. Researchers working for private industries have had to be careful even with the contract they sign for sometimes they could not practice what was considered scientifically sound procedure - such as publishing the results of an experiment. If you are employed by a private investor and he is paying for the lab and your salary, what you discover may only be patented by him and you are bound by secrecy. Time has revealed a balance in these methods. It is now considered legitimate that scientists can publish without revealing company secrets. Still, this showed that the change that was impending once medicine entered the competitive field of industry and where part of the money being invested to obtain new drugs was going into corporate profits. The same can be said of insurance.

But these are not necessarily 'necessary evils'. It is good for motivation that the private sector enters the field of health care. The problem is that an entrepreneur, concerning himself solely with profits can easily make this industry a parasite on medicine and sick people. So how to move the relationship between medicine and private corporations from a parasitic one to a symbiotic one has been the main concern. One area was patenting of drugs, which makes the cost of medicine go sky high.

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Of course if I have invested millions of dollars to discover a new drug, I would not wish for someone to copy it and make the profit himself. Like other areas, whilst allowing the scientist to publish results for the common good of the scientific community I must be allowed to recuperate my investments and make a profit. A patent in health care however cannot be given indefinitely as is done with other inventions. I would have too much of a monopoly on a drug which parts of humanity may not be able to afford. Companies are thus given a stipulated time, usually around fifteen years, where only they can market the drug once it is patented. After that period drug companies who manufacture what we refer to as 'generic' drugs, will then be able to use the same knowledge to produce the drug cheaper and use market forces to make profits. In this way a symbiosis is reached.

But research and development are not the only costs involved for a drug company. There are also the costs to regulate and study the drug for side-effects and other things. Research costs money. There are usually three phases of research (although we speak now of a Phase zero as well). The first one starts on healthy volunteers and then progressively on larger groups of patients until you get the fully fledged double blind controlled trial. This consists of asking people, following a due process of informed consent whether they wish to participate in a drug trial and they will get either the drug being studied or a drug to which it is being compared (in this way they will not lose out on the available treatment). Neither the patient nor the doctor will know whether the patient is receiving the control drug or the drug under study. In this way there can be no bias by the physician and one eliminates psychological and placebo effect on the part of the patient. In a final phase, after the drug is given approval by agencies such as the FDA - the Food and Drug Administration - in the United States, which has become a sort of certificate for drugs world-wide (once it is approved by FDA many countries feel safe to follow suit), the drug still continues to be studied by observing any long term effects. It is not the first time

149 Essays ill Bioethics that drugs are later withdrawn because of rare long-term dangers having occurred. Of course this costs the company considerable losses, and so it is understandable that in putting a price on the drug, such risks are also taken into consideration.

The whole point being that if one puts too many brakes and too many risks for the company, many will not enter the field of research, which we all agree is necessary. To add to the (necessary) burden on drug developers, this symbiotic relationship necessitates a considerable amount of rules and regulations are constantly being made. This will be one of the realms of Mr. Dalli as the EU is continually re-visiting patient rights and research protocols. The European Forum for Good Clinical Practice (EFGCP) is one of the major private ethics agencies based in Brussels which applies for Framework Project funds to bring experts together in producing regulations for drug developers. At the moment there is considerable concentration on drugs for children and the elderly. These are usually prescribed in what is known as an 'off-label' manner. In simple terms this means that the dose is adjusted for the age and weight of the patient. In children doses need obviously to be smaller and in the elderly one must take into consideration the decrease in function of organs which eliminate drugs from the body (chiefly kidneys and the liver) which thereby cause higher levels to remain in the blood and therefore a smaller dose being necessary. Now prescribing off-label means that you are not prescribing at the approved recommendations and therefore, unless there are clear standards of care, doctors would prefer boxes with available doses for children and the elderly. Again this puts the costs 0 developing these new drugs even further up.

A new area of concern is pharmacogenetics. If someone has a high blood pressure, for example, we usually start with the recommended drugs and work our way through several doses and drugs until we find the right drug and dose for the individual patient. This takes time, which of course can tax on the health

150 Essays in Bioethics of the patient. Now it is highly probable that this adjustment is necessary because people differ in individual make-up - height age, weight and even genes. In fact genes are probably those factors, besides environment which affect these parameters mostly. Therefore a study of genes can help us understand the dynamics of drugs better and to develop drugs catered for the individual - hence pharmacogenetics. It is not merely the costs here which concern us but the fact that we are dealing with large biobanks which need genetic information about individuals. There are problems with privacy and someone who donates a sample may not be interested in knowing his or her results as these may adversely affect insurance premiums or even employment.

The main issue with genes however is patenting. You can certainly patent a drug which you have developed as this is considered an invention. But can you patent a discovery? Human genes are considered common heritage and just because one discovers a gene does not mean that he can own it. However discovering such genes cost a considerable amount of investment in Research & Development. If you discover a gene and someone else can then use your results and produce a drug before you, it would discourage people from entering this highly relevant field of research so important for health care. How to protect the common heritage of the genome whilst allowing incentives for industry and corporate profits? The answer fortunately is found in the 'invention' necessary to discover the gene sequence. So I can certainly patent a method or process which I use, which will give me the right to keep it secret or to sell it. But I cannot patent the gene itself. This is fair playing ground and again respects the symbiosis sought between medicine and industry.

Developing safe and effective drugs is not like the alternative or complementary drugs that we buy. FDA approval requires investment in safety and in clinically controlled trials. They thus will cost much. Yet when in certain EU states a drug costs five times

151 Essays in Bioethics as much as in another, then one must certainly look and limit the add-on profits which the intermediary companies can make. In a particular country cost of drugs may be higher because of the expense in transport and salaries and other justified expense. Yet after these are taken into account one must uphold the principle that this field is about health and ill people and profits in selling drugs may need to be curbed beyond what the market allows in one way or another. One acceptable way is for companies to show that part of their profits go to patient groups or medical education or indeed into the general health pie which the government must distribute. Doing this without discouraging investors, which would be more detrimental for patients, is not easy. We have already experienced in Malta a taste of this with the fees and licenses for the drugs which were being imported. As a result many companies stopped importing drugs which patients were used to. This, coupled with parallel imports, make it difficult for the smaller enterprise. But all if fair if we have clear standards and level playing grounds.

The minister would do well therefore to start with the premise that those who enter health care and thus make profits on patients, can do so legitimately, but must also enter the field with a humane ethic as well. The ultimate internal good to use Alistair Maclntyre's expression, is the good of the patient. Corporate profits are external goods. But these externals goods cannot be worked out in the same way as with normal business. The corporate profits are after all being made by taking advantage of people's sickness and that medicine needs the investor. I usually use the analogy of insurance. Insuring a person for health can legitimately take into account risk factors, but a person can never be treated as when insuring a car and it is probably wrong that insurances do not have safety nets to be able to fairly insure elderly (even when they go abroad for a holiday) and disabled (and by disabled I am including those who may have some chronic conditions as well - for disabled you are if you cannot go abroad because no one will insure you).

152 chapter Issues in the Beginning and End of life

• The Elderly • Ordinary vs. extraordinary treatment • What is and what is not euthanasia • Treat me right - on Advance Directives

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The Elderly

There are a number of ethical issues which concern our elderly population which over the years need re-looking at. One cannot in all honesty say that over the past two decades, not a lot has been done. When one considers the number of homes which have risen, the re-vamping of what was formerly called 'Has­ Serh', or the degrading name of 'Tax-Xjuh', or, 'L-Imgieret', and not least the creation of a specialized medical hospital, Zammit Cia pp, which continues to set examples and standards much to be envied, one realises that we have moved forward. Yet there are always vacuums to fill and one considers progress by what one is doing at the present moment.

Perhaps the most pertinent question is homes. It is policy, and one which should remain, at that, that as much as possible the elderly should be kept in the community. There is much more than meets the eye in this under-rated statement. We are not only speaking about a social service here but a complete biopsychsocial one. The psychological well-being is perhaps the most pertinent. Whilst in homes, one is taken away from one's environment and friends, new friends are made and there is continual nursing care. In the community one often finds elderly living on their own, with relatives visiting less and less often, that they have to rely on neighbours. Cognitive function does not remain the same; one patient comes and goes to the pharmacy and my clinic about five times each time she needs a valium prescription. She forgets the control card which both doctor and pharmacist need to fill in. Of course the pharmacist will not release the medication without the card and my signature. Cannot we find an easier way to release controlled amounts of medication for those who live alone and are above eighty? If one is concerned about abuse, this, can still happen when one has a card. We need to re-think the comfort and convenience or our elderly population before we think about homes. In the long run it will serve us well as it will avoid all our elderly applying fora home.

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Conversely it is sad when one sees families trying to keep their parents with them at home. One daughter wanted her mother to remain with her; her elder brother did not want her there because he had a row in the past with this daughter's husband. He would not visit his mother there under any circumstance. He preferred having her in a home, and spoke to a minister about it so that everyone would visit her in their own time. The other four brothers and sisters knew that his solution was in the least interest of their mother and individually all wanted her to remain with their sister. But like a pack of dogs which follow the leader, they all gave in to his persistence. The result is that she died depressed and confused in a hospital bed - when she need hospitalisation, he would not allow his sister to take her back home and used the abusive pressure to leave her in hospital against the doctor's advice. We unfortunately have a lot of these cases, and families have learned how to use this sort of pressure to admit their relatives to homes. But if this is the only window, we may need to re-think the cause.

Instead of thinking homes for the elderly we should think elderly at home. One solution would be to use incentives for the sons or daughters who take on their parents. Certainly taking an elderly into the home costs much in electricity, washing, cooking, nursing and doctoring, let alone space. So one can legislate the right that the pension be transferred to the person taking care. Although some siblings may find objection to this, a board can certainly assess the case and take a decision in the best interest of the person. A Minister once pointed out some legal issues; but legal conundrums are there to be solved.

But when we speak of elderly we tend to converge only on the social issues of homes. There is also the biological and psychological well-being involved. Community services are one of them. I have often spoken of the lack of services such as physiotherapy, and occupational therapy in the community. If one had to make a

155 Essays ill Bioethics statistic, I believe that eliminating rehabilitation for fractures, it is the elderly who use these services most. Yet consider this scenario, which is surely familiar to most family doctors. An elderly person suffers a stroke. After a few weeks in hospital she is discharged home and given out-patient appointments for physiotherapy, occupational therapy and if necessary speech therapy. Yet for each of these appointments, people who do not have transport - and most do not because the rest of the family work during the day - have to get up early to get picked up at seven in the morning. They then are taken for a two-hour or more drive to pick up other people in the same condition. They wait in the waiting­ room for another hour or more; are seen for thirty minutes and then wait again for two hours to be transported back home - another ordeal of an hour and a half or more. They arrive home after 1pm (for a half hour visit to a physiotherapist mind) and it is indeed providencial that they survive the event and do not get another stroke. The invariable happens: after one or two visit they give up. If they do not have the money to do things privately, the morbidity remains and an eventual second stroke may ensue, which in turn taxes our health services. Had we been more astute in rehabilitation we would have saved the patient and some of our resources. A pilot study in an area can easily prove this. With the help of the government we can easily carry out this study from the Department of Family Medicine. The solution is simply putting these services in the community, where appOintments are easier, closer to the patient and transport less of a problem. Less morbidity and handicap will mean more independence (and less applications for homes).

When it comes to hospital care we have done wonders with Zammit Cia pp Hospital. It goes to shoe how much, given the right conditions, the Maltese provide excellent services. Changing the ergonomics of the main hospital (from St. Lukes to Mater Dei) has already improved the morale of many; but what makes Zammit Clapp special is the service they provide. They hold

156 in Bioethics weekly meeting and discuss each patient personally, Seeing the interaction of doctors, nurses, physiotherapists, occupational therapists and speach therapists is a lesson in itself, Decisions are taken collectively and one sees teamwork, not only on the ward, but around a table over a coffee and a light atmosphere where each one puts in his or her input giving the holistic approach which all patients deserve, Of course when it comes to sending people back home they do house visits to assess the situation, but once out of hospital they know only too well how difficult it can be to reach out to them A complementary service extended into the community, as we have with the Diabetic clinic will do wonder first and foremost for patients, but also for our resources in the long run, Why not all elderly patients can receive this service still eludes me, If Zammit Clapp has one fault is that they seem not to have sent across the message to the authorities of what they actually do, Like most humble people and service, those who do not blow their trumpets go unnoticed, They have now been dumped at the former hospital and have been told were greeted with a writing on the wall saying 'now it is your turn' (to be there, presumably), But slowly, given the resources, this place will turn into another Zammit Clapp, It is hoped that whoever wrote that will not turn Mater Dei into the dump he left behind, It is all too easy to blame authorities when we are often responsible for the caring,

Last but not least we need to create a bioethics culture, We can start by proving families we end-of-life ethical guidance, We have been giving lip service to the concept of Advance Directives, for example, whereby people write out, with the help of their family doctors, instructions on how they wish to be treated (or not treated) when they are no longer capable of making decisions on their own, In these documents one may also select someone who will have power of attorney - the right to make decisions on their behalf - and to whom doctors can look to legally, I know of too many cases where an elderly person

157 Essays ill Bioethics wishes for his personal doctor or a son or daughter to make the final decision about his or her health care, only to be over-ridden by over-powering cockatoos in the family. These situations are painful for the patient for the doctor, and not least for the person entrusted with the responsibility. Sometimes pressure is put on the elderly persons themselves - to receive treatment for example, which they otherwise would not have wanted. In one particular case, a relative who was a doctor working abroad, pressured the patient to receive the state-of-the-art treatment which he duly procured from abroad, but which the patient clearly did not want. His doctor was over-whelmed but there was nothing he could do. Clearly there was good-will involved; but ethically, the misconduct was appalling.

We have a Parliamentary Secretary for the Elderly. The political pressure he receives is probably unimaginable. We can remove much of this pressure and allow him to work on more important issues if only we had to provide him with the resources to have someone look into these ethical issues. It is a pity that such a resource uses much of its time on social issues only. We have done a lot for our elderly, conSidering, but given there are headaches, there is still room for improvement.

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Ordinary and Extraordinary Treatment, a case for review?

The recent Eluana Englaro case in Italy has again given rise to the controversy of keeping a person alive in a persistent vegetative state by nutrition and hydration through a nasogastric tube. The last controversial case which made a similar outcry was that of Terry Sciavo in the United States. The question to consider is whether nutrition and hydration, especially after several years in a persistent vegetative state (PVS) constitutes an ordinary measure to keep a person alive or an extraordinary and/or heroic one.

The difference between Ordinary / Extraordinary treatment originates from Roman Catholic Medical Ethics and was introduced by Pope Pi us XII in the 50s, as a guidelines to Catholics in the face of new extraordinary means to keep people alive which were becoming more and more common. In fact before being able to keep people alive on a life support system, one was considered dead when one's heart stops beating. (This still applies for medico-Iegal purposes, say, when one attempt Cardiac Resuscitation - thus if the attempt fails one cannot be accused of having caused death). A Harvard neurologist introduced the Brain Death Criteria, to determine whether a person is still scientifically alive and therefore allowing removal of the body from advanced life support.

The first controversial case, ironically, was to put a girl offlife support when she was in fact not yet brain deadlO. Mary Quinlan was a 21 year old on life support. She had been involved in an accident. She also was Roman Catholic as were her parents. The parents thought that keeping her alive on such a system was something they could not bear. They wanted her to die in dignity.

10 Baker, R., "The History of Medical Ethics", in Porter, R., Bynum, w.F. (Eds), Companion Encyclopedia of the History of Medicine, Vol. 2., Routledge, London and New York, 875-878.

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Their Parish Priest defended their case. The doctors however would not agree as she was not brain dead. The case went to court which made historical ground when it was decided that the criteria of a social institution (in this case the Catholic religion) could over-ride scientific thought. She was subsequently removed from life support and allowed to die even though she was not brain dead.

At this juncture it is important to note that the definition of the Church, subsequently put through scholarly rigour]] takes note of two particular (and important) points. First what is to be defined as ordinary or extraordinary has nothing to do with the state-of­ the-art of the medicine. Blood transfusion was then considered as quite an extraordinary form of treatment. Today it is very common place. Yet we still note the controversy over Jehova Witnesses, which to them is an extraordinary measure. But what is ordinary for one person, such as having CPR, may be considered extraordinary for another. In this regard, having an Advance Directive (or living will) can be very helpful.

This brings up the second point - the relatives. The burden of the relatives is considered very important in determining whether treatment is ordinary or extraordinary. Therefore if the relatives have to go through extraordinary measures, such as selling a house, or extreme psychological distress, as in the Quinlan Case, then the treatment is considered extraordinary.

It is here that case become controversial, although in reality they should remain confidential. The fact that respect for confidentiality seems not to take place here implies that we are still in an evolutionary phase of understanding these cases, and there is still to be found a balance between what is important to the patient/relatives, and what is important to society.

11 Kelley, G., Medico Moral Problems, St. Louis: Catholic Hospital Association, 1958, p. 135. (quoted from Jonsen et al. idem.)

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Roman Catholic moralists have however traditionally argued, as in the Quinlan case, that moral obligation demands only the use of 'ordinary' means:

Extraordinary means of preserving life are all medicine, treatments, and operations, which cannot be obtained or used without excessive expense, pain or other inconvenience for the patient or for others, or which, if used, would not offer a reasonable hope of benefit to the patient.12

Whilst it is important to note that the statement, accepted as 'dogma' nowadays, as it follows directly from the declaration of Pope Pius XII, includes 'other'. The Quinlan case showed how true to the word this is. When it come to nutrition and hydration however there is still controversy among ethicists.

Many ethicists consider nutrition and hydration to be so basic as to always constitute an 'ordinary' measure. Just as much ethicists however still believe that this is not the case. These arguments arise on whether to start a person in a PVS on hydration and nutrition. Definitely a person in such a state cannot be considered to experience hunger in the psychological state. Any nutrition and hydration does not give any satiety or satisfaction. It is simply to keep the physiological status of the body. The Englaro case showed, as opposed to the Sciavo case, however much life can be being held on a thread with nutrition. Jonsen, Siegler and Winslade, following Catholic moral teaching, propose that since controversy exist, both positions are ethically permissible and there is legal ground for both13. Certainly, Jonsen is a renown Catholic theologian in the U.S ..

12 Ibid. nd 13 Jonsen, A.R., Siegler, M., Winslade, W., Clinical Ethics, 2 ed. MacmilIan New York, Toronto, London, p. 110

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What is unfortunate about these cases is that all form of confidentiality is lost; people become overly emotional and judgemental about the relatives; and the application of the moral rule of what constitutes extraordinary is lost to public scrutiny and opinion. Some countries may decide to legislate to make tings easier. This of course will remove one's right to having advance directives about one's own care, which seemed to be the issue in this case as well.

There will hopefully come a time when we can have a structure which protects both patients and family, keeping the dignity of the situation. This would have to include some form of scrutiny to avoid abuse. Certainly if we decide that both options (giving or withholding nutrition and hydration) are both morally permissible, such policing would not be necessary. For many living in a persistent vegetative state for over seventeen years is extraordinary in itself. Other than contact with the person who feeds them two or three times a day, these people may be put on a chair, but the body usually remains alone all day.

There is a growing literature and evidence on people in PVS. Some drugs have been shown to improve their condition and even bring them back to a relatively normal life. Classifications are continuously developed with .further understanding. Indeed many do recover within the first six months. After that the chances are very slim and deteriorate with time. There are exceptional cases and it may be the case that one will be able to identify these with further knowledge on these cases obtained by the use of imaging techniques. There is certainly not enough evidence at the moment and one has to respect that there is both an evolutionary phase of definitions like ordinary and extraordinary treatment and whether this applies to a form of nutrition in cases of PVS. Does it become extraordinary after a few years? Should we allow the person to die in dignity or leave them in this abyss, if abyss it is?

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Conversely PVS has been around since the early seventees, when it was described by a neurosurgeon from Scotland. It is a side­ effect of modern medicine, and we are still in the evolutionary phase of understanding even the classification, let alone the state itself. In the meantime should we be 'prudent' and give physiological feeding to these people and keep them in this abyss for seventeen years; or should we build an evidence­ based literature which guides us as to when, early in the process, feeding would be considered extraordinary. For the family it is always difficult but as with life support systems, there will be those who, as in the Quinlan case, would see the advance as a technology which interferes with the natural dying process. There will be others who, even after the relative is brain dead, will object to the removal, thinking that since their heart can be kept beating, then there is still the possibility of a miracle. WE have moved forward with life support systems, and chances are that we will move forward in PVS.

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What is euthanasia and what is not?

The fact that morality stops just short of direct killing when it comes to end-of-life decisions keeps many confused between what is actually euthanasia and what is not. Unfortunate cases reach the news, breaching all confidentiality, and make a show of people, the ill and their families, which should be top priority on the agendas of governments rather than trying to instigate laws which will put proper medical intervention in a cui de sac. We have to realise that life is not straight forward and that the dividing line in many cases is difficult already for the professionals to affirm. When news is made public all we get is an outcry full of emotions and even those professionals, who are by tort law, liable if they give bad information which can cause harm, resort to personal opinions rather than fact. In the aftermath of the Eluana case it is perhaps pertinent to try and make some sense out of the questions raised.

First of all there is a difference between killing and letting one die. We all have to die and we are not obliged to keep everybody on life support, be it simple or advanced and not respect this value of life - that death leads us to a new life, or that, at least, it has to be accepted as part of life. We have to respect the fact that many dying people stop eating, and force feeding them is not part of a natural death. Feeding tubes are only there to help an ill person through a dire phase in the illness, or when it is thought, at least, that death is not imminent.

Now killing, or euthanasia, in our case, has to be divided into active killing, such as giving a lethal injection, and passive killing - the omission of treatment which is considered standard of care. Some say that food and water should always be considered standard. Given the disagreements, morality has it that both can be considered both morally and legally. What we centre about is whether the burden on the family can be

164 Essays in Bioethics legitimate. Even our Catechism states clearly, in the section on Euthanasia, that the wishes of the family have to be respected. One has to consider that families often want closure and just because medical intervention can keep a person alive, in an institution, in a vegetative state, is unacceptable to many. It is for this sole reason that the Catholic church, which pioneered the ordinary/extraordinary argument, and today even speaks about 'disproportionate', made the distinction between that which should morally be acceptable and that which morally is not necessary. If one had to visit one's daughter every day for several years, perhaps travelling a number of hours and setting back one's own life, then it would be disproportionate if the person has no chance of survival. It would be seen as medical technology interfering where it should not. Just because a new technology can keep people from dying, but without a hope of bringing them back to some form or perception, does not mean that we should all be kept in this way. Cases like that of Eluana Englaro are merely a side-effect of understanding these processes and will definitely decrease in time. It is a passing dilemma, which responsible thinking will and can avoid.

There are ample cases to confirm this; cases in which families who had relatives on life-support systems sought the help of their religious spiritual directors, or bishops, etc, who were given the official advice that these heroic measures are not necessary. One may argue that these decisions may not be in the interest of the patient, but of the family. Whilst this is true we have to respect that morally, many frown on an individualistic society, and for the family to be kept as the building block of society, then its weight must bear in. Of course we may make exception when we seriously consider that the patients best interests are not being considered. What seemed to make the Terry Sciavo case controversial was the fact that the husband was awaiting a court judgement before he asked that the extraordinary treatment be removed.

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But this brings us to an important point. We cannot make external judgements. For all the defending of life that the people in the streets were making recently in Italy, they were being judgmental about a parent whom nobody could ever have appreciated what he was going through. I cannot here say what was the right thing to do, and neither should this weight be put unfairly on one judge (who then has to make a decision over a life). The decision must be taken by the health care team, the family, their spiritual directors, and if necessary a health care ethicist.

There seems to be a schism within our Catholic Church, when such things happen, which should not be there. For instance the Cardinal who did not want the life of Eluana terminated stated that Eluana had 'perception', that she was in a state of deep sleep, etc. If this were truly the case then she was not in a vegetative state, but simply in a coma. Were people confusing a Coma with a Vegetative state? This seems to have been the case. In a coma the cortical matter of the brain, the part responsible for voluntary actions, is not dead. When the body depends only on the non-voluntary parts of the central nervous system - the spine and the transition zone between the spine and upper brain, known as the brain stem then we say we have a vegetative state. Although studies are being done and successes have been recorded within the first six months, beyond a certain pOint for many, it becomes a disproportionate and an extraordinary measure to be kept in a vegetative state. The use of the words 'comatose' in the media confused many.

On another level we have to admit that morality is not made in the streets and neither, for that matter, in the media, including a column like this. In fact there is no space for personal opinion here either, unless clearly pointed out. What we look for are the rational scholarly reflections and interpretations of statements such as that issued by Pope Pius XII on extraordinary measures, which remains the same until today. Many Catholic universities therefore have looked into details, such as whether there is a difference between inserting a

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NasoGastric tube (NGT), and removing one, There is agreement that in fact there should be no difference, For when I insert an NGT I may do so within a circumstance that subsequently changes, requiring a re-assessment of the necessity of that same NGT, Therefore the issue is not, as some have pointed out, not to start such treatment in the first place, The issue is to give the moral breath to professionals, families and ethicists, to remove such a tube when necessary and accept death, This moral space does indeed exist but is hindered when a personal case becomes sensationalized. or when other interests, be them political or not, interfere,

The whole point is that we can only look at these cases from afar and cannot make a moral judgement, even as ethicists, unless we consider on a scholarly level all the factors involved, Ethics is not only a feeling: it is based on rational thought, which in turn is based on natural law - the law that the human animal is a rational being and has the ability, through reason, to discover the laws of morality, There may be cultural and temporal differences, but all parameters being equal we would come to similar, if not the same, solutions,

Not all that looks like euthanasia, therefore, is euthanasia, Removing treatment is not an act of omission which constitutes passive euthanasia, if that act is the responsible act to do, On the recent Xarabank programme which dealt with euthanasia, a video of a live assisted suicide was shown, What made the case a direct killing was not the removal of the air supply, which the patient switched off himself, and indeed which could legitimately have been switched off by the personnel. This could have been seen as an extraordinary measure, It was the lethal solution which the patient drank which changed the situation, The extraordinary measures could have been removed and a palliative solution to put the patient in a somnolent state could have been given until he died.

Such was the case of Mr, Larry James McAfee who suffered a motor vehicle accident in 1985 and remain totally paralysed and on a

167 Essays in Bioethics mechanical ventilator. Although he was conscious and competent he petitioned the court to be able to remove his ventilator and be given a sedative beforehand. The court found in his favour and the Archdiocese of Atlanta found that his request was justified as he 'receives no enjoyment out of life', his 'continued treatment by ventilator merely prolongs his emotional pain and suffering', and he was still in a lot of pain and had nothing to look forward to. They applied the subjective criteria presented by Bishop Daniel Cronin to Mr. McAfee's situation and deemed the ventilator as extraordinary. The Archdiocese of Atlanta took the position therefore that the patient had the right under ecclesiastical law to either continue his present treatment or to interrupt that treatment 'even though such interruption will end in death'14. Certainly not an easy case, but an illuminative one.

But the difference is that with euthanasia the process is hastened and to many this seems to be more humane. So the controversy goes on. But when we have a legitimate alternative it should probably be used. When people are kept alive with technology against their will we have to respect their wishes to stop their treatment and give palliative, not lethal, modes to aid in the process. This is a charitable way to remove distress and the solution given is only intended to remove this distress and not to bring about the death. Some are more heroic and therefore we morally should continue to assist them. On the other hand these solutions cannot apply to people with severe disabilities, such as quadriplegia, in which a person is paralysed from the neck down. One cannot keep doctors from treating people in an emergency either, and this unfortunate result changes the quality of life, but it will not be a matter of 'allowing' a person to die. The person is still alive. The point being that, as in the case of McAfee, what is a standard of due care in one situation (the emergency), may change in time to a situation in which the care instilled be considered extraordinary. There is a moral equivalence to not instilling treatment in the first place and removing it in another instance.

14 'Georgia Man Asks to Turn Off Life-Support Ventilator', Archdiocese ofAtlanta, Origins 19, September 28,1989: 273-279.

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Treat me right - the usefulness of an Advance Directive

A client's grandmother always refused going to hospital. She came from an age when to go to hospital was something for very ill people, and was frowned upon. Hospital wards were not the wards of today. When she later could not take decisions on her own, she had said this often enough to her children that when there was nothing more that could be done at home, when she eventually became ill, the family doctor, acceded immediately to her wish of dying at home.

A cancer patient told me that she did not want to know anything about her illness but made it clear that she would want all measures taken to keep her alive. She developed cancer of the stomach and eventually had to be admitted due to deterioration. She became semiconscious and on two occasions was given Cardiopulmonary resuscitation. When she was in her final stages, the health care team discussed her situation with her sons and daughters and decided that although she would have wanted CPR it is doubtful that she would want to withstand the stress being caused - every time fractures of the ribs were bound to develop, which would cause her more pain. It was decided to stop this extraordinary measure and continue only with ordinary measures such as feeding and palliative measures.

In the light of the recent discussions on end-of-life issues it is pertinent to discuss how patients can make their preferences on treatment known to the medical team, making a decision when they are still competent to do so. The Eluana Elglaro case has shed light on how the public may not trust the expressions of relatives with regards to their loved one. Her father had made it known very early that she often had expressed a wish not to be left in that state. Yet he was judged and the fact is that in reality we cannot know, let alone make these

169 Essays in Bioethics judgements. Why should I not be able to tell doctors what a loved one wished and whether this loved one wanted any extraordinary measures to be taken or not? It has been known that sometimes even GPs may find it difficult to communicate with consultants. In a talk I had given on the subject the Chairperson, a renowned local physician, had pointed this out.

So how can we make our wishes heard in the unfortunate event that something had to happen to us? Whilst bioethics is putting its weight around, meaning that it is more and more becoming natural for relatives and family doctors to speak out on behalf of patients, having a directive given in advance of a situation (hence Advance Directive), can make things much easier. If the law can be arranged to have these recognized, so much the better, but having something to show is much more useful than not having anything. It is the same with donor cards. They are not yet legal documents, yet they clearly express the wish of the patient, even though the families are still consulted, and indeed may over-ride that wish. I will leave the topic on donor cards and donation for another issue and will stick to advance directives.

Patients may not wish particular treatments to be given to them when they approach the end of life. This does not mean that in an emergency, doctors should not do their normal duty. It just means that if we know that there is a terminal condition, or the patient is very old, they have a right to refuse extraordinary measures to keep them alive, whilst accepting ordinary treatment. As often pointed out it is important to realise that extraordinary has nothing to do with the common acceptability, or state-of-the-art, of the treatment­ like advanced life support and Cardiopulmonary resuscitation. For an elderly person, extraordinary may simply mean not wanting to be sent to hospital and wishing to die at home, even if sending them to hospital may prolong their life further.

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These issues, of course should preferably be discussed with the family and it should be pointed out that they are not always possible. One patient wished to die at home and although he was short of breath, we arranged for oxygen tanks and the works to keep him comfortable. It was explained that what we can do at home is limited and that hospitalisation is clearly better. We can have access to home nurses, a private Chest physician when necessary, etc. But his wishes were clear. Even feeding becomes an issue, but people who are at the end usually do not feed much. This patient preferred dying at home. Eventually however it proved difficult even to sit him on a comode. He was a heavy man. We had to make the decision to send him to a home for his final days. He died at home the day we were to arrange a transfer, saving us the difficulty of going against his wishes. The point being however that sometimes it is difficult to accede to all wishes.

The legitimacy

It is not always clear whether doctors should follow instructions given in advance. Certainly someone who decides to put what he or she wishes on paper and have it countersigned by a witness may make them more legitimate. They may even decide whom they would wish to have as their power of attorney, should any decisions on their behalf need be made. A GP can also help in formulating such wishes. But even if we had a law on advance directives, what has to be put in them need be instructions which the doctor or medical team can follow legitimately. There someone cannot give an instruction for terminating his life (assisted suicide) in case he loses consciousness and is distressed. As the Englaro case has shown, what seems to many to be euthanasia is not, but unless doctors have clear guidelines it is very easy for the health care team to steer away from complicated cases (as in the case of Elauna Englaro) because of lack of clear ethical/moral guidance.

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It is often the case, where advance directives are implemented, that when people develop early stages of dementia they decide to have an advance directive before things get worse. In these cases, one would have to reassure oneself that the patient repeats the same wishes on several occasions in periods when they are lucid in order to make sure that they continue to hold the same wish, especially when it involves refusal of certain treatment.

It is also clear that sometimes the patient's wishes cannot be acceded to, especially if the treatment is considered futile. No doctor is under the moral or legal obligation to give treatment considered futile. This may include treating infections towards the end of life. Conversely a doctor may treat an infection at this stage not so much to kill the underlying pathogens and eradicate the disease but merely to relieve symptoms. For example, if a dying person develops a urinary tract infection, one may decide to treat if one perceives that the patient is distressed when passing urine. Therefore what is futile be curative measures, need not be futile for palliative care. But if one has an advance directive to stop all treatment and not to go through extraordinary measure when one is at the end of one's life, would this count? A doctor may, after discussion with the team and relatives, decide to give treatment anyway, not so much as to over-ride the patient's wishes, but to make the person more comfortable, even if this means prolonging life by a few days (which one, of course, never knows). Allowing a person to die in distress is never a goal of good medical practice, even in the face of such directives.

Advance directives apply to decisions at the end of life. They do not include requests by relatives, especially when they are concerned on wills. IT is therefore a living will - that is, wishes to be done when one is still alive. It does not concern normal wishes, and moreover concerns only medical care. It may name a person, who may be a close friend or relative, or indeed a doctor,

172 Essays in Bioetilics to have power of attorney for the patient, that is, to act on the patient's behalf. The team would of course need to ensure that the person is acting in the patient's best interest. The person with power of attorney would have legal authority, but gaining the trust of the health care team is indeed another matter. This person would then be in a position to discuss with the doctors what he or she considers ordinary or extraordinary for the patient. But if there are no expressed wishes of the patient it can get complicated. Putting someone on life support, for example, is a big decision. Patients have a right to refuse this treatment if they foresee it as a possibility due to their terminal illness. But someone with power of attorney cannot simply tell the doctors not to put someone on life support without producing more evidence to this effect - that is, without showing that this is what the patient actually wanted. Moreover the doctor may not consider the measure futile.

This is why Advance Directives are difficult to implement where there is no legislation; and legislating for these sort of directives requires considerable thought to these situations. Nevertheless this should not distract patients from expressing their wishes, as in many instance, the doctors would be more than willing to help and to know what the wishes of the patient were.

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• Introducing the PUME matrix • Ethics matrices 2 • Philosophy of Medicine

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The Ethics matrix TheSynopse

It helps us define 'what are we discussing'. In a moral debate we often bring in many arguments, some of which have to do directly, and other indirectly with the main moral issue at hand. Moreover the moral issue may lead to other ethical choices and to areas or issues of which we are unsure. In order to clarify one's thinking, in teaching, and in moral debate, it is useful to distinguish therefore the main moral argument at hand, for example, Sale of Organs, the pragmatic moral issues which arise - which indeed can have weight on the outcome. Then there are other ethical choices to be made - are there exceptions to when we can tolerate the sale of an organ, for example if it is put as a condition in one's will - is it ethical? There are areas which we are unsure about - unsure whether they form part of the main moral argument or are more pragmaticsuch as the use of masturbation as an argument against Invitro Fertilization. PUME stands for Pragmatic, Moral, Unsure and Ethicaj15. The four main areas therefore are:

1. The Central MORAL question being discussed. 2. PRAGMATIC moral issues related to the central moral question 3. Areas in which we are UNSURE between the above. 4. Other ETHICAL outcomes or choice related to this issue.

As a matrix it is present thus:

15 The PUME matrix was devised over several years of public debate and reflective teaching in bioethics with students of the University of Malta, and not least after the training imparted in Malta in adult learning, by the RCGP. I had been using the argu­ ment of separating the main argument at hand, from those other moral issues that arise from the main one, in order to create less confusion and to focus on the argument at hand. It mayor may not be useful to people.

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p U

PRAGMATIC UNSURE

M E

MORAL ETHICAL

We see that 2, 3, and 4 can all have an influence on the central moral question. This means that although we can find nothing inherently wrong with the central issue, the other three areas can have enough weight to make it overall prohibitive, as we shall see. Conversely, the central issue may be inherently wrong, for example the use of animals in experiments, but under certain circumstances, and because of the benefits, we allow it. Clarifying areas 2 - 4 is important as the reasoning may change in time. Thus we tolerate pollution to have cars, but if cars exceed a limit the pollution may be too much, or indeed we may have created other problems, such as congestion. We then revisit the central argument.

Having a matrix with these for areas, allows for better ciarification in thinking, and especially in discussion. The matrix has indeed been used in group discussions both for teaching and public debates and can be used by a facilitator to focus the argument. He may, for instance, say, 'yes, indeed, that is an important point. It is perhaps a pragmatic moral argument which although important is not the main issue we are discussing; it is more of an outcome of the issue, which if resolved, will still leave us having to answer what we are debating here. Let us put it under Pragmatic

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Moral Issues. The PUME matrix is a mnemonic to remember four areas of a moral debate. It is useful insofar as it helps one distinguish between the true moral arguments and those which can be 'resolved'. This helps one distinguish in turn what are the true areas of conflict, where there is a difference in values, and areas of potential dispute, which if resolved, can help move one forward. One has to keep in mind that we may resolve a hundred disputes without resolving the main conflict, given that the conflict has to do more with a difference in values. To illustrate this by an external example, one can resolve many disputes between the Jewish and Palestinian states, and yet the main conflict between them remains. On the other hand, we may not really have a strong objection to the moral issue per se, but what matter more are the other moral issues which are raised. These I term the 'pragmatic issues'. This is clearly illustrated by the cases for Invitro Fertilization and that of Organ Transplantation described below.

The reason for putting them in a matrix is two-fold. A matrix makes it easier to picture a problem. One can separate the arguments and put them into the respective box. This can even be done in one's mind, since it is simple. Conversely, The columns on the left hand side of the reader are the main moral arguments, the columns on the right are outcomes and choice with which we still have to deal. On the other hand, if we look at the matrix as rows, the upper row deals with moral issues external to the problem at hand, whilst the lower row are more inherent to the problem. Even if some are not the main issue at hand (the ethical choices), they are a direct result of the moral issue.

On the other hand the most important column for discussion is the left. We have to immediately divide the moral issues into the pragmatic ones and the real one being discussed. In the example of organ transplanation the real issue is the morality of sale of organs; abuse of sale, or exploitation are pragmatic moral

178 Essays ill Bioethics issues, which albeit can have an overall weight and become themselves the moral issues to decide the fate of the moral issue being discussed, are not in and of themselves the central moral issues - sale of organs. Conversely, with IVF, the fact that IVF

The matrix mayor may not be useful to some, however it does have the advantage of clearly defining what we are talking about and at least agreeing on what is at stake and what is the true moral issue and what is not.

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Ethics Matrices 11

The first part of this article has tackled the issue of separating the main moral argument at hand from other moral pragmatic issues, It was seen that when negotiating moral problems it is sometimes clear what is the main argument - such as, should we have InVitro Fertilization, or Should we sell organ - from other moral arguments, called pragmatic, which are not the main argument but can have weight on the final acceptance of the moral issue at hand, What can be unclear is a separation between the pragmatic arguments and the ethical.

Pragmatic arguments are those which may be resolved in time, with advancing technology, for example, Ethical arguments are other moral issues which may not be resoloved but which in and of themselves present another moral argument for discussion, In the previous argument, autostimulation to produce a sample of sperm for IVF was considered an ethical issue, It is not pragmatic as this cannot be resolved in time, Yet it is legitimately another moral argument, It should be made clear that this was not the main argument being discussed, if what was being deliberated was IVF, It may merit a separate discussion and within that context be put into the category (or box) labeled moral. But that would then be another argument,

Another example is freezing of embryos, This again is considered immoral by many, It cannot be the main argument against the use of IVF, however, as it may be bypassed, Conversely it is another ethical issue and may merit discussion on its own, being then put in the category of moral. It is not a pragmatic issue however as it is not a technology which can be improved, other than its omission,

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Sometimes we can be unclear as to whether an argument is simply pragmatic or ethical and therefore we have the convenient category, box, labeled 'unknown'. We can come to it later without sidelining the arguments at hand. For example, one argument often brought into the case for IVF is that couples should not be encouraged to go through extreme sacrifices like selling a house; for others, having a baby may be more important than owning a large, nice house.

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Principles Matrix Another ethics matrix convenient for use is that developed by Ben Mepham which considers a principles approach. Mepham uses three principles: well-being, autonomy and Fairness. It is basically an attempt to move away from a four-principled approach developed by Beauchamp and Childress, which have been exhausted in this column in previous articles. He applies this matrix, an example of which is given here, in various parts of his book, dealing with many areas of bioethics.

Respect for: Well-being Autonomy Fairness Farmers Satisfactory Managerial Fair trade laws income freedom and practices Consumers Food Safety Informed choice Affordable food The Biota conservation biodiversity Sustainability GM Crop Flourishment Adaptability Intrinsic value

~~-

The above matrix deals with genetically modified crops. In reality fairness is a principle used in Justice. Justice has fairness and equality as two principles usually defined within it. I prefer to use a modification of the above matrix using the four principles, respect for autonomy, beneficence, nonlamleficence, and Justice (one may put beneficience and non maleficence in one category for convenience, or separate Justice into 'equality', and 'fairness', according to the topic being discussed. One should keep in mind that the four principles do not resolve moral problems. They simply allow a framework for discussion and allows one to formulate a path for arriving to a conclusion. This conclusion however is usually based

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Autonomy Beneficence Nonmaleficence Justice Patient Can/cannot Treatment Side effects What is in make a choice best interests Relatives Who is to act as Information Giving (bad) Any right to proxy news (know)ledge Medical Explaining/taking Is treatment Balance benefits Costlbenefitt team medical choices futile with side effect Community Does it have a Can others Slippery slope Justice to say benefit arguments the community

In the case of the Terre Schiavo, one applies the four principles to all parties concerned: the patients, the husband, the parents, the religious community at large, the medical team making the decision. We usually balance between principles and specify them to the situation; but arriving at a moral conclusion is usually an a priori affair. One uses the matrix simply to put one's arguments in a clear, understandable, and indeed common ethical language. Not all boxes need be 'filled'.

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Philosophy of medicine - is there such a thing?

The first thing we need to ask is whether philosophy of science matters at all for medicine; and indeed what do we mean by philosophy of science anyway? Perhaps the best way is to answer the question whether medicine, as a science, depends on tradition, and secondly, if there is a tradition, what are the goals of this tradition. Prima facie most doctors would agree that there is a tradition of medicine, which is to heal patients and to do good. Yet this tradition is being challenged when some doctors fell it their duty of assist in ending the life of a suffering individual. When one asks whether this is or should be the goal of medicine, one is making an inquiry about the philosophy of one's practice. Even if it is not the aim, the ethos, of medicine, it may still be within the grasp of the general aim of scientific method. To illustrate this better, we can use reproductive technology or stem cell research as an example. SCientific advances in this area by no means held back the medical profession from using them; at least the former. Yet some may still challenge them on moral grounds outside medicine and then ask whether it should be within the scope of medical practice to host these technologies which some (or many) may question on moral grounds.

There.are two principal movements in the philosophy of science, which can be applied to medicine, which have made their voice heard even in circles not inherent to the field. These are those of Karl Popper and Thomas Kuhn. Both did not concern themselves with medicine, but with philosophy of science per se. Popper is portrayed as the more objectivist and traditional, 16 putting science on a level of challenges • We uphold a theory until it is challenged by a better one. The good scientist thus allows his theory as a working tool but is open to challenges and indeed may challenge it himself. Kuhn, on the other hand can be thought of more as coming from the American Pragmatic school

16 See Fuller, S., The struggle for the soul of science. Kuhn vs Popper, Revolutions in Science, Icon Books, UK, 2003.

184 Essays in Bioethics and is considered more liberal and indeed relativist, saying that science moves forward by the practice or though of the day, which he called paradigms'? These paradigms create small revolutions in themselves and scientists work around them. It is therefore more authoritarian and based on historical research as well. This historicism is a learning experience, if you may, on which one builds. Yet when a paradigm changes, all the material of the previous thoughts are put aside. Kuhn was a physicist and limited his discussion to this field. A clear example was theoretical physics which at the time was passing through a revolution of thought because of general relativity, quantum physics. Cosmology, with the 'Big Bang' created this new paradigm of thought, for example, and cosmologists work around this theory even though some still challenge the Big Bang concept.

Do we do the same in medicine? In many ways, we do. We speak of current thoughts in medical practice and historical development do take their toll. If one asks whether medicine is liberal or indeed relativist, there are indeed those who would go to all means in order to cure patients, or indeed to gain external advantages, given the necessity of industry to push forward medical research and development. Thus some would little question the embryo once this is for the gain of benefits obtained by stem cell research. Yet medicine has it long tradition and we take joy in speaking about the Hippocratic Oath and such. When it comes therefore to the teaching of bio- and medical ethics, one often appeals to tradition: but this tradition does change with the times. The principle of respecting autonomy has, for example, challenged paternalism - the notion that the doctor knows all and the patient must obey.

Does this matter at all? Indeed if medicine is to maintain its repute as doing good, it does. Doctors who are paternalistic are not only challenged but may face trouble. Whereas in the past it was relatively fine to take .organs from dead bodies for research and

17 Idem.

185 Essays ill Bioethics study purposes; today medicine has fallen in line with obtaining consent and indeed has pioneer the concept of 'informed' consent - something which the business world, for example, including those giving out medical insurance, must still master. Moreover medicine has become socialized Today people are more and more aware of their cholesterol, weight, exercise. Far from what certain authors say, that medicine has manipulated the world, this is the result of society. The very fact that many other social factors come into play in medicine - politics, insurances, pharmaceutical industry etc, implies that there are more that doctors and paramedics involved in health care. This breeds the question - should these not all have the same ethics? Should they be obliged to follow the rules of medicine?

If we can speak of a philosophy of medicine, then we can answer in the affirmative. This would oblige insurance, politicians, and even brands promoting a certain butter to follow the same rules - that of respecting the principles which we as doctors uphold - respecting autonomy, beneficence, nonmaleficenceandjustice. Whilstthelatter would apply mostly to pOliticians, we would not tolerate advertising which works upon scare mongering techniques - if you do not choose this butter you may be at a disadvantage; or manipulation - such as facial creams 'approved' by dermatological foundations sponsored by the same company producing the cream. As conflicts of interest apply to doctors, they should apply to anyone who is in any way making a profit on patients.

If medicine had no philosophy, no ethos, then there is nothing to stop us from making profit the main principle and motive factor as morally correct. This would be relativism at its best. Even if paradigms may be the rule of the day, it does not mean they are always correct (and many, including myself, do not believe in Big Bang, a term which after all was coined by its great opponent Fred Hoyle. Many are blind however and continue to work notwithstanding many unanswered questions). What results

186 Essays in Bioethics is that we try to build an ethics which suits our needs, as scientist would try to work around experiments which prove rather than disprove a theory. This is perhaps the challenge of modern medicine today. We must not lose sight of what Maclntyre18 calls the 'practice', which as a 'tradition' defines the goals and goods internal to the practice, even if the practice itself can have the benefits of goods 'external', such as profits and prestige. The fact that we have to a certain extent omitted this has meant that defining and teaching of ethics within the medical community has been lostto external forces such as theology, philosophy and sociology - all inputting, defining, dictating what doctors should or should not be doing. When the same people come on the hospital bed they will realise that they have been shouting in vain as they may indeed realise that the science of medicine is not, after all, the enemy. Then maybe, these much important fields will help medicine by becoming facilitative rather than didactive - that is, by helping the profession maintain its identity by their important contributions. Doctors will indeed appreciate the value of philosophy because they feel the need to define the philosophy of medicine. Medicine can only work within the cultural, social, and psychological spheres and does not concern itself, even if the rest of science does, with solely the scientific and biological. Perhaps that is why it continues to procure the title of an 'art' as well as a science. Yet it has to maintain a sense of what it stands for; even if assisted suicide may become acceptable to society, does this mean that doctors should do it?

Thus whereas Popper may have been wrong by strongly being opposed to what he called 'historicism', that is, the notion that historical instances made us into what we are today (one cannot argue thatthe second world war did not teach us lessons. One can forgive Popper for his ideas as he was an exiled Jew during the war, but he took too much to heart the 'historicist' philosophers such as HegeL who really meant that both good and bad work towards forming humanity, and not that we are not free to choose our paths. He seemed to interpret

18 MacIntyre, A., After Virtue. A study in moral theory. 2"d edition. Duckworth, 1994

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Hegel as too deterministic on humanity and that thus the attempt at the extermination of the Jews was an inevitable process); Kuhn, on the other hand, with his notion of paradigms, puts us in dangerous grounds of having to define our ethos by the socio-psycho-cultural 'paradigm' of the day. This sets us back to having medicine defined by the regimes and thoughts of the day - as indeed was reflected in the Nuremberg trials.

If you have to be within a tradition to understand it and formulate your ethos with the changing times, then perhaps, Popper, with his limitations, gives us a better working formula, for at the end of the day medicine does move forward in research by 'challenges' to current thought and when it comes to moral values and the goals of medicine, as Maclntyre said in his more analytical book Whose Justice, Which morality?79, a tradition is upheld when is withstands the challenges of the times. This is why he upholds Aristotelian and Thomistic morality over the geneologists like Neitchze and Foucault who resent conservatism. Yet with its limits, conservative values have withstood challenges in time and indeed it is because of what was built on conservative values that the so-called post-modernist thought can build its nest. Yet at the same time conservatism has responded to changing times as well. If Christian values have withstood many tests in time, then one cannot blame medicine for upholding those values before it ventures too deep into research such as the New Genetics - for that would be the philosophy of this 'tradition' . To do this properly one has to give due importance to teaching young doctors the philosophy of their practice and tradition, which otherwise would simply be subject to relativist thoughts. One cannot then speak of a unifying tradition any longer.

19 MacIntyre, A., Whose Justice, Which Rationality, Duckworth Press, Oxford and New York, 1994

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