Malayan Law Journal Articles/2008/Volume 6/PATENTS AND 'HUMAN BEINGS': GLOBAL TRENDS AND ETHICAL CONCERNS [2008] 6 MLJ

lxxxiii Malayan Law Journal Articles 2008

PATENTS AND 'HUMAN BEINGS': GLOBAL TRENDS AND ETHICAL CONCERNS

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Professor Dr Ida Madieha bt Abdul Ghani Azmi Private Law Department, International Islamic University Malaysia PART 1: INTRODUCTION As recent advances in life sciences involving human embryonic stem cells and biological materials of human origin challenge many of the basic norms of ethics and morality, not to mention religion, many countries sought to debate the permissibility of such inventions within patents. Many of these countries appointed national ethics committees that debate the issue and weigh all the competing ethical concerns against the patentability of such inventions. Some countries revised their legislative framework to reflect their concerns on the patentability of such inventions. The European Parliament (EPO) has made its stand clear by revising the European Patent Convention (EPC) and inserting Rule 23(d) and (e) into the Convention. Thus, under the revised EPC, certain biological inventions are not patentable particularly those involving human cloning, processes for modifying the germ line genetic identity of human beings and uses of human embryos for industrial or commercial purposes. Whilst, other biological inventions such as human genes, pluri-potent cells taken from foetus and elements isolated from the human body would be patentable. The provision however, does not explicitly refer to human embryonic stem cells. In two recent decisions, Edinburgh and WARF, the EPO refused to grant patents on inventions that involve human embryonic stem cell. These decisions have been heavily criticised by other members of the European Union as there is no common stand on the procurement of stem cells from embryos. Countries like Austria, Germany, Ireland, Luxembourg, Italy and Portugal prohibit the procurement of stem cells from supernumerary embryos. Denmark, Spain, Finland, France, Greece, the Netherlands, and Sweden allow such activities. Even more liberal are countries like UK and Belgium that allow the creation of human embryos for the procurement of hES cells. In Malaysia, there is no explicit exclusion for inventions that involve human biological material under the Patents Act 1983. In the context of patent law, the incorporation of 'public order and morality' in s 31 as a yardstick for the grant of patents, brings into question to what extent such inventions would be acceptable in Malaysia and to what extent s 31 could be invoked to bar such inventions. In the 2006 guidelines by the Ministry of Health, the extraction of stem cells from embryos was not allowed.2 In a later policy guideline on cell transplantation, embryonic stem cell therapy is also not allowed.3 However, research on stem cells is allowed, although not encouraged, if the existing guidelines on ethical standards are followed. Stem cell lines could also be imported. The creation of embryos specifically for research is however prohibited. It is, thus, the objective of this paper to explore the various stands taken by national countries when debating on the boundary of patents in relation to inventions involving 'human beings'. For that purpose this paper would appraise:

(i) (ii)

the various ethical concerns on the patentability of human embryonic stem cells; a discussion on the legislative framework of various countries' on inventions that involve human beings.

Ethical Dilemma: From Lab to Patent Office Stem cells are (1) unspecialised cells (2) that can divide continuously (3) to produce cells like themselves (self renewal), or cells of one or several specific differentiated types.4 Stem cells are of two main specialties; self replicate and immortal. The scientific community has ear-marked stem cells as a revolution to medicine, particularly for incurable degenerative diseases, such as Parkinson's and Alzheimer's. Stem cells can be harvested from a number of sources, namely: (i) (ii) (iii) adult stem cells stem cells of foetal origin stem cells of embryonic origin5

These stem cells serve different purposes and their ability to differentiate differs. The potential applications of stem cells are: basic research into human development and disorders; discovery of novel proteins for tissue regeneration and repair; development of human cell models for drug discovery and toxicology as well as development of tissue for transplantation. Of all the three, the most complex and compelling is stem cells of embryonic origin.6 The main technology of harvesting stem cells from human embryos necessitates the destruction of the human embryos in the first place. It is thus, understandable that the main ethical objection raised against such research is that it cannot be right to destroy human embryos for research purposes.7 As many of the research outputs have been patented or are being filed for patents, this has resulted in ethical debates finding their way into patent law. In terms of numbers, statistics shows that by May 2002, over 2,000 patent applications involving human and animal stem cells had been filed worldwide, one quarter of which relate to embryonic stem cells (ES).8 The types of products and processes claimed in filed patent applications include stem cells, stem cell lines, and differentiated and genetically modified stem cells.9 They also include processes for the creation of embryos by somatic cell nuclear transfer and parthenogenesis; isolating and culturing stem cells; inducing stem cells to differentiate; and genetically modifying stem cells for particular applications.10 It has been raised that the patent office is ill-equipped to deal with ethical issues. Nevertheless, ethical determination is part and parcel of the patent examiner's concerns. This is understandable as decisions made by patent examiners are affected by the values and social interests of the community of which they are a part. Therefore, ethical considerations are implicitly and unavoidably part of the patent granting process. For the sake of simplicity, the ethical debate chronicles around three main issues: (i) The ontological (and in some countries, religious) debate on the moral status of an embryo. Is an embryo a human being? Even if an embryo is not yet a 'human', should it be treated as a person on the basis that it can develop into a 'human' or that it is a potential 'human'? If it is, then logically it is owed full respect and no research which, has the effect of destroying the embryo, is permissible. The practical determination of whether even if research on an embryo is allowed and the products of such research are patentable, what kind of inventions should be accepted? Could there be implications to the granting of patents on high-end technology on health, further advances on science and technology? Should there be limits to patents on embryonic stem cells?

(ii) (iii)

As is clear from the above list, the kind of ethical questions that resulted from the extension of patents to human embryonic stem cells ranges from the most difficult philosophical and religious questions on the ontological status of a human embryo. It also extends to the most pragmatic concerns of the parameters and boundaries of patentability in order to provide a system that would be supportive of further advances of science and technology. Moral Status of the Embryo: Is it or is it not a Human?

The most important ethical question is whether research on human embryo should be allowed or not? Central to this is the issue whether an early embryo should be treated as a person, or at least potentially a person. This determination is important as for those who take the view that the early embryo is a person, then logically it would be against the dignity of the embryo to subject it to research, what more that which involves its destruction. On this the UK Select Committee on Stem Cell Research stressed that respecting the dignity of the embryo would mean that we should not treat it as mere 'means' or 'instruments' especially so with embryo where capacities to act are not only lacking but non- existent. 11 On this the Committee considers two basic arguments that are widely put forward. The first advances the view that since the embryo is alive it has a right to life. The second argument contends that as the early embryo has the potential to become a person; it enjoys the full rights of a human being and should be accorded the respect owed to a human being. On the first argument, the Committee points out that the fact that a cell or piece of human tissue is alive is not itself a reason for according it a full right to life. In this instance, an embryo is no different from a live cell or piece of human tissue. On the second argument, the Committee advances the view that although an embryo has the potential to develop into a human being, it requires many other factors, particularly those provided by the maternal environment in the womb, to enable it to realise its potential. Left in the Petri dish it would not develop further. In adopting this stand, the Committee articulates that it does not mean that a human embryo should be treated like mere research artefacts. There are morally weighty grounds to treat human embryo differently than other research instruments. On this point, the UK Select Committee endorses the earlier stand made by the Nuffield's Council on Bio-ethics on the limited permissibility of embryo research.12 In a 2000 Report, the Nuffield's Council on Bio-ethics views that the 'removal and cultivation of cells from such an embryo does not indicate lack of respect for the embryo. Indeed, such a process could be regarded as being analogous to tissue donation'. The Nuffield's Council further recommended that the purpose of research on embryos, which could be conducted under the Human Fertilisation Act (HFE), be extended further to include research for the purpose of developing tissue therapies from the derived ES cells. The Council points to the need to set out conditions for more effective consent from the donors. Under the HFE, couples 'must be given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps' and they 'must be provided with such relevant information as is proper'. On this note, the UK Select Committee recommended that any consent obtained to the use of foetal material in the establishment of EG cell lines should also cover the use of such cell lines in therapy. After considering all arguments, including those based on theology, the Committee was not persuaded that all research on early human embryos should be totally prohibited. However, the allowance of such research must be subject to strict regulation and monitoring. The Committee further considers that 14 days should remain the limit for research on early embryos as prescribed by the Warnock Committee13 provided that no embryo subjected to research be implanted back in to a woman's womb.14 In the European Union, the European Group of Ethics (the EGE) deliberated on the same issue in 2002.15 In the EGE's opinion, 'the question of the dignity and the moral status of the embryo remain highly controversial in a pluralistic society such as the European Union'.16 The EGE considers whether to forbid patenting of stem cells or stem cell lines. The EGE was of the opinion that taking the option to forbid patenting would be contrary to public interests (and especially patients) as it would lead to major slowing of research. However, in view of the highly controversial nature of stem cell research, it should only be allowed under strict public control by centralised authorities.17 However, in a dissenting opinion by Prof Gunter Virt:
Human embryonic stem cells and also embryonic stem cell lines are excluded from patentability because we cannot get embryonic stem cell lines without destroying an embryo and that means without use of embryos. This is as material contradicts the dignity of an embryo as a human being with the derived right to life. If the condition for patentability is the industrial and commercial purposes is not patentable (Article 6.2.c), then every exception, which cannot exclude industrial and commercial purposes, is against the ethical sense of the directive. Patenting is an incentive. Patentability of human embryonic stem cells and stem cell lines would push research towards embryonic stem cells and thus undermine the priority of research using non embryonic stem cells. Despite the relatively clear regulations in the directive this incentive for research will lead to forms of 'bypasses' which makes it impossible to guarantee an ethically tolerable situation in the field of patentability.

The importance of the dissenting opinion cannot be underestimated as it has been invoked by the European

Technical Board of Appeal as a ground to reject the Edinburgh18 and WARF patents.19 The entity's possession of a full human genome Whilst the philosophical and religious arguments would focuses on the fact that the embryo is the beginning of a human life,20 the scientific community stresses on the fact that the embryo possesses full human genome, thus making it human. The American Association for the Advancement of Science and Institute for Civil Society articulates that the ethical status of human embryonic stem cells hinges on these criteria: (i) (ii) (iii) The entity's possession of a full human genome; Its potential for development into a human being; sentience; and The presence of well developed cognitive abilities such as consciousness, reasoning ability, or the possession of self-concept.21

On the first argument that an embryo should be treated as a person as it is an entity that posses a full human genome, the Association draws the fact that most cells in the human body possess a unique diploid genome. Furthermore, developments in mammalian cloning technology suggest that any human cell (or tissue) may have the potential to become a person. This does not give the stem cell any special status over other human cells. Furthermore, embryonic stem cells are isolated from the total structure of the embryo or blastocyst, and therefore will not develop the trophoblast (the outer layer of cells of the embryo) or other structures needed for continued development. The cells thus, are no longer capable of developing into a human being. Based on scientific facts, the Association advances the view that stem cell research does not offer unique ethical issues.22 Cells taken from human embryo are like any other cells extracted from other parts of a human body. Commodification and non-commercialisation of the human body Related to the human dignity argument is the notion that humans and human bodies should not be the subject of commodification and commercialisation. This notion stems from the premise that human slavery and commercialisation of the human body is morally unacceptable as enshrined in Art 3 of the Charter of Fundamental Rights. On this the EGE was of the opinion that the donation of stem cells of human origin (adult, foetal or embryonic) must not give rise to payment of donors, apart from the justified compensation of constraints. On this same point, the Human Genome Organisation Ethics Committee (HUGO Committee) and the United Nations Educational, Scientific and Cultural Organization23 analyses whether the objectification of human body parts is compatible with respect for human dignity because it reduces human beings to merchandise. The premise of this argument is that granting a patent over genetic material is akin to allowing parts of people to be owned by others, and some have likened it to 'a form of modern slavery'. These arguments have been criticised on the basis that treating parts of humans (such as natural genetic materials) as objects does not necessarily equate with treating whole persons as objects: in other words, commodifying genetic materials does not entail commodifying individuals. The Committee further stressed that patents do not grant physical property rights in or over parts of a person's body, and so do not enable one person to exert control over how another individual uses his or her own body.24 Addressing the same point, the Australian Law Reform Committee (The ALRC Report)25 noted that human embryonic stem cells may raise concerns such as inappropriate commodification of human biological material, and in particular human reproductive material, and may violate fundamental principles against the ownership of human beings. Despite those ethical objections the Committee was of the view that research and the patenting of embryonic stem cells could be done under strict control and regulation. The Committee was of the view that the ethical objections raised against human embryonic stem cell research are similar to those that have been articulated about gene patents. Procurement of excess embryos, the principle of free and informed consent of the donor Another concern that arises from the harvesting of stem cells from human embryos is the fear that this might lead to illicit and unethical ways of procuring human embryos for purposes of research. There is also a risk that

women may be submitted to undue pressure to donate oocytes.26 This concern has been discussed by the ALRC, EGE and The American Association for the Advancement of Science and Institute for Civil Society (the AA). On this point, the AA recommends that: (1) (2) (3) (4) Women should not undergo extra cycles of ovulation and retrieval in order to produce more 'spare' embryos in the hope that some of them might eventually be donated for research. Analogous to the current practice for organ donation, there should be a solid "wall" between personnel working for stem cell purposes Women and men, as individuals or couples, should not be paid to produce embryos, nor should they receive reduced fees for their infertility procedures for doing so; and Consent of both gamete donors should be obtained.

The importance of free and informed consent of the donor should be stressed more in the case of donation of embryos for purposes of research. As stressed in the EGE opinion, this principle is reflected in Article 3 of the Charter of Fundamental Rights and in Recital 26 of the 1998 EU Patent Directive.27 The UK Select Committee Report expresses concern that 'embryos' should not simply be created for the purpose of research. It expresses the common concern that the source of embryonic stem cells should be coming from excess embryos of IVF treatment.28 In the UK, it is mandated that excess embryos are destroyed. In 1996, over 3000 such frozen embryos were mandatorily discarded. There has been estimate that the number of embryos that are untransferable or abandoned ranges up to 100,000. These excess embryos instead of being discarded would be a rich source of stem cell research. One finds that this is one area in which the UK authorities have reversed their policy so as to allow even the creation of embryos for research. Discovery v Inventions: The Patent Bar The expansion of patents to processes and products involving human embryonic stem cells also implicates the traditional patent boundary between discovery and inventions. Would cells derived from a human embryo be treated as products of nature and hence unpatentable? On this, the EGE opines that only stem cell lines which have been modified by invitro treatments or genetically modified so that they have acquired characteristics for specific industrial application, fulfil the legal requirements for patentability.29 Isolated stem cells which have not been modified do not, as product, fulfil the legal requirements, especially with regards to industrial applications, to be seen as patentable. In addition, such isolated cells are so close to the human body, to the foetus or to the embryo that they have been isolated from, that their patenting may be considered as a form of commercialisation of the human body.30 The EGE considers that patenting of inventions allowing the transformation of unmodified stem cells from human embryonic origin into genetically modified stem cell lines or specific differentiated stem cell lines for specific therapeutic or other uses, is ethically acceptable, as long as the inventions fulfil the criteria of patentability, as in respect of the abovementioned ethical principles.31 As to the patentability of processes involving human cells, whatever their source, there is no specific ethical obstacle, in so far as they fulfil the requirements of patentability (novelty, inventive step and industrial application).32 Commercialisation of inventions relating to embryonic stem cells: scope of patents The EGE33 raises concerns that conferring patents on such high-end technology at an early stage, particularly broad patents, might stifle further research and development in this area. To avoid this from happening, the EGE espouses for a broad academic exception in patent law. This means that patents on stem cell lines should not be too broad, and that research exceptions should be generously granted to eliminate any possible adverse effects on further innovation to the benefit of health care. It is also recommended that patents shall only be granted, when the patent claim refers to a specific and an accurately described stem cell line and its industrial application. That involves a consistent relationship between a patent claim and the description of the invention.34 Reflecting the same concerns, the ALRC raises the following issues: (i) (ii) the promotion of innovation, in particular in view of the grants of broad patents, the commercial and economic aspects of patenting and the practice of licensing stem cell

(iii) (iv) (v)

patents35 resource use and knowledge sharing; benefit sharing and research outcomes; and equitable access to healthcare. 36

The monopolistic nature of patents raises concerns to the academics, in the science and medical community. Professors Michael Heller and Rebecca Eisenberg suggested that the grant of numerous patents for bio-medical inventions has produced a 'tragedy of the anti-commons'--the under-use of a scarce resource where multiple owners exclude others and no one has an effective privilege to use the resource.37 In the context of gene patents, this occurs when multiple blocking patents are granted over pre-market or 'upstream' research products, particularly isolated genetic materials.38 The cost and inconvenience of obtaining multiple licences to use these upstream products in marketable or 'downstream' research may stifle research and innovation.39 On this, the Nuffield Council on Bio-ethics has earlier cautioned of the evils of conferring broad patents on stem cells in 2000.40 The Council recommended that the granting of over-generous patents with broad claims in this important field should be discouraged. The Healthcare sector that is equally impacted with overly broad patents established a committee to study the impact of IPRs and Genetics.41 The Committee opines that the race to patent genes and gene fragments, including stem cells, may lead to the increase of cost, patients being deprived of access to new techniques and drugs; that researchers and carers will not share information; that research will become too complicated to enter upon (perhaps because of the so called 'anti-commons effect' of there being too many right holders); and equally that there could be premature commercialisation in the race to get ahead. A concern also shared by Glen Mc Gee in his study on embryonic stem cell patents.42 One particular example is the WARF patent. The WARF patent makes extraordinarily broad claims as to many aspects of hES cells as they are discovered in their embryonic environment. In particular, in its claim # 9, the inventor claims to be the inventor not only of the stem cells themselves, but the resulting cell lines, in essence a claim to whatever use is made of those cells in virtue of his claim to the derivation of the cells in the first place!43 According to Mc Gee, there should be a differentiation between the composition of matter (the cells themselves) and the information to be gleaned from the composition of matter, potentially preventing labs with interest in stem cell research from engaging in even basic work on hES cells without first paying a license.44 LEGISLATIVE FRAMEWORK ON THE PATENTABILITY (OR NOT) OF INVENTIONS INVOLVING 'HUMAN BEINGS'. Some national and regional patent law has specified what form of human biological inventions is patentable and what is not in their patent law. Typical of such provision is an explicit exclusion on human cloning, human body or a natural substance isolated from a human body such as genes, etc. Below are some of the examples of such provisions (not comprehensive). This article would start with Australia, United States, Canada and UK patent frameworks first before venturing into the European Patent Conventions and the European Patent Directive. The reason for this is that in lieu of the divergent approaches in the European member countries, the two regional instruments require deeper elaboration. Australia Section 18(2) of the Patents Act excludes 'human beings and the biological processes for their generation'. The Act does not define 'human beings' or 'biological processes for their generation', which leads to differing contentions on this as is illustrated in two cases; Fertilitescentrum AB and Luminis Pty Ltd45 and Woo Suk Hwang.46 In Fertilitescentrum AB and Luminis Pty Ltd,47 the Deputy Commissioner of Patents had to determine whether a patent application for a method of growing pre-blastocyst human embryos' would offend s 18(2). The main claim of the patent application; ie Claim 10 reads:
A method of growing preblastocyst human embryos, the method including the step of incubating the embryos invitro in a culture medium containing an effective amount of human GM-CSF to increase the chance of implantation of the embryos, the amount of the GM-CSF being sufficient to increase the proportion of blastocysts formed from the preblastocyst embryos when compared to embryos incubated in a medium lacking GM-CSF.

The core determination was what constitutes a human being? At what point in the reproductive process does a human being come into existence? On this point, it was noted that there is no legislative or agreed societal definition of what constitutes a human being. The Deputy Commissioner of Patents adopted the approach that the generation of a human being (as distinct from a human life form) occurs over a substantial period of time. In his view, there is little doubt that a human life is created at fertilisation. He considered it to have at least SOME of the characteristics that go to make up a human being -- such that it properly falls within the ambit of the term 'human being'. He adds further that human life is still being generated up to at least the sixteenth week. He noted further that some legislation made a distinction between abortions and still-birth, which occurs at the twentieth week. This suggests that by this stage of its development there is both a legislative and societal recognition that the foetus has significant aspects of being a human being, sufficient to require 'proper' disposal rather than as hospital waste. Another important point is that the full status of human being is not acquired until birth. Therefore to him, the correct interpretation of s 18(2) is ascertained by recognising a human being in the process of generation from the time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity) up until the time of birth. Thus, the prohibition of 'human beings' in his view relates to the prohibition of patenting of any entity that might reasonably claim the status of a human being. Clearly a person that has been born is covered by this exclusion. But to that extent there is a process of generation of a human being that lasts from fertilisation to birth, the Deputy Commissioner of Patents was of the view that a fertilised ovum and all its subsequent manifestations are covered by this exclusion. The prohibition of 'biological processes' (for the generation of human beings) clearly covers all biological processes applied from fertilisation to birth -- so long as the process is indeed one that directly relates to the generation of the human being. He also considered the exclusion of biological processes to include the processes of generating the entity that can first claim the status of a human being. For example, processes for fertilising an ovum; processes for cloning at the 4 cell stage by division; processed for cloning by replacing nuclear DNA. The Deputy Commissioner of Patent therefore concludes that Claims 10 to 23 are directed to a method of growing pre-blastocyst human embryos. It is a method applied to a human embryo. The method has clear advantages in better stimulating the natural environment, and reducing apoptosis of cells in the blastocyct, resulting in greater success in implantation, and babies of greater body mass and having fewer complications compared to IVF babies born without the benefit of the method -- all of which demonstrates that the process is one that directly relates to the generation of a human being. The process is a biological process -- it is a process involving the presence of a chemical such that the invitro environment better stimulates the natural fallopian tube environment. He is therefore satisfied that these claims fall within the ambit of 'biological processes' for the generation of human beings as proscribed by s 18(2). Clearly, the Deputy Commissioner's view that a fertilised ovum is already a human life does not accord well with all the discourse in relation to the status of an early embryo especially in relation to embryo research and stem cells. On the same token, the Deputy Commissioner had also equated the artificial means of fertilisation as equivalent to biological processes to the generation of the human being. In Woo Suk Hwang,48 the Deputy Commissioner of Patents had to determine an application for patents on a method for producing chimeric embryos by employing inter-species nuclear transplantation techniques. Specifically, the application claimed a method of producing a hybrid embryo using inter-species nuclear transplantation techniques. The embryo is created by transferring the nucleus of a human cell into a bovine ovum and thereby activating the ovum. The decision was that the claimed invention was contrary to s 18(2), it being for a method of generating a human being. The fact that the ovum was artificially activated, and the mitochondrial DNA of the ovum was bovine, did not remove the method from the ambit of s 18(2). In this case, there are two distinguishing factors. Firstly, there is no step of fertilisation per se. Secondly; the embryo is a hybrid involving both human and bovine DNA. Could this invention still be treated as human beings and the biological processes for their production? Could a chimera still be considered a human being? On this, the Deputy Commissioner noted that:

In natural reproductive processes, the activation of an ovum arises as a direct result of the fertilisation process. However, it is clear that fertilisation by a sperm is not the only way in which an ovum can be activated. In his view, an ovum that has been artificially activated is in principle no different to an ovum that has been fertilised by natural means (noting of course that the DNA content of the ovum will be different). Accordingly the fact that the claimed method uses post-activation of the ovum does not remove the process from the ambit of s 18(2) of the Patents Act 1990 by reason of it being a method for the generation of a human being.

Further, it was noted that the embryo produced by the claimed process has both human and bovine DNA present. It is clear that the nuclear DNA is intended to be entirely human DNA. The mitochondrial DNA, which essentially is relevant to the energy use of the cell, is entirely bovine. The primary characteristics of mammals are governed by the nuclear DNA of the cells. In his view, the presence of the bovine mitochondrial DNA does not take away the essentially human characteristic of the embryo that is determined by the nuclear DNA. That is, the embryo that is produced by this method -- while being hybrid -- is properly described as human. It has also been raised that the invention is contrary to the Prohibition of Human Cloning Act 200249 which disallows the creation of a hybrid embryo. The definition of a hybrid embryo in the Act typically covers chimera as claimed by the patent application.50 The Deputy Commissioner is thus of the view that the invention is contrary to law and should be refused. The importance of Woo Suk Hwang is that it raises the issue as to what constitutes a human being and when would a chimera cease to be a 'human being'. These are difficult issues that requires deeper analysis not only from a scientific point of view but also from the points of view of ontology and religion as well. However, one point of distinction between both Woo Suk Hwang and Fertilitescentrum AB and Luminis Pty Ltd is that both inventions target the creation of human embryos which have the potential to develop into a full human being; whilst the harvesting of embryonic stem cells does not. Section 18(2) deals explicitly with the human body. The position of stem cells is however silent. This leads to the ALRC further debating whether there should be special provisions dealing with embryonic stems cells.51 The Committee, however, does not recommend for revision of the Act and preferred the usage of terms that are technologically neutral. The Committee, however, recommended the Patent Office to come up with clear examination guidelines setting out the types of inventions involving stem cell technologies that it regards as patentable and the extent to which any of such inventions are not patentable. In answering the call, the Australian Patent Office issued a Manual of Practice and Procedure (the Manual). The Manual indicates that, while the precise scope of the provision is unclear, certain inventions are 'clearly encompassed' by the exception, including: (i) (ii) (iii) human beings, foetuses, embryos or fertilised ovum, methods of invitro fertilisation or cloning methods that generate human beings; and processes -- beginning with fertilisation and ending with birth-that are wholly biological and result in a human being.52

On that basis, the Australian IP Office made clear that human genes, tissues and cell lines are clearly acceptable based on the premise that they are not regarded as human beings. Clearly, the difficult question of what constitutes a human being and when a human life would form remain unanswered. United States The prevailing US practice seems to be that purified and isolated stem cell lines were patentable subject matter under 35 USC S 101.53 In 2004, in an attempt to codify the Patent Office's (USPTO) position on stem cells, the Congress passed a bill known as the Weldon Amendment which prevents the USPTO from issuing patents on a 'human organism'. It was made clear that the provision would also ban patents directed to genetically engineered human embryos, foetuses and human beings but would not affect patents on genes, cells, tissue and other biological products. Many quarters welcome the Weldon Amendment, which to them appears to be in line with the Thirteenth

Amendment to the US Constitution, which, prohibits any party from possessing property rights in a human being.54 In practice, there have been several patents on human stem cells that have been granted in the US.55 Besides the WARF patent, at least 2 patents have also been granted to the National Jewish Center for Immunology and Respiratory Medicine; US Patent Nos 5,874,301 and 5,914,268. The '301 patent claims':
A pluripotent cell population wherein said cell population is transformed with a HOX11 gene, [an immortalizing gene], and wherein said cell population differentiates into cellular lineages including primitive erythroid cells and definitive erythroid cells.

Currently, there is no federal law that prohibits the use of embryos in stem cell research. However, there are federal policies and legislations that limit funding of such research. Canada In Canada, the Canadian Bio-technology Advisory Committee (CBAC)56 recommended that 'human bodies at all stages of development' should not be patentable. CBAC explains that this recommendation only applies to entire human bodies such as zygotes to an adult body but does not include nucleotide sequences, gametes, stem and other cells, or organs that remain patentable. It was the recommendation of the committee that such provisions should be narrowly construed and was not intended to prevent patent claims being granted with respect to stem cell lines, (adult) cell lines or DNA sequences. The plural term 'bodies' indicate that only the entire human body was encompassed by the exclusion and not its parts. It was the view of the Committee that human beings are a metaphysical concept and not a biological one. To them, stem cells are not human cells as 'these are removed from a multi-cellular precursor of the human body (except for the zygote) and thus do not comprise a human body at any stage of development.57 The UK Patent Office As for the UK Patent Office,58 a distinction is drawn between human totipotent cells and human embryonic pluripotent cells.59 Human totipotent cells have the potential to develop into an entire human body. Thus, they are not patentable as the human body at the various stages of their formation and development; they are excluded from patentability by para 3(a) of Schedule A2 to the Patents Act 1977. Human embryonic pluripotent cells, on the other hand, arise from further division of totipotent cells and do not have the potential to develop into an entire human body. The UK Patent Office noted the enormous potential of stem cell research, including embryonic stem cell research, to deliver new treatments for a wide range of serious diseases. This indicates that on balance the commercial exploitation of inventions concerning human embryonic pluripotent stem cells would not be contrary to public policy or morality in the United Kingdom. Thus, the Patent Office is ready to grant patents for inventions involving such cells provided they satisfy the normal requirements for patentability. Whilst the stem cells themselves may be patentable, the processes for obtaining stem cells from human embryos are not. Paragraph 3(d) of Schedule A2 to the Patents Act 1977 clearly stipulates that uses of human embryos for industrial or commercial purposes are not patentable inventions. On this basis, the Patent Office will not grant patents for processes of obtaining stem cells from human embryos. The UK's more relax attitude towards stem cells is reflective of the prevailing view that research on human embryos was morally permissible beginning from the Warnock Report and the Human Fertilisation and Embryology Act 1990.60 The main thrust of the Act is to regulate research on embryos. The allowance of the research is based on three central principles: (i) (ii) (iii) That the HFEA should licence such work only if it is necessary; That if the HFEA is satisfied that such research is necessary (because it cannot be done in any other way), then a licence should be granted only if the particular activity is judged to be necessary or desirable in relation to one of the proportionality and good purpose; and That in no circumstances, should research on embryos run beyond 14 days or the appearance of the primitive streak.

In the 1990 legislation, five purposes are listed as approved. These are: (a) (b) (c) (d) (e) promoting advances in the treatment of infertility increasing knowledge about the causes of congenital disease, increasing knowledge about the causes of miscarriages developing more effective techniques for contraception Developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation.

There was no explicit reference to stem cell research in the 1990 legislation. For that reason, the Human Fertilisation and Embryology (Research Purposes) Regulations 2001 added three new purposes: (a)increasing knowledge about the development of embryos (b)increasing knowledge about serious diseases, or (c)Enabling any such knowledge about to be applied in developing treatments for serious diseases. With the new Regulations, the HFEA (the Human Fertilisation and Embryology Authority (HFEA) allows the licensing of derivation of stem cells from embryos that are: (i) (ii) (iii) surplus to IVF requirements; created by IVF specifically for research purposes; and created by therapeutic cloning.

One relevant point to note that reproductive cloning was not allowed under the Human Reproductive Cloning Act 2001 which provides for up to 10 years' imprisonment and an unlimited fine on conviction. As most embryonic stem cell research would fall under either one of the three new purposes, such research was clearly allowed in the UK. As one commentator put it, the UK position is described as the 'proportional position' that affords the embryo a proportional moral status, which is neither an absolutist statement of intrinsic value nor a wholly perspective open utility.61 In furtherance to that the UK government set up a Stem Cell Bank62 and a Code of Conduct that governs it. According to the Code, since embryonic stem cell tissues may be obtained following the termination of a human life their use is indeed a matter of moral concern. It contains a policy that: 'adult or foetal somatic stem cell lines created at the Stem Cell Bank may only be used for research leading to the development of therapies, or for clinical trials of human therapies, or for basic research which underpins these aims.' It is no wonder that as of June 2006, the UK patent office has issued at least fourteen patents that are directed to or at least make explicit reference to hESC.63 The UK's approach is not entirely criticism free. One criticism of the codes of practice is as to their framing of ethical issues largely in terms of donation, consent and embryo status. The European Directive for the Legal Protection of Bio-technological Inventions The European Directive for the Legal Protection of Bio-technological Inventions (the European Directive) was officially adopted by the Council of the European Union and the European Parliament on July 6, 1998.64 The two main provisions under the Directive are Article 5 and 6, which bears substantial similarity to Rule 23(d) and (e) of the European Patent Convention.65 Article 5 reads:
(1) (2) (3) The human body, at the various stages of its formation and development, and the simple discovery of one its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application.

Article 6 reads: 1. 2. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to public order or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: (a) Processes for cloning human beings; (b) Processes for modifying the germ line identity of human beings; (c) Uses of human embryos for industrial or commercial purposes; (d) Processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

The Patenting of Human Body and Human Body Parts One opinion is that the underlying rationale for the exclusion provision in Article 6 as stated by the European Commission and the European Court of Justice has to be either for the (i) the respect of human dignity and (ii) to guard against the instrumentalisation of the human body. Some others have attributed the directive to be pushed primarily due to economic grounds.66 Thus, under the directive, there is an explicit exclusion for the patenting of human bodies or a natural element isolated from the human body. What amounts to parts of a human body? According to a document dated 16 December 1992, this means parts of the body that are within the body and that a human cell line used in the development of medicines can be patented.67 The Commission further stressed that this refers to parts of the human body as found inside the body. This distinction is important as patents have been granted in respect of human lymphoblastoid cell lines, human hepatocyte culture processes and methods for producing human antibody. In a common position adopted by the Council in 1991, it was further clarified that the position of human genes would be no different than human cells.68 The position raises some doubt, however, with regard to the patentability of human stem cells, of embryonic or foetal origin. In 1995, the Council stressed on the need for technical processes and proceeds on the grounds that an element of the human body that had not been obtained with the aid of a technological process, but simply detached, removed or collected, may not be regarded as a patentable invention.69 Thus a limb, or organ, or a bodily fluid (eg sperm, blood, tears or sweat) cannot be patentable. The memorandum thus suggests that the decisive element to turn material from the human body from a non patentable issue (discovery) into patentable subject matter (invention) is (1) the technical process, the human intervention and (2) the way in which the biological material provides a technical solution for a technical problem. Would stem cells harvested from a human body be considered as part of a human body? In view of all the discussion that takes place from the EU documental history, Van Overwalle, was of the view that human stem cells as they appear in their natural environment would not be considered patentable, whereas human stem cells which have been isolated, identified and reproduced outside the human body would not be excluded from patentability.70 The touchstone to decide whether or not elements of human origin are patentable or not, whether they are to be considered as discoveries or not, lies in the technical intervention -- the isolation, purification or reproduction of the element --techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing by itself.71 Again there is no explicit exclusion for embryonic stem cells but that does not stop many from interpreting the exclusion for the 'uses of human embryos for industrial or commercial purposes' or to include the procurement

of stem cells that require the destruction of embryos. Processes For Modifying Human Germline Genetic Identity This is equally excluded under the directive. According to Recital 40, there is a consensus within the Community that intervention in the human germ line and the cloning of human beings offends against 'ordre public' and morality and it is therefore important to exclude unequivocally processes for modifying the germ line genetic identity of human beings and processes for cloning human beings from patentability. It is commonly understood that the exclusion does not extend to somatic cell gene therapy. This is further clarified in 1994 to exclude only those which are contrary to the dignity of man. If the modification is for the purpose of correcting certain genetic deficiencies, such a process would be compatible to human dignity. Uses of Human Embryos Would the exclusion cover only spare embryos? Does it cover the use of created 'research' embryos? To this Recital 42 states that the exclusion of human embryos for industrial or commercial purposes in any case does not affect 'inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it'. Processes to Produce Chimeras (Processes to Produce) Totipotent Human or Animal Cells (Recital 38) Van Overwalle was of the view that the exclusion seems to be limited to processes to produce chimeras from totipotent human or animal cells and not to processes to produce chimeras from pluripotent (eg embryonic) human or animal stem cells. All in all, there could be three potential objections to an application to patent human embryonic stem cells; either it could implicate the patenting of a human body; or represent the use of a human embryo for industrial or commercial purposes; or the general prohibition of patenting of inventions deemed to be offensive to 'ordre public' or morality. These uncertainties were further clarified by a resolution passed by the European Parliament in 2005. European Parliament Resolution on Patents for Bio-Technological Inventions (26 October 2005, Wednesday) As the 98/44 Directive is silent on stem cells, a further resolution was entered in late 2005. This is as a response to a patent granted on 2 February 2005 (EP 1257 168) that includes a selection of human germ cells and of the germ cells themselves, and the grant of an European Patents, EP 1121015, that covers frozen human embryos. The European patent Office accepted the opposition to patent EP 695351 (the Edinburgh patent) and made it clear that patents on human embryonic stem cells cannot be granted. It was also made clear in the Directive that human DNA can only be patented in connection with a function. The European Parliament noted in particular that the creation of embryonic stem cells requires the destruction of the embryos. It was thus the opinion of the Parliament that the patenting of technologies where human embryos are destroyed or used for commercial or industrial purposes is excluded under the directive. It was further clarified that Article 6 of the directive excludes the cloning of human beings and the Council made it clear in its explanatory statements to Parliament that this ban on patenting does not cover only reproductive cloning and that the term 'human being' in this regard includes the embryonic phase. The Resolution dampens many hopes for a softer approach towards stem cells within the European Union. This is further excerbated with the restrictive decision given by the European Patent Office Opposition Division Opinion in the Edinburgh and the Examining Division's Opinion in the Wisconsin Alumni Research Foundation. The following discussion centers on both decisions. The Edinburgh Patent This relates to patent number 695 351 entitled 'Isolation, selection and propagation of animal transgenic stem

cells'. The patent was granted to the Edinburgh University on 8 December 1999. Claim 48: a method of preparing a transgenic animal, said animal comprising a selectable marker capable of differential expression in (a) desired stem cells and (b) cells other than desired stem cells, the method comprising: providing a blastocycst; providing animal cells according to any of claim 37-38, introducing the animal cells into the blastocysts, transferring the blastocyst to a recipient and allowing an embryo to develop to a chimaeric animal to enable germline transmission of the selectable marker. As the claim relates to animal cells, this would include human grants.72 Realising the controversial nature of the grant, the EPO call for opposition and a request to correct the decision to grant was filed by the University of Edinburgh. The correction related to the insertion of 'non human' before animal in claims 47 and 48. At the opposition division, one major concern raised is that the methodology claimed and disclosed in the contested patent could be employed for the purpose of human cloning. The Opposition Division clarified that. Cloning is a process of asexual reproduction of an organism that creates multiple genetically identical copies (a clone) of the original. This is achieved experimentally by nuclear transfer from a somatic cell into an enucleated oocyte. However, the patent in suit neither describes nor comprises nuclear transfer. Furthermore, embryonic stem cells cannot develop into an organism on their own.73 They can only contribute to and form parts of a developing organism upon integration into a host blastocyst. The resulting animal is genetically different from both the blastocyst and the embryonic stem cell donor. Therefore, it becomes apparent that the methodology described in the contested patent is not cloning. Thus, the contested patent, being absolutely distinct (both in strategy and utility) from cloning, does not offend against Rule 23(d) of the EPC. The main concern with the Edinburgh patent it that it includes a technique for the genetic modification of the germline of human embryos and of the embryos themselves, a patent on isolation, selection and propogation of animal and transgenic stem cells, which could be used for the cloning of human beings. As is mentioned earlier, the European Parliament soon after passed a resolution to condemn the grant of the patent.74 Another point of attack is that although the claim covers cells from all animal species, including mammals, such as humans, the experimental examples in the specification of the patent in suit only relate to mouse embryonic stem (ES) cell lines. The Opposition Division (OD) thus raised serious doubts that the results obtained for mouse ES cells as exemplified in the contested patent can be extrapolated across species, ie to human cell lines. In interpreting Rule 23d(c) of the EPC, the crucial question was whether the legislator when introducing the Rule into the EPC in September 1999 had intended to ban from patenting human embryos as such or human embryos together with the cells. The OD took note of Recital 16 that states 'patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person; whereas it is important to assert the principle that the human body, at any stage in its formation or development, including germ cells, cannot be patented'. The OD concluded that only a broad interpretation of Rule 23d(c) could have been intended. Naturally, this encompasses not only the industrial or commercial use of human embryos but also the human ES cells retrieved therefrom by destruction of human embryos.75 Wisconsin Alumni Research Foundation76 In this case, the Examining Division of the European Patent Office refused the patent application No 96903521.1 pursuant to Article 97(1) of the EPC. The applicant appealed to the Technical Board of Appeal that further allowed the referral of the 4 questions of law to the Enlarged Board of Appeal. Claim 1 of the application reads: 1. A cell culture comprising primate embryonic stem cells which (i) are capable of proliferation invitro culture for over one year, (ii) maintain a karyotype in which all chromosomes normally characteristic of the primate species are present and are not noticeably altered through culture for over one year, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are prevented from differentiating when cultured on fibroblast feeded layer".

The case is now before the Enlarged Board of Appeal for the determination of four questions of law:

(1) (2)

(3) (4)

Does Rule 23d(c) of the EPC apply to an application filed before the entry into force of the rule? If the answer to question 1 is yes, does Rule 23d(c) of the EPC forbid the patenting of claims directed to products (here: human embryonic stem cell cultures) which -- as described in the application -- at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryos from which the said products are derived, if the said method is not part of the claims? If the answer to question 1 or 2 is no, does Article 53(a) of the EPC forbid patenting such claims? in the context of questions 2 and 3, is it of relevance that after the filing date the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos (here: eg derivation from available human embryonic cell lines)?

The Examining Division refused the application as it uses human embryos as starting material for the generation of a product of industrial application. It is therefore irrelevant that the claimed subject matter related to cell cultures and not to a method of production of the said cultures. It was the opinion of the Examining Division that the exception to the exclusion to from patentability with regard to the use of human embryos derivable from Recital 42 of the Directive 98/44/EC (document D5) did not apply to the present case because the generated cell cultures did not serve any therapeutic or diagnostic purpose useful to the embryo that gave rise to the said cultures, even if the availability of the said cell culture would potentially benefit the development of substances for treating conditions relating to human infertility. The main question involved a question of construction of a provision of the laws, namely whether Rule 23d(c) of the EPC should be construed narrowly (thereby excluding from patentability only applications whose claims were directed to the use of human embryos) or broadly (thereby extending the exclusion to products whose isolation necessitated the direct and unavoidable use of human embryos). The applicant raised the issue that there was no consensus amongst the contracting states as to the ethical acceptability of suing human embryonic stem cells. The deployment of human embryonic stem cells from supernumerary embryos was permitted in several EPC states and there was an ongoing debate as to the ethics of using human embryonic stem cells, it being clear that moral attitudes were changing as was eg shown by the fact that in November 2003 the European Parliament voted to permit public funding for human embryonic stem cell research. The applicants further argued that inventions relating to human embryonic stem cells were clearly not of the type that was so abhorrent that the grant of patent rights would be inconceivable. The applicant maintains that the claims in the application make no reference to any method of isolating stem cells from primate embryos. On the contrary, the claimed subject matter is expressly limited to the cell cultures and methods of maintaining them in the undifferentiated state and obtaining differentiated cells from them. The purpose and effect of r 23d is to exclude from patentability the specific activities and products listed in sub-paras (a) - (d). whether or not a patent application contravenes r 23d is to be judged solely by reference to the matter for which protection is sought ie as set out in the claims. The patent applicant argues that a broad construction could not distinguish between existing lines of hES cells and hES cells obtained by other means. In practice, hES cells now can be obtained readily without handling or disposition of an embryo. The patent applicant, thus, argued that the proper construction should be a narrow one such that it excludes only patent applications whose claimed subject matter comprises the use of human embryos.77 It would appear that the decision of the Enlarged Board of Appeal would be decided sometime at the end of this year. Considering how political and divisive embryonic stem cell patents have been in Europe, it remains to be seen how the Enlarged Board of Appeal would decide on the issue. The Regulation of Research on Embryo: The Moral Arbiter It has often been asserted that the patent system is an ineffective mechanism for dealing with ethical issues.78 Moreover, patents are normally applied at the stage of the commercialisation of the embryonic stem cells. It does not influence any decision making at the level of R & D. Nevertheless, it should be pointed out that availability of patents is crucial for continued sustenance of R & D, particularly so in the bio-tech industry where the

cost of R & D is prohibitive. Thus, should the ethical filter be applied only at the R & D level without a second tier determination at the patent level? Adopting such mechanisms would make it easier for the Patent Office to move.79 On this Graeme Laurie proposes three alternatives: (i) (ii) (iii) If we accept the permissibility of embryo research, are there any objections of a different order about granting patents over derived products or related processes? If we do not accept the permissibility of embryo research then, a fortiori, patenting is also unacceptable. But what if the law is silent on embryo research? In such a case we might once again hear the call that the prospect of patenting leads to offensive practices, in that it might encourage research which is offensive per se.

To him the exclusion of early stage interventions seems to make more moral sense because the closer we are to treating a naturally occurring human organism as a commodity the more offensive it becomes. Laurie distinguished two broad types of moral concerns; one that targets embryo research and the latter relates to the prospect of patenting the outcomes of stem cell research such as the problem of granting overly broad patents. This stems from the concern that the reward of the patent is not deserved. The Edinburgh patent reveals a more general underlying unease about stem cell technology; but it is not for patent law to address that concern if the objection is to science rather than to the grant of a monopoly right. Laurie's observation echoes the opinion expressed in the report commissioned by the UK Department of Health. The Committee therein requested for the disentanglement of the objections against research on embryo, which should be the ambit of the Human Fertilisation and Embryology Authority, than that concerns the scope of patents.80 Could it be that despite assertions by many quarters backed by scientific theories that human embryos could not be properly treated as human beings, there grew a lot of unease and uncertainty as to the commercialisation of any inventions derived therefrom? It is for this reason that the European countries have divergent views and laws on both research on embryo and patents. The European Convention on Human Rights and Bio-medicine81 leaves each country free to decide how to regulate embryo research. Countries are however, obliged to respect two conditions: the prohibition on producing human embryos for research purposes, and the adoption of rules designed to assure adequate protection for the embryo.82 Research on Human Embryo and Stem Cell Research in Malaysia In Malaysia, there is no explicit exclusion for inventions that involve human biological material under the Patents Act 1983. The recent incorporation of 'order public and morality' in s 31 as a yardstick for the grant of patents, brings into question the extent to which such inventions are acceptable in Malaysia and the extent to which s 31 could be invoked to bar such inventions. It is not quite sure what is the stand of the Malaysian Patent Office with regards to such inventions. However, it could be possible that the developments in the UK and the EPO would catch on in Malaysia, considering the long relationship and continuous technical transfer assistance we have with these countries. The position is not entirely dormant with the health authorities. Concerned with the wide practices and abuses of stem cell collection and therapy, especially involving haemotopoietic stem cells, the Health Ministry came up with guidelines on Therapeutic Human Cloning and Stem Research in 2007.83 Among the policies that the Ministry of Health undertook to encourage and promote are stem cell research in Malaysia. Second, all stem cell research must pass through an institutional review board and an institutional ethics committee to prevent unethical research and unethical use of stem cells. Third, research on stem cells derived from adult stem cells is allowed in accordance with existing guidelines. Fourth, the use of foetal tissues from legally performed termination of pregnancies is also allowed in accordance with existing guidelines. Fifth, the use of non-human stem cell lines is also allowed (mice and primates). Sixth, the use of embryonic stem cell lines (from 64 cell lines) for therapeutic purposes should be allowed. Seventh, the creation of embryos either from ART or SCNT specifically for the purpose of scientific research is presently prohibited.

These guidelines were based in an earlier fatwa from the Majlis Fatwa Kebangsaan in 2005 that declares the following: (i) (ii) That therapeutic human cloning is permitted (diharuskan) if for - medical treatment - through the creation of certain cells or replacing damaged organs 'taking into account the limits permitted by the Shariah; The use of embryos left-over from IVF for research purposes is permitted (harus) on two conditions: (a) the couples had consented; (b) before the embryo reaches the stage of 'alaqah. Research on pre-embryos for purposes other than for therapeutic purposes is also permitted provided that -(a) the couples consented; (b) the embryo is not implanted into any womb. Research on pre-embryos to detect any pre-disposition to any genetic diseases for high risk couples is allowed and only embryos that were determined to be clear from any such diseases could be implanted in the womb of the mother during the marital term. Any genetic treatment on pre-embryo to change the natural characteristics of the pre-embryo such as hair, hair colour, intelligence, height including sex determination is not allowed. However, sex determination is allowed if is linked to predisposition to fatal genetic diseases. Any type of research for commercial gain or that which has no relation to the health of the mother or the foetus is not permitted. Research done must be -(a) legal with a clear research proposal (b) for scientific purposes (c) Carried out by qualified research personnel who are trustworthy and responsible. Sources of stem cells permitted -(a) (b) ess embryos (consent obtained from parents) aborted foetus as a result of natural abortion or from medical treatment that is allowed under the Shariah and is carried out with the consent of the family members; not from aborted fetus that is carried out deliberately without any causes accepted by the medical fraternity and Shariah.

(iii)

(iv) (v (vi) (vii)

(vi)

(vii)

stem cells created from SCNT are not permitted based on sadd al-zara'i (blocking the means of evil) 84

Pursuant to the 2007 Guidelines on Stem Cells, it was further declared in the National Organ, Tissue and Cell Transplantation Policy, Ministry of Health Malaysia, June 2007 that no embryonic stem cell therapy shall be permitted.85 From both guidelines, the position in Malaysia is that: (i) (ii) (iii) extraction of human embryonic stem cells is not allowed. use of embryonic stem cell lines (from 64 cell lines) for therapeutic purposes should be allowed. creation of embryos either from ART or SCNT specifically for the purpose of scientific research is presently prohibited.

As extraction of human embryonic stem cells is not allowed under the guidelines; it would be considered to be contrary to public order. However, as importation of stem cell lines is allowed and research on stem cell is encouraged, one could expect that some of the research output that has reached the Malaysian scientist would eventually reach the patent office.

Following the Ministry of Health guidelines, it would appear that Malaysia has chosen Option 2 from among the 6 policy options as identified by Le Roy Walters:86 Option 1:No human embryo research is permitted, and no explicit permission is given to perform research on existing human embryonic stem cells; Option 2: Research is permitted only on existing human embryonic stem cells lines, not on human embryos; Option 3: Research is permitted only on remaining embryos no longer needed for reproduction; Option 4: Research is permitted both on remaining embryos and on embryos created specifically for research purposes through invitro fertilization (IVF); Option 5: Research is permitted both on remaining embryos and on embryos created specifically for research purposes through somatic cell nuclear transfer into human eggs or zygotes; and Option 6: Research is permitted both on remaining embryos and on embryos created specifically for research purposes through the transfer of human somatic cell nucler into non-human eggs, for example, rabbit eggs. National countries stand on stem cell research could be classified under the six options as followed: (not extensive) Country Option United Kingdom Option 4 and 5 Germany Option 2 (before 1st January 2002) Belgium Option 4 and 5 Austria Option 1 Ireland Option 1 Italy Option 1 Norway Option 1 Poland Option 1 Czech Republic Option 3 Denmark Option 3 Finland Option 3 Greece Option 3 The Netherlands Option 3 Hungary Option 3 Russia Option 3 Spain Option 3 Israel Option 5 China Option 6 Singapore Option 4 and 5 Australia Option 4 and 5 (beginning 12 June 2006) India Option 5 Canada Option 3 The above table illustrates that there is a marked divergence in terms of legislative framework in embryonic stem cells in the world. Countries with the most relaxed policies such as the UK, Israel, Singapore, Korea and Japan, allow a wide variety of embryonic stem cell procedures, including the creation of embryos for research purposes. In Canada, France and Australia, research on spare embryos is allowed but criminally bans all forms of somatic cell nuclear transfer. Australia however further liberalised this position through Prohibition of Human Cloning for reproduction and the regulation of Human Embryo Research (A) Act 2006.87 Germany in contrast through its Stem Cell Act 2000, forbids the generation of hES cells but does not impede the import of hES cells from abroad (derived before 1 January 2002) and their subsequent use for research or any other purposes.88 On the most restrictive stand are countries like Austria and Ireland that ban virtually all forms of research involving human embryos. With regards to patents, there are several options that the Malaysian Patent Office could take: (i) Using patents to research regulations

At the moment, the extraction of stem cells from embryos is not allowed in Malaysia following the 2007 Ministry of Health's guidelines on Therapeutic Human Cloning and Stem Research. However, the importation of stem cells lines into Malaysia for research purposes is allowed. In fact, Malaysian scientists are already working on imported stem cell lines. In such a situation, the Patent Office would have to determine the patentability of the research output of such R & D process. The feeling of the scientific community in Malaysia is that if inventions are developed from imported stem cell lines, such products should be patentable on the basis that the R & D, labour and expertise spent on the project should be remunerated. (ii) Provide a mechanism by which ethically contentious patent applications are to be reviewed by an Ethics Committee that might comprise of scientists and religious scholars representing the diverse religious interests in Malaysia. This could be done during the examination stage. However, the current patent law does not accommodate representations by others or reference being made to others at the examination stage. Another option would be to re-introduce the invalidation proceedings into the patent system. This post registration attack system has been the core avenue for opposition against inventions perceived to be unethically immoral. This would create a healthy, open and transparent system where voices of dissent are heard. Invalidation proceedings could be a powerful tool to check on contentious patent applications that have gone through the system undetected. Amend the law to include explicit exclusion on the patenting of human beings; human cloning, as has been done in other countries is another obvious option. On this, we could emulate the Australian style with its wide prohibition on the patenting of 'human beings' or the Canadian style with its broad prohibition of patenting of human bodies at all its stages of development. Another option it to adopt a two tier prohibition like the European Directive and the European Patent Convention. This essentially involves a broad prohibition against patenting of inventions against 'ordre public' and morality and another prohibition that lists the specific prohibition targeting against either the human body or bodily parts and the commercial use of human embryo. The two tier system could give rise to difficulties in interpretation as to what would fall under the broad prohibition and what would fall under the specific provision.

(iii)

Even if there is such explicit exclusions, problems with interpretation are expected with ever evolving technology. But there would be problem of interpretation of what would amount to a 'human being' etc. (i) there is a need to formulate guidelines on the patenting of cells derived from human beings following the practice in other major Patent Offices. This would provide the assurance to the scientific community that a certain level of certainty exists. To provide more credence, there should be a move to set up a national ethics committee entrusted to study the ethical, legal and social implications of recent advances in life sciences as have been done in other countries. One of the aspects considered by this committee could be the position of the ensuing patents resulting from human stem cell research.89 'ordre public' and morality provisions should be interpreted according to religious convictions and norms of ethics and morality in Malaysia. Considering that Malaysia is a multiracial country, it would be prudent to widen the engagement process to include all representations from religious communities. This is not difficult to perceive as the National Fatwa on stem cells are rather permissive. However the Ministry of Health decided to adopt the most conservative view so as to appease other religious views. regards to the regulatory framework on research on stem cells, a lot needs to be done. At the moment the draft Human Cloning Bill is still waiting to be tabled to Parliament. This Draft Bill, with its absolute prohibition against cloning accords well with the Ministry of Health guidelines that prohibit the creation of embryo through the SCNT process to harvest stem cells. other related issues are the permissibility of research on human embryos. The Human Tissue Act 1974, drafted in the pre-bio-technology era is beyond obsolete as the Act talks of organs and not cells. There is currently no clear law on the usage of human embryos for research. However, research on embryos may fall under the existing guidelines on assisted reproductive technologies. For this purpose, two guidelines would be important; the Ministry of Health Code of Practice and Guidelines for Assisted Reproductive Techniques (ART) Centres 2002 and the Malaysian Medical Council Guidelines on ART 2005. These guidelines do not allow research on embryos except

(ii)

(iii)

(iv)

(v)

by way of licence from the Ministry of Health. However, as these are mere guidelines, the effectiveness of the monitoring mechanism is very much suspect. There is thus a dire need for the creation of an umbrella act on governing the creation and use of embryos. Moreover, the creation of an oversight body to grant licences, monitor and enforce laws would provide the institutional framework for the regulation of research on human embryos in Malaysia. for stem cells research and therapy, the current guidelines drafted by the Ministry of Health the much needed policy direction for the scientific community. However, these are mere guidelines whose implementation, monitoring system and threat of enforcement are very much suspect.

CONCLUSION Moral Dilemma: The critics Ethical dilemma raised by virtue of rapid advances in bio-technological inventions is historically speaking not new. As early as 1998, Jeremy Rifkin, had already warned of the consequences of the bio-tech revolution on human kind. In his words:
The bio-tech revolution will force each of us to put a mirror to our most deeply held values, making us ponder the ultimate question of the purpose and meaning of existence. This may turn out to be its most important contribution. The rest is up to us.90

The decision to open up patents to embryonic stem cells has caused an uproar among the scientific community and patent offices all over the world. It is the view of many that 'human embryos' should not be simply treated as starting materials just like any other 'composition of matter'. What more if the research requires the destruction of human embryos, an act which is described by many as akin to 'abortion'. To that extent, the Patent Office would have to be prudent in examining applications relating to stem cells. It would be useful to delineate this boundary through express provisions in the patent law. However, from the experience of the UK, EU and Australia, whatever phrase or words that one adopts to delineate what is not patentable would be highly contentious; otherwise it runs into the danger of becoming obsolete due to the rapid changes in technology. Ultimately, what is more important would be a policy decision by each country depending on the prevailing social mores, religious sentiments and moral views of the country.

1 This article is based on a research project on Patents, Human Embryonic Stem Cells and Ethics, conducted at the Max Planck Institute in August 2006 and University of Nottingham in November 2006 as part of the Association of Commonwealth Universities (ACU) Joint Research Project. The researcher is grateful to the Max Planck Institute and the ACU for the generous funding given for the completion of this research. Personal thanks to Prof Paul Torremans and Prof Strauss for hosting the researcher during this period. Parts of the research findings have been presented at the Conference on Law and Technology, UKM, 14-15 September 2006; Seminar on Bio-ethics: Meeting the Challenges, organised by the Centre for Civilisational Dialogue, Centre for Research in Bio-technology for Agriculture (CEBAR) & the Faculty of Medicine, University of Malaya, 15-16 March 2007 and Forum on Genetic Testing, Profiling and Therapy, organised by Academy of Sciences, 21 July 2007. 2 Pekeliling Ketua Pengarah Kesihatan Bil 1/2006. 3 National Organ, Tissue and Cell Transplantation Policy, Ministry of Health, June 2007. 4 Cf. Commission of the European Communities, Commission Staff working Paper. Report on Human Embryonic Stem Cell Research, Brussels, 3 April 2003. Available at ec.europa.eu/research/press/2003/pdf/sec2003-441report_en.pdf. 5 European Group on Ethics in Science and New Technologies to the European Commission, 'Ethical Aspects of Patenting Inventions Involving Human Stem Cells', 7 May 2002. Available online at http://europa/eu.int/comm(The EGE Opinion) at p 4. 6 As described in by the Nuffield Council of Bio-ethics, human stem cells can give rise to many different types of cells, such as muscle cells, nerve cells, heart cells, blood cells and others. They raise the possibility, therefore, of major advances in healthcare. For example, stem cells could be used to generate replacement cells and tissues to treat many diseases and conditions, including Parkinson's disease, Alzheimer"s disease, leukaemia, stroke, heart disease, diabetes, multiple sclerosis, rheumatoid arthritis, spinal cord injury and skin conditions, including burns. See, Stem Cell Therapy: the Ethical Issues: A Discussion Paper, April 2000. For an earlier related paper on DNA, see, Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002), Nuffield Coun-

cil on Bioethics, London, see [#8810]www.nuffieldbioethics.org[#8811]. 7 The literature on this is extensive. See Michael Ruse and Christopher A Pynes, The Stem Cell Controversy: Debating the Issues, (2006) Prometheus, New York; Aurora Plomer, The law and Ethics of Medical Research: International Bioethics and Human Rights, (2005) Cavendish Publishing, UK; Oliver Mills, Bio-technological Inventions: Moral Restraints and Patent law, (2005) Ashgate, UK. See also Roger Brownsword, Bio-technology and Rights: Where Are We Coming From and Where Are We Going, in Mathias Klang and Andrew Murray (ed), Human Rights in the Digital Age, Glasshouse press (2005). 8 The Australian Law Reform Commission (2003), Gene Patenting and Human Health, available at http://www.austlii.edu.au. 9 The EGE Opinion, fn 5 above. 10 The EGE Opinion, fn 5 above. 11 See Report of the House of Lords Select Committee on Stem Cell Research, available athttp://www.publications.parliament.uk (Report 13 February 2002.) This Committee was appointed under the chairmanship of the Bishop of Oxford to reconsider and report on the issues connected with human cloning and stem cell research arising from the Human Fertilisation and Embryology (Research Purposes) Regulations 2001. 12 Stem Cell Therapy: The Ethical Issues: A Discussion Paper, April 2000. For an earlier related paper on DNA, see, Nuffield Council on Bioethics, The Ethics of Patenting DNA (2002), Nuffield Council on Bioethics, London, see [#8810]www.nuffieldbioethics.org[#8811], 22-23. 13 There are scientific justifications for the 14 days window period for research on embryos. The 14 day stage immediately precedes the primitive streak stage at which both the development of individual embryos and cell determination for the future foetus are established. The pro-life group criticises the 14 days restriction. According to them, from the rights perspective, the attachment to a 14-day limit has no clear rationale. Even on a precautionary approach, the possibility that the embryo is already an agent does not markedly alter at this stage of what we understand to be its developmental path. 14 Critics also question the UK Select Committee's Report for the lack of respect and understanding of the concept of human dignity. Thus critics argue that any form of commodification of the human body should not be allowed -- whether in the form of commerce in human organs or tissue, prostitution, surrogacy for profit, or patenting of human genes -- is just one of a number of practices that are regularly cited as instances of human dignity being compromised. Typically, human dignity as constraint also condemns sex selection and positive eugenic, gene selection, germ line gene therapy, embryo research and abortion, euthanasia and assisted suicide, genetic discrimination, and perhaps (top of the current list) human reproductive cloning. 15 The EGE Opinion, fn 5. 16 Page 13 of the EGE Opinion, fn 5. 17 See its earlier Opinion No 15 of 14 November 2000 cited in its Opinion No 16 of 7 May 2002 at p 14. 18 Patent No EP 0695351. 19 Patent application No 96903521.1. 20 For religious viewpoints, see the Church of Scotland: Church and Society Council, Report of the Working Group on Embryo Research, Human Stem Cells and Cloned Embryos, available at http://www.srtp.org.uk/cloning.shtml. See also George P Smith, II, The Christian Religion and Biotechnology: A Search for Principled Decision Making, (2005), Springer, US; Dariusch Atighetchi, Islamic Bioethics: Problems and Perspectives, (2007) Springer, US. 21 Audrey Chapman, et al, Stem Cell Research and Applications: Monitoring the Frontiers of Biomedical Research, (1999) The American Association for the Advancement of Science and Institute for Civil Society, US. 22 Ibid. 23 Human Genome Organisation's (HUGO) Ethics Committee and by the United Nations Educational, Scientific and Cultural Organization. HUGO Ethics Committee, Statement on the Principled Conduct of Genetics Research (1996), Human Genome Organisation, see [#8810]www.hugo-international.org[#8811]; Universal Declaration on the Human Genome and Human Rights, UNESCO, [#8810]www.unesco.org/ibc/en/genome/projet/[#8811], 19 February 2003, art 12(a). See also Recommendation No. 1425 on Biotechnology and Intellectual Property, Council of Europe, (entered into force on 23 September 1999), rec 10; Recommendation No 1468 on Bio-technologies, Council of Europe, (entered into force on 29 June 2000), rec 10. 24 An opinion which may not be acceptable to many. Some views that thanks to intellectual property, the boundary of proprietary rights expands. 'In fact, just like non-human living matter, the parts of the human body can now, under certain conditions, give rise

to one kind of property: intellectual property. Thanks to bio-technologies, the part that is non-appropriable is therefore becoming smaller as we gradually succeed in 'building' everything, even life, by accumulating technology and labour, which must both be rewarded by protected access to the market and which are likely to generate considerable financial profits'. Bellivier, F and Noiville, C, 'The commercialisation of human biomaterials: what are the rights of donors of biological material?', Journal of Biotechnology Law, Vol 1, 2004; 89-97, par p 93. 25 The ALRC Report, fn 8. 26 Footnote 21. See also the EGE Opinion, fn 5 above, at p 13. 27 Footnote 21. See also the EGE Opinion, fn 5 above, at p 13. 28 The UK Select Committee came up with the same finding on this. The Committee was of the view that embryos should not be created specifically for research purposes unless there are demonstrable and exceptional needs which, cannot be met by the use of surplus embryos. 29 The EGE Opinion, fn 5 above, at p 15. 30 Ibid, The EGE Opinion, fn 5 above, at p 15. 31 The EGE Opinion, fn 5 above, p 16. 32 The EGE Opinion, fn 5 above, p 16. 33 The EGE Opinion, fn 5 above. 34 The Opinion, p 17. 35 On this, the ALRC highlights a report of the Organisation for Economic Co-operation and Development (OECD Report) that identified the following as issues relevant to commercialisation: (i) patent thickets and royalty stacking; (ii) reach-through claims; and (iii) dependence and uncertainty. See the ALRC Issues Paper, fn 8. 36 The ALRC Issues Paper, fn 8. 37 Heller, M and Eisenberg, R, 'Can Patents Deter Innovation? The Anti-commons in Bio-medical Research', (1998) 280 Science 698, 698 as cited in the ALRC Issues Paper 27, fn 8 above. This is the same concern with patents on genes, human DNA sequence and human genome. The scientific committee was of the view that the patenting of such products raises concern over the co-modification of crucial scientific finding to the human kind. Instead of conferring the incentive required by the industry, it may lead to the 'locking up' of crucial resources to only a few hands. 38 The term 'upstream' describes inventions which are the result of fundamental research. Usually, they do not have a significant commercial applicability but rather represent the starting point for applied science research. Upstream research includes, for instance, the identification of gene sequences and their functions. The term 'downstream' refers to products developed by using upstream inventions. Usually downstream inventions have a narrow applicability. In bio-technology, typical downstream inventions are drugs, research tools or tools for diagnostic purposes. See Matthias Dau, 'Bio-technology, Patents and the Need for a 'Fair Use' Exception in US Patent Law', Journal of International Bio-technology Law, Vol 1, 2004, pp 146-152. 39 The concern that patents may result on early technologies has spurred some academics to voice for greater fair use exception in patent law. See Mathias Dau, 'Bio-technology, Patents and the Need for a 'Fair Use' Exception in US Patent Law', Journal of Bio-technology Law, Vol 1 [2004], pp 146-152. 40 The Nuffield Council on Bioethics, The Ethics of Patenting DNA (July 2002) available at www.nuffieldbioethics.org. 41 Intellectual Property Rights (IPRs) and Genetics: A Study into the Impact and Management of Intellectual Property Rights within the Healthcare Sector, July 2003. The Committee comprises of three renowned academics; Prof WR Cornish, Dr M Llewelyn and Dr M Adcock. 42 Glen Mc Gee and Elizabeth Banger, 'Ethical Issues in the Patenting and Control of Stem Cell Research, in Who Owns Life, David Magnus et al, (2002) NY. 43 Claim # 9: A method of isolating a human embryonic stem cell line, comprising the steps of: (a) (b) isolating a human blastocyct isolating cells from the inner cell mass of the blastocyste of (a)

(c) (d) (e) (f) (g)

plating the inner cell mass cells on the embryonic fibroblasts, wherein inner cell mass-derived cell masses are formed. Disassociating the mass into disassociated cells Replating the disassociated cells on embryonic feeder cells Selecting colonies with compact morphologies and cells with high nucleus to cytoplasm ratios and prominent nucleoli; and Culturing cells of the selected colonies to thereby obtain an isolated pluripotent human embryonic stem cell line.

44 Another survey published in early 2006 revealed that more than 1,400 patents can be identified from the US Patents Database. These patents are owned by at least six companies and institutions, including (1) Wisonsin Alumni Research Foundation (WARF); (2) Vanderbilt University; (3) Geron Corporation (4) Amrad Corporation Limited (5) The John Hopkins University; and (6) Maria Biotech Co. Ltd. See Esmond, RW, Schwartzman, RA and Ebersole, TJ Stem Cells: The Patent Landscape, Intellectual Property and Technology Law Journal, Vol 18, No 1, Jan 2006, 1-3. The authors suggested that a law should be passed to provide for stem cell research exemption to patent infringement and compulsory licensing. The authors also believed that the creation of a patent pool may be able to address the issue of multiple blocking and complementary stem cell patents. 45 [2004] APO 19. 46 [2004] APO 24 47 [2004] APO 19. 48 [2004] APO 24. 49 Section 20 of the Act provides: Section 20 Offence-creating a chimeric or hybrid embryo. (1) A person commits an offence if the person intentionally creates a chimeric embryo. Maximum penalty: imprisonment for 10 years. (2) A person commits an offence if the person intentionally creates a hybrid embryo Maximum penalty: imprisonment for 10 years. 50 The Act includes the following definition of a hybrid embryo: (a) An animal egg into which the nucleus of a human cell has been introduced.

51 The ALRC Issues Paper 27, fn 8 above. 52 Available at http://www.ipaustralia.gov.au/pdfs/patentsmanual/WebHelp/Patent_Examiners_Manual.htm#National/Patentable/2.9.5.1_stem_cel ls.htm. 53 Mantra,RR and Russo, AA 'Stem Cells and Patenting and Related Regulatory Issues: A United States Perspective', [2004/2005] 4 BSLR 143. For the position in Germany, see Bonn, Hans-Georg Dederer, Regulation of Human Embryonic Stem Cell Research in Germany, Journal of International Bio-technology Law, Vol 3, March/April 2006, 63-71. 54 The Thirteenth Amendment states: Section 1: Neither slavery not involuntary servitude, except as punishment for crime whereof the party shall have been duly convicted, shall exist within the United States, or any place subject to their jurisdiction. US Const Amend XIII, s 1.

55 See also Patent No 6,255,112 for the regulation of hematopoietic stem cell differentiation by use of human mesenchymal stem cells, No, 6,090,622 for human embryonic pluripotent germ cells, No 6,110,739 for method of produce novel embryonic cell populations, No 6,194,635 for embryonic germ cells, method for making the same, and using the cells to produce a chimeric porcine. 56 The Canadian Biotechnology Advisory Committee (CBAC) prepared a final report in June 2002 entitled Patenting of Higher Life Forms and Related Issues, available at http://cbac-cccb.ca/epic/site/cbac-cccb.nsf/en/ah00190e.html. 57 Though it would appear that in Canada, patent examiners in their determination of patentability have no discretion to consider moral or ethical issues. Thus, resulting in a call for the inclusion of 'public ordre' and 'morality' into patent law.

58 The UK notices on stem cell available at http://www.ipo.gov.uk/patent/p-decisionmaking/p-law/p-law-notice/p-law-notice-stemcells.htm. 59 Human embryonic stem cells are of three types: (i) (ii) (iii) pluripotent stem cells, ie those cells which have an unlimited capacity to divide and the potential ability to develop into most of the specialised cells or tissues of the body. Multipotent stem cells, ie cells which can be multiplied and maintained in culture but do not have an unlimited capacity for renewal, can be derived from foetuses and are present throughout life but in progressively decreasing numbers in adults. Totipotent cells, according to one definition, can differentiate into every kind of cell line found in a developing embryo, and hence could, on their own, develop into an embryo.

60 The Warnock report was of the view that the embryo of the human species should be afforded some protection in law' and that 'legislation should provide that research may be carried out on any embryo resulting from in vitro fertilisation, whatever its provenance, up to the end of the fourteenth day after fertilisation, but subject to all other restrictions as may be imposed by the licensing body.For a more detailed analysis on the UK experience on embryo research, see Roger Brownword, 'Bioethics Today, Bioethics Tomorrow: Stem Cell Research and the 'Dignitarian Alliance', (2003) 17 Notre Dame Journal of Law, Ethics and Public Policy 15. 61 Twine, R 'From Warnock to the Stem Cell Bank -- Evaluating the UK's Regulatory Measures for Stem Cell Research,' Journal of International Biotechnology Law, Vol 2, Jan/Feb 2005, p 1. 62 See also UK Stem Cell initiative, Report and Recommendations, Nov. 2005 available at www.advisorybodies.doh.gov.uk/uksci/uksci-reportnov05.pdf. 63 See Stem Cell Patents: European Patent Law and Ethics Report, Nottingham, 28th July 2006. The author is thankful to Prof Paul Torremans for sharing a copy of the report. 64 The European Directive 98/44/EC. 65 Rule 23(d) reads: Exceptions to patentability Under Article 53(a), European Patents shall not be granted in respect of biological inventions which, in particular, concern the following: (b) processes for cloning human beings; (c) processes for modifying the germ line genetic identity of human beings (d) uses of human embryos for industrial or commercial purposes; (e) Processes for modifying the genetic identity of animals which are likely to cause them suffering without any medical benefit to man or animal, and also animals resulting from such processes. Rule 23(e) reads: Human body and its elements (1) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (2) An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. (3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. 66 This is primarily because the bio-technology industry was --and still is -- viewed as being a commercial sector poised for dramatic growth during the 21st century. 67 Amended proposal for an EU Bio-technology Directive. 68 Common Position adopted by the Council on 7 February 1984, Official Journal EC-C- 9 April 1994, 101/65. 69 See 96/C 296/03, COM (95) 661 final, 95/0350 (COD), p 13, No 43. 70 Geertrui Van Overwalle, Study on the Patenting of Inventions Related to Human Stem cell research, European Communities, 2002. 71 The distinction between invention and discovery further stressed by the Court of Justice in 2001 Kingdom of Netherlands by

the Italian Republic and by Kingdom of Norway v European Parliament and Council of the European Union, supported by Commission of the European Communities, Judgment of the Court of Justice, 9 October 2001, Case C-377/98, an application would only be accepted if it is accompanied by both a description of the original method of sequencing which led to the invention and an explanation of the industrial application to which to which the work is to lead. 72 The Opposition Division held that in contrast to human ES cells which can only be obtained by destroying human embryos, the animal stem cells other than embryonic stem cells will be obtained from adults without causing any harm to them or will be isolated from foetal tissues obtained after pregnancy termination. 73 See eg Science, vol 283, p 1468-1470, 1999. 74 European Parliament Resolution on the Decision by the European Patent Office with Regard to Patent No EP 695 351 Granted on 8 December 1999 (Document BS-0299, issued on 30 March 2000), Official Journal EC-L, 29 December 2000, 378/95. 75 Page 22 of the grounds of decision by the Opposition Division dated 21 July 2003. In arriving to that conclusion, the OD disagreed with the finding of the European Group of Ethics on the issue, citing that there are too many inconsistencies, logical flaws, and incompatibility with existing patent law and the EU Directive. 76 T 1374/04 -- Decision of the Board of Appeal. 77 See the Statement of Grounds of Appeal on European Patent Application No 96903521.1, Wisconsin Alumni Research Foundation. 78 Also shows great divergence and lack of clarity in the notion of ethics and morality' Vivienne Green, for example calls for the reification of bioethical principles into the current discourse as found by the European Union Bio-Med II Project. The four principles are autonomy, dignity, integrity and vulnerability. See, 'The Ethics of Patenting Inventions Derived from Human Embryonic Stem Cells in the European Union', Journal of the Intellectual Property Society of Australia and New Zealand Inc, March 2006, 10-19. 79 Graeme Laurie, 'Patenting Stem Cells of Human Origin', EIPR 2004, 26(2), pp 59-66. 80 Intellectual Property Rights (IPRs) and Genetics: A Study into the Impact and Management of Intellectual Property Rights Within the Healthcare Sector, July 2003. 81 Signed in Oviedo in 1997 (http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm). 82 Helen Cline & Anoushka Myers, 'Regulation of Human Embryonic Stem Cell Research: A Comparative Review', [2003/2004] 2 BSLR 47. 83 Pekeliling Ketua Pengarah Kesihatan Bil 1/2006, MOH/P/PAK/119.06/(GU). 84 Majlis Fatwa Kebangsaan ke 66; 22 February 2005. 85 MOH/P/PAK/131/07 (BP). 86 LeRoy Walters, Human Embryonic Stem Cell Research: An Intercultural; Perspective, in Tuse, M and Pynes, CA, The Stem Cell Controversy: Debating the Issues, (2006), Prometheus Books, US, pp 259-284. 87 Passed in December 2006 with effect from 12 June 2007, amending the Research Involving Human Embryos Act 2002 that regulates activities involving the use of human embryos. This reg clarifies that the prohibition against human cloning pertains only to reproductive cloning and not therapeutic cloning. The regulation further allows these practices with licence: (i) (ii) (iii) (iv) Creating a human embryo other than by fertilisation or developing such embryo. Creating or developing a human embryo containing genetic material provided by more than 2 persons. Using precursor cells from a human embryo or human fetus to create a human embryo or developing such embryo Creating a hybrid embryo.

88 The main criticism with the German regulatory framework are: (1) (2) (3) The choice of the cut-off date. It appears that all stem cell lines legally available in accordance with this requirement are contaminated by so called 'feeder cells'. Place the German scientist on a competitive disadvantage, as scientists abroad base their research more and more on hES-cells derived from stem cells established after the 1 January 2002. German scientist might be restricted from participating from overseas research project that utilises hES cells derived from stem cells established after the deadline.

(4)

The definition of embryo might only cover biological entities that are capable of developing into a human individual; thus may not apply to non-viable human embryos and human parthenotes.

89 Some of the reports have been summarised in this article. See also the 2002 report by the Bioethics Advisory Committee, Singapore. 'Ethical, Legal and Social Issues in Human Stem Cell Research. Reproductive and Therapeutic Cloning', June 2002. 90 Jeremy Rifkin, The Bio-tech Century: Harnessing the Gene and the Remaking the World, (1998) Putnam, US, at p 237.

Malayan Law Journal Articles/2007/Volume 4/REFUSAL OF MEDICAL TREATMENT: ASSESSING THE REQUIRED CAPACITY [2007] 4 MLJ cxlv Malayan Law Journal Articles 2007

REFUSAL OF MEDICAL TREATMENT: ASSESSING THE REQUIRED CAPACITY

Dr Puteri Nemie bte Jahn Kassim Associate Professor Ahmad Ibrahim Kulliyyah of Laws International Islamic University Malaysia Introduction The right to undertake or refuse medical treatment presupposes a capacity to do so. Every adult is presumed to have that capacity, but it is a presumption that can be rebutted. Some patients may not possess the necessary capacity due to their mental illness or retarded development or simply because they are under the age of majority. Problem usually arises with patients who have the necessary capacity but may be deprived of it or have it reduced by reason of temporary factors, such as unconsciousness, confusion or other effects of shock, severe fatigue, pain or drugs being used in their treatment. Medical professionals faced with a refusal of consent have to give very careful and detailed consideration to the patient's capacity to decide at the time when the decision was made. It may not be the simple case of the patient having no capacity but the more difficult case of a temporarily reduced capacity at the time when the decision was made, particularly, in relation to pregnant women and persons bound by certain religious beliefs. The right of self-determination An adult of sound mind has the right to make his own choices as to what treatment, if any, can be carried out on him. The right to determine what shall be done with one's own body is a basic human right firmly entrenched in and protected by the common law1. The concepts inherent in this right are the bedrock upon which the principles of self-determination2 and individual autonomy are based. Medical treatment carried out without the consent of an adult of sound mind amounts to unlawful touching or battery3. Lord Goff of Chieveley said in Airedale NHS Trust v Bland4:
First, it is established that the principle of self-determination requires that respect must be given to the wishes of the patient, so that, if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for his care must give effect to his wishes, even though they do not consider it to be in his best interests to do so . . . To this extent, the principle of the sanctity of human life must yield to the principle of self-determination : and, for present purposes perhaps more important, the doctor's duty to act in the best interests of his patient must likewise be qualified5.

Further, Lord Donaldson in Re T (An Adult: Medical Treatment)6 stated that:

The patient's right of choice is not limited to decisions which others might regard as sensible. It exists notwithstanding that

the reasons for making the choice are rational, irrational, unknown or even non-existent7.

Butler-Sloss LJ reiterated this point in Re MB (An Adult: Medical Treatment)8, by stating that:
A mentally competent patient has an absolute right to refuse to consent to medical treatment for any reason, rational or irrational, or for no reason at all, even where that decision may lead to his or her own death9.

Requirements for a legally valid consent The requirement for valid consent is a basic tenet of medical law. Consent is only valid if the consent is informed in nature10, given voluntary11 and the person have the necessary capacity to give consent. To have the necessary capacity to give consent, the patient must be able to have sufficient 'understanding' of the nature, purpose and effect of the proposed treatment. The term 'understanding' has been subjected to intense discussion through a series of cases as to what are the true requirements for the term12. It was not until the case of Re C (Adult : Refusal of Treatment)13 that the appropriate test was laid out to determine whether the patient has sufficient 'understanding' to be considered fully competent to consent or refuse to consent to medical treatment. The criteria for assessing capacity The common law has developed, through several cases, the criteria to be used in assessing whether the patient has the capacity in refusing medical treatment14. The criteria was clearly enunciated in the leading House of Lords case of is F v West Berkshire Health Authority15, where Lord Brandon indicated that the issue of whether the patient has the capacity to consent or refuse to consent hinges on whether patients are able to understand the nature and purpose of the care. This probably involves appreciating what will be done to them if they accept treatment, the likely consequences of leaving their condition untreated and understanding the risks and side effects of undertaking the treatment. Further, in Re C (Adult: Refusal of Treatment)16, the patient who was a paranoid schizophrenic refused to have his gangrenous leg amputated even though he might die if the operation was not performed. Thorpe J held that there is a rebuttable presumption in favour of capacity and accepted expert evidence on what is involved in determining a person's capacity. The expert proffered the view that there are three stages to a decision, firstly, whether they are able to take in and retain treatment information; secondly, whether they believe it, and; thirdly whether they are able to weigh that information by balancing the risks and needs17. Thorpe J. considered the expert's analysis to be helpful in determining the question, which he said was 'whether it has been established that C's capacity is so reduced by his chronic mental illness that he does not sufficiently understand the nature, purpose and effects of the proffered amputation18.' Applying that test, the court held that it had not been proved that the patient did not understand the choice he was being asked to make, and consequently whether he was competent to withhold his consent. An order was made forbidding the amputation without patient's written consent19. A similar approach was used by the Court of Appeal in Re MB (An Adult: Medical Treatment)20. Re MB involved a pregnant woman who had consented to an elective Caesarean section because her fetus was in a breech position. However, her pathological fear of needles caused her to refuse permission for the anaesthetic and thus, not making the caesarian section possible. The health authority applied for and was granted a declaration that it would be lawful for the doctors to carry out the Caesarean section, and MB's appeal was dismissed by the Court of Appeal. Butler-Sloss LJ, giving the judgment of the court, stated that:
A person lacks capacity if some impairment or disturbance of mental functioning renders the person unable to make a decision whether to consent to or to refuse treatment. That inability to make a decision will occur when: (a) (b) the patient is unable to comprehend and retain the information which is material to the decision, especially as to the likely consequences of having or not having the treatment in question; the patient is unable to use the information and weigh it in the balance as part of the process of arriving at the decision. If, as Thorpe J observed in Re C (above), a compulsive disorder or phobia from which the patient suffers stifles belief in the information presented to her, then the decision may not be a true one. As Lord Cockburn CJ put it in Banks v Goodfellow (1870) LR 5 QB 549, 569: '... one object may be so forced upon the attention of the invalid as to shut out all others that might require consideration.

Thus, a patient's competence can be successfully challenged if it can be shown that he does not comprehend or absorb information to the extent he understands it or if he is thought not to believe the information or if he cannot balance this information against other considerations when making his choice. At the moment, the Malaysian Mental Disorder Ordinance 195221 does not have any provisions pertaining to the issue of consent or refusal to medical treatment. However, once enforced, the Malaysian Mental Health Act 200122 will have a specific provision on the issue of consent to treatment23, addressing the issue of assessment of capacity. The criteria for assessing capacity laid down in section 77 of the 2001 Act is somewhat similar to the criteria developed by the common law as discussed above. Section 77 of the 2001 Act requires consent to be given by the mental patient himself24 unless he is incapable of doing so after being assessed by the relevant persons. Section 77 is as follows: (1) Where a mentally disordered person is required to undergo surgery, electroconvulsive therapy or clinical trials, consent for any of them may be given -(a) by the patient himself if he is capable of giving consent as assessed by a psychiatrist; (b) by his guardian in the case of a minor or a relative in the case of an adult, if the patient is incapable of giving consent; (c) by two psychiatrists, one of whom shall be the attending psychiatrist, if there is no guardian or relative of the patient available or traceable and the patient himself is incapable of giving consent For purposes of subsection (1), it shall be the duty of the registered medical practitioner concerned to ensure that informed consent is first obtained from the patient himself under paragraph 1(a) before invoking paragraph 1(b) and (c).

(2)

In order to assess whether he is capable of giving the required consent, s 77(5) set out the factors that need to be considered such as whether the patient understands the condition for which the treatment is proposed, the nature and purpose of the treatment, the risks involved in undergoing and not undergoing the treatment and whether or not his ability to consent is affected by his condition. If after considering these factors, it is shown that the patient is incapable of giving consent, then only consent can be procured from the guardian, if the patient is a minor, or a relative of the patient, if the patient is an adult25. If the guardian or relative is nowhere to be found, then only consent can be taken from two psychiatrists who have examined the patient26. The problem with pregnant women and the rights of the fetus Pregnant women, particularly those who are in the late stages of pregnancy, present a clear example of the inherent problem in assessing whether the patient has the required capacity. In such situation, the pregnant woman's respect for bodily integrity and autonomy is seen to be in conflict with respect for the life of the unborn child. The common law has for many years decided that the fetus has no legal rights until it is born. For example, in the 1979 abortion case of Paton v Trustees of British Advisory Services27, Sir George Baker, held that:
The fetus cannot, in English law, in my view, have a right of its own until it is born and has a separate existence from its mother. That permeates the whole of the civil law of this country28.

However, in the Court of Appeal case of Re T (An Adult) (Refusal of Medical Treatment)29, Lord Donaldson MR expressed concern about the issue of sanctity of human life which will be violated if the life of the healthy and viable fetus is put at risk by the refusal of the mother's consent to medical treatment. His Lordship held that there was only one hypothetical exception to the right of a competent pregnant patient to refuse treatment:
An adult patient who . . . suffers from no mental incapacity has an absolute right to choose . . . one rather than another of the treatments being offered. The only possible qualification is a case in which the choice may lead to the death of a viable fetus. That is not this case and, if and when it arises, the courts will be faced with a novel problem of considerable legal and ethical complexity30.

Lord Donaldson's judgment was applied in the controversial case of Re S (Adult: Refusal of Medical Treatment)31 which has in fact allowed a caesarian section to be done on the pregnant woman despite her refusal to consent in order to save her life and the unborn child. In Re S, the patient, Mrs S, was in labour with her third pregnancy, having been admitted into the hospital with ruptured membranes six days overdue from the expected birth date of her unborn child. The fetus was in a 'transverse lie' position with an elbow projecting through the dilating cervix. Her obstetrician advised a Caesarean section, as there was a high risk of uterine rupture, which would put both lives in great danger. However, Mrs S refused surgery for religious reasons, a decision which was supported by her husband. The hospital asked the court to intervene. Sir Stephen Brown declared that a Caesarean section could lawfully be performed despite the patient's refusal, as it was necessary in the interests of both the mother and her unborn child. This decision was noted to be an exception as it is not possible to force someone to submit to medical intervention to preserve the life of the fetus, which, have yet to achieve its legal personhood32. The issue was further taken up by the case of Re MB (Adult: Medical Treatment)33 in which, the court held that her fear of needles rendered her temporarily incompetent to make the necessary decision of refusing the caesarian section. In such situation, the court had the power at common law to authorise the use of reasonable force, thus, overriding her refusal to consent to the anaesthetic injection. The court relied on the judgment given in Norfolk and Norwich Healthcare (NHS) Trust v W34 which Johnson J stated that:
The patient was in the throes of labour with all that is involved in terms of pain and emotional stress. I concluded that a patient who could, in those circumstances speak in terms which seemed to accept the inevitability of her own death, was not a patient who was able properly to weigh up the considerations that arose so as to make any valid decision, about anything of even the most trivial kind, still one which involved her own life35.

Thus, the court in Re MB held that the patient's extreme needle phobia amounted to an involuntary compulsion that disabled her from weighing treatment information in the balance to make a choice. She therefore, lacked the relevant mental competence to make the treatment decision and it was in her best interest to have the operation. In giving the court's judgment, Butler-Sloss LJ clarified the position of a competent person to refuse medical treatment and the rights of the fetus. Her Lordship stated that:
A competent woman, who has the capacity to decide, may, for religious reasons, other reasons, for rational or irrational reasons or for no reason at all, choose not to have medical intervention, even though the consequence may be the death or serious handicap of the child she bears, or her own death. In that event the courts do not have the jurisdiction to declare medical intervention lawful and the question of her own best interests, objectively considered, does not arise36.

Further in her judgment, her Lordship observed that:

A fetus, up to the moment of birth, does not have any separate interests capable of being taken into account by a court considering an application in respect of the performance of a Caesarean section on the pregnant woman carrying the fetus. A court does not have jurisdiction to declare medical intervention lawful to protect the interests of an unborn child, even at the point of its birth37.

From the judgment in Re MB, it can be concluded that a person who lacks capacity due to some impairment or disturbance of mental functioning is unable to make a decision whether to consent to, or to refuse, treatment. However, if the person has the requisite capacity to consent or refuse treatment, the interests of the unborn fetus would not take precedence over those of its mother. The decision in Re MB was soon followed by St George's Healthcare NHS Trust v S38. In St George, Mrs S was suffering from pre-eclampsia, and was admitted under an order from a mental hospital to a maternity hospital. Delivery by Caesarean section was recommended, but she refused. The court was asked to intervene. The court of first instance declared that a Caesarean section would not be unlawful, and so this was carried out. After delivery she appealed against the decision. The Court of Appeal upheld its earlier decision in Re MB, and held that the operation on Mrs S had been unlawful and a trespass because there was no clear evidence of current abnormalities in her mental state. In any event, Mrs S did not represent any significant continuing risk to anyone. She had fully understood the risks that her life and the baby's life would be put in danger if she pro-

ceeded with natural delivery. As her capacity to consent was intact, she has the right to refuse medical treatment even when her life depends on it or that she may be endangering the life of her fetus. The fetus is not protected because it is not considered as a separate being from its mother. As such, its needs for medical care and assistance cannot prevail over that of the mother. Clearly, the decision in St George reiterated that consent remains a necessary prerequisite to medical treatment for adult patient of legally sound mind and the interests of the unborn fetus would not normally take precedence over those of its mother unless she is incapable of making a reasoned choice regarding her medical treatment by reason of an impairment of mental functioning. Although pregnancy increased the responsibilities, which a woman had, it did not diminish her right to refuse medical treatment, as long as she is of sound mind. The recent case of Trust A and Trust B v H (An Adult Patient)39 had also adopted a similar sentiment as St George. In Trust A and Trust B, H, a female patient aged 45 was schizophrenic and delusional, with the mistaken belief that she was childless. She suffered from an ovarian cyst with gynaecological complications, which caused her general discomfort, breathing and feeding difficulties. H refused surgery, asserting that she wanted children. Medical evidence indicated that there was no feasible alternative to surgery to manage H's physical condition and that her psychiatric condition could not be sufficiently improved in time to allow a realistic prospect of her consenting to treatment. The trusts sought declarations that H lacked capacity to make decisions about her condition and it was in her best interests to receive a total hysterectomy. The court first considered whether H has the required capacity to refuse the treatment. If the patient lacked capacity to consent, then it was lawful to overcome non-cooperation by sedation and reasonable restraint in order to achieve treatment, which was in the patient's best interests. However, the lawfulness of such restraint had to be carefully considered in the context of the patient' best interests. In considering whether it was in H's best interests to undergo the proposed surgery, the court had to consider a the broad spectrum of medical, social, emotional and welfare conditions and the balance between the likely benefits and disadvantages of the proposed treatment. The decision in Trust A and Trust B concluded that if an adult patient did not have the capacity to decide at the time of the purported refusal and still does not have that capacity, it is the duty of the doctors to treat him in whatever way they consider, in the exercise of their clinical judgment, to be in his best interests. Although there are no Malaysian cases directly on the issue of refusal of consent by pregnant women, the common law cases have been instrumental in many consent to medical treatment cases such as Tan Ah Kau v Government of Malaysia40, Hong Chuan Lay v Dr Eddie Soo Fook Mun41 and Foo Fio Na v Hospital Assunta & Anor42 in which adult patient of sound mind has a right to decide whether they want to opt for the medical treatment or not. Thus, pregnancy will not lead to a dilution or modification of a woman's right to make autonomous decisions concerning medical treatment if she is competent to do so. The rights of the fetus will also not prevail over its mother as Paton v Trustees of British Advisory Services43 was approved and followed in the local case of Chin Yoke Teng & Anor v William Ui Ye Mein44. Mohd Hishamuddin J aptly stated that:
An unborn child or fetus is a biologically distinct organism from the mother, it is not a legal person, it has been accepted that in order to have a right of action, the fetus must be born and be a child. When an unborn child becomes a living person and suffers damages as a result of pre-natal injuries, the child is able to bring proceedings. On birth, the child acquires legal status and thus, legal rights.45.

Treatment in absence of capacity At common law, a doctor can lawfully operate on or give other treatment to adult patients who are incapable of consenting to his doing so, provided that the operation or treatment is in the 'best interests' of such patients. Prior to 2000, the operation or treatment will be in their best interests only if it is carried out in order either to save their lives or to ensure improvement or prevent deterioration in their physical or mental health. This is mentioned in the case of F v West Berkshire Health Authority or Re F (Mental Patient: Sterilisation)46, in which, the court held that they did have jurisdiction to make a declaration that the proposed operation was lawful on the ground that it is in the best interests of the patient. A doctor can lawfully operate on or give treatment to adult patients who are incapable of consenting to his doing so, provided that the operation or treatment is in the best interests of such patients. In determining whether the proposed operation was in the best interests of the patient, the court should apply the established Bolam test of what would be accepted as appropriate treatment

at the time by a reasonable body of medical opinion skilled in that particular form of treatment. However, in Re S (Sterilisation: Patient's Best Interests)47, the court held that it was for the judge, not the doctor, to decide whether a treatment was in the best interests of a patient, a decision which would incorporate broader ethical, social and moral considerations than those set out in Bolam, with the patient's welfare as the paramount consideration.48 Thus, 'best interests' is not limited to 'best medical interests.' Thorpe J in Re A (Mental Patient: Sterilisation)49 held that the evaluation of best interests was akin to a welfare appraisal in that it was necessary to draw up a balance sheet between possible gains and losses. If the account were significantly in credit, then the application was considered in the best interests of the patient. The considerations, which would not be the same in the case of men and women encompassed medical, emotional and all welfare issues50. Anticipatory refusals while competent A person who is competent to make decisions but wish to make anticipatory decisions on medical treatment just in case they become incapacitated in future, can resort to the use of advance directives. An advance directive is an anticipatory decision made while a person is capable, which is intended to give effect to that person's wishes as to how he or she shall be treated or cared for after the loss of capacity51. An advance directive will allow an individual to make decisions while competent and these will be binding in any subsequent period of incapacity. Although there is no English legislation giving statutory effect to advance directives, the House of Lords Select Committee on Medical Ethics has endorsed the use of advance directives as a way of enabling patients to express in advance their individual preferences to medical treatment in the event they become subsequently incompetent52. In Malaysia, advance directives for medical treatment have yet to be given any formal recognition53. Even though, advance directives has considerable theoretical attraction, due care must be given to the consequences of these directives. For instance, an individual refusing treatment for a physical condition in advance might or might not have refused a new treatment for the condition, discovered after the directive have been made54. Thus, it is imperative that before advance directives are given formal recognition, it has to be ensured that proper safeguards are introduced. Conclusion The common law is clear in that a competent adult patient once properly informed, has the unassailable legal right to refuse medical treatment. However, problems can arise on the issue of capacity to consent to or refuse treatment. Assessment of capacity requires the patient to comprehend the nature of the particular conduct in question and to understand its quality and consequences. Once the patient understands the nature, purpose of the proposed treatment, and the risks and likely prognosis involved in the decision to refuse or accept it, the patient achieves the required capacity to refuse the proposed treatment. In such circumstances, medical professionals should ensure that the advice given to the patient should be recorded together with written, unequivocal assurances from the patient that the refusal represents an informed decision.
1 Justice Benjamin Cardozo, in Schloendorff v Society of New York Hospital 105 NE 92 (NY 1914) stated that '[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages.' 2 Self-determination involves (1) the right to consent to treatment, to decide who shall treat and to choose the form of treatment; and as a corollary (2) the right to refuse consent. 3 A battery takes place when there is non-consensual touching. In Wilson v Pringle [1986] 2 All ER 440, the Court of Appeal suggested that the touching must be 'hostile' in order to constitute battery. The court was prepared to adopt a very wide view of hostility so as not to confine to acts of ill will but a little more than non-consensual touching. The reason for this is the need to eliminate actions in battery as a result of physical contact, which is generally acceptable in the ordinary conduct of everyday life. See further, Re F (Mental Patient: Sterilisation) [1990] 2 AC 1. 4 [1993] 1 All ER 821; [1993] AC 789. 5 [1993] 1 All ER 821 at p 866. 6 [1992] 2 FCR 861. 7 Ibid. at p 865.

8 [1997] 2 FCR 541. 9 Ibid. at p 549. 10 This requires patient to be given 'sufficient' information about the treatment. 'Sufficient' information has been interpreted as explaining the material risks inherent in the treatment. However, the assessment of material risks depends on whether the 'reasonable prudent doctor test' is applied (Sidaway Board Governors of Bethlem Royal Hospital and the Maudsley Hospital [1985] 1 AC 871, or the 'reasonable prudent patient test' as enunciated in Rogers v Whitaker [1992] 175 CLR 479. For further reading on this issue, see Puteri Nemie, JK 'Abandoning the Bolam principle in Doctor's Duty to Disclose Risks in Malaysia: Are we heading in the right direction?' [2007] 1 Law Review pp 5-16. 11 Consent must be given through the patient's own free will, with no duress or undue influence. See Freeman v Home Office [1984] 1 All ER 1036 and Re T (Adult: Refusal of Medical Treatment) [1992] 3 WLR 782. 12 See I Kennedy & A Grubb, 2000, Medical Law (3rd Ed) London: Butterworths, at pp 122-123. 13 [1994] 1 All ER 819, [1994] 1 WLR 290. 14 Some of these common law principles have been reproduced in English statutes such as the Mental Capacity Act 2005 and amendments to the Mental Health Act 1983. 15 [1989] 2 All ER 545. 16 [1994] 1 All ER 819, [1994] 1 WLR 290. 17 [1994] 1 WLR 290, at p 295. 18 Ibid. 19 The low level of comprehension that the test for capacity entails means that most patients will be competent to consent. In Re JT, the patient suffered from a severe learning disability with sufficiently disturbed behaviour to justify detention under the Mental Health Act 1983. Nevertheless, she as entitled to refuse dialysis treatment for kidney failure, as she understood that she would dies, had made a 'calm and rational' decision and was consistent in her choice to die. 20 [1997] 2 FLR 426. 21 At the moment, the Ordinance regulates the law for the mentally ill in West Malaysia. 22 The Mental Health Act 2001 has said to comprehensively cover all aspects of mental health care by consolidating the laws relating to mental disorders and to provide for the admission, detention, lodging, care, rehabilitation, control and protection of persons who are mentally disordered and for related matters. At this time, the 2001 Act has yet to come in force notwithstanding it received Royal Ascent on 6 September 2001 and was published in the Gazette on 27 September 2001. 23 Section 77. 24 The requirement for informed consent marks the influence of Principle 11 of the United Nation Principles for the protection of persons with mental illness. 25 Section 77(1)(b). 26 Section 77(1)(c). 27 [1979] QB 276. 28 Ibid. at p 279. This case was subsequently followed by C v S [1987] 1 All ER 1230 and Re F (in utero) [1988] 2 All ER 193. 29 [1992] 4 All ER 649. This case concerned a pregnant patient who had been involved in a car accident and had refused blood transfusion during hospital treatment which she claimed was contrary. 30 Ibid. at p 653. 31 [1992] 4 All ER 671.

32 Although Re S has never been appealed, in English legal circles it is generally believed that this decision was discordant with previous case law, and also with the Congenital Disabilities (Civil Liabilities) Act 1976 which gives a child after birth the right to sue anyone who has caused it pre-birth injury, except for its own mother. 33 [1997] 2 FLR 426. For facts, see above. 34 (1997) 34 BMLR 16. 35 Ibid. at p 19. 36 . 37 Ibid. 38 [1998] 2 FLR 528. 39 [2006] EWHC 1230 (Fam). 40 [1997] 2 AMR 1382. 41 [1998] 7 MLJ 481. 42 [1999] 6 MLJ 738. 43 [1979] QB 276. 44 [2005] 5 MLJ 480, see para 19. 45 Ibid. 46 Supra. 47 [2000] 2 FLR 389. 48 This decision was heavily influenced by the case of Bolitho v City Hackney Health Authority [1997] 4 All ER 771. 49 [2000] 1 FLR 549. 50 Ibid. at p 560. 51 Norchaya Talib, 2002, Euthanasia -- A Malaysian Perspective, Kuala Lumpur: Sweet & Maxwell Asia, at p 53. 52 Ibid at p 54. Report of the Select Committee on Medical Ethics, HL paper 2-I of 1993-94 at paragraphs 263-267. 53 From a personal interview with the relevant person from Gleneagles Hospital in Kuala Lumpur, it is mentioned that the hospital will take into account the wishes of the patient in the event an advance directive is drawn up. 54 See P Bartlett & R Sandland, 2003, Mental Health Law: Policy and Practice, (2nd edition), London: Oxford University Press, at pp 602-603. These problems have also been highlighted by officials from the Malaysian Medical Association and the Malaysian Medical Council, see Norchaya Talib, 2002, Euthanasia -- A Malaysian Perspective, at pp 121-122.

Malayan Law Journal Articles/2007/Volume 2/REFUSAL OF MEDICAL TREATMENT: ASSESSING THE REQUIRED CAPACITY [2007] 4 MLJ cxlv Malayan Law Journal Articles 2007

REFUSAL OF MEDICAL TREATMENT: ASSESSING THE REQUIRED CAPACITY

Dr Puteri Nemie bte Jahn Kassim Associate Professor Ahmad Ibrahim Kulliyyah of Laws International Islamic University Malaysia Introduction The right to undertake or refuse medical treatment presupposes a capacity to do so. Every adult is presumed to have that capacity, but it is a presumption that can be rebutted. Some patients may not possess the necessary capacity due to their mental illness or retarded development or simply because they are under the age of majority. Problem usually arises with patients who have the necessary capacity but may be deprived of it or have it reduced by reason of temporary factors, such as unconsciousness, confusion or other effects of shock, severe fatigue, pain or drugs being used in their treatment. Medical professionals faced with a refusal of consent have to give very careful and detailed consideration to the patient's capacity to decide at the time when the decision was made. It may not be the simple case of the patient having no capacity but the more difficult case of a temporarily reduced capacity at the time when the decision was made, particularly, in relation to pregnant women and persons bound by certain religious beliefs. The right of self-determination An adult of sound mind has the right to make his own choices as to what treatment, if any, can be carried out on him. The right to determine what shall be done with one's own body is a basic human right firmly entrenched in and protected by the common law1. The concepts inherent in this right are the bedrock upon which the principles of self-determination2 and individual autonomy are based. Medical treatment carried out without the consent of an adult of sound mind amounts to unlawful touching or battery3. Lord Goff of Chieveley said in Airedale NHS Trust v Bland4:
First, it is established that the principle of self-determination requires that respect must be given to the wishes of the patient, so that, if an adult patient of sound mind refuses, however unreasonably, to consent to treatment or care by which his life would or might be prolonged, the doctors responsible for his care must give effect to his wishes, even though they do not consider it to be in his best interests to do so . . . To this extent, the principle of the sanctity of human life must yield to the principle of self-determination : and, for present purposes perhaps more important, the doctor's duty to act in the best interests of his patient must likewise be qualified5.

Further, Lord Donaldson in Re T (An Adult: Medical Treatment)6 stated that:

The patient's right of choice is not limited to decisions which others might regard as sensible. It exists notwithstanding that the reasons for making the choice are rational, irrational, unknown or even non-existent7.

Butler-Sloss LJ reiterated this point in Re MB (An Adult: Medical Treatment)8, by stating that:
A mentally competent patient has an absolute right to refuse to consent to medical treatment for any reason, rational or irrational, or for no reason at all, even where that decision may lead to his or her own death9.

Requirements for a legally valid consent The requirement for valid consent is a basic tenet of medical law. Consent is only valid if the consent is informed in nature10, given voluntary11 and the person have the necessary capacity to give consent. To have the necessary capacity to give consent, the patient must be able to have sufficient 'understanding' of the nature, purpose and effect of the proposed treatment. The term 'understanding' has been subjected to intense discussion through a series of cases as to what are the true requirements for the term12. It was not until the case of

Re C (Adult : Refusal of Treatment)13 that the appropriate test was laid out to determine whether the patient has sufficient 'understanding' to be considered fully competent to consent or refuse to consent to medical treatment. The criteria for assessing capacity The common law has developed, through several cases, the criteria to be used in assessing whether the patient has the capacity in refusing medical treatment14. The criteria was clearly enunciated in the leading House of Lords case of is F v West Berkshire Health Authority15, where Lord Brandon indicated that the issue of whether the patient has the capacity to consent or refuse to consent hinges on whether patients are able to understand the nature and purpose of the care. This probably involves appreciating what will be done to them if they accept treatment, the likely consequences of leaving their condition untreated and understanding the risks and side effects of undertaking the treatment. Further, in Re C (Adult: Refusal of Treatment)16, the patient who was a paranoid schizophrenic refused to have his gangrenous leg amputated even though he might die if the operation was not performed. Thorpe J held that there is a rebuttable presumption in favour of capacity and accepted expert evidence on what is involved in determining a person's capacity. The expert proffered the view that there are three stages to a decision, firstly, whether they are able to take in and retain treatment information; secondly, whether they believe it, and; thirdly whether they are able to weigh that information by balancing the risks and needs17. Thorpe J. considered the expert's analysis to be helpful in determining the question, which he said was 'whether it has been established that C's capacity is so reduced by his chronic mental illness that he does not sufficiently understand the nature, purpose and effects of the proffered amputation18.' Applying that test, the court held that it had not been proved that the patient did not understand the choice he was being asked to make, and consequently whether he was competent to withhold his consent. An order was made forbidding the amputation without patient's written consent19. A similar approach was used by the Court of Appeal in Re MB (An Adult: Medical Treatment)20. Re MB involved a pregnant woman who had consented to an elective Caesarean section because her fetus was in a breech position. However, her pathological fear of needles caused her to refuse permission for the anaesthetic and thus, not making the caesarian section possible. The health authority applied for and was granted a declaration that it would be lawful for the doctors to carry out the Caesarean section, and MB's appeal was dismissed by the Court of Appeal. Butler-Sloss LJ, giving the judgment of the court, stated that:
A person lacks capacity if some impairment or disturbance of mental functioning renders the person unable to make a decision whether to consent to or to refuse treatment. That inability to make a decision will occur when: (a) (b) the patient is unable to comprehend and retain the information which is material to the decision, especially as to the likely consequences of having or not having the treatment in question; the patient is unable to use the information and weigh it in the balance as part of the process of arriving at the decision. If, as Thorpe J observed in Re C (above), a compulsive disorder or phobia from which the patient suffers stifles belief in the information presented to her, then the decision may not be a true one. As Lord Cockburn CJ put it in Banks v Goodfellow (1870) LR 5 QB 549, 569: '... one object may be so forced upon the attention of the invalid as to shut out all others that might require consideration.

Thus, a patient's competence can be successfully challenged if it can be shown that he does not comprehend or absorb information to the extent he understands it or if he is thought not to believe the information or if he cannot balance this information against other considerations when making his choice. At the moment, the Malaysian Mental Disorder Ordinance 195221 does not have any provisions pertaining to the issue of consent or refusal to medical treatment. However, once enforced, the Malaysian Mental Health Act 200122 will have a specific provision on the issue of consent to treatment23, addressing the issue of assessment of capacity. The criteria for assessing capacity laid down in section 77 of the 2001 Act is somewhat similar to the criteria developed by the common law as discussed above. Section 77 of the 2001 Act requires consent to be given by the mental patient himself24 unless he is incapable of doing so after being assessed by the relevant persons. Section 77 is as follows: (1) Where a mentally disordered person is required to undergo surgery, electroconvulsive therapy or clinical trials, consent for any of them may be given -(a) by the patient himself if he is capable of giving consent as assessed by a psychiatrist;

(b) (c)

by his guardian in the case of a minor or a relative in the case of an adult, if the patient is incapable of giving consent; by two psychiatrists, one of whom shall be the attending psychiatrist, if there is no guardian or relative of the patient available or traceable and the patient himself is incapable of giving consent

(2)

For purposes of subsection (1), it shall be the duty of the registered medical practitioner concerned to ensure that informed consent is first obtained from the patient himself under paragraph 1(a) before invoking paragraph 1(b) and (c).

In order to assess whether he is capable of giving the required consent, s 77(5) set out the factors that need to be considered such as whether the patient understands the condition for which the treatment is proposed, the nature and purpose of the treatment, the risks involved in undergoing and not undergoing the treatment and whether or not his ability to consent is affected by his condition. If after considering these factors, it is shown that the patient is incapable of giving consent, then only consent can be procured from the guardian, if the patient is a minor, or a relative of the patient, if the patient is an adult25. If the guardian or relative is nowhere to be found, then only consent can be taken from two psychiatrists who have examined the patient26. The problem with pregnant women and the rights of the fetus Pregnant women, particularly those who are in the late stages of pregnancy, present a clear example of the inherent problem in assessing whether the patient has the required capacity. In such situation, the pregnant woman's respect for bodily integrity and autonomy is seen to be in conflict with respect for the life of the unborn child. The common law has for many years decided that the fetus has no legal rights until it is born. For example, in the 1979 abortion case of Paton v Trustees of British Advisory Services27, Sir George Baker, held that:
The fetus cannot, in English law, in my view, have a right of its own until it is born and has a separate existence from its mother. That permeates the whole of the civil law of this country28.

However, in the Court of Appeal case of Re T (An Adult) (Refusal of Medical Treatment)29, Lord Donaldson MR expressed concern about the issue of sanctity of human life which will be violated if the life of the healthy and viable fetus is put at risk by the refusal of the mother's consent to medical treatment. His Lordship held that there was only one hypothetical exception to the right of a competent pregnant patient to refuse treatment:
An adult patient who . . . suffers from no mental incapacity has an absolute right to choose . . . one rather than another of the treatments being offered. The only possible qualification is a case in which the choice may lead to the death of a viable fetus. That is not this case and, if and when it arises, the courts will be faced with a novel problem of considerable legal and ethical complexity30.

Lord Donaldson's judgment was applied in the controversial case of Re S (Adult: Refusal of Medical Treatment)31 which has in fact allowed a caesarian section to be done on the pregnant woman despite her refusal to consent in order to save her life and the unborn child. In Re S, the patient, Mrs S, was in labour with her third pregnancy, having been admitted into the hospital with ruptured membranes six days overdue from the expected birth date of her unborn child. The fetus was in a 'transverse lie' position with an elbow projecting through the dilating cervix. Her obstetrician advised a Caesarean section, as there was a high risk of uterine rupture, which would put both lives in great danger. However, Mrs S refused surgery for religious reasons, a decision which was supported by her husband. The hospital asked the court to intervene. Sir Stephen Brown declared that a Caesarean section could lawfully be performed despite the patient's refusal, as it was necessary in the interests of both the mother and her unborn child. This decision was noted to be an exception as it is not possible to force someone to submit to medical intervention to preserve the life of the fetus, which, have yet to achieve its legal personhood32. The issue was further taken up by the case of Re MB (Adult: Medical Treatment)33 in which, the court held that her fear of needles rendered her temporarily incompetent to make the necessary decision of refusing the cae-

sarian section. In such situation, the court had the power at common law to authorise the use of reasonable force, thus, overriding her refusal to consent to the anaesthetic injection. The court relied on the judgment given in Norfolk and Norwich Healthcare (NHS) Trust v W34 which Johnson J stated that:
The patient was in the throes of labour with all that is involved in terms of pain and emotional stress. I concluded that a patient who could, in those circumstances speak in terms which seemed to accept the inevitability of her own death, was not a patient who was able properly to weigh up the considerations that arose so as to make any valid decision, about anything of even the most trivial kind, still one which involved her own life35.

Thus, the court in Re MB held that the patient's extreme needle phobia amounted to an involuntary compulsion that disabled her from weighing treatment information in the balance to make a choice. She therefore, lacked the relevant mental competence to make the treatment decision and it was in her best interest to have the operation. In giving the court's judgment, Butler-Sloss LJ clarified the position of a competent person to refuse medical treatment and the rights of the fetus. Her Lordship stated that:
A competent woman, who has the capacity to decide, may, for religious reasons, other reasons, for rational or irrational reasons or for no reason at all, choose not to have medical intervention, even though the consequence may be the death or serious handicap of the child she bears, or her own death. In that event the courts do not have the jurisdiction to declare medical intervention lawful and the question of her own best interests, objectively considered, does not arise36.

Further in her judgment, her Lordship observed that:

A fetus, up to the moment of birth, does not have any separate interests capable of being taken into account by a court considering an application in respect of the performance of a Caesarean section on the pregnant woman carrying the fetus. A court does not have jurisdiction to declare medical intervention lawful to protect the interests of an unborn child, even at the point of its birth37.

From the judgment in Re MB, it can be concluded that a person who lacks capacity due to some impairment or disturbance of mental functioning is unable to make a decision whether to consent to, or to refuse, treatment. However, if the person has the requisite capacity to consent or refuse treatment, the interests of the unborn fetus would not take precedence over those of its mother. The decision in Re MB was soon followed by St George's Healthcare NHS Trust v S38. In St George, Mrs S was suffering from pre-eclampsia, and was admitted under an order from a mental hospital to a maternity hospital. Delivery by Caesarean section was recommended, but she refused. The court was asked to intervene. The court of first instance declared that a Caesarean section would not be unlawful, and so this was carried out. After delivery she appealed against the decision. The Court of Appeal upheld its earlier decision in Re MB, and held that the operation on Mrs S had been unlawful and a trespass because there was no clear evidence of current abnormalities in her mental state. In any event, Mrs S did not represent any significant continuing risk to anyone. She had fully understood the risks that her life and the baby's life would be put in danger if she proceeded with natural delivery. As her capacity to consent was intact, she has the right to refuse medical treatment even when her life depends on it or that she may be endangering the life of her fetus. The fetus is not protected because it is not considered as a separate being from its mother. As such, its needs for medical care and assistance cannot prevail over that of the mother. Clearly, the decision in St George reiterated that consent remains a necessary prerequisite to medical treatment for adult patient of legally sound mind and the interests of the unborn fetus would not normally take precedence over those of its mother unless she is incapable of making a reasoned choice regarding her medical treatment by reason of an impairment of mental functioning. Although pregnancy increased the responsibilities, which a woman had, it did not diminish her right to refuse medical treatment, as long as she is of sound mind. The recent case of Trust A and Trust B v H (An Adult Patient)39 had also adopted a similar sentiment as St George. In Trust A and Trust B, H, a female patient aged 45 was schizophrenic and delusional, with the mistaken belief that she was childless. She suffered from an ovarian cyst with gynaecological complications, which caused her general discomfort, breathing and feeding difficulties. H refused surgery, asserting that she wanted

children. Medical evidence indicated that there was no feasible alternative to surgery to manage H's physical condition and that her psychiatric condition could not be sufficiently improved in time to allow a realistic prospect of her consenting to treatment. The trusts sought declarations that H lacked capacity to make decisions about her condition and it was in her best interests to receive a total hysterectomy. The court first considered whether H has the required capacity to refuse the treatment. If the patient lacked capacity to consent, then it was lawful to overcome non-cooperation by sedation and reasonable restraint in order to achieve treatment, which was in the patient's best interests. However, the lawfulness of such restraint had to be carefully considered in the context of the patient' best interests. In considering whether it was in H's best interests to undergo the proposed surgery, the court had to consider a the broad spectrum of medical, social, emotional and welfare conditions and the balance between the likely benefits and disadvantages of the proposed treatment. The decision in Trust A and Trust B concluded that if an adult patient did not have the capacity to decide at the time of the purported refusal and still does not have that capacity, it is the duty of the doctors to treat him in whatever way they consider, in the exercise of their clinical judgment, to be in his best interests. Although there are no Malaysian cases directly on the issue of refusal of consent by pregnant women, the common law cases have been instrumental in many consent to medical treatment cases such as Tan Ah Kau v Government of Malaysia40, Hong Chuan Lay v Dr Eddie Soo Fook Mun41 and Foo Fio Na v Hospital Assunta & Anor42 in which adult patient of sound mind has a right to decide whether they want to opt for the medical treatment or not. Thus, pregnancy will not lead to a dilution or modification of a woman's right to make autonomous decisions concerning medical treatment if she is competent to do so. The rights of the fetus will also not prevail over its mother as Paton v Trustees of British Advisory Services43 was approved and followed in the local case of Chin Yoke Teng & Anor v William Ui Ye Mein44. Mohd Hishamuddin J aptly stated that:
An unborn child or fetus is a biologically distinct organism from the mother, it is not a legal person, it has been accepted that in order to have a right of action, the fetus must be born and be a child. When an unborn child becomes a living person and suffers damages as a result of pre-natal injuries, the child is able to bring proceedings. On birth, the child acquires legal status and thus, legal rights.45.

Treatment in absence of capacity At common law, a doctor can lawfully operate on or give other treatment to adult patients who are incapable of consenting to his doing so, provided that the operation or treatment is in the 'best interests' of such patients. Prior to 2000, the operation or treatment will be in their best interests only if it is carried out in order either to save their lives or to ensure improvement or prevent deterioration in their physical or mental health. This is mentioned in the case of F v West Berkshire Health Authority or Re F (Mental Patient: Sterilisation)46, in which, the court held that they did have jurisdiction to make a declaration that the proposed operation was lawful on the ground that it is in the best interests of the patient. A doctor can lawfully operate on or give treatment to adult patients who are incapable of consenting to his doing so, provided that the operation or treatment is in the best interests of such patients. In determining whether the proposed operation was in the best interests of the patient, the court should apply the established Bolam test of what would be accepted as appropriate treatment at the time by a reasonable body of medical opinion skilled in that particular form of treatment. However, in Re S (Sterilisation: Patient's Best Interests)47, the court held that it was for the judge, not the doctor, to decide whether a treatment was in the best interests of a patient, a decision which would incorporate broader ethical, social and moral considerations than those set out in Bolam, with the patient's welfare as the paramount consideration.48 Thus, 'best interests' is not limited to 'best medical interests.' Thorpe J in Re A (Mental Patient: Sterilisation)49 held that the evaluation of best interests was akin to a welfare appraisal in that it was necessary to draw up a balance sheet between possible gains and losses. If the account were significantly in credit, then the application was considered in the best interests of the patient. The considerations, which would not be the same in the case of men and women encompassed medical, emotional and all welfare issues50. Anticipatory refusals while competent A person who is competent to make decisions but wish to make anticipatory decisions on medical treatment just in case they become incapacitated in future, can resort to the use of advance directives. An advance directive is an anticipatory decision made while a person is capable, which is intended to give effect to that person's wishes as to how he or she shall be treated or cared for after the loss of capacity51. An advance directive will al-

low an individual to make decisions while competent and these will be binding in any subsequent period of incapacity. Although there is no English legislation giving statutory effect to advance directives, the House of Lords Select Committee on Medical Ethics has endorsed the use of advance directives as a way of enabling patients to express in advance their individual preferences to medical treatment in the event they become subsequently incompetent52. In Malaysia, advance directives for medical treatment have yet to be given any formal recognition53. Even though, advance directives has considerable theoretical attraction, due care must be given to the consequences of these directives. For instance, an individual refusing treatment for a physical condition in advance might or might not have refused a new treatment for the condition, discovered after the directive have been made54. Thus, it is imperative that before advance directives are given formal recognition, it has to be ensured that proper safeguards are introduced. Conclusion The common law is clear in that a competent adult patient once properly informed, has the unassailable legal right to refuse medical treatment. However, problems can arise on the issue of capacity to consent to or refuse treatment. Assessment of capacity requires the patient to comprehend the nature of the particular conduct in question and to understand its quality and consequences. Once the patient understands the nature, purpose of the proposed treatment, and the risks and likely prognosis involved in the decision to refuse or accept it, the patient achieves the required capacity to refuse the proposed treatment. In such circumstances, medical professionals should ensure that the advice given to the patient should be recorded together with written, unequivocal assurances from the patient that the refusal represents an informed decision.
1 Justice Benjamin Cardozo, in Schloendorff v Society of New York Hospital 105 NE 92 (NY 1914) stated that '[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages.' 2 Self-determination involves (1) the right to consent to treatment, to decide who shall treat and to choose the form of treatment; and as a corollary (2) the right to refuse consent. 3 A battery takes place when there is non-consensual touching. In Wilson v Pringle [1986] 2 All ER 440, the Court of Appeal suggested that the touching must be 'hostile' in order to constitute battery. The court was prepared to adopt a very wide view of hostility so as not to confine to acts of ill will but a little more than non-consensual touching. The reason for this is the need to eliminate actions in battery as a result of physical contact, which is generally acceptable in the ordinary conduct of everyday life. See further, Re F (Mental Patient: Sterilisation) [1990] 2 AC 1. 4 [1993] 1 All ER 821; [1993] AC 789. 5 [1993] 1 All ER 821 at p 866. 6 [1992] 2 FCR 861. 7 Ibid. at p 865. 8 [1997] 2 FCR 541. 9 Ibid. at p 549. 10 This requires patient to be given 'sufficient' information about the treatment. 'Sufficient' information has been interpreted as explaining the material risks inherent in the treatment. However, the assessment of material risks depends on whether the 'reasonable prudent doctor test' is applied (Sidaway Board Governors of Bethlem Royal Hospital and the Maudsley Hospital [1985] 1 AC 871, or the 'reasonable prudent patient test' as enunciated in Rogers v Whitaker [1992] 175 CLR 479. For further reading on this issue, see Puteri Nemie, JK 'Abandoning the Bolam principle in Doctor's Duty to Disclose Risks in Malaysia: Are we heading in the right direction?' [2007] 1 Law Review pp 5-16. 11 Consent must be given through the patient's own free will, with no duress or undue influence. See Freeman v Home Office [1984] 1 All ER 1036 and Re T (Adult: Refusal of Medical Treatment) [1992] 3 WLR 782. 12 See I Kennedy & A Grubb, 2000, Medical Law (3rd Ed) London: Butterworths, at pp 122-123. 13 [1994] 1 All ER 819, [1994] 1 WLR 290.

14 Some of these common law principles have been reproduced in English statutes such as the Mental Capacity Act 2005 and amendments to the Mental Health Act 1983. 15 [1989] 2 All ER 545. 16 [1994] 1 All ER 819, [1994] 1 WLR 290. 17 [1994] 1 WLR 290, at p 295. 18 Ibid. 19 The low level of comprehension that the test for capacity entails means that most patients will be competent to consent. In Re JT, the patient suffered from a severe learning disability with sufficiently disturbed behaviour to justify detention under the Mental Health Act 1983. Nevertheless, she as entitled to refuse dialysis treatment for kidney failure, as she understood that she would dies, had made a 'calm and rational' decision and was consistent in her choice to die. 20 [1997] 2 FLR 426. 21 At the moment, the Ordinance regulates the law for the mentally ill in West Malaysia. 22 The Mental Health Act 2001 has said to comprehensively cover all aspects of mental health care by consolidating the laws relating to mental disorders and to provide for the admission, detention, lodging, care, rehabilitation, control and protection of persons who are mentally disordered and for related matters. At this time, the 2001 Act has yet to come in force notwithstanding it received Royal Ascent on 6 September 2001 and was published in the Gazette on 27 September 2001. 23 Section 77. 24 The requirement for informed consent marks the influence of Principle 11 of the United Nation Principles for the protection of persons with mental illness. 25 Section 77(1)(b). 26 Section 77(1)(c). 27 [1979] QB 276. 28 Ibid. at p 279. This case was subsequently followed by C v S [1987] 1 All ER 1230 and Re F (in utero) [1988] 2 All ER 193. 29 [1992] 4 All ER 649. This case concerned a pregnant patient who had been involved in a car accident and had refused blood transfusion during hospital treatment which she claimed was contrary. 30 Ibid. at p 653. 31 [1992] 4 All ER 671. 32 Although Re S has never been appealed, in English legal circles it is generally believed that this decision was discordant with previous case law, and also with the Congenital Disabilities (Civil Liabilities) Act 1976 which gives a child after birth the right to sue anyone who has caused it pre-birth injury, except for its own mother. 33 [1997] 2 FLR 426. For facts, see above. 34 (1997) 34 BMLR 16. 35 Ibid. at p 19. 36 [1997] 2 FCR 541 at p 561. 37 Ibid. 38 [1998] 2 FLR 528. 39 [2006] EWHC 1230 (Fam).

40 [1997] 2 AMR 1382. 41 [1998] 7 MLJ 481. 42 [1999] 6 MLJ 738. 43 [1979] QB 276. 44 [2005] 5 MLJ 480, see para 19. 45 Ibid. 46 Supra. 47 [2000] 2 FLR 389. 48 This decision was heavily influenced by the case of Bolitho v City Hackney Health Authority [1997] 4 All ER 771. 49 [2000] 1 FLR 549. 50 Ibid. at p 560. 51 Norchaya Talib, 2002, Euthanasia -- A Malaysian Perspective, Kuala Lumpur: Sweet & Maxwell Asia, at p 53. 52 Ibid at p 54. Report of the Select Committee on Medical Ethics, HL paper 2-I of 1993-94 at paragraphs 263-267. 53 From a personal interview with the relevant person from Gleneagles Hospital in Kuala Lumpur, it is mentioned that the hospital will take into account the wishes of the patient in the event an advance directive is drawn up. 54 See P Bartlett & R Sandland, 2003, Mental Health Law: Policy and Practice, (2nd edition), London: Oxford University Press, at pp 602-603. These problems have also been highlighted by officials from the Malaysian Medical Association and the Malaysian Medical Council, see Norchaya Talib, 2002, Euthanasia -- A Malaysian Perspective, at pp 121-122.

Malayan Law Journal Articles/2004/Volume 2/CONTEMPORARY LEGAL AND ETHICAL DILEMMAS RAISED BY ADVANCEMENT IN MEDICINE, SCIENCE AND TECHNOLOGY [2004] 2 MLJ i Malayan Law Journal Articles 2004

CONTEMPORARY LEGAL AND ETHICAL DILEMMAS RAISED BY ADVANCEMENT IN MEDICINE, SCIENCE AND TECHNOLOGY
Dr Puteri Nemie Jahn Kassim Assistant Professor Ahmad Ibrahim Kulliyyah of Laws International Islamic University Malaysia Jalan Gombak, 53100 Kuala Lumpur, Malaysia Introduction The late twentieth century depicts medical practice as being technologically advance-orientated environment. These rapid developments in medicine, science and technology have awakened many moral and legal questions. The law is required to establish rights and responsibilities in this developing area but how far has the law managed to keep pace with advances in medicine and medical technology is a question to be answered. A

host of legal problems have arisen from various medical processes such as in vitro fertilization, freezing of embryos, genetic engineering, organ transplant and artificial insemination. The court is faced with the daunting task to make decisions in these areas where there exist conflicts of moral, ethical and religious values. In many cases, the legal outcome may not always be the same as the ethical perspective as the law, being an instrument of social regulation, has a more intrusive or coercive function. Consent to treatment Advances in medicine, science and technology has saved and improved the quality of lives of thousands of people each year. But these advances have led to situations where medical practitioners are unclear about their ethical and legal obligations to particular patients. This is evident where the law of consent allows patients to opt for high-risk operations when doctors are ethically bound by the principle of beneficence in ensuring that the patient's life is not being put in jeopardy. As a general rule, medical treatment, even of a minor nature, should not proceed unless the doctor has first obtained the patient's consent. Lord Goff in Re F (Mental Patient: Sterilisation)1 stated that "it is well established that, as a general rule, the performance of a medical operation upon a person without his or her consent is unlawful, as constituting both the crime of battery and the tort of trespass to person."2 However, with the demands of patient autonomy and the right to self-determination, patient's consent will only be legally valid if the consent is informed in nature. In other words, the validity of the consent must now be based on the patient's knowledge of the nature, risks, consequences and alternatives associated with the proposed therapy.3 Once the required information has been given to the patient, the patient "has an absolute right to choose whether to consent to medical treatment, to refuse it or to choose one rather than another of the treatments being offered."4 However, problem arise when there is a conflict between the right of a patient to opt for a treatment once the consent is valid and the ethical principle of beneficence of "doing the least harm to the patient" which must be strictly adhered to by medical professionals. Such is evident from recent case of the conjoined craniopagus twins, Ladan and Laleh Bijani who travelled from Iran to Singapore with fervent desires to live separate lives. With the advances in medical technology5, a team of doctors believed that the operation had a reasonable chance of success. It was an unprecedented surgery as no one had attempted such separation on adult conjoined twins of 29 years. The operation turn out to be unsuccessful and when the Bijani twins died, many argued that the operation was not proper as the risks were too high. From a legal perspective, the operation on the Bijani twins would be regarded as proper as the consent given was valid. They were competent to give a valid consent. Before the operation took place, the twins spent months with psychologists. They understood what they were in for; they understood what the outcome would be. They knew the risks were high, they knew the result could be the death of either of them or both, or severe disability or vegetative state. They were told the reasonable chance of a good outcome, they were conversant with all the risks, and they opted for the operation. The legal point of view would discard the irrationality of their decision if the consent given was legally valid. In Re T (An Adult: Medical Treatment)6, Lord Donaldson stated that "[t]he patient's right of choice right of choice is not limited to decisions which others might regard as sensible. It exists notwithstanding that the reasons for making the choice are rational, irrational, unknown or even non-existent." Ian Kennedy further reiterated7 that: "...if the beliefs and values of the patient, though incomprehensible to others, are of long standing and have formed the basis for all the patient's decisions about his life, there is a strong argument to suggest that the doctor should respect and give effect to a patients' decision based on them. That is to say the doctor should regard such a patient as capable of consenting (or refusing). To argue otherwise, would effectively be to rob the patient of his right to his own personality, which may be far more serious and destructive than anything that could follow from the patient's decision as regards a particular proposed treatment." From the ethical point of view, some ethicists claimed that the operation should not have taken place, as the risks were too high. Fifty-fifty chance of success is not a good sign to proceed with an operation. The central tenet of medical ethics is first "to do no harm" and if the result of the operation could be either the death of one of the twins or both, then the doctors should not have agreed to go ahead with the surgery. Such legal and ethical dilemmas are currently present in such surgeries. It is undeniable that advances in medical science may, at times, contribute to over-optimism. But it has to be remembered that contemporary technologies should not be looked at as bestowal of miracles. Euthanasia and Assisted Suicide

The law relating to euthanasia and assisted suicide have been considered morally acceptable in certain compelling circumstances but the law has yet to reach a perfect balance. The word "euthanasia" refers to the means of inducing or bringing about a gentle and easy death.8 Euthanasia can be characterised as voluntary and involuntary. Voluntary euthanasia denotes that it is performed with the consent of the recipient whereas non-voluntary euthanasia occurs where the person concerned has been unable to express an opinion, usually because she lack the capacity to do so. Usually, her relatives will consider whether it is in her best interests to end her life at that time.9 Recent advances in medical technology have made it possible to maintain the works of some bodily functions. This is normally done through what is known as life support machines. For patients who are totally dependant on such machine, living may amount to little more than survival. Life may have been saved but only because dying has been prolonged, the quality of life is questionable. The crucial question raised by this situation concern exactly how death is defined. In other words, at what stage death has occurred.10 The traditional criterion of death was the cessation of respiration and circulation. However, this criterion of death was not considered satisfactory with the advent of technology capable of artificially sustaining one's vital signs even though the brain ceased functioning. To solve this problem, death has been redefined as requiring whole brain death including the brain stem. Brain stem death refers to situation when part of the brain, which operates respiration and heartbeat, are dead and there is no electrical impulse, that is, irreversible loss of brain stem function. Consciousness or sensate awareness will have decayed. The patient is considered to have no capacity to live and will not recover from it.11 This occurred in the Karen Quinlan case.12 Karen Quinlan, a young woman suddenly stricken illness, lay in a coma attached to a life-support machine and presented a terrible dilemma to her family and hospital authorities. Although she was not dead by the applicable medical criteria for determining brain death, the medical authorities were satisfied that there was no hope that she would ever return to a cognitive state; she was characterised as being in a "chronic, persistent, vegetative condition" kept alive only with the assistance of the respirator. Her parents decided that it would be best for her to be removed from the life support machine. The father applied to the court for this purposes. The Supreme Court of New Jersey upheld her father's claim and concludes that since there was no reasonable possibility of her ever emerging from her comatose condition to a cognitive state, the life support equipment should be discontinued. The judgment in Quinlan was greeted with mixed reactions. Those who are in favour of euthanasia consider it as respecting patient's right of self -determination. Those who are against euthanasia in any form argue that there is no certainty regarding death. Many terminally ill patients have known to recover and maybe in future modern technology may find a cure for a terminal disease. Furthermore, there is value and dignity in every human life. Thus, it can be seen that the availability of these high technology equipments in prolonging the life of the dying has profound implications on the patients, their relatives, dependants and medical carers. This dilemma raises legal, social and ethical questions to which there are no easy solutions. Organ transplantation Organ transplantation is the medical procedure whereby living tissue from a human body is removed from that body and transferred to another part of that body or to another person. This procedure is undoubtedly one of the triumphs of modern medicine. The procedure has become increasingly routine as means of saving and improving the quality of the lives of thousands of people each year. However, transplant activity is increasingly constrained by the shortage of organs, a phenomenon affecting every country that has developed the ability to undertake this form of surgery. The living donor is an important source of procuring important organs for transplant especially for certain tissues that can only be procured from live donors such as bone marrow, skin and blood. However, legal problems that need to be solved for live donation are questions on consent, whether the consent was given freely and not under duress, whether the risks were explained to the donor and whether any payment is involved.13 The major ethical dilemma in living transplantation is how far is it permissible to expose a person to harm or the risk of harm, in order to benefit another? Respect for persons dictates that a person should not be used as a means to another's ends. But the lack of cadaveric donors has made living donors an important source of procuring organs for transplant. Recently, much research effort has gone into the possibility of xenografting, which literally involves the use of organs and tissue taken from non-human animals. In other words, xenotransplantation is a kind of organ transplantation where other mammals' organs like pig14 or baboon's heart15 are used for transplant into human beings. The high degree of evolutionary relatedness between human beings and some mammals suggests that such procedure might be successful. However, xenotransplantation of animal organs and tissue carries with it

the potential risk that diseases will be transmitted from animals to xenograft recipients and to a wider human population. It is difficult to assess this risk, since it is impossible to predict whether infectious organisms that are harmless in their animal host will cause disease in human xenograft recipients or whether the disease will spread into the wider population. Thus, it is not possible to predict or quantify the risk that xenotransplantation will result in the mergence of new human diseases. Such consequences are clearly far-reaching and difficult to control. Human Cloning Cloning is the technique of producing a genetically identical duplicate of an organism. A clone is thus asexual progeny of a single individual.16 The birth of Dolly the lamb in 1997 sparked one of the most controversial furors to affect the discipline of medical law and ethics. Dolly was the first example of an adult vertebrate cloned from another adult. She was created using a "fusion" techniques whereby the nucleus from an adult cell was fused with an unfertilized egg from which the nucleus was removed. This egg was then transplanted into a normal sheep for normal gestation to take place.17 The main advantages of experiments on cloning would appear to be the identification of biomedical and physiological controls which might allow the reconstitution of an organ from a small number of cells. This can be particularly helpful as it may offer greater insights of cancer and other cellular development processes such as ageing and cell commitment.18 However, these developments have raised the possibilities of human cloning. The notion that human beings could clone themselves and have children who share precisely the same genetic make-up undoubtedly evokes widespread fear and repugnance. An important aspect that might be foreboding is that if people were "manufactured" in this way, deep-rooted notions of human dignity might be placed in jeopardy.19 The traditional familial hierarchies and relationships would be distorted and the production of human clones may be used as sources of spare parts. Genetic engineering The term "genetic engineering" is used here to encompass any manipulation of an early embryo (including testing it for its genetic traits and deciding whether to implant it), which has consequences for the characteristics possessed by the child that is subsequently born. In this regard, an important distinction may be drawn between the positive and negative forms of such engineering. Negative genetic engineering is aimed at elimination disabilities associated with genetic defects. At present, it requires that couples at risk of passing on genetic diseases to their children undergo IVF treatment, and the embryos produces are subjected to "pre-implantation genetic diagnosis." Only those embryos free of the genes associated with the disease will be implanted, while the other ones are discarded.20 Positive genetic engineering, on the hand, seeks to introduce new genetic elements, not naturally present in an embryo, in order to produce a child with certain positive attributes desired on the part of its parents. There are various causes for concern in genetic engineering, particularly, positive genetic engineering. One concern is the deliberate use of genetic engineering for perverted ends. The other concern is the accidental side effects of well-intentioned uses. One problem that may be overlooked is some genetic linkage between different characteristics. In choosing genes for high intelligence, one may inadvertently choose genes for high levels of aggression and depression. All technology carries with it risk of mistakes and unwanted side effects. In such cases, the "mistakes" will be human beings. There is also the risk of disasters, which are irreversible, that is, "mistaken" genes would be passed on to future generations. Reproductive technologies Advanced medical processes have introduced many modern reproductive techniques, which allow conception to occur without resorting to normal sexual intercourse. These artificial reproductive methods have helped many couples having difficulty conceiving naturally to have children. The most common and oldest method to deal with infertility is artificial insemination, which is a technique whereby a man's sperm is mechanically introduced into the woman's vagina with the intention that conception should take place. However, reproductive technologies that allows donor sperm or ovum to be used to achieve pregnancy has caused genetic, gestational and social parenthood to be separated, with the result that children can have a number of parents. The use of donated gametes and embryos raises issues about the interests and needs of children by donation to be told about their genetic background.21 Legislation22 ensuring that the social parents are the legal parents helps to reinforce the secrecy that has surrounded conception using donor gametes or embryos. If the child were not told of his or her conception by her parents, he or she would be entirely unaware of her genetic makeup, as birth certificates are issued in the name of the legal parents not the genetic parents.23 Thus, a quest for "normality" can result in secrecy and dishonesty. Nevertheless, secrecy and the anonymity of the

donor has been the cornerstone of assisted reproduction using donor gametes. Secrecy stems from fear that the child may reject the social parents, fear that the donor may interfere in the child"s upbringing, and fear of stigmatisation and societal disapproval. Anonymity implies that conception by donation is a furtive and "unnatural" way of forming a family, rather than simply one method of family formation. The state is also party to secrecy by issuing birth certificates in the name of the social parents with no notification on the register of the genetic parents. Those who undergo medically assisted conception using donor gametes or embryos tend to view the procedure as medical treatment and want to blot out the involvement of the donor. However denial and secrecy can lead to problems within the family. Secrecy carries the danger that a child by donation will discover his status and, as a consequence, never trusts his parents again. It is much better if parents are open about the means of conception and for the children to have knowledge of their medical history. Children by donation should have a right to know the identity of their genetic parents.24 There was an acknowledgement that medical history would be needed 25 but not a recognition that there is a desire to know one"s genetic origins for the sake of forming one's own identity.26 Conclusion Medical technology advances inexorably and it does so in an ambience of rapidly changing societal values. It is the function of the law to interpret and to reflect public attitudes. Legal as well as ethical dilemmas were always involved in medical developments but only recently they have been perceived as questions that could be taken to the courts for decision. Legal intervention in medicine is deemed necessary and to some extent inevitable. Developments will always be taking place in medicine and the legal outcome may not always be the same, as some would suggest it from a philosophical perspective. However, the law, even if it is an imperfect and often inaccessible weapon, is at least one of the means of controlling medical practice in the interests of the community as a whole.
1 [1990] 2 AC 1. 2 Similar sentiment can be found in the judgment of Mr Justice Benjamin Cardozo in Schloendorff v Society of New York Hospital (105 N.E. 92 (N.Y. 1914)), where His Honour stated that "[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages." 3 See Chester v Afshar [2002] 3 All ER 552; Rogers v Whitaker (1992) 175 CLR 479; Chappel v Hart [1998] 156 ALR 517. 4 Re T (Adult: Refusal of Medical Treatment) [1992] 4 All ER 649, at pp. 652-653. 5 The advent of imaging technologies such as CT scan, MRI, and angiogram has made it possible to separate conjoined twins and give them hopes for a better life. 6 [1992] 2 FCR 861 at 865. 7 "Consent to treatment: the capable person" (1992: Oxford, Blackwell Science), at p. 56. 8 In other words, death without suffering. 9 Active euthanasia occurs whenever positive steps are taken which result in death such as injecting a lethal dose of medication into the patient. Assisted suicide, where one person offers another assistance required to bring about his or her suicide, is also described as a form of active euthanasia. Passive euthanasia, on the other hand, occurs where available measures to prolong life are withheld from the patient such as withholding supply of fluids and nutritional feeding. 10 If the patient is dead, it is easier to take a decision to cease treatment and switch off the machine. 11 De Cruz, Peter, Comparative Healthcare Law, 2001, London: Cavendish Publishing, at p.297. 12 In re Quinlan (1976) 355 A. 2d. 647. 13 In England, donation from living donors is regulated by the Human Organs Transplant Act 1989 which was passed to stop payments for organs which are then used for transplants. The Act also seeks to criminalise the commercialization of live donor transplantation. In Malaysia, living donors are not protected under any statutory enactments. The Malaysian Human Tissue Act 1974 only regulates removal of organs from dead donors.

14 Pig's heart has been used successfully for humans but there has not been any success with transplantation of other animal organs. 15 In 1984, a Californian infant, Baby Fae, survived only three weeks with a baboon's heart. 16 "Dolly" the sheep was produced by CNR cloning in Scotland in 1997 and in February 2002, it was announced in Texas that a kitten had been cloned in the same way. 17 Mason, J.K. & McCall, S. 2002. Law and Medical Ethics. London : Butterworths, at p. 233. 18 Cloning Issues in Reproduction, Science and Medicine, A Consultation Document, Human Genetics Advisory Commission and Human Fertilisation & Embryology Authority, Department of Health, 1998. 19 As regards to the law, the creation of an embryonic human clone by nucleus substitution is prohibited by section 3(3)(d) of the Human Fertilisation Embryology Act 1990 (England). Later, the Human Reproductive Cloning Act 2001 (England) prohibits placing a CNR cloned embryo in a woman's uterus. 20 In 1999, this practice was the subject of a consultation document, Pre-Implantation Genetic Diagnosis, prepared by the HFE Authority and Advisory Committee on Genetic Testing, which concluded that it was justified, at least in the case of serious genetic diseases such as cystic fibrosis. 21 Legislators in England and in Australia first responded to technological advances in reproduction by addressing the status of children born where donor gametes were used. Even those states in Australia that do not have legislation on assisted reproduction have legislation dealing with the status of children born from donor gametes or donor embryos. In England, sections 27 and 28 of the Human Fertilisation and Embryology Act 1990 (HFE Act) determine who a child"s legal parents are. Section 27 provides that the gestational mother is the legal mother. In most cases the gestational mother also intends to be the social mother. Where treatment takes place at a licensed centre in accordance with the HFE Act, and the woman"s husband or partner consents to the treatment, he is the legal father. 22 In Australia amendments were made to the federal law in 1983 to deal with the status of children born using donor gametes or embryos; these are contained in section 60H of the Family Law Act 1975 (Cth). The legislation provides that where a child is born as a result of medically assisted reproduction using donor gametes, the woman who gave birth to the child is the legal mother and if her husband or partner consented to the procedure he is the legal father. The Australian states followed with their own status of children legislation. If the treatment is without his consent, then he might still be the legal father under state law. Federal and state legislation provide that the donor has no legal rights or responsibilities toward the child. 23 It is estimated that less than 5% of parents of children conceived by donor insemination tell their child of their conception. See M. Rayner, "The Child"s Right to an Identity" Rights Now, December 1998, at p 20. 24 In Australia committees of inquiry have generally supported disclosure within the family of the facts of the conception of a child by donation. The committee of inquiry that took place in the state of Victoria emphasised the importance of parents in being honest and open about donation. A recent discussion paper of the South Australian Council on Reproductive Technology included amongst its recommendations that recipients give an undertaking to tell their donor offspring of their method of conception. 25 For instance, information about whether or not the child by donation and the person he or she propose to marry is related. 26 However, the Human Fertilisation and Embryology Act 1990 provides a compromise. Section 31 provides that the HFEA shall keep a register detailing the provision of treatment services and use of gametes. At the age of 18 a person may, after proper counselling, request information from the register. However, the Authority has the discretion to decide how much information children born from gamete and embryo donation may be entitled to.

Malayan Law Journal Articles/1999/Volume 1/RIGHT TO LIFE UNDER THE FEDERAL CONSTITUTION AND ENVIRONMENTAL ISSUES [1999] 1 MLJ lx Malayan Law Journal Articles 1999

RIGHT TO LIFE UNDER THE FEDERAL CONSTITUTION AND ENVIRONMENTAL ISSUES

Dr Abdul Aziz Bari Head, Department of Public Law Kulliyyah of Laws, International Islamic University Malaysia My colleague, Dr Abdul Haseeb Ansari, 1wrote in his article 2 published in this journal two months ago that:
In the Federal Constitution of Malaysia, there is no explicit right to a healthful environment. However, this right, like in other countries, falls within the ambit of art 5, which guarantees right to life and liberty. Thus, we can say that art 5 of the Federal Constitution of Malaysia implicitly recognizes the right to a healthful environment. There is a move in the country to amend the Constitution to explicitly provide for a right to a healthful environment. 3

Thus, in Dr Ansari's view, the right to live in a healthy environment is something implicit in art 5 of the Federal Constitution ('the Constitution'). In any case, he seems to prefer a more explictit provision guaranteeing a healthy environment to be inserted in the Constitution. This view has highlighted the scope and meaning of 'life' in art 5 as well as its significance in environmental issues. And it must be said that this is not the first time one comes across such a liberal interpretation of art 5. The Court of Appeal, in Tan Tek Seng v Suruhanjaya Perkhidmatan Pendidikan & Anor, 4 has also given a liberal meaning to art 5. However, before we deal with these views it is perhaps worth looking at the provision itself. Article 5 of the Federal Constitution -- which talks about liberty of the person -- is one of nine articles 5 under Pt II of the Constitution, under the title 'Fundamental Liberties'. This provision has been characterized as the 'most fundamental of all fundamental rights provisions (and available) to all persons, not just citizens'. 6 Apart from the right to life and liberty, 7 art 5 also provides the right to habeas corpus, 8 the right of an arrested person to be informed of the grounds of his arrest and legal representation 9 and the right to be produced before a magistrate within 24 hours of arrest. 10 The Constitution does not explain what it means by fundamental liberties. Neither did the Reid Commission Report; which contained the recommendations that laid the foundations of our constitution. Be that as it may, one could say that fundamental liberties, which are synonymous with human rights, are:
... those rights which are inherent in our nature and without which we cannot live as human beings ... together, they allow us to fully develop and use our human qualities, our intelligence, our talents and our conscience and to satisfy our spiritual and other needs. [These rights] are based on mankind's increasing demands for a life in which the inherent dignity and worth of each human being will receive respect and protection. 11

Article 5(1) of the Federal Constitution reads: 'No person shall be deprived of his life or personal liberty save in accordance with law'. It is a pity that Dr Ansari did not discuss this provision exhaustively before asserting that this particular provision implicitly includes the right to live under a healthy environment. Given the relatively pedantic approach taken by the Court of Appeal in Bakun's 12 case it is perhaps unlikely, at least for the moment, to expect the liberal approach taken by the Supreme Court of India in cases like MC Mehta, 13 Subash Kumar 14 and Virandra Gaur, 15 all of which have been included by the learned writer in his article, 16 to be followed here. In Bakun, the Court of Appeal acknowledged the natives' complaint came within the scope of 'life' under art 5(1) which:
... incorporates all those facets that are an integral part of life itself and those matters which go to form the quality of life ... . It includes the right to live in a reasonably healthy and pollution free environment. 17

Indeed, the court acknowledged that in Bakun 'there is deprivation of livelihood or one's way of life, that is to say, one's culture; there is deprivation of life itself'. But, the court ruled, all was done in accordance with law. 18 Obviously, there the Court of Appeal took a line similar to the one taken by the Privy Council 19 and the Federal Court 20 in relation to the need for the 'law' in art 5(1) to incorporate fundamental rules of natural justice. In practical terms, the right under art 5(1) remains an academic one for the natives. In Bakun, the decision revolved

around the question of whether the process to amend the Environmental Quality Act 1974 ('EQA') to exclude dams from the federal law was valid as it was done retrospectively and took away vested rights of the natives. At the High Court, the exclusion was held to be invalid. 21 But on appeal, the Court of Appeal overturned the decision on the grounds that: (i) from the constitutional viewpoint, the state of Sarawak had the exclusive jurisdiction to exclude the federal EQA; and (ii) the natives had no substantive locus standi to obtain declaratory relief. In Tan Tek Seng, 22 the Court of Appeal, by majority, had imported the liberal approach taken by the American and Indian courts which explained 'life' as 'something more than mere minimal existence' 23 and that life must, inter alia:
... at least ... include the protection of health and strength of workers, men and women, and of tender age of children abuse ... educational facilities, just and humane condition of work and maternity relief. These are minimum requirements which must exist in order to enable a person to live with human dignity and no state ... has the right to take any action which will deprive a person of the enjoyment of these basic essentials.24

In Tan Tek Seng, the court ruled that the expression of 'life' in art 5(1) needs to be given a broad and liberal meaning if the true intention of the framers of the constitution was to be implemented. 25 The court observed that it 'should keep in tandem with the national ethos when interpreting provisions of a living document like the Federal Constitution, lest they be left behind while the winds of modern and progressive change pass them by. Judges must not be blind to the realities of life'. 26 One could say that although in Tan Tek Seng, the liberal meaning of life has not been achieved in a direct way. It was in fact done through art 135(2)27 which is about the right of a civil servant to have a reasonable hearing before he or she is dismissed or reduced in rank: art 5(1) is not quite central in the case. It is submitted that the significance of the liberal meaning would have been greater had Tan Tek Seng specifically dealt with art 5. A critique of Tan Tek Seng has been made elsewhere 28 and thus need not be repeated here. But what needs to be said here in relation to art 5(1) is that there is no need to stretch the provision in order for the court to strengthen the doctrine of procedural fairness. With respect, the relationship between arts 5(1) and 8(1) 29 with art 135(2), which was central in Tan Tek Seng, was explained by the Court of Appeal in a rather convoluted manner. The same result could have been achieved in a straightforward and simpler manner as has been exemplified in Ekambaram a/l Savarimuthu v Ketua Polis Daerah Melaka Tengah & Ors. 30 In that case, Suriyadi J was able to mete out justice without going too far from art 132(2) which is, inter alia, about the power of the Yang di-Pertuan Agong to make regulations pertaining to the appointment and qualifications and other conditions of service for public servants. There the notion of fairness was explained in the light of the constitutional provision itself. It has been observed that the decision in Bakun was a 'missed opportunity to breathe dynamic force into the Malaysian Constitution'. 31 The decision 'was particularly unfortunate as, when the Constitution was drafted in 1956, environmental concerns were not even in the remote consciousness of the members of the Reid Commission and could hardly be identified as a subject head for inclusion in the Constitution's enumerated power list'. 32 Having noted that, however, it must be said that such a position does not mean that the Constitution is not environment-friendly. Perhaps one day we will have a situation where the right to life under art 5(1) would have a real significance. In the meantime, one could perhaps use other provisions in the Constitution. A positive development has emerged in a recent decision, Kerajaan Negeri Johor & Anor v Adong bin Kuwau & Ors, 33 where an issue which can be put under the environmental head was decided under art 13 of the Federal Constitution. The plight of the aborigines there was somewhat similar to that of the natives in Bakun. In Adong bin Kuwau, 34 the aborigines were claiming compensation pursuant to art 13(2). 35 There the state government had acquired land, which the aborigines claimed was their traditional ancestral land upon which they depended to forage for their livelihood. They submitted that the rights were accorded to them by the common law, statutory law 36 and fell within the ambit of proprietary rights under the Federal Constitution. 37 At the High Court, 38 it was held that the aborigines' rights over the land included the right to move freely about their land without any form of disturbance or interference and also to live from the produce of the land itself, though it is not to the land itself in the modern sense; such as the permissibility of leasing out, rent etc. The aborigines were therefore entitled to compensation under the Constitution. On appeal by the state government, the Court of Appeal affirmed the decision, saying that:

... deprivation of livelihood may amount to deprivation of life itself and that state action which produces such a consequence may be impugned on well-established grounds ... . 39

Despite the decision in Adong bin Kuwau, the fact remains that it is better to have an explicit provision spelling out the need to protect the environment. Indeed, this is the trend that is emerging at present. For example, the new constitution of Ukraine expressly declares that 'everyone shall have the right to the environment that is ecologically safe for life and health'. 40 Corresponding positions are also to be found in the Constitution of the Russian Federation, the Constitution of the Republic of Belarus and the Constitution of the Republic of Kazakhstan. 41 Apart from the emerging consciousness about the environment, such expression may have been due to the lack of environmental protection in international documents of human rights, most of which confine the notion of right to life to human existence and issues such as capital punishment, voluntary euthanasia, abortion and the like. 42
1 Associate Professor of Law, International Islamic University Malaysia. 2 'Right to a Healthful Environment as a Means to Ensure Environmental Justice: An Overview with Special Reference to India, Philippines and Malaysia' [1998] 4 MLJ xxv. 3 Ibid, p xli. 4 [1996] 1 MLJ 261. 5 These are art 5 (liberty of the person), art 6 (slavery and forced labour), art 7 (protection against retrospective criminal laws and repeated trials), art 8 (equality), art 9 (prohibition of banishment and freedom of movement), art 10 (freedom of speech, assembly and association), art 11 (freedom of religion), art 12 (rights in respect of education) and art 13 (rights to property). 6 Andrew Harding, Law, Government and the Constitution in Malaysia (1996) at p 209. 7 Federal Constitution, art 5(1). 8 Ibid, art 5(2). 9 Ibid, art 5(3). 10 Ibid, art 5(4). 11 Tunku Sofiah Jewa, Public International Law: A Malaysian Perspective (Vol 1) (1996), p 465. 12 Ketua Pengarah Jabatan Alam Sekitar & Anor v Kajing Tubek & Ors and other appeals [1997] 3 MLJ 23 (CA). 13 MC Mehta v Union of India & Ors AIR 1988 SC 1115. 14 Subash Kumar v State of Bihar AIR 1991 SC 420. 15 Virendra Gaur & Ors v State of Haryana 1995 (2) Supreme Court Cases 577. 16 Supra n 2 at pp xxxiv-xxxviii. 17 See the court's earlier decision in Tan Tek Seng [1996] 1 MLJ 261 at p 288H. 18 Supra n 12 at p 43E-I. 19 See Ong Ah Chuan v PP [1981] AC 648 at p 670. See also Andrew Harding, 'Natural Justice and the Constitution' [1981] 23 Mal LR 226. 20 See Che Ani bin Itam v PP [1984] 1 MLJ 113. See also PP v Lau Kee Ho [1983] 1 MLJ 157 and PP v Yee Kim Seng [1983] 1 MLJ 252.

21 [1996] 2 MLJ 388. 22 Supra n 4. 23 Per Fields J in Munn v Illinois (1877) 94 US 113 at p 142. 24 Per Bhagwati J in Bandhua Mukti Morcha v Union of lndia & Ors AIR 1984 SC 802 at pp 811-812. 25 Supra n 4 at p 288. 26 Ibid. 27 It reads, inter alia, 'No member of such a service as aforesaid shall be dismissed or reduced in rank without being given a reasonable opportunity of being heard: ...' . 28 See Abdul Aziz Bari, 'Administrative Law' in Sharifah Suhanah Syed Ahmad (ed), Survey of Malaysia Law 1996, pp 179-212, at pp 198-201. But cf V Anantaraman, 'Procedural Fairness in Dismissal Proceedings in Malaysia' [1996] 2 MLJ cxiii and B Lobo, 'Security of Tenure in Employment -- Constitutional and Proprietary Rights of Employees' [1996] 3 MLJ cxviii. 29 It reads: 'All persons are equal before the law and entitled to the equal protection of the law'. 30 [1997] 2 MLJ 454. 31 Gurdial Singh Nijar, 'The Bakun Dam Case: A Critique' [1997] 3 MLJ ccxxix at p ccxlii. 32 Ibid. 33 [1998] 2 MLJ 158 (CA). 34 Ibid. 35 This provision of the Federal Constitution reads, 'No law shall provide for the compulsory acquisition or use of property without adequate compensation'. 36 Aboriginal Peoples Act 1954. 37 Article 13(1) which reads 'No person shall be deprived of property save in accordance with law'. 38 [1997] 1 MLJ 418. 39 [1998] 2 MLJ 158 at p 164D-I. 40 See Deimann & Dyssli (eds), Environmental Rights Law, Litigation & Access to Justice (1995) at p 34. Ibid, pp 34-35. 41 Ibid, pp 34-35. 42 See Meron (ed), Human Rights in International Law -- Legal and Policy Issues (1984), pp 120-124. See also McDonald, Legal Rights in the Canadian Charter of Rights and Freedom (2nd Ed, 1989), pp 106-107.

Malayan Law Journal Articles/1994/Volume 3/WITHDRAWAL OF LIFE-SUSTAINING TREATMENT: A COMPARISON OF LANDMARK US AND UK CASES [1994] 3 MLJ lxxiii Malayan Law Journal Articles 1994

WITHDRAWAL OF LIFE-SUSTAINING TREATMENT: A COMPARISON OF

LANDMARK US AND UK CASES

Myint Zan Former Lecturer Faculty of Law, Universiti Kebangsaan Malaysia A recent news item stated that one American medical doctor, a Dr Jack Kevorkian aka 'Dr Death', was charged in a Michigan court (in the United States) for assisting terminally ill patients who had requested him to help bring about their deaths by means of a 'suicide machine'. Dr Kevorkian was charged under a newly promulgated Michigan law which prohibits anyone with knowledge that another person intends to commit suicide from either 'intentionally providing the physical means' or 'intentionally participating in a physical act' in which that other person commits suicide.1 In a related news item, it was stated that the Dutch Parliament had passed an euthanasia law which would exempt doctors from being criminally prosecuted in certain situations of 'mercy killing' of terminally ill patients. The exact contents and contours of the new Dutch legislation is not known as yet. The Oxford English Dictionary defines euthanasia as 'the bringing about of a mercifully easy and painless death for persons suffering from an incurable and painful disease'.2 Would Dr Jack Kevorkian's actions be exempted from criminal prosecution under the new Dutch law if he were to 'assist' the terminally ill patients in the Netherlands instead of in Michigan?3 The thrust of this article is not to discuss the practice of euthanasia or the issue of whether euthanasia should be legalized nor even to attempt at a fairly comprehensive definition of 'euthanasia' . It is merely to contrast the different decisions of the highest courts of the United States and the various courts and judicial authorities of the United Kingdom concerning the narrower issue of withdrawal of life support systems or termination of artificial feeding of food and water to a terminally ill patient or a patient who is in a 'persistent vegetative state' (PVS). In both cases, the requests to withdraw such treatment were made by the patients' parents. If a doctor or doctors, at the request of the patients' closest next of kin remove the artificial life support systems, be it concerned with breathing (respirator), feeding (gastronomy tube), or provision of water (hydration tube) would their actions amount to 'euthanasia'? More importantly would, or should, their actions be legally permissible? In the case of Nancy Beth Cruzan v Director, Missouri Department of Health4 the United States Supreme Court by a majority of one (in a 5:4 decision) decided that in the absence of clear, specific and prior expression from the patient herself that her life-sustaining treatment be removed or terminated, a request by the patient's family to that effect need not be honoured by the State of Missouri. It must be mentioned that Nancy Cruzan, who sustained severe injuries in a car accident in January 1983, was/is technically alive5 and was/is able to give 'reflexive responses to sound and perhaps to painful stimuli'.6 However the Missouri State Government and the US Supreme Court agreed that Nancy Cruzan was/is in a 'persistent vegetative state' although she was/is 'neither dead within the meaning of Missouri's definition of death nor terminally ill'.7 The majority of the US Supreme Court found that the state of Missouri's requirement that 'evidence of an incompetent individual's wishes as to withdrawal of life-sustaining treatment be proved by clear and convincing evidence' was not unconstitutional and Missouri could apply 'such standards in proceedings where a guardian sought to discontinue nutrition and hydration of a person diagnosed to be in a persistent vegetative state'.8 About five years before her accident, Nancy Cruzan had 'in somewhat serious conversation with her housemate stated that if she got sick or injured she would not wish to continue her life unless she could live at least half-way normally'.9 The Supreme Court of Missouri and the United States Supreme Court did take note of this fact but the US Supreme Court nevertheless affirmed the finding of the Missouri Supreme Court that 'the woman's desire to have hydration and nutrition withdrawn was not proved at the trial pursuant to the standard of clear and convincing evidence under Missouri law'.10 The majority also ruled that under the due process clause of the United States Constitution a state was not required 'to repose the right to judge whether an incompetent patient wishes to have life-sustaining treatment

withdrawn, with anyone but the patient herself'.11 It further held that 'a state was not required to repose a right of substituted judgement as to such decisions with close family members of the patient, and it could chose to defer to only the patient's wishes'.12 The difficulty with this part of the Supreme Court's ruling is that it did not take into account the fact that the patient in her present persistent vegetative state was unable to speak and unable to communicate her wishes in any way. And the majority of both the Missouri and the United States Supreme Courts considered Nancy Cruzan's expressed wish that she would not wish to 'continue her life unless she could live half-way normally' as falling short of 'clear and convincing evidence' required by the state of Missouri. In addition, the majority felt that Nancy Cruzan's 'statement to her housemate and other observations to the same effect ... did not deal in terms with withdrawal of medical treatment or of hydration and nutrition'.13 The majority's statement in this regard is 'literalism' par excellence without, one might venture to suggest, the legal or moral excellence which it should entail. John Paul Stevens J in a powerful dissent stated that the majority's 'focussing the entire inquiry as to whether an incompetent person would refuse medical treatment on the person's prior unambiguous expression of intent while competent afforded no protection to children, young people who were victims of unexpected accidents or illnesses, or elderly persons who either failed to decide or failed to explain how they would want to be treated'.14 The oldest15 and longest serving member of the (then) US Supreme Court16 the (now retired) William Brennan J also dissented. Brennan asserted that Missouri's 'general interest in someone's life which was completely abstracted from the interest of the person living that life could not outweigh the person's choice to avoid medical treatment' and also that 'an inability to withdraw life-sustaining treatment in the absence of clear and convincing evidence might discourage starting such treatment, which would impair rather than serve the state's interest'.17 Brennan J also stated that Nancy Cruzan 'had a fundamental right under the due process clause [of the United States Constitution], to be free of unwanted artificial nutrition and hydration'.18 Diametrically opposed to Brennan J's statements were those that could be found in the concurring opinion of Scalia J, who to us judicial and political liberals is at best a 'staunch conservative'. Declared Scalia J (over) confidently:
What was sought in the woman's case was indistinguishable from ordinary suicide; and even when demonstrated by clear evidence that a patient no longer wished certain measures to be taken to preserve her life, it was up to the citizens of Missouri to decide through their elected representatives, whether such wish should be honoured. ... American law had always accorded states the power to prevent suicide - including suicide by refusing to take appropriate measures to preserve one's life - by force if necessary.19

If one were to take Scalia's words to its (il)logical conclusion, what Nancy Cruzan's parents had sought all the way to the US Supreme Court was nothing more than 'assisted suicide' and they could be liable for 'attempted assisted suicide' if, as Scalia said, Nancy Cruzan's case was 'indistinguishable from ordinary suicide'. One trusts that Missouri's law enforcement officials have not taken Scalia J's opinions too seriously by looking into the possibility of charging Nancy Cruzan's parents with 'attempted assisted suicide' if Missouri (like in Michigan) does have a law prohibiting assisted suicide. For, in the writer's opinion, it is clear that there is a difference between what Jack Kevorkian had done20 and what Nancy Cruzan's parents unsuccessfully sought from the state of Missouri. It could perhaps be argued that Kevorkian provided the means, the opportunity, and facilitated the suicide by letting the patients self-administer (however, in the case of Hyde and according to the news item, Kevorkian himself 'administered' the carbon monoxide), some lethal liquid or carbon monoxide into their body by means of the 'suicide machine'.21 Nancy Cruzan's parents were only seeking to claim the common law right of refusal of treatment on her behalf based on her previous assertions that she would not wish to live unless she could 'act half-way normally'. A fortiori she would not have preferred to live in a persistent vegetative state. But as one who was in a persistent vegetative state she could not communicate her wishes. Hence the parental request to end the 'artificial intervention'. This is different from assisting suicide, even in the case of terminally ill patients, by providing the means such as poison gas or lethal liquids for the patients to administer to themselves or by direct administra-

tion by the assistant as in the Hyde case. Indeed it is also different from 'active euthanasia' where the doctors themselves administer the drug or initiate action to terminate their patients' lives with or without the patients' request or explicit consent.22 Needless to say, 'active euthanasia' is prima facie illegal in almost all countries of the world with the possible exception of the Netherlands if the 'euthanasia law' has come into force. Even under the Netherlands law, doctors have strict guidelines to follow and would have to justify, to the public prosecutor, in each and every case of active euthanasia, that their actions fall within the provisions of the euthanasia law. Be that as it may, the Cruzans' claim on behalf of their daughter was rejected by the Supreme Court. It was stated that with artificial feeding and supply of water, Nancy Cruzan could continue to live for another 30 years in a vegetative state since her illness was/is not terminal.23 As stated earlier, John Paul Stevens J (dissenting) in Cruzan drew attention to the fact that the state of Missouri's requirement for a clear, unambiguous and prior request to withdraw artificial feeding and provision of water from a PVS patient by the patient himself before he becomes PVS affords 'no protection to children, young people who were victims of unexpected accidents or illnesses'. A tragic case involving another young person is the case of Airedale NHS Trust v Bland,24 a case in which the United Kingdom's highest judicial authority, the Judicial Committee of the House of Lords ruled on the issue of the withdrawal of life-sustaining treatment in the case involving Anthony David Bland, a teenager who was 171/2 years old at the time he met with his accident in April 1989. Bland was crushed by the crowd in Hillsborough ground during the course of a football match in April 1989. He was described to be in a persistent vegetative state.25 So was Cruzan. Cruzan was described as being 'oblivious to her environment, except for reflexive responses to sound and perhaps to painful stimuli ' and 'suffered anoxia of the brain resulting in a massive enlargement of the ventricles filling with cerebrospinal fluid where the brain had degenerated and the cerebral cortical atrophy' was 'irreversible, permanent, progressive and ongoing'.26 Similarly Bland's 'lungs were crushed and punctured and the supply of oxygen to his brain was interrupted'. Bland 'suffered catastrophic and irreversible damage to the higher centres of the brain'.27 Bland 'cannot swallow and is fed by means of a tube, threaded through the nose and down into the stomach, through which liquefied food is mechanically pumped'28 and all medical witnesses and outstanding authorities in the United Kingdom were agreed on the diagnosis as well as on the prognosis: 'there is no prospect whatever that Anthony Bland will ever make any recovery from his present condition.'29 Cruzan also 'had no cognitive or reflex ability to swallow water or to maintain her daily essential needs, and would never recover such ability'.30 And, like Cruzan, it was expected that if such care and life-support systems continued, there was every likelihood that Bland would maintain his present state of existence for many years.31 Most importantly, Bland had never given 'any indication of his wishes should he find himself in such a condition'.32 At least in the case of Cruzan and though she did not directly state her wishes in terms of 'withdrawal of medical treatment or of hydration and nutrition' she did mention to her housemate that if sick or injured 'she would not wish to continue her life unless she could live at least half-way normally'.33 In Bland, it was not only Bland's parents but also the Airedale National Health Service Trust which acted as plaintiffs in applying to the Family Division of the High Court for declarations that they might '... Iawfully discontinue all life-sustaining treatment and medical support measures designed to keep [Bland] alive in his existing persistent vegetative state including the termination of ventilation nutrition and hydration by artificial means ...'.34 When the Family Court made the requested declaration, the Official Solicitor acting on behalf of Anthony Bland appealed against that decision to the Court of Appeal and when that appeal was rejected unanimously, the Official Solicitor appealed to the House of Lords. The House of Lords ruled that:
A doctor who had in his care a patient who was incapable of deciding whether or not to consent to treatment was under no absolute obligation to prolong the patient's life regardless of the circumstances or quality of the patient's life. Medical treatment, including artificial feeding ... could lawfully be withheld from an insensate patient with no hope of recovery ... provided responsible and competent medical opinion was of the view that it would be in the patient's best interests not to continue his life by continuing that form of medical treatment because such continuance was futile and would not confer any benefit on him. Furthermore, discontinuance of life support by the withdrawal of artificial feeding or other means of support did not amount to a criminal act because if the continuance of an intrusive life-support system was not in the pa-

tient's best interests the doctor was no longer under a duty to maintain the patient's life but was simply allowing his patient to die of his pre-existing condition and his death would be regarded in law as exclusively caused by the injury or disease to which his condition was attributable.35

Anthony Bland died a few days after the life-support treatment was terminated in accordance with the declaration. It should be immediately added that all three tiers of courts in Bland were emphatic that the granting of a declaration in this particular case did not open the doors for doctors to withdraw treatment, without first applying to the courts. Hence until the law changes or the British Parliament enacts new legislation, in every case of withdrawal of life support and medical treatment, an application would have to be made to the British courts for a declaratory relief similar to the one in Bland. At the same time and coming back to Cruzan, the concurring opinion of Sandra Day O'Connor J is worth mentioning. She declared that:
Nothing in the [US Supreme] court's decision precluded a future determination by the United States Supreme Court that the Federal Constitution required the states to implement the decisions of incompetent individuals' duly appointed surrogates or prevented the states from developing other approaches for protecting such individuals' liberty interest in refusing medical treatment.36

Hence, as per the caveats in both Cruzan and Bland, the United Kingdom courts and the United States Supreme Court and other courts may yet have certain roles to play in matters of 'life and death' as it relates to withdrawal of artificial life-support in cases of patients who are in a persistent vegetative state or those who are terminally ill. One final comment as to the possible differences in approach in Cruzan and Bland. In Cruzan, the US Supreme Court relied greatly on American constitutional doctrine, as it invariably does, whether the case before it involved the permissibility of abortion37 or the constitutionality of legislation mandating that 'equal time' and 'balanced treatment' be given to 'creationism' whenever evolution is taught in public schools.38 The UK courts did not appear to have 'constitutionalized' the issues, at least not to the extent that the US courts did.39 Nevertheless, the UK courts' judgments in Bland touched on issues dealing with the common law right to refuse treatment, doctor-patient-guardian relationship, aspects of criminal law and the parallel, if at times competing, claims of individual self-determination and state and society's interest to preserve life. It has a better perspective, is more perceptive and touches more extensively on a range of legal, philosophical and moral issues than the majority judgement of the United States Supreme Court in Cruzan. In the writer's opinion, the House of Lords decision in Bland is truly a land mark and is to be preferred to the majority decision of the US Supreme Court in Cruzan. None of the cases are in any sense binding on Malaysian courts. Indeed Malaysian courts have not hitherto being confronted with the issue of withdrawal of life-support treatment. In this context and in a related issue, Malaysia as yet does not have a 'living will' arrangement which, in effect, permits a person to explicitly, legally, and in advance of his possibly becoming PVS to refuse to accept any 'death-prolonging' treatment. The states of Victoria and South Australia in Australia as well as some American states including Missouri have laws allowing living wills. The double tragedy of Nancy Cruzan was that she did not made a living will before she met with her tragic accident.40 Would or should a 'living will' be accepted or honoured by Malaysian doctors or courts? (Let's face it: doctors are the first persons who would have to confront such an instruction from patients. And such a 'living will' need not be elaborate; some in the United States just carry a necklace with the words 'Do not resuscitate'.) What are the legal effects of such an instruction? Would doctors be subject to lawsuits and/or proceedings if they honour such requests from terminally ill or PVS patients? Would they be subjected to lawsuits and proceedings if they do not? What would/should medical doctors and the Malaysian courts do in cases similar to Cruzan or Bland where there is no prior unequivocal indication from the PVS patient and the patient's guardians wish to remove lifesustaining or death-prolonging treatment? Would or should doctors and courts honour such a request even if

the patient does so clearly and prior to his/her becoming terminally ill or PVS? In the light of the presence of sophisticated life-saving equipment and technology in Malaysian hospitals and medical centres, not all of the questions can be discounted or merely 'kept in view'. It is a cliche to say that there are no easy answers but the issues must be addressed first. 'Let's run and face the incoming danger (crisis)' was a slogan popular with the Burmese resistance in the first freedom struggle against British colonialism during the 1930s.41 Medical doctors from all fields, lawyers and legal scholars, religious, professional, academic and other bodies and ultimately, if need be, a Parliamentary committee could look into these issues which in the near or distant future could arguably come to the fore in Malaysia.
1 The New Straits Times, 4 May 1994 at p 21, reported under the heading, 'Doctor Freed of Assisted Suicide Charge' that Dr Kevorkian was charged in the 4 August death of Thomas Hyde, 30, who suffered from the degenerative nerve disorder, Lou Gehrig's disease. By the time Kevorkian hooked Hyde up to a canister of carbon monoxide on a mattress in the back of his old, rusty van, Hyde could barely walk, talk or feed himself. Dr Kevorkian, who had faced up to four years in prison and a US$2,000 (RM5,400) fine if convicted, acknowledged he supplied the carbon monoxide and placed the clear plastic mask over Hyde's nose and mouth. But it wasn't enough for the jurors to convict. Three jurors interviewed after the verdict concluded that Kevorkian's main intent was to relieve Hyde's suffering not to cause his death. 'We believe the intent was not to help Hyde commit suicide,' juror Gwen Bryson said. 'We believe it was to relieve pain and suffering.' Jurors said their sympathy for Hyde's suffering also played a factor in their verdict. 2 The New Webster Encyclopedic Dictionary of the English Language defines euthanasia as '[a]n easy death; a putting to death by painless means; a means of putting to a painless death'; and The Budget Macquaire Dictionary defines it as 'the putting of a person to death painlessly, especially a person suffering from an incurable and painful disease'. 3 Note that the query here is whether Kevorkian would have been exempted from criminal prosecution in the first place under the new Netherlands law and not as to whether he would have been acquitted under the Michigan law against assisted suicide as he eventually was. The Michigan law against assisted suicide was partly prompted by Kevorkian's previous actions before the Hyde case of 'assisting in the suicides' of terminally ill patients and was promulgated ostensibly with the purpose of deterring such actions. Dr Kevorkian, after his acquittal, stated (quoted in The New Straits Times, supra n 1) that 'he is still receiving letters from people who want his help, but refused to say whether he would resume his assisted suicide practice any time soon'. 4 [1990] US Supreme Court Reports 111 L Ed 2d 224, argued 6 December 1989, decided 25 June 1990. Hereafter cited as 'Cruzan'. 5 At the time of writing (July 1994) the writer was unable to verify whether Nancy Cruzan is or is not still technically alive. Hence the use of the qualifier was/is in discussing Nancy Cruzan's condition. 6 Cruzan, supra n 4 at p 225. 7 Ibid. 8 Ibid. 9 Ibid. 10 Supra n 4 at p 226. 11 Ibid. 12 Ibid. 13 Ibid. 14 Ibid. 15 William Brennan J was born in April 1906. 16 Brennan J was appointed to the Supreme Court by President Eisenhower in 1956. After serving 34 years on the Bench, Brennan J submitted his resignation to President Bush in July 1990 barely a month after the Cruzan decision was delivered on 25 June 1990.

17 Cruzan, supra n 4 at p 227. 18 Ibid. 19 Cruzan, supra n 4 at p 226. Compare (and instructively contrast) Scalia J's statement with that of Hoffman LJ's statement in Airedale NHS Trust v Bland [1993] 1 All ER 821 at n 40 (infra). 20 This is written without prejudice to the jury's acquittal of Kevorkian in the Hyde case supra n 1. 21 Supra n 1. 22 Compare the statement of Sir Thomas Bingham MR in the Court of Appeal in Bland, infra n 22 at p 835: '[Bland] is not about euthanasia, if by that is meant the taking of positive action to cause death. It is not about putting the down the old and infirm, the mentally defective or the physically imperfect. It has nothing to do with the eugenic practices associated with fascist Germany. The issue is whether artificial feeding and antibiotic drugs may lawfully be withheld from an insensate patient with no hope of recovery when it is known that if that is done the patient will shortly thereafter die.' The same remarks could be made about the Cruzan case as with all other genuine cases of withdrawal of life-sustaining or deathprolonging treatment from patients who, like Cruzan and Bland, are in a persistent vegetative state. 23 Cruzan, supra n 4 at p 231. 24 [1993] 1 All ER 821. Decided 12 March 1993, hereafter cited as 'Bland'. 25 Sir Thomas Bingham MR graphically described the condition of Anthony Bland thus (ibid at p 834): '... [Bland's] lungs were crushed and punctured and the supply of oxygen to his brain was interrupted. ... although his eyes are open, he cannot see. He cannot hear. Although capable of reflex movement, particularly in response to painful stimuli, the patient is incapable of voluntary movement and can feel no pain. He cannot taste or smell. He cannot speak or communicate in any way. ... Mr Bland lies in bed in the Airedale General Hospital, his eyes open, his mind vacant, his limbs crooked and taut ...'

26 Cruzan, supra n 4 at p 225. 27 Bland, supra n 24 at p 834. 28 Ibid. 29 Supra n 24 at p 859. 30 Cruzan, supra n 4 at p 225. 31 Bland, supra n 24 at p 835. 32 Supra n 24 at p 835. Bingham MR further stated in his judgement is not a topic most adolescents address'. Compare this statement of Bingham MR in Bland with that of the dissenting opinion of Stevens J in Cruzan in the text accompanying n 14 (supra). 33 Supra n 9. In Bland, supra n 24 at p 835, Bingham MR stated that '[a]fter careful thought [Bland's] family agreed that the feeding tube should be removed and felt that this was what Mr Bland would have wanted'. ( Emphasis added.) 34 Bland, supra n 24 at p 825. 35 Bland, supra n 24 at p 825. 36 Cruzan, supra n 4 at p 226. 37 See, eg Roe v Wade [1973] 410 US 113.

38 See, eg Edwin W Edwards v Don Aguillard [1987] 482 US 578. 39 In fact there were a few references to Cruzan in Bland, both in the House of Lords and in the Court of Appeal. In the House of Lords in Bland, supra n 24 at pp 888-889, Lord Mustill stated that 'a very similar problem [to that of Bland] arose in a different constitutional and legal framework [in Cruzan]'. In the Court of Appeal, Butler-Sloss LJ quoted with approval a passage from the dissenting opinion of Stevens J at pp 846-847. 40 Compare the discussion on this matter in the judgement of Hoffmann LJ in Bland, supra n 24 at pp 852-853 with that of Stevens J's dissenting opinion in text accompanying n 14 (supra). Part of Hoffmann LJ's statement reads: 'Some people make it clear in advance that, if they should fall into a state which seems to them in anticipation to be intolerable, they do not want life-sustaining treatment to be continued. ... But Anthony Bland expressed none at all. ... Does this mean that people who have not expressed their wishes in advance and are now [in their vegetative state] incapable of expression must lose all right to have treatment discontinued and that those caring for them are in every case under a corresponding duty to keep them alive as long as medical science will allow? ... To continue treatment is as much a choice as to discontinue it.'

41 As for the second freedom struggle of the Burmese, see Aung San Suu Kyi, Freedom From Fear and Other Writings (Michael Aris, editor) (1991, Penguin) at pp 199-204.