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

Australia Section 18(2) of the Patents Act excludes 'human beings and the biological processes for their generation'. The Healthcare sector that is equally impacted with overly broad patents established a committee to study the impact of IPRs and Genetics. benefit sharing and research outcomes. including stem cells.44 LEGISLATIVE FRAMEWORK ON THE PATENTABILITY (OR NOT) OF INVENTIONS INVOLVING 'HUMAN BEINGS'. In particular. but the resulting cell lines. there should be a differentiation between the composition of matter (the cells themselves) and the information to be gleaned from the composition of matter. which leads to differing contentions on this as is illustrated in two cases. and equitable access to healthcare. ie Claim 10 reads: A method of growing preblastocyst human embryos. 36 The monopolistic nature of patents raises concerns to the academics. the inventor claims to be the inventor not only of the stem cells themselves. this occurs when multiple blocking patents are granted over pre-market or 'upstream' research products.42 One particular example is the WARF patent. Canada and UK patent frameworks first before venturing into the European Patent Conventions and the European Patent Directive. particularly isolated genetic materials. potentially preventing labs with interest in stem cell research from engaging in even basic work on hES cells without first paying a license.41 The Committee opines that the race to patent genes and gene fragments. . The Act does not define 'human beings' or 'biological processes for their generation'. Fertilitescentrum AB and Luminis Pty Ltd45 and Woo Suk Hwang.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). Below are some of the examples of such provisions (not comprehensive). United States. patients being deprived of access to new techniques and drugs. 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.(iii) (iv) (v) patents35 resource use and knowledge sharing. etc. Typical of such provision is an explicit exclusion on human cloning. The reason for this is that in lieu of the divergent approaches in the European member countries.37 In the context of gene patents. 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 main claim of the patent application. Some national and regional patent law has specified what form of human biological inventions is patentable and what is not in their patent law. 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. 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.39 On this. in its claim # 9. 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). that researchers and carers will not share information.46 In Fertilitescentrum AB and Luminis Pty Ltd. The WARF patent makes extraordinarily broad claims as to many aspects of hES cells as they are discovered in their embryonic environment. and equally that there could be premature commercialisation in the race to get ahead. the two regional instruments require deeper elaboration.38 The cost and inconvenience of obtaining multiple licences to use these upstream products in marketable or 'downstream' research may stifle research and innovation. may lead to the increase of cost. This article would start with Australia.40 The Council recommended that the granting of over-generous patents with broad claims in this important field should be discouraged. A concern also shared by Glen Mc Gee in his study on embryonic stem cell patents. human body or a natural substance isolated from a human body such as genes. the Nuffield Council on Bio-ethics has earlier cautioned of the evils of conferring broad patents on stem cells in 2000. in the science and medical community.

processed for cloning by replacing nuclear DNA. 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. resulting in greater success in implantation. Another important point is that the full status of human being is not acquired until birth. 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. the Deputy Commissioner noted that: . The embryo is created by transferring the nucleus of a human cell into a bovine ovum and thereby activating the ovum. there is little doubt that a human life is created at fertilisation. He adds further that human life is still being generated up to at least the sixteenth week. 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 Woo Suk Hwang. The Deputy Commissioner of Patent therefore concludes that Claims 10 to 23 are directed to a method of growing pre-blastocyst human embryos. The prohibition of 'biological processes' (for the generation of human beings) clearly covers all biological processes applied from fertilisation to birth -. 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. But to that extent there is a process of generation of a human being that lasts from fertilisation to birth. did not remove the method from the ambit of s 18(2). In this case. Firstly. 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. the embryo is a hybrid involving both human and bovine DNA. it was noted that there is no legislative or agreed societal definition of what constitutes a human being.so long as the process is indeed one that directly relates to the generation of the human being. Secondly. The method has clear advantages in better stimulating the natural environment. the application claimed a method of producing a hybrid embryo using inter-species nuclear transplantation techniques. He considered it to have at least SOME of the characteristics that go to make up a human being -. 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. and the mitochondrial DNA of the ovum was bovine. and babies of greater body mass and having fewer complications compared to IVF babies born without the benefit of the method -. which occurs at the twentieth week. In his view.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. For example.all of which demonstrates that the process is one that directly relates to the generation of a human being. Clearly. processes for fertilising an ovum. processes for cloning at the 4 cell stage by division. Specifically. there is no step of fertilisation per se. It is a method applied to a human embryo. He noted further that some legislation made a distinction between abortions and still-birth.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. 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.such that it properly falls within the ambit of the term 'human being'. 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). sufficient to require 'proper' disposal rather than as hospital waste. 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. there are two distinguishing factors. The fact that the ovum was artificially activated. The decision was that the claimed invention was contrary to s 18(2). Clearly a person that has been born is covered by this exclusion. On the same token. and reducing apoptosis of cells in the blastocyct. the Deputy Commissioner had also equated the artificial means of fertilisation as equivalent to biological processes to the generation of the human being. it being for a method of generating a human being. the Deputy Commissioner of Patents was of the view that a fertilised ovum and all its subsequent manifestations are covered by this exclusion.

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. does not recommend for revision of the Act and preferred the usage of terms that are technologically neutral. That is. It is clear that the nuclear DNA is intended to be entirely human DNA. it was noted that the embryo produced by the claimed process has both human and bovine DNA present. foetuses. cells. In his view. the embryo that is produced by this method -. 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. This leads to the ALRC further debating whether there should be special provisions dealing with embryonic stems cells. 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. 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. embryos or fertilised ovum. which essentially is relevant to the energy use of the cell. The Manual indicates that. The primary characteristics of mammals are governed by the nuclear DNA of the cells. the Australian Patent Office issued a Manual of Practice and Procedure (the Manual). the Congress passed a bill known as the Weldon Amendment which prevents the USPTO from issuing patents on a 'human organism'. including: (i) (ii) (iii) human beings.53 In 2004. The position of stem cells is however silent. certain inventions are 'clearly encompassed' by the exception. the activation of an ovum arises as a direct result of the fertilisation process. it is clear that fertilisation by a sperm is not the only way in which an ovum can be activated. the Australian IP Office made clear that human genes.while being hybrid -. Further. methods of invitro fertilisation or cloning methods that generate human beings.51 The Committee. and processes -. which to them appears to be in line with the Thirteenth . while the precise scope of the provision is unclear.In natural reproductive processes.50 The Deputy Commissioner is thus of the view that the invention is contrary to law and should be refused. in an attempt to codify the Patent Office's (USPTO) position on stem cells.52 On that basis. The mitochondrial DNA. foetuses and human beings but would not affect patents on genes. Clearly. however. tissue and other biological products. Many quarters welcome the Weldon Amendment. The definition of a hybrid embryo in the Act typically covers chimera as claimed by the patent application. tissues and cell lines are clearly acceptable based on the premise that they are not regarded as human beings. 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. 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). 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. 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'. However. 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. In his view. However. however. Section 18(2) deals explicitly with the human body. is entirely bovine. the difficult question of what constitutes a human being and when a human life would form remain unanswered. In answering the call.is properly described as human. The Committee. It was made clear that the provision would also ban patents directed to genetically engineered human embryos.beginning with fertilisation and ending with birth-that are wholly biological and result in a human being. whilst the harvesting of embryonic stem cells does not.

there is no federal law that prohibits the use of embryos in stem cell research. 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. The UK Patent Office noted the enormous potential of stem cell research. they are not patentable as the human body at the various stages of their formation and development.268. The plural term 'bodies' indicate that only the entire human body was encompassed by the exclusion and not its parts.60 The main thrust of the Act is to regulate research on embryos.301 and 5. 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. to deliver new treatments for a wide range of serious diseases. 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. and wherein said cell population differentiates into cellular lineages including primitive erythroid cells and definitive erythroid cells. and That in no circumstances. Whilst the stem cells themselves may be patentable. . there have been several patents on human stem cells that have been granted in the US. there are federal policies and legislations that limit funding of such research. Thus.59 Human totipotent cells have the potential to develop into an entire human body. US Patent Nos 5. the processes for obtaining stem cells from human embryos are not. Thus. 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. arise from further division of totipotent cells and do not have the potential to develop into an entire human body. 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. That if the HFEA is satisfied that such research is necessary (because it cannot be done in any other way). at least 2 patents have also been granted to the National Jewish Center for Immunology and Respiratory Medicine. stem and other cells. The '301 patent claims': A pluripotent cell population wherein said cell population is transformed with a HOX11 gene.874. (adult) cell lines or DNA sequences. the Patent Office will not grant patents for processes of obtaining stem cells from human embryos. Canada In Canada. [an immortalizing gene]. 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.914.58 a distinction is drawn between human totipotent cells and human embryonic pluripotent cells. on the other hand. they are excluded from patentability by para 3(a) of Schedule A2 to the Patents Act 1977. To them. the Canadian Bio-technology Advisory Committee (CBAC)56 recommended that 'human bodies at all stages of development' should not be patentable.57 The UK Patent Office As for the UK Patent Office. Currently. Human embryonic pluripotent cells.Amendment to the US Constitution. the Patent Office is ready to grant patents for inventions involving such cells provided they satisfy the normal requirements for patentability.55 Besides the WARF patent. However. CBAC explains that this recommendation only applies to entire human bodies such as zygotes to an adult body but does not include nucleotide sequences. should research on embryos run beyond 14 days or the appearance of the primitive streak. It was the view of the Committee that human beings are a metaphysical concept and not a biological one. 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. including embryonic stem cell research.54 In practice. prohibits any party from possessing property rights in a human being. which. gametes. On this basis. or organs that remain patentable.

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. 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. For that reason. consent and embryo status. 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.64 The two main provisions under the Directive are Article 5 and 6. cannot constitute patentable inventions. . five purposes are listed as approved.' It is no wonder that as of June 2006.65 Article 5 reads: (1) (2) (3) The human body. including the sequence of a gene. There was no explicit reference to stem cell research in the 1990 legislation. or for clinical trials of human therapies. and the simple discovery of one its elements. One criticism of the codes of practice is as to their framing of ethical issues largely in terms of donation. As one commentator put it. which is neither an absolutist statement of intrinsic value nor a wholly perspective open utility. and created by therapeutic cloning. created by IVF specifically for research purposes. As most embryonic stem cell research would fall under either one of the three new purposes. at the various stages of its formation and development. With the new Regulations. may constitute a patentable invention. 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.61 In furtherance to that the UK government set up a Stem Cell Bank62 and a Code of Conduct that governs it. 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. 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. the UK patent office has issued at least fourteen patents that are directed to or at least make explicit reference to hESC. These are: (a) (b) (c) (d) (e) promoting advances in the treatment of infertility increasing knowledge about the causes of congenital disease.In the 1990 legislation. which bears substantial similarity to Rule 23(d) and (e) of the European Patent Convention. or (c)Enabling any such knowledge about to be applied in developing treatments for serious diseases. the UK position is described as the 'proportional position' that affords the embryo a proportional moral status. An element isolated from the human body or otherwise produced by means of a technical process. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. such research was clearly allowed in the UK. including the sequence or partial sequence of a gene. or for basic research which underpins these aims. 1998. even if the structure of that element is identical to that of a natural element.63 The UK's approach is not entirely criticism free.

may not be regarded as a patentable invention. On the basis of paragraph 1. (b) Processes for modifying the germ line identity of human beings.69 Thus a limb. the following. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to public order or morality. Van Overwalle. was of the view that human stem cells as they appear in their natural environment would not be considered patentable. 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. lies in the technical intervention -. In 1995. 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. it was further clarified that the position of human genes would be no different than human cells. but simply detached. 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. however. (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. blood.70 The touchstone to decide whether or not elements of human origin are patentable or not. shall be considered unpatentable: (a) Processes for cloning human beings. of embryonic or foetal origin. removed or collected. whether they are to be considered as discoveries or not. 2. or organ. Some others have attributed the directive to be pushed primarily due to economic grounds. 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. 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. and also animals resulting from such processes. identified and reproduced outside the human body would not be excluded from patentability. the human intervention and (2) the way in which the biological material provides a technical solution for a technical problem. or a bodily fluid (eg sperm. with regard to the patentability of human stem cells. in particular. however.66 Thus.Article 6 reads: 1. In a common position adopted by the Council in 1991. human hepatocyte culture processes and methods for producing human antibody. there is an explicit exclusion for the patenting of human bodies or a natural element isolated from the human body. This distinction is important as patents have been granted in respect of human lymphoblastoid cell lines. What amounts to parts of a human body? According to a document dated 16 December 1992.71 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 .the isolation. 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.68 The position raises some doubt. (c) Uses of human embryos for industrial or commercial purposes. exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. tears or sweat) cannot be patentable. under the directive. whereas human stem cells which have been isolated.67 The Commission further stressed that this refers to parts of the human body as found inside the body.

or represent the use of a human embryo for industrial or commercial purposes. The European Parliament noted in particular that the creation of embryonic stem cells requires the destruction of the embryos. It was also made clear in the Directive that human DNA can only be patented in connection with a function. or the general prohibition of patenting of inventions deemed to be offensive to 'ordre public' or morality. there could be three potential objections to an application to patent human embryonic stem cells. 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. This is further clarified in 1994 to exclude only those which are contrary to the dignity of man. that covers frozen human embryos. a further resolution was entered in late 2005. 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'. selection and propagation of animal transgenic stem . either it could implicate the patenting of a human body. 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. It is commonly understood that the exclusion does not extend to somatic cell gene therapy. EP 1121015. All in all.of stem cells that require the destruction of embryos. and the grant of an European Patents. Processes For Modifying Human Germline Genetic Identity This is equally excluded under the directive. If the modification is for the purpose of correcting certain genetic deficiencies. such a process would be compatible to human dignity. 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. The Edinburgh Patent This relates to patent number 695 351 entitled 'Isolation. 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. 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. Wednesday) As the 98/44 Directive is silent on stem cells. The following discussion centers on both decisions. 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. 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. According to Recital 40. European Parliament Resolution on Patents for Bio-Technological Inventions (26 October 2005. These uncertainties were further clarified by a resolution passed by the European Parliament in 2005.

1 pursuant to Article 97(1) of the EPC.75 Wisconsin Alumni Research Foundation76 In this case. this would include human grants. the European Parliament soon after passed a resolution to condemn the grant of the patent.73 They can only contribute to and form parts of a developing organism upon integration into a host blastocyst. one major concern raised is that the methodology claimed and disclosed in the contested patent could be employed for the purpose of human cloning. said animal comprising a selectable marker capable of differential expression in (a) desired stem cells and (b) cells other than desired stem cells. embryonic stem cells cannot develop into an organism on their own. the method comprising: providing a blastocycst. The patent was granted to the Edinburgh University on 8 December 1999. 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. 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. Naturally. The resulting animal is genetically different from both the blastocyst and the embryonic stem cell donor. which could be used for the cloning of human beings. including germ cells. The Opposition Division clarified that. Therefore. and (iv) are prevented from differentiating when cultured on fibroblast feeded layer". However.74 Another point of attack is that although the claim covers cells from all animal species. at any stage in its formation or development. being absolutely distinct (both in strategy and utility) from cloning. A cell culture comprising primate embryonic stem cells which (i) are capable of proliferation invitro culture for over one year. cannot be patented'. and ectoderm tissues throughout the culture. the Examining Division of the European Patent Office refused the patent application No 96903521. As is mentioned earlier. 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. The correction related to the insertion of 'non human' before animal in claims 47 and 48. the experimental examples in the specification of the patent in suit only relate to mouse embryonic stem (ES) cell lines.cells'. whereas it is important to assert the principle that the human body. ie to human cell lines. a patent on isolation. the contested patent. (iii) maintain the potential to differentiate to derivatives of endoderm. the EPO call for opposition and a request to correct the decision to grant was filed by the University of Edinburgh. At the opposition division. selection and propogation of animal and transgenic stem cells. 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. providing animal cells according to any of claim 37-38. Claim 1 of the application reads: 1. The case is now before the Enlarged Board of Appeal for the determination of four questions of law: . This is achieved experimentally by nuclear transfer from a somatic cell into an enucleated oocyte. mesoderm. does not offend against Rule 23(d) of the EPC. 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. introducing the animal cells into the blastocysts. 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 patent in suit neither describes nor comprises nuclear transfer. Cloning is a process of asexual reproduction of an organism that creates multiple genetically identical copies (a clone) of the original. Furthermore. As the claim relates to animal cells. The OD concluded that only a broad interpretation of Rule 23d(c) could have been intended.72 Realising the controversial nature of the grant. it becomes apparent that the methodology described in the contested patent is not cloning. Thus. such as humans. In interpreting Rule 23d(c) of the EPC. Claim 48: a method of preparing a transgenic animal. transferring the blastocyst to a recipient and allowing an embryo to develop to a chimaeric animal to enable germline transmission of the selectable marker. including mammals. (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.

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. patents are normally applied at the stage of the commercialisation of the embryonic stem cells. The patent applicant. 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). thus. 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.(d). 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. hES cells now can be obtained readily without handling or disposition of an embryo. particularly so in the bio-tech industry where the . 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. The patent applicant argues that a broad construction could not distinguish between existing lines of hES cells and hES cells obtained by other means. it should be pointed out that availability of patents is crucial for continued sustenance of R & D. even if the availability of the said cell culture would potentially benefit the development of substances for treating conditions relating to human infertility. The applicant maintains that the claims in the application make no reference to any method of isolating stem cells from primate embryos. 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 remains to be seen how the Enlarged Board of Appeal would decide on the issue. does Article 53(a) of the EPC forbid patenting such claims? in the context of questions 2 and 3.as described in the application -. 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. 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. 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. On the contrary. The main question involved a question of construction of a provision of the laws. The purpose and effect of r 23d is to exclude from patentability the specific activities and products listed in sub-paras (a) . In practice. Considering how political and divisive embryonic stem cell patents have been in Europe. does Rule 23d(c) of the EPC forbid the patenting of claims directed to products (here: human embryonic stem cell cultures) which -.77 It would appear that the decision of the Enlarged Board of Appeal would be decided sometime at the end of this year. 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. Nevertheless.(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. if the said method is not part of the claims? If the answer to question 1 or 2 is no. 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.78 Moreover. 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. It does not influence any decision making at the level of R & D.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.

considering the long relationship and continuous technical transfer assistance we have with these countries. Thus. the use of non-human stem cell lines is also allowed (mice and primates). 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. Second. obliged to respect two conditions: the prohibition on producing human embryos for research purposes. Countries are however. and the adoption of rules designed to assure adequate protection for the embryo. a fortiori.82 Research on Human Embryo and Stem Cell Research in Malaysia In Malaysia. 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. 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. 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. in that it might encourage research which is offensive per se. Fifth.79 On this Graeme Laurie proposes three alternatives: (i) (ii) (iii) If we accept the permissibility of embryo research. 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. Fourth. patenting is also unacceptable. 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. Concerned with the wide practices and abuses of stem cell collection and therapy. research on stem cells derived from adult stem cells is allowed in accordance with existing guidelines.83 Among the policies that the Ministry of Health undertook to encourage and promote are stem cell research in Malaysia. 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. 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. . The position is not entirely dormant with the health authorities. Sixth. Seventh. The European Convention on Human Rights and Bio-medicine81 leaves each country free to decide how to regulate embryo research. the use of foetal tissues from legally performed termination of pregnancies is also allowed in accordance with existing guidelines. especially involving haemotopoietic stem cells. The Committee therein requested for the disentanglement of the objections against research on embryo. The recent incorporation of 'order public and morality' in s 31 as a yardstick for the grant of patents. This stems from the concern that the reward of the patent is not deserved. Laurie's observation echoes the opinion expressed in the report commissioned by the UK Department of Health.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. than that concerns the scope of patents. It is not quite sure what is the stand of the Malaysian Patent Office with regards to such inventions. However. 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 could be possible that the developments in the UK and the EPO would catch on in Malaysia. which should be the ambit of the Human Fertilisation and Embryology Authority. the use of embryonic stem cell lines (from 64 cell lines) for therapeutic purposes should be allowed. there is no explicit exclusion for inventions that involve human biological material under the Patents Act 1983.cost of R & D is prohibitive. the creation of embryos either from ART or SCNT specifically for the purpose of scientific research is presently prohibited. Laurie distinguished two broad types of moral concerns. the Health Ministry came up with guidelines on Therapeutic Human Cloning and Stem Research in 2007. The Edinburgh patent reveals a more general underlying unease about stem cell technology.

June 2007 that no embryonic stem cell therapy shall be permitted.medical treatment . Research on pre-embryos for purposes other than for therapeutic purposes is also permitted provided that -(a) the couples consented. creation of embryos either from ART or SCNT specifically for the purpose of scientific research is presently prohibited. 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. However. The use of embryos left-over from IVF for research purposes is permitted (harus) on two conditions: (a) the couples had consented. 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. 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. 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. Any genetic treatment on pre-embryo to change the natural characteristics of the pre-embryo such as hair. 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. hair colour. as importation of stem cell lines is allowed and research on stem cell is encouraged.85 From both guidelines. (b) before the embryo reaches the stage of 'alaqah. . As extraction of human embryonic stem cells is not allowed under the guidelines.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 . intelligence. However. it would be considered to be contrary to public order. use of embryonic stem cell lines (from 64 cell lines) for therapeutic purposes should be allowed.through the creation of certain cells or replacing damaged organs 'taking into account the limits permitted by the Shariah. it was further declared in the National Organ. height including sex determination is not allowed. sex determination is allowed if is linked to predisposition to fatal genetic diseases. one could expect that some of the research output that has reached the Malaysian scientist would eventually reach the patent office. the position in Malaysia is that: (i) (ii) (iii) extraction of human embryonic stem cells is not allowed. Tissue and Cell Transplantation Policy. Ministry of Health Malaysia. (b) the embryo is not implanted into any womb.

With regards to patents. Israel. for example. Australia however further liberalised this position through Prohibition of Human Cloning for reproduction and the regulation of Human Embryo Research (A) Act 2006. not on human embryos. Countries with the most relaxed policies such as the UK.88 On the most restrictive stand are countries like Austria and Ireland that ban virtually all forms of research involving human embryos. allow a wide variety of embryonic stem cell procedures. France and Australia. research on spare embryos is allowed but criminally bans all forms of somatic cell nuclear transfer. Option 3: Research is permitted only on remaining embryos no longer needed for reproduction. including the creation of embryos for research purposes. there are several options that the Malaysian Patent Office could take: (i) Using patents to research regulations . 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.Following the Ministry of Health guidelines. and no explicit permission is given to perform research on existing human embryonic stem cells. Korea and Japan.87 Germany in contrast through its Stem Cell Act 2000. In Canada. Option 2: Research is permitted only on existing human embryonic stem cells lines. 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. Singapore. 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. rabbit eggs. 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. Option 4: Research is permitted both on remaining embryos and on embryos created specifically for research purposes through invitro fertilization (IVF). 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.

it would be prudent to widen the engagement process to include all representations from religious communities. Another option it to adopt a two tier prohibition like the European Directive and the European Patent Convention. This is not difficult to perceive as the National Fatwa on stem cells are rather permissive. there should be a move to set up a national ethics committee entrusted to study the ethical. two guidelines would be important. In fact. a lot needs to be done. such products should be patentable on the basis that the R & D. (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. At the moment the draft Human Cloning Bill is still waiting to be tabled to Parliament. 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. These guidelines do not allow research on embryos except (ii) (iii) (iv) .At the moment. labour and expertise spent on the project should be remunerated. However the Ministry of Health decided to adopt the most conservative view so as to appease other religious views. the Patent Office would have to determine the patentability of the research output of such R & D process. One of the aspects considered by this committee could be the position of the ensuing patents resulting from human stem cell research. legal and social implications of recent advances in life sciences as have been done in other countries. For this purpose. 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. other related issues are the permissibility of research on human embryos. (iii) Even if there is such explicit exclusions. This would create a healthy. Considering that Malaysia is a multiracial country. The feeling of the scientific community in Malaysia is that if inventions are developed from imported stem cell lines. In such a situation. However. drafted in the pre-bio-technology era is beyond obsolete as the Act talks of organs and not cells. 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. However. There is currently no clear law on the usage of human embryos for research. Invalidation proceedings could be a powerful tool to check on contentious patent applications that have gone through the system undetected. regards to the regulatory framework on research on stem cells. Another option would be to re-introduce the invalidation proceedings into the patent system. research on embryos may fall under the existing guidelines on assisted reproductive technologies. human cloning. 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. problems with interpretation are expected with ever evolving technology. (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. Malaysian scientists are already working on imported stem cell lines. open and transparent system where voices of dissent are heard. To provide more credence. On this. the current patent law does not accommodate representations by others or reference being made to others at the examination stage. The Human Tissue Act 1974. But there would be problem of interpretation of what would amount to a 'human being' etc. 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. as has been done in other countries is another obvious option. This Draft Bill. Amend the law to include explicit exclusion on the patenting of human beings.89 'ordre public' and morality provisions should be interpreted according to religious convictions and norms of ethics and morality in Malaysia. This post registration attack system has been the core avenue for opposition against inventions perceived to be unethically immoral. the importation of stem cells lines into Malaysia for research purposes is allowed. This would provide the assurance to the scientific community that a certain level of certainty exists. However. 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.

June 2007. As early as 1998. leukaemia. monitoring system and threat of enforcement are very much suspect. heart cells. EU and Australia. Available at ec. making us ponder the ultimate question of the purpose and meaning of existence. What more if the research requires the destruction of human embryos. such as muscle cells. including Parkinson's disease. Nuffield Coun- . whatever phrase or words that one adopts to delineate what is not patentable would be highly contentious. of major advances in healthcare. Commission Staff working Paper. stroke. 1 This article is based on a research project on Patents. stem cells could be used to generate replacement cells and tissues to treat many diseases and conditions. see. organised by Academy of Sciences. what is more important would be a policy decision by each country depending on the prevailing social mores. There is thus a dire need for the creation of an umbrella act on governing the creation and use of embryos. 5 European Group on Ethics in Science and New Technologies to the European Commission. human stem cells can give rise to many different types of cells. UKM.pdf. Ultimately. For an earlier related paper on DNA. monitor and enforce laws would provide the institutional framework for the regulation of research on human embryos in Malaysia. Nuffield Council on Bioethics. 'Ethical Aspects of Patenting Inventions Involving Human Stem Cells'. an act which is described by many as akin to 'abortion'. Parts of the research findings have been presented at the Conference on Law and Technology. otherwise it runs into the danger of becoming obsolete due to the rapid changes in technology. Jeremy Rifkin. 2 Pekeliling Ketua Pengarah Kesihatan Bil 1/2006. For example. They raise the possibility. Centre for Research in Bio-technology for Agriculture (CEBAR) & the Faculty of Medicine. 15-16 March 2007 and Forum on Genetic Testing. It would be useful to delineate this boundary through express provisions in the patent law. Ministry of Health. 6 As described in by the Nuffield Council of Bio-ethics. from the experience of the UK. had already warned of the consequences of the bio-tech revolution on human kind. Commission of the European Communities. Available online at http://europa/eu. See. However. Moreover. for stem cells research and therapy. Stem Cell Therapy: the Ethical Issues: A Discussion Paper. Report on Human Embryonic Stem Cell Research. Alzheimer"s disease. religious sentiments and moral views of the country. organised by the Centre for Civilisational Dialogue. 3 April 2003. the effectiveness of the monitoring mechanism is very much suspect.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. Personal thanks to Prof Paul Torremans and Prof Strauss for hosting the researcher during this period. 3 National Organ.(v) by way of licence from the Ministry of Health. Human Embryonic Stem Cells and Ethics.int/comm(The EGE Opinion) at p 4. these are mere guidelines whose implementation.eu/research/press/2003/pdf/sec2003-441report_en. 14-15 September 2006. 7 May 2002. multiple sclerosis. However. Profiling and Therapy. nerve cells. To that extent. 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. 21 July 2007. as these are mere guidelines. The Ethics of Patenting DNA (2002). The researcher is grateful to the Max Planck Institute and the ACU for the generous funding given for the completion of this research. April 2000. University of Malaya. 4 Cf. CONCLUSION Moral Dilemma: The critics Ethical dilemma raised by virtue of rapid advances in bio-technological inventions is historically speaking not new. Seminar on Bio-ethics: Meeting the Challenges. the Patent Office would have to be prudent in examining applications relating to stem cells. including burns. Brussels. the creation of an oversight body to grant licences.europa. In his words: The bio-tech revolution will force each of us to put a mirror to our most deeply held values. However. spinal cord injury and skin conditions. diabetes. This may turn out to be its most important contribution. rheumatoid arthritis. The rest is up to us. therefore. heart disease. the current guidelines drafted by the Ministry of Health the much needed policy direction for the scientific community. blood cells and others. Tissue and Cell Transplantation Policy. It is the view of many that 'human embryos' should not be simply treated as starting materials just like any other 'composition of matter'.

in Mathias Klang and Andrew Murray (ed). Scientific and Cultural Organization.is just one of a number of practices that are regularly cited as instances of human dignity being compromised. the parts of the human body can now. 11 See Report of the House of Lords Select Committee on Stem Cell Research. the boundary of proprietary rights expands. available athttp://www. Gene Patenting and Human Health. Universal Declaration on the Human Genome and Human Rights. UK. See Michael Ruse and Christopher A Pynes. The law and Ethics of Medical Research: International Bioethics and Human Rights. prostitution.whether in the form of commerce in human organs or tissue. Nuffield Council on Bioethics. Human Stem Cells and Cloned Embryos.nuffieldbioethics. See also Roger Brownsword. Human Rights in the Digital Age.austlii. see. Some views that thanks to intellectual property. or patenting of human genes -. 23 Human Genome Organisation's (HUGO) Ethics Committee and by the United Nations Educational. The Christian Religion and Biotechnology: A Search for Principled Decision Making.org[#8811].org[#8811]. For an earlier related paper on DNA. UNESCO. April 2000. UK. 21 Audrey Chapman. fn 5. the attachment to a 14-day limit has no clear rationale. (2005). The pro-life group criticises the 14 days restriction.parliament. see [#8810]www. 24 An opinion which may not be acceptable to many. Aurora Plomer. London. see [#8810]www. human dignity as constraint also condemns sex selection and positive eugenic. 19 February 2003.nuffieldbioethics.edu. [#8810]www. London. US. Bio-technological Inventions: Moral Restraints and Patent law. US. 17 See its earlier Opinion No 15 of 14 November 2000 cited in its Opinion No 16 of 7 May 2002 at p 14.cil on Bioethics. Recommendation No 1468 on Bio-technologies. et al.srtp. Human Genome Organisation. Council of Europe. available at http://www. rec 10.publications. (2007) Springer. 15 The EGE Opinion.au. (2005) Ashgate. 22-23. 9 The EGE Opinion.shtml. give rise . 12 Stem Cell Therapy: The Ethical Issues: A Discussion Paper. Thus critics argue that any form of commodification of the human body should not be allowed -. Report of the Working Group on Embryo Research. genetic discrimination. New York.1. US. Council of Europe. just like non-human living matter. 19 Patent application No 96903521. See also George P Smith. and perhaps (top of the current list) human reproductive cloning. gene selection. The Stem Cell Controversy: Debating the Issues. Islamic Bioethics: Problems and Perspectives. rec 10. According to them. see the Church of Scotland: Church and Society Council. 14 Critics also question the UK Select Committee's Report for the lack of respect and understanding of the concept of human dignity. Stem Cell Research and Applications: Monitoring the Frontiers of Biomedical Research. under certain conditions. 8 The Australian Law Reform Commission (2003). 20 For religious viewpoints. 16 Page 13 of the EGE Opinion. (2005) Cavendish Publishing. 1425 on Biotechnology and Intellectual Property. fn 5 above. 10 The EGE Opinion. 13 There are scientific justifications for the 14 days window period for research on embryos. art 12(a). Typically. (1999) The American Association for the Advancement of Science and Institute for Civil Society. (entered into force on 29 June 2000). Springer.hugo-international.uk/cloning.unesco. Oliver Mills. Nuffield Council on Bioethics. see [#8810]www.org. fn 5.) 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. Even on a precautionary approach. embryo research and abortion.org[#8811]. 22 Ibid. 7 The literature on this is extensive.uk (Report 13 February 2002. (2006) Prometheus. HUGO Ethics Committee. Glasshouse press (2005). Dariusch Atighetchi.org/ibc/en/genome/projet/[#8811]. See also Recommendation No. germ line gene therapy. (entered into force on 23 September 1999). 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. euthanasia and assisted suicide. II. fn 5 above. available at http://www. 'In fact. from the rights perspective. Statement on the Principled Conduct of Genetics Research (1996). The Ethics of Patenting DNA (2002). surrogacy for profit. 18 Patent No EP 0695351. Bio-technology and Rights: Where Are We Coming From and Where Are We Going. 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 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. 32 The EGE Opinion. 89-97. Vol 1. fn 5 above. at p 13.to one kind of property: intellectual property. 33 The EGE Opinion. fn 8. par p 93. 36 The ALRC Issues Paper. 25 The ALRC Report. (1998) 280 Science 698. in Who Owns Life. fn 5 above. at p 15. comprising the steps of: (a) (b) isolating a human blastocyct isolating cells from the inner cell mass of the blastocyste of (a) . Journal of Bio-technology Law. human DNA sequence and human genome. typical downstream inventions are drugs. they do not have a significant commercial applicability but rather represent the starting point for applied science research. by accumulating technology and labour. (2002) NY. Patents and the Need for a 'Fair Use' Exception in US Patent Law'. Upstream research includes. fn 5 above. The Committee comprises of three renowned academics. In bio-technology. p 16. 'Bio-technology. fn 5 above. See also the EGE Opinion. The Ethics of Patenting DNA (July 2002) available at www. p 17. 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 also the EGE Opinion. fn 5 above. pp 146-152.nuffieldbioethics. R. 'Can Patents Deter Innovation? The Anti-commons in Bio-medical Research'. 27 Footnote 21. cannot be met by the use of surplus embryos. 28 The UK Select Committee came up with the same finding on this. the identification of gene sequences and their functions. 41 Intellectual Property Rights (IPRs) and Genetics: A Study into the Impact and Management of Intellectual Property Rights within the Healthcare Sector. Vol 1 [2004]. the part that is non-appropriable is therefore becoming smaller as we gradually succeed in 'building' everything. C. for instance. Dr M Llewelyn and Dr M Adcock. Vol 1. fn 5 above. 2004. 40 The Nuffield Council on Bioethics. Prof WR Cornish. 35 On this. it may lead to the 'locking up' of crucial resources to only a few hands. David Magnus et al. Usually downstream inventions have a narrow applicability. at p 13. 34 The Opinion. 31 The EGE Opinion. The Committee was of the view that embryos should not be created specifically for research purposes unless there are demonstrable and exceptional needs which. 698 as cited in the ALRC Issues Paper 27. even life. Usually. 30 Ibid. Journal of International Bio-technology Law. This is the same concern with patents on genes. 'Ethical Issues in the Patenting and Control of Stem Cell Research. fn 8. and (iii) dependence and uncertainty. Thanks to bio-technologies. which must both be rewarded by protected access to the market and which are likely to generate considerable financial profits'. July 2003. 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. M and Eisenberg. at p 15. 42 Glen Mc Gee and Elizabeth Banger. See Matthias Dau. Journal of Biotechnology Law. fn 5 above. 'The commercialisation of human biomaterials: what are the rights of donors of biological material?'. Patents and the Need for a 'Fair Use' Exception in US Patent Law'. See the ALRC Issues Paper. Bellivier. pp 146-152. Instead of conferring the incentive required by the industry. 2004. The term 'downstream' refers to products developed by using upstream inventions. The EGE Opinion. fn 8. (ii) reach-through claims. 29 The EGE Opinion. research tools or tools for diagnostic purposes.org. fn 8 above. 37 Heller. F and Noiville. 38 The term 'upstream' describes inventions which are the result of fundamental research. 'Bio-technology. p 16. 26 Footnote 21. 43 Claim # 9: A method of isolating a human embryonic stem cell line. See Mathias Dau.

63-71. RW.622 for human embryonic pluripotent germ cells. Thus. Intellectual Property and Technology Law Journal. Ltd. available at http://cbac-cccb. including (1) Wisonsin Alumni Research Foundation (WARF). 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. Journal of International Bio-technology Law. Vol 18. 57 Though it would appear that in Canada. 48 [2004] APO 24. No 1. s 1. fn 8 above.194. 45 [2004] APO 19. Vol 3. 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.au/pdfs/patentsmanual/WebHelp/Patent_Examiners_Manual.ca/epic/site/cbac-cccb. 56 The Canadian Biotechnology Advisory Committee (CBAC) prepared a final report in June 2002 entitled Patenting of Higher Life Forms and Related Issues. patent examiners in their determination of patentability have no discretion to consider moral or ethical issues. Regulation of Human Embryonic Stem Cell Research in Germany. [2004/2005] 4 BSLR 143. 49 Section 20 of the Act provides: Section 20 Offence-creating a chimeric or hybrid embryo. see Bonn.090. method for making the same.400 patents can be identified from the US Patents Database. 46 [2004] APO 24 47 [2004] APO 19.htm.nsf/en/ah00190e.gov. 52 Available at http://www. March/April 2006.5. and Culturing cells of the selected colonies to thereby obtain an isolated pluripotent human embryonic stem cell line.635 for embryonic germ cells. For the position in Germany.RR and Russo. shall exist within the United States.112 for the regulation of hematopoietic stem cell differentiation by use of human mesenchymal stem cells. and using the cells to produce a chimeric porcine.9. Jan 2006. except as punishment for crime whereof the party shall have been duly convicted.(c) (d) (e) (f) (g) plating the inner cell mass cells on the embryonic fibroblasts. US Const Amend XIII. or any place subject to their jurisdiction. These patents are owned by at least six companies and institutions. (3) Geron Corporation (4) Amrad Corporation Limited (5) The John Hopkins University. Hans-Georg Dederer.110. AA 'Stem Cells and Patenting and Related Regulatory Issues: A United States Perspective'. 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. See Esmond. 54 The Thirteenth Amendment states: Section 1: Neither slavery not involuntary servitude. TJ Stem Cells: The Patent Landscape. Schwartzman. . RA and Ebersole. 44 Another survey published in early 2006 revealed that more than 1. wherein inner cell mass-derived cell masses are formed. No 6.1_stem_cel ls.htm#National/Patentable/2.255. 55 See also Patent No 6. 1-3. No. and (6) Maria Biotech Co. Maximum penalty: imprisonment for 10 years. resulting in a call for the inclusion of 'public ordre' and 'morality' into patent law.html. (1) A person commits an offence if the person intentionally creates a chimeric embryo. 6. (2) Vanderbilt University. No 6.ipaustralia. The authors suggested that a law should be passed to provide for stem cell research exemption to patent infringement and compulsory licensing. (2) A person commits an offence if the person intentionally creates a hybrid embryo Maximum penalty: imprisonment for 10 years. 53 Mantra.739 for method of produce novel embryonic cell populations. 51 The ALRC Issues Paper 27.

at the various stages of its formation and development. 68 Common Position adopted by the Council on 7 February 1984. (3) The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. R 'From Warnock to the Stem Cell Bank -. even if the structure of that element is identical to that of a natural element. European Patents shall not be granted in respect of biological inventions which. European Communities. No 43. can be derived from foetuses and are present throughout life but in progressively decreasing numbers in adults.gov. and hence could. 'Bioethics Today. 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.ipo. whatever its provenance. COM (95) 661 final. including the sequence or partial sequence of a gene. and also animals resulting from such processes. including the sequence or partial sequence of a gene. 2005 available at www. Official Journal EC-C. Report and Recommendations. 71 The distinction between invention and discovery further stressed by the Court of Justice in 2001 Kingdom of Netherlands by . Bioethics Tomorrow: Stem Cell Research and the 'Dignitarian Alliance'. ie cells which can be multiplied and maintained in culture but do not have an unlimited capacity for renewal. Multipotent stem cells.htm. 63 See Stem Cell Patents: European Patent Law and Ethics Report. up to the end of the fourteenth day after fertilisation.uk/uksci/uksci-reportnov05. 66 This is primarily because the bio-technology industry was --and still is -. Nov. 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. Nottingham. in particular. 65 Rule 23(d) reads: Exceptions to patentability Under Article 53(a).viewed as being a commercial sector poised for dramatic growth during the 21st century. but subject to all other restrictions as may be imposed by the licensing body.uk/patent/p-decisionmaking/p-law/p-law-notice/p-law-notice-stemcells. 101/65. may constitute a patentable invention. can differentiate into every kind of cell line found in a developing embryo. 61 Twine. see Roger Brownword. 59 Human embryonic stem cells are of three types: (i) (ii) (iii) pluripotent stem cells.58 The UK notices on stem cell available at http://www. The author is thankful to Prof Paul Torremans for sharing a copy of the report. 95/0350 (COD). 70 Geertrui Van Overwalle. on their own. Vol 2.pdf. p 13.advisorybodies. (e) Processes for modifying the genetic identity of animals which are likely to cause them suffering without any medical benefit to man or animal. 2002. 62 See also UK Stem Cell initiative. 67 Amended proposal for an EU Bio-technology Directive. Rule 23(e) reads: Human body and its elements (1) the human body. Jan/Feb 2005. 28th July 2006. 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.doh. Study on the Patenting of Inventions Related to Human Stem cell research. 64 The European Directive 98/44/EC.' Journal of International Biotechnology Law.Evaluating the UK's Regulatory Measures for Stem Cell Research.For a more detailed analysis on the UK experience on embryo research.9 April 1994. 69 See 96/C 296/03.gov. (2003) 17 Notre Dame Journal of Law. cannot constitute patentable inventions (2) An element isolated from the human body or otherwise produced by means of a technical process. Totipotent cells. p 1. according to one definition. Ethics and Public Policy 15. and the simple discovery of one of its elements. develop into an embryo.

29 December 2000. amending the Research Involving Human Embryos Act 2002 that regulates activities involving the use of human embryos. Wisconsin Alumni Research Foundation. 78 Also shows great divergence and lack of clarity in the notion of ethics and morality' Vivienne Green. Judgment of the Court of Justice. 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. 86 LeRoy Walters. 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. 77 See the Statement of Grounds of Appeal on European Patent Application No 96903521. In arriving to that conclusion. EIPR 2004. pp 59-66. Creating or developing a human embryo containing genetic material provided by more than 2 persons. integrity and vulnerability. 83 Pekeliling Ketua Pengarah Kesihatan Bil 1/2006. dignity. Prometheus Books.06/(GU). 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. The regulation further allows these practices with licence: (i) (ii) (iii) (iv) Creating a human embryo other than by fertilisation or developing such embryo. the OD disagreed with the finding of the European Group of Ethics on the issue. CA. M and Pynes. and incompatibility with existing patent law and the EU Directive. Official Journal EC-L. 75 Page 22 of the grounds of decision by the Opposition Division dated 21 July 2003. 84 Majlis Fatwa Kebangsaan ke 66.htm). The four principles are autonomy. 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. The Stem Cell Controversy: Debating the Issues. 9 October 2001. vol 283. p 1468-1470.Decision of the Board of Appeal.the Italian Republic and by Kingdom of Norway v European Parliament and Council of the European Union. 85 MOH/P/PAK/131/07 (BP). See. 'Regulation of Human Embryonic Stem Cell Research: A Comparative Review'. US. 10-19. 1999. March 2006. MOH/P/PAK/119. pp 259-284. in Tuse. 76 T 1374/04 -. supported by Commission of the European Communities. 22 February 2005. citing that there are too many inconsistencies. logical flaws. 80 Intellectual Property Rights (IPRs) and Genetics: A Study into the Impact and Management of Intellectual Property Rights Within the Healthcare Sector. Using precursor cells from a human embryo or human fetus to create a human embryo or developing such embryo Creating a hybrid embryo. 73 See eg Science. (2006). Perspective. German scientist might be restricted from participating from overseas research project that utilises hES cells derived from stem cells established after the deadline. 87 Passed in December 2006 with effect from 12 June 2007. . for example calls for the reification of bioethical principles into the current discourse as found by the European Union Bio-Med II Project. issued on 30 March 2000). 'Patenting Stem Cells of Human Origin'. Human Embryonic Stem Cell Research: An Intercultural. July 2003.coe. as scientists abroad base their research more and more on hES-cells derived from stem cells established after the 1 January 2002. 378/95. 81 Signed in Oviedo in 1997 (http://conventions. This reg clarifies that the prohibition against human cloning pertains only to reproductive cloning and not therapeutic cloning. Case C-377/98. 82 Helen Cline & Anoushka Myers.1. Journal of the Intellectual Property Society of Australia and New Zealand Inc. 26(2). 79 Graeme Laurie. 72 The Opposition Division held that in contrast to human ES cells which can only be obtained by destroying human embryos. 88 The main criticism with the German regulatory framework are: (1) (2) (3) The choice of the cut-off date. [2003/2004] 2 BSLR 47. 'The Ethics of Patenting Inventions Derived from Human Embryonic Stem Cells in the European Union'.int/Treaty/en/Treaties/Html/164.

if an adult patient of sound mind refuses. but it is a presumption that can be rebutted. 'Ethical. 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. the doctor's duty to act in the best interests of his patient must likewise be qualified5. if any. The right of self-determination An adult of sound mind has the right to make his own choices as to what treatment. The Bio-tech Century: Harnessing the Gene and the Remaking the World. it is established that the principle of self-determination requires that respect must be given to the wishes of the patient.(4) The definition of embryo might only cover biological entities that are capable of developing into a human individual. to consent to treatment or care by which his life would or might be prolonged. Lord Goff of Chieveley said in Airedale NHS Trust v Bland4: First. . even though they do not consider it to be in his best interests to do so . June 2002. To this extent. so that. 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. Singapore. thus may not apply to non-viable human embryos and human parthenotes. particularly. It exists notwithstanding that . Legal and Social Issues in Human Stem Cell Research. 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. such as unconsciousness. can be carried out on him. severe fatigue. pain or drugs being used in their treatment. Reproductive and Therapeutic Cloning'. Further. (1998) Putnam. for present purposes perhaps more important. 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. Medical treatment carried out without the consent of an adult of sound mind amounts to unlawful touching or battery3. US. in relation to pregnant women and persons bound by certain religious beliefs. at p 237. See also the 2002 report by the Bioethics Advisory Committee. 89 Some of the reports have been summarised in this article. the doctors responsible for his care must give effect to his wishes. however unreasonably. the principle of the sanctity of human life must yield to the principle of self-determination : and. The concepts inherent in this right are the bedrock upon which the principles of self-determination2 and individual autonomy are based. . 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. 90 Jeremy Rifkin. 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. confusion or other effects of shock. 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.

not making the caesarian section possible. rational or irrational. the likely consequences of leaving their condition untreated and understanding the risks and side effects of undertaking the treatment. her pathological fear of needles caused her to refuse permission for the anaesthetic and thus. irrational. whether they are able to take in and retain treatment information. To have the necessary capacity to give consent. whether they believe it. especially as to the likely consequences of having or not having the treatment in question. the court held that it had not been proved that the patient did not understand the choice he was being asked to make. and MB's appeal was dismissed by the Court of Appeal. 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. Re MB involved a pregnant woman who had consented to an elective Caesarean section because her fetus was in a breech position. the criteria to be used in assessing whether the patient has the capacity in refusing medical treatment14. Requirements for a legally valid consent The requirement for valid consent is a basic tenet of medical law. As Lord Cockburn CJ put it in Banks v Goodfellow (1870) LR 5 QB 549. thirdly whether they are able to weigh that information by balancing the risks and needs17. firstly. If. giving the judgment of the court. purpose and effect of the proposed treatment. through several cases. The criteria was clearly enunciated in the leading House of Lords case of is F v West Berkshire Health Authority15. The term 'understanding' has been subjected to intense discussion through a series of cases as to what are the true requirements for the term12. The criteria for assessing capacity The common law has developed. a compulsive disorder or phobia from which the patient suffers stifles belief in the information presented to her. Butler-Sloss LJ reiterated this point in Re MB (An Adult: Medical Treatment)8. then the decision may not be a true one. considered the expert's analysis to be helpful in determining the question.. 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. secondly. Consent is only valid if the consent is informed in nature10. the patient is unable to use the information and weigh it in the balance as part of the process of arriving at the decision.the reasons for making the choice are rational. and. 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. 569: '. purpose and effects of the proffered amputation18. 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. by stating that: A mentally competent patient has an absolute right to refuse to consent to medical treatment for any reason. even where that decision may lead to his or her own death9. The health authority applied for and was granted a declaration that it would be lawful for the doctors to carry out the Caesarean section. This probably involves appreciating what will be done to them if they accept treatment. 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. unknown or even non-existent7. An order was made forbidding the amputation without patient's written consent19. Further.. as Thorpe J observed in Re C (above). or for no reason at all. . Butler-Sloss LJ. The expert proffered the view that there are three stages to a decision. However. 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. Thorpe J. one object may be so forced upon the attention of the invalid as to shut out all others that might require consideration. 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. in Re C (Adult: Refusal of Treatment)16.' Applying that test. A similar approach was used by the Court of Appeal in Re MB (An Adult: Medical Treatment)20. given voluntary11 and the person have the necessary capacity to give consent. the patient must be able to have sufficient 'understanding' of the nature. and consequently whether he was competent to withhold his consent.

once enforced. If the guardian or relative is nowhere to be found. the Malaysian Mental Health Act 200122 will have a specific provision on the issue of consent to treatment23. (c) by two psychiatrists. Sir George Baker. have a right of its own until it is born and has a separate existence from its mother.Thus. If after considering these factors. . in my view. 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). . However. 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. it is shown that the patient is incapable of giving consent. 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. . That permeates the whole of the civil law of this country28. However. the risks involved in undergoing and not undergoing the treatment and whether or not his ability to consent is affected by his condition. electroconvulsive therapy or clinical trials. At the moment. or a relative of the patient. the courts will be faced with a novel problem of considerable legal and ethical complexity30. 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 . 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). 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. Section 77 is as follows: (1) Where a mentally disordered person is required to undergo surgery. in English law. That is not this case and. In such situation. 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. the Malaysian Mental Disorder Ordinance 195221 does not have any provisions pertaining to the issue of consent or refusal to medical treatment. 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. addressing the issue of assessment of capacity. then only consent can be procured from the guardian. in the 1979 abortion case of Paton v Trustees of British Advisory Services27. if and when it arises. . 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. one rather than another of the treatments being offered. . particularly those who are in the late stages of pregnancy. suffers from no mental incapacity has an absolute right to choose . held that: The fetus cannot. For example. one of whom shall be the attending psychiatrist. The common law has for many years decided that the fetus has no legal rights until it is born. then only consent can be taken from two psychiatrists who have examined the patient26. if the patient is a minor. The problem with pregnant women and the rights of the fetus Pregnant women. in the Court of Appeal case of Re T (An Adult) (Refusal of Medical Treatment)29. if the patient is an adult25. the nature and purpose of the treatment. (2) In order to assess whether he is capable of giving the required consent. The only possible qualification is a case in which the choice may lead to the death of a viable fetus. if the patient is incapable of giving consent. present a clear example of the inherent problem in assessing whether the patient has the required capacity. (b) by his guardian in the case of a minor or a relative in the case of an adult. 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.

and so this was carried out. objectively considered. Butler-Sloss LJ clarified the position of a competent person to refuse medical treatment and the rights of the fetus. Mrs S refused surgery for religious reasons. I concluded that a patient who could. Mrs S did not represent any significant continuing risk to anyone. Her Lordship stated that: A competent woman. In St George. After delivery she appealed against the decision. does not arise36. but she refused. which. Delivery by Caesarean section was recommended. as it was necessary in the interests of both the mother and her unborn child. 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. In Re S.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 any event. for rational or irrational reasons or for no reason at all. 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. The Court of Appeal upheld its earlier decision in Re MB. which would put both lives in great danger. Mrs S was suffering from pre-eclampsia. From the judgment in Re MB. the court held that her fear of needles rendered her temporarily incompetent to make the necessary decision of refusing the caesarian section. 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. other reasons. her Lordship observed that: A fetus. 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. Further in her judgment. However. may. or her own death. Sir Stephen Brown declared that a Caesarean section could lawfully be performed despite the patient's refusal. However. choose not to have medical intervention. She had fully understood the risks that her life and the baby's life would be put in danger if she pro- . was not a patient who was able properly to weigh up the considerations that arose so as to make any valid decision. Mrs S. if the person has the requisite capacity to consent or refuse treatment. 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. She therefore. have yet to achieve its legal personhood32. The hospital asked the court to intervene. Thus. still one which involved her own life35. overriding her refusal to consent to the anaesthetic injection. Her obstetrician advised a Caesarean section. thus. the patient. even at the point of its birth37. The court of first instance declared that a Caesarean section would not be unlawful. or to refuse. even though the consequence may be the death or serious handicap of the child she bears. In giving the court's judgment. lacked the relevant mental competence to make the treatment decision and it was in her best interest to have the operation. 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. The issue was further taken up by the case of Re MB (Adult: Medical Treatment)33 in which. for religious reasons. the court had the power at common law to authorise the use of reasonable force. The decision in Re MB was soon followed by St George's Healthcare NHS Trust v S38. a decision which was supported by her husband. who has the capacity to decide. the interests of the unborn fetus would not take precedence over those of its mother. The court was asked to intervene. as there was a high risk of uterine rupture. In that event the courts do not have the jurisdiction to declare medical intervention lawful and the question of her own best interests. was in labour with her third pregnancy. and was admitted under an order from a mental hospital to a maternity hospital. In such situation. treatment. up to the moment of birth. about anything of even the most trivial kind. in those circumstances speak in terms which seemed to accept the inevitability of her own death. A court does not have jurisdiction to declare medical intervention lawful to protect the interests of an unborn child. 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.

emotional and welfare conditions and the balance between the likely benefits and disadvantages of the proposed treatment. legal rights. Although there are no Malaysian cases directly on the issue of refusal of consent by pregnant women. 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. Thus. H refused surgery. 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. 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. it has been accepted that in order to have a right of action.ceeded with natural delivery. 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 common law cases have been instrumental in many consent to medical treatment cases such as Tan Ah Kau v Government of Malaysia40. provided that the operation or treatment is in the 'best interests' of such patients. The fetus is not protected because it is not considered as a separate being from its mother. As such. As her capacity to consent was intact. 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. Prior to 2000. Treatment in absence of capacity At common law. in the exercise of their clinical judgment. the court should apply the established Bolam test of what would be accepted as appropriate treatment . On birth. social. Mohd Hishamuddin J aptly stated that: An unborn child or fetus is a biologically distinct organism from the mother. the child acquires legal status and thus. which a woman had. as long as she is of sound mind. A doctor can lawfully operate on or give treatment to adult patients who are incapable of consenting to his doing so. the court had to consider a the broad spectrum of medical. the lawfulness of such restraint had to be carefully considered in the context of the patient' best interests. 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. then it was lawful to overcome non-cooperation by sedation and reasonable restraint in order to achieve treatment. However. breathing and feeding difficulties. asserting that she wanted children. If the patient lacked capacity to consent. Clearly. This is mentioned in the case of F v West Berkshire Health Authority or Re F (Mental Patient: Sterilisation)46. H. Although pregnancy increased the responsibilities. When an unborn child becomes a living person and suffers damages as a result of pre-natal injuries. to be in his best interests. with the mistaken belief that she was childless. it did not diminish her right to refuse medical treatment. a doctor can lawfully operate on or give other treatment to adult patients who are incapable of consenting to his doing so. 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. provided that the operation or treatment is in the best interests of such patients. the child is able to bring proceedings. In considering whether it was in H's best interests to undergo the proposed surgery. She suffered from an ovarian cyst with gynaecological complications. 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. which caused her general discomfort. in which. 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. a female patient aged 45 was schizophrenic and delusional. In Trust A and Trust B. 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. which was in the patient's best interests. the fetus must be born and be a child.45. it is the duty of the doctors to treat him in whatever way they consider. its needs for medical care and assistance cannot prevail over that of the mother. The court first considered whether H has the required capacity to refuse the treatment. In determining whether the proposed operation was in the best interests of the patient. it is not a legal person. The recent case of Trust A and Trust B v H (An Adult Patient)39 had also adopted a similar sentiment as St George.

An advance directive is an anticipatory decision made while a person is capable. For instance. which would not be the same in the case of men and women encompassed medical. 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. An advance directive will allow an individual to make decisions while competent and these will be binding in any subsequent period of incapacity. 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. However. the Court of Appeal suggested that the touching must be 'hostile' in order to constitute battery. In such circumstances. In Wilson v Pringle [1986] 2 All ER 440. problems can arise on the issue of capacity to consent to or refuse treatment. it is imperative that before advance directives are given formal recognition. medical professionals should ensure that the advice given to the patient should be recorded together with written. due care must be given to the consequences of these directives. an individual refusing treatment for a physical condition in advance might or might not have refused a new treatment for the condition. Re F (Mental Patient: Sterilisation) [1990] 2 AC 1. and the risks and likely prognosis involved in the decision to refuse or accept it. and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. Conclusion The common law is clear in that a competent adult patient once properly informed. The considerations. 3 A battery takes place when there is non-consensual touching. to decide who shall treat and to choose the form of treatment. 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. social and moral considerations than those set out in Bolam. In Malaysia. 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.at the time by a reasonable body of medical opinion skilled in that particular form of treatment. purpose of the proposed treatment.48 Thus. advance directives has considerable theoretical attraction. unequivocal assurances from the patient that the refusal represents an informed decision. The reason for this is the need to eliminate actions in battery as a result of physical contact. at p 865. 1 Justice Benjamin Cardozo. in Re S (Sterilisation: Patient's Best Interests)47. See further. . 7 Ibid. If the account were significantly in credit. not the doctor. Even though.' 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. emotional and all welfare issues50. [1993] AC 789. the court held that it was for the judge. can resort to the use of advance directives. 5 [1993] 1 All ER 821 at p 866. then the application was considered in the best interests of the patient. discovered after the directive have been made54. 6 [1992] 2 FCR 861. has the unassailable legal right to refuse medical treatment. it has to be ensured that proper safeguards are introduced. a decision which would incorporate broader ethical. Thus. Assessment of capacity requires the patient to comprehend the nature of the particular conduct in question and to understand its quality and consequences.' 2 Self-determination involves (1) the right to consent to treatment. 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. Although there is no English legislation giving statutory effect to advance directives. with the patient's welfare as the paramount consideration. However. Once the patient understands the nature. and as a corollary (2) the right to refuse consent. the patient achieves the required capacity to refuse the proposed treatment. to decide whether a treatment was in the best interests of a patient. 'best interests' is not limited to 'best medical interests. 4 [1993] 1 All ER 821. which is generally acceptable in the ordinary conduct of everyday life. advance directives for medical treatment have yet to be given any formal recognition53.

[1994] 1 WLR 290. rehabilitation. 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. However. 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. 9 Ibid. 20 [1997] 2 FLR 426. 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. 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. 18 Ibid. 17 [1994] 1 WLR 290. 31 [1992] 4 All ER 671. 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. 19 The low level of comprehension that the test for capacity entails means that most patients will be competent to consent. 13 [1994] 1 All ER 819. 16 [1994] 1 All ER 819.8 [1997] 2 FCR 541. the patient suffered from a severe learning disability with sufficiently disturbed behaviour to justify detention under the Mental Health Act 1983. 27 [1979] QB 276. 25 Section 77(1)(b). care. at p 653. at pp 122-123. 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. control and protection of persons who are mentally disordered and for related matters. 30 Ibid. . 21 At the moment. at p 279. 26 Section 77(1)(c). 28 Ibid. For further reading on this issue. 10 This requires patient to be given 'sufficient' information about the treatment. at p 295. with no duress or undue influence. detention. at p 549. In Re JT. or the 'reasonable prudent patient test' as enunciated in Rogers v Whitaker [1992] 175 CLR 479. Nevertheless. 11 Consent must be given through the patient's own free will. 23 Section 77. 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. the Ordinance regulates the law for the mentally ill in West Malaysia. see Puteri Nemie. [1994] 1 WLR 290. This case was subsequently followed by C v S [1987] 1 All ER 1230 and Re F (in utero) [1988] 2 All ER 193. 'Sufficient' information has been interpreted as explaining the material risks inherent in the treatment. Medical Law (3rd Ed) London: Butterworths. had made a 'calm and rational' decision and was consistent in her choice to die. she as entitled to refuse dialysis treatment for kidney failure. as she understood that she would dies. 2000. See Freeman v Home Office [1984] 1 All ER 1036 and Re T (Adult: Refusal of Medical Treatment) [1992] 3 WLR 782. At this time. 29 [1992] 4 All ER 649. lodging. 12 See I Kennedy & A Grubb.

Euthanasia -. Kuala Lumpur: Sweet & Maxwell Asia. 2002.A Malaysian Perspective. at p 53. 2003. at pp 602-603. 54 See P Bartlett & R Sandland. These problems have also been highlighted by officials from the Malaysian Medical Association and the Malaysian Medical Council. HL paper 2-I of 1993-94 at paragraphs 263-267. at p 19. 33 [1997] 2 FLR 426. 50 Ibid. except for its own mother. see Norchaya Talib. 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. For facts. see above. in English legal circles it is generally believed that this decision was discordant with previous case law. (2nd edition). 46 Supra.A Malaysian Perspective. Malayan Law Journal Articles/2007/Volume 2/REFUSAL OF MEDICAL TREATMENT: ASSESSING THE REQUIRED CAPACITY [2007] 4 MLJ cxlv Malayan Law Journal Articles 2007 . 49 [2000] 1 FLR 549. 44 [2005] 5 MLJ 480. at pp 121-122. 52 Ibid at p 54. 37 Ibid. 51 Norchaya Talib. Euthanasia -. see para 19.32 Although Re S has never been appealed. London: Oxford University Press. 34 (1997) 34 BMLR 16. 2002. 48 This decision was heavily influenced by the case of Bolitho v City Hackney Health Authority [1997] 4 All ER 771. it is mentioned that the hospital will take into account the wishes of the patient in the event an advance directive is drawn up. 41 [1998] 7 MLJ 481. 35 Ibid. 43 [1979] QB 276. 39 [2006] EWHC 1230 (Fam). 45 Ibid. 36 . 40 [1997] 2 AMR 1382. 38 [1998] 2 FLR 528. 42 [1999] 6 MLJ 738. Report of the Select Committee on Medical Ethics. 53 From a personal interview with the relevant person from Gleneagles Hospital in Kuala Lumpur. Mental Health Law: Policy and Practice. at p 560. 47 [2000] 2 FLR 389.

The right of self-determination An adult of sound mind has the right to make his own choices as to what treatment. however unreasonably. To this extent. Butler-Sloss LJ reiterated this point in Re MB (An Adult: Medical Treatment)8. confusion or other effects of shock.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. 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. Medical treatment carried out without the consent of an adult of sound mind amounts to unlawful touching or battery3. 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. Consent is only valid if the consent is informed in nature10. the doctor's duty to act in the best interests of his patient must likewise be qualified5. or for no reason at all. even where that decision may lead to his or her own death9. if any. such as unconsciousness. The concepts inherent in this right are the bedrock upon which the principles of self-determination2 and individual autonomy are based. the patient must be able to have sufficient 'understanding' of the nature. irrational. 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. 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 is established that the principle of self-determination requires that respect must be given to the wishes of the patient. the principle of the sanctity of human life must yield to the principle of self-determination : and. To have the necessary capacity to give consent. can be carried out on him. given voluntary11 and the person have the necessary capacity to give consent. . if an adult patient of sound mind refuses. unknown or even non-existent7. by stating that: A mentally competent patient has an absolute right to refuse to consent to medical treatment for any reason. Every adult is presumed to have that capacity. even though they do not consider it to be in his best interests to do so . so that. Lord Goff of Chieveley said in Airedale NHS Trust v Bland4: First. pain or drugs being used in their treatment. rational or irrational. but it is a presumption that can be rebutted. in relation to pregnant women and persons bound by certain religious beliefs. for present purposes perhaps more important. 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. to consent to treatment or care by which his life would or might be prolonged. It exists notwithstanding that the reasons for making the choice are rational. severe fatigue. Requirements for a legally valid consent The requirement for valid consent is a basic tenet of medical law. 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. purpose and effect of the proposed treatment. particularly. the doctors responsible for his care must give effect to his wishes. 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. It was not until the case of . Further.

especially as to the likely consequences of having or not having the treatment in question. considered the expert's analysis to be helpful in determining the question. This probably involves appreciating what will be done to them if they accept treatment. As Lord Cockburn CJ put it in Banks v Goodfellow (1870) LR 5 QB 549. Butler-Sloss LJ. and.. the court held that it had not been proved that the patient did not understand the choice he was being asked to make. firstly. her pathological fear of needles caused her to refuse permission for the anaesthetic and thus. whether they believe it. The health authority applied for and was granted a declaration that it would be lawful for the doctors to carry out the Caesarean section. the criteria to be used in assessing whether the patient has the capacity in refusing medical treatment14.. 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. The expert proffered the view that there are three stages to a decision. thirdly whether they are able to weigh that information by balancing the risks and needs17. The criteria was clearly enunciated in the leading House of Lords case of is F v West Berkshire Health Authority15. . 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. Re MB involved a pregnant woman who had consented to an elective Caesarean section because her fetus was in a breech position. Thus. the likely consequences of leaving their condition untreated and understanding the risks and side effects of undertaking the treatment. whether they are able to take in and retain treatment information. the Malaysian Mental Health Act 200122 will have a specific provision on the issue of consent to treatment23. the patient is unable to use the information and weigh it in the balance as part of the process of arriving at the decision. as Thorpe J observed in Re C (above). The criteria for assessing capacity The common law has developed. A similar approach was used by the Court of Appeal in Re MB (An Adult: Medical Treatment)20. in Re C (Adult: Refusal of Treatment)16. However. 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. 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. 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. An order was made forbidding the amputation without patient's written consent19.' Applying that test. purpose and effects of the proffered amputation18. the Malaysian Mental Disorder Ordinance 195221 does not have any provisions pertaining to the issue of consent or refusal to medical treatment. 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. not making the caesarian section possible. through several cases. and consequently whether he was competent to withhold his consent. a compulsive disorder or phobia from which the patient suffers stifles belief in the information presented to her. However. then the decision may not be a true one. once enforced. Section 77 is as follows: (1) Where a mentally disordered person is required to undergo surgery. addressing the issue of assessment of capacity. electroconvulsive therapy or clinical trials. 569: '. If. 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.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. 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. Thorpe J. secondly. 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. and MB's appeal was dismissed by the Court of Appeal. one object may be so forced upon the attention of the invalid as to shut out all others that might require consideration. giving the judgment of the court. 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. At the moment. Further.

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 issue was further taken up by the case of Re MB (Adult: Medical Treatment)33 in which. as it was necessary in the interests of both the mother and her unborn child. The only possible qualification is a case in which the choice may lead to the death of a viable fetus. In Re S. which would put both lives in great danger. However. one rather than another of the treatments being offered. 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). one of whom shall be the attending psychiatrist. If the guardian or relative is nowhere to be found. That permeates the whole of the civil law of this country28. the risks involved in undergoing and not undergoing the treatment and whether or not his ability to consent is affected by his condition. if the patient is incapable of giving consent. having been admitted into the hospital with ruptured membranes six days overdue from the expected birth date of her unborn child. The hospital asked the court to intervene. That is not this case and. if the patient is a minor. it is shown that the patient is incapable of giving consent. . then only consent can be procured from the guardian. The problem with pregnant women and the rights of the fetus Pregnant women. in my view. 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). If after considering these factors. suffers from no mental incapacity has an absolute right to choose . then only consent can be taken from two psychiatrists who have examined the patient26. Mrs S.(b) (c) by his guardian in the case of a minor or a relative in the case of an adult. Sir Stephen Brown declared that a Caesarean section could lawfully be performed despite the patient's refusal. However. For example. . have a right of its own until it is born and has a separate existence from its mother. Her obstetrician advised a Caesarean section. present a clear example of the inherent problem in assessing whether the patient has the required capacity. . In order to assess whether he is capable of giving the required consent. the nature and purpose of the treatment. or a relative of the patient. 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. was in labour with her third pregnancy. a decision which was supported by her husband. in the Court of Appeal case of Re T (An Adult) (Refusal of Medical Treatment)29. 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 . 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. 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. which. Mrs S refused surgery for religious reasons. in the 1979 abortion case of Paton v Trustees of British Advisory Services27. as there was a high risk of uterine rupture. held that: The fetus cannot. have yet to achieve its legal personhood32. in English law. In such situation. The common law has for many years decided that the fetus has no legal rights until it is born. the courts will be faced with a novel problem of considerable legal and ethical complexity30. if and when it arises. Sir George Baker. particularly those who are in the late stages of pregnancy. 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. the patient. if the patient is an adult25. by two psychiatrists. The fetus was in a 'transverse lie' position with an elbow projecting through the dilating cervix. . the court held that her fear of needles rendered her temporarily incompetent to make the necessary decision of refusing the cae- .

Although pregnancy increased the responsibilities. However. In that event the courts do not have the jurisdiction to declare medical intervention lawful and the question of her own best interests. The court of first instance declared that a Caesarean section would not be unlawful. the interests of the unborn fetus would not take precedence over those of its mother. other reasons. treatment. Her Lordship stated that: A competent woman. or to refuse. it did not diminish her right to refuse medical treatment. who has the capacity to decide. up to the moment of birth. choose not to have medical intervention. 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. A court does not have jurisdiction to declare medical intervention lawful to protect the interests of an unborn child. The court was asked to intervene. I concluded that a patient who could. or her own death. H refused surgery. about anything of even the most trivial kind. and so this was carried out. which a woman had. Thus. 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. 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. with the mistaken belief that she was childless. still one which involved her own life35. for rational or irrational reasons or for no reason at all. Further in her judgment. a female patient aged 45 was schizophrenic and delusional. the court had the power at common law to authorise the use of reasonable force. asserting that she wanted . In Trust A and Trust B. even though the consequence may be the death or serious handicap of the child she bears. was not a patient who was able properly to weigh up the considerations that arose so as to make any valid decision. for religious reasons. After delivery she appealed against the decision. if the person has the requisite capacity to consent or refuse treatment. In any event. as long as she is of sound mind. Butler-Sloss LJ clarified the position of a competent person to refuse medical treatment and the rights of the fetus. As such. thus. As her capacity to consent was intact. objectively considered.sarian section. 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. The fetus is not protected because it is not considered as a separate being from its mother. does not arise36. even at the point of its birth37. in those circumstances speak in terms which seemed to accept the inevitability of her own death. Mrs S was suffering from pre-eclampsia. may. In such situation. her Lordship observed that: A fetus. 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. She therefore. From the judgment in Re MB. which caused her general discomfort. Mrs S did not represent any significant continuing risk to anyone. H. and was admitted under an order from a mental hospital to a maternity hospital. 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. Delivery by Caesarean section was recommended. She suffered from an ovarian cyst with gynaecological complications. The Court of Appeal upheld its earlier decision in Re MB. its needs for medical care and assistance cannot prevail over that of the mother. 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. 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. 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. In St George. Clearly. overriding her refusal to consent to the anaesthetic injection. but she refused. breathing and feeding difficulties. The recent case of Trust A and Trust B v H (An Adult Patient)39 had also adopted a similar sentiment as St George. The decision in Re MB was soon followed by St George's Healthcare NHS Trust v S38.

social.48 Thus.45. provided that the operation or treatment is in the best interests of such patients. 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. The considerations. it is not a legal person. then it was lawful to overcome non-cooperation by sedation and reasonable restraint in order to achieve treatment. The court first considered whether H has the required capacity to refuse the treatment. In determining whether the proposed operation was in the best interests of the patient. with the patient's welfare as the paramount consideration. it is the duty of the doctors to treat him in whatever way they consider. to decide whether a treatment was in the best interests of a patient. it has been accepted that in order to have a right of action. which would not be the same in the case of men and women encompassed medical. When an unborn child becomes a living person and suffers damages as a result of pre-natal injuries. If the account were significantly in credit. Prior to 2000. legal rights. If the patient lacked capacity to consent. An advance directive will al- . Mohd Hishamuddin J aptly stated that: An unborn child or fetus is a biologically distinct organism from the mother. However. in the exercise of their clinical judgment. 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. the common law cases have been instrumental in many consent to medical treatment cases such as Tan Ah Kau v Government of Malaysia40. 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. to be in his best interests. However. Treatment in absence of capacity At common law. the child is able to bring proceedings. 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. An advance directive is an anticipatory decision made while a person is capable. in Re S (Sterilisation: Patient's Best Interests)47. a decision which would incorporate broader ethical. A doctor can lawfully operate on or give treatment to adult patients who are incapable of consenting to his doing so. 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.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. then the application was considered in the best interests of the patient. a doctor can lawfully operate on or give other treatment to adult patients who are incapable of consenting to his doing so. in which. This is mentioned in the case of F v West Berkshire Health Authority or Re F (Mental Patient: Sterilisation)46. the child acquires legal status and thus. the lawfulness of such restraint had to be carefully considered in the context of the patient' best interests. which was in the patient's best interests. In considering whether it was in H's best interests to undergo the proposed surgery. 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. Although there are no Malaysian cases directly on the issue of refusal of consent by pregnant women. Thus. 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. the court had to consider a the broad spectrum of medical. the fetus must be born and be a child. 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 court held that it was for the judge.' 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. 'best interests' is not limited to 'best medical interests. emotional and welfare conditions and the balance between the likely benefits and disadvantages of the proposed treatment. provided that the operation or treatment is in the 'best interests' of such patients. 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. social and moral considerations than those set out in Bolam. On birth. can resort to the use of advance directives. not the doctor. 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.

see Puteri Nemie. In such circumstances. Medical Law (3rd Ed) London: Butterworths. In Malaysia. 7 Ibid. 3 A battery takes place when there is non-consensual touching. 6 [1992] 2 FCR 861. Assessment of capacity requires the patient to comprehend the nature of the particular conduct in question and to understand its quality and consequences. which is generally acceptable in the ordinary conduct of everyday life. Even though. an individual refusing treatment for a physical condition in advance might or might not have refused a new treatment for the condition. the Court of Appeal suggested that the touching must be 'hostile' in order to constitute battery. discovered after the directive have been made54. 2000. and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. it is imperative that before advance directives are given formal recognition. at pp 122-123. 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. due care must be given to the consequences of these directives. the patient achieves the required capacity to refuse the proposed treatment. Re F (Mental Patient: Sterilisation) [1990] 2 AC 1. 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. Conclusion The common law is clear in that a competent adult patient once properly informed. with no duress or undue influence. Although there is no English legislation giving statutory effect to advance directives. See Freeman v Home Office [1984] 1 All ER 1036 and Re T (Adult: Refusal of Medical Treatment) [1992] 3 WLR 782. Once the patient understands the nature. 1 Justice Benjamin Cardozo. 10 This requires patient to be given 'sufficient' information about the treatment. In Wilson v Pringle [1986] 2 All ER 440. 11 Consent must be given through the patient's own free will. 'Sufficient' information has been interpreted as explaining the material risks inherent in the treatment. 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. For further reading on this issue. 4 [1993] 1 All ER 821. to decide who shall treat and to choose the form of treatment. at p 549. it has to be ensured that proper safeguards are introduced. 5 [1993] 1 All ER 821 at p 866. problems can arise on the issue of capacity to consent to or refuse treatment. has the unassailable legal right to refuse medical treatment. purpose of the proposed treatment. [1994] 1 WLR 290. 13 [1994] 1 All ER 819. 12 See I Kennedy & A Grubb. and the risks and likely prognosis involved in the decision to refuse or accept it. 9 Ibid. medical professionals should ensure that the advice given to the patient should be recorded together with written. Thus. However. and as a corollary (2) the right to refuse consent. . unequivocal assurances from the patient that the refusal represents an informed decision. advance directives has considerable theoretical attraction. [1993] AC 789. 8 [1997] 2 FCR 541. However. 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. See further. 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. For instance. at p 865. advance directives for medical treatment have yet to be given any formal recognition53.' 2 Self-determination involves (1) the right to consent to treatment. or the 'reasonable prudent patient test' as enunciated in Rogers v Whitaker [1992] 175 CLR 479.low an individual to make decisions while competent and these will be binding in any subsequent period of incapacity.

31 [1992] 4 All ER 671. had made a 'calm and rational' decision and was consistent in her choice to die. she as entitled to refuse dialysis treatment for kidney failure. at p 19. rehabilitation. 38 [1998] 2 FLR 528. 39 [2006] EWHC 1230 (Fam). 37 Ibid. 29 [1992] 4 All ER 649. . At this time. 17 [1994] 1 WLR 290. 18 Ibid. lodging. This case was subsequently followed by C v S [1987] 1 All ER 1230 and Re F (in utero) [1988] 2 All ER 193. at p 653. 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. care. 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. 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. 30 Ibid. except for its own mother. 16 [1994] 1 All ER 819. 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. 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. 25 Section 77(1)(b). In Re JT. 19 The low level of comprehension that the test for capacity entails means that most patients will be competent to consent. 33 [1997] 2 FLR 426. 32 Although Re S has never been appealed. see above. at p 279. in English legal circles it is generally believed that this decision was discordant with previous case law. 15 [1989] 2 All ER 545. control and protection of persons who are mentally disordered and for related matters.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. detention. Nevertheless. 27 [1979] QB 276. 34 (1997) 34 BMLR 16. For facts. at p 295. the Ordinance regulates the law for the mentally ill in West Malaysia. [1994] 1 WLR 290. as she understood that she would dies. the patient suffered from a severe learning disability with sufficiently disturbed behaviour to justify detention under the Mental Health Act 1983. 28 Ibid. 20 [1997] 2 FLR 426. 26 Section 77(1)(c). 23 Section 77. 21 At the moment. 36 [1997] 2 FCR 541 at p 561. 35 Ibid.

These problems have also been highlighted by officials from the Malaysian Medical Association and the Malaysian Medical Council. 2002. 43 [1979] QB 276. These rapid developments in medicine. 2002. 49 [2000] 1 FLR 549. at pp 121-122. Report of the Select Committee on Medical Ethics. at p 560. 51 Norchaya Talib. see para 19. 42 [1999] 6 MLJ 738. 48 This decision was heavily influenced by the case of Bolitho v City Hackney Health Authority [1997] 4 All ER 771. SCIENCE AND TECHNOLOGY [2004] 2 MLJ i Malayan Law Journal Articles 2004 CONTEMPORARY LEGAL AND ETHICAL DILEMMAS RAISED BY ADVANCEMENT IN MEDICINE. 2003. science and technology have awakened many moral and legal questions. 44 [2005] 5 MLJ 480. 45 Ibid. 52 Ibid at p 54. Euthanasia -. see Norchaya Talib. at p 53.A Malaysian Perspective. it is mentioned that the hospital will take into account the wishes of the patient in the event an advance directive is drawn up. 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. 50 Ibid. HL paper 2-I of 1993-94 at paragraphs 263-267. (2nd edition).A Malaysian Perspective. Malaysia Introduction The late twentieth century depicts medical practice as being technologically advance-orientated environment. 53100 Kuala Lumpur. Euthanasia -. Kuala Lumpur: Sweet & Maxwell Asia. 54 See P Bartlett & R Sandland. 46 Supra. at pp 602-603. Mental Health Law: Policy and Practice. SCIENCE AND TECHNOLOGY Dr Puteri Nemie Jahn Kassim Assistant Professor Ahmad Ibrahim Kulliyyah of Laws International Islamic University Malaysia Jalan Gombak. London: Oxford University Press. A . 41 [1998] 7 MLJ 481. Malayan Law Journal Articles/2004/Volume 2/CONTEMPORARY LEGAL AND ETHICAL DILEMMAS RAISED BY ADVANCEMENT IN MEDICINE. 47 [2000] 2 FLR 389.40 [1997] 2 AMR 1382. 53 From a personal interview with the relevant person from Gleneagles Hospital in Kuala Lumpur.

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

For patients who are totally dependant on such machine. Thus. their relatives. whether the risks were explained to the donor and whether any payment is involved. Those who are against euthanasia in any form argue that there is no certainty regarding death. legal problems that need to be solved for live donation are questions on consent. 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 quality of life is questionable. a young woman suddenly stricken illness.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. dependants and medical carers. This is normally done through what is known as life support machines. her relatives will consider whether it is in her best interests to end her life at that time.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. Consciousness or sensate awareness will have decayed. This dilemma raises legal. In other words. lay in a coma attached to a life-support machine and presented a terrible dilemma to her family and hospital authorities. This procedure is undoubtedly one of the triumphs of modern medicine. that is. whether the consent was given freely and not under duress. Life may have been saved but only because dying has been prolonged. which literally involves the use of organs and tissue taken from non-human animals. irreversible loss of brain stem function. The judgment in Quinlan was greeted with mixed reactions. a phenomenon affecting every country that has developed the ability to undertake this form of surgery. xenotransplantation of animal organs and tissue carries with it . at what stage death has occurred. Usually. Those who are in favour of euthanasia consider it as respecting patient's right of self -determination. skin and blood. The crucial question raised by this situation concern exactly how death is defined. Her parents decided that it would be best for her to be removed from the life support machine. she was characterised as being in a "chronic. The procedure has become increasingly routine as means of saving and improving the quality of the lives of thousands of people each year. death has been redefined as requiring whole brain death including the brain stem. are dead and there is no electrical impulse. Many terminally ill patients have known to recover and maybe in future modern technology may find a cure for a terminal disease. Recently. However.8 Euthanasia can be characterised as voluntary and involuntary. The patient is considered to have no capacity to live and will not recover from it. much research effort has gone into the possibility of xenografting. 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. 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. vegetative condition" kept alive only with the assistance of the respirator.9 Recent advances in medical technology have made it possible to maintain the works of some bodily functions. 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.10 The traditional criterion of death was the cessation of respiration and circulation. Furthermore. However. 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. The word "euthanasia" refers to the means of inducing or bringing about a gentle and easy death. 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.11 This occurred in the Karen Quinlan case.12 Karen Quinlan. which operates respiration and heartbeat. transplant activity is increasingly constrained by the shortage of organs. persistent. the life support equipment should be discontinued. 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. The father applied to the court for this purposes. usually because she lack the capacity to do so. 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. social and ethical questions to which there are no easy solutions. In other words. However. Although she was not dead by the applicable medical criteria for determining brain death. The high degree of evolutionary relatedness between human beings and some mammals suggests that such procedure might be successful. Brain stem death refers to situation when part of the brain. To solve this problem. the medical authorities were satisfied that there was no hope that she would ever return to a cognitive state. there is value and dignity in every human life. living may amount to little more than survival.

" Only those embryos free of the genes associated with the disease will be implanted. In this regard. If the child were not told of his or her conception by her parents. It is difficult to assess this risk. 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. Reproductive technologies Advanced medical processes have introduced many modern reproductive techniques. 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). these developments have raised the possibilities of human cloning. 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. The most common and oldest method to deal with infertility is artificial insemination. particularly. 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. the "mistakes" will be human beings.18 However. Nevertheless. as birth certificates are issued in the name of the legal parents not the genetic parents. There is also the risk of disasters. deep-rooted notions of human dignity might be placed in jeopardy. 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. reproductive technologies that allows donor sperm or ovum to be used to achieve pregnancy has caused genetic. This can be particularly helpful as it may offer greater insights of cancer and other cellular development processes such as ageing and cell commitment.19 The traditional familial hierarchies and relationships would be distorted and the production of human clones may be used as sources of spare parts. Human Cloning Cloning is the technique of producing a genetically identical duplicate of an organism. The other concern is the accidental side effects of well-intentioned uses.23 Thus. which has consequences for the characteristics possessed by the child that is subsequently born. not naturally present in an embryo. in order to produce a child with certain positive attributes desired on the part of its parents. Negative genetic engineering is aimed at elimination disabilities associated with genetic defects. This egg was then transplanted into a normal sheep for normal gestation to take place. 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. gestational and social parenthood to be separated.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. with the result that children can have a number of parents. These artificial reproductive methods have helped many couples having difficulty conceiving naturally to have children. and the embryos produces are subjected to "pre-implantation genetic diagnosis. In such cases. A clone is thus asexual progeny of a single individual. it requires that couples at risk of passing on genetic diseases to their children undergo IVF treatment. one may inadvertently choose genes for high levels of aggression and depression. One concern is the deliberate use of genetic engineering for perverted ends.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. which allow conception to occur without resorting to normal sexual intercourse.20 Positive genetic engineering. However. Such consequences are clearly far-reaching and difficult to control. positive genetic engineering. At present. There are various causes for concern in genetic engineering. All technology carries with it risk of mistakes and unwanted side effects. seeks to introduce new genetic elements. a quest for "normality" can result in secrecy and dishonesty. An important aspect that might be foreboding is that if people were "manufactured" in this way. that is. while the other ones are discarded. he or she would be entirely unaware of her genetic makeup. "mistaken" genes would be passed on to future generations. it is not possible to predict or quantify the risk that xenotransplantation will result in the mergence of new human diseases.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. In choosing genes for high intelligence.the potential risk that diseases will be transmitted from animals to xenograft recipients and to a wider human population. Dolly was the first example of an adult vertebrate cloned from another adult. One problem that may be overlooked is some genetic linkage between different characteristics. secrecy and the anonymity of the . which are irreversible. on the hand. an important distinction may be drawn between the positive and negative forms of such engineering. Thus.

Comparative Healthcare Law. at pp. 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." 3 See Chester v Afshar [2002] 3 All ER 552. Passive euthanasia. on the other hand. 12 In re Quinlan (1976) 355 A. MRI. and angiogram has made it possible to separate conjoined twins and give them hopes for a better life. 1914)). and fear of stigmatisation and societal disapproval. even if it is an imperfect and often inaccessible weapon. as a consequence. never trusts his parents again. It is the function of the law to interpret and to reflect public attitudes. 4 Re T (Adult: Refusal of Medical Treatment) [1992] 4 All ER 649. 6 [1992] 2 FCR 861 at 865.297. Children by donation should have a right to know the identity of their genetic parents. as some would suggest it from a philosophical perspective. 10 If the patient is dead. 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. . 2 Similar sentiment can be found in the judgment of Mr Justice Benjamin Cardozo in Schloendorff v Society of New York Hospital (105 N. It is much better if parents are open about the means of conception and for the children to have knowledge of their medical history. 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. fear that the donor may interfere in the child"s upbringing. 2001. 8 In other words. 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. at p. is also described as a form of active euthanasia. 9 Active euthanasia occurs whenever positive steps are taken which result in death such as injecting a lethal dose of medication into the patient.26 Conclusion Medical technology advances inexorably and it does so in an ambience of rapidly changing societal values. London: Cavendish Publishing. Secrecy carries the danger that a child by donation will discover his status and.donor has been the cornerstone of assisted reproduction using donor gametes. Chappel v Hart [1998] 156 ALR 517. 11 De Cruz. 2d. 13 In England. However denial and secrecy can lead to problems within the family. The Malaysian Human Tissue Act 1974 only regulates removal of organs from dead donors. Peter. where one person offers another assistance required to bring about his or her suicide. Secrecy stems from fear that the child may reject the social parents. it is easier to take a decision to cease treatment and switch off the machine. 5 The advent of imaging technologies such as CT scan. Rogers v Whitaker (1992) 175 CLR 479. The Act also seeks to criminalise the commercialization of live donor transplantation. Developments will always be taking place in medicine and the legal outcome may not always be the same. 1 [1990] 2 AC 1. In Malaysia.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.E. death without suffering. living donors are not protected under any statutory enactments. 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. at p. occurs where available measures to prolong life are withheld from the patient such as withholding supply of fluids and nutritional feeding. the law. 652-653. and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages. Legal intervention in medicine is deemed necessary and to some extent inevitable.Y. 56. Assisted suicide. 92 (N. Anonymity implies that conception by donation is a furtive and "unnatural" way of forming a family. is at least one of the means of controlling medical practice in the interests of the community as a whole. rather than simply one method of family formation. 647. Blackwell Science). 7 "Consent to treatment: the capable person" (1992: Oxford.

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

. in Tan Tek Seng v Suruhanjaya Perkhidmatan Pendidikan & Anor. This provision has been characterized as the 'most fundamental of all fundamental rights provisions (and available) to all persons.. In practical terms. Given the relatively pedantic approach taken by the Court of Appeal in Bakun's 12 case it is perhaps unlikely.which talks about liberty of the person -. 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'. we can say that art 5 of the Federal Constitution of Malaysia implicitly recognizes the right to a healthful environment.RIGHT TO LIFE UNDER THE FEDERAL CONSTITUTION AND ENVIRONMENTAL ISSUES Dr Abdul Aziz Bari Head. which are synonymous with human rights. at least for the moment. the court ruled. the decision revolved . In Bakun. before we deal with these views it is perhaps worth looking at the provision itself. 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. 4 has also given a liberal meaning to art 5. In Bakun. all was done in accordance with law. [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. There is a move in the country to amend the Constitution to explicitly provide for a right to a healthful environment. 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. under the title 'Fundamental Liberties'. 3 Thus. However. But. that is to say. 7 art 5 also provides the right to habeas corpus. the court acknowledged that in Bakun 'there is deprivation of livelihood or one's way of life.. one could say that fundamental liberties. are: . Article 5 of the Federal Constitution -. the right to live in a healthy environment is something implicit in art 5 of the Federal Constitution ('the Constitution'). In any case. And it must be said that this is not the first time one comes across such a liberal interpretation of art 5. This view has highlighted the scope and meaning of 'life' in art 5 as well as its significance in environmental issues. It includes the right to live in a reasonably healthy and pollution free environment.. However. 13 Subash Kumar 14 and Virandra Gaur. our talents and our conscience and to satisfy our spiritual and other needs.. one's culture. this right. Dr Abdul Haseeb Ansari. 10 The Constitution does not explain what it means by fundamental liberties. Thus. they allow us to fully develop and use our human qualities. 1wrote in his article 2 published in this journal two months ago that: In the Federal Constitution of Malaysia.is one of nine articles 5 under Pt II of the Constitution. 16 to be followed here. International Islamic University Malaysia My colleague. Neither did the Reid Commission Report. 18 Obviously. the Court of Appeal acknowledged the natives' complaint came within the scope of 'life' under art 5(1) which: . which guarantees right to life and liberty. our intelligence. those rights which are inherent in our nature and without which we cannot live as human beings . falls within the ambit of art 5. 6 Apart from the right to life and liberty.. Be that as it may. which contained the recommendations that laid the foundations of our constitution. there is deprivation of life itself'. together. 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. Department of Public Law Kulliyyah of Laws... not just citizens'. in Dr Ansari's view. to expect the liberal approach taken by the Supreme Court of India in cases like MC Mehta.. 15 all of which have been included by the learned writer in his article. 17 Indeed. like in other countries. incorporates all those facets that are an integral part of life itself and those matters which go to form the quality of life . he seems to prefer a more explictit provision guaranteeing a healthy environment to be inserted in the Constitution. the right under art 5(1) remains an academic one for the natives. The Court of Appeal. there is no explicit right to a healthful environment.

however. the Court of Appeal affirmed the decision. the liberal meaning of life has not been achieved in a direct way. 26 One could say that although in Tan Tek Seng. The aborigines were therefore entitled to compensation under the Constitution. and (ii) the natives had no substantive locus standi to obtain declaratory relief. These are minimum requirements which must exist in order to enable a person to live with human dignity and no state . Perhaps one day we will have a situation where the right to life under art 5(1) would have a real significance. 30 In that case.. On appeal by the state government... inter alia: .. educational facilities. 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. 21 But on appeal. by majority. lest they be left behind while the winds of modern and progressive change pass them by.. 37 At the High Court. the Court of Appeal overturned the decision on the grounds that: (i) from the constitutional viewpoint..24 In Tan Tek Seng. 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. the state of Sarawak had the exclusive jurisdiction to exclude the federal EQA. when the Constitution was drafted in 1956. 33 where an issue which can be put under the environmental head was decided under art 13 of the Federal Constitution. has the right to take any action which will deprive a person of the enjoyment of these basic essentials. just and humane condition of work and maternity relief. men and women. 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. rent etc. It is submitted that the significance of the liberal meaning would have been greater had Tan Tek Seng specifically dealt with art 5. at least . In the meantime. 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. 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. which was central in Tan Tek Seng. The plight of the aborigines there was somewhat similar to that of the natives in Bakun. A critique of Tan Tek Seng has been made elsewhere 28 and thus need not be repeated here. 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. one could perhaps use other provisions in the Constitution. and of tender age of children abuse . 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'. the relationship between arts 5(1) and 8(1) 29 with art 135(2). statutory law 36 and fell within the ambit of proprietary rights under the Federal Constitution.. Kerajaan Negeri Johor & Anor v Adong bin Kuwau & Ors. There the notion of fairness was explained in the light of the constitutional provision itself.. though it is not to the land itself in the modern sense. 35 There the state government had acquired land. It has been observed that the decision in Bakun was a 'missed opportunity to breathe dynamic force into the Malaysian Constitution'. such as the permissibility of leasing out.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. inter alia. which the aborigines claimed was their traditional ancestral land upon which they depended to forage for their livelihood. 22 the Court of Appeal. 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. Judges must not be blind to the realities of life'. At the High Court. the exclusion was held to be invalid. include the protection of health and strength of workers. With respect. 32 Having noted that. They submitted that the rights were accorded to them by the common law. was explained by the Court of Appeal in a rather convoluted manner. In Tan Tek Seng. 31 The decision 'was particularly unfortunate as. Suriyadi J was able to mete out justice without going too far from art 132(2) which is. 34 the aborigines were claiming compensation pursuant to art 13(2). In Adong bin Kuwau. A positive development has emerged in a recent decision. saying that: . 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. it must be said that such a position does not mean that the Constitution is not environment-friendly.

12 Ketua Pengarah Jabatan Alam Sekitar & Anor v Kajing Tubek & Ors and other appeals [1997] 3 MLJ 23 (CA). 3 Ibid.. Public International Law: A Malaysian Perspective (Vol 1) (1996). 2 'Right to a Healthful Environment as a Means to Ensure Environmental Justice: An Overview with Special Reference to India. 8 Ibid. the fact remains that it is better to have an explicit provision spelling out the need to protect the environment. the Constitution of the Republic of Belarus and the Constitution of the Republic of Kazakhstan. 14 Subash Kumar v State of Bihar AIR 1991 SC 420. International Islamic University Malaysia. the new constitution of Ukraine expressly declares that 'everyone shall have the right to the environment that is ecologically safe for life and health'. art 5(3). 'Natural Justice and the Constitution' [1981] 23 Mal LR 226. 13 MC Mehta v Union of India & Ors AIR 1988 SC 1115. 15 Virendra Gaur & Ors v State of Haryana 1995 (2) Supreme Court Cases 577. 11 Tunku Sofiah Jewa. Philippines and Malaysia' [1998] 4 MLJ xxv. 41 Apart from the emerging consciousness about the environment. 9 Ibid. art 5(4). voluntary euthanasia. . 19 See Ong Ah Chuan v PP [1981] AC 648 at p 670.. p 465. art 6 (slavery and forced labour). 7 Federal Constitution. For example. See also Andrew Harding.. Government and the Constitution in Malaysia (1996) at p 209. art 9 (prohibition of banishment and freedom of movement). 10 Ibid. 17 See the court's earlier decision in Tan Tek Seng [1996] 1 MLJ 261 at p 288H. Indeed. assembly and association). 40 Corresponding positions are also to be found in the Constitution of the Russian Federation.. See also PP v Lau Kee Ho [1983] 1 MLJ 157 and PP v Yee Kim Seng [1983] 1 MLJ 252. . art 12 (rights in respect of education) and art 13 (rights to property). art 5(2). 39 Despite the decision in Adong bin Kuwau. art 11 (freedom of religion). art 5(1). abortion and the like. 20 See Che Ani bin Itam v PP [1984] 1 MLJ 113. 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 . p xli. most of which confine the notion of right to life to human existence and issues such as capital punishment. art 10 (freedom of speech. Law. 16 Supra n 2 at pp xxxiv-xxxviii. 18 Supra n 12 at p 43E-I.. 5 These are art 5 (liberty of the person). this is the trend that is emerging at present. 4 [1996] 1 MLJ 261. 42 1 Associate Professor of Law. art 8 (equality). art 7 (protection against retrospective criminal laws and repeated trials). such expression may have been due to the lack of environmental protection in international documents of human rights. 6 Andrew Harding.

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

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 . specific and prior expression from the patient herself that her life-sustaining treatment be removed or terminated.LANDMARK US AND UK CASES Myint Zan Former Lecturer Faculty of Law. If a doctor or doctors. 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. Universiti Kebangsaan Malaysia A recent news item stated that one American medical doctor. or should.8 About five years before her accident. In both cases.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'. 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'.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'. a request by the patient's family to that effect need not be honoured by the State of Missouri.1 In a related news item. 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. It must be mentioned that Nancy Cruzan. or provision of water (hydration tube) would their actions amount to 'euthanasia'? More importantly would. 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'. was/is technically alive5 and was/is able to give 'reflexive responses to sound and perhaps to painful stimuli'. be it concerned with breathing (respirator). who sustained severe injuries in a car accident in January 1983. 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'. at the request of the patients' closest next of kin remove the artificial life support systems. 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. a Dr Jack Kevorkian aka 'Dr Death'. the requests to withdraw such treatment were made by the patients' parents.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' . their actions be legally permissible? In the case of Nancy Beth Cruzan v Director.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'. The exact contents and contours of the new Dutch legislation is not known as yet. 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). feeding (gastronomy tube).

which would impair rather than serve the state's interest'. young people who were victims of unexpected accidents or illnesses.18 Diametrically opposed to Brennan J's statements were those that could be found in the concurring opinion of Scalia J. 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.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. 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.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.13 The majority's statement in this regard is 'literalism' par excellence without. 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. did not deal in terms with withdrawal of medical treatment or of hydration and nutrition'.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'.. and it could chose to defer to only the patient's wishes'.14 The oldest15 and longest serving member of the (then) US Supreme Court16 the (now retired) William Brennan J also dissented. as Scalia said. A fortiori she would not have preferred to live in a persistent vegetative state. even in the case of terminally ill patients. the opportunity.19 If one were to take Scalia's words to its (il)logical conclusion. whether such wish should be honoured. Hence the parental request to end the 'artificial intervention'.17 Brennan J also stated that Nancy Cruzan 'had a fundamental right under the due process clause [of the United States Constitution]. the legal or moral excellence which it should entail. Nancy Cruzan's case was 'indistinguishable from ordinary suicide'. American law had always accorded states the power to prevent suicide . Kevorkian himself 'administered' the carbon monoxide). with anyone but the patient herself'. But as one who was in a persistent vegetative state she could not communicate her wishes. 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. Declared Scalia J (over) confidently: What was sought in the woman's case was indistinguishable from ordinary suicide..withdrawn. This is different from assisting suicide. 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. by providing the means such as poison gas or lethal liquids for the patients to administer to themselves or by direct administra- . or elderly persons who either failed to decide or failed to explain how they would want to be treated'. For.. 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. It could perhaps be argued that Kevorkian provided the means. to be free of unwanted artificial nutrition and hydration'. In addition. . some lethal liquid or carbon monoxide into their body by means of the 'suicide machine'. and facilitated the suicide by letting the patients self-administer (however..by force if necessary. in the writer's opinion.including suicide by refusing to take appropriate measures to preserve one's life . one might venture to suggest. who to us judicial and political liberals is at best a 'staunch conservative'. in the case of Hyde and according to the news item. the majority felt that Nancy Cruzan's 'statement to her housemate and other observations to the same effect . 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.

.33 In Bland.. '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. it was expected that if such care and life-support systems continued. Be that as it may. Bland 'suffered catastrophic and irreversible damage to the higher centres of the brain'. that their actions fall within the provisions of the euthanasia law. Medical treatment.. progressive and ongoing'. Furthermore. 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. Nancy Cruzan could continue to live for another 30 years in a vegetative state since her illness was/is not terminal.22 Needless to say. 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.'29 Cruzan also 'had no cognitive or reflex ability to swallow water or to maintain her daily essential needs..30 And. 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. including artificial feeding . and would never recover such ability'.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. young people who were victims of unexpected accidents or illnesses'..25 So was Cruzan. 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. 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. doctors have strict guidelines to follow and would have to justify.. Cruzan was described as being 'oblivious to her environment. like Cruzan. Bland had never given 'any indication of his wishes should he find himself in such a condition'.27 Bland 'cannot swallow and is fed by means of a tube.. 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 '. the Official Solicitor appealed to the House of Lords.'. in each and every case of active euthanasia. there was every likelihood that Bland would maintain his present state of existence for many years. He was described to be in a persistent vegetative state.tion by the assistant as in the Hyde case. Even under the Netherlands law.. to the public prosecutor. 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. the Cruzans' claim on behalf of their daughter was rejected by the Supreme Court. 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- .31 Most importantly.24 a case in which the United Kingdom's highest judicial authority. 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. 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.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'. threaded through the nose and down into the stomach.23 As stated earlier. A tragic case involving another young person is the case of Airedale NHS Trust v Bland. could lawfully be withheld from an insensate patient with no hope of recovery . It was stated that with artificial feeding and supply of water. John Paul Stevens J (dissenting) in Cruzan drew attention to the fact that the state of Missouri's requirement for a clear. 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 .26 Similarly Bland's 'lungs were crushed and punctured and the supply of oxygen to his brain was interrupted'.

in every case of withdrawal of life support and medical treatment. the UK courts' judgments in Bland touched on issues dealing with the common law right to refuse treatment. permits a person to explicitly. Malaysia as yet does not have a 'living will' arrangement which. philosophical and moral issues than the majority judgement of the United States Supreme Court in Cruzan. as per the caveats in both Cruzan and Bland. at least not to the extent that the US courts did. The states of Victoria and South Australia in Australia as well as some American states including Missouri have laws allowing living wills. the US Supreme Court relied greatly on American constitutional doctrine. legally. In the writer's opinion. in effect. It has a better perspective. In Cruzan. the concurring opinion of Sandra Day O'Connor J is worth mentioning. 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.38 The UK courts did not appear to have 'constitutionalized' the issues.35 Anthony Bland died a few days after the life-support treatment was terminated in accordance with the declaration. if at times competing. Indeed Malaysian courts have not hitherto being confronted with the issue of withdrawal of life-support treatment.39 Nevertheless. In this context and in a related issue.36 Hence. Hence until the law changes or the British Parliament enacts new legislation.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.) 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 . doctor-patient-guardian relationship. some in the United States just carry a necklace with the words 'Do not resuscitate'. 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. and in advance of his possibly becoming PVS to refuse to accept any 'death-prolonging' treatment. At the same time and coming back to Cruzan. as it invariably does. claims of individual self-determination and state and society's interest to preserve life. 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. without first applying to the courts. The double tragedy of Nancy Cruzan was that she did not made a living will before she met with her tragic accident. One final comment as to the possible differences in approach in Cruzan and Bland. None of the cases are in any sense binding on Malaysian courts. 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.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. 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. And such a 'living will' need not be elaborate. aspects of criminal law and the parallel. is more perceptive and touches more extensively on a range of legal. an application would have to be made to the British courts for a declaratory relief similar to the one in Bland.

supra n 1) that 'he is still receiving letters from people who want his help. After serving 34 years on the Bench. 15 William Brennan J was born in April 1906. 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. who suffered from the degenerative nerve disorder. who had faced up to four years in prison and a US$2.' juror Gwen Bryson said. Lou Gehrig's disease. especially a person suffering from an incurable and painful disease'. 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. 6 Cruzan. a Parliamentary committee could look into these issues which in the near or distant future could arguably come to the fore in Malaysia. Three jurors interviewed after the verdict concluded that Kevorkian's main intent was to relieve Hyde's suffering not to cause his death. lawyers and legal scholars. acknowledged he supplied the carbon monoxide and placed the clear plastic mask over Hyde's nose and mouth.400) fine if convicted. But it wasn't enough for the jurors to convict. 8 Ibid. academic and other bodies and ultimately. professional. and The Budget Macquaire Dictionary defines it as 'the putting of a person to death painlessly.' Jurors said their sympathy for Hyde's suffering also played a factor in their verdict. 11 Ibid. Dr Kevorkian.41 Medical doctors from all fields. Hence the use of the qualifier was/is in discussing Nancy Cruzan's condition. 5 At the time of writing (July 1994) the writer was unable to verify whether Nancy Cruzan is or is not still technically alive. argued 6 December 1989. 4 May 1994 at p 21. a means of putting to a painless death'. 7 Ibid. supra n 4 at p 225. religious. talk or feed himself. decided 25 June 1990. 'We believe the intent was not to help Hyde commit suicide. By the time Kevorkian hooked Hyde up to a canister of carbon monoxide on a mattress in the back of his old. Hereafter cited as 'Cruzan'. . 12 Ibid. a putting to death by painless means. Brennan J submitted his resignation to President Bush in July 1990 barely a month after the Cruzan decision was delivered on 25 June 1990. after his acquittal. reported under the heading. 'Doctor Freed of Assisted Suicide Charge' that Dr Kevorkian was charged in the 4 August death of Thomas Hyde. 9 Ibid.000 (RM5. It is a cliche to say that there are no easy answers but the issues must be addressed first. 10 Supra n 4 at p 226. 4 [1990] US Supreme Court Reports 111 L Ed 2d 224. but refused to say whether he would resume his assisted suicide practice any time soon'. not all of the questions can be discounted or merely 'kept in view'. rusty van. '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. 14 Ibid.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. 2 The New Webster Encyclopedic Dictionary of the English Language defines euthanasia as '[a]n easy death. Dr Kevorkian. 'We believe it was to relieve pain and suffering. 30. 1 The New Straits Times. if need be. Hyde could barely walk. 13 Ibid. 16 Brennan J was appointed to the Supreme Court by President Eisenhower in 1956. stated (quoted in The New Straits Times.

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. Mr Bland lies in bed in the Airedale General Hospital. He cannot taste or smell.' 26 Cruzan. 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). 28 Ibid. supra n 24 at p 825. 24 [1993] 1 All ER 821. 21 Supra n 1. like Cruzan and Bland. his limbs crooked and taut . [Bland's] lungs were crushed and punctured and the supply of oxygen to his brain was interrupted. if by that is meant the taking of positive action to cause death. 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). Decided 12 March 1993.. .. supra n 24 at p 835. eg Roe v Wade [1973] 410 US 113. Bingham MR further stated in his judgement is not a topic most adolescents address'.. his eyes open. 29 Supra n 24 at p 859. hereafter cited as 'Bland'. 18 Ibid. are in a persistent vegetative state. 25 Sir Thomas Bingham MR graphically described the condition of Anthony Bland thus (ibid at p 834): '. He cannot speak or communicate in any way. 23 Cruzan. 37 See.. he cannot see. . although his eyes are open. It is not about putting the down the old and infirm. It has nothing to do with the eugenic practices associated with fascist Germany. supra n 24 at p 834. He cannot hear. 19 Cruzan. supra n 4 at p 226.. . supra n 24 at p 825. ( Emphasis added.. supra n 24 at p 835. supra n 4 at p 225. particularly in response to painful stimuli. the mentally defective or the physically imperfect. the patient is incapable of voluntary movement and can feel no pain. 35 Bland. 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'. 33 Supra n 9. 30 Cruzan.17 Cruzan. supra n 4 at p 227. 20 This is written without prejudice to the jury's acquittal of Kevorkian in the Hyde case supra n 1. supra n 4 at p 225. supra n 4 at p 231. his mind vacant. 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.' 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.) 34 Bland. supra n 4 at p 226. 32 Supra n 24 at p 835.. In Bland. 36 Cruzan. 27 Bland. Although capable of reflex movement.. 31 Bland.

if they should fall into a state which seems to them in anticipation to be intolerable.... . Part of Hoffmann LJ's statement reads: 'Some people make it clear in advance that. Penguin) at pp 199-204. editor) (1991..' 41 As for the second freedom struggle of the Burmese. Lord Mustill stated that 'a very similar problem [to that of Bland] arose in a different constitutional and legal framework [in Cruzan]'. Freedom From Fear and Other Writings (Michael Aris. 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? . both in the House of Lords and in the Court of Appeal. 40 Compare the discussion on this matter in the judgement of Hoffmann LJ in Bland.. supra n 24 at pp 888-889. they do not want life-sustaining treatment to be continued. eg Edwin W Edwards v Don Aguillard [1987] 482 US 578. But Anthony Bland expressed none at all. In the Court of Appeal. . see Aung San Suu Kyi. . To continue treatment is as much a choice as to discontinue it..38 See. supra n 24 at pp 852-853 with that of Stevens J's dissenting opinion in text accompanying n 14 (supra). In the House of Lords in Bland. 39 In fact there were a few references to Cruzan in Bland. Butler-Sloss LJ quoted with approval a passage from the dissenting opinion of Stevens J at pp 846-847.