Banking of Human Materials, Intellectual Property Rights and Ownership Issues: International Policy Positions and Emerging Trends in the Literature: Chapter 1: An annotated bibliography.

This article explains several different views on human tissue as human property. There are two main views; these views are human tissues as property from a personal right approach and the second is from a property rights approach. As I kept reading the article I found out that people started to claim intellectual properties as well as the tissues. This article talks about all of the legal aspects as well as personal rights to the claims of both intellectual properties and tissues as properties. I think that the article is a good one for discusing all of the legal parts of claiming these two things as property. The article is from a website in Canada: http://www.ic.gc.ca/eic/site/ippd-dppi.nsf/eng/ip00167.html. I do not know the author of the article.




Banking of Human Materials, Intellectual Property Rights and Ownership Issues: International Policy Positions and Emerging Trends in the Literature: Chapter 1
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Section 1 - Emerging Trends in the Literature
In the context of this study, the terms "personal rights" and "property rights" approach reflect two different philosophical approaches of the relationship between a person and her or his body parts and material once they are removed from the body. In referring to these two approaches, one is not referring to explicit and comprehensive legal regimes but rather to philosophical bases that form the opposing ends of a scale along which are identified diverse legal regimes. Both the personal rights and the property rights approaches are based on certain preconceptions about the issues of the status of the human person and of human material and its commercialisation and patentability. In order to discern emerging trends and to understand why various policy approaches have been developed, then, we shall briefly overview the literature on the personal and property rights approaches, the proposed alternatives and the policy issues surrounding patenting.
Section 1.1 - Approaches to Ownership of Human Tissue
The legal relationship between a person and her or his bodily material once they are removed from the body, are generally of two types: a personal rights (§ A) or a property rights (§ B) approach.
§ A - Personal Rights Approach
A personal rights approach reflects both the classical Common Law and Civil Law enshrinement of the principle that the human person is not a commodity subject to property rights(12). Thus, in general terms, the legal status of human material may be negatively defined as being neither the person nor a commodity that can be appropriated, but rather a part of a person. It is this relation it maintains with the person from whom it originated that warrants that the integrity of the person still apply to the material once removed from the body. In a personal rights approach, an individual right to integrity includes respect for bodily material once removed from the body and still identifiable to that person. The mechanism employed to ensure respect and protection of the integrity of the person and of bodily material is informed consent. As a component of a person's integrity, personal dominion over bodily material will be ensured by requiring that the informed consent of the person from whom the material originated be secured and by providing remedies for any harm resulting from non compliance.
Yet, since the current legal doctrine of informed consent "fails to require disclosure regarding what will happen to the patient's body parts after they have been removed from her body"(13), an expansion of the informed consent doctrine(14) has been proposed in order to ensure respect for the person's integrity in removed bodily material. Hence, it is argued that a person's right to self-determination encompasses a "dignitary interest in one's body and extracorporeal body parts"(15). This includes the right to control what happens to excised tissues and cells, an interest wholly distinct and independent from property rights(16). An expanded doctrine of informed consent would impose a duty on the physician to disclose not only the risks and benefits associated with a certain medical treatment, "but also the proposed use, if any, of the patient's body parts."(17) The provisions of the new Civil Code of Quebec on consent, treatment and research(18) constitute an expansion of the informed consent doctrine with respect to bodily integrity and privacy since informed consent will need to be obtained prior to the subsequent use of any bodily material removed form the body during medical care.
In addition to respect for the inviolability and integrity of the person, additional sources of personal control over the disposal of bodily material and information are founded on respect for fundamental rights and freedoms such as the rights to liberty and privacy as found under public law(19). Indeed, the right to privacy provides protection for genetic material and information(20) since it protects against unwarranted intrusions on the body as well as unauthorised procedures to obtain information about a person.
§ B - Property Rights Approach
Strong arguments have also been made in favor of recognition of proprietary interests in extracorporeal material(21). It has been submitted that a property framework may be the most efficient way of protecting rights of patients and of research subjects since property law provides precise rights of control and thus would recognize people's interest in controlling what happens to their body parts(22). Principles of equity and fairness would be better served and unjust enrichment prevented(23). Characterizing body parts as property does not mean however, that they must be completely transferable as restrictions on alienability may be imposed(24). In this line of thought, a study paper presented to the Royal Commission on New Reproductive Technologies, maintains that rejection of the property approach to control over one's extracorporeal material stems from misconception of the modern concept of property(25). The legal concept of property refers not to material objects but to a bundle of rights, the "rights of control and domination over both tangible and intangible things or spheres of activity."(26) Viewed in terms of control over one's body, property rights enhance personal dignity rather than diminish it.
Prior to the French legislation of 1994(27), several French commentators on civil law had proposed a property rights approach to control over human genetic material. Accordingly, human genetic material is the person's property and may be the object of commercial transactions, even if they are gratuitous(28). Individuals maintain personal control over removed material from their bodies. Thus, abandonment or donation of tissue or bodily material may not be presumed but rather requires intentional abandonment or donation(29). Another author proposed that the legal regime of human genetic material be based on the legal regime of assigning property to a person, that is, that property has a formal assignment(30). Biological material is naturally assigned to a person's body. Even if removed from the body and detained by third persons, the natural assignment of human genetic material to the person will change only after the expressed consent of that person. Only when that human material is no longer assigned to a person may it be the object of commerce(31).
C - Alternative Approaches
Several interesting alternative approaches have been proposed by Canadian authors. In 1989, Marusyk and Swain proposed a three-tiered legal classification of human substances(32). The first level looks at the human body as a whole (including the persona). Thus the sum total of tissues, organs and genetic material that create a unique individual would "fall under the classification of property rights in that person" as long as the parts remain in that person. The second level of the legal structure covers res nullius, things without an owner. Bodily material removed from the body in a way that no longer serves the original possessor would fall into this category. Such extracorporeal material would become a corporal moveable owned by no one and ownership could be acquired by the first person to take possession of the material. The third tier of the legal structure characterizes bodily material permanently removed from the body as res communes omnium, the common property of all. This approach would prevent human material from becoming a marketable commodity but would allow a product derived from human material through labour and technology to generate property rights(33).
A somewhat similar approach to the three-tiered legal structure has been proposed by civil law commentators and may be translated as a theory of gradual distancing(34). This theory is directly rooted in Quebec civil law. It suggests that the human body be considered on three levels. When the body is a comprehensive entity, it follows the personal interests of the person. The second level of distancing, refers to body parts removed from the body that may be "alienated" and thus are no longer "parts of persons" but have become things. The gratuity of the alienation reflects the respect due to these bodily parts such as organs(35). At the third level of distancing, it is maintained that as the distance increases between the extracorporeal material and the person from whom it originated, the restrictions imposed on the circulation of the human material would decrease accordingly(36). General rules of property law and ownership would govern removed body parts once they are at the third level of distancing.
Finally, a report presented to the Royal Commission on New Reproductive Technologies proposed a unique, sui generis regime for the qualification of the juridical character of an object(37). A sui generis interest need not have any particular characteristics as the utility of this category is precisely that courts may develop the law relating to a particular object on a case-by-case basis, "without the fetter of proprietary or other preconceptions."(38) However, "in practice ... sui generis interests, as they relate to objects, will always have proprietary characteristics. Some degree of control will be conferred on someone."(39) Maintaining that a property rights discourse should not be used with respect to human genetic material for symbolic as well as political reasons, the sui generis regime was submitted since it does not reject property principles, some of which are useful in defining the type of control over human material, and would afford courts latitude in interpretation without "evoking an unwarranted and unnecessary emotional debate."(40)
It should be noted that although possible economic value that is, commercialism, and property overlap, the former should not automatically be associated with the latter. Moreover, underlying the debate on the applicable legal regime is that of sale or gift of human material(41). Whether the gift philosophy prevails or rather the possibility of selling one's human material, underscores the role of the citizen in society, that is contributing freely to the common good or seeking to "profit" from one's materials. Whether or not the legal regime espoused is one of personal rights or of property rights may however be irrelevant as is evident in the contentious issue of patenting.
Section 1.2 - Approaches to Intellectual Property Protection
In recent years, the issue of patenting human genes has become increasingly controversial. The potential commercial exploitation of research in human genetics adds a certain urgency to the need to find a suitable means of protecting research results and stimulating such research while considering industrial and academic interests as well as the attendant controversial moral and ethical concerns surrounding the use(s) of human genetic material.
At the outset of the controversy, is the debate over the most suitable legal form of eventual intellectual property protection of human genetic material. The most widely sought protection has been that of patent rights, although strong arguments have been made in favour of copyright protection(42) and a hybrid or sui generis protection(43). During a 1995 UNESCO international workshop on legal systems of protection of research results in genetics, consensus seems to have been reached by the international commentators in favour of patent protection(44) for the results of human genetic research. Opting for protection through the patent system, appears to be in accordance with growing practice(45). In fact, as we will see below, under current European and US. patent laws, inventions derived from or containing human genetic material are generally considered as patentable subject matter by patent offices. In addition, human genes and DNA sequences of demonstrated purpose as well as related processes are patentable(46).
Despite this seemingly established practice, patent applications on DNA sequences remain controversial. The gene patenting controversy arises from international tension symptomatic of the opposing views and attitudes of government agencies (mostly US and European), researchers, industries, non governmental organisations and lay persons(47) , based not only on the property-person, sale-gift dichotomies, but also on differing interpretations of the actual and potential reach of patent law. While differences in US. and European patent laws may be at the source of some difficulties encountered in attempting to resolve this controversy, in general, competing arguments as found in the literature may be summarized under three headings: ethical, industrial policy, and legal.
A - Ethical Concerns
Opposition to the patenting of human genetic material is often based on the recognition of rights of ownership, that is exclusive rights of exploitation, over human biological material that are an intrinsic part of human beings(48). Strong ethical arguments against patenting genes are also based upon the premise that genes are the common heritage of mankind(49) and as such, may not be appropriated. Further arguments of privacy(50) and distributive justice(51) have also been raised. Interestingly, ethical concerns in favour of patenting have also been raised. Based on concepts of fairness and efficiency(52) , not rewarding researchers for work which eventually benefits society as a whole is deemed unethical. Controversy may stem from different perceptions of what it is that is being patented(53): life forms, genetic information, or an innovative process. In the event of genes of unknown function the distinction may be even harder to draw. As we will see below, however, the greatest challenge of the gene patent controversy is ensuring that these ethical concerns are considered.
B - Industrial Policy Concerns
Industrial policy arguments foresee several possible outcomes for gene patenting. A recent study notes that willingness in the United States to recognize and protect intellectual property rights in technological advances is a manifestation of the desire to advance genotechnology in the US(54). However, these authors recognize that "[t]o the extent that the PTO has de facto relaxed its requirements for genotech inventions and will issue more questionable pat ents, the rest of the industry bears the burden of either litigating the validity of these patent or entering into license agreements with those who hold them."(55) The validity of such patent applications remain unclear and controversial, as the unsuccessful NIH gene patent application, followed by that of the UK Medical Research Council, exemplifies(56). More importantly, the impact of gene patenting applications on the dissemination of genomic information and on international cooperation and collaboration is troublesome(57).
C - Legal Concerns
Turning to the legal debate as found in the legal literature, the determination of whether genes are patentable rests on two criteria: the first is the threshold criterion of patentable subject matter; and, the second, the technical criteria that refers to novelty, non-obviousness and utility (usefulness being the European counterpart) of any inventions(58). Of upmost interest for our purposes is the latter criterion. Several commentators have argued that the main issue will be to determine the degree of utility necessary for patenting. Here the debate turns on whether gene sequences of unknown function may be patented(59). Distinctions between fundamental and applied research are also at issue(60). Fundamental research has long been categorized as knowledge belonging to the public domain, "freely available for further use"(61), and thus unlike applied research, not patentable. Research in biotechnology, however, may be difficult to clearly categorize. It has also been suggested that human genes lack the novelty required(62) and that awarding patents over genetic material could hinder downstream patent applications over products eventually derived from genetic sequences(63). Other commentators argue that human genes will probably meet all the technical requirements(64) and that the "true" issue at stake is the threshold criterion of patentable subject matter(65). In fact, two American analysts recently wrote:
"Less certain is whether patent protection will be available for the discovery of a gene sequence or partial sequence. In the notorious genotech patent controversy involving the NIH's application for patents on partial gene sequences, the PTO rejected the applications based upon lack of utility, novelty or non obviousness -- not for lack of statutory subject matter. This reflects either the PTO's willingness to avoid the issue of statutory subject matter in this context or a substantiation of the contention that the historical distinction between discovery and invention has been eroded to a nullity."(66)
In addressing whether genes are patentable subject matter, the differences between the US. and European patent laws are manifest. European patent laws explicitly provide a criterion for exclusion from patentability for ordre public (public order) or morality motives, an ethical criterion that falls under the evaluation of the patent office(67). In contrast, US. patent law only has provisions with specific exclusions from patentable subject matter(68) and no such ethical criterion. Ethical considerations are only implicitly considered and consequently, as has been noted in US. patent law, "the threshold test [...] fails as an ethical safeguard"(69). While then, the role of ethical analysis differs, several commentators on both the European and US. patent systems believe this will have little effect on the issue of gene patenting. Indeed, several have concluded that under current legal threshold requirements, genes seemingly constitute patentable subject matter in both Europe and the US.(70). Furthermore, it has been suggested that the public order exclusion in the European Patent Convention was not designed for the resolution of such controversial issues and that the European Patent Office may in fact not be the appropriate body to undertake such complex universal pressing ethical analysis(71).
In short, as concerns human genetic material, the current literature holds that the patent law framework does not explicitly address important ethical concerns. A growing consensus seems to be that patent law is unable to serve as a tool to solve the controversy because of the limited attention paid to the underlying ethical and policy concerns(72) . Indeed, governmental intervention on national and international levels has been called for in order to reach an international consensus that might take several forms. One suggestion is to establish an international registry system, a "Human Genome Trust", to monitor genome progress and ensure collective "ownership" while permitting the co-existence of commercial development incentives(73) . Other propositions call for international agreements on a range of issues such as data sharing or limiting protection to the "moral" recognition of scientists who "discover" gene sequences(74) . As early as 1992, it was suggested that international agreements affirm that any rights to patented sequences be enforced only when the biologic function becomes known(75) .
Working toward such agreements will be difficult and time consuming, as exemplified by the recent rejection of the European Directive, as explained below(76) . However, the alternative case-by-case analysis by patent offices and subsequent case law may prove to be not only equally time consuming but also expensive. A policy or legislated resolution process would allow for extensive debate over these sensitive issues. This process has begun.



Banking of Human Materials, Intellectual Property Rights and Ownership Issues: International Policy Positions and Emerging Trends in the Literature: Chapter 2
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SECTION 2 - Comparative Overview of Policy Positions
International and regional instruments/documents seldom bind national governments. Only national legislation or statutes (where they exist(77)), are binding. The absence of enforcement procedures further undermines the authority of these international and regional instruments. For example, while international conventions adopted by the United Nations bodies bind member States upon their signature and ratification, difficulties in ensuring their enforcement make the actual legal strength of these instruments quite limited. Moreover, declarations adopted by the United Nations bodies are not legally binding upon member states but rather have a moral pursuasive force(78). At the European level, the only body that binds member states is the European Parliament. Hence, had the draft European Directive of the Parliament on the legal protection of biotechnological inventions(79), been adopted, member European nations would have been bound by it and be required to modify or interpret their national legislation accordingly.
The reports of governmental commissions, agencies or working groups, recognized international, regional or local organizations, expert committees, and workshops, constitute the main source of policy positions. The common thread of all these texts is the formulation of recommendations following deliberation and study.
Thus, the vast majority of documents surveyed here, are not binding on governments. They find their value in the discussion and consensus work of groups of experts resulting in recommendations that have moral persuasion and normative influence since they reflect a consensus position. Such texts and their recommendations may also influence the legislative bodies during the drafting of legislation. In countries where legislation already exists, they may indicate possible interpretations or desirable amendments. This is especially true of instruments developed by bodies set up by governments either at the international, European or national levels. For example, even though the Council of Europe does not have legislative power to bind European nations by the recommendations(80) it adopts, it does reflect a consensus agreed upon following deliberations of experts from every member country, hence its moral strength. In contrast to the non binding nature of its recommendations, however, the Council of Europe's Draft Bioethics Convention will be upon adoption (since it is a convention), binding upon member states that sign and ratify the convention. Finally, at the national level, study papers and reports from commissions generally have consultative and interpretative force. The influence of these policy positions should not be underestimated in that they are often considered as "soft law" and as sufficient to provide normative guidance along with prevailing professional codes of ethics and practice guidelines. The perspectives found in these policy positions on the issues of property and persons with respect to the status of human genetic materials (2.1) and once banked with respect to possible intellectual property rights (2.2) reveal a gradual convergence toward similar solutions although coming from different positions.
Section 2.1- Perspectives on Property and Person Issues
Like in the general literature, the questions: "What is the legal basis for the right of the individual to determine what happens to his or her body?" "May human materials removed from the body be considered property, or ought they still be considered as part of the body and thus, of the person and controlled by that person's personal rights?", dominate policy discussions around the world.
With a few notable exceptions(81), these policy texts do not generally address the issue of ownership of bodily material by explicitly stating whether they adopt a property rights or a personal rights legal regime. Indeed, option for one or the other regime can only be inferred from the position taken on commercialism as the personal rights approach generally forbids any monetary compensation for human materials. Exceptions do exist, however, and commercial transactions are sometimes allowed under a personal rights approach while they are forbidden in a property rights regime. A survey of international (§ A), regional (§ B) and national policy positions (§ C) and legislation relevant to the transfer and banking of human material, will clarify the different positions.
§ A - International Positions
Among the few international organisations that have made statements on the status of human material, the tendency has been to present general policy positions rather than precise statements. In its 1991 Guiding Principals on Human Organ Transplantation(82), the World Health Organization adopted the position that the human body and its parts could not be subject to commercial transactions. Therefore, any giving or receiving of payments for organs a s well as any other commercial dealings in human tissues and cells should be prohibited by member states. With regard to human material used for genetic research, several other international bodies(83) have endorsed the spirit of a personal rights approach in one's bodily material and information derived therefrom by asserting the importance of respecting the will of persons participating and their right to decide on the extent of participation. Recently, the International Bioethics Committee of UNESCO reiterated that "the human genome is a fundamental component of the common heritage of humanity"(84) but did not include a specific statement on commercialisation in its proposed Outline of a Declaration on the Human Genome and its Protection in Relation to Human Dignity and Human Rights.The preamble, however, incorporates a reference to general patent law principles and thus seemingly, does not exclude eventual commercial applications.
§ B - Regional Positions
At the regional European level, the Council of Europe has adopted a similar position in its recommendation on genetic testing and screening for health care purposes. It would require a person's permission for the further use of any sample collected for a specific medical or scientific purpose(85). But in contrast to the UNESCO International Bioethics Committee, the 1995 proposed Draft Bioethics Convention, explicitly affirms the principle of non-commercialism of the human body and its parts and substances(86). In addition, it states that the human body, its parts, organs and tissues may not be a source of profit through the trade of body parts for neither the individual source of the human material, nor for any third parties such as hospitals(87). However, the proposed prohibition would not extend to the sale of tissue that is part of a medical device nor to tissue considered as waste, such as hair and nails(88).
The Working Group on the ethical, social, and legal aspects of the European Commission's Programme on Human Genome Analysis(89), briefly addressed the more specific issue of ownership of materials collected for human genome analysis recommending that the issue be solved at the international level. Its 1991 report enunciated the guiding principle that "data and materials must be readily available to bona fide researchers" and that material be available at a nominal charge to cover the cost of distribution(90).
§ C - National Positions
Several European nations have taken specific positions on the ownership of bodily material once removed from the body. In France, bioethics legislation(91) adopted in July 1994 follows the position of the National Ethical Consultative Committee for the Life and Health Sciences(92) affirming the non-commercialisation of the human genome or of any parts of the person. This legislation most definitely adopts a personal rights approach as it clearly states that the human body and body parts may not be subject to patrimonial rights(93). Individuals maintain control over removed materials through the requirement of obtaining informed consent for the collecting of identifiable samples and the right to revoke such consent at any time(94).
Prior to the adoption of these bioethics laws, a report by the French Ministry of Higher Education and Research on The Intellectual Protection of the Results of Research on the Human Genome, Cell Collection and DNA Sequencing Data, (1994), also based its recommendations on the principle of "non-proprietorship of the elements and products of the human body"(95). Hence, not having any property rights in body parts, individuals should "donate" such substances and would be protected through consent procedures. In addition, this report clearly denied to every person involved in the collection of samples (donor, investigators or promoters), any proprietary rights in the material although the promoter (granting agency) would have other rights with respect to the collection(96).
In 1995, the Nuffield Council on Bioethics, of the United Kingdom, published a report on the ethical and legal issues raised by the use of human tissue in medical research(97). In accordance with most European policy positions, commercialisation of tissue procurement should be prohibited except for certain removed body products such as hair and nails that may be bought and sold since they are common waste products(98). The Nuffield Council does not explicitly establish whether a person from whom tissue is removed retains any claim over the tissue. The report recalls that, in addition to rights over the actual removed tissue, "a person may also claim an entitlement to share in any benefits arising from the exploitation of the tissue removed and, where relevant, any consequent intellectual property rights. Abandonment and donation, however, do not ordinarily give rise to intellectual property rights."(99) However, it recommended that any claim over removed tissue should be examined on the basis of the consent given to the procedure resulting in the removal of the tissue and not on the basis of a property claim. It further specified that consent to medical treatment should be regarded as entailing the abandonment of any tissue removed. Finally, the Report noted that even though a property approach seems to have been endorsed in other UK. legislation, for example, that pertaining to human tissue, organ tra nsplantation and anatomy, any tissue removed from donors is given free of all claims(100).
As early as 1989, the Health Council of the Netherlands addressed the issue of cell banks in a large study on issues in human genetics(101). The Health Council while in favour of the adoption of a code of conduct setting out the legal position of the "donor" also sought to ensure that no unnecessary barriers to the use of banked cells for research were created. Furthermore, it recommended that written agreements should be made at the time of collection of samples setting out the specific rights of the donor, including, time of storage, use of material, confidentiality, withdrawal of consent, etc. In so far as consent procedures are favoured and no mention is made of any proprietary rights in banked material, can we infer that these early recommendations endorsed a personal rights approach to bodily materials?
In 1994, the Health Council of the Netherlands(102) seemingly rejected the notion of property rights over the human body as a whole(103). It considered that human tissue removed from the body as having a distinct "legal position"(104). In addressing this issue of the "legal position" of human tissue removed from the body, this report of the Health Council of the Netherlands centered its reflection on how an individual's right to self-determination might best be protected: through property law, contract law, or that of constitutional law protecting rights of the person(105). Although the Health Council did not take an explicit position on the legal status of human tissue, it did state that individuals have the right to determine what happens to identifiable material as a "personal right". Moreover, in commenting on its earlier 1989 report, it reiterated that "should exceptional cases arise in which [cell material] is identifiable, then the principle of non-commercialism means that the "donor" has no claims to any revenue that may be earned."(106)
In 1993, the Norwegian government issued a report on Biotechnology related to Human Beings(107) which was partially enacted into legislation(108) the following year. No specific provisions discuss banking. Even though current Norwegian transplant legislation does not contain a ban on commercial exploitation of organs or parts of organs(109), the 1993 report of the Norwegian government considered its stance to be in accordance with the European Draft Bioethics Convention(110) thus, endorsing the position that there be no commercial exploitation of such materials(111).
In the United States, the existence of possible legal claims of individuals whose tissue have been removed, has been particularly controversial. Moore v. Regents of the University of California(112) is a landmark case on this issue. In 1991, the Supreme Court of California overruled the Court of Appeal's recognition of Moore's proprietary interest in his cell line. The California Supreme Court granted Moore relief based on the doctor's breach of "fiduciary duty to disclose facts material to the patient's consent, or alternatively, on the performance of medical procedures without first having obtained the patient's informed consent."(113) In doing so, it examined the policy implications of recognizing individual property rights in cells, substances and body parts against the need to pursue medical research, advance scientific knowledge, and provide incentives for biotechnology industry.
Various policy positions in the United States demonstrate how controversial this topic has come to be. In fact, as early as 1987, the American Society of Human Genetics stated that "[b]anked DNA is the property of the depositor unless otherwise stipulated. Therefore, the word "donor", which implies a gift, is inappropriate."(114) A similar "property" position was also adopted in a proposed 1995 Genetic Privacy Act which provides that "an individ ually identifiable DNA sample is the property of the sample source,"(115) who has the right to order the destruction of the sample. Distancing itself from the preceding positions, a recent report commissioned by the National Institutes of Health and the Centre for Disease Control and Prevention(116) endorses a personal rights approach and discusses the components of an expanded informed consent. A recent statement by the American College of Medical Genetics (ACMG)(117) on storage and use of genetic material, adopts a similar approach. Avoiding all property-person discourse the ACMG statement makes recommendations on the scope of informed consent recognizing sample "sources'" right to control the outcome of their removed bodily material.
Turning finally to the Canadian context, the only legislation that deals with the status of human materials is the Civil Code of Quebec. It adopts a personal rights approach(118), that in fact constitutes an expansion of informed consent. Article 22 reads as follows: "A part of a body, whether an organ, tissue or other substance, removed from a person as part of the care he receives may, with his consent or that of the person qualified to give consent for him, be used for purposes of research." Hence, according to this provision, all types of research be it on nominative, anonymous or anonymized samples, requires that specific consent be obtained for the use of removed material until recently considered as waste.
Few reports deal directly with the issue of the legal status of human material removed from the body. In 1992, the report of the Law Reform Commission of Canada on the Procurement and Transfer of Human Tissues and Organs(119) (in conformity with most provincial legislation), recommended the general principles of altruism, voluntarism, gratuity and universality(120). More specifically, the Law Reform Commission recommended that the purchase or sale of human bodies, organs and other non-regenerative tissue should constitute a criminal offence(121). No mention was made however, of regenerative tissue. Finally, in cases where health providers, hospitals or researchers develop a commercial interest in a patient's tissue or cellular matter or where the development of any such interest is reasonably foreseeable, the health providers, hospitals or researchers should be obliged to disclose such an interest to the patient prior to obtaining his consent(122). The Law Reform Commission recognized that the issue of who should have commercial and patent rights to therapeutic products developed from human cells remains uncertain.
Closer to the issue of use of human genetic material, the 1991 Science Council of Canada report on genetics in Canadian health care, similarly endorsed the philosophy of gift-based donorship and warned against its possible undermining by the recognition of property rights in genetic material. Without taking a position on this debate, the Science Council emphasized that "even if genetic material were deemed property, the donor's claim in any commercial profits might be limited to the value of the tissues when they were removed."(123) Moreover, "extension of the donor philosophy would mean that genetic material could not be sold, and donors would not have commercial interest in products developed using their tissues."(124) It remains critical, however, "that in all cases, individuals have control over the use of their tissues, including use in research or in the development of commercial products."(125)
These two reports, together with comments by the Royal Commission on New Reproductive Technologies(126), indicate that Canadian policy discourse generally endorses a personal rig hts approach to human genetic material via the endorsement of expanded informed consent. This approach is also reflected in current positions on banked human genetic material as recently stated by the Quebec Network of Applied Human Genetics of the FRSQ(127).
Section 2.2- Banked Materials and Patents
The issue of patenting human genetic material has raised greater debate at the international and national levels than has the legal status of such material. In fact, the Human Genome initiative has inspired or compelled a number of international and national bodies to make policy statements on the "patentability" of the human genome or more simply, of genes. Since the gene is the basic unit of life, positions on patenting the human genome may be determinant of the patentability of other bodily parts and tissue. Moreover, an examination of the international (§ A), regional (§ B), and national (§ C) position on patenting reveals that a clarification of patenting issues may well put the property-person debate to rest.
§ A - International Positions
At the international level, two positions have been endorsed with respect to the patentability of the human genome or parts of it. The first, simply states that no patents should be given(128). The second position qualifies this "blanket" refusal by maintaining that no patents should be allowed on genes per se, but accepts that uses or applications of genes or sequences can be patented(129). A 1995 statement by the international Human Genome Organization(130) (HUGO) further clarified the issue of patentability of DNA sequences by distinguishing between different steps in the research process of molecular biology and by qualifying what is "discovered" at each step. Thus, HUGO recommended that routine procedures such as sequencing expressed sequence tags or genes should not be patentable(131) , while the "more difficult and significant discoveries"(132) of determining the underlying biological functions should receive patent protection.
§ B - Regional Positions
At the regional European level, a 1991 Working Group of the European Commission(133) opposed patenting the human genome or any part of it since granting patents for DNA sequences with unknown utility could have an inhibitory effect on research(134). Again, this would not exclude patent protection of products or processes that are the result of innovative research. It is also interesting to note that an earlier 1988 draft directive of the European Parliament and Council, aimed at providing clear guidelines without modifying existing legislation on the patentability of human genes, was finally rejected in 1995(135). This directive sought to prohibit patenting of elements of the human body as such, but allowed patenting of inventions that included elements of the human body modified in such a way that they could no longer be directly linked to a specific individual. As a consequence of the rejection of the Directive, applications for gene patents in Europe will remain subject to national law and to a case by case interpretation by the European Patent Office under the unchanged European Patent Convention(136).
§ C - National Positions
At the national level, the clearest position on whether genes should be offered patent protection, is found in French legislation. In 1994, the French legislature enacted amendments to its intellectual property code declaring unpatentable "...the human body and its elements and products, as well as knowledge of the total or partial structure of a human gene"(137) (since contrary to public order). Earlier national reports in France had already come to this position(138).
In 1994, the Danish Council of Ethics produced a report that specifically addressed the issue of patenting human genes(139). It endorsed the position that patents should not be allowed on human genes in naturally occurring form, allowing, however, patenting of the information content of DNA sequences, in the manufacture of a specific product(140). The Danish Council further proposed that a forum be established in order to continuously monitor developments in the legal protection of biotechnical inventions.
The Norwegian Ministry of Health and Social Affairs in its 1993 report on Biotechnology related to Human Beings, did not recommend that human cells and genes be explicitly excluded from patent protection but only that current patent criteria be applied. In the Ministry's view, "genes that have no known function will not be patentable in Norway because they do not fulfil the requirements for patentability."(141) Thus, the simple application of the current Norwegian law was deemed sufficient to decline patents on human genes and cells.
In the United Kingdom, the 1995 report of the Nuffield Council on Bioethics extensively covered the issue of patentability of inventions derived from human tissue with particular reference to the "immorality exclusion" criteria (public order) of the European Patent Convention(142). The Nuffield Council remarked that "human genes, human cells, and the products and processes derived from them are already patentable (and patented) under European patent law"(143) since they have not been excluded on the basis of immorality, restrictively interpreted by the European Patent Office. However, the Report noted that oppositions to awarded patents had been filed and that a body of opinion believes that the immorality exclusion deserves clarification(144). Indeed, the rejection of the European draft Directive in 1995 as mentioned above, exemplifies the continuing controversy over this issue. Because of this situation, the Nuffield Council made several recommendations. First, the notion of invention requires that "some technical intervention should have taken place that justifies the granting of an intellectual property right."(145) Second, the Nuffield Council recommended that in the interpretation of the exclusion based on immorality (public order), account be taken of ethical factors and sensitivities in the patenting of inventions derived from human tissue."(146) Finally, it recommended that clarification of the immorality exclusion be attempted once more in a protocol that could be adopted under the European Patent Convention.
Later in 1995, in a report on human genetics(147), the UK. House of Commons Select Committee on Science and Technology made a recommendation precluding patenting of gene or gene fragments of unknown function concluding that only a combination of a gene and a known utility which is novel and not obvious should be patentable in the context of that utility. In addition, a combination of the same gene and a further novel utility should also be patentable. Interestingly, the Committee considered that the exclusion from patentability on the grounds of immorality should remain "narrowly construed, rarely applied, and then only in extreme cases."(148) The increased importance given to the concept of human dignity by the European Parliament was not deemed "inconsistent with the proper use of patenting in creating conditions in which new therapies can be developed to relieve suffering and improve the quality of life."(149) Concern was raised, however, that patent examiners apply the novelty and utility criteria too loosely with over-generous patents being granted. Due to the absence of provisions in the European Patent Convention to challenge the scope of patent claims, the Committee called for review of grounds under which opposition to patents may be filed(150).
In the United States, there is no such exclusion based on the notion of public order. Rather, the debate has focused on the question of sharing of profits gained through patent protection and only to a lesser extent on the patentability of inventions derived from human tissues(151). In 1991, however, the NIH patent applications for thousands of partial complementary DNA sequences of unknown function raised much polemic in scientific, industrial and lay gro ups(152). The NIH policy justification for such an application was that patent protection would promote product development by US. industries through the granting of exclusive licenses over DNA sequences(153). The scientific community opposed this application considering it an obstacle to technology transfer and product development rather than an incentive. The NIH patent application was denied since it lacked patentable novelty and utility, the functions of the cDNA being unknown(154). In spite of this ruling, as the above survey of the literature demonstrates, the debate on the issue of granting patent protection over human genetic material with no known function continues.
Finally, in Canada, few policy statements have been made on this issue. In its report on tissue procurement and transfer, the 1991 Law Reform Commission report asked "whether there is something intrinsically wrong with patenting human life, particularly human life forms. That human life forms have formally been patentable subject-matter in Canada since the early 1980s may suggest that it is not."(155) In contrast, the 1993 report of the Royal Commission on New Reproductive Technologies considered that the patenting of human cell lines raises some concern and, as already mentioned, asks for further study(156). In addition, the commissioners held that human zygotes, embryos, and fetuses are inappropriate subject matter for intellectual property protection(157). In its general principles regarding intellectual property rights, the Canadian Genome Analysis and Technology Program (CGAT) does not consider the issue of gene patenting. CGAT simply states that researchers supported by the program may seek intellectual property protection for their inventions providing that publication is not denied(158).
In short, intellectual property rights for persons who contribute their human genetic material to research that eventually leads to inventions awarded patent protection is still under discussion. Potential claims to a share of patent profits by contributors may be summarized in two general tendencies as found in policy positions according to the person-property dichotomy. Under a personality rights approach, where human material is usually considered as extra-commercial, a person has no right to claim a share of profits derived from patents on inventions containing their bodily material. However, during the process of obtaining informed consent from the sample "sources", some have suggested that the person should be informed of whether a share of any potential profits can be expected by the researcher, the institution and possibly by the participant(159). Accordingly, under this approach, contractual institutional arrangements could be drawn up in which the person's right to a share of eventual profits derived from patents is ensured through the informed consent mechanism. Similarly, under a property rights approach, ab initioproprietary interests in the removed material could extend beyond the raw material to include rightful claims of a share of profits on any patented inventions containing the sample, provided that there is no legal authority to the contrary(160). Individual "bargaining" or exploitation under these approaches cannot be ruled out. In any event, another possibility would be to provide a percentage of eventual profits not to the individual participant or patient but to a non profit foundation or organization whose goal is to educate and help lay members with that disease. Hence, the issue of whether individuals maintain any claims over profits derived from removed bodily material remains unclear and merits continued discussion.
Whatever the type of arrangement convened with respect to sharing profits from patent protection, there will be implications for individuals who contribute their bodily material, to researchers as well as to institutions where research is conducted(161). For example, will the remote hope of obtaining a share of profits influence individual's informed consent? Will researchers who offer a share in their potential profits be considered as imposing undue inducement on their potential sample contributors? How and under what form will profits be redistributed? In large research projects, how will the value of one person's genetic material be evaluated with respect to other people's material also studied? What will the institution's duty be in such a context? Are there other models for potential profit sharing that are not patent law based? Finally, how will any compensation scheme realistically be implemented?


Banking of Human Materials, Intellectual Property Rights and Ownership Issues: International Policy Positions and Emerging Trends in the Literature: Conclusion
Pevious Table of Content Next
Conclusions
Whether drawing its origins from the sale-gift debate that has dominated the organ transplant debate for years, or from the property-person debate in the legal literature on other human tissue, it is evident that the advent of DNA banking has forced a re-examination of the issues. While the dichotomy is still philosophically relevant, the solutions proposed share common elements: expanded forms of control through a more extensive and detailed informed consent procedure, through access, storage and destruction options and through the provision of explicit written policies and choices for possible research. The issue of possible commercialism through payment for procurement or even through a sharing of eventual profits is then secondary in importance. With the future expansion of international and North American "biotech" industry into Canada, other ways than possible (and generally highly hypothetical) individual financial rewards of returning benefits to scientific research, to the patient associations and the research participants need to be developed with the stakeholders.
Moreover, the issue of patentability is international. While the exact form of such expanded consent and sharing of profits is largely culturally dependant and should remain so in order to respect cultural diversity, patent law with respect to human genetic material is definitely an international issue. An explicit national, regional and international reaffirmation of patent law principles together with a clarification of how they apply to the specific situation of "uses" discovered for human genes may be the first step towards a necessary consensus that respects research participants and scientific endeavour.
** Addendum: Three-way European discussions, between the the European Parliament, the European Commission and the Council of Ministers, are to take place in January 1996 to decide whether to propose a new draft directive on the issue of patenting biotechnologies. This initiative follows from the unexpected rejection, in March 1995 by the European Parliament of the previous directive. The new draft directive is not yet publicly available(162).