extracted from their body?
Introduction
One of the toughest and not resolved legal and ethical issues in the field of patent law is thought to be the establishment of ‘the optimal means of distribution among biomedical researchers and their research participants of any rights in commercial products and revenues derived from human tissue’ (Gitter p.261). In consists in the fact whether a patient is granted a property right to a cell-line, particularly tissue, extracted from his body. Tissue itself is defined as ‘a collection of cells of similar structure organized to carry out one or more particular functions’ (Gitter p. 261). On the one hand, it is logical that it was exactly a person, who has given a ‘material’ for a research, namely he also gave his consent for the action, which produced certain scientific results, which were later patented, thus, a patient is to be rewarded for that. On the other hand, the intellectual property law, particularly ‘a market-inalienability model’ (Gitter p. 264) establishes the rule, when only inventors are to be granted patent, thus, a patient, who did not put any efforts in the scientific sphere, is to be neither inventor nor a person to have benefits from patent.
This issue is regulated by case law, particularly by Moore’s case as well as Lack’s one; in UNESCO Declaration on Bioethics and Human Rights it is foreseen that «both scientific research and medical interventions should only be carried out with the prior, free, express and informed consent of the person concerned." (Henk, A.M., Jean p.123), that only shows the importance of the role of a patient in all the processes concerning his physical integrity and usage of his cells and tissues.
Issue
Will a patient own their own human tissue and should they benefit, both medically and econonomically, from advancaes and achievement derived from it? (Stump p.131)
Party A
ULSA Medical Center’s Concise Statement
It is understood that a patient, who has been informed that his tissues will be used in order to obtain new drugs, medicals, conduct new experiments, and probably gain profit, is not entitled a property right, derived from patent. Additionally, it was foreseen that center can dispose of any severed tissue or member by cremation.
Detailed Rationale for Center’s Position
We illustrate our position with already existing decision in case of Moore v. Regents of the University of California, in which the issue of property rights if a patient in his body parts was raised and which became classical in the field discussed. In this case plaintiff, Moore, was a cancer patient of medical center, in which his blood and other fluids were removed; consequently, the “cell line” was patented for commercial issue, which was the matter of plaintiff’s concern (Moore v. Regents of the University of California). Particularly, Moore ‘sued surgeon, us for using his spleen cells to develop and patent a valuable anti-cancer drug’ (Blakeslee p.1).
In this case the ‘Supreme Court of California rejected Mr. Moore’s claim to ownership interest in the patent - he was not one of the inventors, as well as Court has come to the conclusion that he could not exercise property rights over discarded body tissues’ (Von der Roop, Taubman p.1). Even though the Court has concluded that there was a duty of a doctor to obtain informed consent of Mr. Moore about any economic or personal interest in using or studying his tissues; and that if the fiduciary bond of trust is broken, the patient may sue for breach of that duty (Moore v. Regents of the University of California p.2), it does not the matter of our discussion, since we deal with the issue of rights from patent.
The case is important in context of distinction between accesses to the human materials per se and obtaining of a patent for the activity, which arose from exploitation of the materials. On the other hand, the lawyers admit Court’s giving ‘scientists and industrialists 'the right to appropriate and exploit a patient's tissue for their sole economic benefit'' and has failed to recognize the patient's 'property interest in his own body and its products’ (Blakeslee p.2). Though, we still have to analyze the position of the opponents of patient’s property rights.
Also, we can conclude that there is already existence of proper regulation in this sphere, particularly we would like to mention the fact that patient’s rights are well protected due to the principle of informed consent as well as theories of breach of fiduciary duty, which are applied and were mentioned in the Moore’s case particularly (Gitter p.262). The idea, reflected in the Moore’s case, was later supported in a number of cases, particularly in Hecht v. Superior Court (Korobkin and Munzer p. 218) Also, we can refer to the similar situation taking place during the exploration of so-called HeLa cell line, named after Henrietta Lacks, who died due to cancer and after unsuccessful radium treatment (Devine p.1). ‘Without Lacks’ knowledge or consent, her doctor shared a sample of her tumors with a researcher, Dr. George Gey, intent on developing an immortal cell line, that led to medical advancements’ (Devine p.1). Hence, we can claim claim that everything we can do only benefited people, who need treatment and new medicals.
Moore’s Position and why Our Position is To Be More Compelling
On the contrary, John Moore states that he has to obtain the financial benefits from the tissue extracted. He claims that he has not been informed about the consequences of such extraction, particularly about the intent to patent it. Thus, to his mind, no consent no deal. We can conclude that a lot of representatives of the medical and pharmaceutical fields claim that ‘calls for increased control by patients over the use of their tissue would suggest that only subsuming the matter under property law would suffice’(Winickoff p. 1180). Also, it is known that during our cooperation with him his consent was taken, since he signed consent form, according to which we, hospital, could ‘dispose of any severed tissue or member by cremation’(Moore v. Regents of the University of California). Additionally, Alta Charo (p.1518) states that ‘recognizing property rights in excised tissue would threaten their ability to use stored tissue samples effectively’
Party B
Patient’s (John Moore) Concise Statement
Detailed Rationale for Patient’s Position
As far as I know, there are examples, when ‘property rights’ for the tissues were granted to the patients. That was the example of PXE International (PXE - pseudoxanthoma elasticum - a genetic disease that causes calcification of the connective tissue of the skin, eyes, and arteries), which has established the rule, according to which it is possible to share property rights from the patent with patients, who took part in the research (Gitter p.262). Among the rights were ‘royalties from any diagnostic test or marketable product resulting from the discovery of the gene, as well as the authority to control licensing of such genetic tests’(Gitter p.263). In my case, it has not been and, consequently, I had to sue the center in order to obtain benefits.
The importance of prior informed consent derives from common law, particularly from the case McFall v. Shimp, according to which we ‘enjoy the right to exclude others from using our tissue, moreover, we are entitled to our tissues against the claims of others who need them, despite the level of need (Korobkin and Munzer p. 214).
It is possible that researchers negotiate about uncompensated donations, however, the authors mention that under such circumstances certain consent documents defining donor control over potential commercial activities and donor rights to present or future compensation are to be provided (Korobkin and Munzer p.219). Also, Korobkin and Munzer (p.200) argue about the main concerns relating to the issue of the ‘commercialization of the tissues’.
First one, which, in my opinion, clearly demonstrates the necessity for the clinic or researches to pay for the material, extracted from one’s body, is ‘consent requirement, which ensures that researchers must communicate in a substantive way with potential donors prior to using their tissues, and negotiations about the compensation are to be the part of general interaction between the sides (Korobkin and Munzer p.200).
Other matter which is necessary to be analyzed and can be used by the opponents of the compensation principle is permissibility of compensation, namely whether there is either no-compensation regime or not. If there is no-compensation regime it is scientists’ freedom of choice how much to compensate for tissues (Korobkin and Munzer p.200). In contrast, when compensation principle is established, the price of any research would be much higher and the probability of closing or abandoning it becomes more real (p. 200). Everything could change, if the matter of concern is difficult or risky to collect tissues, e.g. donors for genetic diseases, when no-compensation principle will lead to absence of potential ‘altruists’, who are to donate parts of their body as well as it will lead to the fixed prices for the tissues, according to their market value (p. 201). Under compensation principle, if potential benefits justify the costs, the research could be conducted (p.201).
Medical Center’s Statement and Why Moore’s Position Seems More Compelling
Medical Center tries to deceives the audience with a so-called consent form in case of creamtion, which is being used as if it provides my consent to center’s benefits from patenting of my tissue. They refer to the circumstances of such state of affairs, when everybody will try to sue hospitals, in such way that it will make it impossible for them to work. But perhaps it would be better to previously negotiate and to cover all the circumstances of the agreement?
The precedental decision in my case is overestimated: not only it is not binding, but also in much, if not most of the United States, non-payment for research materials is a norm rather than a mandate (Charlotte H. Harrison cited in Gitter p. 267). Lacks’ case is also in my favor, since it was criticized because of not obtaining her prior consent arises. Additionally, the market-inalienability model is not followed by the majority of the researchers dealing with this issue nowadays. Finally, certain authors agree that neither of the mentioned models is effective. In contrast, they propose so-called hybrid model, which is aimed at ‘enacting legislation permitting and regulating the sale of human tissue used for research purposes, and establish a tort of conversion in the event that a scientific researcher wrongfully exercises dominion over a research participant's tissue’(Gitter p.268). Such model has certain advantages, particularly in my case, comparing to the other models, mentioned above.
Firstly, such model can define borders of cooperation between me and clinic, preventing from inconvenience, medical risks, loss of privacy, and possibility of genetic discrimination inherent in such participation (Gitter p.340). Secondly, such model, when there is promise of profits, will stimulate the concurrency among the participants, namely they will debate, whose tissue possesses greater value and uniqueness (Gitter p.341). Thirdly, the possibility of perspective monetary damages (liability) after a lawsuit against a researches due to lack of consent will motivate the researchers to provide it (Gitter p.341). Fourth, such model ensures the participants that their tissue is used correctly due to the right to bargain, in which all the conditions of using of the tissue are prescribed (p.341).
Thus, I can conclude that existing system of patent law, particularly, has to be modernized and changed, according to, inter alia, common law principles. The judicial practice shows how many problems lack of consent could create in future. In contrast, the hybrid model, proposed by certain authors, can lead to awareness of people about certain researches and the possibility of being paid could cause their desire to participate as well as it can provide the humanity with necessary explorations faster, than it is nowadays. The ability to negotiate and to cover all the conditions of one’s extracting of the tissues will also lead to rise of trust towards medical centers as well as prevent the centers per se from potential lawsuits, which could cause monetary damages.
Works Cited
Alta Chero, J.D. Body of Research — Ownership and Use of Human Tissue. The New England Journal of Medicine, 2006. Retrieved from:
http://www.nejm.org/doi/full/10.1056/nejmp068192
Blakeslee, S. Patient’s Right to Tissue Is Limited The New York Times, 1990. Retrieved from:
http://www.nytimes.com/1990/07/10/science/patient-s-right-to-tissue-is-limited.html
Gitter, Donna M. Ownership of Human Tissue: A Proposal for Federal Recognition of Human Research Participants' Property Rights in Their Biological Material Washington and Lee Law Review 61(1) 5. Retrieved from:
http://scholarlycommons.law.wlu.edu/cgi/viewcontent.cgi?article=1389&context=wlulr
Stump, J.L. Henrietta Lacks and The HeLa Cell: Rights of Patients and Responsibilities of Medical Researchers The History Teacher 48(1), 2014. Retrieved from:
http://www.societyforhistoryeducation.org/pdfs/N14_Stump.pdf
Henk, A.M., Jean, M.S. The UNESCO Universal Declaration on Biotheics and Human Rights: Background, principles and application Paris: UNESCO, 2009. Print.
Korobkin, R., Muzner, S.R.Stem Cell Century: Law and Policy for a Breathrough Technology New Heaven: Yale University Press, 2007. Print
Moore v. Regents of the University of California. 793 P.2d 479 at 490 (Cal. 1990) Retrieved from:http://www.casebriefs.com/blog/law/property/property-law-keyed-to-cribbet/non-traditional-objects-and-classifications-of-property/moore-v-regents-of-the-university-of-california-2/2/
Von der Ropp, A., Taubman, T. Bioethics and Patent Law: The Cases of Moore and the Hagahai People, World Intellectural Property Oranization, 2006. Retrieved from:
http://www.wipo.int/wipo_magazine/en/2006/05/article_0008.html
Winickoff, D.E., Winickoff, R.N. The Charitable Trust as a Model for Genomic Biobanks The New England Journal of Medicine, 2003. Retrieved from:
http://www.nejm.org/doi/full/10.1056/NEJMsb030036
