A Study on the Legal Status of Human Materials

Posted on    by Hyunju Cho

 

A Study on the Legal Status of Human Materials

 

Abstract

The development of technologies for extracting and using genetic information has made it possible to use human materials in ways that were not imagined in the past. As informational functions and values of human body and human materials transcend their physical values, there are problems regarding the attribution of related rights and new property. As a result ethical and social conflicts are expected to arise. The term “human material” means a component of the human body, such as a tissue, a cell, blood, or body fluid collected or extracted from the human body, or serum, plasma, chromosomes, DNA (Deoxyribonucleic Acid), RNA (Ribonucleic Acid), protein, etc. isolated from such component. It is urgent to discuss how to protect the rights of donors of human materials, considering the potential for explosive market value to be generated through donations for research purposes. In this article, the author will examine the issue of the attribution problem arising between donor and recipient, particularly in regards to human material. First, the author will examine the legal status of human material in the Korean legal system. Second, domestic and foreign cases of human material will be investigated and examined.Finally, the author will contemplate the possibility of new rights to deal with human material in the Korean legislation.

 

Ⅰ. Introduction

Slavery, which places the human being under the ownership of another being, has been abolished, and the introduction of modern history centered on ‘human rights’ has refused to regard all or part of the human body as possessions. However the development of technology has given way to the view that hair, blood and organs can be separated and disposed of, as one’s property. Furthermore, as biopharmaceuticals and the biomedical industry develop, research on human cells and specific antigens is increasing. Particularly, the development of technologies for extracting and using genetic information has made it possible to use human materials in ways that were not imagined in the past. As informational functions and values of human body and human materials transcend their physical values, there are problems regarding the attribution of related rights and new property. As a result ethical and social conflicts are expected to arise. The term “human material” means a component of the human body, such as a tissue, a cell, blood, or body fluid collected or extracted from the human body, or serum, plasma, chromosomes, DNA (Deoxyribonucleic Acid), RNA (Ribonucleic Acid), protein, etc. isolated from such component[1].In the past, human materials werejust used for medical practice or for making wigs. However, not only is the scope of use widening, but commercial use is rapidly increasing, and the need for legal protection is increasing. In particular, the market potential of stem cells and gene therapy technology is very high, but it is still managed only in the area of ​​research and development. Therefore, it is urgent to discuss how to protect the rights of donors of human materials, considering the potential for explosive market value to be generated through donations for research purposes. In this article, the author will examine the issue of the attribution problem arising between donor and recipient, particularly in regards tohuman material. First, the author will examine thelegal status of human material in the Korean legal system. Second, domestic and foreign cases of human material will be investigated and examined.Finally, the author will contemplate the possibility of new rights to deal with human material in the Korean legislation.

 

Ⅱ. Statutory Law

  1. Legal status of human material

In regards to whether property rights can be established for parts of human body, human by-products and their products, the Civil Code of Korea broadly defines “a thing”to mean “corporeal things, electricity, and other natural forces which can be managed” in Article 98, but does not explicitly specify the relationship between human material and their legal nature. However, on the basis of the natural rights of man established by modern law, most scholarsperceivethe man to be the holder of rights, not as the object of rights. To be a thing that can be subjected to ownership, it must be part of the outside world, which does not apply to the body or a part of a body of a living man. Therefore, the organs attached to the human body and attached medical aids (e.g., artificial legs, artificial heart, etc.) of the human body are part of the human being, and are not considered property that can be objects of ownership.In contrast, when separated from a part of the body, they are treated as independent objects in the socio-common sense. Furthermore, unless contrary to social order, separating parts of the body and disposing the separated parts (for example, the sale of hair for wigs) are considered to be valid.On the other hand, monetary transactions of human tissuesare prohibited, andonly free donations are allowed.The purpose of these provisionsare to prevent ethical problems that may arise in human organ transactions, and are stipulated in Article 23 of the Bioethicsand Safety Act, Article 7 of the Internal Organs, etc. Transplant Act, Article 5 of the Safety, Management, etc. of Human Tissue Act, and Article 3 of the Blood Management Act:

BIOETHICS AND SAFETY ACT, Article 23 (Rules on Production of Embryos)

(1) No person shall produce an embryo for any purpose other than pregnancy.

(2) No person shall conduct any of the following procedures in producing an embryo:

  1. Selecting an ovum and spermatozoon for fertilization with intent to choose a particular gender;
  2. Fertilizing with a decedent’s ovum or spermatozoon;
  3. Fertilizing with a minor’s ovum or spermatozoon: Provided, That cases where a married minor attempts to fertilize in order to have a child shall be excluded herefrom.

(3) No person shall provide or use an embryo, ovum, or spermatozoon for money, an interest in property, or any other consideration, solicit another person to provide or use an embryo, ovum, or spermatozoon for such consideration, or act as a broker for providing or using an embryo, ovum, or spermatozoon.

INTERNAL ORGANS, ETC. TRANSPLANT ACT, Article 7 (Prohibition of Purchase or Sale, etc. of Organs, etc.)

(1) No person shall give, receive or promise to give or receive money, any financial gain, or other consideration, to do anyof the following acts:

  1. Giving organs, etc. of another to a third person, receiving organs, etc. of another to give such organs, etc. to a third person, or promising to do either act;
  2. Giving one’s own organs, etc. to another, receiving organs, etc. of another to transplant into one’s own body, or promising to do either act;
  3. Abetting, assisting, or aiding another to do any act falling under subparagraph 1 or 2.

(2) No person shall abet, assist, or aid another to do any act falling under paragraph (1) 1 or 2.

(3) No person who learns of a violation of paragraph (1) or (2) shall recover or transplant organs, etc. involved in such violation.

 

SAFETY, MANAGEMENT, ETC. OF HUMAN TISSUE ACT, Article 5 (Prohibition of Purchase or Sale, etc. of Tissue)

(1) No one shall do or promise to do any of the following acts in exchange for money, financial gain, or other consideration:

  1. Giving tissue of a brain-dead donor or a deceased donor to a third person, receiving such tissue to give it to a third person, or promising to do either act;
  2. Giving one’s own tissue to another person, receiving tissue from another to transplant into one’s own body, or promising to do either act;
  3. Assisting another to do any act under subparagraph 1 or 2.

(2) No person aware of a violation of paragraph (1) shall manage or transplant any tissue relating to such violation.

BLOOD MANAGEMENT ACT, Article 3 (Prohibition against Blood Transactions, etc.)

(1) No person shall provide or promise to provide his/her blood (including a blood donor card referred to in Article 14) upon obtaining or promising to obtain any monetary or property interests, or other compensatory benefits.

(2) No person shall be provided with or promise to be provided with blood (including a blood donor card referred to in Article 14) of any third person upon giving or promising to give any monetary or property interests, or other compensatory benefits.

(3) No person shall instigate, assist or mediate any act violating paragraph (1) or (2).

(4) When a person becomes aware that any act violating paragraph (1) or (2) has been done, he/she shall not collect or transfuse blood related to such act.

[This Article Wholly Amended by Act No. 11525, Oct. 22, 2012]

In the case of the human corpse and ashes, there is a view that acknowledges theirstatus as “things” or “objects and aview that denies it. , there is no substantial difference between the two theories because, even their legal status as objects are acknowledged, it means that they are recognized as objects only for rights and duties concerned with burial and funeral, and are not given the generaland not characteristics of objects, such as the characteristic to be used or profited from. In relation to the ownership of the corpse, it is presumed to presiding priest in accordance with Article 1008-3 of the Civil Code. The act of disposing a corpse is void because it is contrary to social order.[2]

However, if one agrees in writing or in a will, you may donate in accordance with the Internal Organs, etc. Transplant Act. Article 22 of the Internal Organs and Etc. Transplant Act states that even if a deceased person agrees to have his or her organ removed from his body, if the family expressly refuses it, the organ cannot be removed from the body.This rule is problematic because it does not respect the opinions of organ donors.This can be seen as a recognition of family ownership or similar rights to the body of the dead man. However, there is no explicit basis.In addition to the social necessity, the donor’s will to donate organs before his or her death seems to be worthy of legal protection as an exercise of self-determination.

  1. Regulations concerning the donation of human material

The Bioethics Act was amended in 2012 to include provisions for the study and storage of human material in Chapter 5. Accordingly, to regulatestudies of human material, standards for: review of the studies theInstitutional Review Board (IRB), donation and collection, preservation and disposal of the research plan, and the establishment and operation of the human materialbank, were established. In addition, Chapter 6 provides for gene therapy and testing. This chapter also applies to genetic information obtained from donated human material. The Bioethics Act in Article 37 defines “informed consent”, which is consent obtained by the donor’s free will,after the human body donor receives sufficient explanation from the collector. The informed consent is also stipulated in Article 42 of the Act on the Bank of Human Origination and Article 51 on the offer to human material researchers of Genetic Testing Objects or the Bank of Human Diversity. The Bioethics Act does not have a clear definition of the right of donors to donate human material, but it accepts the withdrawal of consent without restriction:

BIOETHICS AND SAFETY ACT

Article 37 (Consent to Research on Human Materials)

(1) A human materials researcher shall obtain written consent with regard to the following matters from donors of a human material before commencing the research on human materials:

  1. Objectives of the research on human materials;
  2. Protection and management of personal information;
  3. Preservation and discarding of human materials;
  4. Provisions of human materials and genetic information obtained from human materials (hereinafter referred to as “human materials, etc.”);
  5. Withdrawal of consent, disposal of human materials if consent is withdrawn, the right of the donor of a human material, change of objectives, and other matters specified by Ordinance of the Ministry of Health and Welfare.

(2) Notwithstanding paragraph (1), if a human materials researcher conducts research with a human material provided by a person who is not a human materials researcher, but extracted the human material, the human materials researcher shall be deemed to have obtained written consent pursuant to paragraph (1) at the time the person who extracted the human material obtained written consent from the donor of the human material with regard to matters specified in paragraph (1).

(3) Article 16 (3) shall apply to the exemption of research on human materials from written consent. In such cases, the term “human subject of research” shall be construed as “donor of a human material”.

(4) A human materials researcher shall fully explain the matters specified in paragraph (1) to a donor of a human material before obtaining written consent from him/her pursuant to paragraph (1).

(5) Matters necessary for the form of written consent under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare.

 

Ⅲ. Case Law

  1. Greenberg(Claimant) v. Miami Children’s Hospital Research Institute(Respondent)[3], in U.S.A.

(1) Facts of the Case

In 1987, Greenberg couple who were parents of two children with Canavans disease, agreed to provide Reuben Matalon, a physician and researcher with support for prenatal testing, for prenatal testing methods to identify diseases. The couple provided genetic and medical information about the couple and their children, hoping that the research results would be used for public interest. The couple developed donation activities, visited families with Canavans disease, and encouraged to donate tissue samples. However, Matalon, who discovered the Canavans disease gene in 1997, applied for a patent on this gene without seeking consent from the couple. Since the patent registration, the Miami Hospital has restricted donor access to the study.

(2) The issues of the case and the judgment of the court

1) Lack of informed consent

The Florida District Court did not accept the Greenberg couple’s argument that they did not receive information on Matalon’seconomic interests, since the information was extracted by treatment, and the applicants voluntarily donated for medical research, and the Respondent continued to obtain consent for medical research. Therefore, the Court found Matalonto be under no obligation to seek consent for a patent application for the Canavans disease.

2) Donors’ property rights

The Court held that the claimants had voluntarily provided and therefore did not retain the property benefits of the donated biological material. In addition, because claiming ownership of the research result conducted under the management and supervision of the donee could interfere with medical research,the Court ruled that the Claimantscould not claim property rights or ownership of the donated substance. However, since the Respondentbenefited from the contribution of the Claimants to the study, the Court found that the benefit of the research beyond the scope of the researchers agreed to by the applicants was unfair.

  1. Case Number 2007DA27670, November 2008, Supreme Court, Korea

In the absence of a separate provision on the human material, this case concerned a predecessor and the successor of the body and ashes of dead person who specified through their living act or will how to dispose of the body and ashes,and where to store them.

(1) The successor of body and ashes of dead person.

Body and ashes of dead person are corporeal things that can be the object of burial, management, sacrifice, or offering. The ancestor’s body and ashes placed in the tomb are inherited to the priest presiding over the tomb along with the tomb itself, as provided by Article 1008-3 of the Civil Code. His or her body and ashes shall also be succeeded to the presiding officer[4].

(2) Validity of a living act or willspecifying a storage location or method of disposal for his or her own body or ashes

1) Majority opinion

The will of the predecessor in specifying a storage location or the method of disposal of his corpse or ashes shall be respected, insofar as it is not contrary to good morals and other social order. However, the obligation of the successor or the presiding officer to respect the predecessor’s will is only a moral obligation; It cannot be assumed that the presiding officer bears an unconditional legal obligation to be bound by the deceased will.

2) Dissenting opinions of Justices Shi-hwan, Park and Su-an, Jun

Even if the presiding officer has the right to manage and dispose of a predecessor ‘s body and ashes, this does not mean that he can dispose the bodyand ashes or change the location of a store against the will of a predecessor without justifiable reason.

3) Dissenting opinions of Justices Dae-hee, Ahn and Chang-soo, Yang chancellor’s objection

In case that the final will which the dead person is handling his funeral and other fluids in accordance with their original nature and this will is clearly stated before death, the will must be legally respected and given a certain legal force. Furthermore, when a burial or opening of the tomb or the other handlings of the dead body were already done in accordance with the dead person’s will, even the owner of the body cannot claim from his ownership that he has the right to uncover the grave and retrieve the body.

 

Ⅳ. Review

  1. Decision Review of Greenberg v. Miami Children’s Hospital Research Institute

According to the California court’s decision, researchers are not obligated to explain a patent even if it contravenes the purpose of the donor’s public interest, and the donor cannot exercise hisor her property rights because he donated it voluntarily.The court tried to protect the minimum rights by allowing the donor (plaintiff) to claim the unjust gain. In conclusion, however, the courts have chosen ways to protect the interests of research institutions.This seems to take into account the economic and policy benefits for the development of medical research, which requires a large sum ofdevelopment costs.

  1. Review of 2007DA27670 the Supreme Court decision

There is no Korean precedent concerning the rights of donors and donees of human derivatives. Thus, as a similar case, this judgment on the ownership of the body is examined.

The case ruled that the corpse was succeeded to the presiding priest,similar to the property of the priest. The court does not separately mention which rights of the body are to be inherited by the presiding priest. The content of the right is therefore unclear.In addition, when the dead man decides how to dispose of his or her body or ashes by his will, the opinion of the Supreme Court is divided on its effect, and each opinion warrants examination.

The majority opinion of the Supreme Court ruled that “certain right” would be succeeded to the person who superintends the ancestral rites. The Court also ruled that the obligation to respect the will of the deceased is moral and not a legal obligation. However, this can be considered as a violation of personal rights and self-determination rights derived from Article 10 of the Constitution. Although one cannot choose birth, one should be able to choose how one disposes hisbody at the end of his life. As long as this commitment is not contrary to societal wisdom, the will of the deceased must be more strongly protected.

Because the deceased has the right of self-determination, the obligation to respect the deceased will cannot be regarded as merely moral, and should take the form of a legal obligation. According to the dissenting opinion of the Supreme Court Justice Si-hwan, Park and Su-an, Jun the person who superintends the ancestral rites has the right to manage and dispose of the body. This is contrary to the conventional wisdom that the person who superintends the ancestral rites has the right to use, profit, and dispose. This opinion is also lacks support in that the basis for accepting the legal bindingness of the will of the dead body is weak.

According to the dissenting opinions of Justices Dae-hee, Ahn and Chang-soo, Yang, they did not confirm that the priest was the owner of the corpse. However, even if the ownership of the dead is recognized, the will of the dead body itself is legally effective. This opinion does not accurately state the legal basis for acknowledging the will of the dead. In conclusion, however, this opinionseems to be the most reasonable. The majority opinion of the Supreme Court does not recognize the legal bindingness of a dead person’s apparent intention to dispose of his or her body. This is in line with the consciousness that the Article 22.3.2.ofthe Internal Organs, etc. TransplantAct, which prohibits the donation of organ donation if the family has explicitly denied it.Therefore, it is important to specify what rights the presiding officer has on the body. Furthermore, under the Korean legislation, it is necessary to expand the discussion on what rights are granted to donors in the case of physical derivatives.

 

Ⅴ. Suggestions on the Rights of Human Material

  1. Necessity for discussion

As mentioned, the Internal Organs, etc. TransplantActprohibits the donation of organs if there is an explicit denial of the family. The majority opinion of the Supreme Court does not respect the will of the deceased. California courts in the United States do not recognize the donor’s property interests in respect of human material. According to Californian court, there is only one “Informed Consent” that can be claimed by a human endowment donor. However, it is not enough to explain the donor ‘s right of consent, right of withdrawal, etc. under the Bioethics and Safety Act. The right of consent and withdrawal from the donor under the Bioethics and Safety act is the right of the donor to agree or withdraw his or her donation at any time after donation. If the donor can only claim an informed consent, it is hard to admit that the donor can renew or withdraw from the human body at any time. Eventually, ownership of the human material must be recognized. People in most countries are reluctant to recognize exclusive ownership of some parts of the body because of experience such as slavery and violent human experimentation during World War II. In Korea, it is expected that it will be easier to recognize ownership of some parts of human body than other countries, because the concept of ownership of the corpse is easily recognized. The most important reason for granting a donor ownership of a human material is because it contains the donor’s personal information (including sensitive information). It is important that personal information is legally protectedbecause it is difficult to recover when it is leaked, and because it may have negative consequences such as social discrimination by the contents of the information. Therefore, it is worth protecting as property rights of the donor. This requires a unified interpretation of the donor’s right of consent and the right to withdraw from the Korean legislation.

  1. Real right properties of human materials:whether a donor of human materials can be granted a real property right similar to superficies

Real rights are largely property rights[5], absolute rights[6], and “herrschaftsrecht,” or the right to control[7]. In modern countries, property is a basis for denying ownership of the human body, since the human body should not be judged by economic value.However, a major reason for acknowledging ownership of human material is to protect sensitive personal information, such as the DNA of an individual. Personal information belongs to an individual forever. Therefore, in the case of human material, it is necessary to recognize the form of special rights that have the property of absolute power and herrschaftsrecht excluding property rights. Human materials have a character as an intellectual property right and a character as an object. Therefore, if the donor is granted the special rights like superficies, the rights of the intellectual property can be recognized publicallyby utilizing both characteristics of the human material. A superficiary is entitled to use the land of another person for the purpose of owning buildings, other structures or trees thereon.(Civil Act Article 279). It can be transferred and inherited as real rights. In addition, since the right of others is the land, the superficies cease to exist when the superficies and land ownership are attributed to the same person. It also refers to the right to use the land of another person exclusively as a usufruct, and the fee is not a constituent element of the superficies.

  1. Specific characteristics of human derivatives: a discussion of rights similar to superficies

In the case of human material, property rights are excluded, so the fee for use should not be accepted. If the rights like superficial rights are admitted to the human material, it can be defined as “the right to use it to research, process, trade, and burial the fluids, ashes and human material of others”. If such rights are recognized, the donor cannot claim rights to the researcher’s commercial use of the human material and its profits. Also, the ownership of the human material belongs to the donor and the researcher has acquired the above rights for use only.The researcher can transfer this to another researcher or transfer the research paper to another place. If there is a previous reason, the researcher should bear the responsibility of explaining it to the owner, the donor, and obtain the consent of the donor. Donors who consent may revoke it at any time. This is a right, so there is a need to make an official announcement. It is necessary to distinguish between the owner and the user by registering it even though it is a moving object such as a car. If the owner of the human material wishes to anonymize all of his or her information, registration cannot be made, and therefore the validity of the human material cannot be recognized. In this case, ownership is attributed to the researcher because the donor has certified the human material.

As for the remains of the dead, the heir who superintends the ancestral rites has the special rights like superficial rights. If the owner clarifies the method of disposing of his or her remains and the heir desires another way of disposing, the special rights like superficial rights will not be extinguished even if the heir acquires ownership of the body due to death. This point is different from the superficies. And in this case, the heir has a legal obligation to handle the body according to the will of the man who was the owner. However, in order to recognize such rights, excessive administrative costs and procedures are required for registration and disclosure. In addition, it seems that there is a problem that the risk of leakage of personal information cannot be excluded due to the existence of recorded electronic records. Therefore, more discussion is needed about whether or not to admit such rights.

 

[1] BIOETHICS AND SAFETY ACT, Article 2.11.

[2] Ji Won-Lim, Civil Law Lecture(7th ed.), HongMun (2008), at 153-54

[3]Jung Hyun Lee, Ren Jin Piao, A permissible range of property right human material and equipment way of connection Legislation, Law Studies, 37th edition (Feb 2010), at 56-58.

[4]“The presiding officer” means the heir of a dead man running a ceremony to remember the dead.

[5]Property Rights means any right that is of economic value

[6]Absolute rights: the right to be exclusively governed by the right to claim to all, and to oppose the other.

[7]Herrschaftsrecht: The right to dominate the object of rights directly and to refrain from infringement by others and to enjoy its profits.

 

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Posted in Spring 2017.