THE LEGAL STATUS OF THE UTILIZATION OF STEM CELLS IN MEXICO*
Marcia MUÑOZ DE ALBA MEDRANO**
Original Text (Spanish) PDF
SUMMARY
I. Introduction. II. Conceptual framework: cloning, an "asexual" reproduction. III. Positions on the regulation. IV. International law framework. V. Domestic legal framework. VI. Colophon. VII. Sources.
I. INTRODUCTION
The progress reached by scientific research in human genetic has gone through an important international revolution, since the topic of human cloning is one of the most consternation at present. It was not by chance that all the countries members of the United Nations Organizations have rejected it through the 1998 Universal Declaration on Human Rights and the Human Genome, which establishes in its 11th article that "practices against human dignity, such as cloning with purposes of reproducing human beings, shall not be allowed".
However, the progress in genomic research has given new possibilities to genetic therapy, establishing the benefits of what has been called therapeutic cloning, facing the rejected reproductive cloning.
The purpose of this brief work is to know the legal status of cloning and, particularly, to analyze the status of research on stem cells or mother cells required for genetic therapy. This work is divided into seven sections, the first one presenting the conceptual framework; the second one makes an analysis of the positions about the regulation of cloning; the third one presents the legal framework adopted by several countries and international organizations, and finally, in the fourth section we analyze the position of the Mexican legal system towards these topics.
II. CONCEPTUAL FRAMEWORK: CLONING, AN "ASEXUAL" REPRODUCTION
The analysis about cloning and mother cells is worth to explain certain concepts, such as the adjective "pluripotential" or "sexual reproduction" and "asexual reproduction".
Of course, for the scientific understanding and explanation of these terms it is recommendable to consult the works of biomedical scientists, who have analyzed these processes from their own perspectives. However, we may clarify concisely that in the reproduction we have called "sexual", there is a fusion of the sexual cells, the sperm and the ovule, both unicellular cells, creating a zygote. Then we say "…in the first stages of this process (sexual reproduction) each of the cells is pluripotent, that is, each one is capable by itself, to create a complete organism of such species…" and here is where the mother or pluripotent cells are found.1 Therefore, it is in this stage where the feature of omnipotence is transmitted to the embryo.
As we know, when the masculine and feminine gametes unite, and evolve to create a unicellular zygote, which acquires the totality of the genetic charge that is for humans 46 chromosomes, that is, two identical sets of 23 chromosomes. Here, we shall mention that although practically all the genes are found in the chromosomes, a few of them are in the mitochondrias, which are structures basically in charge of the cellular breathing.
Every time a sexual reproduction takes place, when the feminine and masculine gametes fuse, new living being is created whose genetic charge is completely genuine and different to their progenitors’.
In the process of asexual reproduction, typical of many plant species and some animals that have not evolved much, it does not happen the same thing. Effectively, differently from the sexual reproduction, in the asexual reproduction the genetic heritage transmitted to the new living being is identical to that of its progenitor.
Here we find some of the most important characteristics of sexual reproduction:
1) Individuality: because the new living being has an unyielding character, and each and every one of its cells are different to those of all the other living beings of its species.
2) Diversity: the individuality element induces the variability of the living beings, that is, diversity of that species. It produces an easy adaptation of the species, but at the same time those species do not have genetic stability.
3) Survival: the individuals’ variety constitutes a warranty of the adaptation of some of their members to environmental adversities, and consequently of the specie’s survival.2
On the other hand, asexual reproduction has the following features:
a) Genetic stability: with asexual reproduction, which operates during cloning, a genetic stability is reached because they have the same genetic predetermined code, but there is no diversity.
b) "Optimum" organisms: identical organisms to the previous one, which for some reason is considered worth to reproduce, are created.
c) Genetic descendant control: a predetermined genetic code is then generated.
In this line of ideas, we could define that cloning is the process of producing "genetically identical" organisms, and it exists in nature accidentally.
However, the cloning that concerns us is that which could be generated in a laboratory using human embryos that could create adult human beings. In order to carry out this process, two techniques are followed:
1) Cloning by twin division:± It is presented when an embryo is taken in the stage in which the others are still pluripotent —approximately two days after fecundation— and a cellular division in provoked. Each of these divisions develops giving place to a being with an identical genetic code to the rest of the beings resulting of this division. This is what happens with monozygotic twins, where only one egg or zygote, by spontaneous division, gives place to two or more embryos with the same genetic charge.
2) Nuclear transference cloning: It consists in transferring the nucleus of a somatic cell, that is, the one that has all the chromosome charge and not only half of it, as it happens with gametes or germinal cells, to an ovule to which the nucleus has been previously removed. These somatic cells could be cells of already born individuals, or cells of embryos or fetus. If the nucleus transferred is that of a cell, fetus or embryo, according to Bellver Capella, it is a paracloning, not a cloning as such.3 Through electric discharges the nucleus can be united to the ovule and it starts growing as if the ovule had been fecundated by a masculine gamete.
Cloning is subject of a moral and legal debate. Certainly, we are prone to thinking that Law is the positivized ethics, that is, that the legal norm represents the contents of the ethical norm, which acquires validity through the fundamental processes of Law. Regardless that we shall know the various postures regarding the control or possibility of cloning, we consider that the technological imperative sets the postures according to this circumstance. As Von Neuman said, "the technological possibilities are irresistible to man. If man can go to the moon, he will go. If he can control climate, he will". In this logic, as long as cloning is presented as a secure technique, it is probable that it will be accepted. After all, the debate around power over human life is not new, and since the apparition of techniques of assisted reproduction, it has not been solved, but technological development has not stopped either.
III. POSITIONS ON THE REGULATION
Next we will analyze the different postures the countries have adopted regarding cloning, as well as the use of embryos and the possibilities of stem cells.
1. Posture of the juridical pragmatics
To juridical pragmatics, as long as technology of cloning shows to be successful and secure, that is, that does not produce risks to human health, it will be regulated in terms of protecting human being’s integrity. In this sense, the ethical debate on cloning will remain closed until the cloning technique becomes secure enough.
2. Individualist posture
The individualist perspective has two lines of analysis: on the one hand, considering the arguments of the autonomy of will, cloning is part of the catalogue of rights, freedoms and powers of the personal decision. From that position, cloning is another option to persecute the individual right to reproduction. On the other hand, regarding the concept of "reproductive liberty" cloning is considered as an instrument to elude infertility’s whims; besides it also eludes the necessary presence of man and woman in reproduction.
3. Liberal posture
This posture is founded on the principle of harm or no harm. An action cannot be banned unless it demonstrates to hurt others in their rights. In this sense, except for the argument of the future generations’ rights, cloning could not be considered as harmful.
4. Utilitarian posture
This one intends to take into consideration how useful cloning embryos for already born humans could be, which constitutes the most important reason to support research and practice of cloning.
It is a fact, as we said before, that since the use of techniques of assisted reproduction, the place, value and transcendence of human reproduction have been set into question. The scientificism, economicism, individualism and utilitarianism have had an important role in the so-called sexual generation of the seventies until now.
Facts such as the unmasking of the neutral character of science, for example with the well-known Tuskengee judgment, the denunciations about the serious ecological crises and environmental risks, and the application of the scientific advances to medicine, have raised bioethical discussions. In fact, the raising of bioethical reflections created social distrust towards science.
IV. INTERNATIONAL LAW FRAMEWORK
In order to find out how the uses of stem cells as well as the viability of cloning have been regulated, we shall turn to the regulation of assisted reproduction techniques, because there is where both ethical and legal principles emerge in order to infer or find the legal status of these concepts.
There are two basic motivations for the regulation of these techniques:
a) Assisted reproduction techniques: Taking the principles derived of the verdict of Roe vs. Wade, and reproduction rights, any State intervention banning the woman to freely dispose of the nasciturs, represents a violation to constitutional right to privacy.
b) The protection to the embryo: Inspired in the sentence of the German Constitutional Tribunal of 1975, and the beginnings of life, the embryo is title-holder subject of the constitutional right to life, and the State shall protect it.
With respect to the specific format of the legislation, we find four basic models:
1. Legal regulation models
Most of the countries are found in this situation, but we could mention the case of Italy, which has been discussing the normative of assisted reproduction and protection of the embryo for almost ten years. Even when the National Bioethics Committee has rendered reports on cloning considering it as illegal, it has not promulgated a specific legal text yet. The case of Mexico is similar, because it has refrained from expressly regulating these topics. The absolute absence of norms on cloning has granted these countries the adjective of "genetic paradises", for the possibility of carrying out reproductive cloning. However, this cloning reproductive technique has been quite rejected by the scientific community for social and ethical reasons.
Here we have the following countries:
Germany, with the Law for the Protection of Embryos, of 1990.
France, with the Law for the Respect towards the Human Body, of 1994.
Sweden with Law no. 1140 of December 20, 1984 on Artificial Insemination.
Norway, with Law no. 56 of August 5, 1994 about the Biotechnological Applications in Medicine.
Spain, with the Law about Assisted Reproduction Techniques, of 1988.
Germany establishes in article 6 of the mentioned law that "who artificially provokes the creation of a human embryo with identical genetic information of another embryo, fetus, human being, or dead person, would be punished with deprival of freedom for up to 5 years, or fee penalty". The basic points of the Law about Protection of Embryos are:
a) The creation of embryos can only be made given causes of sterility or infertility in order to produce pregnancy.
b) No embryos could be created for manipulation or research.
c) Any genetic alteration in germinal cells is banned.
d) Although it does not ban cloning expressly, the presence of the former ones makes it impossible.
France, with the Law for the Respect towards the Human Body, by regulating the assisted reproduction techniques establishes that "no one could damage the manipulation of the human species. Every eugenic practice for the manipulation of the selection of people is banned".
In general terms, both countries accept the techniques of assisted reproduction in order to give response to the problems of couple manipulation; every time they are man and woman; that they are alive; that they are in an age to reproduce; that they prove to be married or be living together for two years, and through the reported consent of those who participate.
There are similarities in Sweden’s regulation, with the Law on Artificial Insemination, and Norway, with the Law of Biotechnological Applications in Medicine, accepting the assisted reproduction techniques, accepting them as a right paid by the State and available to sterile couples, unable to be carried by an individual.
A significant difference is the one Spain points out in the Law about Assisted Reproduction Techniques, accepting them as a woman’s right, whenever she is an adult; assuring the woman’s right to establish her own family; defending the child’s right to a natural filiation; mediating the informed consent. In this country there is a manipulation in the criminal field, establishing in 1992 specific figures for "crimes relative to genetic manipulation".4
In this model we find the legal framework of Switzerland, which in 1999 approved a constitutional revision introducing this topic for the first time in the constitution. An article was established specifically about reproductive medicine and genetic engineering in the human ambit. The text establishes:
1. The human being is protected from abuses of reproductive medicine and genetic engineering;
2. The Confederation shall approve prescriptions about the use of the germinal and genetic human heritage. In this ambit, it shall provide the personality and the family to human dignity, and it will submit particularly, to the following principles:
a. All kinds of cloning and the interventions in the genetic heritage of germinal cells and human embryos are inadmissible.
b. The non-human germinal and genetic heritage cannot be transferred to the genetic heritage neither be fused with it.
c. The techniques of assisted reproduction can be applied only when there is no other way to cure infertility or to prevent the danger of transmitting serious diseases, but not to get determined characters in the nasciturus neither for research purposes; fecundation of human ovules outside the woman’s body is allowed only under the conditions established by the law; outside the woman’s body only can be fecundated the amount of human ovules that will be immediately transplanted.
d. The donation of embryos and any form of subrogated maternity are inadmissible;
e. It is banned to trade either with the human germinal heritage and with the products of the embryo;
f. The genetic heritage of a person can only be analyzed, registered or revealed with his or her consent or through a legal prescription.5
In general terms, the new Constitution of Switzerland bans cloning in most of the modalities known up to now, both artificial twining‡ or therapeutic cloning, and the reproductive cloning.
In this type of legislation we find the cases of England and the United States, which through different legislations accept research on embryos in different circumstances. On the one hand, England with the Law of Human Fertilization and Embryology of November 1st, 1990, although it does not expressly ban cloning, when referring to bans it mentions in its third article: "d. Substituting the nucleus of an embryo’s cell with the nucleus extracted form any person’s cell, either it is the embryo or its subsequent development", from which we could understand that the restriction is tacit.
None the less, we shall mention that in this country there is the Human Genetics Advisory Commission (HGAC) and the Human Fertilization and Embryology Authority (HFEA) that carried in 1998 a proposal so that the cloning of human embryos could be viable with therapeutic purposes, that is, in order to obtain tissues useful in transplants.
However, the progress and outcomes in the research on cellular tissues, led to a deeper analysis of research on stem cells. Both in Europe and in the US and Canada there was an urge to approach the theme with more precision.
Both scientific and legislative entities dedicated to convoke to an international forum and reconsider the topic, organizing congresses and meetings about it. The Health Department of the United Kingdom in 2000 issued the "Stem Cell Research: Medical Progress with Responsibility,6 which it appoints about the benefits found in the so-called mother cells or pluripotent cells accepting the granting of public funds for research on embryos and their cellular structure in accordance with the 1990 Law. The usable embryos may be those created in vitro for fertilizing purposes or for cellular replacement.7 This document bans the use of somatic adult cells in combination with animal cells of any species.8
In the United States the Warnock Report of 1984 has been quite significant, inspired in the reactions around the creation of the first girl in vitro, which suggested the creation of a special commission for the study of the human fertilizing techniques. This report of liberal and utilitarian character has influenced many legislations of this field.9
The normative background of this country has been variable and varied, without following a logic further than changes of moral attitude depending on the party in power. We observe the creation of the National Bioethics Committee in the period of President Clinton after the announcement of the cloning of the first sheep in 1997. In its report about ethical and legal aspects of the techniques of human cloning, in favor of the tendency of the international opinion, it banned cloning with reproductive purposes, considering it morally unacceptable. This report proposed an extension of time of five years about the use of federal funds for research on cloning.10 In Bellver Capella’s words, the restrictive character of the report has been object of criticism for not giving solutions to the problems such as cloning with therapeutic purposes, besides it has been extremely pragmatic, since in addition to moral or social arguments that reject it, it denies if for not existing guarantees for its successful application.11
With respect to pluripotent cells, in the US the national institutes of health issued the Guidelines for Research Involving Human Pluripotent Stem Cells in December 1999. Such document accepts the research on embryos using public funds, whenever they are those remains created in infertility processes; insists in the differentiation of the informed consent in order to accept to be submitted to the infertility therapy and to donate the remaining embryos; and approves a protocol with very strict and specific requirements for research. In this executive order was established that the national institutes of health would grant the researchers of existing material —64 cellular lines—.12
So far we have analyzed the domestic legislative models that refer to stem cells or to the possibility of reproductive cloning. Now we shall know the dispositions of international organizations about this topic.
2. International organizations
Certain international organizations have pronounced the same way with respect to human genetics, and particularly about cloning, such as the following:
UNESCO has issued two important documents about this subject:
1) The Universal Declaration of Human Rights of the Future Generations, issued in La Laguna on February 26, 1994, without standing for national positions, being elaborated by experts as a personal opinion, established in article 3:
The people belonging to future generations have the right to life and keeping and perpetuating humanity in the different expressions of their identity. Therefore, it is forbidden to cause any kind of damage to the human form of life, particularly with actions that yield irreversibly and definitely the preservation of the human species, as well as the genome and the genetic inheritance of humanity.
This document has been taken by some detractors of reproductive cloning, though, it does not contradict the possibility of the so-called therapeutic cloning, since it clearly rejects any action that causes damage, and these investigations intend the opposite.
2) The Universal Declaration on the Human Genome, basic document in this field, represented an international agreement by being ratified by all the nations. In our opinion, this Declaration of principles shall become, as the Universal Declaration of Human Rights, in a document of compulsory application in all that involves research in human genetics, biotechnology and bioethics in the present century. As we mentioned at the beginning of these lines, this is the first document that expressly refers to the prohibition of human cloning with reproductive purposes.13
This organism has worked hardly in building guidelines and parameters for the use of genetic engineering. We have the following documents:
a) Recommendation 934 about genetic engineering, of 1982.
b) Recommendation 1046 about the use of human embryos and fetus for diagnostic, therapeutic, scientific, industrial and commercial purposes, of 1986.
c) Recommendation 1100 about the use of human embryos and fetus in scientific research, of 1989.
d) 1996 Convention for the Protection of Human Rights and Human Dignity with respect to the Applications of Biology and Medicine, or Convention on Human Rights and Biomedicine.
This last document is clear when asserting that: "no intervention shall be carried on the human genome if it is for purposes other than prevention, diagnosis or therapy, and with the condition of not having as a purpose modifying the lineage’s genome".
On the other hand, this document has created another more specific one about this topic, which is the Additional Protocol on Cloning of 1997, which adopts a prohibitive posture about reproductive cloning, as it states: "Every intervention that intends to create a human being genetically identical to another one, either alive or dead is banned".
This organization issued in 1988 the International Code of Conduct on Human Reproduction Technologies, which regulates the procedure of genetic research. The basic points are:
- The guarantee of security of the human genetic material.
- The human being’s dignity.
- The human person’s inviolability.
- The human body’s inalienability.
- The penalization.
V. DOMESTIC LEGAL FRAMEWORK
Now we shall know the dispositions of the General Health Law on these themes. This Law, in its article 98 incorporates the creation of the Biosecurity Commission for the "revision of investigations focused on techniques of genetic engineering or even ionizing radiations", besides those that already exist about Ethics and Investigation when research on human beings are carried.
Here we believe that with respect to the Biosecurity Commission’s opinion there could be problems, because the term genetic engineering is not specified and within the current biomedical ambit an interesting number of investigations related to cells and tissues, particularly with human and animal chromosomes and genomes, is been made, without this being necessarily covered by the term of genetic engineering. There are more adequate names to designate what really wants to be understood with this concept, such as genomic medicine, for human beings, and biogenetics, for the case of fauna and flora. In our point of view, the text of the Law should be more specific without putting adjectives to the research activity and clarifying what should be submitted to a legal opinion.
Although it is not quite related with cloning, the Law integrated the term biotechnology in order to regulate the so-called biotechnological products,14 establishing in article 281 bis that:
…biotechnological products are those nourishments, ingredients, additives, raw materials, health inputs, pesticides, toxic or dangerous substances, and their rights, in which process intervene living organisms or part of them, modified by a traditional technique or by genetic engineering.
In this disposition, the legislator, considering the possible genetic modifications, incorporates in the norm practice that had been done frequently. However, the norm is confusing, because it does not define nor distinguish what is understood by traditional technique of the modification of living beings of the processes of genetic engineering.15
This Law only limits to define concepts like cells, tissues, embryos or artificial reproduction, which of course are elements that would be involved in cloning or in the handling of mother cells, but it does not make any reference to the topic. In this sense, it is important to regulate the management of the patient and/or the donor who participates in the assisted reproduction practices; as well as the time of cells’ sheltering and also, their destination of research and/or fertilization.
On the other hand, and with regards to the possible intervention of human being and the cloning process, the General Health Law in its article 100 establishes the bases on which the research on human beings shall develop, specifying that:
- It shall adapt to the scientific and ethical principles that justify medical investigation, especially regarding their possible contribution to the solution of health problems and to the development of new fields of the medical science.
- It shall only be carried when the knowledge intended to be produced cannot be obtained through another ideal method.
- It shall only be carried when there is a reasonable security that the subject of experiment is not exposed to unnecessary risks or harm.
- It shall have the written consent of the subject of the investigation or of his legal representative in case of legal incapacity of the latter, once he knows about the objectives of the experimentation and about the possible positive or negative consequences for health.
- It shall only be carried by health professionals in medical institutions that act under the supervision of the competent sanitary authorities.
- The professional which is responsible shall suspend the investigation in any moment if there is a risk of serious lesions, disability, or death of the subject to whom the investigation is carried.
These bases are extended and clarified in the Regulations of the General Health Law on Health Investigation, which establishes in its article 10 that in investigations with human beings, besides following the previous bases, it shall have the positive law opinion of the mentioned commissions.
The most important points to underline regarding investigation on human beings in the Mexican legislation are:
1) Reported consent: the written agreement through which the subject of investigation, or if it were the case, his or her legal representative authorizes his participation in the investigation with full knowledge of the nature of the proceedings and risks to which he will be submitted, with the capacity of free choice and without any kind of coercion.
Regarding genetic experimentation, emphasis has been put in the fact that the consent shall be effectively, integrally informed, that is, with veracity, clarity and understanding the subject the objectives and scope of the investigation, he agrees in participating in it. On the other hand, there are arguments to consider that sometimes it is hard to explain the scientific nature of the investigation for being too complex. Although it is true that these cases could come up, the basic idea is to prevent abuses to the subject or patient who takes part in the experiment in order to protect the respect towards his human dignity.
On the other hand, the Regulation refers to investigation in communities, establishing that:
When the individuals that form part of a community do not have the capacity to understand the implications of taking part in an investigation, the Ethics Commission of the institution to which the main researcher belongs, may authorize or not that the written informed consent of the subjects is obtained through a reliable person with moral authority over the community. In case the Commission does not authorize it, the investigation shall not be carried. On the other hand, the participation of individuals shall be completely voluntary and each one of them shall be free to abstain or stop participating in any moment of the study.16
This point is important because as we know, the future of the project of the human genome will be addressed to the genetics of populations in order to study, depending on the genetic profile, the similarities and differences between the population groups, and it will be very important to protect in any moment the respect to the dignity of these groups, both at a communal and individual levels, without witnessing cases of abuse.
2) Investigation with risk or without risk: the Regulations establish three types of investigation: without risk, with minimal risk, and with a risk bigger than the minimal.
a) Investigation without risk: it comprises those studies that use documentary investigation techniques and methods without any intervention in the subjects.
b) Investigation with minimal risk: are studies that use information through common procedures in physical or psychological exams of ordinary diagnose or treatment among which are considered: electrocardiogram, thermograph, collection of external excretions and secretions, obtaining of placenta during labor; collection of amniotic liquid when the membranes break, and the obtaining of saliva, among others.
c) Investigation with a risk bigger than the minimal: is the one in which the possibilities of affecting the subject are significant, among which are considered: radiology studies and with microwaves, testing with medications, studies that include surgical procedures, blood extraction, 2% of the circulating volume in new-born babies, amniocentesis, and other major invading techniques or procedures, those which use fortuitous methods of assignation to therapeutic schematizations, and those which control through placebos, among others.
It is important to mention that regarding the extraction of the placenta during labor, the Law considers it as an investigation procedure with minimal risk, and the extraction of blood in new-born babies —as could be freezing the blood of the umbilical cord, practice that has just started in our country— is considered by the Law as an investigation with a risk bigger than the minimal.
In brief, neither the General Health Law nor the regulatory dispositions mention the process of cloning in any of their facets. We esteem that with respect to the aspects of human genome and cloning, the following points shall be incorporated in our Law:
The Law should protect human genome, which is the genetic material that characterizes the human species, which contains all the individual’s genetic information that is considered as the fundamental biological unit of the human being.
The knowledge of the human genome is humanity’s heritage, thus, the Law shall protect it.
The genetic information is part of the health information, both having a sensitive nature, for which they shall not create discrimination or violation to the rights, freedoms, and the dignity of man.
Regarding the techniques of assisted reproduction, precise guidelines about the management of cells and embryos shall be established, including the property rights of the subjects involved, as well as the type of freezing of the embryos and their fate in case they are not used.
With respect to cloning, according to the majority opinion of the scientific community, the one with reproductive purposes is banned.
Protecting the research rights and the granting of patents that are made because of the investigation, even when they reach the modification of the genetic structure of a molecule or cell.
VI. COLOPHON
Finally, we would like to finish this work with the following thought: it is equally alarming that the States ban prematurely certain investigation in order to please the frightened public opinion, with ignorance or lack of real knowledge about the scope and scientific aims, yielding the right to free investigation, as it is the pressure of scientists or the economic interests cause that the scientific investigation is not submitted to a continuous social evaluation of its processes and outcomes in a legally orderly way.
The Mexican society, through members of the civil society, of scientific academies, of elected representatives, of scientists and humanists shall take the time and space for the debate, discussion and learning about these topics. The obscurantist spirit cannot be the one who dictates the pattern to follow.
The trilogy of biotechnology, that is, the trilogy of the present century, composed by Law, bioethics and science shall coexist very closely in the future, they shall find a constant and secure dialogue that looks forward towards the balance between the humanity’s benefit and the respect to personal dignity.
VII. SOURCES
BELLVER CAPELLA, Vicente, ¿Clonar? Ética y derecho ante la clonación humana, Granada, Comares, 2000.
DEPARTMENT OF HEALTH, Stem Cell Research: Medical Progress with Responsibility, United Kingdom, June 2000.
FEMENIA LÓPEZ, Pedro, Status jurídico del embrión humano, con especial consideración al concebido in vitro, Madrid, McGraw-Hill, 1999.
MUÑOZ DE ALBA MEDRANO, Marcia, "Aspectos sobre la regulación del genoma humano en México", Reflexiones en torno al derecho genómico, México, UNAM, Instituto de Investigaciones Jurídicas, 2002.
———, "La biotecnología en la Ley General de Salud: ¿podemos estar tranquilos?", Anuario Jurídico, new series, 1997.
NATIONAL BIOETHICS ADVISORY COMMISSION, Report Cloning Human Beings, New York, Norton and Co., 1998.
PERIS RIERA, Jaime Miguel, La regulación penal de la manipulación genética en España. Principios penales fundamentales y tipificación genotecnológicas, Madrid, Civitas, 1995.
VARSI ROSPIGLIOSI, Enrique, Derecho y manipulación genética, Lima, Universidad de Lima-Fondo de Desarrollo Editorial, 1996.
———, Derecho genético, 4th ed., Lima, Editora Jurídica Grijley, 2001.
Notes
* Translated by Ingrid Berlanga Vasile.
**Coordinator of the Nucleus of Interdisciplinary Studies in Health and Law of the Legal Research Institute of the UNAM. She died in 2005.
1 Bellver Capella, Vicente, ¿Clonar? Ética y derecho ante la clonación humana, Granada, Comares, 2000, pp. 9-26.
2 Ibidem, p. 12.
± In Spanish "división gemelar" [N. of the T.].
3 Ibidem, p. 17.
4 Crimes are established in title V of book II: "About the genetic manipulation of human embryos and fetus, of artificial insemination not consented". Cfr. Peris Riera, Jaime Miguel, La regulación penal de la manipulación genética en España. Principios penales fundamentales y tipificación genotecnológicas, Madrid, Civitas, 1995.
5 Constitution of Switzerland of April 18, 1999, article 119.
‡ In Spanish "gemelación artificial" [N. of the T.].
6 Department of Health, Stem Cell Research: Medical Progress with Responsibility, June 2000.
7 Ibidem, p. 45.
8 Recommendation 6, p. 47.
9 Cfr. Femenia López, Pedro, Status jurídico del embrión humano, con especial consideración al concebido in vitro, Madrid, McGraw-Hill, 1999.
10 Cfr. National Bioethics Advisory Commission, Report Cloning Human Beings, New York, Norton and Co., 1998.
11 Ibidem, p. 62, note 1.
12 New York Times, August 27, 2001.
13 It may be checked in: http://www.unesdoc.unesco.org/images.
14 Reformed in 1997. Cfr. Muñoz de Alba Medrano, Marcia, "La biotecnología en la Ley General de Salud: ¿podemos estar tranquilos?", Anuario Jurídico, new series, 1997, p. 91.
15 Cfr. Muñoz de Alba Medrano, Marcia, "Aspectos sobre la regulación del genoma humano en México", Reflexiones en torno al derecho genómico, México, UNAM, Instituto de Investigaciones Jurídicas, 2002, pp. 191-209.
16 Regulations of the General Health Law on Health Investigation, article 30.
