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Navigation mode: ON SCIENTIFIC INVESTIGATION IN THE HUMAN BEING, ITS GENOME, AND PROHIBIT THE
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Regulation: Law 20120 Version: Unique From: SEP 22, 2006 Publication Date: SEP 22, 2006 Promulgation Date: SEP 07, 2006
Exp. Norma Back Next Organism: MINISTRY OF HEALTH; UNDERSECRETARIAT OF PUBLIC HEALTH
Tree Loading (8%) Subjects: Human Genome; Cloning; Law no. 20,120
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LAW NUM. 20,120
ON SCIENTIFIC INVESTIGATION IN THE HUMAN BEING, HIS
GENOME, AND PROHIBITS HUMAN CLONING
Bearing in mind that the H. National Congress has approved the
next bill originated on the motion of Brother Senator Mr. Mariano
Ruiz-Esquide Jara and the former Senators Messrs. Nicolás Díaz Sánchez, Juan
Hamilton Depassier, Sergio Páez Verdugo and Andrés Zaldívar Larraín
Bill:
Article 1 .- This law is intended to protect the lives of beings
human, from the moment of conception, their physical and mental integrity,
as well as its diversity and genetic identity, in relation to research
biomedical science and its clinical applications.
Article 2 ° .- The freedom to carry out research activities
Biomedical scientific research in human beings is limited by respect for
essential rights and freedoms emanating from human nature,
recognized both by the Political Constitution of the Republic and by the
international treaties ratified by Chile and that are in force.
Article 3.- Any eugenic practice is prohibited, except counseling.
genetics.
Article 4.- All forms of arbitrary discrimination based on the
people's genetic heritage.
Consequently, the results of genetic tests and analyzes
predictive of the same nature may not be used for that purpose.
Article 5º.- The cloning of human beings is prohibited, whatever
be the end pursued and the technique used.
Article 6.- The cultivation of tissues and organs will only proceed for the purpose of
therapeutic diagnoses or scientific research. In no case may they
destroy human embryos to obtain stem cells that give
origin to these tissues and organs.
Article 7º.- Gene therapy in somatic cells will be authorized only
for the purpose of treating diseases or to prevent their appearance.
Article 8.- Knowledge of the human genome is the common heritage of the
humanity. Consequently, no one can claim or constitute property
on it or on part of it. Knowledge of the structure of a gene
and of the total or partial DNA sequences are not patentable.
Biotechnological processes derived from knowledge of the genome
human, as well as the products obtained directly from them, diagnostics or
Therapeutic, they are patentable according to the general rules.
Article 9º.- Only the genetic identity of a
human being if you have your prior and informed consent or, in your
defect, that of one who must supply his will in accordance with the law. The
above is without prejudice to the power of the courts of law, in the form and
in the cases established by law.
Article 10.- All scientific research in human beings that involves
some type of physical or psychological intervention must always be carried out by
qualified professionals in the field, justify their objective and methodology and
adjust in everything to the provisions of this law.
A scientific investigation cannot be carried out if there are antecedents that
suggest that there is a risk of destruction, death or bodily injury
serious and lasting for a human being.
All biomedical scientific research must have authorization
express of the director of the establishment within which it is carried out, prior
favorable report of the corresponding Scientific Ethics Committee, according to the
regulation.
Article 11.- All scientific research in a human being must have
with your prior, express, free and informed consent, or, failing that, that of
one who must supply his will in accordance with the law.
For the purposes of this law, there is informed consent when the
person who must provide it knows the essential aspects of the investigation,
especially its purpose, benefits, risks and procedures or treatments
alternatives. For this, adequate information must have been provided,
enough and understandable about it. It must also be made special
Mention of your right not to authorize the investigation or to revoke your
consent at any time and by any means, without
amount responsibility, sanction or loss of any benefit.
The consent must appear in a record signed by the person who has
to consent to the investigation, by the director responsible for it and by the
director of the center or establishment where it will be held, who,
in addition, he will act as a minister of faith.
In any case, consent must be requested again each time
that the terms or conditions in which the research is carried out suffer
modifications, unless they are considered minor by the Ethics Committee
Scientist who has approved the research project.
Article 12.- The genetic information of a human being will be reserved. The
above is without prejudice to the powers of the courts of justice, in the
cases and in the manner established by law. Also, for the purposes of this
law, the provisions on professional secrecy are fully applicable.
Article 13.- The collection, storage, treatment and dissemination of
People's genome will comply with the provisions of Law No. 19,628,
on protection of personal data.
The data of the human genome that allow the identification of a person
They must be encrypted for storage and transmission.
Encryption may be temporarily omitted for reasons of public utility.
Article 14.- It is prohibited to request, receive, inquire, possess and use information
on the genome related to a person, unless expressly authorized by it
or, failing that, the one who must supply his will in accordance with the law. The
above is without prejudice to the powers of the courts of justice, in the
cases and in the manner established by law.
Article 15.- Create a National Bioethics Commission, which will be integrated
by nine professionals, experts in bioethics, appointed by the President of
the Republic, with the agreement of the Senate adopted by two thirds of its
practicing members, in a special session called for that purpose.
The members of this Commission will last four years in their positions and may
be re-elected. The President of the Republic, at the time of requesting the
The agreement of the Senate will propose the member who will assume the position of President.
The Commission will have an Executive Secretariat, which will coordinate its
operation and will comply with the agreements that it adopts and will be formed
by the personnel assigned for this purpose by the Ministry of Health.
Article 16.- The National Bioethics Commission will have, among its functions,
advise the different Powers of the State on ethical issues
present as a product of scientific and technological advances in
biomedicine, as well as in matters related to research
biomedical scientist in humans, recommending dictation,
modification and suppression of the rules that regulate it.
The resolutions or agreements of the Commission will be adopted by simple
majority, notwithstanding which the differences produced must be recorded
within it and the minority position.
Article 17.- The one that clones or initiates a process of cloning human beings and
the one who will carry out any eugenic procedure in contravention of the article
3 °, he will be punished with the sentence of minor prison in its medium to maximum degree and
with the absolute disqualification for the exercise of the profession during the time
that the sentence lasts.
In case of recidivism, the offender will also be sanctioned with the penalty
perpetual disqualification to practice the profession.
Article 18.- Anyone who violates the reservation of information about the genome
human, outside the cases authorized by article 12, will suffer penalties
established in both paragraphs of article 247 of the Penal Code, as the case may be.
Whoever omits the encryption required in this law will be sanctioned with a fine
up to a thousand development units.
Article 19.- Whoever falsifies the act referred to in the third paragraph of
Article 11 will be sanctioned with the penalty of minor imprisonment in its minimum degree
and with a fine of 10 to 20 monthly tax units.
The same penalty will be applied to those who maliciously use, for any purpose, a
false record.
The one who omits the referred act or will manifestly prepare it
incomplete will be sanctioned with a fine of 10 to 20 tax units
monthly.
Article 20.- Everyone who develops a scientific research project
biomedical in humans or in their genome, without authorization
corresponding required by this law, will be sanctioned with the
suspension for three years of professional practice and with the absolute prohibition
of professional practice in the national territory in case of recidivism.
Article 21.- The Ministry of Health shall establish, by means of
regulation, norms that complement or develop the contents of this
law.
And because I have seen fit to approve and sanction it; therefore enact
and it takes effect as Law of the Republic.
Santiago, September 7, 2006.- MICHELLE BACHELET JERIA,
President of the Republic.- María Soledad Barría Iroume, Minister of Health.
What I transcribe to you, for your knowledge.- Say hello to you, Lidia Amarales
Osorio, Undersecretary of Public Health.
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