Key Benefits:
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PROPOSED LAW NO. 65 /X
Exhibition of Motives
The XVII Constitutional Government Programme has taken on as one of its priorities a
getting gains in health, which are reflected, inter alia, in years of life
healthy, free from illness and disability.
One of the ways to achieve that goal translates into the increment of the donation of
organs, tissues and cells, seeking to respond to the needs of patients who
they are waiting for a transplant that improves the respective quality of life.
Simultaneously, it is forcible to develop a mechanism that provides those with
intend to donate their organs, tissues or cells to any other individuals, the
possibility of doing so, always ensuring the gratuitousness of such an act and the safety
of the donation, as well as the freedom, enlightenment, information, accuracy and clarity of the
consent provided.
Thus, the present diploma aims, on the one hand, to reduce the waiting time for citizens who
wait for a transplant that improves them the quality of life, decrease costs
associated with that wait and, on the other hand, allow those wishing to donate tissues
or non-regenerable organs, provided that this does not involve a serious decrease and
permanent of your physical integrity and health, who do so, even if they do not find themselves
with the receiver in a kinship relationship up to the 3. degree, limitation imposed by the
previous legislation.
Finally, this diploma harmonizes the terminology of domestic law with the right
community, replacing, in the name and in the text of the diploma, the previous references to
substances by current and more suitable references to cells.
Thus:
Under the terms of the paragraph d) of Article 197 (1) of the Constitution, the Government presents to the
Assembly of the Republic the following proposal for a law:
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Article 1.
Subject
This Law partially transposes to the national legal order the Directive n.
2004 /23/CE, of the European Parliament and of the Council of March 31, 2004, concerning
to the establishment of quality and safety standards in relation to the donation, harvesting,
analysis, processing, preservation, storage and distribution of tissues and cells
of human origin, in the part concerning the donation and harvesting of tissues and cells of
human origin.
Article 2.
Amendment to Law No. 12/93 of April 22
Articles 1, 3, 5, 8, 9, and 15 and 15 of Law No. 12/93 of April 22 on the
harvesting and transplantation of organs and tissues of human origin, go on to have the following
wording:
" Article 1.
[...]
1-A This Law applies to acts that are the subject of the donation or
harvesting of organs, tissues and cells of human origin, for purposes
therapeutic or transplantation, as well as to the interventions of
transplant.
2-[...].
3-[...].
Article 3.
[...]
1-[...].
2-[...].
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3-Harvesting centres and transplant centres are authorised by the
Minister of Health and are subject to periodical evaluation of their
activities and results.
4-The harvesting centres and the transplant centres already in operation
do not lack the permission provided for in the preceding paragraph, owing,
however, submit to the said periodical evaluation.
Article 5.
[...]
1-A donations of organs, tissues and cells, for therapeutic or
transplantation, cannot, under any circumstances, be remunerated, being
prohibited its marketing.
2-[ Revoked ].
3-The agents of the acts referred to in Article 1 (1) and the
establishments authorized to perform organ transplants, tissues and
cells can receive a remuneration, unique and exclusively, by the
service provided, and may not the calculation of this remuneration ascribe
any value to the organs, tissues or cells harvested or transplanted.
Article 6.
[...]
1-Without prejudice to the provisions of the following numbers, they are always
permissible the donation and harvesting in life of organs, tissues and cells to
therapeutic or transplant purposes.
2-In the case of donation and harvesting of non-regenerable organs or tissues, the
respective admissibility becomes dependent on assent, issued
by the Verification Entity of Harvest for
Transplantation (EVA).
3-Are always prohibited from donation and harvesting of organs or tissues not
regenerable when they involve minors or other incapable.
4-Are always prohibited from donation and harvesting of organs, tissues or from
cells when, with a high degree of probability, involve the
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serious and permanent decrease in physical integrity or health of the
dador. "
Article 8.
[...]
1-[...].
2-The consent of the donor and the receiver is provided in the face of:
a) A physician appointed by the clinical director of the establishment where the
harvest if it performs, when it deals with organ transplantation, tissues and
regenerable cells;
b) A physician appointed by the clinical director of the establishment where the
harvest perform and that it does not belong to the transplant team, when
treat yourself to organ transplantation, tissues and non-regenerable cells.
3-[...].
4-A donations and harvesting of organs, tissues and cells of minors with
ability to understand and manifestation of will lack also
of concordance of these.
5-[...].
6-[...].
Article 9.
[...]
1-The donor is entitled to medical assistance up to the complete
re-establishment.
2-Without prejudice to the provisions of Article 5 (1), the donor shall be entitled to
compensated for the damage suffered, of a patrimonial nature and not
patrimonial, regardless of guilt, notably by the expenses
arising from the donation.
3-It is up to the establishments referred to in Article 3 (1) to ensure the
rights referred to in paragraphs 1 and 2 of this Article.
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4-The establishments mentioned in Article 3 (1) are to celebrate
an insurance contract in favour of the donor and bearing the respective
charges.
Article 15.
[...]
1-The Government should promote information campaigns on the
meaning, in terms of social solidarity, health policy and means
therapeutics, the harvesting of organs, tissues and cells and the realization of
transplants.
2-[...]. "
Article 3.
Addition to Law No. 12/93 of April 22
They are deferred to Law No. 12/93 of April 22, Articles 1-and 6-to-with the following
wording:
" Article 1.
Definitions
For the purposes of this Law, it is understood by:
a) "Organ", a differentiated and vital part of the human body,
consisting of several tissues, which keeps largely
autonomous to its structure, vascularization and capacity of
develop physiological functions;
b) "Tissue", all constitutive parts of the human body formed
by cells;
c) "Cells", the individual cells or a set of cells of
human origin, not connected with each other by any type of tissue
connective.
d) "Dador", any human source, living or dead, of organs, tissues and
cells of human origin;
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e) "Dádiva", any donations of organs, tissues and cells of origin
human, intended for applications in the human body;
f) "Harvesting", a process in which organs, tissues are made available
and cells of human origin.
Article 6-The
Verification Authority of Admissibility of Harvest for
Transplantation
1-A Verification of the Admissibility of the Harvest for
Transplantation (EVA) is the body to whom it is up to the issuing of opinion
binding in the event of donation and harvesting in life of organs, tissues or
cells for therapeutic or transplantation purposes.
2-A EVA is created, in each hospital establishment where to perform the
harvest, by dispatch of the Minister of Health, under joint proposal of the
respective Board of Directors and the Portuguese Organization of
Transplantation.
3-A EVA works on dependency and as a section of the Ethics Commission
for the Health of the hospital establishment where to perform the harvest. "
Article 4.
Transitional provisions
Up to the commissioning of the EVA at each hospital establishment where if
carry out the harvest, Article 6 of Law No 12/93 of April 22 on April 22, in the
its originary wording.
Article 5.
Republication
It is republished, in annex, which is an integral part of this Act, the Act No. 12/93, 22 of
April, with the current wording.
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Seen and approved in Council of Ministers of April 13, 2006
The Prime Minister
The Minister of the Presidency
The Minister of Parliamentary Affairs
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ANNEX
Republication of Law No. 12/93 of April 22
Harvesting and transplantation of organs, tissues and cells of human origin.
CHAPTER I
General provisions
Article 1.
Scope material of application
1-A This Law applies to acts which have the object of the donation or harvesting of
organs, tissues and cells of human origin, for therapeutic or transplantation purposes,
as well as to the transplant interventions themselves.
2-A blood transfusion, the donation of egg and sperm and the transfer and
manipulation of embryos are the subject of special legislation.
3-They are also the subject of special legislation the donation and the harvesting of organs for
purposes of scientific research.
Article 1-The
Definitions
For the purposes of this Law, it is understood by:
a) "Organ", a differentiated and vital part of the human body, constituted by
various tissues, which keeps largely autonomous to its structure,
vascularization and ability to develop physiological functions;
b) "Tissue", all constitutive parts of the human body formed by cells;
c) "Cells", the individual cells or a set of cells of origin
human, not connected with each other by any kind of connective tissue.
d) "Dador", any human source, living or dead, of organs, tissues and
cells of human origin;
e) "Dádiva", any donations of organs, tissues and cells of origin
human, intended for applications in the human body;
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f) "Harvesting", a process in which organs, tissues and
cells of human origin.
Article 2.
Personal scope of application
1-A This Law applies to national citizens and to stateless and foreign residents
in Portugal.
2-In relation to foreigners occasionally in Portugal, the legal regime of the
acts provided for in Article 1 (1) shall be governed by their personal status.
Article 3.
Authorized establishments and qualified persons
1-The acts referred to in Article 1 (1) may only be carried out under the
liability and direct medical surveillance, according to the respective leges
artis and in public or private hospital establishments.
2-There can still be made tissue harvesting for therapeutic purposes in the course of
autopsy at the institutes of legal medicine.
3-The harvesting centres and transplant centres are authorised by the Minister of
Health and are subject to periodic evaluation of their activities and results.
4-The harvesting centres and the transplant centres already in operation do not lack
of the permit provided for in the preceding paragraph, and shall, however, submit to the said
periodical evaluation.
Article 4.
Confidentiality
Unless the consent of who of law is prohibited, it is prohibited to reveal the identity of the donor or
of the organ or tissue receiver.
Article 5.
Gratuitousness
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1-A donation of organs, tissues and cells, for therapeutic or transplantation purposes, not
may, under no circumstances, be remunerated, being prohibited to your
marketing.
2-[ Revoked ].
3-The agents of the acts referred to in Article 1 (1) and the establishments
authorized to perform organ, tissue, and cell transplants can receive a
one-time remuneration and solely for the service provided, and may not the calculation
of this remuneration to assign any value to the organs, tissues or cells harvested or
transplanted.
CHAPTER II
From harvest to life
Article 6.
Admissibility
1-Without prejudice to the provisions of the following numbers, the donation and
harvesting in life of organs, tissues or cells for therapeutic or de-
transplant.
2-In the case of donation and harvesting of non-regenerable organs or tissues, the respective
admissibility becomes dependent on assent, issued by the Entity of
Verification of Admissibility of Harvest for Transplantation (EVA).
3-Are always prohibited from donation and harvesting of organs or non-regenerable tissues
when they involve minors or others unable.
4-Are always prohibited from donation and harvesting of organs, from tissues or from cells when,
with a high degree of probability, involve the severe and permanent decrease of the
physical integrity or the health of the donor.
Article 6-The
Verification Authority of Admissibility of Harvest for Transplant
1-A Verification of the Admissibility of the Harvest for Transplant (EVA)
is the body to whom it is up to the issuance of binding opinion in the event of donations and
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harvesting in life of organs, tissues or cells for therapeutic or de-
transplant.
2-A EVA is created, in each hospital establishment where the harvest is carried out, by
dispatch of the Minister of Health, on a joint proposal from the respective Council of
Administration and the Portuguese Transplantation Organization.
3-A EVA works on dependency and as a section of the Ethics Commission for Health
of the hospital establishment where to perform the harvest.
Article 7.
Information
The physician must inform, in a loyal, appropriate and intelligible manner, the donor and the recipient of the
possible risks, the consequences of donations and treatment and their effects
secondary as well as of the care to be observed later.
Article 8.
Consent
1-The consent of the donor and the receiver shall be free, enlightened and unequivocal and the
donor can identify the beneficiary.
2-The consent of the donor and the receiver is provided in the face of:
a) A physician designated by the clinical director of the establishment where the harvest
perform, when it deals with organ transplantation, tissues or cells
regenerable;
b) A physician designated by the clinical director of the establishment where the harvest
perform and that it does not belong to the transplant team, when it deals with
transplantation of organs, tissues or non-regenerable cells.
3-Addressing of minor donors, consent must be provided by the parents,
provided that it is not inhibited from the exercise of parental power, or, in the event of inhibition or
lack of both.
4-A donation and harvesting of organs, tissues or cells of minors with capacity of
understanding and manifestation of will lack the concordance also
of these.
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5-A harvesting in larger incapable for reasons of psychic anomaly can only be done
upon judicial authorization.
6-The consent of the donor or of whom lawfully the represent is freely
revocable.
Article 9.
Right to assistance and compensation
1-The donor is entitled to medical assistance until complete re-establishment.
2-Without prejudice to the provisions of Article 5 (1), the donor shall be entitled to
compensated for the damage suffered, of a patrimonial and non-patrimonial nature,
regardless of guilt, particularly by the expenses arising from the donation.
3-It is up to the establishments referred to in Article 3 (1) to secure the rights
referred to in paragraphs 1 and 2 of this Article.
4-The establishments mentioned in Article 3 (1) shall conclude a contract
of insurance in favour of the donor and bear the respective charges.
CHAPTER III
From harvest in corpses
Article 10.
Potential donors
1-Are considered as potential donors post mortem all national citizens
and stateless and foreign nationals residing in Portugal who have not expressed
together with the Ministry of Health its quality of non-donors.
2-When the unavailability for the donation is limited to certain organs or tissues or
to certain purposes, they must the restrictions be expressly stated in the respective
records and card.
3-A unavailability for the gift of the minors and the unable is manifested, for
registration effects, by the respective legal representatives and may also be
expressed by the minors with capacity for understanding and manifestation of
will.
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Article 11.
National Register
1-A National Register of non-Dators (RENNDA), computerised, is created for
registration of all those who hajam manifested, together with the Ministry of Health, its
quality of non-donors.
2-The Government shall be authorized, preceding the opinion of the National Commission on Protection
of Informatized Personal Data, to regulate the organization and operation of the
RENNDA and the issuance of an individual card, in which you will make mention of the quality
of non-donor.
3-RENNDA must be regulated and start up its business until October 1 of
1993.
Article 12.
Certification of death
1-It is up to the Order of the Doctors, heard the National Council of Ethics for Science
of Life, enunciate and keep up to date, in accordance with the scientific advances that
come to register, the set of criteria and rules of medico-legal semiology
idogens for the verification of brain death.
2-The bastonary shall communicate to the Ministry of Health the text approved by the Order
of the Doctors by fixing the criteria and rules referred to in the preceding paragraph, to
publication in the 1 th series of the Journal of the Republic .
3-A The first publication is to be made by October 1, 1993.
Article 13.
Formalities for certification
1-Doctors who carry out the harvest must wash, in duplicate, self that
constem the identity of the deceased, the day and time of the death check, the mention
from the consultation to RENNDA and the individual card, and from the lack of opposition to the
harvest, the organs or tissues collected and the respective destination.
2-In the verification of death should not intervene doctor who integrates the team of
transplant.
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3-A harvest must be carried out by a medical team authorised by the clinical director
of the establishment where to perform.
4-The self referred to in paragraph 1 is to be signed by the intervening physicians and
by the clinical director of the establishment.
5-One of the copies of the self shall be archived in the establishment in which the
harvest and the other is remitted, for statistical purposes, to the Service of Informatics
of the Ministry of Health.
6-When it has not been possible to identify the corpse, it is presumed to be non-opposition to the
donate if something else does not result from the circumstantial elements.
Article 14.
Care to be observed in the implementation of the harvest
1-In the execution of the harvest must avoid mutilations or dissections not strictly
indispensable to the collection and use of tissues or organs and those that may
harm the post-mortem, when it will take place.
2-The fact that death has occurred in conditions that impose the achievement of
medical-legal autopsy shall not preclude the effectivation of the harvest, and shall, however,
doctor report in writing all and any observation that may be useful in order to
complete the report from that.
CHAPTER IV
Supplementary provisions
Article 15.
Information campaign
1-The Government should promote information campaigns on the meaning, in
terms of social solidarity, health policy and therapeutic means, of the harvest of
organs, tissues and cells and the realization of transplants.
2-A The information campaign should also elucidate on the possibility of whether
manifest the outage for the godsend post mortem , on the existence of the
National Register of these decisions and on the issuance and use of the individual card in
that this mention is made.
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Article 16.
Responsibility
Offenders of the provisions of this law incur civil, criminal and criminal liability
discipline, in the general terms of law.
Article 17.
Abrogation standard
The Decree-Law No. 553/76 of June 13 is repealed.
Article 18.
Entry into force
1-Articles 11 and 12 of this Law shall come into force in the general terms.
2-The remaining provisions of this Act come into force on the day following that of the publication
in the 1 th grade of the Journal of the Republic of the criteria and rules referred to in Article 12.
and the communication of the Minister of Health declaring the entry into operation of the
RENNDA.