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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.