Law No. 2 Of 8 January 1998 On The Taking And Transplantation Of Human Organs And Tissues

Original Language Title:  LEGE nr. 2 din 8 ianuarie 1998 privind prelevarea şi transplantul de ţesuturi şi organe umane

Read the untranslated law here: https://www.global-regulation.com/law/romania/3071161/-lege-nr.-2-din-8-ianuarie-1998-privind-prelevarea-i-transplantul-de-esuturi-i-organe-umane.html

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Law No. 2 of 8 January 1998 on the taking and transplantation of human organs and tissues, the PARLIAMENT published in ISSUING the OFFICIAL GAZETTE nr. 8 of 13 January 1998, the Romanian Parliament adopts this law.


Chapter 1 General provisions Article 1 (1) the sampling and transplanul of tissues and human organs for therapeutic purposes shall be made, under the present law.
  

(2) by sampling means the collection of tissues and/or human organs healthy, functional, and morphological realisation of a transplant.
  

(3) by transplantation of tissues and/or human organs means the job complex medical, therapeutic purposes, replaces tissues and/or compromised human organs, morphologically and functionally from the body of a human subject with other similar structures, proven as being healthy.
  

(4) for the purposes of this Act, through donor means subject matter in life or State of cerebral death, genetically compatible with the potential recipient who, for medical purposes, donate organs and/or tissues.
  

(5) by inviting the subject means benefiting from carrying out a transplant.
  


Article 2 (1) taking and discharging transplantation and human organs cannot be subject to any transaction.
  

(2) the donation during life or written consent for the collection of tissues and organs after death, given by the donor or family members whenever kin as provided by law, after his death, is a deeply humanitarian act that could allow saving the life of a man.
  

(3) Sampling and transplantation of tissues and organs as a result of physical constraints or morals of a person are prohibited.
  


Article 3 (1) need the levy and transplantation of human organs and tissues, coordination and supervision of these activities devolved Commission medical transplant tissues and human organs, which operates within the Ministry of health, as well as regional centers for transplant.
  

(2) component, organization, functioning and tasks of this Commission, and regional centres for transplantation shall be established by the regulation, approved by the College of physicians from Romania and approved by the Minister of health.
  


Article 4 (1) it is prohibited the disclosure of any information that would allow identification of the recipients of the donated tissue or an organ. From this provision may be departed from only in case of necessity.
  

(2) advertising is prohibited in favour of tissue and organ donation on behalf of a person or of an institution for the hospital.
  


Chapter 2 Sampling of tissues and human organs Article 5 (1) the taking of human organs and tissues for medical purposes may be carried out at the people in his life, mental capacity full, only if there is a danger for the life of the donor's written consent and with the free, prior, express, and conforming to the specimen contained in annex 4. 1. (2) preliminary control, laboratory, clinical and donor is required.
  

(3) Consent is given only after the donor has been advised by the doctor on the possible risks and consequences on the physical, psychological, familial and professional, results from the fact that the levy.
  

(4) the donor may return before sampling over the consent given.
  


Article 6 prohibits the removal of organs and human tissue from potential donors, as well as to persons deprived of discernment in life.


Article 7 (1) bone marrow Sampling may be carried out and a minor, but on behalf of his brother or sister.
  

(2) the collection of bone marrow from minors can only be made with the consent of the holders of parental authority or of the minor's legal representative. Consent is expressed in front of the county courthouse or the President of the municipality of Bucharest, where appropriate, in whose radius of activity are minor, or before a magistrate, after conducting a survey of the tutelara jurisdiction.
  

(3) the refusal of the minor counter any sampling.
  


Article 8 (1) the collection of tissues and human organs from deceased persons shall take place only if the death was confirmed.
  

(2) the levy shall be made in this case with the written consent of the members of the family or relatives, in the following order: spouse, parent, child, brother, sister times. In the absence of their consent will be taken from the person legally authorized to represent the defunct, in both cases as popular discontent culminated in annex No. 2. (3) if the person in possession of the deceased donor, has expressed in writing, during life, willingness to donate organs and/or tissues, according to the model given in annex. 4, it is not necessary the consent required by paragraph 1. (2) and (4) if the deceased is a minor, the taking of organs and/or tissues may be made only with written consent of their parents or legal representative, in accordance with the specimen contained in annex 4. 3. Article 9 (1) the elements and criteria on the basis of which it makes medical confirmation of brain death, and the data must include the Act of recognition are set out in the annex. 5. (2) doctors find brain death, on the one hand, and those which carry out sampling or organ transplantation, on the other hand, must be part of the functional unit or health services.
  

(3) the transplantation of human organs and tissues from the Health Ministry must be informed of any sampling and organ transplant, according to the law.
  

(4) doctors who did the harvesting of organs or tissue from a deceased person shall be obliged to provide for restoration of its decency.
  


Article 10 (1) the collection of tissues and human organs may be carried out only if consent has been expressed in writing to make such activities, as well as whether the levy under the Act does not compromise a forensic autopsy required under the law.
  

(2) the introduction or removal of tissues, organs, and other elements or products of the human body can only be made on the basis of special authorization issued by the transplantation of tissues and organs of the Ministry of Health, for every situation, without prejudice to national reserve stocks.
  

(3) the donor is alive cannot yield the unique organ or vital.
  

(4) Sampling of single organs can only be made from corpses.
  


Chapter 3 the transplantation of human tissues and organs Article 11 (1) the transplantation of human organs and tissues is carried out for medical purposes and only with the written consent of the receiver, given the present doctor-head that is operated and of two witnesses in accordance with the specimen contained in annex 4. 6. (2) where the recipient is unable to give consent, it may be given in writing in the following order: by the one of the family members, another relative or legal representative.
  

(3) For minors or people lacking in discernment, consent will be given by the parents or, where appropriate, by their legal representative, in accordance with the specimen contained in annex 4. 7. (4) Consent may be given only after the doctor informed the recipient or, where appropriate, the persons referred to in paragraph 1. (2) and (3) any medical risks resulting from transplantation.
  


Article 12 the transplantation of human organs and tissues can be done without consent; 11 if, due to objective circumstances, connected with the family or with legal representatives of beneficiary, which is unable to give consent, you can't get in a timely manner, and the delay would lead inevitably to death, a fact noted by the physician-in-Chief of section and two witnesses, according to the model given in annex. 8. Chapter 4 Sanctions Article 13 violation this law shall entail disciplinary, material, administrative, civil or criminal, as appropriate.


Article 14 the levy or transplantation of tissues and/or human organs without consent, under the present law, constitutes infringement and is punishable with imprisonment from two years to five years.


Article 15 the Act of the person who ordered or carried out sampling when thereby compromising a forensic autopsy, required under the law, constitutes an offence and is punishable with imprisonment from one year to three years.


Article 16 (1) constitutes infringement and is punishable with imprisonment from one year to three years for murdering the person to donate tissues and/or human organs for the purposes of obtaining an advantage.
  

(2) determination of bad faith or coercing a person to donate tissues and/or human organs in any form, constitutes an offence and is punishable with imprisonment from one year to three years.
  


Article 17 and/or Organization making the levy and/or transplantation of tissues and/or human organs, in order to obtain any profit from the sale of tissues and/or organs, constitutes infringement and is punishable by imprisonment from three years to seven years.


Violation of the provisions of article 18, article. 10 para. (2) constitutes infringement and is punishable by imprisonment from three years to six years.


Chapter 5 transitional and final Provisions article 19 (1) taking and discharging and transplantation of human organs is carried out by medical specialty and solely in hospitals approved by the Ministry of health and who are transplant centers.
  


(2) the conditions for approval referred to in paragraphs 1 and 2 hospitals. (1) shall be certified by the College of physicians from Romania and will be established by the regulation authorizing the levy and transplantation of human organs and tissues, approved by order of the Minister of health.
  


Article 20 voluntary Donation during life or written consent for the taking of organs and tissues after death, for the purpose of transplantation, deeply humanitarian act for entitlement to the registration of the person concerned and receiving the donor card, in accordance with the models set out in annexes no. 4 and 9.


Article 21 the cost of investigations, hospitalization, medicines, operations, maintenance and sanitary materials, and postoperative care, it supports by the Hospital where patients are donors and recipients of tissues and human organs, by the health insurance and by the person concerned, as appropriate, in accordance with the law.


Article 22 the business of sampling and transplant tissues and human organs can be done within their own networks of other medical ministries, according to the law.


Article 23 appendices. 1-9 are an integral part of this law.


Article 24 (1) this law shall enter into force on the 60th day following its publication in the Official Gazette of her Country.
  

(2) on the same date, the provisions of art. 129-137 from the section 2, entitled "Therapy with blood and blood derivatives. Taking and transplanting of human organs and tissues ', of chapter V of law No. 3/1978 concerning public health insurance, as well as any other provisions to the contrary are hereby repealed.
  

This law was adopted by the Chamber of Deputies and the Senate sitting in the commune of 24 November 1997, in compliance with the provisions of art. 74 para. (1) and of article 23. 76 para. (2) of the Constitution of Romania.
PRESIDENT of the CHAMBER of DEPUTIES ION DIACONESCU SENATE PRESIDENT PETRE ROMAN Annex 1 DECLARATION the undersigned (a) ... ... ... ... ... , informed and aware of the risks and benefit of transplantation of organs and tissues, consistent with the laws in force, I declare that I agree with the donation of the following organs and/or tissues: ... ... ... .... for transplant, the ... ... ... ... . , care este . . . . . . . . . . . . . . . . (degree of kinship Yes/No).

 

I understand my gesture as a deeply humanitarian act. On my not made any kind of pressures. I agree not to solicit or receive, not me or my family, any kind of reward.

 


 


 

Donor ... ... ... ....

 

Date ... ...

 

Physician-in-Chief of section ... ... ....


Annex 2 DECLARATION I, the undersigned (a) ... ... ... ... ... .., as a husband (wife), parent, child, brother, sister of so-called (so-called) ... ... ... ..., deceased, I declare that I agree to the collection and with the donation of the following organs and tissues: ... ... ... ... ... ...

 

I declare that I understand my gesture as a deeply humanitarian act and I have no pretensions.

 


 


 

Data . . . . . . . .

 


 

The representative of the donor (the degree of kinship) ... ... ... ... ... ...


Schedule 3 DECLARATION the undersigned (a) ... ... ... ... ... ... ... ... ... ...., (father/mother, legal representative) of the so-called (so-called) ... ... ...., minor, informed and aware of the risks and benefit of transplantation of organs and tissues, in accordance with the legal provisions in force relating to the levy and transplantation of human organs and tissues, I declare that I agree to the collection and donation of the following organs and tissues: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...

 

I understand my gesture as a deeply humanitarian act. On my not made any kind of pressures. I agree to receive, not me or my family, any kind of reward.

 


 


 

Data . . . . . . . . . . .

 


 

Tatăl . . . . . . . . . . . . . . . . . . . . .

 


 

Mama . . . . . . . . . . . . . . . . . . . . .

 


 

Legal representative ... ... ... ... ...


Annex 4 DECLARATION I, the undersigned (a) ... ... ... ... .., hoping that after my death may help others sow mine, I declare that I accept that after my death to be harvested and donated the following anatomical organs and tissues ... ... ... ... .., for the purpose of transplantation.

 


 


 

Data . . . . . . . . .

 


 

Signature ... ... ... ... ... ... ...

 


 

Martor . . . . . . . . . . . . . . . . . . .

 


 

Martor . . . . . . . . . . . . . . . . . . .

 

This document is in accordance with the legal provisions in force relating to the levy and transplantation of human organs and tissues.

 


 


 

Commission of transplantation of human organs and tissues ... ... ... ... ... ... ...


Annex 5 DIAGNOSTIC criteria for brain death confirmation i. Diagnosis of brain death is determined on the basis of the following criteria: 1. Clinical Examination:-the State of deep coma, flaccid, areactiva;
-lack of brainstem reflexes (specifically, the absence of reflexes photomotor reflex and corneean).
2. Absence of spontaneous ventilatiei, confirmed by the apnea test (Pa CO/2 60 mm Hg).
3. Two routes carried out 6 EEG hours, stating the lack of cortical electrogenezei.
(Ii) Cause the cerebral death must be clearly established.
III. Exclude other causes reversible which could produce a clinical picture and EEG, a path similar to those of cerebral death (hypothermia, less than 35 degrees C, depresoare of central nervous system, blood pressure hypotension-average less than 55 mm Hg. IV. The diagnosis of brain death will be determined by two different anaesthetic reanimatori or an anesthesiologist whose and a neurologist or neurosurgeon, through two repeated examinations at an interval of 6 hours.


Annex 6 STATEMENT Undersigned (a) ... ... ... ... ... .., informed and aware of the risks and benefit of transplantation of organs and tissues, in accordance with the legal provisions in force relating to the levy and transplantation of human organs and tissues, I declare that I agree with receiving the following organs and/or tissues anatomical: ... ... ... ....

 


 


 

Data . . . . . . . . . . .

 


 

Physician-in-Chief of section ... ... ... ....

 


 

Martor . . . . . . . . . . . . . . . . . . . .

 


 

Martor . . . . . . . . . . . . . . . . . . . .


Annex 7 DECLARATION I, the undersigned (keep) ... ... ... ..., the parents (child, brother, sister, legal representatives) of this (so-called) ... ... ... ...., minor () (the mentally handicapped), (s) and informed (s) about the risks and benefit of transplantation of organs and tissues, in accordance with the legal provisions in force relating to the levy and transplantation of human organs and tissues, I declare (declare) that I am (we are) agree with receiving the following organs and/or tissues anatomical : . . . . . . . . . . . .

 


 


 

Data . . . . . . . . . .

 


 

Semnătura . . . . . . . . . . . . . . . . . .

 


 

Physician-in-Chief of section ... ... ... ...

 


 

Martor . . . . . . . . . . . . . . . . . . . .

 


 

Martor . . . . . . . . . . . . . . . . . . . .


Annex 8 STATEMENT-Commission DECISION of transplantation of human tissues and organs of the Ministry of health has tried, through all the usual means, to get in touch with your family (descendants, legal representatives) this (so-called) ... ... ... ... .., located on the waiting list in order to transplant ... ... ....

 

Whereas this has not been possible in the time available for the avoidance of beneficiary's death, the Commission decided the commencement day of transplant. ....,. ....

 


 


 


 

Data . . . . . . . . . . . . .

 


 


 

Physician-in-Chief of section .... .... .

 


 

Martor . . . . . . . . . . . . . . . .

 


 

Martor . . . . . . . . . . . . . . . .

 

The Board of transplant tissues and human organs: 1 ... ... ... ...

 


 

2. . . . . . . . . . . .

 


 

3. . . . . . . . . . . .

 


 

4. . . . . . . . . . . .

 


 

5. . . . . . . . . . . .


Annex 9-DECISION STATEMENT

 


 


 


 


I, the undersigned (a) ... ... ... ... ... ...., informed and aware of the risks and benefit of transplantation of organs and tissues, in accordance with the legal provisions in force relating to the levy and transplantation of human organs and tissues, I declare that I agree with my enrollment as a volunteer donor to post-mortem inspection for the following organs and tissues: ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ...

 

I agree with my periodic investigation and my free health status, receiving in Exchange the donor card.

 

Under the law, upon my judgment may return at any time, provided that the reversion Act writing to be signed by two witnesses.

 


 


 

Data . . . . . . . . . . . . .

 


 


 

Signature ... ... ... ... ... ...

 


 

Martor . . . . . . . . . . . . . . . .

 


 

Martor . . . . . . . . . . . . . . . .

 

The Board of transplant tissues and human organs: 1 ... ... ... ...

 


 

2. . . . . . . . . . . .

 


 

3. . . . . . . . . . . .

 


 

4. . . . . . . . . . . .

 


 

5. . . . . . . . . . . .

 


 


 


 

Agree with donating organs and tissues mentioned above and with the release of the donor.

 


 


 

Data . . . . . . . . . . .

 


 


 

Registration No. ... ... ... ... — — — — — — — — — — — — —