Advanced Search

Law No. 113 Of July 11, 2014 Approving Government Emergency Ordinance No. 35/2012 Amending And Supplementing Certain Acts In Healthcare

Original Language Title:  LEGE nr. 113 din 11 iulie 2014 privind aprobarea Ordonanţei de urgenţă a Guvernului nr. 35/2012 pentru modificarea şi completarea unor acte normative în domeniul sanitar

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.
LEGE no. 113 113 of 11 July 2014 on approval Government Emergency Ordinance no. 35/2012 amending and supplementing certain normative acts in the field of health
ISSUER PARLIAMENT
Published in OFFICIAL MONITOR no. 530 530 of 16 July 2014



The Romanian Parliament adopts this law + Article I Approval Government Emergency Ordinance no. 35 35 of 27 June 2012 for amending and supplementing certain normative acts in the field of health, published in the Official Gazette of Romania, Part I, no. 434 of 30 June 2012, with the following amendments and additions: 1. in Article I, point 6, points a) and c) of Article 142 shall be amended and shall read as follows: " a) accreditation-the granting by the National Transplant Agency of the right to carry out activities of donation, procurement, preservation and transplantation of organs, tissues and cells of human origin according to the specificity of each activity, after the determination of the criteria established by order of the Minister of Health Accreditation is made by the National Transplant Agency; .................................................................. c) authorization-document issued by the National Transplant Agency in order to allow the introduction or removal into/from the country of organs, tissues and/or cells of human origin, given that donation, sampling, processing, conservation, storage and transplantation are done in accredited units and/or agreed by the National Transplant Agency; ". 2. In Article I, point 6, after the letter c) of Article 142, a new letter, letter c ^ 1) is inserted, with the following contents: " c ^ 1) special authorization-document issued by the National Transplant Agency in order to allow the introduction or removal into/from the country of placental blood, umbilical cord blood and tissues of human origin for a maximum period of one year, given that the processing, preservation and storage are done in an accredited bank/agreed by the National Transplant Agency; ". 3. in Article I, point 8, points a) and f) of paragraph 1 of Article 144 shall be amended and shall read as follows: " a) the procurement of organs, tissues and cells of human origin, for therapeutic purposes, can be carried out from major persons in life, having full exercise capacity, after obtaining informed, written, free, prior and express consent of the they, according to the form approved by order of the Minister of Health. It is prohibited to take organs, tissues and cells from people without discernment; ..................................................................... f) the donor and the recipient will sign an authentic inscription declaring that the donation is made for humanitarian purposes, is selfless character and does not constitute the object of legal acts and deeds for the purpose of obtaining material or other use, according to the model form approved by order of the Minister of Health; ". 4. In Article I, paragraph 8, paragraph 3 of Article 144 shall be amended and shall read as follows: "" (3) Monitoring of living donors shall include compulsory periodic medical checks which shall be carried out at one month, 3 months, 6 months and one year after-donation, and thereafter if necessary. " 5. in Article I, paragraph 9, letter a) of paragraph 2 of Article 145 shall be amended and shall read as follows: " a) the collection of medullary or peripheral hematopoietic stem cells from minors may be made only with the consent of the minor if he has reached the age of 10 years, and with the written consent of the legal protector, respectively of his parents, guardian or of the curator, according to the form approved by order of the Minister of Health. If the minor has not reached the age of 10, the sampling can be done with the consent of the legal protector; ". 6. In Article I, point 11, paragraphs 4 and 5 of Article 147 shall be amended and shall read as follows: " 4. the removal of organs, tissues and/or cells from deceased persons shall be made only with the written consent of at least one of the major members of the family or relatives, in the following order: surviving spouse, parents, descendants, brother/sister, other relative in collateral line up to the fourth degree inclusive, according to the model form approved by order of the Minister of Health; 5. the procurement can be done without the consent of the family members if, during their lifetime, the deceased person has already expressed the option in favour of donation, through a notarial act of consent for sampling and enrolment in the National Register of organ, tissue and cell donors, according to the form approved by order of the Minister of Health; ". 7. In Article I, paragraph 12, paragraphs 2, 3, 8, 9, 11, 13 and 14 of Article 148 shall be amended and shall read as follows: "" (2) The distribution of organs, tissues and cells of human origin, with the exception of hematopoietic stem cells from unrelated donors, taken at national level shall be carried out by the National Transplant Agency, depending on the established rules. of this on the allocation of organs, tissues and cells of human origin within the transplant system in Romania. ((3) Under the conditions under which there is no recipient compatible with the available human organs, tissues and cells of human origin, they may be assigned to the international transplant network, on the basis of an authorization issued by The National Transplant Agency, according to the form approved by order of the Minister of Health. .................................................................. (8) The sampling of organs, tissues and cells of human origin, in forensic cases, is done only with the consent of the coroner and must not compromise the result of the forensic autopsy, according to the form model approved by order of Health Minister ((9) The introduction or removal from the country of organs, tissues, cells of human origin, with the exception of hematopoietic stem cells, is made only on the basis of the authorization issued by the National Transplant Agency, according to the form approved by order of the Minister of Health, according to customs .................................................................. (11) The reporting of authorizations issued by the National Transplant Agency to the Ministry of Health is made annually, within the activity report or at the request of the Minister of Health .................................................................. (13) Health facilities accredited and implementing the National Transplant Program may settle funeral services and/or transport of the corpse, in the case of donors from which organs and/or tissues and/or cells were taken, within the limits of the funds assigned. (14) After each organ sampling, tissues and/or cells from the corpse donors will be completed, with the data from the time of sampling, the Fisa for the declaration of the donor and the Organ Sampling Sheet, according to the form model approved by order of the Minister of Health. 8. In Article I, point 13, Article 152 is amended and shall read as follows: "" Art. 152. -By exception to the provisions of art. 150, in the case of minors or persons deprived of exercise capacity, consent will be given by parents or other persons who have the status of their legal protector, as the case may be, according to the form model approved by order of Minister of Health 9. In Article I, paragraph 17, paragraphs 1 to 4 and 6 of Article 160 shall be amended and shall read as follows: "" Art. 160. -(1) Sampling and transplantation of organs, tissues and cells of human origin shall be carried out by specialized physicians, in public or private health facilities. The list of accredited public or private health facilities will be published on the website of the National Transplant Agency and will be updated permanently. (2) Accreditation in the field of transplantation of public or private health facilities has validity of 5 years. Any modification of the initial accreditation criteria occurred within the accredited units shall be notified within 5 days to the National Transplant Agency for reaccreditation. (3) The accreditation criteria of the health facilities provided in par. (1) are proposed by the National Transplant Agency and approved by order of the Minister of Health, in accordance with European legislation in the field. (4) The National Transplant Agency may suspend the activity or revoke the accreditation, if following the assessments carried out by the representatives of the National Transplant Agency, as well as the notification of the health inspectors it is found that that health unit does not comply with the legal provisions in force ................................................................... (6) Health facilities accredited for processing and/or use of tissues and/or cells shall keep a record of their activity, including the types and quantities of tissues and/or cells procured, tested, preserved, stored, distributed or scrapped, and the origin and destination of these tissues and/or cells for human use. They will send an annual activity report to the National Transplant Agency, which will be published both on its website and on the website of the National Transplant Agency. The provisions of this paragraph shall also apply in the case of organ transplantation. " + Article II (1) Within 60 days from the entry into force of this Law, the Minister of Health hereby approves the forms of forms for the application of the provisions of Title VI of Law no. 95/2006 on health reform, with subsequent amendments and completions. (2) On the date of entry into force of the order provided in par. ((1) Annexes no. 1 1-13 of Law no. 95/2006 , as amended and supplemented, shall be repealed. + Article III On the date of entry into force of the order provided for in II, references to the Annexes referred to in art. II para. (2) shall be considered to be made on the forms specified in art. II para. ((1). This law was adopted by the Romanian Parliament, in compliance with the provisions of art. 75 75 and art. 76 76 para. (1) of the Romanian Constitution, republished. CHAMBER OF DEPUTIES PRESIDENT VALERIU-STEFAN ZGONEA SENATE PRESIDENT CĂLIN-CONSTANTIN-ANTON POPESCU-TARICEANU Bucharest, July 11, 2014. No. 113. -------