Law Amending The Law On Transplantation Of Organs, Tissues And Cells

Original Language Title: Закон за изменение и допълнение на Закона за трансплантация на органи, тъкани и клетки

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Name of law
Law amending the Law on transplantation of organs, tissues and cells




Name Bill
Bill amending the Law on transplantation of organs, tissues and cells





Date of adoption
25/07/2012



Number / year Official Gazette
60/2012







DECREE № 296
Pursuant to Art. 98 pt. 4 of the Constitution of the Republic of Bulgaria
DECREE:
To be published in the "Official Gazette" Law amending the Law on transplantation of organs, tissues and cells, adopted by HLI National Assembly on July 25 2012
Released in Sofia on July 31, 2012
President of the Republic: Rosen Plevneliev
stamped with the state seal.
Minister of Justice Diana Kovacheva

Law amending the Law on transplantation of organs, tissues and cells (prom. SG. 83 of 2003 .; amend., SG. 88 2005 pcs. 71, 2006, issue. 36 and 41 of 2009, pcs. 98 2010, pcs. 9 of 2011)
§ 1. In art. 1 made the following amendments:
1. A new paragraph. 2:
"(2) The purpose of the law is to establish rules to ensure standards of quality and safety of organs, tissues and cells for transplantation in human medicine and to ensure high level of protection of human health."
2. Former para. 2 becomes para. 3 and it creates so. 5:
"5. the use of organs for research purposes, unless the bodies are intended for transplantation into human medicine. "
§ 2. In art. 2 para. 5 the word "insurance" is replaced by "donation, insurance characterization" and then the word "preserving" a comma and added "transportation."
§ 3. In art. 4 para. 6 words "and store" are replaced by "preservation and transplantation of organs."
§ 4. In art. 10 para. 2 is repealed.
§ 5. In art. 11, para. 5 following amendments and additions:
1. In item. 3 finally added "in compliance with the Law on Protection of Personal Data."
2. Point 7 is amended as follows:
"7. register, store and analyze information on the details of the donor, the health of the living donor and the recipient at the time of transplantation and post transplantation, and serious adverse events and serious adverse events related to transplantation; ". 3
. At p. 10 after the word "between" insert "European organ exchange organizations, competent authorities of the Member - States of the European Union, other countries - parties to the Agreement on the European Economic Area, the Swiss Confederation and third parties."
4. A t. 16:
"16a. provide every three years a report to the European Commission on all activities on organ transplantation and experience of the transplant; ".
5. Created t. 18, 19 and 20:
"18. gives the European Commission or a Member - State of the Union to another country - party to the Agreement on the European Economic Area and the Swiss Confederation, upon request, information on the requirements for issuing permits and certificates of medical institutions for activities on organ transplantation, as well as information on medical institutions which carry out transplantation;
19. issue permits for import and export of organs, tissues and cells from and to third countries;
20. control organ sharing with Member - States of the European Union, other countries - parties to the Agreement on the European Economic Area and Swiss Confederation, as well as imports from and exports to third countries. "
§ 6. In art. 15, para. 3 after "providing" insert "bodies".
§ 7. In art. 15a para. 1, 'making, handling, processing, storage and / or grafting "are replaced by" Art. 2 ".
§ 8. In art. 15b make the following additions:
1. In para. 1 after the word "expertise" add "characterization" and a comma after the words "intended for transplantation" is added "occurred during transplantation and beyond in donor and recipient" and a comma.
2. In para. 2 after the word "all" is added "authorities". 3
. In para. 3, after the words "destroy" insert "bodies".
§ 9. In art. 16 para. 1 made the following amendments:
1. In the text before item. 1 the words "under Art. 13 para. 1, 2 and 3 for transplantation activities "are replaced by" for these activities. "
2. In item. 1 after the words "treat" insert "and the donor."
§ 10. A Art. 16:
"Art. 16a. Executive Agency for Transplantation finance activities promoting organ donation and expression of reverence and respect for deceased donors and their families. "
§ 11. In art. 24 new paragraph. 9:

"(9) Living organ donors may receive compensation only if it is strictly limited to related donation expenses and loss of income."
§ 12. In art. 36 is amended as follows:
1. Paragraph 3 is amended as follows:
"(3) Imports of organs intended for transplantation from third countries shall be allowed only when they are provided by an institution recognized by the established order in the country that implements all quality requirements safety, traceability, reporting of adverse events and serious adverse reactions and for providing information on the characterization of organs and organ donors established in this law. "
2. In para. 4 the words "the Minister of Health or authorized by the Deputy Minister, which is issued to each donor proposal" shall be deleted.
§ 13. A Art. 36a:
"Art. 36a. (1) Exchange of organs with countries - members of the European Union, other countries - parties to the Agreement on the European Economic Area and Swiss Confederation is subject to the requirements of quality, safety, traceability, reporting of adverse events and serious adverse reactions and for providing information on the characterization of organs and organ donors established in this law.
(2) Exchange of organs with European organ exchange organizations is done after an agreement between the Executive Agency for Transplantation and the organization if the organization ensures compliance with the requirements of quality, safety, traceability, reporting of adverse events and serious adverse reactions and for providing information on the characterization of organs and organ donors established in this law.
(3) The terms and conditions for the sharing of organs under par. 1 and 2 shall be settled in accordance with Art. 36, para. 4. "
§ 14. In art. 37, para. 1, 'the Minister of Health or authorized by the Deputy Minister at the proposal of "shall be deleted.
§ 15. In art. 38, para. 1, 'the Minister of Health or authorized by the Deputy Minister at the proposal of the Director "is replaced by" Executive Director ".
§ 16. In art. 40, para. 1 after the word "expertise" a comma and added "insurance characterization."
§ 17. In art. 41, para. 1 after the words "cells and" insert "and the sharing of organs."
§ 18. In additional provisions be made the following amendments:
1. In § 1:
a) point 3 is amended as follows:
"3. "Body" is part of the human body, formed by different tissues, that maintains its structure and vascular system and can perform physiological functions. Authorities and parts of organs, where they are intended to be used for the same purpose as the entire organ in the human body, while retaining its structure and the vascular system. "
B) the item. 26a:
"26a. "Organ donation" is the donation of organs, tissues and cells for transplantation. "
C) paragraph 31 is amended as follows:
"31. "Saving" is activity on the use of chemical and physical agents, changes in environmental conditions or other means to prevent or retard biological or physical deterioration of organs, tissues and cells to ensure their transplant. "
D) are created item. 39, 40, 41, 42 and 43:
"39. "Characterization of the donor" is an activity of gathering information on potential donor of organs, tissues and cells necessary for assessment of suitability for donation of organs, tissues and cells in order to assess and reduce the risk to the recipient, and to optimize the process of allocating organs.
40. "Characterization of authority" is an activity of gathering information on organ transplant necessary for assessment of suitability for grafting in order to assess and reduce the risk for the recipient, and optimize the process of allocating organs.
41. "European organ exchange organization 'is a public or private non-profit organization dedicated to national or international exchange organizations in which the majority of its members - member of the European Union.
42. "Destruction" is the final destination of the body when it is not used for transplantation.
43. "Insurance" is the process by which the donated organs, tissues and cells become available. "
2. In § 1a finally put a comma and added "and Directive 2010/53 / EC of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ, L 207 / 14 of August 6, 2010). "
Transitional and final provisions
§ 19. The medical institutions that received permits under Art. 36, 37 and 38 until the entry into force of this Act shall operate on the basis of permits issued to them.

§ 20. The first report under Art. 11, para. 5 pt. 16 is provided in the European Commission's Executive Agency for Transplantation within August 27, 2013
law was adopted by the 41 th National Assembly on July 25, 2012 and was affixed with the official seal of the National Assembly .
Chairman of the National Assembly Tsetska Tsacheva
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