Handling And Transplantation Of Cells, Tissues And Organs Act

Link to law: https://www.riigiteataja.ee/en/eli/ee/Riigikogu/act/509012015005/consolide
Published: 2015-01-01

Handling and Transplantation of Cells, Tissues and Organs Act1
[RT I 2008, 25, 163 - entry into force 01.01.2009]

Passed 30.01.2002
RT I 2002, 21, 118
Entry into force 04.03.2002, §§ 3 and 17 entered into force 01.09.2002
Amended by the following legal instruments (show)

Passed
Published
Entry into force

05.06.2002
RT I 2002, 53, 336
01.07.2002

19.06.2002
RT I 2002, 63, 387
01.09.2002

18.12.2002
RT I 2002, 110, 660
31.12.2002

13.04.2005
RT I 2005, 24, 179
01.01.2006

15.06.2005
RT I 2005, 39, 308
01.01.2006

19.04.2006
RT I 2006, 21, 159
01.06.2006

20.12.2007
RT I 2008, 3, 22
01.09.2008

04.06.2008
RT I 2008, 25, 163
01.01.2009

30.09.2009
RT I 2009, 49, 331
01.01.2010

26.11.2009
RT I 2009, 62, 405
01.01.2010

22.04.2010
RT I 2010, 22, 108
01.01.2011 enters into force on the date which has been determined in the Decision of the Council of the European Union regarding the abrogation of the derogation established in respect of the Republic of Estonia on the basis provided for in Article 140 (2) of the Treaty on the Functioning of the European Union, Council Decision 2010/416/EU of 13 July 2010 (OJ L 196, 28.07.2010, p. 24 - 26).

23.02.2011
RT I, 25.03.2011, 1
01.01.2014; date of entry into force changed 01.07.2014 [RT I, 22.12.2013, 1]

05.12.2013
RT I, 22.12.2013, 1
01.01.2014

19.02.2014
RT I, 13.03.2014, 4
01.07.2014

19.06.2014
RT I, 12.07.2014, 1
01.01.2015

19.06.2014
RT I, 29.06.2014, 109
01.07.2014, official titles of ministers replaced on the basis of subsection 107³ (4) of the Government of the Republic Act.

Chapter 1 GENERAL PROVISIONS  
[RT I 2008, 25, 163 - entry into force 01.01.2009]

§ 1.  Scope of application

(1) This Act establishes the conditions of and procedure for the handling and transplantation of cells, tissues and organs of human origin and the procedure for state supervision and liability.
[RT I, 13.03.2014, 4 – entry into force 01.07.2014]
(2) This Act applies to the cells, tissues and organs which are removed from a living or deceased donor (hereinafter donor) and are or are not processed in vitro and which come into immediate contact with a human organism by way of topical or systemic transplantation or in any other manner.
(3) This Act does not regulate:
1) the transplantation of gametes and embryos within the meaning of the Artificial Insemination and Embryo Protection Act;
2) the handling of blood products within the meaning of the Blood Act;
3) the transplantation of cells, tissues and organs taken from a person to the person in the course of one surgical procedure;
4) the use of cells, tissues and organs in scientific research if used for purposes other than medical use on human beings.
(4) The provisions of the Administrative Procedure Act apply to the administrative proceedings prescribed in this Act, taking account of the specifications provided for in this Act.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 2.  Definitions

(1) For the purposes of this Act, the handling of cells, tissues and organs means the procurement of cells, tissues and organs, including removal for transplantation purposes, coding, labelling, testing, preservation, processing, packaging, storage, release and distribution.
(2) For the purposes of this Act, the transplantation of cells, tissues and organs means the implantation of cells, tissues and organs removed from a donor into another person (hereinafter recipient) for therapeutic purposes.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 3.  Seeking financial gain

Offering reward or seeking financial gain for the donation of organs or tissues is prohibited, except in the cases provided for in the Artificial Insemination and Embryo Protection Act.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 11 HANDLING AND TRANSPLANTATION OF CELLS, TISSUES AND ORGANS  
[RT I 2008, 25, 163 - entry into force 01.01.2009]

§ 4.  Licence obligation

[RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]
(1) Special medical care providers (hereinafter the handler) must hold an activity licence for the handling of cells, tissues and organs.
[RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]
(2) Special medical care providers who hold an activity licence for the provision of specialised medical care which is issued on the basis of the Health Services Organisation Act have the right to transplant cells, tissues and organs.
[RT I 2008, 25, 163 – entry into force 01.01.2009]
(3) An activity licence grants the handler the right to commence and perform economic activities in the place of business specified in the activity licence.
[RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 41.  Activity licence for handling of cells, tissues and organs

[Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 42.  Obligations of handlers

(1) A handler is required to:
1) guarantee the existence of conditions for the handling of cells, tissues and organs in compliance with this Act and legislation established on the basis thereof and with the requirements of other legislation regulating the handling of cells, tissues and organs;
2) guarantee that the competent person, and in the absence thereof, his or her substitute, has necessary conditions and means for performing his or her duties;
3) guarantee that cells, tissues and organs are handled taking account of the developments in the area of science and technology;
4) guarantee that cells, tissues and organs are distributed, under the conditions and pursuant to the procedure provided by this Act and legislation established on the basis thereof, only to persons with the right to handle or transplant such cells, tissues and organs;
5) maintain records on the handling of cells, tissues and organs and submit a report thereon to the State Agency of Medicines once a year;
6) guarantee the quality of cells, tissues and organs and that their purposeful use is effective and safe for the recipient.
(2) In order to ensure the safety and quality of cells, tissues and organs, the handler shall develop a quality assurance system. The applied quality assurance system must be fully documented and continuously monitored in all its stages. In order to apply the quality assurance system, the necessary resources, such as competent personnel, suitable facilities, equipment and means must be ensured.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 43.  Application for activity licence

(1) An application for activity licence shall be adjudicated by the State Agency of Medicines with the grant of or refusal to grant an activity licence within sixty days after the submission of an application.
(2) In addition to the data provided for in the General Part of the Economic Activities Code Act, an application for activity licence shall separately set out the following data and documents for each object of handling:
1) documents certifying the right of use of the handling facilities;
2) description of the handler’s quality system;
3) description of the handler’s document management system with the work instructions used upon handling and the list and forms of certification documents;
4) organisation chart reflecting the composition and structure related with handling and the list of job descriptions of employees;
5) description of the qualification requirements for the staff engaged in handling and the procedure for training of the staff;
6) the name of the competent person and his or her substitute, a copy of a document certifying qualification, a copy of an identity document and a copy of a document certifying change of name, if necessary, data on professional work experience and training and areas of responsibility and procedure for substitution;
7) the data specified in clause 6) of this subsection on a quality manager if one has been appointed;
8) layout and description of the facilities of the place of handling with the classification of handling facilities and the types of construction and finishing materials;
9) movement plans of the staff and materials related to handling;
10) simplified plan and description of the ventilation system of the handling facilities, types of filters and positioning of airlocks;
11) simplified plan and description of the water system of the handling facilities and quality classes of water;
12) the list of equipment used in the handling process and quality control and the purpose of each equipment;
13) a copy of radiation practice licence if radiation is involved in handling;
14) the plan of handling procedure and short description with references to literary sources used;
15) the list of third parties performing contract works related with handling and the description of the content of contract works;
16) the list of critical materials used upon handling with the specifications;
17) the procedure for cleaning, maintenance and sterilisation of the handling facilities and equipment;
18) description of the procedure for the procurement of cells, tissues and organs;
19) description of the procedure for the release of cells, tissues and organs;
20) quality requirements for the procured and handled cells, tissues and organs;
21) description of the handler’s risk analysis, validation, qualification and calibration procedure;
22) description of the procedure for the withdrawal of cells, tissues and organs and description of the procedure for handling of claims;
23) description of the procedure for waste management.
[RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 44.  Subject of review of activity licence

An activity licence shall be granted if the applicant complies with the requirements provided for in this Act and the legislation established on the basis thereof and other legislation regulating the handling of cells, tissues and organs.
[RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 45.  Secondary conditions of activity licence

The following secondary conditions may be added to an activity licence:
1) particular type of cell, tissue or organ allowed upon handling;
2) particular type of handling operation allowed upon handling;
3) additional requirements for the measures applied upon handling;
4) additional requirements for the health protection measures applied upon commencement and termination of activities.
[RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 46.  Information entered on activity licence

[Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force amended - RT I, 22.12.2013, 1)]

§ 47.  Refusal to issue or renew activity licence

[Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force amended - RT I, 22.12.2013, 1)]

§ 48.  Validity of activity licence

[Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 49.  Change of data and alteration of data contained in activity licence

[Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 410.  Specifications for revocation of activity licence

Upon revocation of an activity licence in part or in full or upon prohibition of economic activities, the State Agency of Medicines may set a term and conditions for the holder of an activity licence for the sale or destruction of the handled materials and submission of reports.
[RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 411.  Renewal of activity licence

[Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 412.  Competent person

(1) For the purposes of this Act, a competent person is a person designated by the handler who complies with the requirements provided for in subsection (2) of this section.
(2) A competent person shall have the following qualifications:
1) an academic degree in medicine or biology or specialities relating to biology acquired in a university or a foreign qualification equal thereto;
2) at least two years of practical work experience in the field of handling cells, tissues and organs.
(3) The obligation of a competent person is to ensure that the handler handlers cells, tissues and organs in accordance with the requirements established in this Act and on the basis thereof.
(4) [Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]
(5) A person may be designated as a competent person by one handler at a time.
(6) The substitute for a competent person must comply with the requirements set for competent persons. The substitute for a competent person shall be designated by the handler.
(7) [Repealed - RT I, 25.03.2011, 1 – entry into force 01.07.2014 (entry into force changed - RT I, 22.12.2013, 1)]

§ 413.  Conditions for handling cells, tissues and organs

(1) The handling of cells, tissues and organs shall be carried out in compliance with good manufacturing practice valid within the European Union.
(2) The minister responsible for the area shall establish, by a regulation, the rules for the handling of cells, tissues and organs which provides for the requirements for the procurement, coding, labelling, testing, preservation, processing, packaging, storage, release, distribution and transportation of cells, tissues and organs and the requirements for the personnel, facilities, equipment and documentation and for the quality assurance system and settling of complaints.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 5.  Medical preconditions for transplantation of cells, tissues or organs

Cells, tissues or organs may be transplanted if the medical investigations performed to the recipient and the results of such investigations give reason to expect successful transplantation, and improvement of the recipient’s quality of life after transplantation.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 6.  Informed consent

(1) For the purposes of this Act, informed consent is consent for removal or transplantation of cells, tissues or organs which is granted on a voluntary basis by the donor or recipient or, in cases provided by law, by their legal representatives.
(2) Consent granted by the persons specified in subsection (1) of this section is valid if they have been provided with appropriate information beforehand as to the purpose and nature of the removal or transplantation of cells, tissues or organs, as well as on its consequences and risks.
(3) Consent for the removal or transplantation of cells, tissues or organs shall be given by the persons specified in subsection (1) of this section expressly and specifically in writing.
(4) A person who has granted consent may freely withdraw it at any time until the performance of the transplantation.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 7.  Conditions for transplantation of cells, tissues or organs into recipient

(1) The transplantation of cells, tissues or organs into a recipient is permitted only with the informed consent of the recipient.
(2) The transplantation of cells, tissues or organs into a recipient with restricted active legal capacity is permitted only with the informed consent of the legal representative of the recipient.
(3) If a recipient with active legal capacity is not able, because of his or her state of health, to express consent, or if the legal representative of a recipient with restricted active legal capacity refuses to grant consent for the transplantation of cells, tissues or organs, or if other circumstances prevent the obtaining of consent from the legal representative of the recipient, the transplantation of the cells, tissues or organs is permitted on the basis of a decision of a doctor on condition that transplantation is the only means of treatment that has the potential to be life-saving for the recipient.
(4) In the case specified in subsection (3) of this section, the medical history of the recipient shall contain a notation concerning the circumstances which prevented the obtaining of consent, and a justification of the necessity of transplantation of a cell, tissue or organ to the recipient.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 8.  Protection of personal data

(1) The processing of personal data of living donors and recipients shall be carried out pursuant to the Personal Data Protection Act.
(2) The personal data of deceased donors shall be protected in the same manner as the personal data of living donors and recipients, and such data shall be disclosed only to the handler and the provider of specialised medical care performing transplantation and to persons who need such data for the performance of their duties arising from law.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 2 REMOVAL OF CELLS, TISSUES AND ORGANS FROM DONORS  
[RT I 2008, 25, 163 - entry into force 01.01.2009]

§ 81.  Donor

(1) A person declared suitable by a doctor arising from the state of health of the person and the requirements provided for in this Chapter may become a donor.
(2) The selection criteria for donors of cells, tissues and organs shall be established by a regulation of the minister responsible for the area.
(3) The handler shall ensure that laboratory testing is carried out upon donation of cells, tissues and organs.
(4) The list of laboratory testing compulsory for donors and the conditions and procedure for the testing shall be established by a regulation of the Minister of Social Affairs.
(5) If necessary, a doctor has the right to carry out supplementary testing to ascertain the suitability of a donor.
(6) In addition to the requirements provided for in this Act, the special requirements provided for in the Artificial Insemination and Embryo Protection Act apply to the donors of gametes.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 9.  Conditions for removal of cells, tissues and organs from living donors

(1) Cells, tissues or organs may be removed from a living donor if:
1) an informed consent for the removal and transplantation of cells, tissues or organs has been granted by the living donor;
2) medical investigations performed on the living donor ascertain that the risk to the life or health of the living donor implied by the removal is not higher than the risk implied by any other surgical operation of the same degree of complexity;
3) the purpose of the removal of the organ is its transplantation for therapeutic purposes into the donor’s descendant, spouse, cohabitee, parent, grandparent or their descendants;
4) there is no suitable organ available from a deceased person for transplantation within a reasonable period of time.
(2) With the informed consent of the living donor, a removed organ may be used for transplantation into another recipient if it is impossible to transplant the organ into the recipient specified in clause (1) 3) of this section.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 91.  Rights and obligations of living donors

(1) A living donor has the rights and obligations of a patient as provided by the Law of Obligations Act.
(2) A living donor has the right to:
1) obtain relevant information regarding the handling and transplantation of cells, tissues or organs;
2) obtain information regarding the dangers arising from the donation of cells, tissues or organs;
3) decline from the donation of cells, tissues or organs at any time if he or she so decides;
4) receive information on his or her state of health, on the results of the tests conducted on his or her cells, tissues and organs, and the suitability for treatment of the cells, tissues and organs donated by him or her;
5) confidentiality of identity.
(3) A living donor is required to:
1) submit his or her personal data and contact information to the handler;
2) disclose all information and circumstances to the handler which, to the donor’s best understanding are relevant to the donation of cells, tissues or organs;
3) inform the handler of circumstances which become known to him or her after donation of cells, tissues or organs, and of any changes which occur in his or her state of health after donation which could affect the suitability for treatment of the donated cells, tissues or organs;
4) confirm the correctness of the submitted information by his or her signature.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 10.  Persons with restricted active legal capacity as donors

(1) Persons with restricted active legal capacity may not be living donors, except on the conditions provided for in subsection (2) of this section.
(2) Persons with restricted active legal capacity may be living donors if:
1) regenerative cells or tissues are transplanted;
2) there is no compatible donor available who has active legal capacity;
3) the recipient is the donor’s descendant, spouse, cohabitee, parent, grandparent or their descendants;
4) consent of the legal representative of the donor and permission of a court for transplantation has been obtained;
5) the potential donor does not object to transplantation.
(3) A county court shall decide on the grant of court permission provided for in clause (2) 4) of this section in proceedings on petition at the request of the legal representative of the donor or the specialised medical care provider performing the removal of a cell or tissue from the donor.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 3 REMOVAL OF CELLS, TISSUES AND ORGANS FROM DECEASED DONORS  
[RT I 2008, 25, 163 - entry into force 01.01.2009]

§ 11.  Conditions for removal of cells, tissues and organs from deceased donors

(1) Cells, tissues or organs may be removed from a deceased donor if:
1) the death of the person has been certified pursuant to the procedure provided for in § 12 of this Act;
2) during lifetime, the deceased donor had expressed a wish to donate cells, tissues or organs for transplantation after his or her death, or if no information is available that the person had objected to it;
3) the removal of the cells, tissues or organs does not impede the conduct of forensic medical examination of a deceased person who died a violent death.
(11) A person may express his or her wish to donate cells, tissues or organs for transplantation after his or her death and certify the fact by digital signature through the health information system.
(2) If no information is available whether a deceased person, during his or her lifetime, had expressed an opinion on the post-mortem removal of cells, tissues and organs for transplantation purposes, the doctor who provided treatment to the deceased person during his or her lifetime is required, if possible, to ascertain through the descendants or ascendants, brothers, sisters, legal representative, spouse or cohabitee of the deceased person the opinion which the person held on the matter during his or her lifetime.
(3) Other persons shall not prohibit the removal of cells, tissues or organs if the deceased person, during his or her lifetime, had consented to the removal or donation after his or her death. Other persons shall not permit the removal of cells, tissues or organs if the deceased person, during his or her lifetime, had refused to donate cells, tissues or organs after his or her death.
(4) The removal of cells, tissues or organs from a deceased person who had died a violent death shall be approved by a forensic pathologist.
(5) The doctors who participate in the removal or transplantation of cells, tissues or organs from a deceased donor shall not be the same doctors who provided treatment to the deceased donor during his or her lifetime or who were members of the committee of doctors who certified his or her death.
(6) A doctor who removes cells, tissues or organs from a deceased donor shall prepare a statement on the removal of the cells, tissues or organs.
(7) The minister responsible for the area shall establish, by a regulation, the standard format for statements on the removal of cells, tissues or organs.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 12.  Certification of death

(1) If cells, tissues or organs of a person will be used for transplantation after the death of the person, the death of the person shall be certified by a committee of doctors with at least two members, who shall prepare a statement on the certification of death.
(2) The standard format for statements on the certification of death shall be established by a regulation of the minister responsible for the area.
(3) The death of a person shall not be certified by a doctor who directly participates in the removal or transplantation procedures of cells, tissues or organs of the deceased person or a doctor whose obligations involve care of the possible recipients of the cells, tissues or organs of the deceased person.
(4) Death shall be certified pursuant to the Establishment of Cause of Death Act.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 13.  Use of cells, tissues or organs removed from deceased donors in international exchange

(1) If suitable recipients for cells, tissues or organs removed from deceased donors cannot be found in Estonia, such cells, tissues and organs may be used in the international exchange of cells, tissues or organs.
(2) If an organ is sent into another state, the handler shall document the reasons why the organ cannot be used on Estonian recipients.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 31 TRACEABILITY OF HANDLING OF CELLS, TISSUES AND ORGANS AND BIOVIGILANCE  
[RT I 2008, 25, 163 - entry into force 01.01.2009]

§ 131.  Traceability of handling of cells, tissues and organs

(1) The handler shall ensure the traceability of cells, tissues or organs from the donor to the recipient and vice versa.
(2) A unique code shall be provided to donated organs and tissues and to cell donation.
(3) The handler shall preserve the information necessary to ensure traceability for at least thirty years as of transplantation of cells, tissues or organs into a recipient.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 132.  Biovigilance

(1) Biovigilance means the provision of information concerning any serious adverse event associated with the handling of cells, tissues and organs and any serious adverse reaction occurring at the time or after transplantation of cells, tissues or organs into a recipient, and the procedure for establishing the reasons thereof.
(2) A serious adverse event means an unfavourable event associated with the handling of cells, tissues and organs which may cause the spread of infectious diseases, may endanger the life of a living donor or a recipient or cause his or her death, require his or her extended hospitalisation, cause long-term loss of capacity for work or a severe or profound disability.
(3) A serious adverse reaction means an undesirable consequence associated with the transplantation of cells, tissues and organs, including the spread of infectious diseases which endangers the life of a living donor or a recipient or causes his or her death, requires his or her extended hospitalisation, causes long-term loss of capacity for work or a severe or profound disability.
(4) The health care provider shall inform the handler which issued the transplanted cells, tissues and organs to the recipient of any post-transplantation serious adverse reaction.
(5) The handler shall inform the State Agency of Medicines of serious adverse events and serious adverse reactions which have become evident upon handling of cells, tissues and organs or after the handling.
(6) The conditions and procedure for biovigilance and withdrawal applied in respect of cells, tissues and organs and the forms of giving notification of serious adverse events and serious adverse reactions shall be established by a regulation of the minister responsible for the area.
(7) Cells, tissues and organs shall be withdrawn immediately after a serious adverse event has been ascertained.
(8) Based on the information forwarded to the State Agency of Medicines, an annual consolidated report concerning the serious adverse events and the serious adverse reactions shall be prepared by the State Agency of Medicines.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 133.  Importation and exportation of cells, tissues and organs

(1) Cells, tissues and organs shall be imported and exported under the conditions and pursuant to the procedure provided for in the Medicinal Products Act.
(2) The handlers shall ensure the compliance of imported and exported cells, tissues and organs with the quality requirements set out in the rules for the handling of cells, tissues and organs established pursuant to § 413 of this Act.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 4 FINANCING  

§ 14.  Financing of handling and transplantation

Handling and transplantation shall be financed by the recipient, unless the obligation to compensate for medical expenses is assumed by the Estonian Health Insurance Fund.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 15.  Compensation of medical expenses out of national health insurance budget

(1) The Estonian Health Insurance Fund shall assume the obligation to compensate health care providers for the medical expenses incurred in connection with the handling and transplantation of cells, tissues and organs to recipients covered by health insurance.
(2) Living donors and recipients covered by health insurance shall be paid benefits for temporary incapacity for work by the Estonian Health Insurance Fund pursuant to the procedure provided in the Health Insurance Act.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 5 STATE SUPERVISION AND REPORTING OBLIGATION  
[RT I, 13.03.2014, 4 - entry into force 01.07.2014]

§ 16.  State supervision

[RT I, 13.03.2014, 4 – entry into force 01.07.2014]
(1) State supervision over compliance with this Act and the requirements of legislation established on the basis thereof shall be exercised by the State Agency of Medicines and the Health Board.
[RT I, 13.03.2014, 4 – entry into force 01.07.2014]
(2) The State Agency of Medicines exercises state supervision over compliance of the handlers of cells, tissues and organs with the requirements for the handling of cells, tissues and organs provided for in this Act and legislation established on the basis thereof, with the exception of compliance with the requirements for the removal of cells, tissues and organs.
[RT I, 13.03.2014, 4 – entry into force 01.07.2014]
(3) The Health Board exercises state supervision over compliance of the specialised medical care providers whose practice involves the removal and transplantation of cells, tissues and organs with the requirements for the removal and transplantation of cells, tissues and organs provided for in this Act and legislation established on the basis thereof.
[RT I, 13.03.2014, 4 – entry into force 01.07.2014]

§ 161.  Special state supervision measures

[RT I, 13.03.2014, 4 – entry into force 01.07.2014]
For the execution of state supervision provided for in this Act, the law enforcement agency may apply the special state supervision measures provided for in §§ 30, 31, 32, 50, 51 and 52 of the Law Enforcement Act on the basis of and pursuant to the procedure provided for in the Law Enforcement Act..
[RT I, 13.03.2014, 4 – entry into force 01.07.2014]

§ 162.  Limit of penalty payment

[RT I, 13.03.2014, 4 – entry into force 01.07.2014]
In the event of failure to comply with a precept, the upper limit of penalty payment imposed pursuant to the procedure provided for in the Substitutive Enforcement and Penalty Payment Act shall be 1600 euros.
[RT I, 13.03.2014, 4 – entry into force 01.07.2014]

§ 163.  Contestation of precept

[Repealed - RT I, 13.03.2014, 4 – entry into force 01.07.2014]

§ 164.  Reporting obligation

(1) The State Agency of Medicines shall submit to the European Commission a report regarding the handling of cells, tissues and organs and the results of state supervision by 7 April 2009 and after that, once in every three years by the same due date.
[RT I, 13.03.2014, 4 – entry into force 01.07.2014]
(2) The State Agency of Medicines shall regularly maintain records on handlers and their activities.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 51 LIABILITY  
[RT I 2002, 63, 387 - entry into force 01.09.2002]

§ 17.  Derivation of financial gain for donation of cells, tissues and organs

Donation of cells, tissues and organs, if the donor or his or her legal representative has derived financial gain for it, is punishable by a fine of up to 300 fine units.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 171.  Violation of requirements for handling of cells, tissues and organs

(1) Violation of the requirements for the handling of cells, tissues and organs is punishable by a fine of up to 300 fine units.
(2) The same act, if committed by a legal person, is punishable by a fine of up to 3200 euros.
[RT I 2010, 22, 108 – entry into force 01.01.2011]

§ 172.  Interference with exercise of state supervision
[Repealed - RT I, 12.07.2014, 1 - entry into force 01.01.2015]

§ 173.  Procedure

(1) [Repealed - RT I, 12.07.2014, 1 - entry into force 01.01.2015]
(2) Extra-judicial proceedings concerning the misdemeanours provided for in § 17 of this Act shall be conducted by police authorities.
[RT I 2009, 62, 405 – entry into force 01.01.2010]
(3) The State Agency of Medicines is the extra-judicial body which conducts proceedings in matters of misdemeanours provided for in §§ 171 and 172 of this Act.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

§ 174.  Implementation of Act

Specialised medical care providers shall apply for an activity licence for the handling of cells, tissues and organs not later than by 1 April 2009.
[RT I 2008, 25, 163 – entry into force 01.01.2009]

Chapter 6 IMPLEMENTING PROVISION  

§ 18.  Entry into force of Act

This Act enters into force on the tenth day after publication in the Riigi Teataja, except for §§ 3 and 17 which enter into force simultaneously with the Penal Code.

1Directive 2004/23/EC of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.04.2004, p. 48–58); Commission Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (OJ L 38, 9.02.2006, p. 40–52); Commission Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, p. 32–50). [RT I 2008, 25, 163 – entry into force 01.01.2009]
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