Organ Transplant Law - Otpg And Amendment Of The Federal Law On Hospitals And Sanatoria, Of The Medicines Act, The Tissue Safety Act And The Federal Act On The...

Original Language Title: Organtransplantationsgesetz - OTPG sowie Änderung des Bundesgesetzes über Krankenanstalten und Kuranstalten, des Arzneimittelgesetzes, des Gewebesicherheitsgesetzes und des Bundesgesetzes über die ...

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108. Federal law establishing a federal law on the transplantation of human organs (organ transplant law-OTPG) and the federal law on hospitals and spa institutions, the pharmaceutical law, tissue safety law and The Federal Act on the Health of Austria GmbH is amended

The National Council has decided:

Article I

Federal law on the transplant of human organs (organ transplant law-OTPG)

table of contents

Federal Law on the Transplantation of Human Organs

(Organ Transplant Act-OTPG)

Section 1
Subject matter, scope and definitions

§ 1.

Subject matter

§ 2.

Scope

§ 3.

Definitions

Section 2

Principles of organ donation

§ 4.

Principles of donation

Section 3
Protection of the donor and recipient as well as the selection and assessment of donors

§ 5.

Removal of organs of deceased for transplantation purposes

§ 6.

Opposition Register

§ 7.

Obligation of withdrawal units

§ 8.

Live End

§ 9.

Aftercare for live donors/live donors

Section 4
Quality and safety of organs

§ 10.

Procedural instructions

§ 11.

Organ and donor characterisation

§ 12.

Transport of organs

Section 5
Traceability, organ vigilance, reporting

§ 13.

Traceability

§ 14.

Organvigilance

§ 15.

Records and reports

§ 16.

Automation-supported traffic

6.

§ 17.

International organ exchange

Section 7

§ 18.

Administrative penalty provisions

8. Section

§ § 19. to 21.

Final provisions

Section 1

Subject matter, scope and definitions

Subject matter

§ 1. This federal law defines the conditions under which human organs may be removed and used for transplant purposes.

Scope

§ 2. (1) This federal law applies to the donation, testing, characterisation, provision, preservation, transport and transplantation of organs intended for transplantation into the human body.

(2) This federal law does not apply to the use of organs for research purposes, provided that they are not intended for transplantation into the human body.

Definitions

§ 3. In the sense of this federal law, the term:

1.

"provision" means a process by which donated organs are made available;

2.

"withdrawal unit" means a hospital or a mobile team, the institution of which is responsible for carrying out or co-ordinating the provision of organs;

3.

"Recipient"/"recipient" means the person receiving an organ transplant;

4.

"disposal" means the final whereabout of an organ if it is not used for transplantation;

5.

"conservation" means the use of chemical substances, modified environmental conditions or other means to prevent or delay a biological or physical impairment of organs from removal to transplantation;

6.

"Organ" means a differentiated part of the human body, which consists of different tissues and maintains its structure, vascularization and ability to perform physiological functions with distinct autonomy. Parts of organs shall also be considered as organs if their function is to be used in the human body for the same purpose as the whole body, while maintaining the requirements of structure and vascularisation;

7.

"Organ characterisation" means the collection of relevant information on the properties of an organ which is required to assess its suitability for transplantation in order to carry out a proper risk assessment, the risks for to minimise the recipient/recipient and to optimise the allocation of organs;

8.

"Traceability" means the possibility of locating and identifying the organ at each stage from donation to transplantation or disposal, including the possibility of the donor/donor, the removal unit and the to identify recipients in the transplant centres and to locate and identify all relevant non-personal information about products and materials with which the organ comes into contact;

9.

"serious incident" means any undesirable and unexpected event associated with any link of the chain from donation to transplantation, which could lead to the transmission of an infectious disease, to death or to conditions which may result in the transmission of are life-threatening, have a disability or a loss of function, or have a hospitalization or morbidity, or extend;

10.

"serious adverse reaction" means any unintended reaction, including an infectious disease, in the live donor/live donor or recipient (s), with any link in the chain from the donation to the In the case of transplantation, the patient may be associated with a disability or loss of function, or may have a hospital stay or morbidity, or may have a disability or morbidity;

11.

"donation" means any provision of organs for transplant purposes;

12.

"donor"/"donor" means any person who expresses the will to donate organs to the staff working in the case of a withdrawal unit, and any deceased person, to the institution for transplant purposes;

13.

"donor characterisation"/"donor characterisation" means the collection of the relevant information on the characteristics of the donor/donor, which are required to assess their suitability for organ donation, in order to obtain a proper to carry out risk assessment, to minimise the risks to the recipient (s) and to optimise the allocation of organs;

14.

"Transplantation" means a method by which certain functions of the human body are to be restored by the transfer of an organ from one donor/donor to one recipient (s);

15.

"transplantation centre" means a hospital where the transplantation of organs is carried out and the authorization granted by the respective state government in accordance with the relevant State Sickness Fund Act includes this;

16.

"procedural instruction" means a written instruction which describes the steps of a specific procedure, including the materials and methods to be used and the expected final result.

Section 2

Principles of organ donation

Principles of donation

§ 4. (1) Institutions may only be donated voluntarily and free of charge.

(2) It is prohibited to provide a financial gain or equivalent advantage to donors/donors of organs or third parties for a donation. Legal transactions that contravene this prohibition shall be void.

(3) (3) (1) and (2) are the granting of appropriate compensation for living donors/donors in respect of earnings and other expenses caused by the donation and related medical measures, and the granting of Compensation for damages in the event of damage resulting from the donation and other medical measures associated with it shall not be countered.

(4) Advertisements for the need for organs or their availability shall not include any reference to financial gain or comparable benefits.

(5) Institutions may not be the subject of legal transactions aimed at profit.

(6) Data on the person of donor/donor or recipient/recipient are of the right of information according to § 26 of the Data Protection Act 2000, BGBl. I No 165/1999, except.

Section 3

Protection of the donor and recipient as well as the selection and assessment of donors

Removal of organs of deceased for transplantation purposes

§ 5. (1) It is permissible to remove deceased individual organs in order to save the life of another human being or to restore the health of another person by transplant. The assessment and selection of the organs shall be carried out in accordance with the state of medical science. The removal is inadmissible if the doctors have a declaration with which the deceased or, in the case of his/her death, her/his legal representative expressly rejected an organ donation. A statement shall also be made if it is registered in the register of opposition held at health Austria GmbH. The removal must not lead to a demise of the corpse, which is injuring the piety.

(2) The removal may only be carried out if a doctor/doctor who is entitled to exercise his/her self-employed professional practice has found the death. This doctor may not carry out the removal or the transplant. You/He may not be involved in or affected by these interventions.

(3) The removal may only be carried out in or by means of removal units which are subject to the requirements of § 16 paragraph 1 lit. a and c to g of the federal law on hospitals and courting institutions (KAKuG), BGBl. No 1/1957.

(4) The removal of organs and organ parts of deceased for the purpose of transplantation shall take precedence over the removal of cells and tissues for use in humans. The availability of organs and organ parts of deceased for transplantation must not be impaired by the removal of cells and tissues for use in humans.

Opposition Register

§ 6. (1) The register of opposition held by Health Österreich GmbH (Section 5 (1)) serves the purpose of documenting, at the request of persons who expressly refuse an organ donation, the objection in order to take effect on the removal of organs effectively prevent.

(2) The declaration of the objection shall be subject to the consent of the processing of personal data. The declaration is to be signed by the person who expressly opposes an organ donation.

(3) In the Register of Appeal, the following data may be processed by the person who has declared a contradiction or for which a contradiction has been declared: name, date of birth, sex, social security number, address, where applicable the name of the Legal representative.

(4) A confirmation of registration is issued by the health Austria GmbH concerning the registration. The opposition to the removal of organs and the associated consent to the processing of the data in the opposition register can be revoked at any time in writing. In this case, the registration shall be deleted immediately.

(5) Health Österreich GmbH has to take data security measures in accordance with § § 14f Data Protection Act 2000 for the operation of the opposition register. A data security concept, in which all the data security measures necessary for the operation of the opposition register are to be arranged, shall be drawn up, which shall be binding for all employees of the health Austria GmbH is.

(6) The Managing Director has to assign the access rights for the authorized employees of the health Austria GmbH individually. Access rights to the opposition register may only be granted if the persons entitled to access have been informed of the provisions in accordance with Section 15 of the Data Protection Act 2000 and the Data Security Concept according to paragraph 5.

(7) Access rights shall be excluded from the further exercise of their access rights if they no longer require them to perform the tasks assigned to them or they do not use the data according to their intended purpose. .

(8) In the case of data processing in accordance with para. 2 and 3, the use of the name and the area-specific personal identifier GH and AS (§ 10 paragraph 2 E-Government-Gesetz, BGBl, BGBl. I n ° 10/2004).

(9) Health Austria GmbH is entitled to request information at the Federal Institute of Statistics Austria on the date of death and the cause of death of persons whose data are processed in the register.

(10) The Managing Director shall ensure that the identity and the role of the persons entitled to access are identified and recorded in accordance with the state of the art in the case of each access.

(11) The Managing Director shall ensure that appropriate measures taken into account in accordance with the relevant state of the art are taken into account in accordance with § 14 (1) of the DSG 2000 in order to destroy or alter the situation. to prevent the data from being destroyed (viruses) and to prevent destruction, alteration or retrieval of the data by unauthorized users or systems.

(12) All data use operations carried out in the area of the opposition register, such as entries, changes, queries and transfers, must be recorded.

Obligation of withdrawal units

§ 7. Each withdrawal unit shall be obliged to ensure, before the removal of organs at the deceased person by means of a request to the health Austria GmbH, that there is no registration of an objection in the opposition register.

Live End

§ 8. (1) An organ donation of persons who are the 18. They have not yet completed their life year, is inadmissible.

(2) The assessment and selection of donors shall be carried out according to the status of medical science.

(3) The removal may only be carried out if the live donor comprehensively and in a manner comprehensible to the donor/donor about the planned removal, the purpose of which is to be understood by the donor/doctor before taking the product. the associated risks and consequences, in particular any further studies necessary after the removal, the analytical tests to be carried out and the consequences of abnormal findings, the therapeutic purpose of the institution taken, the potential benefits for the recipient (s) to be expected Chances of success, on measures to protect the donor/donor and her/his data as well as on existing confidentiality obligations, and the donor/donor consent to the removal and testing as well as to the further use of the institution. The Enlightenment has also pointed to the need for regular medical checks on donor protection. The Enlightenment must be done in writing as well as orally. Any omission of this medical enlightenment shall be legally ineffective.

(4) The consent must be recorded in written form. The consent must be dated and signed by the donor/donor. If the donor/donor is not in a position to receive the signature, the consent must be given to three witnesses who are not involved in the intervention or who have a personal interest in the donation of the organ and to confirm the consent of the person concerned by his/her signature. The consent can be revoked at any time in writing or orally.

(5) Prior to the removal of organs, the live donor shall be subjected to the necessary examinations to assess the physical and mental risks to their health. A withdrawal must not be carried out if this poses a serious risk to the life or health of the donor/donor. If, according to the state of medical science, this is indicated according to the type of donation for the protection of the donor/donor, this is to be offered regular medical checks after the donation.

Aftercare for live donors/live donors

§ 9. In any case, the collection unit is obliged to offer live donors a post-inspection three months after the donation. After that, withdrawal units in the state of the medical science must remind the living donor in writing that they are concerned with the protection of the interior of the donor/donor protection of a medical check-up. , For this purpose, the sampling unit has to produce an individual, risk-based after-care plan for each and every living donor/living donor and hand it out to the donor/donor.

Section 4

Quality and safety of organs

Procedural instructions

§ 10. Health Österreich GmbH has made scientific recommendations for all phases from donation to transplantation or disposal, as well as for follow-up care, with the involvement of the advisory board set up by the Advisory Council on transplant questions. to the donor/donor and to publish it on the Internet. These procedures have in particular been

1.

the verification of the identity of the donor/donor,

2.

the examination of the consent of the live donor/living donor or the absence of a contradiction of a deceased person,

3.

the review of the collection of the information necessary for the selection and assessment of the donor/donor and the transmission of such information to the transplant centre, as required by this provision,

4.

of the rules on the allocation of organs to be in accordance with the status of medical science, in particular on the basis of success and urgency for appropriate patients, taking into account the criteria of the Foundation Eurotransplant International,

5.

the provision, preservation, packaging and labelling of organs,

6.

the transport referred to in § 12,

7.

ensuring the traceability of organs,

8.

the reporting of serious incidents and serious adverse reactions and the measures taken pursuant to Article 14 of this Directive and the measures taken in accordance with Article 14 of the Directive.

9.

of the individual, risk-based after-care plan according to § 9

to be included.

Organ and donor characterisation

§ 11. (1) In order to ensure the best possible protection of the recipient/recipient, the removal has to be preceded by a characterization of both the organ and the donor/donor. To this end, sampling units shall be required to: Annex A shall collect data on the organ to be removed and the donor (s) of the organ to be removed. The in Appendix B shall be made only on the basis of the decision taken by the sampling unit, taking into account their availability and the particular circumstances of the individual case.

(2) If, due to a serious risk to life or health, the expected benefit to the recipient/recipient is greater than the risks arising from incomplete data, an institution may, by way of derogation from paragraph 1, also apply to the Transplantation, if not all of the Annex A , the minimum particulars shall be available.

(3) The information collected for the evaluation and selection of the donor/donor shall be transmitted immediately from the sampling unit to the transplant centre.

(4) The tests required for the evaluation and selection of the donor/donor shall be carried out by laboratories which have the appropriate personnel, spatial, operational and technical equipment according to the state of the art in science and technology. .

Transport of organs

§ 12. (1) In compliance with the procedures described in § 10 Z 6, the person carrying the organ transport shall ensure the integrity of the organs during transport and an appropriate transport time.

(2) The transport containers used for the transport of the organs shall be provided with the following information:

1.

the name of the hospital where the provision was made and the name of the collection unit by which the provision was made, including its address, telephone number and e-mail address;

2.

Name of the transplant centre, including its address, telephone number and e-mail address;

3.

an indication that the container contains an organ, stating the nature of the institution and, where appropriate, its link or legal system, and the inscriptions "PRUDENCE TO HANDLE" and "HANDLE WITH CARE";

4.

Recommended transport conditions, including instructions for the appropriate ambient temperature and position of the container.

(3) Each institution transported shall be accompanied by a report on the characterisation of organs and donors/donor characterisation.

(4) Any person involved in the transport of an institution shall be bound to secrecy over all the facts entrusted to her in the performance of her duties or aware of which there is a legitimate interest in confidentiality, provided that: is not already subject to such a duty of confidentiality in accordance with other legal or service law provisions.

Section 5

Traceability, organ vigilance, reporting

Traceability

§ 13. All participants in the transplant chain have to ensure that every provision and every transplant of an organ is fully comprehensible.

Organvigilance

§ 14. (1) serious incidents which may affect the quality and safety of organs and which may be attributed to the provision, characterisation, preservation or transport of the organs and serious undesirable effects; Reactions which may be observed during or after transplantation and which may be attributed to the provision, characterization, preservation or transport of the organs are immediately available to the Foundation Eurotransplant International and, where appropriate, to report to the transplant centre concerned. In addition, the above serious incidents and serious adverse reactions are to be reported within three working days of the Austrian health service GmbH.

(2) The measures taken in the event of a serious incident or a serious adverse reaction shall be reported within three working days of health Austria GmbH.

(3) In the event of a serious incident or a serious adverse reaction, Austria GmbH shall, if necessary, notify the respective regional governor who, in accordance with the sanitary supervision referred to in § § 60 et seq. of the Federal Act on hospitals and health-care institutions, BGBl. No 1/1957, has to do so.

(4) The Federal Minister of Health may, by means of a regulation, adopt detailed rules on the procedures to be followed in the reporting of serious incidents and serious adverse reactions, as well as the nature and scope of such notifications.

(5) Health Österreich GmbH and the Federal Office for Health and Safety (Bundesamt für Sicherheit im Healthcare) have an exchange of information according to paragraphs 1 to 4 and of the information from the tissue vigilance reports according to the tissue safety law, BGBl. I n ° 49/2008.

Records and reports

§ 15. (1) Pick-up units and transplant centres have reports on the number of potential and diagnosed deceased donors/donors, number of donors/donors in a quarterly manner in anonymized form as well as the nature and quantity of organs provided and transplanted or disposed of in the previous months. These data shall be transmitted immediately upon request to the Federal Minister for Health and the respective Land Governor.

(2) Health Österreich GmbH shall publish an annual report on the activities of all withdrawal units and transplant centres by 31 May of the following year at the latest, which shall in particular include the number of presumers and centres of transplantation. to include live donors and donors, as well as the type and quantity of organs that have been provided and transplanted or disposed of.

(3) In the course of the Federal Ministry of Health of the European Commission, Health Austria GmbH has published a report on the activities of the collection units and transplant centres every three years, by 27 August 2013 and every three years thereafter. To submit the framework of this Federal Act.

Automation-supported traffic

§ 16. Health Österreich GmbH is authorized to collect data according to § 14 in the or for the automation-supported data traffic and to transmit these data to

1.

the Federal Ministry of Health,

2.

the European Commission,

3.

competent authorities of other Contracting Parties to the Agreement on the European Economic Area, and

4.

the Foundation Eurotransplant International.

6.

International organ exchange

§ 17. (1) Transplant centres may only introduce organs from third countries for the purpose of transplantation, if the organ can be traced back to the donor/donor and it is ensured that quality and safety standards are met , which are at least equivalent to those of this Federal Law.

(2) The Federal Minister of Health may, by means of a regulation, lay down detailed rules on the characterization of organs and donors, as well as on the information required to ensure traceability with regard to the international exchange of organs, provided that this is necessary in the interests of the quality and safety of organs.

Section 7

Administrative penalty provisions

§ 18. (1) Who

1.

Contrary to § 11, para. 1, no characterization of the organ or the donor is carried out before the removal or in the case of the donor Annex A shall not collect data relating to the institution to be removed and the donor/donor thereof,

2.

Contrary to Section 11 (3), the information collected is not immediately transmitted to the transplant centre,

3.

is in breach of the obligation under Section 11 (4),

4.

in the case of transport, does not comply with the requirements of § 12;

5.

is in breach of the obligation of confidentiality in accordance with Section 12 (4),

6.

the reporting obligations under Section 14 (1) and (2) shall not be complied with; or

7.

in the case of a collection or transplant centre in breach of the reporting obligation pursuant to Article 15 (1),

provided that the action does not comply with the facts of a criminal offence under the jurisdiction of the courts, an administrative surrender and a fine of up to EUR 7 270.

(2) Who

1.

Donors/donors of institutions or third parties contrary to § 4 para. 2 a financial gain or comparable advantage shall be provided or promised,

2.

in the case of the need for institutions or their availability in accordance with Article 4 (4), advertise or achieve a financial gain or equivalent advantage,

3.

Contrary to Article 4 (5), legal transactions are concluded, the institutions are subject to the subject matter and are directed to profit,

4.

, contrary to § 5 (1), a withdrawal is made, although there is a declaration with which the deceased/deceased or, in the case of his/her death, her/his legal representative expressly refused an organ donation,

5.

Contrary to § 5, para. 1, a demise of a corpse violates the piety of piety,

6.

is in breach of Section 5 (3),

7.

Contrary to § 7 prior to the removal of organs at the deceased person, no request is made with the Austrian health insurance company health insurance GmbH,

8.

contrary to Article 8 (1), a withdrawal shall be carried out by a person who is 18. Year of life has not yet been completed,

9.

carry out a withdrawal without the consent of the live donor/live donor or without the medical education provided for in section 8 (3),

10.

, contrary to Section 8 (5), a withdrawal is carried out, although this poses a serious risk to the life or health of the donor/donor,

11.

in breach of § 13, or

12.

contrary to § 17 para. 1 organs from third countries for the purpose of transplantation, without the organ being able to be traced back to/from the donor/donor or ensuring that quality and safety standards have been complied with, the at least equivalent to this federal law,

, provided that the action does not comply with the facts of a criminal offence under the jurisdiction of the courts, an administrative surrender and a fine of up to EUR 36 340. The same applies if, according to paragraph 1, a serious danger to life and health has been created or if the offender has already been punished twice in accordance with paragraph 1.

(3) In the cases referred to in paragraph 2, the attempt shall also be punishable.

8. Section

Final provisions

§ 19. Insofar as other federal laws are referred to in this Federal Act, these are to be applied in their respectively applicable version.

§ 20. The Federal Minister of Health is responsible for the enforcement of this federal law.

§ 21. This federal law provides for Directive 2010 /53/EU on quality and safety standards for human organs intended for transplantation, OJ L 327, 22.3.2010, p. No. 14., as amended by the corrigendum OJ L 207, 6.8.2010, p. No. OJ L 243 of 16.09.2010 p. 68.

Article II

Amendment of the Federal Act on hospitals and health care institutions

Federal law on hospitals and health care institutions, BGBl. No. 1/1957, as last amended by the Federal Law BGBl. I No 147/2011, shall be amended as follows:

Part 1

(Basic provisions)

1. In Section 1 (1) (4), the word shall be "or" replaced by a dash, at the end of paragraph 1, Z 5, the word "or" and the following Z 6 shall be added:

" 6.

on the provision of organs for the purpose of transplantation "

2. In § 2b para. 2 Z 3 the quote shall be "§ 6 para. 1 lit. b" by quoting "§ 6 para. 1 lit. d" replaced.

3. In accordance with § 3d, the following § § 3e and 3f shall be inserted together with the headings:

" Pick Units

§ 3e. (1) Withdrawal units are legally approved hospitals, which are the provision of organs within the meaning of the Organ Transplant Act, BGBl. I No 108/2012, as amended, carried out or co-ordinated.

(2) The removal unit may also be used by mobile teams carrying out or coordinating the removal of organs from the premises of other hospitals.

(3) The carrier of the sampling unit shall ensure that, within the framework of the quality system, at least standard operating procedures (SOPs), guidelines, training or reference manuals, as well as records of assurance the traceability of organs. The documentation shall have a complete traceability of the transplant chain from donation to transplantation or disposal according to the state of the scientific community, insofar as this falls within the remit of the collection unit, and is to be kept for a period of at least 30 years.

Transplant centres

§ 3f. (1) Transplant centres are hospitals which carry out transplants within the meaning of the Organ Transplant Act and whose approval is granted by the respective state government in accordance with the respective State Hospital Act (Landeskrankenanstaltengesetz). The range of services includes.

(2) Before carrying out a transplant, the transplant centre must ensure that the organs and donor characterisation as well as the conservation and transport of the organs removed are subject to the provisions of the Organ transplant laws have been observed.

(3) The institution of the transplant centre shall ensure that, within the framework of the quality system, at least standard operating procedures (SOPs), guidelines, training or reference manuals, as well as records of To ensure traceability of organs. According to the state of science, documentation has a complete traceability of the transplant chain from donation to transplantation or disposal, insofar as this falls within the remit of the transplant centre, , and shall be kept for a period of at least 30 years. "

4. In § 6 para. 6, the quote becomes " 1 lit. a and b as well as d and e " by quoting " 1 lit. a and b and f and g " replaced.

5. In § 9 para. 1, the quote shall be "§ 62a" by quoting " § 5 of the Organ Transplantation Act, BGBl. I No 108/2012 " replaced.

6. In § 10 paragraph 1 Z 6 the quote shall be "§ 62a" by quoting " § 5 Organ Transplantation Act, BGBl. I No 108/2012 " replaced.

7. In § 10 paragraph 1 Z 8 the quote shall be "§ 62a (1)" by quoting " § 5 (1) Organ Transplantation Act, BGBl. I No 108/2012 " replaced.

Part 2

(Federal Law Applicable directly)

8. The following sentence shall be added to the final part of Section 60 (4):

"The review shall also include the review of the drug supply pursuant to section 20 (2)."

9. § § 62a to 62e are deleted.

10. The previous main piece G is given the name "Main piece F" , the previous § § 62f and 62g are given the name "§ 62a" and "§ 62b" .

11. According to Section 65 (4i), the following paragraph 4j is added:

" (4j) The state legislation has the implementing provisions for § § 1, 2b (2) Z 3, 3e, 3f and 6 (6) in the version of the Federal Law BGBl. I n ° 108/2012 within six months. '

Article III

Amendment of the Medicines Act

The Drug Law, BGBl. No. 185/1983, as last amended by the Federal Law BGBl. I n ° 146/2009, shall be amended as follows:

In § 1 para. 3 Z 10 lit. b does not use the word "and" , in Section 1 (3) (11), the point shall be given by the word "and" , and the following Z 12 is added to Article 1 (3):

" 12.

Organs or parts of organs within the meaning of the Organ Transplant Act, BGBl. I No 108/2012. '

Article IV

Amendment of the tissue safety law

The tissue safety law, BGBl. I n ° 49/2008, as last amended by the Federal Law BGBl. I n ° 63/2009, shall be amended as follows:

1. In Section 4 (5), the quote shall be: " § 62a of the Federal Act on hospitals and health care institutions, BGBl. No. 1/1957, " by quoting " § 5 of the Organ Transplantation Act, BGBl. I No 108/2012, " replaced.

(2) The following paragraph 5a is inserted in accordance with Article 4 (5):

" (5a) Pick-up facilities are obliged to ensure, prior to the removal of cells or tissues at the deceased by a request to health Österreich GmbH, that no registration of an objection in the opposition register (§ 6 "Organ Transplant Act").

3. § 35 para. 2 Z 6 reads:

" 6.

is in breach of the obligations under Section 4 (5) or (5a), "

Article V

Amendment of the Federal Act on Health Austria GmbH

The Federal Act on Health Austria GmbH (GÖGG), BGBl. I n ° 132/2006, as last amended by the Federal Law BGBl. I n ° 77/2008, shall be amended as follows:

1. § 4 (1) Z 6 reads:

" 6.

Coordination and implementation of projects in the area of organ and stem cell transplantation, organ-care and reporting in the area of organ transplantation, "

2. § 4 (1) Z 8 reads:

" 8.

Management of the IVF register in accordance with § 7 of the Federal Act, which establishes a fund to finance in-vitro fertilisation (IVF-Fonds-Gesetz), BGBl. I No 180/1999 idF BGBl. I n ° 3/2010, of the opposition register in accordance with § 6 of the Organ Transplantation Act, BGBl. I n ° 108/2012, and other registers in the field of health, in accordance with special legal provisions, '

Fischer

Faymann