Law on the donation, removal and transfer of organs and tissues (Transplant Act-TPG)

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TPG

Date of completion: 05.11.1997

Full quote:

" Transplant Act in the Version of the Notice of 4 September 2007 (BGBl. 2206), the most recent of which is Article 5d of the Law of 15 July 2013 (BGBl. I p. 2423).

Status:	New by Bek. v. 4.9.2007 I 2206
	Last amended by Art. 5d G v. 15.7.2013 I 2423

For more details, please refer to the menu under Notes

Footnote

(+ + + Text evidence from: 1.12.1997 + + +) 

  

Heading: IdF d. Art. 1 No. 1 G v. 20.7.2007 I 1574 mWv 1.8.2007 Unofficial table of contents

Input formula

With the approval of the Federal Council, the Bundestag has adopted the following law: Unofficial table of contents

Content Summary

	Section 1 General provisions
§ 1	Objective and scope of the law
§ 1a	Definitions
§ 2	Education of the population, explanation of organ and tissue donation, organ and tissue deregister, organ and tissue organ ID
	Section 2 Removal of organs and tissues in the case of dead donors
§ 3	Withdrawal with the consent of the donor
§ 4	Withdrawal with the consent of other persons
Section 4a	Removal of dead embryos and foetuses
§ 5	Detection procedure
§ 6	Respect for the dignity of the organ and tissue dispenser
§ 7	Data collection and use; information to be provided
	Section 3 Removal of organs and tissues in living donors
§ 8	Removal of organs and tissues
§ 8a	Withdrawal of bone marrow in underage persons
§ 8b	Removal of organs and tissues in special cases
§ 8c	Removal of organs and tissues for retransmission
	Section 3a tissue establishments, Examination laboratories, registers
§ 8d	Special obligations of tissue establishments
§ 8e	Investigation laboratories
§ 8f	Register of tissue establishments
	Section 4 Removal, mediation and Transmission of institutions, cooperation in the case of removal of organs and tissues
§ 9	Admissibility of organ removal and transfer, priority of organ donation
§ 9a	Withdrawal hospitals
Section 9b	Transplant Officer
§ 10	Transplant centres
§ 10a	Organ and donor characterisation, transport of organs, regulation authorisations for organ and donor characterisation and transport
§ 11	Cooperation in the removal of organs and tissues, coordination body
§ 12	Exchange of organs, mediation
	Section 5 Reports, documentation, Traceability, data protection, deadlines
§ 13	Documentation, traceability, regulatory authorisation to report serious adverse reactions and serious adverse reactions
§ 13a	Documentation of transmitted tissue by means of medical care facilities
§ 13b	Notification of serious adverse events and serious adverse reactions in tissues
§ 13c	Vaulting methods for tracing
§ 14	Data protection
§ 15	Retention and deletion periods
	Section 5a State of the art guidelines of the findings of the medical Science, Regulation empowerment
§ 16	Guidelines on the state of knowledge of medical science in organs
§ 16a	Authorisation
§ 16b	Guidelines on the state of knowledge of medical science for the removal of tissues and their transmission
	Section 6 Prohibitions
§ 17	Prohibition of organ and tissue treatment
	Section 7 Criminal and penal rules
§ 18	Organ and tissue trade
§ 19	Other criminal provisions
§ 20	Fines
	Section 8 Final provisions
Section 21	Competent federal authority
Section 22	Relationship with other legal areas
Section 23	Bundeswehr
§ 24	Amendment of the Criminal Code
Section 25	Transitional arrangements
Section 26	Entry into force, external force

Section 1
General provisions

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§ 1 Objective and scope of the law

(1) The aim of the law is to promote the willingness to donate organs in Germany. To this end, every citizen and every citizen should regularly be able to deal with the question of his or her own willingness to donate, and be asked to document the respective declaration. In order to enable an informed and independent decision of each individual, this law provides for a broad understanding of the population on the possibilities of organ and tissue donation. (2) This law applies to the donation and removal of the human organs or tissues for the purpose of transmission and for the transmission of the organs or tissues, including the preparation of these measures. It shall also apply to the prohibition of trade in human organs or tissues. (3) This Act shall not apply to:

1.

tissue taken from within one and the same surgical intervention by a person in order to be transferred back to that person;

2.

Blood and blood components.

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§ 1a Definitions

For the purposes of this Act

1.

Organs, with the exception of the skin, all differentiated parts of the human body, consisting of different tissues, a functional unit with respect to structure, blood vessel supply and ability to perform physiological functions , including the organ parts and individual tissues of an organ which, while maintaining the requirements for structure and blood vessel supply, can be used for the same purpose as the whole organ in the human body, with the exception of: of such tissues which are used for the manufacture of advanced therapy medicinal products are intended for the purposes of Section 4 (9) of the Medicines Act;

2.

Organs liable to be mediated shall be the organs of the heart, lungs, liver, kidney, pancreas and intestine as defined in paragraph 1, taken in accordance with § 3 or § 4;

3.

Non-regenerating organs are all organs which cannot be re-formed in the donor after removal;

4.

Tissues are all cells consisting of cells of the human body, which are not organs as defined in paragraph 1, including individual human cells;

5.

next family members are in the order of their enumeration

a)

the spouse or registered life partner,

b)

all-year-old children,

c)

the parents or, if the possible organ or tissue pendant was a minor at the time of death, and the concern for his person at that time was only one parent, a guardian or a nurse, that sorrow holder,

d)

the full-year siblings,

e)

the grandparents;

6.

extraction is the production of organs or tissues;

7.

transmission is the use of organs or tissues in or on a human receiver, and the use of human beings outside the body;

8.

Tissue establishment shall be a means of taking, examining, processing, processing, conserving, marking, packaging, storage or other delivery of tissues for the purpose of transmission;

9.

Establishment of medical care is a hospital or other facility with immediate patient care, which is subject-medically under medical supervision and is provided in medical medical services;

10.

Procedural instructions are written instructions describing the steps of a specific procedure, including the materials and methods to be used and the expected result;

11.

Traceability is the possibility to trace and identify the organ at any stage from the donation to the transfer or the transfer; this also includes the possibility of the donor, the removal hospital and the recipient in the To identify and identify the transplant centre as well as all relevant non-personal data on products and materials with which the organ comes into contact.

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§ 2 Enlightenment of the population, explanation of organ and tissue donation, organ and tissue penderegister, organ and tissue organ deputiation

(1) The authorities responsible under national law, the federal authorities within the framework of their competence, in particular the Federal Agency for Health Education, as well as the health insurance funds, are to inform the public about the

1.

the possibilities of organ and tissue donation,

2.

the conditions for the removal of organs and tissues from dead donors, including the importance of an explanation of organ and tissue donation issued during his lifetime, including in relation to a patient's order, and the legal consequence of an underage Declaration with regard to the right of decision of the next of kin according to § 4 and

3.

the importance of organ and tissue transfer in relation to the potential benefits for sick people of medicinal use of organs and tissues, including medicinal products manufactured from tissues.

The Enlightenment must encompass the entire scope of the decision and must be open to results. The bodies designated in the first sentence shall also provide evidence of the declaration of organ and tissue donation (organ donation card) together with appropriate information documents and make available to the public. The Federal Government and the Länder ensure that the federal and state bodies responsible for issuing and issuing official identity documents are available for organ donation together with appropriate information documents and that: (1a) The sickness funds shall, without prejudice to their obligations as referred to in paragraph 1, have the right to issue an organ-donation certificate together with appropriate information documents. 3 mentioned documents to their insured persons, who shall be the 16. They shall be made available when the electronic health card is issued to them in accordance with Section 291a of the Fifth Book of Social Code. The private health insurance undertakings shall have the documents referred to in the third sentence of paragraph 1 of this Article to their insured persons, who shall be the 16. All five years are completed every five years together with the contribution announcement according to § 10 paragraph 2a sentence 9 of the Income Tax Act. If the sickness insurance funds and the private health insurance undertakings are not able to fulfil the obligations laid down in sentences 1 and 2 for the first time within 12 months of the entry into force of this Act, they shall have the documents referred to in paragraph 1 1 sentence 3 shall be made available to its insured persons in a different appropriate manner within the said period. As long as the possibility of storing the declarations of insured persons on organ and tissue donations is not available in accordance with Section 291a (3), first sentence, point 7 of the Fifth Book of Social Code, the health insurance funds and the private persons Sickness insurance undertakings shall submit the documents referred to in the third sentence of paragraph 1 to their insured person every two years. With the provision of the documents, the health insurance companies and the private health insurance companies ask the insured persons to document a declaration on organ and tissue donations and nominate them to qualified qualified professionals. Contact person for questions about organ and tissue donation as well as the meaning of an explanation of organ and tissue donation, also in relation to a patient's order. (2) Anyone who makes a statement on organ and tissue donation can Consent to the removal of organs and tissues in accordance with § 3, or transfer the decision of a named person of his or her trust (declaration on organ and tissue donation). The declaration may be limited to certain organs or tissues. The consent and the transfer of the decision can be explained by the completed sixteenth, the contradiction can be explained by the completed fourteenth year of life. (2a) No one can be obliged to make a declaration on organ and tissue donation (3) The Federal Ministry of Health may, by means of a regulation with the consent of the Federal Council, confer on a body the task of storing the explanations of organ or tissue donation at the request of the explanatory statements and above authorized persons (organ and tissue deregister). The stored personal data may only be used for the purpose of determining whether an organ or tissue removal according to § 3 or § 4 is permitted in the case of the person who had made the declaration. The Regulation shall, in particular:

1.

the public authorities responsible for receiving or amending a declaration on organ or tissue donation, the use of a form, the nature of the data to be supplied and the examination of the identity of the Declaring,

2.

the transmission of the declaration by the contact points to the register and the storage of the declaration and the data contained therein, in the case of the contact points and the register;

3.

the record of all recalls in the automated procedure pursuant to section 10 of the Federal Data Protection Act and other information from the register for the purpose of examining the admissibility of the questions and information,

4.

the storage of the personal data of the doctors who are entitled to be informed pursuant to paragraph 4, first sentence, and the allocation, storage and composition of the user's identifiers and passwords for their right to access,

5.

the deletion of the stored data and

6.

the financing of the register.

(4) The information from the register may be issued only to the declaring person and to a doctor designated as eligible for information by a hospital in the register, who is not responsible for the removal or transmission of the organs or tissues of the potential organ or tissue donors, and shall not be subject to instructions from a doctor who is involved in these measures. The request may only be made after the death has been established in accordance with § 3 (1) sentence 1 no. 2. The information may only be passed on to the physician who makes the removal of organs or tissues or under whose responsibility the tissue removal is to be carried out in accordance with § 3 (1) sentence 2, and to the person who, according to § 3 (3) sentence 1, is to be taken over the (5) The Federal Government may, by means of general administrative provision with the consent of the Federal Council, provide a model for the organ and tissue certificate. and make it known in the Federal Gazette.

Section 2
Removal of organs and tissues from dead donors

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§ 3 Removal with the consent of the donor

(1) The removal of organs or tissues shall only be permitted if there is no derogation in § 4 or § 4a of this Regulation, if:

1.

the organ or tissue organ had consented to the withdrawal,

2.

the death of the organ or tissue dispenser according to rules which correspond to the state of knowledge of medical science, and

3.

the surgery is carried out by a doctor.

By way of derogation from the third sentence of paragraph 3, the removal of tissues may also be carried out by other persons qualified for this purpose under the responsibility of a physician and subject to professional instruction. (2) The removal of organs or tissues shall be inadmissible if:

1.

the person whose death is found to have objected to the removal of organs or tissues;

2.

not before the removal of the organ or tissue, the final, non-recoverable loss of the overall function of the cerebral brain, the cerebellum and the brain stem according to the rules of procedure, which are based on the state of the knowledge of medical science , is determined.

(3) The physician has to inform the next member of the organ or tissue dispenser about the intended organ or tissue removal. The receiving person shall record the sequence and extent of the removal of organs or tissues. The next family shall have the right of inspection. He can add a person of his trust. Unofficial table of contents

§ 4 Removal with the consent of other persons

(1) If the physician who is responsible for the removal of organs or tissue or under whose responsibility the removal of tissue is to be carried out in accordance with § 3 (1) sentence 2, neither a written consent nor a written contradiction of the possible If the organ or tissue dispenser is present, its next member is to be asked whether he or she is aware of an explanation of the organ or tissue donation from the latter. If such a declaration is not known to the next of kin, the removal under the conditions of § 3 (1), first sentence, no. 2 and 3, sentence 2 and para. 2 No. 2 shall only be permitted if a doctor has to question the next of kin via one of the following persons: and has agreed to the removal of the organ or tissue. If several organs or tissues are to be taken into consideration, the consent shall be collected together. In his decision, the next person has to pay attention to a suspected will of the possible organ or tissue dispenser. The doctor has to inform the next of kin. The next person may agree with the doctor that he/she may withdraw his/her declaration within a specified agreed period of time; the agreement shall require the written form. (2) The next family member shall be subject to a decision only after Paragraph 1 shall be empowered if, in the last two years preceding the death of the possible organ or tissue dispenser, he has had the power to make such personal contact. The doctor has to determine this by questioning the next of kin. In the case of a number of other members of the same rank, it is sufficient for one of them to be involved in accordance with paragraph 1 and for a decision to be taken; however, the contradiction of each one of them is considerable. If a priority next of kin is not available within a reasonable period of time, the participation and decision of the next of kin, which can be reached first, will suffice. The next of kin is the same person as a person who has clearly been close to the possible organ or tissue penal until his death in a special personal connection; she joins the next of kin. (3) Had the person who is not in the custody of the person. (4) The doctor shall have the procedure, content and result of the involvement of the next person in the body or tissue. (4) The doctor shall have the right to decide whether to transfer the organ or tissue to a particular person. Persons referred to in the fifth sentence of paragraph 2 and the persons referred to in paragraph 2. The next of kin, as well as the persons referred to in the fifth sentence of paragraph 2 and paragraph 3, shall have the right to view them. Unofficial table of contents

Section 4a Removal of dead embryos and foetuses

(1) The removal of organs or tissues in the case of a dead embryo or foetus is only permitted if:

1.

the death of the embryo or fetus according to rules corresponding to the state of knowledge of medical science is established,

2.

the woman who was pregnant with the embryo or fetus has been informed by a doctor about a possible organ or tissue removal and has consented in writing to the removal of the organs or tissues; and

3.

the surgery is carried out by a doctor.

In the cases of the first sentence of sentence 1, section 3 (1) sentence 2 shall apply accordingly. The enlightenment and the collection of consent may only be made after the death has been established. (2) The doctor has to record the sequence, content and result of the Enlightenment and the consent of the first sentence of paragraph 1, no. 2. The receiving person shall record the sequence and extent of the removal of organs or tissues. The woman who was pregnant with the embryo or fetus has the right to view. She can add a person of her trust. The consent may be revoked in writing or orally. (3) In the cases referred to in paragraph 1, the woman who was pregnant with the embryo or fetus applies only for the purposes of documentation, traceability and data protection as a donor. Unofficial table of contents

§ 5 Detection Procedure

(1) The findings of Section 3 (1), first sentence, No. 2 and second paragraph 2 no. 2 shall be made by two qualified physicians who have independently investigated the organ or tissue penal. By way of derogation from the first sentence of the first sentence of Section 3 (1), first sentence, the examination and determination by a doctor if the final, unrecoverable standstill of the heart and circulation has occurred and has since been more than three hours (2) The doctors involved in the investigations referred to in paragraph 1 may not be involved in the removal or transmission of the donor's organs or tissues. They may also not be subject to instructions from a doctor who is involved in these measures. The findings of the examination results and their date shall be recorded and signed immediately by the physicians, indicating the underlying findings of the investigation, in a minutes. The next of kin as well as the persons pursuant to § 4 (2) sentence 5 and (3) shall be given the opportunity to consult. You can add a person of your trust. (3) The determination according to § 4a (1) sentence 1 no. 1 shall be made by a physician who shall not be involved in the removal or transmission of the organs or tissues of the embryo or foetus. He may also not be subject to instructions from a doctor who is involved in these measures. The results of the examination and the date of their determination shall be recorded and signed immediately by the physicians, indicating the underlying findings, in a separate minutes. The woman who was pregnant with the embryo or fetus is an opportunity to consult. She can add a person of her trust. Unofficial table of contents

§ 6 respect for the dignity of the organ and tissue donors

(1) The removal of organs or tissue in the case of deceased persons and all measures relating to it must be carried out in a manner appropriate to medical care, while respecting the dignity of the organ or tissue dispenser. (2) The corpse of the organ or tissue dispenser must be handed over to the funeral in a dignised condition. (3) Paragraphs 1 and 2 shall apply mutatily to dead embryos and foetuses. Unofficial table of contents

§ 7 Data collection and use; information required

(1) The collection and use of personal data of a possible organ or tissue dispenser, of a next relative or of a person pursuant to § 4 (2) sentence 5 or paragraph 3 and the transmission of such data to the data referred to in the first sentence of paragraph 3 Persons entitled to information shall be allowed, as far as is necessary

1.

for clarification as to whether an organ or tissue removal according to § 3 (1) and (2), § 4 (1) to (3) and § 9 (3) sentence 2 is admissible and whether their medical reasons are contrary to

2.

to inform the next of kin in accordance with Article 3 (3), first sentence,

3.

for organ and donor characterisation in accordance with § 10a,

4.

to be traced in accordance with Article 13 (1) or

5.

for the reporting of serious incidents and serious adverse reactions on the basis of the regulation pursuant to Section 13 (4).

(2) In order to provide immediate information on the data required under paragraph 1, the following shall be required:

1.

physicians who had treated the potential organ or tissue organ for a disease that had been previously reported to be

2.

Doctors who have received information from the organ and tissue deregister according to § 2 para. 4, via the possible organ or tissue doner,

3.

the establishment of medical care in which the death of the possible organ or tissue dispenser has been established in accordance with Article 3 (1), first sentence, No. 2,

4.

Doctors who made the corpse look at the possible organ or tissue pender,

5.

the authorities in whose custody or custody the corpse of the possible organ or tissue dispenser is or has been found,

6.

the transplant officer of the removal hospital,

7.

the responsible physician of the transplant centre in which the institution is to be transferred or has been transferred; and

8.

the person instructed by the coordinating body (§ 11) or a tissue institution, insofar as it has received information on the data required in accordance with paragraph 1.

The obligation to provide immediate information only exists after the death of the possible organ or tissue dispenser is determined in accordance with § 3 (1) sentence 1 no. 2. (3) Have a right to information on the data required pursuant to paragraph 1

1.

Doctors who intend to remove organs in accordance with § 3 or § 4 and who are active in a hospital approved in accordance with Section 108 of the Fifth Book of the Social Code or in accordance with other legal provisions for the transfer of such organs, or cooperate with such a hospital for the purpose of the removal of such organs, as well as the transplant officer of the removal hospital and the responsible physician of the transplant centre in which the institution is to be transferred, or has been transferred,

2.

Doctors who intend to remove tissues in accordance with § 3 or § 4 or under whose responsibility tissues are to be removed in accordance with § 3 (1) sentence 2 and are engaged in a medical care facility that takes such tissues or with them shall cooperate with such a body for the purpose of removing such tissue, and

3.

the person responsible for the coordination office.

The information shall be obtained for all the organs or tissues which are intended to be removed. It may be obtained only after the death of the possible organ or tissue dispenser is determined in accordance with § 3 (1) sentence 1 no. 2.

Section 3
Removal of organs and tissues from living donors

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§ 8 Removal of organs and tissues

(1) The removal of organs or tissues for the purpose of transfer to others shall only be permissible with a living person, unless otherwise specified in § 8a, if:

1.

the person

a)

is all year round and capable of consent,

b)

in accordance with the provisions of the first and second sentences of paragraph 2 and has consented to the removal,

c)

is suitable as a donor after a medical assessment and is not likely to be at risk beyond the risk of surgery or to be adversely affected by the immediate effects of the withdrawal,

2.

the transfer of the organ or tissue to the intended recipient, following a medical assessment, is likely to preserve the life of that person or to heal a serious illness, to prevent the aggravation of that person or to heal her to alleviate complaints,

3.

in the case of organ removal, a suitable organ of a donor is not available in accordance with § 3 or § 4 at the time of the removal of the organs, and

4.

the surgery is carried out by a doctor.

In addition, the removal of a kidney, part of a liver or other non-regenerating organs is only permitted for the purpose of transfer to relatives of first or second degree, spouse, registered life partner, fiancée or (2) The donor shall be informed by a doctor in an intelligible form on the subject of

1.

the purpose and the nature of the intervention,

2.

the investigations and the right to be informed of the results of the investigations,

3.

the measures used to protect the donor and the extent and possible, also indirect, consequences and late consequences of the intended organ or tissue removal for his or her health,

4.

the medical confidentiality,

5.

the expected success of the organ or tissue transfer and the consequences for the recipient as well as other circumstances to which it can be identified as meaning for the donation, as well as the consequences for the recipient.

6.

the collection and use of personal data.

The donor shall be informed that his consent is a prerequisite for the removal of organs or tissues. The Enlightenment has to be made in the presence of another physician, in accordance with § 5 (2) sentence 1 and 2, and, where necessary, of other expert persons to be carried out. The content of the Enlightenment and the declaration of consent of the donor shall be recorded in a transcript which is to be signed by the enlightenment persons, the other physician and the donor. The minutes shall also include an indication of the insurance coverage of the health risks as set out in the first sentence. Consent may be revoked in writing or orally. Sentence 3 shall not apply in the case of the intended withdrawal of bone marrow. (3) In the case of a living, the removal of organs shall not be carried out until the donor and the recipient, the removal of tissues, only after the donor has become Participation in a medically recommended post-care has been agreed. A further condition for the removal of organs from a living is that the Commission responsible under national law has taken an opinion on whether there are reasonable grounds for evidence that the consent has been given in the Organ donation is not voluntary or the organ is the subject of prohibited commercial activities in accordance with § 17. The Commission must not be subject to instructions from a doctor who is not involved in the removal or transfer of organs, who is involved in such measures, a person with the qualifications of the judge's office and one in the psychological questions of experienced person. The details of the procedure, in particular on the composition of the Commission, on the procedure and on the financing thereof, shall be determined by national law. Unofficial table of contents

Section 8a Removal of bone marrow for underage persons

The removal of bone marrow in the case of an underage person for the purpose of the transfer shall be permitted by way of derogation from the first sentence of Article 8 (1) (1) (a) and (b) and (2), with the following conditions:

1.

The use of the bone marrow is intended for relatives of first grades or siblings of the minor.

2.

The transfer of the bone marrow to the intended recipient is suitable, according to a medical assessment, to cure a life-threatening disease in the recipient.

3.

A suitable donor pursuant to § 8 (1) sentence 1 no. 1 shall not be available at the time of removal of the bone marrow.

4.

The legal representative has been enlighted in accordance with § 8 (2) and has consented to the removal and use of the bone marrow. § 1627 of the Civil Code shall apply. The underage person must be informed by a doctor in accordance with § 8 para. 2, insofar as this is possible with regard to her age and her mental maturity. If the minor is opposed to the intended removal or use, or if it does so in any other way, this must be observed.

5.

If the minor is able to recognise the nature, meaning and scope of the removal and to orient it accordingly, his/her consent shall also be required.

If the bone marrow of the underage person is to be used for relatives of the first degree, the legal representative must immediately notify the family court to make a decision pursuant to § 1629 (2) sentence 3 in conjunction with § 1796 of the Civil code. Unofficial table of contents

Section 8b Removal of organs and tissues in special cases

(1) If organs or tissues have been taken from a living person in the course of a medical treatment of that person, their transfer shall be admissible only if the person is able to consent and enlighed in accordance with § 8 (2) sentence 1 and 2 has been consented to in this transfer of organs or tissues. § 8 (2) sentence 4 shall apply mutagenically to the recording of the Enlightenment and the consent. (2) Paragraph 1 shall apply mutagenically to the production of human sperm cells intended for medically assisted fertilization. (3) For a The revocation of consent shall apply in accordance with Section 8 (2) sentence 6. Unofficial table of contents

Section 8c Removal of organs and tissues for retransmission

(1) The removal of organs or tissues for the purpose of retransmission shall be permitted with a living person only if:

1.

the person

a)

is eligible for consent,

b)

has been enlighted in accordance with § 8 (2) sentence 1 and 2, and has consented to the removal and the retransmission of the organ or tissue,

2.

the removal and retransmission of the organ or tissue within the framework of a medical treatment and, in accordance with the generally accepted state of medical science, are necessary for this treatment; and

3.

the withdrawal and the retransmission by a doctor.

(2) By way of derogation from paragraph 1, the removal of organs or tissues for the purpose of retransmission to a person who is not in a position to recognize the nature, importance and scope of the removal provided for and to orient its will hereto shall be: No 1 shall be admissible only if the legal representative or an authorised representative has been informed in accordance with § 8 (2) sentence 1 and 2 and has consented to the removal and the retransmission of the organ or tissue. § § 1627, 1901 (2) and (3) and § 1904 of the Civil Code shall apply. (3) The removal of organs or tissues for the purpose of retransmission in the case of a living embryo or foetus shall be subject to the conditions laid down in paragraph 1 (2) and 3 only if the woman who is pregnant with the embryo or foetus has been informed in accordance with § 8 (2) sentence 1 and 2 and has consented to the removal and the retransmission of the organ or tissue. If this woman is not in a position to recognize the nature, meaning and scope of the intended removal and to orient her will hereafter, paragraph 2 shall apply. (4) For the recording of the enlightenment and consent, § 8 para. 2 sentence 4 shall apply. (5) In the event of a revocation of consent, Section 8 (2) sentence 6 shall apply accordingly.

Section 3a
Tissue establishments, examination laboratories, registers

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§ 8d Special duties of tissue establishments

(1) Without prejudice to the provisions of the law on medicinal products, a tissue body which takes or examines tissues may be operated only if it has appointed a doctor who has obtained the necessary expertise in accordance with the state of the art. Science. The tissue establishment shall be obliged to:

1.

comply with the requirements for the removal of tissues according to the state of medical science and technology, in particular the donor identification, the withdrawal procedure and the donor documentation,

2.

to ensure that only tissues from donors who have obtained a medical assessment according to the state of medical science and technology that the donor is medically suitable for this purpose are taken from the donor's medical device,

3.

to ensure that the laboratory tests required for tissue samples in accordance with the state of medical science and technology are carried out in an examination laboratory according to § 8e,

4.

ensure that the tissues are released for treatment, processing, preservation or storage only if the medical assessment referred to in point 2 and the laboratory tests referred to in point 3 have shown that the tissues are intended for use in the those purposes are appropriate,

5.

before and after removal of tissue from live donors, to ensure the necessary medical care for donors, and

6.

to ensure quality assurance for the measures referred to in points 2 to 5.

The details of a legal regulation according to § 16a. (2) A tissue establishment shall have, without prejudice to medical documentation requirements, any removal and delivery of tissue and the associated measures as well as the information on products and materials which have been provided with come into contact with the acquired or delivered tissues, for the purposes regulated by this Act, for the purpose of tracing, for the purposes of medical care of the donor and for the purposes of risk collection and surveillance in accordance with the Provisions of the Medicines Act or other legislation in accordance with (3) Each tissue institution shall carry out a documentation of its activity, including the information on the type and quantity of the examined, processed, processed, processed or processed, preserved, stored, or otherwise used, imported and exported tissues, as well as the place of origin and destination of the tissues, and shall make available to the public a presentation of their activities. Each year, it shall submit a report to the competent authority of the Federal Republic of Germany containing the information on the type and quantity of tissues taken, processed, processed, processed, stored or otherwise used, imported, exported or exported. The report is based on a form published by the Federal Supreme Authority and published in the Federal Gazette (Bundesanzeiger). The form can also be made available and used electronically. The report shall be submitted after the end of the calendar year, at the latest by 1 March of the following year. The competent authority of the Federal Republic of Germany shall make the information transmitted by the tissue establishments anonymized in an overall report and shall make it publicly known. If the report of a tissue establishment is incomplete or if it is not available until the expiry of the period provided for in the fifth sentence, the competent federal authority shall inform the competent authority responsible for the supervision. Tissue establishments shall send to the competent authority, at least every two years, or on request, a list of supplies of medical care supplied. Unofficial table of contents

§ 8e Investigation laboratories

The laboratory tests prescribed for tissue samples in accordance with § 8d (1) sentence 2 No. 3 may only be carried out by an investigative laboratory for which a permit has been granted in accordance with the provisions of the Medicines Act. The investigative laboratory is obliged to ensure quality assurance for the laboratory tests prescribed in accordance with § 8d (1) sentence 2 no. 3. Unofficial table of contents

§ 8f Register of tissue establishments

(1) The German Institute for Medical Documentation and Information shall keep a publicly accessible register of tissue establishments operating within the scope of this law and shall ensure its ongoing operation. The register shall contain information on tissue establishments and their accessibility, as well as on the activities for which the manufacturing authorization, the permit for the processing, preservation, storage or placing on the market, or the Import licence has been granted in accordance with the provisions of the Medicines Act. The competent authorities of the Länder shall transmit the information provided for in the second sentence to the German Institute for Medical Documentation and Information. The German Institute for Medical Documentation and Information may use the register Charges are required. The Remuneration Catalogue requires the approval of the Federal Ministry of Health in consultation with the Federal Ministry of Finance. The competent authorities of the Länder and the European Commission are exempt from payment of charges. (2) The Federal Ministry of Health may, by means of a regulation with the consent of the Federal Council, provide the information to be included in the register. in accordance with the second sentence of paragraph 1, as well as the details of their transmission by the competent authorities of the countries and the use of the register. The legal regulation may also provide for information to be provided to bodies and authorities within and outside the scope of this Act.

Section 4
Removal, transfer and transfer of organs, cooperation in the removal of organs and tissues

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§ 9 Admissibility of the removal and transfer of organs, priority of organ donation

(1) The removal of organs from deceased donors may only be carried out in removal hospitals in accordance with § 9a. (2) The transfer of organs of deceased donors, as well as the removal and transfer of organs of living donor, may only be carried out in Transplant centres according to § 10 are made. If organs have been removed from the scope of this Act, their transfer shall be permitted only if the removal of organs is organised by the coordinating body in accordance with Article 11 (4), sentence 5, and in compliance with the other rules laid down in § 11 has been carried out. In addition, the transfer of organs subject to investigation shall be admissible only if the institutions have been mediated by the agency in accordance with the provisions of Section 12 (3) sentence 1. (3) The possible removal and transfer of a Organs shall take precedence over the removal of tissues; they shall not be affected by tissue removal. The removal of tissues from a possible donor of organs in accordance with Article 9a (2) (1) shall not be allowed until a person instructed by the coordination body has documented that the removal or transfer of organs is not possible. is or is not affected by tissue removal. Unofficial table of contents

§ 9a Withdrawal Hospitals

(1) Pick-up hospitals are the hospitals approved in accordance with section 108 of the Fifth Book of Social Code or in accordance with other statutory provisions, who are able to take out organ harvesting from a possible location in accordance with their spatial and human resources. to enable donors pursuant to § 3 or § 4 in accordance with § 11 (4) sentence 5. The competent authority shall designate, in relation to the coordinating body, the withdrawal hospitals which fulfil the conditions set out in the first sentence and shall inform the removal hospitals in writing of this designation. (2) The withdrawal hospitals shall be: ,

1.

the final, non-recoverable loss of the overall function of the cerebral brain, the cerebellum and the brain stem of patients who are considered as organ donors under § 3 or § 4 after a medical assessment, according to § 5 and the to inform the coordinating body without delay in accordance with § 11; if these patients are also considered as tissue donors in accordance with § 3 or § 4, this is to be communicated at the same time,

2.

to ensure that the removal is carried out in an operating room which corresponds to the state of medical science and technology in order to ensure the quality and safety of the organs removed,

3.

ensure that the medical staff appointed by them are qualified to perform their duties; and

4.

to comply with the rules on the removal of organs pursuant to § 11.

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§ 9b Transplantation Officer

(1) Pick-up hospitals shall appoint at least one transplant officer who is qualified for the performance of his duties. In the performance of his duties, the transplant officer is directly under the supervision of the medical director of the removal hospital. He shall be independent in the performance of his duties and shall not be subject to any instructions. The transplant officer shall be released to the extent necessary for the proper performance of his duties; the removal hospitals shall ensure that the transplant officer is responsible for his/her duties (2) Transplant officers are responsible, in particular, for the fact that:

1.

the withdrawal hospitals comply with their obligation under Section 9a (2) (1);

2.

the relatives of donors are duly accompanied in accordance with § 3 or § 4,

3.

the responsibilities and actions in the withdrawal hospitals are defined in order to fulfil the obligations under this Act; and

4.

the medical and nursing staff in the removal hospital are regularly informed about the importance and the process of organ donation.

(3) The further details, in particular the required qualification and organization status of the transplant officers, as well as their exemption from their other activities in the removal hospital, shall be determined by national law. National law may lay down the conditions under which several withdrawal hospitals may, in order to fulfil their obligation under paragraph 1, make a written agreement on the appointment of a joint transplant officer. In doing so, it is necessary to ensure that the transplant officer is able to perform his duties properly in each of the withdrawal hospitals. Derogations from the obligation to appoint a transplant officer may also be provided for in national law to the extent and as long as the implementation of the removal of organs in justified exceptional cases is due to the particularities of the Withdrawal hospital is excluded. The exceptions may be subject to authorisation by the competent authority. Unofficial table of contents

§ 10 Transplant Centres

(1) Transplant centres are hospitals or institutions at hospitals which, according to § 108 of the Fifth Book of Social Code or other legal provisions governing the transfer of organs from deceased donors, as well as to the Removal and transfer of organs of living donors are permitted. In the case of the admission in accordance with § 108 of the Fifth Book of the Social Code, the priorities for the transfer of these institutions are to be set up in order to ensure a needs-based, efficient and economic supply and to ensure the necessary quality of the transfer of organs. (2) The transplant centres are obliged to:

1.

Waiting lists of patients who have been accepted for the transfer of organs subject to medical prescription to the information required for the transfer of organs in accordance with § 12, as well as without delay of the acceptance of a patient for organ transmission and his/her to decide on the waiting list and to inform the attending physician, as well as the withdrawal of a patient from the waiting list,

2.

to decide on the inclusion in the waiting list according to rules which correspond to the state of knowledge of medical science, in particular according to the necessity and the success of an organ transmission,

3.

to comply with the regulations on organ removal and in the case of organs subject to investigation pursuant to section 11 of the regulations on organ placement in accordance with § 12 of this Regulation,

4.

to establish before the transfer of organs, that the characterisation of organs and donors is completed and documented in accordance with § 10a, and that the conditions for conservation and transport have been complied with,

5.

to document, without delay, any transfer of organs in such a way as to enable the institutions to be traced without delay from the recipient to the donor; in the case of the transfer of organs from deceased donors, the identification number (Article 13 (1), first sentence) must be given in order to: to enable traceability by the coordinating body,

6.

to record the live organ donations carried out,

7.

to ensure, before and after organ transmission, measures for the mental health care of patients in hospital, and

8.

in accordance with the provisions of the Fifth Book of the Social Code, measures for quality assurance, which also allow a comparison with other transplantation centres to be carried out in the course of their activities under this Act; this shall apply to: After-care of organ donors according to § 8 para. 3 sentence 1 accordingly.

Article 9a (2) (2) and (3) shall apply accordingly. (3) The information required for the transfer of organs pursuant to paragraph 2, first sentence, number 1 shall be collected, documented and sent to the agency by a doctor or a person appointed by that physician. in accordance with the third sentence of Article 13 (3). The persons referred to in the first sentence shall be prohibited,

1.

in order to report in accordance with § 13 (3) sentence 3 the state of health of a patient inaccurate or inaccurate to document or

2.

transmit an incorrect state of health of a patient when reporting in accordance with Article 13 (3) sentence 3;

to give preference to patients in the management of the uniform waiting list in accordance with Section 12 (3) sentence 2. Unofficial table of contents

§ 10a Organ and donor characterisation, transport of organs, regulation authorisations for organ and donor characterisation and transport

(1) The person responsible for the coordination body shall ensure, under medical advice and guidance, that the organs are released for transmission only if, according to a medical assessment, the organ and donor characterisation are carried out in accordance with the The state of medical science and technology has shown that the organ is suitable for transmission. The relevant information on the donor necessary to assess its suitability for organ donation and the relevant information on the characteristics of the institution required for the assessment referred to in the first sentence shall be provided on the basis of a In order to carry out a proper risk assessment, to minimise the risks to the recipient of the organ, and to optimise the transfer of organs, according to the provisions of paragraph 4. When this information is collected, as far as this is possible and appropriate, the next members of the family shall also be informed in accordance with § 3 (3) sentence 1 or the interview pursuant to § 4 (1) sentence 1 or further persons, the information on the Organ donors can make, interviewed. The provisions of sentences 1 and 2 shall apply mutagenely to the collection of the relevant information prior to the removal and transfer of an organ of a living donor by the responsible doctor of the transplant centre. (2) The coordinating body shall establish: ensure that the laboratory tests necessary for organ and donor characterisation referred to in paragraph 1 are carried out in laboratories with qualified staff and appropriate equipment and equipment. The laboratories shall have appropriate procedures to ensure that the information on organ and donor characterisation of the coordinating body is immediately communicated. (3) The transport of organs shall be carried out in accordance with Procedural instruction of the coordinating body in accordance with Article 11 (1a), second sentence, point 7. The Federal Ministry of Health may, with the consent of the Federal Council, after consultation of the Federal Medical Association, be responsible for the regulation of the containers for the transport of organs. (4) and other expert regulations on organ and donor characterisation and on the transport of organs. In particular, provisions may be adopted in the regulation on the requirements of:

1.

the information which must be collected at each organ donation according to the state of medical science and technology,

2.

the information required to be additionally collected after medical assessment, taking into account the availability of the relevant information and the particular circumstances of the case, in accordance with the state of medical science and technology,

3.

the procedure for the transmission of information on the characterisation of organs and donors, and

4.

the labelling of containers for the transport of organs.

If, in a particular case, including a life-threatening emergency, a risk-benefit analysis shows that the expected benefit to the organ recipient is greater than the risks due to incomplete data, an institution may also , unless all the minimum particulars laid down in the legal regulation referred to in the second subparagraph of paragraph 1 are available prior to the transfer. Unofficial table of contents

Section 11 Cooperation in the removal of organs and tissues, coordination body

(1) The removal of organs from deceased donors, including the preparation of removal, transfer and transfer, is a joint task of the transplant centres and of the withdrawal hospitals in regional cooperation. To organise this task, the Association of German Health Insurance Funds, the Bundesärztekammer (Federal Medical Association) and the German Hospital Association (Bundesärztekammer) or the Federal Associations of Hospitals Jointly establish or instrute a suitable institution to organise this task. (coordination office). It must ensure, on the basis of a financial and organisational independent sponsorship, the number and qualifications of its employees, its operational organisation and its factual equipment, that the measures referred to in the first sentence of this Article shall be: shall be carried out in cooperation with the transplant centres and the withdrawal hospitals in accordance with the provisions of this Act. Transplant centres must be adequately represented in the coordinating body. The Association of German Health Insurance Funds, the Federal Medical Association and the German Hospital Association or the Federal Associations of Hospitals Jointly have to ensure that the coordinating body meets the conditions set out in sentence 3 , and operates according to the principles of economic efficiency. The coordinating body has the basic financial and organizational decisions of the top association of the health insurance companies, the Federal Medical Association and the German Hospital Association or the federal associations of the hospital providers. together without delay. On the initiative of the Federal Government of the Health Insurance Funds, the Federal Medical Association and the German Hospital Association or the Federal Associations of Hospitals, the budget and the financial independence can be jointly determined by the Federal Association of the Health Insurance Funds. independent experts will be examined. The coordinating body shall publish a annual report annually. The top association of the health insurance companies, the Federal Medical Association and the German Hospital Association or the federal associations of the hospital carriers have in common to ensure that the coordination body is obliged to publish the information. (1a) The coordinating body shall cooperate on the removal of organs from deceased donors and the implementation of all measures necessary for the transfer, with the exception of the mediation of organs by the agency in accordance with § 12 in compliance with the guidelines according to § 16, to organize the existing To perceiving the possibilities of organ donation and to keep the health risks of the organ recipients as low as possible by the removal and provision of suitable donor organs. To this end, the coordinating body shall draw up appropriate procedural instructions in compliance with the Directives referred to in Article 16, in particular

1.

to report in accordance with Article 9a (2) (1),

2.

on the review of donor identity,

3.

for the verification of the details of the donor's consent pursuant to § 3 or the consent of other persons under § 4,

4.

on the review of the conclusion of organ and donor characterisation in accordance with Article 10a (1),

5.

to ensure that information on organ and donor characterisation reaches the transplant centre in good time, in the case of organs subject to investigation, the mediation body in accordance with § 12, in good time,

6.

for the collection, preservation, packaging and labelling of organs,

7.

for the transport of the institutions, in order to ensure their integrity during transport and an appropriate transport time,

8.

in order to ensure traceability in accordance with Article 13 (1),

9.

to ensure the immediate reporting of serious incidents and serious adverse reactions and the measures taken in this context on the basis of the legal regulation pursuant to Article 13 (4).

The coordinating body shall ensure that the medical staff appointed by it is qualified for its tasks. The contract referred to in the second sentence of the second sentence of the second sentence of the second sentence of the second sentence of the second sentence of the second sentence of the second sentence of paragraph 2 of the Treaty shall be adopted by the Federal Association of the Health Insurance Funds, the Federal Medical Association, the German Hospital Association or the Federal Associations of Hospitals. together and the coordinating body shall regulate by contract the further tasks of the coordinating body with effect for the transplant centres and the withdrawal hospitals. The Treaty shall in particular

1.

the requirements for the measures necessary in connection with the removal of organs for the protection of organ recipients, and the framework for cooperation between the parties concerned,

2.

cooperation and exchange of experience with the agency,

3.

support of transplantation centres in quality assurance measures;

4.

the replacement of appropriate expenses of the coordinating body for the performance of its tasks under this Act, including the repayment of services provided by removal hospitals in the context of the removal of organs,

5.

an appropriate flat-rate surcharge to the removal hospitals for the appointment of transplant officers and

6.

a conciliation procedure in the event of a lack of agreement on the replacement of reasonable expenses in accordance with point 4.

The contract in accordance with the first sentence requires the agreement with the association of private health insurance. (3) The contract pursuant to paragraphs 1 and 2 as well as its amendment requires the approval by the Federal Ministry of Health and is in the Federal Gazette (Bundesanzeiger) to make known. The authorisation shall be granted if the contract or its amendment complies with the provisions of this law and other law. The top association of the health insurance companies, the Federal Medical Association and the German Hospital Association, or the federal associations of the hospital carriers jointly monitor compliance with the provisions of the Treaty. In order to fulfil their obligation under sentence 3, they shall set up a Commission which shall be composed of at least one representative of the Federal Government of the Health Insurance Funds, the Federal Medical Association and the German Hospital Association or the Federal Associations. together with two representatives of the countries of the hospital. The coordinating body, the transplant centres and the removal hospitals shall be obliged to provide the Commission with the necessary documentation and to provide the necessary information. The Commission is obliged to pass on information to the competent authorities of the countries on violations of this law or of legal orders issued under this Act. As far as the composition of the Commission, the working methods and the procedure are to be found, the Treaty lays down the rules laid down in paragraph 2. (4) The transplant centres and the withdrawal hospitals are obliged to cooperate with each other and with the coordinating body. The removal of organs and the removal of tissues from possible organ donors in accordance with § 3 or § 4. The coordinating body shall clarify whether the conditions for the removal of organs are met. To this end, it collects the personal data of these possible organ donors and other personal data required for the carrying out of the removal of organs and the transfer of organs. The withdrawal hospitals are obliged to transmit these data to the coordinating body. The organ removal is organised by the coordinating body and is carried out by the doctors who are responsible for it. (5) The coordination point lists a list of the removal hospitals according to § 9a and on the transplant centres according to § 10. It documents the activities of the removal hospitals and the transplant centres and publishes annually a report on the activities of the removal hospitals and the transplant centres in the past calendar year. , and in particular contains the following non-personal data:

1.

Number and type of organ harvesting carried out in accordance with Article 9 (1), separated by organs from donors in accordance with § § 3 and 4, including the number and type of organs discarded after removal,

2.

the number and nature of the transfer of organs carried out in accordance with § 9 (2) and their results, separated by organs from donors in accordance with § § 3 and 4, and in accordance with § 8,

3.

the development of the waiting list in accordance with Article 10 (2), first sentence 1, point 1, in particular received, transplanted, other patients who have been excreted for other reasons,

4.

the reasons for the inclusion or non-inclusion in the waiting list in accordance with § 10 (2), first sentence, point 2,

5.

Age group, sex, marital status and insurance status of patients affected by numbers 2 to 4,

6.

the post-care of the donors pursuant to § 8 (3) sentence 1 and the documentation of their health risks due to organ donation,

7.

the quality assurance measures carried out in accordance with Article 10 (2) (8).

In the contract referred to in paragraph 2, it is possible to agree on uniform requirements for the activity report and the information on the removal hospitals and transplant centres on which it is based. (6) (omitted) Unofficial table of contents

§ 12 Organ placement, switching centre

(1) In order to communicate the institutions subject to the investigation, the Federal Association of the Health Insurance Funds, the Federal Medical Association and the German Hospital Association or the Federal Associations of Hospitals Jointly establish or instructs the Federal Medical Association of the Federal Medical Association to provide the necessary information. appropriate equipment (switching centre). It must ensure, on the basis of a financially and organisationally independent sponsorship, the number and qualifications of its employees, its operational organisation and its factual equipment, that the transfer of organs is carried out in accordance with the provisions of this Act. To the extent that it imparts organs which are taken from countries not Member States of the European Union or other States Parties to the Agreement on the European Economic Area, in order to reach the institutions within the scope of this Act in order to transfer the institutions to countries other than the Member States of the European Union or to other States Parties to the Agreement on the European Economic Area, or also ensure that the necessary measures to protect the recipients of the organ measures taken in accordance with the state of the knowledge of medical science and meeting the quality and safety requirements laid down in this law and by law adopted pursuant to this Act and by the law requirements are equivalent, and that a complete traceability of the institutions is ensured. Only organs which have been removed in accordance with the legislation in force at the place of removal may be mediated if the application of such legislation does not result in a result which is fundamental to the principles of German law, (2) A suitable body which has its head office outside the scope of this Act and which has the authority to act within the framework of a body of international exchange of organs in accordance with the provisions of this law for the Organ placement. In this connection, it must be ensured that the provisions of § § 14 and 15 apply mutatherly; appropriate data protection supervision must be ensured. (3) The institutions subject to the obligation to be mediated shall be subject to the rules governing the status of the Knowledge of medical science, especially after success and urgency for suitable patients, to be conveyed. The waiting lists of transplant centres are to be treated as a uniform waiting list. The conciliation decision must be documented for each institution, giving the reasons for the decision and, using the identification number, to be sent to the transplant centre and to the coordinating body in order to ensure full traceability of the institutions. (4) The top association of the health insurance companies, the Federal Medical Association, the German Hospital Association or the Federal Associations of Hospitals Jointly and the Conciliation Body regulate by contract the tasks of the Switching center with effect for transplant centers. The Treaty shall in particular

1.

the nature of the information on patients to be reported by the transplant centres in accordance with Article 13 (3), third sentence, and the use of that information by the exchange in uniform waiting lists for the respective species of the patients to be carried out Transfers of organs,

2.

the collection of the institutions notified by the coordinating body in accordance with Article 13 (1) sentence 4;

3.

the mediation of the institutions in accordance with the provisions of paragraph 3, as well as procedures for compliance with the provisions of the third and fourth sentences of paragraph 1,

3a.

for institutions taken in another Member State of the European Union or other State Party to the Agreement on the European Economic Area, in order to transfer the institutions within the scope of this Act, or to The scope of this Act is drawn up in order to transfer these institutions in those States, the requirements for the mediation of these institutions, in compliance with the provisions of this Act and the provisions adopted pursuant to this Act. Legal Regulations,

4.

the review of conciliation decisions at regular intervals,

5.

cooperation and exchange of experience with the coordinating body and the transplant centres,

6.

regular reporting by the exchange to the other contracting parties,

7.

the replacement of appropriate expenses of the agency for the performance of their duties under this Act;

8.

a contractual possibility of termination in the event of infringements of the contract of the exchange.

The contract in accordance with the first sentence requires the agreement with the association of private health insurance. (5) The contract pursuant to paragraphs 1 and 4 as well as its amendment requires the approval by the Federal Ministry of Health and is in the Federal Gazette to make known. The authorisation shall be granted if the contract or its amendment complies with the provisions of this law and other law. The top association of the health insurance companies, the Federal Medical Association and the German Hospital Association, or the federal associations of the hospital carriers jointly monitor compliance with the provisions of the Treaty. In order to fulfil their obligation under sentence 3, they shall set up a Commission which shall be composed of at least one representative of the Federal Government of the Health Insurance Funds, the Federal Medical Association and the German Hospital Association or the Federal Associations. together with two representatives of the countries of the hospital. The conciliation body and the transplant centres shall be obliged to provide the Commission with the necessary documentation and to provide the necessary information. The Commission is obliged to pass on information to the competent authorities of the countries on breaches of this law and legal orders issued under this Act. As far as the composition of the Commission, the working method and the procedure are to be found, the Treaty shall govern the contract referred to in paragraph 4. (6) (omitted)

Section 5
Reports, documentation, traceability, data protection, deadlines

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§ 13 Documentation, traceability, regulation authorisations to report serious adverse events and serious adverse reactions

(1) The coordinating body shall, in a procedure coordinated with the transplantation centres, encrypt the personal data of the organ donor and shall constitute an identification number which shall be used exclusively by the coordinating body to establish a reference to the Person of the organ donor to allow for a complete traceability of the organs. The identification number shall be included in the accompanying documents for the institution to be taken. The accompanying documents also contain all the medical information required for the transmission of organs, including the information on organ and donor characterisation in accordance with § 10a. The coordinating body shall notify the institution, the identification number and the medical information necessary for the transfer of the organ to the agency and, after decision of the agency, shall transmit the accompanying documents to the office of exchange to the Transplant centre in which the organ is to be transferred to the recipient. Further information is provided in the contract in accordance with Section 11 (2). (2) The coordinating body may use information from the accompanying documents with the personal data of the organ donor for further information on this information only, in particular: and pass them on to the transplant centres in which organs of the donor have been transferred, in so far as this is necessary for the defence of a health risk to be feared by the organ recipients. (3) The treating physician has Patients who are medically responsible for the transmission of medically-controlled organs is indicated, with the written consent thereof, to the transplant centre in which the transfer of organs is to be carried out. The message shall also be reported when a replacement therapy is carried out. The transplant centres shall report the information required for the transfer of organs via the patients admitted to the waiting lists after their written consent to the switching centre. Prior to consent, the patient shall be informed of the positions to which his/her personal data will be transmitted. If the notification referred to in sentence 1 or 3 is not delayed due to the risk of death or serious injury to the health of the patient, it may also be made without the prior consent of the patient; the consent shall be retrospected immediately after the date of the notification. (4) The Federal Ministry of Health may, with the consent of the Federal Council, regulate the procedure by means of a legal regulation

1.

for the transmission of the information necessary to ensure the traceability of the institutions referred to in paragraph 1,

2.

for the reporting, documentation, investigation and evaluation of serious adverse events and serious adverse reactions and, to the extent that tissue has been removed from the organ donor simultaneously, for the reporting to the tissue establishment, which shall: the tissue, and

3.

in order to ensure the reporting of incidents of live organ donation, which may be related to the quality and safety of the donated organ, and of serious adverse reactions to the living donor.

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§ 13a Documentation of transmitted tissue by means of medical care

Health care institutions shall ensure that, for the purposes of tracing or for the purposes of the collection of risks, in accordance with the provisions of the Medicines Act or other legislation, any tissue carried over by the shall be documented under the conditions laid down in a legal regulation pursuant to § 16a. Unofficial table of contents

Section 13b Notification of serious adverse events and serious adverse reactions in tissues

The institutions of medical care have

1.

any serious incident within the meaning of Section 63i (6) of the Medicines Act; and

2.

any serious adverse reaction within the meaning of Article 63i (7) of the Medicines Act, which has been observed during or after the transmission of tissues and which may be related to the quality and safety of tissues;

to report immediately after they have been established and to report to the tissue establishment from which they have received the tissue immediately after sentence 2. In doing so, they shall communicate all the information necessary for traceability and quality and safety control in accordance with a regulation in accordance with § 16a. Unofficial table of contents

§ 13c Retrace procedures for tissues

Each tissue establishment shall establish a procedure by which it shall determine any tissue caused by a serious incident within the meaning of Section 63i (6) of the Medicines Act, or a serious adverse reaction within the meaning of Section 63i (7) of the (2) If a tissue establishment or an establishment of medical care may be disrupted by the delivery of the medicinal product, it may be adversely affected by the delivery of the medicinal product. (2) If a tissue establishment or a medical device has been established, the medical care must Supply the reasonable suspicion that tissue is a serious It must immediately follow the cause of the disease and trace the tissue back from the donor to the recipient or vice versa. It also has to identify, investigate and block the donor's previous tissue donation if the suspicion is confirmed. Unofficial table of contents

§ 14 Data protection

(1) If the coordinating body, the switching centre or the tissue establishment is a non-public body within the scope of this law, § 38 of the Federal Data Protection Act shall apply with the proviso that the supervisory authority shall: Implementation of the provisions on data protection also controlled in so far as its scope is further than assumed in § 38 (1) sentence 1 of the Federal Data Protection Act. This also applies to the use of personal data by persons, with the exception of the declarant, to which information from the organ and tissue deregister is given in accordance with § 2 para. 4, or to which the information has been disclosed. (2) Die on der Grant or disclosure of the information pursuant to § 2 (4) of the participating persons with the exception of the declaring party, who, in accordance with § 8, paragraph 3, sentence 2, of the communication, information or transmission pursuant to § 9a (2) (1) and (11) (4) of the opinion , as well as the removal of organs or tissue, the transfer of organs or the transfer of tissue, or the transfer of tissue or transfer of persons involved may not disclose the personal data of the donors and the recipients. This also applies to personal data of persons who have been informed according to § 3 (3) sentence 1 about the intended or in accordance with § 4 or § 4a of a in-question organ or tissue removal. The personal data collected under this law may not be used for purposes other than those mentioned in this law. They may be used for judicial proceedings, the subject of which is the violation of the prohibition of disclosure in accordance with the first sentence or the second sentence. The bodies referred to in the first sentence of paragraph 1 shall take technical and organisational measures to ensure that the data are protected against unauthorised addition, deletion or alteration and that no unauthorised disclosure is made. (2a) Doctors and other persons scientific staff of the removal hospital, the transplant centre, the coordinating body referred to in § 11 and the switching centre in accordance with § 12 may use personal data within the framework of the organ and donor characterisation of the institution, or tissue donors, or within the framework of organ or tissue transfer to the institution or body, By way of derogation from the third sentence of paragraph 2, tissue receivers shall be used for their own scientific research projects. Such data may be transmitted to third parties and to persons other than those referred to in the first sentence for a specific research project, and may be used by the persons referred to in the first sentence if:

1.

the data of the data subject can no longer be allocated,

2.

in the case where the research purpose requires the possibility of assignment, the person concerned has given his consent or

3.

in the event that neither the allocation possibility nor the consent can be obtained with a proportionate effort, the public interest in carrying out the research project is the interests of the persons concerned that are worthy of protection The person is not subject to the research purpose in any other way.

The personal data are, insofar as this is possible according to the research purpose and does not require a disproportionate effort in relation to the intended protection purpose, to anonymize or, as long as an anonymization is not yet possible, (3) In the case of the seed donation, the right of the child to knowledge of his own descent remains unaffected by these regulations. In the case of bone marrow donation, by way of derogation from paragraph 2, the identity of the tissue donor and of the tissue recipient may be given to one another or to the respective relatives if the tissue donor and tissue recipient or their legal tissue recipient or their legal Representatives who have expressly consented to it. Unofficial table of contents

Section 15 Retention and deletion periods

(1) The records of the participation in accordance with § 4 (4), on the Enlightenment pursuant to § 4a (2), on the determination of the results of the investigation pursuant to § 5 (2) sentence 3 and (3) sentence 3, for the clarification pursuant to § 8 paragraph 2 sentence 4, also in conjunction with § 8a Sentence 1 (4), § 8b (1) and (2), § 8c (1) (1) (b) and (2) and (3), and for the opinion of the Committee pursuant to § 8 (3) sentence 2, as well as the documentation of the removal, transfer and transfer of organs and the information collected pursuant to § 10a. Organ and donor characterisation must be kept for at least 30 years in order to ensure full traceability of the (2) The information to be documented in accordance with Article 8d (2) must be at least 30 years after the expiry of the expiry date of the tissue and the data to be documented in accordance with Article 13a of the Regulation shall be at least 30 years after the transfer of the tissue (3) After expiry of the retention period referred to in paragraphs 1 and 2, the information shall be deleted or anonymized.

Section 5a
Guidelines on the state of knowledge of medical science, regulation empowerment

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§ 16 Guidelines on the state of knowledge of medical science in organs

(1) The Federal Medical Association shall establish the state of the findings of medical science in guidelines for

1.

the rules for determining the death in accordance with § 3 (1) sentence 1 no. 2 and the procedural rules for the determination of the final, unrecoverable failure of the overall function of the cerebral brain, the cerebellum and the brain stem in accordance with § 3 para. 2 no. 2 including the necessary medical qualification,

1a.

the rules for the determination of death in accordance with Section 4a (1) sentence 1 (1),

2.

the rules for inclusion in the waiting list in accordance with Section 10 (2) (2), including documentation of the reasons for the inclusion or rejection of the inclusion,

3.

the medical assessment referred to in Article 9a (2) (1),

4.

the requirements for the measures necessary in connection with the removal of organs for the protection of the organ recipients, including their documentation, in addition to the organ and donor characterisation according to § 10a, in particular to:

a)

the investigation of the organ donor, the organs removed and the organ recipient in order to minimise the health risks to the recipient of the organ, in particular the risk of transmission of diseases,

b)

the preservation, preparation, storage and transport of the organs in order to obtain them in a manner suitable for the purpose of transferring or further processing and storing them prior to transfer;

c)

the detection and treatment of incidents of live organ donation which may be related to the quality and safety of the donated organ, or serious adverse reactions in the case of the living donor, within the framework of the after-care has been established,

5.

the rules on organ placement in accordance with § 12 (3) sentence 1,

6.

the requirements for quality assurance and quality assurance measures in connection with the removal and transmission of organs; and

7.

the requirements for the recording of the live organ donation in accordance with Section 10 (2) (6).

Compliance with the state of the knowledge of medical science is presumed if the guidelines of the Federal Medical Association have been complied with. (2) The Bundesärztekammer lays down the procedure for the preparation of the guidelines referred to in paragraph 1 and for the decision-making process. The guidelines referred to in paragraph 1 shall be justified, and in particular the determination of the state of the findings of medical science to be explained in a comprehensible way. In the drafting of the guidelines, the appropriate participation of experts from the relevant specialist and transport circles, including the top association of the health insurance companies, the German Hospital Association, the German A transplant company, the coordinating body referred to in Article 11, the agency referred to in § 12 and the competent authorities of the countries. In addition, in the preparation of the directives referred to in the first sentence of paragraph 1, 1, 1a and 5, doctors who are not involved in the removal or transfer of organs, shall be subject to instructions from a doctor who shall be responsible for such measures. , in the preparation of the Directives referred to in the first sentence of paragraph 1, the second sentence of paragraph 1 and the qualification of the judge and persons from the circle of patients, in the preparation of the directives referred to in the first sentence of paragraph 1, no. 5, of persons from the A group of persons belonging to organ donors according to § 3 or § 4 shall be adequately represented. (3) The guidelines according to Paragraph 1 and amendments thereof shall be submitted to the Federal Ministry of Health for approval. The Federal Ministry of Health may request additional information and additional comments from the Federal Medical Association within the framework of the approval procedure. Unofficial table of contents

§ 16a Regulation authorisation

The Federal Ministry of Health may, with the consent of the Federal Council, after consultation of the Federal Medical Association and other experts, with the approval of the Federal Council, the requirements for the quality and safety of the removal of tissues and their transmission , provided that this is necessary for the prevention of risks to human health or to the prevention of risks. In particular, the legal regulation may provide for more detailed information on the requirements of

1.

the removal and transfer of tissues, including their documentation, and the protection of the documented data;

2.

the medical assessment of medical fitness as tissue pits,

3.

the study of tissue donors,

4.

the reporting of quality and safety deficiencies and serious adverse reactions by medical care institutions; and

5.

the enlightenment and the collection of the consent of tissue donors or consent to tissue removal

, The Federal Ministry of Health may, without the consent of the Federal Council, transfer the authorisation provided for in the first sentence of the first sentence to the competent federal authority. Unofficial table of contents

§ 16b Guidelines on the state of knowledge of medical science for the removal of tissues and their transmission

(1) The Federal Medical Association may, in addition to the provisions of the legal regulation according to § 16a in Guidelines, the generally accepted state of the findings of medical science in agreement with the competent federal authority for the collection of tissues and their transmission, in particular with regard to the requirements

1.

the medical assessment of medical fitness as tissue pits,

2.

the study of tissue donors and

3.

the removal, transmission and use of human tissues.

In drawing up the directives, it is necessary to ensure the appropriate participation of experts from the specialist and transport sectors concerned, including the competent authorities of the Federal Government and the Länder. The guidelines are published by the competent federal authority in the Federal Gazette (Bundesanzeiger). (2) Compliance with the state of the knowledge of medical science is presumed if the guidelines of the Federal Medical Association comply with paragraph 1. .

Section 6
Prohibitions

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§ 17 Prohibition of organ and tissue treatment

(1) It is forbidden to trade with organs or tissues intended to treat another medicinal treatment of another. Sentence 1 shall not apply to:

1.

the granting or acceptance of an appropriate pay for the measures necessary to achieve the therapeutic objective, in particular for the collection, preservation, further preparation, including the protection of the infection, the storage and transport of the organs or tissues, and

2.

Medicinal products manufactured from or using organs or tissues and the provisions concerning the authorisation pursuant to § 21 of the Medicinal Products Act, including in conjunction with § 37 of the Medicines Act, or the registration according to § 38 or § § § 38. 39a of the Medicines Act, or by legal regulation pursuant to § 36 of the Medicinal Products Act, are exempt from registration or pursuant to section 39 (3) of the Medicinal Products Act, or active substances within the meaning of § 4 (19) of the German Medicines Act (Medicinal Products Act) Pharmaceutical legislation which is produced from or using cells.

(2) Likewise, it shall be prohibited to withdraw organs or tissues which are the subject of prohibited commercial activities in accordance with the first sentence of paragraph 1, to transfer to another person or to have them transferred.

Section 7
Criminal and penal rules

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Section 18 Organ and Organ Trade

(1) Anyone who, contrary to § 17 (1) sentence 1, is trading with an organ or tissue or who, contrary to § 17 (2), is responsible for taking, transmitting, transmitting or transferring an organ or tissue, shall be punished with imprisonment of up to five years or a fine. (2) If the perpetrator is commercial in the cases referred to in paragraph 1, the sentence is a term of imprisonment of one year up to five years. (3) The trial is punishable. (4) The court may be subject to any organ or tissue donors whose organs or tissues are subject to prohibited articles. In the case of organ or tissue recipients, a punishment as referred to in paragraph 1 , or mitigate the sentence at its discretion (Section 49 (2) of the Criminal Code). Unofficial table of contents

Section 19 Further Criminal Provisions

(1) Who

1.

Contrary to Article 8 (1) sentence 1 (1) (a) or (b) or (4) or Article 8c (1) (1) or (3) (2) sentence 1, also in conjunction with paragraph 3, sentence 2, or § 8c (3) sentence 1, an organ or tissue shall be removed,

2.

, contrary to Article 8 (1) sentence 2, an institution or

3.

, contrary to § 8b (1) sentence 1, also in conjunction with paragraph 2, an organ or tissue is used for transmission to another person or gains human sperm,

shall be punished with imprisonment of up to five years or a fine. (2) Anyone who takes up an organ or tissue contrary to § 3 (1) sentence 1 or (2), § 4 (1) sentence 2 or § 4a (1) sentence 1 shall be liable to imprisonment for up to three years or with a sentence of imprisonment. A fine of up to two years imprisonment or a fine is punishable by a person who deliberately collects, documents or transmits the state of health of a patient, contrary to § 10 (3) sentence 2. (3) Who

1.

, contrary to the first sentence of Article 2 (4) or the third sentence, information shall be given or forwarded,

2.

uses an indication contrary to Article 13 (2); or

3.

Contrary to § 14 (2) sentence 1, also in conjunction with sentence 2, or sentence 3, personal data is disclosed or used,

shall be punishable by a custodial sentence of up to one year or a fine. (4) In the cases of paragraphs 1, 2 and 2a, the trial shall be punishable. (5) If the offender is negligent in the cases referred to in paragraph 2, the penalty shall be a custodial sentence of up to one year or more. Fine. Unofficial table of contents

Section 20 Penal rules

(1) Contrary to the law, those who intentionally or negligently act

1.

does not make a record, not correct, not complete or not in time, contrary to Section 5 (2) sentence 3 or 3 sentence 3,

2.

Contrary to § 8d (1) sentence 2 no. 3 in conjunction with a regulation pursuant to § 16a sentence 2 no. 3, it does not ensure that a laboratory examination is carried out,

3.

Contrary to § 8d (2) in conjunction with a decree of law pursuant to § 16a sentence 2 no. 1, a tissue removal, a tissue transfer, a related measure or an indication mentioned there is not, not correct, not complete or not in good time document,

4.

, in accordance with Article 9 (1) or (2), first sentence, or sentence 3, of an institution,

5.

, contrary to Article 9 (2), second sentence, an institution without the institution ' s removal being organised by the coordinating body,

6.

Contrary to § 10, paragraph 2, point 4, not correct, not complete or not in time determines that the organ and donor characterisation is completed in accordance with § 10a paragraph 1 or that the conditions for the transport pursuant to § 10a (3) sentence 1 are complied with,

7.

Contrary to § 10, paragraph 2, point 5, the transfer of organs is not documented in a correct manner, not in full or in a timely manner,

8.

Contrary to the first sentence of Article 10a (1), it does not ensure that an institution is released for a transfer only in accordance with the conditions laid down therein;

9.

Contrary to § 13a in connection with a decree of law pursuant to § 16a sentence 2 no. 1, it is not ensured that a transmitted tissue is documented,

10.

contrary to § 13b sentence 1 in conjunction with a legal regulation pursuant to § 16a sentence 2 no. 4, a lack of quality or safety or a serious adverse reaction not, not correct, not timely or not fully documented, or does not make a notification, not correct, not complete or not timely, or

11.

a legal regulation pursuant to § 10a (4) sentence 1, § 13 (4) or § 16a sentence 1 or a enforceable order shall be contrary to such a decree, in so far as the legal regulation for a particular event is applicable to such a case Fine-money provision refers to.

(2) The administrative offence can be punished with a fine of up to thirty thousand euros.

Section 8
Final provisions

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Section 21 Federal Supreme Authority

The competent federal authority within the meaning of this law is the Paul-Ehrlich-Institut. Unofficial table of contents

Section 22 Relationship with other legal areas

The provisions of the Embryo Protection Act and the stem cell law remain unaffected. Unofficial table of contents

Section 23 Bundeswehr

In the business unit of the Federal Ministry of Defence, the enforcement of this law is the responsibility of the competent authorities and experts of the Bundeswehr. Unofficial table of contents

§ 24

(Amendment of the Criminal Code) Unofficial table of contents

Section 25 Transitional arrangements

(1) Upon the entry into force of this Act, existing contracts relating to regulatory objects pursuant to § 11 shall continue to apply until they are replaced by the contract in accordance with Section 11 (1) and (2) or replaced by legal regulation pursuant to Section 11 (6). (2) Law existing contracts relating to regulatory matters pursuant to § 12 shall continue to apply until they are replaced by contract in accordance with § 12 (1) and (4) or replaced by legal regulation pursuant to Section 12 (6). Unofficial table of contents

Section 26 (Entry into force, expiry of the external force)

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