Rs 810.21 Federal Act Of 8 October 2004 On Transplantation Of Organs, Tissues And Cells (Transplant Law)

Original Language Title: RS 810.21 Loi fédérale du 8 octobre 2004 sur la transplantation d’organes, de tissus et de cellules (Loi sur la transplantation)

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810.21 federal law on transplantation of organs, tissues and cells (transplant law) of October 8, 2004 (Status January 1, 2014) the Federal Assembly of the Swiss Confederation, view of art. 119, art. 1 and 2, of the Constitution, given the message of the federal Council of 12 September 2001, stop: Chapter 1 provisions general art. 1 purpose this Act sets out the conditions in which organs, tissues or cells can be used for transplantation purposes.
It must contribute to that of organs, tissues and human cells available for transplantation purposes.
It is intended to prevent misuse of organs, tissues or cells, including the trade in organs, when applied to human transplant medicine and to ensure the protection of human dignity, personality and health.

Art. 2 scope of application this Act applies to any use of organs, tissues or cells of human or animal origin as well as products of these (transplant) intended to be transplanted in humans.
It does not apply to the use: a. of organs, tissues and cells artificial or devitalized; b. the blood, with the exception of cells strains; c. blood products; d. gamete, impregnated ovules and embryos as part of medically assisted procreation of human beings human.

The use of organs, tissues or cells for autogenous transplantation is governed by art. 36 and 50 to 71. The federal Council may, for the organs, tissues and cells intended for autogenous transplantation, which are processed before the transplant, enact measures to ensure the quality and safety of the operation. The transplant for autogenous transplants are governed by arts. 4, 7, al. 2, let. b, 49 and 63 to 65.

Art. 3 definitions for the purposes of this Act means: a. bodies: all parts of the body including the cells and tissues form a whole with a particular function; are assimilated to the bodies, parts of bodies who can assume the function as well as the parts of the body composed of different tissues that perform a particular function; (b) fabrics: cell associations structured, composed of similar cells either different cells having a common function in the body; c. cells: cells, cells unstructured settlements and suspensions of cells composed only of similar cells; d. standardized transplants: products made from organs, tissues or cells of human or animal origin, which can be standardized or whose manufacturing process can be standardized.

Art. 4 general duty of diligence anyone using organs, tissues, cells or the transplant must take all the necessary measures according to the State of science and technology for do not endanger the health of people.

Art. 5 samples for purposes other than transplantation when organs, tissues or cells were collected for other purposes than the transplant, they cannot be stored or assigned to a transplant or transplant only if making art. 8, 12, let. b, 13, al. 2, let. f and g, 39, al. 2-40, al. 2, governing information and the consent of the donor have been respected.
The provisions referred to in para. 1 apply also to the use of cord blood stem cells.

Chapter 2 organs, tissues and cells of human origin Section 1 free and prohibition of trade art. 6 free the gift it is forbidden to grant or to perceive an any pecuniary benefit or other benefits for the donation of organs, tissues or cells of human origin.
Are not considered a monetary benefit or another benefit: a. compensation for the donor for the loss of income and direct costs that are incurred to him; (b) compensation for the donor for damage suffered because of the removal of organs, tissues or cells; c. a gesture symbolic of posterior transplant thanks; d. cross-transplant.

Art. 7 Prohibition of the trade shall: a. to trade of organs, tissues or cells of human origin in Switzerland or abroad, from the Switzerland; (b) to take or to transplant organs, tissues or cells of human origin obtained against a pecuniary benefit or other benefit.

This prohibition does not apply: a. to the reimbursement of the costs associated with the transplant, including costs of collection, transport, treatment, storage and transplantation itself; b. to the transplant referred to in art. 49 section 2 sampling of organs, tissues or cells on deceased individuals art. 8 requirements for the removal of organs, tissues or cells can be taken from a deceased if: a. she consented, before his death, to a such levy; b. the death was found.

In the absence of any evidence of consent or the refusal of the deceased, is asked relatives if they know a statement of don.
If the relatives have no knowledge of such a statement, a collection of organs, tissues or cells can be done only with their consent. In making their decision, they must respect the presumed will of the deceased.
If the deceased person has no family or that it is not possible to get in touch with them, it is not permitted to a levy.
The will of the deceased prime the loved ones.
If it is proved that the deceased person has delegated to a trusted person the jurisdiction to make a decision on a collection of organs, tissues or cells, the latter is in place and relatives.
Anyone under 16 years of age is entitled to make a declaration of don.
The federal Council defines the circle of relatives.

Art. 9 the death test and determination of death a person died when the functions of the brain, including the brain stem, suffered an irreversible decision.
The federal Council issues regulations on the determination of death. It determines including: a. clinical signs which must be observed so that we can conclude one irreversible stop of the functions of the brain, including the brainstem; b. requirements that must meet the doctors called to confirm the death.

Art. 10 preliminary medical measures medical measures that have exclusive object the conservation of organs, tissues or cells can be taken, before the death of the donor, only with the free and informed consent of the latter.
Such measures are prohibited when they: a. accelerate the occurrence of the death of the patient; b. may bring down the donor in a sustainable vegetative state.

In the absence of a statement of don, such measures may be taken after the death of the patient until the decision of the family is known. The federal Council determines the maximum of such measures.

Art. 11 independence of personnel in the doctor who certified the death of a person may not: a. participate the removal or transplantation of organs, tissues or cells; b. receive guidance from a specialist doctor who is involved in the removal or transplantation.

Physicians who charge or transplant organs, tissues or cells, as well as the medical staff involved in such acts, must exert no pressure related to the emergency or any other influence on the people who care the patient dying or who see his death.

Section 3 removal of organs, tissues or cells on living persons art. 12 requirements for the removal of organs, tissues or cells can be taken from a living person if: a. it is major and capable of discernment; b. it has his free and informed consent, in writing c. it does no serious risk to his life or health; d. the recipient cannot be treated by any other therapeutic method having a comparable efficiency.

Art. 13 protection of minors or incapable of discernment may not be taken of organs, tissues or cells on minor people or incapable of discernment.
Exceptionally, tissues or cells that regenerate can be taken on minor or incapable of discernment so people: a. levy is only minimal risk and minimal for the donor burden; b. the receiver can not be treated by any other therapeutic method with comparable efficiencies. c there is no donor capable of discernment to provision; d. the recipient's father , the mother, a child, a brother or sister of the donor; e. the donation can save the life of the receiver; f. the legal representative has given his free and informed consent, in writing; g. uwate, capable of discernment but still a minor, has his free and informed consent, in writing; h. no index suggests that the person incapable of discernment oppose a levy; i. an independent authority gave its authorization.


Donors incapable of discernment are associated to the extent possible to the information process and the procedure to request their consent.
The cantons shall set up an independent authority within the meaning of para. 2, let. i, and regulate the procedure.

Art. 14 compensation of costs and insurance anyone who takes on a living person organs, tissues or cells ensures that it is provided in an appropriate way against possible serious consequences of sampling.
The insurer which, in the absence of donation by a living person, should the costs of the treatment of the disease of the receiver, supports: a. the cost of this insurance; b. fair compensation for loss of earnings or other costs borne by the donor in connection with the levy.

The obligation to pay costs within the meaning of para. 2 exists even if the removal or transplantation cannot be performed. If the insurer of the recipient is not known, the Confederation supports the costs.
The federal Council sets including: a. serious consequences against which the donor must be assured; b. the content and the extent of insurance within the meaning of para. 1; c. other costs that must be supported within the meaning of para. 2, let. b. art. 15 provisions enacted by the federal Council federal Council sets out the requirements that must meet the information to the senses of the art. 12, let. b and 13, al. 2, let. f and g.
It can determine the therapeutic methods that do not have comparable efficacy for the receiver.

Section 4 assignment of bodies art. 16 scope this section governs the allocation of organs when donors have not designated recipient.
The federal Council: a. determine the organs to be awarded in accordance with this section; (b) may declare this section applicable to the allocation of tissues and cells.

Art. 17 non-discrimination in the award of a body, no one should be discriminated against.
In the allocation of organs, persons domiciled in Switzerland must be treated equally.
An available organ is attributed to a person not domiciled in Switzerland on the queue in accordance with art. 21, al. 1: a. If the transplant is urgent from the medical point of view and that no person domiciled in Switzerland is in the same situation; b. If transplantation is not urgent but that there is no receiver domiciled in Switzerland.

No one can claim a right to the allocation of a body.

Art. 18 criteria in particular, the following criteria must be taken into account for the award: a. the medical urgency of the transplant; (b) the effectiveness of transplantation from the medical point of view; c. the time-out.

During the assignment, we strives to ensure that patients who, because of their physiological characteristics, should expect a very long waiting time have the same probability of receiving an organ than those who do not have these characteristics.
The federal Council shall determine the order in which the criteria are to be applied or weights them.

Art. 19 national service of responsibilities Confederation created a national service awards.
The national allocations service: a. maintains a list of people awaiting a transplant (waiting list); b. assigns available organs to recipients after consultation with transplant centers; c. organizes and coordinates all activities related to the powers at the national level; d. collaborates with foreign organizations for assignment.

Assignments national service establishes a record for every decision and kept for 10 years.
The federal Council shall regulate the procedure applicable to assignments.

Art. 20 disclosure of the names of patients needing a transplant physician shall communicate promptly to a transplant center the name of the patient for which a transplant is medically indicated, the written consent of that person being required. The communication must also take place if the patient undergoes a replacement therapy.

Art. 21 waitlist the waitlist is open to persons domiciled in Switzerland. The federal Council lays down the conditions under which persons not domiciled in Switzerland can be listed there.
Transplant centers refer to people who are registered on the waiting list and those that are written off. Their decisions are based only on medical grounds. Art. 17, al. 1, shall apply by analogy.
Transplant centers communicate their decisions with the necessary data to the national service of assignments.
Federal Council described precisely: a. medical reasons referred to in para. 2; (b) the data referred to in para. 3 art. 22 communication of the names of the donors hospitals and transplant centers communicate to the national service assignments, with the necessary data, the name of the deceased that lend themselves to an organ retrieval. The federal Council specifies the necessary data.
Doctors, hospitals and transplant centers to which one person stated his willingness to give his life a body to an unknown person are required to communicate the name of this potential donor to the national service awards.

Art. 23 exchange of bodies with overseas when there is no receiver in Switzerland, the national service awards offers the body a foreign award organization. Is for the exchange of a body for international programs to patients within the meaning of art. 18, al. 2. only national service awards is authorized to accept an offer of body from abroad.
The national service of assignments can conclude with foreign organizations of attribution of the conventions on the reciprocity of the exchanges of organs. These agreements are subject to the approval of the federal Office of public health (office).

Section 5 withdrawal, storage, import, export and preparation art. Obligation to announce withdrawals 24 anyone who samples of organs, tissues or cells on human beings humans must announce it to the office.
The federal Council determines the data that must be announced and duties of persons subject to the obligation to announce.

Art. 25 plan approval for the storage, import and export must hold an authorisation issued by the Agency anyone who: a. stores tissue or cells; b. important or export organs which are not allocated according to the art. 16 to 23, as well as tissue or cells;

The storage in a customs warehouse is considered to be import.
The authorization is issued: a. if professional qualifications and operational requirements are met; (b) if there is an appropriate quality assurance system.

Federal board regulates the conditions for the grant of the authorization as well as the procedure and set the obligations of those subject to authorisation.

Art. 26 preparing the federal Council may issue provisions on the preparation of organs, tissues and cells. In doing so, it takes into account the guidelines and recognized international standards.

Section 6 transplant art. 27 plan approval only transplant centers for the benefit of a leave of the Agency are authorized to transplant organs.
Authorization is issued: a. if professional qualifications and operational requirements are met; (b) if there is a system of quality assurance appropriate that also ensures the medical follow-up of living donors; c. If the quality of transplants is ensured.

Transplant centers to record, evaluate and regularly publish the results of transplants, according to uniform criteria.
The federal Council may submit transplants of tissues and cells to an authorization issued by the Agency.

Art. 28 limitation on the number of transplant Council centers federal may limit the number of transplant centers after consultation with the cantons and taking into account the developments in the field of transplantation medicine.

Art. 29 obligation to announce anyone transplanted tissues or cells must announce it to the office.
The federal Council determines the data that must be announced and duties of persons subject to the obligation to announce.

Section 7 duty of care art. 30 ability of the donor anyone levies or transplanted organs, tissues or cells must consider the ability of the donor for this purpose are excluded from donors: a. people on which were transplanted organs, tissues or cells of animal origin or standardized transplants obtained from such organs, tissues or cells; (b) those who are not referred to in the let. has and which organs, tissues or cells can transmit pathogens or be accountable to another title of the deterioration of the State of health of the recipient; art. 31, al. 2, let. c, is reserved.

The federal Council lays down requirements concerning the ability of the donor, the competence to establish this ability and the data that must be noted on this occasion.

Art. 31 duty to perform tests


Anyone who takes or transplanted organs, tissues or cells must ensure that they have been tested for the presence of pathogens or indications of such a presence.
The federal Council shall determine including: a. pathogens or the signs of their presence which must be subject to testing; b. tests that can be used; (c) the cases in which the organs, tissues or cells, although having been responsive to the test, can be transplanted.

It may make exceptions to the obligation to test if it can be guaranteed in another way that any infection by pathogens is excluded.

Art. 32 removal and inactivation of pathogens the federal Council may provide for the use of methods of elimination or inactivation of pathogens to be subject to authorisation from the office.

Art. 33 mandatory labelling the organs, tissues and cells, as well as the analysis of these samples must be labelled so as to be perfectly identifiable.

Art. 34 obligation to record and traceability anyone using organs, tissues or cells must: a. save all operations important public health; b. make the records so that the recorded data to go back to the donor and the recipient.

During each sampling or each transplant of organs, tissues or cells, the name, names and date of birth of the donor and the recipient are recorded.

Art. 35 duty to keep records and documents records required in art. 34 and all important documents must be kept for 20 years.
In the event of cessation of the activities before the expiry of this period, all records and documents are kept in a safe place or, if this is not possible, the possession of the office.

Section 8 testing clinics art. 36 before be made, clinical trials for transplantation of organs, tissues or cells of human origin require the approval of the Agency. The federal Council may subtract the authorization of clinical trials determined plan or be subject to an obligation to announce.
The office make the organs, tissues, or cells used in the clinical trial to meet the requirements set by this Act. It can control the execution of a clinical trial at any time.
The federal Council regulations of procedure. He can submit authorization any change in a clinical trial.
It can provide for a duty to announce and to inform, in particular in the following cases: a. clinical trial is completed or interrupted; b. adverse events occur during the trial; c. events occurring during the trial could affect the safety or health of people participating.

The federal Council enacts the provisions required under paras. 3 and 4 taking into account recognised international regulations.
Research on the human act of September 30, 2011 apply in addition to clinical trials.

New content according to section 4 of the annex to the LF Sept. 30. 2011 relating to research on the human being, in effect since Jan. 1. 2014 (2013 3215 RO; FF 2009 7259) RS 810.30 Section 9 use of tissues or cells from embryos or fetuses of human origin art. 37 principle and bans the date of termination of pregnancy and the method used must be selected independently of a later transplant of tissue or cells from the embryo or fetus.
It is forbidden: a. to maintain artificially alive whole embryos developed beyond the seventh day or embryos or whole fetuses from abortions in order to collect tissue and cells for transplant purposes; b. to transplant tissue or cells from an embryo or a fetus on a person designated by the woman whose pregnancy is interrupted; c. to use for a transplant, the tissue or cells from embryos or fetuses from women incapable of discernment.

Art. 38 plan approval, anyone who wants to piggyback on a human tissue or cells from embryos or fetuses of human origin must first obtain a permit issued by the Agency.
The authorization to conduct a clinical trial: a. If it can be expected that transplantation will have a therapeutic purpose; (b) if professional qualifications and operational requirements are met; c. If there is an appropriate quality assurance system.

The authorization to administer a standard treatment if: a. the therapeutic usefulness of the treatment is established; b. the receiver cannot be treated by any other therapeutic method having a comparable efficiency; (c) the requirements in para. 2, let. b and c, are met.

Art. 39 information and consent of the donor consent of a pregnant woman for the use, for purposes of transplantation, tissue or cells from the embryo or fetus, can be requested that once his decision to terminate her pregnancy.
Tissues or cells from an embryo or a fetus can be transplanted only with the free and informed consent of the donor, given in writing.

Art. 40 information and consent of the couple concerned the consent of the couple concerned for the use for purposes of transplantation of tissues or cells from supernumerary embryo cannot be called once established the existence of such an embryo.
Tissues and cells from supernumerary embryos can be transplanted only with the free and informed consent of the couple concerned, given in writing.

Art. 41 independence of medical personnel who participate in transplantation must not influence medical personnel who proceeds to abortion or medically assisted procreation. They may not participate or give instructions to the people involved in the response.

Art. 42 provisions enacted by the federal Council, the federal Council shall determine: a. requirements to satisfy the information to the senses of the art. 39 and 40; b. the obligations of persons subject to the authorization regime; c. the conditions relating to the authorization and the approval procedure.

Chapter 3 organs, tissues and cells of animal origin art. 43 plan approval, anyone who wants to transplant human organs, tissues, or cells of animal origin or from transplant of these must first get permission from the Agency.
The authorization to conduct a clinical trial if: a. risk of infection of the population can be excluded with large probability; b. it can be expected that transplantation will have a therapeutic use; c. professional qualifications and operational requirements are met; d. There is an appropriate quality assurance system.

The authorization to administer a standard treatment if: a. risk of infection of the population can be excluded; b. the therapeutic utility of transplantation is established; c. the requirements in para. 2, let. c and d, are met.

Art. 44 obligations of the holder of the authorisation the holder of the authorization shall: a. to examine the receiver on a regular basis and over a long period to detect the presence of pathogens or evidence of such a presence; b. upon the death of the recipient, to examine the corpse in order to detect possible infection; c. to record all data and important public health operations d. saving data so that it can identify the receiver and trace the animal on which the sample was taken, as well as biological samples; e. retain and, at the request of the competent authority, to produce the records and biological samples collected; f. to take as soon as possible, with the statement of facts that can have important consequences for public health, all measures that are necessary and notify immediately the competent authorities.

Art. 45 mandatory tests anyone picks or transplanted organs, tissues or cells from animals or from these transplant must ensure that they have been tested for the presence of pathogens or indications of such a presence.

Art. 46 securities the federal Council may, for the purposes of protecting the injured: a. require the people who put in trade or transplant organs, tissues or cells of animal origin to ensure against their liability costs or to produce other security; b. determine such security and fix the duration; c. oblige the persons required to provide security to communicate to the office the existence suspension or deletion of security rights.

Art. 47 administrative costs the person causing them assumes the cost of the measures taken by the competent authorities to:

a. protect the population of risk of infection or to mitigate it; b. establish damage caused by infections or to remedy.

Art. 48 provisions enacted by the federal Council the federal Council issues regulations governing the use of organs, tissues and cells of animal origin. It regulates including: a. requirements that must meet the use of animal resource; (b) the requirements for the quality of organs, tissues or cells of animal origin; (c) the requirements for the tests to control the health of recipients and animals resource; (d) the conditions for the grant of the authorization and the approval procedure; e. the duration and mode of preservation data and recorded operations as well as samples; e. pathogens or the signs of the presence of such agents who must be subject to a test; g. the cases in which organs, tissues, or cells of animal origin may be transplanted, even though they have been responsive to the test; h. labelling of organs, tissues and cells of animal origin obtained according to the techniques of genetic engineering; i. the requirements to be met : 1 the recipient information and consent to the operation, 2. the information of the members of the medical staff and their consent to perform the required acts, 3 contacts for the recipient information.

The federal Council may: a. limit or ban the use of animals of certain species for transplantation purposes; b. make exceptions to the obligation to conduct a test in the sense of art. 45, when other measures help to ensure that any risk of infection by pathogens is excluded; c. impose additional obligations on the holder of the authorization and obligations of the recipient when conditions; d. declare the art. 6 to 42 related to the organs, tissues and cells of human origin for the use of organs, tissues and cells of animal origin.

Chapter 4 transplant art. 49 in addition to the provisions of this Act, art. 3, 5-33, 58 to 67 as well as the art. 84 to 90 of the Act of 15 December 2000 on therapeutic products (accuracies) apply by analogy to the use of transplant.
The Swiss Institute for therapeutic products is also competent to carry out inspections concerning the transplants standardized in accordance with art. 60, al. 2, accuracies.
In addition, the art. 36-41 and 53 to 57 accuracies apply by analogy to the use of from transplant of organs, tissues or cells of human origin.
Anyone who samples of organs, tissues or cells for transplant production must verify the ability of the licensor in the sense of art. 36. accuracies art. 86, al. 1, let. d, accuracies apply also to the use of transplant of human origin.

SR 812.21 Chapter 5 enforcement Section 1 Confederation art. 50 principle execution of this Act is the responsibility of the Confederation insofar as it is not expressly reserved to the cantons.
The federal Council shall issue implementing provisions.

Art. 51 monitoring Confederation monitors the execution of this Act by the cantons.
It coordinates enforcement of the cantons where a uniform performance is needed at the national level. Therefor, may: a. require the cantons to inform him of the enforcement measures they take; b. impose certain measures in the cantons in order to ensure a uniform implementation of the law.

Art. 52 international cooperation at the international level, the Federal Government takes appropriate measures to facilitate the exchange of information, to provide a fast and secure exchange of organs, tissues and cells, and to actively fight against the traffic in organs.

Art. 53 professional development and continuous training of staff medical the Confederation can organize or support professional development programs and training continues preparing medical personnel to take care of appropriately donors and their relatives.

Art. 54 delegation of tasks the federal Council may delegate some tasks to organizations and persons governed by public law or private law.
This competence applies in particular: a. the allocation of organs within the meaning of art. 19; b. to the keeping of the register of stem cells provided in art. 62; c. to control within the meaning of art. 63. the federal Council provides for the compensation of the delegated tasks.

Art. 55 reviews the Agency's scientific assessments of execution and the effects of this Act.
These assessments include on: a. the impact of the law on the State of the situation, the opinion and the attitude of the population and of the medical staff; b. practice of allocation of organs, the quality of transplants and the availability of organs, tissues and cells for transplantation.

The Department federal done inside report to the federal Council on the results of the evaluations and it submits proposals on the follow-up to these assessments.

Section 2 Cantons art. 56 organizing and coordinating the cantons organise and coordinate activities relating to organ transplants: a. in hospitals where donors are supported; b. in transplant centers.

They include that each hospital and Transplant Center: a. has a local coordinator; b. organizes programs of professional development and training of medical personnel.

The local coordinator shall particularly ensure that: a. the donors and their families are taken care of appropriately; b. the name of donors is communicated to the national service of powers (art. 22).

Section 3 duty to keep the secret and disclosure of data art. 57 obligation to keep secret any person charged with the execution of this Act is required to keep the secret.

Art. 58 confidentiality of any data data collected by virtue of this Act whose disclosure might adversely affect an interest worthy of protection should be treated confidentially.

Art. 59 communication of data unless a predominant private interest does, the data may be communicated in some cases, on written request and based: a. the civil courts, where they are necessary to judge a dispute; b. the criminal courts and the authorities of criminal investigation, when they are needed to solve a crime or misdemeanour.

Unless a predominant private interest does, data can be disclosed: a. services of the Confederation and the cantons as well as to organizations and persons governed by public law or private law who are responsible for the execution of this Act, if they are necessary for the accomplishment of the tasks entrusted to them under this Act; b. the authorities of criminal investigation If the information or the prevention of a crime or an offence within the meaning of this Act requires.

The data of general interest concerning the application of this Act may be published. The persons concerned may not be identifiable.
Moreover, can be communicated to third parties: a. data which do not relate to people, as long as their communication meets an overriding interest; (b) the personal data, provided that the person concerned has given, in each case, consent in writing.

Only the data needed for the intended purpose may be communicated.
The federal Council shall regulate the terms of the communication of data and information of the persons concerned.

Art. 60 exchange of data with foreign authorities and organizations international the federal Council regulates the responsibilities and procedures for the exchange of data with the authorities and foreign institutions and international organizations.
Communication of confidential data to authorities and foreign institutions or international organizations is permitted only if: a. international conventions or decisions emanating from international organizations requires; (b) it is essential to prevent an imminent risk to the life or health; OUC. This allows to update an illegal or other serious offences under this Act.

Section 4 public art Information 61. the office and the cantons inform the public regularly on issues related to transplantation medicine. For this purpose, they collaborate with organizations and persons in public law or private law.
The information includes to: a. give everyone the opportunity to express their will regarding the donation of organs, tissues or cells in full knowledge of the facts; b. promote the regulation and practice, especially to present the conditions of collection, allocation and transplantation of organs, tissues and cells in Switzerland.

The federal Council may provide for the possibility to include in a document or a data medium appropriate the will of a person regarding the donation of organs, tissues or cells.

Section 5 registry Art. stem cells 62


The office maintains a register of stem cells.
The registry of stem cells used to find likely to be transplanted on a specific receptor cells. The data entered in the register cannot be used for the above-mentioned purpose.
Entered in the register the data necessary for the establishment of the compatibility of tissues or data: a. stored stem cells; b. people who are ready to make a donation.

Anyone who deals with the data referred to in para. 3 passes to the authority which keeps the record. Data must be transmitted in a manner custom that if the purpose mentioned in para. 2 requires it.
Any person registered in the register may request, at any time, that the data are written off.
The federal Council specifies the type of the cells maintained in this register.

Section 6 control and measures art. 63 the office control ensures that the provisions of this Act are met. For this purpose, he realizes such periodic inspections.
It may take the necessary samples for free, require information and relevant documents and seek any other assistance required. It can load customs services samples.
It has access, for the accomplishment of its tasks, buildings, companies, premises and vehicles.

Art. 64 duty to co-operate the person using organs, tissues or cells or standardized transplants must attend for free agency in the performance of its tasks. It must include: a. allow him to collect samples and give those requested; b. provide the required information; c. enable the records and access to the premises.

Art. 65 measures the Agency may take all measures necessary for the implementation of this Act.
May, in particular: a. challenge a statement of fact and set a time limit appropriate to restore a situation in conformity with the law; b. put under receivership or remove organs, tissues, cells or standardized transplants who are likely to threaten the health or are inconsistent with this Act; c. prohibit the use of premises or facilities or order the closure of a business; (d) suspend or revoke permissions.

The Agency may take provisional measures that are necessary. In case of justified suspicion, it can including confine or placed in his custody of organs, tissues, cells or disputed transplant.
When they suspect a violation of this Act, the customs services are empowered to grasp at the border or in the warehouses of the Customs shipments of organs, tissues, cells, or suspicious transplant and request the assistance of the office. It proceeds to subsequent investigations and takes the steps that are necessary.

Section 7 funding art. 66 Division of labour the Confederation and the cantons support, each in their field of competence, the costs associated with the execution of this Act.

Art. 67 fees fees are charged for: a. the granting, suspension and withdrawal of permissions; (b) enforcement of controls; c. the prescription and enforcement of measures.

The federal Council sets the scale of the fees in respect of enforcement of this Act by the federal authorities.

Section 8 remedies art. 68. the decisions taken in application of this law and its implementing provisions may be appealed before the federal administrative court.
If the appeal against a decision relating to the allocation of organs is based, the federal administrative court merely to see to what extent the impugned decision violates federal law.
Moreover, the remedies are governed by the General provisions of the Federal procedure.

New content according to ch. I-11 of the O of the SSA. fed. Dec 20. 2006 concerning the adaptation of legal acts to the disp. of the Federal Act on the TF and the LF on the TAF, in effect since July 1. 2007 (RO 2006 5599; FF 2006 7351).

Chapter 6 provisions criminal art. 69 crimes is punishable by imprisonment or a fine of 200,000 francs at most, unless he had done a more serious offence within the meaning of the penal code, anyone who, intentionally: a. gives or receives an any pecuniary benefit or other benefits for the donation of organs, tissues or cells of human origin (art. 6, al. 1); b. done trade bodies tissues or cells of human in Switzerland or abroad, from the Switzerland, origin or samples or transplanted organs, tissues or cells obtained against a pecuniary benefit or other benefit (art. 7, para. 1); c. takes on a deceased person of organs, tissues or cells in the absence of any consent (art. 8); d. contravene the provisions on preliminary medical measures (art. 10); e. takes bodies tissues or cells and cause, doing so, a serious risk to the life or health of the donor (art. 12, let. c); f. samples organs, tissues or cells on living persons incapable of discernment, without the required conditions are fulfilled (art. 13, para. 2 and 3) or minor; g. disadvantage a person when registering on the waiting list or in the allocation of organs (arts. 17 and 21 al. (2) or assigns organs without respecting the criteria (art. 18); h. violates the provisions relating to the duties of diligence (art. 30 to 35 and art. 45) and, in doing so, endangers the health of people i. endangers people's health by conducting clinical trials not comply with the requirements of this Act (art. 36); j determines the date and the method of termination of pregnancy on the basis of a later transplant of tissue or cells from the embryo or fetus (art. 37, al. 1); k. kept artificially alive of the entire surplus embryos developed beyond the seventh day or the embryos or whole fetuses from abortions in order to collect tissue and cells for transplantation purposes (art. 37, al. 2, let. a); l. transplanted tissues or cells from an embryo or a fetus on a person designated by the woman whose pregnancy is interrupted (art. 37, para. 2, let. b); Mr. used for purposes of transplantation of tissues and cells from embryos or fetuses from women incapable of discernment (art. 37, al. 2, let. c); n. contravenes the provisions relating to the information and the consent of the donor or of the couple concerned (arts. 39 and 40).

If the author is by profession, shall be punished for an imprisonment of more than five years or a fine of 500,000 francs at most.
If the author acts negligently, shall be punished for an imprisonment of six months or a fine of 100,000 francs at most.

RS 311.0 art. 70 contraventions punishable is stops or a fine of 50,000 francs to most anyone who, intentionally or negligently, and provided that he has not committed a crime within the meaning of art. 69: a. contravene the provisions governing the removal of organs, tissues or cells for purposes other than transplantation (art. 5); b. contravenes the provisions relating to the independence of nursing staff and medical personnel (art. 11 and 41); c. samples, organs, tissues or cells on living persons when well even the receiver could be treated by any other therapeutic method with comparable efficiency (art. 12 Let's. (d); d. contravenes the obligations to communicate and to announce (art. 20, 21, para. 3, 22, 24, 29, 36 and 62, al. 4); e. accepts, without authorization, bodies from abroad (art. 23, para. 2); f. performs acts subject to authorisation without being in possession of such authorization or without satisfying the charges related to the granting of the authorization (art. 25 27, 38 and 43); g. contravenes the obligation of secrecy without violating the art. 320 and 321 of the penal code (art. 57); h. violates the obligation to cooperate (art. 64); i. commits the acts referred to in art. 69, al. 1, let. h and i, without however jeopardizing people health; j. violates a provision of execution whose failure is declared punishable by the federal Council, or does not comply with a decision that was served under the threat of the penalty provided for in this section.

The attempt and complicity are punishable.
The contravention and the penalty prescribes five years.
In the case of very little gravity, we can give to the criminal complaint, the criminal prosecution and punishment.

RS 311.0 art. 71 jurisdiction and administrative criminal law pursuit and judgment of offences lies with the cantons.
The art. 6 and 7 (offences committed in a company) and 15 (false in securities, fraudulent obtaining a false statement) of the Federal Act of 22 March 1974 on administrative penal law shall apply.

RS 313.0 Chapter 7 provisions final art. 72 repeal of the law in force the federal decree of 22 March 1996 on the control of transplants is repealed.

[RO 1996 2296, 2001 1505 2790 annex ch. 7, 2002 3335 s. 1, 2005 4779]

Art. 73 amendment of the law in force the following laws are changed as follows:...

Mod. can be found at the RO 2007 1935.

Art. 74 transitional provision


Anyone who already has an activity referred to in art. 24 and 29 must notify the agency within six months of the entry into force of this Act.
Anyone who already has an activity referred to in art. 25 and 27 must ask permission to the office within six months of the entry into force of this Act. He may continue to exercise this activity until the notification of the decision of the office.
The permissions to the senses of the art. 18 and 18A of the federal decree of 22 March 1996 on the control of transplants are valid until their expiry date.
Are reserved the measures of the Agency as defined in art. 65. [2001 1505 RO] art. 75 referendum and entry into force the present law is subject to the referendum.
The federal Council shall determine the date of entry into force.

Date of entry into force: 1 July 2007 RO 2007 1935 RS 101 FF 2002 19A starting from Jan 1. 2007, the penalties and time limits must be adjusted according to the conversion of the art key. al 333. 2 to 6 CP (RS 311.0), in the content of the Federal Act of 13 Dec. 2002 (2006 3459 RO; FF 1999 1787).
ACF of March 16, 2007 status on January 1, 2014

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