¹ No person shall grant or collect any pecuniary benefit or other benefit for the donation of organs, tissues or cells of human origin.

² Not considered to be a pecuniary benefit or other benefit:

A.

The compensation of the donor for the loss of gain and the direct costs incurred;

B.

Compensation to the donor for damage suffered as a result of the removal of organs, tissues or cells;

C.

A symbolic gesture of post-transplant thanks;

D.

Cross-transplantation.

¹ It is prohibited:

A.

To trade organs, tissues or cells of human origin in Switzerland or abroad, from Switzerland;

B.

To collect or transplant organs, tissues or cells of human origin obtained against a pecuniary benefit or other benefit.

² This prohibition does not apply to:

A.

Reimbursement of costs related to transplantation, including the costs of collection, transportation, treatment, conservation and transplantation itself;

B.

Standard transplants referred to in s. 49.

¹ Organs, tissues or cells may be removed from a deceased person if:

A.

The person consented, before death, to such a collection;

B.

The death was noted.

² In the absence of any document attesting to the consent or refusal of the deceased, relatives are asked if they are aware of a donation declaration.

³ If the relatives are not aware of such a declaration, a removal of organs, tissues or cells may be made only if they consent to it. In making their decision, they must respect the presumed will of the deceased.

⁴ If the deceased does not have relatives or is not able to contact them, a levy is prohibited.

⁵ The will of the deceased takes precedence over that of the relatives.

⁶ If it is proved that the deceased has delegated to a person of trust the competence to make a decision concerning the removal of organs, tissues or cells, the latter shall act in place of the relatives.

⁷ A person who is 16 years of age is entitled to make a donation declaration.

⁸ The Federal Council defines the circle of relatives.

¹ One person died when brain functions, including brain stem, were irreversible.

² The Federal Council shall lay down provisions on the finding of death. In particular, it determines:

A.

The clinical signs that must be observed in order to be able to conclude that the functions of the brain, including the brainstem, are irreversible;

B.

The requirements to be met by physicians who are required to report death.

¹ Medical measures exclusively aimed at the conservation of organs, tissues or cells may be taken, prior to the death of the donor, only with the free and informed consent of the donor.

² Such measures are prohibited when they:

A.

Accelerate the death of the patient;

B.

May cause the donor to fall into a sustainable vegetative state.

³ In the absence of a donation declaration, such measures may be taken after the death of the patient until the decision of the relatives is known. The Federal Council shall determine the maximum permitted duration of such measures.

¹ A physician who reports the death of a person cannot:

A.

To participate in the collection or transplantation of organs, tissues or cells;

B.

Receive instructions from a specialized physician who is involved in the collection or transplantation.

² Physicians who remove or transplant organs, tissues or cells, as well as medical personnel involved in such acts, must not exert any pressure related to urgency or any other influence on persons who Caring for the patient at the end of life or when he or she dies.

Organs, tissues or cells may be removed from a living person if:

A.

It is major and capable of discernment;

B.

Gave free and informed consent, in writing;

C.

There is no serious risk to his or her life or health;

D.

The recipient cannot be treated with any other therapeutic method of comparable effectiveness.

¹ It cannot be removed from organs, tissues or cells on minor or indiscriminant presnants.

² Exceptionally, regenerating tissues or cells may be collected from underage or incompetent persons if:

A.

This is only a minimal risk and a minimal burden on the donor;

B.

The recipient cannot be treated with any other therapeutic method of comparable effectiveness;

C.

There is no major donor and capable of discernment;

D.

The recipient is the father, mother, child, brother or sister of the donor;

E.

The donation can save the life of the recipient;

F.

The legal representative gave free and informed consent in writing;

G.

The donor, capable of discernment but still a minor, gave his free and informed consent in writing;

H.

There is no evidence to suggest that the indiscriminating person would oppose a levy;

I.

An independent authority has given its consent.

³ Incompetent donors are involved to the greatest extent possible in the information process and in the process of seeking consent.

⁴ The cantons establish an independent authority within the meaning of para. 2, let. I, and settle the procedure.

¹ Anyone who collects on a living person from organs, tissues or cells shall ensure that it is adequately insured against possible serious consequences of the levy.

² An insurer who, in the absence of a gift by a living person, should bear the costs of the treatment of the recipient's disease, is responsible for:

A.

The costs of this insurance;

B.

A fair compensation for loss of gain or other costs incurred by the donor in relation to the levy.

³ The obligation to bear costs within the meaning of para. 2 exists even if retrieval or transplantation cannot be performed. If the insurer of the recipient is not known, the Confederation will bear the costs.

⁴ The Federal Council rules in particular:

A.

The serious consequences for which the donor must be insured;

B.

The content and extent of insurance within the meaning of para. 1;

C.

Other costs which must be borne within the meaning of para. 2, let. B.

¹ The Federal Council defines the requirements to be met by information within the meaning of s. 12, let. B and 13, para. 2, let. F and g.

² It can identify therapeutic methods that do not have comparable effectiveness for the recipient.

¹ This section governs the allocation of organs when donors have not designated a recipient.

² The Federal Council:

A.

Determine the bodies to be awarded in accordance with this section;

B.

May declare this section applicable to the assignment of tissues and cells.

¹ When assigning a body, no one shall be discriminated against.

² When allocating organs, persons domiciled in Switzerland must be treated equally.

³ An available organ is assigned to a non-resident person in Switzerland on the waiting list in accordance with Art. 21, para. 1:

A.

If the transplantation is urgent from a medical point of view and no person domiciled in Switzerland is in the same situation;

B.

If the transplant is not urgent but there is no resident recipient in Switzerland.

⁴ No one shall have the right to the assignment of an organ.

¹ In particular, the following criteria should be considered for the award:

A.

The medical emergency of transplantation;

B.

The effectiveness of transplantation from a medical perspective;

C.

The timeout period.

² At the time of allocation, efforts are being made to ensure that patients who, because of their physiological characteristics, have to expect a very long waiting period have the same probability of receiving a body as those who do not Not these characteristics.

³ The Federal Council shall determine the order in which the criteria shall be applied or the laying down.

¹ The Confederation created a national remit service.

² The national authority service:

A.

Maintains a list of persons awaiting organ transplantation (waiting list);

B.

Allocates organs available to recipients after consultation with transplant centres;

C.

Organises and coordinates all activities relating to allocations at national level;

D.

Collaborates with the relevant foreign organisations for the tasks.

³ The National Allocations Service establishes a record for each decision and retains it for 10 years.

⁴ The Federal Council shall rule on the procedure applicable to allocations.

The attending physician must notify a transplant centre as soon as possible of the name of the patient for whom a transplant is medically appropriate, with the written consent of that person being required. Communication must also take place if the patient is undergoing replacement therapy.

¹ The waiting list is open to persons domiciled in Switzerland. The Federal Council lays down the conditions to which persons who are not domiciled in Switzerland may be registered.

² Transplant Centres refer to persons who are on the waiting list and those who are deregistered. Their decisions are based solely on medical reasons. Art. 17, para. 1, shall apply mutatis mutandis.

³ Transplant centres shall communicate their decisions with the data necessary for the national authorities.

⁴ The Federal Council specifically describes:

A.

The medical reasons referred to in para. 2;

B.

The necessary data referred to in para. 3.

¹ Hospitals and transplant centres shall communicate to the national authority, with the necessary data, the names of the deceased persons who are amenable to organ removal. The Federal Council shall specify the necessary data.

² Physicians, hospitals and transplant centres to which a person has declared his or her willingness to give his or her lifetime an organ to an unknown person are required to communicate the name of that potential donor to the national service of the Allotments.

¹ Where there is no suitable recipient in Switzerland, the national authority service provides the body to a foreign allocation organisation. It is reserved for the exchange of a body within the framework of international programmes for patients within the meaning of Art. 18, para. 2.

² Only the national authority service has the authority to accept an offer from abroad.

³ The national authority service may enter into agreements with foreign allocation organisations on the reciprocal exchange of organs. These conventions are subject to the approval of the Federal Office of Public Health (Office).

¹ Any person who collects organs, tissues or cells on human beings shall announce it to the Office.

² The Federal Council shall determine the data to be announced and the duties of the persons subject to the obligation to announce.

¹ To be the holder of an authorisation issued by the Office any person:

A.

Stores tissues or cells;

B.

Imports or exports organs that are not allocated under s. 16 to 23, as well as tissues or cells;

² Storage in a customs warehouse is considered to be imported.

³ The authorization is issued:

A.

Whether the requirements for professional qualifications and exploitation are met;

B.

If there is an appropriate quality assurance system.

⁴ The Federal Council regulates the conditions for granting authorisation, as well as the procedure and lays down the obligations of persons subject to authorisation.

The Federal Council may make provisions for the preparation of organs, tissues and cells. In doing so, it takes into account recognized international guidelines and standards.

¹ Only transplant centres for the benefit of an authorisation by the Office are authorised to transplant organs.

² The authorization is issued:

A.

Whether the requirements for professional qualifications and exploitation are met;

B.

If there is an appropriate quality assurance system that also ensures the medical follow-up of living donors;

C.

If the quality of the transplants is assured.

³ Transplantation centres must regularly record, evaluate and publish the results of transplants according to uniform criteria.

⁴ The Federal Council may submit the grafts of tissues and cells to an authorisation issued by the Office.

The Federal Council may limit the number of transplant centres after consulting the cantons and taking into account developments in the field of transplantation medicine.

¹ Anyone who transplants tissue or cells should announce it to the Office.

² The Federal Council shall determine the data to be announced and the duties of the persons subject to the obligation to announce.

¹ Any person who collects or transplants organs, tissues or cells shall examine the suitability of the donor for this purpose.

² Are excluded from donors:

A.

Persons on whom organs, tissues or cells of animal origin or standardized transplants obtained from such organs, tissues or cells have been transplanted;

B.

Persons who are not covered by the let. A and whose organs, tissues or cells can transmit disease agents or be responsible for another title of the degradation of the recipient's health; s. 31, para. 2, let. C, is reserved.

³ The Federal Council shall lay down the requirements relating to the suitability of the donor, the competence to establish such aptitude and the data to be identified on that occasion.

¹ Anyone who collects or transplants organs, tissues or cells must ensure that they have been tested to detect the presence of pathogens or evidence of such presence.

² In particular, the Federal Council determines:

A.

Pathogens or indices of their presence to be tested for detection;

B.

Tests that can be used;

C.

Cases in which organs, tissues or cells, although reactive to the test, may be transplanted.

³ It may provide for derogations from the obligation to carry out tests if it can be guaranteed in a different way than any infection by pathogens is excluded.

The Federal Council may provide that the use of processes for the removal or inactivation of pathogens is subject to authorisation by the Office.

The organs, tissues and cells, as well as the samples of analysis thereof, must be labelled in such a way as to be perfectly identifiable.

¹ Anyone who uses organs, tissues or cells must:

A.

Record all major public health operations;

B.

Make the recordings in such a way that the recorded data can be traced back to the donor and the recipient.

² At each organ, tissue or cell transplant or transplant, the donor's and recipient's name, first name, and date of birth are recorded.

¹ The records required by s. 34 and all important documents must be kept for 20 years.

² In the event of cessation of activities prior to the expiration of the time limit, all records and documents shall be kept in a secure place or, if not possible, returned to the Office.

¹ Before being carried out, clinical trials for the transplantation of organs, tissues or cells of human origin require the authorisation of the Office. The Federal Council may exempt the regime from the authorization of specified clinical trials or plan to submit them to an obligation to advertise.

² The Office shall verify that the organs, tissues or cells used in the clinical trial meet the requirements of this Law. It can control the execution of a clinical trial at any time.

³ The Federal Council shall issue procedural provisions. Any amendment to a clinical trial may be subject to authorization.

⁴ It may provide for an obligation to advertise and inform, in particular in the following cases:

A.

The clinical trial is completed or discontinued;

B.

Adverse events occur during the clinical trial;

C.

Events that occur during the clinical trial may affect the safety or health of the individuals involved.

⁵ The Federal Council shall issue the provisions required under paras. 3 and 4 taking into account recognized international regulations.

⁶ The Human Research Act of 30 September 2011 ² Also applies to clinical trials.

¹ The date of termination of pregnancy and the method used must be chosen independently of a subsequent transplantation of tissues or cells from the embryo or fetus.

² It is prohibited:

A.

Artificially maintain the life of whole supernumerary embryos developed beyond the seventh day or embryos or whole fetuses from abortion for the purpose of removing tissues and cells for transplantation;

B.

Transplant tissue or cells from an embryo or fetus into a person designated by a woman whose pregnancy is interrupted;

C.

To use, for transplantation, tissues or cells derived from embryos or fetuses from women who are unable to discernment.

¹ Any person who intends to graft tissue or cells from human embryos or fetuses on the human being must first obtain an authorization issued by the Office.

² The authorization to conduct a clinical trial is issued:

A.

If it is expected that transplantation will be of therapeutic benefit;

B.

Whether the requirements for professional qualifications and exploitation are met;

C.

If there is an appropriate quality assurance system.

³ The authorization to administer a standard treatment is issued if:

A.

The therapeutic usefulness of the treatment is established;

B.

The recipient cannot be treated with any other therapeutic method of comparable effectiveness;

C.

The requirements set out in para. 2, let. B and c are completed.

¹ The consent of a pregnant woman for the use, for the purposes of transplantation, of tissues or cells derived from the embryo or foetus, can only be sought after the decision to interrupt the pregnancy has been made.

² The tissue or cells derived from an embryo or foetus can only be transplanted with the free and informed consent of the donor, given in writing.

¹ The consent of the couple concerned for the use in transplantation of tissues or cells derived from a supernumerary embryo may be sought only once the existence of such an embryo has been established.

² Tissues and cells derived from supernumerary embryos may be transplanted only with the free and informed consent of the couple concerned, given in writing.

Persons involved in transplantation should not influence medical personnel who are engaged in termination of pregnancy or medically assisted procreation. They cannot participate or provide guidance to those involved in the intervention.

The Federal Council fixes:

A.

The requirements to be met by the information within the meaning of s. 39 and 40;

B.

The obligations of persons subject to the authorization regime;

C.

Conditions relating to the authorisation and authorisation procedure.

¹ The execution of this Law shall be the responsibility of the Confederation in so far as it is not expressly reserved for the cantons.

² The Federal Council shall issue the implementing provisions.

¹ The Confederation shall supervise the execution of this Law by the cantons.

² It shall coordinate the implementing measures of the cantons where uniform execution is required at national level. For this purpose, it may in particular:

A.

Require the cantons to inform them of the implementing measures they take;

B.

Impose certain measures on the cantons in order to ensure a uniform enforcement of the law.

At the international level, the Confederation is taking measures to facilitate the exchange of information, to promote a rapid and safe exchange of organs, tissues and cells, and to actively combat organ trafficking.

The Confederation may organise or support professional development and continuing training programmes preparing medical staff to take appropriate care of the donors and their relatives.

¹ The Federal Council may delegate implementation tasks to organisations and persons governed by public law or private law.

² This jurisdiction applies in particular to:

A.

The allocation of organs within the meaning of Art. 19;

B.

The maintenance of the stem cell registry provided for in s. 62;

C.

Control within the meaning of s. 63.

³ The Federal Council provides for the remuneration of delegated tasks.

¹ The Office shall conduct scientific assessments of the performance and effects of this Law.

² These evaluations include:

A.

The impact of the law on the state of the situation, the opinion and attitude of the population and medical staff;

B.

The practice of organ allocation, the quality of transplants and the availability of organs, tissues and cells for transplantation.

³ The Federal Department of the Interior reports to the Federal Council on the outcome of the evaluations and submits proposals for further evaluation.

¹ The cantons organise and coordinate the activities relating to transplants:

A.

In hospitals where donors are supported;

B.

In transplant centres.

² In particular, they provide that each hospital and transplant centre:

A.

Has a local coordinator;

B.

Organises professional development and continuing training programs for medical staff.

³ The local coordinator shall ensure that:

A.

Donors and their families are adequately cared for;

B.

The names of the donors are communicated to the national authorities (art. 22).

Every person responsible for the execution of this Law shall be obliged to keep the secret.

Any data collected under this Act, the disclosure of which is likely to affect a trustworthy interest, shall be treated as confidential.

¹ Unless there is a overriding private interest, data may be disclosed in certain cases, upon written and substantiated request:

A.

Civil courts, where they are necessary to judge a dispute;

B.

Criminal courts and criminal investigation authorities, where they are necessary to solve a crime or a crime.

² Unless there is overriding private interest, data may be provided:

A.

To the services of the Confederation and the cantons and to the organisations and persons governed by public law or by private law who are responsible for the implementation of this Law, if they are necessary for the performance of the tasks which Entrusted to them under this Act;

B.

Criminal investigation authorities, if the denunciation or prevention of a crime or an offence within the meaning of this Act requires it.

³ Data of general interest relating to the application of this Law may be published. The data subjects must not be identifiable.

⁴ Moreover, they may be communicated to third parties:

A.

Data that does not relate to individuals, provided that their communication is of overriding interest;

B.

Personal data, provided that the person concerned has given, in each case, his or her consent in writing.

⁵ Only the data necessary for the intended use can be communicated.

⁶ The Federal Council regulates the way in which data and information are communicated to the data subjects.

¹ The Federal Council regulates the competences and the procedure for exchanging data with foreign authorities and institutions and with international organisations.

² The disclosure of confidential data to foreign authorities and institutions or to international organizations shall be permitted only if:

A.

International conventions or decisions emanating from international organizations;

B.

This is necessary to prevent an imminent risk to life or health; or

C.

This allows for the development of illegal traffic or other serious offences under this Act.

¹ The Office and the Cantons shall regularly inform the public on issues related to transplantation medicine. To this end, they may collaborate with organisations and persons of public or private law.

² The information includes:

A.

Give everyone the opportunity to express their will concerning the donation of organs, tissues or cells in full knowledge of the facts;

B.

Introduce regulations and practice, including the conditions for the collection, allocation and transplantation of organs, tissues and cells in Switzerland.

³ The Federal Council may provide for the possibility to include in a document or data medium appropriate the will of a person concerning the donation of organs, tissues or cells.

¹ The Office maintains a register of stem cells.

² The stem cell registry is used to identify cells that can be transplanted to a specified recipient. The data entered in the register can only be used for the purpose mentioned above.

³ The data necessary for the establishment of the compatibility of the tissues shall be entered in the Register, or the data concerning:

A.

Stored stem cells;

B.

Those who have declared themselves ready to make a donation.

⁴ Anyone who deals with the data referred to in para. 3 transmits them to the authority holding the register. The data must be transmitted in a personalised manner only if the purpose mentioned in para. 2 requires it.

⁵ Any person who is registered in the Register may request, at any time, that the data concerning him be deleted.

⁶ The Federal Council specifies the type of stem cells managed in this register.

¹ The Office shall ensure that the provisions of this Law are complied with. For this purpose, it shall conduct periodic inspections in particular.

² It may take the necessary samples free of charge, require the relevant information and documents and request further assistance. It may instruct the customs authorities to take samples.

³ It has access to buildings, businesses, premises and vehicles for the performance of its tasks.

The person who uses standardized organs, tissues or cells or transplants shall be free to assist the Office in the performance of its tasks. It should include:

A.

Allow it to take samples and provide them with the samples requested;

B.

Provide the required information;

C.

Allow it to view the files and to access the premises.

¹ The Office may take any measures necessary for the implementation of this Law.

² It may include:

A.

Challenge a de facto situation and allow for an appropriate period of time to re-establish a situation in accordance with the law;

B.

Sequester or dispose of standardized organs, tissues, cells or transplants that are likely to threaten health or are not in accordance with this Act;

C.

Prohibit the use of premises or facilities or order the closure of a business;

D.

Suspend or revoke authorizations.

³ The Office may take appropriate provisional measures. In the event of suspicion, it may, in particular, sequester or place in its custody organs, tissues, cells or standardised transplants contested.

⁴ When suspecting an offence under this Act, customs services shall be entitled to seize, at the border or in the customs warehouses, shipments of suspected standardized organs, tissues, cells or transplants and to request The competition of the Office. The Committee shall carry out the necessary further investigations and shall take the necessary measures.

The Confederation and the Cantons shall bear, each in their field of competence, the costs associated with the implementation of this Law.

¹ Fees are collected for:

A.

The granting, suspension and withdrawal of licences;

B.

The carrying out of controls;

C.

Prescribing and carrying out measures.

² The Federal Council shall fix the scale of fees collected for the performance of this Act by the federal authorities.

¹ Decisions taken pursuant to this Act and its implementing provisions may be appealed to the Federal Administrative Tribunal.

² If the appeal against a decision on the allocation of organs is well founded, the Federal Administrative Court merely notes the extent to which the contested decision infringes federal law.

³ In addition, the legal remedies are governed by the general provisions of the federal procedure.