This order shall rule:

A.

Clinical trials and standard xenotransplantation treatments, as well as the duty of care to be followed in this regard;

B.

Safety measures and the rules of behaviour that persons affected by xenotransplantation must observe;

C.

Liability coverage.

¹ For the purposes of this order:

A.

Xenotransplantation: Any transplantation or infusion:

1.

Organs, tissues or cells of animal origin,

2.

Human organs, tissues, cells or fluids that have been in contact, outside the human body, with organs, tissues or cells of animal origin, or

3.

Standardized transplants derived from the organs, tissues or cells referred to in c. 1 and 2;

B.

Contact persons: Persons who are likely to come into direct or indirect contact with the recipient's biological fluids, including through percutaneous or other direct exposure, or through contact with mucous membranes, including the partner Intimate, medical and laboratory personnel;

C. ¹

Health-related intervention: Any preventive, diagnostic, therapeutic, palliative or rehabilitative act studied in a clinical trial;

D. ²

Proponent: Any person or institution whose registered office or representation is located in Switzerland, who is responsible for the initiative of a clinical trial in Switzerland, including launch, management and funding;

E. ³

Investigator: Any person responsible for the practical implementation of the clinical trial in Switzerland and the protection of the persons involved in the research project at the place of realization; where an investigator assumes responsibility for the initiative of a trial Clinic in Switzerland, it is also a promoter.

² In addition, the definitions given to s. 2, para. 1, of the order of 16 March 2007 on transplantation ⁴ And art. 2 of the Clinical Trials Order of September 20, 2013 (OClin) ⁵ Are applicable. ⁶

¹ The authorization to conduct a clinical trial is issued if:

A.

The operation has a technical person with the necessary knowledge and experience, empowered to give instructions in his field of activity and responsible for quality;

B.

The following specialists participate in the clinical trial with the attending physicians:

1.

An infectious disease specialist, a microbiologist and a virologist, each of which is responsible for continuing education and experience in the field of zoonoses,

2.

An epidemiologist,

3.

A veterinarian with experience in the fields of infectiology of resource species and animal husbandry, with specific knowledge of animal protection, characteristics, needs And diseases of the resource species and their use in xenotransplantation;

C.

The necessary medical staff is available;

D.

A microbiology laboratory with a department of virology is available, the head of which specialises in scientific work and diagnosis and possesses the required knowledge in the fields of isolation and identification Human and animal pathogens;

E.

Appropriate premises and facilities to ensure, in particular, quarantine facilities are available;

F.

The person seeking the authorization proves that the security conditions are met.

² The authorisation to carry out a clinical trial involving the use of genetically modified organs, tissues or cells of animal origin or of standardised transplants shall be issued if, in addition:

A.

The quality and biological safety of genetically modified organs, tissues or cells of animal origin, or of the standardised transplants derived from them, are guaranteed with regard to the research subject and, in general, to the human being, Animals and the environment;

B.

The Federal Office for the Environment (OFEV) has, in consideration of the protection of the environment and the indirect protection of the human being, given its agreement for the trial.

A clinical trial of xenotransplantation may be conducted on an incompetent person:

A. And b. ¹ ...

C.

If it is ensured that the rules of behaviour and the measures imposed by xenotransplantation, in particular the obligation to submit to life follow-up, will be observed;

D.

If no alternative therapy with comparable efficacy exists, and

E.

If any of the following conditions are met:

1.

It is highly likely that xenotransplantation will save the life of the research subject,

2.

It is highly likely that the research subject will regain its ability to discernment through xenotransplantation,

3.

It is highly likely that xenotransplantation greatly relieves the suffering of the research subject.

¹ A clinical trial of xenotransplantation can only be conducted if the recipient or his or her legal representative has been fully and understandably informed and has consented freely and in writing to xenotransplantation and the rules of The behaviour and measures it imposes.

² Information should include:

A.

The risk of infection by known or unknown zoonotic agents;

B.

The need for the recipient to undergo regular medical examinations;

C.

The obligation to notify any new contact person of the risk of infection with zoonotic agents, and to report the person to the authorization holder without delay;

D.

The need to retain biological information and samples, and the extent of data protection;

E.

The need for an autopsy on the recipient after death;

F.

The rules of behaviour that the recipient must observe in order to avoid any transmission of an infection.

³ ... ¹

¹ Prior to xenotransplantation, the holder of the authorization shall ensure that the contact persons are fully and understandably informed by the investigator of the rules of conduct and of the measures that the xenotransplantation Impose. These individuals confirm in writing that they have been informed.

² In particular, contact persons should be informed of the risks posed by:

A.

Contact with or care of the recipient;

B.

Use of biological samples.

³ The obligation to inform also applies to any new contact person.

¹ The holder of the authorization regularly submits the recipient to medical examinations.

² These medical examinations are carried out:

A.

At least once immediately before and immediately after xenotransplantation;

B.

At regular intervals within days and weeks following xenotransplantation;

C.

Then, within ten years, at least once a year; thereafter, at least every five years if there has been no clinical suspicion of infection due to transplantation in the last two years.

³ Appropriate biological samples, in particular serum, plasma, and peripheral blood mononuclear leukocytes, are collected from the recipient at each medical examination and then analyzed for the presence of agents Pathogens or indices suggesting the presence of such agents.

⁴ The holder of the authorisation shall immediately inform the Federal Office of Public Health (OFSP) if the recipient no longer submits to the medical examinations.

¹ If the recipient has signs of infection or a contact person has an inexplicable infection, the holder of the authorization will take all appropriate measures to prevent the spread of these infections.

² It shall immediately carry out detailed diagnostic and epidemiological examinations until the cause of the infection is clearly identified or all signs of infection have practically disappeared.

When the recipient dies, the holder of the authorization:

A.

Immediately notifies the FPO of his or her death;

B.

Conducts microbiological, pathological and histopathological examinations on the recipient's body for possible infection;

C.

Immediately forward the results of these reviews to the FOPH.

¹ Art. 3 to 5, 6, para. 1, 2 and 4, and art. 7 to 9, 24 to 29, 37 to 41, 43 and 44 OClin ² As well as the organization's order concerning the HR of 20 September 2013 ³ Are applicable.

² The obligations with regard to the Swiss Institute for Therapeutic Products as set out in Art. 37 to 41 and 43 OClin, are applicable to the FOPH for xenotransplantation clinical trials.

¹ Any changes made in the course of a clinical trial require the authorization of the FOPH.

² The holder of the authorisation shall deliver the documents concerned by the amendment to the OFSP. ¹

¹ The authorization to conduct a xenotransplantation in a standard treatment is issued if:

A.

The operation has a technical person with the necessary knowledge and experience, empowered to give instructions in his field of activity and responsible for quality;

B.

The person seeking the authorization proves that the security conditions are met;

C.

If there is no other treatment with comparable effectiveness for the recipient.

² The authorisation to carry out xenotransplantation in the course of a standard treatment involving the use of genetically modified organs, tissues or cells of animal origin, or of standardised transplants derived from them, shall be issued if, In addition:

A.

The quality and biological safety of genetically modified organs, tissues or cells of animal origin, or standardised transplants derived from them, are guaranteed to the patient and, in general, to the human being, the animals And the environment;

B.

The OFEV has, in consideration of the protection of the environment and the indirect protection of the human being, given its agreement for standard treatment.

Xenotransplantation may be carried out if the recipient or his or her legal representative has been informed in a comprehensive and understandable manner and has consented freely and in writing to xenotransplantation and the rules of conduct and measures Imposes.

In medical examinations carried out as a result of xenotransplantation, the holder of the authorization takes appropriate biological samples from the recipient to detect the presence of pathogens or indications of presence Such agents.

When the recipient dies, the authorization holder conducts microbiological, pathological and histopathological examinations on the recipient's body for possible infection.

¹ Cell lines of animal origin may be used for xenotransplantation:

A.

Whose provenance is documented;

B.

For which it is established, according to a procedure adapted to the state of science and technology, that they are free of pathogenic organisms for the species species and for the human being.

² The authorisation holder regularly analyses the animal cell lines used, in order to detect the presence of pathogenic organisms in accordance with para. 1, let. B.

¹ It is forbidden to use primates as resource animals. Xenotransplantation of primate cells may exceptionally be permitted if the latter are derived from cell lines. This exception does not apply to anthropoid monkeys.

² Can be used as animal resources only:

A.

Have been bred in captivity for so many generations that it is possible to guarantee, through a procedure adapted to the state of science and technology, that they are free of pathogenic organisms for the resource species and for the human being;

B.

Whose provenance is exhaustively documented;

C.

That come from flocks in a confined environment.

³ The requirements for animal resources and cell lines of animal origin used in standard treatments are the same as those for clinical trials. This includes:

A.

Genetic properties of resource animals and cell lines;

B.

Surveillance and health status of resource animals and control of cell lines, including possible infections with viruses or bacteria;

C.

The conditions for the raising and holding of the resource animals and the conditions for the cultivation and preservation of the cell lines.

⁴ The authorisation holder regularly carries out a review of the health status of resource animals, including clinical, microbiological and histological analyses; he also carries out pathological and histopathological examination of the Animals after their death.

⁵ It shall not use the resource animals, their organs, tissues, cells or standardized transplants derived from them for other purposes; it shall eliminate them in accordance with art. 13 of the Order of 23 June 2004 concerning the disposal of animal by-products ¹ .

¹ The organs, tissues or cells of animal origin, the standardised transplants derived from them, or the animal on which they were collected shall be analysed in accordance with the state of science and technique, by means of available tests; These analyses will be aimed at detecting zoonoses or prion diseases that can cause infection in humans.

² The purpose of these analyses is to detect the presence of:

A.

Known or potential zoonotic agents;

B.

Human pathogens known to be human pathogens;

C.

Infectious agents with a high risk of mutation and recombination;

D.

Agents whose pathogenic risk is still unknown.

³ If the analyses are carried out abroad, the OFSP must be certified to be in compliance with the state of science and technology.

⁴ The FOPH may require that the results of the analyses be confirmed by an independent reference laboratory.

Xenotransplantation is prohibited if there is an index suggesting the presence of a pathogenic infection for the known or potential human being.

Organs, tissues or cells which are derived from genetically modified animals or have undergone genetic modification after their removal, the standardised transplants derived from them and the genetically modified animals are Labelled with the words "genetically modified".

¹ The holder of the authorization shall remove a sufficient quantity of biological samples for examination under s. 7 to 9, and 15 to 19.

² It must take a quantity of its own to allow the FOPH to perform at least three times a complete examination of the samples during the retention period prescribed in s. 24.

³ Samples are prepared so that they can be stored for a long period of time.

The authorization holder shall record all relevant data and processes for the protection of public health, including results:

A.

Medical examinations referred to in s. 7 and 15;

B.

An autopsy referred to in s. 9 and 16;

C.

Diagnostic and epidemiological examinations referred to in s. 8;

D.

Controls of cell lines of animal origin referred to in s. 17;

E.

Monitoring of the health status of animals referred to in s. 18;

F.

Analyses referred to in s. 19.

¹ The holder of the authorization shall keep all records and biological samples important for the protection of public health:

A.

For unlimited duration, for those who come from clinical trials;

B.

For at least 20 years after the death of the recipient, for those who come from standard treatments.

² Biological records and samples:

A.

Are labelled and maintained so that they can be found and identified quickly;

B.

Are made available to the FOPH and the competent cantonal doctor when making the request.

¹ If the holder of the authorisation finds a fact which may be of importance for the protection of public health, it shall be held:

A.

Inform the OFSP and the competent cantonal doctor immediately;

B.

Take all necessary measures immediately.

² The authorities referred to in para. 1, let. A, must continually be informed of the measures taken and planned and their effects.

¹ Anyone who practices xenotransplantation or gives to third parties organs, tissues or cells for xenotransplantation must guarantee, at a cost of 20 million francs, the coverage of the damage that it is responding to.

² The obligation to provide guarantees may be fulfilled by the conclusion of a civil liability insurance contract or the provision of guarantees for an equivalent amount. The civil liability insurance contract shall be concluded with an insurance company authorised to practice in this field of activity.

³ The Confederation and its corporations and establishments governed by public law are not subject to the obligation to provide guarantees.

⁴ The person covering the civil liability shall communicate to the FOPH the dates on which the guarantee takes effect and ends, as well as any suspension.

The processing of personal data and the security of data are governed by Art. 48 and 49 of the order of 16 March 2007 on transplantation ¹ .

¹ The application for an authorization under s. 3 and 13 should be addressed to the FOPH.

² The application for authorization of a xenotransplantation clinical trial (s. 3) must include:

A.

Detailed basic scientific literature;

B.

A study documentation in accordance with Schedule 2 and the documents referred to in s. 29 of the order of 16 March 2007 on transplantation ¹ ;

C.

A document certifying that records and biological samples may be kept in accordance with s. 24.

³ The application for authorization of xenotransplantation as part of a standard treatment (s. 13) shall include:

A.

Scientific literature, including the results of pre-clinical and clinical trials;

B.

Documents and forms accounting for the information given to the recipient or the recipient's legal representative and consent;

C.

A document certifying that records and biological samples may be kept in accordance with s. 24.

⁴ If genetically modified organs, tissues or cells of animal origin, or standardized transplants derived from them, are used for xenotransplantation, the application for authorization must also include:

A.

Data on risks to humans, animals and the environment; this data must also include the results of the risk assessment carried out pursuant to the order of 25 August 1999 on the contained use ² Conducted in the context of a foreign proceeding applicable to the use of confined organisms;

B.

Risk assessment of xenotransplantation for humans, animals and the environment;

C.

A description of the safety measures necessary to protect humans, animals and the environment, in particular to prevent the release of microorganisms into the environment during and after xenotransplantation; and Transportation, storage and disposal;

D.

A document attesting to the integrity of the animals from which the genetically modified organs, tissues and cells originate, in accordance with art. 8 and 9 of the Law of 21 March 2003 on Genetic Engineering ³ .

¹ The FOPH shall decide on applications for authorisation of xenotransplantation involving the use of genetically modified organs, tissues or cells of animal origin, or of standardised transplants resulting from it, after having taken the opinion of the Office of the European Parliament, The Federal Commission of Experts on Biological Safety (CFSB) and the Federal Ethics Commission for Biotechnology in the Non-Human Domain (CENH).

² If the application relates to xenotransplantation within the meaning of s. 2, para. 1, paragraph a, c. 3, the FOPH also requests the opinion of the Swiss Institute for Therapeutic Products.

³ It shall forward its decision to the OFEV, the CFSB and the CENH; where the decision concerns an application for a clinical trial authorisation, it shall also forward it to the relevant Ethics Commission and, where it relates to an application referred to in para. 2, also at the Swiss Institute for Therapeutic Products.

¹ The FOPH conducts an inspection to verify that the conditions for granting the authorization are met.

² It may, at any time, carry out additional inspections. It may instruct the cantons or third parties to carry out inspections.

The scientific assessment of applications for authorisation and the scope, duration of validity, suspension, withdrawal and publication of authorisations shall be governed by Art. 38 and 41 to 43 of the order of 16 March 2007 on transplantation ¹ .

The Federal Department of the Interior may issue technical requirements relating to the authorisation system and records, taking into account relevant international standards.

The Federal Department of the Interior may update the annexes in order to adapt them to international developments or technical developments. It shall carry out updates which may constitute technical barriers to trade in agreement with the Federal Department of Economics, Training and Research ¹ .

This order shall enter into force on 1 ^Er July 2007.