Rs 810.213 Order Of 16 March 2007 On The Transplantation Of Organs, Tissues And Cells Of Animal Origin (Ordinance On Xenotransplantation)

Original Language Title: RS 810.213 Ordonnance du 16 mars 2007 sur la transplantation d’organes, de tissus et de cellules d’origine animale (Ordonnance sur la xénotransplantation)

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.
810.213 order on the transplantation of organs, tissues and cells of animal origin (Ordinance on xenotransplantation) of March 16, 2007 (Status January 1, 2014) the Swiss federal Council, view the art. 48, 50, al. 2, 59, al. 6, and 60, al. 1, of the Act of 8 October 2004 on transplantation, stop: Section 1 purpose and definitions art. 1 purpose this rule order: a. clinical trials and standard treatments of xenotransplantation and the duties of diligence to respect in this area; b. security measures and rules of behavior that those involved in xenotransplantation should observe; c. the liability coverage.

Art. 2 definitions to the meaning of the Ordinance, means: a. xenotransplantation: any transplantation or infusion: 1. of organs, tissues or cells of animal origin, 2. of organs, tissues, cells or human biological liquids that have been in contact, outside the human body with organs, tissues or cells of animal origin, or 3. transplants standardized from the organs, tissues or cells referred to in points 1 and 2;

b. contact persons: persons likely to come into contact directly or indirectly with liquids biological of the recipient, including percutaneously or by any other form of direct exposure, or by contact with mucous membranes, including the intimate partner, medical staff and laboratory personnel; c. health-related intervention: any preventive, diagnostic, therapeutic, palliative or rehabilitation studied in a clinical trial; d. promoter : any person or institution whose headquarters or representation are in Switzerland, who is responsible for the initiative of a clinical trial in Switzerland, including the launch, management and fundraising; e. investigator: anyone responsible for implementing practical trial in Switzerland and the protection of persons participating in the research instead of making project; When an investigator is responsible for the initiative of a clinical trial in Switzerland, it is also promoter.

In addition, the definitions given in art. 2, al. 1, of the Ordinance of March 16, 2007 on transplantation and art. 2 the order of September 20, 2013, on clinical trials (Clino) are applicable.

Introduced by section 2 of Schedule 6 to the O from 20 sept. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
Introduced by section 2 of Schedule 6 to the O from 20 sept. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
Introduced by section 2 of Schedule 6 to the O from 20 sept. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
RS 810.211 RS 810.305 new content according to section 2 of Schedule 6 to the O from 20 sept. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).

Section 2 tests clinics art. 3 conditions for the grant of the authorization relating to the qualifications of the staff and operating the authorization to conduct a clinical trial is issued if: a. has operating a technical official with the knowledge and experience needed, empowered to give instructions in its field of activity and the quality manager; b. the following specialists participate in the clinical trial with referring physicians : 1. a number, a microbiologist and a virologist, each in front of show experience and continuous training in the field of zoonoses, 2. an epidemiologist, 3. a veterinarian experience in the areas of the infectious disease of the species resources and breeding of laboratory animals, and with specific knowledge on the protection of animals, on the characteristics, needs and resources species and on the use of these diseases in xenotransplantation;

c. staff medical necessary is available; d. a Microbiology Laboratory with a Department of Virology is available, whose Chief specializes in scientific work and diagnosis and has the required knowledge in the areas of isolation and identification of human and animal pathogens; e. premises and facilities appropriate to ensure in particular, a quarantine are available; (f) the person seeking the authorization proves that security conditions are met.

The authorization to conduct a clinical trial involving the use of organs, tissues or cells of animal origin, genetically modified, or transplant resulting, if, additionally: a. quality and biological security organs, tissues or cells of animal origin, genetically modified, or standardized transplants who emerged, are guaranteed to the research topic and in general, for human beings, animals and the environment; (b) the federal Office for the environment (FOEN) has, consideration of protection of the environment and the indirect protection of the human being, given its agreement for the test.

Art. 4 protection of incapable persons of discernment a xenotransplantation clinical trial can be performed on a person incapable of discernment: a. and b... c. If it is guaranteed that the behavior rules and measures imposed xenotransplantation, particularly the obligation to undergo a follow-up to life, will be observed; d. If there is no alternative therapy whose efficacy is comparable summer. If any of the following conditions are met: 1. it is highly likely that xenotransplantation saves the life of the research subject, 2. it is highly likely the research topic covers its ability of discernment through xenotransplantation, 3. it is highly likely that xenotransplantation considerably relieves the suffering of the research topic.

Repealed by no. 2 of Schedule 6 to the O on Sept. 20. 2013 on clinical trials, with effect from Jan 1. 2014 (2013 3407 RO).

Art. 5 information and consent of the receiver a xenotransplantation clinical trial can be done only if the receiver or his legal representative was informed in a comprehensive and understandable and that he consented freely and in writing to xenotransplantation and the behavior rules and measures it imposes.
Information must be including: a. the risk of infection by zoonotic agents known or unknown; (b) the need for the recipient to submit to life regular medical examinations; (c) the obligation to inform any new contact person to the risk of infection by zoonotic agents that it incurs, and to report this person without delay to the holder of the authorization; (d) the need to retain the information and biological samples , and on the scope of the data protection; (e) the need to perform an autopsy on the receiver after his death; f. the rules of behavior that the recipient must observe in order to avoid any transmission of infection.



Repealed by no 2 of annex 6 to the O on Sept. 20. 2013 on clinical trials, with effect from Jan 1. 2014 (2013 3407 RO).

Art. 6 information of contact persons before a xenotransplantation, the holder of the authorization ensures that the contact persons are informed in a comprehensive and understandable by the investigator of behavior and rules of what xenotransplantation will impose them. These people confirm in writing that they have been informed.
Contact persons must be informed of the risks that may present: a. contact with the receiver or the care given to the latter; (b) the use of biological samples.

The obligation to notify also applies to any new contact person.

Art. 7 medical examinations the holder of the authorization shall submit regularly the receiver medical examinations.
These medical examinations are carried out: a. at least once immediately before and immediately after the xenotransplantation; b. at regular intervals in the days and weeks following xenotransplantation; c. then, in the ten years following, at least once a year; Thereafter, at least every five years if it has not been, during the last two years of clinical suspicion of an infection due to transplantation.

Appropriate biological samples, especially of serum, plasma and mononuclear leukocytes of peripheral blood, are taken on the receiver at each medical examination and then analysed in order to detect the presence of pathogens or indices suggesting the presence of such agents.
The authorisation holder shall immediately inform the federal Office of public health (FOPH) if the receiver does more submit to medical examinations.

Art. 8 procedure to follow in case of suspected infection if the present receiver for signs of infection or that a contact person introduce inexplicable infection, the holder of the authorization takes all appropriate measures to prevent the spread of these infections.
It immediately conducts diagnostic and epidemiological reviews in-depth until the cause of the infection is clearly identified or that all signs of infection have virtually disappeared.

Art. 9 procedure to be followed at the death of the recipient when the recipient dies, the holder of the authorization:

a. shall immediately notify the FOPH to his death; b. performs reviews microbiological, pathological and histopathological on the recipient's body to detect possible infection; c. shall forthwith forward to the FOPH the results of these reviews.

Art. 10Application of legislation on research on human beings art. 3 to 5, 6, al. 1, 2 and 4, and the art. 7-9, 24-29, 37-41, 43 and 44 Clino as well as the order of organization of the HRA on September 20, 2013 are applicable.
The Swiss Institute for therapeutic products obligations set out in art. 37-41 and 43 Clino, are applicable in relation to the FOPH for clinical trials of xenotransplantation.

New content according to section 2 of Schedule 6 to the O from 20 sept. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).
RS 810.305 RS 810.308 art. 11 repealed by section 2 of Schedule 6 to the O from 20 sept. 2013 on clinical trials, with effect from Jan 1. 2014 (2013 3407 RO).

Art. 12 changes in clinical trial modifications made during the clinical trial requires the permission of the FOPH.
The holder of the authorization shall provide the FOPH documents affected by the change.

New content according to section 2 of Schedule 6 to the O from 20 sept. 2013 on clinical trials, in force since Jan. 1. 2014 (2013 3407 RO).

Section 3 working standards art. 13 conditions of granting the permission to make a xenotransplantation standard treatment is issued if: a. exploitation has a technical official with the knowledge and experience needed, empowered to give instructions in its field of activity and the quality Manager; (b) the person seeking the authorization shows that security conditions are met; c. If there is no other treatment with comparable efficiencies for the recipient.

The authorization to perform a xenotransplantation standard treatment involving the use of organs, tissues or cells of animal origin, genetically modified, or transplant resulting, if, additionally: a. quality and biological safety of organs, tissues or cells of animal origin, genetically modified, or transplants standardized who come from , are guaranteed to the patient and, in general, for human beings, animals and the environment; b. the FOEN has, consideration of protection of the environment and the indirect protection of the human being, given its agreement for the standard treatment.

Art. 14 information and consent of the receiver a xenotransplantation can be made if the receiver or his legal representative was informed in a comprehensive and understandable and that he consented freely and in writing to xenotransplantation and the behavior rules and measures it imposes.

Art. 15 medical examinations during medical examinations took place as a result of xenotransplantation, the holder of the authorization will be charged on the receiver of the appropriate biological samples to detect the presence of pathogens or evidence to suggest the presence such agents.

Art. 16 procedure to be followed at the death of the recipient when the recipient dies, the holder of the authorization performs reviews microbiological, pathological and histopathological on the recipient's body to detect possible infection.

Section 4 duties of care art. 17 use of cell of animal origin lines can be used for xenotransplantation cell of animal origin lines: a. whose provenance is documented; (b) for which it is established, under a procedure adapted to the State of science and technology, they are free of pathogenic organisms for the resource species and for human beings.

The holder of the authorization regularly analyzes the animal cell lines used in order to detect the presence of pathogenic organisms in accordance with para. 1, let. b. art. 18 use of animals resources it is forbidden to use primates as pets resources. Xenotransplantation of cells in primates may exceptionally be permitted if these are from cell lines. This exception does not apply to the apes.
Can be used as animal resources than animals: a. who were raised in captivity for many generations it is possible to ensure, through a procedure adapted to the State of science and technology, that they are free of pathogenic organisms for the resource species and for human beings; b. including the source is documented extensively; c. which are derived from flocks in confined.

The requirements applicable to animal resources and cell lines of animal origin used in the standard treatments are the same as those provided for clinical trials. This includes: a. genetic animal resources properties and cell lines; b. monitoring and health animal status resources as well as the control of cell lines, especially in respect of possible infections by viruses or bacteria; c. livestock and animals resources detention conditions and the conditions of culture and conservation of cell lines.

The holder of the authorization routinely to a review of the State of health of animals resources, including clinical, microbiological and histological analyses; He also performed a pathological examination and histopathological animals after their death.
It can use animals resources, their bodies, their tissues, cells or from transplant to other purposes; He helped eliminate pursuant to art. 13 of the Ordinance of 23 June 2004 on the disposal of animal by-products.

[RO 2004 3079, 2005 4199 annex 3 ch. II 9, 2006 5217 annex c. 6, 2007 2711 ch. II 2, 2008-1189. RO 2011 2699 Annex 8 ch. I.. Currently, see O on May 25, 2011 (RS 916.441.22).

Art. 19 duty to perform analyses the organs, tissues or cells of animal origin, the transplant that arise from, or the animal on which they were taken should be analyzed in accordance with the State of science and technology, through tests available; These analyses will seek to detect the zoonoses or prion diseases that can cause infection in humans.
These tests are designed to detect the presence: a. zoonotic agents known or potential; b. pathogen for humans who are known; c. infectious agents at high-risk of mutation and recombination; d. agents which pathogen risk is still unknown.

The analyses are carried out abroad, should attest to the OFSP that they conform to the State of science and technology.
The FOPH may require that the test results are confirmed by an independent reference laboratory.

Art. 20 ban on xenotransplantation xenotransplantation is prohibited if there is a clue suggesting the presence of a pathogen infection to the human being known or potential.

Art. 21 labelling of organs, tissues, or cells of animal origin genetically engineered organs, tissues or cells that are derived from animals genetically modified or who have suffered after their removal, the transplant resulting from genetic modification and animals genetically modified resources are labeled with the words "genetically modified".

Art. 22 biological samples the holder of the authorization will be charged a sufficient quantity of biological samples for the tests referred to in art. 7 to 9 and 15 to 19.
It must take a quantity of clean to allow the FOPH to perform at least three times a full review of the samples within the time prescribed in art conservation. 24. the samples are prepared so that they can be kept for a long time.

Art. 23 record the holder of the authorization records all the data and all the important processes for the protection of public health, including the results: a. medical examinations referred to in art. 7 and 15; b. the autopsy referred to in art. 9 and 16; c. diagnostic and epidemiological examinations referred to in art. 8; (d) the control of cell lines of animal origin referred to in art. 17; (e) the monitoring of the State of health of animals referred to in art. 18; f. analyses referred to in art. 19 art. 24 conservation approval holder retains all records and biological samples that are important for the protection of public health: a. for an unlimited period, 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.

Records and biological samples: a. are labeled and stored so that we can find and identify them quickly; b. are put at the disposal of the FOPH and the cantonal doctor when they demand.

Art. 25 information of the competent authorities if the holder of the authorization a fact which could be of importance for the protection of public health, it is required:

a. to inform immediately the FOPH and the competent cantonal physician; b. to take immediately all necessary measures.

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

Section 5 liability art. 26. anyone who practice a xenotransplantation or calls to other organs, tissues or cells to a xenotransplantation should ensure coverage of damage which he responds to the tune of 20 million francs.
The obligation to provide guarantees can be completed by the conclusion of a civil liability insurance contract or collateral for an equivalent amount. The liability insurance contract is concluded with a licensed insurance company in this field of activity.
The Confederation and its corporations and institutions under public law are not subject to the obligation to provide guarantees.
The person who covers the civil liability shall inform the FOPH the dates on which the guarantee takes effect and ends, as well as any suspension.

Section 6 Protection of data art. 27. the processing of personal data and data security are governed by arts. 48 and 49 of the order of 16 March 2007 on the transplant.

RS 810.211 Section 7 authorisation art. 28 application the application for authorisation referred to in art. 3 and 13 should be directed to the FOPH.
The application for authorisation of a clinical trial of xenotransplantation (art. 3) must include: a. detailed elementary scientific documentation; b. a study material in accordance with Schedule 2 and the documents referred to in art. 29 order of 16 March 2007 on the transplant; c. a document attesting that the records and biological samples can be kept in accordance with art. 24. the application for authorization of a xenotransplantation standard treatment (art. 13) must understand: a. scientific documentation detailing including the results of pre-clinical tests and of clinical trials; b. documents and forms reporting on the information given to the receiver or his legal representative and the consent of one or the other; c. a document attesting that the records and biological samples can be kept in accordance with art. 24 if organs, tissues or cells of animal origin genetically modified, or transplant who emerged, are used to a xenotransplantation, the application for authorization must also include: a. data on risks to humans, animals and the environment; These data should also include the results of the risk assessment made pursuant to the order of 25 August 1999 on the use of confined or conducted as part of a foreign procedure for the use of organizations in confined; b. assessment risks associated with xenotransplantation to humans, animals and the environment; c. a description of the security measures necessary to protect human being , animals and the environment, particularly to avoid dissemination of microorganisms in the environment during and after xenotransplantation, as well as during transport, storage and disposal; d. a document attesting to the respect for the integrity of the animals come from organs, tissues and cells genetically modified, according to the art. 8 and 9 of the Act of 21 March 2003 on genetic engineering.

RS 810.211 [RO 1999 2783, 2003 4793 c. I 3, 2006 4705 ch. II 82, 2007 4477 ch. IV 35, 2008 4377 annex 5 ch. 6] RO 2012 2777 art. 33 CH 1]. See now the O of 9 may 2012 (SR 814.912).
RS 814.91 art. 29 the FOPH consultation procedure shall decide on applications for authorization of xenotransplantation involving the use of organs, tissues or cells of animal origin genetically modified, or transplant who emerged, after taking the opinion of the FOEN, of the Federal Commission of experts for biosafety (SECB) and the Federal Commission of ethics for biotechnology in the non-human field (ECNH).
If the application concerns a xenotransplantation to the senses of the art. 2, al. 1, let. a, point 3, the FOPH also asked the opinion of the Swiss Institute for therapeutic products.
It shall forward its decision to the FOEN, the SECB and ECNH; When the decision concerns an application for clinical trial authorisation, it passes the Commission Ethics Committee and, when it concerns an application referred to in para. 2, also at the Swiss Institute for therapeutic products.

Art. 30 inspection the FOPH is conducting an inspection to determine whether the conditions for approval are met.
He may, at any time, carry out additional inspections. It can load the cantons or third parties to carry out inspections.

Art. 31 assessment, validity, suspension, withdrawal and publication of the permissions the scientific assessment of applications, as well as the scope, the duration of validity, suspension, withdrawal and the publication of permissions are governed by arts. 38 and 41 to 43 of the order of 16 March 2007 on the transplant.

SR 810.211 art. 32 technical requirements the federal Department of the Interior may issue technical requirements to the authorisation system and records; It takes into account for this purpose the relevant international standards.

Section 8 provisions final art. 33 update of the annexes the federal Department of the Interior can update the annexes to adapt to international developments or to technical progress. He proceeds to the updates which may constitute technical barriers to trade in accordance with the federal Department of the economy, training and research.

The name of the administrative unit has been adapted to 1 Jan. 2013 in application of art. 16 al. 3 o from 17 nov. 2004 on official publications (RS 170.512.1).

Art. 34 entry into force this order comes into force on July 1, 2007.

Annex 1 (art. 11) Directives of good clinical practices guidelines good clinical practices of the International Conference on harmonization (ICH Guidelines), in their version of June 10, 1996.

The text of these guidelines can be ordered against payment or accessed for free from the federal Office of public health, division of biomedicine, 3003 Bern; It can also be downloaded on the Internet www.bag.admin.ch/transplantation/.

State on January 1, 2014, annex 2 (art. 28, al. 2, let. b) Documentation of study 1 protocol the Protocol should state: 1.1 the purpose of the clinical trial; 1.2 the transplant, including guidance on immunosuppression pre - and postoperative procedure; 1.3 the procedure of transportation of the animal resource as well as organs, tissues or cells, or transplant resulting; 1.4 details of recipients including: a. the number planned to recipients; b. the criteria for inclusion and exclusion leading to their selection; c. the information of recipients and their consent solicitation procedure;

1.5 all documents for information and the consent of the recipient; 1.6 protocol hygiene measures, including guidance on training for specific groups of people; 1.7 Protocol monitoring of infections, methods, security measures and the reporting system for post-transplantatoires infections found, including: a. the recipient; b. contact persons; c. people in relation to animal resources; d. exposed individuals unexpectedly at a higher risk, e.g. by contact with blood as a result of an accident;

1.8 the Protocol collection and conservation of biological samples and data, with details of their treatment and rights of access; 1.9 details of funding for the clinical trial, including the long-term monitoring and conservation of data and biological samples; 1.10 the name of all the people participating in the project with an indication of the activities responsibilities, qualifications and experience of each of them; 1.11 the indication of the different places and premises where are conducted clinical trials with the indication of the person responsible for each of them.

2 specifications of observation of an empty notebook model must be attached.

3 documentation of the resource, organs, tissues, or cells of animal origin animal or cell line of animal origin documentation should include: 3.1 details of animal resources, including: a. origin; (b) their breeding conditions, including details of their cottage, the care given them, their food and their vaccinations; c. their genetic features as well as the description of their genetic modification; d. the Protocol of monitoring their State of health;


3.2 identification of pathogens of the species resource, as well as measures to exclude their transmission to man; 3.3 the pathogen of the animal status indication resource at the time of the bodies, of tissues or cells as well as the indication of genetic modification and characterization of tissues or cells that need to be transplanted; 3.4 as appropriate, detailed information on the cell line used including: a. its origin (including detailed information on the resource species), the laboratory of origin and place of origin; b. the laboratory of origin and place of origin if they are known; c. code ATCC (American Type Culture Collection) if available; d. designation and its accurate characterization; e. genetic features as well as the description of the genetic modification and biological safety of the animal resource of origin or cell line; f. indications on reviews as well as on the results of the latter; g. the indication of known or potential viruses and other pathogens potential of the cell line, as well as of the measures planned to exclude their transmission to man.

4 journal of animal resource health the health of the animal resource log should indicate: 4.1 records on the health of the animal resource and results of tests performed on him, including drug treatments; 4.2 on request: records on the health of the herd and the results of the tests carried out on the latter.

As long as they are available in advance; the other indications are provided later.
Information on final exams that lead to the approval of transplantation are provided later if they are not available at the time of the request.
Information on final exams that lead to the approval of transplantation are provided later if they are not available at the time of the request.

State on January 1, 2014

Related Laws